Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Poor quality product administered, Product colour issue, Product label issue, Product packaging quantity issue, SARS-CoV-2 test
Clinical narrative: It was an opaque liquid; Employee stated that it looked like a regular syringes to her with no labels and the liquid was in the syringe; medication is seeping out, and was told there's extra in the syringe; Employee feels that they lost as much as 0.20 mL from the syringe as it was being administered. Vaccine was seeping out when it was being given; sore throat; flu; feeling sick; headaches; She says she definitely did not receive 0.5 mL - says she received a greater amount, they both did; It was an opaque liquid; This spontaneous case was reported by a patient family member or friend and describes the occurrence of OROPHARYNGEAL PAIN (sore throat), INFLUENZA (flu), MALAISE (feeling sick), HEADACHE (headaches) and OVERDOSE (She says she definitely did not receive 0.5 mL - says she received a greater amount, they both did) in a 75-year-old male patient who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (batch no. ASKU) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     Previously administered products included for Product used for unknown indication: Influenza Vaccine (Influenza Oct 4). Past adverse reactions to the above products included No adverse effect with Influenza Vaccine.    On 09-Oct-2024, the patient received dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (unknown route) .5 milliliter. On 09-Oct-2024, the patient experienced OROPHARYNGEAL PAIN (sore throat), INFLUENZA (flu), MALAISE (feeling sick), HEADACHE (headaches), OVERDOSE (She says she definitely did not receive 0.5 mL - says she received a greater amount, they both did), PRODUCT COLOUR ISSUE (It was an opaque liquid), PRODUCT LABEL ISSUE (employee stated that it looked like a regular syringes to her with no labels and the liquid was in the syringe), PRODUCT PACKAGING QUANTITY ISSUE (medication is seeping out, and was told there's extra in the syringe) and SYRINGE ISSUE (employee feels that they lost as much as 0.20 mL from the syringe as it was being administered. Vaccine was seeping out when it was being given). On an unknown date, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (It was an opaque liquid). At the time of the report, OROPHARYNGEAL PAIN (sore throat), INFLUENZA (flu), MALAISE (feeling sick), HEADACHE (headaches), OVERDOSE (She says she definitely did not receive 0.5 mL - says she received a greater amount, they both did), PRODUCT COLOUR ISSUE (It was an opaque liquid), POOR QUALITY PRODUCT ADMINISTERED (It was an opaque liquid), PRODUCT LABEL ISSUE (employee stated that it looked like a regular syringes to her with no labels and the liquid was in the syringe), PRODUCT PACKAGING QUANTITY ISSUE (medication is seeping out, and was told there's extra in the syringe) and SYRINGE ISSUE (employee feels that they lost as much as 0.20 mL from the syringe as it was being administered. Vaccine was seeping out when it was being given) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative.     The action taken with mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Unknown) was unknown.   For mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. It was reported that the patient received other vaccines in the 4 weeks prior to COVID-19 vaccine. With previous vaccines, they had the normal side effects from the medication. But this time, here it is over a week, and they are still having headaches, he also got a sore throat. It was reported that they definitely did not receive 0.5 mL and received a greater amount. He had multiple vaccines in the past. It was also reported that the vaccine was seeping out when it was given and hoped that the symptoms would go away, and they both had headaches. When he previously had the flu, it was worse than the symptoms he was having now.  No treatment medications were reported.   This case was linked to US-MODERNATX, INC.-MOD-2024-775496 (E2B Linked Report). This case was linked to MOD-2024-775536 (Patient Link).   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 17-Oct-2024: Live non-significant follow up received and added Reference number.; Sender's Comments:  US-MODERNATX, INC.-MOD-2024-775496:same reporter