Sex: U
Vaccine: COVID19
Symptoms: Vaccination site reaction
Clinical narrative: myocarditis; local injection-site reactions; inability to work or attend school; headache; fatigue; pain; This is a literature report, Program ID: for the following literature source(s): "Safety Monitoring of COVID-19 mRNA Vaccine First Booster Doses Among Persons Aged 12 Years with Presumed Immunocompromise Status January 12, 2022March 28, 2022", MMWR-Morb-Mortal-Wkly-Rep, 2022. A patient (no qualifiers provided) received BNT162b2 (COMIRNATY), in 2022 as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (dose 3), for COVID-19 immunisation, reaction(s): "inability to work or attend school", "local injection-site reactions"; Covid-19 vaccine (dose 2), for COVID-19 immunisation; Covid-19 vaccine (dose 1), for COVID-19 immunisation. The following information was reported: MYOCARDITIS (medically significant), outcome "unknown"; VACCINATION SITE REACTION (non-serious), outcome "unknown", described as "local injection-site reactions"; LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (non-serious), outcome "unknown", described as "inability to work or attend school"; HEADACHE (non-serious), outcome "unknown"; FATIGUE (non-serious), outcome "unknown"; PAIN (non-serious), outcome "unknown". Clinical information: Safety findings for COVID-19 mRNA vaccine first booster doses among persons with presumed immunocompromise status are similar to those among non-immunocompromised persons. This is the one of the findings of a study published by the Centers for Disease Control and Prevention (CDC) in their Morbidity and Mortality Weekly Report of 15 July 2022. The study years with presumed immunocompromise status. The study reviewed adverse events and health impact assessments reported during the period from 12 January to 28 March 2022 to US safety surveillance systems (v-safe and the Vaccine Adverse Event Reporting System [VAERS]) during the week after receipt of an mRNA COVID-19 vaccine (mRNA-1273 [Moderna] or BNT162b2 [Pfizer-BioNTech]). The analysis of data from 4015 v-safe reports showed that local injection-site reactions were less frequently reported after COVID-19 mRNA vaccine first booster doses (dose 4 for immunocompromised persons) than after dose 3 of the primary series (70.1% vs 81.7%). Similarly, systemic reactions were also less frequently reported after dose 4 than after dose 3 (65.4% vs 76.8%). Furthermore, inability to work or attend school was less frequently reported after dose 4 than after dose 3 (9.2% vs 13.8%). The review of 145 VAERS reports showed that most events were non-serious (88.3%). The non-serious events included headache (23.4%), fatigue (20.3%) and pain (17.2%). A report of myocarditis remains under review. Serious reports to VAERS were rare (17 [11.7%]) and included a range of adverse events. "It is important that health care providers, immunocompromised persons, and parents of immunocompromised children be advised that local and systemic reactions are expected after a booster dose, and that serious adverse events are rare," conclude the researchers. Sender's Comments: Based on the current available limited information in the case provided, the causal association between the events and the use of suspect product BNT162B2 cannot be fully excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.