Age: 61.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Vaccination site swelling, Weight, Weight increased
Clinical narrative: Traumatic brain injury; Muscle pain; I am having like a higher fever; Pain of the joints, the muscle; I have pain all the time; I have excruciating pain because I have a bad back; It's total body aches and it pains like a flu; Redness and swelling; I gained weight that's really weird; Pain of the joints, the muscle; I have pain all the time; It's total body aches and it pains like a flu; Redness and swelling; Loose stools; This is a spontaneous report from a contactable other HCP (Patient herself). A 61-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number: FA7W8U; Expiration date: unknown) dose 1 via intramuscular route in arm left on 10Aug2021 (at age of 61-years-old) as single dose for COVID-19 immunization. The patient medical history was not reported. The patient was taking medication called Methocarbamol or the American name for it Robaxin 500mg (Not appropriately clarified if consumer was taking Methocarbamol or Robaxin, hence not captured in tab) as concomitant medication. Historical vaccine included Flu shot taken on an unspecified date; 15 years ago, she had a reaction to a Flu Shot (Unspecified Flu Shot) that she give out at her job. Consumer (Retired Nurse) stated that, she had the shot 10 days ago, she was having all kinds of side effects that were not good, did not want to get the COVID vaccination. So now unfortunately she was experiencing a lot of the side effects from the first shot alright that was about 10 days ago. It was reported that, on an unspecified date the, patient experienced traumatic brain injury she had muscle pain, at the injection site (Not clarified). She had a little bit of loose stool, after in regards to the pain of the joints the muscle, she had pain all the time, meaning having excruciating pain because she have a bad back, so this pain was a lot worse, it was not specifically arm pain where she had the injection but it was total body aches and it pains like a flu, like she had a flu before. So she was saying basically with the exception of the injection site, redness and swelling (Further clarification was unknown if consumer had redness and swelling, hence captured as event). She had colonoscopy and gynecological testing (Clarification unknown), so it was nothing like relating to that, so the only thing she said, it must be related to the first injection. She gained weight that was really weird it was like about 145, 150 in between there. The patient underwent lab tests and procedures which included body temperature: 98 something on an unspecified date, weight: gained; gained weight that's really weird it's like about 145, 150 in between there. The outcome of all events was unknown.; Sender's Comments: As there is limited information in the case provided, the causal association between the event traumatic brain injury and the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available.  The impact of this report on the benefit-risk profile of the Pfizer product and on the conduct of the study 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.