chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Myalgia, Piloerection, Tremor, Vomiting
Clinical narrative: bleeding; stomach pain; felt light-headed; legs start shaking; her legs were shaking so much she couldn't even feel them; goosebumps; headaches; body aches; vomiting; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of HAEMORRHAGE (bleeding) in a 26-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026L20A, 004M20A and 053C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included VENLAFAXINE HYDROCHLORIDE (EFFEXOR SR), PROPRANOLOL HYDROCHLORIDE (PROPRANOLOL [PROPRANOLOL HYDROCHLORIDE]) and HYDROXYZINE HYDROCHLORIDE (HYDROXYZINE [HYDROXYZINE HYDROCHLORIDE]) for an unknown indication.   On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Nov-2021, the patient experienced HAEMORRHAGE (bleeding) (seriousness criterion medically significant), ABDOMINAL PAIN UPPER (stomach pain), DIZZINESS (felt light-headed), TREMOR (legs start shaking), PILOERECTION (goosebumps), HEADACHE (headaches), MYALGIA (body aches), VOMITING (vomiting) and FATIGUE (fatigue). 05-Nov-2021, the patient experienced HYPOAESTHESIA (her legs were shaking so much she couldn't even feel them). At the time of the report, HAEMORRHAGE (bleeding), HEADACHE (headaches) and MYALGIA (body aches) had not resolved and ABDOMINAL PAIN UPPER (stomach pain), DIZZINESS (felt light-headed), TREMOR (legs start shaking), HYPOAESTHESIA (her legs were shaking so much she couldn't even feel them), PILOERECTION (goosebumps), VOMITING (vomiting) and FATIGUE (fatigue) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment medications was not provided.  Company comment- This case concerns a 26-year-old female patient with no relevant medical history, who experienced the unexpected event of Hemorrhage. The event occurred the same day after receiving the third dose of mRNA-1273 (Moderna COVID-19 Vaccine). The rechallenge was not applicable since only information about the third dose was disclosed. The benefit-risk relationship of mRNA-1273 (Moderna COVID-19 Vaccine) is not affected by this report.   This case was linked to MOD-2021-378037, MOD-2021-378042 (Patient Link).; Sender's Comments: This case concerns a 26-year-old female patient with no relevant medical history, who experienced the unexpected event of Hemorrhage. The event occurred the same day after receiving the third dose of mRNA-1273 (Moderna COVID-19 Vaccine). The rechallenge was not applicable since only information about the third dose was disclosed. The benefit-risk relationship of mRNA-1273 (Moderna COVID-19 Vaccine) is not affected by this report.
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: This spontaneous case reported by a healthcare professional, describes the occurrence of administered expired product (doses administered past the published expiry date) in a female patient, of an unknown age, who received mRNA-1273 (Moderna COVID-19 vaccine, batch/lot# 047B21A) for COVID-19 immunization. No medical history reported. On Oct 12, 2021, patient received the second dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Oct 12, 2021, patient experienced administered expired product (doses administered past the published expiry date). On Oct 12, 2021, administered expired product (doses administered past the published expiry date) resolved. The reporter did not provide any causality assessments, concomitant medication or treatment information. Reportedly, the vaccine was removed from  freezer on Oct 12, 2021.
Sex: M
Vaccine: COVID19
Symptoms: Product administration error
Clinical narrative: 35 patints exposed to vaccine from which vial may have been punctured more than 20 times; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT ADMINISTRATION ERROR (35 patints exposed to vaccine from which vial may have been punctured more than 20 times) in an elderly male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Nov-2021, the patient experienced PRODUCT ADMINISTRATION ERROR (35 patints exposed to vaccine from which vial may have been punctured more than 20 times). On 04-Nov-2021, PRODUCT ADMINISTRATION ERROR (35 patints exposed to vaccine from which vial may have been punctured more than 20 times) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Date of birth year was provided as 1949 No concomitant medications were provided. No treatment information was provided by the reporter.
Sex: M
Vaccine: COVID19
Symptoms: Product administration error
Clinical narrative: 35 patints exposed to vaccine from which vial may have been punctured more than 20 times; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT ADMINISTRATION ERROR (35 patints exposed to vaccine from which vial may have been punctured more than 20 times) in an adult male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Nov-2021, the patient experienced PRODUCT ADMINISTRATION ERROR (35 patints exposed to vaccine from which vial may have been punctured more than 20 times). On 04-Nov-2021, PRODUCT ADMINISTRATION ERROR (35 patints exposed to vaccine from which vial may have been punctured more than 20 times) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. Treatment information was not provided.  A vial at was punctured 30 times at the clinic from which the vaccine had been given to the patient.
Sex: F
Vaccine: COVID19
Symptoms: Product administration error
Clinical narrative: 35 patints exposed to vaccine from which vial may have been punctured more than 20 times; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT ADMINISTRATION ERROR (35 patints exposed to vaccine from which vial may have been punctured more than 20 times) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Nov-2021, the patient experienced PRODUCT ADMINISTRATION ERROR (35 patints exposed to vaccine from which vial may have been punctured more than 20 times). On 04-Nov-2021, PRODUCT ADMINISTRATION ERROR (35 patints exposed to vaccine from which vial may have been punctured more than 20 times) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient's year of birth is 1961. Concomitant medication was not provided. Treatment information was not provided.
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: doses administered past the published expiry date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (doses administered past the published expiry date) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Oct-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (doses administered past the published expiry date). On 15-Oct-2021, EXPIRED PRODUCT ADMINISTERED (doses administered past the published expiry date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Product removed from freezer 8 AM,15-OCT-2021 No Treatment information was provided. No concomitant medication was provided
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Product administration error
Clinical narrative: 35 patients exposed to vaccine from which vial may have been punctured more than 20 times; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT ADMINISTRATION ERROR (35 patients exposed to vaccine from which vial may have been punctured more than 20 times) in a 47-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 04-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Nov-2021, the patient experienced PRODUCT ADMINISTRATION ERROR (35 patients exposed to vaccine from which vial may have been punctured more than 20 times). On 04-Nov-2021, PRODUCT ADMINISTRATION ERROR (35 patients exposed to vaccine from which vial may have been punctured more than 20 times) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Concomitant products were not provided. Treatment medication were not reported.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Accidental underdose, Product administration error
Clinical narrative: 35 patints exposed to vaccine from which vial may have been punctured more than 20 times; Accidental underdose; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT ADMINISTRATION ERROR (35 patints exposed to vaccine from which vial may have been punctured more than 20 times) and ACCIDENTAL UNDERDOSE (Accidental underdose) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Nov-2021, the patient experienced PRODUCT ADMINISTRATION ERROR (35 patints exposed to vaccine from which vial may have been punctured more than 20 times) and ACCIDENTAL UNDERDOSE (Accidental underdose). On 04-Nov-2021, PRODUCT ADMINISTRATION ERROR (35 patints exposed to vaccine from which vial may have been punctured more than 20 times) and ACCIDENTAL UNDERDOSE (Accidental underdose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication provided. A vial was punctured 30 times at the clinic. 10 patients who were administered the vaccine were affected. No treatment medication provided.
Sex: F
Vaccine: COVID19
Symptoms: Product administration error
Clinical narrative: 35 patints exposed to vaccine from which vial may have been punctured more than 20 times; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT ADMINISTRATION ERROR (35 patints exposed to vaccine from which vial may have been punctured more than 20 times) 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 04-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Nov-2021, the patient experienced PRODUCT ADMINISTRATION ERROR (35 patints exposed to vaccine from which vial may have been punctured more than 20 times). On 04-Nov-2021, PRODUCT ADMINISTRATION ERROR (35 patints exposed to vaccine from which vial may have been punctured more than 20 times) 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.
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Doses administered past the published expiry date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Doses administered past the published expiry date) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Doses administered past the published expiry date). On 18-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Doses administered past the published expiry date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not provided. Treatment information was not provided.  On 18-Oct-2021, the vial was removed from freezer at 8 AM.
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: doses administered past the published expiry date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (doses administered past the published expiry date) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (doses administered past the published expiry date). On 18-Oct-2021, EXPIRED PRODUCT ADMINISTERED (doses administered 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 medication were reported.  The vaccine was removed from freezer on 18-Oct-2021 at 8 am. No treatment information was provided by the reporter. This case concerns a female patient, unknown age, with no known medical history, who experienced the non-serious event of expired product administered. The event occurred on the same day after first dose of Moderna vaccine. The benefit-risk relationship of Moderna vaccine is not affected by this report.; Sender's Comments: This case concerns a female patient, unknown age, with no known medical history, who experienced the non-serious event of expired product administered. The event occurred  on the same day after first dose of Moderna vaccine. The benefit-risk relationship of Moderna vaccine is not affected by this report.
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Doses administered past the published expiry date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Doses administered past the published expiry date) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Doses administered past the published expiry date). On 18-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Doses administered 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 was provided by the reporter. No treatment medications was provided by the reporter.  Company comment : This is a case of Expired Product Administered concerning a male patient of unknown age, with no relevant medical history, who experienced no other adverse events. The event occurred the same day after the first dose of mRNA-1273 (Moderna COVID-19 Vaccine). The benefit-risk relationship of mRNA-1273 (Moderna COVID-19 Vaccine) is not affected by this report.; Sender's Comments: This is a case of Expired Product Administered concerning a male patient of unknown age, with no relevant medical history, who experienced no other adverse events. The event occurred the same day after the first dose of mRNA-1273 (Moderna COVID-19 Vaccine). The benefit-risk relationship of mRNA-1273 (Moderna COVID-19 Vaccine) is not affected by this report.
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: doses administered past the published expiry date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (doses administered past the published expiry date) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (doses administered past the published expiry date). On 18-Oct-2021, EXPIRED PRODUCT ADMINISTERED (doses administered 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 were reported. No Treatment information was reported. This case concerns a female patient, unknown age, with no known medical history, who experienced the non-serious event of expired product administered. The event occurred  on the same day after first dose of Moderna vaccine. The rechallenge is not applicable due to the nature of the event. The benefit-risk relationship of Moderna vaccine is not affected by this report   This case was linked to MOD-2021-364617 (Patient Link).; Sender's Comments: This case concerns a female patient, unknown age, with no known medical history, who experienced the non-serious event of expired product administered. The event occurred  on the same day after first dose of Moderna vaccine. The rechallenge is not applicable due to the nature of the event. The benefit-risk relationship of Moderna vaccine is not affected by this report.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Feeling abnormal, Influenza like illness, Myalgia
Clinical narrative: not feeling up to par; with flu like symptoms that are not nearly as severe as after the 2nd shot; a little tired; feeling a little bit the the usual achy; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (not feeling up to par), INFLUENZA LIKE ILLNESS (with flu like symptoms that are not nearly as severe as after the 2nd shot), MYALGIA (feeling a little bit the the usual achy) and FATIGUE (a little tired) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939904) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Nov-2021, the patient experienced MYALGIA (feeling a little bit the the usual achy). On an unknown date, the patient experienced FEELING ABNORMAL (not feeling up to par), INFLUENZA LIKE ILLNESS (with flu like symptoms that are not nearly as severe as after the 2nd shot) and FATIGUE (a little tired). At the time of the report, FEELING ABNORMAL (not feeling up to par), INFLUENZA LIKE ILLNESS (with flu like symptoms that are not nearly as severe as after the 2nd shot), MYALGIA (feeling a little bit the the usual achy) and FATIGUE (a little tired) outcome was unknown.            Concomitant medication was not provided. Treatment information was not provided.   This case was linked to MOD-2021-089432 (Patient Link).
Age: 88.0
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Headache after the booster; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache after the booster) in an 89-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 051F21A, 010M20A and 010M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Nov-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 HEADACHE (Headache after the booster). At the time of the report, HEADACHE (Headache after the booster) outcome was unknown.            No concomitant medication  were reported. No Treatment information was provided.   This case was linked to MOD-2021-041014 (Patient Link).
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Pain, Pain in extremity, Pyrexia, Underdose
Clinical narrative: Achy; sore arm; low grade fever; On 29Oct2021 they administered 15 Moderna COVID-19 booster half doses to patients; Received booster from expired vial; This spontaneous case was reported by a physician and describes the occurrence of PAIN (Achy), PAIN IN EXTREMITY (sore arm), PYREXIA (low grade fever), UNDERDOSE (On 29Oct2021 they administered 15 Moderna COVID-19 booster half doses to patients) and EXPIRED PRODUCT ADMINISTERED (Received booster from expired vial) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038C21A) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: Influenza (Manufacturer is Sanofi Pasteur.  Lot number: U77383JA route given has intramuscular and anatomical site is left arm.) on 11-Oct-2021. Past adverse reactions to the above products included No adverse event with Influenza. Concurrent medical conditions included Sleep apnea and Impaired fasting glucose.    On 29-Oct-2021 at 12:50 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Oct-2021, the patient experienced UNDERDOSE (On 29Oct2021 they administered 15 Moderna COVID-19 booster half doses to patients) and EXPIRED PRODUCT ADMINISTERED (Received booster from expired vial). On an unknown date, the patient experienced PAIN (Achy), PAIN IN EXTREMITY (sore arm) and PYREXIA (low grade fever). On 29-Oct-2021, UNDERDOSE (On 29Oct2021 they administered 15 Moderna COVID-19 booster half doses to patients) and EXPIRED PRODUCT ADMINISTERED (Received booster from expired vial) had resolved. At the time of the report, PAIN (Achy), PAIN IN EXTREMITY (sore arm) and PYREXIA (low grade fever) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications are provided. No treatment medications are provided.   This case was linked to MOD-2021-370301 (Patient Link).
Age: 23.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, SARS-CoV-2 test, Underdose, Vaccination site pain
Clinical narrative: Arm sore for couple of days; Received booster from expired vial; On 29Oct2021 they administered 15 Moderna COVID-19 booster half doses to patients; This spontaneous case was reported by a physician and describes the occurrence of VACCINATION SITE PAIN (Arm sore for couple of days), EXPIRED PRODUCT ADMINISTERED (Received booster from expired vial) and UNDERDOSE (On 29Oct2021 they administered 15 Moderna COVID-19 booster half doses to patients) in a 23-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038C21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in March 2021. Concurrent medical conditions included Crohn's disease. Concomitant products included ADALIMUMAB (HUMIRA) for Crohn's disease.    On 29-Oct-2021 at 1:00 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 29-Oct-2021 at 1:00 PM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received booster from expired vial) and UNDERDOSE (On 29Oct2021 they administered 15 Moderna COVID-19 booster half doses to patients). On an unknown date, the patient experienced VACCINATION SITE PAIN (Arm sore for couple of days). On 29-Oct-2021 at 1:00 PM, EXPIRED PRODUCT ADMINISTERED (Received booster from expired vial) and UNDERDOSE (On 29Oct2021 they administered 15 Moderna COVID-19 booster half doses to patients) had resolved. At the time of the report, VACCINATION SITE PAIN (Arm sore for couple of days) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In March 2021, SARS-CoV-2 test: positive (Positive) Positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment medications were provided.   This case was linked to MOD-2021-370301 (Patient Link).
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, SARS-CoV-2 test, Underdose
Clinical narrative: Received booster from expired vial; On 29Oct2021 they administered 15 Moderna COVID-19 booster half doses to patients; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received booster from expired vial) and UNDERDOSE (On 29Oct2021 they administered 15 Moderna COVID-19 booster half doses to patients) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038C21A) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes and Cancer.    On 29-Oct-2021 at 1:30 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 29-Oct-2021 at 1:30 PM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received booster from expired vial) and UNDERDOSE (On 29Oct2021 they administered 15 Moderna COVID-19 booster half doses to patients). On 29-Oct-2021 at 1:30 PM, EXPIRED PRODUCT ADMINISTERED (Received booster from expired vial) and UNDERDOSE (On 29Oct2021 they administered 15 Moderna COVID-19 booster half doses to patients) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, SARS-CoV-2 test: positive (Positive) Positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication information was provided. The patient had no allergies to medication, food and other products. The patient had no acute illness at the time of vaccination or up to one month before. It was unknown if the patient took prescriptions, over the counter medications, dietary supplements or herbal remedies at the time of vaccination.  No treatment medication information was provided.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Expired product administered, Myalgia, Underdose
Clinical narrative: Sore arm; Chills; Received booster from expired vial; On 29Oct2021 they administered 15 Moderna COVID-19 booster half doses to patients; This spontaneous case was reported by a physician and describes the occurrence of MYALGIA (Sore arm), CHILLS (Chills), EXPIRED PRODUCT ADMINISTERED (Received booster from expired vial) and UNDERDOSE (On 29Oct2021 they administered 15 Moderna COVID-19 booster half doses to patients) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038C21A) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: High dose flu (Manufacturer- Sanofi Pasteur Lot number- UJ731AB Route- Intramuscular Body site- Left arm) on 30-Sep-2021. Past adverse reactions to the above products included No adverse event with High dose flu. Concurrent medical conditions included Hypercholesteraemia and Erectile dysfunction. Concomitant products included TADALAFIL (CIALIS) for Erectile dysfunction, SIMVASTATIN for Hyperlipidemia.    On 29-Oct-2021 at 1:50 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received booster from expired vial) and UNDERDOSE (On 29Oct2021 they administered 15 Moderna COVID-19 booster half doses to patients). On an unknown date, the patient experienced MYALGIA (Sore arm) and CHILLS (Chills). On 29-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Received booster from expired vial) and UNDERDOSE (On 29Oct2021 they administered 15 Moderna COVID-19 booster half doses to patients) had resolved. At the time of the report, MYALGIA (Sore arm) and CHILLS (Chills) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Concomitant product use was reported. No treatment information was provided.  It is reported that patient had no allergies and no history of COVID-19.  The patient experienced sore arm and chills. The symptoms went away within 24 hours.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Asthenia, Fatigue, Headache, Insomnia
Clinical narrative: Felt weak/ Felt weak in the legs; Felt sick; Felt cold; Sick to my stomach; Left arm hurt up to the shoulder and down to my elbow; Could hardly sleep; Very bad headache/ Head hurt; Felt like I had a fever; Tiredness; Ached everywhere; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Felt weak/ Felt weak in the legs), ILLNESS (Felt sick), NASOPHARYNGITIS (Felt cold), ABDOMINAL DISCOMFORT (Sick to my stomach) and PAIN IN EXTREMITY (Left arm hurt up to the shoulder and down to my elbow) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017F21A, 030A21A and 025P21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Nov-2021, the patient experienced PAIN (Ached everywhere). On an unknown date, the patient experienced ASTHENIA (Felt weak/ Felt weak in the legs), ILLNESS (Felt sick), NASOPHARYNGITIS (Felt cold), ABDOMINAL DISCOMFORT (Sick to my stomach), PAIN IN EXTREMITY (Left arm hurt up to the shoulder and down to my elbow), INSOMNIA (Could hardly sleep), HEADACHE (Very bad headache/ Head hurt), PYREXIA (Felt like I had a fever) and FATIGUE (Tiredness). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Adverse event, at an unspecified dose and frequency. At the time of the report, ASTHENIA (Felt weak/ Felt weak in the legs) had not resolved, ILLNESS (Felt sick), NASOPHARYNGITIS (Felt cold), ABDOMINAL DISCOMFORT (Sick to my stomach), PAIN IN EXTREMITY (Left arm hurt up to the shoulder and down to my elbow), PAIN (Ached everywhere), HEADACHE (Very bad headache/ Head hurt) and PYREXIA (Felt like I had a fever) was resolving and INSOMNIA (Could hardly sleep) and FATIGUE (Tiredness) outcome was unknown.            Concomitant medication included blood pressure medication.  05-Nov-2021 at night, patient ached everywhere. Patient had a very bad headache, felt weak and sick. Patient also mentioned feeling cold, sick to stomach, like had a fever and head hurt. Patient's left arm hurt up to the shoulder and down the arm to the elbow. Patient could hardly get any sleep. Now, patient feels better but weak in the legs. Patient also feels tiredness which attributes it to not being able to sleep well.   This case was linked to MOD-2021-377971, MOD-2021-377972 (Patient Link).
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Nasopharyngitis, Pain, Pain in extremity, Pyrexia
Clinical narrative: Felt weak/ Felt weak in the legs; Felt sick; Felt cold; Sick to my stomach; Left arm hurt up to the shoulder and down to my elbow; Could hardly sleep; Very bad headache/ Head hurt; Felt like I had a fever; Tiredness; Ached everywhere; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Felt weak/ Felt weak in the legs), ILLNESS (Felt sick), NASOPHARYNGITIS (Felt cold), ABDOMINAL DISCOMFORT (Sick to my stomach) and PAIN IN EXTREMITY (Left arm hurt up to the shoulder and down to my elbow) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017F21A, 030A21A and 025P21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Nov-2021, the patient experienced PAIN (Ached everywhere). On an unknown date, the patient experienced ASTHENIA (Felt weak/ Felt weak in the legs), ILLNESS (Felt sick), NASOPHARYNGITIS (Felt cold), ABDOMINAL DISCOMFORT (Sick to my stomach), PAIN IN EXTREMITY (Left arm hurt up to the shoulder and down to my elbow), INSOMNIA (Could hardly sleep), HEADACHE (Very bad headache/ Head hurt), PYREXIA (Felt like I had a fever) and FATIGUE (Tiredness). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Adverse event, at an unspecified dose and frequency. At the time of the report, ASTHENIA (Felt weak/ Felt weak in the legs) had not resolved, ILLNESS (Felt sick), NASOPHARYNGITIS (Felt cold), ABDOMINAL DISCOMFORT (Sick to my stomach), PAIN IN EXTREMITY (Left arm hurt up to the shoulder and down to my elbow), PAIN (Ached everywhere), HEADACHE (Very bad headache/ Head hurt) and PYREXIA (Felt like I had a fever) was resolving and INSOMNIA (Could hardly sleep) and FATIGUE (Tiredness) outcome was unknown.            Concomitant medication included blood pressure medication.  05-Nov-2021 at night, patient ached everywhere. Patient had a very bad headache, felt weak and sick. Patient also mentioned feeling cold, sick to stomach, like had a fever and head hurt. Patient's left arm hurt up to the shoulder and down the arm to the elbow. Patient could hardly get any sleep. Now, patient feels better but weak in the legs. Patient also feels tiredness which attributes it to not being able to sleep well.   This case was linked to MOD-2021-377971, MOD-2021-377972 (Patient Link).
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: felt tiredness; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (felt tiredness) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025P21A and 030A21A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure abnormal.   On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Apr-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 FATIGUE (felt tiredness). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Adverse event, at an unspecified dose and frequency. At the time of the report, FATIGUE (felt tiredness) outcome was unknown.            Concomitant product includes unspecified Blood pressure medication.   This case was linked to MOD-2021-377971, MOD-2021-377968 (Patient Link).
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: 10 patients administered vaccine past the beyond use date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (10 patients administered vaccine past the beyond use date) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939905) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (10 patients administered vaccine past the beyond use date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (10 patients administered vaccine past the beyond use date) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Treatment informations were reported.    This case was linked to MOD-2021-377975 (Patient Link).
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: 10 patients administered vaccine past the beyond use date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (10 patients administered vaccine past the beyond use date) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939905) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (10 patients administered vaccine past the beyond use date). On 05-Nov-2021, EXPIRED PRODUCT ADMINISTERED (10 patients administered vaccine past the beyond use date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant and treatment information was reported by reporter.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of fatigue (after first dose) in a 25-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch/lot# 026L20A) for COVID-19 immunization. No medical history reported. Concomitant products included Effexor (venlafaxine hydrochloride) for depression; propranolol and hydroxyzine for anxiety. On Dec 30, 2020, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On an unknown date, patient had fatigue (after first dose). At the time of the report, fatigue (after first dose) outcome: unknown. The reporter did not provide any causality assessments or treatment information. Concomitant products included unknown drug for birth control. This case linked to MOD-2021-377816, MOD-2021-378042 (patient link).
Sex: F
Vaccine: COVID19
Symptoms: Hypokinesia, Incorrect route of product administration, Vaccination site pain
Clinical narrative: Could not move it; Real sore arm/ Really painful; Needle way high on my shoulder into my acromion joint/ Injection was not given into the muscle; This spontaneous case was reported by a consumer and describes the occurrence of HYPOKINESIA (Could not move it), VACCINATION SITE PAIN (Real sore arm/ Really painful) and INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Needle way high on my shoulder into my acromion joint/ Injection was not given into the muscle) 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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced HYPOKINESIA (Could not move it), VACCINATION SITE PAIN (Real sore arm/ Really painful) and INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Needle way high on my shoulder into my acromion joint/ Injection was not given into the muscle). On 08-Nov-2021, HYPOKINESIA (Could not move it) had resolved. At the time of the report, VACCINATION SITE PAIN (Real sore arm/ Really painful) outcome was unknown and INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Needle way high on my shoulder into my acromion joint/ Injection was not given into the muscle) had resolved.            No concomitant medicines were reported. No treatment medicines were reported.  Patient had real sore arm because the pharmacist at Costco put the needle way high on shoulder into acromion joint. Patient believed that injection was not given into the muscle. Patient could not move it until just current morning. It was really painful.   Most recent FOLLOW-UP information incorporated above includes: On 08-Nov-2021: Follow-up received contains no new information.
Age: 71.0
Sex: U
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Patients that received aModerna vaccine doses after the vaccine  had been refrozen and rethawed; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT STORAGE ERROR (Patients that received aModerna vaccine doses after the vaccine  had been refrozen and rethawed) in a 71-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047C21A) 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) (Intramuscular) .25 milliliter. 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 PRODUCT STORAGE ERROR (Patients that received aModerna vaccine doses after the vaccine  had been refrozen and rethawed). At the time of the report, PRODUCT STORAGE ERROR (Patients that received aModerna vaccine doses after the vaccine  had been refrozen and rethawed) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant drugs were not reported. Treatment medications were not provided.  Company Comment: This is a case of Product storage error for this 71-year-old patient of unknown gender with no relevant medical history, who experienced no adverse event. The medication error occurred on the day of the third dose of Moderna COVID-19 Vaccine. The benefit-risk relationship of Moderna COVID-19 Vaccine is not affected by this report.   This case was linked to MOD-2021-381027, MOD-2021-381128, MOD-2021-381138, MOD-2021-381141, MOD-2021-381142, MOD-2021-381145, MOD-2021-381149, MOD-2021-381155, MOD-2021-381161, MOD-2021-381169 (Patient Link).; Sender's Comments: This is a case of Product storage error for this 71-year-old patient of unknown gender with no relevant medical history, who experienced no adverse event. The medication error occurred on the day of the third dose of Moderna COVID-19 Vaccine. The benefit-risk relationship of Moderna COVID-19 Vaccine is not affected by this report.
Age: 67.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: patient received a re frozen dose of the vaccine; patient received a re frozen dose of the vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patient received a re frozen dose of the vaccine) and PRODUCT STORAGE ERROR (patient received a re frozen dose of the vaccine) in a 67-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047C21A) 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (patient received a re frozen dose of the vaccine) and PRODUCT STORAGE ERROR (patient received a re frozen dose of the vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (patient received a re frozen dose of the vaccine) and PRODUCT STORAGE ERROR (patient received a re frozen dose of the vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.    No treatment information provided.   This case was linked to MOD-2021-381132 (Patient Link).; Sender's Comments: This is a case of Expired product administered  and Product storage error for this 67-year-old patient of unknown gender with no relevant medical history, who experienced no adverse event. The medication error occurred on the day of the third dose of Moderna COVID-19 Vaccine. The benefit-risk relationship of Moderna COVID-19 Vaccine is not affected by this report.
Age: 77.0
Sex: U
Vaccine: COVID19
Symptoms: Product preparation issue
Clinical narrative: This spontaneous case reported by a pharmacist, describes the occurrence of product preparation issue (patient received a re-frozen dose of the vaccine) in a 77-year-old patient, of an unknown gender, who received mRNA-1273 (Moderna COVID-19 vaccine, batch/lot# 047C21A) for COVID-19 immunization. No medical history reported. On an unknown date, patient received the third dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 0.25 milligram. On an unknown date, patient experienced product preparation issue (patient received a re-frozen dose of the vaccine). At the time of the report, product preparation issue (patient received a re-frozen dose of the vaccine) resolved. The reporter did not provide any causality assessments, concomitant medication or treatment information. Sender's comments: This case concerns a 77-year-old patient, unknown gender, with no known medical history, who experienced the event of product preparation issue. The event occurred on unknown date after the third dose of Moderna vaccine, whereupon patient received a re-frozen dose of the vaccine. The benefit-risk relationship of Moderna vaccine not affected by this report.