chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Insomnia, X-ray
Clinical narrative: Slight shortness of breath; I sleep for 7-8 hours and wake up with a feeling as if I had not slept at all; Extreme fatigue\ I Feel exhausted, physically weak; Joint pain; Second dose of Moderna COVID-19 vaccine administered more than 35 days after first dose.; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Slight shortness of breath), INSOMNIA (I sleep for 7-8 hours and wake up with a feeling as if I had not slept at all), FATIGUE (Extreme fatigue\ I Feel exhausted, physically weak) and ARTHRALGIA (Joint pain) in a 32-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028A21A and 046B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 09-Jun-2021, the patient experienced DYSPNOEA (Slight shortness of breath) (seriousness criterion medically significant), INSOMNIA (I sleep for 7-8 hours and wake up with a feeling as if I had not slept at all) (seriousness criterion medically significant), FATIGUE (Extreme fatigue\ I Feel exhausted, physically weak) (seriousness criterion medically significant), ARTHRALGIA (Joint pain) (seriousness criterion medically significant) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose of Moderna COVID-19 vaccine administered more than 35 days after first dose.). On 09-Jun-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose of Moderna COVID-19 vaccine administered more than 35 days after first dose.) had resolved. At the time of the report, DYSPNOEA (Slight shortness of breath), INSOMNIA (I sleep for 7-8 hours and wake up with a feeling as if I had not slept at all), FATIGUE (Extreme fatigue\ I Feel exhausted, physically weak) and ARTHRALGIA (Joint pain) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Blood test: normal (normal) not find anything out of the ordinary and thus discharged the patient. In 2021, X-ray: normal (normal) not find anything out of the ordinary and thus discharged the patient.         Over-the-counter "stimulants" and "energy drinks" were provided as treatment drug information. 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. Further information has been requested.; 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. Further information has been requested.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: 72 hours later he got shingles; This spontaneous case was reported by a consumer and describes the occurrence of HERPES ZOSTER (72 hours later he got shingles) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023C21A) for COVID-19 vaccination.     The patient's past medical history included Spinal cord injury, Aortic valve disease (clogged aortic valve in his heart.), Back surgery (2 surgeries.), Cholecystectomy and Heart valve replacement (an artificial valve in his heart). Concomitant products included CHONDROITIN SULFATE, GLUCOSAMINE SULFATE (GLUCOSAMINE CHONDROITIN [CHONDROITIN SULFATE;GLUCOSAMINE SULFATE]), CALCIUM, ZINC, UBIDECARENONE (COQ10 [UBIDECARENONE]), METHYLSULFONYLMETHANE (MSM [METHYLSULFONYLMETHANE]), COLECALCIFEROL (VITAMIN D3), FISH OIL (OMEGA 3 6 9 [FISH OIL]), VITAMIN E NOS, VITAMIN C [ASCORBIC ACID], MULTIVITAMIN [VITAMINS NOS] and FISH OIL (OMEGA 3 FISH OIL [FISH OIL]) for an unknown indication.    On 13-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced HERPES ZOSTER (72 hours later he got shingles) (seriousness criterion medically significant). The patient was treated with LORAZEPAM ongoing since an unknown date for Pain, at an unspecified dose and frequency and GABAPENTIN for Shingles, at a dose of 100 mg. At the time of the report, HERPES ZOSTER (72 hours later he got shingles) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was 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. Further information has been requested.; 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. Further information has been requested.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Hypersomnia
Clinical narrative: Slept a lot; Headache; This spontaneous case was reported by a consumer and describes the occurrence of HYPERSOMNIA (Slept a lot) and HEADACHE (Headache) in a 52-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 005C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-May-2021, the patient experienced HYPERSOMNIA (Slept a lot) (seriousness criterion medically significant) and HEADACHE (Headache) (seriousness criterion medically significant). At the time of the report, HYPERSOMNIA (Slept a lot) and HEADACHE (Headache) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Concomitant product was not provided by the reporter.  Treatment information was not provided after first dose.  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.  Further information has been requested.   This case was linked to MOD-2021-231690 (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.  Further information has been requested.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Myalgia, Peripheral swelling, Swelling
Clinical narrative: a couple days after the second shot his arm swelled up; After his whole upper torso swelled up; has no strength in his arm; pain in his muscl; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (a couple days after the second shot his arm swelled up), SWELLING (After his whole upper torso swelled up), ASTHENIA (has no strength in his arm) and MYALGIA (pain in his muscl) in a 62-year-old male adult exposed to mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unk) , while the parent received the product for COVID-19 vaccination.     No Medical History information was reported.    In 2021, the parent received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. In 2021, the adult was diagnosed with PERIPHERAL SWELLING (a couple days after the second shot his arm swelled up) (seriousness criterion hospitalization), SWELLING (After his whole upper torso swelled up) (seriousness criterion hospitalization), ASTHENIA (has no strength in his arm) (seriousness criterion hospitalization) and MYALGIA (pain in his muscl) (seriousness criterion hospitalization). The patient was hospitalized on sometime in 2021 due to ASTHENIA, MYALGIA, PERIPHERAL SWELLING and SWELLING. At the time of the report, PERIPHERAL SWELLING (a couple days after the second shot his arm swelled up), SWELLING (After his whole upper torso swelled up), ASTHENIA (has no strength in his arm) and MYALGIA (pain in his muscl) outcome was unknown.            The action taken with mRNA-1273 in response to the event was not applicable.  The patient had been in the hospital for a week due to symptoms. couple days after the second shot his arm swelled up and then after his whole upper torso swelled up. The patient had no strength in his arm and pain in his muscle. No concomitant medication information was provided by the reporter. No treatment information was provided by the reporter.  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: U
Vaccine: COVID19
Symptoms: Arthralgia, Dyspnoea, Hepatic pain, Lymph node pain, Palpitations
Clinical narrative: shortness of breath; palpitations/rapid heartbeat; liver pain,4 weekspain in the li; severe pain in the lymph nodes under the arms; hip pain; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (shortness of breath), PALPITATIONS (palpitations/rapid heartbeat), HEPATIC PAIN (liver pain,4 weekspain in the li), LYMPH NODE PAIN (severe pain in the lymph nodes under the arms) and ARTHRALGIA (hip 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DYSPNOEA (shortness of breath) (seriousness criterion medically significant), PALPITATIONS (palpitations/rapid heartbeat) (seriousness criterion medically significant), HEPATIC PAIN (liver pain,4 weekspain in the li) (seriousness criterion medically significant), LYMPH NODE PAIN (severe pain in the lymph nodes under the arms) (seriousness criterion medically significant) and ARTHRALGIA (hip pain) (seriousness criterion medically significant). At the time of the report, DYSPNOEA (shortness of breath), PALPITATIONS (palpitations/rapid heartbeat), HEPATIC PAIN (liver pain,4 weekspain in the li), LYMPH NODE PAIN (severe pain in the lymph nodes under the arms) and ARTHRALGIA (hip pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       After first dose the patient had severe pain in the lymph nodes under the arms liver pain hip pain shortness of breath and palpitations, rapid heartbeat. The concomitant medications on use were not provided. No laboratory data was provided. No treatment information was provided. This case concerns a patient of unknown age and gender with serious unexpected events of dyspnea, palpitations, hepatic pain, lymph node pain, and arthralgia. Event onset with unknown latency after first dose mRNA-1273. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender's Comments: This case concerns a patient of unknown age and gender with serious unexpected events of dyspnea, palpitations, hepatic pain, lymph node pain, and arthralgia. Event onset with unknown latency after first dose mRNA-1273. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Sex: U
Vaccine: COVID19
Symptoms: Ear pain, Facial discomfort, Headache
Clinical narrative: A lot facial sensitivity on my right side of my face; Earache; Really bad headache; This spontaneous case was reported by a consumer and describes the occurrence of FACIAL DISCOMFORT (A lot facial sensitivity on my right side of my face), EAR PAIN (Earache) and HEADACHE (Really bad headache) 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 24-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Jun-2021, the patient experienced FACIAL DISCOMFORT (A lot facial sensitivity on my right side of my face) (seriousness criterion medically significant), EAR PAIN (Earache) (seriousness criterion medically significant) and HEADACHE (Really bad headache) (seriousness criterion medically significant). At the time of the report, FACIAL DISCOMFORT (A lot facial sensitivity on my right side of my face), EAR PAIN (Earache) and HEADACHE (Really bad headache) outcome was unknown.            Concomitant product use was not provided.  Treatment information was 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: 93.0
Sex: M
Vaccine: COVID19
Symptoms: Abnormal loss of weight, Dysphagia, Fatigue, Hospice care, Lethargy
Clinical narrative: hospice care; Coughing up mucus; Couldn't swallow food because of mucus build up; lost a lot of weight; Went from very active to very inactive and rapid decline; tired/ asthenia; This spontaneous case was reported by a consumer and describes the occurrence of HOSPICE CARE (hospice care) in a 93-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Hospice care since an unknown date. Concurrent medical conditions included Smoker and COPD (Patient was diagnosed with Chronic Obstructive Pulmonary Disease although his oxygen level is at 99).    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 HOSPICE CARE (hospice care) (seriousness criterion disability), PRODUCTIVE COUGH (Coughing up mucus), DYSPHAGIA (Couldn't swallow food because of mucus build up), ABNORMAL LOSS OF WEIGHT (lost a lot of weight), LETHARGY (Went from very active to very inactive and rapid decline) and FATIGUE (tired/ asthenia). At the time of the report, HOSPICE CARE (hospice care), PRODUCTIVE COUGH (Coughing up mucus), DYSPHAGIA (Couldn't swallow food because of mucus build up), ABNORMAL LOSS OF WEIGHT (lost a lot of weight), LETHARGY (Went from very active to very inactive and rapid decline) and FATIGUE (tired/ asthenia) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Oxygen saturation: 99 (Inconclusive) Inconclusive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medication were reported  No treatment information was provided  Reporter was not sure if it was the  Moderna vaccine.  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.   This case was linked to MOD-2021-236538 (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: 93.0
Sex: M
Vaccine: COVID19
Symptoms: Oxygen saturation, Productive cough
Clinical narrative: hospice care; Coughing up mucus; Couldn't swallow food because of mucus build up; lost a lot of weight; Went from very active to very inactive and rapid decline; tired/ asthenia; This spontaneous case was reported by a consumer and describes the occurrence of HOSPICE CARE (hospice care) in a 93-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Hospice care since an unknown date. Concurrent medical conditions included Smoker and COPD (Patient was diagnosed with Chronic Obstructive Pulmonary Disease although his oxygen level is at 99).    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 HOSPICE CARE (hospice care) (seriousness criterion disability), PRODUCTIVE COUGH (Coughing up mucus), DYSPHAGIA (Couldn't swallow food because of mucus build up), ABNORMAL LOSS OF WEIGHT (lost a lot of weight), LETHARGY (Went from very active to very inactive and rapid decline) and FATIGUE (tired/ asthenia). At the time of the report, HOSPICE CARE (hospice care), PRODUCTIVE COUGH (Coughing up mucus), DYSPHAGIA (Couldn't swallow food because of mucus build up), ABNORMAL LOSS OF WEIGHT (lost a lot of weight), LETHARGY (Went from very active to very inactive and rapid decline) and FATIGUE (tired/ asthenia) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Oxygen saturation: 99 (Inconclusive) Inconclusive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medication were reported  No treatment information was provided  Reporter was not sure if it was the  Moderna vaccine.  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.   This case was linked to MOD-2021-236538 (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.
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Dyspnoea, Muscular weakness, Palpitations
Clinical narrative: Shortness of breath; Heart palpitations; Legs are weak; Dizziness; This spontaneous case was reported by a patient family member or friend and describes the occurrence of DYSPNOEA (Shortness of breath) and PALPITATIONS (Heart palpitations) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. UNK) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Urinary tract infection (hospitalized with urinary tract infection) in 2020.   On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-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 DYSPNOEA (Shortness of breath) (seriousness criterion hospitalization), PALPITATIONS (Heart palpitations) (seriousness criterion hospitalization), MUSCULAR WEAKNESS (Legs are weak) and DIZZINESS (Dizziness). At the time of the report, DYSPNOEA (Shortness of breath), PALPITATIONS (Heart palpitations), MUSCULAR WEAKNESS (Legs are weak) and DIZZINESS (Dizziness) outcome was unknown.            No concomitant medication information was reported. No treatment information was reported.  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   Most recent FOLLOW-UP information incorporated above includes: On 25-Jun-2021: Additional events.; 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: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Haemoptysis, Pulmonary thrombosis
Clinical narrative: Found a clot in his lungs; Coughing up blood; This spontaneous case was reported by a consumer and describes the occurrence of PULMONARY THROMBOSIS (Found a clot in his lungs) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040B21A and 026A21A) 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 FINASTERIDE, FLUOXETINE, SIMVASTATIN, MELOXICAM, LEVOTHYROXINE, FOLIC ACID, ATORVASTATIN, VITAMIN D3 and TESTOSTERONE for an unknown indication.   On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-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 PULMONARY THROMBOSIS (Found a clot in his lungs) (seriousness criterion medically significant) and HAEMOPTYSIS (Coughing up blood). At the time of the report, PULMONARY THROMBOSIS (Found a clot in his lungs) and HAEMOPTYSIS (Coughing up blood) outcome was unknown.            It was reported that after taking the second vaccine,  the patient was coughing up blood and went to the emergency room, and they found a clot in his lungs.  Treatment information was not provided by the reporter.  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: F
Vaccine: COVID19
Symptoms: Product dose omission issue, Pulmonary embolism
Clinical narrative: Pulmonary embolism; she had to quarantine and was not able to get her second dose; This spontaneous case was reported by a pharmacist and describes the occurrence of PULMONARY EMBOLISM (Pulmonary embolism) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. UNK) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-May-2021, the patient experienced PULMONARY EMBOLISM (Pulmonary embolism) (seriousness criteria hospitalization and medically significant). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (she had to quarantine and was not able to get her second dose). At the time of the report, PULMONARY EMBOLISM (Pulmonary embolism) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (she had to quarantine and was not able to get her 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.   Concomitant product use was not provided. Treatment information was not provided.  Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. Further information has been requested.   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 event, a causal relationship cannot be excluded. Further information has been requested
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Dizziness, Headache, Loss of consciousness, Vision blurred
Clinical narrative: Passed out; Dizziness; Blurry vision; Stomach ache; Headache; Was throwing up; This spontaneous case was reported by a patient and describes the occurrence of LOSS OF CONSCIOUSNESS (Passed out) in a 19-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 02621A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 27-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced LOSS OF CONSCIOUSNESS (Passed out) (seriousness criterion medically significant), DIZZINESS (Dizziness), VISION BLURRED (Blurry vision), ABDOMINAL PAIN UPPER (Stomach ache), HEADACHE (Headache) and VOMITING (Was throwing up). At the time of the report, LOSS OF CONSCIOUSNESS (Passed out), DIZZINESS (Dizziness), VISION BLURRED (Blurry vision) and VOMITING (Was throwing up) had resolved and ABDOMINAL PAIN UPPER (Stomach ache) and HEADACHE (Headache) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. Vaccination taken after 5 PM. Nothing felt at the injection site. No other side effects reported. No treatment information was provided.  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: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Passed out; Dizziness; Blurry vision; Stomach ache; Headache; Was throwing up; This spontaneous case was reported by a patient and describes the occurrence of LOSS OF CONSCIOUSNESS (Passed out) in a 19-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 02621A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 27-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced LOSS OF CONSCIOUSNESS (Passed out) (seriousness criterion medically significant), DIZZINESS (Dizziness), VISION BLURRED (Blurry vision), ABDOMINAL PAIN UPPER (Stomach ache), HEADACHE (Headache) and VOMITING (Was throwing up). At the time of the report, LOSS OF CONSCIOUSNESS (Passed out), DIZZINESS (Dizziness), VISION BLURRED (Blurry vision) and VOMITING (Was throwing up) had resolved and ABDOMINAL PAIN UPPER (Stomach ache) and HEADACHE (Headache) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. Vaccination taken after 5 PM. Nothing felt at the injection site. No other side effects reported. No treatment information was provided.  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: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Discomfort, Dyspnoea, Hypoaesthesia, Myocardial infarction, Nausea
Clinical narrative: Patient was airlifted to the hospital where she was diagnosed with a heart attack; Difficulty breathing; Numbness; Discomfort; Nausea; Vomiting; Burning/arm felt sore; This spontaneous case was reported by a consumer and describes the occurrence of MYOCARDIAL INFARCTION (Patient was airlifted to the hospital where she was diagnosed with a heart attack), DYSPNOEA (Difficulty breathing), HYPOAESTHESIA (Numbness), DISCOMFORT (Discomfort), NAUSEA (Nausea) and VOMITING (Vomiting) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 01003807772739901769) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 13-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Mar-2021, the patient experienced MYOCARDIAL INFARCTION (Patient was airlifted to the hospital where she was diagnosed with a heart attack) (seriousness criteria hospitalization and medically significant). On an unknown date, the patient experienced DYSPNOEA (Difficulty breathing) (seriousness criterion medically significant), HYPOAESTHESIA (Numbness) (seriousness criterion medically significant), DISCOMFORT (Discomfort) (seriousness criterion medically significant), NAUSEA (Nausea) (seriousness criterion medically significant), VOMITING (Vomiting) (seriousness criterion medically significant) and PAIN IN EXTREMITY (Burning/arm felt sore). At the time of the report, MYOCARDIAL INFARCTION (Patient was airlifted to the hospital where she was diagnosed with a heart attack), DYSPNOEA (Difficulty breathing), HYPOAESTHESIA (Numbness), DISCOMFORT (Discomfort), NAUSEA (Nausea), VOMITING (Vomiting) and PAIN IN EXTREMITY (Burning/arm felt sore) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  Treatment information was not provided.  The patient was discharged several days later.  Very limited information regarding this event/s has been provided at this time.  Further information has been requested.   This case was linked to MOD-2021-237455 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 28-Jun-2021: Non-significant follow-up added  to include Lot number; Sender's Comments: Very limited information regarding this event/s has been provided at this time.  Further information has been requested.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Vomiting
Clinical narrative: Patient was airlifted to the hospital where she was diagnosed with a heart attack; Difficulty breathing; Numbness; Discomfort; Nausea; Vomiting; Burning/arm felt sore; This spontaneous case was reported by a consumer and describes the occurrence of MYOCARDIAL INFARCTION (Patient was airlifted to the hospital where she was diagnosed with a heart attack), DYSPNOEA (Difficulty breathing), HYPOAESTHESIA (Numbness), DISCOMFORT (Discomfort), NAUSEA (Nausea) and VOMITING (Vomiting) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 01003807772739901769) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 13-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Mar-2021, the patient experienced MYOCARDIAL INFARCTION (Patient was airlifted to the hospital where she was diagnosed with a heart attack) (seriousness criteria hospitalization and medically significant). On an unknown date, the patient experienced DYSPNOEA (Difficulty breathing) (seriousness criterion medically significant), HYPOAESTHESIA (Numbness) (seriousness criterion medically significant), DISCOMFORT (Discomfort) (seriousness criterion medically significant), NAUSEA (Nausea) (seriousness criterion medically significant), VOMITING (Vomiting) (seriousness criterion medically significant) and PAIN IN EXTREMITY (Burning/arm felt sore). At the time of the report, MYOCARDIAL INFARCTION (Patient was airlifted to the hospital where she was diagnosed with a heart attack), DYSPNOEA (Difficulty breathing), HYPOAESTHESIA (Numbness), DISCOMFORT (Discomfort), NAUSEA (Nausea), VOMITING (Vomiting) and PAIN IN EXTREMITY (Burning/arm felt sore) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  Treatment information was not provided.  The patient was discharged several days later.  Very limited information regarding this event/s has been provided at this time.  Further information has been requested.   This case was linked to MOD-2021-237455 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 28-Jun-2021: Non-significant follow-up added  to include Lot number; Sender's Comments: Very limited information regarding this event/s has been provided at this time.  Further information has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Atrial fibrillation, Atrial flutter, Ventricular extrasystoles
Clinical narrative: Afib; PVCs; atrial flutter; This spontaneous case was reported by a consumer and describes the occurrence of ATRIAL FIBRILLATION (Afib) 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 ATRIAL FIBRILLATION (Afib) (seriousness criterion medically significant), VENTRICULAR EXTRASYSTOLES (PVCs) and ATRIAL FLUTTER (atrial flutter). At the time of the report, ATRIAL FIBRILLATION (Afib), VENTRICULAR EXTRASYSTOLES (PVCs) and ATRIAL FLUTTER (atrial flutter) 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.  No treatment information was provided.  For mRNA-1273 (Moderna COVID-19 Vaccine) (unknown), the reporter did not provide any causality assessments.  Company Comment  Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.; Sender's Comments: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.
Age: 84.0
Sex: M
Vaccine: COVID19
Symptoms: Atrial fibrillation
Clinical narrative: Atrial Fibrillation; This spontaneous case was reported by a consumer and describes the occurrence of ATRIAL FIBRILLATION (Atrial Fibrillation) in an 84-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003B21A and 016M20A) for COVID-19 vaccination.     The patient's past medical history included Shortness of breath. Concurrent medical conditions included COPD (treated with prednisone) and Heart disorder. Concomitant products included PREDNISONE for COPD, BUDESONIDE, FORMOTEROL FUMARATE (SYMBICORT) and ALBUTEROL [SALBUTAMOL] for an unknown indication.   On 20-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 22-Feb-2021, the patient experienced ATRIAL FIBRILLATION (Atrial Fibrillation) (seriousness criterion medically significant). The patient was treated with DILTIAZEM for Atrial fibrillation, at an unspecified dose and frequency; APIXABAN (ELIQUIS) at an unspecified dose and frequency; LISINOPRIL at an unspecified dose and frequency and OXYGEN at a dose of 1 liter. On 22-Feb-2021, ATRIAL FIBRILLATION (Atrial Fibrillation) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment medication included unknown medication that starts with the letter "T".  The action taken for m-RNA-1273 Covid-19 Moderna Vaccine was not applicable.  This case concerns a 84-year-old male with a serious unexpected event of atrial fibrillation. Event latency 2 days after first dose mRNA-1273. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.   This case was linked to MOD-2021-238713 (Patient Link).; Sender's Comments: This case concerns a 84-year-old male with a serious unexpected event of atrial fibrillation. Event latency 2 days after first dose mRNA-1273. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 84.0
Sex: M
Vaccine: COVID19
Symptoms: Cerebrovascular accident, Dyspnoea
Clinical narrative: Suffered a stroke\ spent 2 to 3 days in the hospital\ spent 10 days in Rehab; Shortness of breath is now really bad/ shortness of breath sometimes extreme/ shortness of breath a lot worse now; This spontaneous case was reported by a consumer and describes the occurrence of CEREBROVASCULAR ACCIDENT (Suffered a stroke\ spent 2 to 3 days in the hospital\ spent 10 days in Rehab) in an 84-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003B21A and 016M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Shortness of breath. Previously administered products included for Atrial fibrillation: Diltiazem; for an unreported indication: PREDNISON ("burst" (one-week course)). Concurrent medical conditions included COPD. Concomitant products included BUDESONIDE, FORMOTEROL FUMARATE (SYMBICORT), ALBUTEROL [SALBUTAMOL] and DULOXETINE HYDROCHLORIDE (DUAL [DULOXETINE HYDROCHLORIDE]) for an unknown indication.   On 20-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced CEREBROVASCULAR ACCIDENT (Suffered a stroke\ spent 2 to 3 days in the hospital\ spent 10 days in Rehab) (seriousness criteria hospitalization and medically significant) and DYSPNOEA (Shortness of breath is now really bad/ shortness of breath sometimes extreme/ shortness of breath a lot worse now). The patient was treated with APIXABAN (ELIQUIS) ongoing since an unknown date for Stroke, at a dose of 1 dosage form and LISINOPRIL ongoing since an unknown date for Stroke, at a dose of 1 dosage form. At the time of the report, CEREBROVASCULAR ACCIDENT (Suffered a stroke\ spent 2 to 3 days in the hospital\ spent 10 days in Rehab) and DYSPNOEA (Shortness of breath is now really bad/ shortness of breath sometimes extreme/ shortness of breath a lot worse now) outcome was unknown.            Patient stated that he was on one litter of oxygen (unknown flow rate). Patient stated the stroke affected his right "writing" hand. He reported that he had no history of heart problems prior to receiving the Moderna COVID-19 vaccine series   Action taken with mRNA-1273 in response to the events was not applicable.  Based on current available information and the temporal association between product use and the start date of the events which is greater than two (2) months a causal relationship is unlikely.   This case was linked to MOD-2021-238669 (Patient Link).; Sender's Comments: Based on current available information and the temporal association between product use and the start date of the events which is greater than two (2) months a causal relationship is unlikely.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Multiple sclerosis, Visual impairment
Clinical narrative: Multiple Sclerosis; Decreased eyesight; This spontaneous case was reported by a health care professional and describes the occurrence of MULTIPLE SCLEROSIS (Multiple Sclerosis) in a 24-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 information was reported.    In February 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MULTIPLE SCLEROSIS (Multiple Sclerosis) (seriousness criterion medically significant) and VISUAL IMPAIRMENT (Decreased eyesight). At the time of the report, MULTIPLE SCLEROSIS (Multiple Sclerosis) and VISUAL IMPAIRMENT (Decreased eyesight) 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.   Patient was treated with steroid for decreased eyesight, and was recovered  70%. concomitant product details not provided.  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.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Meniere's disease, Vertigo, Vomiting
Clinical narrative: First attack of Ménière's disease; Severe spinning; Violent vomiting; This spontaneous case was reported by a consumer and describes the occurrence of MENIERE'S DISEASE (First attack of Ménière's disease) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 009C21A and 036B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Breast cancer and Breast conserving surgery on 03-May-2021. Concomitant products included ESOMEPRAZOLE SODIUM (NEXIUM [ESOMEPRAZOLE SODIUM]), MILNACIPRAN HYDROCHLORIDE (SAVELLA), FAMOTIDINE and OXCARBAZEPINE (TRILEPTAL) for an unknown indication.   On 16-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 18-May-2021, the patient experienced MENIERE'S DISEASE (First attack of Ménière's disease) (seriousness criterion medically significant), VERTIGO (Severe spinning) and VOMITING (Violent vomiting). The patient was treated with PROMETHAZINE at a dose of 1 UNK and DIAZEPAM (VALIUM) at an unspecified dose and frequency. On 18-May-2021, MENIERE'S DISEASE (First attack of Ménière's disease), VERTIGO (Severe spinning) and VOMITING (Violent vomiting) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient got diagnosed with Meniere's disease on 08-Jun-2021. Other treatment medicine included Diuretic.  The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was not applicable.  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: 89.0
Sex: F
Vaccine: COVID19
Symptoms: Illness, Malaise, Pancreatitis, Product availability issue, Product dose omission issue
Clinical narrative: Pancreatitis; When she got back home she wasn't feeling well so went back to the hospital two weeks after; She got sick and got into the hospital for 3 weeks; She was supposed to get the second dose on february but the second dose wascancelled due to lack of the product.; second dose was cancelled due to lack of product; This spontaneous case was reported by a consumer and describes the occurrence of PANCREATITIS (Pancreatitis), ILLNESS (She got sick and got into the hospital for 3 weeks) and MALAISE (When she got back home she wasn't feeling well so went back to the hospital two weeks after) in an 89-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In March 2021, the patient experienced ILLNESS (She got sick and got into the hospital for 3 weeks) (seriousness criterion hospitalization prolonged). On an unknown date, the patient experienced PANCREATITIS (Pancreatitis) (seriousness criteria hospitalization prolonged and medically significant), MALAISE (When she got back home she wasn't feeling well so went back to the hospital two weeks after) (seriousness criterion hospitalization prolonged), PRODUCT AVAILABILITY ISSUE (She was supposed to get the second dose on february but the second dose wascancelled due to lack of the product.) and PRODUCT DOSE OMISSION ISSUE (second dose was cancelled due to lack of product). At the time of the report, PANCREATITIS (Pancreatitis), ILLNESS (She got sick and got into the hospital for 3 weeks) and MALAISE (When she got back home she wasn't feeling well so went back to the hospital two weeks after) outcome was unknown and PRODUCT AVAILABILITY ISSUE (She was supposed to get the second dose on february but the second dose wascancelled due to lack of the product.) and PRODUCT DOSE OMISSION ISSUE (second dose was cancelled due to lack of product) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provide by the reporter.  Treatment information was not provided by the reporter. Very limited information regarding the events "pancreatitis" , "illness" and malaise" has been provided at this time.  Further information has been requested. For the events, product dose omission, product availability issue causality is assessed as not applicable.; Sender's Comments: Very limited information regarding the events "pancreatitis" , "illness" and malaise" has been provided at this time.  Further information has been requested. For the events, product dose omission, product availability issue causality is assessed as not aplicable.