Age: 55.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Headache, Hypokinesia, Impaired work ability, Injection site pain
Clinical narrative: CANNOT WORK FULL TIME; NEUROPATHY; CONSTIPATION; URINARY URGENCY; CHILLING; VOMITING; NAUSEA; SHAKING; FEVER; COULDN'T GET UP; APPETITE ABSENT; SEVERE HEADACHE (COULD NOT RAISE HEAD OF THE BED); INJECTION SITE TENDERNESS; TIREDNESS; EXTREME WEAKNESS; This spontaneous report received from a patient concerned a 55 year old female of an unspecified race and ethnic origin. The patient's height, and weight were not reported. On an unspecified date in 2020, the patient had coronavirus (covid-19) two times and has suffered severely from it, and the patient has a history of Meniere's disease for the past 15 years which had been well maintained and managed. The patient received covid-19 vaccine  (series 1) (suspension for injection, route of admin not reported, batch number: 18200915 expiry: Unknown) dose was not reported, 1 total administered on right arm on 29-JUL-2021 17:00:00 for prophylactic vaccination. No concomitant medications were reported.  On 30-JUL-2021 at 03:00:00, the patient had fever which was measured to be at 102 Degrees Fahrenheit and lasted for almost three days, the patient was also shaking, chilling, vomiting and had nausea. These symptoms had not gone down for three days. The patient was administered Intravenous (IV) fluids because of the history of Meniere's disease. On an unspecified date in JUL-2021, the patient experienced severe headache so much so that the patient could not raise head of the bed or was unable to get up, the patient also experienced extreme weakness. The patient had taken Zofran thrice but it did not help with the patient's adverse events. When the patient was able to get up, the patient took some water and Ibuprofen for the fever. It took almost a week for the symptoms to recover. On an unspecified date in JUL-2021, the patient still had a little headache, was extremely tired (tiredness), was not able to eat a whole as had no appetite for a week and complained about injection site tenderness which lasted a few days. On 09-AUG-2021, the patient had started experiencing tingling in toes but was not concerned about it as it was not severe, then the patient started experiencing numbness which was severe in toes and was unto the knees, the HCP (patient) felt like the symptoms were like a limited GBS sort of response, but disregarded the provisional diagnosis, the symptoms further progressed to a feeling of difficulty in walking progressing to pain in feet, which was diagnosed as a neuropathy. The patients left side was more affected than the right side. The patient initially had tingling and then weakness in her hands but was resolved in the month of August. On an unspecified date during the end of AUG-2021, the symptoms progressed until a point where the patient was having bladder and bowel troubles, the patient was constipated and had urinary urgency so much so that she was unable to get to the restroom, the patient had never experienced these symptoms before. On an unspecified date in SEP-2021, the patient had been working part time (cannot work full time) and once fell at work due to the symptoms (which lasted until the end of OCT-2021) and decided to reach out to a primary care physician (PCP) but was unable to get an appointment until 17-NOV-2021. On an unspecified date in NOV-2021, the patient visited the Neurologist (Physician's office visit) and was prescribed gabapentin for her symptoms associated with the Neuropathy. The physician associated the symptoms to be related with the vaccine as it was coincidental based on the temporal relationship. As per the Neurologists assessment the symptoms were recovering slowly, the patient still had a little bit of pain in the left feet leading to limping and balance was also recovering which was worse in September/October than in November.  The action taken with covid-19 vaccine  was not applicable. The patient recovered from appetite absent, shaking, couldn't get up, chilling, vomiting, nausea, severe headache (could not raise head of the bed), tiredness, and extreme weakness on AUG-2021, constipation, and urinary urgency on OCT-2021, injection site tenderness, and fever on 02-AUG-2021, was recovering from neuropathy, and had not recovered from cannot work full time. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20211207767-COVID-19 VACCINE -Neuropathy. This event is considered unassessable. The event 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.