chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 75.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Feeling abnormal
Clinical narrative: First shot make me tired; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (First shot make me tired) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038K20A) for COVID-19 vaccination.     Patient had no allergies.  The patient's past medical history included Stent insertion NOS (3 Heart Stents). Concurrent medical conditions included Emphysema pulmonary (prior vaccination), Cholesterol and Breathing difficult. Concomitant products included THEOPHYLLINE for Breathing difficult, ATORVASTATIN for High cholesterol, METOPROLOL, DILTIAZEM, TIOTROPIUM BROMIDE MONOHYDRATE (SPIRIVA) and FLUTICASONE PROPIONATE, SALMETEROL XINAFOATE (ADVAIR) for an unknown indication.    On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced FATIGUE (First shot make me tired). At the time of the report, FATIGUE (First shot make me tired) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative negative.     mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       The patient did not register any change on her illness status post vaccination. Patient did not tested positive for COVID-19 and did not received any other vaccine within 1 month prior to Moderna's. Patient did not register any change on her illness status post vaccination. Patient confirm that received all the vaccines in her left deltoid and did not seek for medical care post vaccination. The patient did not experienced a similar event on the past. No treatment medications were reported by the reporter.   This case was linked to MOD-2022-533310, MOD-2022-533315, MOD-2022-533316 (Patient Link).
Age: 75.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Nausea
Clinical narrative: First shot make me tired; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (First shot make me tired) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038K20A) for COVID-19 vaccination.     Patient had no allergies.  The patient's past medical history included Stent insertion NOS (3 Heart Stents). Concurrent medical conditions included Emphysema pulmonary (prior vaccination), Cholesterol and Breathing difficult. Concomitant products included THEOPHYLLINE for Breathing difficult, ATORVASTATIN for High cholesterol, METOPROLOL, DILTIAZEM, TIOTROPIUM BROMIDE MONOHYDRATE (SPIRIVA) and FLUTICASONE PROPIONATE, SALMETEROL XINAFOATE (ADVAIR) for an unknown indication.    On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced FATIGUE (First shot make me tired). At the time of the report, FATIGUE (First shot make me tired) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative negative.     mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       The patient did not register any change on her illness status post vaccination. Patient did not tested positive for COVID-19 and did not received any other vaccine within 1 month prior to Moderna's. Patient did not register any change on her illness status post vaccination. Patient confirm that received all the vaccines in her left deltoid and did not seek for medical care post vaccination. The patient did not experienced a similar event on the past. No treatment medications were reported by the reporter.   This case was linked to MOD-2022-533310, MOD-2022-533315, MOD-2022-533316 (Patient Link).
Age: 76.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Fatigue, SARS-CoV-2 test
Clinical narrative: Second shot i felt i was hit by a bus; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Second shot i felt i was hit by a bus) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031M20A and 038K20A) for COVID-19 vaccination.     The patient had no allergies. Patient did not tested positive for Covid-19 and did not received any other vaccine within 1 month prior to Moderna's.  The patient's past medical history included Stent placement (Patient has 3 Heart Stents prior vaccination). Concurrent medical conditions included Emphysema pulmonary (Lung Emphysema prior vaccination) and Blood cholesterol abnormal. Concomitant products included ATORVASTATIN for Blood cholesterol abnormal, THEOPHYLLINE for Emphysema, METOPROLOL, DILTIAZEM, TIOTROPIUM BROMIDE MONOHYDRATE (SPIRIVA) and FLUTICASONE PROPIONATE, SALMETEROL XINAFOATE (ADVAIR) for an unknown indication.   On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-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 FEELING ABNORMAL (Second shot i felt i was hit by a bus). At the time of the report, FEELING ABNORMAL (Second shot i felt i was hit by a bus) outcome was unknown.     The patient did not register any change on her illness status post vaccination. Patients confirm that did not seek for medical care post vaccination. She did not experience a similar event on the past.  No treatment medications were reported by the reporter.   This case was linked to MOD-2022-533304, MOD-2022-533315 (Patient Link).
Age: 76.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Feeling abnormal
Clinical narrative: Second shot i felt i was hit by a bus; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Second shot i felt i was hit by a bus) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031M20A and 038K20A) for COVID-19 vaccination.     The patient had no allergies. Patient did not tested positive for Covid-19 and did not received any other vaccine within 1 month prior to Moderna's.  The patient's past medical history included Stent placement (Patient has 3 Heart Stents prior vaccination). Concurrent medical conditions included Emphysema pulmonary (Lung Emphysema prior vaccination) and Blood cholesterol abnormal. Concomitant products included ATORVASTATIN for Blood cholesterol abnormal, THEOPHYLLINE for Emphysema, METOPROLOL, DILTIAZEM, TIOTROPIUM BROMIDE MONOHYDRATE (SPIRIVA) and FLUTICASONE PROPIONATE, SALMETEROL XINAFOATE (ADVAIR) for an unknown indication.   On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-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 FEELING ABNORMAL (Second shot i felt i was hit by a bus). At the time of the report, FEELING ABNORMAL (Second shot i felt i was hit by a bus) outcome was unknown.     The patient did not register any change on her illness status post vaccination. Patients confirm that did not seek for medical care post vaccination. She did not experience a similar event on the past.  No treatment medications were reported by the reporter.   This case was linked to MOD-2022-533304, MOD-2022-533315 (Patient Link).
Age: 76.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Nausea
Clinical narrative: Second shot i felt i was hit by a bus; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Second shot i felt i was hit by a bus) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031M20A and 038K20A) for COVID-19 vaccination.     The patient had no allergies. Patient did not tested positive for Covid-19 and did not received any other vaccine within 1 month prior to Moderna's.  The patient's past medical history included Stent placement (Patient has 3 Heart Stents prior vaccination). Concurrent medical conditions included Emphysema pulmonary (Lung Emphysema prior vaccination) and Blood cholesterol abnormal. Concomitant products included ATORVASTATIN for Blood cholesterol abnormal, THEOPHYLLINE for Emphysema, METOPROLOL, DILTIAZEM, TIOTROPIUM BROMIDE MONOHYDRATE (SPIRIVA) and FLUTICASONE PROPIONATE, SALMETEROL XINAFOATE (ADVAIR) for an unknown indication.   On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-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 FEELING ABNORMAL (Second shot i felt i was hit by a bus). At the time of the report, FEELING ABNORMAL (Second shot i felt i was hit by a bus) outcome was unknown.     The patient did not register any change on her illness status post vaccination. Patients confirm that did not seek for medical care post vaccination. She did not experience a similar event on the past.  No treatment medications were reported by the reporter.   This case was linked to MOD-2022-533304, MOD-2022-533315 (Patient Link).
Age: 76.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Fatigue, SARS-CoV-2 test
Clinical narrative: Third shot make me nausea; This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (Third shot make me nausea) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 052E21A, 038K20A and 031M20A) for COVID-19 vaccination.     The patient did not have any allergies, did not tested positive for COVID-19 and did not received any other vaccine within 1 month prior to Moderna's.  The patient's past medical history included Stent placement (3 Heart Stents). Concurrent medical conditions included Emphysema (Lung Emphysema, prior vaccination), Cholesterosis and Lung disorder NOS. Concomitant products included ATORVASTATIN for Cholesterosis, THEOPHYLLINE for Lung disorder NOS, METOPROLOL, DILTIAZEM, TIOTROPIUM BROMIDE MONOHYDRATE (SPIRIVA) and FLUTICASONE PROPIONATE, SALMETEROL XINAFOATE (ADVAIR) for an unknown indication.   On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced NAUSEA (Third shot make me nausea). At the time of the report, NAUSEA (Third shot make me nausea) outcome was unknown.            Patient stated that she did not register any change on her illness status post vaccination, did not seek for medical care post vaccination and did not experienced a similar event in the past.  No treatment was taken by the patient.   This case was linked to MOD-2022-533310, MOD-2022-533316, MOD-2022-533304 (Patient Link).
Age: 76.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Feeling abnormal
Clinical narrative: Third shot make me nausea; This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (Third shot make me nausea) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 052E21A, 038K20A and 031M20A) for COVID-19 vaccination.     The patient did not have any allergies, did not tested positive for COVID-19 and did not received any other vaccine within 1 month prior to Moderna's.  The patient's past medical history included Stent placement (3 Heart Stents). Concurrent medical conditions included Emphysema (Lung Emphysema, prior vaccination), Cholesterosis and Lung disorder NOS. Concomitant products included ATORVASTATIN for Cholesterosis, THEOPHYLLINE for Lung disorder NOS, METOPROLOL, DILTIAZEM, TIOTROPIUM BROMIDE MONOHYDRATE (SPIRIVA) and FLUTICASONE PROPIONATE, SALMETEROL XINAFOATE (ADVAIR) for an unknown indication.   On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced NAUSEA (Third shot make me nausea). At the time of the report, NAUSEA (Third shot make me nausea) outcome was unknown.            Patient stated that she did not register any change on her illness status post vaccination, did not seek for medical care post vaccination and did not experienced a similar event in the past.  No treatment was taken by the patient.   This case was linked to MOD-2022-533310, MOD-2022-533316, MOD-2022-533304 (Patient Link).
Age: 76.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Nausea
Clinical narrative: Third shot make me nausea; This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (Third shot make me nausea) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 052E21A, 038K20A and 031M20A) for COVID-19 vaccination.     The patient did not have any allergies, did not tested positive for COVID-19 and did not received any other vaccine within 1 month prior to Moderna's.  The patient's past medical history included Stent placement (3 Heart Stents). Concurrent medical conditions included Emphysema (Lung Emphysema, prior vaccination), Cholesterosis and Lung disorder NOS. Concomitant products included ATORVASTATIN for Cholesterosis, THEOPHYLLINE for Lung disorder NOS, METOPROLOL, DILTIAZEM, TIOTROPIUM BROMIDE MONOHYDRATE (SPIRIVA) and FLUTICASONE PROPIONATE, SALMETEROL XINAFOATE (ADVAIR) for an unknown indication.   On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced NAUSEA (Third shot make me nausea). At the time of the report, NAUSEA (Third shot make me nausea) outcome was unknown.            Patient stated that she did not register any change on her illness status post vaccination, did not seek for medical care post vaccination and did not experienced a similar event in the past.  No treatment was taken by the patient.   This case was linked to MOD-2022-533310, MOD-2022-533316, MOD-2022-533304 (Patient Link).
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: administered with expired vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered with expired vaccine) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L21B) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Apr-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered with expired vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administered with expired vaccine) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided by the reporter.  Vial was initially stored in the refrigerator on 28-Mar-2022. Vial did not undergo any temperature excursions.  No treatment information was provided by the reporter.
Sex: F
Vaccine: COVID19
Symptoms: Immunisation reaction
Clinical narrative: Had my own blood washed and put it back in; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Had my own blood washed and put it back in) in a female patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Had my own blood washed and put it back in). At the time of the report, VACCINATION COMPLICATION (Had my own blood washed and put it back in) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       No concomitant medications were reported. No treatment information was provided.
Sex: F
Vaccine: COVID19
Symptoms: Immunisation reaction, Rash, Urticaria
Clinical narrative: a furious reaction that does not itch at all; big hives; two large rashes repeatedly; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (a furious reaction that does not itch at all), URTICARIA (big hives) and RASH (two large rashes repeatedly) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Previously administered products included for Flu: Flu shot; for Shingles: Shingles vaccine (also experienced big hives with Shingles vaccine); for Product used for unknown indication: PENICILLIN NOS (also experienced big hives) and Cipro (also experienced big hives). Past adverse reactions to the above products included No adverse event with Flu shot; and Rash with Cipro, PENICILLIN NOS and Shingles vaccine. Concurrent medical conditions included Penicillin allergy.   On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and 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 VACCINATION COMPLICATION (a furious reaction that does not itch at all), URTICARIA (big hives) and RASH (two large rashes repeatedly). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Rash, at an unspecified dose and frequency. At the time of the report, VACCINATION COMPLICATION (a furious reaction that does not itch at all) and URTICARIA (big hives) outcome was unknown and RASH (two large rashes repeatedly) had resolved.            No concomitant medications were reported.  It was reported that 2 days after receiving the booster dose, the patient started to experience the adverse events.  The patient believed that the patient had a problem with the binder.  The rashes went away on taking Benadryl and the patient had been treating them with Benadryl every time whenever the rash appeared.   This case was linked to MOD-2022-533441, MOD-2022-533436 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Erythema
Clinical narrative: She experienced a slight redness on her arm; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (She experienced a slight redness on her arm) in a female patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: FLU, Penicillin and Cipro. Past adverse reactions to the above products included Adverse event with Cipro and Penicillin; and No adverse event with FLU. Concurrent medical conditions included Penicillin allergy.    On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced ERYTHEMA (She experienced a slight redness on her arm). At the time of the report, ERYTHEMA (She experienced a slight redness on her arm) outcome was unknown.            Patient mentioned that it was not the first time she experienced as she had adverse event with shingles, the cipro and penicillin but not with the flu shot. Patient believed she had a problem with the binder.  No concomitant medications were reported.  No treatment  medications were reported.   This case was linked to MOD-2022-533441, MOD-2022-533363 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue
Clinical narrative: Very woozy; Tired; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Very woozy) and FATIGUE (Tired) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DIZZINESS (Very woozy) and FATIGUE (Tired). At the time of the report, DIZZINESS (Very woozy) and FATIGUE (Tired) outcome was unknown.     Concomitant product information was not provided. Treatment information was not provided.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: administration past expiry date, 6 days of the expiration date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administration past expiry date, 6 days of the expiration date) in a 43-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 059H21A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (administration past expiry date, 6 days of the expiration date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administration past expiry date, 6 days of the expiration date) outcome was unknown.        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.  Date of administration of vaccine was reported as 04-Apr-2022 and 05-Apr-2022. No treatment information was provided.  The vial was initially stored in the refrigerator: It was stored in the freezer, thawed on the day of administration. The vial did not undergo any temperature excursions.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Renal failure
Clinical narrative: Kidney failure; This spontaneous case was reported by a consumer and describes the occurrence of RENAL FAILURE (Kidney failure) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001C21A, 003B21A and 031H21A) for COVID-19 vaccination.     No Medical History information was reported.   On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced RENAL FAILURE (Kidney failure) (seriousness criteria hospitalization and medically significant). The patient was hospitalized on sometime in 2021 due to RENAL FAILURE. At the time of the report, RENAL FAILURE (Kidney failure) outcome was unknown.            No concomitant medications were provided. The patient never had problem  with kidneys before. No treatment medications were reported. Company comment-This spontaneous case concerns a 48-year-old, female patient with no medical history reported, who experienced the unexpected, serious (hospitalization/medically significant) AESI of Renal failure at an unknown interval after second dose of mRNA-1273 vaccine. It was reported that patient was hospitalized for kidney failure after second dose of Moderna. She apparently did not have renal issues before the vaccination. No further details on clinical course, lab test results and treatment given were reported. Patient had received 1st dose of mRNA-1273 vaccine 28 days prior to 2nd dose.  Outcome of the event was Unknown. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   This case was linked to MOD-2022-533518 (Patient Link).; Sender's Comments: This spontaneous case concerns a 48-year-old, female patient with no medical history reported, who experienced the unexpected, serious (hospitalization/medically significant) AESI of Renal failure at an unknown interval after second dose of mRNA-1273 vaccine. It was reported that patient was hospitalized for kidney failure after second dose of Moderna. She apparently did not have renal issues before the vaccination. No further details on clinical course, lab test results and treatment given were reported. Patient had received 1st dose of mRNA-1273 vaccine 28 days prior to 2nd dose.  Outcome of the event was Unknown. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: dose was administered after published expiration date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (dose was administered after published expiration date) in a male patient of an unknown age who received mRNA-1273 (Spikevax) (batch no. 017F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Apr-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 04-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (dose was administered after published expiration date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (dose was administered after published expiration date) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication of the patient was not reported.  Limited patient identifier was provided by the reporter. As per the reporter, it was unknown when the vial was initially stored in the refrigerator and the vial did not undergo any temperature excursion.  No treatment information was provided by the reporter.   Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: dose administered after published expiration date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (dose administered after published expiration date) in a female patient of an unknown age who received mRNA-1273 (Spikevax) (batch no. 017F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Apr-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 04-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (dose administered after published expiration date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (dose administered after published expiration date) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported. It was reported that vial did not undergo any temperature excursion.   This case was linked to MOD-2022-533493 (Patient Link).   Reporter did not allow further contact
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: administration past expiry date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administration past expiry date) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 059H21A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (administration past expiry date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administration past expiry date) outcome was unknown.        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. No treatment information was provided. The vial was initially stored in the refrigerator: It was stored in the freezer, thawed on the day of administration. The vial did not undergo any temperature excursions.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Administration of vaccine past published expiry; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administration of vaccine past published expiry) in a 58-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 059H21A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administration of vaccine past published expiry). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administration of vaccine past published expiry) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications was not provided by the reporter.  The HCP stated that 19 patients were administered on 29Mar2022, 30Mar2022, 31Mar2022, 01Apr2022 and 04Apr2022.   On 01 Apr 2022, the vial was initially stored in the refrigerator and thawed on the day of use. The administration was spread out throughout the end of March to the beginning of April.  The vial did not undergo any temperature excursions.  Treatment information was not provided.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: More than 35 days gap between 1st and 2nd dose; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (More than 35 days gap between 1st and 2nd dose) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 047a21a and 031l20a) for COVID-19 vaccination.     Concurrent medical conditions included Allergy to antibiotic (vancomycin). Concomitant products included ATORVASTATIN CALCIUM (LIPITOR), ASPIRIN [ACETYLSALICYLIC ACID], CARVEDILOL (COREG), CELECOXIB (CELEXA [CELECOXIB]), CLOPIDOGREL BISULFATE (PLAVIX), MIRTAZAPINE (REMERON), LOSARTAN POTASSIUM (COZAAR), BRIMONIDINE TARTRATE, TIMOLOL MALEATE (COMBIGAN), NETARSUDIL MESILATE (RHOPRESSA), LATANOPROST, VITAMINS NOS, CALCIUM, FISH OIL, IRON, MULTIVITAMINS [VITAMINS NOS], VITAMIN C [ASCORBIC ACID], ZINC, VITAMIN B12 [VITAMIN B12 NOS] and COLECALCIFEROL (VITAMIN D3) for an unknown indication.   On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 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,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (More than 35 days gap between 1st and 2nd dose). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (More than 35 days gap between 1st and 2nd dose) outcome was unknown.            The patient had not tested positive or diagnosed with COVID-19. Patient was not given other vaccines within 1 month prior to Moderna COVID-19 vaccine.  No treatment information was reported.   This case was linked to MOD-2022-533262 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: Vertigo
Clinical narrative: vertigo; This spontaneous case was reported by a consumer and describes the occurrence of VERTIGO (vertigo) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Apr-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Apr-2022, the patient experienced VERTIGO (vertigo). At the time of the report, VERTIGO (vertigo) outcome was unknown.            No concomitant medications were provided by the reporter. No treatment information was provided by the reporter.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: had a sore arm for 5 days; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (had a sore arm for 5 days) in a female patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (had a sore arm for 5 days). At the time of the report, PAIN IN EXTREMITY (had a sore arm for 5 days) had resolved.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       No concomitant medications were reported  No treatment medications were reported
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Product administered to patient of inappropriate age, Somnolence
Clinical narrative: Sleepy; Grandchildren who are below 18 years of age received moderna vaccine; Tired; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (Sleepy), PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Grandchildren who are below 18 years of age received moderna vaccine) and FATIGUE (Tired) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced SOMNOLENCE (Sleepy), PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Grandchildren who are below 18 years of age received moderna vaccine) and FATIGUE (Tired). At the time of the report, SOMNOLENCE (Sleepy), PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Grandchildren who are below 18 years of age received moderna vaccine) and FATIGUE (Tired) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       Concomitant mediations were not reported.  Treatment information was not reported.  Grand children are  below 18 years of age.   This case was linked to MOD-2022-533771, MOD-2022-533772 (Patient Link).
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: received an expired vaccination; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (received an expired vaccination) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Sep-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (received an expired vaccination). At the time of the report, EXPIRED PRODUCT ADMINISTERED (received an expired vaccination) outcome was unknown.  For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication information was not provided by the reporter.  Vial was initially stored in the refrigerator on 31 Aug 2021 and it was reported that the vial did not undergo ay temperature excursion.  Treatment medication was not provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 06-Apr-2022: Patient initials, date of birth, suspect start date and expiration date of vaccine were added.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Product administered to patient of inappropriate age, Somnolence
Clinical narrative: Sleepy; Tired; Grandchildren who are below 18 years of age; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (Sleepy), FATIGUE (Tired) and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Grandchildren who are below 18 years of age) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced SOMNOLENCE (Sleepy), FATIGUE (Tired) and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Grandchildren who are below 18 years of age). At the time of the report, SOMNOLENCE (Sleepy), FATIGUE (Tired) and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Grandchildren who are below 18 years of age) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       It mentioned that this occurred with the reporter's grandchildren who are below 18 years of age. No concomitant medications were reported. No treatment medications were reported.   This case was linked to MOD-2022-533772, MOD-2022-533725 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Product administered to patient of inappropriate age, Somnolence
Clinical narrative: sleepy; tired; grandchildren who are below 18 years of age; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (sleepy), FATIGUE (tired) and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (grandchildren who are below 18 years of age) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced SOMNOLENCE (sleepy), FATIGUE (tired) and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (grandchildren who are below 18 years of age). At the time of the report, SOMNOLENCE (sleepy), FATIGUE (tired) and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (grandchildren who are below 18 years of age) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       Reporter mentioned that 3 of her grandchildren are below 18 years of age. Concomitant medications was not provided by the reporter. Treatment information was not provided.   Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Antibody test, Illness
Clinical narrative: extremely ill, between her two doses of the Moderna COVID-19 vaccines; This spontaneous case was reported by a patient and describes the occurrence of ILLNESS (extremely ill, between her two doses of the Moderna COVID-19 vaccines) in an adult female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     It was unknown if patient had any allergies and ever had COVID positive test or diagnosis.  Concurrent medical conditions included Immune disorder (NOS) (history of primary and secondary immune deficiency. She was born with it but the condition wasn't diagnosed until 14 years ago.). Concomitant products included ESOMEPRAZOLE MAGNESIUM TRIHYDRATE (NEXIUM [ESOMEPRAZOLE MAGNESIUM TRIHYDRATE]), GABAPENTIN, NORTRIPTYLINE, POTASSIUM, CYANOCOBALAMIN (B12 [CYANOCOBALAMIN]), MAGNESIUM, MULTIVITAMINS [VITAMINS NOS] and ELDERBERRY [SAMBUCUS NIGRA] for an unknown indication.    On an unknown date, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) .5 milliliter. On an unknown date, the patient experienced ILLNESS (extremely ill, between her two doses of the Moderna COVID-19 vaccines). At the time of the report, ILLNESS (extremely ill, between her two doses of the Moderna COVID-19 vaccines) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Antibody test: positive (Positive) Positive.     mRNA-1273 (Spikevax) (Unknown) dosing remained unchanged.       It was reported patient receives IVIg treatments for her medical condition every 3 weeks.   The patient stated that 4 doctors told her to not receive any COVID-19 vaccines due to the fact that she receives IVIg treatments for her condition. The patient went ahead and received  Moderna COVID-19 vaccine. She said that in between her two doses of the Moderna COVID-19 vaccines, she stopped her IVIg treatment which made her extremely ill. Since then, she has resumed her treatments again in fear of getting sick.   This case was linked to MOD-2022-533773 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Feeling cold
Clinical narrative: Freezing at night/freezing while sleeping; This spontaneous case was reported by a consumer and describes the occurrence of FEELING COLD (Freezing at night/freezing while sleeping) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002MJ1A, 051F21A, 030A21A and 013M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Apr-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced FEELING COLD (Freezing at night/freezing while sleeping). On 06-Apr-2022, FEELING COLD (Freezing at night/freezing while sleeping) had resolved.            No concomitant medication information was provided.  Patient experienced events after second booster dose. the after vaccination patient experienced event. Patient felt cold no matter how many blanket patient put on body. Patient stated that had 3 blankets on patient. Next morning on 06-Apr-2022 patient woke up and was no longer freezing.  No treatment medication information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 06-Apr-2022: Follow-up received contains start and stop date of the e vent, outcome of the event and narrative updated.
Age: 70.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Accidental overdose
Clinical narrative: Should have been a half dose because the patient is not immunocompromised/full dose booster; This spontaneous case was reported by a consumer and describes the occurrence of ACCIDENTAL OVERDOSE (Should have been a half dose because the patient is not immunocompromised/full dose booster) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     It was reported that patient has never been diagnosed/tested positive for Covid-19. The patient did not receive other vaccines within 1 month prior to Moderna COVID-19 vaccine.  The patient's past medical history included Tuberculosis (when he was 3 to 4 years of age.). Concurrent medical conditions included Seasonal allergy.   On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 15-Aug-2021, the patient experienced ACCIDENTAL OVERDOSE (Should have been a half dose because the patient is not immunocompromised/full dose booster). At the time of the report, ACCIDENTAL OVERDOSE (Should have been a half dose because the patient is not immunocompromised/full dose booster) outcome was unknown.            The patient was on unknown concomitant for cholesterol. No treatment medication were provided. The patient was wondering if he should refrain from getting the 2nd booster dose and also asked whether second booster shot affect those patients who received full booster dose.   This case was linked to MOD-2022-533792 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 06-Apr-2022: Follow up contains no new Information.
Age: 70.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Fatigue
Clinical narrative: Should have been a half dose because the patient is not immunocompromised/full dose booster; This spontaneous case was reported by a consumer and describes the occurrence of ACCIDENTAL OVERDOSE (Should have been a half dose because the patient is not immunocompromised/full dose booster) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     It was reported that patient has never been diagnosed/tested positive for Covid-19. The patient did not receive other vaccines within 1 month prior to Moderna COVID-19 vaccine.  The patient's past medical history included Tuberculosis (when he was 3 to 4 years of age.). Concurrent medical conditions included Seasonal allergy.   On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 15-Aug-2021, the patient experienced ACCIDENTAL OVERDOSE (Should have been a half dose because the patient is not immunocompromised/full dose booster). At the time of the report, ACCIDENTAL OVERDOSE (Should have been a half dose because the patient is not immunocompromised/full dose booster) outcome was unknown.            The patient was on unknown concomitant for cholesterol. No treatment medication were provided. The patient was wondering if he should refrain from getting the 2nd booster dose and also asked whether second booster shot affect those patients who received full booster dose.   This case was linked to MOD-2022-533792 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 06-Apr-2022: Follow up contains no new Information.
Age: 19.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: patient have been administered from an expired dose; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patient have been administered from an expired dose) in a 19-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 059H21A) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (patient have been administered from an expired dose). At the time of the report, EXPIRED PRODUCT ADMINISTERED (patient have been administered from an expired dose) outcome was unknown.      For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant product reported by reporter.  Vial did not undergo any temperature excursion issue.  The vials initially stored in the refrigerator on 08 Mar 2022 was administered 1 dose on 29 Mar 2022 and 4 doses on 31 Mar 2022.  The vials initially stored in the refrigerator on 30 Mar 2022 was administered 2 doses on 05 Apr 2022 and no other side effects were reported.  No treatment medication reported by reporter.   Most recent FOLLOW-UP information incorporated above includes: On 06-Apr-2022: Follow-up received: Vaccine administration dates updated in narrative.