Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Hidradenitis, Mental impairment, Nerve injury, Pyrexia
Clinical narrative: Mental impairment; Nerve injury; Hidradenitis suppurativa; Fever; Chills; This spontaneous case was reported by a consumer and describes the occurrence of MENTAL IMPAIRMENT (Mental impairment) in a 33-year-old male patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Hidradenitis suppurativa.    No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form On an unknown date, received first dose of mRNA-1273 (Spikevax) (Intramuscular) dosage was changed to 1 dosage form. and ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate free. In 2021, the patient experienced PYREXIA (Fever) and CHILLS (Chills). In February 2022, the patient experienced MENTAL IMPAIRMENT (Mental impairment) (seriousness criterion medically significant), NERVE INJURY (Nerve injury) and HIDRADENITIS (Hidradenitis suppurativa). At the time of the report, MENTAL IMPAIRMENT (Mental impairment), NERVE INJURY (Nerve injury) and HIDRADENITIS (Hidradenitis suppurativa) was resolving and PYREXIA (Fever) and CHILLS (Chills) had resolved.        The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown.       No concomitant medications were reported. No treatment medication was reported.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.  Company comment: This spontaneous case concerns a 33-year-old, male patient with medical history of Moderate-to-severe Hidradenitis suppurativa treated with the co-suspect product Humira (adalimumab), who experienced the unexpected, serious (medically significant) event of mental impairment, the unexpected, non-serious event of hidradenitis suppurativa, and other unexpected and expected, non-serious events. The events mental impairment, hidradenitis suppurativa and nerve injury occurred unknown number of days after receiving Humira and unknown number of days after receiving the second dose of the mRNA-1273 vaccine. Of note, the administration date of Humira and the vaccination dates of the mRNA-1273 vaccine were not provided while the event onset dates were reported as unspecified dates in Feb2022, hence, the onset latency could not be assessed. The other non-serious events occurred unknown number of days after receiving Humira and unknown number of days after receiving the second dose of the mRNA-1273 vaccine. Of note, the administration date of Humira and the vaccination dates of the mRNA-1273 vaccine were not provided while the event onset dates were reported as unspecified dates in 2021, hence, the onset latency could not be assessed. It was reported that the patient experienced fever and chills with both doses of the mRNA-1273 vaccine. It was also reported that the patient might have hit a nerve and started to get 'like a mind block'. He also experienced hidradenitis suppurativa flare-up. Treatment information was not provided. The medical history of Hidradenitis suppurativa, a chronic inflammatory skin condition characterized by flare-ups, remains a confounder for the event hidradenitis suppurativa. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.   Most recent FOLLOW-UP information incorporated above includes: On 04-Apr-2022: Live Significant Follow-up - Updated event information and narrative description received.; Sender's Comments: This spontaneous case concerns a 33-year-old, male patient with medical history of Moderate-to-severe Hidradenitis suppurativa treated with the co-suspect product Humira (adalimumab), who experienced the unexpected, serious (medically significant) event of mental impairment, the unexpected, non-serious event of hidradenitis suppurativa, and other unexpected and expected, non-serious events. The events mental impairment, hidradenitis suppurativa and nerve injury occurred unknown number of days after receiving Humira and unknown number of days after receiving the second dose of the mRNA-1273 vaccine. Of note, the administration date of Humira and the vaccination dates of the mRNA-1273 vaccine were not provided while the event onset dates were reported as unspecified dates in Feb2022, hence, the onset latency could not be assessed. The other non-serious events occurred unknown number of days after receiving Humira and unknown number of days after receiving the second dose of the mRNA-1273 vaccine. Of note, the administration date of Humira and the vaccination dates of the mRNA-1273 vaccine were not provided while the event onset dates were reported as unspecified dates in 2021, hence, the onset latency could not be assessed. It was reported that the patient experienced fever and chills with both doses of the mRNA-1273 vaccine. It was also reported that the patient might have hit a nerve and started to get 'like a mind block'. He also experienced hidradenitis suppurativa flare-up. Treatment information was not provided. The medical history of Hidradenitis suppurativa, a chronic inflammatory skin condition characterized by flare-ups, remains a confounder for the event hidradenitis suppurativa. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.