chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Blood glucose decreased, Decreased appetite, Headache, Illness, Loss of consciousness
Clinical narrative: She got up to go to bathroom came out and passed out; Lost her appetite; all she wanted to do was sleep; Daughter thought patient's sugar was low; Her muscles hurt; Head was splitting - had a severe bad headache; She got ill about 4 or 5 hours after 2nd dose; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (She got up to go to bathroom came out and passed out), DECREASED APPETITE (Lost her appetite), SOMNOLENCE (all she wanted to do was sleep), ILLNESS (She got ill about 4 or 5 hours after 2nd dose) and BLOOD GLUCOSE DECREASED (Daughter thought patient's sugar was low) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 015M20A and 011L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included SARS-CoV-2 test positive (Patient reported that she tested positive for COVID-19.) on 30-Dec-2020.   On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 13-Feb-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced ILLNESS (She got ill about 4 or 5 hours after 2nd dose). On an unknown date, the patient experienced LOSS OF CONSCIOUSNESS (She got up to go to bathroom came out and passed out), DECREASED APPETITE (Lost her appetite), SOMNOLENCE (all she wanted to do was sleep), BLOOD GLUCOSE DECREASED (Daughter thought patient's sugar was low), MYALGIA (Her muscles hurt) and HEADACHE (Head was splitting - had a severe bad headache). At the time of the report, LOSS OF CONSCIOUSNESS (She got up to go to bathroom came out and passed out), DECREASED APPETITE (Lost her appetite), SOMNOLENCE (all she wanted to do was sleep), ILLNESS (She got ill about 4 or 5 hours after 2nd dose), BLOOD GLUCOSE DECREASED (Daughter thought patient's sugar was low), MYALGIA (Her muscles hurt) and HEADACHE (Head was splitting - had a severe bad headache) outcome was unknown.            Concomitant product use was not provided by the reporter.   No treatment information provided.   This case was linked to MOD-2022-437428 (Patient Link).
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Somnolence
Clinical narrative: She got up to go to bathroom came out and passed out; Lost her appetite; all she wanted to do was sleep; Daughter thought patient's sugar was low; Her muscles hurt; Head was splitting - had a severe bad headache; She got ill about 4 or 5 hours after 2nd dose; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (She got up to go to bathroom came out and passed out), DECREASED APPETITE (Lost her appetite), SOMNOLENCE (all she wanted to do was sleep), ILLNESS (She got ill about 4 or 5 hours after 2nd dose) and BLOOD GLUCOSE DECREASED (Daughter thought patient's sugar was low) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 015M20A and 011L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included SARS-CoV-2 test positive (Patient reported that she tested positive for COVID-19.) on 30-Dec-2020.   On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 13-Feb-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced ILLNESS (She got ill about 4 or 5 hours after 2nd dose). On an unknown date, the patient experienced LOSS OF CONSCIOUSNESS (She got up to go to bathroom came out and passed out), DECREASED APPETITE (Lost her appetite), SOMNOLENCE (all she wanted to do was sleep), BLOOD GLUCOSE DECREASED (Daughter thought patient's sugar was low), MYALGIA (Her muscles hurt) and HEADACHE (Head was splitting - had a severe bad headache). At the time of the report, LOSS OF CONSCIOUSNESS (She got up to go to bathroom came out and passed out), DECREASED APPETITE (Lost her appetite), SOMNOLENCE (all she wanted to do was sleep), ILLNESS (She got ill about 4 or 5 hours after 2nd dose), BLOOD GLUCOSE DECREASED (Daughter thought patient's sugar was low), MYALGIA (Her muscles hurt) and HEADACHE (Head was splitting - had a severe bad headache) outcome was unknown.            Concomitant product use was not provided by the reporter.   No treatment information provided.   This case was linked to MOD-2022-437428 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Therapeutic response unexpected
Clinical narrative: cleared her blackout from the trauma of getting kidnapped; caught Covid again after getting the vaccine; This spontaneous case was reported by a consumer and describes the occurrence of THERAPEUTIC RESPONSE UNEXPECTED (cleared her blackout from the trauma of getting kidnapped) and COVID-19 (caught Covid again after getting the vaccine) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced THERAPEUTIC RESPONSE UNEXPECTED (cleared her blackout from the trauma of getting kidnapped) and COVID-19 (caught Covid again after getting the vaccine). At the time of the report, THERAPEUTIC RESPONSE UNEXPECTED (cleared her blackout from the trauma of getting kidnapped) and COVID-19 (caught Covid again after getting the vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant and treatment medications were reported.  This is a spontaneous case concerning  a  patient of unknown age and gender, with no relevant medical history, who experienced the unexpected non-serious event of therapeutic response and Covid-19 as an additional event. The events occurred approximately on an unknown day after the unknown dose of mRNA-1273 COVID 19 Vaccine. The rechallenge was not applicable, as information about further dosing was not disclosed. The events outcome was unknown. The benefit-risk relationship of mRNA-1273 COVID 19 Vaccine, is not affected by this report.; Sender's Comments: This is a spontaneous case concerning  a  patient of unknown age and gender, with no relevant medical history, who experienced the unexpected non-serious event of therapeutic response and Covid-19 as an additional event. The events occurred approximately on an unknown day after the unknown dose of mRNA-1273 COVID 19 Vaccine. The rechallenge was not applicable, as information about further dosing was not disclosed. The events outcome was unknown. The benefit-risk relationship of mRNA-1273 COVID 19 Vaccine, is not affected by this report.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: Covid; This spontaneous case was reported by an other health care professional and describes the occurrence of COVID-19 (Covid) 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 COVID-19 (Covid). At the time of the report, COVID-19 (Covid) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not provided. Treatment information was not provided.  Company comment: This case concerns a patient of an unknown age and gender with no medical history provided, who experienced non-serious unexpected event of special interest COVID-19, after receiving the mRNA-1273 vaccine. The temporal relationship between the event occurrence and vaccination cannot be determined as the date of vaccination and the date of the event were not provided. The outcome of the event was unknown at the time of the report and no details regarding the symptoms of COVID-19 infection, as well as regarding the clinical course of the events was provided.  Based on the current available information, the mRNA-1273 vaccine does not contain a virus capable of causing COVID-19 infection after vaccination, therefore, the causality for COVID-19 is not applicable. The benefit risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This case concerns a patient of an unknown age and gender with no medical history provided, who experienced non-serious unexpected event of special interest COVID-19, after receiving the mRNA-1273 vaccine. The temporal relationship between the event occurrence and vaccination cannot be determined as the date of vaccination and the date of the event were not provided. The outcome of the event was unknown at the time of the report and no details regarding the symptoms of COVID-19 infection, as well as regarding the clinical course of the events was provided.  Based on the current available information, the mRNA-1273 vaccine does not contain a virus capable of causing COVID-19 infection after vaccination, therefore, the causality for COVID-19 is not applicable. The benefit risk relationship of mRNA-1273 is not affected by this report.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: contract COVID-19 after 2 doses; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (contract COVID-19 after 2 doses) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In April 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In May 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 COVID-19 (contract COVID-19 after 2 doses). At the time of the report, COVID-19 (contract COVID-19 after 2 doses) outcome was unknown.            No concomitant drug details were reported. No treatment information was provided.  Company comment: This case concerns a patient of an unknown age and gender, with no medical history provided, who experienced non-serious unexpected event of COVID-19. It was reported that the patient developed COVID-19 after receiving the both doses of the vaccine. The temporal relationship between the reported event and vaccination with the mRNA-1273 vaccine cannot be determined as the start date of the event, as well as exact dates of vaccination were not disclosed. The outcome of the event was unknown and no information regarding the clinical course of the event was provided.  Based on the current available information, the mRNA-1273 vaccine does not contain a virus capable of causing COVID-19 infection after vaccination, therefore, the causality for COVID-19 is not applicable. The benefit risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This case concerns a patient of an unknown age and gender, with no medical history provided, who experienced non-serious unexpected event of COVID-19. It was reported that the patient developed COVID-19 after receiving the both doses of the vaccine. The temporal relationship between the reported event and vaccination with the mRNA-1273 vaccine cannot be determined as the start date of the event, as well as exact dates of vaccination were not disclosed. The outcome of the event was unknown and no information regarding the clinical course of the event was provided.  Based on the current available information, the mRNA-1273 vaccine does not contain a virus capable of causing COVID-19 infection after vaccination, therefore, the causality for COVID-19 is not applicable. The benefit risk relationship of mRNA-1273 is not affected by this report.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: COVID; This spontaneous case was reported by an other health care professional and describes the occurrence of COVID-19 (COVID) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced COVID-19 (COVID). At the time of the report, COVID-19 (COVID) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  The patient had received first and second dose of the mRNA-1273 vaccine.  The patient had been taking monoclonal infusion as part of the treatment after three days from the start of the symptoms. The patient wanted to know when the patient could receive the booster dose of the vaccine.  Company comment: This case concerns a patient of an unknown age and gender, who experienced non serious unexpected event of special interest COVID-19. The event occurred after vaccination with the first and second dose of the mRNA-1273 vaccine. The exact temporal relationship between vaccination and the reported event cannot be determined as the date of vaccination and start date of the event were not provided. It was stated that the patient had symptoms of COVID-19, however, these symptoms were not disclosed at the time of this report. The patient was treated with unspecified monoclonal infusion. The outcome of the event was unknown. Based on the current available information, the mRNA-1273 vaccine does not contain a virus capable of causing COVID-19 infection after vaccination, therefore, the causality for COVID-19 is not applicable. The benefit risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This case concerns a patient of an unknown age and gender, who experienced non serious unexpected event of special interest COVID-19. The event occurred after vaccination with the first and second dose of the mRNA-1273 vaccine. The exact temporal relationship between vaccination and the reported event cannot be determined as the date of vaccination and start date of the event were not provided. It was stated that the patient had symptoms of COVID-19, however, these symptoms were not disclosed at the time of this report. The patient was treated with unspecified monoclonal infusion. The outcome of the event was unknown. Based on the current available information, the mRNA-1273 vaccine does not contain a virus capable of causing COVID-19 infection after vaccination, therefore, the causality for COVID-19 is not applicable. The benefit risk relationship of mRNA-1273 is not affected by this report.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: 69 expired doses administered; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (69 expired doses administered) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012H21B) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (69 expired doses administered). On 10-Jan-2022, EXPIRED PRODUCT ADMINISTERED (69 expired doses administered) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The  concomitant medications on use were not provided. No treatment information was provided.  The vials was placed in the refrigerator on 06 Dec 2021.   This case was linked to MOD-2022-449524 (Patient Link).
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity
Clinical narrative: Sore arm; Tired; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) and FATIGUE (Tired) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007cz1a) for COVID-19 vaccination.     Concurrent medical conditions included Sulfonamide allergy, Drug allergy (Neosprin) and Adhesive tape allergy. Concomitant products included FLUTICASONE PROPIONATE (FLONASE [FLUTICASONE PROPIONATE]) for Allergy, ETHINYLESTRADIOL, NORETHISTERONE ACETATE (JUNEL) for Birth control, ASCORBIC ACID, VACCINIUM MACROCARPON (CRANBERRY [ASCORBIC ACID;VACCINIUM MACROCARPON]) for Urine analysis, BIFIDOBACTERIUM INFANTIS, LACTOBACILLUS ACIDOPHILUS (PROBIOTIC [BIFIDOBACTERIUM INFANTIS;LACTOBACILLUS ACIDOPHILUS]) and FISH OIL for an unknown indication, DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (TDAP).    On 25-Apr-2021 at 12:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Apr-2021, the patient experienced PAIN IN EXTREMITY (Sore arm) and FATIGUE (Tired). On 30-Apr-2021, PAIN IN EXTREMITY (Sore arm) and FATIGUE (Tired) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment medication were not reported.  The patient was taking Probiotic for healthy bacteria, Cranberry for urinary support and Fish oil for healthy heart. The patient noticed sleep helped a lot for her to felt better.   This case was linked to MOD-2021-403106, MOD-2021-403163 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Menstrual disorder
Clinical narrative: "Vaccine impaired my menstrual cycle"; This spontaneous case was reported by an other health care professional and describes the occurrence of MENSTRUAL DISORDER ("Vaccine impaired my menstrual cycle") in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MENSTRUAL DISORDER ("Vaccine impaired my menstrual cycle"). At the time of the report, MENSTRUAL DISORDER ("Vaccine impaired my menstrual cycle") outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant products and treatment information were reported.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: muscle pain all over body 2nd dose; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (muscle pain all over body 2nd dose) in a 47-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 016C21A and 037B21A) for COVID-19 vaccination.     Concomitant products included FISH OIL for an unknown indication.   On 12-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-May-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 MYALGIA (muscle pain all over body 2nd dose). At the time of the report, MYALGIA (muscle pain all over body 2nd dose) had resolved.            No medical history was provided by the reporter.  Concomitant medication included Intermittent multi-vitamin for an unknown indication. No treatment medications were reported.  The event took a day to resolve.   This case was linked to MOD-2022-450439 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Face oedema, Inflammation
Clinical narrative: Inflammation where filler was injected; Generalized facial edema; This spontaneous case was reported by a physician and describes the occurrence of INFLAMMATION (Inflammation where filler was injected) and FACE OEDEMA (Generalized facial edema) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In October 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 INFLAMMATION (Inflammation where filler was injected) and FACE OEDEMA (Generalized facial edema). At the time of the report, INFLAMMATION (Inflammation where filler was injected) and FACE OEDEMA (Generalized facial edema) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication list was not provided.  Treatment information was not provided.  Late September 2021, the patient received Galderma's co-suspect filler through injection (unknown dosage, unknown anatomical location, unknown batch/lot number). Two months after receiving the co-suspect, patient experienced the events.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Vial was stored in the refrigerator beyond 30 days; All patients received Expired Moderna COVID-19 vaccine from a vial; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (All patients received Expired Moderna COVID-19 vaccine from a vial) and PRODUCT STORAGE ERROR (Vial was stored in the refrigerator beyond 30 days) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027H21B) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (All patients received Expired Moderna COVID-19 vaccine from a vial). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial was stored in the refrigerator beyond 30 days). On 30-Dec-2021, EXPIRED PRODUCT ADMINISTERED (All patients received Expired Moderna COVID-19 vaccine from a vial) had resolved. At the time of the report, PRODUCT STORAGE ERROR (Vial was stored in the refrigerator beyond 30 days) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment and concomitant medications were provided.
Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: received Expired Moderna COVID-19 vaccine from a vial that was stored in the refrigerator; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (received Expired Moderna COVID-19 vaccine from a vial that was stored in the refrigerator ) in an 82-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027H21B) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (received Expired Moderna COVID-19 vaccine from a vial that was stored in the refrigerator ). On 30-Dec-2021, EXPIRED PRODUCT ADMINISTERED (received Expired Moderna COVID-19 vaccine from a vial that was stored in the refrigerator ) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant products were reported.  No treatment information was reported.  Patient received vaccine from a vial that was stored in the refrigerator beyond 30 days. There were no side effects reported so far.   This case was linked to MOD-2022-446648 (Patient Link).
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: patients received Expired Moderna COVID-19 vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patients received Expired Moderna COVID-19 vaccine) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027H21B) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (patients received Expired Moderna COVID-19 vaccine). On 30-Dec-2021, EXPIRED PRODUCT ADMINISTERED (patients received Expired Moderna COVID-19 vaccine) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment medication was reported. No concomitant medication was reported. Patient received Expired Moderna COVID-19 vaccine from a vial that was stored in the refrigerator beyond 30 days.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: All patients received Expired Moderna COVID-19 vaccine from a vial that was stored in the refrigerator beyond 30 days; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (All patients received Expired Moderna COVID-19 vaccine from a vial that was stored in the refrigerator beyond 30 days) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027H21B) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (All patients received Expired Moderna COVID-19 vaccine from a vial that was stored in the refrigerator beyond 30 days). On 30-Dec-2021, EXPIRED PRODUCT ADMINISTERED (All patients received Expired Moderna COVID-19 vaccine from a vial that was stored in the refrigerator beyond 30 days) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided by the reporter No treatment medication was provided by the reporter.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: All patients received Expired Moderna COVID-19 vaccine from a vial that was stored in the refrigerator beyond 30 days; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (All patients received Expired Moderna COVID-19 vaccine from a vial that was stored in the refrigerator beyond 30 days) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027H21B) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (All patients received Expired Moderna COVID-19 vaccine from a vial that was stored in the refrigerator beyond 30 days). On 30-Dec-2021, EXPIRED PRODUCT ADMINISTERED (All patients received Expired Moderna COVID-19 vaccine from a vial that was stored in the refrigerator beyond 30 days) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. No treatment medication was reported.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patients received Expired Moderna COVID-19 vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patients received Expired Moderna COVID-19 vaccine) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027H21B) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patients received Expired Moderna COVID-19 vaccine). On 30-Dec-2021, EXPIRED PRODUCT ADMINISTERED (Patients received Expired Moderna COVID-19 vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not reported.  No treatment details were provided.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: All patients received Expired Moderna COVID-19 vaccine from a vial that was stored in the refrigerator; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (All patients received Expired Moderna COVID-19 vaccine from a vial that was stored in the refrigerator) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027H21B) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (All patients received Expired Moderna COVID-19 vaccine from a vial that was stored in the refrigerator). On 30-Dec-2021, EXPIRED PRODUCT ADMINISTERED (All patients received Expired Moderna COVID-19 vaccine from a vial that was stored in the refrigerator) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant information was reported. No treatment information was reported.
Sex: F
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: flu; Initial information was received on 06-Jan-2022 regarding an unsolicited valid Social Media non-serious case received from patient.  This case involves Adult female patient who experienced flu while receiving vaccine INFLUENZA VACCINE.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient had received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (strength, formulation, dose, route, batch number and expiry date: unknown) in unknown administration site for prophylactic vaccination.  On an unknown date the patient developed a non-serious event "flu" (influenza) (unknown latency) following the administration of INFLUENZA VACCINE. It was reported, "the only time patient got the flu was when got the flu shot. Same with hubby so no coincidence there!! Never again. Plus my mother & her sister for years would get the flu shot, only ones that ended up with dementia! Sorry no! Nothing beats your immune system, learn what to take to stay healthy."  Action taken with INFLUENZA VACCINE (INFLUENZA VACCINE) was not applicable.  It was not reported if the patient received a corrective treatment for the event (flu).  At time of reporting, the outcome was Unknown for the event flu.
Sex: F
Vaccine: FLU4
Symptoms: Local reaction, Skin test positive
Clinical narrative: "positive" skin tests using the Fluzone Quadrivalent vaccine; local reactions; Initial information received on 04-Jan-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves an unknown age female patient who experienced "positive" skin tests using the fluzone quadrivalent vaccine and local reactions while receiving vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT].   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.    On an unknown date, the patient received a  dose of suspect INFLUENZA QUADRIVAL A-B VACCINE lot number not reported via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date the patient developed a non-serious "positive" skin tests using the fluzone quadrivalent vaccine (skin test positive) (unknown latency) following the administration of INFLUENZA QUADRIVAL A-B VACCINE. On an unknown date the patient developed a non-serious local reactions (local reaction) (unknown latency) following the administration of INFLUENZA QUADRIVAL A-B VACCINE.  Action taken with QUADRIVALENT INFLUENZA VACCINE (FLUZONE QUADRIVALENT) was not applicable.  It was not reported if the patient received a corrective treatment for the events ("positive" skin tests using the Fluzone Quadrivalent vaccine, local reactions).  At time of reporting, the outcome was Unknown for the event "positive" skin tests using the fluzone quadrivalent vaccine and was Unknown for the event local reactions.
Sex: F
Vaccine: FLUX
Symptoms: Dementia
Clinical narrative: only ones that ended up with dementia; Initial information received on 06-Jan-2022 regarding an unsolicited valid Social Media serious case received from a consumer/non-hcp.  This case involves an unknown age female patient who had only ones that ended up with dementia while receiving vaccine INFLUENZA VACCINE.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a  dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number not reported via unknown route in unknown administration site.  On an unknown date the patient developed a serious only ones that ended up with dementia (dementia) (unknown latency) following the administration of INFLUENZA VACCINE. This event was assessed as medically significant.  Action taken with INFLUENZA VACCINE (INFLUENZA VACCINE) was not applicable.  It was not reported if the patient received a corrective treatment for the event (only ones that ended up with dementia).  At time of reporting, the outcome was Unknown for the event only ones that ended up with dementia.; Sender's Comments: Sanofi company comment dated 17-Jan-2022: This case involves an unknown age female patient who had only ones that ended up with dementia while receiving vaccine INFLUENZA VACCINE. lack of information regarding event details, medical history, concurrent condition during vaccination, previous vaccination, concomitant medication and tolerance, allergic history, excluding alternative etiologies for the reported event are needed to fully assess this case. Based upon the reported information, the role of the individual suspect vaccine cannot be assessed.
Sex: F
Vaccine: FLUX
Symptoms: Dementia
Clinical narrative: only ones that ended up with dementia; Initial information received on 06-Jan-2022 regarding an unsolicited valid Social Media serious case received from a consumer/non-hcp.  This case involves an unknown age female patient who had experienced an event, only ones that ended up with dementia while receiving vaccine Influenza Vaccine.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect Influenza Vaccine produced by unknown manufacturer (strength, formulation, dose, route, batch number and expiry date: unknown) in unknown administration site for prophylactic vaccination (flu).  On an unknown date the patient had experienced an event, ended up with dementia (dementia) (unknown latency) following the administration of Influenza Vaccine. This event was assessed as medically significant.  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the event (only ones that ended up with dementia).  At time of reporting, the outcome was Unknown for the event only ones that ended up with dementia.; Sender's Comments: Sanofi Company Comment dated 14-Jan-2022: This case involves an unknown age female patient who had experienced an event, only ones that ended up with dementia while receiving vaccine Influenza Vaccine. Further information regarding medical history, concurrent condition during vaccination, previous vaccination, concomitant medication and tolerance, allergic history, laboratory investigations excluding alternative etiologies for the reported event are needed to fully assess this case. Based upon the reported information, the role of the individual suspect vaccine cannot be assessed.
Sex: U
Vaccine: DTAP, DTAPIPV, DTAPIPVHIB, UNK
Symptoms: Product storage error
Clinical narrative: temperature excursion for the following unopen products: QUADRACEL, DAPTACEL, PENTACEL, and TUBERSOL with no reported adverse event; Initial information received on 10-Jan-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a patient with unknown demographics who had temperature excursion for the following unopen products: quadracel, daptacel, pentacel, and tubersol with no reported adverse event while receiving vaccines DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL], DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] and DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [QUADRACEL] and while treated with TUBERCULIN PPD [TUBERSOL].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.    On an unknown date, the patient started taking TUBERSOL (TUBERCULIN PPD) Unknown dosage unknown route unknown (lot - C5735AA). On an unknown date, the patient received a  dose of suspect DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE lot C5862BA via unknown route in unknown administration site. On an unknown date, the patient received a  dose of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE lot C5816AA via unknown route in unknown administration site. On an unknown date, the patient received a  dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE lot UJ597AAA in unknown administration site.  On 07-JAN-2022 the patient had a non-serious temperature excursion for the following unopen products: quadracel, daptacel, pentacel, and tubersol with no reported adverse event (product temperature excursion issue) (unknown latency) following the administration of DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the event (temperature excursion for the following unopen products: QUADRACEL, DAPTACEL, PENTACEL, and TUBERSOL with no reported adverse event).  At time of reporting, the outcome was Unknown for the event temperature excursion for the following unopen products: quadracel, daptacel, pentacel, and tubersol with no reported adverse event.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Polymenorrhoea
Clinical narrative: Decrease in days of menstrual bleeding (from 5 to 3).
Sex: F
Vaccine: COVID19
Symptoms: Cough, Headache, Rhinorrhoea, SARS-CoV-2 test
Clinical narrative: SYMPTOMS OF COUGH; RUNNY NOSE; FEELING OF BEING STOPPED UP IN THE HEAD; This spontaneous report received from a patient concerned a 51 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 201A121A expiry: UNKNOWN) dose was not reported, administered on 30-JUL-2021 for prophylactic vaccination. No concomitant medications were reported.  On 13-JAN-2022, Laboratory data included: COVID-19 antigen test (NR: not provided) Negative. On an unspecified date, the patient experienced symptoms of cough, runny nose, and feeling of being stopped up in the head. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the symptoms of cough, runny nose and feeling of being stopped up in the head was not reported. This report was non-serious.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Influenza like illness
Clinical narrative: patient had a feeling of flu coming on for a day after the second Moderna Covid-19 shot; Mainly the flu symptoms were body aches in my back.; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (patient had a feeling of flu coming on for a day after the second Moderna Covid-19 shot) and BACK PAIN (Mainly the flu symptoms were body aches in my back.) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 041B21A and 003B21A) for COVID-19 vaccination.     Concomitant products included LOSARTAN, APIXABAN (ELIQUIS), ROSUVASTATIN, BUMETANIDE, SPIRONOLACTONE, CLOPIDOGREL, POTASSIUM CHLORIDE, COLECALCIFEROL (VITAMIN D3) and VITAMIN C [ASCORBIC ACID] for an unknown indication.   On 27-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Apr-2021, the patient experienced INFLUENZA LIKE ILLNESS (patient had a feeling of flu coming on for a day after the second Moderna Covid-19 shot) and BACK PAIN (Mainly the flu symptoms were body aches in my back.). At the time of the report, INFLUENZA LIKE ILLNESS (patient had a feeling of flu coming on for a day after the second Moderna Covid-19 shot) and BACK PAIN (Mainly the flu symptoms were body aches in my back.) had resolved.            The patient slept for a day and felt better.  The patient received her Moderna booster dose on 22-DEC-2021 in her left arm shoulder deltoid muscle (lot number 068H21A). Patient reported no adverse reactions or side effects to her Moderna booster dose.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Vial was stored in the refrigerator beyond 30 days; All patients received Expired Moderna COVID-19 vaccine from a vial; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (All patients received Expired Moderna COVID-19 vaccine from a vial) and PRODUCT STORAGE ERROR (Vial was stored in the refrigerator beyond 30 days) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027H21B) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (All patients received Expired Moderna COVID-19 vaccine from a vial). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial was stored in the refrigerator beyond 30 days). On 30-Dec-2021, EXPIRED PRODUCT ADMINISTERED (All patients received Expired Moderna COVID-19 vaccine from a vial) had resolved. At the time of the report, PRODUCT STORAGE ERROR (Vial was stored in the refrigerator beyond 30 days) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant and treatment information were provided.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: Covid-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Covid-19) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for an unknown indication.     Concurrent medical conditions included Multiple sclerosis. Concomitant products included OCRELIZUMAB (OCREVUS) for an unknown indication.   In April 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In April 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 31-Dec-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced COVID-19 (Covid-19). At the time of the report, COVID-19 (Covid-19) was resolving. Not Provided          No treatment information was provided.  Company Comment: This spontaneous case concerns a 31-year-old, female patient with relevant medical history of administration of Ocrevus (ocrelizumab), who experienced the unexpected, non-serious AESI of COVID-19. The event occurred approximately 1 month after administration of the third dose of the Moderna mRNA-1273 vaccine. No further details were provided. Treatment information was also not provided. However, the event was resolving at the time of the report. The medical history of administration of Ocrevus, which is an immunosuppressive drug used for the treatment of Multiple Sclerosis, remains a confounder. The benefit-risk relationship of the Moderna mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a 31-year-old, female patient with relevant medical history of administration of Ocrevus (ocrelizumab), who experienced the unexpected, non-serious AESI of COVID-19. The event occurred approximately 1 month after administration of the third dose of the Moderna mRNA-1273 vaccine. No further details were provided. Treatment information was also not provided. However, the event was resolving at the time of the report. The medical history of administration of Ocrevus, which is an immunosuppressive drug used for the treatment of Multiple Sclerosis, remains a confounder. The benefit-risk relationship of the Moderna mRNA-1273 vaccine is not affected by this report.