Received Oct 13, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (MODERNA)) | MODERNA | UNK | — | — |
covid arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (covid arm) in a 73-year-old female patient who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis. The patient's past medical history included COVID-19 in November 2022. Previously administered products included for Allergic asthma: Nucala. Past adverse reactions to the above products included No adverse effect with Nucala. Concurrent medical conditions included Allergic asthma (asthma was allergy-induced). Concomitant products included Omalizumab (Xolair) for Allergic asthma. On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE REACTION (covid arm). At the time of the report, VACCINATION SITE REACTION (covid arm) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In November 2022, SARS-CoV-2 test: (Positive) on a home test. The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Unknown) was unknown. It was reported that, they gave her the shot, and she waited a half only because she had problems in the past with vaccines, not Moderna, but she was highly allergic to different things, so she chose to wait 30 minutes after vaccination. She did not want to get COVID, as she had asthma, her immune system, the older she got the more problems she had, and she got allergy shots twice a week because her asthma was allergy-induced. She used to be on Nucala, but they were now trying on Xolair. She also timed out her COVID vaccine between her Xolair shots. The patient had not missed one COVID vaccine. She had a COVID arm once and had previously reported it, could not recall when she had it. She wore a mask everywhere she went because she could not chance COVID and she could not chance getting the RSV virus again. She stated that it would be two years ago that winter and it almost killed her. She stated that the RSV triggered her asthma, went into pneumonia and she ended up in the hospital. It was unknown if the patient experienced any additional symptoms/events. No treatment information was provided. This case was linked to MOD-2021-026563 (Patient Link).
Allergic asthma (asthma was allergy-induced)
Medical History/Concurrent Conditions: COVID-19
Xolair
Test Date: 202211; Test Name: COVID test; Test Result: Positive