Age: 89.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Cough, Dyspnoea, Lung opacity, Platelet count, Platelet count decreased
Clinical narrative: COVID-19; Dyspnoea; Cough; Lung opacity; Sputum discoloured; SARS-CoV-2 test positive; Blood sodium decreased; Chest X-ray abnormal; Platelet count decreased; Productive cough; White blood cell count normal; This spontaneous report received from a health care professional by a Regulatory Authority VAERS (Vaccine Adverse Event Reporting System) (VAERS ID: 2002108) concerned an 89 year old female of unspecified race and ethnicity. The patient's height, and weight were not reported. The patient's past medical history included chronic diastolic CHF (congestive heart failure), and concurrent conditions included COPD (chronic obstructive pulmonary disease, and Drug allergy (levofloxacin, lidocaine, naproxen, xarelto). The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805018, expiry: unknown) dose was not reported, 1 total administered at right arm on 15-MAR-2021 for an unspecified indication. Drug start period was 273 days. Concomitant medications included acetylsalicylic acid, alprazolam, ascorbic acid/tocopheryl acetate/xantofyl/zeaxanthin/zinc, atenolol, famotidine, ipratropium bromide/salbutamol sulfate, loratadine, paracetamol, salbutamol, multivitamins, and simvastatin. On 13-DEC-2021, Patient was sent to the emergency room for persistent cough. Workup in the ER revealed a sodium of 123, normal white blood cell count but a significantly decreased platelet count of 81. She was given infusion of regeneron and was supposed to be discharged home but given the fact that she was 90 years old and had some shortness of breath at the time of reporting. She was admitted on 13-DEC-2021. Due to high risk, she probably needed to be put in the hospital at least for a few days to see how she responded and depending upon her chest x-ray results and for her low sodium, She did complained of a cough productive occasionally of yellowish-green sputum. No epistaxis or hemoptysis, no chest pain, no nausea, vomiting, diarrhea, no abdominal pain. She was diagnosed with Covid-19. She was placed on doxycycline and dexamethasone for 7 days. She required 2 L (liter) of NC (nasal cannula) eventually. She was discharged on 15-DEC-2021. Laboratory data included: Blood sodium (NR: not provided) Decreased, Chest X-ray (NR: not provided) Abnormal, Platelet count (NR: not provided) Decreased, SARS-CoV-2 test positive (NR: not provided) Positive, and White blood cell count (NR: not provided) Normal. Treatment medications (dates unspecified) included: oxygen, dexamethasone, and doxycycline. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from covid-19, dyspnoea, cough, lung opacity, sputum discoloured, sars-cov-2 test positive, blood sodium decreased, chest x-ray abnormal, platelet count decreased, productive cough, and white blood cell count normal. This report was serious (Hospitalization Caused / Prolonged). This report was associated with a product quality complaint: 90000212619. The suspected product quality complaint has been confirmed to be the reported allegation was not confirmed and the root cause was determined to be not manufacturing related based on the PQC evaluation/investigation performed.  Additional information was received from central complaint vigilance department on 25-JAN-2022. The following information was updated and incorporated into case narrative: Product quality complaint investigation result.; Sender's Comments: V2: This version updates: Product quality complaint investigation result. Medical assessment comment updated.   20220126252-covid-19 vaccine ad26.cov2.s-   Covid-19,  Dyspnoea, Cough, Lung opacity,  Sputum discoloured,  Sars-cov-2 test positive, Blood sodium decreased, Chest x-ray abnormal, Platelet count decreased, Productive cough, White blood cell count normal. 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).