Received Sep 23, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| UNK | VACCINE NOT SPECIFIED (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | 3052671 | IM |
| UNK | VACCINE NOT SPECIFIED (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | — | — |
kind of like a blacking out low blood pressure type of sensation/to lie down on the floor in house where she was working like 3 or 4 times in the last 3 hours/light lightheadedness/feeling really spacey/overcome by the urge to just lie down on floor; like jaw and face tingling that's pretty substantial feeling really spacey or twitchy kind of things go on; This spontaneous case was reported by an other health care professional and describes the occurrence of PRESYNCOPE (kind of like a blacking out low blood pressure type of sensation/to lie down on the floor in house where she was working like 3 or 4 times in the last 3 hours/light lightheadedness/feeling really spacey/overcome by the urge to just lie down on floor) and PARAESTHESIA (like jaw and face tingling that's pretty substantial feeling really spacey or twitchy kind of things go on) in a 41-year-old female patient who received mRNA-1273.251 (Spikevax LP.8.1 PFS) (batch no. 3052671) for COVID-19 prophylaxis. Co-suspect product included non-company product Influenza vaccine inact sAg 4v (Cell based quadrivalent influenza vaccine) for an unknown indication. The patient's past medical history included COVID-19 in February 2025. Previously administered products included for Product used for unknown indication: Pfizer vaccine; for Drug use for unknown indication: Paxlovid. Past adverse reactions to the above products included No adverse effect with Paxlovid and Pfizer vaccine. Concurrent medical conditions included Postural orthostatic tachycardia syndrome, Hypotension and Marfan's syndrome (Mildly). On 09-Sep-2025, the patient received dose of Influenza vaccine inact sAg 4v (Cell based quadrivalent influenza vaccine) (unknown route) 1 dosage form. On 09-Sep-2025 at 9:30 AM, the patient received dose of mRNA-1273.251 (Spikevax LP.8.1 PFS) (Intramuscular use) .5 milliliter. On 09-Sep-2025, the patient experienced PRESYNCOPE (kind of like a blacking out low blood pressure type of sensation/to lie down on the floor in house where she was working like 3 or 4 times in the last 3 hours/light lightheadedness/feeling really spacey/overcome by the urge to just lie down on floor) and PARAESTHESIA (like jaw and face tingling that's pretty substantial feeling really spacey or twitchy kind of things go on). At the time of the report, PRESYNCOPE (kind of like a blacking out low blood pressure type of sensation/to lie down on the floor in house where she was working like 3 or 4 times in the last 3 hours/light lightheadedness/feeling really spacey/overcome by the urge to just lie down on floor) and PARAESTHESIA (like jaw and face tingling that's pretty substantial feeling really spacey or twitchy kind of things go on) had not resolved. The action taken with mRNA-1273.251 (Spikevax LP.8.1 PFS) (Intramuscular use) was unknown. For mRNA-1273.251 (Spikevax LP.8.1 PFS) (Intramuscular use), the reporter did not provide any causality assessments. No concomitant medication was reported. The patient initially received some Pfizer doses, but mostly it had been Moderna since then. The patient received a lot of Moderna shots. It was reported that the patient had inquired regarding antibody response following the vaccine administration and stated that she was definitely having a response. It was explained that it was similar but slightly stronger compared to the prior one, so the patient was not sure and did not want anybody to think she was having an adverse event that needed follow-up. It was also reported that the patient was happy to share the information with the company. It was reported that the patient had strong responses to vaccines, though most people only noticed that she was a little tired. It was explained that it was common and that she sometimes got pretty dramatic symptoms and described that it was just slightly different this time, enough that it made her check online, as it did not feel like the previous Spikevax. It was reported that the patient was trying to get a good primary care doctor for some time but had not yet succeeded. It was reported that it was kind of like a blacking out low blood pressure type of sensation, but patient was not even sure that her blood pressure was dropping. Patient just have had to lie down on the floor in the house where she was working like 3 or 4 times and that was in the last 3 hours and patient got it at 9:30 in morning on 09-SEP-2025 and patient had like light lightheadedness before or like jaw and face tingling that was pretty substantial feeling really spacey or twitchy kind of things go on. Patient was just standing at her desk looking at her phone and overcame the urge to just lie down on the floor at the time of report. It kind of made a little goofy and it was usually short-lived. No treatment medication was reported. This case was linked to MOD-2025-789307, MOD-2025-789350 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 09-Sep-2025: Live follow-up received contains non-significant information reference added.; Reporter's Comments: Co-suspect product Influenza vaccine inact sAg 4v, past medical history included COVID-19 and Concurrent medical conditions Postural orthostatic tachycardia syndrome, Hypotension and Marfan's syndrome are confounders for the events. The benefit -risk relationship of product is not affected by this report.
Hypotension; Marfan's syndrome (Mildly); Postural orthostatic tachycardia syndrome
Medical History/Concurrent Conditions: COVID-19