Age: 58.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Nausea, Neurological symptom, Paraesthesia, Pneumonia, Pyrexia
Clinical narrative: GUILLAIN-BARRE SYNDROME; DIAPHRAGM MUSCLE WEAKNESS; HYPERTENSIVE URGENCY; PNEUMONIA; ASTHENIA; AUTONOMIC NERVOUS SYSTEM IMBALANCE; COVID-19; COUGH; DIARRHOEA; DYSPNOEA; INTENSIVE CARE; NAUSEA; NEUROLOGICAL SYMPTOM; PARAESTHESIA; PYREXIA; RESPIRATORY DISORDER; RESPIRATORY MUSCLE WEAKNESS; VOMITING; SUSPECTED CLINICAL VACCINATION FAILURE; SARS-COV-2 TEST POSITIVE; This spontaneous report received from a health care professional via a Regulatory Authority Vaccine Adverse Event Reporting System (VAERS) (VAERS ID 1623640), concerned a 58-year-old male patient. The patient's height, and weight were not reported. The patient medical history included obesity, borderline hypertension, gastrooesophageal reflux disease (GERD) and obstructive sleep apnea (OSA) [not on continuous positive airway pressure (CPAP)]. The patient experienced dizziness, headache and nausea when treated with tramadol, and edema when treated with vitamin B complex.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 205A21A and expiry: unknown) dose was not reported, 1 total, administered on left arm on 29-APR-2021 for prophylactic vaccination. Concomitant medications included cefalexin, and omeprazole.  On 30-JUL-2021, the patient experienced fever (pyrexia), emesis (vomiting), nausea, diarrhea, dyspnea and cough. On the same day, the patient's severe acute respiratory syndrome coronavirus 2 (SARS-cov-2) test was positive and he experienced coronavirus disease (COVID-19) and suspected clinical vaccination failure. The patient also developed neurological symptoms that included weakness (asthenia), parasthesias, diaphragmatic and respiratory muscle involvement (diaphragm muscle weakness and respiratory muscle weakness), pneumonia, respiratory disorder, hypertensive urgency, dysautonomia (autonomic nervous system imbalance), and was hospitalized at the neuro intensive care (ICU). On 03-AUG-2021, the patient was diagnosed with acute inflammatory demyelinating polyneuropathy (AIDP) Guillain-Barre syndrome. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from asthenia, autonomic nervous system imbalance, covid-19, cough, diaphragm muscle weakness, diarrhoea, dyspnoea, Guillain-Barre syndrome, hypertensive urgency, intensive care, nausea, neurological symptom, paraesthesia, pneumonia, pyrexia, respiratory disorder, respiratory muscle weakness, sars-cov-2 test positive, vomiting, and suspected clinical vaccination failure. This report was serious (Hospitalization Caused / Prolonged, and Life Threatening). This case is associated with product quality complaint: 90000192498 and 90000192670. The suspected product quality complaint has been confirmed to be undetermined. A manufacturing related root cause could not be identified evaluation/investigation performed.  Additional information was received from a government body on 08-OCT-2021. The following information was updated and incorporated into case: investigation result was added.; Sender's Comments: V4: The follow up updates product investigation result. This follow up information does not alter the causality of previously reported events.  20210908094 -COVID-19 VACCINE AD26.COV2.S- Diaphragm muscle weakness, hypertensive urgency, pneumonia, asthenia, autonomic nervous system imbalance, COVID-19, cough, diarrhoea, dyspnoea, intensive care, nausea, neurological symptom, paraesthesia, pyrexia, respiratory disorder, respiratory muscle weakness, vomiting, SARS-COV-2 test positive. This event(s) is 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). 20210908094 -COVID-19 VACCINE AD26.COV2.S- Guillain-barre syndrome. This event is considered related. The event has a compatible/suggestive temporal relationship, is unlabeled, and is scientifically plausible. There is no information on any other factors potentially associated with the event. 20210908094-COVID-19 VACCINE AD26.COV2.S- Suspected clinical vaccination failure . 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: SPECIAL SITUATIONS