Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site mass, Vaccination site pain, Weight
Clinical narrative: they feel it could be an allergic reaction; big bump; her elbow was really sore; she was very tired; swelling; large welt; injection site hurt/She says the welt underneath was hard, raised, firm to the touch, and sore to the touch; Injection site redness; This is a spontaneous report from a two contactable consumer. This consumer (mother) and 34-year-old female consumer (patient) reported that she received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: EN6206) via an unspecified route of administration on 12Mar2021 at 14:00 hours in left arm (at 34-year-old), as dose 1, single for COVID-19 immunization. The patient's medical history was reported as none and no concomitant medications and investigation assessment were received. On 12Mar2021, the patient experienced injection site hurt/she says the welt underneath was hard, raised, firm to the touch, and sore to the touch, injection site redness. Patient said that her reaction began the next morning or overnight. She said it hurted right away, and was achy which was a common thing. She woke up with a big bump about the size of a half dollar, with the redness being twice the size of the bump. Her area of redness was more oblong than round, her mom's was round. Patient took Ibuprofen before bed because she was aching a little. Ibuprofen. Patient took one pill of the regular strength, dosage unknown. The redness grew and got bigger and welt got bigger. The welt was not as big as the red area. The analogy they have been using was the red area was around the size of a hamburger bun, just the redness. The welt underneath was hard, raised, firm to the touch, and sore to the touch. Consumer had a few other side effects. This only happened to her, and it went away after 4 days or so, but day 10 the bump came back and it was not quite as big a bump, but it hurted with a red lump underneath it, and when she moved her arm it was achy. She felt like was it was also in her neck a little bit and the back of neck and shoulder were sore. Her arm was still a little achy after 3 weeks. She clarified that the injection site for both of them was where all lumps and redness were. Her injection site was itchy, but this was not true for her daughter. Consumer's daughter said that her elbow was really sore for 5-6 days, and she was very tired, which was a common side effect. She says she slept for hours and hours. Caller's daughter said that the main thing that was out of the norm was the red bump, swelling or welt, and redness. Her reaction lasted longer, the redness and lump, they lasted 5-6 days, and hers went away. Consumer says she would like to know if they should get the second shot, since they were turned away and told to call the number. She says she thinks that was to make sure that they wouldn't have a more severe reaction with the second dose, they were told to see what Pfizer thinks. Caller also experienced arm soreness, neck tightness, itching and achy. Caller wanted to know the time frame for the second dose, would it be less effective if taken later then 21 days. It was mentioned that consumer and her daughter had an allergic reaction to the first dose of Pfizer vaccine. When they went to get the second shot, they were turned away because the HCP was worried it may be worse than the first allergic reaction and referred the caller to call Pfizer. The event outcome was unknown.  No follow-up attempts were possible. No further information was expected.