Sex: F
Vaccine: COVID19
Symptoms: Erythema, Swelling, Vaccination site pain, Vaccination site rash
Clinical narrative: Pretty bad severe rash on the injection site; Redness; Swelling; Pain at the injection site; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from medical information team.  A 72-year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE: 1, Unknown manufacturer), for COVID-19 Immunization, reaction(s): "Redness", "Pain at the injection site", "Swelling". The following information was reported: VACCINATION SITE RASH (non-serious), outcome "unknown", described as "Pretty bad severe rash on the injection site"; ERYTHEMA (non-serious), outcome "unknown", described as "Redness"; SWELLING (non-serious), outcome "unknown", described as "Swelling"; VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "Pain at the injection site".  Additional information: Question: Caller wanted to know if there had been reported cases of a bone marrow transplant patient who experienced a 2 weeks delayed reaction (severe rash on the injection site that had spread) after the getting the 2nd dose of the Pfizer BioNTech Covid-19 Vaccine. DSU: Caller stated that a safety report was previously sent regarding the patient's case. The patient experienced a 2 weeks delayed reaction after the administration of the 2nd dose of Pfizer BioNTech Covid-19 Vaccine. Caller described the reaction as a "pretty bad severe rash on the injection site that started to spread on the patient's body". Caller also stated that there is no evidence of dress syndrome or serum sickness. Caller also stated that the 2nd dose was taken 30 days after the 1st dose. Age: 72 Years Old. Gender: Female. E-transmitting potential AE duplicate to DSU. Response: Advised caller that per Journal, there is no information on AEs being reported and data is more on the efficacy of the Pfizer BioNTech Covid-19 Vaccine for solid organ transplant recipients. Also spoke from Manufacturer: In participants 56 years of age and older after receiving Dose 2, the mean duration of pain at the injection site was 2.4 days (range 1 to 36 days), for redness 3.0 days (range 1 to 34 days), and for swelling 2.6 days (range 1 to 34 days) for participants in the COMIRNATY group. Table 3: Study 2 - Frequency and Percentages of Participants with Solicited Local Reactions, by Maximum Severity, Within 7 Days After Each Dose - Participants 56 Years of Age and Older- Reactogenicity Subset of the Safety Population Redness - Dose 1:Severe5 (0.2) / Dose 2: 10 (0.5) Swelling -Dose 1:Severe2 (0.1) / Dose 2: 4 (0.2) Pain at the injection site - Dose 1:Severe4 (0.2) / Dose 2: 10 (0.5) 6.2 Postmarketing Experience The following adverse reactions have been identified during postmarketing use of COMIRNATY, including under Emergency Use Authorization. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to vaccine exposure. Immune System Disorders: severe allergic reactions, including anaphylaxis, and other hypersensitivity reactions (e.g., rash, pruritus, urticaria, angioedema) Advised caller that there is no information on severe rash on Serious and Severe Adverse Events (v11.0).   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.