Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Hypersensitivity, Lip dry, Lip pain, Malaise
Clinical narrative: severe allergic reaction; Second dose: throat is sore; Second dose: lips feel like someone is pricking them with a pin; Second dose: her lips look windburned; Second dose: face is starting to itch, her neck is itching really bad; Second dose: doesn't feel the greatest; Second dose: looks like she's starting to get a rash on her neck; Second dose: her head hurts; Second dose: head is itching so bad; This is a spontaneous report from a contactable consumer (patient). A 50-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EW0171, expiration date: not reported), via an unspecified route of administration, administered on arm left on Tuesday 11May2021 13:30 at single dose for covid-19 immunisation/to prevent the Covid 19 virus. Medical history included migraine from an unknown date and unknown if ongoing, multiple sclerosis (diagnosed in Oct2020, her doctor said she probably has had multiple sclerosis for 20 years, but no one would do an MRI to verify the diagnosis) from Oct2020 and ongoing. No additional vaccines administered on same date with the Pfizer vaccine considered as suspect. No prior vaccinations (within 4 weeks). The concomitant medications included glatiramer acetate (COPAXONE) injection (Lot number: 107311, NDC: 68546-317-30), the first medication which she took for ongoing multiple sclerosis made her throat close up. It has been several months, maybe 3 months since she took Copaxone. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EW0164, expiration date: not reported), via an unspecified route of administration, administered on arm right on 20Apr 2021 at single dose for covid-19 immunisation. The patient previously took flu vaccine (NDC/lot/Expiry: unknown) years ago and was told never to take the flu vaccine again. She doesn't remember what kind of reaction she had. She reports she's been through so much she doesn't know anything anymore. On 11May2021, about 3 hours after receiving the second Covid 19 vaccine, the patient experienced face is starting to itch and her neck is itching really bad. Her throat is sore and her lips feel like someone is pricking them with a pin. She doesn't know what to think. She doesn't feel the greatest. It looks like she's starting to get a rash on her neck. Her lips aren't swollen but her lips look windburned. Her head hurts. She has migraines but she's not sure what her head hurting is from. Her head is itching so bad. The events has not resulted in emergency or physician visit. There was no relevant lab tests reported. The outcome of the events was not recovered. Upon follow up on 14May2021, She experienced a ongoing severe allergic reaction which included a swollen tongue and lips, tingling of tongue and lips, facial redness, and itching. She took Benadryl the day of the reaction and was prescribed prednisone starting 12May2021. If she doesn't take her medications on time her lips tingle and her face turns red. She notes that the swelling has improved her but lips are tingling and itchy. It was reported as there was product complaint(PQC).  Follow up (14May2021): Upon follow up, new information included: treatment details for events, Therapy and lot details of first dose and second dose, ongoing details of event reactions.  No follow-up attempts are needed. No further information is expected.