Age: 46.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Sleep disorder, Somnolence
Clinical narrative: sleepy; does not sleep well; tingling in her mouth; internal itching; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the parent.  A 46 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 11Mar2021 11:00 (Batch/Lot number: unknown) at the age of 46 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: JUNEL FE (ongoing); GABAPENTIN. Vaccination history included: Bnt162b2 (She reports her daughter's itching started about 1.5 to 2 hours after receiving the first Covid 19 vaccine), administration date: 18Feb2021, when the patient was 46 years old, for COVID-19 immunization, reaction(s): "daughter's itching started about 1.5 to 2 hours after receiving the first Covid 19 vaccine". The following information was reported: PRURITUS (non-serious) with onset 11Mar2021 03:00, outcome "unknown", described as "internal itching"; SOMNOLENCE (non-serious), outcome "unknown", described as "sleepy"; SLEEP DISORDER (non-serious), outcome "unknown", described as "does not sleep well"; PARAESTHESIA ORAL (non-serious), outcome "unknown", described as "tingling in her mouth". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of pruritus.  Additional information: Caller reported that her daughter, who is a teacher, received the first dose of the Covid vaccine in early January and the second in early March, 4 weeks after the first dose. Since then she reports that her daughter has experienced internal itching that has persisted for 7 months during the day and night, she has also been sleepy and does not sleep well and its now interfering with her quality of life and and having an emotional toll. Caller reports that her daughter has been to her Primary care physician, an allergist, and allergist immunologist, a neurologist and now has an appointment that has been rescheduled to 11Jan for a immunologist at PRIVACY. Caller reports that there was mention of a clinical trial but her daughter does not want to be a guinea pig. She also reports that now her daughter is experiencing some financial difficulty from her symptoms. Caller then reported that she also experienced internal itching with nothing on the surface of the skin, no rash but just internal itching for 5 weeks after getting vaccinated, she was vaccinated near the same time as her daughter but at a different location, but she reports that her itching was a milder case than her daughters and it has now resolved. She reports that she took Benadryl a couple times a night, but had no rash or issues with her skin. She only experienced the symptoms during the day. Caller reports that she herself is afraid to get the booster dose being offered because she does not want to get the symptoms to the extent that her daughter has it. The daughter of the caller experienced internal itching and it has been going on for 7 months and she is having it at nighttime and daytime. Her daughter also experienced sleepiness and does not sleep well. She received the first Covid 19 vaccine on 18Feb2021 at a PRIVACY at 5:15PM. She does not have the NDC/Lot/Expiry. She received the second Covid 19 vaccine on 11Mar2021 at a PRIVACY at 11:00AM. She does not have the NDC/Lot/Expiry. Her daughter is still having the internal itching and it is getting frustrating and the doctor is are asking is she sure she is not crazy with this complaint because the doctor can not see anything on the body of the daughter. The husband of her daughter has seen it at night and it is not on the skin of her daughter and it is miserable. She reports the itching of her daughter started about 1.5 to 2 hours after receiving the first Covid 19 vaccine. Her daughter took one Benadryl and the itching stopped. After receiving the second Covid 19 vaccine at around 3:00PM on the same day, the internal itching began. Her daughter also had tingling in her mouth. Her daughter did not have any external itching. Her daughter took 2 Benadryl and that did not help at all. NDC/Lot/Expiry unknown for the Benadryl. Her daughter has had bloodwork for environmental andfood allergies. At the neurologist her daughter has had a nerve test, she does not know the exact name, but it's a test to see if her nerves are working ok. She also had an MRI of her brain. All of her tests have been normal, nothing was found. The nerve test and all the bloodwork everything was negative. Her daughter takes birth control pills, Junel FE, but there is no interaction. When probing which arm she received the Covid 19 vaccines in she thinks the right arm because that is the arm that her daughter moves the most. The itching of her daughter is getting worse because her daughter is having to take medications more frequently. Her daughter is taking Gabapentin 300mg three times a day. Since the itching has gotten worse her daughter takes the Gabapentin about every 3 hours now. The Gabapentin is not working well and it makes her sleepy. Additional Information Did any AE(s) require a visit to: Emergency Room? No Physician Office? Yes. Prior Vaccinations (within 4 weeks) list any other vaccinations within four weeks prior to the first administration date of the suspect vaccine(s) was None. After receiving the second Covid 19 vaccine at around 3:00PM on the same day the internal itching began. Caller reports on herself (Patient 1) and her daughter (Patient 2). Patient 1 is the caller/reporter: Female patient; age = 77 years old. "I had the Pfizer Vaccine in Feb2021 and Mar2021 and had the same symptoms as my daughter, internal itching but mine occurred at night. I was able to take 1-2 Benadryls at night to sleep. I suffered with it for 5 weeks, and it finally went away." Patient #2 Is the reporter's daughter; female patient; age = 47 years old "My daughter took the Pfizer Vaccine on 18Feb2021 (first dose) and 11Mar2021 (second dose) and she has been having terrible side effects ever since. She has internal itching inside her body all over. She is still suffering 8 months later and continues to itch day and night. She has to take gabapentin and a sleeping pill at night but she is still rubbing her body since it is internal, not on the outside. It is not a swelling or rash; there is nothing on the surface of the skin. She is a professional teacher and she has been suffering physically, emotionally, financially and it has impacted her quality of life. She can barely function. She is a zombie. We have reported it to Pfizer,. I did get a letter from Pfizer, they misunderstood the whole situation since I said she was on gabapentin. My daughter went on (Name) and saw that there were thousands of reports of side effects and some patients being hospitalized."   The batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.; Sender's Comments: Linked Report(s) : -PFIZER INC-202101325439 similar report from same reporter