Received Sep 16, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| UNK | VACCINE NOT SPECIFIED (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | 3052549 | IM |
her arm hurt; It was just really a malaise, and the worst reaction ever to a vaccine; she was clammy/was cold and clammy from 2 or 3 in the afternoon on Friday until 2 or 3 in the afternoon on Saturday.; she didn't sleep all night.; was cold and clammy from 2 or 3 in the afternoon on Friday until 2 or 3 in the afternoon on Saturday/ she was so cold that on a day when it was 90 degrees; felt really awful after the vaccine; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (her arm hurt), MALAISE (It was just really a malaise, and the worst reaction ever to a vaccine), COLD SWEAT (she was clammy/was cold and clammy from 2 or 3 in the afternoon on Friday until 2 or 3 in the afternoon on Saturday.), INSOMNIA (she didn't sleep all night.) and FEELING COLD (was cold and clammy from 2 or 3 in the afternoon on Friday until 2 or 3 in the afternoon on Saturday/ she was so cold that on a day when it was 90 degrees) in a 78-year-old female patient who received mRNA-1273.251 (Spikevax LP.8.1 PFS) (batch no. 3052549) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 05-Sep-2025, the patient received dose of mRNA-1273.251 (Spikevax LP.8.1 PFS) (Intramuscular use) .5 milliliter. On an unknown date, the patient experienced PAIN IN EXTREMITY (her arm hurt), MALAISE (It was just really a malaise, and the worst reaction ever to a vaccine), COLD SWEAT (she was clammy/was cold and clammy from 2 or 3 in the afternoon on Friday until 2 or 3 in the afternoon on Saturday.), INSOMNIA (she didn't sleep all night.), FEELING COLD (was cold and clammy from 2 or 3 in the afternoon on Friday until 2 or 3 in the afternoon on Saturday/ she was so cold that on a day when it was 90 degrees) and FEELING ABNORMAL (felt really awful after the vaccine). At the time of the report, PAIN IN EXTREMITY (her arm hurt), MALAISE (It was just really a malaise, and the worst reaction ever to a vaccine), COLD SWEAT (she was clammy/was cold and clammy from 2 or 3 in the afternoon on Friday until 2 or 3 in the afternoon on Saturday.), INSOMNIA (she didn't sleep all night.), FEELING COLD (was cold and clammy from 2 or 3 in the afternoon on Friday until 2 or 3 in the afternoon on Saturday/ she was so cold that on a day when it was 90 degrees) and FEELING ABNORMAL (felt really awful after the vaccine) outcome was unknown. The action taken with mRNA-1273.251 (Spikevax LP.8.1 PFS) (Intramuscular use) was unknown. Concomitant medication was not provided. It was reported that the patient had received her most recent vaccine in the previous week and had experienced the worst reaction to any vaccine she had ever had. The patient had initially thought that she had received Spikevax 2024-2025 formula or last year's formulation, but on further investigation it had been confirmed that she had received Spikevax 2025-2026 formula. The patient had been very upset that no one at Pharmacy had offered her mNEXSPIKE as an option. On Saturday, she had felt so cold that, although the temperature had been 90 degrees, she had needed two quilts. She never had COVID and also not had fever. She had not slept all night on Friday. She felt crappy and had cold and not sweaty. It was also reported that after that horrible reaction and then seeing a commercial for mNEXSPIKE, which she had not been offered, had caused her to question whether she had received the most up-to-date vaccine formulation Treatment medication was not reported.. This case was linked to US-MODERNATX, INC.-MOD-2021-034872 (E2B Linked Report). This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (her arm hurt), MALAISE (It was just really a malaise, and the worst reaction ever to a vaccine), COLD SWEAT (she was clammy/was cold and clammy from 2 or 3 in the afternoon on Friday until 2 or 3 in the afternoon on Saturday.), INSOMNIA (she didn't sleep all night.) and FEELING COLD (was cold and clammy from 2 or 3 in the afternoon on Friday until 2 or 3 in the afternoon on Saturday/ she was so cold that on a day when it was 90 degrees) in a 78-year-old female patient who received mRNA-1273.251 (Spikevax LP.8.1 PFS) (batch no. 3052549) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 05-Sep-2025, the patient received dose of mRNA-1273.251 (Spikevax LP.8.1 PFS) (Intramuscular use) .5 milliliter. On an unknown date, the patient experienced PAIN IN EXTREMITY (her arm hurt), MALAISE (It was just really a malaise, and the worst reaction ever to a vaccine), COLD SWEAT (she was clammy/was cold and clammy from 2 or 3 in the afternoon on Friday until 2 or 3 in the afternoon on Saturday.), INSOMNIA (she didn't sleep all night.), FEELING COLD (was cold and clammy from 2 or 3 in the afternoon on Friday until 2 or 3 in the afternoon on Saturday/ she was so cold that on a day when it was 90 degrees) and FEELING ABNORMAL (felt really awful after the vaccine). At the time of the report, PAIN IN EXTREMITY (her arm hurt), MALAISE (It was just really a malaise, and the worst reaction ever to a vaccine), COLD SWEAT (she was clammy/was cold and clammy from 2 or 3 in the afternoon on Friday until 2 or 3 in the afternoon on Saturday.), INSOMNIA (she didn't sleep all night.), FEELING COLD (was cold and clammy from 2 or 3 in the afternoon on Friday until 2 or 3 in the afternoon on Saturday/ she was so cold that on a day when it was 90 degrees) and FEELING ABNORMAL (felt really awful after the vaccine) outcome was unknown. The action taken with mRNA-1273.251 (Spikevax LP.8.1 PFS) (Intramuscular use) was unknown. Concomitant medication was not provided. It was reported that the patient had received her most recent vaccine in the previous week and had experienced the worst reaction to any vaccine she had ever had. The patient had initially thought that she had received Spikevax 2024-2025 formula or last year's formulation, but on further investigation it had been confirmed that she had received Spikevax 2025-2026 formula. The patient had been very upset that no one at Pharmacy had offered her mNEXSPIKE as an option. On Saturday, she had felt so cold that, although the temperature had been 90 degrees, she had needed two quilts. She never had COVID and also not had fever. She had not slept all night on Friday. She felt crappy and had cold and not sweaty. It was also reported that after that horrible reaction and then seeing a commercial for mNEXSPIKE, which she had not been offered, had caused her to question whether she had received the most up-to-date vaccine formulation Treatment medication was not reported.. This case was linked to US-MODERNATX, INC.-MOD-2021-034872 (E2B Linked Report).; Sender's Comments: US-MODERNATX, INC.-MOD-2021-034872:Same patient, Moderna COVID-19 Vaccine