Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 antibody test
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team and product quality group. A 65-year-old female patient received BNT162b2 (BNT162B2), on 23Aug2021 as dose 1, single (Lot number: FC3180) and on 17Sep2021 as dose 2, single (Lot number: FC3180) at the age of 65 years for Covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 18Sep2021, outcome "not recovered" and all described as "she has been on Paxlovid for 3 days/2nd dose; Symptoms that felt like COVID virus instead of the vaccine"; PYREXIA (non-serious) with onset 18Sep2021 at 02:00, outcome "not recovered", described as "High Fever"; BACK PAIN (non-serious), CHEST PAIN (non-serious) all with onset 18Sep2021, outcome "recovering" and all described as "Back pain that moved to Chest pain"; FATIGUE (non-serious) with onset 18Sep2021, outcome "not recovered", described as "Exhausted and could not do anything and had to go lie down/dizzy"; DYSPEPSIA (non-serious) with onset 18Sep2021, outcome "recovering", described as "Lot of heart burn"; CHILLS (non-serious) with onset 18Sep2021 at 02:00, outcome "not recovered"; MYALGIA (non-serious), outcome "recovering", described as "terrible muscle joint aches and body aches". The patient underwent the following laboratory tests and procedures: Blood test: (Nov2021) zero antibodies, notes: her test result showed she had zero antibodies; Pyrexia: (18Sep2021) 102 Fahrenheit, notes: temperature was almost 102 degrees Fahrenheit; SARS-CoV-2 antibody test: (Nov2021) 0, notes: Result: 0; Unit: Not Provided. Clinical significance: Description Of Complaint: 66 years old Female patient calling about the product PAXLOVID. The caller was asking and added that she had been on it for 3 days and she doesn't feel much better and she doesn't know if it had worked for her. The caller added she had received her first Pfizer Covid-19 Vaccine in Sep2021. After the fist shot, she felt really tired, that was all she experienced, but it took over a week to get better. After her second shot of the Pfizer Covid-19 Vaccine, she ended up being so sick for 6 days with symptoms she never had experienced before. After being so sick from her second dose, she didn't want to get a Booster dose. She didn't want to have the same experience as she did after the second dose. Then she got tested for antibodies and the result had shown zero antibodies. The caller wondered was there some reason she didn't show antibodies after being so sick after the second dose of the vaccine. The caller experienced a really high fever, she had chills, and she felt like she had COVID-19 instead of being vaccinate for the second time. She felt she got COVID-19 for 6 days. She felt better the following week, 6 days later and during this on the 4th day, she felt so bad that she went to the Urgent Care. The caller was curious why she got so sick after the second dose of the Pfizer Covid-19 Vaccine. She got a blood test that would indicate the antibodies and that result she received indicated how many antibodies she had. Her Doctor advised the caller that her test result showed she had zero antibodies. She was not feeling 100% and may not be talking that great. She then said after taking Paxlovid, she was feeling better but not as good as she wished. She had first dose of Pfizer COVID Vaccine in Sep2021, which she later corrected to 23Aug2021. She just felt tired and did not feel herself for about a week. When she got the second vaccine it was in the afternoon and by 2am, she woke up with a fever, terrible chills and feeling terrible and went back to bed. The next morning, she still had the chills and temperature was almost 102 degrees Fahrenheit. She had chest pains in back and then they went to her chest. It started in her back and went to her front. She had a lot of heart burn, but it only lasted about an hour. She later said that back pain was 20 minutes and then chest pain was 20 minutes and heart burn was 20 minutes. She said maybe it wasn't heart burn but just maybe chest pain. She then had terrible muscle joint aches and body aches and mind was telling her it was ridiculous. She was supposed to go to work on Monday. She got vaccine on Friday and was in bed all weekend. She could not go to work. She tried to get dressed Tuesday and was so exhausted she could not do anything and had to go lay down. She called 2 different pharmacist. They told her to go Urgent Care. She did call with the number on the back of the vaccine. It was VAERS. She confirmed she did not complete a report with Pfizer. She did not receive any medical treatment for any of her symptoms. When completing report, caller stated she was so dizzy. She has had to see different doctors since her physician was busy and she did not like her. 18Sep2021 is the date of her first vaccine. She then said she was not looking where she should. It was 23Aug2021, the date of her first Pfizer COVID vaccine with Lot FC3180, expiration was unknown. Injected in unknown arm. 2nd dose was 17Sep2021 and FC3180, expiration is unknown. Injected in unknown arm. 1st dose tiredness persisted for a week. No medical Treatment required. High fever - she got up to go to bathroom and felt terrible and went back to bed. She knew she had a fever. She is just going by what her kids said and what she read. She had not gotten COVID before. This was after having the symptoms for so long. For her symptoms and what she read, it would have seemed like she had COVID. She does not take any medications. She was thinking because she went through so much after getting the vaccine that she would have antibodies. She had asked a lot of people. Why did she have such a reaction, and they said it was probably because she had a lot of antibodies. She got specific blood test for the exact amount of antibodies after getting the COVID Vaccine and when she went to the doctor to get results it was zero. The date of the antibody test was Nov 2021. Nobody has any idea why you don't have antibodies after you get the vaccine. She wanted to know why. Date and Outcome of taking Paxlovid and not feeling much better was not provided. She did not receive any medical treatment for any of her symptoms. No follow-up attempts are possible. No further information is expected. Follow-up (24May2022): This is a spontaneous follow-up report received from a contactable consumer. This consumer (patient) reported that included: Reporter's name and address; Patient information: Address, Height- 168 cm, Weight- 58.51 kg; Lab data: COVID-19 antibody test on Nov2021 and Fever on 18Sep2021; Vaccination date: 17Sep2021; Onset dates and Outcome of events updated; New event: Back pain, Chest pain, Heartburn, Exhaustion and Pain muscle and additional information. No follow-up attempts are possible. No further information is expected. Follow-up (25May2022): This is a follow-up report from product quality group providing investigation results. This report included Conclusion of Previously Completed Investigation, product information and additional information. Additional information: PR ID (CR): Unknown; Product Description (CR): Compound BNT 162 Covid-19 Vaccine Suspension for Intramuscular 2ml Multiple Dose Vial X 1; Lot-# (CR): FC3180. Conclusion of Previously Completed Investigation (FCI/SI/OffCI): The complaint for lack of effect of the PFIZER BIONTECH COVID-19 VACCINE lot FC3180 was investigated. The investigation included a review of manufacturing and packaging batch records, deviation investigations, and an analysis of complaint history for the reported lot and product type. The final scope included the reported finished goods lot FC3180, fill lot EY546, and bulk formulation lot EP8650. A complaint sample was not returned. No related quality issues were identified during the investigation. There is no impact on product quality. No root cause or CAPA were identified as the complaint was not confirmed. All release testing performed prior to the release of the reported batch was within specifications. PR ID of Previously Completed Inv: Unknown. PR Link (Previously Investigated CR): Unknown. Follow-Up (27May2022): Follow-up attempts are completed. No further information is expected.