Sex: M
Vaccine: COVID19
Symptoms: Discomfort, Product administration error, Product dispensing error, Therapeutic response shortened
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of DISCOMFORT (started getting uncomfortable two days before to take Humira injections), PRODUCT DISPENSING ERROR (syringe to prefilled pen/patient got syringe then they sent prefilled pen and patient also took one), PRODUCT ADMINISTRATION ERROR (syringe to prefilled pen/patient got syringe then they sent prefilled pen and patient also took one) and THERAPEUTIC RESPONSE SHORTENED (started getting uncomfortable two days before to take Humira injections) in an elderly male patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Rheumatoid arthritis.    There was no reported medical history.  Concomitant products included PREDNISONE ACETATE for an unknown indication.   On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to at an unspecified dose. On an unknown date, the patient experienced DISCOMFORT (started getting uncomfortable two days before to take Humira injections), PRODUCT DISPENSING ERROR (syringe to prefilled pen/patient got syringe then they sent prefilled pen and patient also took one), PRODUCT ADMINISTRATION ERROR (syringe to prefilled pen/patient got syringe then they sent prefilled pen and patient also took one) and THERAPEUTIC RESPONSE SHORTENED (started getting uncomfortable two days before to take Humira injections). At the time of the report, DISCOMFORT (started getting uncomfortable two days before to take Humira injections), PRODUCT DISPENSING ERROR (syringe to prefilled pen/patient got syringe then they sent prefilled pen and patient also took one), PRODUCT ADMINISTRATION ERROR (syringe to prefilled pen/patient got syringe then they sent prefilled pen and patient also took one) and THERAPEUTIC RESPONSE SHORTENED (started getting uncomfortable two days before to take Humira injections) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown.       It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  The reporter's causality for the event(s) of syringe to prefilled pen/patient got syringe then they sent prefilled pen and patient also took one unknown onset, syringe to prefilled pen/patient got syringe then they sent prefilled pen and patient also took one unknown onset, started getting uncomfortable two days before to take Humira injections unknown onset and started getting uncomfortable two days before to take Humira injections unknown onset was not provided.  No treatment information was provided.  Company Comment:  This is a spontaneous case concerning a 65-year-old male patient with no medical history reported, who experienced the unexpected non-serious event of Discomfort in the context of a dose of mRNA-1273 vaccine. Latency cannot be properly assessed since vaccination date nor event onset date were provided. Additionally, Product dispensing error, Product administration error, and Therapeutic response shortened were also reported. It was reported that the patient started to get uncomfortable two days before Humira administration. It was also mentioned that the patient was given a vaccine in a syringe and also had a prefilled pen. No further details about the clinical course, diagnostic procedures and treatments were provided. Outcome of the events were unknown. The benefit-risk relationship of mRNA-1273 is not affected by this report. Sender's Comments: This is a spontaneous case concerning a 65-year-old male patient with no medical history reported, who experienced the unexpected non-serious event of Discomfort in the context of a dose of mRNA-1273 vaccine. Latency cannot be properly assessed since vaccination date nor event onset date were provided. Additionally, Product dispensing error, Product administration error, and Therapeutic response shortened were also reported. It was reported that the patient started to get uncomfortable two days before Humira administration. It was also mentioned that the patient was given a vaccine in a syringe and also had a prefilled pen. No further details about the clinical course, diagnostic procedures and treatments were provided. Outcome of the events were unknown. The benefit-risk relationship of mRNA-1273 is not affected by this report.