chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 59.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Patient was given 0.25mL booster dose from a vial that was was out in room temperature past 25 hrs.; Patient was given 0.25mL booster dose from a vial that was was out in room temperature past 25 hrs.; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient was given 0.25mL booster dose from a vial that was was out in room temperature past 25 hrs.) and PRODUCT STORAGE ERROR (Patient was given 0.25mL booster dose from a vial that was was out in room temperature past 25 hrs.) in a 59-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 005M21A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Apr-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 22-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient was given 0.25mL booster dose from a vial that was was out in room temperature past 25 hrs.). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Patient was given 0.25mL booster dose from a vial that was was out in room temperature past 25 hrs.). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient was given 0.25mL booster dose from a vial that was was out in room temperature past 25 hrs.) and PRODUCT STORAGE ERROR (Patient was given 0.25mL booster dose from a vial that was was out in room temperature past 25 hrs.) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.  The Dose administered after exposure to room temperature was more than 24 hours. The Number of doses reported was 1 dose. The vial was initially stored in the refrigerator on 13Apr2022. The vial had not undergone any temperature excursion. Total amount of time the vial was exposed to room temperature range was 25 hours. The patient had administered second booster dose.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received an expired vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received an expired vaccine) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007J21-2a) for COVID-19 vaccination.     The patient had never been tested positive or diagnosed with COVID disease. The patient had no allergies to medications, food and other products. The patient had no medical history related to mentioned adverse events and did not have any acute and chronic illnesses at the time of vaccination. The patient did not receive any other vaccine within 1 month prior to Moderna COVID-19 vaccination.  Concurrent medical conditions included Asthma.    On 20-Apr-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received an expired vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received an expired vaccine) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information was provided. No treatment information was provided.  On 20-Apr-2022, the patient received the first booster dose of the vaccine.
Sex: F
Vaccine: COVID19
Symptoms: Knee arthroplasty
Clinical narrative: Immunocompromised patient recently had a knee replacement; This spontaneous case was reported by a consumer and describes the occurrence of KNEE ARTHROPLASTY (Immunocompromised patient recently had a knee replacement) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised. Concomitant products included ACETYLSALICYLIC ACID (ASPIRINE) for an unknown indication.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced KNEE ARTHROPLASTY (Immunocompromised patient recently had a knee replacement). At the time of the report, KNEE ARTHROPLASTY (Immunocompromised patient recently had a knee replacement) outcome was unknown.            Concomitant products included unspecified Blood thinners for an unknown indication. No treatment information was provided.  Patient stated that she was immunocompromised and wanted to receive the second booster but that she recently had a knee replacement done, she also mentioned that she was taking blood thinners and low dose aspirin. No more information was provided.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received a expired vaccine 16-Apr-2022) in a 21-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007J21-2a) for COVID-19 vaccination. No Medical History information was reported. On 20-Apr-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received a expired vaccine 16-Apr-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received a expired vaccine 16-Apr-2022) outcome was unknown. Not Provided. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medication was provided. No treatment medication was provided. The patient did not had COVID positive test or diagnosis ever.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received a expired vaccine 16Apr2022; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received a expired vaccine 16Apr2022) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007J21-2a) for COVID-19 vaccination.     The patient's past medical history included Liver disorder.    On 20-Apr-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received a expired vaccine 16Apr2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received a expired vaccine 16Apr2022) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.
Sex: U
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: hives; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (hives) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced URTICARIA (hives). At the time of the report, URTICARIA (hives) outcome was unknown.            No concomitant medication information was provided. No treatment medication information was provided.   This case was linked to MOD-2022-549388 (Patient Link).   Reporter did not allow further contact
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: receiving expired doses; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (receiving expired doses) in a 60-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 07-Apr-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (receiving expired doses). At the time of the report, EXPIRED PRODUCT ADMINISTERED (receiving expired doses) outcome was unknown. Not Provided. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information provided. It was reported that there was incident because of miscommunication as a coworker told that there were some lot number whose expirations dates have been extended. Patient received expired dose from the lot number:059H21A. No treatment medication information provided. Most recent FOLLOW-UP information incorporated above includes: On 25-Apr-2022: patient identifiers added.
Age: 23.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: 26 Patient received a expired vaccine 16Apr2022; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (26 Patient received a expired vaccine 16Apr2022) in a 23-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007J21-2a) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Apr-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (26 Patient received a expired vaccine 16Apr2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (26 Patient received a expired vaccine 16Apr2022) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications details were not reported by the reporter. Patient received first booster dose. Treatment details was not reported by the reporter.   This case was linked to MOD-2022-548975 (Patient Link).
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: 26 Patient received a expired vaccine 16Apr2022; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (26 Patient received a expired vaccine 16Apr2022) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007J21-2a) for COVID-19 vaccination.     No Other vaccines given within 1 month prior to Moderna COVID-19 vaccine.  Patient never had COVID positive test or diagnosis.  No Allergies (medications, food and other products) were reported.  Concurrent medical conditions included Diabetes.    On 22-Apr-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (26 Patient received a expired vaccine 16Apr2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (26 Patient received a expired vaccine 16Apr2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications information was reported.  Patient received first booster dose on 22 Apr 2022.   This case was linked to MOD-2022-548975 (Patient Link).
Age: 26.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received a expired vaccine 16Apr2022; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received a expired vaccine 16Apr2022) in a 26-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007J21-2a) for COVID-19 vaccination.     It was reported that patient did not have any allergies and never had COVID positive test or diagnosis. Patient did not had history relating to mentioned AE . No acute and chronic illnesses at the time of vaccination.     On 22-Apr-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received a expired vaccine 16Apr2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received a expired vaccine 16Apr2022) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant drug information was provided.  Patient received first booster dose of vaccine.  No treatment drug information was reported.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received a expired vaccine 16Apr2022; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received a expired vaccine 16Apr2022) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007J21-2a) for COVID-19 vaccination.     History relating to mentioned adverse event and  both Acute and Chronic illnesses at the time of  vaccination was reported as no. Other vaccines given within 1 month prior to  Moderna COVID-19 vaccine was reported as no.  Concurrent medical conditions included COPD, Asthma and Drug allergy (Tylonol).    On 22-Apr-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received a expired vaccine 16Apr2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received a expired vaccine 16Apr2022) 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. On 22 Apr 2022, the patient received the first booster dose of the vaccine. Treatment information was not provided.
Sex: M
Vaccine: COVID19
Symptoms: Immunisation reaction, Mobility decreased
Clinical narrative: Bad reaction; felt like almost paralysis/could not move; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Bad reaction) and MOBILITY DECREASED (felt like almost paralysis/could not move) in an elderly male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001M21A, 038K20A and 039K20A) for COVID-19 vaccination.     Concurrent medical conditions included Glaucoma (2 eye drops a day for Glaucoma.) and Sulfonamide allergy (Suspicion of Sulfa allergy). Concomitant products included VITAMIN D3 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) (Intramuscular) dosage was changed to 1 dosage form. On 26-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 23-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Bad reaction) and MOBILITY DECREASED (felt like almost paralysis/could not move). The patient was treated with ASPIRIN [ACETYLSALICYLIC ACID] for Adverse event, at a dose of 1 dosage form. At the time of the report, VACCINATION COMPLICATION (Bad reaction) was resolving and MOBILITY DECREASED (felt like almost paralysis/could not move) outcome was unknown.            Concomitant medication also included unspecified 2 eye drops for glaucoma. Patient did not had positive COVID test or diagnosis.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: 26 Patient received a expired vaccine 16 Apr 2022; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (26 Patient received a expired vaccine 16 Apr 2022) in a 50-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Apr-2022, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 22-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (26 Patient received a expired vaccine 16 Apr 2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (26 Patient received a expired vaccine 16 Apr 2022) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant product reported by reporter.  No allergy was reported by reporter.  Patient was never diagnosed with COVID-19.  No treatment medication reported by reporter.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness
Clinical narrative: Flu like symptoms after 2nd primary dose; This spontaneous case was reported by a patient and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu like symptoms after 2nd primary dose) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INFLUENZA LIKE ILLNESS (Flu like symptoms after 2nd primary dose). On 03-Apr-2021, INFLUENZA LIKE ILLNESS (Flu like symptoms after 2nd primary dose) had resolved. Concomitant medication information was not provided by the reporter.  Treatment information was not provided by the reporter.   This case was linked to MOD-2022-549161, MOD-2022-549162 (Patient Link).
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: 26 Patients received a expired vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (26 Patients received a expired vaccine) in a 28-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 007J21-2a) for COVID-19 vaccination. No Medical History information was reported.    On 22-Apr-2022, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 22-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (26 Patients received a expired vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (26 Patients received a expired vaccine) outcome was unknown. For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments. Concomitant medications details were not reported by the reporter.  Treatment details were not reported by the reporter.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patients received expired doses; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patients received expired doses) in a 78-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 07-Apr-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patients received expired doses). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patients received expired doses) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were provided. No treatment details were provided.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, SARS-CoV-2 test positive
Clinical narrative: Patient received a expired vaccine 22-Apr-2022; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received a expired vaccine 22-Apr-2022) in a 54-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007J21-2a) for COVID-19 vaccination.     The patient's past medical history included COVID-19.    On 22-Apr-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received a expired vaccine 22-Apr-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received a expired vaccine 22-Apr-2022) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test positive: positive (Positive) Patient was diagnosed with COVID-19 positive.     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. On 22-Apr-2022, the patient received the first booster dose of the vaccine. Patient did not have allergies to medications, food and other products. No Other vaccines were given within one month prior to Moderna COVID-19 vaccine to Patient. Patient did not have any acute and Chronic illnesses at the time of vaccination. Treatment information was not provided.
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Balance disorder, Dysstasia, Fall, Gait inability
Clinical narrative: Loss of energy; Sleepiness; Recurrent falls; Losing his balance; After falling he was unable to pick himself up and even with assistance had issues; issues getting his feet under him and walking; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Loss of energy), SOMNOLENCE (Sleepiness), FALL (Recurrent falls), BALANCE DISORDER (Losing his balance) and DYSSTASIA (After falling he was unable to pick himself up and even with assistance had issues) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On an unknown date, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, 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 ASTHENIA (Loss of energy), SOMNOLENCE (Sleepiness), FALL (Recurrent falls), BALANCE DISORDER (Losing his balance), DYSSTASIA (After falling he was unable to pick himself up and even with assistance had issues) and GAIT INABILITY (issues getting his feet under him and walking). At the time of the report, ASTHENIA (Loss of energy), SOMNOLENCE (Sleepiness), FALL (Recurrent falls), BALANCE DISORDER (Losing his balance), DYSSTASIA (After falling he was unable to pick himself up and even with assistance had issues) and GAIT INABILITY (issues getting his feet under him and walking) outcome was unknown.            No concomitant medication were reported.   It was reported that the feet did not seems to listen to his head and was lucid and responsive throughout.   No treatment drug were reported.   This case was linked to MOD-2022-549164 (Patient Link).
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Somnolence
Clinical narrative: Loss of energy; Sleepiness; Recurrent falls; Losing his balance; After falling he was unable to pick himself up and even with assistance had issues; issues getting his feet under him and walking; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Loss of energy), SOMNOLENCE (Sleepiness), FALL (Recurrent falls), BALANCE DISORDER (Losing his balance) and DYSSTASIA (After falling he was unable to pick himself up and even with assistance had issues) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On an unknown date, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, 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 ASTHENIA (Loss of energy), SOMNOLENCE (Sleepiness), FALL (Recurrent falls), BALANCE DISORDER (Losing his balance), DYSSTASIA (After falling he was unable to pick himself up and even with assistance had issues) and GAIT INABILITY (issues getting his feet under him and walking). At the time of the report, ASTHENIA (Loss of energy), SOMNOLENCE (Sleepiness), FALL (Recurrent falls), BALANCE DISORDER (Losing his balance), DYSSTASIA (After falling he was unable to pick himself up and even with assistance had issues) and GAIT INABILITY (issues getting his feet under him and walking) outcome was unknown.            No concomitant medication were reported.   It was reported that the feet did not seems to listen to his head and was lucid and responsive throughout.   No treatment drug were reported.   This case was linked to MOD-2022-549164 (Patient Link).
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: 26 Patient received a expired vaccine 16Apr2022; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (26 Patient received a expired vaccine 16Apr2022) in a 41-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007J21-2a) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Apr-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (26 Patient received a expired vaccine 16Apr2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (26 Patient received a expired vaccine 16Apr2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications details were not reported by the reporter. Patient received first booster dose. Treatment details was not reported by the reporter.   This case was linked to MOD-2022-548975 (Patient Link).
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received expired dose; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received expired dose) in an 84-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 07-Apr-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received expired dose). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received expired dose) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were reported.  No treatment medication were reported.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness
Clinical narrative: After the first booster dose, she had Flu like symptoms; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (After the first booster dose, she had Flu like symptoms) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Nov-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INFLUENZA LIKE ILLNESS (After the first booster dose, she had Flu like symptoms). On 30-Nov-2021, INFLUENZA LIKE ILLNESS (After the first booster dose, she had Flu like symptoms) had resolved.            No concomitant medications were reported.  No treatment details were reported.   This case was linked to MOD-2022-549151, MOD-2022-549162 (Patient Link).
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site haemorrhage, Vaccination site swelling
Clinical narrative: Instant Bruise on the injection site as soon as 2nd booster was injected; Pouring out blood injection site right after 2nd Booster; Could not stand up right after 2nd Booster; Felt terrible right after 2nd Booster; Sweating really bad after 2nd Booster; Felt like fainting right after 2nd Booster , and felt dizzy; Puffy Injection Site, Swollen Injection Site (1 inch) right after 2nd Booster; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE BRUISING (Instant Bruise on the injection site as soon as 2nd booster was injected), VACCINATION SITE HAEMORRHAGE (Pouring out blood injection site right after 2nd Booster), DYSSTASIA (Could not stand up right after 2nd Booster), FEELING ABNORMAL (Felt terrible right after 2nd Booster) and HYPERHIDROSIS (Sweating really bad after 2nd Booster) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001M21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Apr-2022 at 9:23 AM, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Apr-2022, the patient experienced VACCINATION SITE BRUISING (Instant Bruise on the injection site as soon as 2nd booster was injected), VACCINATION SITE HAEMORRHAGE (Pouring out blood injection site right after 2nd Booster), DYSSTASIA (Could not stand up right after 2nd Booster), FEELING ABNORMAL (Felt terrible right after 2nd Booster), HYPERHIDROSIS (Sweating really bad after 2nd Booster), DIZZINESS (Felt like fainting right after 2nd Booster , and felt dizzy) and VACCINATION SITE SWELLING (Puffy Injection Site, Swollen Injection Site (1 inch) right after 2nd Booster). On 25-Apr-2022, VACCINATION SITE BRUISING (Instant Bruise on the injection site as soon as 2nd booster was injected), VACCINATION SITE HAEMORRHAGE (Pouring out blood injection site right after 2nd Booster), DYSSTASIA (Could not stand up right after 2nd Booster), FEELING ABNORMAL (Felt terrible right after 2nd Booster), HYPERHIDROSIS (Sweating really bad after 2nd Booster) and DIZZINESS (Felt like fainting right after 2nd Booster , and felt dizzy) had resolved. At the time of the report, VACCINATION SITE SWELLING (Puffy Injection Site, Swollen Injection Site (1 inch) right after 2nd Booster) outcome was unknown.            On 27-Nov-2021, the patient received first booster dose and on 25-Apr-2022 at 9:23 AM received 2nd booster dose.  No concomitant medications was reported. No treatment medications was reported.   This case was linked to MOD-2022-549161 (Patient Link).
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received a expired vaccine 16Apr2022; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received a expired vaccine 16Apr2022) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Patient height reported as unknown. Patient never had COVID positive test nor diagnosed. No Other vaccines given within 1 month prior to Moderna COVID-19 vaccine.  Concurrent medical conditions included Kidney disorder, Diabetes, Hypertension and Allergy to antibiotic.    On 20-Apr-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received a expired vaccine 16Apr2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received a expired vaccine 16Apr2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   It was reported unknown for recent change in status such as improvement or worsening of each condition kidney disease, diabetes, and hypertension. No concomitant medication was reported.  Patient took second Booster on 20-Apr-2022.  It was unknown if adverse event cause patient to seek medical care (office visit, Urgent care, ER, hospitalized) and unknown if patient experienced a similar event in the past. No death occurred.  No treatment medication was reported.
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Balance disorder, Fall, Gait inability, Somnolence
Clinical narrative: Significant loss of energy; Sleepiness; Recurrent falls; Losing his balance; After falling he was unable to pick himself up and even with assistance had issues; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Significant loss of energy), SOMNOLENCE (Sleepiness), FALL (Recurrent falls), BALANCE DISORDER (Losing his balance) and GAIT INABILITY (After falling he was unable to pick himself up and even with assistance had issues) in a 79-year-old male patient 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, the patient experienced ASTHENIA (Significant loss of energy), SOMNOLENCE (Sleepiness), FALL (Recurrent falls), BALANCE DISORDER (Losing his balance) and GAIT INABILITY (After falling he was unable to pick himself up and even with assistance had issues). At the time of the report, ASTHENIA (Significant loss of energy), SOMNOLENCE (Sleepiness), FALL (Recurrent falls), BALANCE DISORDER (Losing his balance) and GAIT INABILITY (After falling he was unable to pick himself up and even with assistance had issues) outcome was unknown.            No concomitant medication was provided.  It was reported that the feet did not seems to listen to his head and it was lucid and responsive throughout.    No treatment medication was provided.   This case was linked to MOD-2022-549155, MOD-2022-549165, MOD-2022-549166 (Patient Link).
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Therapeutic response unexpected
Clinical narrative: Her long COVID symptoms improved after receiving Moderna vaccines 1, 2 and 3. She recently received the 4th dose; This spontaneous case was reported by a consumer and describes the occurrence of THERAPEUTIC RESPONSE UNEXPECTED (Her long COVID symptoms improved after receiving Moderna vaccines 1, 2 and 3. She recently received the 4th dose) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in March 2020.   On an unknown date, the patient received fourth 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, second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and 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 THERAPEUTIC RESPONSE UNEXPECTED (Her long COVID symptoms improved after receiving Moderna vaccines 1, 2 and 3. She recently received the 4th dose). At the time of the report, THERAPEUTIC RESPONSE UNEXPECTED (Her long COVID symptoms improved after receiving Moderna vaccines 1, 2 and 3. She recently received the 4th dose) outcome was unknown.            No Concomitant medication reported. No Treatment medication reported. It had been stated that Covid Symptom was Loss of energy and Several Neuro related side effects which reported paitent long covid symptom improved after Moderna.   This case was linked to MOD-2022-549164, MOD-2022-549166 (Patient Link).
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: receiving expired doses; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (receiving expired doses) in a 76-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 12-Apr-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (receiving expired doses). At the time of the report, EXPIRED PRODUCT ADMINISTERED (receiving expired doses) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient received 2nd booster dose. No concomitant medication was reported. No treatment medication was reported.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, SARS-CoV-2 test
Clinical narrative: 26 Patient received a expired vaccine 16Apr2022; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (26 Patient received a expired vaccine 16Apr2022) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007J21-2a) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Apr-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (26 Patient received a expired vaccine 16Apr2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (26 Patient received a expired vaccine 16Apr2022) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) Negative.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were reported.   No treatment drug were reported.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received a expired vaccine 16Apr2022; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received a expired vaccine 16Apr2022) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007J21-2a) for COVID-19 vaccination.     Patient had no Allergies. Patient never had COVID positive test or diagnosis. No Other vaccines given within 1 month prior to Moderna COVID-19 vaccine.  Concurrent medical conditions included Asthma. On 22-Apr-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received a expired vaccine 16Apr2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received a expired vaccine 16Apr2022) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information provided. No treatment medication information provided.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: 26 Patient received a expired vaccine 16Apr2022; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (26 Patient received a expired vaccine 16Apr2022) in a 72-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 007J21-2a) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes.    On 20-Apr-2022, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 20-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (26 Patient received a expired vaccine 16Apr2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (26 Patient received a expired vaccine 16Apr2022) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   The patient did not received any other vaccines within 1 month prior to Moderna COVID-19 vaccine.  No concomitant medications were reported. No treatment medications were reported.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received vaccine on date 31-MAR-2022 which was expired 24-MAR-2022; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received vaccine on date 31-MAR-2022 which was expired 24-MAR-2022) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031H21A) for COVID-19 vaccination.     No Medical History information was reported.  On 31-Mar-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Mar-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received vaccine on date 31-MAR-2022 which was expired 24-MAR-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received vaccine on date 31-MAR-2022 which was expired 24-MAR-2022) outcome was unknown. Not Provided    For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported  Patient received 2nd booster dose.  No treatment medications were reported
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received a expired vaccine 16 Apr 2022; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received a expired vaccine 16 Apr 2022) in a 42-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007J21-2a) for COVID-19 vaccination.     The patient did not have any allergies No other vaccine was given prior to Moderna Covid-19 Vaccine.     On 22-Apr-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received a expired vaccine 16 Apr 2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received a expired vaccine 16 Apr 2022) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   It was reported that patient had never had COVID positive test nor diagnosis.  No concomitant medication were reported.  No treatment medication were reported.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Receiving expired doses; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Receiving expired doses) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Apr-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Receiving expired doses). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Receiving expired doses) outcome was unknown.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. The patient was given 2nd booster dose on 21-Apr-2022. Concomitant medication list was not provided. Treatment information was not provided.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Vaccine was expired on 27 Mar 2022 and was administered on 07 Apr 2022; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine was expired on 27 Mar 2022 and was administered on 07 Apr 2022) in a 69-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 07-Apr-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine was expired on 27 Mar 2022 and was administered on 07 Apr 2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine was expired on 27 Mar 2022 and was administered on 07 Apr 2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications was reported. It was reported patient received second booster dose. No treatment information was reported.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (26 Patient received a expired vaccine 16-Apr-2022) in a 55-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 007J21-2a) for COVID-19 vaccination. No Medical History information was reported. On 22-Apr-2022, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 22-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (26 Patient received a expired vaccine 16-Apr-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (26 Patient received a  expired vaccine 16-Apr-2022) outcome was unknown. For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments. No Concomitant medication was reported. No Treatment medication was reported.