Sex: F
Vaccine: COVID19
Symptoms: Neuropathy peripheral, Off label use
Clinical narrative: Offlabel use; Booster; neuropathy/burning neuropathy; she has a history of neuropathy but hasn't had any since June, and it came back after she had the Pfizer Bivalent vaccine; chills; burning all come back; joint pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 76-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "neuropathy" (unspecified if ongoing), notes: Caller states that she has a history of neuropathy; "arthritis" (unspecified if ongoing), notes: I already have arthritis; "Guillain-Barre syndrome" (unspecified if ongoing); "a lot of surgeries" (unspecified if ongoing), notes: had so many surgeries that I have some neuropathy from the waist down; "infusion pump" (unspecified if ongoing), notes: I had an infusion pump with hydromorphone for 13 years. In Jun we turned the pump off. The patient's concomitant medications were not reported. Past drug history included: Hydromorphone, notes: I had an infusion pump with hydromorphone for 13 years. In Jun we turned the pump off. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 immunization; Bnt162b2 (DOSE 2, SINGLE), for COVID-19 immunization; Bnt162b2 (DOSE 3, SINGLE BOOSTER 1), for COVID-19 immunization; Bnt162b2 (DOSE 4, SINGLE BOOSTER 2), for COVID-19 immunization. The following information was reported: OFF LABEL USE (medically significant), outcome "unknown", described as "Offlabel use"; IMMUNISATION (medically significant), outcome "unknown", described as "Booster"; NEUROPATHY PERIPHERAL (medically significant), outcome "unknown", described as "neuropathy/burning neuropathy"; DISEASE RECURRENCE (medically significant), outcome "unknown", described as "she has a history of neuropathy but hasn't had any since June, and it came back after she had the Pfizer Bivalent vaccine"; CHILLS (non-serious), outcome "unknown"; BURNING SENSATION (non-serious), outcome "unknown", described as "burning all come back"; ARTHRALGIA (non-serious), outcome "unknown", described as "joint pain".  Clinical course: Patient was not well to begin with. Patient got the first two Pfizer shots and the first two boosters and the third booster on Monday (the label said Pfizer BIVAL). In years passed she had so many surgeries that I have some neuropathy from the waist down and patient had an infusion pump with hydromorphone for 13 years, but in Jun2022 hydromorphone was hard for her clinic to get and we turned the pump off it in Jun2022, and patient was doing real good, having no problems with all the burning but I got the third booster dose on Monday and started out with chills so bad that you can't get warm, when the weather was hot you wear a sweatshirt and get under a blanket, the chills were so bad that she felt like burning, even if its sunny she needs a flannel sweater. I didn't think much of that because that is one of the side effects but then the burning all come back. And my question was, do you know if this will be long lasting or short lived. I already have arthritis so I don't worry about the joint pain, it's just the chills and neuropathy. She got the vaccine on Monday and the side effects started on Wednesday. This burning is just terrible." Her neuropathy has came back. She called to see how long it would last. Caller corrected that the Neuropathy is so bad, that its like she is rolling around burning, her question was if the company knew if its short lived because if this is long term then she will need a new pump. The previous agent said the chills don't last long, she read the instructions on 3rd booster, it has different stuff in it, but she doesn't know if that stuff would cause neuropathy to return. She wants her question address. It doesn't sound like neuropathy has been called in. She also wonders if Guillain-Barre syndrome has anything to do with burning. If its not a big issue, she doesn't know why she started burning, but its hard for her to get around, she is okay with follow up if it helps somebody else but she just wishes to get her question answered. The previous agent said it was in her history and referred her to a doctor, the doctors cant help the neuropathy, she would have to go through a pain center which she was in and it is 30-40 hours away, and the train doesn't works. Caller states that she has a history of neuropathy but hasn't had any since Jun, and it came back after she had the Pfizer Bivalent vaccine. Caller states that when she got the first 2 Pfizer Covid19 vaccines and booster shots, she had no side effects. Caller states that her pharmacist told her that there are 3 new ingredients in the Pfizer Bivalent booster vaccine and caller is asking "would these new ingredients cause me to get the neuropathy back but caller said to follow up with her HCP for clarification.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.