BCG Induced Cold Abscess as a Complication of Inadvertent Vaccine Injection, a Case Series

We report a four-month-old girl with a right thigh swelling, an eight-month-old girl with a left thigh swelling, and a five-month-old boy with a left thigh swelling with the final diagnosis of BCG-induced cold abscess as a result of erroneous injection of BCG vaccine into the infants’ thigh muscle.

Elapsed time since BNT162b2 vaccine and risk of SARS-CoV-2 infection: test negative design study

Objectives To determine whether time elapsed since the second injection of the Pfizer-BioNTech BNT162b2 mRNA vaccine was significantly associated with the risk of covid-19 infection after vaccination in people who received two vaccine injections. Design Test negative design study. Setting Electronic health records of a large state mandated healthcare organisation, Israel. Participants Adults aged ≥18 years who had received a reverse transcription polymerase chain reaction (RT-PCR) test between 15 May 2021 and 17 September 2021, at least three weeks after their second vaccine injection, had not received a third vaccine injection, and had no history of covid-19 infection. Main outcome measures Positive result for the RT-PCR test. Individuals who tested positive for SARS-CoV-2 and controls were matched for week of testing, age category, and demographic group (ultra-orthodox Jews, individuals of Arab ancestry, and the general population). Conditional logistic regression was adjusted for age, sex, socioeconomic status, and comorbid conditions. Results 83 057 adults received an RT-PCR test for SARS-CoV-2 during the study period and 9.6% had a positive result. Time elapsed since the vaccine injection was significantly longer in individuals who tested positive (P<0.001). Adjusted odds ratio for infection at time intervals >90 days since vaccination were significantly increased compared with the reference of <90 days: 2.37 (95% confidence interval 1.67 to 3.36) for 90-119 days, 2.66 (1.94 to 3.66) for 120-149 days, 2.82 (2.07 to 3.84) for 150-179 days, and 2.82 (2.07 to 3.85) for ≥180 days (P<0.001 for each 30 day interval). Conclusions In this large population of adults tested for SARS-CoV-2 by RT-PCR after two doses of mRNA BNT162b2 vaccine, a gradual increase in the risk of infection was seen for individuals who received their second vaccine dose after at least 90 days.

Good Practices of Comirnaty® Vaccine Injection Using Uncrimped Materials

Background In 2020, the first mRNA COVID vaccine was approved by the with six doses from single vial. In the context of material shortages, the aim of the study was to compare different protocols to extract doses using uncrimped materials with good trueness and reproducibility. Methods To optimize the extraction of the sixth dose from a single vial with uncrimped materials, alternative protocols of preparation were tested, derived from the drug information. Results The repeatability of injected volume was acceptable for all protocols (CV<5.3%). To prepare six 0.3mL doses using uncrimped materials, protocols with an air bubble were evaluated to offset the high dead volume inherent to uncrimped materials. Regarding the limited doses observed using long intramuscular needle (92.8% of the reference dose), the air bubble protocol with a liquid volume adjustment at 0.27mL was finally validated to respect the administration of full doses. Conclusion Results highlighted the necessity to adapt the drug information protocol for the preparation and administration of Cominarty®, due to the use of high dead volume materials. Despite the good reproducibility and accuracy of the air bubble protocols, some precautions have therefore to be taken to maintain the integrity of the vaccine suspension for efficient administration.

335. Staphylococcus aureus Bacteremia as a Potential and Severe Complication from Intramuscular COVID-19 Vaccine Injection

Background Abscess formation and bacteremia following intramuscular injections are rare complications from vaccine injections, and they are most commonly seen in immunocompromised individuals. Staphylococcus aureus is one of the etiological agents that can be found during this complication. Spain started to vaccine its population at the beginning of 2021. We noticed an important increase in Staphylococcus aureus infections and bacteremia during this period of time, leading us to study the relationship with previous vaccination. Methods In this case series we present a cohort of twenty patients with Staphylococcus aureus bacteremia (SAB) during the study period (January 1, 2021 through May 31, 2021), attended in our Institution (Hospital Nuestra Señora de Sonsoles, Ávila, Spain). We tried to establish or at least create the debate of a possible relationship with a previous COVID-19 vaccine. Results From January 1, 2021 through May 31, 2021, 20 SAB were identified in our Institution. 13/20 patients were vaccinated (all of them with the mRNA vaccine type). 5/13 (38%) were male and 8/13 (62%) female. 10 of them (77%) received at least one dose of the vaccine before hospital admission, and 3 of them (23%) after admission. From the 10 previously COVID-19-vaccinated patients treated for SAB (CVPSAB), 4 died - 40% (2 deaths directly related to the SAB). Conclusion Although SAB may be a rare side effect after intramuscular injections or vaccines, it always implies an outstanding risk due to potential complications. Even if our study is not able to directly establish a link between SAB and previous vaccination, it implies a possible association between the vaccine injection and a threating disease (SAB). We should be aware of this probable relationship, so that we can maximize preventive measures. Disclosures All Authors: No reported disclosures

Herpes zoster following mRNA-1273 COVID-19 vaccination

Sir, Skin rashes have been associated with COVID-19 and studies suggest the inclusion of skin diseases in the list of COVID-19 symptoms. Skin eruptions are also associated with the mRNA-1273 COVID-19 vaccine. Findings by Baden et al. [1] describe immediate injection-site reactions observed in 84.2% of participants after the first dose, with delayed onset reactions—on or after day eight—occurring much more infrequently, 0.8% after the first dose and 0.2% after the second dose. Blumenthal et al. [2] discuss twelve cases of delayed vaccine reactions, with all patients experiencing reactions in the vaccination site. Herein, we describe two cases of herpes zoster within days of receiving their first mRNA-1273 vaccine. Both cases presented to the same dermatology clinic. A 77-year-old male presented with a bumpy, itchy, red rash on the upper right arm and axilla three days following an mRNA-1273 vaccine injection. The symptoms continued to worsen and the patient was clinically diagnosed with herpes zoster and treated with valacyclovir (Fig. 1). Another patient, also a 77-year-old male, complained of a rash located on the right upper arm and axilla. It was a red, itchy, bumpy rash that the patient developed two days after an mRNA-1273 vaccine injection (Fig. 2). Both rashes demonstrated a similar distribution pattern and both patients responded well to valacyclovir with the resolution of the erythema; however, one patient did have residual post-herpetic neuralgia.

The Day after Mass COVID-19 Vaccination: Higher Hypermetabolic Lymphadenopathy Detection on PET/CT and Impact on Oncologic Patients Management

The widespread COVID-19 vaccination led to unexpected PET findings. Notably, axillary and interpectoral lymphadenopathies ipsilateral to the vaccine inoculation were observed. We aimed to assess the hypermetabolic lymphadenopathy (HLN) detection rate on PET/CT. Secondly, we investigated factors that might help in HLN differential diagnosis. A retrospective analysis on 1196 consecutive patients referred for a PET/CT was performed. All patients were asked about the date, type and site of vaccine injections. HLNs were recorded and categorized according to risk classes and SUVmax grades. A statistical analysis was performed to assess the correlation between HLN detection and different clinical/vaccine data. HLN detection rate was 15% and 27% in the No Vac- and vac-groups (p < 0.001), respectively. In the Vac-group, age (p < 0.001) and time interval from vaccine-to-PET (p = 0.010) were inversely correlated with HLN detection. Furthermore, SUVmax significantly changed during time intervals, with lower values beyond 20 days (p < 0.001). In the era of mass COVID-19 vaccination, a higher axillary and interpectoral lymphadenopathies detection ipsilateral to vaccine injection was observed. These PET findings can be wrongly interpreted, complicating cancer patients’ management. To minimize these pitfalls, a detailed vaccination anamnesis must be recorded and should take into account the appropriate PET schedule.