chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Bell's palsy
Clinical narrative: bell's palsy after the vaccine; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of BELL'S PALSY (bell's palsy after the vaccine) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced BELL'S PALSY (bell's palsy after the vaccine) (seriousness criterion medically significant). At the time of the report, BELL'S PALSY (bell's palsy after the vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient's friend reported that patient experienced bell's palsy after the Moderna vaccine. No concomitant medications were provided by the reporter.  No treatment information was provided by the reporter. Company Comment: Very limited information regarding this event/s has been provided at this time.  Patient age and gender not reported. Further information has been requested.; Sender's Comments: Very limited information regarding this event/s has been provided at this time.  Patient age and gender not reported. Further information has been requested.
Sex: M
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 male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced THROMBOSIS (Blood clots) (seriousness criteria death, hospitalization and medically significant). The reported cause of death was blood clots. It is unknown if an autopsy was performed.            The concomitant medication was not reported.  A consumer called and stated that his uncle passed away 2 days after receiving Moderna Covis-19 Vaccine.  Reporter stated that his uncle had to go to ICU due to blood clots and died from  it.  No treatment medication information was provided.  This is a case of death of a Male subject who passed away two days after receiving the vaccine. Very limited information regarding the event has been provided at this time. No further information is expected.; Sender's Comments: This is a case of death of a Male subject who passed away two days after receiving the vaccine. Very limited information regarding the event has been provided at this time. No further information is expected.; Reported Cause(s) of Death: blood clots
Sex: U
Vaccine: COVID19
Symptoms: Death
Clinical narrative: patient died after the second dose of the Moderna vaccine; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of DEATH (patient died after the second dose of the Moderna vaccine) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Death occurred on an unknown date The cause of death was not reported. It is unknown if an autopsy was performed.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.  Treatment information was not provided. Company Comment: Very limited information regarding the events has been provided at this time.; Sender's Comments: Very limited information regarding the events has been provided at this time.; Reported Cause(s) of Death: patient died after the second dose of the Moderna vaccine
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Hospitalisation, Inappropriate schedule of product administration
Clinical narrative: admitted inpatient into a substance treatment facility; at least 13 weeks between the first and second doses; This spontaneous case was reported by a consumer and describes the occurrence of HOSPITALISATION (admitted inpatient into a substance treatment facility) in a 25-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 01-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced HOSPITALISATION (admitted inpatient into a substance treatment facility) (seriousness criterion hospitalization) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (at least 13 weeks between the first and second doses). The patient was hospitalized until 09-Jul-2021 due to HOSPITALISATION. On 09-Jul-2021, HOSPITALISATION (admitted inpatient into a substance treatment facility) outcome was unknown. At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (at least 13 weeks between the first and second doses) had resolved.            No concomitant medication were reported. No treatment history were reported.  Patient denies any side effects or any changes after vaccination. Patient stated that there was no way of receiving the second dose vaccination as patient was admitted inpatient into a substance treatment facility until 09JUL2021. Patient is currently still in treatment living in a sober house.  Company comment- This report refers to a case of Inappropriate schedule of product administration for mRNA-1273, lot # unknown with associated AE (Hospitalisation). Very limited information regarding this event has been provided at this time.  Further information has been requested.; Sender's Comments: This report refers to a case of Inappropriate schedule of product administration for mRNA-1273, lot # unknown with associated AE (Hospitalisation). Very limited information regarding this event has been provided at this time.  Further information has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Death
Clinical narrative: Death after vaccination; This spontaneous case was reported by a consumer and describes the occurrence of DEATH (Death after vaccination) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Death occurred on an unknown date The cause of death was not reported. It is unknown if an autopsy was performed.            No concomitant medication details was provided. No treatment medication details was provided.  Company comment: Very limited information regarding the events has been provided at this time. Further information is not expected.; Sender's Comments: Very limited information regarding the events has been provided at this time. Further information is not expected.; Reported Cause(s) of Death: unknown cause of death
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error, Product temperature excursion issue
Clinical narrative: Vaccine administered to about 9 to 10 patients after being stored in refrigerator for 31 days.; The vaccine was administered to about 9 to 10 patients before the excursion error was discovered; vaccine expired by 1 day; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT STORAGE ERROR (Vaccine administered to about 9 to 10 patients after being stored in refrigerator for 31 days.), PRODUCT TEMPERATURE EXCURSION ISSUE (The vaccine was administered to about 9 to 10 patients before the excursion error was discovered) and EXPIRED PRODUCT ADMINISTERED (vaccine expired by 1 day) in a 37-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 008C21A and 008C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 29-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine administered to about 9 to 10 patients after being stored in refrigerator for 31 days.), PRODUCT TEMPERATURE EXCURSION ISSUE (The vaccine was administered to about 9 to 10 patients before the excursion error was discovered) and EXPIRED PRODUCT ADMINISTERED (vaccine expired by 1 day). At the time of the report, PRODUCT STORAGE ERROR (Vaccine administered to about 9 to 10 patients after being stored in refrigerator for 31 days.), PRODUCT TEMPERATURE EXCURSION ISSUE (The vaccine was administered to about 9 to 10 patients before the excursion error was discovered) and EXPIRED PRODUCT ADMINISTERED (vaccine expired by 1 day) had resolved.            No relevant concomitant medications were reported.  No treatment information was provided.   This case was linked to MOD-2021-207778 (Patient Link).
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Pulmonary granuloma
Clinical narrative: Developed large aggressive amounts of granulation in lungs; This spontaneous case was reported by a consumer and describes the occurrence of PULMONARY GRANULOMA (Developed large aggressive amounts of granulation in lungs) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013A21A and 037BEIA) for COVID-19 vaccination.     Concurrent medical conditions included Thyroid disorder NOS and Heart disease, unspecified.   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) (unknown route) dosage was changed to 1 dosage form. On 23-Jun-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PULMONARY GRANULOMA (Developed large aggressive amounts of granulation in lungs) (seriousness criterion medically significant). At the time of the report, PULMONARY GRANULOMA (Developed large aggressive amounts of granulation in lungs) outcome was unknown.            Patient's laboratory details reported included CAT scan (computed axial tomography) for which result was not specified. At the time of report patient was under doctor's care and doing better.  No concomitant medication information was reported.  No treatment information was reported.  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: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Facial paralysis
Clinical narrative: drooping to one (right)  side of the mouth; This spontaneous case was reported by an other health care professional and describes the occurrence of FACIAL PARALYSIS (drooping to one (right)  side of the mouth) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Dental cleaning in February 2021, Facial swelling (after her first Sculptra injection which lasted 3-4 days before it resolved.) in January 2021, Facial paralysis and Pain. Previously administered products included for Product used for unknown indication: Sculptra Aesthetic in January 2021. Concurrent medical conditions included Seasonal allergy and Osteoporosis. Concomitant products included ALENDRONATE SODIUM (SODIUM ALENDRONATE) for Osteoporosis, VITAMINS NOS for an unknown indication.   In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In April 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Jun-2021, the patient experienced FACIAL PARALYSIS (drooping to one (right)  side of the mouth) (seriousness criterion medically significant). On 21-Jun-2021, FACIAL PARALYSIS (drooping to one (right)  side of the mouth) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient was injected with Sculptra Aesthetic January 2021 (exact date unknown) to the lines above and below mouth. Patient was injected again with Sculptra Aesthetic on 21-Jun-2021. Patient reported pain during both injections, but she stated it was tolerable pain during the January injection and the injection in June was incredibly painful, lasting several hours. Patient noted lack of effect since her January injection and also after her June injection. Patent had swelling to her entire face in January 2021 after her first injection which lasted three-four days before it resolved. The lack of effect was still there. Patient contacted the HCP and was recommended a second treatment and super photo facial (second treatment and super photo facial done on 21-Jun-2021. HCP stated to patient that it takes eight months to see optimal results.    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. However, the medical history/ occurrence of Sculptra aesthetic (drooping to one side of mouth for 2 times) could be a contributory factor.; 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. However, the medical history/ occurrence of Sculptra aesthetic (drooping to one side of mouth for 2 times)could be a contributory factor.
Sex: U
Vaccine: COVID19
Symptoms: Product temperature excursion issue
Clinical narrative: Administered to patients after possible temperature excursion; This case was initially received via an unknown source (no reference has been entered for a health authority or license partner) on 29-Jul-2021. The most recent information was received on 11-Aug-2021 and was forwarded to Moderna on 12-Aug-2021.    Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Administered to patients after possible temperature excursion) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027C21A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Administered to patients after possible temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Administered to patients after possible temperature excursion) 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.   No relevant concomitant medications was reported.  Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 11-Aug-2021: Significant FU: Reporter stated that no one has had any problems after the excursion.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: Patient is past day 36 since the first dose and has not received the second; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Patient is past day 36 since the first dose and has not received the second) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Patient is past day 36 since the first dose and has not received the second). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Patient is past day 36 since the first dose and has not received the second) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant drug was not reported. Treatment medication was not reported.  It was reported that due to vaccine unavailability patient didn't receive dose 2. Her daughter had the first dose of the Moderna COVID-19 vaccine either in Jan2021 or Feb2021.   Most recent FOLLOW-UP information incorporated above includes: On 10-Aug-2021: Non-significant TCR attached. email added. On 10-Aug-2021: Follow up received on 17-Aug-2021 contained no new information.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Herpes zoster, Rash
Clinical narrative: Shingles/ shingles is still developing in different places from his lymph nodes to around his waist and around nerve endings; Has spots all over his body /Arm pits and waist rash; This spontaneous case was reported by a consumer and describes the occurrence of HERPES ZOSTER (Shingles/ shingles is still developing in different places from his lymph nodes to around his waist and around nerve endings) and RASH (Has spots all over his body /Arm pits and waist rash) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. U37C21A and 037C21A) for COVID-19 vaccination.     The patient's past medical history included Chickenpox.   On 29-Jun-2021 at 2:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Aug-2021 at 3:00 AM, the patient experienced RASH (Has spots all over his body /Arm pits and waist rash). On 01-Aug-2021 at 3:00 PM, the patient experienced HERPES ZOSTER (Shingles/ shingles is still developing in different places from his lymph nodes to around his waist and around nerve endings). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Shingles, at an unspecified dose and frequency and STEROIDS (oral) ongoing from 08-Aug-2021 for Shingles, at an unspecified dose and frequency. At the time of the report, HERPES ZOSTER (Shingles/ shingles is still developing in different places from his lymph nodes to around his waist and around nerve endings) and RASH (Has spots all over his body /Arm pits and waist rash) had not resolved.            No concomitant medications reported.  Shingles outbreak after second vaccine. Patient had arm pits and waist rash as first observation of the reaction   No other know causes.  Patient was  in recovery. Patient had  A+ blood type   Most recent FOLLOW-UP information incorporated above includes: On 09-Aug-2021: Follow up information received contains dose 2 information, vaccine facility information added, narrative supplement updated .
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Blood glucose increased, Glycosylated haemoglobin increased
Clinical narrative: Rise in blood sugar levels/Sugar went up like crazy; Rise in hemoglobin A1c; This spontaneous case was reported by a consumer and describes the occurrence of BLOOD GLUCOSE INCREASED (Rise in blood sugar levels/Sugar went up like crazy) and GLYCOSYLATED HAEMOGLOBIN INCREASED (Rise in hemoglobin A1c) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced BLOOD GLUCOSE INCREASED (Rise in blood sugar levels/Sugar went up like crazy) (seriousness criterion hospitalization) and GLYCOSYLATED HAEMOGLOBIN INCREASED (Rise in hemoglobin A1c) (seriousness criterion hospitalization). At the time of the report, BLOOD GLUCOSE INCREASED (Rise in blood sugar levels/Sugar went up like crazy) and GLYCOSYLATED HAEMOGLOBIN INCREASED (Rise in hemoglobin A1c) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood glucose increased: increased (High) Rise in blood sugar levels. On an unknown date, Glycosylated haemoglobin increased: increased (High) Rise in hemoglobin A1c.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was given. Treatment medication was mentioned as patient medicines were changed and prescribed with a new pill.  Company Comment: Very limited information regarding this events has been provided at this time. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.  Further information has been requested.; Sender's Comments: Very limited information regarding this events has been provided at this time. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.  Further information has been requested.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Bell's palsy, Deformity, Feeling abnormal, Grief reaction
Clinical narrative: caused me a lot of grief in speaking; this has been brutal; contracted Bell's Palsy; face was deformed; This spontaneous case was reported by a consumer and describes the occurrence of BELL'S PALSY (contracted Bell's Palsy), DEFORMITY (face was deformed), GRIEF REACTION (caused me a lot of grief in speaking) and FEELING ABNORMAL (this has been brutal) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027A21A and 030M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 22-Mar-2021, the patient experienced BELL'S PALSY (contracted Bell's Palsy) (seriousness criteria disability and medically significant). 22-Mar-2021, the patient experienced DEFORMITY (face was deformed) (seriousness criterion medically significant). On an unknown date, the patient experienced GRIEF REACTION (caused me a lot of grief in speaking) (seriousness criterion medically significant) and FEELING ABNORMAL (this has been brutal) (seriousness criterion medically significant). At the time of the report, BELL'S PALSY (contracted Bell's Palsy), DEFORMITY (face was deformed), GRIEF REACTION (caused me a lot of grief in speaking) and FEELING ABNORMAL (this has been brutal) outcome was unknown.            Concomitant medication were not reported. Treatment medication were not reported.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; 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: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Electrocardiogram, Loss of consciousness, Muscle spasms, Pain in extremity, Product dose omission issue
Clinical narrative: passed out/ woke up on the bathroom floor.; only received one dose; cramp behind her leg; arm was a little sore; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (passed out/ woke up on the bathroom floor.) in a 66-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.     No Medical History information was reported.    On 14-Apr-2021 at 4:30 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced LOSS OF CONSCIOUSNESS (passed out/ woke up on the bathroom floor.) (seriousness criterion medically significant), PRODUCT DOSE OMISSION ISSUE (only received one dose), MUSCLE SPASMS (cramp behind her leg) and PAIN IN EXTREMITY (arm was a little sore). At the time of the report, LOSS OF CONSCIOUSNESS (passed out/ woke up on the bathroom floor.), MUSCLE SPASMS (cramp behind her leg) and PAIN IN EXTREMITY (arm was a little sore) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (only received one dose) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In April 2021, Electrocardiogram: normal (normal) Normal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was provided.  After the patient received her first dose her arm was a little sore but two days later she passed out in her house.  She got up in the early morning, remembers going into the bathroom woke up on the bathroom floor.  She was not sure how long she was on the floor.  When she woke up she crawled to her bed.  She went to the doctor two days later and they did an electrocardiogram (EKG) and it came back normal.  She also mentioned she had a cramp behind her leg the night she was in bed and then passed out.  The patient was scheduled for the second dose but appointment was cancelled by the facility and the patient doesn't want to get the second dose after what had happened in the first dose administration.  No treatment information was provided.   Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Chills, Gait disturbance, Headache, Intestinal obstruction
Clinical narrative: Bowel blockage; Fever; Severe stomach cramp pain; Headache; Nauseous; Shaky with chills; Could not walk; Chills; Turned pale white like a ghost after vaccination; This spontaneous case was reported by a consumer and describes the occurrence of INTESTINAL OBSTRUCTION (Bowel blockage), PYREXIA (Fever), ABDOMINAL PAIN UPPER (Severe stomach cramp pain), HEADACHE (Headache), NAUSEA (Nauseous), NERVOUSNESS (Shaky with chills), GAIT DISTURBANCE (Could not walk) and CHILLS (Chills) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Dialysis (15 years in dialysis with multiple medical conditions).   On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Apr-2021, the patient experienced PYREXIA (Fever) (seriousness criterion hospitalization), ABDOMINAL PAIN UPPER (Severe stomach cramp pain) (seriousness criterion hospitalization), HEADACHE (Headache) (seriousness criterion hospitalization), NAUSEA (Nauseous) (seriousness criterion hospitalization), NERVOUSNESS (Shaky with chills) (seriousness criterion hospitalization), GAIT DISTURBANCE (Could not walk) (seriousness criterion hospitalization) and CHILLS (Chills) (seriousness criterion hospitalization). On 26-Apr-2021, the patient experienced INTESTINAL OBSTRUCTION (Bowel blockage) (seriousness criteria death, hospitalization and medically significant). On an unknown date, the patient experienced PALLOR (Turned pale white like a ghost after vaccination). The patient was hospitalized for 6 days due to ABDOMINAL PAIN UPPER, CHILLS, GAIT DISTURBANCE, HEADACHE, INTESTINAL OBSTRUCTION, NAUSEA, NERVOUSNESS and PYREXIA. On 26-Apr-2021, PYREXIA (Fever), ABDOMINAL PAIN UPPER (Severe stomach cramp pain), HEADACHE (Headache), NAUSEA (Nauseous), NERVOUSNESS (Shaky with chills), GAIT DISTURBANCE (Could not walk) and CHILLS (Chills) outcome was unknown. The patient died on 26-Apr-2021. The reported cause of death was Intestinal obstruction. It is unknown if an autopsy was performed.            Concomitant medications was not reported. No treatment information was provided.   Very Limited information regarding the events has been provided at this time and a causal relationship cannot be excluded. Further information has been requested   Very Limited information regarding the events has been provided at this time and a causal relationship cannot be excluded. Further information has been requested.; Reported Cause(s) of Death: Intestinal obstruction
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Nervousness, Pallor, Pyrexia
Clinical narrative: Bowel blockage; Fever; Severe stomach cramp pain; Headache; Nauseous; Shaky with chills; Could not walk; Chills; Turned pale white like a ghost after vaccination; This spontaneous case was reported by a consumer and describes the occurrence of INTESTINAL OBSTRUCTION (Bowel blockage), PYREXIA (Fever), ABDOMINAL PAIN UPPER (Severe stomach cramp pain), HEADACHE (Headache), NAUSEA (Nauseous), NERVOUSNESS (Shaky with chills), GAIT DISTURBANCE (Could not walk) and CHILLS (Chills) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Dialysis (15 years in dialysis with multiple medical conditions).   On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Apr-2021, the patient experienced PYREXIA (Fever) (seriousness criterion hospitalization), ABDOMINAL PAIN UPPER (Severe stomach cramp pain) (seriousness criterion hospitalization), HEADACHE (Headache) (seriousness criterion hospitalization), NAUSEA (Nauseous) (seriousness criterion hospitalization), NERVOUSNESS (Shaky with chills) (seriousness criterion hospitalization), GAIT DISTURBANCE (Could not walk) (seriousness criterion hospitalization) and CHILLS (Chills) (seriousness criterion hospitalization). On 26-Apr-2021, the patient experienced INTESTINAL OBSTRUCTION (Bowel blockage) (seriousness criteria death, hospitalization and medically significant). On an unknown date, the patient experienced PALLOR (Turned pale white like a ghost after vaccination). The patient was hospitalized for 6 days due to ABDOMINAL PAIN UPPER, CHILLS, GAIT DISTURBANCE, HEADACHE, INTESTINAL OBSTRUCTION, NAUSEA, NERVOUSNESS and PYREXIA. On 26-Apr-2021, PYREXIA (Fever), ABDOMINAL PAIN UPPER (Severe stomach cramp pain), HEADACHE (Headache), NAUSEA (Nauseous), NERVOUSNESS (Shaky with chills), GAIT DISTURBANCE (Could not walk) and CHILLS (Chills) outcome was unknown. The patient died on 26-Apr-2021. The reported cause of death was Intestinal obstruction. It is unknown if an autopsy was performed.            Concomitant medications was not reported. No treatment information was provided.   Very Limited information regarding the events has been provided at this time and a causal relationship cannot be excluded. Further information has been requested   Very Limited information regarding the events has been provided at this time and a causal relationship cannot be excluded. Further information has been requested.; Reported Cause(s) of Death: Intestinal obstruction
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Sepsis
Clinical narrative: sepsis; complications during knee replacement; aching all over her legs aching in the middle,whole legs aching; bones pain; aching in the joints, aching in the ankles,aching in the elbows and hip, the joints kill her, her artificial knee it's aching as well; aching all over,the muscles kill her; headaches off and on; This spontaneous case was reported by a consumer and describes the occurrence of SEPSIS (sepsis) and COMPLICATIONS OF TRANSPLANT SURGERY (complications during knee replacement) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027L20A and 039K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was reported.  The patient's past medical history included Knee replacement in March 2021. Concomitant products included ATENOLOL, LISINOPRIL, METFORMIN, MONTELUKAST SODIUM (SINGULAIR), ALPRAZOLAM (XANAX), ACETYLSALICYLIC ACID (BABY ASPIRIN), DULOXETINE and VITAMIN D NOS for an unknown indication.   On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced SEPSIS (sepsis) (seriousness criterion medically significant), COMPLICATIONS OF TRANSPLANT SURGERY (complications during knee replacement) (seriousness criterion medically significant), PAIN IN EXTREMITY (aching all over her legs aching in the middle,whole legs aching), BONE PAIN (bones pain), ARTHRALGIA (aching in the joints, aching in the ankles,aching in the elbows and hip, the joints kill her, her artificial knee it's aching as well), MYALGIA (aching all over,the muscles kill her) and HEADACHE (headaches off and on). The patient was treated with PARACETAMOL (TYLENOL) for Ache and Headache, at an unspecified dose and frequency. At the time of the report, SEPSIS (sepsis), COMPLICATIONS OF TRANSPLANT SURGERY (complications during knee replacement), PAIN IN EXTREMITY (aching all over her legs aching in the middle,whole legs aching), BONE PAIN (bones pain), ARTHRALGIA (aching in the joints, aching in the ankles,aching in the elbows and hip, the joints kill her, her artificial knee it's aching as well), MYALGIA (aching all over,the muscles kill her) and HEADACHE (headaches off and on) outcome was unknown.            Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.  Case may be confounded by recent knee surgery. Further information is expected.   This case was linked to MOD-2021-276513 (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.  Case may be confounded by recent knee surgery. Further information is expected.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Lip swelling, Rash, Urticaria, Vaccination complication
Clinical narrative: lips also began to swell pretty bad; worst reaction; woke up the next morning covered in hives; full body rash; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (woke up the next morning covered in hives), RASH (full body rash) and LIP SWELLING (lips also began to swell pretty bad) in a 23-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 078C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included BUPROPION HYDROCHLORIDE (WELLBUTRIN) for an unknown indication.    On 01-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Aug-2021, the patient experienced URTICARIA (woke up the next morning covered in hives) (seriousness criterion medically significant), RASH (full body rash) (seriousness criterion medically significant) and VACCINATION COMPLICATION (worst reaction). On 03-Aug-2021, the patient experienced LIP SWELLING (lips also began to swell pretty bad) (seriousness criterion medically significant). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at a dose of 1 dosage form and EPINEPHRINE (EPIPEN) at a dose of 1 dosage form. At the time of the report, URTICARIA (woke up the next morning covered in hives), RASH (full body rash), LIP SWELLING (lips also began to swell pretty bad) and VACCINATION COMPLICATION (worst reaction) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reporter has asked is there anything she can ask for from her doctor that isn't a steroid that can combat the rash.  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   Most recent FOLLOW-UP information incorporated above includes: On 04-Aug-2021: vaccine start date was updated, concomitant medicines were added : Benadryl and Wellbutrin. adverse events were added.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded
Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Dyspnoea, Pericarditis
Clinical narrative: Pericarditis; Shortness of Breath; Pain in Chest; This spontaneous case was reported by a physician and describes the occurrence of PERICARDITIS (Pericarditis) in a 27-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 19-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jul-2021, the patient experienced PERICARDITIS (Pericarditis) (seriousness criterion medically significant), DYSPNOEA (Shortness of Breath) and CHEST PAIN (Pain in Chest). At the time of the report, PERICARDITIS (Pericarditis), DYSPNOEA (Shortness of Breath) and CHEST PAIN (Pain in Chest) 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.   No relevant concomitant medications and treatment medications were reported  Patient was went through Electrocardiogram and treated for the symptoms  One week after the side effects subsided and are no longer present  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: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Arthropathy, Back pain, Pain, Spondylitis, Tremor
Clinical narrative: Since the middle of July I also have tremors in my hands.; Inflamation in my lower 5 vertebrae; excrutiating back pain; Pain went from my waist to my right ankle; right knee collapsed; This spontaneous case was reported by a consumer and describes the occurrence of SPONDYLITIS (Inflammation in my lower 5 vertebrae), BACK PAIN (excruciating back pain), PAIN (Pain went from my waist to my right ankle) and ARTHROPATHY (right knee collapsed) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.    On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 09-May-2021, the patient experienced SPONDYLITIS (Inflamation in my lower 5 vertebrae) (seriousness criterion medically significant), BACK PAIN (excrutiating back pain) (seriousness criterion medically significant), PAIN (Pain went from my waist to my right ankle) (seriousness criterion medically significant) and ARTHROPATHY (right knee collapsed) (seriousness criterion medically significant). In July 2021, the patient experienced TREMOR (Since the middle of July I also have tremors in my hands.). The patient was treated with HYDROCODONE for Pain, at an unspecified dose and frequency and TRAMADOL for Pain, at an unspecified dose and frequency. At the time of the report, SPONDYLITIS (Inflamation in my lower 5 vertebrae) and BACK PAIN (excrutiating back pain) was resolving and PAIN (Pain went from my waist to my right ankle), ARTHROPATHY (right knee collapsed) and TREMOR (Since the middle of July I also have tremors in my hands.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       NO Treatment drug reported. Patient went to the Hospital where they did a CT scan. The Hospital gave him Hydrocodone and Tramadol for pain. The patient has had a CT scan as well as two MRI scans.  The Spine Dr. provided a series of injectable steroids. The steroids helped enough so that when I went to see a Surgeon I was well enough to not need surgery. The patient went to go see a surgeon, however she felt well enough that she did not need back surgery.  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.   Most recent FOLLOW-UP information incorporated above includes: On 05-Aug-2021: Live Follow-up with Patient demography added.; 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: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: oderna covid vaccine found to be out of date after administration on 8/4/21.; This spontaneous case was reported by a health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (oderna covid vaccine found to be out of date after administration on 8/4/21.) in a 53-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 04-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (oderna covid vaccine found to be out of date after administration on 8/4/21.). At the time of the report, EXPIRED PRODUCT ADMINISTERED (oderna covid vaccine found to be out of date after administration on 8/4/21.) 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.   No concomitant medications were reported.  No treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 10-Aug-2021: follow-up received on 10-AUG-2021 , race updated, and no new information added
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Mucormycosis, Poor quality sleep
Clinical narrative: Started having terrible reactions to Black Fungus after second vaccine; Felt totally wiped out after the second vaccine; Some nights sleeps well and other nights  does not, after second vaccine; This spontaneous case was reported by a consumer and describes the occurrence of MUCORMYCOSIS (Started having terrible reactions to Black Fungus after second vaccine) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011A21A and 06M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Mar-2021, the patient experienced POOR QUALITY SLEEP (Some nights sleeps well and other nights  does not, after second vaccine). On 13-Mar-2021, the patient experienced MUCORMYCOSIS (Started having terrible reactions to Black Fungus after second vaccine) (seriousness criterion medically significant) and FATIGUE (Felt totally wiped out after the second vaccine). At the time of the report, MUCORMYCOSIS (Started having terrible reactions to Black Fungus after second vaccine), POOR QUALITY SLEEP (Some nights sleeps well and other nights  does not, after second vaccine) and FATIGUE (Felt totally wiped out after the second vaccine) outcome was unknown.            The treatment history was not reported. The concomitant medication was not reported Patient stated that some nights he sleeps well and other nights he does not. The patient was wiped out. The blood work was done but no results provided.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.