Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Cough, Diarrhoea, Fatigue, Guillain-Barre syndrome
Clinical narrative: UTI; GUILLAIN BARRE  SYNDROME; COUGH; MUSCLE PAIN; VOMITING; DIARRHEA; TIREDNESS; NAUSEA; HEADACHE; This spontaneous report received from a consumer concerned herself a 40 year old female. Initial information was processed with additional information received on 21-JUL-2021 via a telephone outreach with the patient. The patient's height, and weight were not reported. The patient's concurrent conditions included asthma, diabetes (Type II), pollen allergy, tobacco use (3-4 cigarettes daily and vaping), no drug abuse or illicit drug use, no alcohol use. She reports a semi-active lifestyle; with no recent infectious illnesses or traveling. The patient was not recently vaccinated or hospitalized 6 weeks prior to onset of the event. She also did not have any of the following prior the the events: common cold, flu, or infection with Epstein-Barr, Herpes simplex, Herpes Zoster, adenovirus infection, cytomegalovirus, respiratory syncytial virus infection, coxsackievirus, diarrhea or bloody diarrhea, Lyme disease. Her HIV status was negative. The patient's family history included maternal grandmother with ovarian and breast cancer; no known neurological or autoimmune family history. The patient's last menstruation was 03-JUN-2021; and did not have her period last month. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805025) dose was not reported, administered on 22-MAR-2021 in her right arm for prophylactic vaccination. No concomitant medications were reported.  On 23-MAR-2021, 1 day after receiving the vaccine,  the patient experienced diarrhea, tiredness, nausea, vomiting and headache (also reported as a week after the vaccination). She stated all symptoms worsened at night more than during the day.  On 29-MAR-2021, the patient experienced cough and muscle pain. She stated muscle pain relief with a muscle relaxant. On 13-JUL-2021, the patient reported being diagnosed with Guillain-Barre Syndrome, and was not hospitalized. Both her arms and legs had pain, weakness bilateral; she was falling and dropping things from her hands due to the weakness. She reported the symptoms as starting gradually, spreading and becoming worse. The patient also had problems with her left eye blurry, shortness of breath, left jaw weak when chewing, trouble swallowing both liquids and solids. On an unspecified date, the patient also experienced urinary tract infection (UTI) and frequent urination. Laboratory data (dates unspecified) included: COVID-19 as negative. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from Guillain-Barre Syndrome, cough, diarrhea, tiredness, nausea, headache, muscle pain and vomiting. The outcome of UTI was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: This spontaneous report received from a consumer concerned herself, a 40-year-old female, who experienced Guillain Barre syndrome (GBS), with symptoms starting approximately 3 days after vaccine. Concurrent conditions included asthma, diabetes, tobacco use. She reports no recent infections or travel. The patient was not recently vaccinated with other products. She also did not have any of the following prior the events: common cold, flu, or infection with Epstein-Barr, Herpes simplex, Herpes Zoster, adenovirus infection, cytomegalovirus, respiratory syncytial virus infection, coxsackievirus, diarrhea or bloody diarrhea, Lyme disease. Her HIV status was negative. There was no known neurological or autoimmune family history. No concomitant medications were reported. On day 1, the patient experienced diarrhea, tiredness, nausea, vomiting and headache (also reported as a week after the vaccination). She stated all symptoms worsened at night more than during the day. On day 7, the patient experienced cough and muscle pain. On day 113, the patient reported being diagnosed with Guillain-Barre Syndrome (date of diagnosis not specified) and was not hospitalized. Both her arms and legs had pain, weakness bilateral; she was falling and dropping things from her hands due to the weakness. She reported the symptoms as starting gradually, spreading and becoming worse. The patient also had problems with her left eye blurry, shortness of breath, left jaw weakness when chewing, trouble swallowing both liquids and solids. On an unspecified date, the patient also experienced urinary tract infection (UTI) and frequent urination. COVID-19 testing was negative (date unknown). The occurrence of GBS could represent background incidence of such events in the general population. Considering the temporal relationship, the event is assessed to have an indeterminate relationship with vaccination.