Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Cough, Pain in extremity, SARS-CoV-2 test positive
Clinical narrative: COVID-19 vaccine: arm pain/his arm was sore; Cough; postponed getting the second dose of the COVID-19 vaccine until 90 days after getting the infusion; postponed getting the second dose of the COVID-19 vaccine until 90 days after getting the infusion; COVID-19 molecular test: positive/COVID-19 PCR test: positive; COVID-19 molecular test: positive/COVID-19 PCR test: positive; This is a spontaneous report from a contactable physician (patient). A 68-year-old male patient received first dose of bnt162b2 (Batch/lot number: EL1284), via an unspecified route of administration in left arm on 31Dec2020 at single dose for covid-19 immunization. Medical history included ongoing hyperlipidaemia (this was diagnosed about 10 years ago), nasal spray, borderline thyroid, coronary artery disease (very mild, it was diagnosed a couple years ago) all from an unknown date and unknown if ongoing. Concomitant medication included montelukast, levothyroxine sodium (SYNTHROID) at 75mcg for his borderline thyroid, levothyroxine. The patient experienced covid-19 molecular test: positive/covid-19 PCR test: positive on 06Jan2021, covid-19 vaccine: arm pain/his arm was sore, cough on an unspecified date. The events were reported as non-serious. Caller said he got the first dose of the COVID-19 vaccine on 31Dec2020 on New Years Eve, and then on 06Jan2021 came down with COVID, then subsequently got the Eli Lilly monoclonal antibodies infusion and has postponed getting the second dose of the COVID-19 vaccine until 90 days after getting the infusion, which means second dose will be 08Apr2021. He said since he is 68 he qualified to get the infusion on Jan 8th. He said that the monoclonal antibodies infusion they recommend you didn't get the second vaccine dose until 90 days after receiving the antibodies. He got the vaccine through work, but he thinks that the (Vaccination Facility Name) provided it, they were 1B at the time for physicians to get it, so it was given through hospital employee health department. On 06Jan2021 he had two positive tests, a rapid and a send out, rapid was a molecular COVID test and the send out was a PCR, he was pretty sure both were positive. He said it was on 08Jan2021 he got the infusion of the Eli Lilly monoclonal antibodies. when he had COVID, he had no fevers, he had a cough just like a cold, and the only reaction he had from getting the vaccine was his arm was sore, he did no treatment for either of these. Eli Lilly monoclonal antibodies infusion: He said that it says it is a BAM LAM IV IMAB infusion, and it was infused over an hour on Jan 8th. Caller says he has had no new medications or recent vaccinations, he had the flu shot in Aug or Sep. The event was not required the initiation of new medication or other treatment or procedure. He hasn't had repeat tests, it has been 10 days from diagnosis and his symptoms have resolved. He also has got allergic rhinitis, so he takes three nasal sprays and Montelukast, medication came in an orange pharmacy. He took generic levothyroxine sodium (SYNTHROID) 75mcg for his borderline thyroid. He took Levothyroxine 88mcg, they upped it. Levothyroxine NDC: 65862-57490, LOT: 57420095A1, EXP: Jul2023. Not any pre-existing diseases worsened during the SARS-CoV2 infection. The patient hadn't been treated with immunomodulating or immunosuppressing medications or received any other vaccines around the time of COVID-19 vaccination. The patient underwent lab tests and procedures which included COVID-19 PCR test: positive on 06Jan2021, COVID-19 molecular test: positive on 06Jan2021. The outcome of events for covid-19 molecular test: positive/covid-19 PCR test: positive was resolved in Jan2021, for other events was unknown.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported events of COVID-19,  suspected LOE and other events  due to temporal relationship.   There is limited information provided in this report.  This case will be reassessed once additional information is available.  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.