Age: 86.0
Sex: M
Vaccine: COVID19, FLUX
Symptoms: Abdominal pain, Cholelithiasis, Computerised tomogram, Cough, Eating disorder
Clinical narrative: Cough; Muscle Ache; Sleep a lot; Flu like symptoms; Did not want to eat; nausea; midline abdominal pain; Gall Stones; This is a solicited report based on the information received by Pfizer (Manufacturer Control No: 21K-163-4107102-00).   An 86-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), intramuscular on 25Sep2021 (Batch/Lot Number: 301458A) (at age 86-years-old) as dose 3 (booster), single for covid-19 immunisation; influenza vaccine, via an unspecified route of administration from 25Sep2021 (Batch/Lot number was not reported) to 25Sep2021, at dose number unknown, single for an unspecified indication; carbidopa, levodopa (DUOPA), via an unspecified route of administration from 14Oct2020 (Batch/Lot number was not reported) and ongoing, at unspecified dose for an unspecified indication. Medical history included penicillin allergy, quadruple bypass from 2002 to an unknown date. Concomitant medication(s) included losartan potassium (LOSARTAN POTASSIUM) taken for an unspecified indication, start and stop date were not reported; acetylsalicylic acid (ASPIRIN 81) taken for an unspecified indication, start and stop date were not reported. On 29Jan2021, patient received 1st dose COVID-19 Vaccine manufactured by Pfizer (lot: EL9262, expiration date: 20May2021) at age 85 years-old) and on 19Feb2021, patient received 2nd dose COVID-19 Vaccine manufactured by Pfizer (lot: EN6200) at age 85-years-old). The patient previously took carbidopa (RYTARY). On unknown dates, the patient experienced cough, muscle ache, sleep a lot, flu like symptoms and did not want to eat. On unknown dates, muscle ache, sleep a lot and did not want to eat resolved. The patient took the flu and COVID 19 vaccine two hours before going to the emergency room. He went to the emergency room on 25Sep2021 but was not admitted. On 26Sep2021, he had emergency room visit for pain in gallbladder. His wife was unsure if the vaccines was linked to the reported events. His wife stated there was not intervention for the diagnosed gall stones and physician's suggested him speak to a surgeon but had no plans to see a surgeon. On 26Sep2021, the patient had midline abdominal pain and resolved on the same day. Nausea was also recovered. Midline abdominal pain and nausea causality was not related. The patient was treated with Coricidin and Morphine. His wife stated that he was not in a study for the COVID-19 vaccine. His wife stated she did not have a vaccination card for the flu vaccine. The patient underwent lab tests and procedures which included computerised tomogram with contrast: gall stones on 25Sep2021. Outcome of the events gallstone and cough was not recovered, for event abdominal pain was recovered on 26Sep2021 and for the remaining events was recovered on an unspecified date. Action taken for carbidopa, levodopa was dose not changed.  The reporter's causality for the event (s) of call stones, couch, muscle ache, sleep a lot, flu like symptoms and did not want to eat with Duopa (levodopa/carbidopa) was no reasonable possibility. opinion is that there is no reasonable possibility that the events of call stones, couch, muscle ache, sleep a lot, flu like symptoms and did not want to eat are related to Duopa (Levcdopa/Carbidopa).  The reporter's assessment of the causal relationship of the events with the suspect product, bnt162b2 was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.; Sender's Comments: Based on available information and the drug temporal relationship, the causality between the all reported events Cholelithiasis,cough,myalgia, Somnolence, Flu like symptoms,eating disorder,nausea,abdominal pain and the suspect drug "BNT162B2" cannot be completely 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 regulatory authorities, Ethics Committees, and Investigators, as appropriate.