Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Oesophageal discomfort, Skin discolouration, Thrombosis, Tremor
Clinical narrative: esophageal problem that I just found out; not felt good since received the shot/looking at the people on the TV, I don't act like that in normal interaction with people and whether it's from the shot/does not look like those people or anybody; The patient asked if the lumps are clots; Had black and blue marks/Lumps on the arms were black and blue at first; A lump on left clavicle / 1 on left arm, 2 are on right arm/5 to 6 lumps on her right arm, 2 lumps on the left arm; Shaking; Felt really sick; Chills; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of THROMBOSIS (The patient asked if the lumps are clots), SKIN DISCOLOURATION (Had black and blue marks/Lumps on the arms were black and blue at first), LIMB MASS (A lump on left clavicle / 1 on left arm, 2 are on right arm/5 to 6 lumps on her right arm, 2 lumps on the left arm), OESOPHAGEAL DISCOMFORT (esophageal problem that I just found out) and FEELING ABNORMAL (not felt good since received the shot/looking at the people on the TV, I don't act like that in normal interaction with people and whether it's from the shot/does not look like those people or anybody) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007C21A and 018B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Stroke (history of 3 strokes prior to the vaccine with the 1st stroke being over 30 years ago) in 1991. Concurrent medical conditions included Drug allergy (Allergic to Lipitor class drugs), Drug allergy (Allergic to all Stomach medications), Drug allergy (Allergic to Pink color pills), Bee sting hypersensitivity, Endometriosis and High cholesterol. Concomitant products included CLONAZEPAM (KLONOPIN), CLOPIDOGREL BISULFATE (PLAVIX), OXYCODONE HYDROCHLORIDE, PARACETAMOL (PERCOCET [OXYCODONE HYDROCHLORIDE; PARACETAMOL]), VITAMINS NOS, CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) and ALFUZOSIN for an unknown indication.   On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Apr-2021, the patient experienced SKIN DISCOLOURATION (Had black and blue marks/Lumps on the arms were black and blue at first) (seriousness criterion life threatening), LIMB MASS (A lump on left clavicle / 1 on left arm, 2 are on right arm/5 to 6 lumps on her right arm, 2 lumps on the left arm) (seriousness criterion life threatening), TREMOR (Shaking), ILLNESS (Felt really sick), CHILLS (Chills) and NAUSEA (Nausea). On an unknown date, the patient experienced THROMBOSIS (The patient asked if the lumps are clots) (seriousness criteria medically significant and life threatening), OESOPHAGEAL DISCOMFORT (esophageal problem that I just found out) (seriousness criterion life threatening) and FEELING ABNORMAL (not felt good since received the shot/looking at the people on the TV, I don't act like that in normal interaction with people and whether it's from the shot/does not look like those people or anybody) (seriousness criterion life threatening). At the time of the report, THROMBOSIS (The patient asked if the lumps are clots), SKIN DISCOLOURATION (Had black and blue marks/Lumps on the arms were black and blue at first), LIMB MASS (A lump on left clavicle / 1 on left arm, 2 are on right arm/5 to 6 lumps on her right arm, 2 lumps on the left arm), OESOPHAGEAL DISCOMFORT (esophageal problem that I just found out), FEELING ABNORMAL (not felt good since received the shot/looking at the people on the TV, I don't act like that in normal interaction with people and whether it's from the shot/does not look like those people or anybody), TREMOR (Shaking), ILLNESS (Felt really sick), CHILLS (Chills) and NAUSEA (Nausea) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Medical history includes Motility issues in stomach, psychiatric issue. Concomitant medications includes recyclovir Treatment medication was not provided by the reporter.  Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.   This case was linked to MOD-2021-263697, MOD-2021-263805 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 13-Aug-2021: Follow-up information included case upgraded to serious and new events were added; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.