Received Oct 31, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (MODERNA MNEXSPIKE)) | MODERNA | UNK | — | IM / RA |
had 2 ocular migraines in one day; felt a little bit dizzy too; this time it was kind of more from the area where got the vaccine down; right foot and my right calf got numb/not getting any more numbness in my foot or my calf; upper right lip got numb/lower lip is a little bit numb again today/upper lip, but then it kind of became more lower lip that was numb; That evening right arm went numb from elbow all the way down to fingertips/right arm went numb again; very bad headaches; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA ORAL (upper right lip got numb/lower lip is a little bit numb again today/upper lip, but then it kind of became more lower lip that was numb), OPHTHALMIC MIGRAINE (had 2 ocular migraines in one day), DIZZINESS (felt a little bit dizzy too), INJECTION SITE HYPOAESTHESIA (this time it was kind of more from the area where got the vaccine down) and HEADACHE (very bad headaches) in a 61-year-old female patient who received mRNA-1273.251 (Spikevax LP.8.1 PFS) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below. The suspect product included Pre-filled Syringe injection for COVID-19 prophylaxis. The patient's past medical history included Tick bite (20 years ago) in 2005. Concurrent medical conditions included Blood pressure high and Autoimmune disorder (Autoimmune illness" due to a tick bite 20 years ago leaving with "MS-like symptoms." in a state of hyper-reactivity.) since 2005. On 25-Sep-2025 at 1:00 PM, the patient received dose of mRNA-1273.251 (Spikevax LP.8.1 PFS) (Intramuscular use) 1 dosage form. On an unknown date, the patient started Pre-filled Syringe (unknown route) at an unspecified dose. On 25-Sep-2025, the patient experienced HEADACHE (very bad headaches). 25-Sep-2025, the patient experienced HYPOAESTHESIA (That evening right arm went numb from elbow all the way down to fingertips/right arm went numb again). On 28-Sep-2025, the patient experienced HYPOAESTHESIA ORAL (upper right lip got numb/lower lip is a little bit numb again today/upper lip, but then it kind of became more lower lip that was numb) and HYPOAESTHESIA (right foot and my right calf got numb/not getting any more numbness in my foot or my calf). 28-Sep-2025, the patient experienced DIZZINESS (felt a little bit dizzy too). 28-Sep-2025, the patient experienced INJECTION SITE HYPOAESTHESIA (this time it was kind of more from the area where got the vaccine down). In October 2025, the patient experienced OPHTHALMIC MIGRAINE (had 2 ocular migraines in one day). The patient was treated with Paracetamol (Tylenol) at an unspecified dose and frequency; Loratadine (Claritin) at an unspecified dose and frequency and Dexamethasone sodium succinate (Dexamethasone) at a dose of for a few days. At the time of the report, HYPOAESTHESIA ORAL (upper right lip got numb/lower lip is a little bit numb again today/upper lip, but then it kind of became more lower lip that was numb), OPHTHALMIC MIGRAINE (had 2 ocular migraines in one day), DIZZINESS (felt a little bit dizzy too) and HYPOAESTHESIA (That evening right arm went numb from elbow all the way down to fingertips/right arm went numb again) had not resolved and INJECTION SITE HYPOAESTHESIA (this time it was kind of more from the area where got the vaccine down), HEADACHE (very bad headaches) and HYPOAESTHESIA (right foot and my right calf got numb/not getting any more numbness in my foot or my calf) was resolving. No concomitant medication was reported. Patient had a COVID booster about a month ago and this year patient had some kind of alarming reactions to it "That evening, patient right arm went numb from elbow all the way down to fingertips, like when laying on arm and it felt asleep. that lasted about 30 seconds to a minute. And patient thought, well, that was really weird. It felt like, so numb, like, when felt asleep on arm and before the pins and needles set in, where kind of were just like super numb. It did not last very long. So that was Thursday night after the shot. Friday and Saturday, nothing happened. Sunday, at about 11 in the morning, right arm went numb again. But this time it was kind of more from the area where patient got the vaccine down and it did not go away. And patient felt a little bit dizzy too. So, at that point, she got a little bit alarmed, and she took a Tylenol and took Claritin and got off the heating pad and going to lay down on the couch for a while and see if it goes away. When she lay down on the couch, upper right lip got numb, right foot and right calf got numb. At that point, this was a little more than normal, patient thought. she went up to urgent care. The only thing they really could did they offered to patient a brain MRI which patient didn't want to get one. Patient had many and she did not want to get; she did not want to do that. There were no signs of having a stroke or anything like that. So, they put patient on dexamethasone for a few days. That gave terrible side effects, so patient stopped taking it and she did not know that it helped at all. If it did, it helped just slightly. She was also having very bad headaches, and those have kind of died off a little bit. did not know if it was an allergy thing, but this felt different. This did not feel like normal headache. That was kind of gotten better, but the other alarming thing that happened was maybe 2 weeks ago or a week ago, maybe 10 days ago. Patient had 2 ocular migraines in one day. had 4 in life and patient had not had one for years, but she had 2 in 1 day." "And basically, this just kind of persisted. This Thursday, it was 4 weeks. It started as upper lip, but then it kind of became more lower lip that was numb. It was reported that patient lower lip felt just slightly numb now. Patient was not getting any more numbness in foot or calf. Patient right arm, the numbness has gotten better, but right hand was still numb. When it first started, it was kind of thumb that ended up being the worst. Now, patient thumb feels ok now. It was more like last, 4th and 5th finger that felt kinda numb, and the palm of hand was very numb. It was more the palm of hand and the back of hand. The headaches have gotten better. patient had gotten better. Every once in a while, though, they would come and go now, but at first it was really kind of persistent. lower lip had gotten better, but this morning, Actually, the reason as today was patient just felt a little worse today and patient lower lip was a little bit numb again. This case was linked to MOD-2023-744170 (Patient Link).
Autoimmune disorder (Autoimmune illness" due to a tick bite 20 years ago leaving with "MS-like symptoms." in a state of hyper-reactivity.); Blood pressure high
Medical History/Concurrent Conditions: Tick bite (20 years ago)