Age: 59.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Asthenia, COVID-19, Headache, Intervertebral disc protrusion, Malaise
Clinical narrative: SUSPECTED CLINICAL VACCINATION FAILURE; COVID-19; HERNIATED BACK; UNEVALUABLE EVENT; FELT HURTING; NOT FEELING GOOD; SEVERE HEADACHES; WEAK; This spontaneous report received from a patient via other pharma company concerned a 59 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included acromegaly, pituitary tumor, chronic migraines, functional gastrointestinal disorder, and swollen hands, and other pre-existing medical conditions included a history of drug ineffectiveness for an unspecified injectable therapy used in the treatment of acromegaly.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported, 1 total, for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. Non-company suspect drugs included: octreotide acetate(Mycapssa) (capsule, oral) 20 mg, frequency, and therapy dates were not reported for acromegaly; Concomitant medications included botulinum toxin type a (Botox- onabotulinumtoxina). On an unspecified date in 2021, the patient felt hurt, was not feeling good after starting the product (Mycapssa). The patient was in a part of the clinical study of Mycapssa. The patient felt nice while travelling with family as at times she felt of not making it. The patient experienced herniated back but still took the subway. The patient experienced severe headaches and wondered if it was from her medications or her.  The patient felt doing well with the Mycapssa, and her problem was the pain about "all the other things that had gone wrong in her body". On an unspecified date in 2021, after receiving the vaccine the patient experienced Covid-19. The patient was hospitalized for the events (date of admission and exact reason for hospitalization not provided (unevaluable event)). On an unspecified date, the patient felt weak after returning from hospital. As of 03-FEB-2021, the treatment with Mycapssa, headaches, and "all the other things that had gone wrong in the body" were all ongoing. The patient had an appointment later that day (03-FEB-2021) at her pain management clinic. As of 27-APR-2021, treatment with Mycapssa continued. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from severe headaches, and the outcome of covid-19, weak, not feeling good, herniated back, felt hurting, suspected clinical vaccination failure and unevaluable event was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20210504604-COVID-19 VACCINE AD26.COV2.S-suspected clinical vaccination failure. This event(s) is considered not related. The event(s) has an unknown/unclear 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  20210504604-COVID-19 VACCINE AD26.COV2.S-Covid-19, herniated back, unevaluable event, felt hurting. This event(s) is considered unassessable. The event(s) has a 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).  20210504604-COVID-19 VACCINE AD26.COV2.S- not feeling good, severe headache, weak. This event(s) is labeled per RSI and is therefore considered potentially related.