Symptomtext
HYPONATREMIA; SUSPECTED COVID-19 INFECTION; REVACCINATION WITH DIFFERENT COVID-19 VACCINE; This spontaneous report received from a patient via other manufacturer (pfizer) concerned a patient of unspecified age, sex, race and ethnic origin. The patient's height, and weight were not reported. The patient's concurrent conditions included: rheumatoid arthritis, diabetes insipidus (since 2015), hypothyroidism, and unspecified drug allergy. The patient received covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, route of admin not reported, batch number: 1805020, expiry: UNKNOWN) dose was not reported, 1 total administered on 30-OCT-2021 for covid-19 prophylaxis. It was unknown whether patient had any adverse events following vaccination with first dose of covid-19 vaccine ad26.cov2.s. (dose number in series 1). The patient received non-company suspect moderna covid-19 vaccine (elasomeran) (dose number in series 2) (form of admin and route of admin were not reported batch number: 071F21A, expiry: UNKNOWN) dose was not reported, administered on 14-MAY-2022 for covid-19 prophylaxis. It was unknown whether patient had any adverse events following vaccination moderna covid-19 vaccine (elasomeran) (dose number in series 2). The patient additionally received non-company suspect pfizer (tozinameran) (dose number in series 3) (form of admin and route of admin were not reported, batch number: UT7751KA, expiry: UNKNOWN) dose was not reported, administered on 30-SEP-2022 for covid-19 prophylaxis which was revaccination with different covid-19 vaccine (dose number in series 3). Concomitant medications included desmopressin, diphenhydramine, estradiol, guaifenesin, hydroxychloroquine, ibuprofen, levothyroxine, paracetamol, phenylephrine, and pseudoephedrine hydrochloride. On an unspecified date in 2023, the patient experienced suspected covid-19 infection (dose number in series 3). The patient administered non-company suspect drug (name unspecified) (form of admin, route of admin, batch number and expiry were not reported) dose was not reported, administered first dose on 02-OCT-2023 and last dose on 03-OCT-2023 for treatment of covid 19. On 03-OCT-2023 at 08:00, the patient experienced hyponatremia, and was hospitalized (date unspecified) (dose number in series 3). Duration of hospitalization was reported as 3 and discharge information were not reported. Laboratory data (dates unspecified) included: Blood test not reported. Treatment medications (dates unspecified) included: IV (intravenous) fluids, sodium tablet and fluid restricts. The action taken with covid-19 vaccine ad26.cov2.s, elasomeran, and tozinameran was not applicable. The patient recovered from hyponatremia on 04-OCT-2023, and the outcome of suspected covid-19 infection and revaccination with different covid-19 vaccine was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20231013890-hyponatremia. The event shows an incompatible temporal relationship. Therefore, this event is considered inconsistent with vaccine administration.