chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Chills, Decreased appetite, Myalgia, Nausea
Clinical narrative: Neuropathy gets worse; Loss of appetite; Feels crampy after meal; Lost 5 lbs; Nausea; Chills; Arm soreness; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of NEUROPATHY PERIPHERAL (Neuropathy gets worse) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Pre-diabetic.  Concomitant products included ESCITALOPRAM for Antidepressant therapy, GABAPENTIN for Neuropathy, VITAMIN D2 for Vitamin D deficiency.   On 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.  On 08-Apr-2021, the patient experienced CHILLS (Chills) and MYALGIA (Arm soreness). On 19-Apr-2021, the patient experienced NEUROPATHY PERIPHERAL (Neuropathy gets worse) (seriousness criterion medically significant), DECREASED APPETITE (Loss of appetite), ABDOMINAL PAIN (Feels crampy after meal), WEIGHT DECREASED (Lost 5 lbs) and NAUSEA (Nausea).   On 10-Apr-2021, CHILLS (Chills) and MYALGIA (Arm soreness) had resolved. At the time of the report, NEUROPATHY PERIPHERAL (Neuropathy gets worse) and ABDOMINAL PAIN (Feels crampy after meal) had not resolved and DECREASED APPETITE (Loss of appetite), WEIGHT DECREASED (Lost 5 lbs) and NAUSEA (Nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient took Ondansetron 4 mg for nausea. patient mentioned that she is Pre-diabetic. Anti-emetic drug was prescribed by her Physician from Cymbalta reaction.; 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.  Myalgia, chills and nausea are consistent with the product safety profile
Sex: F
Vaccine: COVID19
Symptoms: Neuropathy peripheral, Weight decreased
Clinical narrative: Neuropathy gets worse; Loss of appetite; Feels crampy after meal; Lost 5 lbs; Nausea; Chills; Arm soreness; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of NEUROPATHY PERIPHERAL (Neuropathy gets worse) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Pre-diabetic.  Concomitant products included ESCITALOPRAM for Antidepressant therapy, GABAPENTIN for Neuropathy, VITAMIN D2 for Vitamin D deficiency.   On 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.  On 08-Apr-2021, the patient experienced CHILLS (Chills) and MYALGIA (Arm soreness). On 19-Apr-2021, the patient experienced NEUROPATHY PERIPHERAL (Neuropathy gets worse) (seriousness criterion medically significant), DECREASED APPETITE (Loss of appetite), ABDOMINAL PAIN (Feels crampy after meal), WEIGHT DECREASED (Lost 5 lbs) and NAUSEA (Nausea).   On 10-Apr-2021, CHILLS (Chills) and MYALGIA (Arm soreness) had resolved. At the time of the report, NEUROPATHY PERIPHERAL (Neuropathy gets worse) and ABDOMINAL PAIN (Feels crampy after meal) had not resolved and DECREASED APPETITE (Loss of appetite), WEIGHT DECREASED (Lost 5 lbs) and NAUSEA (Nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient took Ondansetron 4 mg for nausea. patient mentioned that she is Pre-diabetic. Anti-emetic drug was prescribed by her Physician from Cymbalta reaction.; 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.  Myalgia, chills and nausea are consistent with the product safety profile
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Renal artery thrombosis
Clinical narrative: Renal Artery Thrombosis; Severe Back pain; This spontaneous case was reported by a patient (subsequently medically confirmed) and describes the occurrence of RENAL ARTERY THROMBOSIS (Renal Artery Thrombosis) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010A21A and 007M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No relevant medical history was reported.  Concomitant products included LISINOPRIL and AMLODIPINE 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 26-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 2 dosage form. On 05-Apr-2021, the patient experienced RENAL ARTERY THROMBOSIS (Renal Artery Thrombosis) (seriousness criterion medically significant). 05-Apr-2021, the patient experienced BACK PAIN (Severe Back pain). At the time of the report, RENAL ARTERY THROMBOSIS (Renal Artery Thrombosis) and BACK PAIN (Severe Back pain) outcome was unknown.            On 05Apr2021, the patient was evaluated in the emergency room for back pain. On 16Apr2021, the patient was diagnosed with renal artery thrombosis approximately 40 days after receiving the second dose of the vaccine.   The patient was prescribed Eliquis 5mg bid by her Primary Care Physician.  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: Chills, Dyspnoea, Gastric dilatation, Gastrointestinal inflammation, Headache
Clinical narrative: hard to breathe, trouble breathing; distended stomach; looks like he is 9 months pregnant like he is going to pop; Sweating; feels like he has pins and needles; Cramps; Headache; Chills; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (hard to breathe, trouble breathing) 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 COVID-19 (had reoccurring covid for the weeks following with symptoms coming and going. ) on 09-Mar-2021.    On 22-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.   On 23-Apr-2021, the patient experienced DYSPNOEA (hard to breathe, trouble breathing) (seriousness criterion medically significant), GASTRIC DILATATION (distended stomach), GASTROINTESTINAL INFLAMMATION (looks like he is 9 months pregnant like he is going to pop), HYPERHIDROSIS (Sweating), PAIN (feels like he has pins and needles), MUSCLE SPASMS (Cramps), HEADACHE (Headache) and CHILLS (Chills). At the time of the report, DYSPNOEA (hard to breathe, trouble breathing), GASTRIC DILATATION (distended stomach), GASTROINTESTINAL INFLAMMATION (looks like he is 9 months pregnant like he is going to pop), HYPERHIDROSIS (Sweating), PAIN (feels like he has pins and needles), MUSCLE SPASMS (Cramps), HEADACHE (Headache) and CHILLS (Chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment included continuous positive airway pressure (CPAP) to help patient breathe.; 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. Chills and headache are consistent with the product safety profile
Sex: M
Vaccine: COVID19
Symptoms: Hyperhidrosis, Muscle spasms, Pain
Clinical narrative: hard to breathe, trouble breathing; distended stomach; looks like he is 9 months pregnant like he is going to pop; Sweating; feels like he has pins and needles; Cramps; Headache; Chills; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (hard to breathe, trouble breathing) 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 COVID-19 (had reoccurring covid for the weeks following with symptoms coming and going. ) on 09-Mar-2021.    On 22-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.   On 23-Apr-2021, the patient experienced DYSPNOEA (hard to breathe, trouble breathing) (seriousness criterion medically significant), GASTRIC DILATATION (distended stomach), GASTROINTESTINAL INFLAMMATION (looks like he is 9 months pregnant like he is going to pop), HYPERHIDROSIS (Sweating), PAIN (feels like he has pins and needles), MUSCLE SPASMS (Cramps), HEADACHE (Headache) and CHILLS (Chills). At the time of the report, DYSPNOEA (hard to breathe, trouble breathing), GASTRIC DILATATION (distended stomach), GASTROINTESTINAL INFLAMMATION (looks like he is 9 months pregnant like he is going to pop), HYPERHIDROSIS (Sweating), PAIN (feels like he has pins and needles), MUSCLE SPASMS (Cramps), HEADACHE (Headache) and CHILLS (Chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment included continuous positive airway pressure (CPAP) to help patient breathe.; 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. Chills and headache are consistent with the product safety profile
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea, Heart rate increased, Hunger, Syncope
Clinical narrative: He was faint; Shortness of breathe; Rapid heart beat; Hungry; This spontaneous case was reported by a consumer and describes the occurrence of SYNCOPE (He was faint) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 04021a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    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 SYNCOPE (He was faint) (seriousness criterion medically significant), DYSPNOEA (Shortness of breathe), HEART RATE INCREASED (Rapid heart beat) and HUNGER (Hungry). At the time of the report, SYNCOPE (He was faint), DYSPNOEA (Shortness of breathe), HEART RATE INCREASED (Rapid heart beat) and HUNGER (Hungry) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications reported were blood pressure medications. No further information regarding names of the medications was provided. No treatment information for the events was reported.; 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: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Feeling of body temperature change, Pruritus, Urticaria
Clinical narrative: now chilly and then warm; Itching; tired; Worst case of hives the doctor had ever seen; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of URTICARIA (Worst case of hives the doctor had ever seen) in a 46-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038B214) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 23-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Apr-2021, the patient experienced URTICARIA (Worst case of hives the doctor had ever seen) (seriousness criterion medically significant). On 24-Apr-2021, the patient experienced FEELING OF BODY TEMPERATURE CHANGE (now chilly and then warm), PRURITUS (Itching) and FATIGUE (tired). At the time of the report, URTICARIA (Worst case of hives the doctor had ever seen) had resolved and FEELING OF BODY TEMPERATURE CHANGE (now chilly and then warm), PRURITUS (Itching) and FATIGUE (tired) 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 Treatment medications included were intravenous drip( IV), prednisone, diphenhydramine, famotidine and was given epinephrine pen on discharge, just in case needed to use it(has not used it).  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: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Pulmonary embolism
Clinical narrative: This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of PULMONARY EMBOLISM (Developed a pulmonary embolism) in a 45-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.   No Medical History information was reported.  On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Apr-2021, the patient experienced PULMONARY EMBOLISM (Developed a pulmonary embolism) (seriousness criterion medically significant). At the time of the report, PULMONARY EMBOLISM (Developed a pulmonary embolism) outcome was unknown. Not Provided   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 concomitant medications and treatment details were not provided.  Company comment: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; 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.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: Blood clots; This spontaneous case was reported by a consumer and describes the occurrence of THROMBOSIS (Blood clots) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 044A21A and 031B21a) for COVID-19 vaccination.     No Medical History information was reported.   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 an unknown date, the patient experienced THROMBOSIS (Blood clots) (seriousness criterion medically significant). At the time of the report, THROMBOSIS (Blood clots) outcome was unknown.            No treatment information was provided.  No concomitant medication was reported.  The patient received both scheduled doses of mRNA-1273 prior to the event(s); therefore, action taken with the drug in response to the event(s) is not applicable.  Company Comment: Very limited information regarding this event/s has been provided at this time.  Further information has been requested.  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.; Sender's Comments: Very limited information regarding this event/s has been provided at this time.  Further information has been requested.  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.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Multiple sclerosis relapse
Clinical narrative: multiple sclerosis flare up; chills; fatigue; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of MULTIPLE SCLEROSIS RELAPSE (multiple sclerosis flare up) in a 55-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.     Concurrent medical conditions included Multiple sclerosis.    On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Apr-2021, the patient experienced MULTIPLE SCLEROSIS RELAPSE (multiple sclerosis flare up) (seriousness criterion medically significant), CHILLS (chills) and FATIGUE (fatigue). At the time of the report, MULTIPLE SCLEROSIS RELAPSE (multiple sclerosis flare up), CHILLS (chills) and FATIGUE (fatigue) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.  Treatment medication included prednisone which patient was taking until 29-Apr-2021.  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: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Furuncle, Rash
Clinical narrative: This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of RASH (rash started by the knees and genital area and rash spread out all over the body) and FURUNCLE (Boil spot showed up) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Tuberculosis (The patient was infected with Tuberculosis four years ago and was hospitalized.) in 2017.   On 22-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-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 RASH (rash started by the knees and genital area and rash spread out all over the body) (seriousness criterion hospitalization) and FURUNCLE (Boil spot showed up) (seriousness criterion hospitalization). The patient was hospitalized on 25-Mar-2021 due to FURUNCLE. At the time of the report, RASH (rash started by the knees and genital area and rash spread out all over the body) and FURUNCLE (Boil spot showed up) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   After the second dose of the Moderna vaccine, the patient developed a rash between 23-Mar-2021 or 24-Mar-2021. The son is not sure what exact date the symptoms  had started. The rash started on the patient's knees, spread to his genital area and then all over his body. The patient was hospitalized later on (the reporter was not able to remember the date). On an unspecified date, the patient was sent their primary care and to their dermatologist for follow up. The dermatologist only recommended to wash with water, since the doctor suspected it was from the Moderna-COVID-19 vaccine. Caregiver reported the symptoms were getting worse due to boils had formed. Treatment provided wash with water, no additional treatment was provided.  Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the 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 the event, a causal relationship cannot be excluded.
Sex: M
Vaccine: COVID19
Symptoms: Cardiac failure congestive, Dyspnoea, Joint swelling, Peripheral swelling, X-ray
Clinical narrative: Congestive heart failure; Couldn't breathe in and had short breaths/shortness of breath hit him; Swelling got up his leg; ankles, knees swollen; This spontaneous case was reported by a consumer and describes the occurrence of CARDIAC FAILURE CONGESTIVE (Congestive heart failure) and DYSPNOEA (Couldn't breathe in and had short breaths/shortness of breath hit him) in a 77-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.     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) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced CARDIAC FAILURE CONGESTIVE (Congestive heart failure) (seriousness criterion hospitalization), DYSPNOEA (Couldn't breathe in and had short breaths/shortness of breath hit him) (seriousness criterion hospitalization prolonged), PERIPHERAL SWELLING (Swelling got up his leg) and JOINT SWELLING (ankles, knees swollen). The patient was hospitalized for 5 days due to CARDIAC FAILURE CONGESTIVE and DYSPNOEA. At the time of the report, CARDIAC FAILURE CONGESTIVE (Congestive heart failure), DYSPNOEA (Couldn't breathe in and had short breaths/shortness of breath hit him), PERIPHERAL SWELLING (Swelling got up his leg) and JOINT SWELLING (ankles, knees swollen) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, X-ray: no evidence of blood clot no evidence of blood clot.         No concomitant medications provided.  Treatment of these events included oxygen.  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.   This case was linked to US-MODERNATX, INC.-MOD-2021-089692 (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. US-MODERNATX, INC.-MOD-2021-089692:
Sex: F
Vaccine: COVID19
Symptoms: Eye colour change, Eye haemorrhage, Lacrimation increased, Malaise, Myalgia
Clinical narrative: Broken blood vessels in eye; Sinus infection type symptoms; Pigment color in eye different; Red streaks in eye; Blood shot and watery eyes; Didnt feel good; Body aches; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of EYE HAEMORRHAGE (Broken blood vessels in eye) and SINUSITIS (Sinus infection type symptoms) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026L20A and 046A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Cataract operation. Concurrent medical conditions included Glaucoma.   On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.  On 18-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 18-Mar-2021, the patient experienced EYE HAEMORRHAGE (Broken blood vessels in eye) (seriousness criterion medically significant), SINUSITIS (Sinus infection type symptoms) (seriousness criterion medically significant), EYE COLOUR CHANGE (Pigment color in eye different), OCULAR HYPERAEMIA (Red streaks in eye), LACRIMATION INCREASED (Blood shot and watery eyes), MYALGIA (Body aches) and MALAISE (Didnt feel good). At the time of the report, EYE HAEMORRHAGE (Broken blood vessels in eye), SINUSITIS (Sinus infection type symptoms), EYE COLOUR CHANGE (Pigment color in eye different), LACRIMATION INCREASED (Blood shot and watery eyes), MYALGIA (Body aches) and MALAISE (Didnt feel good) outcome was unknown and OCULAR HYPERAEMIA (Red streaks in eye) had not resolved.            Treatment included unknown steroid.; Sender's Comments: The event of sinus infection involves an infective origin, and hence assessed as unlikely related. Based on the information provided which includes a temporal association between the use of mRNA-1273 vaccine and onset of the other reported events, a causal relationship cannot be excluded. Myalgia is consistent with the product safety profile.
Sex: F
Vaccine: COVID19
Symptoms: Ocular hyperaemia, Sinusitis
Clinical narrative: Broken blood vessels in eye; Sinus infection type symptoms; Pigment color in eye different; Red streaks in eye; Blood shot and watery eyes; Didnt feel good; Body aches; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of EYE HAEMORRHAGE (Broken blood vessels in eye) and SINUSITIS (Sinus infection type symptoms) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026L20A and 046A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Cataract operation. Concurrent medical conditions included Glaucoma.   On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.  On 18-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 18-Mar-2021, the patient experienced EYE HAEMORRHAGE (Broken blood vessels in eye) (seriousness criterion medically significant), SINUSITIS (Sinus infection type symptoms) (seriousness criterion medically significant), EYE COLOUR CHANGE (Pigment color in eye different), OCULAR HYPERAEMIA (Red streaks in eye), LACRIMATION INCREASED (Blood shot and watery eyes), MYALGIA (Body aches) and MALAISE (Didnt feel good). At the time of the report, EYE HAEMORRHAGE (Broken blood vessels in eye), SINUSITIS (Sinus infection type symptoms), EYE COLOUR CHANGE (Pigment color in eye different), LACRIMATION INCREASED (Blood shot and watery eyes), MYALGIA (Body aches) and MALAISE (Didnt feel good) outcome was unknown and OCULAR HYPERAEMIA (Red streaks in eye) had not resolved.            Treatment included unknown steroid.; Sender's Comments: The event of sinus infection involves an infective origin, and hence assessed as unlikely related. Based on the information provided which includes a temporal association between the use of mRNA-1273 vaccine and onset of the other reported events, a causal relationship cannot be excluded. Myalgia is consistent with the product safety profile.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Anaphylactic reaction
Clinical narrative: This spontaneous case was reported by a health care professional and describes the occurrence of ANAPHYLACTIC REACTION (experienced an anaphylactic reaction) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 009C21A and 018B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 24-Mar-2001, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Apr-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 ANAPHYLACTIC REACTION (experienced an anaphylactic reaction) (seriousness criterion medically significant). At the time of the report, ANAPHYLACTIC REACTION (experienced an anaphylactic reaction) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided.  Treatment information was unknown.  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.; 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.
Sex: M
Vaccine: COVID19
Symptoms: Heart rate increased, Pyrexia, Syncope
Clinical narrative: Fever; Fainting (15h post injection); Increased HR; This spontaneous case was reported by a consumer and describes the occurrence of SYNCOPE (Fainting (15h post injection)) in a 35-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 018B21A and 039A21B) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included ADALIMUMAB (HUMIRA) for an unknown indication.   On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 18-Apr-2021, the patient experienced SYNCOPE (Fainting (15h post injection)) (seriousness criterion medically significant). 18-Apr-2021, the patient experienced HEART RATE INCREASED (Increased HR). On 19-Apr-2021, the patient experienced PYREXIA (Fever). At the time of the report, SYNCOPE (Fainting (15h post injection)) had resolved and HEART RATE INCREASED (Increased HR) and PYREXIA (Fever) outcome was unknown.            Treatment received in response to the event was acetaminophen.  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: DTAP
Symptoms: Blood pressure increased, Pulmonary embolism
Clinical narrative: patient had an increase in blood pressure and it was thought that she had a pulmonary embolus; Initial information received on 14-Apr-2021 regarding an unsolicited valid serious case from a non-health care professional (patient's husband). This case involves a 39 years old female patient who had an increase in blood pressure and it was thought that she had a pulmonary embolus (pulmonary embolus), after receiving DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.   In 2007, the patient received a dose of suspect DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE produced by unknown manufacturer (lot number not reported and expiry date:30-Nov-2009) via unknown route in an unknown administration site for prophylactic vaccination.  In 2007, the patient developed a serious increase in blood pressure and it was thought that she had a pulmonary embolus (pulmonary embolism), 24 hours following the administration of DIPHTHERIA and TETANUS AND ACELLULAR PERTUSSIS VACCINE. This event was assessed as medically significant and the patient was hospitalized for this event for 2 days.  It was reported that a husband was calling on behalf of his wife who was looking to get the Covid (coronavirus disease) vaccine. He was trying to get the ingredient list from that vaccine (Tdap) as well as the Moderna and Pfizer Covid vaccines. The reason for the reaction was unknown. They were trying to see if there were any similarities. Caller stated he knows that it was a Sanofi vaccine but not the name of the product and had it because she needed a tetanus vaccine. Husband stated his wife, refused name or initials, had a vaccine the doctor's office told them was a Sanofi product for tetanus in 2007. Caller does not have the lot number and stated that his wife does not like her personal information given out.   Other relevant laboratory data were not reported.  It was not reported if the patient received a corrective treatment.  At time of reporting, the outcome was unknown for the reported event.  Information on the batch number to be requested for this case.; Sender's Comments: This case involves a 39 years old female patient who had pulmonary embolus, 24 hours after vaccination with DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE. The time to onset is compatible. Patient had an increase in the blood pressure. However, patient's medical condition at the time of vaccination and lab data ruling out other etiologies were not reported. Based upon the reported information, the role of a vaccine cannot be assessed.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Fatigue, Muscle twitching, Pyrexia
Clinical narrative: Fatigue Severe-chills Extreme joint pains/aches Fever up to 101.1 (normal temp resides@ 96.5  Muscle twitching specking
Age: 74.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Dyspnoea, Fatigue, Oedema, Pain, Vomiting
Clinical narrative: Shortness of breath Edema Pain Vomiting Extreme fatigue
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Unevaluable event
Clinical narrative: None.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Peripheral swelling
Clinical narrative: Swollen red arm - Allegra chills
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Influenza like illness, Injection site pain, Myalgia
Clinical narrative: Joint and muscle aches, fatigue, soreness at injection site. Flu-like symptoms.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Chills, Diarrhoea, Fatigue, Feeling hot
Clinical narrative: By 10:00am the next day after getting the 2nd dose I had a fever and body aches. I rested that afternoon by leaving work early. When I woke up after a 2 hour nap I felt a little fatigued but other symptoms were gone. The next day I felt normal and had a normal Saturday, but in the middle of the night around 2:00am I woke up with chills, aches, headache, and nausea. I also had diarrhea. The chills with come and go but be replaced with being really hot. I spent all day Sunday in bed and went to sleep eventually in the evening. I woke up Monday morning with a small headache that went away and all other symptoms disappeared. I did feel tired or a lack of energy by Monday evening.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Nausea, Pain, Pyrexia
Clinical narrative: By 10:00am the next day after getting the 2nd dose I had a fever and body aches. I rested that afternoon by leaving work early. When I woke up after a 2 hour nap I felt a little fatigued but other symptoms were gone. The next day I felt normal and had a normal Saturday, but in the middle of the night around 2:00am I woke up with chills, aches, headache, and nausea. I also had diarrhea. The chills with come and go but be replaced with being really hot. I spent all day Sunday in bed and went to sleep eventually in the evening. I woke up Monday morning with a small headache that went away and all other symptoms disappeared. I did feel tired or a lack of energy by Monday evening.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Panic attack
Clinical narrative: i?ve had several panic attacks, which i have never experienced before
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Dyskinesia, Loss of consciousness
Clinical narrative: 1455 1ST DOSE PFIZER VACCINE ADMINISTERED 1457 PT WITH LOSS OF CONSCIOUSNESS, WITH ARMS AND LEGS JERKING MOVEMENTS. AMMONIA INHALANT USED, PT AROUSED AFTER STERNAL RUB AND INHALANT. ORIENTED TO SITUATION PROVIDED. PT STATES "I'M SO EMBARRASSED, I FELT THAT COMING ON" 911 CONTACTED AND PT ASSISTED TO STRETCHER. 1458 BP 137/81 HR 72. PT DENIES ANY OTHER COMPLAINTS. DOES CONFIRM HE WAS ANXIOUS ABOUT INJECTION AND WAS SCARED HE WOULD FAINT. 1500 EMS HERE, BP128/80 HR 92. PT REFUSED TRANSPORT WITH EMS AFTER DISCUSSION WITH EMTS.  1530 PT STATES FEEL OK TO LEAVE WITH GIRLFRIEND DRIVING. BP 165/64 HR 65. DENIES ANY COMPLAINTS. INSTRUCTED TO CALL 911 OR SEEK MEDICAL ATTENTION IF NEEDED. VOICED UNDERSTANDING.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Enuresis, Feeling cold, Hot flush
Clinical narrative: Day after shot was intense muscle pains/chills/hot and cold flashes abs dizziness. Took vitamins b,c,d and slept for 5hours and felt so much better. Then on Friday the 24th around 7am peed in bed for the fiirst time since 2years old (didn?t have water/alcohol etc) haven?t done so Again (today is 4/27)
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: Day after shot was intense muscle pains/chills/hot and cold flashes abs dizziness. Took vitamins b,c,d and slept for 5hours and felt so much better. Then on Friday the 24th around 7am peed in bed for the fiirst time since 2years old (didn?t have water/alcohol etc) haven?t done so Again (today is 4/27)
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pruritus, Injection site warmth, Pain in extremity
Clinical narrative: I have a large red, itchy, and warm to the touch spot where the shot was given. My arm was sore for a few days after the shot they got itchy and now has a red mark.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Menstruation irregular
Clinical narrative: Irregular periods
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Syncope, Unresponsive to stimuli
Clinical narrative: Systemic: Fainting / Unresponsive-Mild, Additional Details: Patient has a history of fainting upon receiving vaccinations.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Vision blurred, Visual impairment
Clinical narrative: Systemic: Visual Changes/Disturbances-Mild, Additional Details: Patient's wife called into the pharmacy about 3 hours after the patient recieved their vaccine. Patient's wife reported that the patient was experiencing blurred vision. No other symptoms were reported and patient's wife answered no when asked if the patient was experiencing trouble breathing, rash/hives, dizziness, nausea/vomiting etc.
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Hyperhidrosis, Hypotension, Pallor
Clinical narrative: Sweating, dizziness, paleness, low bp,
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Blood test, Chills, Echocardiogram, Fatigue
Clinical narrative: Exhaustion, fever/chills, upset stomach, headache - may have triggered fib - afib led to ICU on 4/22/2021.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pyrexia, Vital signs measurement
Clinical narrative: Exhaustion, fever/chills, upset stomach, headache - may have triggered fib - afib led to ICU on 4/22/2021.
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Erythema, Throat tightness
Clinical narrative: Received 1st dose of Moderna.  A few minutes later  PT began to complain of tightness in the throat, and redness on their chest.  Vitals: BP: 126/80 O2: 98% Pul: 76 Lungs where clear bi-lateral  PT was administered PO antihistamine 50mg PT remained at vaccination site for additional time and left after 30 minutes under their own control.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Confusional state, No adverse event
Clinical narrative: Systemic: Confusion-Mild, Additional Details: Pt reported that she is not sure she received the vaccine, as she felt a splatter on her face/arm when the vaccine was administered.  Pt does not report any adverse side effects.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Muscle contractions involuntary
Clinical narrative: about 7;30 p.m. all my leg muscles contracted tightly and extreme burning while I was getting out of my seat at the restaurant.  I could on stand.  excruciating all over burning and complete tightness in both my legs.  my husband had to help me get to car.   it lightened up for about an hour.  still all over burning while I was laying down.  then both legs contracted tightly and it started again.  I could not stand  .  shaking  crying. my husband helped my again.  i curled up sideways ..I almost called 911.  it took another 1/2 hour to lightened up.  this was my reaction.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect route of product administration
Clinical narrative: Error: Wrong Route (SC, IM, etc.)
Age: 46.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Tinnitus
Clinical narrative: Tinnitus in both ears since 3 days past 1st dose. Has gotten worse with 2nd dose.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dysstasia, Fall, Gait disturbance, Laboratory test
Clinical narrative: I had the 1st Covid vaccine shot on the 25th of March, and by the 30th of March, I was admitted to the hospital because I was losing strength in my body.   Ive been in the hospital twice. The 2nd time was from the 9th of April till 04-24-2021.  I was admitted then bcuz  I lost all of my strength in my muscles and couldn?t stand, walk, move, touch my face, nothing!!  I kept falling because my legs were too weak to hold me up.  The doctor told my kids that I had to go back to the hospital bcuz it wasn?t safe to be home.  They?ve been running all kinds of tests on me but can?t find anything to explain the muscle weakness to date.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Mobility decreased, Movement disorder, Muscular weakness
Clinical narrative: I had the 1st Covid vaccine shot on the 25th of March, and by the 30th of March, I was admitted to the hospital because I was losing strength in my body.   Ive been in the hospital twice. The 2nd time was from the 9th of April till 04-24-2021.  I was admitted then bcuz  I lost all of my strength in my muscles and couldn?t stand, walk, move, touch my face, nothing!!  I kept falling because my legs were too weak to hold me up.  The doctor told my kids that I had to go back to the hospital bcuz it wasn?t safe to be home.  They?ve been running all kinds of tests on me but can?t find anything to explain the muscle weakness to date.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Unevaluable event
Clinical narrative: Patient presented to the ED on 3/17/21, 3/20/21, 3/22/21. He presented to the ED on 4/3/21 and was subsequently hospitalized.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Disturbance in attention, Dizziness, Fatigue, Feeling abnormal
Clinical narrative: second day after vaccine i felt extremely tired, body aches, some congestion , couldn't get out of bed , chills and some dizziness, my head felt fluey., dizzy and chills. from third day on I felt  body aches , tired and groggy, , felt just not right , not 100% good, now I had a runny nose too.  up until that day , i still feel not completely well, body aches, run down , tired, able to hold concentration, runny nose and some chest congestion, tired and groggy.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Mobility decreased, Nasal congestion, Pain, Respiratory tract congestion
Clinical narrative: second day after vaccine i felt extremely tired, body aches, some congestion , couldn't get out of bed , chills and some dizziness, my head felt fluey., dizzy and chills. from third day on I felt  body aches , tired and groggy, , felt just not right , not 100% good, now I had a runny nose too.  up until that day , i still feel not completely well, body aches, run down , tired, able to hold concentration, runny nose and some chest congestion, tired and groggy.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Rhinorrhoea, Somnolence
Clinical narrative: second day after vaccine i felt extremely tired, body aches, some congestion , couldn't get out of bed , chills and some dizziness, my head felt fluey., dizzy and chills. from third day on I felt  body aches , tired and groggy, , felt just not right , not 100% good, now I had a runny nose too.  up until that day , i still feel not completely well, body aches, run down , tired, able to hold concentration, runny nose and some chest congestion, tired and groggy.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Erectile dysfunction
Clinical narrative: Approximately 7 hours after the vaccination the patient reported that he had an erection for 24 hours.
Sex: F
Vaccine: COVID19
Symptoms: Abortion spontaneous, Exposure during pregnancy, Pain, Pyrexia
Clinical narrative: MISCARRIAGE; VACCINE EXPOSURE DURING PREGNANCY; BODY ACHES; FEVER; This spontaneous report received from a consumer (company representative) concerned an female of unspecified age. The patient's height, and weight were not reported. The patient was gravida 1, para 0. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, 1 total administered on 10-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 10-APR-2021, the patient experienced body aches and fever. On 10-APR-2021, the patient was pregnant when she had vaccine. On 12-APR-2021, the patient experienced hemorrhage, miscarriage (spontaneous abortion) and was hospitalized (date unspecified). The duration of hospitalization was not reported. The date of patient's last menstrual period and expected delivery date were not reported. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever, body aches, miscarriage and vaccine exposure during pregnancy was not reported. This report was serious (Other Medically Important Condition). .; Sender's Comments: V0: -covid-19 vaccine ad26.cov2.s-miscarriage, vaccine exposure during pregnancy. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pyrexia, Vaccination complication
Clinical narrative: HEADACHE; FEVER; VACCINATION ADVERSE REACTION; This spontaneous report received from a consumer concerned a 45 year old female. The patient's weight was 163 pounds, and height was 63 inches. The patient's past medical history included sulfa allergy, and iodine allergy, and concurrent conditions included sterilization, anxiety, depression, and rheumatoid arthritis. The patient experienced drug allergy when treated with diphenhydramine hydrochloride. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number was not reported) dose was not reported, administered on 2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. Concomitant medications included clonazepam for anxiety, bupropion hydrochloride for depression, fluoxetine hydrochloride for depression, metoprolol succinate for high blood pressure, and adalimumab for rheumatoid arthritis. On APR-2021, the subject experienced vaccination adverse reaction. On 08-APR-2021, the subject experienced fever. On 11-APR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from vaccination adverse reaction on APR-2021, and headache, and fever on 13-APR-2021. This report was non-serious.