Age: 72.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Nausea
Clinical narrative: GIANT HIVES/HIVES STARTED; SEVERE CHILLS; MUSCLE ACHES; NAUSEA; FATIGUE; HEADACHE; This spontaneous report received from a patient concerned a 72 year old female. The patient's weight was 127 (pound), and height was 147.32 centimeters. The patient's concurrent conditions included sulpha allergy, latex allergy, heart disease, blood pressure, non-alcohol use, non-smoker, and cervical headaches, and other pre-existing medical conditions included the patient had no history of drug abuse. The patient was not pregnant at the time of vaccination. The patient did not have acute illness 30 days prior to vaccination and did not have history of any disease or allergy to vaccine or food. The patient did not have significant family history of diseases or hospitalizations. The patient was not breast feeding. The patient experienced drug allergy when treated with iodine.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805018 expiry: UNKNOWN) dose was not reported,1 total administered on 12-MAR-2021 10:00 to right arm for prophylactic vaccination. Concomitant medications included butalbital/caffeine/codeine phosphate/paracetamol for cervical headaches.  On 12-MAR-2021, the patient experienced severe chills, muscle aches, nausea, fatigue, headache and itching. On 16-MAR-2021, the patient hives started and on 18-MAR-2021, the patient experienced dizzy spells. She also had upper body hives several hours later and had severe itching and shortness of breath. On 19-MAR-2021, the patient visited the ER. On 20-MAR-2021, the patient had rash all over the body, had giant hives and also experienced swelling and difficulty swallowing. The patient was hospitalized on 21-MAR-2021. Unspecified lab tests were performed for the patient. The patient received unspecified prescriptions to treat the skin eruptions. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from giant hives/hives started, and the outcome of severe chills, headache, muscle aches, fatigue and nausea was not reported. This report was serious (Hospitalization Caused / Prolonged).  Additional information was received from patient on 06-APR-2021. The following information was updated and incorporated in to the case narrative: reporter details (physicians details added), patient demographic details (DOB, age, age group, height, weight, pregnancy information, date of admission and age at the time of vaccination), concurrent condition added (heart disease, blood pressure, sulpha allergy, latex allergy, abstains from alcohol, non-smoker, and cervical headaches), events added (severe chills, muscle aches, nausea, fatigue, headache, giant hives), no. of days hospitalized added for all the events (no information), other AE characteristics added (events giant hives/hives started), hospital address added for all the events, products added (Iodine and Fioricet with codeine), seriousness criteria added for all event (Hospitalization Caused / Prolonged). Upon review following information was amended (removed the event normal side effect and severe skin eruptions).; Sender's Comments: V1: This version is created to update regarding patient's demographic details, concurrent conditions, events added -  severe chills, muscle aches, nausea, fatigue, headache, giant hives, dizzy spells and difficulty swallowing), other AE characteristics added (events giant hives/hives started and dizzy spells), products added, seriousness criteria added for event giant hives and difficulty swallowing (Hospitalization Caused / Prolonged)  20210351080-COVID-19 VACCINE AD26.COV2.S-giant hives. Follow-up received regarding Clinical Details. This event(s) is considered unassessable. The event(s) 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(s).  20210351080-COVID-19 VACCINE AD26.COV2.S-severe chills, muscle ache, nausea, fatigue, headache. Follow-up received regarding Clinical Details. This event(s) is labeled and is therefore considered potentially related.