chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Accidental overdose
Clinical narrative: Injected with Moderna Lot No. 063H021A 1273 0.58 ML vaccine; This spontaneous case was reported by a consumer and describes the occurrence of ACCIDENTAL OVERDOSE (Injected with Moderna Lot No. 063H021A 1273 0.58 ML vaccine) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 063H021A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Jan-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .58 milliliter. On 19-Jan-2022, the patient experienced ACCIDENTAL OVERDOSE (Injected with Moderna Lot No. 063H021A 1273 0.58 ML vaccine). On 19-Jan-2022, ACCIDENTAL OVERDOSE (Injected with Moderna Lot No. 063H021A 1273 0.58 ML vaccine) had resolved.            Concomitant medications were not provided.  Treatment information was not provided.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Inadvertently administered an expired Moderna Covid-19 vaccine to patient; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Inadvertently administered an expired Moderna Covid-19 vaccine to patient) in a 52-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 049C21A, 012M20A and 027L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Jan-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .25 milliliter. On 06-Jan-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Inadvertently administered an expired Moderna Covid-19 vaccine to patient). On 06-Jan-2022, EXPIRED PRODUCT ADMINISTERED (Inadvertently administered an expired Moderna Covid-19 vaccine to patient) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were provided. No treatment medications were reported.
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Dose administered >12 hours post puncture; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered >12 hours post puncture) in a 29-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030H21B) for COVID-19 vaccination.     Concurrent medical conditions included Allergy. Concomitant products included FLUTICASONE PROPIONATE (FLONASE [FLUTICASONE PROPIONATE]) and LORATADINE (CLARITIN [LORATADINE]) for Allergy, DOCUSATE SODIUM (COLACE) for Stools abnormal, BUPROPION, UBIDECARENONE (COQ10 [UBIDECARENONE]) and TRAZODONE for an unknown indication.    On 20-Jan-2022 at 2:45 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 20-Jan-2022 at 2:45 PM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered >12 hours post puncture). On 20-Jan-2022 at 2:45 PM, EXPIRED PRODUCT ADMINISTERED (Dose administered >12 hours post puncture) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment information was unknown. Colace was used as a stool softener.  1 dose was administered from the vial. Use by date was on  21-Jan-2022. On 19-Jan-2022 at 14:10 the vial was first punctured. Post puncture the vial was stored in Fridge. The vial did not undergo any temperature excursions. Just when drawing doses the vial was exposed to room temperature range (8 degree to 25 degree Celsius which is equal to 46 degree to 77 degree F).
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Alopecia, Induration
Clinical narrative: her alopecia getting worse; hardness; This spontaneous case was reported by a consumer and describes the occurrence of ALOPECIA (her alopecia getting worse) and INDURATION (hardness) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001821a and 007821a) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concurrent medical conditions included Alopecia since 2001. Concomitant products included METFORMIN, SIMVASTATIN, LISINOPRIL, FLUOXETINE HYDROCHLORIDE (PROZAC) and BUPROPION HYDROCHLORIDE (WELLBUTRIN) for an unknown indication.   On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In November 2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In December 2021, the patient experienced ALOPECIA (her alopecia getting worse) and INDURATION (hardness). The patient was treated with VITAMINS NOS for Adverse event, at an unspecified dose and frequency. At the time of the report, ALOPECIA (her alopecia getting worse) and INDURATION (hardness) outcome was unknown.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: administered with a vaccine from a vial which has been punctured for more than 12 hours; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered with a vaccine from a vial which has been punctured for more than 12 hours) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022J21A) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Jan-2022 at 10:00 AM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Jan-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (administered with a vaccine from a vial which has been punctured for more than 12 hours). On 21-Jan-2022, EXPIRED PRODUCT ADMINISTERED (administered with a vaccine from a vial which has been punctured for more than 12 hours) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The vial was first punctured on 20-Jan-2022 at 11:53 AM.  Concomitant medication was not provided.  Treatment information was not provided.   This case was linked to MOD-2022-458066 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: administered with vaccine from a vial punctured for more than 12 hours; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered with vaccine from a vial punctured for more than 12 hours) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022J21A) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Jan-2022 at 8:40 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered with vaccine from a vial punctured for more than 12 hours). On 21-Jan-2022, EXPIRED PRODUCT ADMINISTERED (administered with vaccine from a vial punctured for more than 12 hours) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant and treatment Drug details were reported. The vial was 1st punctured on 20Jan2022 at 11:53am. The 1st dose vial was exposed to room temperature for greater than 24 hours-21 hrs.      This case was linked to MOD-2022-458007 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: First dose received was expired; This spontaneous case was reported by a consumer and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (First dose received was expired) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (First dose received was expired). At the time of the report, EXPIRED PRODUCT ADMINISTERED (First dose received was expired) had resolved.            Concomitant product use was not provided by the reporter.   No treatment information provided.  Reporter stated that when the patient received the second dose of the Moderna COVID-19 vaccine, the patient noticed that the first dose was expired.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Administered with expired vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered with expired vaccine) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 049C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 06-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered with expired vaccine). On 06-Jan-2022, EXPIRED PRODUCT ADMINISTERED (Administered with expired vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No details on 1st and 2nd doses provided.  No concomitant medications were mentioned.  No treatment details were reported.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered with expired vaccine) in a 20-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 049C21A) for COVID-19 vaccination. No Medical History information was reported. On 06-Jan-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered with expired vaccine). On 06-Jan-2022, EXPIRED PRODUCT ADMINISTERED (Administered with expired vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.  No treatment medications were reported.
Age: 19.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Administered with expired vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered with expired vaccine) in a 19-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 049C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Jan-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered with expired vaccine). On 07-Jan-2022, EXPIRED PRODUCT ADMINISTERED (Administered with expired vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. Treatment medication was not provided by the reporter.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Mass, Pain
Clinical narrative: a mass on collarbone to left arm; Pain that radiated from arm to neck/Bump that is painful; Horrendous headache; This spontaneous case was reported by a nurse and describes the occurrence of MASS (a mass on collarbone to left arm), PAIN (Pain that radiated from arm to neck/Bump that is painful) and HEADACHE (Horrendous headache) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003J21-2A) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: J&J (J&J) on 16-Mar-2021. Past adverse reactions to the above products included No adverse event with J&J. Concurrent medical conditions included Fibromyalgia (Patient mentioned about having history of Fibromyalgia since 2010 but no medications taken) since 2010.    On 18-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Jan-2022, the patient experienced MASS (a mass on collarbone to left arm), PAIN (Pain that radiated from arm to neck/Bump that is painful) and HEADACHE (Horrendous headache). At the time of the report, MASS (a mass on collarbone to left arm), PAIN (Pain that radiated from arm to neck/Bump that is painful) and HEADACHE (Horrendous headache) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant mediations were reported. No treatment was taken. Patient took the shot.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: enlarged lymph node on his left collarbone; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (enlarged lymph node on his left collarbone) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001C21A) for COVID-19 vaccination.     Concurrent medical conditions included Fibromyalgia and war syndrome.    On 29-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In October 2021, the patient experienced LYMPHADENOPATHY (enlarged lymph node on his left collarbone). At the time of the report, LYMPHADENOPATHY (enlarged lymph node on his left collarbone) had not resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No relevant concomitant medications were reported. Treatment information was unknown.   This case was linked to MOD-2022-458224 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: This spontaneous case was reported by an other health care professional and describes the occurrence of VACCINATION COMPLICATION (got moderna booster and had side effects) 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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (got moderna booster and had side effects). At the time of the report, VACCINATION COMPLICATION (got moderna booster and had side effects) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  Treatment information was not provided.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: administered with expired vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered with expired vaccine) in a 32-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 049C21A, 041B21A and 003C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 13-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Jan-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .25 milliliter. On 07-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered with expired vaccine). On 07-Jan-2022, EXPIRED PRODUCT ADMINISTERED (administered with expired vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.
Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: inadvertently administered an expired vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (inadvertently administered an expired vaccine) in a 27-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 049C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Jan-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (inadvertently administered an expired vaccine). On 10-Jan-2022, EXPIRED PRODUCT ADMINISTERED (inadvertently administered an expired vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant drugs were not reported. Treatment medications were not provided.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: administered with expired vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered with expired vaccine) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 049C21A, 045B21A and 033B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 21-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Jan-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .25 milliliter. On 10-Jan-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (administered with expired vaccine). On 10-Jan-2022, EXPIRED PRODUCT ADMINISTERED (administered with expired vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications were not reported. treatment medications were not reported.  Pharmacist reported that they inadvertently administered an expired Moderna Covid-19 vaccine to 14 patients.
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Bell's palsy, Rash pruritic, Skin discolouration
Clinical narrative: Bells Palsey for 3 days. Brown, itchy large rash in left side of body.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Erythema, Pruritus, Rash, Skin lesion, Skin pressure mark
Clinical narrative: Since late November he has complained of near-daily recurrent episodes of rashes described as raised, red, itchy whelts which can occur anywhere on his body but typically occur at sites of pressure or where his skin is scraped or scratched. He received his COVID19 vaccine booster dose on 18 November, 8 days prior to onset of symptoms. He also notes lesions occur after hot showers. Lesions last less than 24 hours and resolve without post-inflammatory changes. He denies laryngeal, pulmonary, GI, neurologic, and cardiovascular symptoms. Episodes not associated with exercise, sweating, cold, foods, medications, NSAIDs, IV contrast, latex exposure, infections, or insect bites/stings. He has used oral antihistamines with partial control of symptoms. He denies constitutional symptoms.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Swelling, Urticaria
Clinical narrative: Since late November he has complained of near-daily recurrent episodes of rashes described as raised, red, itchy whelts which can occur anywhere on his body but typically occur at sites of pressure or where his skin is scraped or scratched. He received his COVID19 vaccine booster dose on 18 November, 8 days prior to onset of symptoms. He also notes lesions occur after hot showers. Lesions last less than 24 hours and resolve without post-inflammatory changes. He denies laryngeal, pulmonary, GI, neurologic, and cardiovascular symptoms. Episodes not associated with exercise, sweating, cold, foods, medications, NSAIDs, IV contrast, latex exposure, infections, or insect bites/stings. He has used oral antihistamines with partial control of symptoms. He denies constitutional symptoms.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: administered with expired vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered with expired vaccine) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 049C21A, 021C21A and 001C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 20-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Jan-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .25 milliliter. On 12-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered with expired vaccine). On 12-Jan-2022, EXPIRED PRODUCT ADMINISTERED (administered with expired vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant drug details were reported. No treatment details were reported.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: administered with expired vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered with expired vaccine) in a 45-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 049C21A, 035C21A and 003C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 30-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Jan-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .25 milliliter. On 12-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered with expired vaccine). On 12-Jan-2022, EXPIRED PRODUCT ADMINISTERED (administered with expired vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication information was not provided by the reporter.  Treatment information was not provided by the reporter.
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: 3 Doses administered >12 hours post puncture; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (3 Doses administered >12 hours post puncture) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 016J21-2A, 040A21A and 042L20A) for COVID-19 vaccination.     Concomitant products included CALCIUM CARBONATE, COLECALCIFEROL (VITAMIN D 2000), CYANOCOBALAMIN, FOLIC ACID (VITAMIN B12 & FOLIC ACID), DICLOFENAC, GABAPENTIN, LIDOCAINE (LIDODERM), DOCUSATE SODIUM, SENNOSIDE A+B (SENNA S), THYROID, TRAMADOL and ASCORBIC ACID (VITAMIN C ASC ACID) for an unknown indication.   On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 06-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Jan-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 milliliter. On 20-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (3 Doses administered >12 hours post puncture). On 20-Jan-2022, EXPIRED PRODUCT ADMINISTERED (3 Doses administered >12 hours post puncture) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment information was not provided.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Rash pruritic
Clinical narrative: Rash was very itchy; Started to develop a rash in a circle about the size of the bandage on arm,pretty big rash,started out smaller (size of a quarter) but expanded on arm 3 to 3.5 inches or about tennis ball size; This spontaneous case was reported by a consumer and describes the occurrence of RASH PRURITIC (Rash was very itchy) and RASH (Started to develop a rash in a circle about the size of the bandage on arm,pretty big rash,started out smaller (size of a quarter) but expanded on arm 3 to 3.5 inches or about tennis ball size) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination.     Concomitant products included AZILSARTAN MEDOXOMIL, CHLORTALIDONE (EDARBYCLOR) for Blood pressure management, ROSUVASTATIN for an unknown indication.    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, the patient experienced RASH PRURITIC (Rash was very itchy) and RASH (Started to develop a rash in a circle about the size of the bandage on arm,pretty big rash,started out smaller (size of a quarter) but expanded on arm 3 to 3.5 inches or about tennis ball size). The patient was treated with CORTISONE at an unspecified dose and frequency. In February 2021, RASH (Started to develop a rash in a circle about the size of the bandage on arm,pretty big rash,started out smaller (size of a quarter) but expanded on arm 3 to 3.5 inches or about tennis ball size) had resolved. At the time of the report, RASH PRURITIC (Rash was very itchy) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient reported that her doctor thought the cause of the rash was the bandage. Dosage for Edarbyclor tab  was 40-25mg. The patient medical condition include blood pressure.   This case was linked to MOD-2022-458783, MOD-2022-458784 (Patient Link).
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Gait disturbance, Mobility decreased, Myalgia
Clinical narrative: can hardly walk; could hardly get out of bed; dizzy; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of GAIT DISTURBANCE (can hardly walk), MOBILITY DECREASED (could hardly get out of bed), DIZZINESS (dizzy) and MYALGIA (sore arm) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 068H21A, 054C21A and 006B21A) for COVID-19 vaccination.     Concomitant products included INSULIN DEGLUDEC, LIRAGLUTIDE (XULTOPHY), METFORMIN HYDROCHLORIDE, CARVEDILOL, FENOFIBRATE, DESVENLAFAXINE, ROSUVASTATIN, FLUOXETINE, ACETYLSALICYLIC ACID (BABY ASPIRIN), GABAPENTIN, IRON, CYANOCOBALAMIN (B-12) and COLECALCIFEROL (D3) for an unknown indication.   On 29-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Jan-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Jan-2022, the patient experienced MYALGIA (sore arm). On 20-Jan-2022, the patient experienced MOBILITY DECREASED (could hardly get out of bed) and DIZZINESS (dizzy). On an unknown date, the patient experienced GAIT DISTURBANCE (can hardly walk). At the time of the report, GAIT DISTURBANCE (can hardly walk), MOBILITY DECREASED (could hardly get out of bed) and MYALGIA (sore arm) outcome was unknown and DIZZINESS (dizzy) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient said that on Wednesday after the booster shot it was great, the arm was sore. On Thursday, patient was so dizzy she could hardly get out of bed. Patient stayed dizzy until 5 o'clock in the evening and then she was 50% better. On Friday morning, she was just as dizzy as she was on Thursday and on Saturday she woke up and was very dizzy, she can hardly walk. No treatment medications was provided.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Peripheral swelling
Clinical narrative: Left Arm is still sore; Swelling in his left arm after the booster dose.; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Left Arm is still sore) and PERIPHERAL SWELLING (Swelling in his left arm after the booster dose.) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 066H21A, 037C21A and 037C21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 antibody test positive on 05-Dec-2021. Concomitant products included PARACETAMOL (TYLENOL [PARACETAMOL]) for an unknown indication.   On 18-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Jan-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 20-Jan-2021, the patient experienced PAIN IN EXTREMITY (Left Arm is still sore) and PERIPHERAL SWELLING (Swelling in his left arm after the booster dose.). At the time of the report, PAIN IN EXTREMITY (Left Arm is still sore) had not resolved and PERIPHERAL SWELLING (Swelling in his left arm after the booster dose.) outcome was unknown.            No treatment medication was provided by reporter.   This case was linked to MOD-2022-458714 (Patient Link).
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Pruritus
Clinical narrative: after second dose, arm was a little itchy but nothing major; Dose Interval between 1st dose and 2nd dose is beyond 25-35 days; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (after second dose, arm was a little itchy but nothing major) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose Interval between 1st dose and 2nd dose is beyond 25-35 days) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017B21A and 015M20A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure. Concomitant products included AZILSARTAN MEDOXOMIL, CHLORTALIDONE (EDARBYCLOR) for Blood pressure, ROSUVASTATIN for an unknown indication.   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 31-Mar-2021, the patient experienced PRURITUS (after second dose, arm was a little itchy but nothing major) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose Interval between 1st dose and 2nd dose is beyond 25-35 days). The patient was treated with CORTISONE at a dose of 10. On 31-Mar-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose Interval between 1st dose and 2nd dose is beyond 25-35 days) had resolved. At the time of the report, PRURITUS (after second dose, arm was a little itchy but nothing major) outcome was unknown.            Concomitant includes rovastatin 10mg for statin.   This case was linked to MOD-2022-458708, MOD-2022-458784 (Patient Link).
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Vaccination complication, Vaccination site pruritus
Clinical narrative: slight reaction that lasted about 2 weeks; area was itchy/On occasion, left arm feels itchy intermittently; she developed a rash; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (slight reaction that lasted about 2 weeks), VACCINATION SITE PRURITUS (area was itchy/On occasion, left arm feels itchy intermittently) and RASH (she developed a rash) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031H21A, 017B21A and 015M20A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure. Concomitant products included AZILSARTAN MEDOXOMIL, CHLORTALIDONE (EDARBYCLOR) for Blood pressure, ROSUVASTATIN for an unknown indication.   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Dec-2021, the patient experienced VACCINATION COMPLICATION (slight reaction that lasted about 2 weeks), VACCINATION SITE PRURITUS (area was itchy/On occasion, left arm feels itchy intermittently) and RASH (she developed a rash). The patient was treated with CORTISONE for Adverse event, at a dose of UNK (Cortisone 10). In December 2021, VACCINATION COMPLICATION (slight reaction that lasted about 2 weeks) had resolved. At the time of the report, VACCINATION SITE PRURITUS (area was itchy/On occasion, left arm feels itchy intermittently) had not resolved and RASH (she developed a rash) outcome was unknown.            Patient states when it itches Patient looks at it and nothing there but in the same area.   This case was linked to MOD-2022-458783, MOD-2022-458708 (Patient Link).
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Speech disorder
Clinical narrative: Speech issues, speech problems; This spontaneous case was reported by a pharmacist and describes the occurrence of SPEECH DISORDER (Speech issues, speech problems) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Dec-2021, the patient experienced SPEECH DISORDER (Speech issues, speech problems). At the time of the report, SPEECH DISORDER (Speech issues, speech problems) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   It was reported that the patient had intermittent speech problems. Reporter stated that he think it could be something neurological.  No concomitant medications were reported. No treatment medications were reported.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site lymphadenopathy
Clinical narrative: lymph node under my injection site is swollenlen; This spontaneous case was reported by a pharmacist and describes the occurrence of VACCINATION SITE LYMPHADENOPATHY (lymph node under my injection site is swollenlen) 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE LYMPHADENOPATHY (lymph node under my injection site is swollenlen). At the time of the report, VACCINATION SITE LYMPHADENOPATHY (lymph node under my injection site is swollenlen) outcome was unknown.      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 concomitant medication  were reported. No Treatment information was provided
Age: 37.0
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 (doses administered from an expired vial/doses administered >12 hours post puncture) in a 37-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) for COVID-19 vaccination. No Medical History information was reported. On 22-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (doses administered from an expired vial/doses administered >12 hours post puncture). On 22-Jan-2022, EXPIRED PRODUCT ADMINISTERED (doses administered from an expired vial/doses administered >12 hours post puncture) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medications were provided. No treatment medications were provided. On 13 Jan 2022, the vial was initially stored in the fridge. On 21 Jan 2022 9:21 PM, vial was first punctured. No temperature excursions were reported. This case was linked to MOD-2022-459581, MOD-2022-459566 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 23-Jan-2022: Follow up was received and suspect drug details and details of the storage was updated.
Sex: U
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: swollen gland under my arm; This spontaneous case was reported by a physician and describes the occurrence of LYMPHADENOPATHY (swollen gland under my arm) in an adult patient of an unknown 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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced LYMPHADENOPATHY (swollen gland under my arm). At the time of the report, LYMPHADENOPATHY (swollen gland under my arm) 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.
Sex: M
Vaccine: COVID19
Symptoms: Lymphadenopathy, Pain, Vaccination complication
Clinical narrative: recently got the booster vaccine and he's experiencing some side effects; his in pain; bump in the armpit; This spontaneous case was reported by an other health care professional and describes the occurrence of VACCINATION COMPLICATION (recently got the booster vaccine and he's experiencing some side effects), PAIN (his in pain) and LYMPHADENOPATHY (bump in the armpit) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In January 2022, the patient experienced VACCINATION COMPLICATION (recently got the booster vaccine and he's experiencing some side effects), PAIN (his in pain) and LYMPHADENOPATHY (bump in the armpit). At the time of the report, VACCINATION COMPLICATION (recently got the booster vaccine and he's experiencing some side effects), PAIN (his in pain) and LYMPHADENOPATHY (bump in the armpit) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   This was reported for reporters dad who recently got the booster vaccine. No concomitant medication details was provided. No treatment medication details was provided.
Age: 59.0
Sex: U
Vaccine: COVID19
Symptoms: Accidental underdose
Clinical narrative: This spontaneous case was reported by a physician and describes the occurrence of ACCIDENTAL UNDERDOSE (received booster dose instead of full first dose) in a 59-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041J21A) for COVID-19 vaccination. No Medical History information was reported. On 22-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Jan-2022, the patient experienced ACCIDENTAL UNDERDOSE (received booster dose instead of full first dose). On 22-Jan-2022, ACCIDENTAL UNDERDOSE (received booster dose instead of full first dose) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medications were reported. No treatment medications were reported. Three patients received the booster dose of the Moderna vaccine instead of their full first dose of the Moderna vaccine. Patients received half dose from Lot no: 041J21A.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Accidental underdose
Clinical narrative: received booster dose instead of full first dose; This spontaneous case was reported by a physician and describes the occurrence of ACCIDENTAL UNDERDOSE (received booster dose instead of full first dose) in a 24-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041J21A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Jan-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Jan-2022, the patient experienced ACCIDENTAL UNDERDOSE (received booster dose instead of full first dose). On 22-Jan-2022, ACCIDENTAL UNDERDOSE (received booster dose instead of full first dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant information was not provided. Treatment information was not provided.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Accidental underdose
Clinical narrative: received booster dose instead of full first dose; This spontaneous case was reported by a physician and describes the occurrence of ACCIDENTAL UNDERDOSE (received booster dose instead of full first dose) in a 35-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041J21A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Jan-2022, the patient experienced ACCIDENTAL UNDERDOSE (received booster dose instead of full first dose). On 22-Jan-2022, ACCIDENTAL UNDERDOSE (received booster dose instead of full first dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant products were reported. No treatment information was reported.
Sex: U
Vaccine: COVID19
Symptoms: Feeling abnormal
Clinical narrative: I feel to bad; This spontaneous case was reported by a nurse and describes the occurrence of FEELING ABNORMAL (I feel to bad) 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 18-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In January 2022, the patient experienced FEELING ABNORMAL (I feel to bad). At the time of the report, FEELING ABNORMAL (I feel to bad) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were provided.  No treatment medication were provided.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: pretty severe side effects third  dose also did  second dose last year have pretty bad side effects; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (pretty severe side effects third  dose also did  second dose last year have pretty bad side effects) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In January 2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In January 2022, the patient experienced VACCINATION COMPLICATION (pretty severe side effects third  dose also did  second dose last year have pretty bad side effects). At the time of the report, VACCINATION COMPLICATION (pretty severe side effects third  dose also did  second dose last year have pretty bad side effects) outcome was unknown.            No concomitant medications was provided by the reporter. No treatment was provided by the reporter.   This case was linked to MOD-2022-459078 (Patient Link).