Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Lymphadenopathy, Pain in extremity, Peripheral swelling
Clinical narrative: Headache; glands in her neck felt swollen; Left arm painful; Left arm swollen; This is a spontaneous report from a contactable consumer (patient). A 68-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: Solution for injection, Lot number: FC3181, Expiry Date: Unknown) via an unspecified route of administration, administered in left arm on 10Aug2021 at 17:00 (at the age of 68-year-old) as dose 2, single for COVID-19 immunization. Medical history included Type 2 Diabetes, ongoing from an unspecified date (diagnosed about 20 years ago), patient had a surgery on an unspecified date, (Stated that she has metal rods in her lower spine and the discs above and below the rods are bulging against the spinal cord), Migraine, glaucoma, neuropathy in feet and hands, chronic back, hip, knee, shoulder, neck pain from an unspecified date and unknown if ongoing. Family Medical History Relevant to AE included allergic to penicillin on an unspecified date (dad had allergic reactions to bunches of stuff, including allergic to penicillin. Stated that everyone but her has had a severe reaction to penicillin; her 2 sisters, brother, grandmother and aunt. Stated that one of her sister's, her whole face swelled up; Reporter stated that she refused to take penicillin since her family was all allergic to it). Patient did not receive other vaccinations within four weeks prior to the first administration. Concomitant medications included Gabapentin indicated for neuropathy in feet and hands, buprenorphine hydrochloride (BELBUCA) indicate for chronic back, hip, knee, shoulder, and neck pain, insulin degludec (TRESIBA, Lot: LZFT786 Expiry: Jul2023) and Insulin aspart (NOVOLOG) both indicated for type 2 diabetes mellitus all via an unspecified route of administration ongoing from an unspecified date. No other Additional Vaccines Administered on Same Date of the Pfizer Suspect. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: Solution for injection, Lot number: FA6780, Expiry Date: Unknown) via an unspecified route of administration, administered in left arm on 20Jul2021 (68-year-old) 17:30 as dose 1, single for COVID-19 immunization and patient only had a little headache, and "what felt like a flea bite on arm" and administered Flu shot (Lot number: not reported) via an unspecified route of administration on an unspecified date as dose number unknown, single for immunization (20 years ago), It made her have diarrhea and throw up; she had to go to the ER to get an IV, because she lost so much fluid in such a short amount of time. Reporter stated her arm feels like she has been stung by a hornet; Left arm very painful and swollen. She has been using Neosporin with pain on it. Stated that she has had migraines most of her life, and this headache was worse than any migraine that she has ever had, and it has lasted since 10 am on Wednesday morning, 11Aug2021 and hasn't stopped. Stated that the pain and swelling in her left arm started Wednesday night, 11Aug2021. States that on Wednesday night she slept 6 hours which is unusual for her, and when she got up her arm was painful and swollen. It has gotten worse; stated that maybe she should put an ice pack on it. Stated that normally she holds the phone up to her ear because she likes to move around alot, but right now she has the States that the glands in her neck felt swollen after the 2nd dose, she noticed it on Wednesday and Thursday; it's better today. Patient stated that she was waiting to get the vaccine because she didn't have peace about it, so she has been praying about it. She had heard about the Delta virus coming up through (withheld) is a big hub that people stop in when they travel. States that through her prayers she finally got peace about it, so she went and got the vaccine. States that she has heard so much about the side effects of the vaccine; about it causing bells palsy, and people dying, and she finally just turned off her Facebook. Phone on speakerphone, and she wanted to run away in the kitchen because the phone is too loud. It's like a migraine, the light hurts; she feels like she can feel her skull, like her brain is pressing against her skull. Patient did not visit emergency room or physician office visit as a result of the events. Outcome of the event glands in her neck felt swollen was recovering, Outcome of other events were not recovered.  Description of Product Complaint: Description of complaint: Caller was trying to provide the name of her concomitant medication but had a difficult time seeing the name of the product, Tresiba, to be able to spell it for the call handler. Stated that it was written in lime green on the Pen with a lime green outline and she couldn't see it. Caller had to close her left eye to be able to read it. Stated that she had glaucoma and a retina problem in her left eye, so she had to close it.  Manufacturer: Novo Nordisk Inc., Lot: LZFT786, Expiry: Jul2023.  Follow-up attempts are completed. No further information is expected.