Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Bone pain, Headache, Oxygen saturation, Pain in extremity
Clinical narrative: MULTIPLE BLOOD CLOTS ON BOTH SIDES OF THE LUNGS/NAUSEA(THREW UP BLOOD TWICE)/BLACK STOOL (WAS LIKE DIARRHEA)/FEVER/OXYGEN WAS ON 80S/; WEIRD TASTE (AWFUL); BONE PAIN/BONE PAIN AS BONES FELT LIKE A GLASS/PAINFUL (ANYTHING THAT TOUCHED WAS HURTING); SORE ARM; POSITIVE COVID TEST (RAPID TEST)/CAME POSITIVE BOTH TIMES; HEADACHE; This spontaneous report received from a patient concerned a 40 year old White and Non Hispanic or Latino female. The patient's weight, height, and medical history were not reported.  The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown, expiry: unknown) dose was not reported,1 total dose administered on 10-APR-2021 on left arm as prophylactic vaccination. Batch/Lot number was not reported and has been requested. No concomitant medications were reported. The patient was not pregnant at the time of reporting. On 10-APR-2021, 5 hours after the vaccination, the patient started experiencing headache. On an unknown date the patient experienced sore arm for about a week. On an unknown date the patient experienced bone pain as felt like a glass, painful and anything that touched was hurting. On an unknown date the patient experienced weird taste that was awful. On 16-APR-2021 the patient tested positive for covid-19 (rapid test) (coded as: suspected covid-19). On 17-APR-2021 the patient was again tested positive for covid-19 (rapid test) on both time tested as positive. On 17-APR-2021 the patient experienced 2 episodes nausea (threw up blood twice) before visiting hospital and at the hospital. On an unknown date the patient experienced black stool (was like diarrhea). On 18-APR-2021 the patient had body temperature 100.8 to 100.9 and went to hospital again there diagnosed with multiple blood clots on both sides of the lungs. On an unspecified date the patient was taken with tums and pedialyte for an unknown indication. The patient was treated with tylenol (for an unknown indication), nausea medicine, steroids, blood thinner and oxygen (for oxygen level in 80s). On 21-APR-2021 the patient was discharged from hospital. The patient was hospitalized for 4 days. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. On 26-APR-2021 the patient was recovered from headache. On an unknown date the patient was recovered from sore arm and not recovered from multiple blood clots on both sides of the lungs/nausea(threw up blood twice)/black stool (was like diarrhea)/fever/oxygen was on 80s/, and the outcome of positive covid test (rapid test)/came positive both times, weird taste (awful) and bone pain/bone pain as bones felt like a glass/painful (anything that touched was hurting) was not reported. This report was serious (Hospitalization Caused / Prolonged). This report was associated with product quality complaint: 90000179162 The suspected product quality complaint has been confirmed to be voided (did not meet PQC criteria) based on the PQC evaluation/investigation performed. This case, involving the same patient is linked to 20210521944.; Sender's Comments: V0: 20210520244-Covid-19 vaccine ad26.cov2.s-multiple blood clots on both sides of the lungs. 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).