Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Hyperhidrosis, Pain, Swelling face
Clinical narrative: She had facial swelling/face is still swollen; chills; normal body aches; sweating; This is a spontaneous report from Pfizer. A contactable consumer (patient's mother) reported for a female patient (daughter). A 25-years-old female patient received an unknown dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: unknown, Expiration Date: unknown) via an unspecified route of administration, administered at an unspecified anatomical location on an unknown date (age at vaccination was 25 years) as UNKNOWN, SINGLE DOSE for COVID-19 immunisation. Medical history included very allergic, anaphylactic reactions to food, eczema and other allergies. Concomitant medications were not reported. The caller was online looking for a hotline for side effects from the COVID vaccine. Her daughter had a side effect from vaccine. She had facial swelling, body aches and sweating. She was concerned about her. She wanted to know if she should get the 2nd vaccine. The consumer stated that her daughter had the Pfizer COVID 19 vaccine in (State name withheld), she was a teacher and that is why she got it at 25 years old, and she was very concerned because her daughter was very allergic, her daughter had anaphylactic reactions to food, and had eczema and other allergies and she was very reactive. The daughter got the vaccine and the only thing she got other than the normal body aches and chills was facial swelling. The facial swelling had lasted three days and her face was still swollen. Added her daughter took two Benadryl and it didn't really help. No further information provided. Caller was driving and speaking over agent and unhappy because she waited 20 minutes and was transferred from another Pfizer line. Unable to confirm details with caller as she stated her daughter already reported on the ap and she did not want to report she just wanted to be transferred to medical information. She thought she was being transferred to medical information. She wanted to speak to medical information about her daughter's facial swelling. Patient was daughter of reporter, no date of birth, no height, no weight, no ethnicity. Reporter was mother of patient; no email Primary/Prescriber: not provided Product: Pfizer COVID 19 vaccine, treatment just got it, no NDC, lot or expiration date provided as caller declined to report. The description of product complaint included consumer reported an AE for Pfizer COVID 19 vaccine and mentioned the facial swelling had lasted three days and her face was still swollen. Added her daughter took two Benadryl and it didn't really help. No further information provided. Product strength and count size dispensed was not provided. Additional lot numbers were not provided. Whether a sample of the product was available to be returned, if requested was not provided. Packaging sealed and intact was not provided. The outcome of the event facial swelling was not resolved. The outcome of the other events was unknown.   Information on Lot /Batch Number has been requested.  Follow-up (29Jan2021): New information received from a contactable consumer (patient's mother) reported for a patient (daughter) included: Added the patient's age, medical history, treatment medications, clinical course and description of product complaint.  Follow-up (16Apr2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.