Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Insomnia, Pain, Pruritus, Skin disorder
Clinical narrative: experiencing itching on the back and belly, and bumps all over the body; experiencing itching on the back and belly, and bumps all over the body; caller can't sleep; it's a pain; This is a spontaneous report received from contactable reporter(s) (Nurse) from medical information team, Program ID: (159558). The reporter is the patient.  A 69-year-old male patient received BNT162b2 (BNT162B2), on 20Oct2021 as dose 3 (booster), single (Lot number: FF7590) at the age of 68 years for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: BNT162b2 (2nd dose: received at withheld., NDC number: So small, 59267-1000-1, Lot number: 165729, Expiration date: Jul2021), administration date: 03Apr2021, when the patient was 68-year-old, for Covid-19 immunization; BNT162b2 (1st dose: received at withheld, NDC number: 59267-3000-1, Lot number: EN6198, Expiration date: Jun2021, Dose, route: Left deltoid, dose may be 1cc or may be less, maybe half cc. , Start date of adverse event: 14Mar2021), administration date: 12Mar2021, when the patient was 68-year-old, for Covid-19 immunization, reaction(s): "Experiencing itching on the back and belly", "bumps all over the body", "can't sleep", "it's a pain"; Flu shots (flu shots). The following information was reported: SKIN MASS (medically significant), PRURITUS (medically significant), outcome "not recovered" and all described as "experiencing itching on the back and belly, and bumps all over the body"; INSOMNIA (non-serious), outcome "not recovered", described as "caller can't sleep"; PAIN (non-serious), outcome "not recovered", described as "it's a pain".  Additional information:  He said he and his wife had reactions to the Pfizer covid vaccine. He stated that it may be like getting a flu shot wherein sometimes it works right sometimes it doesn't to the point that you can still get a flu. He says that covid mutates from one strain to a different one so he wanted to know how the vaccine is still the same, composition-wise, given that there have been a lot of new strains compared to the original strain and he doesn't know if the Pfizer covid vaccine has the new strain of virus. He said they chose Pfizer even though they have many choice because they know that we have a good product. [Follow-up (18May2022): The initial case was missing the following minimum criteria: ICH-Unspecified AE. Upon receipt of follow-up information on 18May2022, this case now contains all required information to be considered valid]. Follow-up (18May2022): This is a spontaneous follow-up report received from a contactable male consumer (patient), Program ID: [159558]. This male consumer (Patient) reported for himself that: Updated information: Primary reporter's suffix added. Reporter in slide#2 added. Patient's details, height, weight, race added. Historical vaccine information added. Relevant history captured. Suspect product details, lot no., Start and stop date added. Vaccination facility name and type added. Best doctor information added. Noe events added as 'experiencing itching on the back and belly, and bumps all over the body, can't sleep, it's a pain'. Concomitant therapy captured as None.  Additional information: Additional Context: Warm transfer from withheld with Support, CEP ID. Transfer agent has a caller on the other line. Caller said he received the 1st, 2nd, and 3rd doses of the Pfizer COVID-19 vaccine and is experiencing itching on the back and belly, and bumps all over the body. He has been a Registered Nurse for 34 years, was an operating nurse but retired in 2020. He is sure that he and his wife aren't the only two people experiencing this. Her wife is a Registered Nurse as well, retired also. Her first injection was 12Mar2021, injected first time in left arm, Her whole arm, from elbow to shoulder, developed bumps and itching and then her flank, half of her abdomen, and half of her back developed the bumps and itching also. Patient age: 69 years old now, so minus 2 years from now, he would have been 67 years old. Experiencing itching on the back and belly, and bumps all over the body: Start date of adverse event: Probably 2 days later after receiving the 1st dose, so 14Mar2021. The bumps are even in her scalp, went to a haircut place and asked hairdresser if hairdresser has ever seen bumps like that. Hairdresser asked if he got the Pfizer COVID-19 vaccine and he said yes. Hairdresser said a lot of her customers that had been vaccinated are complaining about the bumps on their scalp. Hairdresser looks through people's hair and has had complaints before about it from customers. He does not have any additional information to provide for those people. Seriousness criteria: Serious because it is annoying because he can't sleep, keeps itching, and itching, and itching, it's a pain. Guesses it is medically significant. Manufacturer: Confirmed all 3 doses he received were Pfizer. Indication: At first he couldn't even see a doctor when he retired without doctor knowing that he got the vaccine, had to show card to doctor. Now he is getting emails saying he is due for the next booster, doesn't want any more injections. Causality: Thinks so, never had anything like this all the time he has worked, never had this with flu shots but with the COVID-19 vaccine he has. he doesn't know about the manufacturer or medication. Requesting information regarding when the vaccine started he knows it was manufactured from the original strain but kept getting the same vaccine even though there are a whole lot of variants now. The vaccine hasn't changed to the variants that are coming, like how the flu shot changes. If he can get the flu shot and wind up getting the flu, they would say it wasn't the variant that was coming. Confirmed he is talking hypothetically. He is worried about the next booster, if he doesn't get the next booster he is worried doctor won't see her at the doctor. Worried because both her and her wife are seniors and he wants his health to be in good condition, doesn't want to itch anymore, tired of itching.   No follow-up attempts are needed. No further information is expected.; Sender's Comments: Based on the information in the case report and a plausible temporal relationship, a possible causal relationship between the 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.