Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Illness, Insomnia, Pain in extremity, Paraesthesia, Rash
Clinical narrative: I have been so sick; cannot sleep; skin burns and everything; like somebody is burning you with a lit cigarette and stabbing you with needles that never goes away; severe case of a rash/got rash on breast, under and along left breast-arm-to back rash on back/rash worse; My arm, my back, my breast horrible painful/Sharp, stabbing pains in left breast, arm length inside & onto back; My arm, my back, my breast horrible painful/Sharp, stabbing pains in left breast, arm length inside & onto back; My arm, my back, my breast horrible painful/Sharp, stabbing pains in left breast, arm length inside & onto back; Blood pressure increased; I get shingles; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 81 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 08Nov2021 16:10 (Lot number: FE3590) at the age of 81 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "High Blood Pressure" (unspecified if ongoing); "acid reflux" (unspecified if ongoing); "Cholesterol" (unspecified if ongoing), notes: I take 'Roboc' something that is one for Cholesterol, that is the generic for 'Crestor'. Concomitant medication(s) included: VALSARTAN taken for hypertension; MAXZIDE taken for hypertension; OMEPRAZOLE taken for gastrooesophageal reflux disease; ROSUVASTATIN taken for blood cholesterol abnormal. Vaccination history included: Bnt162b2 (1st dose, Lot# EL9264, Administration time: 02:00 PM, Anatomical site of Injection: left arm), administration date: 05Feb2021, when the patient was 80 years old, for COVID-19 immunization; Bnt162b2 (2nd dose, Lot# EN6203), administration date: 26Feb2021, when the patient was 80 years old, for COVID-19 immunization. The following information was reported: RASH (disability, medically significant) with onset 09Jan2022, outcome "not recovered", described as "severe case of a rash/got rash on breast, under and along left breast-arm-to back rash on back/rash worse"; PAIN IN EXTREMITY (disability, medically significant), BACK PAIN (disability, medically significant), BREAST PAIN (disability, medically significant) all with onset Jan2022, outcome "not recovered" and all described as "My arm, my back, my breast horrible painful/Sharp, stabbing pains in left breast, arm length inside & onto back"; BLOOD PRESSURE INCREASED (disability, medically significant) with onset Jan2022, outcome "not recovered", described as "Blood pressure increased"; HERPES ZOSTER (non-serious) with onset Jan2022, outcome "unknown", described as "I get shingles"; ILLNESS (non-serious), outcome "unknown", described as "I have been so sick"; INSOMNIA (non-serious), outcome "unknown", described as "cannot sleep"; SKIN BURNING SENSATION (non-serious), outcome "unknown", described as "skin burns and everything"; PARAESTHESIA (non-serious), outcome "not recovered", described as "like somebody is burning you with a lit cigarette and stabbing you with needles that never goes away". The events "severe case of a rash/got rash on breast, under and along left breast-arm-to back rash on back/rash worse", "my arm, my back, my breast horrible painful/sharp, stabbing pains in left breast, arm length inside & onto back", "my arm, my back, my breast horrible painful/sharp, stabbing pains in left breast, arm length inside & onto back", "my arm, my back, my breast horrible painful/sharp, stabbing pains in left breast, arm length inside & onto back", "blood pressure increased" and "i get shingles" were evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: blood pressure measurement: (Jan2022) going so high. Therapeutic measures were taken as a result of rash, pain in extremity, back pain, breast pain, blood pressure increased, herpes zoster. Patient got the booster shot on 08Nov2021 went to (state name withheld) to buy timeshare and 10Jan, she came down with severe case of a rash and she sent pictures to her dermatologist. Patient arm, her back, her breast horrible painful and they said it is shingles. So, how in the hell did she get shingles. Then come to find out she talked to her manager at the real state office, and she said her son in law took the booster and he came down with shingles (Further clarification unknown). She knows three other people that the same thing has happened to (Further clarification unknown). So, that is why she was calling you. When probed if patient has any query reporter stated, well, she thinks you should know that people getting shingles (Further clarification unknown) and this is the worst thing she have ever had in my entire life. She has been so sick; you cannot sleep, and your skin burns and everything. So, she thinks you should make people aware that get a booster you, got a good chance of getting horrible shingles (Further not clarified). Reporter stated, (email withheld) but do not send me anything that you want me to print because she cannot do that (Further not appropriately clarified hence not captured in tab). Expiration date reporter stated, no, but she thinks they sent me an email about congratulations on being vaccinated or something. It says anything let me see they gave me four pages about (Incomplete Sentence). Anatomical Site of administration reporter stated, she got, she thought every time they used the same arm, my left (arm) one. Consumer stated, well, she has high blood pressure so, she takes a blood pressure medicine. she takes a cholesterol reducing medicine (Further not clarified). she takes a diuretic (Further not clarified) for my part of my high blood pressure. I take acid reflux medicine (Further not clarified). Reporter stated, what she takes, she takes normally Valsartan (Further not clarified) and Maxide (Further not clarified) and the acid reflux is called, she has to go look up that up better, it is generic for Prilosec whatever that is, and she take Roboc something that is one for Cholesterol, that is the generic for 'Crestor' (Further clarification unknown). Reporter stated, since this happened you mean or before no, not yet because all of these medicines the doctor gave me. He is gonna do my blood work like in a week or two to see what it is is doing to my kidneys and bladder and all of this to 'motion' with all of these pills I have to take now (Further clarification unknown hence not captured). Reporter stated, Yes, she took pictures of my breast and sent them to the skin doctor because like she said, she was in (state name withheld) and she did not know if she came in contact with something or spider bit me or something (Further clarification unknown hence event captured as per verbatim) so she sent the pictures of my breast, my arm and my back to the skin doctor and he wanted me to go to the emergency room, a doctor or clinic (Further clarification unknown) and she said, no she was coming home in a few days and she do not wanna go to a hospital and get COVID from people (Further clarification unknown) you know what she mean. So, he sent me medicine and he sent me prescriptions for me to go pick up at the drug store, but she had to send somebody and pay them to go get it because she cannot go 'like that' to a drug store (Further clarification unknown). Reporter stated, she started in (state name withheld) because she was there for my timeshare time and then she came home, and it is not better, and the pain is like she said before it is the worst thing she have ever got in her life. It is like somebody is burning you with a lit cigarette and stabbing you with needles that never goes away (Further clarification unknown hence event captured as per verbatim) and it is just absolutely horrible your skin burns, and your clothing burns your skin to touch it (Further clarification unknown hence event captured as per verbatim), it is just horrible. It was right before it was getting dark. So, she would say it was like 4 something, 4:30 (Further clarification unknown) say but she could ask my daughter if you need it to be more accurate because we went at the same time, and she drove. No Prior Vaccination (4 weeks prior). She just put it in my arm in normal way, my left arm. reporter stated, no, but she just thinks people should be aware of the possibility of getting this horrible case and the doctor told me that this pain can last for years (Further clarification unknown), and I mean, it is absolutely terrible. She sent that doctor pictures, it was like sending them pornography. It is so terrible, it is my whole left breast, under my arm all the way down my left arm onto my back and it is as big as a saucer in my back. She still has the pictures in my phone. She just wants to help the people you know everybody should report if something is wrong. Vaccination facility type was pharmacy or drug store. Vaccination facility type was pharmacy or drug store. Booster dose due to high risk of frequent institutional or occupational exposure to coronavirus. Event date reported as 09Jan2022 with onset 15hours, Seriousness criteria was persistent/significant disability/incapacity, important medical event. 09Jan2022 on vaccination got rash on breast, under and along left breast-arm-to back rash on back saucer size sent photos to Dr. (Name) in (withheld). To see he prescribes 3 per. MEDS. Returned home 17Jan rash worse, Shingles was diagnosed, went to Dr. office more medicines worst pain was experienced still ongoing today is 10Feb over 1 month as of today. Sharp, stabbing pains in left breast, arm length inside & onto back. Blood pressure going so high do recommend another pill. Never have been sick like this so horrible, hard to take care of herself.   The initial safety information received was reporting only non-serious adverse drug reaction(s), upon receipt of follow-up information on [18Feb2022], this case now contains serious adverse reaction(s). Information processed together.  Follow-up (18Feb2022): New information received from a contactable consumer. This consumer reported in response to Non-HCP letter sent in cross referenced case which included that:Updated information included: General Tab: (Reporter middle name), Patient tab: (Patient middle name, Historical vaccine, Lab test), Product tab (Dose administration date and time), Events Tab: New SAE events (Blood pressure increased), (Outcome, Treatment received).   Follow-up attempts are completed. No further information is expected.