chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Hypokinesia, Illness, Nasopharyngitis, Pyrexia
Clinical narrative: sick; felt like head was gonna explode; couldn't even open bottle of water so weak/stayed in bed all day until 9pm; could not move; did not feel her self all next day; headache so bad induced vomiting; chills; fever for 3 days; had 2 really bad head colds; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (sick), HEAD DISCOMFORT (felt like head was gonna explode), ASTHENIA (couldn't even open bottle of water so weak/stayed in bed all day until 9pm), HYPOKINESIA (could not move) and FEELING ABNORMAL (did not feel her self all next day) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 in March 2021. Concurrent medical conditions included Allergy. Concomitant products included MELOXICAM for an unknown indication.    On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In March 2021, the patient experienced NASOPHARYNGITIS (had 2 really bad head colds). On 17-Mar-2021, the patient experienced ILLNESS (sick), HEAD DISCOMFORT (felt like head was gonna explode), ASTHENIA (couldn't even open bottle of water so weak/stayed in bed all day until 9pm), HYPOKINESIA (could not move), FEELING ABNORMAL (did not feel her self all next day), HEADACHE (headache so bad induced vomiting), CHILLS (chills) and PYREXIA (fever for 3 days). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, ILLNESS (sick), HEAD DISCOMFORT (felt like head was gonna explode), ASTHENIA (couldn't even open bottle of water so weak/stayed in bed all day until 9pm), HYPOKINESIA (could not move), FEELING ABNORMAL (did not feel her self all next day), NASOPHARYNGITIS (had 2 really bad head colds), HEADACHE (headache so bad induced vomiting), CHILLS (chills) and PYREXIA (fever for 3 days) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Other concomitant medications include Allergy pills for an unknown indication.
Age: 24.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Vaccine administered after temperature excursion; Vaccine administered after temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine administered after temperature excursion) and PRODUCT STORAGE ERROR (Vaccine administered after temperature excursion) in a 24-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Apr-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Apr-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine administered after temperature excursion) and PRODUCT STORAGE ERROR (Vaccine administered after temperature excursion). On 02-Apr-2021, EXPIRED PRODUCT ADMINISTERED (Vaccine administered after temperature excursion) and PRODUCT STORAGE ERROR (Vaccine administered after temperature excursion) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication provided. No treatment information mentioned.
Sex: F
Vaccine: COVID19
Symptoms: Adverse event, Illness, Pyrexia
Clinical narrative: extremely sick; other side effects that were listed; very high fever; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (extremely sick), ADVERSE EVENT (other side effects that were listed) and PYREXIA (very high fever) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. UNK) 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 ILLNESS (extremely sick), ADVERSE EVENT (other side effects that were listed) and PYREXIA (very high fever). At the time of the report, ILLNESS (extremely sick), ADVERSE EVENT (other side effects that were listed) and PYREXIA (very high fever) 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: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of URTICARIA (she broke out with hives on arm, back, chest, stomach and face; they are cluster hives that are blistering turning red, burn and are getting worse) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031M20A and 006B21A) for COVID-19 vaccination.     No medical history was provided by the reporter.    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced URTICARIA (she broke out with hives on arm, back, chest, stomach and face; they are cluster hives that are blistering turning red, burn and are getting worse). The patient was treated with HYDROXYZINE for Urticaria, at an unspecified dose and frequency. At the time of the report, URTICARIA (she broke out with hives on arm, back, chest, stomach and face; they are cluster hives that are blistering turning red, burn and are getting worse) outcome was unknown.            Concomitant products were not provided. Treatment products were not provided.   Most recent FOLLOW-UP information incorporated above includes: On 16-Jun-2021: Follow up received on 16-jun-2021 and contains no significant information
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Decreased appetite, Malaise, SARS-CoV-2 test, Sinusitis
Clinical narrative: feeling sick; suspected sinus infection; cough; wheezing; sluggish; no appetite; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of MALAISE (feeling sick), SINUSITIS (suspected sinus infection), COUGH (cough), WHEEZING (wheezing) and SLUGGISHNESS (sluggish) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 immunisation. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Asthma (prior medical history of asthma).    On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Mar-2021, the patient experienced MALAISE (feeling sick), SINUSITIS (suspected sinus infection), COUGH (cough), WHEEZING (wheezing), SLUGGISHNESS (sluggish) and DECREASED APPETITE (no appetite). The patient was treated with PREDNISONE at a dose of 1 dosage form. At the time of the report, MALAISE (feeling sick) had resolved and SINUSITIS (suspected sinus infection), COUGH (cough), WHEEZING (wheezing), SLUGGISHNESS (sluggish) and DECREASED APPETITE (no appetite) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-Apr-2021, SARS-CoV-2 test: negative (Negative) COVID test Negative.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment medication included antibiotics, cough medicine, and prednisone. No concomitant medication details provided.   This case was linked to MOD-2021-066278 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 02-Apr-2021: Follow up received on 02-APR-2021 contains Non significant information.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Sluggishness, Wheezing
Clinical narrative: feeling sick; suspected sinus infection; cough; wheezing; sluggish; no appetite; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of MALAISE (feeling sick), SINUSITIS (suspected sinus infection), COUGH (cough), WHEEZING (wheezing) and SLUGGISHNESS (sluggish) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 immunisation. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Asthma (prior medical history of asthma).    On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Mar-2021, the patient experienced MALAISE (feeling sick), SINUSITIS (suspected sinus infection), COUGH (cough), WHEEZING (wheezing), SLUGGISHNESS (sluggish) and DECREASED APPETITE (no appetite). The patient was treated with PREDNISONE at a dose of 1 dosage form. At the time of the report, MALAISE (feeling sick) had resolved and SINUSITIS (suspected sinus infection), COUGH (cough), WHEEZING (wheezing), SLUGGISHNESS (sluggish) and DECREASED APPETITE (no appetite) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-Apr-2021, SARS-CoV-2 test: negative (Negative) COVID test Negative.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment medication included antibiotics, cough medicine, and prednisone. No concomitant medication details provided.   This case was linked to MOD-2021-066278 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 02-Apr-2021: Follow up received on 02-APR-2021 contains Non significant information.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Hives; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Hives) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Mar-2021, the patient experienced URTICARIA (Hives). The patient was treated with ACRIVASTINE (BENADRYL OTC) for Hives, at an unspecified dose and frequency. At the time of the report, URTICARIA (Hives) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Gait disturbance, Hypertension, Joint swelling, Skin discolouration
Clinical narrative: Ankle is still discolored, happened after the first shot, it went down a week later and then it came back; pain in the left ankle; started lambing; swelling in the left ankle; Blood pressure was elevated; This spontaneous case was reported by a consumer and describes the occurrence of HYPERTENSION (Blood pressure was elevated), GAIT DISTURBANCE (started lambing), JOINT SWELLING (swelling in the left ankle), SKIN DISCOLOURATION (Ankle is still discolored, happened after the first shot, it went down a week later and then it came back) and ARTHRALGIA (pain in the left ankle) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Mar-2021, the patient experienced HYPERTENSION (Blood pressure was elevated). On 26-Mar-2021, the patient experienced GAIT DISTURBANCE (started lambing), JOINT SWELLING (swelling in the left ankle) and ARTHRALGIA (pain in the left ankle). On an unknown date, the patient experienced SKIN DISCOLOURATION (Ankle is still discolored, happened after the first shot, it went down a week later and then it came back). At the time of the report, HYPERTENSION (Blood pressure was elevated), GAIT DISTURBANCE (started lambing), JOINT SWELLING (swelling in the left ankle) and ARTHRALGIA (pain in the left ankle) outcome was unknown and SKIN DISCOLOURATION (Ankle is still discolored, happened after the first shot, it went down a week later and then it came back) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided by the reporter.  No treatment information were provided by the reporter.   This case was linked to MOD-2021-223928 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 29-Jun-2021: Significant follow up report received included new event of skin discoloration and reporter's email address was added.
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHEA (diarrhea) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007MZ0H and 048A21A) 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) (unknown route) 1 dosage form. On 15-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced DIARRHEA (diarrhea). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, DIARRHOEA (diarrhea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medications were reported Treatment medications were reported to be ammonium twice for the diarrhea
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Myalgia, Vaccination site pain
Clinical narrative: headache; body ache; pain at injection site; chills; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chills), HEADACHE (headache), MYALGIA (body ache) and VACCINATION SITE PAIN (pain at injection site) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028A21A and 025A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced CHILLS (chills). On 02-Apr-2021, the patient experienced HEADACHE (headache), MYALGIA (body ache) and VACCINATION SITE PAIN (pain at injection site). At the time of the report, CHILLS (chills), HEADACHE (headache), MYALGIA (body ache) and VACCINATION SITE PAIN (pain at injection site) outcome was unknown.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Lip swelling, Oral herpes, Rash
Clinical narrative: Swollen lower lip as though it's about to form a cold sore and has not gone down at all; Swollen lower lip as though it's about to form a cold sore and has not gone down at all; A rash behind left knee; Headache; This spontaneous case was reported by a consumer and describes the occurrence of LIP SWELLING (Swollen lower lip as though it's about to form a cold sore and has not gone down at all), ORAL HERPES (Swollen lower lip as though it's about to form a cold sore and has not gone down at all), RASH (A rash behind left knee) and HEADACHE (Headache) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced LIP SWELLING (Swollen lower lip as though it's about to form a cold sore and has not gone down at all), ORAL HERPES (Swollen lower lip as though it's about to form a cold sore and has not gone down at all), RASH (A rash behind left knee) and HEADACHE (Headache). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form. At the time of the report, LIP SWELLING (Swollen lower lip as though it's about to form a cold sore and has not gone down at all), ORAL HERPES (Swollen lower lip as though it's about to form a cold sore and has not gone down at all), RASH (A rash behind left knee) and HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Decreased appetite, Feeling abnormal, Pain, Pyrexia
Clinical narrative: Ache; No energy; Haven't been able to eat; Have been in bed ever since (the dose); Fever as high as 107F; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Ache), ASTHENIA (No energy), DECREASED APPETITE (Haven't been able to eat), FEELING ABNORMAL (Have been in bed ever since (the dose)) and PYREXIA (Fever as high as 107F) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011A21A and 807770273-10) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure abnormal.   On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Mar-2021, the patient experienced PAIN (Ache), ASTHENIA (No energy), DECREASED APPETITE (Haven't been able to eat), FEELING ABNORMAL (Have been in bed ever since (the dose)) and PYREXIA (Fever as high as 107F). At the time of the report, PAIN (Ache), ASTHENIA (No energy), DECREASED APPETITE (Haven't been able to eat), FEELING ABNORMAL (Have been in bed ever since (the dose)) and PYREXIA (Fever as high as 107F) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications include blood pressure medicine. Treatment details included Tylenol, Unspecified medication for diarrhea
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia
Clinical narrative: Slight fever; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Slight fever) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Apr-2021, the patient experienced PYREXIA (Slight fever). The patient was treated with NAPROXEN SODIUM (ALEVE) for Fever, at an unspecified dose and frequency. At the time of the report, PYREXIA (Slight fever) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 04-Apr-2021, Body temperature: 99-100.4 (High) Slight fever of 99- 100.4 degree Fahrenheit.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Diarrhoea, Fatigue, Illness, Injection site rash
Clinical narrative: Very very sick; Very weak; Diarrhea; Itching; Fever 3 degrees up; Rash at the injection site; Swollen at the injection site; Very tired; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Very very sick), ASTHENIA (Very weak), DIARRHOEA (Diarrhea), PRURITUS (Itching) and PYREXIA (Fever 3 degrees up) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) 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-19 beginning of January.) and Sinusitis.    On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Mar-2021, the patient experienced ILLNESS (Very very sick), ASTHENIA (Very weak), DIARRHOEA (Diarrhea), PRURITUS (Itching), PYREXIA (Fever 3 degrees up), INJECTION SITE RASH (Rash at the injection site), INJECTION SITE SWELLING (Swollen at the injection site), FATIGUE (Very tired) and NAUSEA (Nausea). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 26-Mar-2021, ILLNESS (Very very sick), ASTHENIA (Very weak), DIARRHOEA (Diarrhea), PYREXIA (Fever 3 degrees up), INJECTION SITE RASH (Rash at the injection site), INJECTION SITE SWELLING (Swollen at the injection site), FATIGUE (Very tired) and NAUSEA (Nausea) had resolved. On 28-Mar-2021, PRURITUS (Itching) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product used included medicines for diabetes type 2.  Treatment medication included Tylenol.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site swelling, Nausea, Pruritus, Pyrexia
Clinical narrative: Very very sick; Very weak; Diarrhea; Itching; Fever 3 degrees up; Rash at the injection site; Swollen at the injection site; Very tired; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Very very sick), ASTHENIA (Very weak), DIARRHOEA (Diarrhea), PRURITUS (Itching) and PYREXIA (Fever 3 degrees up) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) 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-19 beginning of January.) and Sinusitis.    On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Mar-2021, the patient experienced ILLNESS (Very very sick), ASTHENIA (Very weak), DIARRHOEA (Diarrhea), PRURITUS (Itching), PYREXIA (Fever 3 degrees up), INJECTION SITE RASH (Rash at the injection site), INJECTION SITE SWELLING (Swollen at the injection site), FATIGUE (Very tired) and NAUSEA (Nausea). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 26-Mar-2021, ILLNESS (Very very sick), ASTHENIA (Very weak), DIARRHOEA (Diarrhea), PYREXIA (Fever 3 degrees up), INJECTION SITE RASH (Rash at the injection site), INJECTION SITE SWELLING (Swollen at the injection site), FATIGUE (Very tired) and NAUSEA (Nausea) had resolved. On 28-Mar-2021, PRURITUS (Itching) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product used included medicines for diabetes type 2.  Treatment medication included Tylenol.
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: patient with tinnitus states he felt the ringing got louder after receiving first dose/ progressing of tinnitus; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (patient with tinnitus states he felt the ringing got louder after receiving first dose/ progressing of tinnitus) 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.    In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In March 2021, the patient experienced TINNITUS (patient with tinnitus states he felt the ringing got louder after receiving first dose/ progressing of tinnitus). At the time of the report, TINNITUS (patient with tinnitus states he felt the ringing got louder after receiving first dose/ progressing of tinnitus) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Fall
Clinical narrative: Fall; This spontaneous case was reported by a pharmacist and describes the occurrence of FALL (Fall) 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) (unknown route) 1 dosage form. On an unknown date, the patient experienced FALL (Fall). At the time of the report, FALL (Fall) 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.   Concomitant product use was not provided by the reporter. No treatment information was provided.  Very limited information regarding this events has been provided at this time. Further information has been requested. Company assessed the events to be unlikely related to company product.; Sender's Comments: Very limited information regarding this events has been provided at this time. Further information has been requested. Company assessed the events to be unlikely related to company product.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Thinking abnormal
Clinical narrative: back of the head and is concerned and thinks she has a brain tumor; dizziness; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizziness) and THINKING ABNORMAL (back of the head and is concerned and thinks she has a brain tumor) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Mar-2021, the patient experienced DIZZINESS (dizziness). On an unknown date, the patient experienced THINKING ABNORMAL (back of the head and is concerned and thinks she has a brain tumor). At the time of the report, DIZZINESS (dizziness) and THINKING ABNORMAL (back of the head and is concerned and thinks she has a brain tumor) outcome was unknown.            Concomitant product use was not provided by the reporter. No treatment information was provided.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Feeling abnormal, Feeling hot, Headache
Clinical narrative: Within an hour after vaccine, arm was sore and I felt draggy; She was in bed that night by 6pm because she could not stay up; Felt hot at night; I felt draggy; Joint pain; Muscle pain; Fatigue; Head was killing; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Within an hour after vaccine, arm was sore and I felt draggy), UNEVALUABLE EVENT (She was in bed that night by 6pm because she could not stay up), FEELING HOT (Felt hot at night), FEELING ABNORMAL (I felt draggy) and ARTHRALGIA (Joint pain) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Total hip replacement. Concomitant products included EZETIMIBE (ZETIA), FENOFIBRATE and ASPIRIN [ACETYLSALICYLIC ACID] for an unknown indication.    On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Within an hour after vaccine, arm was sore and I felt draggy), UNEVALUABLE EVENT (She was in bed that night by 6pm because she could not stay up), FEELING HOT (Felt hot at night), FEELING ABNORMAL (I felt draggy), ARTHRALGIA (Joint pain), MYALGIA (Muscle pain), FATIGUE (Fatigue) and HEADACHE (Head was killing). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form. At the time of the report, PAIN IN EXTREMITY (Within an hour after vaccine, arm was sore and I felt draggy), UNEVALUABLE EVENT (She was in bed that night by 6pm because she could not stay up), FEELING HOT (Felt hot at night), FEELING ABNORMAL (I felt draggy), ARTHRALGIA (Joint pain), MYALGIA (Muscle pain), FATIGUE (Fatigue) and HEADACHE (Head was killing) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pain in extremity, Unevaluable event
Clinical narrative: Within an hour after vaccine, arm was sore and I felt draggy; She was in bed that night by 6pm because she could not stay up; Felt hot at night; I felt draggy; Joint pain; Muscle pain; Fatigue; Head was killing; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Within an hour after vaccine, arm was sore and I felt draggy), UNEVALUABLE EVENT (She was in bed that night by 6pm because she could not stay up), FEELING HOT (Felt hot at night), FEELING ABNORMAL (I felt draggy) and ARTHRALGIA (Joint pain) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Total hip replacement. Concomitant products included EZETIMIBE (ZETIA), FENOFIBRATE and ASPIRIN [ACETYLSALICYLIC ACID] for an unknown indication.    On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Within an hour after vaccine, arm was sore and I felt draggy), UNEVALUABLE EVENT (She was in bed that night by 6pm because she could not stay up), FEELING HOT (Felt hot at night), FEELING ABNORMAL (I felt draggy), ARTHRALGIA (Joint pain), MYALGIA (Muscle pain), FATIGUE (Fatigue) and HEADACHE (Head was killing). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form. At the time of the report, PAIN IN EXTREMITY (Within an hour after vaccine, arm was sore and I felt draggy), UNEVALUABLE EVENT (She was in bed that night by 6pm because she could not stay up), FEELING HOT (Felt hot at night), FEELING ABNORMAL (I felt draggy), ARTHRALGIA (Joint pain), MYALGIA (Muscle pain), FATIGUE (Fatigue) and HEADACHE (Head was killing) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Myalgia, Pyrexia
Clinical narrative: Fever; Severe chills from the waist up; Feeling achey; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever), CHILLS (Severe chills from the waist up) and MYALGIA (Feeling achey) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029A21A and 028A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-Apr-2021, the patient experienced PYREXIA (Fever), CHILLS (Severe chills from the waist up) and MYALGIA (Feeling achey). At the time of the report, PYREXIA (Fever), CHILLS (Severe chills from the waist up) and MYALGIA (Feeling achey) outcome was unknown.            Concomitant Products include unspecified Blood Pressure medication
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Diarrhoea, Fatigue, Headache
Clinical narrative: Diarrhea; Fatigue; Headache; Muscle pain; Joint pain; Chills; Nausea; Fever; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea), FATIGUE (Fatigue), HEADACHE (Headache), MYALGIA (Muscle pain) and ARTHRALGIA (Joint pain) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026A21A and 021B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Apr-2021, the patient experienced DIARRHOEA (Diarrhea), FATIGUE (Fatigue), HEADACHE (Headache), MYALGIA (Muscle pain), ARTHRALGIA (Joint pain), CHILLS (Chills), NAUSEA (Nausea) and PYREXIA (Fever). The patient was treated with PARACETAMOL at an unspecified dose and frequency; IBUPROFEN at an unspecified dose and frequency and BISMUTH SUBSALICYLATE at an unspecified dose and frequency. At the time of the report, DIARRHOEA (Diarrhea), FATIGUE (Fatigue), HEADACHE (Headache), MYALGIA (Muscle pain), ARTHRALGIA (Joint pain), CHILLS (Chills), NAUSEA (Nausea) and PYREXIA (Fever) had resolved.            No concomitant medications was provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jul-2021: Follow up was received. Non-Significant follow Up-(Contact info updated).
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Nausea, Pyrexia
Clinical narrative: Diarrhea; Fatigue; Headache; Muscle pain; Joint pain; Chills; Nausea; Fever; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea), FATIGUE (Fatigue), HEADACHE (Headache), MYALGIA (Muscle pain) and ARTHRALGIA (Joint pain) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026A21A and 021B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Apr-2021, the patient experienced DIARRHOEA (Diarrhea), FATIGUE (Fatigue), HEADACHE (Headache), MYALGIA (Muscle pain), ARTHRALGIA (Joint pain), CHILLS (Chills), NAUSEA (Nausea) and PYREXIA (Fever). The patient was treated with PARACETAMOL at an unspecified dose and frequency; IBUPROFEN at an unspecified dose and frequency and BISMUTH SUBSALICYLATE at an unspecified dose and frequency. At the time of the report, DIARRHOEA (Diarrhea), FATIGUE (Fatigue), HEADACHE (Headache), MYALGIA (Muscle pain), ARTHRALGIA (Joint pain), CHILLS (Chills), NAUSEA (Nausea) and PYREXIA (Fever) had resolved.            No concomitant medications was provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jul-2021: Follow up was received. Non-Significant follow Up-(Contact info updated).
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness, Myalgia
Clinical narrative: flu like symptoms; extreme aches; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (flu like symptoms) and MYALGIA (extreme aches) in a 26-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product TREPROSTINIL SODIUM for Primary pulmonary hypertension.    Concurrent medical conditions included Pulmonary arterial hypertension. Concomitant products included BOSENTAN (TRACLEER [BOSENTAN]), SILDENAFIL CITRATE (REVATIO) and WARFARIN SODIUM (COUMADIN) for an unknown indication.   On 22-Apr-2009, the patient started TREPROSTINIL SODIUM (Intravenous) .16 microgram/kilogram continously. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 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 an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (flu like symptoms) and MYALGIA (extreme aches). At the time of the report, INFLUENZA LIKE ILLNESS (flu like symptoms) and MYALGIA (extreme aches) outcome was unknown. Not Provided          Action taken with mRNA-1273 in response to the events was not applicable. No concomitant medications were reported. No laboratory details were  provided. No treatment medications were reported.
Age: 55.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Wrong product administered
Clinical narrative: patient was given the J&J vaccine on April 1st and then they realized that received the Modena's COVID-19 Vaccine as a first dose; This spontaneous case was reported by a nurse and describes the occurrence of WRONG PRODUCT ADMINISTERED (patient was given the J&J vaccine on April 1st and then they realized that received the Modena's COVID-19 Vaccine as a first dose) in a 55-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002B21A) for COVID-19 vaccination.    Co-suspect product included non-company product COVID-19 VACCINE for COVID-19 vaccination.    The patient's past medical history included No adverse event (Relevant medical history was not provided.).   On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, the patient received first dose of COVID-19 VACCINE (unknown route) 1 dosage form. On 01-Apr-2021, the patient experienced WRONG PRODUCT ADMINISTERED (patient was given the J&J vaccine on April 1st and then they realized that received the Modena's COVID-19 Vaccine as a first dose). On 01-Apr-2021, WRONG PRODUCT ADMINISTERED (patient was given the J&J vaccine on April 1st and then they realized that received the Modena's COVID-19 Vaccine as a first dose) had resolved. Not applicable    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.   Concomitant medication use was not provided. Treatment information was not provided.   The patient didn't experienced any adverse reactions to the first dose or the second one and it's vital signs are stable according to the nurse.; Sender's Comments: This report refers to a case of Wrong vaccine administration error for mRNA 1273 with no associated AEs.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: sore arm for 5 days; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (sore arm for 5 days) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025A21A and 044A21A) for COVID-19 vaccination.  Concomitant products included NEFAZODONE HYDROCHLORIDE (SERZONE), PRAMIPEXOLE DIHYDROCHLORIDE (MIRAPEX), VALACICLOVIR HYDROCHLORIDE (VALACYCLOVIR HCL), DIAZEPAM (VALIUM) and VITAMIN C [ASCORBIC ACID] for an unknown indication.  On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Mar-2021, the patient experienced VACCINATION SITE PAIN (sore arm for 5 days). The patient was treated with MORPHINE for Pain management, at a dose of 1 dosage form. On 08-Mar-2021, VACCINATION SITE PAIN (sore arm for 5 days) had resolved.            Relevant concomitant products usage  reported by the reporter was supplements - vit c, d, k2, methyl folate, Methylcobalamin , cinnamon extract, chloryphyll, reduced gl. Relevant medical condition provided by the reporter was many chronic conditions.   This case was linked to MOD-2021-066392 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 16-Jul-2021: No new information received.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site reaction
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of vaccination site reaction (COVID arm) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch# 014M20A) for COVID-19 immunization. No reported medical history. On Mar 25, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19  vaccine), unknown route; 1 dosage form. On Apr 2, 2021, patient experienced vaccination site reaction (COVID arm). At the time of the report, vaccination site reaction (COVID arm): not resolved. The action taken with mRNA-1273 (Moderna COVID-19 vaccine): unknown. No relevant concomitant medications  reported. Treatment included paracetamol and ice pack application. This case linked to MOD-2021-066348, MOD-2021-066354 (patient link).
Sex: U
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: past the 42 day mark for receiving the 2nd dose; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (past the 42 day mark for receiving the 2nd dose) 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 INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (past the 42 day mark for receiving the 2nd dose). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (past the 42 day mark for receiving the 2nd dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. No treatment details were provided.   Most recent FOLLOW-UP information incorporated above includes: On 21-Jun-2021: Follow-up information Received on 21-jun-2021 contains no new information.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Scrotal pain, Urine analysis
Clinical narrative: Right scrotal pain; This spontaneous case was reported by a consumer and describes the occurrence of SCROTAL PAIN (Right scrotal pain) in a 34-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039K20A and 027L20A) for COVID-19 vaccination.     Concurrent medical conditions included Scoliosis.   On 24-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 24-Dec-2020, the patient experienced SCROTAL PAIN (Right scrotal pain). At the time of the report, SCROTAL PAIN (Right scrotal pain) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Urine analysis: normal (normal) result did not indicate any infection.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.  The treatment information included antibiotics for ten days.   This case was linked to US-MODERNATX, INC.-MOD-2021-066407 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 09-Aug-2021: Follow-up received contains no new information.; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-066407:2nd dose case
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Cough, Hot flush, Hyperhidrosis, SARS-CoV-2 test negative
Clinical narrative: I am sitting and sweating; delayed reaction from the vaccine; hot flashes; slight cough; seemed like I had a sinus infection; Chills; had the normal redness; had the normal pain in the arm; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HOT FLUSH (hot flashes), COUGH (slight cough), SINUSITIS (seemed like I had a sinus infection), HYPERHIDROSIS (I am sitting and sweating) and TYPE IV HYPERSENSITIVITY REACTION (delayed reaction from the vaccine) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 03A21A03A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.    On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Mar-2021, the patient experienced VACCINATION SITE ERYTHEMA (had the normal redness) and VACCINATION SITE PAIN (had the normal pain in the arm). On 28-Mar-2021, the patient experienced HOT FLUSH (hot flashes), COUGH (slight cough), SINUSITIS (seemed like I had a sinus infection) and CHILLS (Chills). On an unknown date, the patient experienced HYPERHIDROSIS (I am sitting and sweating) and TYPE IV HYPERSENSITIVITY REACTION (delayed reaction from the vaccine). At the time of the report, HOT FLUSH (hot flashes), COUGH (slight cough), SINUSITIS (seemed like I had a sinus infection), HYPERHIDROSIS (I am sitting and sweating), TYPE IV HYPERSENSITIVITY REACTION (delayed reaction from the vaccine), VACCINATION SITE ERYTHEMA (had the normal redness), VACCINATION SITE PAIN (had the normal pain in the arm) and CHILLS (Chills) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 29-Mar-2021, SARS-CoV-2 test negative: negative (Negative) negative.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.  Patient was advised to take tylenol and alternate with Aleve by doctor as treatment medication.