Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Back injury, Fall, Hypoaesthesia, Laboratory test, Limb crushing injury
Clinical narrative: Passed out; She fell in the bathroom and got wedged in between the toilet and the wall; Felt sick with fever and nausea; Felt sick with fever and nausea; she passed out several times and her foot was wedge underneath the drawer and hurt her back, neck and shoulders; she passed out several times and her foot was wedge underneath the drawer and hurt her back, neck and shoulders; she passed out several times and her foot was wedge underneath the drawer and hurt her back, neck and shoulders; Numbness in left arm; Tingling sensation in left arm; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (Passed out), FALL (She fell in the bathroom and got wedged in between the toilet and the wall) and LIMB CRUSHING INJURY (she passed out several times and her foot was wedge underneath the drawer and hurt her back, neck and shoulders) in a 60-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 Psoriatic arthritis.    The patient's past medical history included Nail discomfort (Nail damage) and Non-tobacco user. Previously administered products included for Drug use for unknown indication: Erythromycin (Erythromycin allergy manifested by stomach issues). Past adverse reactions to the above products included Stomach discomfort with Erythromycin. Concurrent medical conditions included Psoriatic arthritis (Joint issue and arthritis), Dust allergy and Pollen allergy. Concomitant products included CELECOXIB (CELEBREX) for Arthritis, VITAMIN D NOS for an unknown indication.   On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Apr-2021, received second 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. In April 2021, the patient experienced LIMB CRUSHING INJURY (she passed out several times and her foot was wedge underneath the drawer and hurt her back, neck and shoulders) (seriousness criterion medically significant), BACK INJURY (she passed out several times and her foot was wedge underneath the drawer and hurt her back, neck and shoulders), NECK INJURY (she passed out several times and her foot was wedge underneath the drawer and hurt her back, neck and shoulders), HYPOAESTHESIA (Numbness in left arm) and PARAESTHESIA (Tingling sensation in left arm). On 26-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PYREXIA (Felt sick with fever and nausea) and NAUSEA (Felt sick with fever and nausea). On 29-Apr-2021, the patient experienced LOSS OF CONSCIOUSNESS (Passed out) (seriousness criterion medically significant) and FALL (She fell in the bathroom and got wedged in between the toilet and the wall) (seriousness criterion medically significant). The patient was treated with IBUPROFEN at an unspecified dose and frequency and PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 29-Apr-2021, LOSS OF CONSCIOUSNESS (Passed out), PYREXIA (Felt sick with fever and nausea) and NAUSEA (Felt sick with fever and nausea) had resolved. In 2021, FALL (She fell in the bathroom and got wedged in between the toilet and the wall) had resolved. At the time of the report, LIMB CRUSHING INJURY (she passed out several times and her foot was wedge underneath the drawer and hurt her back, neck and shoulders) was resolving, BACK INJURY (she passed out several times and her foot was wedge underneath the drawer and hurt her back, neck and shoulders) and NECK INJURY (she passed out several times and her foot was wedge underneath the drawer and hurt her back, neck and shoulders) outcome was unknown and HYPOAESTHESIA (Numbness in left arm) and PARAESTHESIA (Tingling sensation in left arm) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Laboratory test: Unspecified tests that was done in the emergency room to check that everything was okay and there were no significant findings..         Patient had no alcohol use. The patient's joint had been feeling better, but the nail was really damaged and was just mush before started HUMIRA and finally started to look like a regular nail. The patient had other concomitant therapy of Multivitamins and Eye vitamin. On an unknown date, the patient experienced nail getting better/damaged before starting the Humira/look like regular nail. On 29 Apr 2021, she passed out several times, she was sitting in the toilet of bathroom and felt nauseated. She fell in the bathroom and got wedged in between the toilet and the wall. She had to go to the hospital to make sure she did not break anything. She was sent to emergency room. She went on for about three days that she was really sick. She felt better after that. It was reported that patient had unexpected therapeutic benefit. It was unknown if she was enrolled in a COVID-19 Vaccine Trial. The reporter's causality for the event(s) in aspect of Humira of passed out several times, hurt back, hurt neck, hurt shoulders, fever and felt nauseated with Humira 40mg/0.4ml(adalimumab) was no reasonable possibility. The reporter's causality for the event(s) of fell in the bathroom/got wedged in between the toilet and the wall, nail getting better/damaged before starting the Humira/look like regular nail unknown onset, nail getting better/damaged before starting the Humira/look like regular nail unknown onset, numbness in left arm and tingling sensation in left arm was not provided. Opinion was that there was no reasonable possibility that the events of passed out several times, fell in the bathroom/got wedged in between the toilet and the wall, hurt back, hurt neck, hurt shoulders, numbness in left arm, fever, felt nauseated and tingling sensation in left arm were related to Humira. Opinion was that there was a reasonable possibility that the events of nail getting better/damaged before starting the Humira/look like regular nail unknown onset and nail getting better  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 60  year  old, female patient with relevant current condition of Psoriatic arthritis, who experienced the serious medically significant events of loss of consciousness, fall, and limb crushing injury, among other non  serious events. The patient received the second dose of mRNA-1273 vaccine and between the same day and 3 days after vaccination she passed out several times. She mentioned she was feeling nauseated and fell; her foot was wedge underneath the drawer and hurt her back, neck and shoulders. She consulted to the emergency department, unspecified test was performed (result not provided) and was treated with Ibuprofen and Acetaminophen. No further clinical details were provided for medical review. Co-suspect product Adalimumab (Humira) and patient´s medical history could be confounders for fall, which led to limb crushing injury. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   This case was linked to MOD-2021-624114 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 15-Nov-2021: New events were reported.; Sender's Comments: This spontaneous case concerns a 60  year  old, female patient with relevant current condition of Psoriatic arthritis, who experienced the serious medically significant events of loss of consciousness, fall, and limb crushing injury, among other non  serious events. The patient received the second dose of mRNA-1273 vaccine and between the same day and 3 days after vaccination she passed out several times. She mentioned she was feeling nauseated and fell; her foot was wedge underneath the drawer and hurt her back, neck and shoulders. She consulted to the emergency department, unspecified test was performed (result not provided) and was treated with Ibuprofen and Acetaminophen. No further clinical details were provided for medical review. Co-suspect product Adalimumab (Humira) and patient´s medical history could be confounders for fall, which led to limb crushing injury. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.