Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Urticaria
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (completely inoculated and boosted, but she got covid) and URTICARIA (hives got worse) in a 71-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis. Co-suspect product included non-company product NIRMATRELVIR, RITONAVIR (PAXLOVID) for COVID-19 treatment. Concurrent medical conditions included Hives (She got hives every 3 years, and this was going on for the last 24 years.). On 02-Jun-2022, the patient started NIRMATRELVIR, RITONAVIR (PAXLOVID) (unknown route) at an unspecified dose. On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. In 2022, the patient experienced COVID-19 (completely inoculated and boosted, but she got covid) and URTICARIA (hives got worse). At the time of the report, COVID-19 (completely inoculated and boosted, but she got covid) was resolving and URTICARIA (hives got worse) outcome was unknown.    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2022, SARS-CoV-2 test: positive (Positive) Positive (got covid 3 days ago). The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown. Concomitant product use was not provided by the reporter. It was reported that the patient was completely inoculated and boosted, but she got covid 3 days ago. The recommendation was to use Paxlovid, to prevent it, she was 71 years old and in great health, and currently her covid was also better. She had a case of hives currently that had nothing to do with Paxlovid. Currently, she has had the hives for month or 2. She just started the Paxlovid on the night of 02-Jun-2022, and the hives had got worsen. It was not worse to the point that her breathing was bad or anything, clarified her breathing was not bad, her hives were just worse. The patient had Moderna covid-19 vaccine all the way. Caller stated that he was read the material about Paxlovid and it said that Paxlovid may cause hives. Caller states was there a chance that paxlovid could increase hives or cause worsening of hives. There was a product complaint to report, PC1 which was completely inoculated and boosted, but she got covid. The PC 2: She just started the Paxlovid on the night of 02-Jun-2022, and the hives have got worsen. No treatment information was provided. Company Comment: This is a spontaneous case concerning a 71-year-old female patient with no reported medical history, who experienced the unexpected, non-serious, adverse event of special interest, COVID-19 which occurred on an unknown date after receiving a dose of mRNA-1273 Vaccine and the co-suspect, non-company product NIRMATRELVIR, RITONAVIR (PAXLOVID). No further information on risk factors, co morbidities, clinical course and management of the events was available in the report. It was reported that the outcome of the events was unknown. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2022: Upon internal Review on 30-Jun-2022, significant correction was performed to remove tracking only classification and Moderna vaccine was updated from historical vaccine to suspect vaccine.; Sender's Comments: This is a spontaneous case concerning a 71-year-old female patient with no reported medical history, who experienced the unexpected, non-serious, adverse event of special interest, COVID-19 which occurred on an unknown date after receiving a dose of mRNA-1273 Vaccine and the co-suspect, non-company product NIRMATRELVIR, RITONAVIR (PAXLOVID). No further information on risk factors, co morbidities, clinical course and management of the events was available in the report. It was reported that the outcome of the events was unknown. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.