Sex: F
Vaccine: COVID19
Symptoms: Computerised tomogram, Magnetic resonance imaging, Oxygen saturation, SARS-CoV-2 test positive, Vaccination site pain
Clinical narrative: INJECTION SITE SWELLING; INJECTION SITE PAIN; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (INJECTION SITE SWELLING) and VACCINATION SITE PAIN (INJECTION SITE PAIN) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for an unknown indication.    Previously administered products included for Product used for unknown indication: Cymbalta (Cymbalta), Meloxicam, Cymbalta (Heart pounding), Cymbalta, Plaquenil (Plaquenil), Plaquenil (Severe depression/wanted to die), Tramadol (Tramadol), Tramadol, Tramadol, Meloxicam, Alendronate (Alendronate), Alendronate, Alendronate (Inflammation in stomach), Topiramate (Topiramate allergy (Did not relieve any pain and depression)), Gabapentin (Gabapentin), Gabapentin (No pain relief), Meloxicam (Meloxicam), Meloxicam, Meloxicam, Meloxicam (Blood vessels on top of feet broke) and Cymbalta. Past adverse reactions to the above products included Blood pressure increased with Cymbalta and Meloxicam; Bruise with Meloxicam; Constipation with Tramadol; Depression suicidal with Plaquenil; Depression with Cymbalta, Gabapentin, Meloxicam and Tramadol; Drug allergy with Alendronate, Cymbalta, Gabapentin, Meloxicam, Plaquenil, Topiramate and Tramadol; Eczema with Meloxicam; Gastritis with Alendronate; Heart pounding with Cymbalta; Laceration of blood vessel with Meloxicam; and Stomach inflammation with Alendronate. Concurrent medical conditions included Asthma, Non-smoker, Abstains from alcohol, Rheumatoid arthritis, Osteoporosis, Pain, Arthritis, Depression and Chronic obstructive pulmonary disease. Concomitant products included MONTELUKAST, FLUTICASONE PROPIONATE, SALMETEROL XINAFOATE (ADVAIR) and ALBUTEROL [SALBUTAMOL] for Asthma, VENLAFAXINE for Depression, DENOSUMAB (PROLIA) for Osteoporosis, PREDNISONE for Pain and Arthritis, METHOTREXATE and FOLIC ACID for Rheumatoid arthritis.   In 2017, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 40 milligram. On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In 2021, ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to 40 milligram. In March 2021, the patient experienced VACCINATION SITE SWELLING (INJECTION SITE SWELLING) and VACCINATION SITE PAIN (INJECTION SITE PAIN). The patient was treated with DEXAMETHASONE at an unspecified dose and frequency. At the time of the report, VACCINATION SITE SWELLING (INJECTION SITE SWELLING) and VACCINATION SITE PAIN (INJECTION SITE PAIN) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In November 2020, Computerised tomogram: Pneumonia. In November 2020, SARS-CoV-2 test positive: NASAL SWAB: CovId-19 positive. In 2021, Oxygen saturation: 96 and 97. On 15-Jul-2021, Magnetic resonance imaging: SLAP (Superior Labrum Anterior and Posterior) tear, adhesive capsulitis, bursitis, tendonosis on left shoulder.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       On 02-Apr-2021, the patient received 2nd dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. In November 2020, the patient had positive with COVID-19, pneumonia, delirious, loss of smell, oxygen level dropped, loss of taste, dehydration, tachycardia and pelvic pain. In 2020, the dehydration resolved. In 2021, the oxygen level dropped resolved. In Nov 2020, patient went in emergency room because of difficulty of breathing. She was given oxygen and unspecified intravenous steroids and after seven hours, was sent home with oral steroids to take. After seven days, she drove back again to the ER when the steroid effect wore off and she had to be given oxygen and steroids again. She had pain in her pelvic region as like the hip bone cracking in half, and the pounding headache that was like having a stroke. Her loss of taste and smell did not fully come back, and she was having weird smell of gasoline-like although she was not smoking. The cough and difficulty of breathing comes and goes, and with her pre-existing condition of asthma, she always had it.  The formulation for Humira was provided as Solution for injection in pre-filled pen.  The reporter did not provide the causal relationship between Humira and the event (had weird Gasoline-like smell. The reporter assessed the causal relationship between Humira and the events of injection site pain, injection site swelling as not related.   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.   This case was linked to MOD-2021-624450 (Patient Link).