chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache
Clinical narrative: Chills; Headache; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills), HEADACHE (Headache) and FATIGUE (Fatigue) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In March 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced CHILLS (Chills), HEADACHE (Headache) and FATIGUE (Fatigue). At the time of the report, CHILLS (Chills), HEADACHE (Headache) and FATIGUE (Fatigue) outcome was unknown.            No concomitant medication was reported by the reporter. No treatment was reported by the reporter.   This case was linked to MOD-2021-340950, MOD-2021-340922 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Hyperhidrosis, Lymph node pain, Pain in extremity, Vaccination site lymphadenopathy
Clinical narrative: excess sweating; under left arm she has pain; swollen lymph nodes on her left side where she got vaccine/lymph nodes are swollen; pain is in lymph nodes,really hurts; This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (excess sweating), PAIN IN EXTREMITY (under left arm she has pain), VACCINATION SITE LYMPHADENOPATHY (swollen lymph nodes on her left side where she got vaccine/lymph nodes are swollen) and LYMPH NODE PAIN (pain is in lymph nodes,really hurts) 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 Hormone replacement therapy since an unknown date. Concurrent medical conditions included Immunocompromised and Gene mutation.   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, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and 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 HYPERHIDROSIS (excess sweating), PAIN IN EXTREMITY (under left arm she has pain), VACCINATION SITE LYMPHADENOPATHY (swollen lymph nodes on her left side where she got vaccine/lymph nodes are swollen) and LYMPH NODE PAIN (pain is in lymph nodes,really hurts). At the time of the report, HYPERHIDROSIS (excess sweating), PAIN IN EXTREMITY (under left arm she has pain), VACCINATION SITE LYMPHADENOPATHY (swollen lymph nodes on her left side where she got vaccine/lymph nodes are swollen) and LYMPH NODE PAIN (pain is in lymph nodes,really hurts) outcome was unknown.            Treatment information was not provided
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Pyrexia
Clinical narrative: Felt really bad/felt worse for about 24 hours; fever for about 24 hours; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Felt really bad/felt worse for about 24 hours) and PYREXIA (fever for about 24 hours) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 049E21A and 091D21A) for COVID-19 vaccination.     No Medical History information was reported.   On 23-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 22-Aug-2021, the patient experienced FEELING ABNORMAL (Felt really bad/felt worse for about 24 hours) and PYREXIA (fever for about 24 hours). On 23-Aug-2021, FEELING ABNORMAL (Felt really bad/felt worse for about 24 hours) and PYREXIA (fever for about 24 hours) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications were  not reported. Treatment information include ibuprofen.   This case was linked to MOD-2021-341011 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Cerebral haemorrhage, Cerebrovascular accident
Clinical narrative: strokes; brain bleed; 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 CEREBROVASCULAR ACCIDENT (strokes) and CEREBRAL HAEMORRHAGE (brain bleed) 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 CEREBROVASCULAR ACCIDENT (strokes) (seriousness criterion medically significant) and CEREBRAL HAEMORRHAGE (brain bleed) (seriousness criterion medically significant). At the time of the report, CEREBROVASCULAR ACCIDENT (strokes) and CEREBRAL HAEMORRHAGE (brain bleed) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not provided. Treatment information was not provided.  Reporter spoke to reported some people that have received Moderna's COVID-19 vaccine experience strokes and brain bleeds. Also stated that other people reported they had a lot lately and at a "much higher quota than normal", brain bleeds also happened in nursing homes.  Company Comment: This case concerns a patient without identifiers and no relevant medical history reported, who experienced the unexpected events of cerebral vascular accident and cerebral haemorrhage. The event occurred after a dose of mRNA-1273 Moderna vaccine (SD doesn´t clarify if it was 1st or 2nd dose, vaccination date was not provided, onset of events was not provided) . The rechallenge is N/A (no information regarding other dose was provided)  The benefit-risk relationship of mRNA-1273 Moderna vaccine in not affected by this report. Very limited information regarding this events has been provided at this time. Further information has been requested.; Sender's Comments: This case concerns a patient without identifiers and no relevant medical history reported, who experienced the unexpected events of cerebral vascular accident and cerebral haemorrhage. The event occurred after a dose of mRNA-1273 Moderna vaccine (SD doesn´t clarify if it was 1st or 2nd dose, vaccination date was not provided, onset of events was not provided) . The rechallenge is N/A (no information regarding other dose was provided)  The benefit-risk relationship of mRNA-1273 Moderna vaccine in not affected by this report. Very limited information regarding this events has been provided at this time. Further information has been requested
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Vaccination site discomfort
Clinical narrative: Since then her right arm has been bothering her; Since then her right arm has been bothering her  and the pain seems to be moving around her upper shoulder where she got her injection; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE DISCOMFORT (Since then her right arm has been bothering her  and the pain seems to be moving around her upper shoulder where she got her injection) and PAIN IN EXTREMITY (Since then her right arm has been bothering her) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027A21A and 012M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Mar-2021, the patient experienced VACCINATION SITE DISCOMFORT (Since then her right arm has been bothering her  and the pain seems to be moving around her upper shoulder where she got her injection). On an unknown date, the patient experienced PAIN IN EXTREMITY (Since then her right arm has been bothering her). At the time of the report, VACCINATION SITE DISCOMFORT (Since then her right arm has been bothering her  and the pain seems to be moving around her upper shoulder where she got her injection) and PAIN IN EXTREMITY (Since then her right arm has been bothering her) outcome was unknown.            No concomitant product was provided by the reporter. No treatment medication was provided.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal discomfort, Chills, Cough, Fatigue, Inappropriate schedule of product administration
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of sluggishness (dopey), abdominal discomfort (upset stomach), pain in extremity (pain in legs), cough (still have a cough) and inappropriate schedule of vaccine administered in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch/lot# 037C21A) for COVID-19 immunization. The occurrence of additional events detailed below. No medical history reported. On Aug 1, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On Sep 29, 2021, patient received the second dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Sep 29, 2021, patient experienced sluggishness (dopey), abdominal discomfort (upset stomach), pain in extremity (pain in legs), cough (still have a cough), inappropriate schedule of product administration (inappropriate schedule of vaccine administered), chills, fatigue (tired) and pyrexia (on that night had fever). Patient treated with Tylenol (paracetamol) for fever, at an unspecified dose and frequency. On Sep 29, 2021, inappropriate schedule of product administration (inappropriate schedule of vaccine administered): resolved. At the time of the report, sluggishness (dopey), abdominal discomfort (upset stomach), pain in extremity (pain in legs), chills, fatigue (tired) and pyrexia (on that night had fever) outcome: unknown and cough (still have a cough): not resolved. No concomitant medication reported. This case linked to MOD-2021-307264 (patient link).
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia, Sluggishness
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of sluggishness (dopey), abdominal discomfort (upset stomach), pain in extremity (pain in legs), cough (still have a cough) and inappropriate schedule of vaccine administered in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch/lot# 037C21A) for COVID-19 immunization. The occurrence of additional events detailed below. No medical history reported. On Aug 1, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On Sep 29, 2021, patient received the second dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Sep 29, 2021, patient experienced sluggishness (dopey), abdominal discomfort (upset stomach), pain in extremity (pain in legs), cough (still have a cough), inappropriate schedule of product administration (inappropriate schedule of vaccine administered), chills, fatigue (tired) and pyrexia (on that night had fever). Patient treated with Tylenol (paracetamol) for fever, at an unspecified dose and frequency. On Sep 29, 2021, inappropriate schedule of product administration (inappropriate schedule of vaccine administered): resolved. At the time of the report, sluggishness (dopey), abdominal discomfort (upset stomach), pain in extremity (pain in legs), chills, fatigue (tired) and pyrexia (on that night had fever) outcome: unknown and cough (still have a cough): not resolved. No concomitant medication reported. This case linked to MOD-2021-307264 (patient link).
Age: 55.0
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Interchange of vaccine products
Clinical narrative: first dose of COVID-19 vaccine Moderna on 02Sep2021. Patient was given by accident Pfizer COVID-19 vaccine as second dose; This spontaneous case was reported by a pharmacist and describes the occurrence of INTERCHANGE OF VACCINE PRODUCTS (first dose of COVID-19 vaccine Moderna on 02Sep2021. Patient was given by accident Pfizer COVID-19 vaccine as second dose) in a 55-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 020F21A) for COVID-19 vaccination.    Co-suspect product included non-company product TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for COVID-19 vaccination.    No Medical History information was reported.   On 02-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Sep-2021, the patient received second dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1 dosage form. On 27-Sep-2021, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (first dose of COVID-19 vaccine Moderna on 02Sep2021. Patient was given by accident Pfizer COVID-19 vaccine as second dose). On 27-Sep-2021, INTERCHANGE OF VACCINE PRODUCTS (first dose of COVID-19 vaccine Moderna on 02Sep2021. Patient was given by accident Pfizer COVID-19 vaccine as second dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications were not provided.  Treatment information was not provided.
Sex: F
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: didn't receive the 2nd dose; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (didn't receive the 2nd dose) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In April 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (didn't receive the 2nd dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (didn't receive the 2nd dose) had resolved.            The patient stated that she received 1st dose of the Moderna COVID19 vaccine on April 2021 and didn't receive the 2nd dose as she "had to had surgery" that was due to a private cause unrelated to the vaccine.  No concomitant medications reported.  No treatment information was provided.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: Itchy injection site; Swollen Injection site; Inject site hurts; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (Itchy injection site), VACCINATION SITE SWELLING (Swollen Injection site) and VACCINATION SITE PAIN (Inject site hurts) in a 32-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 008C21A and 008C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 01-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PRURITUS (Itchy injection site), VACCINATION SITE SWELLING (Swollen Injection site) and VACCINATION SITE PAIN (Inject site hurts). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form. At the time of the report, VACCINATION SITE PRURITUS (Itchy injection site) and VACCINATION SITE SWELLING (Swollen Injection site) had not resolved and VACCINATION SITE PAIN (Inject site hurts) outcome was unknown.            No concomitant product use was provided by the reporter.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Delivery, Inappropriate schedule of product administration, Maternal exposure during pregnancy
Clinical narrative: gave birth; 2nd dose was administered more than 35 days after 1st dose; Maternal exposure during pregnancy; This spontaneous retrospective pregnancy case was reported by a consumer and describes the occurrence of DELIVERY (gave birth), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose was administered more than 35 days after 1st dose) and MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 05-May-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy). On 10-Jun-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose was administered more than 35 days after 1st dose). On 30-Sep-2021, the patient experienced DELIVERY (gave birth). The delivery occurred, which was reported as Normal Pregnancy Outcome. For neonate 1, The outcome was reported as Delivered NOS. At the time of the report, DELIVERY (gave birth) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose was administered more than 35 days after 1st dose) outcome was unknown and MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment medications were reported. No concomitant medications were reported.  This case concerns a 30 year old pregnant female with no relevant history who experienced the non-serious, unlisted events of Maternal exposure during pregnancy and Inappropriate schedule of vaccine administration of the second dose 37 days after the first dose of mRNA-1273. Re-challenge is not applicable as this was the second dose. Benefit -risk relationship of mRNA-1273 is not affected by this report.   This case was linked to MOD-2021-110128 (Patient Link).; Sender's Comments: This case concerns a 30 year old pregnant female with no relevant history who experienced the non-serious, unlisted events of Maternal exposure during pregnancy and Inappropriate schedule of vaccine administration of the second dose 37 days after the first dose of mRNA-1273. Re-challenge is not applicable as this was the second dose. Benefit -risk relationship of mRNA-1273 is not affected by this report.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Allergy to vaccine
Clinical narrative: Mild allergic reaction; This spontaneous case was reported by a consumer and describes the occurrence of ALLERGY TO VACCINE (Mild allergic reaction) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013M20A and 029L20A) 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 15-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Feb-2021, the patient experienced ALLERGY TO VACCINE (Mild allergic reaction). On 18-Feb-2021, ALLERGY TO VACCINE (Mild allergic reaction) had resolved.            Concomitant medications was not provided by the reporter Treatment information was not provided   This case was linked to MOD-2021-025287 (Patient Link).
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: she experienced soreness; This spontaneous case was reported by a nurse and describes the occurrence of PAIN (she experienced soreness) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006M20A) for COVID-19 vaccination.     Concurrent medical conditions included Psoriasis and Psoriatic arthritis. Concomitant products included APREMILAST (OTEZLA) for Psoriasis and Psoriatic arthritis.    On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Feb-2021, the patient experienced PAIN (she experienced soreness). At the time of the report, PAIN (she experienced soreness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   On 18-MAR-2021 patient took DOSE-2 Moderna vaccine having batch number 001B21A. No treatment information were reported.    This case was linked to MOD-2021-339523 (Patient Link).
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal
Clinical narrative: wasn't feeling good; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (wasn't feeling good) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 034C21A) for COVID-19 vaccination.     The patient's past medical history included Clostridium difficile infection in 2019.    On 23-Aug-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 FEELING ABNORMAL (wasn't feeling good). At the time of the report, FEELING ABNORMAL (wasn't feeling good) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was mentioned. No treatment medication was mentioned. She wasn't feeling good when her 2nd dose was scheduled, so she didn't go back to get it. She was now ready to get it but doesn't have the phone for the vaccination facility. She states that her daughter in law scheduled the 1st dose for her and will help her reschedule her 2nd dose.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Bronchitis, Inappropriate schedule of product administration
Clinical narrative: Bronchitis; Inappropriate schedule of vaccine administered; This spontaneous case was reported by a consumer and describes the occurrence of BRONCHITIS (Bronchitis) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Smoker in May 2021 and Mitral valve disease.    On 21-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-May-2021, the patient experienced BRONCHITIS (Bronchitis) (seriousness criteria hospitalization and medically significant). On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered). The patient was hospitalized from 25-Jul-2021 to 27-Jul-2021 due to BRONCHITIS. The patient was treated with PREDNISONE for Bronchitis, at an unspecified dose and frequency and ALBUTEROL [SALBUTAMOL] for Bronchitis, at an unspecified dose and frequency. At the time of the report, BRONCHITIS (Bronchitis) was resolving and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not reported.  Patient took steroid, Prednisone, & a rescue inhaler, albuterol as a treatment Drug.  Company comment: This case concerns a 56 year-old, female subject with a history of smoking and mitral valve disease, who experienced unexpected event of bronchitis. The event occurred approximately 1 week after the first dose of Moderna Covid-19 vaccine. The rechallenge is positive since the event reportedly happened after each dose was given as per source document. The benefit-risk relationship of the vaccine is not affected by this report.; Sender's Comments: This case concerns a 56 year-old, female subject with a history of smoking and mitral valve disease, who experienced unexpected event of bronchitis. The event occurred approximately 1 week after the first dose of Moderna Covid-19 vaccine. The rechallenge is positive since the event reportedly happened after each dose was given as per source document. The benefit-risk relationship of the vaccine is not affected by this report.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Extra dose administered, Off label use
Clinical narrative: received 3rd dose today despite not being immunocompromised; Got third dose; This spontaneous case was reported by a consumer and describes the occurrence of OFF LABEL USE (received 3rd dose today despite not being immunocompromised) and EXTRA DOSE ADMINISTERED (Got third dose) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   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 04-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Oct-2021, the patient experienced OFF LABEL USE (received 3rd dose today despite not being immunocompromised) and EXTRA DOSE ADMINISTERED (Got third dose). On 04-Oct-2021, OFF LABEL USE (received 3rd dose today despite not being immunocompromised) and EXTRA DOSE ADMINISTERED (Got third dose) had resolved.            No concomitant medications were not reported. No treatment medications were not provided.
Age: 16.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: first dose at 16 year old; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (first dose at 16 year old) in a 16-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011F21A) 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) (unknown route) 1 dosage form. On 01-Oct-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (first dose at 16 year old). On 01-Oct-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (first dose at 16 year old) 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: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Vaccine administered 12 hours post punctured; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine administered 12 hours post punctured) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 076C21A) for COVID-19 vaccination.     No Medical History information was reported.  On 04-Oct-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine administered 12 hours post punctured). On 04-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Vaccine administered 12 hours post punctured) had resolved.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 06-Oct-2021: Follow up added patient demographics, vaccine information start date, dose number, route of administration and anatomical location was added.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain in extremity, Product administration error
Clinical narrative: receiving 3rd dose of Moderna instead of flu shot; Sore Arm; Headache; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT ADMINISTRATION ERROR (receiving 3rd dose of Moderna instead of flu shot), PAIN IN EXTREMITY (Sore Arm) and HEADACHE (Headache) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 049E21A., 049E21A and 091D21A) for COVID-19 vaccination.     No Medical History information was reported.   On 23-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Oct-2021, the patient experienced PAIN IN EXTREMITY (Sore Arm) and HEADACHE (Headache). On an unknown date, the patient experienced PRODUCT ADMINISTRATION ERROR (receiving 3rd dose of Moderna instead of flu shot). At the time of the report, PRODUCT ADMINISTRATION ERROR (receiving 3rd dose of Moderna instead of flu shot) had resolved and PAIN IN EXTREMITY (Sore Arm) and HEADACHE (Headache) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment medications were reported.   This case was linked to MOD-2021-340958 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 04-Oct-2021: follow-up received: Added event.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Pyrexia
Clinical narrative: her husband had fever and chills; her husband had fever and chills; This spontaneous case was reported by a nurse and describes the occurrence of PYREXIA (her husband had fever and chills) and CHILLS (her husband had fever and chills) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Lupus syndrome and 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 PYREXIA (her husband had fever and chills) and CHILLS (her husband had fever and chills). At the time of the report, PYREXIA (her husband had fever and chills) and CHILLS (her husband had fever and chills) 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.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Laboratory test, Treatment failure
Clinical narrative: Treatment failure of prescribed medication possibly related to Moderna vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of TREATMENT FAILURE (Treatment failure of prescribed medication possibly related to Moderna vaccine) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for Prophylaxis.    Co-suspect product included non-company product COBICISTAT, ELVITEGRAVIR, EMTRICITABINE, TENOFOVIR ALAFENAMIDE FUMARATE (GENVOYA) for an unknown indication.    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 and COBICISTAT, ELVITEGRAVIR, EMTRICITABINE, TENOFOVIR ALAFENAMIDE FUMARATE (GENVOYA) (unknown route) at an unspecified dose. In June 2021, the patient experienced TREATMENT FAILURE (Treatment failure of prescribed medication possibly related to Moderna vaccine) (seriousness criterion medically significant). At the time of the report, TREATMENT FAILURE (Treatment failure of prescribed medication possibly related to Moderna vaccine) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In June 2021, Laboratory test: abnormal (abnormal) Spike in my levels.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications information was reported. No treatment medications were provided.  It was reported that the patient's physician switched his medication because it was failing (Genvoya)  This case concerns 61-year-old, female patient with no relevant medical. The patient experienced serious events of Treatment failure unspecified days after the third dose of spikevax. The reporter didn't provide the causality of events. Rechallenge is not applicable  as the event reported to have occurred after the 3rd dose.  The benefit-risk relationship of Spikevax is not affected by this report.; Sender's Comments: This case concerns 61-year-old, female patient with no relevant medical. The patient experienced serious events of Treatment failure unspecified days after the third dose of spikevax. The reporter didn't provide the causality of events. Rechallenge is not applicable  as the event reported to have occurred after the 3rd dose.  The benefit-risk relationship of Spikevax is not affected by this report.
Sex: F
Vaccine: COVID19
Symptoms: Neuropathy peripheral
Clinical narrative: Neuropathy after vaccine; This spontaneous case was reported by a physician and describes the occurrence of NEUROPATHY PERIPHERAL 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 Autoimmune disorder.    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 NEUROPATHY PERIPHERAL (seriousness criteria disability and medically significant). At the time of the report, NEUROPATHY PERIPHERAL outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant products were not provided. Treatment medication were not reported.  Company comment: This case concerns a female patient, age unknown, with relevant medical history of Autoimmune disorder, who experienced the serious unexpected event of Neuropathy peripheral. The event occurred after the dose of mRNA-1273 (COVID-19 Vaccine Moderna) (event onset date unknown). The rechallenge was not applicable since only information about one dose was disclosed. The medical history of Autoimmune disorder remains a confounder. The benefit-risk relationship of mRNA-1273 (COVID-19 Vaccine Moderna) is not affected by this report. Event seriousness assessed as per Health Care (Spontaneous) reporting, however there was no information in the source document supporting that the events resulted in a Disability, persistent or permanent incapacity.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling
Clinical narrative: Legs swelled up after second shot / Legs swelling comes and goes after second shot / Leg swelling has not gone down completely after second shot; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Legs swelled up after second shot / Legs swelling comes and goes after second shot / Leg swelling has not gone down completely after second shot) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007B21A and 022M20A) for COVID-19 vaccination.     Concurrent medical conditions included Allergy to metals.   On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Mar-2021, the patient experienced PERIPHERAL SWELLING (Legs swelled up after second shot / Legs swelling comes and goes after second shot / Leg swelling has not gone down completely after second shot). At the time of the report, PERIPHERAL SWELLING (Legs swelled up after second shot / Legs swelling comes and goes after second shot / Leg swelling has not gone down completely after second shot) had not 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.  Patient visited several doctors. one told to see a psychiatrist and the other 2 told her to put cream on it. Patient has an appointment with her regular clinic where the first 2 doses were received.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Herpes zoster, Musculoskeletal chest pain, Vaccination site pain
Clinical narrative: developed herpes zoster in his T4 area; experienced pain in the chest wall; local pain; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 05-Oct-2021 and was forwarded to Moderna on 05-Oct-2021.    This spontaneous case was reported by an other health care professional and describes the occurrence of HERPES ZOSTER (developed herpes zoster in his T4 area), MUSCULOSKELETAL CHEST PAIN (experienced pain in the chest wall) and VACCINATION SITE PAIN (local pain) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination.     No medical history was provided by reporter.  Concomitant products included INFLUENZA VACCINE (FLU) for an unknown indication.   On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and 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 HERPES ZOSTER (developed herpes zoster in his T4 area), MUSCULOSKELETAL CHEST PAIN (experienced pain in the chest wall) and VACCINATION SITE PAIN (local pain). At the time of the report, HERPES ZOSTER (developed herpes zoster in his T4 area) outcome was unknown, MUSCULOSKELETAL CHEST PAIN (experienced pain in the chest wall) had resolved and VACCINATION SITE PAIN (local pain) was resolving.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient reported a week after flu shot he experienced chest wall pain and herpes zoster.  No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 07-Oct-2021: Follow up received on  07-OCT-2021 has no new information
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal
Clinical narrative: Felt a little bit funny; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Felt a little bit funny) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047A21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included DABIGATRAN ETEXILATE MESILATE (PRADAXA), AMIODARONE, CLOPIDOGREL and QUETIAPINE for an unknown indication.  On 19-Mar-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 FEELING ABNORMAL (Felt a little bit funny). At the time of the report, FEELING ABNORMAL (Felt a little bit funny) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   No treatment information was provided.   This case was linked to MOD-2021-341095 (Patient Link).
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Cardiac disorder, Computerised tomogram, Emphysema, Heart rate, Inappropriate schedule of product administration
Clinical narrative: Emphysema flair-up; I was short of breath/was short of breath , I just couldn't catch my breath; heart isn't functioning right; my lips were purple; I pushed the 2nd dose out a little, because I was still recovering from bronchitis.; This spontaneous case was reported by a consumer and describes the occurrence of EMPHYSEMA and EMPHYSEMA in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Mitral regurgitation. Concurrent medical conditions included Mitral valve prolapse and Ex-tobacco user (quit in May 2021).   On 21-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Jul-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 INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION. On 25-Jul-2021, the patient experienced EMPHYSEMA (seriousness criterion hospitalization). On 12-Aug-2021, the patient experienced EMPHYSEMA (seriousness criterion hospitalization) and LIP DISCOLOURATION. On an unknown date, the patient experienced CARDIAC DISORDER. The patient was hospitalized from 25-Jul-2021 to 27-Jul-2021 due to EMPHYSEMA. The patient was treated with PREDNISONE at an unspecified dose and frequency and ALBUTEROL at an unspecified dose and frequency. At the time of the report, EMPHYSEMA, EMPHYSEMA, LIP DISCOLOURATION, CARDIAC DISORDER, and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available) on 25-Jul-2021, Computerised tomogram (abnormal) Emphysema flair-up. On 25-Jul-2021, Oxygen saturation 84% Low. On 12-Aug-2021, Heart rate 155 beats/min (High). On 12-Aug-2021, Oxygen saturation (Low) 84%.         On 12-AUG-2021 patient went to Emergency room due to Emphysema flair-up.  No relevant concomitant medications were reported  This case concerns inappropriate schedule of vaccine administration in a 56 year-old female patient with no relevant medical history reported, who experienced the unexpected serious event s of Emphysema flair-up x2. The events occurred approximately 3 weeks and 5 weeks after the second dose of mRNA-1273 vaccine. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Although history of emphysema not reported, the source document indicates hospitalization for 2 events of emphysema flair-up.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Lip discolouration, Oxygen saturation
Clinical narrative: Emphysema flair-up; I was short of breath/was short of breath , I just couldn't catch my breath; heart isn't functioning right; my lips were purple; I pushed the 2nd dose out a little, because I was still recovering from bronchitis.; This spontaneous case was reported by a consumer and describes the occurrence of EMPHYSEMA and EMPHYSEMA in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Mitral regurgitation. Concurrent medical conditions included Mitral valve prolapse and Ex-tobacco user (quit in May 2021).   On 21-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Jul-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 INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION. On 25-Jul-2021, the patient experienced EMPHYSEMA (seriousness criterion hospitalization). On 12-Aug-2021, the patient experienced EMPHYSEMA (seriousness criterion hospitalization) and LIP DISCOLOURATION. On an unknown date, the patient experienced CARDIAC DISORDER. The patient was hospitalized from 25-Jul-2021 to 27-Jul-2021 due to EMPHYSEMA. The patient was treated with PREDNISONE at an unspecified dose and frequency and ALBUTEROL at an unspecified dose and frequency. At the time of the report, EMPHYSEMA, EMPHYSEMA, LIP DISCOLOURATION, CARDIAC DISORDER, and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available) on 25-Jul-2021, Computerised tomogram (abnormal) Emphysema flair-up. On 25-Jul-2021, Oxygen saturation 84% Low. On 12-Aug-2021, Heart rate 155 beats/min (High). On 12-Aug-2021, Oxygen saturation (Low) 84%.         On 12-AUG-2021 patient went to Emergency room due to Emphysema flair-up.  No relevant concomitant medications were reported  This case concerns inappropriate schedule of vaccine administration in a 56 year-old female patient with no relevant medical history reported, who experienced the unexpected serious event s of Emphysema flair-up x2. The events occurred approximately 3 weeks and 5 weeks after the second dose of mRNA-1273 vaccine. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Although history of emphysema not reported, the source document indicates hospitalization for 2 events of emphysema flair-up.
Age: 14.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: vaccine administered to an underage patient of 14 years old; This spontaneous case was reported by a health care professional and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (vaccine administered to an underage patient of 14 years old) in a 14-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) 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) (unknown route) 1 dosage form. On 01-Oct-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (vaccine administered to an underage patient of 14 years old). On 01-Oct-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (vaccine administered to an underage patient of 14 years old) 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.  It was reported that the patient had not experienced any other symptoms after vaccination.