Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Illness, SARS-CoV-2 test
Clinical narrative: He got pretty sick with fourth dose; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 55-year-old male patient received BNT162b2 (BNT162B2), on 06Jan2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 54 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Rheumatoid arthritis" (unspecified if ongoing); "hypothyroid" (unspecified if ongoing), notes: hypothyroid; "Anxiety" (unspecified if ongoing); "sleep" (unspecified if ongoing), notes: sleep. Concomitant medication(s) included: ENBREL taken for rheumatoid arthritis, start date: 17Oct2020; LEVOTHYROXINE taken for hypothyroidism; CLONAZEPAM taken for anxiety, start date: 10Jan2020; TETRAHYDROCANNABINOLS NOS taken for sleep disorder, stop date: 28Jun2022. Vaccination history included: BNT162b2 (First dose, BATCH: EN-6198, given in right arm, NDC: unknown, EXP: unknown), administration date: 25Feb2021, when the patient was 54-year-old, for Covid-19 immunization; BNT162b2 (Second dose: , LOT: EP-7534, given in left arm, NDC: unknown, EXP: unknown), administration date: 18Mar2021, when the patient was 54-year-old, for Covid-19 immunization; BNT162b2 (Third dose, LOT: FO181. It is hard to tell if it is FO181 or F0181 , Given in right arm, NDC: unknown, EXP: unknown), administration date: 17Aug2021, when the patient was 54-year-old, for Covid-19 immunization. The following information was reported: ILLNESS (non-serious) with onset 2022, outcome "unknown", described as "He got pretty sick with fourth dose". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Warm transfer from withheld with Pfizer Medical Information. Consumer on the line reporting possible Covid rebound with Paxlovid. He finished Paxlovid 08Jul2022 and tested negative with PCR on 08Jul2022. He took antigen testing 09Jul2022 and 11Jul2022 and was negative. On 12Jul2022, he got symptoms and tested positive on two separate testing. He called because he was not able to submit AE report on line. Enbrel: his doctor had him not take his last dose. Clarified his rheumatologist said to skip last dose of Enbrel due to Covid. Enbrel is a shot. NDC: 58406-032-01, LOT: 1143674, EXP: Jul2024. Caller states he coughs when he goes up stairs. Occasionally he takes 5mg of THC Cannabis for sleep, but he has not since being in withheld. Caller clarified that his last dose of THC Cannabis would have been 28Jun2022. Investigations: antigen test was positive on 12Jul2022. Caller went and got PCR on 12Jul2022 but doesn't have the results back form that yet. He has had five Pfizer Covid Vaccines. It is scary he remembers it all. First dose: given on 25Feb2021, given in right arm, NDC: unknown, EXP: unknown. Second dose: given on 18Mar2021, LOT: EP-7534, given in left arm, NDC: unknown, EXP: unknown. Third dose: given on 17Aug2021, LOT: FO181. It is hard to tell if it is FO181 or F0181 because it is handwritten on the card. He would say based on the pattern it would be FO181. Given in right arm. NDC: unknown, EXP: unknown. He got pretty sick with fourth dose. NDC: unknown. EXP: unknown. Fifth dose: given on 02Jun2022, LOT: FM7553, given in right arm, NDC: unknown, EXP: unknown. Patient's Medical History: Rheumatoid Arthritis, Hypothyroid, Anxiety. Family Medical History: not provided. Relevant Tests: antigen test was positive on 12Jul2022. Caller went and got PCR on 12Jul2022 but doesn't have the results back form that yet. Because of Enbrel he hasn't felt this good since he was 20. It is an amazing drug. He is getting off the anxiety drug, Clonazepam. He had a bad thing happen in his life and that is why he is on Clonazepam, but he is tapering off. Other than having Covid he is doing well. He tried to go cold turkey off of Clonazepam and that was a bad choice. Clonazepam is in pharmacy bottle and caller unable to provide NDC/LOT/EXP.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.