chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: Soreness; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Soreness) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Feb-2021, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to at an unspecified dose. On 20-Jan-2021, the patient experienced MYALGIA (Soreness). At the time of the report, MYALGIA (Soreness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Sex: M
Vaccine: COVID19
Symptoms: Abdominal symptom, Diarrhoea, Fatigue, Headache
Clinical narrative: sick with diarrhea; sick to the stomach; exhausted; splitting headache; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (sick with diarrhea), ABDOMINAL SYMPTOM (sick to the stomach), FATIGUE (exhausted) and HEADACHE (splitting headache) 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) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Feb-2021, the patient experienced DIARRHOEA (sick with diarrhea), ABDOMINAL SYMPTOM (sick to the stomach), FATIGUE (exhausted) and HEADACHE (splitting headache). At the time of the report, DIARRHOEA (sick with diarrhea), ABDOMINAL SYMPTOM (sick to the stomach), FATIGUE (exhausted) and HEADACHE (splitting headache) had resolved.            No concomitant medications were reported.  Patient reported symptoms started four days after the vaccine was given on an unspecified date. Patient stated symptoms stopped three to four days after they began. Treatment was listed as taking Sino-Morphine all day.   Most recent FOLLOW-UP information incorporated above includes: On 06-Jul-2021: Follow-up was received. Reporter details were added. All events' outcome was updated to recovered/resolved.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Pyrexia, Tremor
Clinical narrative: This spontaneous case was reported by an other health care professional and describes the occurrence of ABDOMINAL DISCOMFORT (Stomach issues), TREMOR (Shakes), PYREXIA (Fever) and CHILLS (Chills) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The patient's past medical history included No adverse event (No medical history provided) since an unknown date. Concomitant products included LENVATINIB MESILATE (LENVIMA) for an unknown indication. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ABDOMINAL DISCOMFORT (Stomach issues), TREMOR (Shakes), PYREXIA (Fever) and CHILLS (Chills). At the time of the report, ABDOMINAL DISCOMFORT (Stomach issues) was resolving and TREMOR (Shakes), PYREXIA (Fever) and CHILLS (Chills) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No relevant medical history provided and Treatment information were not provided.
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Nausea, Pyrexia
Clinical narrative: light fever; nausea; redness around the injection site that seems to be moving down her arm (the upper part of the; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (light fever), NAUSEA (nausea) and ERYTHEMA (redness around the injection site that seems to be moving down her arm (the upper part of the) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Latex allergy (Latex of the band aid).   On 17-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 2 dosage form. On 17-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Feb-2021, the patient experienced PYREXIA (light fever), NAUSEA (nausea) and ERYTHEMA (redness around the injection site that seems to be moving down her arm (the upper part of the). On 18-Feb-2021, PYREXIA (light fever) and NAUSEA (nausea) had resolved. At the time of the report, ERYTHEMA (redness around the injection site that seems to be moving down her arm (the upper part of the) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain
Clinical narrative: Injection site was red; Injection site was tender to touch; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (Injection site was red) and VACCINATION SITE PAIN (Injection site was tender to touch) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032H20A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (Allergy to sulfa, codeine and erythromycin).    On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Feb-2021, the patient experienced VACCINATION SITE ERYTHEMA (Injection site was red) and VACCINATION SITE PAIN (Injection site was tender to touch). At the time of the report, VACCINATION SITE ERYTHEMA (Injection site was red) and VACCINATION SITE PAIN (Injection site was tender to touch) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Nasopharyngitis, Tremor
Clinical narrative: cold; Shaking; Chills; This spontaneous case was reported by a consumer and describes the occurrence of NASOPHARYNGITIS (cold), TREMOR (Shaking) and CHILLS (Chills) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 024M20N and 024M20N) for COVID-19 vaccination.     No Medical History information was reported.   On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 19-Feb-2021, the patient experienced NASOPHARYNGITIS (cold), TREMOR (Shaking) and CHILLS (Chills). On 20-Feb-2021, NASOPHARYNGITIS (cold), TREMOR (Shaking) and CHILLS (Chills) had resolved.            No concomitant medication was reported.  No treatment medication was reported.   Most recent FOLLOW-UP information incorporated above includes: On 07-Jul-2021: Follow -up received and contains no new information
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Somnolence
Clinical narrative: Sleepy; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (Sleepy) in a 78-year-old female patient 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 SOMNOLENCE (Sleepy). At the time of the report, SOMNOLENCE (Sleepy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       This case was linked to US-MODERNATX, INC.-MOD-2021-020448, US-MODERNATX, INC.-MOD-2021-020515    Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-020448:Same reporter, reporter herself US-MODERNATX, INC.-MOD-2021-020515:Same reporter, reporter's son
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Peripheral swelling, Pruritus, Vaccination site rash
Clinical narrative: Itchy arm/it was itchier; red circle of around 4 inches; arm was a little swollen; Covid arm; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itchy arm/it was itchier), ERYTHEMA (red circle of around 4 inches), PERIPHERAL SWELLING (arm was a little swollen) and VACCINATION SITE RASH (Covid arm) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination.     Concurrent medical conditions included Seafood allergy (shrimp). Concomitant products included VITAMIN D NOS, VITAMIN B NOS, VITAMIN E NOS, ATORVASTATIN CALCIUM (LIPITOR), HYDROCHLOROTHIAZIDE and ALENDRONATE SODIUM (FOSAMAX) for an unknown indication.    On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRURITUS (Itchy arm/it was itchier), ERYTHEMA (red circle of around 4 inches), PERIPHERAL SWELLING (arm was a little swollen) and VACCINATION SITE RASH (Covid arm). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form and IBUPROFEN (ADVIL [IBUPROFEN]) at a dose of 1 dosage form. At the time of the report, PRURITUS (Itchy arm/it was itchier), ERYTHEMA (red circle of around 4 inches), PERIPHERAL SWELLING (arm was a little swollen) and VACCINATION SITE RASH (Covid arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 14-Jul-2021: Follow Up received on 14-JUL-2021. The reporter contact details were updated.
Sex: F
Vaccine: COVID19
Symptoms: Influenza, Pain, Pyrexia
Clinical narrative: On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PYREXIA (Fever of 101.4°F), INFLUENZA (Feeling of having a flu) and PAIN (Ache all over). At the time of the report, PYREXIA (Fever of 101.4°F) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Fatigue, Injection site pain, Injection site pruritus, Nausea
Clinical narrative: hives; fatigue; itching arm; face itching; nausea; stomach cramps; arm hurts near injection site; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (fatigue) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20A) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 23-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 FATIGUE (fatigue). The patient was treated with PARACETAMOL (TYLENOL) for Pain in arm, at an unspecified dose and frequency and FAMOTIDINE (PEPCID [FAMOTIDINE]) for Stomach discomfort, at an unspecified dose and frequency. At the time of the report, FATIGUE (fatigue) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 27-Jan-2021: No specific follow-up information recorded.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Urticaria
Clinical narrative: hives; fatigue; itching arm; face itching; nausea; stomach cramps; arm hurts near injection site; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (fatigue) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20A) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 23-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 FATIGUE (fatigue). The patient was treated with PARACETAMOL (TYLENOL) for Pain in arm, at an unspecified dose and frequency and FAMOTIDINE (PEPCID [FAMOTIDINE]) for Stomach discomfort, at an unspecified dose and frequency. At the time of the report, FATIGUE (fatigue) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 27-Jan-2021: No specific follow-up information recorded.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: Covid-19; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of COVID-19 (Covid-19) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Feb-2021, the patient experienced COVID-19 (Covid-19). At the time of the report, COVID-19 (Covid-19) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 89.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Heart rate increased
Clinical narrative: Weakness; Dizziness; Rapid heart rate; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Weakness), DIZZINESS (Dizziness) and HEART RATE INCREASED (Rapid heart rate) in an 89-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Feb-2021, the patient experienced ASTHENIA (Weakness), DIZZINESS (Dizziness) and HEART RATE INCREASED (Rapid heart rate). At the time of the report, ASTHENIA (Weakness), DIZZINESS (Dizziness) and HEART RATE INCREASED (Rapid heart rate) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. Treatment details included None.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: Itching with no rash all over the body; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itching with no rash all over the body) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination.     No medical history was reported.     On 10-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 PRURITUS (Itching with no rash all over the body). The patient was treated with PREDNISONE at an unspecified dose and frequency. At the time of the report, PRURITUS (Itching with no rash all over the body) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No new information was provided in the follow up   This case was linked to MOD-2021-062228 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 27-Apr-2021: No specific follow-up information recorded.; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-062228:
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity, Pyrexia
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm next day), FATIGUE (very tired the next day) and PYREXIA (low grade fever 99.4) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038K20A) for COVID-19 vaccination. The patient's past medical history included No adverse event. On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Feb-2021, the patient experienced PAIN IN EXTREMITY (sore arm next day) and FATIGUE (very tired the next day). On an unknown date, the patient experienced PYREXIA (low grade fever 99.4). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (sore arm next day), FATIGUE (very tired the next day) and PYREXIA (low grade fever 99.4) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Myalgia, Pyrexia
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of TENDERNESS (Tenderness), PYREXIA (Fever), HEADACHE (Terrible headache), FATIGUE (Fatigue) and VACCINATION SITE PAIN (Soreness) in a female patient of an unknown age 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 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced TENDERNESS (Tenderness), PYREXIA (Fever), HEADACHE (Terrible headache), FATIGUE (Fatigue), VACCINATION SITE PAIN (Soreness), MYALGIA (Body ache) and CHILLS (Chills). At the time of the report, TENDERNESS (Tenderness), PYREXIA (Fever), HEADACHE (Terrible headache), FATIGUE (Fatigue), VACCINATION SITE PAIN (Soreness) and CHILLS (Chills) outcome was unknown and MYALGIA (Body ache) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Tenderness, Vaccination site pain
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of TENDERNESS (Tenderness), PYREXIA (Fever), HEADACHE (Terrible headache), FATIGUE (Fatigue) and VACCINATION SITE PAIN (Soreness) in a female patient of an unknown age 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 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced TENDERNESS (Tenderness), PYREXIA (Fever), HEADACHE (Terrible headache), FATIGUE (Fatigue), VACCINATION SITE PAIN (Soreness), MYALGIA (Body ache) and CHILLS (Chills). At the time of the report, TENDERNESS (Tenderness), PYREXIA (Fever), HEADACHE (Terrible headache), FATIGUE (Fatigue), VACCINATION SITE PAIN (Soreness) and CHILLS (Chills) outcome was unknown and MYALGIA (Body ache) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: Felt light headed when going to the restroom; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Felt light headed when going to the restroom) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Feb-2021, the patient experienced DIZZINESS (Felt light headed when going to the restroom). At the time of the report, DIZZINESS (Felt light headed when going to the restroom) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea, Injection site pain, Malaise, Pyrexia
Clinical narrative: loose stools; not feeling well; fever of 102.4; pain at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (loose stools), MALAISE (not feeling well), INJECTION SITE PAIN (pain at the injection site) and PYREXIA (fever of 102.4) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination.     No Medical History information was reported.    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 INJECTION SITE PAIN (pain at the injection site). On 21-Feb-2021, the patient experienced DIARRHOEA (loose stools), MALAISE (not feeling well) and PYREXIA (fever of 102.4). At the time of the report, DIARRHOEA (loose stools), MALAISE (not feeling well), INJECTION SITE PAIN (pain at the injection site) and PYREXIA (fever of 102.4) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication and treatment medication was provided.   This case was linked to MOD-2021-032541 (Patient Link).
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Influenza like illness
Clinical narrative: Dizziness; Flu- like symptoms; Tiredness; This spontaneous case was reported by a nurse and describes the occurrence of DIZZINESS (Dizziness), INFLUENZA LIKE ILLNESS (Flu- like symptoms) and FATIGUE (Tiredness) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 11-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 22-Feb-2021, the patient experienced DIZZINESS (Dizziness), INFLUENZA LIKE ILLNESS (Flu- like symptoms) and FATIGUE (Tiredness). At the time of the report, DIZZINESS (Dizziness), INFLUENZA LIKE ILLNESS (Flu- like symptoms) and FATIGUE (Tiredness) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications provided  No treatment medications provided   Most recent FOLLOW-UP information incorporated above includes: On 31-Mar-2021: follow up received on 31st march 2021 contains no new information; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Confusional state, Dizziness, Feeling hot
Clinical narrative: dizziness; a little confused; warm feeling through out her body; This spontaneous case was reported by an other health care professional and describes the occurrence of DIZZINESS (dizziness), CONFUSIONAL STATE (a little confused) and FEELING HOT (warm feeling through out her body) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011L20A and 012M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported). Concomitant products included ARIPIPRAZOLE (ABILIFY) and VENLAFAXINE HYDROCHLORIDE (EFFEXOR) for an unknown indication.   On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 04-Feb-2021, the patient experienced DIZZINESS (dizziness), CONFUSIONAL STATE (a little confused) and FEELING HOT (warm feeling through out her body). At the time of the report, DIZZINESS (dizziness), CONFUSIONAL STATE (a little confused) and FEELING HOT (warm feeling through out her body) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment included Tylenol
Sex: F
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: I have a question about a side effect that I'm experiencing with my covid vaccination; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (I have a question about a side effect that I'm experiencing with my covid vaccination) 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 12-Jan-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 an unknown date, the patient experienced VACCINATION COMPLICATION (I have a question about a side effect that I'm experiencing with my covid vaccination). At the time of the report, VACCINATION COMPLICATION (I have a question about a side effect that I'm experiencing with my covid vaccination) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Concomitant product use was not provided by the reporter.  No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 24-Jun-2021: Follow up received on 24-06-2021 is non significant follow up. Patient Email address was provided.
Sex: U
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Pain on their arms; A spontaneous report was received from a consumer concerning patient of unknown age and sex who developed pain on their arms/pain in extremity.   The patient's medical history was not provided.  Concomitant product use was not provided by the reporter.   The patient received their unknown of two planned doses of mRNA-1273 (Batch number: unknown) on unknown date at unknown injection site for prophylaxis of COVID-19 infection.    The patient developed pain on their arms. Treatment information was not provided.   Action taken with mRNA-1273 in response to the events was not provided.  The outcome of the event pain on their arms was not reported.
Sex: F
Vaccine: COVID19
Symptoms: Heart rate increased
Clinical narrative: Pulse very high; A regulatory authority report was received from a consumer concerning a, female patient whose ethnicity was unknown, who received Moderna's COVID-19 Vaccine (mRNA-1273)on 22JAN2021 and experienced events on 22JAN2021 , In the first four hours, her pulse was very high. It went down after four hours.  The patient's medical history was not provided. .  On 22JAN2021, the patient received their first of two planned doses of mRNA-1273 (lot number /Batch no: unknown) unknown route of administration for prophylaxis of COVID-19 infection.  Laboratory details was not provided.   Concomitant medications was not provided  No treatment information was provided.    Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the reported events high pulse rate was recovering /resolving, In the first four hours, her pulse was very high. It went down after four hours.  Causality was not provided .
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Myalgia, Nausea, Pyrexia
Clinical narrative: chills; fever; muscle aches; nausea; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chills), PYREXIA (fever), MYALGIA (muscle aches), NAUSEA (nausea) and FATIGUE (fatigue) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024MZ0A) for COVID-19 vaccination.     Concomitant products included PARACETAMOL (TYLENOL) for an unknown indication.    On 19-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Feb-2021, the patient experienced CHILLS (chills), PYREXIA (fever), MYALGIA (muscle aches), NAUSEA (nausea) and FATIGUE (fatigue). At the time of the report, CHILLS (chills), PYREXIA (fever), MYALGIA (muscle aches), NAUSEA (nausea) and FATIGUE (fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment was reported.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pruritus, Rash, Swelling, Tenderness
Clinical narrative: tender to touch; achy when I raised my arm; itching; delayed side effect; rash; small swelling; swelling of the arm right below injection site; This spontaneous case was reported by a consumer and describes the occurrence of TENDERNESS (tender to touch), PAIN IN EXTREMITY (achy when I raised my arm), PRURITUS (itching), VACCINATION SITE REACTION (delayed side effect) and RASH (rash) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043L20A) 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 reported medical history). Concomitant products included CICLOSPORIN (RESTASIS) for Dry eye.    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 TENDERNESS (tender to touch), PAIN IN EXTREMITY (achy when I raised my arm), PRURITUS (itching), VACCINATION SITE REACTION (delayed side effect), RASH (rash), SWELLING (small swelling) and VACCINATION SITE SWELLING (swelling of the arm right below injection site). At the time of the report, TENDERNESS (tender to touch), PAIN IN EXTREMITY (achy when I raised my arm), VACCINATION SITE REACTION (delayed side effect), SWELLING (small swelling) and VACCINATION SITE SWELLING (swelling of the arm right below injection site) outcome was unknown and PRURITUS (itching) and RASH (rash) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information were not provided.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site reaction, Vaccination site swelling
Clinical narrative: tender to touch; achy when I raised my arm; itching; delayed side effect; rash; small swelling; swelling of the arm right below injection site; This spontaneous case was reported by a consumer and describes the occurrence of TENDERNESS (tender to touch), PAIN IN EXTREMITY (achy when I raised my arm), PRURITUS (itching), VACCINATION SITE REACTION (delayed side effect) and RASH (rash) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043L20A) 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 reported medical history). Concomitant products included CICLOSPORIN (RESTASIS) for Dry eye.    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 TENDERNESS (tender to touch), PAIN IN EXTREMITY (achy when I raised my arm), PRURITUS (itching), VACCINATION SITE REACTION (delayed side effect), RASH (rash), SWELLING (small swelling) and VACCINATION SITE SWELLING (swelling of the arm right below injection site). At the time of the report, TENDERNESS (tender to touch), PAIN IN EXTREMITY (achy when I raised my arm), VACCINATION SITE REACTION (delayed side effect), SWELLING (small swelling) and VACCINATION SITE SWELLING (swelling of the arm right below injection site) outcome was unknown and PRURITUS (itching) and RASH (rash) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information were not provided.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Pain
Clinical narrative: A spontaneous report was received from a consumer concerning a female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events pain in the shoulder after the injection/arthralgia, now it's radiating, it's shifting from the shoulder to the neck/radiating pain. The patient's medical history was not provided. No relevant concomitant medications were reported. On unknown date, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: unknown) via unknown route for prophylaxis of COVID-19 infection. On an unknown date, the patient experienced the event(s) pain in the shoulder after the injection, now it's radiating, it's shifting from the shoulder to the neck. No treatment information was provided. Action taken with mRNA-1273 in response to the events was not reported.  The outcome of event(s), pain in the shoulder after the injection, now it's radiating, it's shifting from the shoulder to the neck was unknown.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Feeling cold, Hyperhidrosis, Influenza like illness
Clinical narrative: This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of INFLUENZA LIKE ILLNESS (flu like symptoms), FEELING COLD (really cold), HYPERHIDROSIS (sweat) and FATIGUE (really fatigued) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025L20A and 043L20A) for COVID-19 vaccination. Concurrent medical conditions included Hypertension and Cholesterol. On 30-Jan-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 30-Jan-2021, the patient experienced INFLUENZA LIKE ILLNESS (flu like symptoms), FEELING COLD (really cold), HYPERHIDROSIS (sweat) and FATIGUE (really fatigued). At the time of the report, INFLUENZA LIKE ILLNESS (flu like symptoms), FEELING COLD (really cold), HYPERHIDROSIS (sweat) and FATIGUE (really fatigued) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Headache, Vision blurred
Clinical narrative: Blurred vision; fatigue, dizziness, headaches; fatigue, dizziness, headaches; fatigue, dizziness, headaches; This spontaneous case was reported by a consumer and describes the occurrence of VISION BLURRED (Blurred vision), DIZZINESS (fatigue, dizziness, headaches), FATIGUE (fatigue, dizziness, headaches) and HEADACHE (fatigue, dizziness, headaches) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included High cholesterol since an unknown date. Concomitant products included IBUPROFEN for an unknown indication.    On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Feb-2021, the patient experienced VISION BLURRED (Blurred vision), DIZZINESS (fatigue, dizziness, headaches), FATIGUE (fatigue, dizziness, headaches) and HEADACHE (fatigue, dizziness, headaches). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, VISION BLURRED (Blurred vision), DIZZINESS (fatigue, dizziness, headaches), FATIGUE (fatigue, dizziness, headaches) and HEADACHE (fatigue, dizziness, headaches) 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.   Treatment medications included Acetaminophen.  Concomitant medications included an unknown cholesterol medication.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site lymphadenopathy
Clinical narrative: Swelling of the lymph node on the same arm of injection; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE LYMPHADENOPATHY (Swelling of the lymph node on the same arm of injection) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Feb-2021, the patient experienced VACCINATION SITE LYMPHADENOPATHY (Swelling of the lymph node on the same arm of injection). At the time of the report, VACCINATION SITE LYMPHADENOPATHY (Swelling of the lymph node on the same arm of injection) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment and concomitant medications were not provided by reporter.   Reporter did not allow further contact
Age: 83.0
Sex: M
Vaccine: COVID19
Symptoms: Pruritus, Rash
Clinical narrative: itching; rash; A spontaneous report  was received from a consumer concerning a 83-years-old  patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events rash, itching/pruritus.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 12 Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 015M20A) via unknown route in the right arm for prophylaxis of COVID-19 infection.  On 21 Feb 2021, the patient experienced the event(s) rash, itching.  Treatment details included Cortisone cream.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), rash, itching was unknown.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Myalgia, Pain
Clinical narrative: Pains/other pain; Chills; Fatigue; Headache; Muscle aches; Had like a little candle in the injection site (spot where she got the vaccine) like a little mosquito bit/ was red; Swelling at injection site; Uncomfortable at injectionsite; A spontaneous report was received from a 43-year-old female patient concerning herself who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced pains/other pain, had like a little candle in the injection site (spot where she got the vaccine) like a little mosquito bit/ was red, swelling at injection site, uncomfortable at injection site, chills, fatigue, headache and muscle aches.  The patient medical history was not reported. Concomitant medication was not reported.  On 13-Feb-2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: 024M20A) via unknown route in right arm for prophylaxis of COVID-19 infection.  On 20-Feb-2021, after the vaccine administration, the patient experienced events like a little candle in the injection site (spot where the patient got the vaccine) like a little mosquito bit, the patient thought is was an allergy reaction, Like covid arm. It really swelling, red and uncomfortable, the patient took diphenhydramine, the patient also experienced fatigue, chills, headache, muscle aches and pains, other pain.  Action taken with mRNA-1273 in response to the events were not provided  The outcome of the events pains/other pain, had like a little candle in the injection site (spot where she got the vaccine) like a little mosquito bit/ was red, swelling at injection site, uncomfortable at injection site, chills, fatigue, headache and muscle aches was considered unknown at the time of this report.; Reporter's Comments: This case concerns a 43-year-old female with a nonserious unexpected event of pain and nonserious expected vaccination site erythema, vaccination site swelling, injection site discomfort, headache, myalgia, chills, fatigue. Event onset 8 days after the first dose of mRNA-1273. Treatment not reported. Event outcomes unknown. Based on current available information and temporal association between use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site discomfort, Vaccination site erythema, Vaccination site swelling
Clinical narrative: Pains/other pain; Chills; Fatigue; Headache; Muscle aches; Had like a little candle in the injection site (spot where she got the vaccine) like a little mosquito bit/ was red; Swelling at injection site; Uncomfortable at injectionsite; A spontaneous report was received from a 43-year-old female patient concerning herself who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced pains/other pain, had like a little candle in the injection site (spot where she got the vaccine) like a little mosquito bit/ was red, swelling at injection site, uncomfortable at injection site, chills, fatigue, headache and muscle aches.  The patient medical history was not reported. Concomitant medication was not reported.  On 13-Feb-2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: 024M20A) via unknown route in right arm for prophylaxis of COVID-19 infection.  On 20-Feb-2021, after the vaccine administration, the patient experienced events like a little candle in the injection site (spot where the patient got the vaccine) like a little mosquito bit, the patient thought is was an allergy reaction, Like covid arm. It really swelling, red and uncomfortable, the patient took diphenhydramine, the patient also experienced fatigue, chills, headache, muscle aches and pains, other pain.  Action taken with mRNA-1273 in response to the events were not provided  The outcome of the events pains/other pain, had like a little candle in the injection site (spot where she got the vaccine) like a little mosquito bit/ was red, swelling at injection site, uncomfortable at injection site, chills, fatigue, headache and muscle aches was considered unknown at the time of this report.; Reporter's Comments: This case concerns a 43-year-old female with a nonserious unexpected event of pain and nonserious expected vaccination site erythema, vaccination site swelling, injection site discomfort, headache, myalgia, chills, fatigue. Event onset 8 days after the first dose of mRNA-1273. Treatment not reported. Event outcomes unknown. Based on current available information and temporal association between use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Decreased appetite, Dizziness, Fatigue
Clinical narrative: body rash that is a bright red area on her feet, ankles, up her legs, arms, belly, and back; UTI; chills; nausea; dizziness; weakness; no appetite; fast heartbeat; fatigue; headache off and on; A spontaneous report was received from a consumer concerning a 81-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events fatigue, headache off and on, uti, chills, nausea, dizziness, weakness, no appetite, fast heartbeat, body rash that is a bright red area on her feet, ankles, up her legs, arms, belly, and back.  The patient's medical history was not provided. Concomitant medications reported were Prilosec, Vitamin D for drug use for unknown indication.  On unknown date, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: unknown) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 14 Feb 2021, the patient experienced the event(s) fatigue, headache off and on. On 18 Feb 2021, the patient experienced the event(s) uti, chills, nausea, dizziness, weakness, no appetite, fast heartbeat. On 21 Feb 2021, the patient experienced the event(s) body rash that is a bright red area on her feet, ankles, up her legs, arms, belly, and back.  Treatment details included Kenalog for fast heartbeat, Macrobid for the UTI she developed, and Tylenol off and on, which, seemed to help.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), fatigue, headache off and on, uti, chills, nausea, dizziness, weakness, no appetite, fast heartbeat, body rash that is a bright red area on her feet, ankles, up her legs, arms, belly, and back was unknown.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Heart rate increased, Nausea, Rash, Urinary tract infection
Clinical narrative: body rash that is a bright red area on her feet, ankles, up her legs, arms, belly, and back; UTI; chills; nausea; dizziness; weakness; no appetite; fast heartbeat; fatigue; headache off and on; A spontaneous report was received from a consumer concerning a 81-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events fatigue, headache off and on, uti, chills, nausea, dizziness, weakness, no appetite, fast heartbeat, body rash that is a bright red area on her feet, ankles, up her legs, arms, belly, and back.  The patient's medical history was not provided. Concomitant medications reported were Prilosec, Vitamin D for drug use for unknown indication.  On unknown date, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: unknown) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 14 Feb 2021, the patient experienced the event(s) fatigue, headache off and on. On 18 Feb 2021, the patient experienced the event(s) uti, chills, nausea, dizziness, weakness, no appetite, fast heartbeat. On 21 Feb 2021, the patient experienced the event(s) body rash that is a bright red area on her feet, ankles, up her legs, arms, belly, and back.  Treatment details included Kenalog for fast heartbeat, Macrobid for the UTI she developed, and Tylenol off and on, which, seemed to help.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), fatigue, headache off and on, uti, chills, nausea, dizziness, weakness, no appetite, fast heartbeat, body rash that is a bright red area on her feet, ankles, up her legs, arms, belly, and back was unknown.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Swelling, Vaccination site erythema, Vaccination site induration, Vaccination site pruritus
Clinical narrative: Itchy; hard arm; Red; Sore; Swollen; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (Itchy), VACCINATION SITE INDURATION (hard arm), VACCINATION SITE ERYTHEMA (Red), PAIN (Sore) and SWELLING (Swollen) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032H20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history provided). Concomitant products included LEVOTHYROXINE SODIUM (LEVOTIROXIN), VITAMINS NOS and CALCIUM 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 02-Feb-2021, the patient experienced VACCINATION SITE PRURITUS (Itchy), VACCINATION SITE INDURATION (hard arm), VACCINATION SITE ERYTHEMA (Red), PAIN (Sore) and SWELLING (Swollen). At the time of the report, VACCINATION SITE PRURITUS (Itchy), VACCINATION SITE INDURATION (hard arm), VACCINATION SITE ERYTHEMA (Red), PAIN (Sore) and SWELLING (Swollen) 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 medications were not provided by reporter.