Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Rash pruritic, Skin exfoliation, Swelling, Tachycardia, Tenderness
Clinical narrative: Tachycardia; Motion sickness; Numbness of right forearm; Entire body swelling all extremities; itchy red rash: face, neck, upper chest, forearms, thighs, back eyebrows; severe frontal occipital lateral stabbing headache; sore & tender body; sore & tender body; chills; blurry vision; light sensitivity; foggy memory; swollen neck/neck was swelling; nauseated vomiting/Nausea and vomiting; nauseated vomiting/Nausea and vomiting; burning sensation; Right upper shoulder discomfort with swelling that goes into her neck; Light sensitivity; having a rash; rash is itching; scaling, and her skin is peeling; scaling, and her skin is peeling; redness; severe headache; This is a spontaneous report from a contactable Nurse (patient's mother). A 23-year-old female patient (daughter) received first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: ER8737 and expiry date was not reported), via an unspecified route of administration, in Arm Left, on 07Apr2021 at 11:00 AM (age at vaccination: 23 year) as a single dose for COVID-19 immunization. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccine in four weeks. The patient's medical history included anemic, eczema, gastric reflex, known allergies: citrus food, latex gloves, Compazine, Augment, and headaches from concussions. Concomitant medications included Ferrous Sulfate, Diethylpropion HCL, and glucose, sodium chloride (DNS). The patient was not diagnosed with COVID prior vaccination. The patient was not tested for COVID post vaccination. There was a product complaint to report.   On 07Apr2021 12:30, the patient experienced swollen neck/neck was swelling, nauseated vomiting/nausea and vomiting, entire body swelling all extremities, itchy red rash: face, neck, upper chest, forearms, thighs, back eyebrows, severe frontal occipital lateral stabbing headache, sore, tender body and chills. On 07Apr2021, the patient experienced right upper shoulder discomfort with swelling that goes into her neck, light sensitivity, having a rash, rash is itching, her skin is peeling, redness and severe headache. On 09Apr2021, the patient experienced motion sickness and numbness of right forearm. On 12Apr2021, the patient had tachycardia and scaling. When probed to determine when the tachycardia began, the caller mentioned that the tachycardia was noted at the doctor's office. She confirmed the tachycardia began Monday, 12Apr2021. She clarified it was her second doctor's visit so if the caller gave the wrong date, they were able to find it by her records on her second doctor's visit. Caller confirmed with her daughter the tachycardia was still intermittent, it comes and goes. It seems to be that it has improved. She could consider it was medically significant because they didn't know what the root cause was. Her daughter has never experienced tachycardia before being dosed with the Pfizer vaccine. There was not treatment for tachycardia. Her daughter was still having a rash; she was breaking out intermittently. She confirmed she did not report online that her daughter was intermittently breaking out. At that time when she filed the report online, the rash just broke out. At that time, she didn't know if her daughter's rash was going to abate and then re-appear. If so, then she would have had to re-open a new event with a new date and time and rate it. She just looked at her daughter's skin, it's peeling. These were very itchy. Caller then clarified most of these events started the day of the vaccine, 07Apr2021 at 12:30 PM. She confirmed some of these events were reported online on the date of the incident and were still present. The severity of each event was on a grading scale, and right now her daughter's grading scale was 10. Online, the patient couldn't even tell how they really were feeling. The severity of each event needed to be asked. By the lack of getting all the information and the less Pfizer has, the better it looks for Pfizer. When probed for outcome, the caller confirmed the rash was still ongoing and it was medically significant because she was going to have to take her to dermatologist. She has been using hydrocortisone cream as treatment of the rash and it's not working. She did not have the NDC, LOT,EXP for the cream. She explained the skin peeling/scaling has been ongoing. Her skin breaks out in a rash and then becomes really scaly and then it peels. She clarified overall, she had a rash, but the rash was itching, had redness, scaling, and her skin was peeling. On scale of 1 to 10, the caller would rate this event as a 10. She confirmed and that it's continuous/ongoing and had not improved. Stated the rash was not to any localized area on her daughter's body, it's all over. She clarified further the rash can appear on her daughter's eyes, chin, cheeks, forearm, wrist, and leg. The severe headache was reported on the day of the vaccine as well as the rash, too. The severe headache was ongoing; caller gives it a grade 10+. She confirmed the headache was medically significant. It did prevent her daughter from driving a car, reading, or doing activities. Caller added that the headache was also disabling because it disables her daughter from functioning at her normal capacity, she's been hindered. Her normal activities she could not perform if the headache was present. The headache was described as stabbing, excruciating pain and burning sensation. When probed for the outcome of her daughter's severe headache, the caller explains it's in between persistent and worsening. On a good day, it's a grade 8.5. On a bad day, it's a grade 10+. No medical treatment for headache, she was not really allowed to do anything. She was waiting for Pfizer vaccine to wash out of her daughter's system. She explained her daughter was laying low and not introducing any more drugs to enter her body since she had a reaction. Caller again stated they were waiting for Pfizer's vaccine to wash out of her daughter's system because they feel as though something was triggering the rash that keeps appearing and the headaches were still there on a grade level of 10+. Her daughter was afraid to take medications, so they were having to do treatments like hot compresses to her daughter's head and neck, massaging her head/neck/back and turning the lights off. The Nausea and vomiting began on 07Apr2021 and was still ongoing. No treatment for nausea. Her daughter just gets still and goes to sleep. When the headaches were excruciating, it brings on nausea and vomiting. Also, she noticed motion sickness. When her daughter was riding in the car and she was experiencing a headache, she had terrible motion sickness. Caller confirmed the caller never had this motion sickness prior to the vaccine. The motion sickness was still ongoing. Her daughter was not treating the motion sickness in any way. She states maybe her daughter has taken one Zofran because it was so bad. No further details provided. The numbness of the right forearm started on 09Apr2021. She confirms the numbness is still ongoing, it comes and goes, intermittently and did not receive any treatment. On 07Apr2021, her entire neck was swelling, left and right side. The left side was better but the rightnside had intermittent swelling, there was ongoing swelling on the right side of her neck and did not receive any treatment and just rubbing of her daughter's neck. Her daughter also has right upper shoulder discomfort with swelling that goes into her neck that was ongoing. She confirmed this event to be medically significant and it has hindered her daughter's normal activity if her shoulder was swollen too bad and she was hurting. Her daughter just started physical therapy. The light sensitivity was still ongoing. If her daughter was not experiencing a headache, the light sensitivity was pretty good and treatment included dark rooms/ black out. Her daughter was following up with an allergy testing by the allergy doctor. She has to find out if there were any active ingredients in the Pfizer vaccine that triggered her daughter's reaction. Caller stated, "something in the COVID-19 vaccine triggered her daughter's body to react the way that it did". Her daughter also was following up with a dermatologist. Her primary care physician requested her daughter to be followed up with her allergy doctor and to be tested. Caller requested Pfizer's adverse team or someone to call and let the caller know how Pfizer follows up with their patients and how well Pfizer's values each patient. The patient's symptoms have not abated. The events of swelling, nausea, vomiting, tachycardia, motion sickness, hypoaesthesia, musculoskeletal discomfort, photophobia, rash, rash pruritic, skin exfoliation, erythema and headache were considered to be medically significant. The events caused the patient to visit emergency department and physician's office. The patient received IM Benadryl 50mg and IM Solumedrol steroid as treatment for the events. The outcome of tachycardia was recovering and for burning sensation it was unknown, and for all the other events, it was not recovered.; Sender's Comments: There is a reasonable possibility that the events nausea, vomiting, pruritic rash, erythema, and severe headache were related to BNT162b2 based on known drug safety profile and close temporal relationship. The association between the events swelling, tachycardia, motion sickness, hpyoaesthesia, musculoskeletal discomfort, photophobia, skin peeling, and scaly skin with BNT162b2 can not be fully excluded based on temporal relationship.  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.