chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Bronchitis, Off label use, SARS-CoV-2 test, Vaccination complication
Clinical narrative: they had a reaction; She developed a case of bronchitis, so she was advised by her doctor not to get the second dose; she was advised by her doctor not to get the second dose; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (they had a reaction), BRONCHITIS (She developed a case of bronchitis, so she was advised by her doctor not to get the second dose) and OFF LABEL USE (she was advised by her doctor not to get the second dose) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in March 2020.    On 21-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (they had a reaction), BRONCHITIS (She developed a case of bronchitis, so she was advised by her doctor not to get the second dose) and OFF LABEL USE (she was advised by her doctor not to get the second dose). At the time of the report, VACCINATION COMPLICATION (they had a reaction) and BRONCHITIS (She developed a case of bronchitis, so she was advised by her doctor not to get the second dose) outcome was unknown and OFF LABEL USE (she was advised by her doctor not to get the second dose) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In March 2020, SARS-CoV-2 test: positive (Positive) positive.     mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was withdrawn on an unknown date.       no concomitant and treatment medications are provided by the reporter.  First dose was given less then 25 days ago.   Most recent FOLLOW-UP information incorporated above includes: On 01-Nov-2021: Significant follow-up received additional  lab data, suspect product administration date,action taken and event added .
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Hypersomnia, Interchange of vaccine products
Clinical narrative: She had the Johnson and Johnson and the Moderna booster; It wiped her out for a couple days, just tired; slept for about 18 hours; This spontaneous case was reported by a consumer and describes the occurrence of HYPERSOMNIA (slept for about 18 hours), INTERCHANGE OF VACCINE PRODUCTS (She had the Johnson and Johnson and the Moderna booster) and FATIGUE (It wiped her out for a couple days, just tired) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046C21A) for COVID-19 vaccination.     Previously administered products included for COVID-19 vaccination: Johnson & Johnson COVID19 Vaccine (LOT 1805025) on 24-Mar-2021. Past adverse reactions to the above products included No adverse reaction with Johnson & Johnson COVID19 Vaccine.    On 27-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Oct-2021, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (She had the Johnson and Johnson and the Moderna booster). On an unknown date, the patient experienced HYPERSOMNIA (slept for about 18 hours) and FATIGUE (It wiped her out for a couple days, just tired). On 27-Oct-2021, INTERCHANGE OF VACCINE PRODUCTS (She had the Johnson and Johnson and the Moderna booster) had resolved. At the time of the report, HYPERSOMNIA (slept for about 18 hours) outcome was unknown and FATIGUE (It wiped her out for a couple days, just tired) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not provided.  Patient had the Johnson and Johnson and the moderna booster, and her doctor advised it was ok.  Treatment information was not provided.  Company comment: This is a case of interchange of vaccine products (received Johnson and Johnson Covid-19 vaccine) of this 74-year-old, female patient, with no disclosed medical history, who experienced the non-serious, unexpected events of hypersomnia and fatigue. The events occurred on unknown date after the dose of Moderna vaccine. The rechallenge is not applicable as patient only received one dose of Moderna vaccine. The benefit-risk relationship of Moderna vaccine is not affected by this report.; Sender's Comments: This is a case of interchange of vaccine products (received Johnson and Johnson Covid-19 vaccine) of this 74-year-old, female patient, with no disclosed medical history, who experienced the non-serious, unexpected events of hypersomnia and fatigue. The events occurred on unknown date after the dose of Moderna vaccine. The rechallenge is not applicable as patient only received one dose of Moderna vaccine. The benefit-risk relationship of Moderna vaccine is not affected by this report.
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Headache, Myalgia, Pain in extremity
Clinical narrative: arm is still really sore; Soreness, body aches; Fatigue, Fatigue (the typical that they had the first time); Headache, headache (the typical that they had the first time); Joint aches; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm is still really sore), MYALGIA (Soreness, body aches), FATIGUE (Fatigue, Fatigue (the typical that they had the first time)), HEADACHE (Headache, headache (the typical that they had the first time)) and ARTHRALGIA (Joint aches) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026021A, 004M20A and 023M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Oct-2021, the patient experienced PAIN IN EXTREMITY (arm is still really sore). 26-Oct-2021, the patient experienced MYALGIA (Soreness, body aches), FATIGUE (Fatigue, Fatigue (the typical that they had the first time)), HEADACHE (Headache, headache (the typical that they had the first time)) and ARTHRALGIA (Joint aches). At the time of the report, PAIN IN EXTREMITY (arm is still really sore) had not resolved and MYALGIA (Soreness, body aches), FATIGUE (Fatigue, Fatigue (the typical that they had the first time)), HEADACHE (Headache, headache (the typical that they had the first time)) and ARTHRALGIA (Joint aches) had resolved.      Concomitant medication was not provided.  Patient experienced fatigue, headache, the typical that they had the first time, and also soreness, body aches, joint aches, for 24 hours or maybe 48 hours.  Treatment information was not provided.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: A friend who received a expired dose; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (A friend who received a expired dose) 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 EXPIRED PRODUCT ADMINISTERED (A friend who received a expired dose). At the time of the report, EXPIRED PRODUCT ADMINISTERED (A friend who received a expired dose) had resolved.            No concomitant medications were provided. No treatment medications were reported.
Sex: F
Vaccine: COVID19
Symptoms: Dysgeusia
Clinical narrative: metallic taste in their mouth/this funny taste in their mouth that will not go away; This spontaneous case was reported by a consumer and describes the occurrence of DYSGEUSIA (metallic taste in their mouth/this funny taste in their mouth that will not go away) 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.    In February 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, the patient experienced DYSGEUSIA (metallic taste in their mouth/this funny taste in their mouth that will not go away). At the time of the report, DYSGEUSIA (metallic taste in their mouth/this funny taste in their mouth that will not go away) had not resolved.            No concomitant medications reported by reporter No treatment medications provided by the reporter.   This case was linked to MOD-2021-368853 (Patient Link).
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination complication, Vaccination site pain
Clinical narrative: Did not feel good for a day; Sore injection site arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Did not feel good for a day) and VACCINATION SITE PAIN (Sore injection site arm) in a 69-year-old male 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, the patient experienced VACCINATION COMPLICATION (Did not feel good for a day) and VACCINATION SITE PAIN (Sore injection site arm). At the time of the report, VACCINATION COMPLICATION (Did not feel good for a day) and VACCINATION SITE PAIN (Sore injection site arm) outcome was unknown.      No concomitant medication reported. No treatment information was provided. It was reported that the patient received the third dose full dose of the Moderna Covid-19 vaccine in early October.   This case was linked to MOD-2021-369081 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Suspected COVID-19
Clinical narrative: Wife develop symptoms of COVID after fully vaccinated; This spontaneous case was reported by a pharmacist and describes the occurrence of SUSPECTED COVID-19 (Wife develop symptoms of COVID after fully vaccinated) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced SUSPECTED COVID-19 (Wife develop symptoms of COVID after fully vaccinated). At the time of the report, SUSPECTED COVID-19 (Wife develop symptoms of COVID after fully vaccinated) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported.  No treatment information was provided. Case is linked with MOD21-159174  This case concerns a female patient with unknown age, no relevant medical history, who experienced the non-serious unexpected event of Suspected COVID-19. The event occurred on an unknown day after the second dose of Spikevax. The rechallenge was assessed as not applicable as the AE occurred after the second dose. The benefit-risk relationship of Spikevax is not affected by this report. Although referred that COVID-19 is diagnosed being fully vaccinated, the information regarding vaccination dates is incomplete, so lack of efficacy situation cannot be properly assessed.; Sender's Comments: This case concerns a female patient with unknown age, no relevant medical history, who experienced the non-serious unexpected event of Suspected COVID-19. The event occurred on an unknown day after the second dose of Spikevax. The rechallenge was assessed as not applicable as the AE occurred after the second dose. The benefit-risk relationship of Spikevax is not affected by this report. Although referred that COVID-19 is diagnosed being fully vaccinated, the information regarding vaccination dates is incomplete, so lack of efficacy situation cannot be properly assessed.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Received expired booster dose of the Moderna vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received expired booster dose of the Moderna vaccine) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 050E21A, 037B21A and 038A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Oct-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Received expired booster dose of the Moderna vaccine). On 28-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Received expired booster dose of the Moderna vaccine) 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.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient  administered an expired dose of Moderna COVID-19 Vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient  administered an expired dose of Moderna COVID-19 Vaccine) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 008C21A and 026C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 01-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Oct-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient  administered an expired dose of Moderna COVID-19 Vaccine). On 29-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Patient  administered an expired dose of Moderna COVID-19 Vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were provided.   No treatment medications were provided.   This case was linked to MOD-2021-368741, MOD-2021-369061 (Patient Link).
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Received expired booster dose of the Moderna vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received expired booster dose of the Moderna vaccine) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 050E21A) for COVID-19 vaccination.   No Medical History information was reported.   On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received expired booster dose of the Moderna vaccine). On 28-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Received expired booster dose of the Moderna vaccine) had resolved.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided.  No treatment medications were reported.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Moderna COVID-19 vaccine was administered after the beyond use date; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Moderna COVID-19 vaccine was administered after the beyond use date) 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 EXPIRED PRODUCT ADMINISTERED (Moderna COVID-19 vaccine was administered after the beyond use date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Moderna COVID-19 vaccine was administered after the beyond use date) 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 information was provided
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Balance disorder, Feeling abnormal
Clinical narrative: feel off; balance was a little off/a little drifty; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (feel off) and BALANCE DISORDER (balance was a little off/a little drifty) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Jun-2021, the patient experienced FEELING ABNORMAL (feel off) and BALANCE DISORDER (balance was a little off/a little drifty). At the time of the report, FEELING ABNORMAL (feel off) and BALANCE DISORDER (balance was a little off/a little drifty) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was reported. No treatment information was provided.  The next day after receiving the first dose of the vaccine he started to feel off. This was like his balance was a little off. It got better after a couple of weeks, but never completely resolved. He continued to feel a little drifty.   This case was linked to MOD-2021-369161 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Incorrect route of product administration
Clinical narrative: tuberculin syringe and needle used to administer Moderna booster; This spontaneous case was reported by a nurse and describes the occurrence of INCORRECT ROUTE OF PRODUCT ADMINISTRATION (tuberculin syringe and needle used to administer Moderna booster) 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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INCORRECT ROUTE OF PRODUCT ADMINISTRATION (tuberculin syringe and needle used to administer Moderna booster). At the time of the report, INCORRECT ROUTE OF PRODUCT ADMINISTRATION (tuberculin syringe and needle used to administer Moderna booster) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication use was unknown Treatment information was unknown
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Influenza like illness
Clinical narrative: flu-like symptoms for a day or two; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (flu-like symptoms for a day or two) in a 46-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Epididymitis.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (flu-like symptoms for a day or two). At the time of the report, INFLUENZA LIKE ILLNESS (flu-like symptoms for a day or two) 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 provided. Treatment medication included antibiotics.   This case was linked to MOD-2021-369197 (Patient Link).
Age: 86.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site swelling
Clinical narrative: Vaccination site pain; Vaccination site erythema; Vaccination site swelling; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Vaccination site pain), VACCINATION SITE ERYTHEMA (Vaccination site erythema) and VACCINATION SITE SWELLING (Vaccination site swelling) in an 86-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 074C21A, 030L20A and 001A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (Vaccination site pain), VACCINATION SITE ERYTHEMA (Vaccination site erythema) and VACCINATION SITE SWELLING (Vaccination site swelling). At the time of the report, VACCINATION SITE PAIN (Vaccination site pain), VACCINATION SITE ERYTHEMA (Vaccination site erythema) and VACCINATION SITE SWELLING (Vaccination site swelling) outcome was unknown.            Concomitant medication was not reported. Treatment information was not reported.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Ageusia, Lethargy
Clinical narrative: Lose sense of taste; experienced lethargy; This spontaneous case was reported by a consumer and describes the occurrence of AGEUSIA (Lose sense of taste) and LETHARGY (experienced lethargy) in a 78-year-old male 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced AGEUSIA (Lose sense of taste) and LETHARGY (experienced lethargy). At the time of the report, AGEUSIA (Lose sense of taste) and LETHARGY (experienced lethargy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No medical history was provided. No concomitant and treatment medication was provided. This is a spontaneous case concerning a 78-year-old male patient with no relevant medical history reported, who experienced non serious, AESI, unexpected event of Ageusia. The event occurred unknown days after a dose of mRNA-1273. Rechallenge is not applicable. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This is a spontaneous case concerning a 78-year-old male patient with no relevant medical history reported, who experienced non serious, AESI, unexpected event of Ageusia. The event occurred unknown days after a dose of mRNA-1273. Rechallenge is not applicable. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: I believe we vaccinated an individual after the beyond use date of the vaccine.; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (I believe we vaccinated an individual after the beyond use date of the vaccine.) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (I believe we vaccinated an individual after the beyond use date of the vaccine.). On 01-Oct-2021, EXPIRED PRODUCT ADMINISTERED (I believe we vaccinated an individual after the beyond use date of the vaccine.) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medications were provided. No treatment medications were provided.   Reporter did not allow further contact
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Scrotal swelling
Clinical narrative: swelling in the scrotum and testicle area; This spontaneous case was reported by a consumer and describes the occurrence of SCROTAL SWELLING (swelling in the scrotum and testicle area) in a 46-year-old male 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 SCROTAL SWELLING (swelling in the scrotum and testicle area). At the time of the report, SCROTAL SWELLING (swelling in the scrotum and testicle area) had not resolved.            No Concomitant medications were provided. Treatment medication included antibiotics for epididymitis.   This case was linked to MOD-2021-369164 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Rash macular
Clinical narrative: has red blotches all over, and  it was increasing in numbers.; This spontaneous case was reported by a consumer and describes the occurrence of RASH MACULAR (has red blotches all over, and  it was increasing in numbers.) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Chickenpox (when young).   In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In April 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced RASH MACULAR (has red blotches all over, and  it was increasing in numbers.). At the time of the report, RASH MACULAR (has red blotches all over, and  it was increasing in numbers.) had not resolved.            No Concomitant medication details were provided. No Treatment medication details were provided.
Age: 18.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Inappropriate schedule of product administration, Malaise, Vaccination site pain
Clinical narrative: under the weather; had a sore left injection site/sore left arm; tired; The patient received his third Moderna Covid-19 booster dose on 15OCT2021; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (under the weather), VACCINATION SITE PAIN (had a sore left injection site/sore left arm), FATIGUE (tired) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (The patient received his third Moderna Covid-19 booster dose on 15OCT2021) in an 18-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039D21A and 045A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 15-Oct-2021, the patient experienced MALAISE (under the weather), VACCINATION SITE PAIN (had a sore left injection site/sore left arm), FATIGUE (tired) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (The patient received his third Moderna Covid-19 booster dose on 15OCT2021). On 15-Oct-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (The patient received his third Moderna Covid-19 booster dose on 15OCT2021) had resolved. At the time of the report, MALAISE (under the weather), VACCINATION SITE PAIN (had a sore left injection site/sore left arm) and FATIGUE (tired) outcome was unknown.            No Concomitant medications were reported.  No Treatment information was reported.  It was reported that Symptoms were more pronounced than the first two vaccinations on 15-OCT-2021   This case was linked to MOD-2021-369380, MOD-2021-369381 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Sore arm; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 30-Oct-2021 and was forwarded to Moderna on 30-Oct-2021.    This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore arm). At the time of the report, PAIN IN EXTREMITY (Sore arm) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant information was not provided.  Treatment information was not provided.   This case was linked to MOD-2021-369213 (Patient Link).
Age: 84.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia
Clinical narrative: Had no energy at all; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Had no energy at all) in an 84-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 11-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. On 24-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Oct-2021, the patient experienced ASTHENIA (Had no energy at all). On 29-Oct-2021, ASTHENIA (Had no energy at all) had resolved.            No Concomitant medications were provided by the reporter.  No Treatment Information was provided by the reporter.  Patient received the regular flu shot two weeks ago (did not specify date).   This case was linked to MOD-2021-369248 (Patient Link).
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Dyspepsia, Fatigue, Headache, Illness
Clinical narrative: The patient said it's making me so sick I can't barely function; Something for the gut to try and help it/ something to help digest the food; The second shot gave her cramps; Diarrhea; My skin is white; I'm just tired; Had a slight fever; Headache; Body aches said at first it was my breast and around the neck but now is just around the neck; On sept 27th, when she was initially scheduled for the second dose; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (The patient said it's making me so sick I can't barely function), DYSPEPSIA (Something for the gut to try and help it/ something to help digest the food), MUSCLE SPASMS (The second shot gave her cramps), DIARRHOEA (Diarrhea) and SKIN DISCOLOURATION (My skin is white) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 020F21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 in December 2020.    On 26-Oct-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Oct-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (On sept 27th, when she was initially scheduled for the second dose). On an unknown date, the patient experienced ILLNESS (The patient said it's making me so sick I can't barely function), DYSPEPSIA (Something for the gut to try and help it/ something to help digest the food), MUSCLE SPASMS (The second shot gave her cramps), DIARRHOEA (Diarrhea), SKIN DISCOLOURATION (My skin is white), FATIGUE (I'm just tired), PYREXIA (Had a slight fever), HEADACHE (Headache) and MYALGIA (Body aches said at first it was my breast and around the neck but now is just around the neck). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) at an unspecified dose and frequency. On 26-Oct-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (On sept 27th, when she was initially scheduled for the second dose) had resolved. At the time of the report, ILLNESS (The patient said it's making me so sick I can't barely function), DYSPEPSIA (Something for the gut to try and help it/ something to help digest the food), MUSCLE SPASMS (The second shot gave her cramps), DIARRHOEA (Diarrhea), SKIN DISCOLOURATION (My skin is white), FATIGUE (I'm just tired), PYREXIA (Had a slight fever), HEADACHE (Headache) and MYALGIA (Body aches said at first it was my breast and around the neck but now is just around the neck) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In October 2021, Weight: 21 (Low) Lost 21 pounds.         The patient has been taking unspecified medicines and homeopathic. The patient was taking some gastrointestinal stuff and something to help digest the food. The patient said that on sept 27th, when she was initially scheduled for the second dose, felt like I was having a heart attack   This case was linked to MOD-2021-369263 (Patient Link).
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Weight
Clinical narrative: The patient said it's making me so sick I can't barely function; Something for the gut to try and help it/ something to help digest the food; The second shot gave her cramps; Diarrhea; My skin is white; I'm just tired; Had a slight fever; Headache; Body aches said at first it was my breast and around the neck but now is just around the neck; On sept 27th, when she was initially scheduled for the second dose; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (The patient said it's making me so sick I can't barely function), DYSPEPSIA (Something for the gut to try and help it/ something to help digest the food), MUSCLE SPASMS (The second shot gave her cramps), DIARRHOEA (Diarrhea) and SKIN DISCOLOURATION (My skin is white) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 020F21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 in December 2020.    On 26-Oct-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Oct-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (On sept 27th, when she was initially scheduled for the second dose). On an unknown date, the patient experienced ILLNESS (The patient said it's making me so sick I can't barely function), DYSPEPSIA (Something for the gut to try and help it/ something to help digest the food), MUSCLE SPASMS (The second shot gave her cramps), DIARRHOEA (Diarrhea), SKIN DISCOLOURATION (My skin is white), FATIGUE (I'm just tired), PYREXIA (Had a slight fever), HEADACHE (Headache) and MYALGIA (Body aches said at first it was my breast and around the neck but now is just around the neck). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) at an unspecified dose and frequency. On 26-Oct-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (On sept 27th, when she was initially scheduled for the second dose) had resolved. At the time of the report, ILLNESS (The patient said it's making me so sick I can't barely function), DYSPEPSIA (Something for the gut to try and help it/ something to help digest the food), MUSCLE SPASMS (The second shot gave her cramps), DIARRHOEA (Diarrhea), SKIN DISCOLOURATION (My skin is white), FATIGUE (I'm just tired), PYREXIA (Had a slight fever), HEADACHE (Headache) and MYALGIA (Body aches said at first it was my breast and around the neck but now is just around the neck) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In October 2021, Weight: 21 (Low) Lost 21 pounds.         The patient has been taking unspecified medicines and homeopathic. The patient was taking some gastrointestinal stuff and something to help digest the food. The patient said that on sept 27th, when she was initially scheduled for the second dose, felt like I was having a heart attack   This case was linked to MOD-2021-369263 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Facial pain, Headache, Pain in jaw, Swelling, Vaccination site swelling
Clinical narrative: reaction to the booster and big swelling on their right arm; swelling on their neck; face is hurting; jaw is hurting; headache.; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (reaction to the booster and big swelling on their right arm), SWELLING (swelling on their neck), FACIAL PAIN (face is hurting), PAIN IN JAW (jaw is hurting) and HEADACHE (headache.) 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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE SWELLING (reaction to the booster and big swelling on their right arm), SWELLING (swelling on their neck), FACIAL PAIN (face is hurting), PAIN IN JAW (jaw is hurting) and HEADACHE (headache.). At the time of the report, VACCINATION SITE SWELLING (reaction to the booster and big swelling on their right arm), SWELLING (swelling on their neck), FACIAL PAIN (face is hurting), PAIN IN JAW (jaw is hurting) and HEADACHE (headache.) outcome was unknown.            No concomitant medications provided. No treatment medications provided.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Gait inability, Pain, Pain in extremity, Peripheral swelling
Clinical narrative: severe pain in left leg/it's painful and swollen.; 10-fold worse pain since booster dose; cannot walk, it's painful; swollen left leg about 1/5 to 1/6 bigger in size (from the thigh to ankle)/left calf was also bigger/it was painful and swollen; pain at inside of knee/pain at back of  knee; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (severe pain in left leg/it's painful and swollen.), PAIN (10-fold worse pain since booster dose), GAIT INABILITY (cannot walk, it's painful), PERIPHERAL SWELLING (swollen left leg about 1/5 to 1/6 bigger in size (from the thigh to ankle)/left calf was also bigger/it was painful and swollen) and ARTHRALGIA (pain at inside of knee/pain at back of  knee) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032F21A, 039A21A and 012A21A) for COVID-19 vaccination.     Concurrent medical conditions included Pain in leg. Concomitant products included TRAMADOL for Pain, ROSUVASTATIN for an unknown indication.   On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Oct-2021, the patient experienced PAIN IN EXTREMITY (severe pain in left leg/it's painful and swollen.), PAIN (10-fold worse pain since booster dose), GAIT INABILITY (cannot walk, it's painful), PERIPHERAL SWELLING (swollen left leg about 1/5 to 1/6 bigger in size (from the thigh to ankle)/left calf was also bigger/it was painful and swollen) and ARTHRALGIA (pain at inside of knee/pain at back of  knee). The patient was treated with IBUPROFEN, PARACETAMOL (ADVIL DUAL ACTION) for Adverse reaction, at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (severe pain in left leg/it's painful and swollen.), PAIN (10-fold worse pain since booster dose), GAIT INABILITY (cannot walk, it's painful), PERIPHERAL SWELLING (swollen left leg about 1/5 to 1/6 bigger in size (from the thigh to ankle)/left calf was also bigger/it was painful and swollen) and ARTHRALGIA (pain at inside of knee/pain at back of  knee) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Sex: U
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: have a bad headache.; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (have a bad headache.) 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 HEADACHE (have a bad headache.). At the time of the report, HEADACHE (have a bad headache.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications provided. No treatment medications provided.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site oedema, Vaccination site swelling
Clinical narrative: edema in left arm; left arm was swollen; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE OEDEMA (edema in left arm) and VACCINATION SITE SWELLING (left arm was swollen) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025L20A and 010M20A) for COVID-19 vaccination.     Concomitant products included SIMVASTATIN for Cholesterol, LEVOTHYROXINE for Thyroid hypoplasia, APIXABAN (ELIQUIS) and DILTIAZEM HYDROCHLORIDE (CARTIA XT) for an unknown indication.   On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Jan-2021, the patient experienced VACCINATION SITE OEDEMA (edema in left arm) and VACCINATION SITE SWELLING (left arm was swollen). At the time of the report, VACCINATION SITE OEDEMA (edema in left arm) and VACCINATION SITE SWELLING (left arm was swollen) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Lot number for third dose 9399... (patient couldn't read the last two numbers). Patient is not immunocompromised and the pharmacist said that she gave a full dose for the third shot, and that this is the recommended dosage for older patients.   This case was linked to MOD-2021-369367 (Patient Link).
Age: 91.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: patient was administered an expired booster dose; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patient was administered an expired booster dose) in a 91-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (patient was administered an expired booster dose). On 29-Oct-2021, EXPIRED PRODUCT ADMINISTERED (patient was administered an expired booster dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   no concomitant and treatment medications are provided by the reporter. Moderna vaccine given expired in December. But it turned out it expired on 27-Oct-2021. Unfortunately 16 doses were given on 29-Oct-2021 in the pharmacy.is possible that more people got doses from vials with this lot number in another pharmacy of the same chain.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: wanted to file a complain regarding the Moderna covid19 vaccine because  they have had numerous surgeries and etc; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (wanted to file a complain regarding the Moderna covid19 vaccine because  they have had numerous surgeries and etc) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (wanted to file a complain regarding the Moderna covid19 vaccine because  they have had numerous surgeries and etc).        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient was administered an expired booster dose; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient was administered an expired booster dose) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient was administered an expired booster dose). On 29-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Patient was administered an expired booster dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant product use was provided by the reporter. No treatment medication was provided.   This case was linked to MOD-2021-369020 (Patient Link).