Sex: F
Vaccine: COVID19
Symptoms: Nausea, Near death experience, Pain
Clinical narrative: first one had just about killed her.; extremely dizzy and spacey/very dizzy; spacey; Nauseous; extremely tired; felt sick after the vaccine; couldn't focus; she could barely move; muscles were so sore/ muscle hurt so bad; muscles and joints were inflamed; muscles and joints were inflamed; great pain/ pain and graded it at 11 on the scale of 1 to 10; couldn't stand up; This is a spontaneous report from a contactable nurse (patient). A 50-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on an unspecified date in Apr2020 (Batch/Lot number was not reported) as dose 1, single for COVID-19 immunisation. Medical history included arthritis, "fusion in my back", COVID-19, and car accident. Concomitant medications included hydrocodone bitartrate, paracetamol (NORCO); baclofen; meloxicam (MOBIC); morphine sulfate (KADIAN), all taken for an unspecified indications, start and stop dates were not reported. Nurse stated that date of vaccination was approximately April of this last year in 2020. Nurse stated that she got vaccinated at work, but she had severe reaction to the vaccine, so she skipped the second vaccine because the first one had just about killed her. She had COVID already as well before this. Nurse stated that when she had the vaccine, initially, she didn't remember being in this much pain but when it happened at first, she usually works until 6 pm or 6:30 pm, she works 12 hours shifts and she had the vaccine at about 1:30 in the afternoon and she had the work and they made her sit for 20 minutes or half an hour before letting her go back to work and after that she was extremely dizzy and spacey. Nurse stated that she was usually off by 06:30 but within half an hour of having the vaccine, she was very dizzy, nauseous, extremely tired and she couldn't focus which made her stay at work for an extra more than four hours, and was there after 10:30 pm that night. She still has a text documenting that and they were asking why she was there that long, and she felt sick after the vaccine, she couldn't focus least of it. The next morning, thankfully she didn't work, she couldn't even pull her sheets back in bed, she couldn't roll over, she could barely move, her muscles were so sore and it wasn't just like she had the flu, it wasn't like that and she had COVID before this. So, she thought that's why her immune system reacted so strongly, but she was in great pain. Nurse stated that there was no treatment given other than bed rest. The first day she was in agony, her muscles and joints were inflamed. She had arthritis in her body from previous car accidents. She had pain and graded it at 11 on the scale of 1 to 10, may be at least to 10. Through the joints, not just the muscles and she could not even roll over in bed it was so severe and when finally, it was a day or two later, it lasted about 10 days and still continuing today. She was still having extra pain. So, that continues today but most extreme part lasted at least 10 days and an example would be probably two days after the vaccine, well that will be three days, two days after laying in bed when she couldn't stand up. She finally left the house to go to the grocery store and had to take her 12 year old with because she could not pick up the jug of milk, could not pick up cans, could not separate cans, because her muscle hurt so bad and then that continued for at least 10 days at that level and has decreased but pain continued. Nurse stated that she has a fusion in her back and has arthritis. She already has arthritis to start with and it was related to car accident. So, she believed that it got agitated, caused inflammation because her arthritis was already inflammation so she thought it caused it to stay inflamed because she was having more pain than she have had ever since and that's what stopped her from getting the second dose and then she discussed with her pharmacist because she thought she might already have 'protestants' (further clarification unknown) where she reacted so strongly to the first vaccine because she already had COVID, so she felt like the second one (incomplete sentence) as the first one acted as the booster. The patient had no lab test done and had not taken any other vaccine prior to 4 weeks of COVID vaccine. The outcome of the events was unknown.  Relatedness of drug to reactions/events by Primary Source Reporter was related.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.; Sender's Comments: Based on the available information in the case, the causal association between the events near death experience, dizziness, feeling abnormal, nausea, fatigue, illness, disturbance in attention, movement disorder, myalgia, myositis, arthritis, pain, dysstasia and the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.