Sex: M
Vaccine: COVID19, UNK
Symptoms: Immunisation, Urinary tract infection
Clinical narrative: Covid Pfizer booster shot; could be a UTI; This is a solicited report received from contactable reporter (Other HCP and consumer) for a sponsored program. Other Case identifier(s): ACO_170470_2021 (Acorda).   The solicited report was initially received from an other hcp on 29Sep2021. Additional information was received from the patient's daughter on 29Sep2021. A male patient 82 years of age at the time of reporting experienced could be a reaction (unspecified) to Covid-19 Pfizer booster shot (hospitalization), Could be a UTI (Urinary tract infection) (Hospitalization), UTI (Urinary tract infection) (Hospitalization), UTI (Urinary tract infection) (Hospitalization) while on Ampyra.  The patient's past history was not provided. Concomitant medications at onset included Copaxone, Complete therapy details were not provided.  Ampyra (Fampridine) was started on an unspecified date (few years ago) at 10 mg, Orally, Q 12 hrs for an unknown infection. Pfizer BioNTech Covid-19 vaccine was started on an unspecified date at an unspecified dosing regimen, route for an unknown indication.  Other hcp at the pharmacy informed that the patient was in the hospital. Additional information was received on 29Sep2021, patient's daughter informed that the patient was now home and was hospitalized on 25Sep2021 and discharged on 28Sep2021. She informed that the physicians at the hospital thought it could be a UTI or a reaction (unspecified) to Covid-19 Pfizer booster shot, but could not conclude anything. At the hospital the patient continued Ampyra and was not given any specific treatment for hospitalization. Ampyra was started few years ago and exact date was not known. Patient's daughter also informed that ampyra had nothing to do with the hospitalization or the event and it was ongoing. She informed the patient also took Copaxone along with Ampyra since many years. Patient was currently did fine and was recovered. Patient was also hospitalized earlier in Jan and May of this year thinking it could be a urinary tract infection. Patient had recovered from those episode as well and no additional details were available of those admissions. Patient's daughter informed Ampyra had nothing to do with those episode of UTI. No additional information was provided.  The outcome of could be a reaction (unspecified) to Covid-19 Pfizer booster shot, Could be a UTI (urinary Tract Infection), UTI (urinary Tract Infection), UTI (urinary Tract Infection) was recovered/resolved. Ampyra dose was unchanged.   The reporter (Other hcp) did not access the relationship between ampyra and could be a reaction (unspecified) to Covid-19 Pfizer booster shot, Could be a UTI (urinary Tract Infection), UTI (urinary Tract Infection), UTI (urinary Tract Infection). The patient's daughter assessed the relation between the ampyra and the events could be a reaction (unspecified) to Covid-19 Pfizer booster shot, Could be a UTI (urinary Tract Infection), UTI (urinary Tract Infection), UTI (urinary Tract Infection) as not related.  Case comment: Causality of ill-defined disorder and UTI x3 assessed indeterminate to ampyra due to limited information. UTI is listed for ampyra.  The reporter's assessment of the causal relationship of the events with the suspect product 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.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.; Sender's Comments: The information provided is very limited to make a meaningful medical evaluation of the case. However, based on the current information available a possible contributory role of the suspect BNT162B2 for the reported events of Urinary tract infection and Booster cannot be completely excluded. The case will be reassessed further upon receipt of additional information. 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.