Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Headache, Malaise, Nausea, Rash
Clinical narrative: feel strange; rash; throat is not closing; and it was itchy on her arm at the injection site; hard and hot beside the site of injection; woke up this morning with a patch that was 1.5 wide by about 2 inches wide that was raised, red, hot to the touch, and it was itchy on her arm at the injection site; General malaise; Nausea; Headache; This is a spontaneous report from a contactable consumer (Patient). This 70-year-old female consumer reported for herself that she received the first dose of BNT162B2 (PFIZERBIONTECH COVID-19 VACCINE; Solution for injection; Lot number: EL9262; Expiry date: unknown) via intramuscular route, administered in right arm as a single dose (at the age of 70-year-old) for COVID-19 immunization. The patients past medical history included Cesarean section (Had 3 of them. Caller said that did well with anesthesia and had no reactions), cataract removal (First was on 24Nov2020 and the second 01Dec2020. Caller said that did well with anesthesia and had no reactions), Hysterectomy (Caller said that did well with anesthesia and had no reactions), Foot surgery (Caller said that did well with anesthesia and had no reactions), cataract removal on 01Dec2020. The patient was allergic to Penicillin and tetracycline. The patient allergic to Keflex and had a rash.  Tetracycline she had in her 30's got a shooting pain in her left arm and got another shooting pain in her left arm when she took tetracycline again. She had no other allergies aside from ragweed. She said that she had the Penicillin when she was a kid and Keflex as a young adult. Caller does not have the NDC, Lot, or expiration dates for the Penicillin, tetracycline, or Keflex. Lot: SBF021, exp:Aug2021. The only other time that this happened was 2 years ago when she got her flu shot and the year before that. The first year it was mild reaction and 2 years ago it was the size of a golf ball. This year she had nothing from the flu shot. She took Benadryl last night and was surprised when she saw that this morning. It usually wards off any allergy attack. She did not take a whole one and stated that it knocks her out so she only took a half. The patient said that she took a Advil every 4-6 hours and attributed the well being to that. The patients concomitant medications was not reported. The patient was calling about the COVID-19 Vaccine and said that she received the first shot on 20Jan2021. She said that everything had been fine until this morning and it had been 2 weeks. She had no sore arm. On 20Jan2021, patient experienced a headache for a minute for like 2 days. On 21Jan2021, she had nausea lasted a few minutes then it was gone. Caller said that her headache and nausea symptoms were so fleeting that she did not even report it. She said that it was so mild that it was almost insignificant it was so mild. She said that she did report it at the safety reporting system and at the (Website name) for the vaccination check in. One day on an unspecified date, she did feel strange and on 22Jan2021 she had general malaise, she just felt something was wrong and it lasted about 30 minutes. She said that it was a general feeling that she was not well. She said she took a Advil and ignored it.  The patient clarified that last night she started scratching underneath her ear, thought she was going to have a break out, but on 04Feb2021, she woke up this morning with a patch that was 1.5 wide by about 2 inches wide that was raised, red, hot to the touch, and it was itchy on her arm at the injection site. She said that it is no where else, no else on her body. On an unknown date, she felt fine and her throat was not closing and she was not having any trouble breathing or anything. She stated that the spot under her ear was gone. She put Neosporin on it. It was gone this morning. She said that this place on her arm was more of a hard place and a rash now on an unspecified date. She knows the body remembers and years down the road you could get a pain from a injury or surgery. Last night she felt a sharp pain in her right arm. She ignored it and this morning she woke up with this. It is not as hot or red, but it is still raised. The clinical outcome for the events headache recovered on 21Jan2021,  nausea recovered on 22Jan2021, general malaise was recovered on 23Jan2021. The outcome for woke up this morning with a patch that was 1.5 wide by about 2 inches wide that was raised, red, hot to the touch, and it was itchy on her arm at the injection site was recovering. The clinical outcome for the other events was unknown.