Age: 83.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Diarrhoea, Headache, Nausea, Night sweats, Pneumonia
Clinical narrative: Lost 5 pounds; one bout of diarrhea; night sweats so bad; nausea and vomiting; headaches; nausea and vomiting; diagnosed with bronchial pneumonia; This is a spontaneous report from a Pfizer Sponsored Program. Information was received from a contactable nurse (the patient).     A 83-years-old female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Left on 19Mar2021 12:30 (Batch/Lot Number: EL6204) as single dose  for covid-19 immunisation (Age at vaccination 83 years) .  Medical history included mycobacterium avium complex infection.  On 24Feb2021 the patient received the first dose of BNT162B2 vaccine. Concomitant medications included multivitamin  (MULTIVITAMIN) taken for an unspecified indication from 19Mar2021 12:30 to 19Mar2021 12:30; calcium (CALCIUM) taken for an unspecified indication, start and stop date were not reported; vitamin b complex (B COMPLEX (B50)) taken for an unspecified indication, start and stop date were not reported.  The patient was diagnosed with bronchial pneumonia  (medically significant) on Mar2021 with outcome of recovered , lost 5 pounds  (non-serious) on an unspecified date with outcome of recovered , headaches  (non-serious) on Mar2021 with outcome of recovered , nausea and vomiting  (non-serious) on Mar2021 with outcome of recovered , one bout of diarrhea  (non-serious) on an unspecified date with outcome of recovered , night sweats so bad  (non-serious) on Mar2021 with outcome of recovered.    Therapeutic measures were taken as a result of diagnosed with bronchial pneumonia and included antibiotics, albuterol and cough medicine.  Course of the event. Caller states that she then had a sore throat and nasopharynx and throat felt like she was breathing fire.  It got worse and worse.  Caller states that within 48 hours of receiving the vaccine, she also began coughing and coughing. She had headaches, nausea, vomiting, one bout of diarrhea, and night sweats so bad that she had to change her pillow and bedding and was soaked from the waist up. Caller adds she was diagnosed with bronchial pneumonia. She had an appointment with a pulmonologist doctor and was seen at the clinic.  They did x-rays, cat scans, and she was unable to do a breathing test because she could not quit coughing.  Caller does not have additional details. Gave her antibiotics for 21 days, a nebulizer of albuterol and saline and they gave her cough medicine. It was the same cough medicine with codeine.  She spent 6 days just at the clinic with tests in the doctor and came home from the train.  Caller adds she was not admitted. This all stretched out over 3 weeks and gradually increased.  Follow up information has been requested.; Sender's Comments: As there is limited information in the case provided, the causal association between the event and the suspect drug cannot be excluded. The case will be reassessed once new information is available. The contribution of patient's age cannot be completely ruled out in the occurrence of the events.   The impact of this report on the benefit/risk profile of the Pfizer drug 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.