chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Erythema
Clinical narrative: people who got Moderna, their arm was red; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a nurse and describes the occurrence of ERYTHEMA (people who got Moderna, their arm was red) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ERYTHEMA (people who got Moderna, their arm was red). At the time of the report, ERYTHEMA (people who got Moderna, their arm was red) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medication was reported. No treatment medications were reported.   This case was linked to MOD-2021-024374, MOD-2021-024374, MOD-2021-329115, MOD-2021-329194 (Patient Link).
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Pain
Clinical narrative: Aching body after first shot; Joint pain after first shot; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Aching body after first shot) and ARTHRALGIA (Joint pain after first shot) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced PAIN (Aching body after first shot) and ARTHRALGIA (Joint pain after first shot). At the time of the report, PAIN (Aching body after first shot) and ARTHRALGIA (Joint pain after first shot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications was not reported.  Treatment medications was not reported.   This case was linked to MOD-2021-329346 (Patient Link).   Reporter did not allow further contact
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Hives after second shot; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Hives after second shot) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In March 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In March 2021, the patient experienced URTICARIA (Hives after second shot). In March 2021, URTICARIA (Hives after second shot) had resolved.            No Concomitant medications were reported. No Treatment medications were reported.   This case was linked to MOD-2021-329316 (Patient Link).   Reporter did not allow further contact
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: off for a few days (2nd dose); head malaise (2nd dose); This spontaneous case was reported by an other health care professional and describes the occurrence of MALAISE (off for a few days (2nd dose)) and MALAISE (head malaise (2nd dose)) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001A21A and 004M20A) for COVID-19 vaccination.     No medical history provided by reporter.  Concomitant products included LEVOTHYROXINE, ROSUVASTATIN CALCIUM (CRESTOR), LORATADINE, TOLTERODINE L-TARTRATE (DETROL) and ACETYLSALICYLIC ACID (BABY ASPIRIN) for an unknown indication.   On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced MALAISE (off for a few days (2nd dose)) and MALAISE (head malaise (2nd dose)). At the time of the report, MALAISE (off for a few days (2nd dose)) and MALAISE (head malaise (2nd dose)) outcome was unknown.            No concomitant medication information was provided.  No treatment medication information was provided.   This case was linked to MOD-2021-329388 (Patient Link).
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Product temperature excursion issue
Clinical narrative: Second dose administered after temperature excursion; This spontaneous case was reported by a health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Second dose administered after temperature excursion) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026C21A and 026C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 24-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 21-Sep-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Second dose administered after temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Second dose administered after temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant products were reported. No treatment information was reported by the reporter.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Got positive COVID-19 test on 26Aug2021, Pyrexia; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Got positive COVID-19 test on 26Aug2021, Pyrexia) in a 52-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Aug-2021, the patient experienced COVID-19 (Got positive COVID-19 test on 26Aug2021, Pyrexia). At the time of the report, COVID-19 (Got positive COVID-19 test on 26Aug2021, Pyrexia) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 26-Aug-2021, SARS-CoV-2 test: positive (Positive) POSITIVE.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. No treatment information was reported. The patient got positive COVID-19 test  on 26Aug2021. Had fever and got tested had COVID results.  Patient received the vaccination in the right (unclear)   This case concerns a  52-year-old, male patient with no relevant medical history, who experienced the unexpected event of COVID 19. The event occurred approximately 30 days after the second dose of Moderna COVID-19 Vaccine. The rechallenge was unknown since events occurred after first dose and no information about the second dose was disclosed as not yet administered. Based on the current available information, the mRNA-1273 does not contain a virus capable of causing COVID-19 infection after vaccination. The benefit-risk relationship of Moderna COVID-19 Vaccine is not affected by this report.
Sex: M
Vaccine: COVID19
Symptoms: Throat irritation
Clinical narrative: Throat was on fire; This spontaneous case was reported by a consumer and describes the occurrence of THROAT IRRITATION (Throat was on fire) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced THROAT IRRITATION (Throat was on fire). At the time of the report, THROAT IRRITATION (Throat was on fire) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not reported by the reporter Treatment drugs were not reported by the reporter Patient recovered in 2-3 days.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: patients were administered the temperature excursion doses; patients were administered the temperature excursion doses; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT STORAGE ERROR (patients were administered the temperature excursion doses) and EXPIRED PRODUCT ADMINISTERED (patients were administered the temperature excursion doses) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT STORAGE ERROR (patients were administered the temperature excursion doses) and EXPIRED PRODUCT ADMINISTERED (patients were administered the temperature excursion doses). At the time of the report, PRODUCT STORAGE ERROR (patients were administered the temperature excursion doses) and EXPIRED PRODUCT ADMINISTERED (patients were administered the temperature excursion doses) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication use was unknown Treatment information was unknown
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: Shingles as possible side effect; This spontaneous case was reported by a consumer and describes the occurrence of HERPES ZOSTER (Shingles as possible side effect) in a 7-decade-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In July 2021, the patient experienced HERPES ZOSTER (Shingles as possible side effect). At the time of the report, HERPES ZOSTER (Shingles as possible side effect) outcome was unknown.            No Concomitant and Treatment were reported.
Sex: M
Vaccine: COVID19
Symptoms: Hypoacusis
Clinical narrative: Caller stated he had problems hearing; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 23-Sep-2021 and was forwarded to Moderna on 23-Sep-2021.    This spontaneous case was reported by a consumer and describes the occurrence of HYPOACUSIS (Caller stated he had problems hearing) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HYPOACUSIS (Caller stated he had problems hearing). At the time of the report, HYPOACUSIS (Caller stated he had problems hearing) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Caller called to know the information on booster dose  Patient has hearing problem and on the process of preparing for surgery.it was not clarified whether those problem started before or after the vaccine. Concomitant medications were not provided. Treatment information was not provided.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: The staff thought the punctured vial expiration is 24 hours and not 12 hours after 1st puncture/Patients administered dose beyond 12 hours after first vial puncture; putting the vial back in the refrigerator at the end of the day; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (The staff thought the punctured vial expiration is 24 hours and not 12 hours after 1st puncture/Patients administered dose beyond 12 hours after first vial puncture) and PRODUCT STORAGE ERROR (putting the vial back in the refrigerator at the end of the day) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046C21A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (The staff thought the punctured vial expiration is 24 hours and not 12 hours after 1st puncture/Patients administered dose beyond 12 hours after first vial puncture) and PRODUCT STORAGE ERROR (putting the vial back in the refrigerator at the end of the day). At the time of the report, EXPIRED PRODUCT ADMINISTERED (The staff thought the punctured vial expiration is 24 hours and not 12 hours after 1st puncture/Patients administered dose beyond 12 hours after first vial puncture) and PRODUCT STORAGE ERROR (putting the vial back in the refrigerator at the end of the day) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 24-Sep-2021: Follow up case: The lot/batch numbers provided. On 24-Sep-2021: Significant follow-up-Lot details updated.
Sex: M
Vaccine: COVID19
Symptoms: Anxiety, Blood pressure measurement, Dizziness, Ear disorder, Fatigue
Clinical narrative: headaches; dizziness; tiredness; fever; aches; nausea; worsening of a preexistent ear problem; anxiety; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headaches) and DIZZINESS (dizziness) in an elderly male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 07-Sep-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HEADACHE (headaches) (seriousness criterion medically significant), DIZZINESS (dizziness) (seriousness criterion medically significant), FATIGUE (tiredness), PYREXIA (fever), PAIN (aches), NAUSEA (nausea), EAR DISORDER (worsening of a preexistent ear problem) and ANXIETY (anxiety). At the time of the report, HEADACHE (headaches), DIZZINESS (dizziness), FATIGUE (tiredness), PYREXIA (fever), PAIN (aches), NAUSEA (nausea), EAR DISORDER (worsening of a preexistent ear problem) and ANXIETY (anxiety) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: increased (High) High Blood pressure.         concomitant information was not provided by reporter No treatment information was provided. After 2 weeks he still has the same side effects, fatigue, nausea, headaches; Sender's Comments: This case concerns an 80-year-old, male patient with no relevant medical history reported, who experienced the unexpected events of dizziness, anxiety, pain, blood pressure increased and worsening of preexistant ear disorder and expected events of headache, nausea, fatigue and pyrexia. The events occurred after the third dose of Moderna COVID-19 Vaccine. The rechallenge was not applicable as no further dosing is expected. The benefit-risk relationship of Moderna COVID-19 Vaccine is not affected by this report.
Sex: M
Vaccine: COVID19
Symptoms: Headache, Nausea, Pain, Pyrexia
Clinical narrative: headaches; dizziness; tiredness; fever; aches; nausea; worsening of a preexistent ear problem; anxiety; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headaches) and DIZZINESS (dizziness) in an elderly male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 07-Sep-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HEADACHE (headaches) (seriousness criterion medically significant), DIZZINESS (dizziness) (seriousness criterion medically significant), FATIGUE (tiredness), PYREXIA (fever), PAIN (aches), NAUSEA (nausea), EAR DISORDER (worsening of a preexistent ear problem) and ANXIETY (anxiety). At the time of the report, HEADACHE (headaches), DIZZINESS (dizziness), FATIGUE (tiredness), PYREXIA (fever), PAIN (aches), NAUSEA (nausea), EAR DISORDER (worsening of a preexistent ear problem) and ANXIETY (anxiety) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: increased (High) High Blood pressure.         concomitant information was not provided by reporter No treatment information was provided. After 2 weeks he still has the same side effects, fatigue, nausea, headaches; Sender's Comments: This case concerns an 80-year-old, male patient with no relevant medical history reported, who experienced the unexpected events of dizziness, anxiety, pain, blood pressure increased and worsening of preexistant ear disorder and expected events of headache, nausea, fatigue and pyrexia. The events occurred after the third dose of Moderna COVID-19 Vaccine. The rechallenge was not applicable as no further dosing is expected. The benefit-risk relationship of Moderna COVID-19 Vaccine is not affected by this report.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Feeling abnormal, Headache, Influenza like illness, Pyrexia
Clinical narrative: Would feel something if I move it a certain way or made a certain movement; mentally foggy/started to feel off; uncomfortable flu-like symptoms; Headaches; Chills; Fever; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 23-Sep-2021 and was forwarded to Moderna on 23-Sep-2021.    This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE DISCOMFORT (I would feel something if I move it a certain way or made a certain movement), HEADACHE (Headaches), CHILLS (Chills), PYREXIA (Fever) and FEELING ABNORMAL (mentally foggy) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031L20A and 031A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE DISCOMFORT (I would feel something if I move it a certain way or made a certain movement), HEADACHE (Headaches), CHILLS (Chills), PYREXIA (Fever), FEELING ABNORMAL (mentally foggy), FEELING ABNORMAL (started to feel off) and INFLUENZA LIKE ILLNESS (uncomfortable flu-like symptoms). At the time of the report, VACCINATION SITE DISCOMFORT (I would feel something if I move it a certain way or made a certain movement), HEADACHE (Headaches), CHILLS (Chills), PYREXIA (Fever), FEELING ABNORMAL (mentally foggy), FEELING ABNORMAL (started to feel off) and INFLUENZA LIKE ILLNESS (uncomfortable flu-like symptoms) outcome was unknown.            No concomitant medication was reported. No treatment medication was reported. Patient also include blasted event.   This case was linked to MOD-2021-329230 (Patient Link).
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site discomfort
Clinical narrative: Would feel something if I move it a certain way or made a certain movement; mentally foggy/started to feel off; uncomfortable flu-like symptoms; Headaches; Chills; Fever; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 23-Sep-2021 and was forwarded to Moderna on 23-Sep-2021.    This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE DISCOMFORT (I would feel something if I move it a certain way or made a certain movement), HEADACHE (Headaches), CHILLS (Chills), PYREXIA (Fever) and FEELING ABNORMAL (mentally foggy) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031L20A and 031A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE DISCOMFORT (I would feel something if I move it a certain way or made a certain movement), HEADACHE (Headaches), CHILLS (Chills), PYREXIA (Fever), FEELING ABNORMAL (mentally foggy), FEELING ABNORMAL (started to feel off) and INFLUENZA LIKE ILLNESS (uncomfortable flu-like symptoms). At the time of the report, VACCINATION SITE DISCOMFORT (I would feel something if I move it a certain way or made a certain movement), HEADACHE (Headaches), CHILLS (Chills), PYREXIA (Fever), FEELING ABNORMAL (mentally foggy), FEELING ABNORMAL (started to feel off) and INFLUENZA LIKE ILLNESS (uncomfortable flu-like symptoms) outcome was unknown.            No concomitant medication was reported. No treatment medication was reported. Patient also include blasted event.   This case was linked to MOD-2021-329230 (Patient Link).
Age: 37.0
Sex: F
Vaccine: COVID19, FLUX, PPV
Symptoms: Blood pressure measurement, Cold sweat, Dizziness, Dyspnoea, Feeling abnormal
Clinical narrative: clammy; threw up; shortness of breath/cannot catch her breath; dizzy/spinning; rapid heart beat/palpitation; dripping sweat; felt close to pass out.; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (shortness of breath/cannot catch her breath), DIZZINESS (dizzy/spinning), PALPITATIONS (rapid heart beat/palpitation), HYPERHIDROSIS (dripping sweat) and FEELING ABNORMAL (felt close to pass out.) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 061E21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect products included non-company products INFLUENZA VACCINE (FLU VACCINE VII) for an unknown indication and PNEUMOCOCCAL VACCINE POLYSACCH 23V (PNEUMOVAX) for an unknown indication.    Concurrent medical conditions included Hypertension (High blood pressure since last one year). Concomitant products included HYDROCHLOROTHIAZIDE, LISINOPRIL (LISINOPRIL/HYDROCHLOROTHIAZIDE) for Hypertension.   On 22-Sep-2021, the patient received dose of INFLUENZA VACCINE (FLU VACCINE VII) (unknown route) at an unspecified dose and dose of PNEUMOCOCCAL VACCINE POLYSACCH 23V (PNEUMOVAX) (unknown route) at an unspecified dose. On 22-Sep-2021 at 5:30 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Sep-2021 at 10:30 PM, the patient experienced DYSPNOEA (shortness of breath/cannot catch her breath), DIZZINESS (dizzy/spinning), PALPITATIONS (rapid heart beat/palpitation), HYPERHIDROSIS (dripping sweat) and FEELING ABNORMAL (felt close to pass out.). On 23-Sep-2021, the patient experienced COLD SWEAT (clammy) and VOMITING (threw up). At the time of the report, DYSPNOEA (shortness of breath/cannot catch her breath), DIZZINESS (dizzy/spinning), PALPITATIONS (rapid heart beat/palpitation), HYPERHIDROSIS (dripping sweat), FEELING ABNORMAL (felt close to pass out.), COLD SWEAT (clammy) and VOMITING (threw up) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: 72/56 (Low) Blood pressure was 72/56.     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.   Treatment medication was not provided by the reporter
Age: 37.0
Sex: F
Vaccine: COVID19, FLUX, PPV
Symptoms: Hyperhidrosis, Palpitations, Vomiting
Clinical narrative: clammy; threw up; shortness of breath/cannot catch her breath; dizzy/spinning; rapid heart beat/palpitation; dripping sweat; felt close to pass out.; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (shortness of breath/cannot catch her breath), DIZZINESS (dizzy/spinning), PALPITATIONS (rapid heart beat/palpitation), HYPERHIDROSIS (dripping sweat) and FEELING ABNORMAL (felt close to pass out.) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 061E21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect products included non-company products INFLUENZA VACCINE (FLU VACCINE VII) for an unknown indication and PNEUMOCOCCAL VACCINE POLYSACCH 23V (PNEUMOVAX) for an unknown indication.    Concurrent medical conditions included Hypertension (High blood pressure since last one year). Concomitant products included HYDROCHLOROTHIAZIDE, LISINOPRIL (LISINOPRIL/HYDROCHLOROTHIAZIDE) for Hypertension.   On 22-Sep-2021, the patient received dose of INFLUENZA VACCINE (FLU VACCINE VII) (unknown route) at an unspecified dose and dose of PNEUMOCOCCAL VACCINE POLYSACCH 23V (PNEUMOVAX) (unknown route) at an unspecified dose. On 22-Sep-2021 at 5:30 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Sep-2021 at 10:30 PM, the patient experienced DYSPNOEA (shortness of breath/cannot catch her breath), DIZZINESS (dizzy/spinning), PALPITATIONS (rapid heart beat/palpitation), HYPERHIDROSIS (dripping sweat) and FEELING ABNORMAL (felt close to pass out.). On 23-Sep-2021, the patient experienced COLD SWEAT (clammy) and VOMITING (threw up). At the time of the report, DYSPNOEA (shortness of breath/cannot catch her breath), DIZZINESS (dizzy/spinning), PALPITATIONS (rapid heart beat/palpitation), HYPERHIDROSIS (dripping sweat), FEELING ABNORMAL (felt close to pass out.), COLD SWEAT (clammy) and VOMITING (threw up) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: 72/56 (Low) Blood pressure was 72/56.     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.   Treatment medication was not provided by the reporter
Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Pain, Pyrexia, Vomiting
Clinical narrative: the day after getting the shot i had a fever and chills and body aches on top of terrible vomiting that lasted all day.  I was unable to keep any water down at all while my fever kept getting worse and i considered going to the hospital by the end of it. i only had fever from my first shot and i wasn't prepared for how bad the second shot would be.
Sex: F
Vaccine: COVID19
Symptoms: Throat irritation
Clinical narrative: throat was on fire; This spontaneous case was reported by a consumer and describes the occurrence of THROAT IRRITATION (throat was on fire) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    In January 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced THROAT IRRITATION (throat was on fire). At the time of the report, THROAT IRRITATION (throat was on fire) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant drugs were reported. No treatment drugs were reported.  Patient whole family took the Moderna COVID-19 vaccine, her son had to wait until March 2021 to get it. Patient son has a weak immune system, he has a mutated gene on the 5th chromosome. When is Moderna going to have a booster shot? What stage is it in with the FDA? Could her son get a third dose? One day patient husband came home and his throat was on fire (reported in crosslinked case MOD21-146697) and then  patient got it as well and now her son has it (reported in crosslinked case MOD21-146698). They don't know what it is. Patient husband recovered in 2-3 days, Patient recovered in 2 days and her son is recovering but he still has it. Patient works with a high risk population and is worried she might get covid. How many doses of the booster have been distributed in her area? Who would take priority for the booster shot? Patient wants to know that Did her antibodies wane completely since she have been vaccinated almost 10 months ago?   This case was linked to MOD-2021-329582 (Patient Link).
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Back pain, Balance disorder, Dyskinesia, Fatigue, Gait disturbance
Clinical narrative: Wobbly; gate problem; balance problem / his body was out of balance; back pain/he can no longer bend over to put on socks; waking up at night; Felt fatigue; This spontaneous case was reported by a consumer and describes the occurrence of DYSKINESIA (Wobbly), GAIT DISTURBANCE (gate problem), BALANCE DISORDER (balance problem / his body was out of balance), BACK PAIN (back pain/he can no longer bend over to put on socks) and SLEEP DISORDER (waking up at night) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced DYSKINESIA (Wobbly), GAIT DISTURBANCE (gate problem), BALANCE DISORDER (balance problem / his body was out of balance), BACK PAIN (back pain/he can no longer bend over to put on socks), SLEEP DISORDER (waking up at night) and FATIGUE (Felt fatigue). At the time of the report, DYSKINESIA (Wobbly), GAIT DISTURBANCE (gate problem), BALANCE DISORDER (balance problem / his body was out of balance), BACK PAIN (back pain/he can no longer bend over to put on socks), SLEEP DISORDER (waking up at night) and FATIGUE (Felt fatigue) outcome was unknown.            No concomitant medications were reported.  Treatment medications were not provided by the reporter.  Patient was can no longer bend over to put on socks      Most recent FOLLOW-UP information incorporated above includes: On 27-Sep-2021: Follow-up received contains no new information.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Sleep disorder
Clinical narrative: Wobbly; gate problem; balance problem / his body was out of balance; back pain/he can no longer bend over to put on socks; waking up at night; Felt fatigue; This spontaneous case was reported by a consumer and describes the occurrence of DYSKINESIA (Wobbly), GAIT DISTURBANCE (gate problem), BALANCE DISORDER (balance problem / his body was out of balance), BACK PAIN (back pain/he can no longer bend over to put on socks) and SLEEP DISORDER (waking up at night) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced DYSKINESIA (Wobbly), GAIT DISTURBANCE (gate problem), BALANCE DISORDER (balance problem / his body was out of balance), BACK PAIN (back pain/he can no longer bend over to put on socks), SLEEP DISORDER (waking up at night) and FATIGUE (Felt fatigue). At the time of the report, DYSKINESIA (Wobbly), GAIT DISTURBANCE (gate problem), BALANCE DISORDER (balance problem / his body was out of balance), BACK PAIN (back pain/he can no longer bend over to put on socks), SLEEP DISORDER (waking up at night) and FATIGUE (Felt fatigue) outcome was unknown.            No concomitant medications were reported.  Treatment medications were not provided by the reporter.  Patient was can no longer bend over to put on socks      Most recent FOLLOW-UP information incorporated above includes: On 27-Sep-2021: Follow-up received contains no new information.
Sex: U
Vaccine: COVID19
Symptoms: Erythema
Clinical narrative: he had two or three patients that had red arms; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a physician and describes the occurrence of ERYTHEMA (he had two or three patients that had red arms) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ERYTHEMA (he had two or three patients that had red arms). At the time of the report, ERYTHEMA (he had two or three patients that had red arms) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment details were reported.   This case was linked to MOD-2021-329591 (Patient Link).   Reporter did not allow further contact
Sex: M
Vaccine: COVID19
Symptoms: Throat irritation
Clinical narrative: throat was on fire; This spontaneous case was reported by a consumer and describes the occurrence of THROAT IRRITATION (throat was on fire) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced THROAT IRRITATION (throat was on fire). At the time of the report, THROAT IRRITATION (throat was on fire) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       It was reported that patient has a weak immune system, he has a mutated gene on the 5th chromosome. No concomitant medications were reported. No treatment medications were reported.    This case was linked to MOD-2021-329527, MOD-2021-329394 (Patient Link).
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Product temperature excursion issue
Clinical narrative: first dose administered after temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (first dose administered after temperature excursion) in a 24-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Sep-2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (first dose administered after temperature excursion). On 21-Sep-2021, PRODUCT TEMPERATURE EXCURSION ISSUE (first dose administered after temperature excursion) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.
Sex: U
Vaccine: COVID19
Symptoms: Influenza like illness
Clinical narrative: they had the flu for a couple of days after which they felt fine; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (they had the flu for a couple of days after which they felt fine) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (they had the flu for a couple of days after which they felt fine). At the time of the report, INFLUENZA LIKE ILLNESS (they had the flu for a couple of days after which they felt fine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication of the patient was not reported.  No treatment information was provided by the reporter.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Chills, Illness, Lymphadenopathy, Nausea
Clinical narrative: rash on the injected arm; swollen lymph node in arm; felt really sick; Nausea; high fever; chills; heart palpitations/"it felt like my heart pounding out of the chest; little chest pain; This spontaneous case was reported by a consumer and describes the occurrence of PALPITATIONS (heart palpitations/"it felt like my heart pounding out of the chest), CHEST PAIN (little chest pain), ILLNESS (felt really sick), NAUSEA (Nausea) and PYREXIA (high fever) in a 65-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 20-Sep-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Sep-2021, the patient experienced PALPITATIONS (heart palpitations/"it felt like my heart pounding out of the chest) and CHEST PAIN (little chest pain). On 21-Sep-2021, the patient experienced ILLNESS (felt really sick), NAUSEA (Nausea), PYREXIA (high fever) and CHILLS (chills). On 23-Sep-2021, the patient experienced RASH (rash on the injected arm) and LYMPHADENOPATHY (swollen lymph node in arm). On 21-Sep-2021, PALPITATIONS (heart palpitations/"it felt like my heart pounding out of the chest) and CHEST PAIN (little chest pain) had resolved. On 22-Sep-2021, ILLNESS (felt really sick), NAUSEA (Nausea), PYREXIA (high fever) and CHILLS (chills) had resolved. At the time of the report, RASH (rash on the injected arm) outcome was unknown and LYMPHADENOPATHY (swollen lymph node in arm) was resolving.     Concomitant medication was not reported.  Patient noticed she had a rash on the injected arm, but not at the injection site but on the inside elbow.   Treatment information include put some ice on swollen lymph node and it went down.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Palpitations, Pyrexia, Rash
Clinical narrative: rash on the injected arm; swollen lymph node in arm; felt really sick; Nausea; high fever; chills; heart palpitations/"it felt like my heart pounding out of the chest; little chest pain; This spontaneous case was reported by a consumer and describes the occurrence of PALPITATIONS (heart palpitations/"it felt like my heart pounding out of the chest), CHEST PAIN (little chest pain), ILLNESS (felt really sick), NAUSEA (Nausea) and PYREXIA (high fever) in a 65-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 20-Sep-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Sep-2021, the patient experienced PALPITATIONS (heart palpitations/"it felt like my heart pounding out of the chest) and CHEST PAIN (little chest pain). On 21-Sep-2021, the patient experienced ILLNESS (felt really sick), NAUSEA (Nausea), PYREXIA (high fever) and CHILLS (chills). On 23-Sep-2021, the patient experienced RASH (rash on the injected arm) and LYMPHADENOPATHY (swollen lymph node in arm). On 21-Sep-2021, PALPITATIONS (heart palpitations/"it felt like my heart pounding out of the chest) and CHEST PAIN (little chest pain) had resolved. On 22-Sep-2021, ILLNESS (felt really sick), NAUSEA (Nausea), PYREXIA (high fever) and CHILLS (chills) had resolved. At the time of the report, RASH (rash on the injected arm) outcome was unknown and LYMPHADENOPATHY (swollen lymph node in arm) was resolving.     Concomitant medication was not reported.  Patient noticed she had a rash on the injected arm, but not at the injection site but on the inside elbow.   Treatment information include put some ice on swollen lymph node and it went down.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Product temperature excursion issue
Clinical narrative: second dose administered after temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (second dose administered after temperature excursion) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026C21A and 026C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 18-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 20-Sep-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (second dose administered after temperature excursion). On 20-Sep-2021, PRODUCT TEMPERATURE EXCURSION ISSUE (second dose administered after temperature excursion) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant drug was not reported. Treatment medication was not reported.  It was reported that storing vaccine experienced a temperature excursion for a duration of 1 hour and 24 minutes on 18Sep2021.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Myalgia, Pyrexia
Clinical narrative: fever (102.4°F); Arm sore; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever (102.4°F)) and MYALGIA (Arm sore) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Sep-2021, the patient experienced PYREXIA (fever (102.4°F)) and MYALGIA (Arm sore). The patient was treated with PARACETAMOL (TYLENOL) for Symptomatic treatment, at an unspecified dose and frequency. At the time of the report, PYREXIA (fever (102.4°F)) and MYALGIA (Arm sore) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 22-Sep-2021, Body temperature: 102.4 (High) 102.4 degree F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Respiration abnormal
Clinical narrative: Mild breathing symptoms after the 1st dose; This spontaneous case was reported by a consumer and describes the occurrence of RESPIRATION ABNORMAL (Mild breathing symptoms after the 1st dose) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022M20A) for COVID-19 vaccination.     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 an unknown date, the patient experienced RESPIRATION ABNORMAL (Mild breathing symptoms after the 1st dose). At the time of the report, RESPIRATION ABNORMAL (Mild breathing symptoms after the 1st dose) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported.  No treatment information was provided.   This case was linked to MOD-2021-329780, MOD-2021-329985 (Patient Link).
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Feeling abnormal, Rash
Clinical narrative: Brain fog; Bust out in rash all over the body; Rash all over body and was burning; This spontaneous case was reported by a consumer and describes the occurrence of BURNING SENSATION (Rash all over body and was burning), FEELING ABNORMAL (Brain fog) and RASH (Bust out in rash all over the body) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002F21 and 091D21A) for COVID-19 vaccination.     No Medical History information was reported.   On 26-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Aug-2021, the patient experienced BURNING SENSATION (Rash all over body and was burning) and RASH (Bust out in rash all over the body). On 24-Aug-2021, the patient experienced FEELING ABNORMAL (Brain fog). In September 2021, FEELING ABNORMAL (Brain fog) had resolved. At the time of the report, BURNING SENSATION (Rash all over body and was burning) and RASH (Bust out in rash all over the body) outcome was unknown.            Concomitant medication information was not provided by the reporter.  Treatment information was not provided by the reporter.  It was reported that the pharmacist recommended to take but patient didn't took it as she did not like drugs. 1 month after bump down arm she got injection in back and so was rash all over body.   This case was linked to MOD-2021-329732 (Patient Link).