chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Fall, Femur fracture, Product dose omission issue
Clinical narrative: Sustained shattered right femur fracture; Stepped on the cardboard,slipped and fell down; Missed the 2nd dose of vaccine; This spontaneous case was reported by a consumer and describes the occurrence of FEMUR FRACTURE (Sustained shattered right femur fracture) and FALL (Stepped on the cardboard,slipped and fell down) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Neuropathy. Concomitant products included ATENOLOL, GABAPENTIN, AMITRIPTYLINE, SERTRALINE (SERTA [SERTRALINE]) and LETROZOLE for an unknown indication.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Mar-2021, the patient experienced FEMUR FRACTURE (Sustained shattered right femur fracture) (seriousness criteria hospitalization and medically significant), FALL (Stepped on the cardboard,slipped and fell down) (seriousness criterion hospitalization) and PRODUCT DOSE OMISSION ISSUE (Missed the 2nd dose of vaccine). The patient was hospitalized from 15-Mar-2021 to 08-Apr-2021 due to FALL and FEMUR FRACTURE. The patient was treated with OXYCODONE for Pain management, at a dose of UNK dosage form and Surgery (Fixing the fracture) for Femur fracture. On 15-Mar-2021, PRODUCT DOSE OMISSION ISSUE (Missed the 2nd dose of vaccine) had resolved. At the time of the report, FEMUR FRACTURE (Sustained shattered right femur fracture) and FALL (Stepped on the cardboard,slipped and fell down) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       It was reported that patient underwent surgical procedure on 16-MAR-2021.; 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: Malaise, Product dose omission issue
Clinical narrative: Patient has been in and out of hospital; Patient has not received second dose within the appropriated window of time between two doses; This spontaneous case was reported by a nurse and describes the occurrence of MALAISE (Patient has been in and out of hospital) 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 information was reported.    On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MALAISE (Patient has been in and out of hospital) (seriousness criterion hospitalization) and PRODUCT DOSE OMISSION ISSUE (Patient has not received second dose within the appropriated window of time between two doses). At the time of the report, MALAISE (Patient has been in and out of hospital) and PRODUCT DOSE OMISSION ISSUE (Patient has not received second dose within the appropriated window of time between two doses) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered MALAISE (Patient has been in and out of hospital) to be not related. No further causality assessment was provided for PRODUCT DOSE OMISSION ISSUE (Patient has not received second dose within the appropriated window of time between two doses).    Concomitant product use was not provided by the reporter.  Treatment information was not provided.; Sender's Comments: Based on reporter's causality, the events are assessed as unlikely related to mRNA-1273.
Sex: M
Vaccine: COVID19
Symptoms: Erectile dysfunction
Clinical narrative: erectile dysfunction; This spontaneous case was reported by a consumer and describes the occurrence of ERECTILE DYSFUNCTION (erectile dysfunction) 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. 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 ERECTILE DYSFUNCTION (erectile dysfunction) (seriousness criterion medically significant). At the time of the report, ERECTILE DYSFUNCTION (erectile dysfunction) outcome was unknown.            Treatment information was not reported.  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.   Reporter did not allow further contact; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Macular hole, Visual impairment
Clinical narrative: Macular Hole; Optical visual changes; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of MACULAR HOLE (Macular Hole) in a 61-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.  Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID), ASCORBIC ACID (VITAMIN C ACID), VITAMIN D [VITAMIN D NOS], ZINC, FISH OIL and MULTIVITAMIN [VITAMINS NOS] for an unknown indication.   On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 28-Mar-2021, the patient experienced MACULAR HOLE (Macular Hole) (seriousness criterion medically significant) and VISUAL IMPAIRMENT (Optical visual changes). The patient was treated with Surgery for Macular hole. At the time of the report, MACULAR HOLE (Macular Hole) and VISUAL IMPAIRMENT (Optical visual changes) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   It was reported that Macular Hole required a surgery 7 weeks after (17 May 2021).  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: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Rectal haemorrhage
Clinical narrative: Rectal bleeding; Extreme tiredness; This spontaneous case was reported by a patient and describes the occurrence of RECTAL HAEMORRHAGE (Rectal bleeding) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028A21A and 028A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 25-Mar-2021, 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 2 dosage form. On an unknown date, the patient experienced RECTAL HAEMORRHAGE (Rectal bleeding) (seriousness criterion medically significant) and FATIGUE (Extreme tiredness). At the time of the report, RECTAL HAEMORRHAGE (Rectal bleeding) and FATIGUE (Extreme tiredness) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Concomitant medication was not provided by the reporter.   Treatment information was not provided.; Sender's Comments: Limited information regarding these events has been provided at this time. Further information has been requested.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Rectal haemorrhage
Clinical narrative: Rectal bleeding; Extreme tiredness; This spontaneous case was reported by a consumer and describes the occurrence of RECTAL HAEMORRHAGE (Rectal bleeding) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007C21A and 028A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   The patient received the first dose of Moderna COVID-19 vaccine on 25Mar2021(Lot#028A21A) and the second dose on 22Apr2021(Lot#007C21A).  On an unknown date, after receiving the two doses, the patient experienced RECTAL HAEMORRHAGE (Rectal bleeding) (seriousness criterion medically significant) and FATIGUE (Extreme tiredness). At the time of the report, RECTAL HAEMORRHAGE (Rectal bleeding) and FATIGUE (Extreme tiredness) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment information provided.    This case was linked to MOD-2021-211552 (Patient Link).; Sender's Comments: Limited information regarding these events has been provided at this time. Further information has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Multiple sclerosis, Vaccination complication
Clinical narrative: MULTIPLE SCLEROSIS; Considerable health issues since being vaccinated; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of MULTIPLE SCLEROSIS (MULTIPLE SCLEROSIS) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MULTIPLE SCLEROSIS (MULTIPLE SCLEROSIS) (seriousness criterion medically significant) and VACCINATION COMPLICATION (Considerable health issues since being vaccinated). At the time of the report, MULTIPLE SCLEROSIS (MULTIPLE SCLEROSIS) and VACCINATION COMPLICATION (Considerable health issues since being vaccinated) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided. Treatment information was not provided.   Very limited information regarding this events has been provided at this time. Further information has been requested.; Sender's Comments: Very limited information regarding this events has been provided at this time. Further information has been requested.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Blood sodium, Body temperature, Bone pain, Confusional state, Diarrhoea
Clinical narrative: sodium level 20; fatty liver; something wrong with kidneys; diarrhea; bone ache; could not walk; fever; confusion; Not feeling good; Throwing up; This spontaneous case was reported by a consumer and describes the occurrence of HYPONATRAEMIA (sodium level 20), HEPATIC STEATOSIS (fatty liver), RENAL DISORDER (something wrong with kidneys), DIARRHOEA (diarrhea), BONE PAIN (bone ache), GAIT DISTURBANCE (could not walk), PYREXIA (fever) and CONFUSIONAL STATE (confusion) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040B21A and 044A21A) 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 20-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 HYPONATRAEMIA (sodium level 20) (seriousness criterion hospitalization), HEPATIC STEATOSIS (fatty liver) (seriousness criterion hospitalization), RENAL DISORDER (something wrong with kidneys) (seriousness criterion hospitalization), DIARRHOEA (diarrhea) (seriousness criterion hospitalization), BONE PAIN (bone ache) (seriousness criterion hospitalization), GAIT DISTURBANCE (could not walk) (seriousness criterion hospitalization), PYREXIA (fever) (seriousness criterion hospitalization prolonged), CONFUSIONAL STATE (confusion) (seriousness criterion hospitalization prolonged), MALAISE (Not feeling good) and VOMITING (Throwing up). At the time of the report, HYPONATRAEMIA (sodium level 20), HEPATIC STEATOSIS (fatty liver), RENAL DISORDER (something wrong with kidneys), DIARRHOEA (diarrhea), BONE PAIN (bone ache), GAIT DISTURBANCE (could not walk), PYREXIA (fever), CONFUSIONAL STATE (confusion), MALAISE (Not feeling good) and VOMITING (Throwing up) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Blood sodium: 20 (Inconclusive) 20. In 2021, Body temperature: 104 (High) 104 Fahrenheit. In 2021, SARS-CoV-2 test: negative (Negative) rapid test as well as the PCR were negative.         Patient reported that her liver enzymes were elevated.  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.  Further information has been requested.; Sender's Comments: Very limited information regarding the events has been provided at this time.  Further information has been requested.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Gait disturbance, Hepatic steatosis, Hyponatraemia, Malaise, Pyrexia
Clinical narrative: sodium level 20; fatty liver; something wrong with kidneys; diarrhea; bone ache; could not walk; fever; confusion; Not feeling good; Throwing up; This spontaneous case was reported by a consumer and describes the occurrence of HYPONATRAEMIA (sodium level 20), HEPATIC STEATOSIS (fatty liver), RENAL DISORDER (something wrong with kidneys), DIARRHOEA (diarrhea), BONE PAIN (bone ache), GAIT DISTURBANCE (could not walk), PYREXIA (fever) and CONFUSIONAL STATE (confusion) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040B21A and 044A21A) 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 20-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 HYPONATRAEMIA (sodium level 20) (seriousness criterion hospitalization), HEPATIC STEATOSIS (fatty liver) (seriousness criterion hospitalization), RENAL DISORDER (something wrong with kidneys) (seriousness criterion hospitalization), DIARRHOEA (diarrhea) (seriousness criterion hospitalization), BONE PAIN (bone ache) (seriousness criterion hospitalization), GAIT DISTURBANCE (could not walk) (seriousness criterion hospitalization), PYREXIA (fever) (seriousness criterion hospitalization prolonged), CONFUSIONAL STATE (confusion) (seriousness criterion hospitalization prolonged), MALAISE (Not feeling good) and VOMITING (Throwing up). At the time of the report, HYPONATRAEMIA (sodium level 20), HEPATIC STEATOSIS (fatty liver), RENAL DISORDER (something wrong with kidneys), DIARRHOEA (diarrhea), BONE PAIN (bone ache), GAIT DISTURBANCE (could not walk), PYREXIA (fever), CONFUSIONAL STATE (confusion), MALAISE (Not feeling good) and VOMITING (Throwing up) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Blood sodium: 20 (Inconclusive) 20. In 2021, Body temperature: 104 (High) 104 Fahrenheit. In 2021, SARS-CoV-2 test: negative (Negative) rapid test as well as the PCR were negative.         Patient reported that her liver enzymes were elevated.  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.  Further information has been requested.; Sender's Comments: Very limited information regarding the events has been provided at this time.  Further information has been requested.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Renal disorder, SARS-CoV-2 test, Vomiting
Clinical narrative: sodium level 20; fatty liver; something wrong with kidneys; diarrhea; bone ache; could not walk; fever; confusion; Not feeling good; Throwing up; This spontaneous case was reported by a consumer and describes the occurrence of HYPONATRAEMIA (sodium level 20), HEPATIC STEATOSIS (fatty liver), RENAL DISORDER (something wrong with kidneys), DIARRHOEA (diarrhea), BONE PAIN (bone ache), GAIT DISTURBANCE (could not walk), PYREXIA (fever) and CONFUSIONAL STATE (confusion) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040B21A and 044A21A) 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 20-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 HYPONATRAEMIA (sodium level 20) (seriousness criterion hospitalization), HEPATIC STEATOSIS (fatty liver) (seriousness criterion hospitalization), RENAL DISORDER (something wrong with kidneys) (seriousness criterion hospitalization), DIARRHOEA (diarrhea) (seriousness criterion hospitalization), BONE PAIN (bone ache) (seriousness criterion hospitalization), GAIT DISTURBANCE (could not walk) (seriousness criterion hospitalization), PYREXIA (fever) (seriousness criterion hospitalization prolonged), CONFUSIONAL STATE (confusion) (seriousness criterion hospitalization prolonged), MALAISE (Not feeling good) and VOMITING (Throwing up). At the time of the report, HYPONATRAEMIA (sodium level 20), HEPATIC STEATOSIS (fatty liver), RENAL DISORDER (something wrong with kidneys), DIARRHOEA (diarrhea), BONE PAIN (bone ache), GAIT DISTURBANCE (could not walk), PYREXIA (fever), CONFUSIONAL STATE (confusion), MALAISE (Not feeling good) and VOMITING (Throwing up) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Blood sodium: 20 (Inconclusive) 20. In 2021, Body temperature: 104 (High) 104 Fahrenheit. In 2021, SARS-CoV-2 test: negative (Negative) rapid test as well as the PCR were negative.         Patient reported that her liver enzymes were elevated.  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.  Further information has been requested.; Sender's Comments: Very limited information regarding the events has been provided at this time.  Further information has been requested.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Condition aggravated, Death, Disease recurrence, Gastritis, Ultrasound scan
Clinical narrative: Died on the night of 05Jun2021 or Morning 06Jun2021 not Sure; Gastritis; The reaction came back with a vengeance; was doubling over; This spontaneous case was reported by an other health care professional (subsequently medically confirmed) and describes the occurrence of DEATH (Died on the night of 05Jun2021 or Morning 06Jun2021 not Sure) in a 53-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007C21A and 028A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Heart disease, unspecified.   On 25-Mar-2021, 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 28-May-2021, the patient experienced DISEASE RECURRENCE (The reaction came back with a vengeance) and CONDITION AGGRAVATED (was doubling over). On 01-Jun-2021, the patient experienced GASTRITIS (Gastritis). The patient died on 05-Jun-2021. The cause of death was not reported. It is unknown if an autopsy was performed. At the time of death, GASTRITIS (Gastritis), DISEASE RECURRENCE (The reaction came back with a vengeance) and CONDITION AGGRAVATED (was doubling over) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-Jun-2021, Ultrasound scan: abnormal (abnormal) confirmed gastritis..     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications were not provided.  Labs included electrocardiogram (EKG) whose results were not provided.  It was reported that on 01-jun-2021 at Emergency room, gastritis was diagnosed and patient was sent home. Treatment information was not provided.  Company comment: This is a case of sudden death in a 53-year-old male patient with a history of Heart disease, who died 1 month 14 days after receiving last dose of vaccine. Very limited information has been provided at this time.   This case was linked to MOD-2021-211580 (Patient Link).; Sender's Comments: This is a case of sudden death in a 53-year-old male patient with a history of Heart disease, who died 1 month 14 days after receiving last dose of vaccine. Very limited information has been provided at this time.; Reported Cause(s) of Death: Unknown cause of death
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Product dose omission issue
Clinical narrative: Patient got COVID; 110 days after the first dose; This spontaneous case was reported by a pharmacist and describes the occurrence of COVID-19 (Patient got COVID) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Mar-2021, the patient experienced COVID-19 (Patient got COVID) (seriousness criterion hospitalization). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (110 days after the first dose). At the time of the report, COVID-19 (Patient got COVID) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (110 days after the first dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided.   Treatment information included antibody infusion therapy.  This case concerns a patient who had covid-19 after the first dose and missed receiving the of the second dose reported as 110 days since first dose (missed dose).  Based on biological implausibility, a causal relationship between the reported event of COVID-19 and mRNA-1273 use is assessed as unlikely.  The event of missed dose is assessed as not applicable.; Sender's Comments: This case concerns a patient who had covid-19 after the first dose and missed receiving the  of the second dose reported as 110 days since first dose (missed dose). based on biological implausibility, a causal relationship between the reported event of COVID-19 and mRNA-1273 use is assessed as unlikely.  The event of missed dose is assessed as not applicable.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Illness, Loss of consciousness, Tremor
Clinical narrative: Passed out; Felt very sick for 12 hrs; Body was shaking; Chills so bad; This spontaneous case was reported by a patient and describes the occurrence of LOSS OF CONSCIOUSNESS (Passed out) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 023M20A and 030L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Feb-2021, the patient experienced ILLNESS (Felt very sick for 12 hrs), TREMOR (Body was shaking) and CHILLS (Chills so bad). On 26-Feb-2021, the patient experienced LOSS OF CONSCIOUSNESS (Passed out) (seriousness criterion medically significant). On 25-Feb-2021, ILLNESS (Felt very sick for 12 hrs), TREMOR (Body was shaking) and CHILLS (Chills so bad) had resolved. On 26-Feb-2021, LOSS OF CONSCIOUSNESS (Passed out) had resolved.            Concomitant medication and treatment information were not reported. Patient did not experienced any side effects after the first dose of vaccination.   Treatment information was not provided.  Action taken with mRNA-1273 in response to the events was not applicable.  Company Comment  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Gait inability, Hypertension, Malaise, Pain
Clinical narrative: lost the ability to walk; was in so much pain she wanted to die; high blood pressure; didn't feel well; This spontaneous case was reported by a consumer and describes the occurrence of GAIT INABILITY (lost the ability to walk) and PAIN (was in so much pain she wanted to die) in a 72-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 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 GAIT INABILITY (lost the ability to walk) (seriousness criterion hospitalization), PAIN (was in so much pain she wanted to die) (seriousness criterion hospitalization), HYPERTENSION (high blood pressure) and MALAISE (didn't feel well). At the time of the report, GAIT INABILITY (lost the ability to walk), PAIN (was in so much pain she wanted to die), HYPERTENSION (high blood pressure) and MALAISE (didn't feel well) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were reported. Treatment medication includes Antibiotics.  Company Comment: Very limited information regarding this event/s has been provided at this time.  Further information has been requested.; Sender's Comments: Very limited information regarding this event/s has been provided at this time.  Further information has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Transient ischaemic attack
Clinical narrative: suffered a TIA; This spontaneous case was reported by a consumer and describes the occurrence of TRANSIENT ISCHAEMIC ATTACK (suffered a TIA) in a female 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced TRANSIENT ISCHAEMIC ATTACK (suffered a TIA) (seriousness criterion medically significant). At the time of the report, TRANSIENT ISCHAEMIC ATTACK (suffered a TIA) outcome was unknown.            No concomitant medications were reported. No treatment medications were provided by the reporter.  Very limited information regarding the event has been provided at this time. No further information is expected.; Sender's Comments: Very limited information regarding the event has been provided at this time. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Lyme disease
Clinical narrative: Diagnosed with Lyme borreliosis; This spontaneous case was reported by a consumer and describes the occurrence of LYME DISEASE (Diagnosed with Lyme borreliosis) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced LYME DISEASE (Diagnosed with Lyme borreliosis) (seriousness criterion medically significant). At the time of the report, LYME DISEASE (Diagnosed with Lyme borreliosis) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was reported.  No treatment information was provided.  Based on current available information and the temporal association between product use and the start date of the event a causal relationship is unlikely.; Sender's Comments: Based on current available information and the temporal association between product use and the start date of the event a causal relationship is unlikely.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Condition aggravated, Gait disturbance, Malaise, Mobility decreased
Clinical narrative: condition aggravated; attempt to rise from bed difficult and painful; attempts to walk were difficult; severe pain in body joints / in constant knee pain; Malaise; sleepiness; soreness at the injection site; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of GAIT DISTURBANCE (attempts to walk were difficult) and CONDITION AGGRAVATED (condition aggravated) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010M20A and 013L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Spinal stenosis (His Spinal Stenosis is worse.) since 1999, Osteoarthritis (He is scheduled for a right knee replacement on 04 Jun 2021. Both knees will have to be replaced.) since 1999 and Pollen allergy. Concomitant products included METOPROLOL, LISINOPRIL, THEOPHYLLINE, FAMOTIDINE, FINASTERIDE, ROSUVASTATIN, ASPIRIN [ACETYLSALICYLIC ACID], BUDESONIDE, FORMOTEROL FUMARATE (SYMBICORT) and MECLIZINE HCL for an unknown indication.   On 10-Jan-2021 at 11:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021 at 10:30 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 10-Jan-2021, the patient experienced VACCINATION SITE PAIN (soreness at the injection site). On 10-Feb-2021, the patient experienced MALAISE (Malaise). 10-Feb-2021, the patient experienced SOMNOLENCE (sleepiness). On 11-Feb-2021, the patient experienced GAIT DISTURBANCE (attempts to walk were difficult) (seriousness criterion disability), MOBILITY DECREASED (attempt to rise from bed difficult and painful) and ARTHRALGIA (severe pain in body joints / in constant knee pain). On an unknown date, the patient experienced CONDITION AGGRAVATED (condition aggravated) (seriousness criterion disability). The patient was treated with OXYCODONE HYDROCHLORIDE, OXYCODONE TEREPHTHALATE, PARACETAMOL (PERCOCET [OXYCODONE HYDROCHLORIDE;OXYCODONE TEREPHTHALATE;PARACETAMOL]) ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, GAIT DISTURBANCE (attempts to walk were difficult), MOBILITY DECREASED (attempt to rise from bed difficult and painful) and ARTHRALGIA (severe pain in body joints / in constant knee pain) had not resolved and CONDITION AGGRAVATED (condition aggravated), MALAISE (Malaise), SOMNOLENCE (sleepiness) and VACCINATION SITE PAIN (soreness at the injection site) outcome was unknown.            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: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Somnolence, Vaccination site pain
Clinical narrative: condition aggravated; attempt to rise from bed difficult and painful; attempts to walk were difficult; severe pain in body joints / in constant knee pain; Malaise; sleepiness; soreness at the injection site; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of GAIT DISTURBANCE (attempts to walk were difficult) and CONDITION AGGRAVATED (condition aggravated) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010M20A and 013L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Spinal stenosis (His Spinal Stenosis is worse.) since 1999, Osteoarthritis (He is scheduled for a right knee replacement on 04 Jun 2021. Both knees will have to be replaced.) since 1999 and Pollen allergy. Concomitant products included METOPROLOL, LISINOPRIL, THEOPHYLLINE, FAMOTIDINE, FINASTERIDE, ROSUVASTATIN, ASPIRIN [ACETYLSALICYLIC ACID], BUDESONIDE, FORMOTEROL FUMARATE (SYMBICORT) and MECLIZINE HCL for an unknown indication.   On 10-Jan-2021 at 11:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021 at 10:30 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 10-Jan-2021, the patient experienced VACCINATION SITE PAIN (soreness at the injection site). On 10-Feb-2021, the patient experienced MALAISE (Malaise). 10-Feb-2021, the patient experienced SOMNOLENCE (sleepiness). On 11-Feb-2021, the patient experienced GAIT DISTURBANCE (attempts to walk were difficult) (seriousness criterion disability), MOBILITY DECREASED (attempt to rise from bed difficult and painful) and ARTHRALGIA (severe pain in body joints / in constant knee pain). On an unknown date, the patient experienced CONDITION AGGRAVATED (condition aggravated) (seriousness criterion disability). The patient was treated with OXYCODONE HYDROCHLORIDE, OXYCODONE TEREPHTHALATE, PARACETAMOL (PERCOCET [OXYCODONE HYDROCHLORIDE;OXYCODONE TEREPHTHALATE;PARACETAMOL]) ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, GAIT DISTURBANCE (attempts to walk were difficult), MOBILITY DECREASED (attempt to rise from bed difficult and painful) and ARTHRALGIA (severe pain in body joints / in constant knee pain) had not resolved and CONDITION AGGRAVATED (condition aggravated), MALAISE (Malaise), SOMNOLENCE (sleepiness) and VACCINATION SITE PAIN (soreness at the injection site) outcome was unknown.            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: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Headache, Nausea, Pain in extremity
Clinical narrative: Chills; headache; dizziness; pain in the arm; nausea; This is a spontaneous report from a contactable (patient, self-reported). A 57-year-old female patient received a dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number and expiry date were not reported), via an unspecified route of administration, on an unspecified date, as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient reported that on an unspecified date, she experienced chills, headache, dizziness, pain in the arm, and nausea. Outcome of the events was unknown.  No follow-up attempts are possible. No further information is expected.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Nausea
Clinical narrative: tired, I was nauseous and had a headache; tired, I was nauseous and had a headache; tired, I was nauseous and had a headache; This is a spontaneous report from a contactable consumer (patient, self-reported). A 75-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number and Expiration date: unknown), via an unknown route of administration on 22Jan2021 (age at the time 75-years-old) as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unknown date in Jan2021, (about 12 hours after the shot), the patient experienced very very tired, nauseous and had a headache. This lasted about 7 days and even today. About 10 days later, she was still more tired than she normally was. She wanted to ask that, was it ok to get the vaccine in 2 different states. The outcome of events was unknown.   Information on lot and batch number has been requested.  Follow-up attempts are completed. No further information is expected.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Illness, Influenza like illness, SARS-CoV-2 test
Clinical narrative: Flu like symptoms; sick two days; This is a spontaneous report from a contactable consumer or other non hcp. This consumer reported that a 60-years-old female patient received bnt162b2 (BNT162B2, Formulation: Solution for injection, Batch/Lot number: EL0142), via an unspecified route of administration, administered in Arm on 15Jan2021 as 1ST DOSE, SINGLE DOSE for covid-19 immunisation. Medical history included covid-19 from Mar2020. Concomitant medications were not reported. On an unspecified date in Jan2021, the patient experienced sick two days and on an unspecified date, the patient had flu like symptoms. Caller said she was taking Advil, clarified later to being generic Ibuprofen made by Assure. She said she thinks now that she was not supposed to take any, but she took three Advil/generic Ibuprofen every 6 hours, 200mg each. generic Ibuprofen UPC: Unknown, barcode was not on the bottle and the outer package was discarded. LOT: S200302, EXP Nov2022. Caller says after she got the first dose of the vaccine in two days, she recovered from COVID or flu symptoms. It was reported that caller was a certified dental assistant who had a Sars-Cov-2 infection in Mar2020. She received her first dose of Pfizer-Biontech Covid19 vaccine 15Jan2021 and she was due to receive the second dose this Friday 05Feb2021. First dose of the Pfizer 15Jan2021-the only reason she was calling this late-my next one is on Friday-possibly not getting the second vaccine if you had the first dose and previous COVID infection- didn't test positive for it in March and antibodies in March. Consumer says she had her first dose of the Pfizer COVID-19 vaccine 15Jan2021. She says she had COVID last Mar, and after she had the first dose of the COVID-19 vaccine she was sick for two days after, sicker than when she had COVID last year, with flu like symptoms. Pfizer COVID-19 vaccine: Caller says she got her first dose of the COVID-19 vaccine on 15Jan2021 and she was down and out for two days, it was like having COVID again and her husband thinks this was worse and that she was sicker than when she had COVID. She says she was supposed to get the second dose on Friday, but she doesn't want to. Caller says she did have an antibody test before she had the vaccine, in April last year and the results were positive antibody test for SARS. She says that she got a call afterwards from the health department that said that she had had COVID. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on Apr2020. The patient was recovered from the events on an unspecified date in 2021.  Follow-up attempts completed. No further information expected.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Nausea
Clinical narrative: Dizzy; nauseous; This is a spontaneous report from a contactable consumer (patient).    A 72-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: CL8982, Expiration date: unknown) via an unspecified route of administration, administered in Deltoid Left on 29Jan2021 (at the age of 72-year-old) as first dose single dose for covid-19 immunisation. The patient Medical history and concomitant medications were not reported. On 01Feb2021 the patient experienced dizzy, nauseous. patient went for his vaccine shot on Friday, and yesterday morning, he woke up, got out of bed and was dizzy and a little nauseous, he had the same experience, not as bad as yesterday. the outcome of the event dizzy recovering, while nauseous outcome was unknown.    Follow-up attempts are completed. No further information is expected.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Vaccination site pain
Clinical narrative: tenderness at vaccine site on the left arm, it didn't last long; pain in her left arm; This is a spontaneous report from a contactable consumer or other non-healthcare professional.  A 74-years-old female patient received first dose of bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE,), intramuscular, administered in left arm on 08Jan2021 (Batch/Lot Number: EL3246) as single dose for covid-19 immunisation. Medical history included thyroid (synthroid: Taking for years), prevent urinary tract infection (UTI) (methenamine: started a year and a half ago), vitamin supplementation (Preservision Areds 2 eye vitamins more than a year ago; Vitamin C with Zinc 8-9 months ago), dry eyes (Thera tears: dry eye therapy. she has not been consistent with taking), cholesterol (simvastatin: taking 20 years or more), allergic to Sulfa Drugs and Tetracycline, obesity (had been fighting it for 30 years), removed polyps (had a flat polyp that was a little more dangerous the first time and it was removed; non-cancerous), got the flu (08Jun months later, got the flu, went to the hospital and developed PNA) and eczema (took calcium 1200mg). They were calling it a subcutaneous sensitivity, she had eczema and was taking calcium 1200mg. Concomitant medications included levothyroxine sodium (SYNTHROID) 1.12 mg daily for thyroid,Taking for years ,start and stop date were not reported; methenamine 1 gm twice daily To prevent UTI Started a year and a half ago; ascorbic acid, cupric oxide, dl-alpha tocopheryl acetate, xantofyl, zeaxanthin, zinc oxide (PRESERVISION AREDS 2) One tablet twice daily for vitamin supplementation, start and stop date were not reported; ascorbic acid, zinc (VITAMIN C WITH ZINC) one tablet daily for vitamin supplementation, start and stop date were not reported; carmellose sodium (THERA TEARS) for dry eye, start and stop date were not reported; simvastatin 40 mg daily for blood cholesterol, start and stop date were not reported. On 08Jan2021, the patient experienced tenderness at vaccine site on the left arm, it didn't last long ,Pain in her left arm. Outcome of the event Pain in her left arm ,tenderness at vaccine site on the left arm, it didn't last long was reported as unknown at the time of this report.  Information on Lot/Batch has been requested.  Follow-up (16Apr2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Bone pain, Neck pain, Swelling
Clinical narrative: got swelling and pain 4 days in his neck; got swelling and pain 4 days in his neck; soreness on the bone tissue around the neck for 3 days; This is a spontaneous report from Medical Information Team. A contactable consumer reported that a male patient of an unspecified age received first dose of bnt162b2 (BNT162B2, Solution for injection) via unspecified route of administration on an unspecified date as single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Caller mentioned that he already got the first dose of the covid vaccine and he was getting the second shot tomorrow. He said that he got swelling and pain 4 days in his neck and soreness on the bone tissue around the neck for 3 days. It has all gone away. Outcome of the events was recovered on an unspecified date. Follow-up attempts are completed. No further information is expected. Information on about lot/batch number has been requested.
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Echocardiogram, Heart rate, Heart rate increased
Clinical narrative: very fast heart beat; This is a spontaneous report from a contactable consumer or other non hcp. An 85 year old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Batch/Lot number: FN5318) via an unspecified route of administration, administered in arm left on 01Feb2021 at 15:00 (at the age of 84-years-old) as 1st dose, single dose for covid-19 immunization. The second dose was schedule on 22Feb2021 at 12:40. Medical history included hypertension, arthritis. Patient stated that She had arthritis in the knees, 1 knee was worse than the other. She does try to exercise the 1 knee, she had DVD's and stuff she does, aortic aneurysm from 2017 to an unknown date. Concomitant medications were not reported. On 01Feb2021 19:30 the patient experienced very fast heartbeat. Patient clarified that when the fast heartbeat started, she actually took that one pill, it was Benazepril 20 mg, it's a generic for Lotensin. On 01Feb2021 the patient underwent lab tests and procedures which included echocardiogram: unknown results on heart rate: fast. The outcome of the event was recovered on 01Feb2021.  Follow-up(16Apr2021): Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Pain in the arm; This is a spontaneous report from a contactable Nurse. A 74-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via an unspecified route of administration on an unspecified date as 1ST DOSE, SINGLE DOSE for COVID-19 immunization. Information on the Batch/Lot number has been requested. The patient's medical history and concomitant medications were not reported. The patient stated that the first injection (Pfizer vaccine) was great, besides pain in the arm for 12 h pain in the armours. It was also informed that she was scheduled to have a computerized tomography scan (CT scan) with IV (Intravenous) contrast 5 days before the second dose of the Pfizer vaccine. The outcome of the event was recovered on an unspecified date.  Follow-up (16Apr2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made.   Follow-up attempts have been completed and no further information is expected.