Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination failure, Vaccination site warmth
Clinical narrative: Tested positive for COVID; Tested positive for COVID; Felt achy and may have had low grade fever; Felt achy and may have had low grade fever; Right arm warm after second dose; Headache; This is a spontaneous report received from a contactable consumer or other non-health care professional (patient).  A 64-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection; Batch no: not reported /Lot number: EN6203, expiry date not reported) via an unspecified route of administration (She was unable to confirm if both were given in the muscle), administered in Arm right on 05Mar2021 15:20 (age at vaccination 64 years) as dose 2, single for covid-19 immunization at clinic. Medical history included diabetes diagnosed 25 years ago, heart disease When asked to provide diagnosis date, she stated that her cardiologist told her that everyone over the age of 50 has a little bit of heart disease, kidney disease diagnosed 2 years ago it was in the early or beginning stages and allergies. Family medical history relevant to AE(s)  included son tested positive for COVID prior to her. Concomitant medications included fexofenadine hydrochloride (ALLEGRA) tablet for allergies from unknown start and taking it on a regular basis since end of 2020. Historical vaccine included as patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EN6201, Expiry date: unknown) via an unspecified route of administration and administered on in Arm right on 10Feb2021 as dose 1, single for COVID-19 immunization with which she experienced right arm warm and tender after 1st shot on 11Feb2021 at 10:00. No other vaccines received on the same date of vaccination. Patient did not receive any other vaccines within 4 weeks of vaccination. Last vaccines she received before this were in  the fall of 2020. AE(s) following prior vaccinations included she was highly allergic and was afraid she was going to have a reaction but did not. She just had normal reactions. Her arm was warm and tender after first shot. Second shot was more and feels like they got it in the muscle on the second shot. They were given in two different places. One gave it lower and one higher. She does not think they got muscle on first shot and it did not feel the same on the first shot. She took Allegra for her past allergies and spoke to her Allergists and she said to continue taking it when she got the vaccine. She was on something else before Allegra and it was making her too drowsy. That medication was Zyrtec. Her allergist said some medications don't work well with everyone and it was a 24 hour one. She switched her over to Allegra. She threw the Zyrtec out and does not have a lot or expiration for it. She has very bad allergies. When she doesn't take it, she gets sneezing. When she does, it works. She tries not to take it every  day to see how long before she starts to sneeze. She had a bad case of COVID after 2nd dose. On 06Mar2021, the patient experienced headache early in the morning around 07:00, right arm warm after second dose at 07:00, felt achy and may have had low grade fever late morning around 11:00 and on 17Sep2021 18:00, the patient tested for COVID-19 PCR test for SARS-CoV-2 results Positive. She went to the hospital to get the monoclonal antibodies on 18Sep2021 as soon as she got results at 18:00. She was not admitted in hospital and visited ER. Stay after they administered it for about an hour. She gave the ER doctor proof that she was positive. She told about her underlying conditions and indicated that she got Pfizer COVID-19 vaccine 6 months ago. She got COVID, and therefore  she wanted to make a report. On an unspecified date, patient underwent lab tests and procedures which included rapid COVID test SARS-CoV-2 results negative and low-grade fever with 99 degrees Fahrenheit and on 17Sep2021 18:00, the patient tested for COVID-19 PCR test for SARS-CoV-2 results Positive. The outcome of the events was unknown. Description of Product Complaint: Patient received both doses of Pfizer COVID vaccine and later tested positive for COVID. The date of her first dose was 10Feb2021 and second was 05Mar2021. She tested positive for COVID virus 17Sep2021. First, she had a rapid COVID test and it was negative, but she also asked them to do PCR test and got results next day and it was positive. She would assume viral load was not that big since she was negative on the rapid test. Product strength and count size dispensed was Unknown. Second dose of the Pfizer COVID vaccine was on 05Mar2021 with Lot EN6203, expiration is unknown. No sample of the product available to be returned. Packaging sealed and intact was Unknown. First shot she got to sit down, and they already have the shots in the hand and does not know if it was sealed or not.