Age: 60.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Lethargy
Clinical narrative: fall; wrist injury; Lethargic; headache; clammy; hot and cold onset; This is a solicited report based on information received by Pfizer from Company (Mfr. Control No.: 21K-163-4075186-00). A contactable consumer (patient) reported that a 60-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 intramuscular at age of 60 years old on 03Feb2021 (Batch/Lot number was not reported) as dose 2, single for covid-19 immunisation; adalimumab (HUMIRA, strength: 40mg/0.4 ml), subcutaneous from an unspecified date (Batch/Lot number was not reported) to an unspecified date, at unknown dose weekly (1 in 1 wk) for moderate to severe rheumatoid arthritis and unspecified medications. The patient medical history and concomitant medications were not reported. Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 intramuscular on 13Jan2021 at age of 60 years for Covid-19 immunization and had no issues. The patient experienced fall, wrist injury (medically significant), headache (medically significant) on 2021, clammy (medically significant) on 2021 , hot and cold onset (medically significant) on 2021, vaccination adverse reaction (medically significant) on 2021, lethargic.  Solicited report by a consumer of a 60 year old female with events of wrist injury after a fall and non-serious felt lethargic from the medications, covid 19 vaccine reaction/after second dose of Covid 19 vaccine felt out of it with headache, clammy, hot and cold and wrist injury after a fall with humira (adalimumab). On unknown dates, the patient experienced wrist injury after a fall and felt lethargic from the medications. In 2021, the patient experienced covid 19 vaccine reaction/after second dose of covid 19 vaccine felt out of it with headache, clammy, hot and cold. In 2021, the covid 19 vaccine reaction/after second dose of covid 19 vaccine felt out of it with headache, clammy, hot and cold resolved. Pfizer biontech covid-19 vaccine (tozinameran) was also considered suspect. The patient had a wrist surgery to correct an injury after a fall. She had been recovering from wrist surgery. She felt lethargic from the medications she took. Unknown medications also considered as co suspect. She reported that after her second dose of the Covid 19 vaccine, she felt out of it with headache, clammy, hot and cold, etc. She had no issues after the first dose and the booster. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. On 13Jan 2021, she received 1st dose COVID-19 Vaccine manufactured by Pfizer. On 03Feb 2021, she received 2nd dose COVID-19 Vaccine manufactured by Pfizer. In 2021, she received booster dose COVID-19 Vaccine manufactured by Pfizer.  Causality for HUMIRA(ADALIMUMAB). The reporter's causality for the event(s) of wrist injury after a fall unknown onset, covid 19 vaccine reaction/after second dose of covid 19 vaccine felt out of it with headache, clammy, hot and cold onset in 2021, covid 19 vaccine reaction/after second dose of covid 19 vaccine felt out of it with headache, clammy, hot and cold onset in 2021, covid 19 vaccine reaction/after second dose of covid 19 vaccine felt out of it with headache, clammy, hot and cold onset in 2021, wrist injury after a fall unknown onset and covid 19 vaccine reaction/after second dose of covid 19 vaccine felt out of it with headache, clammy, hot and cold onset in 2021 was not provided. The reporter's causality for the event(s) of felt lethargic from the medications with humira(adalimumab) was a reasonable possibility. Company's opinion is that there is no reasonable possibility that the events of wrist injury after a fall unknown onset, covid 19 vaccine reaction/after second dose of covid 19 vaccine felt out of it with headache, clammy, hot and cold onset in 2021, covid 19 vaccine reaction/after second dose of covid 19 vaccine felt out of it with headache, clammy, hot and cold onset in 2021, covid 19 vaccine reaction/after second dose of covid 19 vaccine felt out of it with headache, clammy, hot and cold onset in 2021, wrist injury after a fall unknown onset and covid 19 vaccine reaction/after second dose of covid 19 vaccine felt out of it with headache, clammy, hot and cold onset in 2021 are related to humira(adalimumab). Company's opinion is that the event of felt lethargic from the medications is not assessable. The action taken in response to the events for adalimumab was unknown. The outcome of event headache, clammy, hot and cold onset was recovered in 2021, lethargic was not recovered, other events was unknown.  The reporter's assessment of the causal relationship of the events with the BNT162B2 was not provided at the time of this report. Since no determination has been received, the case is managed based the company causality assessment.  No follow-up attempts are possible, information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events fall,wrist injury,headache,cold sweat,feeling of body temperature change and lethargy cannot be totally excluded.The impact of this report 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.