Age: 37.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Drug ineffective, Hyperhidrosis, Influenza like illness, Injection site pruritus, Skin burning sensation
Clinical narrative: Astigmatism/stigmatism in eyes; Injection site itching; Joint pain; COVID-19; lack of drug effect; Burning skin; Constipation; Sweaty; Bone pain/sore it was like inside of bones hurt; Flu like symptoms/after getting the covid vaccine felt like a milder version of the covid just like the flu; Urinary tract infection; This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (Sweaty), BONE PAIN (Bone pain/sore it was like inside of bones hurt), SKIN BURNING SENSATION (Burning skin), ASTIGMATISM (Astigmatism/stigmatism in eyes) and CONSTIPATION (Constipation) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 041L20A and 013M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Crohn's disease.    The patient's past medical history included Rash. Previously administered products included for Product used for unknown indication: CECLOR. Past adverse reactions to the above products included Rash with CECLOR. Concurrent medical conditions included Abstains from alcohol, Non-smoker, Drug allergy (SULFA DRUGS ALLERGY MANIFESTED BY RASH), Allergy to antibiotic (CECLOR ALLERGY MANIFESTED BY RASH), Neuropathy, Vomiting and Nausea. Concomitant products included DULOXETINE HYDROCHLORIDE (CYMBALTA) for Neuropathy, PROMETHAZINE for Vomiting and Nausea.   In August 2020, the patient ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to 80 milligram. On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 18-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) 80 milligram. On an unknown date, ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to 80 milligram. In September 2020, the patient experienced URINARY TRACT INFECTION (Urinary tract infection). In 2021, the patient experienced HYPERHIDROSIS (Sweaty), BONE PAIN (Bone pain/sore it was like inside of bones hurt) and INFLUENZA LIKE ILLNESS (Flu like symptoms/after getting the covid vaccine felt like a milder version of the covid just like the flu). In July 2021, the patient experienced CONSTIPATION (Constipation). In November 2021, the patient experienced SKIN BURNING SENSATION (Burning skin), COVID-19 (COVID-19) and DRUG INEFFECTIVE (lack of drug effect). On an unknown date, the patient experienced ASTIGMATISM (Astigmatism/stigmatism in eyes), INJECTION SITE PRURITUS (Injection site itching) and ARTHRALGIA (Joint pain). The patient was treated with MAGNESIUM CITRATE at an unspecified dose and frequency; MACROGOL 3350 (MIRALAX) at an unspecified dose and frequency and AZITHROMYCIN (AZO) at an unspecified dose and frequency. At the time of the report, HYPERHIDROSIS (Sweaty), BONE PAIN (Bone pain/sore it was like inside of bones hurt), SKIN BURNING SENSATION (Burning skin), ASTIGMATISM (Astigmatism/stigmatism in eyes), DRUG INEFFECTIVE (lack of drug effect), INFLUENZA LIKE ILLNESS (Flu like symptoms/after getting the covid vaccine felt like a milder version of the covid just like the flu) and ARTHRALGIA (Joint pain) outcome was unknown and CONSTIPATION (Constipation), URINARY TRACT INFECTION (Urinary tract infection), COVID-19 (COVID-19) and INJECTION SITE PRURITUS (Injection site itching) had not resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       The reporter's causality of HUMIRA for the event(s) of constipation, skin burning, sweaty, stigmatism in eyes, joint pain, urinary tract infection, itching at injection site, sore/it was like inside of bones hurt, covid-19 and after getting the COVID vaccine felt like a milder version of the COVID just like the flu was not provided.  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 37-years-old female patient with concurrent medical condition of Crohn's disease that was treated with ADALIMUMAB (HUMIRA) who experienced the unexpected, non-serious AESI event of COVID-19 and other non-serious events. The event occurred on an unknown date in context to a dose of mRNA-1273 vaccine. The Clinical course, Concomitant medication and treatment details were not provided, and the event COVID-19 was not resolved. The co-suspect Adalimumab (Humira)could be the risk factor for the event. Ongoing pandemic remains a confounder for the event COVID-19.The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report. Events seriousness was assessed as per medical judgement and available information.   This case was linked to MOD-2021-635092 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 08-Dec-2021: (Live-follow-up)Significant follow-up received events and dosage information added and narrative updated. Sender's Comments: This spontaneous case concerns a 37-years-old female patient with concurrent medical condition of Crohn's disease that was treated with ADALIMUMAB (HUMIRA) who experienced the unexpected, non-serious AESI event of COVID-19 and other non-serious events. The event occurred on an unknown date in context to a dose of mRNA-1273 vaccine. The Clinical course, Concomitant medication and treatment details were not provided, and the event COVID-19 was not resolved. The co-suspect Adalimumab (Humira)could be the risk factor for the event. Ongoing pandemic remains a confounder for the event COVID-19.The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report. Events seriousness was assessed as per medical judgement and available information.