chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Expired dose administered to patients; Vial was initially stored in the refrigerator on 01 Dec 2021 and administered on 11 Jan 2022; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired dose administered to patients) and PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator on 01 Dec 2021 and administered on 11 Jan 2022) in a 49-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Jan-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired dose administered to patients) and PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator on 01 Dec 2021 and administered on 11 Jan 2022). On 11-Jan-2022, EXPIRED PRODUCT ADMINISTERED (Expired dose administered to patients) and PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator on 01 Dec 2021 and administered on 11 Jan 2022) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications are provided. No treatment medications are provided.   Most recent FOLLOW-UP information incorporated above includes: On 31-Jan-2022: Significant follow-up appended includes patient identifiers, route of administration and additional event was added.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Intentional product use issue
Clinical narrative: I received my first shot March 18 , I am concerned because my second shot was August 6; This spontaneous case was reported by a consumer and describes the occurrence of INTENTIONAL PRODUCT USE ISSUE (I received my first shot March 18 , I am concerned because my second shot was August 6) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026b21a and 044a21a) for COVID-19 vaccination.     The patient's past medical history included Heart attack (patient had a heart attack on the past). Concurrent medical conditions included Diabetic, High cholesterol, Hypertension, Walking pneumonia and Drug resistance.   On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Aug-2021, the patient experienced INTENTIONAL PRODUCT USE ISSUE (I received my first shot March 18 , I am concerned because my second shot was August 6). On 09-Aug-2021, INTENTIONAL PRODUCT USE ISSUE (I received my first shot March 18 , I am concerned because my second shot was August 6) had resolved.            Concomitant product use was not provided by the reporter.  Vaccination date of the second dose was ambiguosly reported as August 6 and August 9.  It was reported that the patient was concerned because second shot was August 6 and he would die if he would got Covid because he had walking pneumonia from 15. Patient had bad kidney pains in left kidney which he did not report or go to the hospital because he had no insurance.  Patient was grateful about the vaccine and made several comments regarding masks and people's behavior regarding the pandemic but blamed the Moderna COVID19 vaccine affecting his life because of the numbness on his hands and the pain in his kidneys.  It was reported that the patient did not get the second shot till August because he was trying to research if he would have that problem again which he did not for the second shot or vaccine shot.  Patient made the following statement: with the 2nd shoot everything was fine.  Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 24-Jan-2022: Follow up received included new event (Hypoesthesia) was added, reporter details, patient details, suspect product details, event verbatim of renal pain and I narrative was updated.
Sex: U
Vaccine: COVID19
Symptoms: Asymptomatic COVID-19
Clinical narrative: got COVID and it was asymptomatic; This spontaneous case was reported by a nurse and describes the occurrence of ASYMPTOMATIC COVID-19 (got COVID and it was asymptomatic) 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 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 ASYMPTOMATIC COVID-19 (got COVID and it was asymptomatic). At the time of the report, ASYMPTOMATIC COVID-19 (got COVID and it was asymptomatic) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication of the patient was not reported.  No treatment information was provided by the reporter.  This is a spontaneous case concerning  a  patient of unknown age and gender, with no reported medical history, who experienced the unexpected non-serious event of asymptomatic covid-19. The event occurred on an unknown day after the second dose of mRNA-1273 COVID 19 Vaccine. The rechallenge was not applicable, as the event happened after the first dose. The event outcome was unknown. The benefit-risk relationship of mRNA-1273 COVID 19 Vaccine, is not affected by this report.; Sender's Comments: This is a spontaneous case concerning  a  patient of unknown age and gender, with no reported medical history, who experienced the unexpected non-serious event of asymptomatic covid-19. The event occurred on an unknown day after the second dose of mRNA-1273 COVID 19 Vaccine. The rechallenge was not applicable, as the event happened after the first dose. The event outcome was unknown. The benefit-risk relationship of mRNA-1273 COVID 19 Vaccine, is not affected by this report.
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Dizziness, Pain, Pyrexia, Tremor
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (shaky), PAIN (body aches), DIZZINESS (dizzy) and PYREXIA (99.5 degree Fahrenheit temperature) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027H21B) for COVID-19 vaccination. No Medical History information was reported.On 25-Jan-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Jan-2022, the patient experienced TREMOR (shaky), PAIN (body aches), DIZZINESS (dizzy) and PYREXIA (99.5 degree Fahrenheit temperature). At the time of the report, TREMOR (shaky), PAIN (body aches), DIZZINESS (dizzy) and PYREXIA (99.5 degree Fahrenheit temperature) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available):On an unknown date, Body temperature: 99.5 (High) degree Fahrenheit temperature.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 information provided. No treatment information provided.
Sex: F
Vaccine: COVID19
Symptoms: Eye irritation, Occupational exposure to product
Clinical narrative: She had burning in the eye; Another nurse was preparing doses of the Moderna Covid-19 Vaccine, and it splashed in her eye; This spontaneous case was reported by a nurse and describes the occurrence of EYE IRRITATION (She had burning in the eye) and OCCUPATIONAL EXPOSURE TO PRODUCT (Another nurse was preparing doses of the Moderna Covid-19 Vaccine, and it splashed in her eye) 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 an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Jan-2022, the patient experienced EYE IRRITATION (She had burning in the eye) and OCCUPATIONAL EXPOSURE TO PRODUCT (Another nurse was preparing doses of the Moderna Covid-19 Vaccine, and it splashed in her eye). On 26-Jan-2022, OCCUPATIONAL EXPOSURE TO PRODUCT (Another nurse was preparing doses of the Moderna Covid-19 Vaccine, and it splashed in her eye) had resolved. At the time of the report, EYE IRRITATION (She had burning in the eye) 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 medications were reported. No treatment medication was reported.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Ventricular tachycardia
Clinical narrative: ventricular tachycardia; This spontaneous case was reported by a consumer and describes the occurrence of VENTRICULAR TACHYCARDIA (ventricular tachycardia) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VENTRICULAR TACHYCARDIA (ventricular tachycardia) (seriousness criteria hospitalization and medically significant). The patient was hospitalized on 21-Dec-2021 due to VENTRICULAR TACHYCARDIA. The patient was treated with Surgery (Cardiac ablation) for Ventricular tachycardia. At the time of the report, VENTRICULAR TACHYCARDIA (ventricular tachycardia) outcome was unknown.            Patient had no prior Heart condition. Had several tests and procedures done along with a cardiac ablation which still did not fix the issue and currently on a heart event monitor awaiting the next step. Case did not met requirements for PQC. No concomitant medication information was provided. No treatment medication was provided.  Company comment:This is a case concerning a 55-year-old female patient with no medical history, who experienced the unexpected serious  AESI event of Ventricular tachycardia (seriousness criterion hospitalization and medically significant) which occurred on unknown date after to the second dose of mRNA1273 vaccine. Patient had no prior Heart condition. Had several tests and procedures done along with a cardiac ablation which still did not fix the issue and currently on a heart event monitor awaiting the next step. The event outcome was reported as unknown. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   Most recent FOLLOW-UP information incorporated above includes: On 27-Jan-2022: Non-significant follow up.; Sender's Comments: This is a case concerning a 55-year-old female patient with no medical history, who experienced the unexpected serious  AESI event of Ventricular tachycardia (seriousness criterion hospitalization and medically significant) which occurred on unknown date after to the second dose of mRNA1273 vaccine. Patient had no prior Heart condition. Had several tests and procedures done along with a cardiac ablation which still did not fix the issue and currently on a heart event monitor awaiting the next step. The event outcome was reported as unknown. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Confirmed COVID-19 infection; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Confirmed COVID-19 infection) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for Prophylactic vaccination.    Co-suspect product included non-company product COVID-19 VACCINE NRVV AD26 (JNJ 78436735) (JANSSEN COVID-19 VACCINE) for Prophylactic vaccination.    No Medical History information was reported.   On 07-Apr-2021, the patient started COVID-19 VACCINE NRVV AD26 (JNJ 78436735) (JANSSEN COVID-19 VACCINE) (unknown route) at an unspecified dose. On 25-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (Confirmed COVID-19 infection). At the time of the report, COVID-19 (Confirmed COVID-19 infection) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 16-Dec-2021, SARS-CoV-2 test: positive (Positive) Positive.         No concomitant medications were provided.  No treatment information was provided.  Company Comment: This spontaneous case concerns a patient, of unknown age and gender, with history of co-suspect administration of the Janssen COVID-19 vaccine, who experienced the unexpected, non-serious AESI of COVID-19 after administration of a dose of the Janssen COVID-19 vaccine on 07Apr2021 and the booster dose of the Moderna mRNA-1273 vaccine on 25Oct2021. On 16Dec2021, the patient tested positive for the COVID-19 virus. On an unspecified date, it was reported that the patient experienced a mild case with congestion, headache and mild fever. No further details were provided. The outcome of the event was unknown at the time of the report. The history of co-suspect administration of the Janssen COVID-19 vaccine remains a confounder. The benefit-risk relationship of the Moderna mRNA-1273 vaccine is not affected by this report.   Most recent FOLLOW-UP information incorporated above includes: On 27-Jan-2022: Non-significant information received.; Sender's Comments: This spontaneous case concerns a patient, of unknown age and gender, with history of co-suspect administration of the Janssen COVID-19 vaccine, who experienced the unexpected, non-serious AESI of COVID-19 after administration of a dose of the Janssen COVID-19 vaccine on 07Apr2021 and the booster dose of the Moderna mRNA-1273 vaccine on 25Oct2021. On 16Dec2021, the patient tested positive for the COVID-19 virus. On an unspecified date, it was reported that the patient experienced a mild case with congestion, headache and mild fever. No further details were provided. The outcome of the event was unknown at the time of the report. The history of co-suspect administration of the Janssen COVID-19 vaccine remains a confounder. The benefit-risk relationship of the Moderna mRNA-1273 vaccine is not affected by this report.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: he got sick with COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (he got sick with COVID-19) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Jan-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In January 2022, the patient experienced COVID-19 (he got sick with COVID-19). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Adverse event, at an unspecified dose and frequency. In January 2022, COVID-19 (he got sick with COVID-19) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In January 2022, SARS-CoV-2 test: negative (Negative) Negative.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant products were not provided.  Reporter was daughter who was calling on behalf of her father. She said that her father had travelled to receive the Moderna shot and he had contracted COVID-19 likely in the family resort or at the airport. Patient had received the first dose of the Moderna Vaccine. One week later (or 5 days later), he got sick with COVID-19. He had just recovered and having no symptoms. The symptoms lasted for about 1.5 weeks and he stopped having fever and cough. His test results came back negative.  Company comment: This case concerns a male patient of unknown age, with no medical history reported, who experienced the unexpected event of COVID 19. The event occurred one week after the third dose of mRNA-1273. As reported, the patient had received the first dose of the Moderna Vaccine and one week later (or 5 days later), he got sick with COVID-19. The symptoms lasted for about 1.5 weeks and he stopped having fever and cough. The patient had recovered. His test results came back negative, as reported. Based on the current available information, the mRNA-1273 does not contain a virus capable of causing COVID-19 infection after vaccination. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This case concerns a male patient of unknown age, with no medical history reported, who experienced the unexpected event of COVID 19. The event occurred one week after the third dose of mRNA-1273. As reported, the patient had received the first dose of the Moderna Vaccine and one week later (or 5 days later), he got sick with COVID-19. The symptoms lasted for about 1.5 weeks and he stopped having fever and cough. The patient had recovered. His test results came back negative, as reported. Based on the current available information, the mRNA-1273 does not contain a virus capable of causing COVID-19 infection after vaccination. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: after the expiration date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (after the expiration date) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Jan-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milligram. On 24-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (after the expiration date). On 24-Jan-2022, EXPIRED PRODUCT ADMINISTERED (after the expiration date) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment medication was not provided. Concomitant medication was not provided.  5 doses of the Moderna covid-19 vaccine were administered by intramuscular injection. None of these patients have reported any known symptoms following vaccination.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 antibody test
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (had Covid-19 back in Sep2021.) and DRUG INEFFECTIVE (Lack of drug effect) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012M20A and 026L20A) for COVID-19 vaccination. Concurrent medical conditions included Latex allergy (allergic to latex). Concomitant products included SERTRALINE HYDROCHLORIDE (ZOLOFT) and CALCIUM, COLECALCIFEROL (CALCIUM & VITAMIN D [CALCIUM; COLECALCIFEROL]) for an unknown indication. On 09-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In September 2021, the patient experienced COVID-19 (had Covid-19 back in Sep2021.) and DRUG INEFFECTIVE (Lack of drug effect). At the time of the report, COVID-19 (had Covid-19 back in Sep2021.) had resolved and DRUG INEFFECTIVE (Lack of drug effect) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In September 2021, SARS-CoV-2 antibody test: positive (Positive) Had COVID-19. Company comment: This spontaneous case concerns a 42  year  old, female patient with no reported relevant medical history, who experienced the unexpected non - serious AESI event of COVID19. The event occurred approximately 7 months after the second dose of mRNA-1273. Drug ineffective was captured since both mRNA  1273 doses were given 31 days apart. No medical assessment or treatment has been informed. At the time of the report the outcome of the event COVID19 was recovered. The Benefit-risk relationship of mRNA-1273 is not affected by this report. This case was linked to MOD-2022-460284 (Patient Link). Sender's Comments: This spontaneous case concerns a 42  year  old, female patient with no reported relevant medical history, who experienced the unexpected non-serious AESI event of COVID19. The event occurred approximately 7 months after the second dose of mRNA-1273. Drug ineffective was captured since both mRNA  1273 doses were given 31 days apart. No medical assessment or treatment has been informed. At the time of the report the outcome of the event COVID19 was recovered. The Benefit-risk relationship of mRNA-1273 is not affected by this report.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Cellulitis
Clinical narrative: Cellulitis in the left leg 7 days after first shot; This spontaneous case was reported by a physician and describes the occurrence of CELLULITIS (Cellulitis in the left leg 7 days after first shot) in a 45-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Mar-2021, the patient experienced CELLULITIS (Cellulitis in the left leg 7 days after first shot). At the time of the report, CELLULITIS (Cellulitis in the left leg 7 days after first shot) 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.   Company comment: This is a spontaneous case concerning a 45-year-old male patient with no reported medical history, who experienced the non-serious unexpected event cellulitis on the left leg, 7 days after the first dose of mRNA-1273. The benefit-risk relationship of mRNA-1273 is not affected by this report.  The patient was afraid of getting the second shot.  No concomitant medications were reported.  No treatment medications were reported.; Sender's Comments: Company comment: This is a spontaneous case concerning a 45-year-old male patient with no reported medical history, who experienced the non-serious unexpected event cellulitis on the left leg, 7 days after the first dose of mRNA-1273. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Body temperature increased, Chills, Headache, Influenza virus test
Clinical narrative: After receiving the booster dose he has continued feeling like hell and like he have been shot; congestion; no energy, tremendous weakness; sore throat; change in taste; temperature of 100.4; chills; headaches; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (After receiving the booster dose he has continued feeling like hell and like he have been shot), NASAL CONGESTION (congestion), ASTHENIA (no energy, tremendous weakness), OROPHARYNGEAL PAIN (sore throat) and TASTE DISORDER (change in taste) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011F21A, 016B21A and 027A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 13-Jan-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 13-Jan-2022, the patient experienced VACCINATION COMPLICATION (After receiving the booster dose he has continued feeling like hell and like he have been shot), NASAL CONGESTION (congestion), ASTHENIA (no energy, tremendous weakness), OROPHARYNGEAL PAIN (sore throat), TASTE DISORDER (change in taste), BODY TEMPERATURE INCREASED (temperature of 100.4), CHILLS (chills) and HEADACHE (headaches). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) at an unspecified dose and frequency. At the time of the report, VACCINATION COMPLICATION (After receiving the booster dose he has continued feeling like hell and like he have been shot), NASAL CONGESTION (congestion), ASTHENIA (no energy, tremendous weakness), OROPHARYNGEAL PAIN (sore throat), TASTE DISORDER (change in taste), BODY TEMPERATURE INCREASED (temperature of 100.4), CHILLS (chills) and HEADACHE (headaches) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 13-Jan-2022, Body temperature increased: temperature of 100.4 (High) temperature of 100.4. On an unknown date, Influenza virus test: negative (Negative) Negative. On an unknown date, SARS-CoV-2 antibody test: results pending test had no result yet..     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was reported. Patient was prescribed by antibiotics and steroids by his HCP.
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Nasal congestion, Oropharyngeal pain, SARS-CoV-2 antibody test, Taste disorder, Vaccination complication
Clinical narrative: After receiving the booster dose he has continued feeling like hell and like he have been shot; congestion; no energy, tremendous weakness; sore throat; change in taste; temperature of 100.4; chills; headaches; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (After receiving the booster dose he has continued feeling like hell and like he have been shot), NASAL CONGESTION (congestion), ASTHENIA (no energy, tremendous weakness), OROPHARYNGEAL PAIN (sore throat) and TASTE DISORDER (change in taste) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011F21A, 016B21A and 027A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 13-Jan-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 13-Jan-2022, the patient experienced VACCINATION COMPLICATION (After receiving the booster dose he has continued feeling like hell and like he have been shot), NASAL CONGESTION (congestion), ASTHENIA (no energy, tremendous weakness), OROPHARYNGEAL PAIN (sore throat), TASTE DISORDER (change in taste), BODY TEMPERATURE INCREASED (temperature of 100.4), CHILLS (chills) and HEADACHE (headaches). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) at an unspecified dose and frequency. At the time of the report, VACCINATION COMPLICATION (After receiving the booster dose he has continued feeling like hell and like he have been shot), NASAL CONGESTION (congestion), ASTHENIA (no energy, tremendous weakness), OROPHARYNGEAL PAIN (sore throat), TASTE DISORDER (change in taste), BODY TEMPERATURE INCREASED (temperature of 100.4), CHILLS (chills) and HEADACHE (headaches) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 13-Jan-2022, Body temperature increased: temperature of 100.4 (High) temperature of 100.4. On an unknown date, Influenza virus test: negative (Negative) Negative. On an unknown date, SARS-CoV-2 antibody test: results pending test had no result yet..     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was reported. Patient was prescribed by antibiotics and steroids by his HCP.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19 infection) 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 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In November 2021, the patient experienced COVID-19 (COVID-19 infection). At the time of the report, COVID-19 (COVID-19 infection) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medication reported. No treatment medication reported. Patient was not sure about when to get their booster. Company Comment: This case concerns a patient of an unknown age and gender, with no medical history reported, who experienced the unexpected event of COVID-19. The event occurred on an unknown date after receiving a dose of mRNA-1273 Vaccine. At the time of the report the outcome of the events was unknown. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Sender's Comments: This case concerns a patient of an unknown age and gender, with no medical history reported, who experienced the unexpected event of COVID-19. The event occurred on an unknown date after receiving a dose of mRNA-1273 Vaccine. At the time of the report the outcome of the events was unknown. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: COVID positive; This spontaneous case was reported by a pharmacist and describes the occurrence of COVID-19 (COVID positive) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (COVID positive). At the time of the report, COVID-19 (COVID positive) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive (Positive) Positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  Treatment medication includes Monoclonal antibodies in Oct-2021.  HCP asked if there is an interval before receiving 3rd full dose due to being immunocompromised. It was reported that unknown dates of 1st and 2nd doses.  This is a spontaneous case concerning  a  patient of unknown age and gender, with Concurrent medical condition of Immunocompromised, who experienced the unexpected non-serious event of Covid-19. The events occurred on an unknown date after the second dose of mRNA-1273 COVID 19 Vaccine. With positive test for Covid. Underwent treatment with monoclonal antibodies. The event outcome was reported as unknown. The Concurrent medical conditions of Immunocompromised, remains a confounder. The benefit-risk relationship of mRNA-1273 COVID 19 Vaccine, is not affected by this report.   Reporter did not allow further contact; Sender's Comments: This is a spontaneous case concerning  a  patient of unknown age and gender, with Concurrent medical condition of Immunocompromised, who experienced the unexpected non-serious event of Covid-19. The events occurred on an unknown date after the second dose of mRNA-1273 COVID 19 Vaccine. With positive test for Covid. Underwent treatment with monoclonal antibodies. The event outcome was reported as unknown. The Concurrent medical conditions of Immunocompromised, remains a confounder. The benefit-risk relationship of mRNA-1273 COVID 19 Vaccine, is not affected by this report.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pain in extremity
Clinical narrative: His arm really hurt; Really bad headache; He was super tired/fatigue; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (His arm really hurt), HEADACHE (Really bad headache) and FATIGUE (He was super tired/fatigue) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Migraine. Concomitant products included BUPROPION HYDROCHLORIDE (WELLBUTRIN XL) for an unknown indication.    On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Mar-2021, the patient experienced PAIN IN EXTREMITY (His arm really hurt), HEADACHE (Really bad headache) and FATIGUE (He was super tired/fatigue). On 11-Mar-2021, PAIN IN EXTREMITY (His arm really hurt), HEADACHE (Really bad headache) and FATIGUE (He was super tired/fatigue) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       Treatment medication was not provided by the reporter.   This case was linked to MOD-2022-463046 (Patient Link).
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: dose administered after 30-day Use by Date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (dose administered after 30-day Use by Date) in a 42-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 939902 and 939902) for COVID-19 vaccination.     No Medical History information was reported.   On 26-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Sep-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (dose administered after 30-day Use by Date). On 23-Sep-2021, EXPIRED PRODUCT ADMINISTERED (dose administered after 30-day Use by Date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   It was reported 2nd dose was stored on the refrigerator since 10 Aug 2021. No concomitant medications details were reported. No treatment information details were reported.
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: 7 booster doses of the Moderna Covid-19 Vaccine given on 3Jan2022 were past the 30-day Use By Date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (7 booster doses of the Moderna Covid-19 Vaccine given on 3Jan2022 were past the 30-day Use By Date) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 058H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (7 booster doses of the Moderna Covid-19 Vaccine given on 3Jan2022 were past the 30-day Use By Date). On 03-Jan-2022, EXPIRED PRODUCT ADMINISTERED (7 booster doses of the Moderna Covid-19 Vaccine given on 3Jan2022 were past the 30-day Use By Date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant were reported.  No treatment were reported.
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: 7 booster doses of the Moderna Covid-19 Vaccine given on 3Jan2022 were past the 30-day Use By Date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (7 booster doses of the Moderna Covid-19 Vaccine given on 3Jan2022 were past the 30-day Use By Date) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 058H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (7 booster doses of the Moderna Covid-19 Vaccine given on 3Jan2022 were past the 30-day Use By Date). On 03-Jan-2022, EXPIRED PRODUCT ADMINISTERED (7 booster doses of the Moderna Covid-19 Vaccine given on 3Jan2022 were past the 30-day Use By Date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided by reporter. No treatment information was provided by reporter.
Sex: U
Vaccine: COVID19
Symptoms: Chills
Clinical narrative: a lot of chills after my booster shot from yesterday/on and off chills; This spontaneous case was reported by a pharmacist and describes the occurrence of CHILLS (a lot of chills after my booster shot from yesterday/on and off chills) 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 26-Jan-2022 at 3:00 AM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Jan-2022, the patient experienced CHILLS (a lot of chills after my booster shot from yesterday/on and off chills). At the time of the report, CHILLS (a lot of chills after my booster shot from yesterday/on and off chills) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication were reported  No treatment information was reported
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Somnolence
Clinical narrative: sleepiness; Achy joints; He experienced fatigue; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (sleepiness), ARTHRALGIA (Achy joints) and FATIGUE (He experienced fatigue) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Migraine (He has usual migraines). Concomitant products included BUPROPION HYDROCHLORIDE (WELLBUTRIN XL) for an unknown indication.   On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Apr-2021, the patient experienced SOMNOLENCE (sleepiness), ARTHRALGIA (Achy joints) and FATIGUE (He experienced fatigue). On 06-Apr-2021, SOMNOLENCE (sleepiness), ARTHRALGIA (Achy joints) and FATIGUE (He experienced fatigue) had resolved.            No treatment were provided.   This case was linked to MOD-2022-462964, MOD-2021-062088 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: 7 booster doses of the Moderna Covid-19 Vaccine given on 3Jan2022 were past the 30-day Use By Date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (7 booster doses of the Moderna Covid-19 Vaccine given on 3Jan2022 were past the 30-day Use By Date) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 058H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (7 booster doses of the Moderna Covid-19 Vaccine given on 3Jan2022 were past the 30-day Use By Date). On 03-Jan-2022, EXPIRED PRODUCT ADMINISTERED (7 booster doses of the Moderna Covid-19 Vaccine given on 3Jan2022 were past the 30-day Use By Date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The dose administered after 30-day used by date. The vial was initially stored in the refrigerator 01-Dec-2021. No concomitant products were reported. No treatment information was reported.
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: 7 booster doses of the Moderna Covid-19 Vaccine given on 3Jan2022 were past the 30-day Use By Date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (7 booster doses of the Moderna Covid-19 Vaccine given on 3Jan2022 were past the 30-day Use By Date) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 058H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (7 booster doses of the Moderna Covid-19 Vaccine given on 3Jan2022 were past the 30-day Use By Date). On 03-Jan-2022, EXPIRED PRODUCT ADMINISTERED (7 booster doses of the Moderna Covid-19 Vaccine given on 3Jan2022 were past the 30-day Use By Date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant information was reported. No Treatment information was reported. Date the vial was initially stored in the refrigerator was 1 Dec 2021 and the vial undergone any temperature excursions and the dose were past the 30-day Use By Date of 30Dec2021.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine administered to 2 of the patients; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to 2 of the patients) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 067H21A and 067H21A) for COVID-19 vaccination.     No Medical History information was reported.   On 28-Dec-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Jan-2022, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Jan-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to 2 of the patients). On 25-Jan-2022, EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to 2 of the patients) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.  Based on their knowledge, vials may be stored refrigerated between 2° to 8°C (36° to 46°F) for up to 30 days prior to first use. The vial that was moved from the freezer to the refrigerator was already expired last 20Jan2022 but they were still able to give it to 2 of their patients
Sex: U
Vaccine: COVID19
Symptoms: Cardiac disorder, Vaccination complication
Clinical narrative: doctor send me to emergency room for my heart; very bad reaction; This spontaneous case was reported by a pharmacist and describes the occurrence of CARDIAC DISORDER (doctor send me to emergency room for my heart) and VACCINATION COMPLICATION (very bad 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 CARDIAC DISORDER (doctor send me to emergency room for my heart) and VACCINATION COMPLICATION (very bad reaction). At the time of the report, CARDIAC DISORDER (doctor send me to emergency room for my heart) and VACCINATION COMPLICATION (very bad reaction) 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 relevant concomitant medications were reported.  Treatment information was unknown.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Feeling hot, Influenza like illness, Myalgia, Pain
Clinical narrative: arm hurt; small ache/achy; flu-like symptoms; it was a small ache and not as hot to the touch; tired; body aches; low grade fever; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm hurt), PAIN (small ache/achy), INFLUENZA LIKE ILLNESS (flu-like symptoms), FEELING HOT (it was a small ache and not as hot to the touch) and FATIGUE (tired) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Exposure to tobacco (smelling cigarette smoke every day for the past 3 to 4 months.) and Cancer surgery (Thyroid cancer surgery) on 29-Apr-2021. Concurrent medical conditions included Immunocompromised and AFib. Concomitant products included METOPROLOL, ATORVASTATIN and APIXABAN (ELIQUIS) for AFib, LEVOTHYROXINE SODIUM (SYNTHROID) for an unknown indication.   In June 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In July 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 PAIN IN EXTREMITY (arm hurt), PAIN (small ache/achy), INFLUENZA LIKE ILLNESS (flu-like symptoms), FEELING HOT (it was a small ache and not as hot to the touch), FATIGUE (tired), MYALGIA (body aches) and PYREXIA (low grade fever). In July 2021, PAIN IN EXTREMITY (arm hurt), PAIN (small ache/achy), INFLUENZA LIKE ILLNESS (flu-like symptoms), FEELING HOT (it was a small ache and not as hot to the touch), FATIGUE (tired), MYALGIA (body aches) and PYREXIA (low grade fever) had resolved.            No treatments medications was reported.   This case was linked to MOD-2022-463070, MOD-2022-463121 (Patient Link).