chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 2.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No adverse event; Second dose in the Moderna Covid-19 vaccine primary series given to a Male patient 22 days after his first Primary Series Vaccine.; This spontaneous case was reported by a medical assistant and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose in the Moderna Covid-19 vaccine primary series given to a Male patient 22 days after his first Primary Series Vaccine.) and NO ADVERSE EVENT (No adverse event) in a 2-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. AR9236B and AX1414B) for COVID-19 vaccination.     No Medical History information was reported.   On 10-Aug-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Sep-2022, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Sep-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose in the Moderna Covid-19 vaccine primary series given to a Male patient 22 days after his first Primary Series Vaccine.). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose in the Moderna Covid-19 vaccine primary series given to a Male patient 22 days after his first Primary Series Vaccine.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose in the Moderna Covid-19 vaccine primary series given to a Male patient 22 days after his first Primary Series Vaccine.).    No concomitant medications were reported. Patient received first dose of vaccine in right leg and second dose of vaccine in left leg. Patient did not report any other adverse reactions. No treatment medications were reported.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: tested positive for COVID/slight cough.; This spontaneous case was reported by an other caregiver and describes the occurrence of COVID-19 (tested positive for COVID/slight cough.) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Disability NOS (severely disabled).    On 09-May-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Aug-2022, the patient experienced COVID-19 (tested positive for COVID/slight cough.). At the time of the report, COVID-19 (tested positive for COVID/slight cough.) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 16-Aug-2022, SARS-CoV-2 test: (Positive) positive.         Concomitant medication list was not provided.  The reporter stated that she took care of a severely disabled adult (the patient). The patient had second booster on 09-May-2022. On 16-Aug-2022, patient tested positive for COVID-19. Patient had no fever, appetite stayed fine. Patient had a slight cough. They patient was quarantined for 10 days, and the cough went away.  Treatment information was not provided.  Company Comment: This is a spontaneous case concerning a 55-year-old female patient with no relevant medical history, who experienced the unexpected, non-serious adverse event of special interest of COVID-19 (with SARS-CoV-2 test positive), approximately 3 months after receiving a dose of mRNA-1273 vaccine (reported as second booster of COVID-19 vaccine). The patient had symptom of slight cough. The patient was quarantined for 10 days and the cough went away. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This is a spontaneous case concerning a 55-year-old female patient with no relevant medical history, who experienced the unexpected, non-serious adverse event of special interest of COVID-19 (with SARS-CoV-2 test positive), approximately 3 months after receiving a dose of mRNA-1273 vaccine (reported as second booster of COVID-19 vaccine). The patient had symptom of slight cough. The patient was quarantined for 10 days and the cough went away. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Age: 4.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered with vaccine from a vial punctured for 20 hours), PRODUCT STORAGE ERROR (The vial was stored post puncture in a cooler with an ice pact somewhere between 44-70 Fahrenheit for about 20 hours) and NO ADVERSE EVENT (No adverse event) in a 4-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 31-Aug-2022 at 3:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Aug-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered with vaccine from a vial punctured for 20 hours). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was stored post puncture in a cooler with an ice pact somewhere between 44-70 Fahrenheit for about 20 hours) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered with vaccine from a vial punctured for 20 hours), PRODUCT STORAGE ERROR (The vial was stored post puncture in a cooler with an ice pact somewhere between 44-70 Fahrenheit for about 20 hours) and NO ADVERSE EVENT (No adverse event) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Administered with vaccine from a vial punctured for 20 hours) and PRODUCT STORAGE ERROR (The vial was stored post puncture in a cooler with an ice pact somewhere between 44-70 Fahrenheit for about 20 hours). No concomitant medication information was provided. Pharmacist reports that they inadvertently administered one dose of the 6 months-5years Moderna vaccine which had been punctured for about 20 hours to a patient on 31-Aug-2022. Number of doses/vials administered 1 dose. The vial was initially stored in the refrigerator on 30-Aug-2022, around 10 or 11am. The vial was first punctured on 30-Aug-2022 at 5:00pm. The vial was stored post puncture in a cooler with an ice pact somewhere between 44-70F. The vial did not undergo any temperature excursions. Total amount of time the vial was exposed to room temperature range (8 degree to 25 degree Celsius which is equal to 46 degree to 77 degree  Fahrenheit ) about 20 hours. No treatment medication were provided.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: knocked out for an entire day/out of it; This spontaneous case was reported by a patient and describes the occurrence of FATIGUE (knocked out for an entire day/out of it) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012H21B, 026L20A and 029K20A) for COVID-19 vaccination.     The patient's past medical history included Rheumatoid arthritis. Concomitant products included METHOTREXATE and FOLIC ACID for an unknown indication.   On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 03-Dec-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 FATIGUE (knocked out for an entire day/out of it). At the time of the report, FATIGUE (knocked out for an entire day/out of it) had resolved.            No Treatment medication were reported.   This case was linked to MOD-2022-637954, MOD-2022-638298 (Patient Link).
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (might have tested positive for COVID-19 Virus the second time she took the test but is unsure/ knocked out for an entire day/out of it/ sore throat) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012H21B, 029K20A and 026L20A) for COVID-19 vaccination. Concurrent medical conditions included Rheumatoid arthritis. Concomitant products included METHOTREXATE and FOLIC ACID for an unknown indication. On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced COVID-19 (might have tested positive for COVID-19 Virus the second time she took the test but is unsure/ knocked out for an entire day/out of it/ sore throat). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, COVID-19 (might have tested positive for COVID-19 Virus the second time she took the test but is unsure/ knocked out for an entire day/out of it/ sore throat) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2  test: (Positive) might have tested positive. None allergies were reported. It was reported that after the second dose and booster dose, patient was knocked out for an entire day and was out of it. Patient felt fine after that day of sleeping. Patient was going to see rheumatologist. No treatment details were provided. Company Comment: This is a spontaneous case concerning a 75-year-old, female patient with no relevant medical history, who experienced the unexpected non-serious AESI event of Covid-19. On an unknown date event Covid-19 occurred. Patient tested for SARS COV-2. No further details on clinical course and treatment received were reported. Outcome of the event was unknown. The benefit-risk relationship of mRNA-1273 Vaccine, is not affected by this report. This case was linked to MOD-2022-637954, MOD-2022-638295 (Patient Link). Sender's Comments: This is a spontaneous case concerning a 75-year-old, female patient with no relevant medical history, who experienced the unexpected non-serious AESI event of Covid-19. On an unknown date event Covid-19 occurred. Patient tested for SARS COV-2. No further details on clinical course and treatment received were reported. Outcome of the event was unknown. The benefit-risk relationship of mRNA-1273 Vaccine, is not affected by this report.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (patient experienced COVID-19) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis. The patient's past medical history included Idiopathic urticaria and Hip osteopenia. Concomitant products included COLECALCIFEROL, GENISTEIN, ZINC AMINO ACID CHELATE (FOSTEUM), CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]), FAMOTIDINE (PEPCID [FAMOTIDINE]), NIRMATRELVIR, RITONAVIR (PAXLOVID) and MONTELUKAST SODIUM (SINGULAIR) for an unknown indication. On 29-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Aug-2022, the patient experienced COVID-19 (patient experienced COVID-19). At the time of the report, COVID-19 (patient experienced COVID-19) was resolving. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No treatment medications were provided by the reporter. Company comment: This spontaneous case concerns a female patient aged 64 years with no relevant medical history reported, who experienced the unexpected non-serious AESI of Covid 19 that occurred approximately 17 months after a dose (dose number not specified) of mRNA-1273 vaccination. No further information on risk factors, detailed clinical course, investigations, treatment of the events and details pertaining to the doses was available in the report. Outcome of the event Covid 19 was resolving at the time of report. The current pandemic situation of COVID 19 may remain as confounder to the event Covid-19. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Event seriousness (non-serious) assessed as per medical judgement and available information. Sender's Comments: This spontaneous case concerns a female patient aged 64 years with no relevant medical history reported, who experienced the unexpected non-serious AESI of Covid 19 that occurred approximately 17 months after a dose (dose number not specified) of mRNA-1273 vaccination. No further information on risk factors, detailed clinical course, investigations, treatment of the events and details pertaining to the doses was available in the report. Outcome of the event Covid 19 was resolving at the time of report. The current pandemic situation of COVID 19 may remain as confounder to the event Covid-19. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Event seriousness (non-serious) assessed as per medical judgement and available information.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Tremor
Clinical narrative: This spontaneous case reported by a patient family member or friend, describes the occurrence of tremor (hand shaking) and fatigue (after the third shot Sep 2021) in a female patient, of an unknown age, who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. September 2021, patient received the third dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On an unknown date, patient received the first and second dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On an unknown date, patient experienced tremor (hand shaking) and fatigue (after the third shot Sep 2021). At the time of the report, tremor (hand shaking) and fatigue (after the third shot Sep 2021): unresolved. No concomitant medication or treatment information provided. It has been one whole year without any improvement.
Age: 70.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Pain in extremity
Clinical narrative: Sore Arm after her second booster dose; This spontaneous case was reported by a nurse and describes the occurrence of PAIN IN EXTREMITY (Sore Arm after her second booster dose) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included CITALOPRAM and HYDROXYCHLOROQUINE SULFATE (PLAQUENIL [HYDROXYCHLOROQUINE SULFATE]) for an unknown indication.   In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In March 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore Arm after her second booster dose). At the time of the report, PAIN IN EXTREMITY (Sore Arm after her second booster dose) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Disease States: Lupus. No treatment medications was reported.   This case was linked  (Patient Link).
Age: 70.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Body temperature, Fatigue, Nausea, Pain in extremity, Pyrexia
Clinical narrative: Sore Arm after her second booster dose; This spontaneous case was reported by a nurse and describes the occurrence of PAIN IN EXTREMITY (Sore Arm after her second booster dose) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included CITALOPRAM and HYDROXYCHLOROQUINE SULFATE (PLAQUENIL [HYDROXYCHLOROQUINE SULFATE]) for an unknown indication.   In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In March 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore Arm after her second booster dose). At the time of the report, PAIN IN EXTREMITY (Sore Arm after her second booster dose) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Disease States: Lupus. No treatment medications was reported.   This case was linked  (Patient Link).
Age: 70.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Urinary incontinence
Clinical narrative: Sore Arm after her second booster dose; This spontaneous case was reported by a nurse and describes the occurrence of PAIN IN EXTREMITY (Sore Arm after her second booster dose) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included CITALOPRAM and HYDROXYCHLOROQUINE SULFATE (PLAQUENIL [HYDROXYCHLOROQUINE SULFATE]) for an unknown indication.   In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In March 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore Arm after her second booster dose). At the time of the report, PAIN IN EXTREMITY (Sore Arm after her second booster dose) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Disease States: Lupus. No treatment medications was reported.   This case was linked  (Patient Link).
Age: 70.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Fatigue, Feeling abnormal, Nausea, Pain in extremity
Clinical narrative: Sore Arm after her second booster dose; This spontaneous case was reported by a nurse and describes the occurrence of PAIN IN EXTREMITY (Sore Arm after her second booster dose) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included CITALOPRAM and HYDROXYCHLOROQUINE SULFATE (PLAQUENIL [HYDROXYCHLOROQUINE SULFATE]) for an unknown indication.   In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In March 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore Arm after her second booster dose). At the time of the report, PAIN IN EXTREMITY (Sore Arm after her second booster dose) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Disease States: Lupus. No treatment medications was reported.   This case was linked  (Patient Link).
Age: 68.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Pain in extremity
Clinical narrative: Did not feel good for a couple of days.; sore arm; Fatigue; nauseated; This spontaneous case was reported by a nurse and describes the occurrence of FEELING ABNORMAL (Did not feel good for a couple of days.), PAIN IN EXTREMITY (sore arm), FATIGUE (Fatigue) and NAUSEA (nauseated) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included CITALOPRAM and HYDROXYCHLOROQUINE SULFATE (PLAQUENIL [HYDROXYCHLOROQUINE SULFATE]) for an unknown indication.   In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In March 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In March 2021, the patient experienced FEELING ABNORMAL (Did not feel good for a couple of days.), PAIN IN EXTREMITY (sore arm), FATIGUE (Fatigue) and NAUSEA (nauseated). In 2021, FEELING ABNORMAL (Did not feel good for a couple of days.) had resolved. At the time of the report, PAIN IN EXTREMITY (sore arm), FATIGUE (Fatigue) and NAUSEA (nauseated) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment drug details was reported. Disease states: Lupus.   This case was linked to MOD-2022-638961, MOD-2022-638963, MOD-2022-638950 (Patient Link).
Age: 68.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Body temperature, Fatigue, Nausea, Pain in extremity, Pyrexia
Clinical narrative: Did not feel good for a couple of days.; sore arm; Fatigue; nauseated; This spontaneous case was reported by a nurse and describes the occurrence of FEELING ABNORMAL (Did not feel good for a couple of days.), PAIN IN EXTREMITY (sore arm), FATIGUE (Fatigue) and NAUSEA (nauseated) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included CITALOPRAM and HYDROXYCHLOROQUINE SULFATE (PLAQUENIL [HYDROXYCHLOROQUINE SULFATE]) for an unknown indication.   In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In March 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In March 2021, the patient experienced FEELING ABNORMAL (Did not feel good for a couple of days.), PAIN IN EXTREMITY (sore arm), FATIGUE (Fatigue) and NAUSEA (nauseated). In 2021, FEELING ABNORMAL (Did not feel good for a couple of days.) had resolved. At the time of the report, PAIN IN EXTREMITY (sore arm), FATIGUE (Fatigue) and NAUSEA (nauseated) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment drug details was reported. Disease states: Lupus.   This case was linked to MOD-2022-638961, MOD-2022-638963, MOD-2022-638950 (Patient Link).
Age: 68.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Urinary incontinence
Clinical narrative: Did not feel good for a couple of days.; sore arm; Fatigue; nauseated; This spontaneous case was reported by a nurse and describes the occurrence of FEELING ABNORMAL (Did not feel good for a couple of days.), PAIN IN EXTREMITY (sore arm), FATIGUE (Fatigue) and NAUSEA (nauseated) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included CITALOPRAM and HYDROXYCHLOROQUINE SULFATE (PLAQUENIL [HYDROXYCHLOROQUINE SULFATE]) for an unknown indication.   In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In March 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In March 2021, the patient experienced FEELING ABNORMAL (Did not feel good for a couple of days.), PAIN IN EXTREMITY (sore arm), FATIGUE (Fatigue) and NAUSEA (nauseated). In 2021, FEELING ABNORMAL (Did not feel good for a couple of days.) had resolved. At the time of the report, PAIN IN EXTREMITY (sore arm), FATIGUE (Fatigue) and NAUSEA (nauseated) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment drug details was reported. Disease states: Lupus.   This case was linked to MOD-2022-638961, MOD-2022-638963, MOD-2022-638950 (Patient Link).
Age: 68.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Fatigue, Feeling abnormal, Nausea, Pain in extremity
Clinical narrative: Did not feel good for a couple of days.; sore arm; Fatigue; nauseated; This spontaneous case was reported by a nurse and describes the occurrence of FEELING ABNORMAL (Did not feel good for a couple of days.), PAIN IN EXTREMITY (sore arm), FATIGUE (Fatigue) and NAUSEA (nauseated) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included CITALOPRAM and HYDROXYCHLOROQUINE SULFATE (PLAQUENIL [HYDROXYCHLOROQUINE SULFATE]) for an unknown indication.   In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In March 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In March 2021, the patient experienced FEELING ABNORMAL (Did not feel good for a couple of days.), PAIN IN EXTREMITY (sore arm), FATIGUE (Fatigue) and NAUSEA (nauseated). In 2021, FEELING ABNORMAL (Did not feel good for a couple of days.) had resolved. At the time of the report, PAIN IN EXTREMITY (sore arm), FATIGUE (Fatigue) and NAUSEA (nauseated) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment drug details was reported. Disease states: Lupus.   This case was linked to MOD-2022-638961, MOD-2022-638963, MOD-2022-638950 (Patient Link).
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity
Clinical narrative: sore arm after first booster dose; fatigue after first booster dose; This spontaneous case was reported by a nurse and describes the occurrence of PAIN IN EXTREMITY (sore arm after first booster dose) and FATIGUE (fatigue after first booster dose) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included CITALOPRAM and HYDROXYCHLOROQUINE SULFATE (PLAQUENIL [HYDROXYCHLOROQUINE SULFATE]) for an unknown indication.    In 2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (sore arm after first booster dose) and FATIGUE (fatigue after first booster dose). At the time of the report, PAIN IN EXTREMITY (sore arm after first booster dose) and FATIGUE (fatigue after first booster dose) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment medications was reported.   This case was linked to MOD-2022-638961, MOD-2022-638962, MOD-2022-638950 (Patient Link).
Age: 2.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: rash on the back of her right leg/rash expands each day/now the rash goes to the patients foot and up to the patients right buttock.; This spontaneous case was reported by a patient family member or friend and describes the occurrence of RASH (rash on the back of her right leg/rash expands each day/now the rash goes to the patients foot and up to the patients right buttock.) in a 2-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AS1416B) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Aug-2022, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Aug-2022, the patient experienced RASH (rash on the back of her right leg/rash expands each day/now the rash goes to the patients foot and up to the patients right buttock.). At the time of the report, RASH (rash on the back of her right leg/rash expands each day/now the rash goes to the patients foot and up to the patients right buttock.) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Chronic disease state reported in this patient. It was reported that patient received the vaccine in right leg.  Concomitant medication included Vitamin D with Probiotic for weekly once. The patients Mom noticed a rash on the back of her right leg on 25AUG2022. The rash expanded each day and now the rash went to the patients foot and up to the patients right buttock. No other Adverse reactions reported. The Pediatrician felt that this was a reaction to the Moderna Covid-19 vaccine Treatment medications were not provided.   This case was linked (Patient Link).
Age: 2.0
Sex: F
Vaccine: COVID19
Symptoms: Somnolence
Clinical narrative: This spontaneous case reported by a patient family member or friend and describes the occurrence of somnolence (sleepy patient) in a 2-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch/lot# AS1416B) for COVID-19 immunization. No chronic disease reported. On Jul 25, 2022, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On an unknown date, patient experienced somnolence (sleepy patient). At the time of the report, somnolence (sleepy patient) outcome unknown. The reporter did not provide any causality assessments or treatment information. Patient received the vaccine in right leg. Concomitant medication included vitamin D with probiotic for weekly once. No other adverse reactions reported. This case linked to MOD-2022-638968 (patient link).
Sex: M
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: The vaccine messed me up for a couple of days; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (The vaccine messed me up for a couple of days) in an adult male patient who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (The vaccine messed me up for a couple of days). At the time of the report, VACCINATION COMPLICATION (The vaccine messed me up for a couple of days) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       The patient age was reported as 50s.  No concomitant medication was reported.  No treatment medication was reported.   This case was linked to US-MODERNATX, INC.-MOD-2022-639294 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-639294:50-year-old Female case
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Nurse). The reporter is the patient.  A 27-year-old female patient (pregnant) received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. Date of last menstrual period: 13Jan2022. The patient was 31 weeks pregnant at the event onset. The patient is expected to deliver a baby(s) on 23Oct2022. Concomitant medication(s) included: MAGNESIUM SULFATE; PRENATAL VITAMINS [ASCORBIC ACID;BIOTIN;MINERALS NOS;NICOTINIC ACID;RETINOL;TOCOPHEROL;VITAMIN B NOS;VITAMIN D NOS]. The following information was reported: COVID-19 (medically significant) with onset 20Aug2022, outcome "not recovered", DRUG INEFFECTIVE (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (20Aug2022) Positive; (25Aug2022) Negative; (31Aug2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Rebound Covid Wed 17Aug was first day of symptoms but they were mild and intermittent and patient tested negative for 4 days til Sat 20Aug was pos. patient started Paxlovid Sat and did 5 day quarantine and tested neg on Thurs 25Aug. patient took last Paxlovid thurs and felt great thurs, fri, sat, sun. Mon 29Aug patient started feeling terrible symptoms again and tested positive for covid today wed 31Aug.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: As there is limited information in the case provided, the causal association between the reported events drug ineffective  and Covid-19 and the suspect drug cannot be excluded. The case will be reassessed once new information is available.
Age: 4.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Pain at the injection site, sore arm; This is a spontaneous report received from a contactable reporter(s) (Nurse).  A 4-year-old male patient received BNT162b2 (BNT162B2), on 08Jul2022 as dose 1, single (Lot number: FT9142, Expiration Date: Jan2023) at the age of 4 years, in right arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 2022, outcome "unknown", described as "Pain at the injection site, sore arm".  Additional Information: The patient had pain at the injection site, sore arm, with the first dose. No additional vaccines was administered on same date of the Pfizer suspect. The patient did not receive other vaccines within four weeks prior to COVID vaccine. No adverse event following prior vaccinations. The NDC number was 59267007804.
Sex: F
Vaccine: COVID19
Symptoms: Discomfort
Clinical narrative: felt like her organs are being squeezed; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: (159558). The reporter is the parent.  An 8-year-old female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DISCOMFORT (non-serious), outcome "unknown", described as "felt like her organs are being squeezed".  Additional information: It was reported that the reporter said on Saturday and then she ask someone what day they got there shots and then said between 8 and 8:30 am for her and her kids and she did get the vaccine. She had her 8 years old daughter and 15 years old son with her. She said her daughter said it felt like her organs are being squeezed. Reporter declined to complete report for her daughter and said she would call back.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: caught covid; caught covid; This is a spontaneous report received from contactable reporter(s) (Nurse), Program ID.  A 73-year-old female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Allergies: Shrimp" (unspecified if ongoing); "Allergies: Peanut, Walnut" (unspecified if ongoing). Concomitant medication(s) included: VITAMIN D3; AMLODIPINE; METFORMIN. Past drug history included: Isovue, reaction(s): "Allergies: Isovue"; Cefaclor, reaction(s): "Allergies: Cefaclor".  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jul2022, outcome "recovered" (2022) and all described as "caught covid". The event "caught covid" required physician office visit. The patient underwent the following laboratory tests and procedures: Blood pressure measurement: (unspecified date) normal, notes: blood pressure maintained normal; SARS-CoV-2 test: (Jul2022) Positive; (Aug2022) negative, notes: covid test was now negative. Therapeutic measures were taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: As there is limited information in the case provided, the causal association between the reported events drug ineffective and Covid-19 and the suspect drug cannot be excluded. The case will be reassessed once new information is available.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Eye pain, Headache, Magnetic resonance imaging head
Clinical narrative: This is a spontaneous report received from contactable other HCP (the patient). A 40-year-old male patient received the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# FC3182) at the age of 40 years, in right arm), on Sep 21, 2021, at 17:00, single dose, for COVID-19 immunisation. Medical history included hypertension (unspecified if ongoing). Concomitant medication included carvedilol. The patient had a headache(s) and eye pain/right eye pain, onset Sep 23, 2021, at 00:15, with outcome of not recovered. These events required a physician's office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of headache and eye pain. Additional information: Reportedly, patient experienced headaches within days of receiving first dose Sep 21, 2021 and right eye pain. Patient had most days out of the week, most hours of the day with headaches, despite never having a history of headaches. Patient had to visit ophthalmologist and had MRI performed on brain. The patient received MRI and daily medications for headache/pain. The patient has no known allergies. No COVID-19 reported prior to vaccination. Sender's comments: Linked report: US-PFIZER INC-202201114674 (same patient/vaccine/event, different vaccine dose); US-PFIZER INC-202201114673 (same patient/vaccine/event, different vaccine dose).
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Nurse). A 60-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 26Jul2021 as dose 1, single (Batch/Lot number: unknown) and on 26Aug2021 as dose 2, single (Batch/Lot number: unknown) at the age of 59 years for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "COPD" (unspecified if ongoing); "fibromyalgia" (unspecified if ongoing); "anxiety" (unspecified if ongoing); "HTN" (unspecified if ongoing); "hyperlipidemia" (unspecified if ongoing); "Depression" (unspecified if ongoing); "IBS" (unspecified if ongoing); "OSA" (unspecified if ongoing). The patient had no known allergies. Concomitant medication(s) included: Albuterol [Salbutamol]; Buspirone; Diazepam; Duloxetine; Gabapentin; Hydroxyzine; Levothyroxine; Mirabegron; Modafinil; Tribenzor; Omeprazole; Crestor; Zolpidem. The patient received other medication in two weeks. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of vaccination failure, covid-19. The patient received Paxlovid from 24Aug2022 to 29Aug2022 via oral route of administration for the treatment of COVID-19. Clinical course: The patient states she started Paxlovid the night of 24Aug2022 and took her last dose the morning of 29Aug2022. The night of 29Aug2022 she turned pale, had 1 episode of vomiting, felt extremely lightheaded, and was disoriented. By disoriented, patient reports that she was talking but could not hear herself. The patient's Husband reported that she kept repeating statements. The patient's Husband reports that it took a couple of hours before her color returned, clamminess resolved, and she stopped repeating herself. The reporter stated that the patient was seen by me on 30Aug2022 with persistent lightheadedness and nausea that were improving. The adverse event start date reported as 29Aug2022 18:00. Adverse event was not resulted in physician office or emergency room visit. The patient was recovering. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received. Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events and the suspect drug BNT162B2.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Disease recurrence, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; Disease recurrence; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 75-year-old male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19"; DISEASE RECURRENCE (medically significant), outcome "unknown". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative, notes: Caller states 5 days after taking the medication, he was negative for the Covid virus; Positive, notes: Treatment: positive; Positive, notes: he tested positive again for Covid. Therapeutic measures were taken as a result of drug ineffective, covid-19. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Eye pain, Headache, Magnetic resonance imaging head, SARS-CoV-2 test
Clinical narrative: recurrent headaches; right eye pain; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 41-year-old male patient received BNT162b2 (BNT162B2), on 19Mar2022 at 17:00 as dose 3 (booster), single (Lot number: FK9896) at the age of 41 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing). Concomitant medication(s) included: CARVEDILOL. Vaccination history included: BNT162b2 (Dose Number: 2, Batch/Lot No: 30130BA, Location of injection: Arm Right, Vaccine Administration Time: 05:00 PM), administration date: 22Sep2021, when the patient was 40-year-old, for COVID-19 immunization, reaction(s): "Inappropriate schedule of vaccine administered", "Headache", "right eye pain"; BNT162b2 (Dose Number: 1, Batch/Lot No: FC3182, Location of injection: Arm Right, Vaccine Administration Time: 05:00 PM, Headaches within days of receiving first dose 21Sep2021 and recurrent headaches/Most days out of the week with headaches, most hours of the day with headaches), administration date: 21Sep2021, when the patient was 40-year-old, for COVID-19 immunization, reaction(s): "Headache", "right eye pain". The following information was reported: HEADACHE (non-serious) with onset 2022, outcome "not recovered", described as "recurrent headaches"; EYE PAIN (non-serious) with onset 2022, outcome "not recovered", described as "right eye pain". The events "recurrent headaches" and "right eye pain" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of headache, eye pain.  Additional information: The facility type of vaccine was reported as pharmacy or drug store. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.  The patient had no known allergies. The patient received Carvedilol 12.5mg within 2 weeks of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination and patient has been tested for COVID-19, since the vaccination. Reported that, Headaches within days of receiving first dose 21Sep2021, and recurrent headaches, right eye pain ever since until this very day. Most days out of the week with headaches, most hours of the day with headaches, NEVER had a history of headaches. Headaches started after Pfizer vaccine and led patient to go to Ophthalmologist and have MRI performed on brain. Patient stated, this vaccine is UNSAFE. The patient receiving the treatment with MRI, DAILY MEDs for Headache PAIN.; Sender's Comments: Linked Report(s) : Same patient/vaccine/event, different vaccine dose;
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Speech disorder
Clinical narrative: Diarrhea; Cannot talk; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 90-year-old female patient received BNT162b2 (BNT162B2), on 31Aug2022 as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "IBS" (unspecified if ongoing), notes: Has had IBS for many years. Has been over 2 hours going to the bathroom. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 2; MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 3: MANUFACTURER UNKNOWN), for COVID-19 immunization. The following information was reported: SPEECH DISORDER (non-serious) with onset 2022, outcome "unknown", described as "Cannot talk"; DIARRHOEA (non-serious) with onset 2022, outcome "unknown", described as "Diarrhea".  Additional Information: It was stated that she had a shot yesterday and said that it could cause diarrhea effects with certain people. Has had IBS for many years. Had been over 2 hours going to the bathroom. Thought it would better to have the shot to be safe. Wanted to know if was there anything to do. Had stopped a great deal. Caller rambling on; unable to clarify details. Mentioned that she might as well go back to the doctor. Thought that she might had to go into the hospital anyway. This was unbelievable. Was for the Pfizer Bio vaccine. Cannot talk. Was kind of out of it. Had the other three shots. Was told that if she was going to have this it would be good to had it now. Had been in the bathroom for the past several hours. Wanted them to know to warn people that ever had a bowel problems. Gets to the point that she dare stand up and it runs out of her. Had never reacted to anything like this time.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.