Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Product dose omission issue, Pruritus, SARS-CoV-2 test, Swelling, Thrombosis
Clinical narrative: seems her eyesight was blur; Did not take second dose; weird feeling on shoulder/arm/dow to my finger tips; Neck has bumps; neck twitches; Small egg, pinky sized swelling on the base of the neck lymph node; small reddish and blood clots in my hand and near thumb; Bruising; irregular heart palpitation; Chest pain like needles; Swelling on left shoulder; Swelling on breast; Red  on breast; Itchiness on breast; Needle pain that goes down to finger tips; upper base of the skull feels numb and tight; Upper base of the skull feels tight; breast still painful; burning in breast; Tight chest; This spontaneous case was reported by a consumer and describes the occurrence of THROMBOSIS (small reddish and blood clots in my hand and near thumb) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047821H) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 on 19-Oct-2020, Asthma (Young age), Urticaria (House insulator materials) in 2007, Anaphylactic reaction (Window Cleaner) in 2005 and Hives (Swiss cheese) in 2004. Concurrent medical conditions included Allergy (Orbitocin allergy), Allergy to NSAIDs (Tylenol allergy), Drug allergy (Aspirin allergy) and Peanut allergy. Concomitant products included VITAMIN C [ASCORBIC ACID] from January 2021 to February 2021 for Vitamin supplementation, SPIRULINA PLATENSIS (SPIRULINA POWDER) from December 2020 to January 2021 and CENTRUM SILVER +50 from January 2021 to February 2021 for an unknown indication.    On 21-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Aug-2021, the patient experienced THROMBOSIS (small reddish and blood clots in my hand and near thumb) (seriousness criterion medically significant), CONTUSION (Bruising), PALPITATIONS (irregular heart palpitation), CHEST PAIN (Chest pain like needles), SWELLING (Swelling on left shoulder), BREAST SWELLING (Swelling on breast), ERYTHEMA (Red  on breast), PRURITUS (Itchiness on breast), PARAESTHESIA (Needle pain that goes down to finger tips), HYPOAESTHESIA (upper base of the skull feels numb and tight), DISCOMFORT (Upper base of the skull feels tight), BREAST PAIN (breast still painful), BURNING SENSATION (burning in breast), CHEST DISCOMFORT (Tight chest) and LYMPHADENOPATHY (Small egg, pinky sized swelling on the base of the neck lymph node). On 04-Sep-2021, the patient experienced FEELING ABNORMAL (weird feeling on shoulder/arm/dow to my finger tips), MUSCULOSKELETAL DISCOMFORT (Neck has bumps) and MUSCLE TWITCHING (neck twitches). On an unknown date, the patient experienced VISION BLURRED (seems her eyesight was blur) and PRODUCT DOSE OMISSION ISSUE (Did not take second dose). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency. At the time of the report, THROMBOSIS (small reddish and blood clots in my hand and near thumb), CONTUSION (Bruising), PALPITATIONS (irregular heart palpitation), CHEST PAIN (Chest pain like needles), SWELLING (Swelling on left shoulder), BREAST SWELLING (Swelling on breast), ERYTHEMA (Red  on breast), PRURITUS (Itchiness on breast), PARAESTHESIA (Needle pain that goes down to finger tips), HYPOAESTHESIA (upper base of the skull feels numb and tight), DISCOMFORT (Upper base of the skull feels tight), BREAST PAIN (breast still painful), BURNING SENSATION (burning in breast), CHEST DISCOMFORT (Tight chest), FEELING ABNORMAL (weird feeling on shoulder/arm/dow to my finger tips), MUSCULOSKELETAL DISCOMFORT (Neck has bumps), MUSCLE TWITCHING (neck twitches), VISION BLURRED (seems her eyesight was blur) and LYMPHADENOPATHY (Small egg, pinky sized swelling on the base of the neck lymph node) had not resolved and PRODUCT DOSE OMISSION ISSUE (Did not take second dose) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 19-Oct-2020, SARS-CoV-2 test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient stated that she had got a mammogram diagnostic on 03-Nov-2021. And also scheduled for ultrasound Lot number is either 04782H or 097821A. Cardiac Lab values of ECG, cardiac test, cardiac enzyme need to be obtained. Some X-rays are done. Ointment is given has treatment medication.  Company Comment: This case concerns a 56-year-old, female patient with previous relevant medical history of COVID-19, asthma and anaphylactic reaction, who experienced the unexpected event of Thrombosis. The event occurred 1 day after the first dose of mRNA-1273 Moderna vaccine. The rechallenge was unknown since the event has not resolved and no information regarding dose number two was disclosed. The medical history of COVID-19 remains a confounder. The benefit-risk relationship of mRNA-1273 Moderna vaccine is not affected by this report.   Most recent FOLLOW-UP information incorporated above includes: On 05-Nov-2021: Upgraded as serious, Patient demographic details added, Relevant history added, Concomitant medication, events outcome was updated to not recovered, new events thrombosis, muscle twitching,Vision blurred, lymphadenopathy, feeling abnormal, burning sensation.; Sender's Comments: This case concerns a 56-year-old, female patient with previous relevant medical history of COVID-19, asthma and anaphylactic reaction, who experienced the unexpected event of Thrombosis. The event occurred 1 day after the first dose of mRNA-1273 Moderna vaccine. The rechallenge was unknown since the event has not resolved and no information regarding dose number two was disclosed. The medical history of COVID-19 remains a confounder. The benefit-risk relationship of mRNA-1273 Moderna vaccine is not affected by this report.