chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Little sore arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Little sore arm) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for an unknown indication.     No Medical History information was reported.    On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Jan-2021, the patient experienced VACCINATION SITE PAIN (Little sore arm). At the time of the report, VACCINATION SITE PAIN (Little sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       No concomitant medications were provided. No treatment medications were provided.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Lip swelling, Swelling face
Clinical narrative: lips and face swelled; lips and face swelled; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING FACE (lips and face swelled) and LIP SWELLING (lips and face swelled) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032LZ0A) for COVID-19 vaccination.     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 22-Jan-2021, the patient experienced SWELLING FACE (lips and face swelled) and LIP SWELLING (lips and face swelled). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL A) at an unspecified dose and frequency. At the time of the report, SWELLING FACE (lips and face swelled) and LIP SWELLING (lips and face swelled) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient confirms taking 2 doses of Benadryl within a 24-hour period.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Hyperhidrosis
Clinical narrative: Sweats; Chills; Fatigue; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of HYPERHIDROSIS (Sweats), CHILLS (Chills) and FATIGUE (Fatigue) in a 54-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. UNKNOWN) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Jan-2021, the patient experienced HYPERHIDROSIS (Sweats), CHILLS (Chills) and FATIGUE (Fatigue). At the time of the report, HYPERHIDROSIS (Sweats), CHILLS (Chills) and FATIGUE (Fatigue) 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.   No concomitant medications were provided Treatment Severe cold Tylenol
Age: 75.0
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site pruritus
Clinical narrative: The site was itching, it hurt, it was bright red, swollen, 4 inches up and down the arm; it was bright red; sore; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (The site was itching, it hurt, it was bright red, swollen, 4 inches up and down the arm), VACCINATION SITE ERYTHEMA (it was bright red) and VACCINATION SITE PAIN (sore) in a 75-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included centrum vitamins, METFORMIN, LEVOTHYROXINE and ATORVASTATIN for an unknown indication.    On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2021, the patient experienced VACCINATION SITE PRURITUS (The site was itching, it hurt, it was bright red, swollen, 4 inches up and down the arm), VACCINATION SITE ERYTHEMA (it was bright red) and VACCINATION SITE PAIN (sore). At the time of the report, VACCINATION SITE PRURITUS (The site was itching, it hurt, it was bright red, swollen, 4 inches up and down the arm), VACCINATION SITE ERYTHEMA (it was bright red) and VACCINATION SITE PAIN (sore) outcome was unknown. Not Provided      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 Benadryl and cortisone cream.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Vaccination site erythema, Vaccination site pruritus
Clinical narrative: Warm to the touch; Itchy at the injection site; red itchy, and warm to the touch; This spontaneous case was reported by a consumer and describes the occurrence of FEELING HOT (Warm to the touch), VACCINATION SITE PRURITUS (Itchy at the injection site) and VACCINATION SITE ERYTHEMA (red itchy, and warm to the touch) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Jan-2021, the patient experienced FEELING HOT (Warm to the touch), VACCINATION SITE PRURITUS (Itchy at the injection site) and VACCINATION SITE ERYTHEMA (red itchy, and warm to the touch). At the time of the report, FEELING HOT (Warm to the touch), VACCINATION SITE PRURITUS (Itchy at the injection site) and VACCINATION SITE ERYTHEMA (red itchy, and warm to the touch) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not provided. Treatment details were not provided.
Sex: F
Vaccine: COVID19
Symptoms: Injection site swelling
Clinical narrative: swelling at injection site 13 days after injection; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE SWELLING (swelling at injection site 13 days after injection) in a female patient of an unknown age exposed to mRNA-1273 (Moderna COVID-19 Vaccine) , while the parent received the product for COVID-19 vaccination.    MEDICAL HISTORY (Parent): Unknown.     No Medical History information was reported.    On an unknown date, the parent received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On an unknown date,  after exposure to mRNA-1273 (Moderna COVID-19 Vaccine), the patient was diagnosed with INJECTION SITE SWELLING (swelling at injection site 13 days after injection). At the time of the report, INJECTION SITE SWELLING (swelling at injection site 13 days after injection) outcome was unknown. Possible      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment was reported.
Sex: U
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: COVID-19 positive; This spontaneous case was reported by a consumer and describes the occurrence of SARS-COV-2 TEST POSITIVE (COVID-19 positive) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.    On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Jan-2021, the patient experienced SARS-COV-2 TEST POSITIVE (COVID-19 positive). At the time of the report, SARS-COV-2 TEST POSITIVE (COVID-19 positive) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided. No treatment information provided.   Reporter did not allow further contact
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pain in extremity
Clinical narrative: sore arm; felt tired; dulling headache that hasn't gone away; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm), FATIGUE (felt tired) and HEADACHE (dulling headache that hasn't gone away) in a 46-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Feb-2021, the patient experienced PAIN IN EXTREMITY (sore arm), FATIGUE (felt tired) and HEADACHE (dulling headache that hasn't gone away). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at an unspecified dose and frequency. On 20-Feb-2021, PAIN IN EXTREMITY (sore arm) and FATIGUE (felt tired) outcome was unknown. At the time of the report, HEADACHE (dulling headache that hasn't gone away) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: Positive for Covid-19 after first shot; This spontaneous case was reported by a consumer and describes the occurrence of SARS-COV-2 TEST POSITIVE (Positive for Covid-19 after first shot) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Feb-2021, the patient experienced SARS-COV-2 TEST POSITIVE (Positive for Covid-19 after first shot). At the time of the report, SARS-COV-2 TEST POSITIVE (Positive for Covid-19 after first shot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Nausea, Vaccination site erythema, Vaccination site pruritus, Vaccination site reaction
Clinical narrative: 2 weeks recation around the injection site in the left arm; Arm of the injection  still swollen, getting bigger; Arm is warm; Arm of the injection red/Redness/erythema; Was very nauseous; Had chills; vomiting; Arm of the injection itching; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (Arm of the injection itching), VACCINATION SITE REACTION (2 weeks recation around the injection site in the left arm), VACCINATION SITE SWELLING (Arm of the injection  still swollen, getting bigger), VACCINATION SITE WARMTH (Arm is warm) and VACCINATION SITE ERYTHEMA (Arm of the injection red/Redness/erythema) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Anaphylactic reaction to drug (Had an anaphylactic reaction to compazine) in 1981. Concurrent medical conditions included High cholesterol, Hypothyroidism, Allergic reaction to bee sting (Bee sting allergy) and Allergy to antibiotic (Neomycin allergy). Concomitant products included SIMVASTATIN for High cholesterol, CALCIUM CARBONATE (TUMS [CALCIUM CARBONATE]) for Hypothyroidism, METFORMIN and VITAMIN D3 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 11-Feb-2021, the patient experienced VACCINATION SITE PRURITUS (Arm of the injection itching), VACCINATION SITE SWELLING (Arm of the injection  still swollen, getting bigger), VACCINATION SITE WARMTH (Arm is warm), VACCINATION SITE ERYTHEMA (Arm of the injection red/Redness/erythema), NAUSEA (Was very nauseous), CHILLS (Had chills) and VOMITING (vomiting). On an unknown date, the patient experienced VACCINATION SITE REACTION (2 weeks recation around the injection site in the left arm). On 16-Feb-2021, VACCINATION SITE SWELLING (Arm of the injection  still swollen, getting bigger), VACCINATION SITE WARMTH (Arm is warm), VACCINATION SITE ERYTHEMA (Arm of the injection red/Redness/erythema), NAUSEA (Was very nauseous), CHILLS (Had chills) and VOMITING (vomiting) had resolved. At the time of the report, VACCINATION SITE PRURITUS (Arm of the injection itching) and VACCINATION SITE REACTION (2 weeks recation around the injection site in the left arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided by the reporter.   This case was linked to MOD-2021-276618 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 04-Aug-2021: Additional reporter details, vaccine facility information, additional patient information, prior vaccination history, additional medical history and additional events were added.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site swelling, Vaccination site warmth, Vomiting
Clinical narrative: 2 weeks recation around the injection site in the left arm; Arm of the injection  still swollen, getting bigger; Arm is warm; Arm of the injection red/Redness/erythema; Was very nauseous; Had chills; vomiting; Arm of the injection itching; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (Arm of the injection itching), VACCINATION SITE REACTION (2 weeks recation around the injection site in the left arm), VACCINATION SITE SWELLING (Arm of the injection  still swollen, getting bigger), VACCINATION SITE WARMTH (Arm is warm) and VACCINATION SITE ERYTHEMA (Arm of the injection red/Redness/erythema) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Anaphylactic reaction to drug (Had an anaphylactic reaction to compazine) in 1981. Concurrent medical conditions included High cholesterol, Hypothyroidism, Allergic reaction to bee sting (Bee sting allergy) and Allergy to antibiotic (Neomycin allergy). Concomitant products included SIMVASTATIN for High cholesterol, CALCIUM CARBONATE (TUMS [CALCIUM CARBONATE]) for Hypothyroidism, METFORMIN and VITAMIN D3 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 11-Feb-2021, the patient experienced VACCINATION SITE PRURITUS (Arm of the injection itching), VACCINATION SITE SWELLING (Arm of the injection  still swollen, getting bigger), VACCINATION SITE WARMTH (Arm is warm), VACCINATION SITE ERYTHEMA (Arm of the injection red/Redness/erythema), NAUSEA (Was very nauseous), CHILLS (Had chills) and VOMITING (vomiting). On an unknown date, the patient experienced VACCINATION SITE REACTION (2 weeks recation around the injection site in the left arm). On 16-Feb-2021, VACCINATION SITE SWELLING (Arm of the injection  still swollen, getting bigger), VACCINATION SITE WARMTH (Arm is warm), VACCINATION SITE ERYTHEMA (Arm of the injection red/Redness/erythema), NAUSEA (Was very nauseous), CHILLS (Had chills) and VOMITING (vomiting) had resolved. At the time of the report, VACCINATION SITE PRURITUS (Arm of the injection itching) and VACCINATION SITE REACTION (2 weeks recation around the injection site in the left arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided by the reporter.   This case was linked to MOD-2021-276618 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 04-Aug-2021: Additional reporter details, vaccine facility information, additional patient information, prior vaccination history, additional medical history and additional events were added.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pyrexia
Clinical narrative: low fever; headache; This spontaneous case was reported by a patient and describes the occurrence of PYREXIA (low fever) and HEADACHE (headache) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for an unknown indication.     The patient's past medical history included No adverse event.   On 24-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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, the patient experienced PYREXIA (low fever) and HEADACHE (headache). At the time of the report, PYREXIA (low fever) and HEADACHE (headache) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment information was not provided. Concomitant medication was not provided.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Urticaria
Clinical narrative: Sore Arm; Hives from left arm to torso; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Hives from left arm to torso) and PAIN IN EXTREMITY (Sore Arm) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022M20A) for COVID-19 vaccination.       On 15-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 URTICARIA (Hives from left arm to torso). On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore Arm). At the time of the report, URTICARIA (Hives from left arm to torso) and PAIN IN EXTREMITY (Sore Arm) outcome was unknown.        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.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Headache, Vaccination site pain, Vaccination site pruritus
Clinical narrative: got very itchy; redness and a knot(very minimal) that spread across; headache; mild soreness at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (redness and a knot(very minimal) that spread across), HEADACHE (headache), VACCINATION SITE PAIN (mild soreness at the injection site) and VACCINATION SITE PRURITUS (got very itchy) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M2OA) for COVID-19 vaccination.     Concomitant products included GABAPENTIN, LEVOTHYROXINE SODIUM (SYNTHROID), BUPROPION HYDROCHLORIDE (WELLBUTRIN), DESVENLAFAXINE, METOPROLOL, ATORVASTATIN, MONTELUKAST and TOPIRAMATE for an unknown indication.    On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Jan-2021, the patient experienced HEADACHE (headache) and VACCINATION SITE PAIN (mild soreness at the injection site). On 04-Feb-2021, the patient experienced ERYTHEMA (redness and a knot(very minimal) that spread across). On 05-Feb-2021, the patient experienced VACCINATION SITE PRURITUS (got very itchy). The patient was treated with CORTISONE at an unspecified dose and frequency and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at a dose of 50 mg. At the time of the report, ERYTHEMA (redness and a knot(very minimal) that spread across), HEADACHE (headache), VACCINATION SITE PAIN (mild soreness at the injection site) and VACCINATION SITE PRURITUS (got very itchy) 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.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Body temperature, Dizziness, Dysgeusia, Heart rate
Clinical narrative: Lightheaded/dizzy; Could taste vaccine; Anxious; This spontaneous case was reported by a nurse and describes the occurrence of DIZZINESS (Lightheaded/dizzy), DYSGEUSIA (Could taste vaccine) and ANXIETY (Anxious) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination.     No medical history was reported by reported.  Concomitant products included OMEPRAZOLE (PRILOSEC [OMEPRAZOLE]) and MULTIVITAMINS [VITAMINS NOS] for an unknown indication.   On 22-Feb-2021 at 3:15 PM, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 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 22-Feb-2021, the patient experienced DIZZINESS (Lightheaded/dizzy), DYSGEUSIA (Could taste vaccine) and ANXIETY (Anxious). The patient was treated with WATER for Dysgeusia, at an unspecified dose and frequency. At the time of the report, DIZZINESS (Lightheaded/dizzy) and ANXIETY (Anxious) outcome was unknown and DYSGEUSIA (Could taste vaccine) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 97.3 (Inconclusive) Inconclusive. On an unknown date, Heart rate: 79 (Inconclusive) Inconclusive, 80 (Inconclusive) Inconclusive and 78 (Inconclusive) Inconclusive. On an unknown date, Oxygen saturation: 97 (Inconclusive) Inconclusive, 98 (Inconclusive) Inconclusive and 98 (Inconclusive) Inconclusive. On an unknown date, Respiratory rate: 36 (Inconclusive) Inconclusive and 32 (Inconclusive) Inconclusive. On an unknown date, Vital signs measurement: 139/86 (Inconclusive) Inconclusive, 119/81 (Inconclusive) Inconclusive and 120/84 (Inconclusive) Inconclusive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   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.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Oxygen saturation, Respiratory rate, Vital signs measurement
Clinical narrative: Lightheaded/dizzy; Could taste vaccine; Anxious; This spontaneous case was reported by a nurse and describes the occurrence of DIZZINESS (Lightheaded/dizzy), DYSGEUSIA (Could taste vaccine) and ANXIETY (Anxious) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination.     No medical history was reported by reported.  Concomitant products included OMEPRAZOLE (PRILOSEC [OMEPRAZOLE]) and MULTIVITAMINS [VITAMINS NOS] for an unknown indication.   On 22-Feb-2021 at 3:15 PM, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 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 22-Feb-2021, the patient experienced DIZZINESS (Lightheaded/dizzy), DYSGEUSIA (Could taste vaccine) and ANXIETY (Anxious). The patient was treated with WATER for Dysgeusia, at an unspecified dose and frequency. At the time of the report, DIZZINESS (Lightheaded/dizzy) and ANXIETY (Anxious) outcome was unknown and DYSGEUSIA (Could taste vaccine) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 97.3 (Inconclusive) Inconclusive. On an unknown date, Heart rate: 79 (Inconclusive) Inconclusive, 80 (Inconclusive) Inconclusive and 78 (Inconclusive) Inconclusive. On an unknown date, Oxygen saturation: 97 (Inconclusive) Inconclusive, 98 (Inconclusive) Inconclusive and 98 (Inconclusive) Inconclusive. On an unknown date, Respiratory rate: 36 (Inconclusive) Inconclusive and 32 (Inconclusive) Inconclusive. On an unknown date, Vital signs measurement: 139/86 (Inconclusive) Inconclusive, 119/81 (Inconclusive) Inconclusive and 120/84 (Inconclusive) Inconclusive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   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.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Gastrointestinal tract irritation, Headache, Illness
Clinical narrative: sick again; diarrhea; intermittent intestinal irritation; headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache), ILLNESS (sick again), DIARRHOEA (diarrhea) and GASTROINTESTINAL TRACT IRRITATION (intermittent intestinal irritation) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Lot# 012L20A) for COVID-19 vaccination.     No Medical History was reported.  The patient's past medical history included No adverse event. Concomitant products included HYDROXYZINE HYDROCHLORIDE (HYDROXYZINE [HYDROXYZINE HYDROCHLORIDE]) for an unknown indication.    On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Feb-2021, the patient experienced HEADACHE (headache). On 15-Feb-2021, the patient experienced DIARRHOEA (diarrhea) and GASTROINTESTINAL TRACT IRRITATION (intermittent intestinal irritation). On 22-Feb-2021, the patient experienced ILLNESS (sick again). At the time of the report, HEADACHE (headache) had resolved and ILLNESS (sick again), DIARRHOEA (diarrhea) and GASTROINTESTINAL TRACT IRRITATION (intermittent intestinal irritation) 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.   No Treatment information  provided
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Influenza like illness, Pain in extremity, Rash, Rhinorrhoea
Clinical narrative: a runny nose; headache; rash on her left breast, chest, and abdomen; flu-like symptoms; Pain in extremity; This spontaneous case was reported by a nurse and describes the occurrence of INFLUENZA LIKE ILLNESS (flu-like symptoms), RHINORRHOEA (a runny nose), RASH (rash on her left breast, chest, and abdomen), HEADACHE (headache) and PAIN IN EXTREMITY (Pain in extremity) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination.     The patient's past medical history included Sinusitis NOS (The patient stated that she has sinuses.). Concurrent medical conditions included Allergy.    On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Jan-2021, the patient experienced INFLUENZA LIKE ILLNESS (flu-like symptoms) and PAIN IN EXTREMITY (Pain in extremity). On 30-Jan-2021, the patient experienced RASH (rash on her left breast, chest, and abdomen). On 24-Feb-2021, the patient experienced RHINORRHOEA (a runny nose) and HEADACHE (headache). On 25-Feb-2021, INFLUENZA LIKE ILLNESS (flu-like symptoms), RASH (rash on her left breast, chest, and abdomen) and PAIN IN EXTREMITY (Pain in extremity) had resolved. At the time of the report, RHINORRHOEA (a runny nose) and HEADACHE (headache) outcome was unknown. Not Provided      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 relevant concomitant medications were reported.  Treatment details included 1 tablet of a Benadryl taken on 01 Feb 2021.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Chills, Diarrhoea, Headache, Malaise
Clinical narrative: headache; diarrhea; rash under her breast, between the breast; the color of her nipples changed, they were kind of pinkish, definitely different color; rash around navel; Felt like warm under the skin where rash was; pain stomach increase, the double over in pain; malaise stomach, the pain increase; chills; very painful; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (malaise stomach, the pain increase), PAIN (very painful), CHILLS (chills), HEADACHE (headache) and ABDOMINAL PAIN UPPER (pain stomach increase, the double over in pain) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by reporter.  Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID), HYDROCHLOROTHIAZIDE, LOSARTAN POTASSIUM (LOSARTAN HCTZ), AMLODIPINE, METOPROLOL and ROSUVASTATIN CALCIUM (CRESTOR) for an unknown indication.    On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Feb-1902, the patient experienced PAIN (very painful). On 16-Feb-2021, the patient experienced MALAISE (malaise stomach, the pain increase) and CHILLS (chills). On 18-Feb-2021, the patient experienced ABDOMINAL PAIN UPPER (pain stomach increase, the double over in pain). On an unknown date, the patient experienced HEADACHE (headache), DIARRHOEA (diarrhea), RASH (rash under her breast, between the breast), SKIN DISCOLOURATION (the color of her nipples changed, they were kind of pinkish, definitely different color), RASH (rash around navel) and SKIN WARM (Felt like warm under the skin where rash was). At the time of the report, MALAISE (malaise stomach, the pain increase), PAIN (very painful), CHILLS (chills), HEADACHE (headache), ABDOMINAL PAIN UPPER (pain stomach increase, the double over in pain), DIARRHOEA (diarrhea), RASH (rash under her breast, between the breast), SKIN DISCOLOURATION (the color of her nipples changed, they were kind of pinkish, definitely different color), RASH (rash around navel) and SKIN WARM (Felt like warm under the skin where rash was) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment details included Cortaid cream, cortisone cream
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Rash, Skin discolouration, Skin warm
Clinical narrative: headache; diarrhea; rash under her breast, between the breast; the color of her nipples changed, they were kind of pinkish, definitely different color; rash around navel; Felt like warm under the skin where rash was; pain stomach increase, the double over in pain; malaise stomach, the pain increase; chills; very painful; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (malaise stomach, the pain increase), PAIN (very painful), CHILLS (chills), HEADACHE (headache) and ABDOMINAL PAIN UPPER (pain stomach increase, the double over in pain) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by reporter.  Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID), HYDROCHLOROTHIAZIDE, LOSARTAN POTASSIUM (LOSARTAN HCTZ), AMLODIPINE, METOPROLOL and ROSUVASTATIN CALCIUM (CRESTOR) for an unknown indication.    On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Feb-1902, the patient experienced PAIN (very painful). On 16-Feb-2021, the patient experienced MALAISE (malaise stomach, the pain increase) and CHILLS (chills). On 18-Feb-2021, the patient experienced ABDOMINAL PAIN UPPER (pain stomach increase, the double over in pain). On an unknown date, the patient experienced HEADACHE (headache), DIARRHOEA (diarrhea), RASH (rash under her breast, between the breast), SKIN DISCOLOURATION (the color of her nipples changed, they were kind of pinkish, definitely different color), RASH (rash around navel) and SKIN WARM (Felt like warm under the skin where rash was). At the time of the report, MALAISE (malaise stomach, the pain increase), PAIN (very painful), CHILLS (chills), HEADACHE (headache), ABDOMINAL PAIN UPPER (pain stomach increase, the double over in pain), DIARRHOEA (diarrhea), RASH (rash under her breast, between the breast), SKIN DISCOLOURATION (the color of her nipples changed, they were kind of pinkish, definitely different color), RASH (rash around navel) and SKIN WARM (Felt like warm under the skin where rash was) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment details included Cortaid cream, cortisone cream
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Emotional disorder, Headache, Hypersensitivity, Muscle fatigue
Clinical narrative: emotionally unstable; Hypersensitivity; rash on both lower legs; diarrhea; headache; nausea; soreness of left arm; muscle fatigue; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (soreness of left arm), MUSCLE FATIGUE (muscle fatigue), DIARRHOEA (diarrhea), RASH (rash on both lower legs) and EMOTIONAL DISORDER (emotionally unstable) in a 51-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.     No medical history was provided by the reporter.     On 18-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Feb-2021, the patient experienced PAIN IN EXTREMITY (soreness of left arm) and MUSCLE FATIGUE (muscle fatigue). On 19-Feb-2021, the patient experienced HEADACHE (headache) and NAUSEA (nausea). On 22-Feb-2021, the patient experienced DIARRHOEA (diarrhea). On 24-Feb-2021, the patient experienced RASH (rash on both lower legs). On an unknown date, the patient experienced EMOTIONAL DISORDER (emotionally unstable) and HYPERSENSITIVITY (Hypersensitivity). At the time of the report, PAIN IN EXTREMITY (soreness of left arm), MUSCLE FATIGUE (muscle fatigue), DIARRHOEA (diarrhea), RASH (rash on both lower legs), EMOTIONAL DISORDER (emotionally unstable), HYPERSENSITIVITY (Hypersensitivity), HEADACHE (headache) and NAUSEA (nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain in extremity, Rash
Clinical narrative: emotionally unstable; Hypersensitivity; rash on both lower legs; diarrhea; headache; nausea; soreness of left arm; muscle fatigue; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (soreness of left arm), MUSCLE FATIGUE (muscle fatigue), DIARRHOEA (diarrhea), RASH (rash on both lower legs) and EMOTIONAL DISORDER (emotionally unstable) in a 51-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.     No medical history was provided by the reporter.     On 18-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Feb-2021, the patient experienced PAIN IN EXTREMITY (soreness of left arm) and MUSCLE FATIGUE (muscle fatigue). On 19-Feb-2021, the patient experienced HEADACHE (headache) and NAUSEA (nausea). On 22-Feb-2021, the patient experienced DIARRHOEA (diarrhea). On 24-Feb-2021, the patient experienced RASH (rash on both lower legs). On an unknown date, the patient experienced EMOTIONAL DISORDER (emotionally unstable) and HYPERSENSITIVITY (Hypersensitivity). At the time of the report, PAIN IN EXTREMITY (soreness of left arm), MUSCLE FATIGUE (muscle fatigue), DIARRHOEA (diarrhea), RASH (rash on both lower legs), EMOTIONAL DISORDER (emotionally unstable), HYPERSENSITIVITY (Hypersensitivity), HEADACHE (headache) and NAUSEA (nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Cough, Pain, Pyrexia
Clinical narrative: dry cough; fever of 102 Degrees Farenheight; chills; body ache; A spontaneous report was received from consumer, concerning a 38-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced fever of 102°F, Chills, dry cough and body aches.  The patient's medical history not provided by the reporter. Concomitant medications included tylenol, ibuprofen, singulair and allergy medication.  On 28 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (batch number: unknown) intramuscularly in left arm for prophylaxis of COVID-19 infection.  On an unknown date, the patient experienced events, fever of 102°F, Chills, dry cough and body aches.  Laboratory details were not provided.  Treatment information not provided  Action taken with mRNA-1273 in response to the events was unknown.  The outcome of the events, fever of 102°F, chills, dry cough and body aches were unknown.
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: Itchiness All Over Body; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itchiness All Over Body) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041620A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Jan-2021, the patient experienced PRURITUS (Itchiness All Over Body). At the time of the report, PRURITUS (Itchiness All Over Body) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was reported.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Rash
Clinical narrative: rash on neck; shortness of breath; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (shortness of breath) and RASH (rash on neck) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination.     Concurrent medical conditions included Allergy (allergic to lactose and sucrose).   On 17-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Feb-2021, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to at an unspecified dose. On 17-Jan-2021, the patient experienced DYSPNOEA (shortness of breath). On 19-Jan-2021, the patient experienced RASH (rash on neck). On 21-Jan-2021, RASH (rash on neck) had resolved. At the time of the report, DYSPNOEA (shortness of breath) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment information was provided.; Sender's Comments: Based on the current available information which shows a temporal association between the use of mRNA-1273 and the onset of the events, a causal relationship cannot be excluded. Rash is consistent with the product known safety
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site swelling, Vaccination complication, Vaccination site erythema, Vaccination site pain, Vaccination site warmth
Clinical narrative: very few side effects; Pain - Near Injection Site; Swelling; Redness - Near Injection Site; Warm to Touch Sensation - Near Injection Site; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE WARMTH (Warm to Touch Sensation - Near Injection Site), VACCINATION COMPLICATION (very few side effects), VACCINATION SITE PAIN (Pain - Near Injection Site), INJECTION SITE SWELLING (Swelling) and VACCINATION SITE ERYTHEMA (Redness - Near Injection Site) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037K20A and 0062MZ0A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy.   On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 2 dosage form. On 27-Jan-2021, the patient experienced VACCINATION SITE WARMTH (Warm to Touch Sensation - Near Injection Site), VACCINATION SITE PAIN (Pain - Near Injection Site), INJECTION SITE SWELLING (Swelling) and VACCINATION SITE ERYTHEMA (Redness - Near Injection Site). On an unknown date, the patient experienced VACCINATION COMPLICATION (very few side effects). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. On 30-Jan-2021, VACCINATION SITE WARMTH (Warm to Touch Sensation - Near Injection Site), VACCINATION SITE PAIN (Pain - Near Injection Site), INJECTION SITE SWELLING (Swelling) and VACCINATION SITE ERYTHEMA (Redness - Near Injection Site) had resolved. At the time of the report, VACCINATION COMPLICATION (very few side effects) had resolved.            No concomitant medication was provided.   Most recent FOLLOW-UP information incorporated above includes: On 19-May-2021: The significant follow up information received on 19-MAY-2021. Patient demographic details were added. Medical history information is added. Second dose details were added.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Eye swelling, Implant site swelling, Swelling face, Vaccination site pain
Clinical narrative: one eye is swollen shut; swelling around breast implant area; sensitive to the touch; swelling face; This spontaneous case was reported by a consumer and describes the occurrence of EYE SWELLING (one eye is swollen shut), SWELLING FACE (swelling face), IMPLANT SITE SWELLING (swelling around breast implant area) and VACCINATION SITE PAIN (sensitive to the touch) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032L20A and 011L20A) for COVID-19 vaccination.     The patient's past medical history included Mastectomy bilateral. Concurrent medical conditions included Breast cancer.   On 09-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 06-Feb-2021, the patient experienced SWELLING FACE (swelling face) and VACCINATION SITE PAIN (sensitive to the touch). On 08-Feb-2021, the patient experienced EYE SWELLING (one eye is swollen shut) and IMPLANT SITE SWELLING (swelling around breast implant area). The patient was treated with FAMOTIDINE (PEPCID AC) for Adverse event, at an unspecified dose and frequency and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency. At the time of the report, EYE SWELLING (one eye is swollen shut), SWELLING FACE (swelling face), IMPLANT SITE SWELLING (swelling around breast implant area) and VACCINATION SITE PAIN (sensitive to the touch) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were given.  Additional treatment includes steroids.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus, Vaccination site warmth
Clinical narrative: warm at injection site; itchy at injection site; right upper arm red spot 8 by 9 cm; This spontaneous case was reported by a health care professional (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE WARMTH (warm at injection site), VACCINATION SITE PRURITUS (itchy at injection site) and VACCINATION SITE ERYTHEMA (right upper arm red spot 8 by 9 cm) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029K20A) for COVID-19 vaccination.     Concomitant products included SITAGLIPTIN PHOSPHATE (JANUVIA [SITAGLIPTIN PHOSPHATE]), EMPAGLIFLOZIN (JARDIANCE), METFORMIN, LOVASTATIN, CALCIUM CARBONATE, COLECALCIFEROL (VITAMIN D 2000) and QUINAPRIL for an unknown indication.    On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Feb-2021, the patient experienced VACCINATION SITE WARMTH (warm at injection site), VACCINATION SITE PRURITUS (itchy at injection site) and VACCINATION SITE ERYTHEMA (right upper arm red spot 8 by 9 cm). At the time of the report, VACCINATION SITE WARMTH (warm at injection site), VACCINATION SITE PRURITUS (itchy at injection site) and VACCINATION SITE ERYTHEMA (right upper arm red spot 8 by 9 cm) 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.   No treatment medications were provided.