chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Tremor
Clinical narrative: Sporadic for a couple of hours and really goofy; Sweating like a stuffed pig; Shakes; Ran a mild fever/ highest was 101.F/ fever/ starting to run another fever; Chills; Sudden headache; Nausea; Could not lift the arm; Diarrhea; Destruction in head; Swelling; Tenderness; Fatigue; Joint pain; Somewhat muscle pain; This spontaneous case was reported by a patient and describes the occurrence of FEELING ABNORMAL (Sporadic for a couple of hours and really goofy), HYPERHIDROSIS (Sweating like a stuffed pig), LIMB DISCOMFORT (Could not lift the arm), DIARRHOEA (Diarrhea) and HEAD DISCOMFORT (Destruction in head) in a 47-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 08-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Oct-2021, the patient experienced MYALGIA (Somewhat muscle pain). On 09-Oct-2021, the patient experienced LIMB DISCOMFORT (Could not lift the arm), DIARRHOEA (Diarrhea), HEAD DISCOMFORT (Destruction in head), SWELLING (Swelling), TENDERNESS (Tenderness), PYREXIA (Ran a mild fever/ highest was 101.F/ fever/ starting to run another fever), CHILLS (Chills), HEADACHE (Sudden headache), NAUSEA (Nausea), FATIGUE (Fatigue) and ARTHRALGIA (Joint pain). On 12-Oct-2021, the patient experienced FEELING ABNORMAL (Sporadic for a couple of hours and really goofy), HYPERHIDROSIS (Sweating like a stuffed pig) and TREMOR (Shakes). The patient was treated with NAPROXEN SODIUM (ALEVE) on 12-Oct-2021 for Headache, at an unspecified dose and frequency. At the time of the report, FEELING ABNORMAL (Sporadic for a couple of hours and really goofy), HYPERHIDROSIS (Sweating like a stuffed pig), TREMOR (Shakes), PYREXIA (Ran a mild fever/ highest was 101.F/ fever/ starting to run another fever), CHILLS (Chills), HEADACHE (Sudden headache) and NAUSEA (Nausea) had not resolved, LIMB DISCOMFORT (Could not lift the arm) was resolving and DIARRHOEA (Diarrhea), HEAD DISCOMFORT (Destruction in head), SWELLING (Swelling), TENDERNESS (Tenderness), MYALGIA (Somewhat muscle pain), FATIGUE (Fatigue) and ARTHRALGIA (Joint pain) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 09-Oct-2021, Body temperature: 101 (High) mild fever, highest was 101 F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications information was reported.  Additional treatment medication was pain pills.
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Depressed mood, Feeling abnormal
Clinical narrative: Feeling bad like how I feel when I get a cold; Not feeling quite as peppy; This spontaneous case was reported by a consumer and describes the occurrence of DEPRESSED MOOD (Not feeling quite as peppy) and FEELING ABNORMAL (Feeling bad like how I feel when I get a cold) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013L20A and 031M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 22-Jan-2021, the patient experienced DEPRESSED MOOD (Not feeling quite as peppy). On 23-Jan-2021, the patient experienced FEELING ABNORMAL (Feeling bad like how I feel when I get a cold). On 23-Jan-2021, DEPRESSED MOOD (Not feeling quite as peppy) and FEELING ABNORMAL (Feeling bad like how I feel when I get a cold) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Immune system was repressed because of vasculitis and the medicines that taken for that. No treatment medication were provided.  The patient received his first dose of the vaccine at 5:00 PM and around 10:00 PM that day he was "not feeling quite as peppy and slept well most of that evening and woke up feeling bad like how he feel when he get a cold.He felt completely improved by noon.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: 6 doses were administered to patients from a vial that expired 3 days ago; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (6 doses were administered to patients from a vial that expired 3 days ago) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (6 doses were administered to patients from a vial that expired 3 days ago). At the time of the report, EXPIRED PRODUCT ADMINISTERED (6 doses were administered to patients from a vial that expired 3 days ago) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.    Reporter stated that patient received his first dose (lot number 011A21A ) of Moderna COVID19 Vaccine on 08Mar2021 in his right deltoid. He received his second dose (lot number 007B21A ) on 08Apr2021 in his left deltoid.   The pharmacist confirmed that the patient was immunocompromised No Concomitant Medications details were provided.  No Treatment Medications details were provided.   Most recent FOLLOW-UP information incorporated above includes: On 12-Oct-2021: Follow up includes patient information
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash macular, Scratch, Sleep deficit, Urticaria
Clinical narrative: itching similar to when I've eaten shellfish when I break out in hives; woke up from my sleep; itching; scratching; red spots; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (itching), SCRATCH (scratching), RASH MACULAR (red spots), URTICARIA (itching similar to when I've eaten shellfish when I break out in hives) and SLEEP DEFICIT (woke up from my sleep) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 015M20A and 030A21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concurrent medical conditions included Shellfish allergy and Allergy to chemicals (Allergic to polyethylene glycol ingredient).   On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Mar-2021, the patient experienced PRURITUS (itching), SCRATCH (scratching), RASH MACULAR (red spots) and SLEEP DEFICIT (woke up from my sleep). On an unknown date, the patient experienced URTICARIA (itching similar to when I've eaten shellfish when I break out in hives). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) (topical) for Itching, at a dose of 1 dosage form once a day. At the time of the report, PRURITUS (itching), SCRATCH (scratching), RASH MACULAR (red spots), URTICARIA (itching similar to when I've eaten shellfish when I break out in hives) and SLEEP DEFICIT (woke up from my sleep) outcome was unknown.            The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was not applicable  No concomitant medications reported.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Gingival swelling, Glossodynia, Oral mucosal blistering
Clinical narrative: Tongue was sore; Blisters inside mouth; Gums were swollen; Chills/Shivering; Was feverish; Very tired/slept all day; This spontaneous case was reported by a consumer and describes the occurrence of GLOSSODYNIA (Tongue was sore), ORAL MUCOSAL BLISTERING (Blisters inside mouth), GINGIVAL SWELLING (Gums were swollen), CHILLS (Chills/Shivering) and PYREXIA (Was feverish) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 08-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Oct-2021, the patient experienced CHILLS (Chills/Shivering), PYREXIA (Was feverish) and FATIGUE (Very tired/slept all day). On 11-Oct-2021, the patient experienced GLOSSODYNIA (Tongue was sore), ORAL MUCOSAL BLISTERING (Blisters inside mouth) and GINGIVAL SWELLING (Gums were swollen). On 10-Oct-2021, CHILLS (Chills/Shivering), PYREXIA (Was feverish) and FATIGUE (Very tired/slept all day) had resolved. At the time of the report, GLOSSODYNIA (Tongue was sore), ORAL MUCOSAL BLISTERING (Blisters inside mouth) and GINGIVAL SWELLING (Gums were swollen) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was reported by the reporter. No treatment was reported by the reporter.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Tongue was sore; Blisters inside mouth; Gums were swollen; Chills/Shivering; Was feverish; Very tired/slept all day; This spontaneous case was reported by a consumer and describes the occurrence of GLOSSODYNIA (Tongue was sore), ORAL MUCOSAL BLISTERING (Blisters inside mouth), GINGIVAL SWELLING (Gums were swollen), CHILLS (Chills/Shivering) and PYREXIA (Was feverish) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 08-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Oct-2021, the patient experienced CHILLS (Chills/Shivering), PYREXIA (Was feverish) and FATIGUE (Very tired/slept all day). On 11-Oct-2021, the patient experienced GLOSSODYNIA (Tongue was sore), ORAL MUCOSAL BLISTERING (Blisters inside mouth) and GINGIVAL SWELLING (Gums were swollen). On 10-Oct-2021, CHILLS (Chills/Shivering), PYREXIA (Was feverish) and FATIGUE (Very tired/slept all day) had resolved. At the time of the report, GLOSSODYNIA (Tongue was sore), ORAL MUCOSAL BLISTERING (Blisters inside mouth) and GINGIVAL SWELLING (Gums were swollen) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was reported by the reporter. No treatment was reported by the reporter.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: dose administered after 30-day use by date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (dose administered after 30-day use by date) in a 53-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 11-Oct-2021 at 5:00 AM, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 ml. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (dose administered after 30-day use by date). On 11-Oct-2021, EXPIRED PRODUCT ADMINISTERED (dose administered after 30-day use by date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product was not provided by the reporter. Treatment information was not provided.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Off label use
Clinical narrative: received the third dose without being immunocompromised; This spontaneous case was reported by a consumer and describes the occurrence of OFF LABEL USE (received the third dose without being immunocompromised) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002B21A, 036B21A and 011D21A) for COVID-19 vaccination.     The patient's past medical history included Implantable cardioverter defibrillator insertion since an unknown date. Concurrent medical conditions included Heart disease, unspecified and Kidney disorder.   On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Aug-2021, the patient experienced OFF LABEL USE (received the third dose without being immunocompromised). On 16-Aug-2021, OFF LABEL USE (received the third dose without being immunocompromised) had resolved.            Concomitant medication information was  provided by the reporter  i.e., several for his heart (13 morning, 2afternoon, 5before going to bed).  Treatment information was not provided by the reporter
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: gave Moderna Covid-19 Vaccines that were beyond the 30 day refrigeration use by date/10 doses administered past the 30 day use by date; gave Moderna Covid-19 Vaccines that were beyond the 30 day refrigeration use by date/10 doses administered past the 30 day use by date; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (gave Moderna Covid-19 Vaccines that were beyond the 30 day refrigeration use by date/10 doses administered past the 30 day use by date) and PRODUCT STORAGE ERROR (gave Moderna Covid-19 Vaccines that were beyond the 30 day refrigeration use by date/10 doses administered past the 30 day use by date) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047821A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-May-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-May-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (gave Moderna Covid-19 Vaccines that were beyond the 30 day refrigeration use by date/10 doses administered past the 30 day use by date) and PRODUCT STORAGE ERROR (gave Moderna Covid-19 Vaccines that were beyond the 30 day refrigeration use by date/10 doses administered past the 30 day use by date). On 19-May-2021, EXPIRED PRODUCT ADMINISTERED (gave Moderna Covid-19 Vaccines that were beyond the 30 day refrigeration use by date/10 doses administered past the 30 day use by date) and PRODUCT STORAGE ERROR (gave Moderna Covid-19 Vaccines that were beyond the 30 day refrigeration use by date/10 doses administered past the 30 day use by date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  Treatment information was not reported.    Most recent FOLLOW-UP information incorporated above includes: On 13-Oct-2021: Dose administration date added
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Decreased appetite, Fatigue, Headache, Pain in extremity
Clinical narrative: Lightly sore arm; Wasn't hungry; Extreme fatigue; Headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Lightly sore arm), DECREASED APPETITE (Wasn't hungry), FATIGUE (Extreme fatigue) and HEADACHE (Headache) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 088D211A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 from 24-Nov-2020 to 14-Jan-2021.    On 03-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Lightly sore arm), DECREASED APPETITE (Wasn't hungry), FATIGUE (Extreme fatigue) and HEADACHE (Headache). At the time of the report, PAIN IN EXTREMITY (Lightly sore arm), DECREASED APPETITE (Wasn't hungry) and HEADACHE (Headache) outcome was unknown and FATIGUE (Extreme fatigue) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       Concomitant medications included blood pressure medication. No treatment medications were reported.   This case was linked to MOD-2021-350654 (Patient Link).
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Ageusia, Erectile dysfunction, Headache, Myalgia, Pyrexia
Clinical narrative: Problem getting an erection; Sick in bed; Lost my taste buds; Body was sore; Fever; Headache; This spontaneous case was reported by a consumer and describes the occurrence of ERECTILE DYSFUNCTION (Problem getting an erection), VACCINATION COMPLICATION (Sick in bed), AGEUSIA (Lost my taste buds), MYALGIA (Body was sore) and PYREXIA (Fever) in a 48-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Mar-2021, the patient experienced VACCINATION COMPLICATION (Sick in bed), AGEUSIA (Lost my taste buds), MYALGIA (Body was sore), PYREXIA (Fever) and HEADACHE (Headache). On an unknown date, the patient experienced ERECTILE DYSFUNCTION (Problem getting an erection). On 30-Mar-2021, VACCINATION COMPLICATION (Sick in bed), MYALGIA (Body was sore), PYREXIA (Fever) and HEADACHE (Headache) had resolved. At the time of the report, ERECTILE DYSFUNCTION (Problem getting an erection) outcome was unknown and AGEUSIA (Lost my taste buds) had resolved.            No concomitant product was provided. No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 13-Oct-2021: Significant follow-up received included :Repoter details and events were updated.; Sender's Comments: This case concerns a 48-year-old male patient with no previous relevant medical history, who experienced the unexpected non serious event/AESI of Ageusia and other non serious events after mRNA- 1273 vaccine / Moderna COVID-19 Vaccine. The event occurred on the days after the second dose of mRNA-1273 and lasted for approximately one day. The rechallenge is not applicable, since the schedule of vaccination has been completed and a further dose is not expected. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: Problem getting an erection; Sick in bed; Lost my taste buds; Body was sore; Fever; Headache; This spontaneous case was reported by a consumer and describes the occurrence of ERECTILE DYSFUNCTION (Problem getting an erection), VACCINATION COMPLICATION (Sick in bed), AGEUSIA (Lost my taste buds), MYALGIA (Body was sore) and PYREXIA (Fever) in a 48-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Mar-2021, the patient experienced VACCINATION COMPLICATION (Sick in bed), AGEUSIA (Lost my taste buds), MYALGIA (Body was sore), PYREXIA (Fever) and HEADACHE (Headache). On an unknown date, the patient experienced ERECTILE DYSFUNCTION (Problem getting an erection). On 30-Mar-2021, VACCINATION COMPLICATION (Sick in bed), MYALGIA (Body was sore), PYREXIA (Fever) and HEADACHE (Headache) had resolved. At the time of the report, ERECTILE DYSFUNCTION (Problem getting an erection) outcome was unknown and AGEUSIA (Lost my taste buds) had resolved.            No concomitant product was provided. No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 13-Oct-2021: Significant follow-up received included :Repoter details and events were updated.; Sender's Comments: This case concerns a 48-year-old male patient with no previous relevant medical history, who experienced the unexpected non serious event/AESI of Ageusia and other non serious events after mRNA- 1273 vaccine / Moderna COVID-19 Vaccine. The event occurred on the days after the second dose of mRNA-1273 and lasted for approximately one day. The rechallenge is not applicable, since the schedule of vaccination has been completed and a further dose is not expected. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: doses administered past the published expiry date; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (doses administered past the published expiry date) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (doses administered past the published expiry date). On 12-Oct-2021, EXPIRED PRODUCT ADMINISTERED (doses administered past the published expiry date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications reported. No treatment information was provided. The doses were administered on 12-OCT-2021, past the published expiry date(??-JUL-2021). The vials were stored in the freezer and taken out of the freezer and placed in the refrigerator on the date of administration. The vials did not underwent any temperature excursions.   This case was linked to MOD-2021-351062 (Patient Link).
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Doses administered past the published expiry date; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Doses administered past the published expiry date) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Doses administered past the published expiry date). On 12-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Doses administered past the published expiry date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment medications were reported.  The vials were stored in the freezer and taken out of the freezer and placed in the refrigerator on the date of administration. The vials did not undergo any temperature excursions.
Age: 87.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Doses administered past the published expiry date; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Doses administered past the published expiry date) in an 87-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Doses administered past the published expiry date). On 12-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Doses administered past the published expiry date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment  medications were reported.   The vials were stored in the freezer and taken out of the freezer and placed in the refrigerator on the date of administration. The vials did not undergo any temperature excursions.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: doses administered past the published expiry date; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (doses administered past the published expiry date) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (doses administered past the published expiry date). On 12-Oct-2021, EXPIRED PRODUCT ADMINISTERED (doses administered past the published expiry date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. No Treatment informations were reported.
Sex: M
Vaccine: COVID19
Symptoms: Cough, Nasal congestion, Throat clearing
Clinical narrative: Cough; Congestion; Clearing his throat constantly; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (Cough), NASAL CONGESTION (Congestion) and THROAT CLEARING (Clearing his throat constantly) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included LOSARTAN for an unknown indication.   In 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced COUGH (Cough), NASAL CONGESTION (Congestion) and THROAT CLEARING (Clearing his throat constantly). The patient was treated with GUAIFENESIN ongoing since an unknown date for Cough and Congestion nasal, at a dose of 400 mg. At the time of the report, COUGH (Cough), NASAL CONGESTION (Congestion) and THROAT CLEARING (Clearing his throat constantly) outcome was unknown.            Treatment medication also includes nasal inhaler.  Patient had past issues with statins that gave him muscle aches.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: doses administered past the published expiry date; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (doses administered past the published expiry date) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (doses administered past the published expiry date). On 12-Oct-2021, EXPIRED PRODUCT ADMINISTERED (doses administered past the published expiry date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication was not reported. Treatment information was not reported.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Doses administered past the published expiry; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Doses administered past the published expiry) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Sep-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Doses administered past the published expiry). On 09-Sep-2021, EXPIRED PRODUCT ADMINISTERED (Doses administered past the published expiry) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were reported. No treatment information was reported.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Doses administered past the published expiry; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Doses administered past the published expiry) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Sep-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Doses administered past the published expiry). On 09-Sep-2021, EXPIRED PRODUCT ADMINISTERED (Doses administered past the published expiry) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant product use was provided by the reporter. No treatment medication was provided.  It was unknown if the doses are first, second or third doses for the patients.The vials were stored in the freezer and taken out of the freezer and placed in the refrigerator on the date of administration. The vials did not undergo any temperature excursions.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Moderna COVID-19 vaccine was administered to patients past the published expiry date; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Moderna COVID-19 vaccine was administered to patients past the published expiry date) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Sep-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Moderna COVID-19 vaccine was administered to patients past the published expiry date). On 09-Sep-2021, EXPIRED PRODUCT ADMINISTERED (Moderna COVID-19 vaccine was administered to patients past the published expiry date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications information was reported. No treatment medications were provided.  The vials were stored in the freezer and taken out of the freezer and placed in the refrigerator on the date of administration. The vials did not undergo any temperature excursions
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Doses administered past the published expiry; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Doses administered past the published expiry) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Sep-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Doses administered past the published expiry). On 16-Sep-2021, EXPIRED PRODUCT ADMINISTERED (Doses administered past the published expiry) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant drugs were not reported. Treatment medications were not provided. It was reported that vial did not undergo any temperature excursions.   This case was linked to MOD21-152032 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Doses administered past the published expiry; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Doses administered past the published expiry) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Sep-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Doses administered past the published expiry). On 16-Sep-2021, EXPIRED PRODUCT ADMINISTERED (Doses administered past the published expiry) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   It was unknown if the doses are first, second or third doses for the patient.  The vials were stored in the freezer and taken out of the freezer and placed in the refrigerator on the date of administration.  The vials was did not undergone any temperature excursions.  Concomitant medications were not reported.  Treatment information was not reported.
Age: 83.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Doses administered past the published expiry; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Doses administered past the published expiry) in an 83-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Sep-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Doses administered past the published expiry). On 16-Sep-2021, EXPIRED PRODUCT ADMINISTERED (Doses administered past the published expiry) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported.  No treatment information was provided.
Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Doses administered past the published expiry; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Doses administered past the published expiry) in an 81-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Sep-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Doses administered past the published expiry). On 16-Sep-2021, EXPIRED PRODUCT ADMINISTERED (Doses administered past the published expiry) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information provided by the reporter. No treatment information provided.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Doses administered past the published expiry; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Doses administered past the published expiry) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Doses administered past the published expiry). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Doses administered past the published expiry) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant product use was provided by the reporter. No treatment medication was provided.  It was unknown if the doses are first, second or third doses for the patients.  The vials were stored in the freezer and taken out of the freezer and placed in the refrigerator on the date of administration. The vials did not undergo any temperature excursions.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Doses administered past the published expiry; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Doses administered past the published expiry) in a 39-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Sep-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Doses administered past the published expiry). On 16-Sep-2021, EXPIRED PRODUCT ADMINISTERED (Doses administered past the published expiry) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant information was not provided.  It was reported that the vials were stored in the freezer and taken out of the freezer and placed in the refrigerator on the date of administration. The vials did not undergo any temperature excursions.  Treatment information was not provided.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Doses administered past the published expiry; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Doses administered past the published expiry) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Sep-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Doses administered past the published expiry). On 16-Sep-2021, EXPIRED PRODUCT ADMINISTERED (Doses administered past the published expiry) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   no concomitant medications were reported. no treatment medications were reported.
Age: 91.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Doses administered past the published expiry; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Doses administered past the published expiry) in a 91-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 07-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Doses administered past the published expiry). On 07-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Doses administered past the published expiry) had resolved.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided.  No treatment medication was provided.  It was reported that, the vials were stored in the freezer and taken out of the freezer and placed in the refrigerator on the date of administration. The vials did not undergo any temperature excursions.
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Doses administered past the published expiry; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Doses administered past the published expiry) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In September 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In September 2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Doses administered past the published expiry). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Doses administered past the published expiry) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant information was not reported.  Treatment information was not reported.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Doses administered past the published expiry; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Doses administered past the published expiry) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Doses administered past the published expiry). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Doses administered past the published expiry) 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.   No concomitant medications were provided by reporter. No treatment medications were reported.
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Doses administered past the published expiry; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Doses administered past the published expiry) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Doses administered past the published expiry). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Doses administered past the published expiry) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was mentioned. No treatment medication was mentioned.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Doses administered past the published expiry; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Doses administered past the published expiry) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Doses administered past the published expiry). On 11-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Doses administered past the published expiry) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported.  No treatment information was provided.
Age: 85.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Doses administered past the published expiry; This spontaneous case was reported by a health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Doses administered past the published expiry) in an 85-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Doses administered past the published expiry). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Doses administered past the published expiry) 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.   No concomitant medication or treatment information were provided.
Age: 87.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Doses administered past the published expiry; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Doses administered past the published expiry) in an 87-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Doses administered past the published expiry). On 11-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Doses administered past the published expiry) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications was reported. No treatment drug details was reported.