chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema
Clinical narrative: loss of taste and smell; loss of taste and smell; Purple , red circle on the injection site; swelling on the injection site; developed a lump underneath her arm that lasted for one week; This spontaneous case was reported by a consumer and describes the occurrence of ANOSMIA (loss of taste and smell), AGEUSIA (loss of taste and smell), LYMPHADENOPATHY (developed a lump underneath her arm that lasted for one week), VACCINATION SITE ERYTHEMA (Purple , red circle on the injection site) and INJECTION SITE SWELLING (swelling on the injection site) 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 20-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 ANOSMIA (loss of taste and smell), AGEUSIA (loss of taste and smell), LYMPHADENOPATHY (developed a lump underneath her arm that lasted for one week), VACCINATION SITE ERYTHEMA (Purple , red circle on the injection site) and INJECTION SITE SWELLING (swelling on the injection site). At the time of the report, ANOSMIA (loss of taste and smell) and AGEUSIA (loss of taste and smell) had not resolved and LYMPHADENOPATHY (developed a lump underneath her arm that lasted for one week), VACCINATION SITE ERYTHEMA (Purple , red circle on the injection site) and INJECTION SITE SWELLING (swelling on the injection site) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 08-Feb-2021, SARS-CoV-2 test negative: negative (Negative) negative. On an unknown date, SARS-CoV-2 test negative: negative negative.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication history not provided. Treatment information not reported.   Most recent FOLLOW-UP information incorporated above includes: On 17-Feb-2021: Follow up received on 18-FEB-2021 contain significant information about additional events after first dose, and outcome of previous events unknown to not recovered. Added lab data information. On 14-Jun-2021: Follow-up received on 14-Jun-2021 and does not contain any new information.
Sex: F
Vaccine: COVID19
Symptoms: Dry eye, Eye irritation, Eye pain, Headache, Pain
Clinical narrative: burning in both eyes; headache; dry eye; in both eye sockets; Pain was worst/pain was getting worse; felt lot like reaction I had to thimerosal; This spontaneous case was reported by a consumer and describes the occurrence of EYE IRRITATION (burning in both eyes), HEADACHE (headache), DRY EYE (dry eye), EYE PAIN (in both eye sockets) and PAIN (Pain was worst/pain was getting worse) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046120A and 013M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event. Previously administered products included for an unreported indication: THIMEROSAL (Patient reported that she had the same adverse events when had to thimerosal).   On 17-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.  On 14-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form.   On 17-Feb-2021, the patient experienced PAIN (Pain was worst/pain was getting worse) and UNEVALUABLE EVENT (felt lot like reaction I had to thimerosal).   On an unknown date, the patient experienced EYE IRRITATION (burning in both eyes), HEADACHE (headache), DRY EYE (dry eye) and EYE PAIN (in both eye sockets).   At the time of the report, EYE IRRITATION (burning in both eyes), HEADACHE (headache), DRY EYE (dry eye), EYE PAIN (in both eye sockets) and PAIN (Pain was worst/pain was getting worse) outcome was unknown and UNEVALUABLE EVENT (felt lot like reaction I had to thimerosal) had resolved.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. No treatment information was provided.
Sex: F
Vaccine: COVID19
Symptoms: Unevaluable event
Clinical narrative: burning in both eyes; headache; dry eye; in both eye sockets; Pain was worst/pain was getting worse; felt lot like reaction I had to thimerosal; This spontaneous case was reported by a consumer and describes the occurrence of EYE IRRITATION (burning in both eyes), HEADACHE (headache), DRY EYE (dry eye), EYE PAIN (in both eye sockets) and PAIN (Pain was worst/pain was getting worse) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046120A and 013M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event. Previously administered products included for an unreported indication: THIMEROSAL (Patient reported that she had the same adverse events when had to thimerosal).   On 17-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.  On 14-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form.   On 17-Feb-2021, the patient experienced PAIN (Pain was worst/pain was getting worse) and UNEVALUABLE EVENT (felt lot like reaction I had to thimerosal).   On an unknown date, the patient experienced EYE IRRITATION (burning in both eyes), HEADACHE (headache), DRY EYE (dry eye) and EYE PAIN (in both eye sockets).   At the time of the report, EYE IRRITATION (burning in both eyes), HEADACHE (headache), DRY EYE (dry eye), EYE PAIN (in both eye sockets) and PAIN (Pain was worst/pain was getting worse) outcome was unknown and UNEVALUABLE EVENT (felt lot like reaction I had to thimerosal) had resolved.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. No treatment information was provided.
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Muscle spasms, Nausea, Pain, Vomiting
Clinical narrative: Nausea; Vomiting; Back muscle spasm on and off from his shoulder to his waist; Has a good pain tolerance but he is almost in tears; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE SPASMS (Back muscle spasm on and off from his shoulder to his waist), PAIN (Has a good pain tolerance but he is almost in tears), FATIGUE (Fatigue), NAUSEA (Nausea) and VOMITING (Vomiting) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006M20A and 041L20A) for COVID-19 vaccination.     Concurrent medical conditions included Fatigue, Hypercholesterolaemia, Anxiety, Depression and Arthritis. Concomitant products included ESCITALOPRAM OXALATE (LEXAPRO) for Anxiety, CELECOXIB for Arthritis, PRAVASTATIN for Cholesterosis, BUPROPION HYDROCHLORIDE (WELLBUTRIN) for Depression, SERTRALINE HYDROCHLORIDE (RETALIN) for Fatigue.   On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-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 MUSCLE SPASMS (Back muscle spasm on and off from his shoulder to his waist) and PAIN (Has a good pain tolerance but he is almost in tears). 19-Feb-2021, the patient experienced FATIGUE (Fatigue). On 22-Feb-2021, the patient experienced NAUSEA (Nausea) and VOMITING (Vomiting). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at a dose of 1 dosage form; CANNABIDIOL (CBD OIL) for Sleep problem, at a dose of 1 dosage form; Bed rest for Muscle spasms; Bed rest for Pain and Bed rest for Fatigue. On 05-Mar-2021, MUSCLE SPASMS (Back muscle spasm on and off from his shoulder to his waist) had resolved. On 06-Mar-2021, PAIN (Has a good pain tolerance but he is almost in tears), FATIGUE (Fatigue), NAUSEA (Nausea) and VOMITING (Vomiting) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered MUSCLE SPASMS (Back muscle spasm on and off from his shoulder to his waist), PAIN (Has a good pain tolerance but he is almost in tears), FATIGUE (Fatigue), NAUSEA (Nausea) and VOMITING (Vomiting) to be possibly related.    Treatment information also included Icing.   Most recent FOLLOW-UP information incorporated above includes: On 27-Apr-2021: Additional information received contact information updated. On 23-Jul-2021: Updated additional reporter information, patient demographics (Height, weight, race, ethnic group), relevant history information, first dose information and second dose site changed to Right arm. Added vaccine facility information, concomitant medications, event (pain), event stop date, duration and outcome of the event. Added non-drug treatment and updated causality as reported.
Age: 86.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Hyperhidrosis, Vaccination site lymphadenopathy
Clinical narrative: sweats; had lymphedema in her left arm; headache; chills; This spontaneous case was reported by a consumer and describes the occurrence of Hyperhidrosis (sweats), Vaccination site lymphadenopathy (had lymphedema in her left arm), Headache (headache) and Chills (chills) in an 86-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 (No medical history reported).   On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.      On 4 Feb 2021, the patient experienced Hyperhidrosis (sweats), Vaccination site lymphadenopathy (had lymphedema in her left arm), Headache (headache) and Chills (chills).  The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.  For mRNA-1273 (COVID 19 Vaccine Moderna) administered intramuscularly, the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. No treatment information was provided.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Cough, Pyrexia, SARS-CoV-2 test, Sneezing
Clinical narrative: positive covid test; Slight fever; sneezing; cough; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Slight fever), SNEEZING (sneezing), COUGH (cough) and COVID-19 (positive covid test) in a 55-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 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Jan-2021, the patient experienced PYREXIA (Slight fever), SNEEZING (sneezing) and COUGH (cough). On 27-Jan-2021, the patient experienced COVID-19 (positive covid test). At the time of the report, PYREXIA (Slight fever), SNEEZING (sneezing), COUGH (cough) and COVID-19 (positive covid test) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 27-Jan-2021, SARS-CoV-2 test: positive (Positive) On Jan 27, Patient had a positive COVID test.   The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   Concomitant product use was not provided by the reporter. No treatment information was provided.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Pruritus, Rash
Clinical narrative: Itching near ribcage, left and right; raised/lumpy rash all over the body; Itching on the back; Rash all over his body (upper to lower body); This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PRURITUS (Itching near ribcage, left and right), RASH (raised/lumpy rash all over the body), PRURITUS (Itching on the back) and RASH (Rash all over his body (upper to lower body)) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Feb-2021, the patient experienced PRURITUS (Itching near ribcage, left and right), RASH (raised/lumpy rash all over the body), PRURITUS (Itching on the back) and RASH (Rash all over his body (upper to lower body)). The patient was treated with CORTISONE at an unspecified dose and frequency and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. On 18-Feb-2021, PRURITUS (Itching near ribcage, left and right) had resolved. At the time of the report, RASH (raised/lumpy rash all over the body), PRURITUS (Itching on the back) and RASH (Rash all over his body (upper to lower body)) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Death, Decreased appetite, Diarrhoea, Nausea
Clinical narrative: Passed away; Arm hurt bad; She could barely eat/drink; She could barely do anything; Diarrhea; Nausea; Vomiting; This spontaneous case was reported by a consumer and describes the occurrence of DEATH (Passed away) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 (had COVID in December 2020.) in December 2020.    On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Jan-2021, the patient experienced PAIN IN EXTREMITY (Arm hurt bad), DECREASED APPETITE (She could barely eat/drink), ASTHENIA (She could barely do anything), DIARRHOEA (Diarrhea), NAUSEA (Nausea) and VOMITING (Vomiting). On 24-Jan-2021, PAIN IN EXTREMITY (Arm hurt bad), DECREASED APPETITE (She could barely eat/drink), ASTHENIA (She could barely do anything), DIARRHOEA (Diarrhea), NAUSEA (Nausea) and VOMITING (Vomiting) had resolved. The patient died on an unknown date. The cause of death was not reported. It is unknown if an autopsy was performed.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   Concomitant medications were not reported. Treatment information was not reported.   Most recent FOLLOW-UP information incorporated above includes: On 06-Aug-2021: Death event added.; Sender's Comments: This case refers to a 73-year-old female patient with a history of COVID-19 infection one month prior to receiving mRNA-1273 who died after unknown duration after the vaccination. Based on the current available information and temporal association between the use of the product mRNA-1273 and the remaining events, a causal relationship cannot be excluded.; Reported Cause(s) of Death: Unknown cause of death
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Vomiting
Clinical narrative: Passed away; Arm hurt bad; She could barely eat/drink; She could barely do anything; Diarrhea; Nausea; Vomiting; This spontaneous case was reported by a consumer and describes the occurrence of DEATH (Passed away) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 (had COVID in December 2020.) in December 2020.    On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Jan-2021, the patient experienced PAIN IN EXTREMITY (Arm hurt bad), DECREASED APPETITE (She could barely eat/drink), ASTHENIA (She could barely do anything), DIARRHOEA (Diarrhea), NAUSEA (Nausea) and VOMITING (Vomiting). On 24-Jan-2021, PAIN IN EXTREMITY (Arm hurt bad), DECREASED APPETITE (She could barely eat/drink), ASTHENIA (She could barely do anything), DIARRHOEA (Diarrhea), NAUSEA (Nausea) and VOMITING (Vomiting) had resolved. The patient died on an unknown date. The cause of death was not reported. It is unknown if an autopsy was performed.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   Concomitant medications were not reported. Treatment information was not reported.   Most recent FOLLOW-UP information incorporated above includes: On 06-Aug-2021: Death event added.; Sender's Comments: This case refers to a 73-year-old female patient with a history of COVID-19 infection one month prior to receiving mRNA-1273 who died after unknown duration after the vaccination. Based on the current available information and temporal association between the use of the product mRNA-1273 and the remaining events, a causal relationship cannot be excluded.; Reported Cause(s) of Death: Unknown cause of death
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Myalgia, Pyrexia, Vaccination site pain
Clinical narrative: body aches; headache; felt like he had a fever; Pain at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (body aches), HEADACHE (headache), PYREXIA (felt like he had a fever) and VACCINATION SITE PAIN (Pain at the injection site) 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 Cholesterol since an unknown date and Hypertension since an unknown date. Concomitant products included METFORMINA [METFORMIN] for an unknown indication.    On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Feb-2021, the patient experienced MYALGIA (body aches), HEADACHE (headache), PYREXIA (felt like he had a fever) and VACCINATION SITE PAIN (Pain at the injection site). At the time of the report, MYALGIA (body aches), HEADACHE (headache), PYREXIA (felt like he had a fever) and VACCINATION SITE PAIN (Pain at the injection site) 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 details included None. This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 18-Feb-2021 and was forwarded to Moderna on 19-Feb-2021.    This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (body aches), HEADACHE (headache), PYREXIA (felt like he had a fever) and VACCINATION SITE PAIN (Pain at the injection site) 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 Cholesterol since an unknown date and Hypertension since an unknown date. Concomitant products included METFORMINA [METFORMIN] for an unknown indication.    On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Feb-2021, the patient experienced MYALGIA (body aches), HEADACHE (headache), PYREXIA (felt like he had a fever) and VACCINATION SITE PAIN (Pain at the injection site). At the time of the report, MYALGIA (body aches), HEADACHE (headache), PYREXIA (felt like he had a fever) and VACCINATION SITE PAIN (Pain at the injection site) 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 details included None.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Nausea, Vaccination complication, Vaccination site pain
Clinical narrative: so sick; terrible headache; arm is hurting; feeling she is going to throw up; having chills; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (so sick), HEADACHE (terrible headache), VACCINATION SITE PAIN (arm is hurting), NAUSEA (feeling she is going to throw up) and CHILLS (having chills) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Feb-2021, the patient experienced VACCINATION COMPLICATION (so sick), HEADACHE (terrible headache), VACCINATION SITE PAIN (arm is hurting), NAUSEA (feeling she is going to throw up) and CHILLS (having chills). At the time of the report, VACCINATION COMPLICATION (so sick), HEADACHE (terrible headache), VACCINATION SITE PAIN (arm is hurting), NAUSEA (feeling she is going to throw up) and CHILLS (having chills) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant drugs were reported. No treatment medications were reported.   This case was linked to MOD-2021-248012 (Dose 2 case) (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 06-Jul-2021: Significant followup was received. Onset date of the event , event outcome and patient demographics were added.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Hallucination, Headache, Lethargy, Myalgia
Clinical narrative: Hallucinations; Lethargic; Dizziness; Headache; Muscle aches; Vaccination site pain; A spontaneous report was received from a consumer concerning herself, a 66-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced vaccination site pain, headache, lethargic, muscle ache, dizziness, and hallucinations.  The patient's medical history was not provided.  Concomitant product use was not provided by the reporter.  On 14 Jan 2021, prior to the onset of symptoms, the patient received their first of two planned doses of mRNA-1273 (Batch#: 013L20A) intramuscularly for prophylaxis of COVID-19 infection. On 11 Feb 2021, the same day as the onset of symptoms, the patient received their second of two planned doses of mRNA-1273 (Batch#: 010M20A) intramuscularly for prophylaxis of COVID-19 infection.  On 11 Feb 2021, the patient became lethargic and experienced headache, muscle ache, dizziness, and hallucinations. Treatment for the events included acetaminophen (one a day), warm cloth and cold compress.  The patient received both scheduled doses of mRNA-1273 prior to the events; therefore, action taken with the mRNA-1273 in response to the events were not applicable.  The outcome of the events, headache, lethargy, muscle ache, dizziness and hallucinations were unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.  Further information has been requested.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Hallucinations; Lethargic; Dizziness; Headache; Muscle aches; Vaccination site pain; A spontaneous report was received from a consumer concerning herself, a 66-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced vaccination site pain, headache, lethargic, muscle ache, dizziness, and hallucinations.  The patient's medical history was not provided.  Concomitant product use was not provided by the reporter.  On 14 Jan 2021, prior to the onset of symptoms, the patient received their first of two planned doses of mRNA-1273 (Batch#: 013L20A) intramuscularly for prophylaxis of COVID-19 infection. On 11 Feb 2021, the same day as the onset of symptoms, the patient received their second of two planned doses of mRNA-1273 (Batch#: 010M20A) intramuscularly for prophylaxis of COVID-19 infection.  On 11 Feb 2021, the patient became lethargic and experienced headache, muscle ache, dizziness, and hallucinations. Treatment for the events included acetaminophen (one a day), warm cloth and cold compress.  The patient received both scheduled doses of mRNA-1273 prior to the events; therefore, action taken with the mRNA-1273 in response to the events were not applicable.  The outcome of the events, headache, lethargy, muscle ache, dizziness and hallucinations were unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.  Further information has been requested.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Vaccination site bruising
Clinical narrative: Bruising; Sharp pain; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE BRUISING (Bruising) and AXILLARY PAIN (Sharp pain) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination.     No medical history information was reported.  Concomitant products included MONTELUKAST and VITAMIN 15 for an unknown indication.    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, the patient experienced VACCINATION SITE BRUISING (Bruising) and AXILLARY PAIN (Sharp pain). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date for product used for unknown indication, at an unspecified dose and frequency. At the time of the report, VACCINATION SITE BRUISING (Bruising) and AXILLARY PAIN (Sharp pain) 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. This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 18-Feb-2021 and was forwarded to Moderna on 19-Feb-2021.    This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE BRUISING (Bruising) and AXILLARY PAIN (Sharp pain) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination.     No medical history information was reported.  Concomitant products included MONTELUKAST and VITAMIN 15 for an unknown indication.    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, the patient experienced VACCINATION SITE BRUISING (Bruising) and AXILLARY PAIN (Sharp pain). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date for product used for unknown indication, at an unspecified dose and frequency. At the time of the report, VACCINATION SITE BRUISING (Bruising) and AXILLARY PAIN (Sharp pain) 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: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Rash erythematous, Swelling
Clinical narrative: Red rash; Swollen; This spontaneous case was reported by a consumer and describes the occurrence of RASH ERYTHEMATOUS (Red rash) and SWELLING (Swollen) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     NO medical history information was reported.     On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Feb-2021, the patient experienced RASH ERYTHEMATOUS (Red rash) and SWELLING (Swollen). At the time of the report, RASH ERYTHEMATOUS (Red rash) and SWELLING (Swollen) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported.  No treatment information was provided. This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 19-Feb-2021 and was forwarded to Moderna on 19-Feb-2021.    This spontaneous case was reported by a consumer and describes the occurrence of RASH ERYTHEMATOUS (Red rash) and SWELLING (Swollen) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     NO medical history information was reported.     On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Feb-2021, the patient experienced RASH ERYTHEMATOUS (Red rash) and SWELLING (Swollen). At the time of the report, RASH ERYTHEMATOUS (Red rash) and SWELLING (Swollen) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported.  No treatment information was provided.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Sciatica
Clinical narrative: Lower right back pain; Sciatic nerve acting up; A spontaneous report was received from a consumer (patient), concerning herself, a 73 years-old female patient, unknown race and ethnicity, who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced lower right back pain (back pain) and sciatic nerve acting up (sciatica).  The patient's medical history was not provided. Concomitant medications were not provided.  On 12 Feb 2021, prior to the onset of events, the patient received their first of two planned doses of mRNA-1273 (Batch number: 031L20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On 13 Feb 2021, the patient experienced lower right back pain and sciatic nerve was acting up. The symptoms were ongoing. Treatment for the events included ibuprofen.   Action taken with second dose of mRNA-1273 in response to the events was unknown.   The outcome of the events, lower right back pain and sciatic nerve acting up were considered as not recovered.
Sex: F
Vaccine: COVID19
Symptoms: Injection site rash, Vaccination site erythema
Clinical narrative: Redness and Rash on injection site; Redness and Rash on injection site; This spontaneous case was reported by a physician and describes the occurrence of VACCINATION SITE ERYTHEMA (Redness and Rash on injection site) and INJECTION SITE RASH (Redness and Rash on injection site) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011M20A) for COVID-19 vaccination.     No medical history information was reported.     On 13-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 VACCINATION SITE ERYTHEMA (Redness and Rash on injection site) and INJECTION SITE RASH (Redness and Rash on injection site). At the time of the report, VACCINATION SITE ERYTHEMA (Redness and Rash on injection site) and INJECTION SITE RASH (Redness and Rash on injection site) 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.   No relevant concomitant medications were reported.   No treatment information was provided. This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 22-Feb-2021 and was forwarded to Moderna on 22-Feb-2021.    This spontaneous case was reported by a physician and describes the occurrence of VACCINATION SITE ERYTHEMA (Redness and Rash on injection site) and INJECTION SITE RASH (Redness and Rash on injection site) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011M20A) for COVID-19 vaccination.     No medical history information was reported.     On 13-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 VACCINATION SITE ERYTHEMA (Redness and Rash on injection site) and INJECTION SITE RASH (Redness and Rash on injection site). At the time of the report, VACCINATION SITE ERYTHEMA (Redness and Rash on injection site) and INJECTION SITE RASH (Redness and Rash on injection site) 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.   No relevant concomitant medications were reported.   No treatment information was provided.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Rash
Clinical narrative: little pain; tiny rash; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (little pain) and RASH (tiny rash) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 042L20A and 015M20A) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes, Hypertension and Glaucoma. Concomitant products included INSULIN ASPART (NOVOLOG) for Diabetes, BIMATOPROST (LUMIGAN) for Glaucoma, EZETIMIBE for Hyperlipidemia, LISINOPRIL for Hypertension.   On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 18-Feb-2021, the patient experienced PAIN (little pain) and RASH (tiny rash). At the time of the report, PAIN (little pain) and RASH (tiny rash) had resolved.            Treatment details included, pre-medication with - 100mg vitamin C, 2 diphenhydramine, 2 naproxen and cold zinc suckers.   This case was linked to MOD-2021-040433 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 23-Feb-2021: Events for 2nd dose added, product details added, treatment details added. On 26-Apr-2021: Reporter's email address added. On 28-Apr-2021: Additional information recieved, contact details added, patient demographics added, history added, product details added, Concomitant medication added, event outcome updated.
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: redness around the injection site; swollen; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE ERYTHEMA (redness around the injection site) and INJECTION SITE SWELLING (swollen) 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 10-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 INJECTION SITE ERYTHEMA (redness around the injection site) and INJECTION SITE SWELLING (swollen). At the time of the report, INJECTION SITE ERYTHEMA (redness around the injection site) and INJECTION SITE SWELLING (swollen) outcome was unknown. Unknown      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided.  No treatment details were provided.   Reporter did not allow further contact
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dysstasia, Hepatic enzyme, Urinary tract infection
Clinical narrative: Fell onto floor and couldn't get up/No strength at all; couldn't get off the floor; couldn't stand up or get on knees to get into chair; still had infection after vaccine; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Fell onto floor and couldn't get up/No strength at all; couldn't get off the floor), DYSSTASIA (couldn't stand up or get on knees to get into chair) and URINARY TRACT INFECTION (still had infection after vaccine) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Stroke (took cholesterol medicine.). Concurrent medical conditions included Urinary tract infection (Patient was on antibiotic for urinary tract infection prior to the shot. Still had infection after vaccine so took another antibiotic.) and Liver enzyme abnormal (Patient has stopped cholesterol medicine due to high liver enzyme). Concomitant products included ASPIRIN [ACETYLSALICYLIC ACID] for Stroke.    On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Jan-2021, the patient experienced ASTHENIA (Fell onto floor and couldn't get up/No strength at all; couldn't get off the floor), DYSSTASIA (couldn't stand up or get on knees to get into chair) and URINARY TRACT INFECTION (still had infection after vaccine). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. On 01-Feb-2021, DYSSTASIA (couldn't stand up or get on knees to get into chair) and URINARY TRACT INFECTION (still had infection after vaccine) had resolved. At the time of the report, ASTHENIA (Fell onto floor and couldn't get up/No strength at all; couldn't get off the floor) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Hepatic enzyme: high (High) high.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient stated that she fell on the floor and had two people help on the floor. It had happened twice. Patient was nervous about getting the shot again but nervous about not getting it. Antibiotic for urinary tract infection was 10 days course and then cleared up.   This case was linked to MOD-2021-016905, MOD-2021-016843 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 14-Jul-2021: Patient mentioned she got the Pfizer vaccine and not Moderna.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Back pain, Chest discomfort, Nausea
Clinical narrative: Chest discomfort; Back ache; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of CHEST DISCOMFORT (Chest discomfort), BACK PAIN (Back ache) and NAUSEA (Nausea) in a 44-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination.     The patient's past medical history included COVID-19.    On 26-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 CHEST DISCOMFORT (Chest discomfort), BACK PAIN (Back ache) and NAUSEA (Nausea). At the time of the report, CHEST DISCOMFORT (Chest discomfort), BACK PAIN (Back ache) and NAUSEA (Nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not reported.  No treatment information was provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 14-Jul-2021: Follow-up document was received. It contains no new information.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Hypersensitivity
Clinical narrative: Shortness of breath; Allergic reaction; This spontaneous case was reported by a patient and describes the occurrence of DYSPNOEA (Shortness of breath) and HYPERSENSITIVITY (Allergic reaction) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Asthma, Drug allergy (Percocet), Bee sting (Bee sting) and Allergy to chemicals (Industrial floor cleaner). Concomitant products included TRETINOIN (ADINA), SALBUTAMOL SULFATE (ALBUTEROL [SALBUTAMOL SULFATE]), DULOXETINE HYDROCHLORIDE (CYMBALTA), HYDROXYCHLOROQUINE, SULFASALAZINE and BUDESONIDE, FORMOTEROL FUMARATE (SYMBICORT) for an unknown indication.    On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Jan-2021, the patient experienced DYSPNOEA (Shortness of breath) and HYPERSENSITIVITY (Allergic reaction). The patient was treated with PREDNISONE for Adverse event, at a dose of 1 dosage form. At the time of the report, DYSPNOEA (Shortness of breath) and HYPERSENSITIVITY (Allergic reaction) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Most recent FOLLOW-UP information incorporated above includes: On 27-Apr-2021: updated postal code,
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate, Oropharyngeal pain, Pharyngeal swelling, Tachycardia
Clinical narrative: swollen throat; stinging in throat; Fast Heart Beat; This spontaneous case was reported by a consumer and describes the occurrence of TACHYCARDIA (Fast Heart Beat), PHARYNGEAL SWELLING (swollen throat) and OROPHARYNGEAL PAIN (stinging in throat) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006M00A) for COVID-19 vaccination.     Concurrent medical conditions included Allergy (She hasdseasonal allergies and uses an inhaler, not using it now.). Concomitant products included LEVOTHYROXINE and PARACETAMOL (TYLENOL REGULAR) for an unknown indication.   On 13-Feb-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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Feb-2021, the patient experienced TACHYCARDIA (Fast Heart Beat) and OROPHARYNGEAL PAIN (stinging in throat). On 15-Feb-2021 at 6:00 AM, the patient experienced PHARYNGEAL SWELLING (swollen throat). On 15-Feb-2021, TACHYCARDIA (Fast Heart Beat) and OROPHARYNGEAL PAIN (stinging in throat) had resolved. On 15-Feb-2021 at 11:00 AM, PHARYNGEAL SWELLING (swollen throat) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-Feb-2021, Heart rate: 120 (High) she had a fast heart beat at 120/BPM.     mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Patient also stated she uses sporadic while exercising but rare; she used the inhaler when she was exercising.  Patient stated she had zero reaction to the 2nd vaccine and declined having any lingering effects.   Most recent FOLLOW-UP information incorporated above includes: On 14-Jul-2021: TCR received-  Dose-1 event outcome and dose-2 info updated.
Sex: U
Vaccine: COVID19
Symptoms: Adverse event
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE EVENT (more intense reactions) in a  patient of an unknown age and gender 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ADVERSE EVENT (more intense reactions). At the time of the report, ADVERSE EVENT (more intense reactions) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. This case was linked to MOD21-033420, MOD21-033319 (E2B Linked Report).; Sender's Comments: MOD21-033420:cross link; MOD21-033319:crosslink.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site warmth, Vaccination site erythema, Vaccination site rash, Vaccination site swelling
Clinical narrative: Warm to the touch Injection Site; Red Rash on the Injection Site; swollen injection site; Red Rash on the Injection Site; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE WARMTH (Warm to the touch Injection Site), VACCINATION SITE RASH (Red Rash on the Injection Site), VACCINATION SITE SWELLING (swollen injection site) and VACCINATION SITE ERYTHEMA (Red Rash on the Injection Site) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination.     No medical history information was reported.     On 09-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 INJECTION SITE WARMTH (Warm to the touch Injection Site), VACCINATION SITE RASH (Red Rash on the Injection Site), VACCINATION SITE SWELLING (swollen injection site) and VACCINATION SITE ERYTHEMA (Red Rash on the Injection Site). At the time of the report, INJECTION SITE WARMTH (Warm to the touch Injection Site), VACCINATION SITE RASH (Red Rash on the Injection Site), VACCINATION SITE SWELLING (swollen injection site) and VACCINATION SITE ERYTHEMA (Red Rash on the Injection Site) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.  No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 13-Jul-2021: Follow up information was received, events outcome was updated to recovered.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: pain in the right artificial knee.; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (pain in the right artificial knee.) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination.     The patient's past medical history included Knee replacement since an unknown date.    On 20-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Feb-2021, the patient experienced ARTHRALGIA (pain in the right artificial knee.). The patient was treated with PARACETAMOL (TYLENOL) at a dose of UNK dosage form, qd. At the time of the report, ARTHRALGIA (pain in the right artificial knee.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.     Most recent FOLLOW-UP information incorporated above includes: On 03-May-2021: On 03-MAY-2021 a follow up was received which contained no new information.