Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Lactose intolerance, Liver function test, Loss of personal independence in daily activities, Middle insomnia, Pain in jaw
Clinical narrative: Injection site discomfort; Arthralgia aggravated; Difficulty in walking; DIFFICULTY IN PERFORMING ACTIVITIES OF DAILY LIVING; Difficulty eating; Jaw pain; JOINT SWELLING ON KNEES PRIMARILY ON HANDS AND FEET; Joint pain; Lactose intolerance; Loose stools; WORSENED DIFFICULTY SLEEPING AS OFTEN WOKE UP AT AND HAD TROUBLE GETTING BACK TO SLEEP; Gastroesophageal reflux disease; Blood at injection site; BURNING SENSATION AT INJECTION SITE; More pain with thigh than abdomen; This spontaneous case was reported by a consumer and describes the occurrence of MIDDLE INSOMNIA (WORSENED DIFFICULTY SLEEPING AS OFTEN WOKE UP AT AND HAD TROUBLE GETTING BACK TO SLEEP), LACTOSE INTOLERANCE (Lactose intolerance), GASTROOESOPHAGEAL REFLUX DISEASE (Gastroesophageal reflux disease), GAIT DISTURBANCE (Difficulty in walking) and LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (DIFFICULTY IN PERFORMING ACTIVITIES OF DAILY LIVING) in a 39-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 Rheumatoid arthritis.    The patient's past medical history included Asthma, Postnasal drip in 2020, Cough in 2020 and Abdominal cramp in November 2020. Previously administered products included for Allergy: codeine since an unknown date, NAPROXEN and codeine (Codeine Allergy Manifested By Vomiting/Dry Heaves) since an unknown date; for Product used for unknown indication: CODEINE. Past adverse reactions to the above products included Dry heaves with codeine; Feeling abnormal with NAPROXEN; No adverse event with CODEINE; and Vomiting with codeine. Concurrent medical conditions included Heartburn since 2004, Rheumatoid arthritis, Difficulty sleeping, Non-smoker, Abstains from alcohol, Allergy since 1979, Lactose intolerance, Food allergy (Honey Allergy Manifested By Intestinal Issue), Allergy to chemicals (Chlorine Allergy Manifested By Anaphylactic Reaction/Allergy With Chlorine Included Bleach Products/Dipping In A Swimming Pool And Drinking Chlorinated Water), Allergy to plants (Iris Flower Allergy Manifested By Anaphylactic Reaction), Environmental allergy, Dust allergy, Allergy to animal dander, Pollen allergy and Allergy to molds. Concomitant products included FEXOFENADINE HYDROCHLORIDE (ALLEGRA ALLERGY) and TRIAMCINOLONE ACETONIDE (NASACORT) for Allergy, MOMETASONE FUROATE (ASMANEX) for Asthma, FAMOTIDINE for Gastroesophageal reflux disease, FOLIC ACID for Prophylaxis, METHOTREXATE for Rheumatoid arthritis.   In 2006, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 40 milligram. In 2006, ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to 40 milligram and ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to 40 milligram. In May 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In May 2021, ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to 40 milligram. In June 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In 2006, the patient experienced INJECTION SITE HAEMORRHAGE (Blood at injection site), INJECTION SITE PAIN (BURNING SENSATION AT INJECTION SITE) and INJECTION SITE PAIN (More pain with thigh than abdomen). In 2019, the patient experienced MIDDLE INSOMNIA (WORSENED DIFFICULTY SLEEPING AS OFTEN WOKE UP AT AND HAD TROUBLE GETTING BACK TO SLEEP) and GASTROOESOPHAGEAL REFLUX DISEASE (Gastroesophageal reflux disease). In 2020, the patient experienced DIARRHOEA (Loose stools). In November 2020, the patient experienced LACTOSE INTOLERANCE (Lactose intolerance). In May 2021, the patient experienced ARTHRALGIA (Joint pain). In June 2021, the patient experienced GAIT DISTURBANCE (Difficulty in walking), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (DIFFICULTY IN PERFORMING ACTIVITIES OF DAILY LIVING), HYPOPHAGIA (Difficulty eating), PAIN IN JAW (Jaw pain), JOINT SWELLING (JOINT SWELLING ON KNEES PRIMARILY ON HANDS AND FEET) and ARTHRALGIA (Arthralgia aggravated). On an unknown date, the patient experienced INJECTION SITE DISCOMFORT (Injection site discomfort). The patient was treated with GASEX at a dose of 1 dosage form. In May 2021, ARTHRALGIA (Joint pain) and INJECTION SITE PAIN (BURNING SENSATION AT INJECTION SITE) had resolved. In October 2021, INJECTION SITE HAEMORRHAGE (Blood at injection site) had resolved. At the time of the report, MIDDLE INSOMNIA (WORSENED DIFFICULTY SLEEPING AS OFTEN WOKE UP AT AND HAD TROUBLE GETTING BACK TO SLEEP), LACTOSE INTOLERANCE (Lactose intolerance), GASTROOESOPHAGEAL REFLUX DISEASE (Gastroesophageal reflux disease), GAIT DISTURBANCE (Difficulty in walking), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (DIFFICULTY IN PERFORMING ACTIVITIES OF DAILY LIVING), HYPOPHAGIA (Difficulty eating), PAIN IN JAW (Jaw pain), JOINT SWELLING (JOINT SWELLING ON KNEES PRIMARILY ON HANDS AND FEET) and ARTHRALGIA (Arthralgia aggravated) was resolving, DIARRHOEA (Loose stools) had not resolved, INJECTION SITE DISCOMFORT (Injection site discomfort) outcome was unknown and INJECTION SITE PAIN (More pain with thigh than abdomen) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Full blood count: Normal. On an unknown date, Liver function test: Normal. On an unknown date, Tuberculin test: Normal.         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.  It was unknown if the patient was enrolled in any clinical trials. It was reported that patient  experienced Inappropriate dose of drug administered,Wrong injection technique,Vascular injury with Humira. The onset date for the events was reported as 07-OCT-2021. The outcome for these events were reported as recovered .The reporter causality for the events Injection site discomfort, Injection site burning,   with respect to Humira was provided as not reported.The reporter causality for the events Injection site pain, Injection site bleeding, Wrong injection technique, Vascular injury was provided as Probable. The reporter causality for the events Gastroesophageal reflux disease, Nocturnal awakening, Lactose intolerance, Postnasal drip, Cough aggravated, Abdominal cramp , Loose stools, Gas, Joint pain, Difficulty in walking, Activities of daily living impaired, Arthralgia aggravated, Oral intake reduced, Jaw pain, Inappropriate dose of drug administered, joint swelling ,Gaseous regurgitation was provided as not related.  The patient was treated with Sudafed.