chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pyrexia
Clinical narrative: CHILLS; FEVER; This spontaneous report received from a patient via a company representative concerned a 39 year old female. 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: 043A21A expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 09-APR-2021, the subject experienced chills. On 09-APR-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fever, and chills. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Pruritus, Rash
Clinical narrative: ITCHY BODY; RASH ALL OVER BODY; This spontaneous report received from a patient concerned a male of unspecified age. 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: 1805029, and expiry: UNKNOWN) dose was not reported, administered on 25-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On an unspecified date, the subject experienced itchy body, and rash all over body. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the rash all over body and itchy body was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Asthenia, Chills, Dizziness, Headache, Pain in extremity
Clinical narrative: FEELING DIZZY AND WOOZY BY THE DAY; CHILLS; SORE ARM; BODILY WEAKNESS; BAD HEADACHE ON SOME PARTS OF HEAD; FEVER; This spontaneous report received from a consumer concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included patient has not had any vaccines in a very long time. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808982, and expiry: UNKNOWN) dose was not reported, administered on 09-APR-2021 10:00 for prophylactic vaccination. No concomitant medications were reported.  On 30-AUG-2020, Laboratory data included: PCR (NR: not provided) Negative.  On 09-APR-2021, the subject experienced feeling dizzy and woozy by the day. On 09-APR-2021, the subject experienced chills. On 09-APR-2021, the subject experienced sore arm. On 09-APR-2021, the subject experienced bodily weakness. On 09-APR-2021, the subject experienced bad headache on some parts of head. On 09-APR-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fever, chills, bad headache on some parts of head, bodily weakness, sore arm, and feeling dizzy and woozy by the day. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Polymerase chain reaction, Pyrexia
Clinical narrative: FEELING DIZZY AND WOOZY BY THE DAY; CHILLS; SORE ARM; BODILY WEAKNESS; BAD HEADACHE ON SOME PARTS OF HEAD; FEVER; This spontaneous report received from a consumer concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included patient has not had any vaccines in a very long time. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808982, and expiry: UNKNOWN) dose was not reported, administered on 09-APR-2021 10:00 for prophylactic vaccination. No concomitant medications were reported.  On 30-AUG-2020, Laboratory data included: PCR (NR: not provided) Negative.  On 09-APR-2021, the subject experienced feeling dizzy and woozy by the day. On 09-APR-2021, the subject experienced chills. On 09-APR-2021, the subject experienced sore arm. On 09-APR-2021, the subject experienced bodily weakness. On 09-APR-2021, the subject experienced bad headache on some parts of head. On 09-APR-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fever, chills, bad headache on some parts of head, bodily weakness, sore arm, and feeling dizzy and woozy by the day. This report was non-serious.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: LITTLE DIZZY; This spontaneous report received from a patient concerned a 70 year old female. 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: 1808978, expiry: UNKNOWN) dose was not reported, administered on 31-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 31-MAR-2021, the subject experienced little dizzy. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from little dizzy on 31-MAR-2021. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Influenza like illness
Clinical narrative: FLU-LIKE SYMPTOMS; This spontaneous report received from a patient concerned a male of unspecified age. 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: Unknown) dose was not reported, administered on 08-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 08-APR-2021, the subject experienced flu-like symptoms. Treatment medications on 08-APR-2021 included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from flu-like symptoms. This report was non-serious.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Back pain
Clinical narrative: SEVERE BACK PAIN ON LOWER LEFT SIDE AND WAS UNABLE TO MOVE OR SIT WITHOUT EXPERIENCING IT; This spontaneous report received from a patient concerned a 72 year old male. The patient's height, and weight were not reported. The patient's past medical history included sciatica. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A, expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 09-APR-2021, the subject experienced severe back pain on lower left side and was unable to move or sit without experiencing it. Treatment medications included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from severe back pain on lower left side and was unable to move or sit without experiencing it. This report was non-serious.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Dizziness, Euphoric mood, Headache, Hyperhidrosis
Clinical narrative: SWEATING; FEELING OFF/HIGH; FLU LIKE SYMPTOMS; FEVER; NAUSEA; DIZZINESS AND LIGHT HEADEDNESS; HEADACHE; COUGH; This spontaneous report received from a patient concerned a 37 year old female. The patient's height, and weight were not reported. The patient's past medical history included pertussis. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported and batch number: 042A21A) dose was not reported, administered on 08-APR-2021 12:00 for prophylactic vaccination. Concomitant medications included salbutamol. On APR-2021, the subject experienced cough. On APR-2021, the subject experienced headache. On 08-APR-2021, the subject experienced dizziness and light headedness. On 08-APR-2021, the subject experienced nausea. On 09-APR-2021, the subject experienced sweating. On 09-APR-2021, the subject experienced feeling off/high. On 09-APR-2021, the subject experienced flu like symptoms. On 09-APR-2021, the subject experienced fever. Laboratory data included: Fever (NR: not provided) 102.7 deg. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from nausea on 09-APR-2021, was recovering from sweating, dizziness and light headedness, and headache, had not recovered from cough, feeling off/high, and flu like symptoms, and the outcome of fever was not reported. This report was non-serious.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness, Nausea, Pyrexia
Clinical narrative: SWEATING; FEELING OFF/HIGH; FLU LIKE SYMPTOMS; FEVER; NAUSEA; DIZZINESS AND LIGHT HEADEDNESS; HEADACHE; COUGH; This spontaneous report received from a patient concerned a 37 year old female. The patient's height, and weight were not reported. The patient's past medical history included pertussis. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported and batch number: 042A21A) dose was not reported, administered on 08-APR-2021 12:00 for prophylactic vaccination. Concomitant medications included salbutamol. On APR-2021, the subject experienced cough. On APR-2021, the subject experienced headache. On 08-APR-2021, the subject experienced dizziness and light headedness. On 08-APR-2021, the subject experienced nausea. On 09-APR-2021, the subject experienced sweating. On 09-APR-2021, the subject experienced feeling off/high. On 09-APR-2021, the subject experienced flu like symptoms. On 09-APR-2021, the subject experienced fever. Laboratory data included: Fever (NR: not provided) 102.7 deg. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from nausea on 09-APR-2021, was recovering from sweating, dizziness and light headedness, and headache, had not recovered from cough, feeling off/high, and flu like symptoms, and the outcome of fever was not reported. This report was non-serious.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia oral, Swollen tongue
Clinical narrative: Tingling tongue; Tongue swelling; This spontaneous case was reported by a non-health professional and describes the occurrence of PARAESTHESIA ORAL (Tingling tongue) and SWOLLEN TONGUE (Tongue swelling) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No adverse event history).    On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Jan-2021, the patient experienced PARAESTHESIA ORAL (Tingling tongue) (seriousness criterion medically significant) and SWOLLEN TONGUE (Tongue swelling) (seriousness criterion medically significant). At the time of the report, PARAESTHESIA ORAL (Tingling tongue) and SWOLLEN TONGUE (Tongue swelling) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Treatment provided was Benadryl 50mg.  This case concerns a 57-year-old female with a serious unexpected event of paraesthesia oral and swollen tongue. Event onset about 20 minutes after first dose mRNA-1273. Treated with Benadryl. Events resolving. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.   Reporter did not allow further contact; Sender's Comments: This case concerns a 57-year-old female with a serious unexpected event of paraesthesia oral and swollen tongue. Event onset about 20 minutes after first dose mRNA-1273. Treated with Benadryl. Events resolving. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Confusional state, Haemophagocytic lymphohistiocytosis, Product dose omission issue, Walking aid user
Clinical narrative: HLH (Hemophagocytic Lymphohistiocytosis); Missed second dose (46 days since first one); Extremely weak; Couldn't walk without a walker; Confused; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HAEMOPHAGOCYTIC LYMPHOHISTIOCYTOSIS (HLH (Hemophagocytic Lymphohistiocytosis)) in a 57-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.     Concurrent medical conditions included Asthma and Allergy. Concomitant products included ALBUTEROL [SALBUTAMOL] for an unknown indication, LORATADINE (CLARITINE), VITAMIN D3 and PROBIOTICS NOS.    On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Mar-2021, the patient experienced CONFUSIONAL STATE (Confused). On 23-Mar-2021, the patient experienced HAEMOPHAGOCYTIC LYMPHOHISTIOCYTOSIS (HLH (Hemophagocytic Lymphohistiocytosis)) (seriousness criterion hospitalization). On 29-Mar-2021, the patient experienced ASTHENIA (Extremely weak) and WALKING AID USER (Couldn't walk without a walker). On 30-Mar-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (Missed second dose (46 days since first one)). The patient was hospitalized from 23-Mar-2021 to 29-Mar-2021 due to HAEMOPHAGOCYTIC LYMPHOHISTIOCYTOSIS. On 29-Mar-2021, HAEMOPHAGOCYTIC LYMPHOHISTIOCYTOSIS (HLH (Hemophagocytic Lymphohistiocytosis)) and CONFUSIONAL STATE (Confused) had resolved. On 30-Mar-2021, PRODUCT DOSE OMISSION ISSUE (Missed second dose (46 days since first one)) had resolved. At the time of the report, ASTHENIA (Extremely weak) and WALKING AID USER (Couldn't walk without a walker) was resolving.        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.   Company comment:57-year-old female patient who missed second dose (product dose omission) after experiencing events of hemophagocytic lymphohistiocytosis, asthenia, walking difficulty and confusion.  The event of product dose omission is assessed as not applicable.  Based on temporality, causality for the other events with mRNA-1273 cannot be excluded.; Sender's Comments: 57-year-old female patient who missed second dose (product dose omission) after experiencing events of hemophagocytic lymphohistiocytosis, asthenia, walking difficulty and confusion.  The event of product dose omission is assessed as not applicable.  Based on temporality, causality for the other events with mRNA-1273 cannot be excluded.
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Feeling abnormal, Impaired work ability, Neuropathy peripheral, Rash
Clinical narrative: Could not get comfortable; Could not function; Rash all over her body; Intense neuropathy; Pain in her back to the point she; This spontaneous case was reported by a consumer and describes the occurrence of NEUROPATHY PERIPHERAL (Intense neuropathy) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Neuropathy and Broken hand.    On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Mar-2021, the patient experienced NEUROPATHY PERIPHERAL (Intense neuropathy) (seriousness criterion medically significant), BACK PAIN (Pain in her back to the point she) and RASH (Rash all over her body). On an unknown date, the patient experienced FEELING ABNORMAL (Could not get comfortable) and IMPAIRED WORK ABILITY (Could not function). At the time of the report, NEUROPATHY PERIPHERAL (Intense neuropathy), BACK PAIN (Pain in her back to the point she), FEELING ABNORMAL (Could not get comfortable), IMPAIRED WORK ABILITY (Could not function) and RASH (Rash all over her body) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. Treatment details included generic Claritin and oxycodone.  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: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Anaphylactic reaction
Clinical narrative: Anaphylaxis; This spontaneous case was reported by a consumer and describes the occurrence of ANAPHYLACTIC REACTION (Anaphylaxis) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Rheumatoid arthritis. Concomitant products included TOCILIZUMAB (ACTEMRA) for an unknown indication.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ANAPHYLACTIC REACTION (Anaphylaxis) (seriousness criterion medically significant). At the time of the report, ANAPHYLACTIC REACTION (Anaphylaxis) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment medication provided  Very limited information regarding this event/s has been provided at this time.  Further information has been requested.   Reporter did not allow further contact; Sender's Comments: Very limited information regarding this event/s has been provided at this time.  Further information has been requested.
Age: 96.0
Sex: F
Vaccine: COVID19
Symptoms: Ascites, Blood test, Feeding disorder, Nausea, Oesophagitis
Clinical narrative: esophagus is severely inflamed; unable to eat or hold down fluids; nausea; vomiting (thick mucusy stomach fluid); Fluid at bottom of lungs; Acites; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PLEURAL EFFUSION (Fluid at bottom of lungs), OESOPHAGITIS (esophagus is severely inflamed), FEEDING DISORDER (unable to eat or hold down fluids), NAUSEA (nausea) and VOMITING (vomiting (thick mucusy stomach fluid)) in a 96-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 05-Mar-2021, the patient experienced PLEURAL EFFUSION (Fluid at bottom of lungs) (seriousness criterion hospitalization). On 16-Mar-2021, the patient experienced NAUSEA (nausea) (seriousness criterion hospitalization) and VOMITING (vomiting (thick mucusy stomach fluid)) (seriousness criterion hospitalization). On 21-Mar-2021, the patient experienced OESOPHAGITIS (esophagus is severely inflamed) (seriousness criterion hospitalization) and FEEDING DISORDER (unable to eat or hold down fluids) (seriousness criterion hospitalization). The patient was hospitalized on 21-Mar-2021 due to FEEDING DISORDER, NAUSEA, OESOPHAGITIS, PLEURAL EFFUSION and VOMITING. At the time of the report, PLEURAL EFFUSION (Fluid at bottom of lungs), OESOPHAGITIS (esophagus is severely inflamed) and FEEDING DISORDER (unable to eat or hold down fluids) had not resolved and NAUSEA (nausea) and VOMITING (vomiting (thick mucusy stomach fluid)) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In February 2021, Blood test: normal (normal) blood work done shortly before getting COVID vaccine and everything came back normal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Additional information: Patient was admitted to the hospital 10 days ago on 21Mar2021. Nausea and vomiting was continuing, patient's esophagus is severely inflamed, patient is unable to eat or hold down fluids, had to start TPN, has had Gastro-Intestinal biopsies performed, Computed Axial Tomography scans, endoscopy, esophagram, oncologist consulted-nothing showing up, fluid in bottom of lungs, ascites-pulling fluid off abdominal cavity with paracentesis (first on 5Mar2021, second paracentesis scheduled for today.) Doctors have been in touch with another facility.; 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: 96.0
Sex: F
Vaccine: COVID19
Symptoms: Pleural effusion, Vomiting
Clinical narrative: esophagus is severely inflamed; unable to eat or hold down fluids; nausea; vomiting (thick mucusy stomach fluid); Fluid at bottom of lungs; Acites; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PLEURAL EFFUSION (Fluid at bottom of lungs), OESOPHAGITIS (esophagus is severely inflamed), FEEDING DISORDER (unable to eat or hold down fluids), NAUSEA (nausea) and VOMITING (vomiting (thick mucusy stomach fluid)) in a 96-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 05-Mar-2021, the patient experienced PLEURAL EFFUSION (Fluid at bottom of lungs) (seriousness criterion hospitalization). On 16-Mar-2021, the patient experienced NAUSEA (nausea) (seriousness criterion hospitalization) and VOMITING (vomiting (thick mucusy stomach fluid)) (seriousness criterion hospitalization). On 21-Mar-2021, the patient experienced OESOPHAGITIS (esophagus is severely inflamed) (seriousness criterion hospitalization) and FEEDING DISORDER (unable to eat or hold down fluids) (seriousness criterion hospitalization). The patient was hospitalized on 21-Mar-2021 due to FEEDING DISORDER, NAUSEA, OESOPHAGITIS, PLEURAL EFFUSION and VOMITING. At the time of the report, PLEURAL EFFUSION (Fluid at bottom of lungs), OESOPHAGITIS (esophagus is severely inflamed) and FEEDING DISORDER (unable to eat or hold down fluids) had not resolved and NAUSEA (nausea) and VOMITING (vomiting (thick mucusy stomach fluid)) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In February 2021, Blood test: normal (normal) blood work done shortly before getting COVID vaccine and everything came back normal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Additional information: Patient was admitted to the hospital 10 days ago on 21Mar2021. Nausea and vomiting was continuing, patient's esophagus is severely inflamed, patient is unable to eat or hold down fluids, had to start TPN, has had Gastro-Intestinal biopsies performed, Computed Axial Tomography scans, endoscopy, esophagram, oncologist consulted-nothing showing up, fluid in bottom of lungs, ascites-pulling fluid off abdominal cavity with paracentesis (first on 5Mar2021, second paracentesis scheduled for today.) Doctors have been in touch with another facility.; 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: Dry throat, Pharyngeal erythema, Pharyngeal swelling, Viral infection
Clinical narrative: Viral infection; throat was red, swollen, and dry; throat was red, swollen, and dry; throat was red, swollen, and dry; This spontaneous case was reported by a consumer and describes the occurrence of VIRAL INFECTION (Viral infection) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunisation. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.    On 24-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Mar-2021, the patient experienced VIRAL INFECTION (Viral infection) (seriousness criterion hospitalization). On an unknown date, the patient experienced PHARYNGEAL ERYTHEMA (throat was red, swollen, and dry), PHARYNGEAL SWELLING (throat was red, swollen, and dry) and DRY THROAT (throat was red, swollen, and dry). The patient was hospitalized on 26-Mar-2021 due to VIRAL INFECTION. At the time of the report, PHARYNGEAL ERYTHEMA (throat was red, swollen, and dry), PHARYNGEAL SWELLING (throat was red, swollen, and dry), DRY THROAT (throat was red, swollen, and dry) and VIRAL INFECTION (Viral infection) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Cerebral haemorrhage, Cerebrovascular accident, Product dose omission issue
Clinical narrative: Brain bleed; Stroke; She has not received the second dose; This spontaneous case was reported by a non-health professional and describes the occurrence of CEREBROVASCULAR ACCIDENT (Stroke) and CEREBRAL HAEMORRHAGE (Brain bleed) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No reported medical history).    On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Feb-2021, the patient experienced CEREBROVASCULAR ACCIDENT (Stroke) (seriousness criterion hospitalization). On an unknown date, the patient experienced CEREBRAL HAEMORRHAGE (Brain bleed) (seriousness criterion hospitalization) and PRODUCT DOSE OMISSION ISSUE (She has not received the second dose). At the time of the report, CEREBROVASCULAR ACCIDENT (Stroke), CEREBRAL HAEMORRHAGE (Brain bleed) and PRODUCT DOSE OMISSION ISSUE (She has not received the second dose) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Based on the current available information and temporal association between the use of the product and the start dates of the events of the serious, a causal relationship cannot be excluded.  It is likely the reported "stroke" and "brain bleed" are descriptions the same event but this is not definitively stated. This report also refers to an event of dose omission.  There were no AEs specifically associated with this medication error; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start dates of the events of the serious, a causal relationship cannot be excluded.  It is likely the reported "stroke" and "brain bleed" are descriptions the same event but this is not definitively stated. This report also refers to an event of dose omission.  There were no AEs specifically associated with this medication error
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain lower, Abscess intestinal, Fear, Incomplete course of vaccination, Pruritus
Clinical narrative: abscess/mass in her intestine; lower abdominal pain; Terrified to receive the 2nd dose; itching; Postponed 2nd dose of the vaccine; urticaria (Hives) all over her body.; This spontaneous case was reported by a consumer and describes the occurrence of ABSCESS INTESTINAL (abscess/mass in her intestine) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No reported medical history).    On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Mar-2021, the patient experienced URTICARIA (urticaria (Hives) all over her body.). On 25-Mar-2021, the patient experienced INCOMPLETE COURSE OF VACCINATION (Postponed 2nd dose of the vaccine). On 01-Apr-2021, the patient experienced PRURITUS (itching). On an unknown date, the patient experienced ABSCESS INTESTINAL (abscess/mass in her intestine) (seriousness criteria hospitalization and medically significant), ABDOMINAL PAIN LOWER (lower abdominal pain) and FEAR (Terrified to receive the 2nd dose). On 25-Mar-2021, INCOMPLETE COURSE OF VACCINATION (Postponed 2nd dose of the vaccine) had resolved. At the time of the report, ABSCESS INTESTINAL (abscess/mass in her intestine), ABDOMINAL PAIN LOWER (lower abdominal pain) and URTICARIA (urticaria (Hives) all over her body.) had not resolved and PRURITUS (itching) and FEAR (Terrified to receive the 2nd dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 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: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: abscess/mass in her intestine; lower abdominal pain; Terrified to receive the 2nd dose; itching; Postponed 2nd dose of the vaccine; urticaria (Hives) all over her body.; This spontaneous case was reported by a consumer and describes the occurrence of ABSCESS INTESTINAL (abscess/mass in her intestine) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No reported medical history).    On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Mar-2021, the patient experienced URTICARIA (urticaria (Hives) all over her body.). On 25-Mar-2021, the patient experienced INCOMPLETE COURSE OF VACCINATION (Postponed 2nd dose of the vaccine). On 01-Apr-2021, the patient experienced PRURITUS (itching). On an unknown date, the patient experienced ABSCESS INTESTINAL (abscess/mass in her intestine) (seriousness criteria hospitalization and medically significant), ABDOMINAL PAIN LOWER (lower abdominal pain) and FEAR (Terrified to receive the 2nd dose). On 25-Mar-2021, INCOMPLETE COURSE OF VACCINATION (Postponed 2nd dose of the vaccine) had resolved. At the time of the report, ABSCESS INTESTINAL (abscess/mass in her intestine), ABDOMINAL PAIN LOWER (lower abdominal pain) and URTICARIA (urticaria (Hives) all over her body.) had not resolved and PRURITUS (itching) and FEAR (Terrified to receive the 2nd dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 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: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Joint stiffness, Pyrexia, Rheumatoid arthritis
Clinical narrative: jumpstart rheumatoid arthritis; couldn't move it for day and a half.; arm had horrible sores; had a temperature over 99.6; joint pain as having "extra stuff in it that wouldn't make it"; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of RHEUMATOID ARTHRITIS (jumpstart rheumatoid arthritis) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (no medical history provided.).    On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Mar-2021, the patient experienced RHEUMATOID ARTHRITIS (jumpstart rheumatoid arthritis) (seriousness criterion medically significant), JOINT STIFFNESS (couldn't move it for day and a half.), SKIN ULCER (arm had horrible sores), PYREXIA (had a temperature over 99.6) and ARTHRALGIA (joint pain as having "extra stuff in it that wouldn't make it"). On 30-Mar-2021, JOINT STIFFNESS (couldn't move it for day and a half.) was resolving. At the time of the report, RHEUMATOID ARTHRITIS (jumpstart rheumatoid arthritis), SKIN ULCER (arm had horrible sores) and ARTHRALGIA (joint pain as having "extra stuff in it that wouldn't make it") was resolving and PYREXIA (had a temperature over 99.6) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 28-Mar-2021, Body temperature: 99.6 had a temperature over 99.6, which is warmer than usual for her.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication and Treatment was not reported. Symptoms are currently healing and are on the downside. Doctor is worried about potential reaction to second dose. Patient wants to know efficacy after one dose and if reaction is normal.  Ok for safety to contact.  Email Preferred.; 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.  Further information has been requested.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Skin ulcer
Clinical narrative: jumpstart rheumatoid arthritis; couldn't move it for day and a half.; arm had horrible sores; had a temperature over 99.6; joint pain as having "extra stuff in it that wouldn't make it"; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of RHEUMATOID ARTHRITIS (jumpstart rheumatoid arthritis) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (no medical history provided.).    On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Mar-2021, the patient experienced RHEUMATOID ARTHRITIS (jumpstart rheumatoid arthritis) (seriousness criterion medically significant), JOINT STIFFNESS (couldn't move it for day and a half.), SKIN ULCER (arm had horrible sores), PYREXIA (had a temperature over 99.6) and ARTHRALGIA (joint pain as having "extra stuff in it that wouldn't make it"). On 30-Mar-2021, JOINT STIFFNESS (couldn't move it for day and a half.) was resolving. At the time of the report, RHEUMATOID ARTHRITIS (jumpstart rheumatoid arthritis), SKIN ULCER (arm had horrible sores) and ARTHRALGIA (joint pain as having "extra stuff in it that wouldn't make it") was resolving and PYREXIA (had a temperature over 99.6) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 28-Mar-2021, Body temperature: 99.6 had a temperature over 99.6, which is warmer than usual for her.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication and Treatment was not reported. Symptoms are currently healing and are on the downside. Doctor is worried about potential reaction to second dose. Patient wants to know efficacy after one dose and if reaction is normal.  Ok for safety to contact.  Email Preferred.; 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.  Further information has been requested.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Hypersensitivity, Meniere's disease, Nausea, Pain
Clinical narrative: Meniere's Disease; Heart started racing; Throat began to get itchy; Extreme dizziness; Nausea; Severe allergic reaction; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of MENIERE'S DISEASE (Meniere's Disease) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 019E21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No relevant medical information provided). Concomitant products included BETAHISTINE for an unknown indication.    On 31-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Mar-2021, the patient experienced PAIN (Sore arm). On 31-Mar-2021, the patient experienced PALPITATIONS (Heart started racing), THROAT IRRITATION (Throat began to get itchy), DIZZINESS (Extreme dizziness), NAUSEA (Nausea) and HYPERSENSITIVITY (Severe allergic reaction). On an unknown date, the patient experienced MENIERE'S DISEASE (Meniere's Disease) (seriousness criterion medically significant). On 03-Mar-2021, PAIN (Sore arm) had resolved. On 31-Mar-2021, PALPITATIONS (Heart started racing), THROAT IRRITATION (Throat began to get itchy), DIZZINESS (Extreme dizziness), NAUSEA (Nausea) and HYPERSENSITIVITY (Severe allergic reaction) outcome was unknown. At the time of the report, MENIERE'S DISEASE (Meniere's Disease) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment medication included "Diazepam, Zofran and Tylenol PM" Action taken with mRNA-1273 in response to the events was 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, a causal relationship cannot be excluded.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Palpitations, Throat irritation
Clinical narrative: Meniere's Disease; Heart started racing; Throat began to get itchy; Extreme dizziness; Nausea; Severe allergic reaction; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of MENIERE'S DISEASE (Meniere's Disease) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 019E21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No relevant medical information provided). Concomitant products included BETAHISTINE for an unknown indication.    On 31-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Mar-2021, the patient experienced PAIN (Sore arm). On 31-Mar-2021, the patient experienced PALPITATIONS (Heart started racing), THROAT IRRITATION (Throat began to get itchy), DIZZINESS (Extreme dizziness), NAUSEA (Nausea) and HYPERSENSITIVITY (Severe allergic reaction). On an unknown date, the patient experienced MENIERE'S DISEASE (Meniere's Disease) (seriousness criterion medically significant). On 03-Mar-2021, PAIN (Sore arm) had resolved. On 31-Mar-2021, PALPITATIONS (Heart started racing), THROAT IRRITATION (Throat began to get itchy), DIZZINESS (Extreme dizziness), NAUSEA (Nausea) and HYPERSENSITIVITY (Severe allergic reaction) outcome was unknown. At the time of the report, MENIERE'S DISEASE (Meniere's Disease) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment medication included "Diazepam, Zofran and Tylenol PM" Action taken with mRNA-1273 in response to the events was 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, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Haematemesis
Clinical narrative: spit out blood and blood clots; This spontaneous case was reported by a consumer and describes the occurrence of HAEMATEMESIS (spit out blood and blood clots) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history. ).    On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HAEMATEMESIS (spit out blood and blood clots) (seriousness criterion medically significant). At the time of the report, HAEMATEMESIS (spit out blood and blood clots) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were not provided, no treatment information were provided.   Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Sex: U
Vaccine: COVID19
Symptoms: Seizure
Clinical narrative: Major motor seizure; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of SEIZURE (Major motor seizure) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No recorded medical history).    On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced SEIZURE (Major motor seizure) (seriousness criterion medically significant). At the time of the report, SEIZURE (Major motor seizure) 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.   Concomitant product use was not provided by the reporter.  Treatment information was not provided.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of this event, a causal relationship cannot be excluded.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Dysentery, Dyspnoea
Clinical narrative: could hardly breathe; right side of chest hurt, like I pulled a muscle; dysentery; This spontaneous case was reported by a consumer and describes the occurrence of DYSENTERY (dysentery) in an 80-year-old female patient 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.     The patient's past medical history included Blood pressure high and Blood sugar abnormal.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In March 2021, the patient experienced DYSENTERY (dysentery) (seriousness criterion medically significant). On 31-Mar-2021, the patient experienced DYSPNOEA (could hardly breathe) and CHEST PAIN (right side of chest hurt, like I pulled a muscle). At the time of the report, DYSENTERY (dysentery), DYSPNOEA (could hardly breathe) and CHEST PAIN (right side of chest hurt, like I pulled a muscle) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant products known to have been used by the patient, within two weeks prior to the event, included high blood pressure medication and medication for sugars.  Treatment of these events included unspecified ointment.  Very limited information regarding the has been provided at this time for the event. Further information has been requested.  The reported events were considered possibly related to mRNA-1273.; Sender's Comments: Very limited information regarding the has been provided at this time for the event. Further information has been requested.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Coronary artery dissection, Myocardial infarction, Pain, Pyrexia
Clinical narrative: Spontaneous coronary artery dissection mild type 2 heart attack; Mild type 2 heart attack; Chest pain; Fever; body ache; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of CORONARY ARTERY DISSECTION (Spontaneous coronary artery dissection mild type 2 heart attack) and MYOCARDIAL INFARCTION (Mild type 2 heart attack) in a 34-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 045A21A and 023M2OA) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 27-Mar-2021, the patient experienced PAIN (body ache) and PYREXIA (Fever). On 28-Mar-2021, the patient experienced CHEST PAIN (Chest pain). On 30-Mar-2021, the patient experienced CORONARY ARTERY DISSECTION (Spontaneous coronary artery dissection mild type 2 heart attack) (seriousness criterion hospitalization) and MYOCARDIAL INFARCTION (Mild type 2 heart attack) (seriousness criterion hospitalization). The patient was hospitalized from 30-Mar-2021 to 31-Mar-2021 due to CORONARY ARTERY DISSECTION and MYOCARDIAL INFARCTION. At the time of the report, CORONARY ARTERY DISSECTION (Spontaneous coronary artery dissection mild type 2 heart attack), MYOCARDIAL INFARCTION (Mild type 2 heart attack), PAIN (body ache), CHEST PAIN (Chest pain) and PYREXIA (Fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In February 2021, Electrocardiogram: results were fine normal.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications were nor reported. Treatment information included unspecified medication.   This case was linked to MOD-2021-066271 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.