Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Burning sensation, Ear discomfort, Extra dose administered, Fatigue
Clinical narrative: woke up with sweats; couldn't sleep; even her earlobe felt like it was pinching; Fatigue; feeling sick; headache; fever of 101/ Fever; aching like her nerves are high pitched; injection site redness, swelling, and itching; injection site redness, swelling, and itching; injection site redness, swelling, and itching; aching burning sensation; Injection site lump; her third, or booster dose; This is a spontaneous report from a contactable consumer or other non hcp. A 66-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection) via an unspecified route of administration, administered in Arm Left on 15Aug2021 at 15:00 (Batch/Lot Number: FC3180) as dose 3, single for covid-19 immunization (at the age of 66-years-old). Medical history included allergic to Sulfa and gastrooesophageal reflux disease (GERD) from an unknown date and unknown if ongoing and ongoing arrhythmia from an unknown date and had family history of cholesterol from an unknown date. Concomitant medication(s) included atenolol taken for arrhythmia; olmesartan medoxomil (BENICAR) taken for prophylaxis; omeprazole taken for gastrooesophageal reflux disease; atorvastatin calcium (LIPITOR) taken for blood cholesterol and flecainide (FLECAINIDE) taken for arrhythmia, start and stop date were not reported for all. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EL3249) on 30Jan2021 early morning in the left arm and received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EL9265) on 20Feb2021 at 09:00 as single dose for COVID-19 immunization and had no side effects. The patient previously also received flu shot last year for immunization and experienced frozen shoulder from the flu shot (mentions she got frozen shoulder from the flu shot last year; but she has no product information, no NDC, lot or expiration for that flu shot). Patient had not received any other vaccine within 4 weeks of vaccination. It was reported that patient received her third, or booster dose of vaccine on 15Aug2021 and stated that the next day on 16Aug2021 she was feeling sick, had headache, fever of 101/ fever, aching like her nerves are high pitched, injection site redness, swelling, and itching, aching burning sensation and injection site lump. On 17Aug2021 she couldn't sleep, even her earlobe felt like it was pinching and had fatigue. On 18Aug2021 she woke up with sweats. The patient stated that "After the booster on 15Aug2021, the next day she reports she got a headache, felt really sick the next day and yesterday; had a fever of 101 and felt an aching burning sensation, even her earlobe felt like it was pinching then at the site of the injection she has a four inch by two inches red red area and it had a lump that may have gone down some; and it is itchy. Adds she also felt fatigue. Adds the ache she would guess it was some kind of vagal response, anytime she felt pain she could feel it projecting to another part of her body, like ants running in her body and her nerves were so high pitched she couldn't sleep. Today her arm maybe is a little less lumpy; and she doesn't feel nearly as bad as Sunday; and today her temperature is normal. Mentions there is no sign of blood so the lump on her arm is not like a hematoma. Adds the worst was on Sunday; she woke up with sweats like menopause. Today she reports all of her symptoms have gone away, except the lump on her arm and it is improved. Adds she would not have called except for the arm. She is asking is this normal or is it something she should be concerned about?. Treatment: Mentions she would have gone to the emergency room if it had not gotten better. Caller confirmed she did not contact her doctor and did not report any treatment". Patient had not visited emergency room or physician office for the events. The patient underwent lab tests and procedures which included body temperature which showed fever of 101 on 17Aug2021 (yesterday) and was normal on 18Aug2021. The outcome of the event vaccination site lump was recovering at the time of report and patient had recovered from the event feeling sick and headache on 17Aug2021 and from event fever on 18Aug2021and was recovered from rest of the other events on an unspecified date in 2021.The outcome was unknown for the event extra dose administered.  The lot number for the vaccine [BNT162B2], was not provided and will be requested during follow-up.