Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Lip pain, Lip swelling, Lymphadenopathy, Nasal discomfort, Oral herpes
Clinical narrative: blisters on her top and bottom lip scabbed up/inside of her nose  was scabby; Painful (sore) nose; blisters on the tip of her nose down to her lip; Fever blisters; Painful lips; Swollen lips/both lips were swollen beyond recognition; Mouth was very sore; Fever blisters on her lips/blisters on both lips; Swollen lymph nodes; Really high fever like 103.4; Chills; Normal aches; she had the Pfizer booster; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 57 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 12Dec2021 14:00 (Lot number: F63527) at the age of 57 years as dose 3 (booster), single for covid-19 immunisation; influenza vaccine (FLU), administered in arm right, administration date 11Dec2021 (Batch/Lot number: unknown) as dose number unknown, single for immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Covid-19 vaccine (MANUFACTURER UNKNOWN, dose 1, single), for COVID-19 immunization; Covid-19 vaccine (MANUFACTURER UNKNOWN, dose 2, single), for COVID-19 immunization. The following information was reported: IMMUNISATION (medically significant) with onset 12Dec2021 14:00, outcome "unknown", described as "she had the Pfizer booster"; PYREXIA (medically significant) with onset 13Dec2021 13:00, outcome "recovered" (15Dec2021), described as "Really high fever like 103.4"; LIP BLISTER (medically significant) with onset 16Dec2021 14:00, outcome "recovering", described as "Fever blisters on her lips/blisters on both lips"; ORAL PAIN (medically significant) with onset 17Dec2021 10:00, outcome "not recovered", described as "Mouth was very sore"; LIP PAIN (medically significant) with onset 17Dec2021 15:00, outcome "not recovered", described as "Painful lips"; LIP SWELLING (medically significant) with onset 17Dec2021 15:00, outcome "recovering", described as "Swollen lips/both lips were swollen beyond recognition"; PAIN (non-serious) with onset 13Dec2021 10:00, outcome "recovered" (2021), described as "Normal aches"; CHILLS (non-serious) with onset 13Dec2021 13:00, outcome "recovered" (2021), described as "Chills"; ORAL HERPES (non-serious) with onset 18Dec2021, outcome "not recovered", described as "Fever blisters"; NASAL DISCOMFORT (non-serious) with onset 18Dec2021 10:00, outcome "not recovered", described as "Painful (sore) nose"; LYMPHADENOPATHY (non-serious) with onset 14Dec2021, outcome "recovered" (18Dec2021), described as "Swollen lymph nodes"; BLISTER (non-serious) with onset 18Dec2021, outcome "not recovered", described as "blisters on the tip of her nose down to her lip"; SCAB (non-serious), outcome "not recovered", described as "blisters on her top and bottom lip scabbed up/inside of her nose  was scabby". The patient underwent the following laboratory tests and procedures: body temperature: (13Dec2021) 103.4; (13Dec2021) 102.8. Therapeutic measures were taken as a result of pyrexia, lip blister, oral pain, lip pain, lip swelling, pain, chills, oral herpes, nasal discomfort, blister, scab. Clinical course: The patient had the Pfizer booster (as reported, pending clarification) last Sunday (a week and a day ago). She stated that that she had the normal aches, chills and really high fever like 103.4. She took Motrin and the fever came down to 102.8. Over the next 24 hours, it continued to come down and it left. She ran a fever for 48 hours total. After the fever, she got a fever blister on her lip the next day which normally happens after she has a fever. She went to sleep that night and both lips were swollen beyond recognition and she had blisters on both lips. It was so painful. She took some Benadryl and slept a couple of hours and put ice on it and the swelling went down little bit. She had blisters on the tip of her nose down to her lip. The inside of her nose was so sore. It kept going from one place to the other. She had some Clack's solution and swished and swallowed it. She used Orajel and Blistex. She gargled some warm salt water for the inside and used the Clack's solution swish and swallow. The blisters on her top and bottom lip scabbed up and were very painful. When she used a q-tip to put salve on her lip there was a little blood. It has still not healed. She stated that the inside of her nose was very sore and scabby and she had to continuously moisturize so not to hurt it really bad and there was always a little blood on the q-tip as well. She was taking oxycodone for her sore mouth.  The reporter assessed the events normal aches, really high fever like 103.4, fever blisters on her lips/blisters on both lips, mouth was very sore, fever blisters, painful (sore) nose, and painful lips as related to BNT162B2; and assessed normal aches, really high fever like 103.4, fever blisters on her lips/blisters on both lips, mouth was very sore, fever blisters, painful (sore) nose, and painful lips as unrelated to the flu vaccine.; Sender's Comments: Based on the information in the case report and a plausible temporal relationship, a possible causal relationship between the reported events and suspect drug BNT162B2 cannot be excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.