Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Illness, Lethargy, Paraesthesia, Scab
Clinical narrative: Fell down, required 3 stitches, site unspecified, after second vaccine; Caller states that one made her sick; feeling lethargic; She stated it looks like a sunburn around her hair line; headache; scabbing/where it tingled has turned into a scab; Dark hairline, like a sunburn, tattoo or scab around her forehead, after the second vaccine; Dizzy, after second vaccine; Hairline, scalp tingling, after second vaccine; just tired, worn out; sensitive, tingling scalp; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558). The reporter is the patient.  A 70 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 20Mar2021 (Lot number: ER2613) at the age of 70 years as dose 2, 0.3 ml single for covid-19 immunisation. Relevant medical history included: "sleep walking" (unspecified if ongoing); "three stitches in lip" (unspecified if ongoing), notes: Caller states her tooth cut through her lip and she got 3 stiches. Concomitant medication(s) included: CLONAZEPAM taken for rapid eye movements sleep abnormal, start date: Oct2020 (ongoing). Vaccination history included: Bnt162b2 (Dose 1, Lot Number/Expiry Date: LOT: EN6202, Caller unsure of expiry date., Route: injection, Anatomical Location: left arm, No. of Previous Doses: One, Date: 27 FEB 2021, Age at Immunization if date not available: 70 years, Dose: 0.3 ml), administration date: 27Feb2021, when the patient was 70 years old, for Covid-19 immunization. The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "Caller states that one made her sick"; PARAESTHESIA (non-serious) with onset Mar2021, outcome "recovering", described as "Hairline, scalp tingling, after second vaccine"; DIZZINESS (non-serious) with onset 20Mar2021, outcome "recovering", described as "Dizzy, after second vaccine"; FALL (non-serious), outcome "unknown", described as "Fell down, required 3 stitches, site unspecified, after second vaccine"; HEADACHE (non-serious) with onset Apr2021, outcome "recovered" (May2021), described as "headache"; SCAB (non-serious) with onset Apr2021, outcome "not recovered", described as "scabbing/where it tingled has turned into a scab"; FATIGUE (non-serious) with onset Mar2021, outcome "not recovered", described as "just tired, worn out"; SCAB (non-serious) with onset 22Mar2021, outcome "recovering", described as "Dark hairline, like a sunburn, tattoo or scab around her forehead, after the second vaccine"; LETHARGY (non-serious), outcome "unknown", described as "feeling lethargic"; SUNBURN (non-serious), outcome "unknown", described as "She stated it looks like a sunburn around her hair line"; SENSITIVE SKIN (non-serious) with onset Mar2021, outcome "recovering", described as "sensitive, tingling scalp". The events "caller states that one made her sick", "hairline, scalp tingling, after second vaccine", "dizzy, after second vaccine", "fell down, required 3 stitches, site unspecified, after second vaccine", "headache", "scabbing/where it tingled has turned into a scab", "just tired, worn out", "dark hairline, like a sunburn, tattoo or scab around her forehead, after the second vaccine" and "feeling lethargic" were evaluated at the physician office visit and emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of headache.  Additional information: Caller states Pfizer call handler did tell her she was asking questions, so she can't remember how far she actually got, she told her that she had fallen and she was telling her that. Caller states the most important reason she called was because she had had after the second vaccine, this tingling on her scalp and on Friday while she was styling her hair, she noticed around her hairline it looked like she had been sunburned but it looked scabby like a flat scab, and it goes all the way back, behind her ears. Caller states in washing, she had noticed that part behind her ears earlier and she didn't know because she washes her face with her hands and so she had felt that, but of course she can't see the back there and she said what was going on behind her ears. Caller states on Friday, she noticed she had this around the face. Caller states she wonder if that came from the tingling on her scalp then she took her phone and she went all the way around her scalp and the back of her neck and she's got that scabbing all the way around, its flat. and she's (ethnicity) and its darker than she was. Caller states she mentioned that she had fallen because it made her dizzy but not unfunctional and she was just going about her day and being careful because she realized she wasn't 100% and she went to Costco and the basket rolled away from her and she turned to get the basket and she turned and fell face first into the ground. Caller states her tooth cut through her lip and she got 3 stiches. Caller states she was really embarrassed, but she didn't think much about it being the Covid shot. Caller states the dizziness lingered, after the dizziness subsided, she got this headache. Caller states then she started to think about the Covid injection. Caller states the headache was constant and she was taking Tylenol extra strength and it would give some relief and that subsided and now she's just worn out, just tired and that started she would say maybe like Thursday or Friday and she just prayed and asked the lord,whatever it was that's cause her body to act this way, she asked if he would just get it out of her body by food or water and that's where she was. Dizzy: Caller states it started right after the second dose, within hours. Caller states it's still ongoing, like if she turns from the sink to go to the fridge, she has to be careful. Caller states she takes medication. Caller states she was telling her doctor about it and her doctor thinks the vaccine reacted with the medication she was taking so she needed to be careful so she just kind of excepted that. Caller states its not as bad as it was. Caller states the dizziness is back to more like the way she felt from her medication before. Scabbing; sensitive, tingly scalp: Caller states she noticed a couple days later, around her hair line it was sensitive and it would be tingly. Caller states a tingly sensation, like maybe if she sprayed something on herself and it doesn't really burn, it tingles and she noticed that each time everyday or whenever she would put oil on because she wears her hair natural and she rubs it on her scalp and she noticed that when it was on the front or the sides she would get a tingly sensation and that lasted maybe 10 days, 2 weeks. Caller states it wasn't painful, it was just there. Caller confirms it started 22Mar2021 or 23Mar2021 and it got a little more intense and it started each day and then it kind of subsided, it wasn't like it tingled at the same level each time, it did go up and back down. Caller confirms it ended Apr2021 when it subsided. Caller confirms well, there's just a very slight, she's rubbing it now, it's more on the side. Caller confirms it is still ongoing, the tingling, and it has improved. Scabbing: Caller states the scabbing behind the ears, she has noticed for a couple of weeks. Caller states she felt that roughness behind her ears, it feels rough, like eczema rough, but not quite that bad. Caller states she wasn't writing down dates, but she's agreeing with the estimates. Caller states she didn't write anything down, she didn't really connect the dots until she saw a scab and then she remembered the tingling as it started to go away but she thought the tingling was from the Covid injection then when she saw the scab, she thought did the blood make the blood rush to her scab. Caller states she asked herself why does she have this scab on her face. Headache: Caller states she took Tylenol last week, not sure which, she's been taking it everyday, because she's not a pill person because she is taking medication she doesn't really want to take now. Caller states the Tylenol, she takes two one day then the next day she would take one, then if she was hurting the next day, she would take two Tylenol Extra Strength. Caller states they told her don't take Advil, don't take Aleve, don't take Motrin. Caller states everything she takes because she is older now, its supposed to have some kind of adverse effect on you. Caller states they told her to not take anything but Tylenol and don't take too much of that either so that's why she would take two then 1 and it did give her some relief. Caller states she hasn't taken any Tylenol in a few days but she did take some last week, she doesn't remember what day, she stopped last week. Caller states she hasn't had a headache for several days. Caller does not confirm that she has recovered completely from headache. Tired: Caller states she's been tired, just tired, but she attributed it to the medication she takes, but Friday she was kind of exhausted, she told her mom that she felt exhausted. Caller states on Saturday, she was really just pitiful and her grandkids wanted her to take them to the mall and she didn't feel like it and said she would take them tomorrow and yesterday, it was raining and cold, she was feeling more tired, and she said can she please take them tomorrow and she doesn't feel like it because they go home tomorrow. Caller states normally she's there with them and she tries on stuff with them because they are all skinny. Caller states she attributed her being tired to the medication clonazepam, she attributed to that the tiredness and feeling lethargic. Caller states she has felt like that since she started on that medication, maybe 3 years ago and it feels like the vaccine intensified it. Clonazepam: Caller states she takes 0.1mg at night, one tablet at bedtime by mouth. Caller states she didn't want to take it. Caller states she has REM, which means the way they explained it to herexplained it that way to keep her in the bed because she could get up and because she knows her home, she's asleep and she could very easily open the basement door and fall down and break her neck or get in her car and drive while she's asleep still. Caller states she went from 0.25mg up to 0.5mg up to 0.75 up to a full 1mg. Caller confirms she is currently taking 1mg of Clonazepam. Caller states they were giving her 50 to cut in half and then she had to take the whole 5 and an additional half then the one mg because she was still getting up, running into the wall she was dreaming that her neighbors puppy s in the street and the neighbor seemed like she didn't hear her and a car was coming and she thought she was sitting on her front porch in the dream and she jumped out of her bed onto her dresser fell back and hit her head on the night stand and that was horrible. Caller verifies it is in a brown bottle and gets it from the pharmacy. Caller provides manufacturer: Caller states it has a prescription number, that she takes one tab by mouth at bedside. Caller states there's an ONG number, looks like it says 1002, she's going to have to get her magnifying glasses, she can't see this. Caller states the numbers are so small and they are so close together. Caller states it may be the date 02Oct2020, that's the dispense date. Caller states it also says the store number. Caller states the quantity in bottle is 90 tablets. Caller provides barcode with number above: # Additional Vaccines administered on SAME DATE of the Pfizer suspect: No, caller states she was due to take her shingles shot, but she did not take it. Caller states they told her she could take it 4 weeks later, but because she was still dizzy and then the headaches started she still hasn't taken the second shingles vaccine. Caller states she had taken the singles vaccine she thinks it was in December or November. Prior Vaccinations within 4 weeks: No. AE(s) following prior vaccinations: Not provided. Patients Medical History (Including any illness at time of vaccination) and Family Medical History relevant to AEs: No. Test Results: Caller states she had an x-ray of her face and a CT scan of her head and spine because she has had some vertebra plates in her neck, about 15 years ago, and they wanted to be sure those were intact. Caller states they said everything was fine except they did find that she had a granuloma. Caller states she goes to the doctor for that, she thinks the appointment is next week, the first available. Caller states she's going to a lung specialist, pulmonary. Caller unsure of when she went to the emergency room; therefore, unsure of when the testing was completed. Caller states she thought it was helpful in case someone else has this, she wanted to let Pfizer know what's going on, like she said it was rushed through, but its either live or get sick possibly. Caller reports that today, about an hour ago, she looked in the mirror, and notices it was dark on her hairline. Caller describes her hairline as being like a sunburn, tattoo or scab, around her forehead.   No follow-up attempts are possible. No further information is expected.