Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Insomnia, Pain, Pruritus, Skin disorder
Clinical narrative: Experiencing itching on the back and belly, and bumps all over the body; Experiencing itching on the back and belly, and bumps all over the body; caller can't sleep; it's a pain; This is a spontaneous report received from contactable reporter(s) (Nurse), Program ID. The reporter is the patient.  A 68-year-old male patient received BNT162b2 (BNT162B2), on 12Mar2021 as dose 1, single (Lot number: EN6198, Expiration Date: Jun2021) at the age of 68 years, in left deltoid for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Flu shots (never had this with flu shots but with the COVID-19 vaccine he has.), for Immunization. The following information was reported: SKIN DISORDER (medically significant), PRURITUS (medically significant) all with onset 14Mar2021, outcome "not recovered" and all described as "Experiencing itching on the back and belly, and bumps all over the body"; INSOMNIA (non-serious) with onset 14Mar2021, outcome "unknown", described as "caller can't sleep"; PAIN (non-serious) with onset 14Mar2021, outcome "unknown", described as "it's a pain". Clinical course: Caller said he received the 1st, 2nd, and 3rd doses of the Pfizer COVID-19 vaccine and is experiencing itching on the back and belly, and bumps all over the body. Caller has been a Registered Nurse for 34 years, was an operating nurse but retired in 2020. Caller is sure that he and his wife aren't the only two people experiencing this. Caller's wife is a Registered Nurse as well, retired also. Caller's first injection was 12Mar2021, injected first time in left arm, caller's whole arm, from elbow to shoulder, developed bumps and itching and then caller's flank, half of caller's abdomen, and half of caller's back developed the bumps and itching also. Patient age: 69 years old now, so minus 2 years from now, caller would have been 67 years old. Experiencing itching on the back and belly, and bumps all over the body: Start date of adverse event: Probably 2 days later after receiving the 1st dose, so 14Mar2021. The bumps are even in caller's scalp, went to a haircut place and asked hairdresser if hairdresser has ever seen bumps like that. Hairdresser asked if caller got the Pfizer COVID-19 vaccine and caller said yes. Hairdresser said a lot of her customers that had been vaccinated are complaining about the bumps on their scalp. Hairdresser looks through people's hair and has had complaints before about it from customers. Caller does not have any additional information to provide for those people. Serious because it is annoying because caller can't sleep, keeps itching, and itching, and itching, it's a pain. Guesses it is medically significant.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the information provided and temporal association, a causal relationship between BNT162B2  and the reported events pruritus, skin disorder cannot be 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 RAs, Ethics Committees, and Investigators, as appropriate.