Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Fatigue, Hypersomnia, Pain in extremity, Pruritus
Clinical narrative: one huge hive from the top of her shoulder to elbow; red hot; red hot; itches insanely; swollen; Fatigue; her arm was still a little sore above her elbow and it will itch a little, but nothing like; Slept five hours could not stay awake after Covid arm started.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 72 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 18Aug2021 14:00 (Lot number: EW0202) at the age of 72 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: URTICARIA (non-serious) with onset 28Aug2021, outcome "recovering", described as "one huge hive from the top of her shoulder to elbow"; SKIN WARM (non-serious), ERYTHEMA (non-serious) all with onset 28Aug2021, outcome "recovering" and all described as "red hot"; PRURITUS (non-serious) with onset 28Aug2021, outcome "recovering", described as "itches insanely"; SWELLING (non-serious) with onset 28Aug2021, outcome "recovering", described as "swollen"; FATIGUE (non-serious) with onset 28Aug2021, outcome "recovered" (2021), described as "Fatigue"; HYPERSOMNIA (non-serious) with onset 2021, outcome "unknown", described as "Slept five hours could not stay awake after Covid arm started."; PAIN IN EXTREMITY (non-serious) with onset 28Aug2021, outcome "unknown", described as "her arm was still a little sore above her elbow and it will itch a little, but nothing like". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of urticaria, skin warm, erythema, pruritus, swelling, fatigue.  Additional information: The patient was a 72-year-old female who got her first dose of the Pfizer BioNtech covid 19 vaccines on 18Aug2021 and 10 days later developed covid arm. The patient described it as one huge hive from the top of her shoulder to elbow, red hot, itches insanely and swollen. It was better now but was not resolved. It was still a little sore above the elbow and itches a little, improving. Patient was asking is this a normal side effect. The patient also mentioned some people were down for 3 or 4 days after the vaccine. The patient seeking information if she should get the second dose on 09Sep2021 of the Pfizer Biontech covid 19 vaccine following the side effects she had after the first dose. Response given as spoke from attached document FAQ-COVID-19 Vaccine-receiving second dose after side effect from first dose (v2.0) and referred to HCP. Patient questions about what the percentage of people was who develop covid arm following the vaccine. Response: No information on this topic. Patient questions about what the percentage of women was who develop blood clots or stroke following the Pfizer Biontech covid 19 vaccine or was that mainly men. Response given as spoke from attached document CONS-Blood clots (v2.0). Patient questions about was the patient taking Pfizer COVID 19 vaccine (Verbatim): age and having to go out places and feeling safer. The patient calling regarding the Pfizer COVID vaccine. Stated she had the first shot 18Aug2021, then on 28Aug2021 she developed COVID arm. Clarifies by COVID arm she was referring a huge hive from the top of her shoulder to her elbow that was red hot and itches insane-ly and swelled up; on the same arm where she got the vaccination. Adds she was due for the second dose 09Sep2021. The patient was asking should she get the second dose and was COVID arm a normal side effect. Mentions she got the vaccination because of her age and because of having to go out places and a lot of other people not wearing masks, so she feels safer. The patient reported that ten days later after she got the vaccination, she noticed her the hive on her right arm with itching, swelling and it was red hot. Adds she didn't have any reaction the first or second day. Today her arm was still a little sore above her elbow and it will itch a little, but nothing like on the 28Aug2021. She did notice yesterday on her left elbow a hive, that was hot and itchy but it didn't spread and went away in a few hours. Concomitant Products: States she took no other medications. The patient stated she googled COVID arm and the internet said COVID arm was one of the side effects that could appear two weeks or more after so she didn't get any treatment. No History of all previous immunization with the Pfizer vaccine considered as suspect. No Additional Vaccines Administered on Same Date of the Pfizer Suspect. No Prior Vaccinations (within 4 weeks). No AE(s) following prior vaccinations, mentioned she never gets vaccines, no flu, no shingles, no pneumonia shot. Per medical records, they lost results, only had record that patient was tested via nasal swab on 30Oct2021. Slept five hours could not stay awake after Covid arm started. The report was not related to a study or programme. Other products reported as none. Vaccination facility type reported as clinic site. The patient was administered with dose 2 on 09Sep2021 at 13:00 via intranuclearly at right arm at public health clinic/private administration. AE was not resulted in emergency room and physician office. Family medical history relevant to AE(s) reported as none. Relevant tests reported as none. Investigation Assessment was reported as no.   Follow-up attempts completed. No further information expected.