Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Exposure during pregnancy, Herpes virus infection, Myalgia
Clinical narrative: POTENTIAL HERPES; MATERNAL EXPOSURE DURING PREGNANCY; ANXIETY; MUSCLE PAIN; This solicited pregnancy report received from a consumer concerned a 37 year old white female. The patient was enrolled in a non-company sponsored study.  The patient's weight was 63.49 kilograms, and height was 170 centimeters. The patient's past medical history included: recreational drug use (substance use), and concurrent conditions included: asthma, multigravida, no alcohol and tobacco use, and other pre-existing medical conditions included: Patient had no relevant obstetrical history. The patient initiated treatment with covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805020, and expiry: UNKNOWN) dose was not reported, 1 total, administered on 29-MAR-2021 for covid-19 immunisation. Gestational age was 22 weeks and two days. Concomitant medications included acetylsalicylic acid, codeine phosphate/paracetamol, minerals nos/vitamins nos, and paracetamol for drug used for unknown indication.  On 29-MAR-2021, the patient was pregnant when she had vaccine and experienced muscle pain. On 09-MAY-2021, the patient experienced anxiety. On an unspecified date, the patient experienced potential herpes. The date of the patient's last menstrual period was 24-OCT-2020 and expected delivery date was 31-JUL-2021. Type of pregnancy was reported as singleton. At gestational age 40 weeks and one day, the patient delivered a live, female, full-term neonate via caesarean method of delivery (C-section). Primary reason for C-section was reported as potential herpes. On an unspecified date, the patient spent four days in the hospital for the delivery. The neonate's birth weight was 8 pounds and 6 ounces, body length 20 inches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from maternal exposure during pregnancy on 01-AUG-2021, anxiety, and muscle pain on 05-APR-2021, and the outcome of potential herpes was not reported. The reporter considered the causality between covid-19 vaccine ad26.cov2.s, and potential herpes, anxiety, and muscle pain as related. The reporter did not provide a causality assessment between covid-19 vaccine ad26.cov2.s, and maternal exposure during pregnancy. Company causality between covid-19 vaccine ad26.cov2.s, and maternal exposure during pregnancy, anxiety was not related and potential herpes, muscle pain as related.  This report was serious (Hospitalization Caused / Prolonged).  This case was reassessed as serious based on additional information received from patient on 01-JAN-2022, the following information was updated and incorporated into case narrative: Patient initials and demographics (height) was added. Patient history, concurrent condition, pregnancy details, delivery details, new events (anxiety and potential herpes) were added. Outcome of event maternal exposure during pregnancy and muscle pain was updated to recovered. Reporter causality was updated.; Sender's Comments: V1: The follow up information in this version updates Patient initials and demographics. Patient history, concurrent condition, pregnancy details, delivery details, new events (anxiety and potential herpes) were added. Outcome of event maternal exposure during pregnancy and muscle pain was updated to recovered. Reporter causality was updated.  20210757916-covid-19 vaccine ad26.cov2.s- Maternal exposure during pregnancy . This event(s) is considered not related. The event(s) 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(s) than the drug. Specifically: SPECIAL SITUATIONS.  20210757916-covid-19 vaccine ad26.cov2.s-potential herpes. This event(s) is considered related. 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).