Age: 69.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Influenza A virus test negative, Influenza B virus test, Injection site pruritus, Injection site rash, Insomnia
Clinical narrative: Booster received on 30Sep2021; Diarrhea; severe stomach cramps; lost her appetite; arm itched like crazy from the injection site on her left arm all the way down to her elbow for weeks; very weak, has no strength; anxiousness; her legs were like jelly; legs not listening to her brain when trying to walk; fall; fall; shaky; shaky and nervousness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 30Sep2021 (Lot number: FC3184) at the age of 69 years as dose 3 (booster), single for COVID-19 immunization. Relevant medical history included: "Anxiety" (unspecified if ongoing), notes: anxiety that started with a C; "cluster of calcifications in her left breast." (unspecified if ongoing), notes: About a year ago, during her regular mammogram, they found a cluster of calcifications in her left breast.; "eye blindness" (unspecified if ongoing), notes: she has a type of eye blindness; "blood pressure medication" (unspecified if ongoing). Family history included: "Hepatitis C" (unspecified if ongoing), notes: She had Hepatitis C about 13-14 years ago., but her mom died with Hepatitis C. The patient took concomitant medications. Past drug history included: Interferon and pegatron, notes: Interferon and Pegatron combination injections; Interferon and pegatron, notes: Interferon and Pegatron combination injections. Vaccination history included: Bnt162b2 (1st dose, Batch/Lot number: EL9265, Expiry: 31May2021), administration date: 18Feb2021, when the patient was 69 years old, for Covid-19 Immunization; Bnt162b2 (2nd dose, Batch/Lot number: EN6198, Expiry: 30Jun2021), administration date: 11Mar2021, when the patient was 69 years old, for Covid-19 Immunization; Shingrix (Arm was swollen, red and itchy after getting the Shingrix vaccine.), administration date: 09Dec2020, when the patient was 69 years old, for Immunization, reaction(s): "Arm was swollen, red and itchy", "Arm was swollen, red and itchy", "Arm was swollen, red and itchy". The following information was reported: IMMUNISATION (non-serious) with onset 30Sep2021, outcome "unknown", described as "Booster received on 30Sep2021"; DIARRHOEA (non-serious) with onset 30Sep2021, outcome "recovered" (2021), described as "Diarrhea"; ABDOMINAL PAIN UPPER (non-serious) with onset 30Sep2021, outcome "recovered" (2021), described as "severe stomach cramps"; NERVOUSNESS (non-serious) with onset 2021, outcome "unknown", described as "shaky and nervousness"; PRURITUS (non-serious) with onset 30Sep2021, outcome "unknown", described as "arm itched like crazy from the injection site on her left arm all the way down to her elbow for weeks"; ASTHENIA (non-serious) with onset 2021, outcome "unknown", described as "very weak, has no strength"; ANXIETY (non-serious) with onset 2021, outcome "unknown", described as "anxiousness"; DECREASED APPETITE (non-serious) with onset 30Sep2021, outcome "unknown", described as "lost her appetite"; LIMB DISCOMFORT (non-serious) with onset 2021, outcome "unknown", described as "her legs were like jelly; legs not listening to her brain when trying to walk; fall"; FALL (non-serious) with onset 2021, outcome "unknown", described as "fall"; NERVOUSNESS (non-serious) with onset 2021, outcome "unknown", described as "shaky". The events "diarrhea", "severe stomach cramps", "shaky and nervousness", "arm itched like crazy from the injection site on her left arm all the way down to her elbow for weeks", "very weak, has no strength", "anxiousness", "lost her appetite", "her legs were like jelly; legs not listening to her brain when trying to walk; fall" and "shaky" were evaluated at the physician office visit and emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of diarrhoea, anxiety.  Additional Information: Patient stated, Prior to getting the booster shot, she was very active and walked fast; she was just an extremely active person before all this, and since the vaccine she did not even recognize herself. She wishes someone would just tell her, maybe they did not want this to get out because it would deter people from getting the vaccine. States that she was still pro-vaccine, but if someone could just tell her when it would wear off or if she was going to had to deal with this for the rest of her life, because the not knowing was making this more difficult. She was smart enough to know that this was all new, and maybe people just did not know, but she was just frustrated. Stated that she was calling because she just wanted it to be documented in case it happens to anyone else. Stated that she knew several people that have had reactions, but they have only lasted several days. No further details provided. Stated that in the past she has had Hepatitis C, about 13-14 years ago. She was never a drug user; she used to be a phlebotomist and a dental assistant back before anyone used gloves, but it's an unsolved mystery as to how she got the hepatitis C. She was taking Interferon and Pegatron combination injections, and she was supposed to take 24 injections, but she only made it to 16 because she became so ill from the medication that her priest gave her the last sacraments. Thank God she didn't die, but they test her liver all the time and the Hepatitis C has never come back, but her mom died with Hepatitis C. Stated her mom had a back fusion year ago, probably before they even screened blood products. Stated that now one of her biggest fears was taking any medications because of the effects on her liver. Her doctor wanted to give her something for anxiety that started with a C because it would have lasted in her body for 12 hours, but it flagged in the system that it could be bad for her liver, so he had to give her the Xanax instead. About a year ago, during her regular mammogram, they found a cluster of calcifications in her left breast. They did a biopsy and made another appointment to have it rechecked; that appointment was 2-3 weeks ago. She told herself to just go and get it done with but didn't tell them how she was feeling when she got there. It was through medical clinic. States that when they did the compression on her breast, she almost passed out. They gave her ice for the back of her neck because they could see that she was weak, and when she tried to stand back up her legs were like jelly. Stated that when you walk, you just walk you don't have to think about it, but her legs were not listening to her brain because of the shakiness. They brought her out to her husband, but her legs still didn't feel right; it was an odd feeling. She asked the nurse what could have caused her to almost pass out and make her legs feel like that, and the nurse asked if she had any kind of nerve damage. Stated that and she told the nurse no, not that she knew of, but that really freaked her out, that her legs were not listening to her bod. she received the Booster for the Pfizer Covid 19 Vaccine on 30Sep2021, and within a few hours she became violently ill, her doctor gave her 0.5mg Xanax and she takes it twice a day. The product is in a brown pharmacy bottle, no Lot/NDC/Expiry to provide, Manufacturer: Aurobindo.  Follow-up attempts are completed. No further information is expected.