Age: 51.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Dyspnoea, Ephelides, Heart rate, Lip blister, Nausea
Clinical narrative: blister on my lower lip; could not breath; Difficulty swallowing; Itching/pruritus; round her legs her skin is very tender and painful mainly her thighs, but all of her leg is tender; round her legs her skin is very tender and painful mainly her thighs, but all of her leg is tender; it stayed light tan all Over like freckles more on my face and neck, shoulders; Rash/ a rash that persisted for 8 weeks; nausea; Hives; 2-8-21 have lumps on top of my clavicle very painful and swollen when touch it feels like jello; 2-8-21 have lumps on top of my clavicle very painful and swollen when touch it feels like jello; 2-8-21 have lumps on top of my clavicle very painful and swollen when touch it feels like jello/swollen clavicle; This spontaneous case was reported by an other health care professional and describes the occurrence of URTICARIA (Hives), VACCINATION SITE MASS (2-8-21 have lumps on top of my clavicle very painful and swollen when touch it feels like jello), BONE PAIN (2-8-21 have lumps on top of my clavicle very painful and swollen when touch it feels like jello), BONE SWELLING (2-8-21 have lumps on top of my clavicle very painful and swollen when touch it feels like jello/swollen clavicle) and LIP BLISTER (blister on my lower lip) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025L20A and 025L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product DUPILUMAB (DUPIXENT) solution for injection for Asthma.    The patient's past medical history included Angina pectoris, Cardiac failure and Anaphylaxis. Concurrent medical conditions included Hypothyroidism, Hyperlipidemia, Chronic kidney disease, Generalised anxiety disorder, Gastrooesophageal reflux, Essential hypertension, Asthma (Severe persistent asthma with acute exacerbation), Drug allergy (Acetaminophen allergy), Drug allergy (Fentanyl allergy), Drug allergy (Ibuprofen allergy), Penicillin allergy (could not breath) and Fruit allergy (Kiwi). Concomitant products included IPRATROPIUM BROMIDE, ACYCLOVIR [ACICLOVIR], GABAPENTIN, BUPROPION, FLUOXETINE, PREDNISONE, ALBUTEROL SULFATE, TRAZODONE, VERAPAMIL, LEVOTHYROXINE SODIUM, GLIPIZIDE, EPINEPHRINE and OXYMORPHONE for an unknown indication.   In December 2020, the patient started DUPILUMAB (DUPIXENT) (Subcutaneous) 600 milligram. On 20-Dec-2020, DUPILUMAB (DUPIXENT) (Subcutaneous) dosage was changed to 300 milligram every two weeks. On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Feb-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 experienced URTICARIA (Hives), VACCINATION SITE MASS (2-8-21 have lumps on top of my clavicle very painful and swollen when touch it feels like jello), BONE PAIN (2-8-21 have lumps on top of my clavicle very painful and swollen when touch it feels like jello), BONE SWELLING (2-8-21 have lumps on top of my clavicle very painful and swollen when touch it feels like jello/swollen clavicle), LIP BLISTER (blister on my lower lip), DYSPNOEA (could not breath), DYSPHAGIA (Difficulty swallowing), PRURITUS (Itching/pruritus), PAIN OF SKIN (round her legs her skin is very tender and painful mainly her thighs, but all of her leg is tender), PAIN IN EXTREMITY (round her legs her skin is very tender and painful mainly her thighs, but all of her leg is tender), EPHELIDES (it stayed light tan all Over like freckles more on my face and neck, shoulders), RASH (Rash/ a rash that persisted for 8 weeks) and NAUSEA (nausea). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL A) for Adverse event, at a dose of UNK dosage form. At the time of the report, URTICARIA (Hives), VACCINATION SITE MASS (2-8-21 have lumps on top of my clavicle very painful and swollen when touch it feels like jello), BONE PAIN (2-8-21 have lumps on top of my clavicle very painful and swollen when touch it feels like jello), EPHELIDES (it stayed light tan all Over like freckles more on my face and neck, shoulders) and RASH (Rash/ a rash that persisted for 8 weeks) had not resolved and BONE SWELLING (2-8-21 have lumps on top of my clavicle very painful and swollen when touch it feels like jello/swollen clavicle), LIP BLISTER (blister on my lower lip), DYSPNOEA (could not breath), DYSPHAGIA (Difficulty swallowing), PRURITUS (Itching/pruritus), PAIN OF SKIN (round her legs her skin is very tender and painful mainly her thighs, but all of her leg is tender), PAIN IN EXTREMITY (round her legs her skin is very tender and painful mainly her thighs, but all of her leg is tender) and NAUSEA (nausea) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 21-Mar-2021, Blood pressure measurement: 120/100 (Inconclusive) 120/100. On 21-Mar-2021, Body temperature: 98.3 (Inconclusive) 98.3. On 21-Mar-2021, Heart rate: 140 (High) 140 beats per minute. On 21-Mar-2021, Respiratory rate: 24 (Inconclusive) 24 breaths per minute. In 2021, Blood pressure measurement: abnormal (abnormal) Systolic blood pressure less than 90 millimeters mercury. In 2021, Heart rate: >100 (High) Increased. greater than 100 beats per minute. In 2021, Oxygen saturation: 94 (Low) Dropped to a 94 from a 98-96.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   It was reported that the patient decided to skip one dose of the co-suspect product, dupilumab after the vaccine reaction (intentional dose omission) on an unspecified date in 2021.   Most recent FOLLOW-UP information incorporated above includes: On 26-Apr-2021: Email/ Events added On 02-Jun-2021: Medwatch form  uploaded. Added concomitant medications, co-suspect drug ( Dupixent), medical history and events (skin tenderness, pain in thigh), added lab data (oxygen saturation) On 06-Jul-2021: ADR form: Added events (freckles, itching, nausea, difficulty swallowing), outcome of event (ongoing), medical history (asthma, anaphylaxis), patient demographics, diagnostic results.