Received Nov 20, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (NOVAVAX)) | NOVAVAX | UNK | 6024MF012 | OT |
| COVID19 | COVID19 (COVID19 (NOVAVAX)) | NOVAVAX | 2 | 6024MF012 | OT |
My eyes, they were swollen, red, huge; I broke a vessel on my eyelid; Still a bit swollen and sore; They felt strained at worse; Very sore arm for a few days; Headache; Legs hurt, my lower legs really hurt like a compartment syndrome type of issue; Currently out of the NVX vaccine; I handle Novavax better than Moderna or Pfizer; Then I started sort of feeling a little crappy, like a week later; Didn't feel good and I got so sick; The swellingwediscussedwasso severe and I ended up with a clogged gland in my eyelid/The glands couldn't function..they were closed off and things couldn't. Secrete the way the way they're supposed to; Little lumps that formed in my eyelid/But then I just go another lump; I really have difficulty in walking/I couldn't drive my car, couldn't walk; My eyes started swelling/My eyes, they were swollen, red, huge/and the eyes were swelling; This non-serious initial spontaneous report was reported by a Consumer and concerns a 63-year-old female patient who experienced VERY SORE ARM FOR A FEW DAYS, HEADACHE, LEGS HURT, MY LOWER LEGS REALLY HURT LIKE A COMPARTMENT SYNDROME TYPE OF ISSUE, I REALLY HAVE DIFFICULTY IN WALKING, MY EYES STARTED SWELLING, CURRENTLY OUT OF THE NVX VACCINE and TODAY WAS MY 3 WEEK APPOINTMENT TO GET MY 2ND SHOT after receiving Novavax COVID-19 Vaccine, Adjuvanted (2024 - 2025 Formula). Treatment included prescription ointments and warm soaks. At the time of the report, the outcome of the Pain in extremity, Pain in extremity, Gait disturbance, Product availability issue, Product dose omission issue was Recovered/Resolved, while for Headache was Unknown and Eye swelling was Not Recovered/Not Resolved/Ongoing. On 27-Nov-2024, significant follow-up information was received from the consumer via Novavax Medical Information (AE Number: NOV24-00880): The following updates were reported: Patients date of birth was reported. Patient's race, weight and height were reported. First vaccine administration details were provided as follows: Administration date: 10-Oct-2024; Lot number 6024MF012. Second vaccine administration was reported on 31-Oct-2024; Lot number 6024MF016A. Vaccination facility details for both vaccinations were provided. The event Product dose omission issue was removed, since the patient received a second dose on planned date (31-Oct-2024). The event verbatim of MY EYES STARTED SWELLING was updated to My eyes started swelling/My eyes, they were swollen, red, huge. 3 new events were reported as follows: On an unknown date the patient experienced MY EYES, THEY WERE SWOLLEN, RED, HUGE, I BROKE A VESSEL ON MY EYELID, STILL A BIT SWOLLEN AND SORE, and THEY FELT STRAINED AT WORSE after receiving the second vaccine dose. At the time of the report, the outcome of Eye swelling, Ocular hyperaemia, and Eye pain was Not Recovered/Not Resolved/Ongoing while the events of Eyelid bleeding and Muscle strain was Unknown. On 11-Aug-2025 and 13-Aug-2025, significant follow-up information was received from the consumer via Novavax Medical Information (AE Number: NOV25-00593 and NOV25-00603): The following updates were reported: The patient's age was updated to 63 years. Cytochrome P450 Deficiency was updated to the current condition with the comment "cytochrome p enzyme deficiency in liver/ genetic diagnosis". Positive Covid-19 test in Sep-2023 was added to the patient's medical history. Concomitant medications, Calcitriol, Calcium, Vitamin D, and Collagen were added. The reported terms for three events were updated as follows: From "My eyes started swelling/my eyes, they were swollen, red, huge" to "My eyes started swelling/my eyes, they were swollen, red, huge/and the eyes were swelling". From "I really have difficulty in walking" to "I really have difficulty in walking"/I couldn't drive my car, couldn't walk". From "Little lumps that formed in my eyelid" to "Little lumps that formed in my eyelid/But then I just got another lump". Five new events were reported as follows: On an unknown date, after vaccination, the patient experienced "I handle Novavax better than Moderna or Pfizer" (PT: Adverse event). On an unknown date in Oct-2024, after vaccination, the patient experienced "Then I started sort of feeling a little crappy, like a week later" (PT: Malaise), "Didn't feel good and I got so sick" (PT: Illness), "The swelling we discussed was so severe and I ended up with a clogged gland in my eyelid/the glands couldn't function..they were closed off and things couldn't secrete the way they're supposed to" (PT: Meibomian gland dysfunction), and "Little lumps that formed in my eyelid/but then I just got another lump. (PT: Eyelid cyst) On an unknown date in Jul-2025, the patient underwent eyelid surgery for the event Eyelid cyst. At the time of the report, the outcomes of the events "Adverse event," Malaise, Illness, Meibomian gland dysfunction, and Eyelid cyst were unknown. On 04-Sep-2025, non-significant information was received from a consumer via contact center, with additional non-significant information received on 08-Sep-2025 via Vaccine Adverse Event Reporting System ( (back-reported case). No new information was identified. The adverse event description (narrative) was provided as follows: "Currently out of the NVX vaccine; My eyes, they were swollen, red, huge; I broke a vessel on my eyelid; Still a bit swollen and sore; They felt strained at worse; They felt strained; I handle Novavax better than Moderna or Pfizer; Very sore arm for a few days; Headache; Legs hurt, my lower legs really hurt like a compartment syndrome type of issue; I really have difficulty in walking/I couldn't drive my car, couldn't walk; My eyes started swelling/My eyes, they were swollen, red, huge/and the eyes were swelling; Then I started sort of feeling a little crappy, like a week later; Didn't feel good and I got so sick; The swellingwediscussedwasso severe and I ended up with a clogged gland in my eyelid/The glands couldn't function .. they were closed off and things couldn't. Secrete the way the way they're supposed to; Theswellingwediscussed was so severe and I ended up with a clogged gland in my eyelid/The glands couldn't function. They were closed off and things couldnt. Secrete the way the way they're supposed to; Little lumps that formed in my eyelid/But then I just go another lump; Little lumps that formed in my eyelid; This non-serious initial spontaneous report from (withheld) was reported by a Consumer and concerns a female of unspecified age who experienced VERY SORE ARM FOR A FEW DAYS, HEADACHE, LEGS HURT, MY LOWER LEGS REALLY HURT LIKE A COMPARTMENT SYNDROME TYPE OF ISSUE, I REALLY HAVE DIFFICULTY IN WALKING, MY EYES STARTED SWELLING, CURRENTLY OUT OF THE NVX VACCINE and TODAY WAS MY 3 WEEK APPOINTMENT TO GET MY 2ND SHOT after receiving Novavax COVID-19 Vaccine, Adjuvanted (2024 - 2025 Formula). Treatment included prescription ointments and warm soaks. At the time of the report, the outcome of the Pain in extremity, Pain in extremity, Gait disturbance, Product availability issue, Product dose omission issue was Recovered/Resolved, while for Headache was Unknown and Eye swelling was Not Recovered/Not Resolved/Ongoing. On 27-Nov-2024, significant follow-up information was received from the consumer via Novavax Medical Information (AE Number: NOV24-00880): The following updates were reported: Patients date of birth was reported. Patient's race, weight and height were reported. First vaccine administration details were provided as follows: Administration date: 10-0ct-2024; Lot number 6024MF012. Second vaccine administration was reported on 31-0ct-2024; Lot number 6024MF016A. Vaccination facility details for both vaccinations were provided. The event Product dose omission issue was removed, since the patient received a second dose on planned date (31-0ct-2024 ). The event verbatim of MY EYES STARTED SWELLING was updated to My eyes started swelling/My eyes, they were swollen, red, huge. 3 new events were reported as follows: On an unknown date the patient experienced MY EYES, THEY WERE SWOLLEN, RED, HUGE, I BROKE A VESSEL ON MY EYELID, STILL A BIT SWOLLEN AND SORE, and THEY FELT STRAINED AT WORSE after receiving the second vaccine dose. At the time of the report, the outcome of Eye swelling, Ocular hyperaemia, and Eye pain was Not Recovered/Not Resolved/Ongoing while the events of Eyelid bleeding and Muscle strain was Unknown. On 11-Aug-2025 and 13-Aug-2025, significant follow-up information was received from the consumer via Novavax Medical Information (AE Number: NOV25-00593 and NOV25-00603): The following updates were reported: The patient's age was updated to 63 years. Cytochrome P450 Deficiency was updated to the current condition with the comment ""cytochrome p enzyme deficiency in liver/ genetic diagnosis"". Positive Covid-19 test in Sep-2023 was added to the patient's medical history. Concomitant medications, Calcitriol, Calcium, Vitamin D, and Collagen were added. The reported terms for three events were updated as follows: From ""My eyes started swelling/my eyes, they were swollen, red, huge"" to ""My eyes started swelling/my eyes, they were swollen, red, huge/and the eyes were swelling"". From ""I really have difficulty in walking"" to ""I really have difficulty in walking""/I couldn't drive my car, couldn't walk"". From ""Little lumps that formed in my eyelid"" to ""Little lumps that formed in my eyelid/But then I just got another lump"". Five new events were reported as follows: On an unknown date, after vaccination, the patient experienced ""I handle Novavax better than Moderna or Pfizer"" (PT: Adverse event). On an unknown date in Oct-2024, after vaccination, the patient experienced ""Then I started sort of feeling a little crappy, like a week later"" (PT: Malaise), ""Didn't feel good and I got so sick"" (PT: Illness), ""The swelling we discussed was so severe and I ended up with a clogged gland in my eyelid/the glands couldn't function .. they were closed off and things couldn't secrete the way they're supposed to"" (PT: Meibomian gland dysfunction), and ""Little lumps that formed in my eyelid/but then I just got another lump. (PT: Eyelid cyst) On an unknown date in Jul-2025, the patient underwent eyelid surgery for the event Eyelid cyst. At the time of the report, the outcomes of the events ""Adverse event,"" Malaise, Illness, Meibomian gland dysfunction, and Eyelid cyst were unknown.; Sender's Comments: This 63-year-old female experienced Pain in extremity, Headache, Pain in extremity, Gait disturbance, Eye swelling, Product availability issue, Ocular hyperaemia, Eyelid bleeding, Eye pain, Muscle strain, Adverse event, Malaise, Illness, Meibomian gland dysfunction, and Eyelid cyst after vaccination with Novavax COVID-19 Vaccine, Adjuvanted (2024 - 2025 Formula). The events Pain in extremity, Headache, Pain in extremity, Gait disturbance, Eye swelling, Product availability issue, Ocular hyperaemia, Eyelid bleeding, Eye pain, Muscle strain, Adverse event, Malaise, Illness, Meibomian gland dysfunction, and Eyelid cyst were reported as non-serious. Based on the spontaneous nature of the report, the causal relationship between Novavax COVID-19 Vaccine, Adjuvanted (2024 - 2025 Formula) and Pain in extremity, Headache, Pain in extremity, Gait disturbance, Eye swelling, Product availability issue, Ocular hyperaemia, Eyelid bleeding, Eye pain, Muscle strain, Adverse event, Malaise, Illness, Meibomian gland dysfunction, and Eyelid cyst is considered Possible." It was reported that, Consumer called physician regarding the possibility of getting a micro dose of our COVID vaccine.Consumer stated she could not handle Novavax full dose and stated, it wasn't as bad as Pfizer. She meant, it's months and months of inflammation and swelling and She had eight or nine visits to the eye doctor plus one little eye surgery. Discrepancies were identified in the source document. Event onset dates were reported as 01-Oct-2024, Dose: Unknown, and Route: OT. The event onset dates, Dose of Dose 1, and Route of Intramuscular were retained since this is a back reported case. Additional information was received on 24-OCT-2025 from consumer/ non-healthcare professional: Patient's initial, demographics was added, company causality and medical causality updated and clinical course updated, narrative amended accordingly.; Sender's Comments: Sanofi Company comment follow-up updated on 17-Nov-2025: New follow-up information received does not change the previous assessment of this case and is not considered as medically relevant. This 63-year-old female experienced Pain in extremity, Headache, Pain in extremity, Gait disturbance, Eye swelling, Product availability issue, Ocular hyperaemia, Eyelid bleeding, Eye pain, Muscle strain, Adverse event, Malaise, Illness, Meibomian gland dysfunction, and Eyelid cyst after vaccination with Novavax COVID-19 Vaccine, Adjuvanted (2024 - 2025 Formula). The events Pain in extremity, Headache, Pain in extremity, Gait disturbance, Eye swelling, Product availability issue, Ocular hyperaemia, Eyelid bleeding, Eye pain, Muscle strain, Adverse event, Malaise, Illness, Meibomian gland dysfunction, and Eyelid cyst were reported as non-serious. Based on the spontaneous nature of the report, the causal relationship between Novavax COVID-19 Vaccine, Adjuvanted (2024 - 2025 Formula) and Pain in extremity, Headache, Pain in extremity, Gait disturbance, Eye swelling, Product availability issue, Ocular hyperaemia, Eyelid bleeding, Eye pain, Muscle strain, Adverse event, Malaise, Illness, Meibomian gland dysfunction, and Eyelid cyst is considered Possible.
CYP450 2D6 slow metabolizer status (Cytochrome p enzyme deficiency in liver/ genetic diagnosis); Drug allergy (Allergy to birth control; Proton pump inhibitors (PPIs); Celebrex, Lyrica; Vitamin D (oral); Bextra; Singulair; antibiotic -amoxycillin)
Medical History/Concurrent Conditions: COVID-19 virus test positive
CALCITRIOL; CALCIUM; VITAMIN D [ERGOCALCIFEROL]; COLLAGEN