Received Mar 4, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (MODERNA MNEXSPIKE)) | MODERNA | UNK | — | IM |
upper lip was like a palsy; twitching really bad/lips were twitching like a palsy/ it was twitching weird. Then upper gum, palate right above two teeth, two front teeth.; swollen lip/swollen on the gum; allergic-like/feels like allergic reaction; bones hurt real bad; felt really lousy/felt awful; fever chills; I had chills; This spontaneous case was reported by a consumer and describes the occurrence of PARALYSIS (upper lip was like a palsy) in a 65-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. Previously administered products included for Product used for unknown indication: Pneumonia vaccine in 2025, INFLUENZA VACCINE (got flu vaccine in the fall.) in 2025 and Shingles vaccine. Past adverse reactions to the above products included No adverse effect with INFLUENZA VACCINE, Pneumonia vaccine and Shingles vaccine. On 16-Feb-2026, 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 18-Feb-2026, the patient experienced BONE PAIN (bones hurt real bad), FEELING ABNORMAL (felt really lousy/felt awful), PYREXIA (fever chills) and CHILLS (I had chills). On 20-Feb-2026, the patient experienced PARALYSIS (upper lip was like a palsy) (seriousness criterion medically significant), MUSCLE TWITCHING (twitching really bad/lips were twitching like a palsy/ it was twitching weird. Then upper gum, palate right above two teeth, two front teeth.), MOUTH SWELLING (swollen lip/swollen on the gum) and HYPERSENSITIVITY (allergic-like/feels like allergic reaction). The patient was treated with Paracetamol (Tylenol) on 18-Feb-2026 at an unspecified dose and frequency. On 19-Feb-2026, BONE PAIN (bones hurt real bad), FEELING ABNORMAL (felt really lousy/felt awful), PYREXIA (fever chills) and CHILLS (I had chills) had resolved. At the time of the report, PARALYSIS (upper lip was like a palsy), MUSCLE TWITCHING (twitching really bad/lips were twitching like a palsy/ it was twitching weird. Then upper gum, palate right above two teeth, two front teeth.) and MOUTH SWELLING (swollen lip/swollen on the gum) had not resolved and HYPERSENSITIVITY (allergic-like/feels like allergic reaction) outcome was unknown. Concomitant medication was not provided. The patient received the first 2 doses of Moderna COVID-19 vaccine 2021 and got COVID- in 2023 (20-May, May, Jun-2023). Patient had received no other vaccines within the past 4 weeks. It was reported that the patient had received the most recent Moderna vaccine a few days prior and subsequently woke up with symptoms she described as "allergic like." She stated that she had been monitoring the symptoms and that they had not worsened. It was further reported that the patient believed she received the vaccine three or four days earlier, most likely on a Monday. She explained that she felt unwell within approximately 48 hours of vaccination. It was reported that the patient had never previously experienced similar lip twitching or swelling. She stated that no changes had occurred in her diet or routine. She continued monitoring the symptoms. She additionally reported receiving the shingles vaccine approximately three years prior, and both the influenza and pneumonia vaccines in October after turning 65. It was reported that the patient described the lip and gum symptoms as mild and questioned whether they might represent the early stage of a fever blister. She stated that she would contact her primary care provider if the symptoms worsened but was not currently concerned. Finally, it was reported that the patient contacted Moderna so that the event would be documented in case her condition changed over the weekend. She commented that allergic reactions typically appear much sooner, whereas her symptoms arose more than 72 hours post vaccination. She described the timing as "a little delayed" if the symptoms were related to the vaccine. It was unknown if the patient experienced any additional symptoms or events. Patient took one Tylenol, went to bed, and felt fine the next morning. This case was linked to MOD-2026-794003 (Patient Link).; Reporter's Comments: Company Comment: The benefit-risk relationship of the product is not affected by this report.