chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: FROZEN VACCINE ADMINISTRATION; VACCINE WAS FROZEN IMMEDIATELY UPON RECEIPT BY ACCIDENT AND WAS WITHIN EXCURSION LIMITS BETWEEN -1.7 TO 2.0F; This spontaneous report received from a pharmacist concerned a 39 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: 1820095, and expiry: 04-JUL-2021) dose was not reported, administered on 13-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 13-MAY-2021, the subject experienced frozen vaccine administration. On 13-MAY-2021, the subject experienced vaccine was frozen immediately upon receipt by accident and was within excursion limits between -1.7 to 2.0f. The action taken with covid-19 vaccine  was not applicable. The outcome of the frozen vaccine administration and vaccine was frozen immediately upon receipt by accident and was within excursion limits between -1.7 to 2.0f was not reported. This report was non-serious. This case, from the same reporter is linked to 20210534639 and 20210534954.
Age: 86.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: DIARRHEA; This spontaneous report received from a patient concerned an 86 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 14-MAY-2021 for drug use for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 18-MAY-2021, the subject experienced diarrhea. The action taken with covid-19 vaccine  was not applicable. The patient had not recovered from diarrhea. This report was non-serious.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Diarrhoea, Dyspnoea, Headache, Hypoaesthesia
Clinical narrative: COLIC ABDOMINAL PAIN; LIQUID STOOLS; NUMBNESS SENSATION IN THE LEFT ARM; HEADACHE; DIFFICULTY BREATHING; PAIN IN ARM; This spontaneous report received from a patient concerned a 28 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 02-MAY-2021 for prophylactic vaccination. The batch number was not reported. The Company was unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On 02-MAY-2021, the subject experienced pain in arm. On 15-MAY-2021, the subject experienced difficulty breathing. On an unspecified date, the subject experienced colic abdominal pain, liquid stools, numbness sensation in the left arm, and headache. The action taken with covid-19 vaccine  was not applicable. The patient recovered from difficulty breathing, and the outcome of pain in arm, colic abdominal pain, liquid stools, headache and numbness sensation in the left arm was not reported. This report was non-serious.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: COLIC ABDOMINAL PAIN; LIQUID STOOLS; NUMBNESS SENSATION IN THE LEFT ARM; HEADACHE; DIFFICULTY BREATHING; PAIN IN ARM; This spontaneous report received from a patient concerned a 28 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 02-MAY-2021 for prophylactic vaccination. The batch number was not reported. The Company was unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On 02-MAY-2021, the subject experienced pain in arm. On 15-MAY-2021, the subject experienced difficulty breathing. On an unspecified date, the subject experienced colic abdominal pain, liquid stools, numbness sensation in the left arm, and headache. The action taken with covid-19 vaccine  was not applicable. The patient recovered from difficulty breathing, and the outcome of pain in arm, colic abdominal pain, liquid stools, headache and numbness sensation in the left arm was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Adverse drug reaction
Clinical narrative: SOME SIDE EFFECTS; This spontaneous report received from a consumer concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the subject experienced some side effects. The action taken with covid-19 vaccine  was not applicable. The outcome of some side effects was not reported. This report was non-serious.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS FROZE BY ACCIDENT  PRIOR TO ADMINSTRATION; This spontaneous report received from a pharmacist concerned a 46 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: 1820095, and expiry: 04-JUL-2021) dose was not reported, administered on 13-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 13-MAY-2021, the subject experienced inappropriate storage. The action taken with covid-19 vaccine  was not applicable. The outcome of inappropriate storage was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Headache, Pain
Clinical narrative: ACHY; HEADACHE; This spontaneous report received from a consumer concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: Unk) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the subject experienced achy, and headache. The action taken with covid-19 vaccine  was not applicable. The patient recovered from achy, and headache. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Tinnitus
Clinical narrative: DIZZINESS; TINNITUS; This spontaneous report received from a consumer concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 28-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On MAY-2021, the subject experienced dizziness. On MAY-2021, the subject experienced tinnitus. The action taken with covid-19 vaccine  was not applicable. The patient recovered from dizziness, and tinnitus on MAY-2021. This report was non-serious. This case, from the same reporter is linked to 20210537345.
Sex: U
Vaccine: COVID19
Symptoms: Acoustic stimulation tests, Tinnitus
Clinical narrative: TINNITUS IN RIGHT EAR; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported.  The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 05-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On MAR-2021, Laboratory data included: Hearing test (NR: not provided) Unknown. On 05-MAR-2021, the subject experienced tinnitus in right ear. The action taken with covid-19 vaccine  was not applicable. The outcome of tinnitus in right ear was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Heart rate increased, Pyrexia, Tinnitus
Clinical narrative: FAST HEART BEAT; DIZZINESS; RINGING IN THE EAR; FEVER; This spontaneous report received from a consumer concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 18-MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On MAY-2021, the subject experienced fast heart beat. On MAY-2021, the subject experienced dizziness. On MAY-2021, the subject experienced ringing in the ear. On MAY-2021, the subject experienced fever. The action taken with covid-19 vaccine  was not applicable. The patient recovered from ringing in the ear on MAY-2021, and the outcome of fast heart beat, dizziness and fever was not reported. This report was non-serious.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: DIZZINESS; This spontaneous report received from a patient concerned a 71 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included penicillin allergy, alcohol use, non-smoker, heart diseases, cholesterol, and blood pressure, and other pre-existing medical conditions included the patient was taking medications for heart diseases, cholesterol and blood pressure. The patient experienced drug allergy when treated with codeine. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 204821A, expiry: UNKNOWN) dose was not reported, administered on 28-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 01-MAY-2021, the subject experienced dizziness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from dizziness. This report was non-serious. This case, from the same reporter is linked to 20210537307.
Sex: F
Vaccine: COVID19
Symptoms: Chest X-ray, Dyspnoea, Oxygen saturation
Clinical narrative: SHORTNESS OF BREATH SOMETIMES WITHOUT ACTIVITY; This spontaneous report received from a patient concerned a 66 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient had no problem with the lungs or heart. T he patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 28-APR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On MAY-2021, the subject experienced shortness of breath sometimes without activity. On 17-MAY-2021, Laboratory data included: Chest X-ray (NR: not provided) Negative.  Laboratory data (dates unspecified) included: Oxygen saturation (NR: not provided) 96% to 98%. The action taken with covid-19 vaccine  was not applicable. The patient had not recovered from shortness of breath sometimes without activity. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: FATIGUE; This spontaneous report received from a patient concerned a 62 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included smoker, non-alcoholic, and allergy, and other pre-existing medical conditions included the patient had no known drug abuse or illicit drug use. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: 1821286 expiry: UNKNOWN) dose was not reported, administered on 18-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 18-MAY-2021, the subject experienced fatigue. The action taken with covid-19 vaccine  was not applicable. The patient had not recovered from fatigue. This report was non-serious.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Injection site pain
Clinical narrative: GENERAL FATIGUE; HEADACHE; INJECTION SITE PAIN; This spontaneous report received from a consumer concerned a 25 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included alcohol consumption (socially, about once per week), non smoker, and grass, tree and pollen allergy, and other pre-existing medical conditions included patient had no drug abuse or illicit drug usage. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 18-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. The batch number was not reported and has been requested.  On 19-MAY-2021, the subject experienced general fatigue. On 19-MAY-2021, the subject experienced headache. On 19-MAY-2021, the subject experienced injection site pain. Treatment medications (dates unspecified) included: acetylsalicylic acid, and paracetamol. The action taken with covid-19 vaccine  was not applicable. The patient had not recovered from general fatigue, and injection site pain, and the outcome of headache was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Poor quality product administered
Clinical narrative: MEDICATION ADMINISTRATION ERROR/PUNCTURED VIAL WAS KEPT MORE THAN 6 HOURS IN THE REFRIGERATOR AND WAS ADMINISTERED; This spontaneous report received from a pharmacist concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced medication administration error/punctured vial was kept more than 6 hours in the refrigerator and was administered. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of medication administration error/punctured vial was kept more than 6 hours in the refrigerator and was administered was not reported. This report was non-serious.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pyrexia, Tremor
Clinical narrative: INSIDES SHAKY LITTLE IN THE BEGINNING; HEADACHE; SUBJECTIVE FEVER; This spontaneous report received from a patient concerned a 64 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included anxiety issues, environmental allergy, allergy to bee stings, and anaphylactic reactions. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: 208a21a, expiry: 21-JUN-2021) dose was not reported, administered on 17-MAY-2021 for prophylactic vaccination. No concomitant medications were reported.  On 17-MAY-2021, the subject experienced insides shaky little in the beginning. On 17-MAY-2021, the subject experienced headache. On 17-MAY-2021, the subject experienced subjective fever. The action taken with covid-19 vaccine  was not applicable. The patient recovered from insides shaky little in the beginning on MAY-2021, headache on 18-MAY-2021, and subjective fever on 17-MAY-2021. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Product administration error
Clinical narrative: 1 VIAL OF JANSSEN COVID-19 VACCINE WAS DILUTED WITH 1.8 ML OF SALINE AND A SINGLE DOSE GIVEN BY MISTAKE; This spontaneous report received from a pharmacist concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's history of drug abuse or illicit drug usage, consume alcohol, and smoking was not reported.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the subject experienced 1 vial of janssen covid-19 vaccine was diluted with 1.8 ml of saline and a single dose given by mistake. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of 1 vial of janssen covid-19 vaccine was diluted with 1.8 ml of saline and a single dose given by mistake was not reported. This report was non-serious.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Asthenopia, Chills, Dizziness, Dyspnoea
Clinical narrative: COULDN'T TAKE A DEEP BREATH; FELT COLD; WHOLE BODY ACHY; DIZZINESS; WEAKNESS; CHILLS; EXTREMELY TIRED; NAUSEATED; EYES GOT HEAVY; This spontaneous report received from a patient concerned a 41 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included type2 diabetes. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: 206A21A, and batch number: 206A21A expiry: UNKNOWN) dose was not reported, administered on 18-MAY-2021 for prophylactic vaccination. Concomitant medications included metformin for type2 diabetes. On 18-MAY-2021, the subject experienced whole body achy. On 18-MAY-2021, the subject experienced dizziness. On 18-MAY-2021, the subject experienced weakness. On 18-MAY-2021, the subject experienced chills. On 18-MAY-2021, the subject experienced extremely tired. On 18-MAY-2021, the subject experienced nauseated. On 18-MAY-2021, the subject experienced eyes got heavy. On 19-MAY-2021, the subject experienced couldn't take a deep breath. On 19-MAY-2021, the subject experienced felt cold. The action taken with covid-19 vaccine  was not applicable. The patient recovered from nauseated on MAY-2021, was recovering from couldn't take a deep breath, had not recovered from extremely tired, whole body achy, weakness, and chills, and the outcome of dizziness, eyes got heavy and felt cold was not reported. This report was non-serious.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Feeling cold, Nausea, Pain
Clinical narrative: COULDN'T TAKE A DEEP BREATH; FELT COLD; WHOLE BODY ACHY; DIZZINESS; WEAKNESS; CHILLS; EXTREMELY TIRED; NAUSEATED; EYES GOT HEAVY; This spontaneous report received from a patient concerned a 41 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included type2 diabetes. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: 206A21A, and batch number: 206A21A expiry: UNKNOWN) dose was not reported, administered on 18-MAY-2021 for prophylactic vaccination. Concomitant medications included metformin for type2 diabetes. On 18-MAY-2021, the subject experienced whole body achy. On 18-MAY-2021, the subject experienced dizziness. On 18-MAY-2021, the subject experienced weakness. On 18-MAY-2021, the subject experienced chills. On 18-MAY-2021, the subject experienced extremely tired. On 18-MAY-2021, the subject experienced nauseated. On 18-MAY-2021, the subject experienced eyes got heavy. On 19-MAY-2021, the subject experienced couldn't take a deep breath. On 19-MAY-2021, the subject experienced felt cold. The action taken with covid-19 vaccine  was not applicable. The patient recovered from nauseated on MAY-2021, was recovering from couldn't take a deep breath, had not recovered from extremely tired, whole body achy, weakness, and chills, and the outcome of dizziness, eyes got heavy and felt cold was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Hyperhidrosis, Pain in extremity
Clinical narrative: Sweating; Sore Arm; This spontaneous report received from a consumer concerned a 63 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the subject experienced sweating, and sore arm. The action taken with covid-19 vaccine  was not applicable. The patient recovered from sweating, and sore arm. This report was non-serious.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Balance disorder, Biopsy endometrium, Blood pressure measurement, Confusional state, Dizziness
Clinical narrative: Postmenopausal bleeding; Dizziness; Confused; Slurring words; Went onto ground, Crashed onto left arm; Head flashes; Vertigo; This spontaneous case was reported by a consumer and describes the occurrence of POSTMENOPAUSAL HAEMORRHAGE (Postmenopausal bleeding) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014M20A and 025b21a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Endometrial biopsy (Failed endometrial linining biopsy due to scar tissue from a previous cerclage placed in 2004) on 21-Apr-2021, Hysteroscopy (Waiting on lab results) on 07-May-2021 and Uterine dilation and curettage (Waiting on lab results) on 07-May-2021. Concurrent medical conditions included Penicillin allergy, Food allergy (mango, pineapple, avocado, shrimp, watermelon, pomegranate, kiwi, cantaloupe) and Drug allergy (opioids, narcotics).   On 12-Mar-2021 at 5:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Mar-2021, the patient experienced DIZZINESS (Dizziness), CONFUSIONAL STATE (Confused), DYSARTHRIA (Slurring words), BALANCE DISORDER (Went onto ground, Crashed onto left arm), HOT FLUSH (Head flashes) and VERTIGO (Vertigo). On 30-Mar-2021, the patient experienced POSTMENOPAUSAL HAEMORRHAGE (Postmenopausal bleeding) (seriousness criterion medically significant). At the time of the report, POSTMENOPAUSAL HAEMORRHAGE (Postmenopausal bleeding) outcome was unknown and DIZZINESS (Dizziness), CONFUSIONAL STATE (Confused), DYSARTHRIA (Slurring words), BALANCE DISORDER (Went onto ground, Crashed onto left arm), HOT FLUSH (Head flashes) and VERTIGO (Vertigo) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 19-Mar-2021, Blood pressure measurement: abnormal (abnormal) 102/73. On 21-Apr-2021, Biopsy endometrium: failed (Inconclusive) failed. On 07-May-2021, Hysteroscopy: unknown (Inconclusive) unknown. On 07-May-2021, Uterine dilation and curettage: unknown (Inconclusive) 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.   This case was linked to (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 10-May-2021: VAERS; 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: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Dysarthria, Hot flush, Hysteroscopy, Postmenopausal haemorrhage, Uterine dilation and curettage
Clinical narrative: Postmenopausal bleeding; Dizziness; Confused; Slurring words; Went onto ground, Crashed onto left arm; Head flashes; Vertigo; This spontaneous case was reported by a consumer and describes the occurrence of POSTMENOPAUSAL HAEMORRHAGE (Postmenopausal bleeding) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014M20A and 025b21a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Endometrial biopsy (Failed endometrial linining biopsy due to scar tissue from a previous cerclage placed in 2004) on 21-Apr-2021, Hysteroscopy (Waiting on lab results) on 07-May-2021 and Uterine dilation and curettage (Waiting on lab results) on 07-May-2021. Concurrent medical conditions included Penicillin allergy, Food allergy (mango, pineapple, avocado, shrimp, watermelon, pomegranate, kiwi, cantaloupe) and Drug allergy (opioids, narcotics).   On 12-Mar-2021 at 5:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Mar-2021, the patient experienced DIZZINESS (Dizziness), CONFUSIONAL STATE (Confused), DYSARTHRIA (Slurring words), BALANCE DISORDER (Went onto ground, Crashed onto left arm), HOT FLUSH (Head flashes) and VERTIGO (Vertigo). On 30-Mar-2021, the patient experienced POSTMENOPAUSAL HAEMORRHAGE (Postmenopausal bleeding) (seriousness criterion medically significant). At the time of the report, POSTMENOPAUSAL HAEMORRHAGE (Postmenopausal bleeding) outcome was unknown and DIZZINESS (Dizziness), CONFUSIONAL STATE (Confused), DYSARTHRIA (Slurring words), BALANCE DISORDER (Went onto ground, Crashed onto left arm), HOT FLUSH (Head flashes) and VERTIGO (Vertigo) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 19-Mar-2021, Blood pressure measurement: abnormal (abnormal) 102/73. On 21-Apr-2021, Biopsy endometrium: failed (Inconclusive) failed. On 07-May-2021, Hysteroscopy: unknown (Inconclusive) unknown. On 07-May-2021, Uterine dilation and curettage: unknown (Inconclusive) 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.   This case was linked to (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 10-May-2021: VAERS; 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: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Vertigo
Clinical narrative: Postmenopausal bleeding; Dizziness; Confused; Slurring words; Went onto ground, Crashed onto left arm; Head flashes; Vertigo; This spontaneous case was reported by a consumer and describes the occurrence of POSTMENOPAUSAL HAEMORRHAGE (Postmenopausal bleeding) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014M20A and 025b21a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Endometrial biopsy (Failed endometrial linining biopsy due to scar tissue from a previous cerclage placed in 2004) on 21-Apr-2021, Hysteroscopy (Waiting on lab results) on 07-May-2021 and Uterine dilation and curettage (Waiting on lab results) on 07-May-2021. Concurrent medical conditions included Penicillin allergy, Food allergy (mango, pineapple, avocado, shrimp, watermelon, pomegranate, kiwi, cantaloupe) and Drug allergy (opioids, narcotics).   On 12-Mar-2021 at 5:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Mar-2021, the patient experienced DIZZINESS (Dizziness), CONFUSIONAL STATE (Confused), DYSARTHRIA (Slurring words), BALANCE DISORDER (Went onto ground, Crashed onto left arm), HOT FLUSH (Head flashes) and VERTIGO (Vertigo). On 30-Mar-2021, the patient experienced POSTMENOPAUSAL HAEMORRHAGE (Postmenopausal bleeding) (seriousness criterion medically significant). At the time of the report, POSTMENOPAUSAL HAEMORRHAGE (Postmenopausal bleeding) outcome was unknown and DIZZINESS (Dizziness), CONFUSIONAL STATE (Confused), DYSARTHRIA (Slurring words), BALANCE DISORDER (Went onto ground, Crashed onto left arm), HOT FLUSH (Head flashes) and VERTIGO (Vertigo) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 19-Mar-2021, Blood pressure measurement: abnormal (abnormal) 102/73. On 21-Apr-2021, Biopsy endometrium: failed (Inconclusive) failed. On 07-May-2021, Hysteroscopy: unknown (Inconclusive) unknown. On 07-May-2021, Uterine dilation and curettage: unknown (Inconclusive) 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.   This case was linked to (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 10-May-2021: VAERS; 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: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Depressed mood, Malaise, Pyrexia, Rash
Clinical narrative: rash; depressed; Fever; doesn't feel good; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of RASH (rash), DEPRESSED MOOD (depressed), PYREXIA (Fever) and MALAISE (doesn't feel good) in a 28-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 07B21A0) for COVID-19 vaccination.     Concurrent medical conditions included Common variable immunodeficiency. Concomitant products included VITAMINS NOS for an unknown indication.    On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, the patient experienced RASH (rash) (seriousness criterion hospitalization), DEPRESSED MOOD (depressed) (seriousness criterion hospitalization), PYREXIA (Fever) (seriousness criterion hospitalization) and MALAISE (doesn't feel good) (seriousness criterion hospitalization). The patient was hospitalized on sometime in April 2021 due to DEPRESSED MOOD, MALAISE, PYREXIA and RASH. At the time of the report, RASH (rash), DEPRESSED MOOD (depressed), PYREXIA (Fever) and MALAISE (doesn't feel good) outcome was unknown. Unknown      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Additional concomitant medication included unspecified muscle relaxants.   Treatment information was not reported.  For mRNA-1273 (Moderna COVID-19 Vaccine), the reporter did not provide any causality assessments.  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 10-May-2021: Case was upgraded to serious as the patient was hospitalized due to events for approximately a week.; 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: F
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Catheterisation cardiac, Dyspnoea, Dysstasia
Clinical narrative: heart cath; Fluid on the lungs; short of breath; Did not get second shot due to illness; sore arm; not being able to stand up and being weak; Aching all over every joint; not being able to stand up and being weak; This spontaneous case was reported by a consumer and describes the occurrence of CATHETERISATION CARDIAC (heart cath) and PULMONARY OEDEMA (Fluid on the lungs) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included SACUBITRIL VALSARTAN SODIUM HYDRATE (ENTRESTO), LEVOTHYROXINE, METOPROLOL, FUROSEMIDE, POTASSIUM, WARFARIN, GABAPENTIN and METOLAZONE 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 17-Mar-2021, the patient experienced CATHETERISATION CARDIAC (heart cath) (seriousness criterion hospitalization). On an unknown date, the patient experienced PULMONARY OEDEMA (Fluid on the lungs) (seriousness criterion medically significant), DYSPNOEA (short of breath), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Did not get second shot due to illness), PAIN IN EXTREMITY (sore arm), ASTHENIA (not being able to stand up and being weak), ARTHRALGIA (Aching all over every joint) and DYSSTASIA (not being able to stand up and being weak). On 17-Mar-2021, CATHETERISATION CARDIAC (heart cath) outcome was unknown. At the time of the report, PULMONARY OEDEMA (Fluid on the lungs), DYSPNOEA (short of breath), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Did not get second shot due to illness), PAIN IN EXTREMITY (sore arm), ASTHENIA (not being able to stand up and being weak), ARTHRALGIA (Aching all over every joint) and DYSSTASIA (not being able to stand up and being weak) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, SARS-CoV-2 test: negative (Negative) negative.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Cardiac catheterization on 17-Mar-2021.  Based on the current available information and temporal association between the use of the product and the start date of the events( cardiac catheterization, dyspnea, pulmonary oedema, dysstasia, asthenia, pain in extremity and arthralgia) a causal relationship cannot be excluded. However for the event of inappropriate schedule of Product administration for  mRNA-1273, causality is assessed as not applicable; 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( cardiac catheterization, dyspnea, pulmonary oedema, dysstasia, asthenia, pain in extremity and arthralgia) a causal relationship cannot be excluded. However for the event of inappropriate schedule of Product administration for  mRNA-1273, causality is assessed as not applicable
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Pain in extremity, Pulmonary oedema, SARS-CoV-2 test
Clinical narrative: heart cath; Fluid on the lungs; short of breath; Did not get second shot due to illness; sore arm; not being able to stand up and being weak; Aching all over every joint; not being able to stand up and being weak; This spontaneous case was reported by a consumer and describes the occurrence of CATHETERISATION CARDIAC (heart cath) and PULMONARY OEDEMA (Fluid on the lungs) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included SACUBITRIL VALSARTAN SODIUM HYDRATE (ENTRESTO), LEVOTHYROXINE, METOPROLOL, FUROSEMIDE, POTASSIUM, WARFARIN, GABAPENTIN and METOLAZONE 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 17-Mar-2021, the patient experienced CATHETERISATION CARDIAC (heart cath) (seriousness criterion hospitalization). On an unknown date, the patient experienced PULMONARY OEDEMA (Fluid on the lungs) (seriousness criterion medically significant), DYSPNOEA (short of breath), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Did not get second shot due to illness), PAIN IN EXTREMITY (sore arm), ASTHENIA (not being able to stand up and being weak), ARTHRALGIA (Aching all over every joint) and DYSSTASIA (not being able to stand up and being weak). On 17-Mar-2021, CATHETERISATION CARDIAC (heart cath) outcome was unknown. At the time of the report, PULMONARY OEDEMA (Fluid on the lungs), DYSPNOEA (short of breath), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Did not get second shot due to illness), PAIN IN EXTREMITY (sore arm), ASTHENIA (not being able to stand up and being weak), ARTHRALGIA (Aching all over every joint) and DYSSTASIA (not being able to stand up and being weak) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, SARS-CoV-2 test: negative (Negative) negative.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Cardiac catheterization on 17-Mar-2021.  Based on the current available information and temporal association between the use of the product and the start date of the events( cardiac catheterization, dyspnea, pulmonary oedema, dysstasia, asthenia, pain in extremity and arthralgia) a causal relationship cannot be excluded. However for the event of inappropriate schedule of Product administration for  mRNA-1273, causality is assessed as not applicable; 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( cardiac catheterization, dyspnea, pulmonary oedema, dysstasia, asthenia, pain in extremity and arthralgia) a causal relationship cannot be excluded. However for the event of inappropriate schedule of Product administration for  mRNA-1273, causality is assessed as not applicable
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Eye haemorrhage, Ocular hyperaemia, Swelling of eyelid
Clinical narrative: Burst blood vessel hemorrhage and is small; eyelids were a little bit swollen; Right eye is red; This spontaneous case was reported by a consumer and describes the occurrence of EYE HAEMORRHAGE (Burst blood vessel hemorrhage and is small) in a 67-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.   In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1. On 04-May-2021, the patient experienced EYE HAEMORRHAGE (Burst blood vessel hemorrhage and is small) (seriousness criterion medically significant), SWELLING OF EYELID (eyelids were a little bit swollen) and OCULAR HYPERAEMIA (Right eye is red). At the time of the report, EYE HAEMORRHAGE (Burst blood vessel hemorrhage and is small), SWELLING OF EYELID (eyelids were a little bit swollen) and OCULAR HYPERAEMIA (Right eye is red) outcome was unknown. Not Provided          Concomitant product use was not provided by the reporter. Treatment information was not provided.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   This case was linked to MOD-2021-109540, MOD-2021-109560 (E2B Linked Report).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. MOD-2021-109540: MOD-2021-109560:
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fall, Headache, Loss of consciousness, Pain in extremity
Clinical narrative: Ended up falling down; did not feel crappy until she was getting up/wave of not feeling well; got really lightheaded; ended up passing out on the floor; arm was really hurting; really bad headache; This spontaneous case was reported by a patient and describes the occurrence of LOSS OF CONSCIOUSNESS (ended up passing out on the floor) in a 27-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    No Medical History information was reported.  On 05-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-May-2021, the patient experienced PAIN IN EXTREMITY (arm was really hurting) and HEADACHE (really bad headache). On 06-May-2021, the patient experienced LOSS OF CONSCIOUSNESS (ended up passing out on the floor) (seriousness criterion medically significant), FALL (Ended up falling down), VACCINATION COMPLICATION (did not feel crappy until she was getting up/wave of not feeling well) and DIZZINESS (got really lightheaded). At the time of the report, LOSS OF CONSCIOUSNESS (ended up passing out on the floor), PAIN IN EXTREMITY (arm was really hurting), FALL (Ended up falling down), VACCINATION COMPLICATION (did not feel crappy until she was getting up/wave of not feeling well), DIZZINESS (got really lightheaded) and HEADACHE (really bad headache) outcome was unknown.  The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.  Concomitant medication information not provided. Treatment information not provided.  Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the 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: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: Ended up falling down; did not feel crappy until she was getting up/wave of not feeling well; got really lightheaded; ended up passing out on the floor; arm was really hurting; really bad headache; This spontaneous case was reported by a patient and describes the occurrence of LOSS OF CONSCIOUSNESS (ended up passing out on the floor) in a 27-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    No Medical History information was reported.  On 05-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-May-2021, the patient experienced PAIN IN EXTREMITY (arm was really hurting) and HEADACHE (really bad headache). On 06-May-2021, the patient experienced LOSS OF CONSCIOUSNESS (ended up passing out on the floor) (seriousness criterion medically significant), FALL (Ended up falling down), VACCINATION COMPLICATION (did not feel crappy until she was getting up/wave of not feeling well) and DIZZINESS (got really lightheaded). At the time of the report, LOSS OF CONSCIOUSNESS (ended up passing out on the floor), PAIN IN EXTREMITY (arm was really hurting), FALL (Ended up falling down), VACCINATION COMPLICATION (did not feel crappy until she was getting up/wave of not feeling well), DIZZINESS (got really lightheaded) and HEADACHE (really bad headache) outcome was unknown.  The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.  Concomitant medication information not provided. Treatment information not provided.  Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Breast operation, Inappropriate schedule of product administration, Malaise
Clinical narrative: 2 MAJOR BREAST CANCER SURGERY; still not feeling well; second shot will potentially be greater than day 36/patient did not receive second shot on time due breast surgery; This spontaneous case was reported by a consumer and describes the occurrence of BREAST OPERATION (2 MAJOR BREAST CANCER SURGERY) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Breast cancer.    On 02-Apr-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 BREAST OPERATION (2 MAJOR BREAST CANCER SURGERY) (seriousness criterion hospitalization), MALAISE (still not feeling well) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second shot will potentially be greater than day 36/patient did not receive second shot on time due breast surgery). The patient was treated with Surgery for Breast operation. At the time of the report, BREAST OPERATION (2 MAJOR BREAST CANCER SURGERY), MALAISE (still not feeling well) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second shot will potentially be greater than day 36/patient did not receive second shot on time due breast surgery) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication and treatment information were not reported.  Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded except for the event of Breast surgery as it is unlikely.   This case was linked to US-MODERNATX, INC.-MOD-2021-109590 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded except for the event of Breast surgery as it is unlikely. US-MODERNATX, INC.-MOD-2021-109590:
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Gait inability, Gastrointestinal haemorrhage, Walking aid user
Clinical narrative: GI bleeding; Walking with a walker; Not Able to Walk; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of GASTROINTESTINAL HAEMORRHAGE (GI bleeding) in a 78-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 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Mar-2021, the patient experienced GASTROINTESTINAL HAEMORRHAGE (GI bleeding) (seriousness criteria hospitalization prolonged and medically significant). On 05-Apr-2021, the patient experienced GAIT INABILITY (Not Able to Walk). On 06-May-2021, the patient experienced WALKING AID USER (Walking with a walker). The patient was hospitalized from 15-Mar-2021 to 05-Apr-2021 due to GASTROINTESTINAL HAEMORRHAGE. The patient was treated with Rehabilitation therapy for Gait inability. At the time of the report, GASTROINTESTINAL HAEMORRHAGE (GI bleeding) outcome was unknown and GAIT INABILITY (Not Able to Walk) and WALKING AID USER (Walking with a walker) was resolving. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.  Concomitant product use was not provided. On 14 Apr 2021, the patient was moved to Rehab, and after 3 weeks in rehab, she is now walking with a walker. It was reported that the patient has not received the second vaccine yet.  Company Comment: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.; Sender's Comments: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.