chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Vaccination site pain; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Vaccination site pain) 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 VACCINATION SITE PAIN (Vaccination site pain). At the time of the report, VACCINATION SITE PAIN (Vaccination site pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was provided by the reporter. No treatment information was provided by the reporter.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain
Clinical narrative: Abdominal pain; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 09-Aug-2021 and was forwarded to Moderna on 09-Aug-2021.    This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN (Abdominal pain) in a 35-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 052E21A and 939676) for COVID-19 vaccination.     No Medical History information was reported.   On 01-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Aug-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced ABDOMINAL PAIN (Abdominal pain). At the time of the report, ABDOMINAL PAIN (Abdominal pain) outcome was unknown.            It's been 72 hours, and patient was still having some abdominal pain on 09Aug2021. It felt like appendicitis, then moved to his kidneys.  No concomitant medication was reported. The treatment information was unknown.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pruritus, Injection site urticaria, Injection site warmth
Clinical narrative: little warm  to touch; hives near the  injection site and describes the hives as, " one spot - 3 &1/4 of a   size, few small ones  which merged together and created  a big spot which is  2  inch  wide &  4  inch long.; slightly itching; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE WARMTH (little warm  to touch), INJECTION SITE URTICARIA (hives near the  injection site and describes the hives as, " one spot - 3&1/4 of a   size, few small ones  which merged together and created  a big spot which is  2  inch  wide &  4  inch long.) and INJECTION SITE PRURITUS (slightly itching) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027B21A) for COVID-19 vaccination.     Concurrent medical conditions included Allergy and Migraine. Concomitant products included CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) for Allergy.    On 30-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Aug-2021, the patient experienced INJECTION SITE WARMTH (little warm  to touch), INJECTION SITE URTICARIA (hives near the  injection site and describes the hives as, " one spot - 3&1/4 of a   size, few small ones  which merged together and created  a big spot which is  2  inch  wide &  4  inch long.) and INJECTION SITE PRURITUS (slightly itching). The patient was treated with FLUTICASONE PROPIONATE (FLONASE [FLUTICASONE PROPIONATE]) for Adverse event, at an unspecified dose and frequency and CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency. At the time of the report, INJECTION SITE WARMTH (little warm  to touch), INJECTION SITE URTICARIA (hives near the  injection site and describes the hives as, " one spot - 3&1/4 of a   size, few small ones  which merged together and created  a big spot which is  2  inch  wide &  4  inch long.) and INJECTION SITE PRURITUS (slightly itching) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant products also included a migraine medication as needed.  Treatment information included ice.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pruritus
Clinical narrative: Has red spots popping up everywhere, all over the back and front of her torso; Itching a little bit; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (Has red spots popping up everywhere, all over the back and front of her torso) and PRURITUS (Itching a little bit) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 088D21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Aug-2021, the patient experienced ERYTHEMA (Has red spots popping up everywhere, all over the back and front of her torso) and PRURITUS (Itching a little bit). At the time of the report, ERYTHEMA (Has red spots popping up everywhere, all over the back and front of her torso) and PRURITUS (Itching a little bit) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant medications were provided. No treatment medications were provided.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Diarrhoea, Fatigue, Headache
Clinical narrative: diarrhea first three days; headache; fatigue; joint pain; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (diarrhea first three days), HEADACHE (headache), FATIGUE (fatigue) and ARTHRALGIA (joint pain) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045B21A) for COVID-19 vaccination.     No Medical History information was reported.  Concomitant products included OMEPRAZOLE for an unknown indication.    On 01-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In 2021, the patient experienced HEADACHE (headache), FATIGUE (fatigue) and ARTHRALGIA (joint pain). On 01-Aug-2021, the patient experienced DIARRHOEA (diarrhea first three days). At the time of the report, DIARRHOEA (diarrhea first three days) had resolved, HEADACHE (headache) and FATIGUE (fatigue) had not resolved and ARTHRALGIA (joint pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Pain, Skin discomfort
Clinical narrative: skin felt like someone rubbed sandpaper on it; body aches; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of SKIN DISCOMFORT (skin felt like someone rubbed sandpaper on it), PAIN (body aches) and FATIGUE (fatigue) 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 SKIN DISCOMFORT (skin felt like someone rubbed sandpaper on it), PAIN (body aches) and FATIGUE (fatigue). At the time of the report, SKIN DISCOMFORT (skin felt like someone rubbed sandpaper on it), PAIN (body aches) and FATIGUE (fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment information was reported.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Administered with the vaccine from prefilled syringe prepared last 06Aug2021; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered with the vaccine from prefilled syringe prepared last 06Aug2021) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025C21A and 017C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 07-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 09-Aug-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered with the vaccine from prefilled syringe prepared last 06Aug2021). On 09-Aug-2021, EXPIRED PRODUCT ADMINISTERED (Administered with the vaccine from prefilled syringe prepared last 06Aug2021) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication details was reported. No treatment medication details was reported.   Most recent FOLLOW-UP information incorporated above includes: On 11-Aug-2021: Follow-up information received and First dose information and batch number were added.
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Chest discomfort, Chest pain, Condition aggravated
Clinical narrative: Symptoms are getting worst; Tightness in the chest; Chest pain; This spontaneous case was reported by a consumer and describes the occurrence of CONDITION AGGRAVATED (Symptoms are getting worst), CHEST DISCOMFORT (Tightness in the chest) and CHEST PAIN (Chest pain) in a 30-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 059E214) for COVID-19 vaccination.     The patient's past medical history included Childhood asthma.    On 06-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Aug-2021, the patient experienced CHEST DISCOMFORT (Tightness in the chest) and CHEST PAIN (Chest pain). On 09-Aug-2021, the patient experienced CONDITION AGGRAVATED (Symptoms are getting worst). At the time of the report, CONDITION AGGRAVATED (Symptoms are getting worst), CHEST DISCOMFORT (Tightness in the chest) and CHEST PAIN (Chest pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medications were reported.  No Treatment medications were reported.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Arrhythmia, Atrial fibrillation, Cerebrovascular accident, Computerised tomogram, Echocardiogram
Clinical narrative: arrhythmia; afib; cryptogenic stroke; tachycardia; feeling tired; having tiny sore arm; This spontaneous case was reported by a consumer and describes the occurrence of ARRHYTHMIA (arrhythmia), ATRIAL FIBRILLATION (afib) and CEREBROVASCULAR ACCIDENT (cryptogenic stroke) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012M20A and 029LZOA) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included L-THYROXINE [LEVOTHYROXINE], NALTREXONE and MULTIVITAMINS [VITAMINS NOS] for an unknown indication.   On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ARRHYTHMIA (arrhythmia) (seriousness criterion medically significant), ATRIAL FIBRILLATION (afib) (seriousness criterion medically significant), CEREBROVASCULAR ACCIDENT (cryptogenic stroke) (seriousness criterion medically significant), TACHYCARDIA (tachycardia), FATIGUE (feeling tired) and VACCINATION SITE PAIN (having tiny sore arm). The patient was treated with ACETYLSALICYLIC ACID (BABY ASPIRIN) for Adverse event, at an unspecified dose and frequency. At the time of the report, ARRHYTHMIA (arrhythmia), ATRIAL FIBRILLATION (afib), CEREBROVASCULAR ACCIDENT (cryptogenic stroke), TACHYCARDIA (tachycardia), FATIGUE (feeling tired) and VACCINATION SITE PAIN (having tiny sore arm) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Computerised tomogram: normal (normal) CAT scan showed no bleeding. In 2021, Echocardiogram: normal (normal) Echo fine. In 2021, Magnetic resonance imaging: abnormal (abnormal) MRI showed the cardiovascular event such that there was an interruption, but there was no structural issue..         Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   This case was linked to MOD-2021-281138 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Magnetic resonance imaging, Tachycardia, Vaccination site pain
Clinical narrative: arrhythmia; afib; cryptogenic stroke; tachycardia; feeling tired; having tiny sore arm; This spontaneous case was reported by a consumer and describes the occurrence of ARRHYTHMIA (arrhythmia), ATRIAL FIBRILLATION (afib) and CEREBROVASCULAR ACCIDENT (cryptogenic stroke) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012M20A and 029LZOA) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included L-THYROXINE [LEVOTHYROXINE], NALTREXONE and MULTIVITAMINS [VITAMINS NOS] for an unknown indication.   On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ARRHYTHMIA (arrhythmia) (seriousness criterion medically significant), ATRIAL FIBRILLATION (afib) (seriousness criterion medically significant), CEREBROVASCULAR ACCIDENT (cryptogenic stroke) (seriousness criterion medically significant), TACHYCARDIA (tachycardia), FATIGUE (feeling tired) and VACCINATION SITE PAIN (having tiny sore arm). The patient was treated with ACETYLSALICYLIC ACID (BABY ASPIRIN) for Adverse event, at an unspecified dose and frequency. At the time of the report, ARRHYTHMIA (arrhythmia), ATRIAL FIBRILLATION (afib), CEREBROVASCULAR ACCIDENT (cryptogenic stroke), TACHYCARDIA (tachycardia), FATIGUE (feeling tired) and VACCINATION SITE PAIN (having tiny sore arm) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Computerised tomogram: normal (normal) CAT scan showed no bleeding. In 2021, Echocardiogram: normal (normal) Echo fine. In 2021, Magnetic resonance imaging: abnormal (abnormal) MRI showed the cardiovascular event such that there was an interruption, but there was no structural issue..         Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   This case was linked to MOD-2021-281138 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Muscle spasms, Pain in extremity, Peripheral swelling, Scan, Thrombosis
Clinical narrative: her leg was swollen with pain; blood clots/whole right leg was filled with blood clots; her leg was swollen with pain; a little cramp; This spontaneous case was reported by a consumer and describes the occurrence of THROMBOSIS (blood clots/whole right leg was filled with blood clots), MUSCLE SPASMS (a little cramp), PERIPHERAL SWELLING (her leg was swollen with pain) and PAIN IN EXTREMITY (her leg was swollen with pain) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 22B214 and 016C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 23-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Jun-2021, the patient experienced MUSCLE SPASMS (a little cramp) (seriousness criterion hospitalization). On 23-Jun-2021, the patient experienced PERIPHERAL SWELLING (her leg was swollen with pain) (seriousness criterion hospitalization). On 25-Jun-2021, the patient experienced THROMBOSIS (blood clots/whole right leg was filled with blood clots) (seriousness criteria hospitalization and medically significant). On 23-Jul-2021, the patient experienced PAIN IN EXTREMITY (her leg was swollen with pain) (seriousness criterion hospitalization). The patient was hospitalized on 25-Jun-2021 due to MUSCLE SPASMS, PAIN IN EXTREMITY, PERIPHERAL SWELLING and THROMBOSIS. At the time of the report, THROMBOSIS (blood clots/whole right leg was filled with blood clots) was resolving and MUSCLE SPASMS (a little cramp), PERIPHERAL SWELLING (her leg was swollen with pain) and PAIN IN EXTREMITY (her leg was swollen with pain) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 25-Jun-2021, Scan: abnormal (abnormal) her leg and the whole right leg was filled with blood clot.         Patient was treatment medication of a diuretic or something like that for the blood clots Concomitant product use was not provided by the reporter.  Company comment Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Myelitis transverse, Paralysis, Product dose omission issue
Clinical narrative: Transverse myelitis; being paralyzed; not receiving 2nd dose of the Moderna COVID19 vaccine; This spontaneous case was reported by a consumer and describes the occurrence of PARALYSIS (being paralyzed) and MYELITIS TRANSVERSE (Transverse myelitis) in a 27-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 054c21a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was reported.  Concomitant products included ANTIDEPRESSANTS for an unknown indication.    On 05-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Jul-2021, the patient experienced PARALYSIS (being paralyzed) (seriousness criteria hospitalization, disability and medically significant). On an unknown date, the patient experienced MYELITIS TRANSVERSE (Transverse myelitis) (seriousness criteria hospitalization, disability and medically significant) and PRODUCT DOSE OMISSION ISSUE (not receiving 2nd dose of the Moderna COVID19 vaccine). At the time of the report, PARALYSIS (being paralyzed) had not resolved, MYELITIS TRANSVERSE (Transverse myelitis) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (not receiving 2nd dose of the Moderna COVID19 vaccine) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was withdrawn on an unknown date.       It was reported patient had multiple tests in the hospital.  No concomitant medications were reported. No treatment information was provided by the reporter. Company Comment : Very limited information regarding these events has been provided at this time. Further information has been requested.; Sender's Comments: Very limited information regarding these events has been provided at this time. Further information has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Fall, Head discomfort, Loss of consciousness, Product dose omission issue
Clinical narrative: Has still not gotten the second dose; passed out; fell; got a node on the head; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (passed out) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 18-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-May-2021, the patient experienced LOSS OF CONSCIOUSNESS (passed out) (seriousness criterion medically significant), FALL (fell) and HEAD DISCOMFORT (got a node on the head). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Has still not gotten the second dose). At the time of the report, LOSS OF CONSCIOUSNESS (passed out), FALL (fell) and HEAD DISCOMFORT (got a node on the head) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (Has still not gotten the second dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication reported.   Earlier, the physician had recommended the patient's mother to wait and hold with the second dose vaccination, probably due to the effects after first dose vaccination and so the patient decided not to get the second dose. The patient wanted to get the second dose now but was unsure whether the patient could receive it or not and if then had to restart the vaccination schedule or just get the second dose.  No treatment information was provided.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Joint swelling, Neuropathy peripheral, Peripheral swelling
Clinical narrative: peripheral neuropathy diagnosis of hands and feet; arm swelling; ankle swelled up 3 weeks to a month later; This spontaneous case was reported by a consumer and describes the occurrence of NEUROPATHY PERIPHERAL (peripheral neuropathy diagnosis of hands and feet) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002C21A and 008B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 20-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-May-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 NEUROPATHY PERIPHERAL (peripheral neuropathy diagnosis of hands and feet) (seriousness criterion medically significant), PERIPHERAL SWELLING (arm swelling) and JOINT SWELLING (ankle swelled up 3 weeks to a month later). The patient was treated with CANNABIDIOL (CBD OIL) for Adverse event, at a dose of 1 dosage form; GABAPENTIN for Peripheral neuropathy, at a dose of 1 dosage form and MARIJUANA at an unspecified dose and frequency. At the time of the report, NEUROPATHY PERIPHERAL (peripheral neuropathy diagnosis of hands and feet), PERIPHERAL SWELLING (arm swelling) and JOINT SWELLING (ankle swelled up 3 weeks to a month later) outcome was unknown.            Concomitant products were not provided.  After administration of second dose of moderna vaccine patient experienced ankle swelling for more than 3 weeks.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.  Very limited information has been provided at this time. Further information is expected   This case was linked to MOD-2021-281227 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.  Very limited information has been provided at this time. Further information is expected
Sex: F
Vaccine: COVID19
Symptoms: Breast cancer, Breast mass, Mammogram, Retracted nipple, Ultrasound breast
Clinical narrative: breast cancer; Retracted nipple; breast lump; This spontaneous case was reported by a consumer and describes the occurrence of BREAST CANCER (breast cancer) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Mar-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 BREAST CANCER (breast cancer) (seriousness criterion medically significant), RETRACTED NIPPLE (Retracted nipple) and BREAST MASS (breast lump). At the time of the report, BREAST CANCER (breast cancer), RETRACTED NIPPLE (Retracted nipple) and BREAST MASS (breast lump) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Mammogram: suspicion of malignancy (abnormal) Suspicion of malignancy. On an unknown date, Ultrasound breast: abnormal (abnormal) 95% likelihood of breast cancer.         Concomitant products were not provided. Treatment medication were not reported.  After vaccine the patient developed retracted nipple.   Later patient developed a small lump and went for an immediate mammography and its results stated suspicion of malignancy, ultrasound results shown 5 on scale indicating 95% likelihood of breast cancer. Doctor confirmed it as breast cancer and mentioned they need biopsy to go for the treatment option. Also stated that patient developed this mass after 4 months of vaccination.  Company Comment :  Very limited information regarding these events has been provided at this time. Additional information required.; Sender's Comments: Very limited information regarding these events has been provided at this time. Additional information required.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Caller states she just had a sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Caller states she just had a sore arm) in a 120-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016M20A) for COVID-19 vaccination.     Concurrent medical conditions included Asthma (She takes Asthma inhalers) and GERD. Concomitant products included CLONAZEPAM (KLONOPIN), OMEPRAZOLE (PROTONIX [OMEPRAZOLE]) and DULOXETINE HYDROCHLORIDE (CYMBALTA) for an unknown indication.    On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Caller states she just had a sore arm). At the time of the report, PAIN IN EXTREMITY (Caller states she just had a sore arm) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       The patient was taking a tranquilizer very seldom along with other concomitant drugs.   This case was linked to MOD-2021-281133 (Patient Link).   Reporter did not allow further contact
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site haemorrhage, Venous haemorrhage
Clinical narrative: his various vein in his leg started bleeding; bleeding from his shot site; This spontaneous case was reported by a consumer and describes the occurrence of VENOUS HAEMORRHAGE (his various vein in his leg started bleeding) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VENOUS HAEMORRHAGE (his various vein in his leg started bleeding) (seriousness criterion medically significant) and VACCINATION SITE HAEMORRHAGE (bleeding from his shot site). At the time of the report, VENOUS HAEMORRHAGE (his various vein in his leg started bleeding) and VACCINATION SITE HAEMORRHAGE (bleeding from his shot site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   Reporter did not allow further contact; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 25.0
Sex: M
Vaccine: COVID19
Symptoms: Intentional product use issue
Clinical narrative: Consumer is beyond 42 days for second dose.; This spontaneous case was reported by a pharmacist and describes the occurrence of INTENTIONAL PRODUCT USE ISSUE (Consumer is beyond 42 days for second dose.) in a 24-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Apr-2021, the patient experienced INTENTIONAL PRODUCT USE ISSUE (Consumer is beyond 42 days for second dose.). At the time of the report, INTENTIONAL PRODUCT USE ISSUE (Consumer is beyond 42 days for second 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.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Erythema, Product dose omission issue, Pyrexia, Vaccination site erythema
Clinical narrative: her husband did not receive the second dose of the vaccine, after the first dose on 05Apr2021; fever of 104 degrees Fahrenheit; deep redness from wrist to shoulder on injection arm; Chest Pain; deep redness from wrist to shoulder on injection arm; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (Chest Pain), ERYTHEMA (deep redness from wrist to shoulder on injection arm), PRODUCT DOSE OMISSION ISSUE (her husband did not receive the second dose of the vaccine, after the first dose on 05Apr2021), PYREXIA (fever of 104 degrees Fahrenheit) and VACCINATION SITE ERYTHEMA (deep redness from wrist to shoulder on injection arm) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Apr-2021, the patient experienced CHEST PAIN (Chest Pain), ERYTHEMA (deep redness from wrist to shoulder on injection arm), PYREXIA (fever of 104 degrees Fahrenheit) and VACCINATION SITE ERYTHEMA (deep redness from wrist to shoulder on injection arm). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (her husband did not receive the second dose of the vaccine, after the first dose on 05Apr2021). At the time of the report, CHEST PAIN (Chest Pain), ERYTHEMA (deep redness from wrist to shoulder on injection arm), PYREXIA (fever of 104 degrees Fahrenheit) and VACCINATION SITE ERYTHEMA (deep redness from wrist to shoulder on injection arm) had resolved and PRODUCT DOSE OMISSION ISSUE (her husband did not receive the second dose of the vaccine, after the first dose on 05Apr2021) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was withdrawn on an unknown date.       No concomitant medication provided. On an unknown date, Body temperature: 104 (Inconclusive) 104 degrees Fahrenheit.   No treatment medication provided.  The patient did not receive second dose at all.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Dementia, Gait disturbance
Clinical narrative: dementia; cannot walk; COVID-brain; This spontaneous case was reported by a consumer and describes the occurrence of DEMENTIA (dementia) 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 DEMENTIA (dementia) (seriousness criterion medically significant), GAIT DISTURBANCE (cannot walk) and COVID-19 (COVID-brain). At the time of the report, DEMENTIA (dementia), GAIT DISTURBANCE (cannot walk) and COVID-19 (COVID-brain) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant product was reported.   On an unspecified date, SARS-CoV-2 test was positive.  No treatment information was reported.  Very limited information regarding these events has been provided at this time. Patient declined further contact; Sender's Comments: Very limited information regarding these events has been provided at this time. Patient declined further contact
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Bone pain, Decreased appetite, Fatigue, Feeling abnormal, Hallucination
Clinical narrative: Never received her second administration of the vaccine and is far outside the allowed time window to do so; Fever of 102 degrees Fahrenheit; Fatigue; Hallucinations; Bones aching; loss of appetite; Foggy feeling in head; This spontaneous case was reported by a consumer and describes the occurrence of HALLUCINATION (Hallucinations) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was reported.  Concomitant products included WARFARIN, METOPROLOL SUCCINATE (TOPROL) and DIGOXIN for an unknown indication.    On 05-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Apr-2021, the patient experienced HALLUCINATION (Hallucinations) (seriousness criterion medically significant), BONE PAIN (Bones aching), DECREASED APPETITE (loss of appetite), FEELING ABNORMAL (Foggy feeling in head), PYREXIA (Fever of 102 degrees Fahrenheit) and FATIGUE (Fatigue). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Never received her second administration of the vaccine and is far outside the allowed time window to do so). At the time of the report, HALLUCINATION (Hallucinations), BONE PAIN (Bones aching), PRODUCT DOSE OMISSION ISSUE (Never received her second administration of the vaccine and is far outside the allowed time window to do so), PYREXIA (Fever of 102 degrees Fahrenheit) and FATIGUE (Fatigue) had resolved and DECREASED APPETITE (loss of appetite) and FEELING ABNORMAL (Foggy feeling in head) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 17-Mar-2020, SARS-CoV-2 test: positive (Positive) positive for the COVID-19.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product includes chlorizide. Treatment information was not provided. Expiry date reported as unknown.  Company comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Product dose omission issue, Pyrexia, SARS-CoV-2 test
Clinical narrative: Never received her second administration of the vaccine and is far outside the allowed time window to do so; Fever of 102 degrees Fahrenheit; Fatigue; Hallucinations; Bones aching; loss of appetite; Foggy feeling in head; This spontaneous case was reported by a consumer and describes the occurrence of HALLUCINATION (Hallucinations) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was reported.  Concomitant products included WARFARIN, METOPROLOL SUCCINATE (TOPROL) and DIGOXIN for an unknown indication.    On 05-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Apr-2021, the patient experienced HALLUCINATION (Hallucinations) (seriousness criterion medically significant), BONE PAIN (Bones aching), DECREASED APPETITE (loss of appetite), FEELING ABNORMAL (Foggy feeling in head), PYREXIA (Fever of 102 degrees Fahrenheit) and FATIGUE (Fatigue). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Never received her second administration of the vaccine and is far outside the allowed time window to do so). At the time of the report, HALLUCINATION (Hallucinations), BONE PAIN (Bones aching), PRODUCT DOSE OMISSION ISSUE (Never received her second administration of the vaccine and is far outside the allowed time window to do so), PYREXIA (Fever of 102 degrees Fahrenheit) and FATIGUE (Fatigue) had resolved and DECREASED APPETITE (loss of appetite) and FEELING ABNORMAL (Foggy feeling in head) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 17-Mar-2020, SARS-CoV-2 test: positive (Positive) positive for the COVID-19.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product includes chlorizide. Treatment information was not provided. Expiry date reported as unknown.  Company comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: M
Vaccine: COVID19
Symptoms: Hypersensitivity, Loss of consciousness, Vaccination site haemorrhage
Clinical narrative: He passed out; Injection site was bleeding; Learn about severe allergic reaction; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (He passed out) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced LOSS OF CONSCIOUSNESS (He passed out) (seriousness criterion medically significant), VACCINATION SITE HAEMORRHAGE (Injection site was bleeding) and HYPERSENSITIVITY (Learn about severe allergic reaction). At the time of the report, LOSS OF CONSCIOUSNESS (He passed out), VACCINATION SITE HAEMORRHAGE (Injection site was bleeding) and HYPERSENSITIVITY (Learn about severe allergic reaction) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication were provided.  No treatment medication were provided.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   Reporter did not allow further contact; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chest discomfort, Chills, Diarrhoea, Dyspnoea
Clinical narrative: felt out of breath; body pain was so severe; had a fever (didn't take it); feeling very tired; tightness in the chest; diarrhea; chills; muscle pain; head ache; joint pain; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (diarrhea), CHEST DISCOMFORT (tightness in the chest), DYSPNOEA (felt out of breath), PAIN (body pain was so severe) and CHILLS (chills) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 088021A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included BUPROPION for an unknown indication.    On 02-Aug-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Aug-2021, the patient experienced DIARRHOEA (diarrhea), CHILLS (chills), MYALGIA (muscle pain), HEADACHE (head ache) and ARTHRALGIA (joint pain). On 04-Aug-2021, the patient experienced CHEST DISCOMFORT (tightness in the chest) and FATIGUE (feeling very tired). On an unknown date, the patient experienced DYSPNOEA (felt out of breath), PAIN (body pain was so severe) and PYREXIA (had a fever (didn't take it)). At the time of the report, DIARRHOEA (diarrhea), DYSPNOEA (felt out of breath), PAIN (body pain was so severe), CHILLS (chills), MYALGIA (muscle pain), HEADACHE (head ache), ARTHRALGIA (joint pain), FATIGUE (feeling very tired) and PYREXIA (had a fever (didn't take it)) had resolved and CHEST DISCOMFORT (tightness in the chest) had not resolved.            NO Treatment drug reported.   This case was linked to MOD-2021-281341 (Patient Link).
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Myalgia, Pain, Pyrexia
Clinical narrative: felt out of breath; body pain was so severe; had a fever (didn't take it); feeling very tired; tightness in the chest; diarrhea; chills; muscle pain; head ache; joint pain; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (diarrhea), CHEST DISCOMFORT (tightness in the chest), DYSPNOEA (felt out of breath), PAIN (body pain was so severe) and CHILLS (chills) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 088021A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included BUPROPION for an unknown indication.    On 02-Aug-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Aug-2021, the patient experienced DIARRHOEA (diarrhea), CHILLS (chills), MYALGIA (muscle pain), HEADACHE (head ache) and ARTHRALGIA (joint pain). On 04-Aug-2021, the patient experienced CHEST DISCOMFORT (tightness in the chest) and FATIGUE (feeling very tired). On an unknown date, the patient experienced DYSPNOEA (felt out of breath), PAIN (body pain was so severe) and PYREXIA (had a fever (didn't take it)). At the time of the report, DIARRHOEA (diarrhea), DYSPNOEA (felt out of breath), PAIN (body pain was so severe), CHILLS (chills), MYALGIA (muscle pain), HEADACHE (head ache), ARTHRALGIA (joint pain), FATIGUE (feeling very tired) and PYREXIA (had a fever (didn't take it)) had resolved and CHEST DISCOMFORT (tightness in the chest) had not resolved.            NO Treatment drug reported.   This case was linked to MOD-2021-281341 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: side effects of moderna vaccine on preganant ladies; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (side effects of moderna vaccine on preganant ladies) 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. Last menstrual period and estimated date of delivery were not provided. On an unknown date, the patient experienced VACCINATION COMPLICATION (side effects of moderna vaccine on preganant ladies). At the time of the report, VACCINATION COMPLICATION (side effects of moderna vaccine on preganant ladies) 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   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication, Vertigo
Clinical narrative: Vertigo; Dr visit due to an adverse reaction; This spontaneous case was reported by a consumer and describes the occurrence of VERTIGO (Vertigo) and VACCINATION COMPLICATION (Dr visit due to an adverse reaction) 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 VERTIGO (Vertigo) (seriousness criterion medically significant) and VACCINATION COMPLICATION (Dr visit due to an adverse reaction) (seriousness criterion medically significant). At the time of the report, VERTIGO (Vertigo) and VACCINATION COMPLICATION (Dr visit due to an adverse reaction) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.  Patient had to go to the hospital.  Treatment medication was not provided by the reporter.  Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   Reporter did not allow further contact; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.