Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: received the 1st dose of the Covid vaccine on 05Mar2021. She tested positive for Covid on 18Mar2021; received the 1st dose of the Covid vaccine on 05Mar2021.She tested positive for Covid on 18Mar2021; This is a spontaneous report from a contactable consumer (patient) reported for herself. A 72-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EN6198, Expiry date: Jun2021) via an unspecified route of administration, administered in right arm on 05Mar2021 at 13:00 pm (age at vaccination was 72 years) as 1ST DOSE, SINGLE DOSE for COVID-19 immunization. Medical history included prediabetes, high blood pressure, chronic kidney disease, PVCs, leaky valves was obese (all were ongoing). The patient did not have any family history. Concomitant medications included lisinopril (20mg; take one twice daily by mouth) taken for blood pressure measurement (taking for years), atenolol (25mg; take one half daily by mouth) taken for blood pressure measurement (taking for years), hydrochlorothiazide (25mg; take once daily by mouth) taken for blood pressure measurement (taking for couple years), atorvastatin (20 mg; once daily by mouth) taken for blood cholesterol (taking for couple years). The caller stated she had first dose of the Pfizer COVID 19 vaccine on 05Mar2021 at 13:00 PM in the right arm. The next day she experienced symptoms which she thought were related to the vaccine however, she tested positive for covid. The very next day she noticed she had sneezes/sneezing, sniffles and congestion. She tested positive for COVID 19 infection yesterday 18Mar2021, it was the rapid test, they called her in ten minutes. Added she got a cough, aches all over and today she had some diarrhea. Last night when she was in bed everything hurt. Mentioned everything seemed worse at night. She was asking whether she should reschedule her second dose of the Pfizer COVID 19 vaccine as she was still not feeling good. The 2nd dose of the vaccine was scheduled for 26Mar2021. Mentioned her daughter who lives with her started to run a fever and also tested positive for COVID 19 but caller stated she never had a fever. They thought the caller had the infection before her daughter did. Caller mentioned she did have an appointment today to see the doctor but she called them to let them know she had COVID 19 so she did not go in. They told her to call back if her symptoms got worse. She was asking whether she should be concerned that they didn't prescribe any kind of treatment considering her other conditions. The caller wanted to know whether she will be able to take the 2nd dose of the covid vaccine with a history of a covid infection. The caller wanted to know how to reschedule her covid vaccine appointment. Advised her to follow up with her HCP for medical advice. Had an appointment with the doctor this morning but they told her if her symptoms get worse to call back. No ER, No hospitalization. No relevant test was done. The vaccination facility was drive through. The vaccine was not administered at Military facility. There was no history of all previous immunization with the Pfizer vaccine considered as suspect. There were no additional vaccines administered on same date of the Pfizer Suspect. The patient had no prior vaccinations within 4 weeks. There was a Product Complaint. The description of complaint included consumer reported she had the first dose of the Pfizer COVID 19 vaccine on 05Mar2021 at 13:00 PM in the right arm. The very next day she noticed she was having sneezes, sniffles and congestion. She tested positive for COVID 19 infection yesterday 18Mar2021; it was the rapid test, they called her in ten minutes. Adds she got a cough; aches all over and today she had some diarrhea. Added last night when she was in bed everything hurt. Mentions everything seems worse at night. Product was Pfizer COVID 19 vaccine, treatment first dose 05Mar2021, provides lot number from vaccination card but does not see NDC or expiration date. Product strength and count size dispensed included first dose of vaccine. Additional lot numbers were none. The sample of the product available to be returned, if requested was not applicable. Packaging sealed and intact was not applicable. The outcome of the event SARS-CoV-2 test positive was unknown. The outcome of the events sneezing and sniffles was resolved on 10Mar2021. The outcome of the event diarrhea was resolved on 19Mar2021. The outcome of the events congestion, cough, pain and she is still not feeling good was resolving.   Follow-up#01 (19Mar2021) and Follow-up#02 (19Mar2021): New information from a contactable consumer (patient) included: Updated the suspect details (start date, lot number, expiration date and dose description), medical history captured, laboratory test, events (drug ineffective cough, congestion, sniffles, sneezes, aches and diarrhea) added with dates and outcome, seriousness and listedness and details of Product Complaint.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.