Age: 61.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Inappropriate schedule of product administration, Injection site papule, Overweight, Pain, SARS-CoV-2 test
Clinical narrative: Sweating; 80 LBS Overweight; Depression; Pain / Pain due to preparation for hysterectomy surgery; COVID-19; Patient had received 2nd dose on 30 march 2021 and 3rd dose on 20 aug 2021; Hot flash at the base of the neck then rush to face; Injection site reaction of raised bumps/ Injection site papule; Hidradenitis suppurativa flare up in left thigh; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19), HIDRADENITIS (Hidradenitis suppurativa flare up in left thigh), HYPERHIDROSIS (Sweating), OVERWEIGHT (80 LBS Overweight) and DEPRESSION (Depression) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) 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.    The patient's past medical history included Hepatitis C.   On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 20-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate Free. On 12-Dec-2012, the patient experienced HOT FLUSH (Hot flash at the base of the neck then rush to face). On 20-Aug-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient had received 2nd dose on 30 march 2021 and 3rd dose on 20 aug 2021). On 27-Apr-2022, the patient experienced COVID-19 (COVID-19). On an unknown date, the patient experienced HIDRADENITIS (Hidradenitis suppurativa flare up in left thigh), HYPERHIDROSIS (Sweating), OVERWEIGHT (80 LBS Overweight), DEPRESSION (Depression), PAIN (Pain / Pain due to preparation for hysterectomy surgery) and INJECTION SITE PAPULE (Injection site reaction of raised bumps/ Injection site papule). On 13-May-2022, COVID-19 (COVID-19) had resolved. At the time of the report, HIDRADENITIS (Hidradenitis suppurativa flare up in left thigh) and INJECTION SITE PAPULE (Injection site reaction of raised bumps/ Injection site papule) had resolved and HYPERHIDROSIS (Sweating), OVERWEIGHT (80 LBS Overweight), DEPRESSION (Depression), PAIN (Pain / Pain due to preparation for hysterectomy surgery), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient had received 2nd dose on 30 march 2021 and 3rd dose on 20 aug 2021) and HOT FLUSH (Hot flash at the base of the neck then rush to face) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 27-Apr-2022, SARS-CoV-2 test: positive (Positive) Positive. On 13-May-2022, SARS-CoV-2 test: negative (Negative) Negative.         No concomitant medications were provided by the reporter  Patient received the booster dose of Moderna COVID-19 vaccine on 20-Aug-2021. It was unknown if patient was enrolled in a COVID-19 vaccine trial.  No treatment medications were provided by the reporter.  The reporter's causality for the event of tested positive for COVID, 80 lbs overweight, depression, hot Flash at the base of neck then rush to face, hidradenitis suppurativa flare up in left thigh, pain due to preparation for hysterectomy surgery and COVID-19 with Humira(adalimumab) was not related. The reporter's causality for the event of sweating was not provided and injection site reaction of raised bumps with Humira(adalimumab) was related.   Most recent FOLLOW-UP information incorporated above includes: On 01-Jun-2022: Live significant followup received and included  patients medical history, lab data and new events were added  Company comment:This is a spontaneous case concerning a 61-year-old, female patient with medical history of hidradenitis suppurative and treatment medication history of Adalimumab (Humira) for hidradenitis suppurative and with vaccine history of receiving first and second dose of mRNA-1273 vaccine with appropriate dosage interval of 32 days, who experienced the unexpected non-serious AESI event of Covid-19, the unexpected non-serious events of hidradenitis suppurative flare up in the left thigh, hyperhidrosis, overweight (80 pounds overweight), depression, hot flush, pain (pain due to preparation for hysterectomy) and expected non-serious event of injection site papule. Inappropriate schedule of product administration was also reported for the third dose of mRNA-1273 vaccine. The event Covid-19 occurred approximately 250 days after the third dose of mRNA-1273 vaccine administration. The event hot flush occurred approximately 9 years before the third dose of mRNA-1273 vaccine administration. The events hidradenitis suppurative flare up in the left thigh, hyperhidrosis, overweight (80 pounds overweight), depression, pain (pain due to preparation for hysterectomy) and injection site papule occurrence unknown with respect to the third dose of mRNA-1273 vaccine administration. No other information surrounding the events was reported. The outcome of the events Covid-19, hidradenitis suppurative flare up in the left thigh and injection site papule was reported as resolved. The outcome of the events hyperhidrosis, overweight (80 pounds overweight), depression, hot flush, pain (pain due to preparation for hysterectomy) was reported as unknown. The current Covid-19 pandemic remain confounder for the event Covid-19. The medical history of hidradenitis remain confounder for the event hidradenitis suppurative flare up in the left thigh. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This is a spontaneous case concerning a 61-year-old, female patient with medical history of hidradenitis suppurative and treatment medication history of Adalimumab (Humira) for hidradenitis suppurative and with vaccine history of receiving first and second dose of mRNA-1273 vaccine with appropriate dosage interval of 32 days, who experienced the unexpected non-serious AESI event of Covid-19, the unexpected non-serious events of hidradenitis suppurative flare up in the left thigh, hyperhidrosis, overweight (80 pounds overweight), depression, hot flush, pain (pain due to preparation for hysterectomy) and expected non-serious event of injection site papule. Inappropriate schedule of product administration was also reported for the third dose of mRNA-1273 vaccine. The event Covid-19 occurred approximately 250 days after the third dose of mRNA-1273 vaccine administration. The event hot flush occurred approximately 9 years before the third dose of mRNA-1273 vaccine administration. The events hidradenitis suppurative flare up in the left thigh, hyperhidrosis, overweight (80 pounds overweight), depression, pain (pain due to preparation for hysterectomy) and injection site papule occurrence unknown with respect to the third dose of mRNA-1273 vaccine administration. No other information surrounding the events was reported. The outcome of the events Covid-19, hidradenitis suppurative flare up in the left thigh and injection site papule was reported as resolved. The outcome of the events hyperhidrosis, overweight (80 pounds overweight), depression, hot flush, pain (pain due to preparation for hysterectomy) was reported as unknown. The current Covid-19 pandemic remain confounder for the event Covid-19. The medical history of hidradenitis remain confounder for the event hidradenitis suppurative flare up in the left thigh. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.