Age: 69.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Electrolyte substitution therapy, Fall, Fatigue, Infusion, Magnetic resonance imaging
Clinical narrative: This is a spontaneous report from a contactable pharmacist (patient). A non-pregnant 69-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in right arm on 24Mar2021 at 15:30 (at the age of 69 years old) (Lot Number: ER8732, unknown expiration) as a single dose for COVID-19 immunisation. Medical history included rheumatoid arthritis, asthma, hypertension, penicillin allergy, and sulfonamide allergy. Concomitant medications included etanercept (ENBREL) from an unspecified start date to 21Mar2021; prednisone; and unspecified blood pressure medication. The patient also received first dose of BNT162B2 for COVID-19 immunisation in left arm on 03Mar2021 at 15:00 (at the age of 69 years old) (lot number: EN6199, unknown expiration). On 25Mar2021, the patient experienced sore arm. On 26Mar2021 at 12:00 PM, the patient had cough, diarrhea, dizziness, fatigue, and loss of appetite. From 27 to 30Mar2021, all symptoms intensified daily and had intermittent chills on 29Mar2021. On 31Mar2021, all symptoms intensified, started using Albuterol inhaler. On 01Apr2021, all symptoms intensified, the patient experienced room spinning dizziness resulted in fall and had temperature 99.9F. On 02Apr2021, the patient visited (hospital name withheld) emergency room, COVID tests negative (Nasal Swab), diagnosis: diverticulitis and pneumonia. Three intravenous antibiotics started metronidazole, clindamycin, and Rocephin. On 03Apr2021, the patient was admitted to hospital with continued antibiotics. On 04Apr2021, electrolyte infusion series started. On 05Apr2021, cough lessening, continued antibiotics and electrolyte infusions. On 06Apr2021, the patient had COVID test negative (Nasal Swab). On 07Apr2021, the patient was transferred to rehab facility with continued antibiotics and electrolyte drinks. From 08 to 14Apr2021, antibiotic courses allowed to expire, symptoms improving, appetite returning slowly (lost 15 lbs; started in Apr2021), negative COVID test (Nasal Swab). On 15Apr2021, the patient was released to home. On 16Apr2021, the patient's diarrhea stopped, slight dizziness remains, appetite improving. The patient did not receive other vaccine in four weeks. The patient has no COVID prior to vaccination. The patient received metronidazole, clindamycin, rocephin, electrolytes as treatment for the events.  The events resulted in emergency room/department or urgent care visit. The patient was recovering from events diverticulitis, pneumonia, sore arm, cough, dizziness/room spinning dizziness, fatigue, loss of appetite, intermittent chills, fall, and temperature 99.9F. Outcome of lost 15 lbs was unknown. The patient recovered from diarrhea on 16Apr2021. The events diverticulitis, pneumonia, sore arm, cough, diarrhea, dizziness/room spinning dizziness, fatigue, loss of appetite, intermittent chills, fall, and temperature 99.9F assessed as serious (hospitalization) for 6 days.   No follow-up attempts are possible. No further information is expected.; Sender's Comments: A possible contributory effect of suspect BNT162B2 on reported events cannot be 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.