chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site mass
Clinical narrative: redness over arm and elbow; Bumps over injection site and arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MASS (Bumps over injection site and arm) and VACCINATION SITE ERYTHEMA (redness over arm and elbow) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 034M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse reaction. Concomitant products included VITAMINS NOS for an unknown indication.  On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.   On 22-Feb-2021, the patient experienced VACCINATION SITE MASS (Bumps over injection site and arm). On 24-Feb-2021, the patient experienced VACCINATION SITE ERYTHEMA (redness over arm and elbow). The patient was treated with ALCOHOL at an unspecified dose and frequency and IBUPROFEN at an unspecified dose and frequency.   At the time of the report, VACCINATION SITE MASS (Bumps over injection site and arm) and VACCINATION SITE ERYTHEMA (redness over arm and elbow) had not resolved.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: pain in the area of injection; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (pain in the area of injection) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011A21A and 041L20A) for COVID-19 vaccination.     no specific medical history was not provided.    On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 24-Feb-2021, the patient experienced VACCINATION SITE PAIN (pain in the area of injection). On 25-Feb-2021, VACCINATION SITE PAIN (pain in the area of injection) had resolved.            Concomitant product was reported as vitamins. No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 06-Aug-2021: Follow-up information included no new information. FU received for Daughter case
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Frequent bowel movements, Gait disturbance
Clinical narrative: Weak; Can't walk straight/kind of bent over; Felt woozy and dizzy; Had to get out of bed to go to the restroom about 10 times; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Weak), GAIT DISTURBANCE (Can't walk straight/kind of bent over), DIZZINESS (Felt woozy and dizzy) and FREQUENT BOWEL MOVEMENTS (Had to get out of bed to go to the restroom about 10 times) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.   On 23-Feb-2021, the patient experienced ASTHENIA (Weak), GAIT DISTURBANCE (Can't walk straight/kind of bent over), DIZZINESS (Felt woozy and dizzy) and FREQUENT BOWEL MOVEMENTS (Had to get out of bed to go to the restroom about 10 times).   At the time of the report, ASTHENIA (Weak) and GAIT DISTURBANCE (Can't walk straight/kind of bent over) had not resolved and DIZZINESS (Felt woozy and dizzy) and FREQUENT BOWEL MOVEMENTS (Had to get out of bed to go to the restroom about 10 times) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   Concomitant product use was not provided by the reporter. No treatment information was provided.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Influenza like illness, Injection site induration, Injection site swelling, Movement disorder
Clinical narrative: Knot in arm; Swollen arm at injection site; Nausea; Severe arm pain; fever; Fatigue; Flu like symptoms; could barely move arm; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE INDURATION (Knot in arm), INJECTION SITE SWELLING (Swollen arm at injection site), NAUSEA (Nausea), VACCINATION SITE PAIN (Severe arm pain) and PYREXIA (fever) in a 53-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.  On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.   On an unknown date, the patient experienced INJECTION SITE INDURATION (Knot in arm), INJECTION SITE SWELLING (Swollen arm at injection site), NAUSEA (Nausea), VACCINATION SITE PAIN (Severe arm pain), PYREXIA (fever), FATIGUE (Fatigue), INFLUENZA LIKE ILLNESS (Flu like symptoms) and MOVEMENT DISORDER (could barely move arm).   At the time of the report, INJECTION SITE INDURATION (Knot in arm), INJECTION SITE SWELLING (Swollen arm at injection site), NAUSEA (Nausea), VACCINATION SITE PAIN (Severe arm pain), PYREXIA (fever), FATIGUE (Fatigue), INFLUENZA LIKE ILLNESS (Flu like symptoms) and MOVEMENT DISORDER (could barely move arm) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   Concomitant product use was not provided by the reporter. No treatment information was provided.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Nausea, Pyrexia, Vaccination site pain
Clinical narrative: Knot in arm; Swollen arm at injection site; Nausea; Severe arm pain; fever; Fatigue; Flu like symptoms; could barely move arm; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE INDURATION (Knot in arm), INJECTION SITE SWELLING (Swollen arm at injection site), NAUSEA (Nausea), VACCINATION SITE PAIN (Severe arm pain) and PYREXIA (fever) in a 53-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.  On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.   On an unknown date, the patient experienced INJECTION SITE INDURATION (Knot in arm), INJECTION SITE SWELLING (Swollen arm at injection site), NAUSEA (Nausea), VACCINATION SITE PAIN (Severe arm pain), PYREXIA (fever), FATIGUE (Fatigue), INFLUENZA LIKE ILLNESS (Flu like symptoms) and MOVEMENT DISORDER (could barely move arm).   At the time of the report, INJECTION SITE INDURATION (Knot in arm), INJECTION SITE SWELLING (Swollen arm at injection site), NAUSEA (Nausea), VACCINATION SITE PAIN (Severe arm pain), PYREXIA (fever), FATIGUE (Fatigue), INFLUENZA LIKE ILLNESS (Flu like symptoms) and MOVEMENT DISORDER (could barely move arm) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   Concomitant product use was not provided by the reporter. No treatment information was provided.
Sex: F
Vaccine: COVID19
Symptoms: Feeling cold, Pain in extremity, Pyrexia
Clinical narrative: Aching all over, legs and feet; Running fever (98°F); Felt cold; This spontaneous case was reported by a consumer and describes the occurrence of FEELING COLD (Felt cold), PAIN IN EXTREMITY (Aching all over, legs and feet) and PYREXIA (Running fever (98°F)) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 25-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Feb-2021, the patient experienced FEELING COLD (Felt cold). On 26-Feb-2021, the patient experienced PAIN IN EXTREMITY (Aching all over, legs and feet) and PYREXIA (Running fever (98°F)). On 26-Feb-2021, FEELING COLD (Felt cold) had resolved. At the time of the report, PAIN IN EXTREMITY (Aching all over, legs and feet) and PYREXIA (Running fever (98°F)) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 26-Feb-2021, Pyrexia: 98 degree F.         No relevant Concomitant medications were reported.   No Treatment information for the event was provided. This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 26-Feb-2021 and was forwarded to Moderna on 26-Feb-2021.    This spontaneous case was reported by a consumer and describes the occurrence of FEELING COLD (Felt cold), PAIN IN EXTREMITY (Aching all over, legs and feet) and PYREXIA (Running fever (98°F)) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 25-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Feb-2021, the patient experienced FEELING COLD (Felt cold). On 26-Feb-2021, the patient experienced PAIN IN EXTREMITY (Aching all over, legs and feet) and PYREXIA (Running fever (98°F)). On 26-Feb-2021, FEELING COLD (Felt cold) had resolved. At the time of the report, PAIN IN EXTREMITY (Aching all over, legs and feet) and PYREXIA (Running fever (98°F)) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 26-Feb-2021, Pyrexia: 98 degree F.         No relevant Concomitant medications were reported.   No Treatment information for the event was provided.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Asthenia, Hot flush, Malaise
Clinical narrative: upset stomach; hot flash; Sick feeling; no energy; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL DISCOMFORT (upset stomach), HOT FLUSH (hot flash), MALAISE (Sick feeling) and ASTHENIA (no energy) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021, the patient experienced ABDOMINAL DISCOMFORT (upset stomach), HOT FLUSH (hot flash), MALAISE (Sick feeling) and ASTHENIA (no energy). At the time of the report, ABDOMINAL DISCOMFORT (upset stomach), HOT FLUSH (hot flash), MALAISE (Sick feeling) and ASTHENIA (no energy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product information was not provided. Treatment information was not provided.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 08-Jul-2021: Follow-up received: Patient declined further follow-up
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination complication, Vaccination site mass, Vaccination site pain, Vaccination site pruritus, Vaccination site rash
Clinical narrative: Vaccination adverse reaction; bump on injection site/hard lump approximately 3cm in diameter; It itches; It is tender; it is getting larger and has a rash; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Vaccination adverse reaction), VACCINATION SITE MASS (bump on injection site/hard lump approximately 3cm in diameter), VACCINATION SITE PRURITUS (It itches), VACCINATION SITE PAIN (It is tender) and VACCINATION SITE RASH (it is getting larger and has a rash) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension. Concomitant products included COLECALCIFEROL (VIT D [COLECALCIFEROL]) from January 2020 to an unknown date and CALCIUM from January 2000 to an unknown date for Bone disorder (NOS), ASCORBIC ACID, BETACAROTENE, COPPER, NICOTINAMIDE, SELENIUM, TOCOPHEROL, XANTOFYL, ZINC (LUTEIN +) from January 2009 to an unknown date for Eye abnormality NOS, HYDROCHLOROTHIAZIDE for Heart disease, unspecified, METOPROLOL from January 2005 to an unknown date for Heart disorder.    On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Feb-2021, the patient experienced VACCINATION COMPLICATION (Vaccination adverse reaction), VACCINATION SITE MASS (bump on injection site/hard lump approximately 3cm in diameter), VACCINATION SITE PRURITUS (It itches), VACCINATION SITE PAIN (It is tender) and VACCINATION SITE RASH (it is getting larger and has a rash). At the time of the report, VACCINATION COMPLICATION (Vaccination adverse reaction), VACCINATION SITE MASS (bump on injection site/hard lump approximately 3cm in diameter), VACCINATION SITE PRURITUS (It itches), VACCINATION SITE PAIN (It is tender) and VACCINATION SITE RASH (it is getting larger and has a rash) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatments medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 26-Jul-2021: additional reporter added, updated patient demographics, added dose information and indication for all concomitants, added concomitant calcium. added event vaccination complication, updated outcome to resolved of events vaccination site rash and vaccination site lump.
Sex: M
Vaccine: COVID19
Symptoms: Adverse event
Clinical narrative: Side effect; A spontaneous report was received from a consumer concerning a unknown age, male patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced side effect/ adverse event.  The patient's medical history, was not provided by the reporter. Concomitant product use was not provided by the reporter.  On unknown date, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Batch number: unknown) via unknown route for prophylaxis of COVID-19 infection.   On unknown date, prior to receiving mRNA-1273, the patient felt side effect. No treatment information was reported.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the events, side effect was considered unknown.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Epinephrine increased, Pain in extremity, Taste disorder
Clinical narrative: Sore arm; Within 3 minutes an unusual taste in her mouth; Sensation of adrenaline rush for about 40 minutes; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), TASTE DISORDER (Within 3 minutes an unusual taste in her mouth) and EPINEPHRINE INCREASED (Sensation of adrenaline rush for about 40 minutes) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014m20a) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure.    On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Feb-2021, the patient experienced PAIN IN EXTREMITY (Sore arm), TASTE DISORDER (Within 3 minutes an unusual taste in her mouth) and EPINEPHRINE INCREASED (Sensation of adrenaline rush for about 40 minutes). At the time of the report, PAIN IN EXTREMITY (Sore arm), TASTE DISORDER (Within 3 minutes an unusual taste in her mouth) and EPINEPHRINE INCREASED (Sensation of adrenaline rush for about 40 minutes) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Hyperhidrosis, Limb discomfort, Pain
Clinical narrative: Diarrhea; Vomiting; Chills; Sweat; Sharp pain; Barely lift arm up; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea), VOMITING (Vomiting), CHILLS (Chills), HYPERHIDROSIS (Sweat) and PAIN (Sharp pain) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 604M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (no medical history was reported).    On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Feb-2021, the patient experienced DIARRHOEA (Diarrhea), VOMITING (Vomiting), CHILLS (Chills), HYPERHIDROSIS (Sweat), PAIN (Sharp pain) and LIMB DISCOMFORT (Barely lift arm up). At the time of the report, DIARRHOEA (Diarrhea), VOMITING (Vomiting), CHILLS (Chills), HYPERHIDROSIS (Sweat), PAIN (Sharp pain) and LIMB DISCOMFORT (Barely lift arm up) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Diarrhea; Vomiting; Chills; Sweat; Sharp pain; Barely lift arm up; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea), VOMITING (Vomiting), CHILLS (Chills), HYPERHIDROSIS (Sweat) and PAIN (Sharp pain) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 604M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (no medical history was reported).    On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Feb-2021, the patient experienced DIARRHOEA (Diarrhea), VOMITING (Vomiting), CHILLS (Chills), HYPERHIDROSIS (Sweat), PAIN (Sharp pain) and LIMB DISCOMFORT (Barely lift arm up). At the time of the report, DIARRHOEA (Diarrhea), VOMITING (Vomiting), CHILLS (Chills), HYPERHIDROSIS (Sweat), PAIN (Sharp pain) and LIMB DISCOMFORT (Barely lift arm up) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Decreased appetite, Fatigue, Feeling hot, Pyrexia
Clinical narrative: Hotness; Not hungry; Fever; Tired; This spontaneous case was reported by a consumer and describes the occurrence of FEELING HOT (Hotness), DECREASED APPETITE (Not hungry), PYREXIA (Fever) and FATIGUE (Tired) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced FEELING HOT (Hotness), DECREASED APPETITE (Not hungry), PYREXIA (Fever) and FATIGUE (Tired). At the time of the report, FEELING HOT (Hotness), DECREASED APPETITE (Not hungry), PYREXIA (Fever) and FATIGUE (Tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not reported  No treatment information was specified
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pain in extremity, Paraesthesia oral, Rash macular
Clinical narrative: Redness in the face , ears , cheeks and neck; Tingling at the tongue and lips; Red spots in the arms and legs; arm felt weird, bothered them, it hurt; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (Redness in the face , ears , cheeks and neck), PARAESTHESIA ORAL (Tingling at the tongue and lips), RASH MACULAR (Red spots in the arms and legs) and PAIN IN EXTREMITY (arm felt weird, bothered them, it hurt) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Sinus infection.    On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Feb-2021, the patient experienced ERYTHEMA (Redness in the face , ears , cheeks and neck), PARAESTHESIA ORAL (Tingling at the tongue and lips) and RASH MACULAR (Red spots in the arms and legs). 23-Feb-2021, the patient experienced PAIN IN EXTREMITY (arm felt weird, bothered them, it hurt). The patient was treated with METHYLPREDNISOLONE ACETATE (MEDROL [METHYLPREDNISOLONE ACETATE]) at a dose of 1 dosage form and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at a dose of 1 dosage form. On 24-Feb-2021, PAIN IN EXTREMITY (arm felt weird, bothered them, it hurt) had resolved. At the time of the report, ERYTHEMA (Redness in the face , ears , cheeks and neck), PARAESTHESIA ORAL (Tingling at the tongue and lips) and RASH MACULAR (Red spots in the arms and legs) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Reporter stated that patient had gone to a health care provider and an allergist for the symptoms being experienced, both providers recommended that the patient go ahead with the second dose even if it's late.  Patient was reported to be taking no daily medications.   Most recent FOLLOW-UP information incorporated above includes: On 29-Jul-2021: Follow-up was received. Reporter's address was updated. Patient's DOB, relevant medical history, vaccination site, treatment drug-benadryl and event- Pain in arm was added.
Sex: M
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: Body ache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Body ache) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.   On 25-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Feb-2021, the patient experienced PAIN (Body ache). At the time of the report, PAIN (Body ache) outcome was unknown.            Concomitant medications were not provided.  Treatment information was not provided.
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Injection site erythema, Injection site pain, Injection site pruritus, Injection site warmth
Clinical narrative: Generalized redness in the upper arm; Generalized itchiness in the upper arm; injected upper arm was warm to touch; injected arm very itchy; injected upper arm was red; injected upper arm was painful; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (Generalized redness in the upper arm), PRURITUS (Generalized itchiness in the upper arm), INJECTION SITE WARMTH (injected upper arm was warm to touch), INJECTION SITE PRURITUS (injected arm very itchy) and INJECTION SITE ERYTHEMA (injected upper arm was red) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No medical history provided.). Concomitant products included WARFARIN, SIMVASTATIN, LOSARTAN, LEVOTHYROXINE and METOPROLOL SUCCINATE (TOPROL XL).   On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 20-Feb-2021, the patient experienced ERYTHEMA (Generalized redness in the upper arm), PRURITUS (Generalized itchiness in the upper arm), INJECTION SITE WARMTH (injected upper arm was warm to touch), INJECTION SITE PRURITUS (injected arm very itchy), INJECTION SITE ERYTHEMA (injected upper arm was red) and INJECTION SITE PAIN (injected upper arm was painful). On 27-Feb-2021, ERYTHEMA (Generalized redness in the upper arm), PRURITUS (Generalized itchiness in the upper arm), INJECTION SITE WARMTH (injected upper arm was warm to touch), INJECTION SITE PRURITUS (injected arm very itchy), INJECTION SITE ERYTHEMA (injected upper arm was red) and INJECTION SITE PAIN (injected upper arm was painful) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Treatment includes Gold bond anti-itch lotion.   Most recent FOLLOW-UP information incorporated above includes: On 01-Mar-2021: NNI
Sex: F
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: Generalized redness in the upper arm; Generalized itchiness in the upper arm; injected upper arm was warm to touch; injected arm very itchy; injected upper arm was red; injected upper arm was painful; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (Generalized redness in the upper arm), PRURITUS (Generalized itchiness in the upper arm), INJECTION SITE WARMTH (injected upper arm was warm to touch), INJECTION SITE PRURITUS (injected arm very itchy) and INJECTION SITE ERYTHEMA (injected upper arm was red) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No medical history provided.). Concomitant products included WARFARIN, SIMVASTATIN, LOSARTAN, LEVOTHYROXINE and METOPROLOL SUCCINATE (TOPROL XL).   On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 20-Feb-2021, the patient experienced ERYTHEMA (Generalized redness in the upper arm), PRURITUS (Generalized itchiness in the upper arm), INJECTION SITE WARMTH (injected upper arm was warm to touch), INJECTION SITE PRURITUS (injected arm very itchy), INJECTION SITE ERYTHEMA (injected upper arm was red) and INJECTION SITE PAIN (injected upper arm was painful). On 27-Feb-2021, ERYTHEMA (Generalized redness in the upper arm), PRURITUS (Generalized itchiness in the upper arm), INJECTION SITE WARMTH (injected upper arm was warm to touch), INJECTION SITE PRURITUS (injected arm very itchy), INJECTION SITE ERYTHEMA (injected upper arm was red) and INJECTION SITE PAIN (injected upper arm was painful) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Treatment includes Gold bond anti-itch lotion.   Most recent FOLLOW-UP information incorporated above includes: On 01-Mar-2021: NNI
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Glucose tolerance test, Maternal exposure during pregnancy, Pregnancy test, Ultrasound scan
Clinical narrative: This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) in a 30-year-old female patient (gravida 2, para 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037K20A) for COVID-19 vaccination.     The patient's past medical history included Alcohol use (occasional wine,3 per week.) on 25-Aug-2020 and Marijuana use (occasional edible, 1 edible a month.) on 30-Jul-2020. Concurrent medical conditions included Vegetable allergy (Carrots), Soy allergy (soy), Allergy to nuts, Allergy to plants (Sesame), Allergy to nuts (almonds), Allergy to nuts (Hazelnuts) and Vegetable allergy (Pea allergy). Concomitant products included MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) for Pregnancy.    On 27-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 15-Jul-2020 and the estimated date of delivery was 21-Apr-2021. On 27-Dec-2020, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  twenty-third week of the pregnancy. The vaginal delivery occurred on 23-Apr-2021, which was reported as Full-term. For neonate 1, the birth weight was 375 grams (0lbs 13oz) with an APGAR score of 9 and 9 at (1, 5 minutes). The outcome was reported as Delivered NOS. On 25-Aug-2020, date of positive pregnancy was reported. On 23-Jan-2021, MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) had resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 25-Aug-2020, Pregnancy test: positive (Positive) Positive. On 23-Nov-2020, Ultrasound scan: normal (normal) normal anatomy scan. On 05-Jan-2021, Glucose tolerance test: normal (normal) normal.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Date of conception was 29 Jul 2020 No pregnancy complication, no perinatal complication for the infant and no identified fetal abnormalities on delivery were reported. No treatment medications were reported.   This case was linked to MOD-2021-273419 (Parent-Child Link).   See case MOD-2021-273419 for details regarding the child case.  Most recent FOLLOW-UP information incorporated above includes: On 15-May-2021: Updated the patient demographics, other relevant history allergic conditions, included lab data. On 02-Aug-2021: Significant Follow up received and medical History added, Pregnancy details delivery date, birth type, fetal outcome updated.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site bruising, Vaccination site erythema, Vaccination site haemorrhage, Vaccination site induration, Vaccination site swelling
Clinical narrative: Bleeding injection site; Big bruise injection site; Hard as a rock injection site; Swollen Right Arm; Red shoulder (as a clown nose); This spontaneous report was received from a consumer concerning a 64-years-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced swollen arm/ vaccination site swelling, red shoulder (as a clown nose)/ vaccination site erythema, bleeding/ vaccination site haemorrhage, big bruise/ vaccination site bruising and hard as a rock/ vaccination site induration.    The patient's medical history included post cancer (younger age) and stroke. No relevant concomitant medications were reported.~     On 22 Feb 2021, prior to the onset of the events, the patient received their second of two planned doses of mRNA-1273 (Batch Number: 031L20A) intramuscularly in the right arm for prophylaxis of COVID-19 infection.  On 22 Feb 2021, the patient experienced started with swollen arm, red shoulder (as a clown nose), bleeding, big bruise and hard as a rock. Treatment details included ibuprofen, ice and aloe vera.  The patient received both scheduled doses of mRNA-1273 prior to the events, therefore action taken with the drug in response to the events was not applicable.  The outcome of the events, swollen arm, red shoulder (as a clown nose), big bruise and hard as a rock was not reported. The outcome of the event bleeding was resolved on 22 Feb 2021.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Soreness in arm after first Moderna vaccine; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Soreness in arm after first Moderna vaccine) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Soreness in arm after first Moderna vaccine). At the time of the report, PAIN IN EXTREMITY (Soreness in arm after first Moderna vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment and concomitant medications were not provided by reporter.   This case was linked to MOD-2021-026958 (Patient Link).   Reporter did not allow further contact
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: small red circle on the injection site; It is hot; swollen; tender and hurts; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE ERYTHEMA (small red circle on the injection site), INJECTION SITE WARMTH (It is hot), INJECTION SITE SWELLING (swollen) and INJECTION SITE PAIN (tender and hurts) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Feb-2021, the patient experienced INJECTION SITE ERYTHEMA (small red circle on the injection site), INJECTION SITE WARMTH (It is hot), INJECTION SITE SWELLING (swollen) and INJECTION SITE PAIN (tender and hurts). At the time of the report, INJECTION SITE ERYTHEMA (small red circle on the injection site), INJECTION SITE WARMTH (It is hot), INJECTION SITE SWELLING (swollen) and INJECTION SITE PAIN (tender and hurts) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications included Blood pressure medicines. Treatment medications included Antibiotics and an allergy pill.
Sex: M
Vaccine: COVID19
Symptoms: Injected limb mobility decreased, Insomnia, Pain in extremity, Paraesthesia
Clinical narrative: tingling in neck; soreness; Can't move arm with throbbing; Couldn't sleep; Couldn't sleep; Tingling in the right arm, tingling in the neck; Constant pain in the right arm, throbbing; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (Tingling in the right arm, tingling in the neck), PAIN IN EXTREMITY (Constant pain in the right arm, throbbing ), INJECTED LIMB MOBILITY DECREASED (Can't move arm with throbbing), the second episode of INSOMNIA (Couldn't sleep) and the first episode of INSOMNIA (Couldn't sleep) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by reporter.  Concomitant products included ATORVASTATIN CALCIUM (LIPITOR) for an unknown indication.    On 09-Feb-2021 at 3:15 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Feb-2021, the patient experienced PARAESTHESIA (Tingling in the right arm, tingling in the neck), PAIN IN EXTREMITY (Constant pain in the right arm, throbbing ) and the first episode of INSOMNIA (Couldn't sleep). On 24-Feb-2021, the patient experienced INJECTED LIMB MOBILITY DECREASED (Can't move arm with throbbing), the second episode of INSOMNIA (Couldn't sleep) and PAIN IN EXTREMITY (soreness). On 25-Feb-2021, the patient experienced PARAESTHESIA (tingling in neck). At the time of the report, PARAESTHESIA (Tingling in the right arm, tingling in the neck), PAIN IN EXTREMITY (Constant pain in the right arm, throbbing ), INJECTED LIMB MOBILITY DECREASED (Can't move arm with throbbing), the last episode of INSOMNIA (Couldn't sleep), PARAESTHESIA (tingling in neck) and PAIN IN EXTREMITY (soreness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment medication included Tylenol.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Influenza like illness, Malaise, Nausea, Vaccination complication
Clinical narrative: Chills/Shivering/Shaking; Felt bad; nausea; Flu like symptoms; After the injection, it "knocked him for a loop"; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu like symptoms), VACCINATION COMPLICATION (After the injection, it "knocked him for a loop"), CHILLS (Chills/Shivering/Shaking), NAUSEA (nausea) and MALAISE (Felt bad) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022M20A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension, Benign prostatic hyperplasia and Food allergy. Concomitant products included ATENOLOL, FAMOTIDINE (PEPCID [FAMOTIDINE]), OLMESARTAN MEDOXOMIL (BENICAR), TAMSULOSIN, FINASTERIDE, MIRTAZAPINE, ACETYLSALICYLIC ACID (BABY ASPIRIN) and FISH OIL for an unknown indication.    On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Feb-2021, the patient experienced VACCINATION COMPLICATION (After the injection, it "knocked him for a loop"). On 24-Feb-2021, the patient experienced INFLUENZA LIKE ILLNESS (Flu like symptoms) and NAUSEA (nausea). On 26-Feb-2021, the patient experienced CHILLS (Chills/Shivering/Shaking) and MALAISE (Felt bad). On 25-Feb-2021, INFLUENZA LIKE ILLNESS (Flu like symptoms), VACCINATION COMPLICATION (After the injection, it "knocked him for a loop") and NAUSEA (nausea) had resolved. At the time of the report, CHILLS (Chills/Shivering/Shaking) and MALAISE (Felt bad) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medications were not provided by reporter.   Reporter did not allow further contact
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Pain, Tremor
Clinical narrative: Shaking and trembling; Headache; Chills; Pains; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache), CHILLS (Chills), PAIN (Pains) and TREMOR (Shaking and trembling) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006M20A) for COVID-19 vaccination.     No medical history was provided by reporter.  Concomitant products included FUROSEMIDE, SPIRONOLACTONE, CARVEDILOL, IRBESARTAN, ATORVASTATIN, IRON (IRON COMPLEX [IRON]) and OMEPRAZOLE for an unknown indication.    On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, the patient experienced CHILLS (Chills) and PAIN (Pains). On 26-Feb-2021, the patient experienced HEADACHE (Headache). On an unknown date, the patient experienced TREMOR (Shaking and trembling). At the time of the report, HEADACHE (Headache), CHILLS (Chills), PAIN (Pains) and TREMOR (Shaking and trembling) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medications were not provided by reporter.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Soreness in arm around the deltoid after second Moderna vaccine; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Soreness in arm around the deltoid after second Moderna vaccine) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 2 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Soreness in arm around the deltoid after second Moderna vaccine). At the time of the report, PAIN IN EXTREMITY (Soreness in arm around the deltoid after second Moderna vaccine) outcome was unknown.            Concomitant medications and treatment information was not provided by the reporter.    This case was linked to MOD-2021-026921 (Patient Link).
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Pruritus, Rash
Clinical narrative: Itchy (rash); rash allover the body; This spontaneous case was reported by a consumer and describes the occurrence of   in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) ongoing since an unknown date at a dose of 1 dosage form; HYDROCORTISONE ongoing since an unknown date at a dose of 1 dosage form and CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) ongoing since an unknown date at a dose of 1 dosage form.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant was provided. Patient was treated with Ant-itchy cream.
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Blood pressure increased, Chest discomfort, Dizziness, Rash
Clinical narrative: rash on her left elbow which is spreading on her both arms; chest tightness; dizzy; elevated blood pressure; anxiety; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of RASH (rash on her left elbow which is spreading on her both arms), CHEST DISCOMFORT (chest tightness), DIZZINESS (dizzy), BLOOD PRESSURE INCREASED (elevated blood pressure) and ANXIETY (anxiety) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history is provided and concomitant drugs are provided.  Concomitant products included LORATADINE (CLARITINE) and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL N).    On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Feb-2021, the patient experienced RASH (rash on her left elbow which is spreading on her both arms), CHEST DISCOMFORT (chest tightness), DIZZINESS (dizzy), BLOOD PRESSURE INCREASED (elevated blood pressure) and ANXIETY (anxiety). At the time of the report, RASH (rash on her left elbow which is spreading on her both arms), CHEST DISCOMFORT (chest tightness), DIZZINESS (dizzy), BLOOD PRESSURE INCREASED (elevated blood pressure) and ANXIETY (anxiety) outcome was unknown.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Muscle tightness
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (Upper middle back was hurting, like a knot) and MUSCLE TIGHTNESS (Tight muscles) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, the patient experienced BACK PAIN (Upper middle back was hurting, like a knot) and MUSCLE TIGHTNESS (Tight muscles). At the time of the report, BACK PAIN (Upper middle back was hurting, like a knot) and MUSCLE TIGHTNESS (Tight muscles) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications reported.  No treatment information was provided.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Vaccination site pain
Clinical narrative: experiencing severe headaches; sore arm 5 min after they got it (vaccination); This spontaneous case was reported by an other and describes the occurrence of HEADACHE (experiencing severe headaches) and VACCINATION SITE PAIN (sore arm 5 min after they got it (vaccination)) in a 26-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023MZ0A) for COVID-19 vaccination.     Concomitant products included MINOXIDIL.   On 20-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 2 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Feb-2021, the patient experienced HEADACHE (experiencing severe headaches) and VACCINATION SITE PAIN (sore arm 5 min after they got it (vaccination)). On 20-Feb-2021, VACCINATION SITE PAIN (sore arm 5 min after they got it (vaccination)) had resolved. On 26-Feb-2021, HEADACHE (experiencing severe headaches) was resolving.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided.  No treatment details were provided.    Most recent FOLLOW-UP information incorporated above includes: On 25-Feb-2021: No specific follow-up information recorded.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Feeling abnormal, Oxygen saturation
Clinical narrative: Shortnessof breath/ difficulty breathing; Doesn't feel comfortable; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Shortnessof breath/ difficulty breathing) and FEELING ABNORMAL (Doesn't feel comfortable) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no medical history reported). Concomitant products included CHLORTHALIDONE, ROSUVASTATIN CALCIUM (CRESTOR), LISINOPRIL and LEVOTHYROXINE for an unknown indication.    On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Feb-2021, the patient experienced DYSPNOEA (Shortnessof breath/ difficulty breathing) and FEELING ABNORMAL (Doesn't feel comfortable). At the time of the report, DYSPNOEA (Shortnessof breath/ difficulty breathing) and FEELING ABNORMAL (Doesn't feel comfortable) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Oxygen saturation: 98 and 99.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: This spontaneous case was reported by a physician and describes the occurrence of RASH (Widespread Rash) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced RASH (Widespread Rash). At the time of the report, RASH (Widespread Rash) outcome was unknown.        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.   Treatment included IM steroid and oral antihistamine.