chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Hospitalisation, Incomplete course of vaccination
Clinical narrative: hospitalized for unrelated problems; Patient has not received 2nd dose\ first dose > 35 days ago; This spontaneous case was reported by an other health care professional and describes the occurrence of HOSPITALISATION (hospitalized for unrelated problems) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    In April 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HOSPITALISATION (hospitalized for unrelated problems) (seriousness criterion hospitalization) and INCOMPLETE COURSE OF VACCINATION (Patient has not received 2nd dose\ first dose > 35 days ago). At the time of the report, HOSPITALISATION (hospitalized for unrelated problems) and INCOMPLETE COURSE OF VACCINATION (Patient has not received 2nd dose\ first dose > 35 days ago) 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 considered HOSPITALISATION (hospitalized for unrelated problems) to be not related. No further causality assessment was provided for INCOMPLETE COURSE OF VACCINATION (Patient has not received 2nd dose\ first dose > 35 days ago).    No treatment information was provided by the reporter. No concomitant medications were provided by the reporter. Patient received Moderna Covid Vaccine in April and was reportedly hospitalized for unrelated problems when it was time for her 2nd dose.  Very limited information regarding hospitalization has been provided. Yet, it is mentioned that patient was hospitalized due to unrelated problems. Based on reporter´s causality the event is assessed as unlikely related to mRNA-1273.   Most recent FOLLOW-UP information incorporated above includes: On 06-Aug-2021: Additional Information received included no new significant Information.; Sender's Comments: Very limited information regarding hospitalization has been provided. Yet, it is mentioned that patient was hospitalized due to unrelated problems. Based on reporter´s causality the event is assessed as unlikely related to mRNA-1273.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Intentional product misuse, Interchange of vaccine products
Clinical narrative: Mixed COVID-19 vaccination series received; Intentional product misuse; This spontaneous case was reported by a nurse and describes the occurrence of INTERCHANGE OF VACCINE PRODUCTS (Mixed COVID-19 vaccination series received) and INTENTIONAL PRODUCT MISUSE (Intentional product misuse) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In April 2021, the patient experienced INTENTIONAL PRODUCT MISUSE (Intentional product misuse). On 06-Aug-2021, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (Mixed COVID-19 vaccination series received). In April 2021, INTENTIONAL PRODUCT MISUSE (Intentional product misuse) had resolved. At the time of the report, INTERCHANGE OF VACCINE PRODUCTS (Mixed COVID-19 vaccination series received) 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 provided by the reporter.  No treatment information was provided by the reporter.  Patient stated that she had received one dose of Johnson& Johnson COVID-19 vaccine in April2021, prior to Moderna COVID-19 vaccine on 06Aug2021; Sender's Comments: This report refers to a case of Interchange of vaccine products and Intentional product misuse for mRNA-1273, lot # 037C21A with no associated AEs.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: Experienced tingling sensation in her left hand; on the left side of her face, lip and ears, towards eye and down her chin area.; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (Experienced tingling sensation in her left hand) and HYPOAESTHESIA (on the left side of her face, lip and ears, towards eye and down her chin area.) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 051CJ1A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose. On 23-Jul-2021, the patient experienced PARAESTHESIA (Experienced tingling sensation in her left hand) (seriousness criterion medically significant) and HYPOAESTHESIA (on the left side of her face, lip and ears, towards eye and down her chin area.) (seriousness criterion medically significant). At the time of the report, PARAESTHESIA (Experienced tingling sensation in her left hand) and HYPOAESTHESIA (on the left side of her face, lip and ears, towards eye and down her chin area.) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was reported. No treatment medication was reported.  About 20 minutes later started to experience tingling sensation in her left hand, and then numbness on the left side of her face, lip and ears, towards eye and down her chin area.  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: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Illness, Pyrexia, SARS-CoV-2 test
Clinical narrative: Sickness; Fever; FATIGUE; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Sickness), PYREXIA (Fever) and FATIGUE (FATIGUE) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 041B21A and 006B21A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension and Asthma. Concomitant products included ALBUTEROL [SALBUTAMOL], ATENOLOL, TRAZODONE and TRAMADOL for an unknown indication.   On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Apr-2021, the patient experienced ILLNESS (Sickness), PYREXIA (Fever) and FATIGUE (FATIGUE). On 21-Apr-2021, ILLNESS (Sickness), PYREXIA (Fever) and FATIGUE (FATIGUE) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In February 2021, SARS-CoV-2 test: positive (Positive) Positive.         Treatment medication was not provided.   This case was linked to MOD-2021-057764 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 06-Aug-2021: Reporter details, patient details, medical history, lab data, suspect drug dose details, concomitant products and events added.
Sex: U
Vaccine: COVID19
Symptoms: Pulmonary embolism
Clinical narrative: developed a pulmonary embolism; This spontaneous case was reported by a consumer and describes the occurrence of PULMONARY EMBOLISM (developed a pulmonary embolism) 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 PULMONARY EMBOLISM (developed a pulmonary embolism) (seriousness criterion medically significant). At the time of the report, PULMONARY EMBOLISM (developed a pulmonary embolism) outcome was unknown.            Concomitant and treatment medication was not provided.  Patient was asked should take the second vaccination. Company Comment : Very limited information regarding this event and temporal association have been provided at this time. Further information is not expected.   Reporter did not allow further contact; Sender's Comments: Very limited information regarding this event and temporal association have been provided at this time. Further information is not expected.
Sex: M
Vaccine: COVID19
Symptoms: Cerebrovascular accident
Clinical narrative: stroke; This spontaneous case was reported by a consumer and describes the occurrence of CEREBROVASCULAR ACCIDENT (stroke) 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced CEREBROVASCULAR ACCIDENT (stroke) (seriousness criteria medically significant and life threatening). At the time of the report, CEREBROVASCULAR ACCIDENT (stroke) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication reported. No Treatment medication reported. He received the vaccination series from the Moderna COVID-19 vaccine and a month and, a half later, he had a stroke.  Company comment- Very limited information regarding this event has been provided at this time. No further follow-up information is expected.; Sender's Comments: Very limited information regarding this event has been provided at this time. No further follow-up information is expected.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Dyspnoea
Clinical narrative: More coughing; Trouble breathing; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (More coughing) and DYSPNOEA (Trouble breathing) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003A21A and 043L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. 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, the patient experienced COUGH (More coughing) and DYSPNOEA (Trouble breathing). At the time of the report, COUGH (More coughing) and DYSPNOEA (Trouble breathing) outcome was unknown.            The concomitant medications were not reported.  Treatment medications include some unknown medication for allergy.   This case was linked to MOD-2021-073201 (Patient Link).
Age: 83.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Decreased appetite, Diarrhoea, Exposure to SARS-CoV-2
Clinical narrative: diarrhea; no appetite; ache; exposed to Covid; patient ran a fever of 102; chills; lack of energy; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (diarrhea), DECREASED APPETITE (no appetite), PAIN (ache), EXPOSURE TO SARS-COV-2 (exposed to Covid) and PYREXIA (patient ran a fever of 102) in an 83-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. On an unknown date, the patient experienced DIARRHOEA (diarrhea), DECREASED APPETITE (no appetite), PAIN (ache), EXPOSURE TO SARS-COV-2 (exposed to Covid), PYREXIA (patient ran a fever of 102), CHILLS (chills) and FATIGUE (lack of energy). On 12-Mar-2021, PAIN (ache), PYREXIA (patient ran a fever of 102), CHILLS (chills) and FATIGUE (lack of energy) had resolved. At the time of the report, DIARRHOEA (diarrhea) and DECREASED APPETITE (no appetite) had resolved and EXPOSURE TO SARS-COV-2 (exposed to Covid) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 102 (High) 102.      No Treatment information was provided.  No Concomitant medication was provided.  COVID-19 test result was not reported.   This case was linked to MOD-2021-058062 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 11-Aug-2021: Follow up received on 11-AUG-2021 and does not contain any new information.
Age: 83.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Pain, Pyrexia
Clinical narrative: diarrhea; no appetite; ache; exposed to Covid; patient ran a fever of 102; chills; lack of energy; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (diarrhea), DECREASED APPETITE (no appetite), PAIN (ache), EXPOSURE TO SARS-COV-2 (exposed to Covid) and PYREXIA (patient ran a fever of 102) in an 83-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. On an unknown date, the patient experienced DIARRHOEA (diarrhea), DECREASED APPETITE (no appetite), PAIN (ache), EXPOSURE TO SARS-COV-2 (exposed to Covid), PYREXIA (patient ran a fever of 102), CHILLS (chills) and FATIGUE (lack of energy). On 12-Mar-2021, PAIN (ache), PYREXIA (patient ran a fever of 102), CHILLS (chills) and FATIGUE (lack of energy) had resolved. At the time of the report, DIARRHOEA (diarrhea) and DECREASED APPETITE (no appetite) had resolved and EXPOSURE TO SARS-COV-2 (exposed to Covid) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 102 (High) 102.      No Treatment information was provided.  No Concomitant medication was provided.  COVID-19 test result was not reported.   This case was linked to MOD-2021-058062 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 11-Aug-2021: Follow up received on 11-AUG-2021 and does not contain any new information.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test, Vaccine breakthrough infection
Clinical narrative: This literature-study case was reported in a literature article and describes the occurrence of VACCINE BREAKTHROUGH INFECTION, COVID-19 and DRUG INEFFECTIVE in a 22-year-old female patient who received mRNA-1273 (MODERNA COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Heart transplant rejection (Recent episode of rejection 6 mths prior treatedwith methylprednisolone, rituximab, thymoglobulin, plasmapheresis, and IVIG) and Heart transplant in 2013. Concurrent medical conditions included Non-ischemic cardiomyopathy and Immunosuppression. Concomitant products included SIROLIMUS, TACROLIMUS and PREDNISONE for Immunosuppression.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINE BREAKTHROUGH INFECTION (Breakthrough infection) (seriousness criterion hospitalization), COVID-19 (COVID-19) (seriousness criterion hospitalization) and DRUG INEFFECTIVE (Lack of drug effect) (seriousness criterion hospitalization). The patient was treated with REMDESIVIR for Adverse event, at an unspecified dose and frequency. At the time of the report, VACCINE BREAKTHROUGH INFECTION (Breakthrough infection), COVID-19 (COVID-19) and DRUG INEFFECTIVE (Lack of drug effect) outcome was unknown. Possible    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, SARS-CoV-2 test: positive (Positive) Positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered VACCINE BREAKTHROUGH INFECTION (Breakthrough infection), COVID-19 (COVID-19) and DRUG INEFFECTIVE (Lack of drug effect) to be possibly related.    Patient was admitted to the hospital with nausea, vomiting, cough and shortness of breath. Was not hypoxic during admission.  Company Comment: Based on the current available information, the mRNA-1273 does not contain a virus capable of causing infection and with the occurrence of COVID-19 infection after vaccination, the causality of this event is assessed as not applicable.   This case was linked to MOD-2021-279918 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 04-Aug-2021: Follow up received by safety on 06-Aug-2021 included an email from the with FTA and abstract containing no new information.; Sender's Comments: Based on the current available information, the mRNA-1273 does not contain a virus capable of causing infection and with the occurrence of COVID-19 infection after vaccination, the causality of this event is assessed as not applicable.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Pain, Peripheral swelling, Pyrexia, Skin mass
Clinical narrative: A lump on her arm; Lump is sore; Patient now has a lump on her arm which has swelled to the size of a golf ball; Fever; Patient received her Covid-19 vaccine less than 26 days between doses; This spontaneous case was reported by a consumer and describes the occurrence of SKIN MASS (A lump on her arm), PAIN (Lump is sore), PERIPHERAL SWELLING (Patient now has a lump on her arm which has swelled to the size of a golf ball) and PYREXIA (Fever) in a 36-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 13-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Aug-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received her Covid-19 vaccine less than 26 days between doses). On 05-Aug-2021, the patient experienced PYREXIA (Fever) (seriousness criterion medically significant). On an unknown date, the patient experienced SKIN MASS (A lump on her arm) (seriousness criterion medically significant), PAIN (Lump is sore) (seriousness criterion medically significant) and PERIPHERAL SWELLING (Patient now has a lump on her arm which has swelled to the size of a golf ball) (seriousness criterion medically significant). On 03-Aug-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received her Covid-19 vaccine less than 26 days between doses) had resolved. On 05-Aug-2021, PYREXIA (Fever) had resolved. At the time of the report, SKIN MASS (A lump on her arm), PAIN (Lump is sore) and PERIPHERAL SWELLING (Patient now has a lump on her arm which has swelled to the size of a golf ball) outcome was unknown.            No relevant concomitant medications were reported. No treatment information was 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, Lump on arm, Pain, Peripheral swelling and Pyrexia a causal relationship cannot be excluded. Causality for the event Inappropriate schedule of product administration is not applicable.   Reporter did not allow further contact; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, Lump on arm, Pain, Peripheral swelling and Pyrexia a causal relationship cannot be excluded. Causality for the event Inappropriate schedule of product administration is not applicable
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Extra dose administered, Inappropriate schedule of product administration, Product storage error
Clinical narrative: Possible third dose being administered; Vaccines left out for more than 24 hours; Vaccine taken which is left out for more than 24 hours.; First dose of vaccine is taken in March 2021 and Second dose on 06 Aug 2021.; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine taken which is left out for more than 24 hours.), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose of vaccine is taken in March 2021 and Second dose on 06 Aug 2021.), PRODUCT STORAGE ERROR (Vaccines left out for more than 24 hours) and EXTRA DOSE ADMINISTERED (Possible third dose being administered) 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.   In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Aug-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 received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In March 2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose of vaccine is taken in March 2021 and Second dose on 06 Aug 2021.). On 06-Aug-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine taken which is left out for more than 24 hours.) and PRODUCT STORAGE ERROR (Vaccines left out for more than 24 hours). On an unknown date, the patient experienced EXTRA DOSE ADMINISTERED (Possible third dose being administered). On 06-Aug-2021, EXPIRED PRODUCT ADMINISTERED (Vaccine taken which is left out for more than 24 hours.), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose of vaccine is taken in March 2021 and Second dose on 06 Aug 2021.) and PRODUCT STORAGE ERROR (Vaccines left out for more than 24 hours) had resolved. At the time of the report, EXTRA DOSE ADMINISTERED (Possible third dose being administered) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication are provided by reporter. HCP was notified that they did not have data on 3rd dose and they can do analysis if the vaccine had activity at the time of administration if she was able to provide a worst case scenario date for when vial was removed from freezer to refrigerator. No treatment information was provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 12-Aug-2021: Additional information included, new event of extra dose administered was added.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Malaise, Myalgia
Clinical narrative: did not feel good; felt very sore; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (did not feel good) and MYALGIA (felt very sore) in a 55-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No medical history was reported.  Concomitant products included VITAMINS NOS for an unknown indication.    In July 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MALAISE (did not feel good) and MYALGIA (felt very sore). The patient was treated with ACETAMINOPHEN for Adverse event, at a dose of 1 dosage form. At the time of the report, MALAISE (did not feel good) and MYALGIA (felt very sore) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.     He had called with a medical inquiry about his son who received the first dose of the Moderna COVID 19 vaccine in July, 2021. His son felt very sore and did not feel good for a couple days. He didn't have information on lot number and vaccination site. He heard that there are more side effects on average after the 2nd dose compared to the 1st dose. His son was committed to get the 2nd dose, but he's worried that there might be severe reactions for his son from the 2nd dose. He's more concerned as his wife passed away from kidney cancer. His son experienced the virus 6 to 8 weeks before vaccination. His son got quite sick at that point and recovered.   This case was linked to US-MODERNATX, INC.-MOD-2021-127618, US-MODERNATX, INC.-MOD-2021-127619 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-127618: US-MODERNATX, INC.-MOD-2021-127619:
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Breast cancer, Inappropriate schedule of product administration
Clinical narrative: Breast cancer; Deviation from dosing schedule; This spontaneous case was reported by a nurse and describes the occurrence of BREAST CANCER (Breast cancer) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was reported.  Concomitant products included CELECOXIB (CELEBREX), PROPRANOLOL HYDROCHLORIDE (INDERAL), TIZANIDINE HYDROCHLORIDE (ZANAFLEX), BUTALBITAL, CAFFEINE, PARACETAMOL (FIORICET), ACETYLSALICYLIC ACID (ASPRIN) and FLUOXETINE HYDROCHLORIDE (PROZAC) for an unknown indication.    On 04-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced BREAST CANCER (Breast cancer) (seriousness criterion medically significant) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Deviation from dosing schedule). At the time of the report, BREAST CANCER (Breast cancer) had not resolved and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Deviation from dosing schedule) 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.   Treatment medication not mentioned, but mentions she is undergoing treatment for breast cancer.  Patient diagnosed with breast cancer and this has led to delaying her second dose. Has not gotten it as of reporting time and the patient is questioning if it is too late to receive the second dose.  Company comment The patient was diagnosed with breast cancer after first dose of mRNA-1273 and very limited information regarding the event has been provided at this time. The patient also experienced Inappropriate schedule of vaccine administration for mRNA-1273, batch no. 038C21A. No further information is expected.; Sender's Comments: The patient was diagnosed with breast cancer after first dose of mRNA-1273 and very limited information regarding the event has been provided at this time. The patient also experienced Inappropriate schedule of vaccine administration for mRNA-1273, batch no. 038C21A. No further information is expected.
Age: 21.0
Sex: M
Vaccine: COVID19
Symptoms: Bowel movement irregularity, Convulsions local, Dizziness, Hyperhidrosis, Nausea
Clinical narrative: arm and leg convulsions; Shaking; sweating; eyes were getting blurry; dizziness; the patient had to go to the toilet for an immediate bowel movement; nausea; This spontaneous case was reported by a consumer and describes the occurrence of CONVULSIONS LOCAL (arm and leg convulsions) in a 21-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 Chronic fatigue syndrome and Immune disorder (NOS).    On 06-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Aug-2021, the patient experienced CONVULSIONS LOCAL (arm and leg convulsions) (seriousness criterion medically significant), TREMOR (Shaking), HYPERHIDROSIS (sweating), VISION BLURRED (eyes were getting blurry), DIZZINESS (dizziness), BOWEL MOVEMENT IRREGULARITY (the patient had to go to the toilet for an immediate bowel movement) and NAUSEA (nausea). At the time of the report, CONVULSIONS LOCAL (arm and leg convulsions), TREMOR (Shaking), HYPERHIDROSIS (sweating), VISION BLURRED (eyes were getting blurry), DIZZINESS (dizziness), BOWEL MOVEMENT IRREGULARITY (the patient had to go to the toilet for an immediate bowel movement) and NAUSEA (nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment information was provided. Lab details were not provided. No relevant concomitant medications were reported.  Company comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 21.0
Sex: M
Vaccine: COVID19
Symptoms: Tremor, Vision blurred
Clinical narrative: arm and leg convulsions; Shaking; sweating; eyes were getting blurry; dizziness; the patient had to go to the toilet for an immediate bowel movement; nausea; This spontaneous case was reported by a consumer and describes the occurrence of CONVULSIONS LOCAL (arm and leg convulsions) in a 21-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 Chronic fatigue syndrome and Immune disorder (NOS).    On 06-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Aug-2021, the patient experienced CONVULSIONS LOCAL (arm and leg convulsions) (seriousness criterion medically significant), TREMOR (Shaking), HYPERHIDROSIS (sweating), VISION BLURRED (eyes were getting blurry), DIZZINESS (dizziness), BOWEL MOVEMENT IRREGULARITY (the patient had to go to the toilet for an immediate bowel movement) and NAUSEA (nausea). At the time of the report, CONVULSIONS LOCAL (arm and leg convulsions), TREMOR (Shaking), HYPERHIDROSIS (sweating), VISION BLURRED (eyes were getting blurry), DIZZINESS (dizziness), BOWEL MOVEMENT IRREGULARITY (the patient had to go to the toilet for an immediate bowel movement) and NAUSEA (nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment information was provided. Lab details were not provided. No relevant concomitant medications were reported.  Company comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 48.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: 10 patients received doses from 1 vial after spending more than 30 days on the refrigerator//Patient7: Second Dose-Vaccine administered BUD (on day 32); This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (10 patients received doses from 1 vial after spending more than 30 days on the refrigerator//Patient7: Second Dose-Vaccine administered BUD (on day 32)) in a 48-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Jul-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (10 patients received doses from 1 vial after spending more than 30 days on the refrigerator//Patient7: Second Dose-Vaccine administered BUD (on day 32)). At the time of the report, EXPIRED PRODUCT ADMINISTERED (10 patients received doses from 1 vial after spending more than 30 days on the refrigerator//Patient7: Second Dose-Vaccine administered BUD (on day 32)) 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 provided by the reporter.  No treatment information was provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 09-Aug-2021: Followup received and added patient demographics. On 10-Aug-2021: Follow up received and  Vaccine information updated.
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Hyperhidrosis, Influenza like illness, Migraine, Musculoskeletal stiffness
Clinical narrative: stiff neck; migraine; rash; vertigo spell; flu like symptoms; sweating; fever; chills; body ache; This spontaneous case was reported by a consumer and describes the occurrence of VERTIGO (vertigo spell), MIGRAINE (migraine), RASH (rash) and MUSCULOSKELETAL STIFFNESS (stiff neck) in an 18-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 30-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 28-Jul-2021, the patient experienced INFLUENZA LIKE ILLNESS (flu like symptoms), HYPERHIDROSIS (sweating), PYREXIA (fever), CHILLS (chills) and MYALGIA (body ache). On 31-Jul-2021, the patient experienced VERTIGO (vertigo spell) (seriousness criterion hospitalization) and RASH (rash) (seriousness criterion hospitalization). On 02-Aug-2021, the patient experienced MIGRAINE (migraine) (seriousness criterion hospitalization) and MUSCULOSKELETAL STIFFNESS (stiff neck) (seriousness criterion hospitalization). The patient was hospitalized from 02-Aug-2021 to 04-Aug-2021 due to MIGRAINE, MUSCULOSKELETAL STIFFNESS, RASH and VERTIGO. The patient was treated with RIMEGEPANT SULFATE (NURTEC ODT) for Migraine, at an unspecified dose and frequency and IBUPROFEN for Migraine, at an unspecified dose and frequency. On 29-Jul-2021, INFLUENZA LIKE ILLNESS (flu like symptoms), HYPERHIDROSIS (sweating), PYREXIA (fever), CHILLS (chills) and MYALGIA (body ache) had resolved. At the time of the report, VERTIGO (vertigo spell), MIGRAINE (migraine), RASH (rash) and MUSCULOSKELETAL STIFFNESS (stiff neck) outcome was unknown.            Concomitant medication reported as unspecified birth control. On 02-Aug-21 patient saw her doctor for the rash that had spread to her entire body and stiff neck that she could not move from side to side. Treatment medications taken by patient did not help her migraine. Patient also reported taking an unspecified steroid for the rash.  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. However, the patient's concomitant medication for birth control is a confounder.   This case was linked to MOD-2021-280143 (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. However, the patient's concomitant medication for birth control is a confounder.
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pyrexia, Rash, Vertigo
Clinical narrative: stiff neck; migraine; rash; vertigo spell; flu like symptoms; sweating; fever; chills; body ache; This spontaneous case was reported by a consumer and describes the occurrence of VERTIGO (vertigo spell), MIGRAINE (migraine), RASH (rash) and MUSCULOSKELETAL STIFFNESS (stiff neck) in an 18-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 30-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 28-Jul-2021, the patient experienced INFLUENZA LIKE ILLNESS (flu like symptoms), HYPERHIDROSIS (sweating), PYREXIA (fever), CHILLS (chills) and MYALGIA (body ache). On 31-Jul-2021, the patient experienced VERTIGO (vertigo spell) (seriousness criterion hospitalization) and RASH (rash) (seriousness criterion hospitalization). On 02-Aug-2021, the patient experienced MIGRAINE (migraine) (seriousness criterion hospitalization) and MUSCULOSKELETAL STIFFNESS (stiff neck) (seriousness criterion hospitalization). The patient was hospitalized from 02-Aug-2021 to 04-Aug-2021 due to MIGRAINE, MUSCULOSKELETAL STIFFNESS, RASH and VERTIGO. The patient was treated with RIMEGEPANT SULFATE (NURTEC ODT) for Migraine, at an unspecified dose and frequency and IBUPROFEN for Migraine, at an unspecified dose and frequency. On 29-Jul-2021, INFLUENZA LIKE ILLNESS (flu like symptoms), HYPERHIDROSIS (sweating), PYREXIA (fever), CHILLS (chills) and MYALGIA (body ache) had resolved. At the time of the report, VERTIGO (vertigo spell), MIGRAINE (migraine), RASH (rash) and MUSCULOSKELETAL STIFFNESS (stiff neck) outcome was unknown.            Concomitant medication reported as unspecified birth control. On 02-Aug-21 patient saw her doctor for the rash that had spread to her entire body and stiff neck that she could not move from side to side. Treatment medications taken by patient did not help her migraine. Patient also reported taking an unspecified steroid for the rash.  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. However, the patient's concomitant medication for birth control is a confounder.   This case was linked to MOD-2021-280143 (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. However, the patient's concomitant medication for birth control is a confounder.
Age: 20.0
Sex: M
Vaccine: COVID19
Symptoms: Back pain, Chills, Dysuria, Fatigue, Muscle contractions involuntary
Clinical narrative: Back were sore/back pain is 1/4 of the way up from his waist between my waist and bottom of my rib cage; Exhaustion; chills; convulsions; shaking really bad, slightly shaky; neck sore; twitching; muscles were contracting uncontrollably and regularly, started in my right leg then went up my back; stinging when I go pee; This spontaneous case was reported by a consumer and describes the occurrence of SEIZURE (convulsions) in a 20-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027C21A and 048C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 08-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Aug-2021, the patient experienced SEIZURE (convulsions) (seriousness criterion medically significant), TREMOR (shaking really bad, slightly shaky), NECK PAIN (neck sore), MUSCLE TWITCHING (twitching), MUSCLE CONTRACTIONS INVOLUNTARY (muscles were contracting uncontrollably and regularly, started in my right leg then went up my back), DYSURIA (stinging when I go pee), FATIGUE (Exhaustion) and CHILLS (chills). On an unknown date, the patient experienced BACK PAIN (Back were sore/back pain is 1/4 of the way up from his waist between my waist and bottom of my rib cage). At the time of the report, SEIZURE (convulsions), TREMOR (shaking really bad, slightly shaky), NECK PAIN (neck sore), MUSCLE TWITCHING (twitching), MUSCLE CONTRACTIONS INVOLUNTARY (muscles were contracting uncontrollably and regularly, started in my right leg then went up my back), DYSURIA (stinging when I go pee), BACK PAIN (Back were sore/back pain is 1/4 of the way up from his waist between my waist and bottom of my rib cage), FATIGUE (Exhaustion) and CHILLS (chills) outcome was unknown. Concomitant product was not provided by the reporter. Patient reported that he experienced chills, shaking really bad worse than he had hypothermia, his neck and back was sore, he had twitching and shaking, he also started convulsions he is craving Gatorade, with salt and sugar after receiving 2nd dose. He has yellow urine and continues to be slightly shaky. His back pain was 1/4 of the way from his waist and bottom of his rib cage. 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. This case was linked to MOD-2021-280138 (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: 20.0
Sex: M
Vaccine: COVID19
Symptoms: Muscle twitching, Neck pain, Seizure, Tremor
Clinical narrative: Back were sore/back pain is 1/4 of the way up from his waist between my waist and bottom of my rib cage; Exhaustion; chills; convulsions; shaking really bad, slightly shaky; neck sore; twitching; muscles were contracting uncontrollably and regularly, started in my right leg then went up my back; stinging when I go pee; This spontaneous case was reported by a consumer and describes the occurrence of SEIZURE (convulsions) in a 20-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027C21A and 048C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 08-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Aug-2021, the patient experienced SEIZURE (convulsions) (seriousness criterion medically significant), TREMOR (shaking really bad, slightly shaky), NECK PAIN (neck sore), MUSCLE TWITCHING (twitching), MUSCLE CONTRACTIONS INVOLUNTARY (muscles were contracting uncontrollably and regularly, started in my right leg then went up my back), DYSURIA (stinging when I go pee), FATIGUE (Exhaustion) and CHILLS (chills). On an unknown date, the patient experienced BACK PAIN (Back were sore/back pain is 1/4 of the way up from his waist between my waist and bottom of my rib cage). At the time of the report, SEIZURE (convulsions), TREMOR (shaking really bad, slightly shaky), NECK PAIN (neck sore), MUSCLE TWITCHING (twitching), MUSCLE CONTRACTIONS INVOLUNTARY (muscles were contracting uncontrollably and regularly, started in my right leg then went up my back), DYSURIA (stinging when I go pee), BACK PAIN (Back were sore/back pain is 1/4 of the way up from his waist between my waist and bottom of my rib cage), FATIGUE (Exhaustion) and CHILLS (chills) outcome was unknown. Concomitant product was not provided by the reporter. Patient reported that he experienced chills, shaking really bad worse than he had hypothermia, his neck and back was sore, he had twitching and shaking, he also started convulsions he is craving Gatorade, with salt and sugar after receiving 2nd dose. He has yellow urine and continues to be slightly shaky. His back pain was 1/4 of the way from his waist and bottom of his rib cage. 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. This case was linked to MOD-2021-280138 (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: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Allergy to vaccine, Blood immunoglobulin E, Blood pressure measurement, Body temperature, Chills
Clinical narrative: redness; itching below the arm pits; rash; body ache; headache; chills; fever; allergy to vaccine; tachycardia; This spontaneous case was reported by a consumer and describes the occurrence of ALLERGY TO VACCINE (allergy to vaccine), TACHYCARDIA (tachycardia), ERYTHEMA (redness), PRURITUS (itching below the arm pits) and RASH (rash) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Allergy to animal dander (Cat fur allergy). Concomitant products included MULTIVITAMIN FOR WOMEN for an unknown indication.    On 20-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Apr-2021, the patient experienced ALLERGY TO VACCINE (allergy to vaccine). On an unknown date, the patient experienced TACHYCARDIA (tachycardia), ERYTHEMA (redness), PRURITUS (itching below the arm pits), RASH (rash), MYALGIA (body ache), HEADACHE (headache), CHILLS (chills) and PYREXIA (fever). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) (oral) from 23-Apr-2021 to 25-Apr-2021 at an unspecified dose and frequency and CETIRIZINE HYDROCHLORIDE (CETRIZINE) (oral) from 23-Apr-2021 to 25-Apr-2021 at an unspecified dose and frequency. At the time of the report, ALLERGY TO VACCINE (allergy to vaccine), TACHYCARDIA (tachycardia), ERYTHEMA (redness), PRURITUS (itching below the arm pits), RASH (rash), MYALGIA (body ache), HEADACHE (headache), CHILLS (chills) and PYREXIA (fever) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 11-Mar-2021, Heart rate: 115 (High) Above 115 bpm, continued for a month on and off. On 12-Mar-2021, Electrocardiogram: normal (normal) Normal. On 26-Mar-2021, Blood immunoglobulin E: 4.3 (Inconclusive) 4.3 <11.0 ug/L. On 26-Mar-2021, Complement factor: 30.2 (Inconclusive) 30.2 <114 Ku/L. On 26-Mar-2021, Electrocardiogram ambulatory: abnormal (abnormal) Tachycardia. On 20-Apr-2021, Body temperature: 101.4 °F (High) 101.4 F. On 20-Apr-2021, Heart rate: 140 (High) 140 bpm. On 21-Apr-2021, Electrocardiogram: 115 (High) 115 bpm. On 21-Apr-2021, Heart rate: 135 (High) 135 bpm. On 23-Apr-2021, Blood pressure measurement: 116/76 (Low) 116/76 mmhg.         This case was linked to MOD-2021-044263 (Patient Link).