Received Jul 3, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (PFIZER-BIONTECH)) | PFIZER\BIONTECH | 3 | — | LA |
Itching/on both sides of body. Is worse in the private area/Deep itch; This is a spontaneous report received from a Consumer or other non HCP, Program ID. An 82-year-old female patient received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 82 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Heart stent" (unspecified if ongoing), notes: Thinks it has been 4 years since the stent. The patient's concomitant medications were not reported. Past drug history included: Morphine, reaction(s): "nauseas". Vaccination history included: Covid-19 vaccine (DOSE 1, SINGLE, Unknown manufacturer), for COVID-19 Immunization. The following information was reported: PRURITUS (non-serious) with onset 2022, outcome "not recovered", described as "Itching/on both sides of body. Is worse in the private area/Deep itch". Additional information: Patient had other conditions. Caller is patient, reporting adverse event after she took Covid shot from Pfizer. When clarifying that she experienced adverse reaction after taking Covid shot from Pfizer, she states, ever since she took it, has itching at night. Age adverse event(s) started: Does not remember exact date she took that shot. Thought she had the paper, can't find it. Had been about 3 years. Clarified, it had been about 3 years since she had the Covid shot and the itching started, right around that time, would have been 82. Weight: Probably weighs 160, Height: About 5, 5, she has shrunk. Ever since she had the itching, ever since she had the shot. Doctor said, it might be what was causing it, she did not give her anything. Itching: Clarified by caller, she only itches, at night, which is weird. Outcome of event: Clarified, caller still experiencing the itching now, it has stayed the same, it is aggravating. Treatment: No, she rubs stuff on there, that does not really help, topical stuff. When clarifying where on the body, caller experiencing the itching, she states, it starts at top of head, goes all the way, not to bottom feet but, all the way down to her ankles and below ankles, clarified, on both sides of body. Is worse in the private area. Clarified, the itching had only ever occurred at night, since she started experiencing it, about 3 year ago. Had card somewhere but, can't remember. When clarifying which arm shot was given in, caller states, she is pretty sure left arm. Thinks they gave it in car window. Was done by the county. When clarifying if this was the only Covid shot she had received, caller stated, she had 2 more. This was the third one. Did not itch when she got the other 2. Does not know if those other 2 were Pfizer or something else. Clarified, caller had 2 Covid shots prior to this third Covid shot, that was Pfizer, that she experienced the itching with. Is not taking anymore shots. Clarified, had been about 3 years now, since she took this third Covid shot. Might have been 4 years. Indication: Everybody recommended it. Concomitant Products/Medical Conditions: Nothing, other than heart stent in 2001, no she thinks it had been 4 years since the stent. Test results: No tests, no prescription medications. Vaccine Supplemental Questionnaire. Patient Details: Patient Age at Time of Vaccination: Would have been 82. Suspect Product: Facility where vaccine was administered: Unknown, given in car window, given by county, patient did not receive any other vaccines on the same date as the Pfizer vaccine. Patient was not taking any other medications (prescription medications) within 2 weeks prior to the event onset. Patient did not receive any other vaccines within 4 weeks prior to the first administration of the suspect vaccine. Stays away from doctors. No AE required a visit to the Emergency Room. No AE required a visit to a Physician's Office. Went for physical, told nurse about it, told her she thought it was Covid shot, she said, it was a great possibility, she gave her nothing. No treatment received for adverse event. Patient previously received 2 Covid shots, manufacturer unknown, unknown if Pfizer. Patient was not allergic to any previous vaccination, medications, food or other products, other than Morphine, can' t take that stuff. Clarified reaction she has to Morphine as, she gets very nauseas. Had been 50 years. Just tells them, not to give it to her. The reporter considered the event itching as caused by suspect product. During an inbound call to report an adverse event, the patient stated, "I just wanted to report, that ever since I took that booster shot, I itch at night like there's, its crazy. Patient itch from the top of my head to the bottom of my feet. And it's a deep, deep itch. It drives her nuts. So, she just wanted to report that." When asked to confirm the information being provided, patient stated, "Yes, I had a, I have an adverse reaction. I itch only at night. When I lie down. All over from the top of my head to the bottom of my feet. And it's a deep, deep itch." When asked to clarify which shots the patient had taken, patient stated, "It was the third one, from Pfizer." The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.
Medical History/Concurrent Conditions: Stent placement (Thinks it has been 4 years since the stent.)