Age: 51.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Swelling face, Throat tightness, Toothache, Tremor
Clinical narrative: SUSPECTED ANAPHYLACTIC TYPE REACTION; SEVERE BONE PAIN; SCIATICA; SHAKY FEELINGS; NUMBNESS IN FACE; TOOTH PAIN; JAW PAIN; HEADACHE; SEVERE MUSCLE PAIN; This spontaneous report received from a patient concerned a 51 year old female. The patient's height, and weight were not reported. The patient's past medical history included head injury, and concurrent conditions included anaphylactic type reaction, and alcohol allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A expiry: unknown) dose was not reported, 1 total administered on 07-APR-2021 to right arm for prophylactic vaccination. No concomitant medications were reported.  On 07-APR-2021, the patient felt very hot, swelling, and breathing stronger out of her mouth. She sat in her car for about an hour before driving off and did notice her face was swelling before she headed home. In addition to this, within the first 3 to 4 hours post vaccination (but not while still at vaccination site) she had headache, tooth pain, and jaw pain. Within the first 3 hours after vaccination she noticed hives on her face, neck, arms, and chest and developed severe purple-red rash. She felt this like an anaphylactic type reaction (coded to suspected anaphylactic type reaction subsumed events hives, nausea, rash, swelling, face swelling, confusion (right and left hand), breathing stronger and faster, heart rate increased, felt very hot). Her resting heart rate was 95 to 111.  She also experienced shaky feelings (spaced out/ felt out of nausea/ felt shaky and out of it). On the same day at night of the injection, she developed severe muscle and bone pain. she experienced sciatica (lower lumbar spine pain, nerve pain down her left side/ nerve pain on her right side and sacroiliac area pain), which was not normal for her. She also developed nerve pain that she described as shooting pain down her left side. It ran from her spine down to her foot. She was mixing up her left and her right, in her mind left was right and right was left'. It reminded her not being able to do math correctly after her head injury. She stated it was not constant, but occasionally she was still breathing stronger or faster than normal. Her heart rate was resolving but still higher than normal. Her rash resolved. Treatment medications (dates unspecified) included: diphenhydramine hydrochloride and also she had been using an inhaler. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from numbness in face on APR-2021, and tooth pain, jaw pain, and headache on 07-APR-2021, and had not recovered from severe muscle pain, severe bone pain, sciatica, shaky feelings, and suspected anaphylactic type reaction. This report was serious (Other Medically Important Condition).; Sender's Comments: V0-20210419891- Covid-19 vaccine ad26.cov2.s-suspected anaphylactic type reaction. This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.