Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Headache, Malaise, Myalgia, Nausea
Clinical narrative: fever; chills; nausea; diarrhea; Weak; dizzy; muscle pain; joint pain; Injection site pain; redness; swelling; feeling unwell; headache; This is a spontaneous report received from contactable consumer. This consumer (Patient) reported for herself that the 73-year-old female patient received first dose of bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 20Mar2021 10:45 AM (Batch/Lot Number: EN6199; Expiration Date: Jun2021) at single dose for covid-19 immunisation. Medical history included covid-19 from Dec2020 to Dec2020 (she had covid in early December and received monoclonal antibodies), arthritis, fibromyalgia, Non Alcoholic cirrhosis, anxiety, depression, granuloma annulare, knee arthroplasty (LTKR '07,, RTKR '09,T ), and all from an unknown date and unknown if ongoing and Known allergies: Penicillin, sulfa, latex, tramadol, Allergic Rhinitis to tree pollen and dust, Small intestinal bacterial overgrowth from unknown date to Oct2020 Prior to getting the vaccine, Irritable Bowel Syndrome from unknown date to 1965. Concomitant medication(s) included pregabalin (LYRICA) taken for an unspecified indication, start and stop date were not reported; colesevelam hydrochloride (WELCHOL) taken for an unspecified indication, start and stop date were not reported; pantoprazole (PANTOPRAZOLE) taken for an unspecified indication, start and stop date were not reported; lorazepam (LORAZEPAM) taken for an unspecified indication, start and stop date were not reported; desvenlafaxine succinate (PRISTIQ) taken for an unspecified indication, start and stop date were not reported. The patient experienced headache on 20Mar2021 with outcome of recovered, fever on an unspecified date with outcome of recovered on 22Mar2021, chills on an unspecified date with outcome of recovered on 20Mar2021 02:00 PM, nausea on an unspecified date with outcome of recovered on 20Mar2021 02:00 PM, diarrhea on an unspecified date with outcome of recovered on 20Mar2021 02:00 PM, weak on an unspecified date with outcome of recovered on 20Mar2021 02:00 PM, dizzy on an unspecified date with outcome of recovered on 20Mar2021 02:00 PM, muscle pain on an unspecified date with outcome of recovered on 20Mar2021 02:00 PM, joint pain on an unspecified date with outcome of recovered on 20Mar2021 02:00 PM, injection site pain on an unspecified date with outcome of recovered on 20Mar2021 02:00 PM, redness on an unspecified date with outcome of recovered on 20Mar2021 02:00 PM, swelling on an unspecified date with outcome of recovered on 20Mar2021 02:00 PM, feeling unwell on an unspecified date with outcome of recovered on 20Mar2021 02:00 PM. Treatment was not received for the adverse events. The patient underwent lab tests and procedures which included polymerase chain reaction positive: positive on unknown date, pyrexia: 100.6 on unknown date. The patient asked if she can get the second dose of the Pfizer-BioNTech COVID-19 Vaccine. Checked the Pfizer-BioNTech COVID-19 EUA article, mentioned no information found on monoclonal antibodies, and referred the clinical decision on the second dose to her HCP. The clinical course was reported as follows:  Consumer reported that 2 hours after receiving the first vaccine dose, she experienced headache, fever, chills, nausea, and diarrhea. Fever "went away" by Monday (22Mar2021) morning. Consumer asked, will she have the same or worse symptoms in the second dose. She is not pregnant at the time of vaccination.  Weak, dizzy2hr after shot. Sat.pm. tired, headache, fever 100.6, chills, muscle pain, joint pain, Injection site pain, redness, slight swelling, nausea, diarrhea, feeling unwell. Fever resolved Mon. AM. Resumed ADLs Tues. Prior to vaccination, the patient was diagnosed with COVID-19. No covid tested post vaccination. No other vaccine in four weeks. Her personal physician recommended she not receive second shot. There were two reasons. One was that she had COVID in early Dec2020, and she received the monoclonal antibodies. The side effects she had after first shot were robust. Based on that information, it was his medical opinion for her not to receive the second shot. She has not been able to get that opinion. Does Pfizer have any recommendation for getting second dose after having COVID and receiving monoclonal antibodies? She had the COVID prior to getting the vaccine. She was given the monoclonal antibodies on day 5 after symptoms and day 4 after the positive PCR test.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.