Received Jun 30, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (MODERNA)) | MODERNA | UNK | — | IM |
not bad but it hurts from thinking properly; hands is constantly shaking/ cannot control body; didn't want to eat and couldn't eat, so lost 70 pounds in a few months; find it very difficult to speak; bump; didn't want to eat and couldn't eat; And the nerves that control lips so can speak properly, have been compromised; sleeps more than 12 hours a day; they don't always go where want them to go; feeling worse everyday; constant headache/pressure headache; This spontaneous case was reported by a consumer and describes the occurrence of MENTAL IMPAIRMENT (not bad but it hurts from thinking properly) in an elderly male patient who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) 1 dosage form. On an unknown date, received dose of SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) dosage was changed to 1 dosage form. On an unknown date, the patient experienced MENTAL IMPAIRMENT (not bad but it hurts from thinking properly) (seriousness criterion medically significant), TREMOR (hands is constantly shaking/ cannot control body), WEIGHT DECREASED (didn't want to eat and couldn't eat, so lost 70 pounds in a few months), SPEECH DISORDER (find it very difficult to speak), SWELLING (bump), FEEDING DISORDER (didn't want to eat and couldn't eat), FACIAL NERVE DISORDER (And the nerves that control lips so can speak properly, have been compromised), HYPERSOMNIA (sleeps more than 12 hours a day), DYSKINESIA (they don't always go where want them to go), FEELING ABNORMAL (feeling worse everyday) and HEADACHE (constant headache/pressure headache). At the time of the report, MENTAL IMPAIRMENT (not bad but it hurts from thinking properly), TREMOR (hands is constantly shaking/ cannot control body), WEIGHT DECREASED (didn't want to eat and couldn't eat, so lost 70 pounds in a few months), SPEECH DISORDER (find it very difficult to speak), SWELLING (bump), FEEDING DISORDER (didn't want to eat and couldn't eat), FACIAL NERVE DISORDER (And the nerves that control lips so can speak properly, have been compromised), HYPERSOMNIA (sleeps more than 12 hours a day), DYSKINESIA (they don't always go where want them to go), FEELING ABNORMAL (feeling worse everyday) and HEADACHE (constant headache/pressure headache) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Weight: lost 70 pounds in a few months. Went from 220 pounds what he weighed now, which was 150 pounds. No concomitant medication was reported. Patient did not want to eat and could not eat, so patient lost 70 pounds in a few months. And the nerves that control lips so he can speak properly, had been compromised. Patient found it very difficult to speak, so normally he did not speak. Patient's hands were constantly shaking, and they did not always go where he want them to go. He also had some bump in the side, he felt it. Patient had most of the side effects with the exception of being blind and having a migraine headache. The patient cannot control his body. He also had constant headache describing it as "not bad but it hurts him from thinking properly." It was reported that it was a pressure headache and that there was no pain associated with it. His headache was like a pressure headache, and it was always there. In regard to him having a difficulty in speaking, he had to speak very slowly so that he can be understood. He received the vaccine 2 years ago in 2022, he thinks. It was the original vaccine and was able to receive it twice, the 2nd time being the booster shot. Patient also had more of the symptoms than most people. He was feeling worse every day. He slept more than 12 hours a day and when he gets up from sleeping, he falls asleep while watching television. No treatment medication was reported.; Reporter's Comments: The advanced age is a contributor for the events. The benefit -risk relationship of product is not affected by this report.
Test Name: Weight; Result Unstructured Data: lost 70 pounds in a few months. Went from 220 pounds what he weighed now, which was 150 pounds