Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, Paralysis
Clinical narrative: ended up sick on Dec due to covid; ended up sick on Dec due to covid; paralyzing; This is a spontaneous report received from contactable reporter(s) (Consumer or other non-HCP) from medical information team and product quality group. The reporter is the patient.  A 48 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 01Nov2021 (Lot number: 30135BA) as dose 4 (booster), single, administered in arm right, administration date 21Oct2021 (Lot number: 30135BA) as dose 3 (booster), single, administered in arm right, administration date 09Apr2021 (Lot number: ER8727) as dose 2, single and administered in arm right, administration date 19Mar2021 (Lot number: EM6203) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Autoimmune disorder" (unspecified if ongoing); "Autoimmune disorder resulted from an exposure to chemicals" (unspecified if ongoing), notes: Autoimmune disorder resulted from an exposure to chemicals. Concomitant medication(s) included: THYROXINE SODIUM taken for autoimmune disorder, start date: 19May2018. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Dec2021, outcome "unknown" and all described as "ended up sick on Dec due to covid"; PARALYSIS (medically significant) with onset 2021, outcome "unknown", described as "paralyzing". Therapeutic measures were taken as a result of paralysis.  Clinical Course: PQC was not present. Doctor stated that she had 2 Pfizer BioNTech Covid-19 Vaccination shots in the springtime of last year and had very little side effects other than an aching arm. Caller also stated that she developed a problem of one quarter of a mile, her muscles gave out which continued until Oct of last year. After Oct, it got down to a couple of muscles giving out. She ended up sick on Dec due to covid, it was massively bad and so did her associates. They self-quarantined and could hardly make it to the restroom due to the paralyzing and can hardly get to a car and to the lab. There are some things that improve, took in astronomic amounts of magnesium and plenty of potassium but could get sick from too much of muscle relaxant which may lead to the muscles falling down. During the first shot, started experiencing muscle weakness 2 days after the vaccination, started laying down a lot and noticed it when I put the dog out for a walk and couldn't walk very longer. During the first shot, 3 months it started tapering off, my associates have gone hiking with me and I said I'm doing pretty good and hiked for half a mile in the first of oct and the for the vaccination in the end of Oct, 2 days after started falling to the ground again then I started to experience more sweating, fatigue and collapsing down again. Response: Advised caller that under 6 OVERALL SAFETY SUMMARY Revised: 31Jan2022, there is no information on muscle weakness as an AE after getting the Pfizer BioNtech Covid-19 Vaccine.6.2 Post Authorization Experience. Musculoskeletal and Connective Tissue Disorders: pain in extremity (arm). Referred to HCP for treatment recommendations. He has a doctor on the line and was not able to probe if medical doctor. She is calling about Pfizer COVID 19 vaccine. She mentioned that she had two vaccination shots in the springtime of last year 2021. She had very little side effects other than pain in arm. A few months after, she mentioned her muscles gave out and this persisted or continued until Oct2021. By Oct2021, it started getting better. She mentioned she got another two extra shots, so 4 shots in total of the Pfizer COVID 19 vaccine. She also ended up sick again on Dec2021, due to COVID, and described symptoms as being massively bad. He thinks she is referring to the COVID. She also mentioned that her main concern was weakening of muscles. She, as well as associates, were self-quarantining and could hardly go to the bathroom due to the paralyzing effects of their muscles. She had been given astronomic amounts of magnesium and plenty of potassium as a muscle relaxant. She also had a bacterial infection but is not sure if it was after the first two initial shots or after the last two shots. At the end of Oct2021, 2 days after, it looks like she started feeling sweating and muscle tightening. Reporter clarified information above. She said it was a few days instead of a few months when her muscles became weak. She also clarified the bacterial infection mentioned above was the COVID virus. She clarified that she is a doctor. She does research. She stated that when you have a vaccination, they advise you to rest for a couple of days and she went out on 3rd day and muscles completely seized and went into cramps and fell out from under her. That continued after she pushed herself after a few blocks. It went away until she got further on her walk until it would collapse. She took her vaccination and after 2 days of resting, she had muscle collapsing and that kept going until end of Dec2021, when she caught COVID. She later stated that she caught COVID virus in 01Jan2022. After she came down with COVID virus, she said she can hardly walk from her apartment to her car. She took a double vaccination end of Oct2021, she took 2 days rest and then went out walking and had the same thing again. She has associates that got it and had muscle contractions and seizures. She does not want to complete report for anyone else. No further details provided. She did not wish to provide her date of birth, height, weight or primary care provider contact details. The first date she originally stated that this occurred was around 15Jul2021, but later stated it was 19Mar2021, so she is totally wrong. That is the date she received it. Her symptoms started 2 days after that. It got better as the months go on and by 01Oct2021, she was able to go from 2 blocks with fatigue to walking 3/4 of a mile before she got fatigued. By the end of Oct2021, she went in and had another vaccination. These are done in two weeks separation. It started out with the same problem and started to get better and then she got COVID. She also started sweating and overheating and still having muscle fatigue collapses. She knows that part of the vaccination syndrome is that the day after receiving, you have a fever and start sweating. They have fatigue of tendons and muscles, and it gets worse when you get COVID virus. She does not know if it will be better in a few months. She has a neighbour that has the same thing and she said she does not know if he has the autoimmune that she does that will be open to the same syndrome. He may not have the same autoimmune with her. She did not wish to complete a separate report for her neighbour. Separate report completed for him. Patient became obstinate when trying to capture details about sweating and was over talking call handler. This consumer is not a health professional but is in research and is also the patient in this report. She called regarding Pfizer product: Vaccination for Covid. Caller reported that she and the majority of her associates took Pfizer product: Vaccination for Covid and ended up with double vaccinations. Most people ended up with the first one and then the second and third shot; but caller ended up with 4 total shots of Vaccination for Covid. Everything seemed to be going fine until they all caught Covid. Caller reported that she specifically was like 30 days worth of bacterial infection. They would like to know, because they all know they're taking the vaccinations as a precaution hoping that everything is going to work out; You know that in science it doesn't mean everyone is the same prototype and everything works out for them; but she called with questions about some of the side effects after testing for COVID to make sure it is not side effects of the vaccination. She is not complaining about the vaccination because until 01Jan she personally was doing fine and thought wow got this really licked it. Caller did not report year of that date: 01Jan. Caller just wanted her inquiries addressed at this time, did not want to complete safety reports for herself or other patients mentioned during the call. Most people ended up with the first one and then the second and third shot; but caller ended up with 4 total shots of Vaccination for Covid. Everything seemed to be going fine until they all caught Covid. Caller reported their own event specifically was like 30 days worth of bacterial infection. They would like to know, because they all know they're taking the vaccinations as a precaution hoping that everything is going to work out; You know that in science it doesn't mean everyone is the same prototype and everything works out for them; but they called with questions about some of the side effects after testing for COVID to make sure it is not side effects of the vaccination. Caller is not complaining about the vaccination because until 01Jan caller personally was doing fine and thought wow got this really licked it. Caller did not report year of that date: 01Jan. Caller just wanted inquiries addressed at this time, did not want to complete safety reports for self or other patients mentioned during the call. Vaccination for Covid: Additional Lots/NDCs/Expiries: Not provided, caller unwilling to complete the report.