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Write-up: ANEMIA SECONDARY TO MENSTRUATION; TINGLING OF TONGUE; SORE THROAT; MUSCLE ACHES; FEVER; HEADACHE; This spontaneous report received from a physician concerned a 27 year old female. The patient''s height, and weight were not reported. The patient''s past medical history included anemia secondary to menstruation. The patient was not pregnant at the time of reporting. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported) dose was not reported, 1 total, administered on 12-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 12-APR-2021 (same day after vaccination), the patient experienced tingling of tongue, sore throat, muscle ache, fever, headache and was hospitalized. On the same day, the patient experienced anemia secondary to menstruation as her hemoglobin was 6.2 (unit not specified) and was transfused. On 13-APR-2021, the patient had a mild headache at night and labile temperatures (her maximum temperature was 101.1 F in 24 hours prior to this report). On 14-APR-2021, the patient symptoms were improved and she had no thrombocytopenia to date. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from tingling of tongue, headache, muscle aches, sore throat, fever, and anemia secondary to menstruation. This report was serious (Hospitalization Caused / Prolonged).; Sender''s Comments: V0 : 20210429348-covid-19 vaccine ad26.cov2.s- anemia secondary to menstruation. This event is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: MEDICAL HISTORY, UNDERLYING DISEASE 20210429348-JANSSEN COVID-19 VACCINE Ad26.COV2.S-Tingling of tongue, Sore throat. This event(s) are 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). 20210429348-covid-19 vaccine ad26.cov2.s - headache, muscle aches, fever. This event(s) are labeled per and is therefore considered potentially related.
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