Received Apr 18, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (MODERNA)) | MODERNA | 5 | 3043157 | IM |
she was having little headaches; she wanted to report a good side effect that she had from the Spikevax vaccine/ she went from drinking 38-30 bottles of wine in a month, to having 4 bottles in the 2 months after receiving the vaccine; after she had the vaccination, she did not feel well for about 60 hours; after a vaccine, she feels achy and feverish and all that stuff; after a vaccine, she feels achy and feverish and all that stuff; This spontaneous case was reported by a patient and describes the occurrence of MALAISE (after she had the vaccination, she did not feel well for about 60 hours), PAIN (after a vaccine, she feels achy and feverish and all that stuff), PYREXIA (after a vaccine, she feels achy and feverish and all that stuff), HEADACHE (she was having little headaches) and THERAPEUTIC RESPONSE UNEXPECTED (she wanted to report a good side effect that she had from the Spikevax vaccine/ she went from drinking 38-30 bottles of wine in a month, to having 4 bottles in the 2 months after receiving the vaccine) in a female patient of an unknown age who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (batch no. 3043157) for COVID-19 prophylaxis. The patient's past medical history included Hives (Allergic to tetanus as she had hives after the tetanus vaccine). Previously administered products included for COVID-19 prophylaxis: Moderna COVID-19 vaccine in 2021, Moderna COVID-19 Vaccine and Bivalent (Original and Omicron BA.4/BA.5) in 2022; for Product used for unknown indication: Pfizer BioNTech COVID-19 vaccine in 2021 and Tetanus. Past adverse reactions to the above products included Hives with Tetanus; and No adverse effect with Moderna COVID-19 Vaccine, Bivalent (Original and Omicron BA.4/BA.5), Moderna COVID-19 vaccine and Pfizer BioNTech COVID-19 vaccine. Concurrent medical conditions included Blood pressure high, Hypercholesteraemia (High cholesterol) and Allergy to vaccine (Allergic to tetanus). On 22-Nov-2024, the patient received fifth dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use) .5 milliliter. In November 2024, the patient experienced MALAISE (after she had the vaccination, she did not feel well for about 60 hours), PAIN (after a vaccine, she feels achy and feverish and all that stuff) and PYREXIA (after a vaccine, she feels achy and feverish and all that stuff). On an unknown date, the patient experienced HEADACHE (she was having little headaches) and THERAPEUTIC RESPONSE UNEXPECTED (she wanted to report a good side effect that she had from the Spikevax vaccine/ she went from drinking 38-30 bottles of wine in a month, to having 4 bottles in the 2 months after receiving the vaccine). The patient was treated with Naltrexone hydrochloride (Naltrexone) at an unspecified dose and frequency. In November 2024, MALAISE (after she had the vaccination, she did not feel well for about 60 hours) had resolved. At the time of the report, PAIN (after a vaccine, she feels achy and feverish and all that stuff), PYREXIA (after a vaccine, she feels achy and feverish and all that stuff), HEADACHE (she was having little headaches) and THERAPEUTIC RESPONSE UNEXPECTED (she wanted to report a good side effect that she had from the Spikevax vaccine/ she went from drinking 38-30 bottles of wine in a month, to having 4 bottles in the 2 months after receiving the vaccine) had resolved. Patient had no other vaccines. Concomitant product use was not provided by the reporter. The reporter had a good side effect that she had from the Spikevax vaccine that she received in November, and she drank wine mostly and that it had been suggested to her that she should probably cut backed. She would typically have about a bottle of wine a day. After she had the vaccination, she felt unwell for about 60 hours. The reporter stated that typically after a vaccine, she felt achy and feverish and all that stuff, nothing real serious for 24-48 hours, however after this vaccine it lasted a little bit longer. But after that, her desire for alcohol decreased a lot. She went for days without having anything (alcohol) and without thinking about having something. In the days that she did drank, she was able to have just one or two glasses of wine, and that was amazing to her. That went on for 2.5 months, where she went from drinking 38-30 bottles of wine in a month, to 4 bottles in the 2 months after receiving the vaccine and there was nothing else that happened in her life or medical history that she could attribute it to except for the vaccine. During the 2-2.5 months when her desire for alcohol was decreased, she had little headaches that were not bothersome, that would last for 15 seconds or so in the top front of her head in both right and left sides. The reporter tried Naltrexone but it did not work for her. After about 2.5 months, when the desire for alcohol came back like it used to be, the headaches were gone and unfortunately, she went back to her normal ways. She always tried to cut backed cause she knew it was not good for her, but it was very hard for anybody with some kind of an addiction. She again started drinking a bottle a day. No other details were provided. It was unknown if the patient experienced any additional symptoms/events.
Allergy to vaccine (Allergic to tetanus); Blood pressure high; Hypercholesteraemia (High cholesterol)
Medical History/Concurrent Conditions: Hives (Allergic to tetanus as she had hives after the tetanus vaccine)