Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Adverse food reaction, Agoraphobia, Depression, Fatigue, Hernia
Clinical narrative: SUICIDAL IDEATION (PATIENT HAD SOME TALK OF DYING); HERNIA (HERNIA WAS STICKING OUT WHEN EATING AND DID NOT WENT BACK IN); ADVERSE FOOD REACTION (EATING ANYTHING MADE PATIENT BLEW UP); AGORAPHOBIA; DEPRESSION; RIB PAIN; FATIGUE AGGRAVATED; This spontaneous report received from a consumer concerned a 6 decade old (age at the time of vaccination 56 years) female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient had history of needing this contact (suicide prevention hotline contact information) in 2019. The patient was previously treated with cyanocobalamin given one month before vaccine for drug used for unknown indication. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: unknown, expiry: unknown) dose was not reported, 1 total, administered on 12-NOV-2021 for covid-19 vaccination. Non-company suspect drugs included: adalimumab (solution for injection in pre-filled pen, subcutaneous, batch number and expiry were not reported) dose, frequency, and therapy dates were not reported for moderate to severe adult Crohn's disease. The batch number was not reported. The Company was unable to perform follow-up to request batch/lot numbers. Concomitant medications included Vitamin B12(cyanocobalamin) for drug used for unknown indication.  On an unspecified date, the patient had some talk of dying (suicidal ideation) and suicide prevention hotline contact information was provided. The patient's hernia was sticking out when eating and did not went back in, she was tired/exhausted/excessive fatigue and eating anything made the patient blew up. It was reported that the patient was tired on constant basis, exhausted. It was reported that the patient's going to the bathroom was less, had improved. The patient was depressed, had excessive fatigue and had tiredness for six months, this was part of her condition. The patient's ribs were in pain, she asked her boyfriend to crack her back harder and it did not hurt but next day her ribs were sore the next day (ribs pain/ribs sore), it might be wrong angle. The patient was agoraphobic (agoraphobia), did not like to leave house, relative due to her depression. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and action taken with adalimumab was not reported. The patient was recovering from fatigue aggravated, depression, and rib pain, had not recovered from hernia (hernia was sticking out when eating and did not went back in), and the outcome of suicidal ideation (patient had some talk of dying), adverse food reaction (eating anything made patient blew up) and agoraphobia was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20220335052-covid-19 vaccine ad26.cov2.s-suicidal ideation (patient had some talk of dying). The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable.