chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Cerebrovascular accident
Clinical narrative: stroke; This spontaneous case was reported by a consumer and describes the occurrence of CEREBROVASCULAR ACCIDENT (stroke) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No relevant medical history provided).   On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 12-Apr-2021, the patient experienced CEREBROVASCULAR ACCIDENT (stroke) (seriousness criteria hospitalization and life threatening). The patient was hospitalized from 12-Apr-2021 to 17-Apr-2021 due to CEREBROVASCULAR ACCIDENT. At the time of the report, CEREBROVASCULAR ACCIDENT (stroke) outcome was unknown. Not Provided          No medical history and concomitant medications were provided. No treatment information provided.  Based on the information provided which includes a temporal association between the use of mRNA-1273 vaccine and onset of the reported events, a causal relationship cannot be excluded; Sender's Comments: Based on the information provided which includes a temporal association between the use of mRNA-1273 vaccine and onset of the reported events, a causal relationship cannot be excluded
Sex: F
Vaccine: COVID19
Symptoms: Abdominal infection
Clinical narrative: infection in her abdomen, currently taking antibiotics; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL INFECTION (infection in her abdomen, currently taking antibiotics) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ABDOMINAL INFECTION (infection in her abdomen, currently taking antibiotics) (seriousness criterion medically significant). At the time of the report, ABDOMINAL INFECTION (infection in her abdomen, currently taking antibiotics) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication not provided.  The patient was treated with antibiotics for abdominal infection.  Very limited information regarding this event/s has been provided at this time.  Further information has been requested.; 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: Chest discomfort, Gait disturbance, Nausea, Pain, Pain of skin
Clinical narrative: Left lung is beginning to hurt again; chest is killing him; can barely walk; pain all over; the knot on the arm is blood clot; knot under the skin on his arm; painful knot under the skin; nauseated; kept vomiting all the next day, threw up about 20 times; This spontaneous case was reported by a patient and describes the occurrence of THROMBOSIS (the knot on the arm is blood clot) in a 45-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007B21A and 027A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Broken bones. Concurrent medical conditions included Autoimmune disorder in September 2020.   On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form.   On 15-Apr-2021, the patient experienced NAUSEA (nauseated) and VOMITING (kept vomiting all the next day, threw up about 20 times). On 18-Apr-2021, the patient experienced SKIN MASS (knot under the skin on his arm) and PAIN OF SKIN (painful knot under the skin). On 19-Apr-2021, the patient experienced THROMBOSIS (the knot on the arm is blood clot) (seriousness criterion medically significant). On 20-Apr-2021, the patient experienced PULMONARY PAIN (Left lung is beginning to hurt again), CHEST DISCOMFORT (chest is killing him), GAIT DISTURBANCE (can barely walk) and PAIN (pain all over). On 17-Apr-2021, NAUSEA (nauseated) and VOMITING (kept vomiting all the next day, threw up about 20 times) had resolved. At the time of the report, THROMBOSIS (the knot on the arm is blood clot), PULMONARY PAIN (Left lung is beginning to hurt again), CHEST DISCOMFORT (chest is killing him), GAIT DISTURBANCE (can barely walk), SKIN MASS (knot under the skin on his arm), PAIN OF SKIN (painful knot under the skin) and PAIN (pain all over) outcome was unknown.            No concomitant medications were reported.   Treatment for the events included Elquis and I.V heparin.   This case was linked to MOD-2021-081600 (Patient Link).; Sender's Comments: Based on the information provided which includes a strong temporal association between the use of mRNA-1273 vaccine and onset of the reported events, a causal relationship cannot be excluded. Nausea and vomiting are consistent with the product safety profile.
Sex: M
Vaccine: COVID19
Symptoms: Pulmonary pain, Skin mass, Thrombosis, Vomiting
Clinical narrative: Left lung is beginning to hurt again; chest is killing him; can barely walk; pain all over; the knot on the arm is blood clot; knot under the skin on his arm; painful knot under the skin; nauseated; kept vomiting all the next day, threw up about 20 times; This spontaneous case was reported by a patient and describes the occurrence of THROMBOSIS (the knot on the arm is blood clot) in a 45-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007B21A and 027A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Broken bones. Concurrent medical conditions included Autoimmune disorder in September 2020.   On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form.   On 15-Apr-2021, the patient experienced NAUSEA (nauseated) and VOMITING (kept vomiting all the next day, threw up about 20 times). On 18-Apr-2021, the patient experienced SKIN MASS (knot under the skin on his arm) and PAIN OF SKIN (painful knot under the skin). On 19-Apr-2021, the patient experienced THROMBOSIS (the knot on the arm is blood clot) (seriousness criterion medically significant). On 20-Apr-2021, the patient experienced PULMONARY PAIN (Left lung is beginning to hurt again), CHEST DISCOMFORT (chest is killing him), GAIT DISTURBANCE (can barely walk) and PAIN (pain all over). On 17-Apr-2021, NAUSEA (nauseated) and VOMITING (kept vomiting all the next day, threw up about 20 times) had resolved. At the time of the report, THROMBOSIS (the knot on the arm is blood clot), PULMONARY PAIN (Left lung is beginning to hurt again), CHEST DISCOMFORT (chest is killing him), GAIT DISTURBANCE (can barely walk), SKIN MASS (knot under the skin on his arm), PAIN OF SKIN (painful knot under the skin) and PAIN (pain all over) outcome was unknown.            No concomitant medications were reported.   Treatment for the events included Elquis and I.V heparin.   This case was linked to MOD-2021-081600 (Patient Link).; Sender's Comments: Based on the information provided which includes a strong temporal association between the use of mRNA-1273 vaccine and onset of the reported events, a causal relationship cannot be excluded. Nausea and vomiting are consistent with the product safety profile.
Age: 95.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Presyncope
Clinical narrative: Almost blacks out/when the patient bends down to tie their shoe their dizziness get to the point where the patient almost blacks out; Dizziness/when the patient bends down to tie their shoe their dizziness get to the point where the patient almost blacks out; This spontaneous case was reported by a consumer and describes the occurrence of PRESYNCOPE (Almost blacks out/when the patient bends down to tie their shoe their dizziness get to the point where the patient almost blacks out) in a 95-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No medical history was reported).   On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 17-Apr-2021, the patient experienced PRESYNCOPE (Almost blacks out/when the patient bends down to tie their shoe their dizziness get to the point where the patient almost blacks out) (seriousness criterion medically significant) and DIZZINESS (Dizziness/when the patient bends down to tie their shoe their dizziness get to the point where the patient almost blacks out). At the time of the report, PRESYNCOPE (Almost blacks out/when the patient bends down to tie their shoe their dizziness get to the point where the patient almost blacks out) and DIZZINESS (Dizziness/when the patient bends down to tie their shoe their dizziness get to the point where the patient almost blacks out) outcome was unknown.            The action taken with mRNA-1273 in response to the events 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.
Sex: F
Vaccine: COVID19
Symptoms: Anaphylactic reaction
Clinical narrative: Had anaphylactic reaction after 12 days; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ANAPHYLACTIC REACTION (Had anaphylactic reaction after 12 days) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 041L20A and 041L20A) for COVID-19 vaccination.     The patient's past medical history included Back surgery. Concomitant products included MACROGOL 3350 (MIRALAX) for an unknown indication.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, 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 ANAPHYLACTIC REACTION (Had anaphylactic reaction after 12 days) (seriousness criterion medically significant). At the time of the report, ANAPHYLACTIC REACTION (Had anaphylactic reaction after 12 days) outcome was unknown. Not Provided          Reporter mentioned that patient has been given steroids for seven days.  Treatment information was not provided.  The patient received both scheduled doses of mRNA-1273 prior to the event; therefore, action taken with the drug in response to the event is not applicable.  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.   This case was linked to US-MODERNATX, INC.-MOD-2021-051952 (E2B Linked Report).; 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. US-MODERNATX, INC.-MOD-2021-051952:Dose 1
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Death, Feeling abnormal, Malaise
Clinical narrative: Found dead; Felt crappy; Wasn't feeling well; This spontaneous case was reported by a health care professional (subsequently medically confirmed) and describes the occurrence of DEATH (Found dead) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 047B21A and 040A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Blood pressure abnormal ("Patient was on blood pressure medications for the last 20 years") and Anticoagulant therapy ("Patient started on a blood thinner in January 2021").   On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 17-Apr-2021, the patient experienced FEELING ABNORMAL (Felt crappy) and MALAISE (Wasn't feeling well). On 18-Apr-2021, FEELING ABNORMAL (Felt crappy) and MALAISE (Wasn't feeling well) outcome was unknown. The patient died on 18-Apr-2021. The cause of death was not reported. It is unknown if an autopsy was performed. Not Provided      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.  The patient was on blood pressure medications (unspecified) for the last 20 years. She was started on blood thinner (unspecified) in January 2021.  Treatment information leading up to the patient's death was not reported.  Action taken with mRNA-1273 in response to the events was not applicable.  A case of death of a 75-year-old, female patient 3 days after the second dose of mRNA-1273 (Lot # 040A21A).  Patient had developed abnormal feeling and malaise 2 days after vaccine use and based on temporal association cannot be excluded.  However, causality cannot be established for the death as cause of death is unknown.  Further information is being requested.; Sender's Comments: A case of death of a 75-year-old, female patient 3 days after the second dose of mRNA-1273 (Lot # 040A21A).  Patient had developed abnormal feeling and malaise 2 days after vaccine use and based on temporal association cannot be excluded.  However, causality cannot be established for the death as cause of death is unknown.  Further information is being requested.; Reported Cause(s) of Death: Found dead
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Cold sweat, Dizziness, Dysstasia, Fatigue
Clinical narrative: head spinning; dizzy; tired; pain at injection site; nauseas; cold sweats; really weak; could barely stand up; sick to his stomach; Passed out to sleep at 745 pm; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (Passed out to sleep at 745 pm) in a 41-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037B21A and 044A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Asthma and Hyperthyroidism. Concomitant products included FLUTICASONE PROPIONATE (FLOVENT) for an unknown indication.   On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced LOSS OF CONSCIOUSNESS (Passed out to sleep at 745 pm) (seriousness criterion medically significant). On 19-Apr-2021 at 11:30 PM, the patient experienced COLD SWEAT (cold sweats), ASTHENIA (really weak), DYSSTASIA (could barely stand up) and ILLNESS (sick to his stomach). On 20-Apr-2021, the patient experienced VERTIGO (head spinning), DIZZINESS (dizzy), FATIGUE (tired), VACCINATION SITE PAIN (pain at injection site) and NAUSEA (nauseas). At the time of the report, LOSS OF CONSCIOUSNESS (Passed out to sleep at 745 pm), COLD SWEAT (cold sweats), ASTHENIA (really weak), DYSSTASIA (could barely stand up), ILLNESS (sick to his stomach), VERTIGO (head spinning), DIZZINESS (dizzy), FATIGUE (tired), VACCINATION SITE PAIN (pain at injection site) and NAUSEA (nauseas) had not resolved. Not Provided          Products known to have been used by the patient, within two weeks prior to the event, included thyroid medication.  Treatment information was not provided.  The patient received both scheduled doses of mRNA-1273 prior to the event; therefore, action taken with the drug in response to the event is not applicable.  Based on the information provided which includes a temporal association between the use of mRNA-1273 vaccine and onset of the reported events, a causal relationship cannot be excluded.  Nausea, fatigue, and vaccination site pain are consistent with the known safety profile of the vaccine.   This case was linked to US-MODERNATX, INC.-MOD-2021-081679 (E2B Linked Report).; Sender's Comments: Based on the information provided which includes a temporal association between the use of mRNA-1273 vaccine and onset of the reported events, a causal relationship cannot be excluded.  Nausea, fatigue, and vaccination site pain are consistent with the known safety profile of the vaccine, US-MODERNATX, INC.-MOD-2021-081679:cross link Dose 1
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Illness, Loss of consciousness, Nausea, Vaccination site pain, Vertigo
Clinical narrative: head spinning; dizzy; tired; pain at injection site; nauseas; cold sweats; really weak; could barely stand up; sick to his stomach; Passed out to sleep at 745 pm; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (Passed out to sleep at 745 pm) in a 41-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037B21A and 044A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Asthma and Hyperthyroidism. Concomitant products included FLUTICASONE PROPIONATE (FLOVENT) for an unknown indication.   On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced LOSS OF CONSCIOUSNESS (Passed out to sleep at 745 pm) (seriousness criterion medically significant). On 19-Apr-2021 at 11:30 PM, the patient experienced COLD SWEAT (cold sweats), ASTHENIA (really weak), DYSSTASIA (could barely stand up) and ILLNESS (sick to his stomach). On 20-Apr-2021, the patient experienced VERTIGO (head spinning), DIZZINESS (dizzy), FATIGUE (tired), VACCINATION SITE PAIN (pain at injection site) and NAUSEA (nauseas). At the time of the report, LOSS OF CONSCIOUSNESS (Passed out to sleep at 745 pm), COLD SWEAT (cold sweats), ASTHENIA (really weak), DYSSTASIA (could barely stand up), ILLNESS (sick to his stomach), VERTIGO (head spinning), DIZZINESS (dizzy), FATIGUE (tired), VACCINATION SITE PAIN (pain at injection site) and NAUSEA (nauseas) had not resolved. Not Provided          Products known to have been used by the patient, within two weeks prior to the event, included thyroid medication.  Treatment information was not provided.  The patient received both scheduled doses of mRNA-1273 prior to the event; therefore, action taken with the drug in response to the event is not applicable.  Based on the information provided which includes a temporal association between the use of mRNA-1273 vaccine and onset of the reported events, a causal relationship cannot be excluded.  Nausea, fatigue, and vaccination site pain are consistent with the known safety profile of the vaccine.   This case was linked to US-MODERNATX, INC.-MOD-2021-081679 (E2B Linked Report).; Sender's Comments: Based on the information provided which includes a temporal association between the use of mRNA-1273 vaccine and onset of the reported events, a causal relationship cannot be excluded.  Nausea, fatigue, and vaccination site pain are consistent with the known safety profile of the vaccine, US-MODERNATX, INC.-MOD-2021-081679:cross link Dose 1
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Amnesia, Loss of consciousness, Nausea, Somnolence
Clinical narrative: Passed out; she does not remember passing out; did not wake up till 3 in the afternoon that day; she was nauseous and in the morning when she got up she was extremely nauseous; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (Passed out) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 048A21A and 006M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No medical history reported).   On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 12-Mar-2021, the patient experienced LOSS OF CONSCIOUSNESS (Passed out) (seriousness criterion medically significant), AMNESIA (she does not remember passing out), SOMNOLENCE (did not wake up till 3 in the afternoon that day) and NAUSEA (she was nauseous and in the morning when she got up she was extremely nauseous). On 12-Mar-2021, LOSS OF CONSCIOUSNESS (Passed out), AMNESIA (she does not remember passing out), SOMNOLENCE (did not wake up till 3 in the afternoon that day) and NAUSEA (she was nauseous and in the morning when she got up she was extremely nauseous) had resolved.            Concomitant medications were not provided. The patient did not remember passing out but found herself on the bathroom floor. Treatment information included bismuth subsalicylate.   This case was linked to MOD-2021-081743 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Computerised tomogram, Food intolerance, Laboratory test, Myalgia
Clinical narrative: Can not eat; severe nausea; very weak; wife was aching and out of sorts; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of MYALGIA (wife was aching and out of sorts), NAUSEA (severe nausea), ASTHENIA (very weak) and FOOD INTOLERANCE (Can not eat) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014m20a) for COVID-19 vaccination.     Concurrent medical conditions included Heart disorder, Diabetic and Kidney disorder (kidney issues). Concomitant products included METOPROLOL, ATORVASTATIN CALCIUM (LIPITOR), ASPIRIN [ACETYLSALICYLIC ACID] and INSULIN for an unknown indication.   On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 26-Mar-2021, the patient experienced MYALGIA (wife was aching and out of sorts) (seriousness criterion hospitalization prolonged). On 27-Mar-2021, the patient experienced NAUSEA (severe nausea) (seriousness criterion hospitalization prolonged) and ASTHENIA (very weak) (seriousness criterion hospitalization prolonged). In April 2021, the patient experienced FOOD INTOLERANCE (Can not eat) (seriousness criterion hospitalization). The patient was hospitalized on 27-Mar-2021 due to ASTHENIA, MYALGIA and NAUSEA, and then on sometime in April 2021 due to FOOD INTOLERANCE. At the time of the report, MYALGIA (wife was aching and out of sorts), NAUSEA (severe nausea), ASTHENIA (very weak) and FOOD INTOLERANCE (Can not eat) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Computerised tomogram: unknown (Inconclusive) unknown. In 2021, Laboratory test: unknown (Inconclusive) unknown.         On 27-MAR-2021, the patient had severe nausea, was very weak and went to the emergency. The patient was admitted for 3 days. Reporter stated his wife was transferred to another hospital for 7 days and then transferred to a rehab for 3 days. The patient was currently back at the first hospital with severe nausea and can not eat. The doctors who had examined the patient could not figure out from where the severe nausea coming from or how to stop it. The patient was given nausea medication. Action taken with mRNA-1273 in response to events 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 MODERNATX, INC.-MOD-2021-081839, MOD-2021-081707 (E2B Linked Report).; 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. MODERNATX, INC.-MOD-2021-081839:Case for dose 1 MOD-2021-081707:same reporter
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: Can not eat; severe nausea; very weak; wife was aching and out of sorts; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of MYALGIA (wife was aching and out of sorts), NAUSEA (severe nausea), ASTHENIA (very weak) and FOOD INTOLERANCE (Can not eat) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014m20a) for COVID-19 vaccination.     Concurrent medical conditions included Heart disorder, Diabetic and Kidney disorder (kidney issues). Concomitant products included METOPROLOL, ATORVASTATIN CALCIUM (LIPITOR), ASPIRIN [ACETYLSALICYLIC ACID] and INSULIN for an unknown indication.   On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 26-Mar-2021, the patient experienced MYALGIA (wife was aching and out of sorts) (seriousness criterion hospitalization prolonged). On 27-Mar-2021, the patient experienced NAUSEA (severe nausea) (seriousness criterion hospitalization prolonged) and ASTHENIA (very weak) (seriousness criterion hospitalization prolonged). In April 2021, the patient experienced FOOD INTOLERANCE (Can not eat) (seriousness criterion hospitalization). The patient was hospitalized on 27-Mar-2021 due to ASTHENIA, MYALGIA and NAUSEA, and then on sometime in April 2021 due to FOOD INTOLERANCE. At the time of the report, MYALGIA (wife was aching and out of sorts), NAUSEA (severe nausea), ASTHENIA (very weak) and FOOD INTOLERANCE (Can not eat) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Computerised tomogram: unknown (Inconclusive) unknown. In 2021, Laboratory test: unknown (Inconclusive) unknown.         On 27-MAR-2021, the patient had severe nausea, was very weak and went to the emergency. The patient was admitted for 3 days. Reporter stated his wife was transferred to another hospital for 7 days and then transferred to a rehab for 3 days. The patient was currently back at the first hospital with severe nausea and can not eat. The doctors who had examined the patient could not figure out from where the severe nausea coming from or how to stop it. The patient was given nausea medication. Action taken with mRNA-1273 in response to events 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 MODERNATX, INC.-MOD-2021-081839, MOD-2021-081707 (E2B Linked Report).; 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. MODERNATX, INC.-MOD-2021-081839:Case for dose 1 MOD-2021-081707:same reporter
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Abnormal sensation in eye, Bell's palsy, Burning sensation, Dysphagia, Oropharyngeal pain
Clinical narrative: side of the neck and ear ache; Nose draining; Sore Throat; Cannot swallow; Felt like hot iron stuck on the face; Eyes clumpy and hard to open mornings; Bell's Palsy; This spontaneous case was reported by a pharmacist (subsequently medically confirmed) and describes the occurrence of FACIAL PARALYSIS (Bell's Palsy) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Cancer (stage 4 of unspecified cancer). Concomitant products included PEMBROLIZUMAB (KEYTRUDA) for an unknown indication.    On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Mar-2021, the patient experienced FACIAL PARALYSIS (Bell's Palsy) (seriousness criterion medically significant). On an unknown date, the patient experienced PAIN (side of the neck and ear ache), RHINORRHOEA (Nose draining), OROPHARYNGEAL PAIN (Sore Throat), DYSPHAGIA (Cannot swallow), BURNING SENSATION (Felt like hot iron stuck on the face) and ABNORMAL SENSATION IN EYE (Eyes clumpy and hard to open mornings). At the time of the report, FACIAL PARALYSIS (Bell's Palsy), PAIN (side of the neck and ear ache), RHINORRHOEA (Nose draining), OROPHARYNGEAL PAIN (Sore Throat), DYSPHAGIA (Cannot swallow), BURNING SENSATION (Felt like hot iron stuck on the face) and ABNORMAL SENSATION IN EYE (Eyes clumpy and hard to open mornings) 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.   The patient's Primary Care Physician and Oncologist recommended not to have the second dose. Treatment included prednisone for 5 days, flonase, and ice pack to open the eyes.  Patient stated that her Primary Care Physician and Oncologist recommended not to have the second dose.  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.   Patient stated that her Primary Care Physician and Oncologist recommended not to have the second dose; 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: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Rhinorrhoea
Clinical narrative: side of the neck and ear ache; Nose draining; Sore Throat; Cannot swallow; Felt like hot iron stuck on the face; Eyes clumpy and hard to open mornings; Bell's Palsy; This spontaneous case was reported by a pharmacist (subsequently medically confirmed) and describes the occurrence of FACIAL PARALYSIS (Bell's Palsy) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Cancer (stage 4 of unspecified cancer). Concomitant products included PEMBROLIZUMAB (KEYTRUDA) for an unknown indication.    On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Mar-2021, the patient experienced FACIAL PARALYSIS (Bell's Palsy) (seriousness criterion medically significant). On an unknown date, the patient experienced PAIN (side of the neck and ear ache), RHINORRHOEA (Nose draining), OROPHARYNGEAL PAIN (Sore Throat), DYSPHAGIA (Cannot swallow), BURNING SENSATION (Felt like hot iron stuck on the face) and ABNORMAL SENSATION IN EYE (Eyes clumpy and hard to open mornings). At the time of the report, FACIAL PARALYSIS (Bell's Palsy), PAIN (side of the neck and ear ache), RHINORRHOEA (Nose draining), OROPHARYNGEAL PAIN (Sore Throat), DYSPHAGIA (Cannot swallow), BURNING SENSATION (Felt like hot iron stuck on the face) and ABNORMAL SENSATION IN EYE (Eyes clumpy and hard to open mornings) 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.   The patient's Primary Care Physician and Oncologist recommended not to have the second dose. Treatment included prednisone for 5 days, flonase, and ice pack to open the eyes.  Patient stated that her Primary Care Physician and Oncologist recommended not to have the second dose.  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.   Patient stated that her Primary Care Physician and Oncologist recommended not to have the second dose; 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: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Cellulitis, Vaccination site erythema, Vaccination site pruritus
Clinical narrative: red in same arm of injection; Cellulitis; It started to itch; This spontaneous case was reported by a non-health professional (subsequently medically confirmed) and describes the occurrence of CELLULITIS (Cellulitis) in a 60-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.     The patient's past medical history included No adverse event (No medical history provided.). Concomitant products included ASPIRIN [ACETYLSALICYLIC ACID], VITAMIN B NOS and VITAMIN C [ASCORBIC ACID] for an unknown indication.   On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Mar-2021, the patient experienced CELLULITIS (Cellulitis) (seriousness criterion medically significant) and VACCINATION SITE PRURITUS (It started to itch). On an unknown date, the patient experienced VACCINATION SITE ERYTHEMA (red in same arm of injection). On 02-Apr-2021, CELLULITIS (Cellulitis), VACCINATION SITE PRURITUS (It started to itch) and VACCINATION SITE ERYTHEMA (red in same arm of injection) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment information included Tylenol and Clindamycin 300.   This case was linked to MOD-2021-082391 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the reported events, a causal relationship cannot be excluded.
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Back pain, Communication disorder, Hypokinesia, Vaccination complication
Clinical narrative: unable to move; unable to communicate with my wife; severe back pain; still weak; got all the same reactions; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 20-Apr-2021 and was forwarded to Moderna on 20-Apr-2021.    This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HYPOKINESIA (unable to move) and COMMUNICATION DISORDER (unable to communicate with my wife) 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.     The patient's past medical history included No adverse event (Past medical history not provided).   On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Mar-2021, the patient experienced HYPOKINESIA (unable to move) (seriousness criterion hospitalization) and COMMUNICATION DISORDER (unable to communicate with my wife) (seriousness criterion hospitalization). On an unknown date, the patient experienced BACK PAIN (severe back pain) and ASTHENIA (still weak). The patient was hospitalized from 13-Mar-2021 to 16-Mar-2021 due to COMMUNICATION DISORDER and HYPOKINESIA. On 16-Mar-2021, COMMUNICATION DISORDER (unable to communicate with my wife) had resolved. At the time of the report, HYPOKINESIA (unable to move) had resolved and BACK PAIN (severe back pain) and ASTHENIA (still weak) had not resolved.            Concomitant medications taken by the patient were not provided. Treatment information was not provided. Action taken with mRNA-1273 in response to the event was not applicable.   This case was linked to MOD-2021-082315 (Patient Link).; Sender's Comments: Limited information regarding the events has been provided at this time and a causal relationship cannot be excluded
Age: 22.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Colitis ulcerative, Colonoscopy, Diarrhoea haemorrhagic, Dizziness
Clinical narrative: Bloody diarrhea; Ulcerative colitis; Dizziness; Feeling "very sick"; Fatigue; Fever; Chills; Headaches; Nausea; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of DIARRHOEA HAEMORRHAGIC (Bloody diarrhea) and COLITIS ULCERATIVE (Ulcerative colitis) in a 22-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 Asthma and Eczema.   On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 09-Apr-2021, the patient experienced DIARRHOEA HAEMORRHAGIC (Bloody diarrhea) (seriousness criterion hospitalization), COLITIS ULCERATIVE (Ulcerative colitis) (seriousness criterion hospitalization), DIZZINESS (Dizziness), MALAISE (Feeling "very sick"), FATIGUE (Fatigue), PYREXIA (Fever), CHILLS (Chills), HEADACHE (Headaches) and NAUSEA (Nausea). On 09-Apr-2021, DIZZINESS (Dizziness), MALAISE (Feeling "very sick"), FATIGUE (Fatigue), PYREXIA (Fever), CHILLS (Chills), HEADACHE (Headaches) and NAUSEA (Nausea) had resolved. At the time of the report, DIARRHOEA HAEMORRHAGIC (Bloody diarrhea) and COLITIS ULCERATIVE (Ulcerative colitis) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In April 2021, Colonoscopy: abnormal (abnormal) it appeared to be an "ulcerative colitis" on the entire colon.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication mentioned topical cream NOS for eczema.  Treatment information mentioned IV Methylprednisolone and Metamizole. 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.  Company comments This case concerns a 22-year-old female hospitalized with serious unexpected events of diarrhea hemorrhagic and colitis ulcerative, nonserious unexpected dizziness, malaise, and expected pyrexia, chills, headache, fatigue, nausea. Event onset 24 hours after second dose mRNA-1273. Serious event outcomes unknown. 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: 22.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache, Malaise, Nausea, Pyrexia
Clinical narrative: Bloody diarrhea; Ulcerative colitis; Dizziness; Feeling "very sick"; Fatigue; Fever; Chills; Headaches; Nausea; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of DIARRHOEA HAEMORRHAGIC (Bloody diarrhea) and COLITIS ULCERATIVE (Ulcerative colitis) in a 22-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 Asthma and Eczema.   On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 09-Apr-2021, the patient experienced DIARRHOEA HAEMORRHAGIC (Bloody diarrhea) (seriousness criterion hospitalization), COLITIS ULCERATIVE (Ulcerative colitis) (seriousness criterion hospitalization), DIZZINESS (Dizziness), MALAISE (Feeling "very sick"), FATIGUE (Fatigue), PYREXIA (Fever), CHILLS (Chills), HEADACHE (Headaches) and NAUSEA (Nausea). On 09-Apr-2021, DIZZINESS (Dizziness), MALAISE (Feeling "very sick"), FATIGUE (Fatigue), PYREXIA (Fever), CHILLS (Chills), HEADACHE (Headaches) and NAUSEA (Nausea) had resolved. At the time of the report, DIARRHOEA HAEMORRHAGIC (Bloody diarrhea) and COLITIS ULCERATIVE (Ulcerative colitis) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In April 2021, Colonoscopy: abnormal (abnormal) it appeared to be an "ulcerative colitis" on the entire colon.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication mentioned topical cream NOS for eczema.  Treatment information mentioned IV Methylprednisolone and Metamizole. 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.  Company comments This case concerns a 22-year-old female hospitalized with serious unexpected events of diarrhea hemorrhagic and colitis ulcerative, nonserious unexpected dizziness, malaise, and expected pyrexia, chills, headache, fatigue, nausea. Event onset 24 hours after second dose mRNA-1273. Serious event outcomes unknown. 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: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Seizure
Clinical narrative: seizure; very tired; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of SEIZURE (seizure) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036B21A and 044A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No Medical history was reported).   On 10-Apr-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 11-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced FATIGUE (very tired). On 12-Apr-2021 at 3:00 AM, the patient experienced SEIZURE (seizure) (seriousness criterion medically significant). At the time of the report, SEIZURE (seizure) and FATIGUE (very tired) outcome was unknown.    No Treatment related information was reported. Patient went to bed like normal that night. Patient called a nearby family member, who took patient to her neurologist later the next day.; Sender's Comments: This case concerns a 63-year-old female with a serious unexpected event of seizure, and nonserious expected fatigue. Event onset 1 day after first dose mRNA-1273, with seizure occurring 2 days after vaccination. Event outcomes unknown. 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: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Cerebrovascular accident, Inappropriate schedule of product administration
Clinical narrative: Stroke; More than 36 days have passed since first dose, still didn't get second dose; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of CEREBROVASCULAR ACCIDENT (Stroke) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Hypertension and Cholesterol. Concomitant products included AMLODIPINE, ENALAPRIL and METOPROLOL TARTRATE for Blood pressure abnormal, ATORVASTATIN and EZETIMIBE for Cholesterol total abnormal NOS, ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) for an unknown indication.    On 13-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Mar-2021, the patient experienced CEREBROVASCULAR ACCIDENT (Stroke) (seriousness criterion hospitalization). On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (More than 36 days have passed since first dose, still didn't get second dose). The patient was hospitalized from 29-Mar-2021 to 15-Apr-2021 due to CEREBROVASCULAR ACCIDENT. At the time of the report, CEREBROVASCULAR ACCIDENT (Stroke) outcome was unknown and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (More than 36 days have passed since first dose, still didn't get 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.   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. However, the patient's past medical history of Hypertension, cholesterol. may remain risk factor for this event.; 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. However, the patient's past medical history of Hypertension, cholesterol. may remain risk factor for this event.