Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Illness, Skin infection
Clinical narrative: He received the 1st and 2nd booster shots and ended up with a pretty severe skin infection and had to be hospitalized for treatment after injections; then got very sick again and ended up in hospital for another 3 or 4 days; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID.  A 71-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 04Sep2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 71 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Husband has an autoimmune disease" (ongoing), notes: Husband has an autoimmune disease; "Still's disease adult onset" (unspecified if ongoing), notes: Still's disease adult onset. The patient took concomitant medications. Vaccination history included: pfizer coviD-19 vaccine (DOSE 1, SINGLE, unknown dose; Right upper arm), administration date: 05Mar2021, when the patient was 71-year-old, for COVID-19 Immunization; pfizer coviD-19 vaccine (DOSE 2, SINGLE), administration date: 26Mar2021, when the patient was 71-year-old, for COVID-19 Immunization. The following information was reported: SKIN INFECTION (hospitalization, medically significant) with onset 05Sep2021, outcome "unknown", described as "He received the 1st and 2nd booster shots and ended up with a pretty severe skin infection and had to be hospitalized for treatment after injections"; ILLNESS (hospitalization) with onset 05Sep2021, outcome "unknown", described as "then got very sick again and ended up in hospital for another 3 or 4 days". Therapeutic measures were taken as a result of skin infection, illness.  Clinical information: Reporter was patient spouse, and she was reported that the first skin infection after First booster dose. Her husband had the skin infection within 24 hours of the first booster dose. 3 to 4 days husband was in the hospital and reason was needed for care and got so sick. The hospital had to use intravenous antibiotics to take care of the infection. her husband suffered a skin infection that escalated into severe problems needing hospitalization. Her husband did have an autoimmune disease that makes him vulnerable to infection. She stated her husband suffers from extreme infections and was highly susceptible with his Autoimmune disease and there had been other injections that might be caused infections as well. She was not saying the booster doses that caused this event because her husband does suffer from those infections frequently. This booster dose was the Pfizer BioNTech COVID-19 Vaccine. She was not certain if her husband recovered completely but did come home and then got very sick again and ended up in hospital for another 3 or 4 days. She did not know if medical personnel thought from first time was reason for his second hospitalization. She stated one thing about; did not have adverse event with flu vaccines and has had those. for the stills disease her husband had a variety of drug therapies and at least one recall skin infection with injection and possible with compromised immune system at least once. his situation has been going on for 10 years, worst drug ever took was advertised a lot. begins with H terrible for him but helps some people. Her husband has an extensive list of medications and did not think she was at liberty to provide that information. Dose/Dosage Form: Gray cap, Original/Omicron BA.4/BA.5 (Bivalent), greater than or equal to 12 years - 15/15 mcg per dos Question: Caller requests information for alternate treatment options to protect patients from COVID-19 when they cannot tolerate the Pfizer-BioNTech COVID-19 vaccine, Bivalent (Original and Omicron BA.4/BA.5) booster dose for 12 years of age and older.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.