Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Malaise, Poor quality product administered, Product administration error, Restlessness
Clinical narrative: Headache; Foggy; has pain in her back where her shoulder blades are and she can't move them; has not been well since the vaccine; extremely tired; her lymph nodes on the left under her arm and on the back of the base of her skull are large; restless; having problems sleeping; injection she received had expired past the 10 week 2 days in the fridge; injection she received had expired past the 10 week 2 days in the fridge; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the parent. A 20-year-old female patient received BNT162b2 (BNT162B2), on 22Nov2022 as dose 1, single (Lot number: FP7138, Expiration Date: 30Nov2022) at the age of 20 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient took concomitant medications. The following information was reported: POOR QUALITY PRODUCT ADMINISTERED (non-serious), PRODUCT ADMINISTRATION ERROR (non-serious) all with onset 22Nov2022, outcome "unknown" and all described as "injection she received had expired past the 10 week 2 days in the fridge"; HEADACHE (non-serious), outcome "not recovered"; FEELING ABNORMAL (non-serious), outcome "not recovered", described as "Foggy"; BACK PAIN (non-serious), outcome "not recovered", described as "has pain in her back where her shoulder blades are and she can't move them"; MALAISE (non-serious), outcome "not recovered", described as "has not been well since the vaccine"; FATIGUE (non-serious), outcome "not recovered", described as "extremely tired"; LYMPHADENOPATHY (non-serious), outcome "not recovered", described as "her lymph nodes on the left under her arm and on the back of the base of her skull are large"; RESTLESSNESS (non-serious), outcome "not recovered", described as "restless"; INSOMNIA (non-serious), outcome "not recovered", described as "having problems sleeping". Therapeutic measures were taken as a result of headache, feeling abnormal, back pain, malaise, fatigue, lymphadenopathy, restlessness, insomnia. Additional information: Concomitant medication reported as Birth Control Pills. No other Conditions and Investigations were reported. Other Products reported as yes. Dates for Concomitant Products Birth Control Pills: (Start: Unspecified Stop: Ongoing). A father calling on behalf of his daughter who received a Pfizer Covid 19 Vaccine 2 weeks ago and she was experiencing problems with her left side lymph nodes and other issues. She got the vaccine at the (vaccine facility name wiithheld) weeks ago, and they were just advised the vaccine was expired beyond the 10 weeks. Confirmed reporter details and above information with the caller. Height and Weight: Unknown. Physician: Unknown. Caller states he was told by the nurse [from the facility where the patient received the injection] the vaccines are good for 10 weeks and then they give 2 days past the 10 weeks. So, what she was telling them, she had just called today, was she said she wanted to let them know the injection they gave his daughter had expired past the 10-week 2 days period in the fridge. Caller states why they are letting them know now, now that it was past 14 days past when she got the injection, he had no idea. He explained when he was looking on the card for the shot record, it said the lot number and that this injection expires on 30Nov2022, but the nurse was saying that was incorrect. Caller had questions about the guidance for the expired vaccine received and if the patient should receive another dose? He states the reason he was asking, was because the nurse said they called Pfizer and Pfizer said there was nothing to worry about and for the patient to come back and get the shot again and then go through the boosters. Caller stated he said wait a minute, he did medical benefits for a living, and he did not understand this, how they administer an expired vaccine, and they said because it is for the entire month of November, so he asked how many people, and she just replied it wasn't a large group and did not answer. He stated he asked her how long out of expiration it was and was told her would need to talk to the Director of the Hospital. Caller states someone must have gotten sick, or something must have happened for them to research into this and find that they had given incorrect injections there that had already expired. Caller states he has already contacted the (name withheld) County Department of Health and they said the facility had already called and notified them about it. Caller asks if the facility as notified Pfizer, call handler informed caller she did not have access to that information. Caller reports the patient had a headache, was foggy, had pain in her back where her shoulder blades are and she could not move them, she had not been well since the vaccine, she was extremely tired, her lymph nodes on the left under her arm and on the back of the base of her skull are large, and she was restless and having problems sleeping. Vaccine was received on 22Nov2022, and it was her first dose. Caller states he could not remember the exact date that each side effect started, but they all started after she got the vaccine. States he will have to get the dates from the patient. Caller states they are all ongoing. When asked the outcome, he stated they were just ongoing. Treatment: Taking Tylenol or Ibuprofen. Caller stated the patient was in nursing school and she had to have the vaccine for clinicals. Now if she was going to have to have this one over again, she was not going to make it in time. Treatment: Taking Tylenol or Ibuprofen. Prior Vaccinations (within 4 weeks): None. Family Medical History Relevant to Adverse Events (AEs): Not Provided.