Age: 57.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Off label use, Paraesthesia, Product use issue, Vomiting
Clinical narrative: NAUSEA; COULD NOT STOP VOMITING; INSOMNIA LAST NIGHT; TINGLING SENSATIONS; TERRIBLE GAS PAINS; BURNING FEET; WOKE UP IN A NIGHT SWEAT; INAPPROPRIATE SCHEDULE OF VACCINE ADMINISTERED; POTENTIAL MEDICATION ERROR; This spontaneous report received from a patient on 12-NOV-2021 and concerned a 57 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient was not diagnosed with COVID-19, the patient had not been tested for COVID-19 since the vaccination, the patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and the patient did not receive any other medications within 2 weeks of vaccination. The patient was previously (prior to vaccination) treated with Zofran (ondansetron) and fluids for unknown indication; and experienced drug allergy when treated with codeine for unknown indication.  The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 205A21A, and expiry: unknown) dose number 1, 1 total was administered in right arm on 15-MAY-2021 14:30 for prophylactic vaccination. Non-company suspect vaccine included: (Pfizer BioNTech) bnt 162 ( batch number: FG3527 and expiry: unknown, form of admin, route of admin, and were not reported) dose number 2, administered in right arm on 15-MAY-2021 for prophylactic vaccination. No concomitant medications were reported.  On 15-MAY-2021, inappropriate schedule of vaccine was administered and experienced potential medication error.  On 29-OCT-2021, the patient felt fine when she left the store. Then after about 6 hours (20:00) she started to get burning feet and terrible gas pains. That night she woke up in sweat followed by two more nights. Then she woke up on monday and felt really good. On NOV-2021, the patient reported that she had tingling sensations so she started on electrolytes and also she had some insomnia at night of the previous day of report. The patient reported that she was almost back to normal. On 02-NOV-2021, nausea came back and she could not stop vomiting and was admitted by ambulance to the hospital. Duration of Hospitalization was 1 day and discharge date was not reported. The patient was in emergency room/department or urgent care. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable; and action taken with bnt 162 was not reported. The patient was recovering from burning feet, terrible gas pains, woke up in a night sweat, nausea, could not stop vomiting, tingling sensations, and insomnia last night, and the outcome of inappropriate schedule of vaccine administered and potential medication error was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20211135128-Covid-19 vaccine ad26.cov2.s-burning feet, terrible gas pains, woke up in a night sweat, insomnia last night,. 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).  20211135128-Covid-19 vaccine ad26.cov2.s-nausea, could not stop vomiting, tingling sensations. This event(s) is labeled per RSI and is therefore considered potentially related.