Age: 57.0
Sex: F
Vaccine: COVID19-2, UNK
Symptoms: COVID-19, SARS-CoV-2 antibody test
Clinical narrative: COVID-19 (headache, body aches, fever, sore throat, cough, congestion); This spontaneous case was reported by a nurse and describes the occurrence of COVID-19 (COVID-19 (headache, body aches, fever, sore throat, cough, congestion)) in a 57-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7162B) for COVID-19 prophylaxis.    Co-suspect product included non-company product NIRMATRELVIR, RITONAVIR (PAXLOVID) for COVID-19 treatment.    Previously administered products included for Drug use for unknown indication: Hydrocodone and Valium and Hydrocodone and Valium. Past adverse reactions to the above products included Allergy with Hydrocodone and Valium and Hydrocodone and Valium. Concurrent medical conditions included Hypertension, Obesity, Asthma, Drug allergy (Valium) and Drug allergy (Hydrocodone). Concomitant products included LISINOPRIL from 01-Jan-2019 to an unknown date and BECLOMETASONE DIPROPIONATE (QVAR) from 01-Jan-2018 to an unknown date for an unknown indication.   On 15-Sep-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 09-Apr-2023 at 11:00 AM, the patient started NIRMATRELVIR, RITONAVIR (PAXLOVID) (Oral) 1 dosage form twice a day. On 09-Apr-2023, the patient experienced COVID-19 (COVID-19 (headache, body aches, fever, sore throat, cough, congestion)). The last dose administered for NIRMATRELVIR, RITONAVIR (PAXLOVID) was on 13-Apr-2023. The patient was treated with PARACETAMOL (TYLENOL) (oral) from 08-Apr-2023 to 10-Apr-2023 at an unspecified dose and frequency. At the time of the report, COVID-19 (COVID-19 (headache, body aches, fever, sore throat, cough, congestion)) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 09-Apr-2023, SARS-CoV-2 antibody test: Positive. On 16-Apr-2023, SARS-CoV-2 antibody test: Negative. On 18-Apr-2023, SARS-CoV-2 antibody test: Negative. On 20-Apr-2023, SARS-CoV-2 antibody test: Positive. On 21-Apr-2023, SARS-CoV-2 antibody test: Positive.     For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   It was reported that patient took other medications/products within 2 weeks of starting COVID-19 treatment.  Patient was up to date on all of the COVID vaccines including all boosters using Moderna only for all vaccines.  On 09-Apr-2023  Sunday, patient woke up with headache, body aches, fever, sore throat. Patient did home test which was positive. Body aches and headache was severe and Tylenol was not helping. Patient called provider and started treatment with Paxlovid that day. Product worked great, within two days patient felt 90 percent better.  On day 7, patient did a rapid test which was negative and again when return to work on day 9 which was also negative. Patient had no lingering side effects.  On day 11, patient woke up with congestion and cough. Patient did another rapid home test which was positive. Symptoms remained mild and just to make sure patient did another rapid home test 24 hours later which was positive.  Patient was able to return to the work on day 8 after two negative rapid test.   Most recent FOLLOW-UP information incorporated above includes: On 05-Jun-2023: Follow-up received: Follow-up case is converted from to Valid case. Medical history, lab data, vaccination details, event details and narrative was updated.