chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Laboratory test, Malaise, Nausea, Neck pain
Clinical narrative: Feel sick; Felt really bad; Neck Pain; Nausea; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of MALAISE (Feel sick) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 059A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, the patient experienced MALAISE (Feel sick) (seriousness criterion hospitalization), FEELING ABNORMAL (Felt really bad), NECK PAIN (Neck Pain) and NAUSEA (Nausea). At the time of the report, MALAISE (Feel sick), FEELING ABNORMAL (Felt really bad), NECK PAIN (Neck Pain) and NAUSEA (Nausea) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 13-Mar-2021, Laboratory test: normal (normal) normal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       On 13-Mar-2021, the patient felt very sick that she ended up going to Emergency. The patient stated that she stayed in hospital for a whole da.  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: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea, Insomnia
Clinical narrative: trouble with breathing, breathing difficult, " my breathing went to hell"; Could not sleep; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DYSPNOEA (trouble with breathing, breathing difficult, " my breathing went to hell") in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) 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 APIXABAN (ELIQUIS) and DOXAZOSIN for an unknown indication.    On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, the patient experienced DYSPNOEA (trouble with breathing, breathing difficult, " my breathing went to hell") (seriousness criterion hospitalization). On an unknown date, the patient experienced INSOMNIA (Could not sleep). The patient was treated with ALBUTEROL [SALBUTAMOL] at an unspecified dose and frequency. At the time of the report, DYSPNOEA (trouble with breathing, breathing difficult, " my breathing went to hell") had not resolved and INSOMNIA (Could not sleep) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was withdrawn on an unknown date.       The patient stated that two weeks after the vaccination he went to Emergency room due to breathing difficulty and was admitted.  He reportedly spent two days in the ICU.  The patient continued to have trouble and did not get the second dose due to the breathing difficulty he experienced.  The patient reported that he could not sleep since he could not breathe.    Additional concomitant medications included heart medications and heart burn medications.  Treatment medications included an Albuterol inhaler.  This case concerns an 80-year-old male hospitalized with a serious unexpected event of dyspnea, and nonserious unexpected event of insomnia. Patient treated with antibiotics. Event latency 15 days after 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.   Most recent FOLLOW-UP information incorporated above includes: On 09-Jun-2021: Case upgraded to serious, Patient demographics updated, additional event reported (could not sleep).; Sender's Comments: This case concerns an 80-year-old male hospitalized with a serious unexpected event of dyspnea, and nonserious unexpected event of insomnia. Patient treated with antibiotics. Event latency 15 days after 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: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Myocarditis
Clinical narrative: Myocarditis; This spontaneous case was reported by an other health care professional and describes the occurrence of MYOCARDITIS (Myocarditis) in a 30-year-old male patient 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In February 2021, the patient experienced MYOCARDITIS (Myocarditis) (seriousness criteria hospitalization and medically significant). The patient was hospitalized on sometime in February 2021 due to MYOCARDITIS. At the time of the report, MYOCARDITIS (Myocarditis) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications were not provided by the reporter.   Treatment information was not provided.  Based on the current available information and temporal association between the use of the product and the start date of this event, 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 this event, a causal relationship cannot be excluded.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Limb discomfort, Neuropathy peripheral, Pain, Sensory disturbance
Clinical narrative: mild soreness; Peripheral neuropathy; heightened sensory feelings at night; Feet feel different; feels heat and warmth; This spontaneous case was reported by a consumer and describes the occurrence of NEUROPATHY PERIPHERAL (Peripheral neuropathy) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 024M20A and 032M20A) 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 ATENOLOL, ACETYLSALICYLIC ACID (ASPIRIN 81), COLECALCIFEROL (VITAMIN D 3) and VITAMIN B12 [VITAMIN B12 NOS] for an unknown indication.   On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Feb-2021, the patient experienced NEUROPATHY PERIPHERAL (Peripheral neuropathy) (seriousness criterion medically significant), SENSORY DISTURBANCE (heightened sensory feelings at night), LIMB DISCOMFORT (Feet feel different) and FEELING HOT (feels heat and warmth). On an unknown date, the patient experienced PAIN (mild soreness). At the time of the report, NEUROPATHY PERIPHERAL (Peripheral neuropathy), SENSORY DISTURBANCE (heightened sensory feelings at night), LIMB DISCOMFORT (Feet feel different), FEELING HOT (feels heat and warmth) and PAIN (mild soreness) outcome was unknown.            Action taken with mRNA-1273 in response to the events was not applicable.  No treatment was prescribed for her events. The patient received both vaccine doses by a Pharmacy. The patient shared that she had heightened sensory feelings at nighttime within the sheets and that her feet started feeling different in February. At the end of March she saw an Internist who did blood work for her because of a procedure she was to have to remove basal cancer from her nose.  The patient thought her Vitamin B12 levels might have been low, however from lab work her B12 levels were actually high and she was advised to stop taking her B12 supplementation at that time. The patient had a future appointment scheduled for August but wanted answers sooner regarding her inquiry.  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-2021-194667 (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: U
Vaccine: COVID19
Symptoms: Asthma, Dyspnoea, Hypersensitivity, Respiratory rate increased
Clinical narrative: severe allergic reaction; shortness of breath; rapid breathing; asthma; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of HYPERSENSITIVITY (severe allergic reaction) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HYPERSENSITIVITY (severe allergic reaction) (seriousness criterion medically significant), DYSPNOEA (shortness of breath), RESPIRATORY RATE INCREASED (rapid breathing) and ASTHMA (asthma). At the time of the report, HYPERSENSITIVITY (severe allergic reaction), DYSPNOEA (shortness of breath), RESPIRATORY RATE INCREASED (rapid breathing) and ASTHMA (asthma) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient had severe allergic reaction to first dose of vaccine. Patient had shortness of breath and rapid breathing. Patient went to ER and they told patient got asthma and steroids and inhaler were given to patient.  Very limited information regarding these events have been provided at this time. No further information is expected.; Sender's Comments: Very limited information regarding these events have been provided at this time. No further information is expected.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Alopecia, Autoimmune disorder, Disability, Psoriasis, Rash
Clinical narrative: psoriasis; autoimmune disorders; She is losing her hair, the hair on the back of her wrist and arms are lost.; red rash all over face, head, ears, neck; back in hell; Broke out scalp; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DISABILITY (back in hell) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 048B21A and 017B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Autoimmune arthritis.   On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 07-May-2021, the patient experienced DISABILITY (back in hell) (seriousness criteria disability and medically significant), SKIN DISORDER (Broke out scalp) and RASH (red rash all over face, head, ears, neck). On an unknown date, the patient experienced PSORIASIS (psoriasis), AUTOIMMUNE DISORDER (autoimmune disorders) and ALOPECIA (She is losing her hair, the hair on the back of her wrist and arms are lost.). The patient was treated with TRIAMCINOLONE ACETONIDE for Rash on face, at a dose of UNK dosage form and ULOBETASOL PROPIONATE (LEXETTE) for Scalp rash, at a dose of UNK dosage form. At the time of the report, DISABILITY (back in hell), SKIN DISORDER (Broke out scalp), PSORIASIS (psoriasis), AUTOIMMUNE DISORDER (autoimmune disorders), ALOPECIA (She is losing her hair, the hair on the back of her wrist and arms are lost.) and RASH (red rash all over face, head, ears, neck) outcome was unknown.            Concomitant medication use was not provided. Action taken with mRNA-1273 in response to the event 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.   This case was linked to MOD-2021-194580 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 02-Jun-2021: Significant follow-up added on 02-JUN-2021, Contact information updated.; 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: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Skin disorder
Clinical narrative: psoriasis; autoimmune disorders; She is losing her hair, the hair on the back of her wrist and arms are lost.; red rash all over face, head, ears, neck; back in hell; Broke out scalp; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DISABILITY (back in hell) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 048B21A and 017B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Autoimmune arthritis.   On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 07-May-2021, the patient experienced DISABILITY (back in hell) (seriousness criteria disability and medically significant), SKIN DISORDER (Broke out scalp) and RASH (red rash all over face, head, ears, neck). On an unknown date, the patient experienced PSORIASIS (psoriasis), AUTOIMMUNE DISORDER (autoimmune disorders) and ALOPECIA (She is losing her hair, the hair on the back of her wrist and arms are lost.). The patient was treated with TRIAMCINOLONE ACETONIDE for Rash on face, at a dose of UNK dosage form and ULOBETASOL PROPIONATE (LEXETTE) for Scalp rash, at a dose of UNK dosage form. At the time of the report, DISABILITY (back in hell), SKIN DISORDER (Broke out scalp), PSORIASIS (psoriasis), AUTOIMMUNE DISORDER (autoimmune disorders), ALOPECIA (She is losing her hair, the hair on the back of her wrist and arms are lost.) and RASH (red rash all over face, head, ears, neck) outcome was unknown.            Concomitant medication use was not provided. Action taken with mRNA-1273 in response to the event 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.   This case was linked to MOD-2021-194580 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 02-Jun-2021: Significant follow-up added on 02-JUN-2021, Contact information updated.; 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, UNK
Symptoms: Burning sensation, Chills, Headache, Muscle spasms, Muscular weakness
Clinical narrative: Rheumatoid arthritis flare up; Burning leg; Cramps legs; Foot cramps; Swelling of legs; Lower extremities weakness; Generalized aching; CHILLS; Headache; This spontaneous case was reported by a consumer and describes the occurrence of RHEUMATOID ARTHRITIS (Rheumatoid arthritis flare up) 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.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) injection for Rheumatoid arthritis.  No Medical History information was reported.   In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In April 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 started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced RHEUMATOID ARTHRITIS (Rheumatoid arthritis flare up) (seriousness criterion medically significant), BURNING SENSATION (Burning leg), MUSCLE SPASMS (Cramps legs), MUSCLE SPASMS (Foot cramps), PERIPHERAL SWELLING (Swelling of legs), MUSCULAR WEAKNESS (Lower extremities weakness), PAIN (Generalized aching), CHILLS (CHILLS) and HEADACHE (Headache). At the time of the report, RHEUMATOID ARTHRITIS (Rheumatoid arthritis flare up), BURNING SENSATION (Burning leg), MUSCULAR WEAKNESS (Lower extremities weakness), PAIN (Generalized aching), CHILLS (CHILLS) and HEADACHE (Headache) outcome was unknown and MUSCLE SPASMS (Cramps legs), MUSCLE SPASMS (Foot cramps) and PERIPHERAL SWELLING (Swelling of legs) had not resolved.  No concomitant medications were reported.No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not applicable.  Company Comment: Very limited information regarding the events and vaccination dates has been provided and is insufficient for causality assessment at this time. A causal relationship cannot be excluded. Further information has been requested.   Most recent FOLLOW-UP information incorporated above includes: On 04-Jun-2021: Follow-up information received on 04 Jun 2021.Second dose events were added.; Sender's Comments: Very limited information regarding the events and vaccination dates has been provided and is insufficient for causality assessment at this time. A causal relationship cannot be excluded. Further information has been requested.
Sex: F
Vaccine: COVID19, UNK
Symptoms: Pain, Peripheral swelling, Rheumatoid arthritis
Clinical narrative: Rheumatoid arthritis flare up; Burning leg; Cramps legs; Foot cramps; Swelling of legs; Lower extremities weakness; Generalized aching; CHILLS; Headache; This spontaneous case was reported by a consumer and describes the occurrence of RHEUMATOID ARTHRITIS (Rheumatoid arthritis flare up) 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.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) injection for Rheumatoid arthritis.  No Medical History information was reported.   In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In April 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 started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced RHEUMATOID ARTHRITIS (Rheumatoid arthritis flare up) (seriousness criterion medically significant), BURNING SENSATION (Burning leg), MUSCLE SPASMS (Cramps legs), MUSCLE SPASMS (Foot cramps), PERIPHERAL SWELLING (Swelling of legs), MUSCULAR WEAKNESS (Lower extremities weakness), PAIN (Generalized aching), CHILLS (CHILLS) and HEADACHE (Headache). At the time of the report, RHEUMATOID ARTHRITIS (Rheumatoid arthritis flare up), BURNING SENSATION (Burning leg), MUSCULAR WEAKNESS (Lower extremities weakness), PAIN (Generalized aching), CHILLS (CHILLS) and HEADACHE (Headache) outcome was unknown and MUSCLE SPASMS (Cramps legs), MUSCLE SPASMS (Foot cramps) and PERIPHERAL SWELLING (Swelling of legs) had not resolved.  No concomitant medications were reported.No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not applicable.  Company Comment: Very limited information regarding the events and vaccination dates has been provided and is insufficient for causality assessment at this time. A causal relationship cannot be excluded. Further information has been requested.   Most recent FOLLOW-UP information incorporated above includes: On 04-Jun-2021: Follow-up information received on 04 Jun 2021.Second dose events were added.; Sender's Comments: Very limited information regarding the events and vaccination dates has been provided and is insufficient for causality assessment at this time. A causal relationship cannot be excluded. Further information has been requested.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Autoimmune disorder, Rash, Rash pruritic
Clinical narrative: triggered something in her body to cause an autoimmune disease; terrible itchy rash/it is on my arms and legs and extremely itchy; rash on her shin, calf and ankle and arm; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of AUTOIMMUNE DISORDER (triggered something in her body to cause an autoimmune disease) in a 48-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.   On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-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 AUTOIMMUNE DISORDER (triggered something in her body to cause an autoimmune disease) (seriousness criterion medically significant), RASH PRURITIC (terrible itchy rash/it is on my arms and legs and extremely itchy) and RASH (rash on her shin, calf and ankle and arm). At the time of the report, AUTOIMMUNE DISORDER (triggered something in her body to cause an autoimmune disease), RASH PRURITIC (terrible itchy rash/it is on my arms and legs and extremely itchy) and RASH (rash on her shin, calf and ankle and arm) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not provided. Treatment included for the events were antihistamine which did not help and topical steroid which helped a little bit for the event rash. The patient had been to a general practitioner, an allergist and a dermatologist and she was having an appointment with a demonologist to follow up.  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.   Most recent FOLLOW-UP information incorporated above includes: On 02-Jun-2021: Initial_Additional1 Follow-up received: updated patient details, added new event and reporter details.; 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.
Sex: M
Vaccine: COVID19
Symptoms: Bell's palsy
Clinical narrative: Bells-Palsy after 1st dose; This spontaneous case was reported by a pharmacist and describes the occurrence of BELL'S PALSY (Bells-Palsy after 1st dose) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    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 BELL'S PALSY (Bells-Palsy after 1st dose) (seriousness criterion medically significant). At the time of the report, BELL'S PALSY (Bells-Palsy after 1st dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were provided.  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 this event, 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 this event, a causal relationship cannot be excluded.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate, Heart rate increased, Myocardial infarction, Palpitations
Clinical narrative: heart attack; Heart palpitations elevated; Heart rate went high; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of MYOCARDIAL INFARCTION (heart attack), PALPITATIONS (Heart palpitations elevated) and HEART RATE INCREASED (Heart rate went high) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     Concomitant products included MULTIVITAMINS [VITAMINS NOS] for an unknown indication.   On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MYOCARDIAL INFARCTION (heart attack) (seriousness criteria hospitalization and medically significant), PALPITATIONS (Heart palpitations elevated) (seriousness criterion hospitalization) and HEART RATE INCREASED (Heart rate went high) (seriousness criterion hospitalization). At the time of the report, MYOCARDIAL INFARCTION (heart attack), PALPITATIONS (Heart palpitations elevated) and HEART RATE INCREASED (Heart rate went high) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Heart rate: high (High) High.         Other concomitant product include high blood pressure medication. Treatment information was not reported.  Action taken with mRNA-1273 in response to the event 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: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, Chills, Myalgia
Clinical narrative: Myalgia; Chills; Taste loss; Smell loss; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Myalgia), CHILLS (Chills), AGEUSIA (Taste loss) and ANOSMIA (Smell loss) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030M20A and 007M20A) for COVID-19 vaccination.     No medical history information was provided.    On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-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 MYALGIA (Myalgia) (seriousness criterion death), CHILLS (Chills) (seriousness criterion death), AGEUSIA (Taste loss) (seriousness criterion death) and ANOSMIA (Smell loss) (seriousness criterion death). The patient died on 06-Mar-2021. The cause of death was not reported. It is unknown if an autopsy was performed.            No Concomitant medication information was provided. No treatment medication information was provided.  Company Comment: This is a case of sudden death in a 74-year-old male patient with unknown medical history died after receiving vaccine. Very limited information has been provided at this time.; Sender's Comments: This is a case of sudden death in a 74-year-old male patient with unknown medical history died after receiving vaccine. Very limited information has been provided at this time.; Reported Cause(s) of Death: Unknown cause of death
Sex: U
Vaccine: COVID19
Symptoms: Blood pressure measurement, Fibrin D dimer, Hypertension
Clinical narrative: High blood pressure; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HYPERTENSION (High blood pressure) 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 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-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 HYPERTENSION (High blood pressure) (seriousness criterion medically significant). At the time of the report, HYPERTENSION (High blood pressure) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: high (High) high. On an unknown date, Fibrin D dimer: unknown (Inconclusive) unknown.  No concomitant medications were reported.   Patient ended up in the ER on 02-MAY-2021 where he reported a DIMER was done. They were able to get his blood pressure down after 2 different medications.  The patient took the second dose of the mRNA-1273, hence action taken with the vaccine in response to the events was not applicable.  Company comment: Based on the current available information which includes a strong temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information which includes a strong temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Haemoglobin, Loss of consciousness, Muscle spasms, Urticaria
Clinical narrative: Passed out; Feels worn out; Cramps like she never did before; Broke out in hives; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (Passed out) in a 63-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 provided by the reporter.    On 20-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-May-2021, the patient experienced LOSS OF CONSCIOUSNESS (Passed out) (seriousness criteria hospitalization and medically significant), MUSCLE SPASMS (Cramps like she never did before) and URTICARIA (Broke out in hives). On an unknown date, the patient experienced FATIGUE (Feels worn out). The patient was hospitalized for 2 days due to LOSS OF CONSCIOUSNESS. The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, LOSS OF CONSCIOUSNESS (Passed out), MUSCLE SPASMS (Cramps like she never did before), URTICARIA (Broke out in hives) and FATIGUE (Feels worn out) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 20-May-2021, Haemoglobin: abnormal (abnormal) out of whack.         The patient stated she experienced cramps like she never did before, broke out in hives everywhere, passed out, and now feels worn out. Th patient reported she did not experience any side effects from the first dose of the vaccine, which she received a few weeks prior. The patient noted she had never taken drugs prior to her second dose administration and she was perfectly healthy until now.  Action taken with mRNA-1273 in response to the events was not applicable.  Concomitant medications, if any, were not provided by the reporter. Treatment medications also included steroids (unspecified) at the hospital, and an antihistamine (unspecified).  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: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Anaphylactic shock, Cough, Dysphonia, Fatigue, Swollen tongue
Clinical narrative: Anaphylactic shock; throat started to close; tongue started swelling; hoarseness; coughing; fatigued; This spontaneous case was reported by a consumer and describes the occurrence of ANAPHYLACTIC SHOCK (Anaphylactic shock) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 034C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included MONTELUKAST SODIUM (SINGULAIR), CETIRIZINE HYDROCHLORIDE (ZYRTEC ALLERGY), FLUTICASONE PROPIONATE (FLONASE ALLERGY RELIEF), SALBUTAMOL SULFATE (PROAIR [SALBUTAMOL SULFATE]), LEVOCETIRIZINE DIHYDROCHLORIDE (PROVENT), ALBUTEROL [SALBUTAMOL], DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]), METFORMIN, EXENATIDE (BYDUREON), LEVETIRACETAM (KEPPRA [LEVETIRACETAM]), DILTIAZEM, ALPRAZOLAM (XANAX), BACLOFEN, SERTRALINE HYDROCHLORIDE (ZOLOFT), EPINEPHRINE (EPIPEN) and PREDNISONE for an unknown indication.    On 20-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-May-2021, the patient experienced ANAPHYLACTIC SHOCK (Anaphylactic shock) (seriousness criterion medically significant), THROAT IRRITATION (throat started to close), SWOLLEN TONGUE (tongue started swelling), DYSPHONIA (hoarseness), COUGH (coughing) and FATIGUE (fatigued). The patient was treated with Hospice care (Intubation) for Anaphylactic shock. On 20-May-2021, ANAPHYLACTIC SHOCK (Anaphylactic shock), THROAT IRRITATION (throat started to close), SWOLLEN TONGUE (tongue started swelling) and COUGH (coughing) had resolved. At the time of the report, DYSPHONIA (hoarseness) and FATIGUE (fatigued) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient received medical treatment since she was at the hospital.Since then she has been fatigued and experiencing hoarseness. Concomitant product include Singulair , Zyrtec , Flonase , Proair , Provent , Neb.Albuterol , Benadryl , Metformin , Bydureon , Keppra ,Diltiazem , Xanax , Baclofen , Zoloft , EpiPen ,Prednisone for unknown indication. Patient was intubated.  Company comment: Based on the current available information and temporal association between the use of the product and the start date of these 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 these events, a causal relationship cannot be excluded.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Throat irritation
Clinical narrative: Anaphylactic shock; throat started to close; tongue started swelling; hoarseness; coughing; fatigued; This spontaneous case was reported by a consumer and describes the occurrence of ANAPHYLACTIC SHOCK (Anaphylactic shock) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 034C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included MONTELUKAST SODIUM (SINGULAIR), CETIRIZINE HYDROCHLORIDE (ZYRTEC ALLERGY), FLUTICASONE PROPIONATE (FLONASE ALLERGY RELIEF), SALBUTAMOL SULFATE (PROAIR [SALBUTAMOL SULFATE]), LEVOCETIRIZINE DIHYDROCHLORIDE (PROVENT), ALBUTEROL [SALBUTAMOL], DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]), METFORMIN, EXENATIDE (BYDUREON), LEVETIRACETAM (KEPPRA [LEVETIRACETAM]), DILTIAZEM, ALPRAZOLAM (XANAX), BACLOFEN, SERTRALINE HYDROCHLORIDE (ZOLOFT), EPINEPHRINE (EPIPEN) and PREDNISONE for an unknown indication.    On 20-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-May-2021, the patient experienced ANAPHYLACTIC SHOCK (Anaphylactic shock) (seriousness criterion medically significant), THROAT IRRITATION (throat started to close), SWOLLEN TONGUE (tongue started swelling), DYSPHONIA (hoarseness), COUGH (coughing) and FATIGUE (fatigued). The patient was treated with Hospice care (Intubation) for Anaphylactic shock. On 20-May-2021, ANAPHYLACTIC SHOCK (Anaphylactic shock), THROAT IRRITATION (throat started to close), SWOLLEN TONGUE (tongue started swelling) and COUGH (coughing) had resolved. At the time of the report, DYSPHONIA (hoarseness) and FATIGUE (fatigued) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient received medical treatment since she was at the hospital.Since then she has been fatigued and experiencing hoarseness. Concomitant product include Singulair , Zyrtec , Flonase , Proair , Provent , Neb.Albuterol , Benadryl , Metformin , Bydureon , Keppra ,Diltiazem , Xanax , Baclofen , Zoloft , EpiPen ,Prednisone for unknown indication. Patient was intubated.  Company comment: Based on the current available information and temporal association between the use of the product and the start date of these 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 these events, a causal relationship cannot be excluded.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: COVID19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID19) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On 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 COVID-19 (COVID19) (seriousness criterion hospitalization). At the time of the report, COVID-19 (COVID19) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication information was not provided. Treatment medication information was not provided.  Company comment: Based on the mechanism of action of mRNA1273, it does not cause Covid 19, therefore the event is unlikely related to the vaccine.; Sender's Comments: Based on the mechanism of action of mRNA1273, it does not cause Covid 19, therefore the event is unlikely related to the vaccine.
Sex: U
Vaccine: COVID19
Symptoms: Angiogram, Coronary artery thrombosis, Myocardial infarction, Pruritus, Rash
Clinical narrative: Heart attack; Clots in my coronary arteries; Lot o itching especially on my arms and legs; Skin rashes; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a health care professional (subsequently medically confirmed) and describes the occurrence of MYOCARDIAL INFARCTION (Heart attack), CORONARY ARTERY THROMBOSIS (Clots in my coronary arteries), PRURITUS (Lot o itching especially on my arms and legs) and RASH (Skin rashes) 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 11-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 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 30-Mar-2021, the patient experienced PRURITUS (Lot o itching especially on my arms and legs) (seriousness criterion life threatening) and RASH (Skin rashes) (seriousness criterion life threatening). On 28-May-2021, the patient experienced MYOCARDIAL INFARCTION (Heart attack) (seriousness criteria hospitalization, medically significant and life threatening) and CORONARY ARTERY THROMBOSIS (Clots in my coronary arteries) (seriousness criteria hospitalization, medically significant and life threatening). At the time of the report, MYOCARDIAL INFARCTION (Heart attack) and CORONARY ARTERY THROMBOSIS (Clots in my coronary arteries) was resolving and PRURITUS (Lot o itching especially on my arms and legs) and RASH (Skin rashes) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 28-May-2021, Angiogram: clots in findings (abnormal) Clots in coronary arteries.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication provided. No treatment information mentioned.  The patient received both scheduled doses of mRNA-1273 prior to the events, therefore action taken with the drug in response to the events was not applicable.  Patient was discharged and is continuing the treatment as prescribed. Company comment:Based on the current available information; although the use of the product and the start date of the events were not temporarily closed, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information; although the use of the product and the start date of the events were not temporarily closed, a causal relationship cannot be excluded.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Autoimmune disorder, Joint swelling, Myalgia, Peripheral swelling
Clinical narrative: auto immune disorder; both wrist started swelling\Swollen Knee/swollen ankle; Swollen hands\swollen feet; muscle pain every night\Pain became persistent and wont go away.; Joint (and muscle ) pain; This spontaneous case was reported by a consumer and describes the occurrence of AUTOIMMUNE DISORDER (auto immune disorder) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031A21A and 004M20A) 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 QUINAPRIL for an unknown indication.   On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-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 AUTOIMMUNE DISORDER (auto immune disorder) (seriousness criterion medically significant), JOINT SWELLING (both wrist started swelling\Swollen Knee/swollen ankle) and MYALGIA (muscle pain every night\Pain became persistent and wont go away.). an unknown date, the patient experienced PERIPHERAL SWELLING (Swollen hands\swollen feet) and ARTHRALGIA (Joint (and muscle ) pain). At the time of the report, AUTOIMMUNE DISORDER (auto immune disorder), JOINT SWELLING (both wrist started swelling\Swollen Knee/swollen ankle), PERIPHERAL SWELLING (Swollen hands\swollen feet) and ARTHRALGIA (Joint (and muscle ) pain) outcome was unknown and MYALGIA (muscle pain every night\Pain became persistent and wont go away.) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, White blood cell count: high (High) extremely high but no visible sign of infection..     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment for the events included steroids.  It was reported that, side effects from both doses were alike and started on the night of vaccination. Two weeks after 2nd dose of vaccine, both wrists started swelling followed by the joint and muscle pain every night. Pain became persistent and won't go away. Pain only subsided 5-6 hours after taking steroids. It's been 6-8 weeks of extended inflammation. The laboratory exams performed to further understand the event included number of drug test and results pointed to an auto immune disorder.  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.