Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Cyanosis, Feeling abnormal, Gait disturbance, Headache
Clinical narrative: COVID-19; COVID-19; can''t walk; can''t move; can't lift her arms; headaches; memory loss, like a brain fog, foggy memory; memory loss, like a brain fog, foggy memory; can''t smell; can''t taste; blue feet; She can't drive her car; had a problem with her hands; blood problems; This is a spontaneous report received from a contactable consumer (patient) via a Pfizer sponsored Program. A 72-year-old female patient received first dose of bnt162b2 via an unspecified route of administration, administered in left arm on 13Feb2021 (Batch/Lot Number: EN6204) at age of 71-year-old at 0.3 ml single dose, second dose via an unspecified route of administration, administered in left arm on 10Mar2021 (Batch/Lot number not clarify, unknown FC3194 or FC3184) at age of 71-year-old at 0.3 ml single dose, for covid-19 immunisation. Medical history included allergies to the sulfa family, she did have allergies to the sulfa family, she can't take any of that or she goes into shock, that's it. She mentioned she was anemic, but she was okay now. She stated she had problems, but hadn't had any recently- she had been watching it. The patient stated a couple years back, she and her husband had the pneumonia shots and they got the flu vaccine every year on time, and never had any problems. The patient received vaccines at the same facility. She clarifies it was a clinic they went to on the top floor (3rd floor). No additional vaccines administered on same date of the Pfizer suspect. No other vaccinations within four weeks prior to the first administration date of the suspect vaccine. She stated she started no new medications, nothing. She clarifies no new medications was given to her until they were in the hospital. Patient had COVID-19 test on 08Jul2021. They got her positive results on 10Jul2021 which was when they went to the hospital. Reported seriousness for COVID-19 was hospitalization, patient was in hospital for COVID-19 from 11Jul2021 to 19Jul2021. Prior to that, her and her husband thought they had a cold. She clarifies further on 10Jul2021, her and her husband went to the emergency room. They spent 24 hours in the ER. She and her husband were given a room on 11Jul2021. She spent approximately 8 days in the hospital, so it would have been approximately 19Jul2021 when she was discharged. She can't walk. She can't drive her car. She can't lift her arms go get the stuff to wash her clothes. She had to hire one person to get things down to wash the clothes with and to clean. She stated she was a mess. She was vaccinated. The patient mentioned she couldn't do two things at once anymore. She can't walk anymore. She got COVID really bad. She can't believe she got sick. The patient stated she had a foggy memory, too. She stated she was a long hauler. She can't walk. She can't move. She has headaches, memory loss like a brain fog. She can't smell and she can't taste still. She had blue feet but did not have a blood clot. She was tested for a blood clot and was told she didn't have one, but that there were 25 patients with the same symptoms, like younger people with the same problems. She was told she was to be seen again in 3 months. She had to deal with this on top of the stress from losing her husband. The only thing that was given to her and her husband was the medication that is supposed to get them out of the hospital, it starts with a d but she forgot the name of it. She states even though she has had all of these problems, she still got her booster. She doesn't want to give up. She did believe in science. She confirmed she already got her booster shot. She was able to retrieve Lot number for her booster shot and mentions it's hard to read due to the person's handwriting. She initially stated it may be FC3194 or FC3144. She then states maybe the last two digits or 94 or 84. She mentioned she had a problem with her hands and she was trying to see if she can open something else. She clarifies she believed the Lot number was FC3194 or FC3184. She confirms she received this COVID-19 booster shot on 25Sep2021. The only other number she sees on the card is #, but she doesn't know what that is. The patient confirmed she had physicals which were okay. She had blood problems in the hospital. She clarified in the hospital, they did blood tests twice a day and everything was normal when she got out. She clarified she was given an injection/ shot in the thigh so she wouldn't get a blood clot because COVID gives you blood clots. She clarified she thought she was anemic, but she was told she wasn't. She states she was a long hauler, and she was just exhausted, and was going through all of this stuff. The outcome of events was unknown.  Product Quality Complaint Group provided the Investigation results: This is a notification generated from the gQTS system. As part of the LOE simplification process, the following Complaint Records were classified as Product Use Attributes // Lack of Effect and have been moved to Closed (No Investigation) state referencing a previously completed investigation for the same product and lot as per the 'One and Done' business process according to in PQS Q1215 and/or Q1252. Refer to the below table for details: Product Description (CR): compound bnt162b2 covid-19 vaccine suspension for intramuscular 2ml multiple dose vial X 1, Lot-# (CR): EN6204. Conclusion of Previously Completed Investigation (FCI/SI/OffCI): The complaint for lack of effect of the PFIZER-BIONTECH COVID-19 vaccine lot EN6204 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. The final scope included the reported finished goods lot EN6204, fill lot EN5335, and the formulated drug product lot EN5325. A complaint sample was not returned, and photographs were not received. No related quality issues were identified during the investigation. There is no impact to product quality. No root cause or corrective/preventative actions were identified as the complaint was not confirmed. All release testing performed prior to the release of the reported batch was within specifications.  The lot number for BNT162B2 was not provided and will be requested during follow-up.