Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling, Poor quality product administered, Product colour issue, Product label issue, Product packaging quantity issue
Clinical narrative: they're feeling sick; Her arm was swollen and red, fiery hot; Every day has not had a day where she doesn't have a cough or headaches; There was so much induration after the vaccine and all the redness; Her arm was swollen and red, fiery hot/ There was so much induration after the vaccine and all the redness; Her arm was swollen and red, fiery hot; no energy; normally takes walks every day, hasn't walked since she's had the vaccine; they are still having headaches/ Every day has not had a day where she doesn't have a cough or headaches; has been so totally exhausted/ still tired; Reporter feels that they lost as much as 0.20 mL from the syringe as it was being administered; told there's extra in the syringe; She says she definitely did not receive 0.5 mL - says she received a greater amount; It was an opaque liquid; Poor quality vaccine administered; Reporter indicated that the vaccine she'd received was in a regular syringe and did not have any label on it; This spontaneous case was reported by an other health care professional and describes the occurrence of MALAISE (they're feeling sick), PERIPHERAL SWELLING (Her arm was swollen and red, fiery hot), COUGH (Every day has not had a day where she doesn't have a cough or headaches), INDURATION (There was so much induration after the vaccine and all the redness) and ERYTHEMA (Her arm was swollen and red, fiery hot/ There was so much induration after the vaccine and all the redness) in a 71-year-old female 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 Oct 4th (Influenza Oct 4th). Past adverse reactions to the above products included No adverse effect with Influenza Oct 4th.    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 MALAISE (they're feeling sick), PERIPHERAL SWELLING (Her arm was swollen and red, fiery hot), COUGH (Every day has not had a day where she doesn't have a cough or headaches), INDURATION (There was so much induration after the vaccine and all the redness), ERYTHEMA (Her arm was swollen and red, fiery hot/ There was so much induration after the vaccine and all the redness), FEELING HOT (Her arm was swollen and red, fiery hot), ASTHENIA (no energy), GAIT INABILITY (normally takes walks every day, hasn't walked since she's had the vaccine), HEADACHE (they are still having headaches/ Every day has not had a day where she doesn't have a cough or headaches), FATIGUE (has been so totally exhausted/ still tired), SYRINGE ISSUE (Reporter feels that they lost as much as 0.20 mL from the syringe as it was being administered), PRODUCT PACKAGING QUANTITY ISSUE (told there's extra in the syringe), OVERDOSE (She says she definitely did not receive 0.5 mL - says she received a greater amount), PRODUCT COLOUR ISSUE (It was an opaque liquid), POOR QUALITY PRODUCT ADMINISTERED (Poor quality vaccine administered) and PRODUCT LABEL ISSUE (Reporter indicated that the vaccine she'd received was in a regular syringe and did not have any label on it). At the time of the report, MALAISE (they're feeling sick), PERIPHERAL SWELLING (Her arm was swollen and red, fiery hot), COUGH (Every day has not had a day where she doesn't have a cough or headaches), INDURATION (There was so much induration after the vaccine and all the redness), ERYTHEMA (Her arm was swollen and red, fiery hot/ There was so much induration after the vaccine and all the redness), FEELING HOT (Her arm was swollen and red, fiery hot), ASTHENIA (no energy), GAIT INABILITY (normally takes walks every day, hasn't walked since she's had the vaccine), HEADACHE (they are still having headaches/ Every day has not had a day where she doesn't have a cough or headaches), FATIGUE (has been so totally exhausted/ still tired) and OVERDOSE (She says she definitely did not receive 0.5 mL - says she received a greater amount) had not resolved and SYRINGE ISSUE (Reporter feels that they lost as much as 0.20 mL from the syringe as it was being administered), PRODUCT PACKAGING QUANTITY ISSUE (told there's extra in the syringe), PRODUCT COLOUR ISSUE (It was an opaque liquid), POOR QUALITY PRODUCT ADMINISTERED (Poor quality vaccine administered) and PRODUCT LABEL ISSUE (Reporter indicated that the vaccine she'd received was in a regular syringe and did not have any label on it) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: Negative.     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. She had Spikevax before and she felt tired and achy, but in less than 72 hours was back to normal. But this has gone on over a week with tiredness. She was hoping that the symptoms would go away. It was also reported that she was fine until receiving the vaccine on the 9th, and she was prepared for the few side effects that are normally associated with vaccines but wasn't expecting for the effects to be lingering over a week. She had a headache the night she received the vaccine, and no energy. She sleeps 8 hours, which she doesn't normally do, gets up, and she was still tired, and she had to push herself to do things. She normally took walks every day, hasn't walked since she's had the vaccine. The pharmacist also told to her about the medication leaking out and she saw the syringes that were filled - they were not 1 cc syringes according to her. she got the full dose of what they had in the syringe, and feels it was more than 0.5mL and it was an opaque liquid, and she had never seen that syringe before, and it looked like a regular syringe to her with no labels and the liquid was in the syringe. No treatment medications were reported.   This case was linked to US-MODERNATX, INC.-MOD-2024-775531 (E2B Linked Report). This case was linked to MOD-2024-775550 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 17-Oct-2024: Non-significant follow up received and added Reference number.; Sender's Comments:  US-MODERNATX, INC.-MOD-2024-775531:same reporter