chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pain in extremity
Clinical narrative: Pain from the shoulder all the way down into the hand (after second dose).mostly in the area of the shot and up to the shoulder; the pain localization varies in the arm (after second dose); This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Pain from the shoulder all the way down into the hand (after second dose) mostly in the area of the shot and up to the shoulder) and PAIN IN EXTREMITY (the pain localization varies in the arm (after second dose)) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007B21A and 040B21A) for COVID-19 vaccination.     Concomitant products included DULOXETINE HCL, BUPROPION HYDROCHLORIDE (BUPROPION HCL XL), LISINOPRIL, AMLODIPINE BESYLATE, OMEPRAZOLE, FAMOTIDINE, HYDROXYZINE, METOPROLOL SUCCINATE, GABAPENTIN, MONTELUKAST and ALPRAZOLAM (XANAX) for an unknown indication.   On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN (Pain from the shoulder all the way down into the hand (after second dose).mostly in the area of the shot and up to the shoulder) and PAIN IN EXTREMITY (the pain localization varies in the arm (after second dose)). At the time of the report, PAIN (Pain from the shoulder all the way down into the hand (after second dose).mostly in the area of the shot and up to the shoulder) and PAIN IN EXTREMITY (the pain localization varies in the arm (after second dose)) outcome was unknown.            The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was not applicable  Other concomitant medications inluded calcium and vitamin C  No treatment reported.   This case was linked to MOD-2021-314898 (Patient Link).
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dermatitis contact, Myalgia, SARS-CoV-2 antibody test
Clinical narrative: Poison ivy; body aches; chills; This spontaneous case was reported by a consumer and describes the occurrence of DERMATITIS CONTACT (Poison ivy), MYALGIA (body aches) and CHILLS (chills) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 088D21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in November 2020.    On 17-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Aug-2021, the patient experienced MYALGIA (body aches) and CHILLS (chills). On 04-Sep-2021, the patient experienced DERMATITIS CONTACT (Poison ivy). The patient was treated with PREDNISONE ongoing since an unknown date for Poison ivy rash, at an unspecified dose and frequency. On 19-Aug-2021, MYALGIA (body aches) and CHILLS (chills) had resolved. At the time of the report, DERMATITIS CONTACT (Poison ivy) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 11-Aug-2021, SARS-CoV-2 antibody test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were provided by the reporter. The patient came in contact with poison Ivy on 04-Sep-2021 and was treated with prednisone. She called to find out how the prednisone might affect her second dose of Moderna Covid-19 vaccine that is due later in September.   Most recent FOLLOW-UP information incorporated above includes: On 10-Sep-2021: Significant follow-up added.  Added event of poison ivy.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site rash
Clinical narrative: red rash about 3 inches by 6 inches on arm where the vaccine was given; red rash about 3 inches by 6 inches on arm where the vaccine was given; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE RASH (red rash about 3 inches by 6 inches on arm where the vaccine was given) and VACCINATION SITE ERYTHEMA (red rash about 3 inches by 6 inches on arm where the vaccine was given) 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 05-Sep-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Sep-2021, the patient experienced VACCINATION SITE RASH (red rash about 3 inches by 6 inches on arm where the vaccine was given) and VACCINATION SITE ERYTHEMA (red rash about 3 inches by 6 inches on arm where the vaccine was given). At the time of the report, VACCINATION SITE RASH (red rash about 3 inches by 6 inches on arm where the vaccine was given) and VACCINATION SITE ERYTHEMA (red rash about 3 inches by 6 inches on arm where the vaccine was given) outcome was unknown.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia, Vaccination site mass
Clinical narrative: knot at injection site; Pain when touched; Fever after second dose; This spontaneous case was reported by an other health care professional and describes the occurrence of VACCINATION SITE MASS (knot at injection site), PAIN (Pain when touched) and PYREXIA (Fever after second dose) in a 27-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030L20A and 012L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 09-Feb-2021, the patient experienced VACCINATION SITE MASS (knot at injection site), PAIN (Pain when touched) and PYREXIA (Fever after second dose). On 11-Feb-2021, PYREXIA (Fever after second dose) had resolved. At the time of the report, VACCINATION SITE MASS (knot at injection site) and PAIN (Pain when touched) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was provided  Treatment medication was not provided by the reporter
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Arm pain which lasted four days; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 10-Sep-2021 and was forwarded to Moderna on 11-Sep-2021.    This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm pain which lasted four days) in a 42-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 050C21A) for COVID-19 vaccination.     Concomitant products included TRIAMCINOLONE ACETONIDE (NASACORT) for an unknown indication.    On 12-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Arm pain which lasted four days). The patient was treated with NAPROXEN SODIUM (ALEVE) for Adverse event, at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Arm pain which lasted four days) had resolved.            Patient received 2nd dose of Moderna vaccine on 09-SEP-2021 in the right dominant arm lot 078C21A.   This case was linked to MOD-2021-316017 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: received the first dose of the Moderna COVID19 vaccine more than 90 days ago; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a health care professional and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (received the first dose of the Moderna COVID19 vaccine more than 90 days ago) 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 PRODUCT DOSE OMISSION ISSUE (received the first dose of the Moderna COVID19 vaccine more than 90 days ago). At the time of the report, PRODUCT DOSE OMISSION ISSUE (received the first dose of the Moderna COVID19 vaccine more than 90 days ago) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment medications were mentioned.
Age: 72.0
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, COVID-19, Diarrhoea, Dizziness, Fatigue
Clinical narrative: Extremely sick the first day; Dizziness; Diarrhoea; For the next five days I was only tired; Vomiting; Achy joints; Tested positive for COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Extremely sick the first day), DIZZINESS (Dizziness), DIARRHOEA (Diarrhoea), COVID-19 (Tested positive for COVID-19) and FATIGUE (For the next five days I was only tired) in a 72-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Aug-2021, the patient experienced COVID-19 (Tested positive for COVID-19). On an unknown date, the patient experienced ILLNESS (Extremely sick the first day), DIZZINESS (Dizziness), DIARRHOEA (Diarrhoea), FATIGUE (For the next five days I was only tired), VOMITING (Vomiting) and ARTHRALGIA (Achy joints). At the time of the report, ILLNESS (Extremely sick the first day), DIZZINESS (Dizziness), DIARRHOEA (Diarrhoea), COVID-19 (Tested positive for COVID-19), VOMITING (Vomiting) and ARTHRALGIA (Achy joints) had resolved and FATIGUE (For the next five days I was only tired) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 20-Aug-2021, SARS-CoV-2 test: positive (Positive) Tested positive for COVID-19.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant product details were provided by the reporter. No Treatment information was provided. Patient had tested COVID-19 positive after 4 months of vaccination.   Most recent FOLLOW-UP information incorporated above includes: On 14-Sep-2021: Non-Significant Follow up
Age: 72.0
Sex: U
Vaccine: COVID19
Symptoms: Illness, SARS-CoV-2 test, Vomiting
Clinical narrative: Extremely sick the first day; Dizziness; Diarrhoea; For the next five days I was only tired; Vomiting; Achy joints; Tested positive for COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Extremely sick the first day), DIZZINESS (Dizziness), DIARRHOEA (Diarrhoea), COVID-19 (Tested positive for COVID-19) and FATIGUE (For the next five days I was only tired) in a 72-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Aug-2021, the patient experienced COVID-19 (Tested positive for COVID-19). On an unknown date, the patient experienced ILLNESS (Extremely sick the first day), DIZZINESS (Dizziness), DIARRHOEA (Diarrhoea), FATIGUE (For the next five days I was only tired), VOMITING (Vomiting) and ARTHRALGIA (Achy joints). At the time of the report, ILLNESS (Extremely sick the first day), DIZZINESS (Dizziness), DIARRHOEA (Diarrhoea), COVID-19 (Tested positive for COVID-19), VOMITING (Vomiting) and ARTHRALGIA (Achy joints) had resolved and FATIGUE (For the next five days I was only tired) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 20-Aug-2021, SARS-CoV-2 test: positive (Positive) Tested positive for COVID-19.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant product details were provided by the reporter. No Treatment information was provided. Patient had tested COVID-19 positive after 4 months of vaccination.   Most recent FOLLOW-UP information incorporated above includes: On 14-Sep-2021: Non-Significant Follow up
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Hyperhidrosis, Pyrexia
Clinical narrative: sweating; fever; leg fatigue or tired; This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (sweating), PYREXIA (fever) and FATIGUE (leg fatigue or tired) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Sep-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Sep-2021, the patient experienced HYPERHIDROSIS (sweating), PYREXIA (fever) and FATIGUE (leg fatigue or tired). At the time of the report, HYPERHIDROSIS (sweating), PYREXIA (fever) and FATIGUE (leg fatigue or tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment and concomitant medications were provided.   Reporter did not allow further contact
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Colon cancer, Colonoscopy, Hypoacusis
Clinical narrative: Cancer of colon; Hard of hearing; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 10-Sep-2021 and was forwarded to Moderna on 10-Sep-2021.    This spontaneous case was reported by a consumer and describes the occurrence of COLON CANCER (Cancer of colon) and HYPOACUSIS (Hard of hearing) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 024M20A and 1013L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced COLON CANCER (Cancer of colon) (seriousness criteria hospitalization and medically significant) and HYPOACUSIS (Hard of hearing) (seriousness criterion hospitalization). The patient was treated with Surgery (40% of colon removed.) for Colon cancer. At the time of the report, COLON CANCER (Cancer of colon) and HYPOACUSIS (Hard of hearing) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Colonoscopy: found a mass that looks suspicious (abnormal) found a mass that looks suspicious.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. Patient was scheduled for a booster shot. patient was finished 8th round of chemotherapy out of 8 and that he was immunocompromised. Patient stated he had no side effects from either dose.  Patient had surgery and 40% of his colon removed, patient also was on chemotherapy.  This case concerns a  72-year-old, male patient with no relevant medical history, who experienced the unexpected event Colon cancer. The event occurred after the second dose of Spikevax but the exact date was not reported. The rechallenge was negative. The benefit-risk relationship of Spikevax in not affected by this report.; Sender's Comments: This case concerns a  72-year-old, male patient with no relevant medical history, who experienced the unexpected event Colon cancer. The event occurred after the second dose of Spikevax but the exact date was not reported. The rechallenge was negative. The benefit-risk relationship of Spikevax in not affected by this report.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Cough, Decreased appetite, Fatigue
Clinical narrative: felt incredibly sick; no appetite; coughing; really feeling awful; weakness; low grade fever; chills; tiredness; body ache/felt like her body was run over by a truck; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (felt incredibly sick), DECREASED APPETITE (no appetite), COUGH (coughing), FEELING ABNORMAL (really feeling awful) and ASTHENIA (weakness) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 048FZ1A, 012M20A and 012M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Seasonal allergy, Drug allergy and Drug allergy. Concomitant products included DULOXETINE HYDROCHLORIDE (CYMBALTA), GABAPENTIN, ALPRAZOLAM (XANAX), METOPROLOL and LAMOTRIGINE (LAMICTAL) for an unknown indication.   On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 06-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 06-Sep-2021, the patient experienced MALAISE (felt incredibly sick), DECREASED APPETITE (no appetite), COUGH (coughing), FEELING ABNORMAL (really feeling awful), ASTHENIA (weakness), PYREXIA (low grade fever), CHILLS (chills), FATIGUE (tiredness) and MYALGIA (body ache/felt like her body was run over by a truck). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 500 mg; ZINC at a dose of Zinc 1 tab for the first two days and AMOXICILLIN on 10-Sep-2021 at a dose of 875 mg twice a day. At the time of the report, MALAISE (felt incredibly sick), DECREASED APPETITE (no appetite), COUGH (coughing), FEELING ABNORMAL (really feeling awful), ASTHENIA (weakness), PYREXIA (low grade fever), CHILLS (chills), FATIGUE (tiredness) and MYALGIA (body ache/felt like her body was run over by a truck) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, SARS-CoV-2 test: negative (Negative) Negative.         This case was linked to MOD-2021-316466 (Patient Link).
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Malaise, Myalgia, Pyrexia, SARS-CoV-2 test
Clinical narrative: felt incredibly sick; no appetite; coughing; really feeling awful; weakness; low grade fever; chills; tiredness; body ache/felt like her body was run over by a truck; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (felt incredibly sick), DECREASED APPETITE (no appetite), COUGH (coughing), FEELING ABNORMAL (really feeling awful) and ASTHENIA (weakness) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 048FZ1A, 012M20A and 012M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Seasonal allergy, Drug allergy and Drug allergy. Concomitant products included DULOXETINE HYDROCHLORIDE (CYMBALTA), GABAPENTIN, ALPRAZOLAM (XANAX), METOPROLOL and LAMOTRIGINE (LAMICTAL) for an unknown indication.   On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 06-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 06-Sep-2021, the patient experienced MALAISE (felt incredibly sick), DECREASED APPETITE (no appetite), COUGH (coughing), FEELING ABNORMAL (really feeling awful), ASTHENIA (weakness), PYREXIA (low grade fever), CHILLS (chills), FATIGUE (tiredness) and MYALGIA (body ache/felt like her body was run over by a truck). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 500 mg; ZINC at a dose of Zinc 1 tab for the first two days and AMOXICILLIN on 10-Sep-2021 at a dose of 875 mg twice a day. At the time of the report, MALAISE (felt incredibly sick), DECREASED APPETITE (no appetite), COUGH (coughing), FEELING ABNORMAL (really feeling awful), ASTHENIA (weakness), PYREXIA (low grade fever), CHILLS (chills), FATIGUE (tiredness) and MYALGIA (body ache/felt like her body was run over by a truck) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, SARS-CoV-2 test: negative (Negative) Negative.         This case was linked to MOD-2021-316466 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: Seizure, Vaccination complication
Clinical narrative: Seizure; Vaccination adverse reaction; This spontaneous case was reported by a physician and describes the occurrence of SEIZURE (Seizure) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced SEIZURE (Seizure) (seriousness criterion medically significant) and VACCINATION COMPLICATION (Vaccination adverse reaction). At the time of the report, SEIZURE (Seizure) and VACCINATION COMPLICATION (Vaccination adverse reaction) 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 medication were not provided. Treatment medication were not reported.  Company Comment: Very limited information regarding these events has been provided at this time. No further information is expected at this time.; Sender's Comments: Very limited information regarding these events has been provided at this time. No further information is expected at this time.
Sex: U
Vaccine: COVID19
Symptoms: Tenderness
Clinical narrative: Tender; This spontaneous case was reported by a consumer and describes the occurrence of TENDERNESS (Tender) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced TENDERNESS (Tender). At the time of the report, TENDERNESS (Tender) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   Concomitant medication was not provided by the reporter. Treatment medication was not provided.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Fatigue, Myocardial infarction, Pain in extremity
Clinical narrative: heart attack; shortness of breath; had soreness in her arm; felt really tired for quite some time after that; This spontaneous case was reported by a nurse and describes the occurrence of MYOCARDIAL INFARCTION (heart attack) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 01L20A and 029K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Costochondritis and Heart attack. Concomitant products included VITAMINS NOS for an unknown indication.   On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced MYOCARDIAL INFARCTION (heart attack) (seriousness criterion medically significant), DYSPNOEA (shortness of breath), PAIN IN EXTREMITY (had soreness in her arm) and FATIGUE (felt really tired for quite some time after that). The patient was treated with RIVAROXABAN (XARELTO) at a dose of Once in a day and METOPROLOL TARTRATE at a dose of Twice a day. At the time of the report, MYOCARDIAL INFARCTION (heart attack), DYSPNOEA (shortness of breath), PAIN IN EXTREMITY (had soreness in her arm) and FATIGUE (felt really tired for quite some time after that) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment information was not reported.  Patient had heart attack on 23 APR 2021.  Patient was not sure which arm was vaccinated but thinks it is probably her left arm as she was right handed.  Company Comment: This case concerns a 73 year-old, female patient, who experienced the unexpected event of myocardial infarction. The event occurred an unknown date. The rechallenge was unknown since there's no clear information about which events are related to the first and the second dose. The age of the patient and the uncertainty of the date on which the event occurred are potential confounders. The benefit-risk relationship of Spikevax is not affected by this report. Further information is required.; Sender's Comments: This case concerns a 73 year-old, female patient, who experienced the unexpected event of myocardial infarction. The event occurred an unknown date. The rechallenge was unknown since there's no clear information about which events are related to the first and the second dose. The age of the patient and the uncertainty of the date on which the event occurred are potential confounders. The benefit-risk relationship of Spikevax is not affected by this report. Further information is required.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Full blood count normal, Induration, Lymph node pain, Lymphadenopathy, Metabolic function test normal
Clinical narrative: Pt presented with painful adenopathy in the posterior  occiput midline , initially treated without effect with doxycycline, only to have it spread to symmetrical shotty nodes only in the posterior neck symmetrically, with a single 1.5 solid node palpated in each supraclavicular fossa . No axillary adenopathy. All very tender and firm.  Pt has " cold sore" on lip, nonspecific. Works in healthcare setting.  This occurred after first injection, no known previously known covid infection.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Heavy menstrual bleeding, Menstruation delayed
Clinical narrative: Menstrual changes - late and very heavy period. About 1 tampon and hour.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Angina pectoris, Anxiety, Asthenia, Malaise, Pyrexia
Clinical narrative: Ok so I was snifling thought to be sick n this man made me get the covid shot wen he already knew I had been sick but still forced me to get the vaccine knowing I was sick at the time. I've had all health problems ever since felt terribly weak had heart pain fever weakness n pooping regularly. I'm hoping I can get better n do not wish to receive another vaccine. I'm very worried n pray u guys can help me overcome this battle. ?  I thank u so much for hearing my concern n pray this man also get the punishment he deserves. He has caused Me a lot of problems. Went to hospital told them of this n they just gave me a shot of adavain to calm me down cause they refused to help me get rid of the problems I was having please hear my concern n help me
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Rhinorrhoea
Clinical narrative: Ok so I was snifling thought to be sick n this man made me get the covid shot wen he already knew I had been sick but still forced me to get the vaccine knowing I was sick at the time. I've had all health problems ever since felt terribly weak had heart pain fever weakness n pooping regularly. I'm hoping I can get better n do not wish to receive another vaccine. I'm very worried n pray u guys can help me overcome this battle. ?  I thank u so much for hearing my concern n pray this man also get the punishment he deserves. He has caused Me a lot of problems. Went to hospital told them of this n they just gave me a shot of adavain to calm me down cause they refused to help me get rid of the problems I was having please hear my concern n help me
Sex: U
Vaccine: COVID19
Symptoms: Appendicitis
Clinical narrative: APPENDICITIS; This spontaneous report received from a patient via a company representative via concerned a patient of unspecified age, sex, race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, frequency was one total administered on 06-AUG-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient experienced appendicitis and had to have emergency surgery. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of appendicitis was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210931861-Covid-19 vaccine ad26.cov2.s-Appendicitis. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Product dose omission issue, SARS-CoV-2 test
Clinical narrative: Missed second dose (37 days); COVID-19; This spontaneous case was reported by a nurse and describes the occurrence of COVID-19 (COVID-19) and PRODUCT DOSE OMISSION ISSUE (Missed second dose (37 days)) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Aug-2021, the patient experienced COVID-19 (COVID-19). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Missed second dose (37 days)). At the time of the report, COVID-19 (COVID-19) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (Missed second dose (37 days)) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 25-Aug-2021, SARS-CoV-2 test: positive (Positive) positive.     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 was provided by reporter. No treatment drug was provided by reporter.   This case was linked to MOD-2021-314265 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 09-Sep-2021: Follow up Received, included updated  Reporter details. Patient details were added and start date of the event was added.
Sex: U
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Symptoms of slight fever that passed for a few days; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Symptoms of slight fever that passed for a few days) 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 PYREXIA (Symptoms of slight fever that passed for a few days). At the time of the report, PYREXIA (Symptoms of slight fever that passed for a few days) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant product use was provided by the reporter. No treatment medication was provided.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: very very sick /really sick; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (very very sick /really sick) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046A21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 and Myocarditis (Myocarditis/Pericarditis).    On 08-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 ILLNESS (very very sick /really sick). At the time of the report, ILLNESS (very very sick /really sick) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient took steroids (which takes on a daily basis) to treat symptoms.  Treatment information was not provided.   This case was linked to MOD-2021-314597, MOD-2021-314599 (Patient Link).
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: patient received a vaccine that had Expiration date Mar 06, 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patient received a vaccine that had Expiration date Mar 06, 2021) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 062G20A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Mar-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (patient received a vaccine that had Expiration date Mar 06, 2021). On 10-Mar-2021, EXPIRED PRODUCT ADMINISTERED (patient received a vaccine that had Expiration date Mar 06, 2021) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications was reported. No treatment drug details was reported.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Ultrasound scan, X-ray
Clinical narrative: Sore arm; This spontaneous case was reported by a patient and describes the occurrence of MYALGIA (Sore arm) in a 59-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 07-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MYALGIA (Sore arm). At the time of the report, MYALGIA (Sore arm) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Ultrasound scan: normal (normal) No blood clots. On an unknown date, X-ray: normal (normal) No broken arms.         Concomitant medications were not provided by reporter.  Treatment information was not provided by reporter.   This case was linked to MOD-2021-286887 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: Adverse reaction; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Adverse reaction) 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 an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Adverse reaction). At the time of the report, VACCINATION COMPLICATION (Adverse reaction) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment medications were reported.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature increased, Eating disorder, Headache, Rash, Somnolence
Clinical narrative: A bad welt on the arm; Rash all over the top of the arm; Extreme headaches both times; Temperature elevation; Could not eat; Was sleeping a lot; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (A bad welt on the arm), RASH (Rash all over the top of the arm), HEADACHE (Extreme headaches both times), BODY TEMPERATURE INCREASED (Temperature elevation) and EATING DISORDER (Could not eat) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Tachycardia. Concomitant products included ATENOLOL for Tachycardia.    On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced URTICARIA (A bad welt on the arm), RASH (Rash all over the top of the arm), HEADACHE (Extreme headaches both times), BODY TEMPERATURE INCREASED (Temperature elevation), EATING DISORDER (Could not eat) and SOMNOLENCE (Was sleeping a lot). At the time of the report, URTICARIA (A bad welt on the arm), RASH (Rash all over the top of the arm), HEADACHE (Extreme headaches both times), BODY TEMPERATURE INCREASED (Temperature elevation), EATING DISORDER (Could not eat) and SOMNOLENCE (Was sleeping a lot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications include Atenolol for tachycardia. Treatment medications were not reported.   This case was linked to MOD-2021-314916 (Patient Link).
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: A bad welt on the arm; Rash all over the top of the arm; Extreme headaches both times; Temperature elevation; Could not eat; Was sleeping a lot; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (A bad welt on the arm), RASH (Rash all over the top of the arm), HEADACHE (Extreme headaches both times), BODY TEMPERATURE INCREASED (Temperature elevation) and EATING DISORDER (Could not eat) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Tachycardia. Concomitant products included ATENOLOL for Tachycardia.    On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced URTICARIA (A bad welt on the arm), RASH (Rash all over the top of the arm), HEADACHE (Extreme headaches both times), BODY TEMPERATURE INCREASED (Temperature elevation), EATING DISORDER (Could not eat) and SOMNOLENCE (Was sleeping a lot). At the time of the report, URTICARIA (A bad welt on the arm), RASH (Rash all over the top of the arm), HEADACHE (Extreme headaches both times), BODY TEMPERATURE INCREASED (Temperature elevation), EATING DISORDER (Could not eat) and SOMNOLENCE (Was sleeping a lot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications include Atenolol for tachycardia. Treatment medications were not reported.   This case was linked to MOD-2021-314916 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Blood pressure measurement, Bone pain, Chills, Confusional state
Clinical narrative: slight pressure in left temple; some aches in the bones; light headedness for 2 days; brain fog; smelling a burnt smell/smelling burnt leaf smell; runny nose; fatigue for a couple of days; arm sore at left shoulder/left side muscle pain; axillary area sore for couple days; left lymph node sore for couple days; rapid heart rate/highest heart rate 110; half hour of chills; This spontaneous case was reported by a consumer and describes the occurrence of PALPITATIONS (rapid heart rate/highest heart rate 110), HEAD DISCOMFORT (slight pressure in left temple), BONE PAIN (some aches in the bones), DIZZINESS (light headedness for 2 days) and CONFUSIONAL STATE (brain fog) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004F21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Long QT and Allergy. Concomitant products included LEVOTHYROXINE and VITAMIN D3 for an unknown indication.    On 04-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Sep-2021, the patient experienced PALPITATIONS (rapid heart rate/highest heart rate 110). On an unknown date, the patient experienced HEAD DISCOMFORT (slight pressure in left temple), BONE PAIN (some aches in the bones), DIZZINESS (light headedness for 2 days), CONFUSIONAL STATE (brain fog), PAROSMIA (smelling a burnt smell/smelling burnt leaf smell), RHINORRHOEA (runny nose), FATIGUE (fatigue for a couple of days), MYALGIA (arm sore at left shoulder/left side muscle pain), AXILLARY PAIN (axillary area sore for couple days), CHILLS (half hour of chills) and LYMPH NODE PAIN (left lymph node sore for couple days). At the time of the report, HEAD DISCOMFORT (slight pressure in left temple), BONE PAIN (some aches in the bones), DIZZINESS (light headedness for 2 days), CONFUSIONAL STATE (brain fog), PAROSMIA (smelling a burnt smell/smelling burnt leaf smell), RHINORRHOEA (runny nose), MYALGIA (arm sore at left shoulder/left side muscle pain), AXILLARY PAIN (axillary area sore for couple days), CHILLS (half hour of chills) and LYMPH NODE PAIN (left lymph node sore for couple days) had resolved and FATIGUE (fatigue for a couple of days) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 04-Sep-2021, Blood pressure measurement: normal (normal) Normal. On 04-Sep-2021, Heart rate: 110-100 (High) highest was 110and the lowest was 100.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment information was provided. ?   Most recent FOLLOW-UP information incorporated above includes: On 10-Sep-2021: Non-Significant follow-up contain no new information
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Head discomfort, Heart rate, Lymph node pain
Clinical narrative: slight pressure in left temple; some aches in the bones; light headedness for 2 days; brain fog; smelling a burnt smell/smelling burnt leaf smell; runny nose; fatigue for a couple of days; arm sore at left shoulder/left side muscle pain; axillary area sore for couple days; left lymph node sore for couple days; rapid heart rate/highest heart rate 110; half hour of chills; This spontaneous case was reported by a consumer and describes the occurrence of PALPITATIONS (rapid heart rate/highest heart rate 110), HEAD DISCOMFORT (slight pressure in left temple), BONE PAIN (some aches in the bones), DIZZINESS (light headedness for 2 days) and CONFUSIONAL STATE (brain fog) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004F21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Long QT and Allergy. Concomitant products included LEVOTHYROXINE and VITAMIN D3 for an unknown indication.    On 04-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Sep-2021, the patient experienced PALPITATIONS (rapid heart rate/highest heart rate 110). On an unknown date, the patient experienced HEAD DISCOMFORT (slight pressure in left temple), BONE PAIN (some aches in the bones), DIZZINESS (light headedness for 2 days), CONFUSIONAL STATE (brain fog), PAROSMIA (smelling a burnt smell/smelling burnt leaf smell), RHINORRHOEA (runny nose), FATIGUE (fatigue for a couple of days), MYALGIA (arm sore at left shoulder/left side muscle pain), AXILLARY PAIN (axillary area sore for couple days), CHILLS (half hour of chills) and LYMPH NODE PAIN (left lymph node sore for couple days). At the time of the report, HEAD DISCOMFORT (slight pressure in left temple), BONE PAIN (some aches in the bones), DIZZINESS (light headedness for 2 days), CONFUSIONAL STATE (brain fog), PAROSMIA (smelling a burnt smell/smelling burnt leaf smell), RHINORRHOEA (runny nose), MYALGIA (arm sore at left shoulder/left side muscle pain), AXILLARY PAIN (axillary area sore for couple days), CHILLS (half hour of chills) and LYMPH NODE PAIN (left lymph node sore for couple days) had resolved and FATIGUE (fatigue for a couple of days) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 04-Sep-2021, Blood pressure measurement: normal (normal) Normal. On 04-Sep-2021, Heart rate: 110-100 (High) highest was 110and the lowest was 100.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment information was provided. ?   Most recent FOLLOW-UP information incorporated above includes: On 10-Sep-2021: Non-Significant follow-up contain no new information