chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Myalgia, Pyrexia
Clinical narrative: Headache; Body Aches; Slight Fever; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache), MYALGIA (Body Aches) and PYREXIA (Slight Fever) in a 32-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Mar-2021, the patient experienced HEADACHE (Headache), MYALGIA (Body Aches) and PYREXIA (Slight Fever). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. At the time of the report, HEADACHE (Headache), MYALGIA (Body Aches) and PYREXIA (Slight Fever) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product information was not provided.   This case was linked to MOD-2021-271852 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Peripheral swelling, Tenderness
Clinical narrative: The arm that they injected is extremely swollen; Extremely tender arm; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (The arm that they injected is extremely swollen) and TENDERNESS (Extremely tender arm) 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.    In July 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PERIPHERAL SWELLING (The arm that they injected is extremely swollen) and TENDERNESS (Extremely tender arm). At the time of the report, PERIPHERAL SWELLING (The arm that they injected is extremely swollen) and TENDERNESS (Extremely tender arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.     No concomitant medications were reported by the reporter.  Treatment information was not provided by the reporter.
Age: 24.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Cough, Illness, Pneumonia, Vaccination site pain
Clinical narrative: Pneumonia; bit sick; Dry cough; Pain at the site of the injection; Chest pain; This spontaneous case was reported by a consumer and describes the occurrence of PNEUMONIA (Pneumonia) in a 24-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 009B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 01-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jul-2021, the patient experienced CHEST PAIN (Chest pain) and VACCINATION SITE PAIN (Pain at the site of the injection). On an unknown date, the patient experienced PNEUMONIA (Pneumonia) (seriousness criterion medically significant), ILLNESS (bit sick) and COUGH (Dry cough). At the time of the report, PNEUMONIA (Pneumonia), CHEST PAIN (Chest pain), ILLNESS (bit sick), COUGH (Dry cough) and VACCINATION SITE PAIN (Pain at the site of the injection) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient was diagnosed with Asthma around 17-Jul-2021 and was prescribed an inhaler.  Patient reported that his condition has not improved and stated that he has pneumonia and a dry cough that hurts. He said he was a bit sick when he got the vaccine but was told that it was okay to get the 1st dose (Patient has not received the 2nd).  Concomitant medication: INHALER.  Treatment information was not provided.  Company comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   Most recent FOLLOW-UP information incorporated above includes: On 18-Aug-2021: Follow-up information received included events pneumonia, dry cough and sickness were added, case seriousness was upgraded from non-serious to serious due to the newly added serious event pneumonia.; 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: 89.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pruritus
Clinical narrative: itchy after one hour; That arm also stayed red for 4 weeks.; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (itchy after one hour) and ERYTHEMA (That arm also stayed red for 4 weeks.) in an 89-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 06-Apr-2021, the patient experienced PRURITUS (itchy after one hour). On an unknown date, the patient experienced ERYTHEMA (That arm also stayed red for 4 weeks.). The patient was treated with HYDROCORTISONE for Itching, at an unspecified dose and frequency. At the time of the report, PRURITUS (itchy after one hour) outcome was unknown and ERYTHEMA (That arm also stayed red for 4 weeks.) had resolved.            No concomitant treatment was provided.   This case was linked to MOD-2021-053403 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 30-Jul-2021: FU: Event added for second dose
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Vaccine administered to patients after 32 days in the refrigerator/Vaccine was given 8 daysbeyond 30 days stored in refrigerator; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT STORAGE ERROR (Vaccine administered to patients after 32 days in the refrigerator/Vaccine was given 8 daysbeyond 30 days stored in refrigerator) in a 30-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 024C21A and 001C21A) for COVID-19 vaccination.     No medical history was reported by the reporter.  Concomitant products included BUPRENORPHINE HYDROCHLORIDE, NALOXONE HYDROCHLORIDE (SUBOXONE) from 02-Dec-2020 to an unknown date for Substance use disorder.   On 05-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine administered to patients after 32 days in the refrigerator/Vaccine was given 8 daysbeyond 30 days stored in refrigerator). At the time of the report, PRODUCT STORAGE ERROR (Vaccine administered to patients after 32 days in the refrigerator/Vaccine was given 8 daysbeyond 30 days stored in refrigerator) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 31-Jul-2021: Patient demographics was updated. Suspect product dose 1 details was added. Dose 2 information of anatomical location was updated. Concomitant medication-Suboxone was added.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Dupuytren's contracture, SARS-CoV-2 test
Clinical narrative: knots within the palms of their left hand; This spontaneous case was reported by a consumer and describes the occurrence of DUPUYTREN'S CONTRACTURE (knots within the palms of their left hand) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013M20A and 027L20A) for COVID-19 vaccination.     Concurrent medical conditions included COVID-19 since 29-Dec-2020.   On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced DUPUYTREN'S CONTRACTURE (knots within the palms of their left hand) (seriousness criterion medically significant). At the time of the report, DUPUYTREN'S CONTRACTURE (knots within the palms of their left hand) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 29-Dec-2020, SARS-CoV-2 test: positive (Positive) Positive.         No concomitant medications were provided by the reporter.  Treatment information was not provided by the reporter.  Company Comment: Very limited information regarding this event has been provided at this time. Additional information required.; Sender's Comments: Very limited information regarding this event has been provided at this time. Additional information required.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Moderna vaccine more than 12 hours after the vaccine was removed from the refrigerator; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Moderna vaccine more than 12 hours after the vaccine was removed from the refrigerator) in a 53-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Aug-2021 at 4:22 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Aug-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Moderna vaccine more than 12 hours after the vaccine was removed from the refrigerator). On 01-Aug-2021, EXPIRED PRODUCT ADMINISTERED (Moderna vaccine more than 12 hours after the vaccine was removed from the refrigerator) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported by the reporter.   Treatment information was not provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 18-Aug-2021: Patient demographics and anatomical location updated.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired Vaccine administered to patient; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired Vaccine administered to patient) in a 42-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939902) for COVID-19 vaccination.     No Medical History information was reported.   On 01-Aug-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Aug-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired Vaccine administered to patient). On 03-Aug-2021, EXPIRED PRODUCT ADMINISTERED (Expired Vaccine administered to patient) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   It is reported that 1 Vial of Moderna COVID-19 vaccine was taken out of the refrigerator, punctured and kept at  room temperature (67.2F) beyond 12 hours. The vial was first punctured at 1:01 PM on 31-JUL-2021.  Patient received his second dose of Moderna COVID-19 Vaccine from a vial that was expired (21 hours and 20 minutes at 67.2 Fahrenheit steady temperature).  No concomitant medication was provided. No treatment medication was provided.   This case was linked to MOD-2021-273129, MOD-2021-273149, MOD-2021-273286, MOD-2021-273448, MOD-2021-273721 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 12-Aug-2021: Follow up document received and patient race, ethnicity and patient anatomical location of second dose is updated.
Sex: F
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: patient missed  the recommended window for her second dose; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (patient missed  the recommended window for her second dose) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (patient missed  the recommended window for her second dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (patient missed  the recommended window for her second dose) 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 medication was reported.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: Never had 2nd Dose; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Never had 2nd Dose) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Never had 2nd Dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Never had 2nd Dose) had resolved.            No Concomitant medications were reported. No Treatment medications were reported.
Sex: M
Vaccine: COVID19
Symptoms: Anxiety, Behaviour disorder, Completed suicide, Depression, Insomnia
Clinical narrative: Suicidal ideation; Mouth blisters; Anxiety; Depression; Insomnia; Major changes in mood, demeanor and thought; Irrational behavior; Took his own life Apr2021; This spontaneous case was reported by a consumer and describes the occurrence of COMPLETED SUICIDE (Took his own life Apr2021) and SUICIDAL IDEATION (Suicidal ideation) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   In February 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 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 April 2021, the patient experienced COMPLETED SUICIDE (Took his own life Apr2021) (seriousness criteria death and medically significant). On an unknown date, the patient experienced SUICIDAL IDEATION (Suicidal ideation) (seriousness criterion medically significant), ORAL MUCOSAL BLISTERING (Mouth blisters), ANXIETY (Anxiety), DEPRESSION (Depression), INSOMNIA (Insomnia), MOOD ALTERED (Major changes in mood, demeanor and thought) and BEHAVIOUR DISORDER (Irrational behavior). The patient was treated with HYDROXYZINE EMBONATE (VISTARIL [HYDROXYZINE EMBONATE]) at an unspecified dose and frequency. The patient died in April 2021. The cause of death was not reported. It is unknown if an autopsy was performed. At the time of death, SUICIDAL IDEATION (Suicidal ideation), ORAL MUCOSAL BLISTERING (Mouth blisters), ANXIETY (Anxiety), DEPRESSION (Depression), INSOMNIA (Insomnia), MOOD ALTERED (Major changes in mood, demeanor and thought) and BEHAVIOUR DISORDER (Irrational behavior) outcome was unknown.            No concomitant medications were given by the reporter.   Patient went to the hospital to have these side effects checked for about 5 times. He was diagnosed to have Depression, Anxiety, Insomnia, and Suicidal Ideation and was prescribed with Vistaril.  Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.; Sender's Comments: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.; Reported Cause(s) of Death: Unknown cause of death
Sex: M
Vaccine: COVID19
Symptoms: Mood altered, Oral mucosal blistering, Suicidal ideation
Clinical narrative: Suicidal ideation; Mouth blisters; Anxiety; Depression; Insomnia; Major changes in mood, demeanor and thought; Irrational behavior; Took his own life Apr2021; This spontaneous case was reported by a consumer and describes the occurrence of COMPLETED SUICIDE (Took his own life Apr2021) and SUICIDAL IDEATION (Suicidal ideation) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   In February 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 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 April 2021, the patient experienced COMPLETED SUICIDE (Took his own life Apr2021) (seriousness criteria death and medically significant). On an unknown date, the patient experienced SUICIDAL IDEATION (Suicidal ideation) (seriousness criterion medically significant), ORAL MUCOSAL BLISTERING (Mouth blisters), ANXIETY (Anxiety), DEPRESSION (Depression), INSOMNIA (Insomnia), MOOD ALTERED (Major changes in mood, demeanor and thought) and BEHAVIOUR DISORDER (Irrational behavior). The patient was treated with HYDROXYZINE EMBONATE (VISTARIL [HYDROXYZINE EMBONATE]) at an unspecified dose and frequency. The patient died in April 2021. The cause of death was not reported. It is unknown if an autopsy was performed. At the time of death, SUICIDAL IDEATION (Suicidal ideation), ORAL MUCOSAL BLISTERING (Mouth blisters), ANXIETY (Anxiety), DEPRESSION (Depression), INSOMNIA (Insomnia), MOOD ALTERED (Major changes in mood, demeanor and thought) and BEHAVIOUR DISORDER (Irrational behavior) outcome was unknown.            No concomitant medications were given by the reporter.   Patient went to the hospital to have these side effects checked for about 5 times. He was diagnosed to have Depression, Anxiety, Insomnia, and Suicidal Ideation and was prescribed with Vistaril.  Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.; Sender's Comments: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.; Reported Cause(s) of Death: Unknown cause of death
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Breast pain, Chest pain, Dizziness, Headache
Clinical narrative: numbness on my head/numbness in head/now the numbness has moved to the back of her head; feel dizzy; left arm pain; itching on forehead; left breast pain,; memory issue; scalp  is  making  noises,; body aches; headache; chest pain on the left side; back pain; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (numbness on my head/numbness in head/now the numbness has moved to the back of her head), DIZZINESS (feel dizzy), PAIN IN EXTREMITY (left arm pain), PRURITUS (itching on forehead) and CHEST PAIN (chest pain on the left side) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027D2IA) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included CLONAZEPAM and PERPHENAZINE for Paranoia, CHLORPHENAMINE MALEATE (CHLORAMINE S) and DIPYRIDAMOLE (PERSANTINE) for an unknown indication.    On 02-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Aug-2021, the patient experienced CHEST PAIN (chest pain on the left side), BACK PAIN (back pain) and HEADACHE (headache). On an unknown date, the patient experienced HYPOAESTHESIA (numbness on my head/numbness in head/now the numbness has moved to the back of her head), DIZZINESS (feel dizzy), PAIN IN EXTREMITY (left arm pain), PRURITUS (itching on forehead), BREAST PAIN (left breast pain,), MEMORY IMPAIRMENT (memory issue), TINNITUS (scalp  is  making  noises,) and MYALGIA (body aches). On 06-Aug-2021, CHEST PAIN (chest pain on the left side) had resolved. At the time of the report, HYPOAESTHESIA (numbness on my head/numbness in head/now the numbness has moved to the back of her head), DIZZINESS (feel dizzy), PAIN IN EXTREMITY (left arm pain), PRURITUS (itching on forehead), BREAST PAIN (left breast pain,), MEMORY IMPAIRMENT (memory issue), TINNITUS (scalp  is  making  noises,) and MYALGIA (body aches) outcome was unknown and BACK PAIN (back pain) and HEADACHE (headache) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Treatment was received by the patient   Most recent FOLLOW-UP information incorporated above includes: On 02-Aug-2021: Follow-up recieved ,events were updated, On 09-Aug-2021: Significant follow up- Events updated On 11-Aug-2021: significant follow up appended
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Memory impairment, Myalgia, Pain in extremity, Pruritus
Clinical narrative: numbness on my head/numbness in head/now the numbness has moved to the back of her head; feel dizzy; left arm pain; itching on forehead; left breast pain,; memory issue; scalp  is  making  noises,; body aches; headache; chest pain on the left side; back pain; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (numbness on my head/numbness in head/now the numbness has moved to the back of her head), DIZZINESS (feel dizzy), PAIN IN EXTREMITY (left arm pain), PRURITUS (itching on forehead) and CHEST PAIN (chest pain on the left side) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027D2IA) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included CLONAZEPAM and PERPHENAZINE for Paranoia, CHLORPHENAMINE MALEATE (CHLORAMINE S) and DIPYRIDAMOLE (PERSANTINE) for an unknown indication.    On 02-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Aug-2021, the patient experienced CHEST PAIN (chest pain on the left side), BACK PAIN (back pain) and HEADACHE (headache). On an unknown date, the patient experienced HYPOAESTHESIA (numbness on my head/numbness in head/now the numbness has moved to the back of her head), DIZZINESS (feel dizzy), PAIN IN EXTREMITY (left arm pain), PRURITUS (itching on forehead), BREAST PAIN (left breast pain,), MEMORY IMPAIRMENT (memory issue), TINNITUS (scalp  is  making  noises,) and MYALGIA (body aches). On 06-Aug-2021, CHEST PAIN (chest pain on the left side) had resolved. At the time of the report, HYPOAESTHESIA (numbness on my head/numbness in head/now the numbness has moved to the back of her head), DIZZINESS (feel dizzy), PAIN IN EXTREMITY (left arm pain), PRURITUS (itching on forehead), BREAST PAIN (left breast pain,), MEMORY IMPAIRMENT (memory issue), TINNITUS (scalp  is  making  noises,) and MYALGIA (body aches) outcome was unknown and BACK PAIN (back pain) and HEADACHE (headache) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Treatment was received by the patient   Most recent FOLLOW-UP information incorporated above includes: On 02-Aug-2021: Follow-up recieved ,events were updated, On 09-Aug-2021: Significant follow up- Events updated On 11-Aug-2021: significant follow up appended
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: numbness on my head/numbness in head/now the numbness has moved to the back of her head; feel dizzy; left arm pain; itching on forehead; left breast pain,; memory issue; scalp  is  making  noises,; body aches; headache; chest pain on the left side; back pain; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (numbness on my head/numbness in head/now the numbness has moved to the back of her head), DIZZINESS (feel dizzy), PAIN IN EXTREMITY (left arm pain), PRURITUS (itching on forehead) and CHEST PAIN (chest pain on the left side) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027D2IA) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included CLONAZEPAM and PERPHENAZINE for Paranoia, CHLORPHENAMINE MALEATE (CHLORAMINE S) and DIPYRIDAMOLE (PERSANTINE) for an unknown indication.    On 02-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Aug-2021, the patient experienced CHEST PAIN (chest pain on the left side), BACK PAIN (back pain) and HEADACHE (headache). On an unknown date, the patient experienced HYPOAESTHESIA (numbness on my head/numbness in head/now the numbness has moved to the back of her head), DIZZINESS (feel dizzy), PAIN IN EXTREMITY (left arm pain), PRURITUS (itching on forehead), BREAST PAIN (left breast pain,), MEMORY IMPAIRMENT (memory issue), TINNITUS (scalp  is  making  noises,) and MYALGIA (body aches). On 06-Aug-2021, CHEST PAIN (chest pain on the left side) had resolved. At the time of the report, HYPOAESTHESIA (numbness on my head/numbness in head/now the numbness has moved to the back of her head), DIZZINESS (feel dizzy), PAIN IN EXTREMITY (left arm pain), PRURITUS (itching on forehead), BREAST PAIN (left breast pain,), MEMORY IMPAIRMENT (memory issue), TINNITUS (scalp  is  making  noises,) and MYALGIA (body aches) outcome was unknown and BACK PAIN (back pain) and HEADACHE (headache) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Treatment was received by the patient   Most recent FOLLOW-UP information incorporated above includes: On 02-Aug-2021: Follow-up recieved ,events were updated, On 09-Aug-2021: Significant follow up- Events updated On 11-Aug-2021: significant follow up appended
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Product dose omission issue
Clinical narrative: have not received second dose; Swollen lymph nodes; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (Swollen lymph nodes) and PRODUCT DOSE OMISSION ISSUE (have not received second dose) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Mar-2021, the patient experienced LYMPHADENOPATHY (Swollen lymph nodes). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (have not received second dose). On 06-Mar-2021, LYMPHADENOPATHY (Swollen lymph nodes) had resolved. At the time of the report, PRODUCT DOSE OMISSION ISSUE (have not received second dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications were not reported.  Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 13-Aug-2021: Non-significant follow up, patient demographic was updated.
Sex: F
Vaccine: COVID19
Symptoms: Illness, Thrombosis
Clinical narrative: Blood clot in her left leg; Has been sick ever since; This spontaneous case was reported by a consumer and describes the occurrence of THROMBOSIS (Blood clot in her left leg) and ILLNESS (Has been sick ever since) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038C21A and 005C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 07-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced THROMBOSIS (Blood clot in her left leg) (seriousness criteria hospitalization, medically significant and life threatening) and ILLNESS (Has been sick ever since) (seriousness criteria hospitalization and life threatening). The patient was hospitalized on 27-Jun-2021 due to ILLNESS and THROMBOSIS. The patient was treated with RIVAROXABAN (XARELTO VASCULAR) for Thrombosis, at a dose of 15 milligram twice a day and RIVAROXABAN (XARELTO VASCULAR) for Thrombosis, at a dose of 20 milligram once a day. At the time of the report, THROMBOSIS (Blood clot in her left leg) and ILLNESS (Has been sick ever since) outcome was unknown.            On 27-JUN-2021 patient went to the emergency room and was hospitalized overnight due to the blood clot in her left leg  currently patient is on blood thinner treatment  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: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Kyphosis, Peri-spinal heterotopic ossification
Clinical narrative: heterotopic ossification; hunch back; This spontaneous case was reported by a consumer and describes the occurrence of PERI-SPINAL HETEROTOPIC OSSIFICATION (heterotopic ossification) 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.     The patient's past medical history included Shoulder operation NOS (shoulder) in March 2021.   On 24-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Jul-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 PERI-SPINAL HETEROTOPIC OSSIFICATION (heterotopic ossification) (seriousness criterion medically significant) and KYPHOSIS (hunch back). At the time of the report, PERI-SPINAL HETEROTOPIC OSSIFICATION (heterotopic ossification) and KYPHOSIS (hunch back) outcome was unknown.            Concomitant product use was not provided by the reporter.  No treatment information was provided.  Company comment: Although a temporal; association exist, based on the information provided, it is unlikely that the reported event is associated with the administration of mRNA-1273 . subject is of an advanced age and event usually occur after spinal cord injury.; Sender's Comments: Although a temporal; association exist, based on the information provided, it is unlikely that the reported event is associated with the administration of mRNA-1273 . subject is of an advanced age and event usually occur after spinal cord injury
Age: 13.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient vaccinated with expired Moderna Covid-19 vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient vaccinated with expired Moderna Covid-19 vaccine) in a 13-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 31-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Jul-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient vaccinated with expired Moderna Covid-19 vaccine). On 31-Jul-2021, EXPIRED PRODUCT ADMINISTERED (Patient vaccinated with expired Moderna Covid-19 vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomittant medications and treatment was reported by the patient.   Most recent FOLLOW-UP information incorporated above includes: On 12-Aug-2021: Follow up received contains new information included updated demographic information of patient.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Cough, Pyrexia
Clinical narrative: Had a little cough; Fever ranges from 101 to 103 degrees F; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (Had a little cough) and PYREXIA (Fever ranges from 101 to 103 degrees F) in a 38-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048C21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included TRAZODONE for an unknown indication.    On 30-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Jul-2021, the patient experienced COUGH (Had a little cough) and PYREXIA (Fever ranges from 101 to 103 degrees F). At the time of the report, COUGH (Had a little cough) and PYREXIA (Fever ranges from 101 to 103 degrees F) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 30-Jul-2021, Body temperature: 101 to 103 degrees f (High) Fever ranges from 101 to 103 degrees F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment medication was  reported.   Most recent FOLLOW-UP information incorporated above includes: On 17-Aug-2021: Follow-up information contain correction of spelling in patient first name.
Age: 88.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Paralysis
Clinical narrative: left elbow becomes paralyzed; on and off sharp left elbow pain; This spontaneous case was reported by a consumer and describes the occurrence of PARALYSIS (left elbow becomes paralyzed) in an 88-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037B21A and 038A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Mastectomy in 2007. Concurrent medical conditions included Drug allergy (Has a lot of medication allergies, but did not list them.). Concomitant products included LEVOTHYROXINE, AMLODIPINE, METOPROLOL, LISINOPRIL, GABAPENTIN, FORMOTEROL FUMARATE (PERFOROMIST), ASCORBIC ACID, BETACAROTENE, CUPRIC OXIDE, TOCOPHERYL ACETATE, ZINC OXIDE (PRESERVISION) and MULTIVITAMIN [VITAMINS NOS] for an unknown indication.   On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PARALYSIS (left elbow becomes paralyzed) (seriousness criterion medically significant) and ARTHRALGIA (on and off sharp left elbow pain). At the time of the report, PARALYSIS (left elbow becomes paralyzed) and ARTHRALGIA (on and off sharp left elbow pain) outcome was unknown.            Additional concomitant medications include vitamin B12 and Timolol Maleate 5% Eye Drops.  This patient received the second dose in the series and she had a little reaction. She started experiencing on and off sharp left elbow pain.  She stated her left elbow becomes paralyzed where she can't move it for 1/2 to 1 second and then it resolves.  She stated these events come and go.  She did not report these events to her healthcare provider.  She has not treated her elbow pain with any medications.  Very limited information regarding this events has been provided at this time.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Very limited information regarding this events has been provided at this time.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: U
Vaccine: COVID19
Symptoms: Adverse event
Clinical narrative: had a reaction; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE EVENT (had a reaction) 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 ADVERSE EVENT (had a reaction) (seriousness criterion hospitalization). At the time of the report, ADVERSE EVENT (had a reaction) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product was not provided. Treatment medication was not reported.; Sender's Comments: Very limited information regarding the events has been provided at this time.
Sex: U
Vaccine: COVID19
Symptoms: Haemophagocytic lymphohistiocytosis
Clinical narrative: We found other cases of HLH post-COVID vaccination, including patients that received the Moderna vaccine./11 VAERS reports of the HLH condition after the Moderna vaccine.; 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 HAEMOPHAGOCYTIC LYMPHOHISTIOCYTOSIS (We found other cases of HLH post-COVID vaccination, including patients that received the Moderna vaccine./11 VAERS reports of the HLH condition after the Moderna vaccine.) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HAEMOPHAGOCYTIC LYMPHOHISTIOCYTOSIS (We found other cases of HLH post-COVID vaccination, including patients that received the Moderna vaccine./11 VAERS reports of the HLH condition after the Moderna vaccine.) (seriousness criterion medically significant). At the time of the report, HAEMOPHAGOCYTIC LYMPHOHISTIOCYTOSIS (We found other cases of HLH post-COVID vaccination, including patients that received the Moderna vaccine./11 VAERS reports of the HLH condition after the Moderna vaccine.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The reporter stated that they found in Vaers 11 reports of the HLH condition after the Moderna vaccine.   No concomitant product information was provided by the reporter.  No treatment information was provided by the reporter.  Company comment: Very scant information is given and follow-up is requested. Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.   Most recent FOLLOW-UP information incorporated above includes: On 02-Aug-2021: Follow-up information included no new information.; Sender's Comments: Very scant information is given and follow-up is requested. Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Bedridden, Joint stiffness, Muscle tightness, Pain, Urticaria
Clinical narrative: muscles tigthened up; joints tightened up; could barely walk and get up from bed; bumps/welts under her skin where the veins are; in serious pain; This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE TIGHTNESS (muscles tigthened up), JOINT STIFFNESS (joints tightened up), BEDRIDDEN (could barely walk and get up from bed), URTICARIA (bumps/welts under her skin where the veins are) and PAIN (in serious pain) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 11-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In July 2021, the patient experienced MUSCLE TIGHTNESS (muscles tigthened up), JOINT STIFFNESS (joints tightened up), BEDRIDDEN (could barely walk and get up from bed), URTICARIA (bumps/welts under her skin where the veins are) and PAIN (in serious pain). At the time of the report, MUSCLE TIGHTNESS (muscles tigthened up), JOINT STIFFNESS (joints tightened up), BEDRIDDEN (could barely walk and get up from bed), URTICARIA (bumps/welts under her skin where the veins are) and PAIN (in serious pain) had not resolved.            No relevant concomitant medications were reported.  No treatment information was provided.    This case was linked to MOD-2021-273412 (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.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Magnetic resonance imaging, Oropharyngeal pain, Pyrexia, Tinnitus
Clinical narrative: sore throat; headache/headaches are debilitating 2 to 3 times per week/headaches each day; ringing in both of her ears/ringing more pronounced in her right ear; fever; mild muscle pain in her left injection site arm; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (sore throat), HEADACHE (headache/headaches are debilitating 2 to 3 times per week/headaches each day) and TINNITUS (ringing in both of her ears/ringing more pronounced in her right ear) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002C21A and 002C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 26-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 26-Apr-2021, the patient experienced VACCINATION SITE PAIN (mild muscle pain in her left injection site arm). On 24-May-2021, the patient experienced HEADACHE (headache/headaches are debilitating 2 to 3 times per week/headaches each day) (seriousness criterion medically significant), TINNITUS (ringing in both of her ears/ringing more pronounced in her right ear) (seriousness criterion medically significant) and PYREXIA (fever). On an unknown date, the patient experienced OROPHARYNGEAL PAIN (sore throat) (seriousness criterion medically significant). At the time of the report, OROPHARYNGEAL PAIN (sore throat), HEADACHE (headache/headaches are debilitating 2 to 3 times per week/headaches each day), TINNITUS (ringing in both of her ears/ringing more pronounced in her right ear), PYREXIA (fever) and VACCINATION SITE PAIN (mild muscle pain in her left injection site arm) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Magnetic resonance imaging: showed nothing wrong (normal) showed nothing wrong.         Steroids , antibiotics used as treatment medications.   Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   This case was linked to MOD-2021-273428 (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.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: sore throat; headache/headaches are debilitating 2 to 3 times per week/headaches each day; ringing in both of her ears/ringing more pronounced in her right ear; fever; mild muscle pain in her left injection site arm; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (sore throat), HEADACHE (headache/headaches are debilitating 2 to 3 times per week/headaches each day) and TINNITUS (ringing in both of her ears/ringing more pronounced in her right ear) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002C21A and 002C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 26-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 26-Apr-2021, the patient experienced VACCINATION SITE PAIN (mild muscle pain in her left injection site arm). On 24-May-2021, the patient experienced HEADACHE (headache/headaches are debilitating 2 to 3 times per week/headaches each day) (seriousness criterion medically significant), TINNITUS (ringing in both of her ears/ringing more pronounced in her right ear) (seriousness criterion medically significant) and PYREXIA (fever). On an unknown date, the patient experienced OROPHARYNGEAL PAIN (sore throat) (seriousness criterion medically significant). At the time of the report, OROPHARYNGEAL PAIN (sore throat), HEADACHE (headache/headaches are debilitating 2 to 3 times per week/headaches each day), TINNITUS (ringing in both of her ears/ringing more pronounced in her right ear), PYREXIA (fever) and VACCINATION SITE PAIN (mild muscle pain in her left injection site arm) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Magnetic resonance imaging: showed nothing wrong (normal) showed nothing wrong.         Steroids , antibiotics used as treatment medications.   Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   This case was linked to MOD-2021-273428 (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.