Received May 7, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (MODERNA MNEXSPIKE)) | MODERNA | UNK | 3052996 | IM |
Lips are extremely swollen; top and bottom lip; Feel hot and cold; Had no energy; No appetite; Just didn't feel good; The injection site, feeling like it was on fire; Had a terrible, terrible headache and nausea; Had a terrible, terrible headache and nausea; This spontaneous case was reported by a consumer and describes the occurrence of FEELING OF BODY TEMPERATURE CHANGE (Feel hot and cold), ASTHENIA (Had no energy), DECREASED APPETITE (No appetite), FEELING ABNORMAL (Just didn't feel good) and LIP SWELLING (Lips are extremely swollen; top and bottom lip) in a 78-year-old female patient who received mRNA-1283 (MNEXSPIKE PFS) (batch no. 3052996) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below. The suspect product included Pre-filled Syringe injection (batch no. 3052996) for COVID-19 prophylaxis. Previously administered products included for COVID-19 prophylaxis: Spikevax LP.8.1 PFS in October 2025. Past adverse reactions to the above products included No adverse effect with Spikevax LP.8.1 PFS. On 29-Apr-2026, the patient received dose of mRNA-1283 (MNEXSPIKE PFS) (Intramuscular use) 1 dosage form. On an unknown date, the patient started Pre-filled Syringe (unknown route) at an unspecified dose. On 29-Apr-2026, the patient experienced VACCINATION SITE PAIN (Woke up with arm, the injection site, feeling like it was on fire), HEADACHE (Had a terrible, terrible headache) and NAUSEA (Nausea). On 30-Apr-2026, the patient experienced FEELING OF BODY TEMPERATURE CHANGE (Feel hot and cold), ASTHENIA (Had no energy), DECREASED APPETITE (No appetite) and FEELING ABNORMAL (Just didn't feel good). On 01-May-2026, the patient experienced LIP SWELLING (Lips are extremely swollen; top and bottom lip). At the time of the report, FEELING OF BODY TEMPERATURE CHANGE (Feel hot and cold), ASTHENIA (Had no energy), DECREASED APPETITE (No appetite), FEELING ABNORMAL (Just didn't feel good), LIP SWELLING (Lips are extremely swollen; top and bottom lip), VACCINATION SITE PAIN (Woke up with arm, the injection site, feeling like it was on fire), HEADACHE (Had a terrible, terrible headache) and NAUSEA (Nausea) had not resolved. Concomitant medication use information was not provided by reporter. The patient experienced some possible side effects from the Moderna shots. The patient had never experienced these side effects before. On 29-Apr-2026, during the night, the patient woke up with her arm at the injection site feeling like it was on fire and had a terrible headache and nausea, although the nausea might have been caused by the headache. The patient woke up and took ibuprofen, finally fell back to sleep, and got up on 30-Apr-2026 and just did not feel good. Patient felt hot and cold, had no energy, and had no appetite. On 01-May-2026, in the morning, the patient woke up and her lips were extremely swollen; top and bottom lips were huge, as if she had surgery on them or something, and that was it. It was unknown if the patient experienced any additional symptoms/events. Initial and follow-up1 received on 01-May-2026 has been processed together in the same case cycle. Most recent FOLLOW-UP information incorporated above includes: On 01-May-2026: Live follow up received contains significant information: Added suspect product batch lot number and updated coding and reference numbers were added.; Reporter's Comments: The benefit-risk relationship of product is not affected by this report.