Sex: F
Vaccine: COVID19, COVID19
Symptoms: Headache, Nausea, Oedema, Osteoarthritis, Supraventricular extrasystoles
Clinical narrative: BLOOD PRESSURE HAS BEEN GETTING HIGHER/BLOOD PRESSURE WAS SKY HIGH (210/125); SUSPECTED COVID-19 INFECTION; PAROXYSMAL SUPRAVENTRICULAR TACHYCARDIA; PAC (PREMATURE ATRIAL CONTRACTION); PVC (PREMATURE VENTRICULAR CONTRACTIONS); OSTEOARTHRITIS INCREASED; EDEMA; NAUSEOUS; REVACCINATION WITH DIFFERENT COVID-19 VACCINE; IT WAS HORRID, FELT LIKE DYING; AWFUL BAD HEADACHE; RINGING IN EAR/TINNITUS; This spontaneous report received from a patient via other company (Moderna) concerned a female of unspecified age, race and ethnicity. The patient's height, and weight were not reported. The patient's past medical history included: covid-19, and concurrent conditions included: high blood pressure, drug allergy (Macrobid, Savella, Venlafaxine, Norvasc, Band Aid glue and Nortriptyline), asthma, alcoholism (in recovery since 2001), osteoarthritis (chronic pain), and bandage allergy (latex gloves). The patient received dose 1 with covid-19 vaccine ad26.cov2.s (Dose number in series 1), (suspension for injection, route of admin, batch number and expiry date were not reported) dose was not reported, 1 total administered on an unspecified date in 2021 for covid-19 prophylaxis. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. Concomitant medications included acetylsalicylic acid, atorvastatin, cetirizine, diclofenac, dicycloverine, diltiazem, ergocalciferol, fluticasone, gabapentin, hydrocodone, isosorbide, lidocaine, lisinopril, montelukast, ondansetron, salbutamol, Flucervax Quadravalent and tizanidine. On an unspecified date, after the vaccination, the patient had a horrible reaction and experienced covid-19 twice (Suspected Covid-19 infection), and PSVT (Paroxysmal supraventricular tachycardia) with PAC (premature atrial contraction), PVC (Premature ventricular contractions) and palpitations (Cardiac discomfort) that have shown up after the vaccine, (Dose number in series 1). Laboratory data (dates unspecified) included: Cardiovascular examination PAC (premature atrial contraction), PSVT (Paroxysmal supraventricular tachycardia), PVC (Premature ventricular contractions) and palpitations (Cardiac discomfort). The patient also received initial booster with Non-company suspect vaccine Moderna covid-19 vaccine (elasomeran), (Dose number in series 2), (form of admin, route of admin, batch number and expiry date were not reported) dose was not reported, administered on 09-NOV-2022 for covid-19 prophylaxis which was associated with revaccination with different covid-19 vaccine (Dose number in series 2). The patient also receive any other vaccines (unspecified) in the 4 weeks prior to this non-company vaccine. On 09-NOV-2022, the patient experienced awful bad headache and don't want to get up, don't want to eat for the first 48 hours after vaccination and It was horrid, felt like they were dying (Dose number in series 2). After that since then on an unspecified date in NOV-2022, the patient experienced ringing in ear/tinnitus (Dose number in series 2) and went to their primary care. Patient was very frustrated and says the ringing makes them want to hit their head and reported that it was the loudest hum they have ever heard in their life, everything was on full blast. Her doctor called it tinnitus. On an unspecified date, the patient experienced blood pressure has been getting higher/blood pressure was sky high (210/125), and osteoarthritis increased (Dose number in series 2). Patient went to the emergency room for what they thought was a pain related issue but blood pressure was 210/125 and they had edema (Dose number in series 2) which they never had before. Due to the ringing in the ear, patient was not able to sleep and eat, and feel nauseous (Dose number in series 2). Laboratory data (dates unspecified) included: Blood pressure blood pressure was 210/125 (unspecified units). A couple of times patient had gone into pain management and blood pressure was sky high. Patient reported to not exclude and only attribute to the pain because of the ringing in the ear and really bad headache. The action taken with covid-19 vaccine ad26.cov2.s, and elasomeran was not applicable. The patient recovered from it was horrid, felt like dying on 11-NOV-2022, had not recovered from awful bad headache, ringing in ear/tinnitus, nauseous, osteoarthritis increased, and edema, and the outcome of suspected covid-19 infection, paroxysmal supraventricular tachycardia, blood pressure has been getting higher/blood pressure was sky high (210/125), revaccination with different covid-19 vaccine, PAC (premature atrial contraction) and PVC (premature ventricular contractions) was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20230223031- blood pressure has been getting higher/blood pressure was sky high (210/125).  The event 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. Specifically: MEDICAL HISTORY. Therefore, this event is considered inconsistent with vaccine administration.