chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Rash, Vaccination complication, Vaccination site pruritus
Clinical narrative: Moderna Arm; she got a rash; it is itchy on her hand; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Moderna Arm), RASH (she got a rash) and VACCINATION SITE PRURITUS (it is itchy on her hand) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Moderna Arm), RASH (she got a rash) and VACCINATION SITE PRURITUS (it is itchy on her hand). At the time of the report, VACCINATION COMPLICATION (Moderna Arm), RASH (she got a rash) and VACCINATION SITE PRURITUS (it is itchy on her hand) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported   No treatment information was provided   Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Mobility decreased, Muscular weakness, Pain in extremity
Clinical narrative: Leg is weak; Arm is sore; Can barely lift arm; Leg is numb; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULAR WEAKNESS (Leg is weak), PAIN IN EXTREMITY (Arm is sore), MOBILITY DECREASED (Can barely lift arm) and HYPOAESTHESIA (Leg is numb) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Nov-2021, the patient experienced MUSCULAR WEAKNESS (Leg is weak), PAIN IN EXTREMITY (Arm is sore), MOBILITY DECREASED (Can barely lift arm) and HYPOAESTHESIA (Leg is numb). At the time of the report, MUSCULAR WEAKNESS (Leg is weak), PAIN IN EXTREMITY (Arm is sore), MOBILITY DECREASED (Can barely lift arm) and HYPOAESTHESIA (Leg is numb) outcome was unknown.            The patient had circulation problems; however, she was not taking medication regularly.  No concomitant medications were reported   No treatment information was provided.  She was having problems with her right side.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pruritus, Rash macular, Scab, Skin exfoliation
Clinical narrative: Itching on her face, shoulders, back, arms, and thighs; They would raise up go from a red spot to a lump, crusted over, like poison ivy or poison oak does, like eczema or psoriasis; Red spot; Crusted over; Covered in red blotches. It's gone to the lower part of her legs: calves and shin areas; Shedding skin/ would leave a trail of where the welts had crusted and the skin started flaking off; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itching on her face, shoulders, back, arms, and thighs), SWELLING (They would raise up go from a red spot to a lump, crusted over, like poison ivy or poison oak does, like eczema or psoriasis), ERYTHEMA (Red spot), SCAB (Crusted over) and RASH MACULAR (Covered in red blotches. It's gone to the lower part of her legs: calves and shin areas) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031M20A and 013L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In March 2021, the patient experienced PRURITUS (Itching on her face, shoulders, back, arms, and thighs), SWELLING (They would raise up go from a red spot to a lump, crusted over, like poison ivy or poison oak does, like eczema or psoriasis), ERYTHEMA (Red spot), SCAB (Crusted over), RASH MACULAR (Covered in red blotches. It's gone to the lower part of her legs: calves and shin areas) and SKIN EXFOLIATION (Shedding skin/ would leave a trail of where the welts had crusted and the skin started flaking off). The patient was treated with TRIAMCINOLONE ACETONIDE for Itching, at an unspecified dose and frequency; CYPROHEPTADINE (oral) at a dose of 4 mg at bedtime and ADALIMUMAB (HUMIRA) on 12-Aug-2021 at a dose of 40 mg every two weeks. At the time of the report, PRURITUS (Itching on her face, shoulders, back, arms, and thighs), SWELLING (They would raise up go from a red spot to a lump, crusted over, like poison ivy or poison oak does, like eczema or psoriasis), ERYTHEMA (Red spot) and SCAB (Crusted over) had not resolved and RASH MACULAR (Covered in red blotches. It's gone to the lower part of her legs: calves and shin areas) and SKIN EXFOLIATION (Shedding skin/ would leave a trail of where the welts had crusted and the skin started flaking off) outcome was unknown.            No concomitant medications were provided. After 2nd dose patient started breaking out in welts, but the welts have gone down, but it still itches.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling
Clinical narrative: Itching on her face, shoulders, back, arms, and thighs; They would raise up go from a red spot to a lump, crusted over, like poison ivy or poison oak does, like eczema or psoriasis; Red spot; Crusted over; Covered in red blotches. It's gone to the lower part of her legs: calves and shin areas; Shedding skin/ would leave a trail of where the welts had crusted and the skin started flaking off; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itching on her face, shoulders, back, arms, and thighs), SWELLING (They would raise up go from a red spot to a lump, crusted over, like poison ivy or poison oak does, like eczema or psoriasis), ERYTHEMA (Red spot), SCAB (Crusted over) and RASH MACULAR (Covered in red blotches. It's gone to the lower part of her legs: calves and shin areas) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031M20A and 013L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In March 2021, the patient experienced PRURITUS (Itching on her face, shoulders, back, arms, and thighs), SWELLING (They would raise up go from a red spot to a lump, crusted over, like poison ivy or poison oak does, like eczema or psoriasis), ERYTHEMA (Red spot), SCAB (Crusted over), RASH MACULAR (Covered in red blotches. It's gone to the lower part of her legs: calves and shin areas) and SKIN EXFOLIATION (Shedding skin/ would leave a trail of where the welts had crusted and the skin started flaking off). The patient was treated with TRIAMCINOLONE ACETONIDE for Itching, at an unspecified dose and frequency; CYPROHEPTADINE (oral) at a dose of 4 mg at bedtime and ADALIMUMAB (HUMIRA) on 12-Aug-2021 at a dose of 40 mg every two weeks. At the time of the report, PRURITUS (Itching on her face, shoulders, back, arms, and thighs), SWELLING (They would raise up go from a red spot to a lump, crusted over, like poison ivy or poison oak does, like eczema or psoriasis), ERYTHEMA (Red spot) and SCAB (Crusted over) had not resolved and RASH MACULAR (Covered in red blotches. It's gone to the lower part of her legs: calves and shin areas) and SKIN EXFOLIATION (Shedding skin/ would leave a trail of where the welts had crusted and the skin started flaking off) outcome was unknown.            No concomitant medications were provided. After 2nd dose patient started breaking out in welts, but the welts have gone down, but it still itches.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Beyond the 12 hours; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Beyond the 12 hours) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 067F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Dec-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Beyond the 12 hours). On 01-Dec-2021, EXPIRED PRODUCT ADMINISTERED (Beyond the 12 hours) 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 details were reported. It was reported that dose was drawn up on 30Nov2021 and the dose was administered on 01Dec2021
Sex: F
Vaccine: COVID19
Symptoms: Vision blurred
Clinical narrative: his sister and The lady that vaccinated him said they also had blurry vision with the vaccine; This spontaneous case was reported by a consumer and describes the occurrence of VISION BLURRED (his sister and The lady that vaccinated him said they also had blurry vision with the vaccine) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VISION BLURRED (his sister and The lady that vaccinated him said they also had blurry vision with the vaccine). At the time of the report, VISION BLURRED (his sister and The lady that vaccinated him said they also had blurry vision with the vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported   No treatment information was provided
Sex: U
Vaccine: COVID19
Symptoms: Chills, Pain
Clinical narrative: Aches; Chills; This spontaneous case was reported by an other health care professional and describes the occurrence of PAIN (Aches) and CHILLS (Chills) 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 PAIN (Aches) and CHILLS (Chills). At the time of the report, PAIN (Aches) and CHILLS (Chills) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided. No treatment medications were reported.   Reporter did not allow further contact
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Insomnia, Vaccination site pain
Clinical narrative: Just can't go to sleep; Area of the injection hurts, really painful; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (Just can't go to sleep) and VACCINATION SITE PAIN (Area of the injection hurts, really painful) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030H21B, 013AZ1A and 141LZ0A) for COVID-19 vaccination.     No Medical History information was reported.   On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In November 2021, the patient experienced INSOMNIA (Just can't go to sleep) and VACCINATION SITE PAIN (Area of the injection hurts, really painful). At the time of the report, INSOMNIA (Just can't go to sleep) and VACCINATION SITE PAIN (Area of the injection hurts, really painful) outcome was unknown.            Concomitant information was not provided. Treatment information was not provided.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Malaise
Clinical narrative: we both didn't feel well/ Her brother didn't feel well/ he felt terrible; had a slight headache, it has passed.; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (we both didn't feel well/ Her brother didn't feel well/ he felt terrible) and HEADACHE (had a slight headache, it has passed.) in a 75-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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MALAISE (we both didn't feel well/ Her brother didn't feel well/ he felt terrible) and HEADACHE (had a slight headache, it has passed.). At the time of the report, MALAISE (we both didn't feel well/ Her brother didn't feel well/ he felt terrible) and HEADACHE (had a slight headache, it has passed.) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: patient claims she received an expired second dose; This spontaneous case was reported by a consumer and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patient claims she received an expired second dose) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043821A) for COVID-19 vaccination.     No Medical History information was reported.    On 21-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-May-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (patient claims she received an expired second dose). On 21-May-2021, EXPIRED PRODUCT ADMINISTERED (patient claims she received an expired second dose) had resolved.            No concomitant medications were reported  No treatment medications were reported   Most recent FOLLOW-UP information incorporated above includes: On 01-Dec-2021: Follow up document received contained No New Information.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Accidental overdose
Clinical narrative: not immunocompromised, but got full dose for booster; This spontaneous case was reported by a consumer and describes the occurrence of ACCIDENTAL OVERDOSE (not immunocompromised, but got full dose for booster) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 939903, 031L20A and 011A21A) for COVID-19 vaccination.     Concurrent medical conditions included Heart disease, unspecified (Heart issues).   On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Nov-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced ACCIDENTAL OVERDOSE (not immunocompromised, but got full dose for booster). On 30-Nov-2021, ACCIDENTAL OVERDOSE (not immunocompromised, but got full dose for booster) had resolved.            No concomitant medication details was reported. No treatment medication details was reported.   This case was linked to MOD-2021-403031 (Patient Link).; Sender's Comments: Case routed out of MR workflow as medical review is not required per new CMOP process for non serious cases which are not AESI and LOE
Age: 90.0
Sex: M
Vaccine: COVID19
Symptoms: Transfusion
Clinical narrative: Had a blood transfusion about a month ago; This spontaneous case was reported by a pharmacist and describes the occurrence of TRANSFUSION (Had a blood transfusion about a month ago) in a 90-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007C21A and 027A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced TRANSFUSION (Had a blood transfusion about a month ago). At the time of the report, TRANSFUSION (Had a blood transfusion about a month ago) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medications were reported. No Treatment information was reported.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site warmth
Clinical narrative: My arm is as hot as a firecracker.; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (My arm is as hot as a firecracker.) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Dec-2021, the patient experienced VACCINATION SITE WARMTH (My arm is as hot as a firecracker.). At the time of the report, VACCINATION SITE WARMTH (My arm is as hot as a firecracker.) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant drug details were reported. No treatment details were reported.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product temperature excursion issue
Clinical narrative: Dose administered to patient that was stored outside the fact sheet guidelines; Had a temperature excursion involving 2 doses of the Moderna Covid-19 vaccine today; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE and EXPIRED PRODUCT ADMINISTERED in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Nov-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Nov-2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED. On 30-Nov-2021, PRODUCT TEMPERATURE EXCURSION ISSUE had resolved. At the time of the report, EXPIRED PRODUCT ADMINISTERED had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant product use was reported. No treatment information was provided.  The vaccine coordinator reported that they had a temperature excursion involving 2 doses of the Moderna Covid-19 vaccine today, on 30-Nov-2021. The reported storage condition at the time of the excursion was refrigerator. The maximum or minimum temperatures reached was plus 32F and were kept in the refrigerator at plus 40.02F. Reportedly, the excursion duration was 9 minutes. No patient has been administered with the impacted vaccine. The reporter also informed that there were 3 doses, and one was given to a patient. It was reported that the dose administered to patient that was stored outside the fact sheet guidelines.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: used it past the 12 hours, administered to 3 patients today- 30Nov2021; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (used it past the 12 hours, administered to 3 patients today- 30Nov2021) in a 66-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 08-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 milliliter. On 30-Nov-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (used it past the 12 hours, administered to 3 patients today- 30Nov2021). On 30-Nov-2021, EXPIRED PRODUCT ADMINISTERED (used it past the 12 hours, administered to 3 patients today- 30Nov2021) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant drugs were not reported. Treatment medications were not provided.  It was reported that the vial was opened on 29-Nov-2021 and also reported that last shot was received from different pharmacy on 08-Apr-2021.   This case was linked to MOD-2021-403053 (Patient Link).
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Off label use, Product administration error
Clinical narrative: received Pfizer pediatric dose (10mcg) combined with 40mcg of Moderna vaccine; parent ended up with the Pfizer pediatric dose administered (10mcg) combined with 40mcg of Moderna vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of OFF LABEL USE (received Pfizer pediatric dose (10mcg) combined with 40mcg of Moderna vaccine) and PRODUCT ADMINISTRATION ERROR (parent ended up with the Pfizer pediatric dose administered (10mcg) combined with 40mcg of Moderna vaccine) in a 47-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027H21B) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 40 microgram. On 29-Nov-2021, the patient experienced OFF LABEL USE (received Pfizer pediatric dose (10mcg) combined with 40mcg of Moderna vaccine) and PRODUCT ADMINISTRATION ERROR (parent ended up with the Pfizer pediatric dose administered (10mcg) combined with 40mcg of Moderna vaccine). On 29-Nov-2021, OFF LABEL USE (received Pfizer pediatric dose (10mcg) combined with 40mcg of Moderna vaccine) and PRODUCT ADMINISTRATION ERROR (parent ended up with the Pfizer pediatric dose administered (10mcg) combined with 40mcg of Moderna vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   the patient was given Pfizer pediatric dose of 10 mcg by the pharmacist and then gave 40 mcg of a Moderna COVID-19 booster dose to equal out 50 mcg, Patient did not not experience any symptoms, No concomitant and treatment medication reported.   This case was linked to MOD21-167912 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 30-Nov-2021: the follow-up received contains significant information which includes Patient demographic updated and dose details updated.
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: several of my friends went through the same thing,similar knee pain like her; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (several of my friends went through the same thing,similar knee pain like her) 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 ARTHRALGIA (several of my friends went through the same thing,similar knee pain like her). At the time of the report, ARTHRALGIA (several of my friends went through the same thing,similar knee pain like her) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication details were reported. No treatment medication details were reported.  Crosslinked to MOD21-117465, MOD21-168423, MOD21-168424, and MOD21-168425
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: received vaccine past published expiry; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (received vaccine past published expiry) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 050e21a) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (received vaccine past published expiry). On 20-Oct-2021, EXPIRED PRODUCT ADMINISTERED (received vaccine past published expiry) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information was provided.  No treatment medication were provided.  Reporter wanted to know if the lot number 050e21a was or would be extended.  No adverse reactions reported.   This case was linked to MOD-2021-403096, MOD-2021-403113 (Patient Link).
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Vaccine administered to the patient past the 12 hours after the vial was punctured; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine administered to the patient past the 12 hours after the vial was punctured) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031H21A) for COVID-19 vaccination.     No Medical History information was reported.   On 14-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine administered to the patient past the 12 hours after the vial was punctured). On 30-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Vaccine administered to the patient past the 12 hours after the vial was punctured) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The reporter who was an HCP stated that the pharmacy opened the Moderna vial for booster doses on 29-Nov-2021 and they used it past the 12 hours. The patient received the booster dose on 30-Nov-2021.  It was reported that the vial was initially stored in the refrigerator on 15-Nov-2021 and the vial was first punctured on 29-Nov-2021 around 9:00 AM. The date of administration of vaccine was 30-Nov-2021 from 9:30 AM to 10:30 AM. The vial was stored back in the refrigerator post puncture. The reporter also stated that the vial didn't undergo any temperature excursions.  No Concomitant product use was reported. No treatment information was provided.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Accidental overdose
Clinical narrative: received a full dose instead of the booster; This spontaneous case was reported by a consumer and describes the occurrence of ACCIDENTAL OVERDOSE in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 01-Dec-2021, the patient 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 received second 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. On 01-Dec-2021, the patient experienced ACCIDENTAL OVERDOSE (received a full dose instead of the booster). On 01-Dec-2021, ACCIDENTAL OVERDOSE (received a full dose instead of the booster) had resolved.            No relevant concomitant medications were reported. Treatment information was unknown.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Accidental overdose, Expired product administered
Clinical narrative: patient received expired dose; patient received .5ml for booster; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patient received expired dose) and ACCIDENTAL OVERDOSE (patient received .5ml for booster) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 042B21A, 005C21A and 054C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 17-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 29-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (patient received expired dose) and ACCIDENTAL OVERDOSE (patient received .5ml for booster). On 29-Nov-2021, EXPIRED PRODUCT ADMINISTERED (patient received expired dose) and ACCIDENTAL OVERDOSE (patient received .5ml for booster) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided No treatment received by the patient   This case was linked to MOD-2021-402877 (Patient Link).
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Dyskinesia, Illness, Pain, Vaccination site erythema
Clinical narrative: couldn't move again after the 2nd dose; was in a lot of pain; she was very sick at the time; diamond shaped blister at the injection site that lasted for months; She also experienced red, diamond shaped blister at the injection site that lasted for months; she had a burning sensation; This spontaneous case was reported by a consumer and describes the occurrence of BURNING SENSATION (she had a burning sensation), DYSKINESIA (couldn't move again after the 2nd dose), PAIN (was in a lot of pain), ILLNESS (she was very sick at the time) and VACCINATION SITE VESICLES (diamond shaped blister at the injection site that lasted for months) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Allergy (highly allergic to a lot of things).    On 13-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Mar-2021, the patient experienced BURNING SENSATION (she had a burning sensation). On an unknown date, the patient experienced DYSKINESIA (couldn't move again after the 2nd dose), PAIN (was in a lot of pain), ILLNESS (she was very sick at the time), VACCINATION SITE VESICLES (diamond shaped blister at the injection site that lasted for months) and VACCINATION SITE ERYTHEMA (She also experienced red, diamond shaped blister at the injection site that lasted for months). At the time of the report, BURNING SENSATION (she had a burning sensation), DYSKINESIA (couldn't move again after the 2nd dose), PAIN (was in a lot of pain) and ILLNESS (she was very sick at the time) outcome was unknown and VACCINATION SITE VESICLES (diamond shaped blister at the injection site that lasted for months) and VACCINATION SITE ERYTHEMA (She also experienced red, diamond shaped blister at the injection site that lasted for months) 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.  Patient says that after the 2nd dose, she was out for 2 weeks. Her healthcare provider thinks that she may be allergic to the propyl glycol in the vaccine and that could have caused the reaction both times.   This case was linked to MOD-2021-403016 (Patient Link).
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site vesicles
Clinical narrative: couldn't move again after the 2nd dose; was in a lot of pain; she was very sick at the time; diamond shaped blister at the injection site that lasted for months; She also experienced red, diamond shaped blister at the injection site that lasted for months; she had a burning sensation; This spontaneous case was reported by a consumer and describes the occurrence of BURNING SENSATION (she had a burning sensation), DYSKINESIA (couldn't move again after the 2nd dose), PAIN (was in a lot of pain), ILLNESS (she was very sick at the time) and VACCINATION SITE VESICLES (diamond shaped blister at the injection site that lasted for months) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Allergy (highly allergic to a lot of things).    On 13-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Mar-2021, the patient experienced BURNING SENSATION (she had a burning sensation). On an unknown date, the patient experienced DYSKINESIA (couldn't move again after the 2nd dose), PAIN (was in a lot of pain), ILLNESS (she was very sick at the time), VACCINATION SITE VESICLES (diamond shaped blister at the injection site that lasted for months) and VACCINATION SITE ERYTHEMA (She also experienced red, diamond shaped blister at the injection site that lasted for months). At the time of the report, BURNING SENSATION (she had a burning sensation), DYSKINESIA (couldn't move again after the 2nd dose), PAIN (was in a lot of pain) and ILLNESS (she was very sick at the time) outcome was unknown and VACCINATION SITE VESICLES (diamond shaped blister at the injection site that lasted for months) and VACCINATION SITE ERYTHEMA (She also experienced red, diamond shaped blister at the injection site that lasted for months) 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.  Patient says that after the 2nd dose, she was out for 2 weeks. Her healthcare provider thinks that she may be allergic to the propyl glycol in the vaccine and that could have caused the reaction both times.   This case was linked to MOD-2021-403016 (Patient Link).
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Myalgia, Nausea
Clinical narrative: tired; nauseous; my arm was sore to the touch; headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE, FATIGUE, NAUSEA, and MYALGIA in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025A21A and 013M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Mar-2021, the patient experienced HEADACHE. On 11-Mar-2021, the patient experienced FATIGUE, NAUSEA, and MYALGIA. At the time of the report, HEADACHE, FATIGUE, NAUSEA, and MYALGIA outcome was unknown.            No concomitant medications were reported. No treatment medications were reported.   This case was linked to MOD-2021-403033, MOD-2021-403058 (Patient Link).
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: My arm was sore to the touch.; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (My arm was sore to the touch.) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Feb-2021, the patient experienced MYALGIA (My arm was sore to the touch.). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) at a dose of 500mg, about 3 in 24hrs. At the time of the report, MYALGIA (My arm was sore to the touch.) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       Concomitant medications were not reported.   This case was linked to MOD-2021-403057, MOD-2021-403033 (Patient Link).
Age: 19.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received vaccine after the 12 hours of expiry) in a 19-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 034F21A) for COVID-19 vaccination. No Medical History information was reported.    On 30-Nov-2021 at 8:30 AM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received vaccine after the 12 hours of expiry). On 30-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Patient received vaccine after the 12 hours of expiry) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant information was not reported. Treatment information was not reported.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Fatigue, Influenza like illness, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: Felt like he had the normal flu, not the COVID flu; He had no energy; Itching injection site; Tired/ Fatigued; Swollen injection site; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Felt like he had the normal flu, not the COVID flu), ASTHENIA (He had no energy), VACCINATION SITE PRURITUS (Itching injection site), FATIGUE (Tired/ Fatigued) and VACCINATION SITE SWELLING (Swollen injection site) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003A21A and 011M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (Felt like he had the normal flu, not the COVID flu), ASTHENIA (He had no energy), VACCINATION SITE PRURITUS (Itching injection site), FATIGUE (Tired/ Fatigued) and VACCINATION SITE SWELLING (Swollen injection site). At the time of the report, INFLUENZA LIKE ILLNESS (Felt like he had the normal flu, not the COVID flu), ASTHENIA (He had no energy), VACCINATION SITE PRURITUS (Itching injection site), FATIGUE (Tired/ Fatigued) and VACCINATION SITE SWELLING (Swollen injection site) outcome was unknown.            No concomitant medication was reported by the reporter. No treatment was reported by the reporter.   This case was linked to MOD-2021-403087 (Patient Link).
Age: 88.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: 19 patients received an expired booster; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (19 patients received an expired booster) in an 88-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (19 patients received an expired booster). On 30-Nov-2021, EXPIRED PRODUCT ADMINISTERED (19 patients received an expired booster) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medication was provided by the reporter. No treatment medication was provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 01-Dec-2021: Follow up received includes patient Information.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: received vaccine past published expiry; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (received vaccine past published expiry) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 050e21a) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (received vaccine past published expiry). On 20-Oct-2021, EXPIRED PRODUCT ADMINISTERED (received vaccine past published expiry) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   It was moved from freezer to refrigerator on date of administration.  No concomitant medications were reported.  No treatment information was reported.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In April 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In April 2021, the patient experienced HEADACHE (headache). In 2021, HEADACHE (headache) had resolved.            No concomitant medication was reported. The treatment information was unknown
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Condition aggravated, Fatigue, Influenza like illness, Pruritus
Clinical narrative: ITCHING; arm is swollen; he does not feel like doing anything; Fatigue; Tired; Swollen injection site; He had no energy; Itching injection site; felt like he had the normal flu, not the COVID flu; Same side effect with booster but worse; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (felt like he had the normal flu, not the COVID flu), CONDITION AGGRAVATED (Same side effect with booster but worse), PRURITUS (ITCHING), ASTHENIA (He had no energy) and VACCINATION SITE PRURITUS (Itching injection site) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039909) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 27-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In November 2021, the patient experienced INFLUENZA LIKE ILLNESS (felt like he had the normal flu, not the COVID flu), CONDITION AGGRAVATED (Same side effect with booster but worse), ASTHENIA (He had no energy), VACCINATION SITE PRURITUS (Itching injection site), FATIGUE (Fatigue), FATIGUE (Tired) and VACCINATION SITE SWELLING (Swollen injection site). On 30-Nov-2021, the patient experienced PRURITUS (ITCHING), VACCINATION SITE SWELLING (arm is swollen) and FATIGUE (he does not feel like doing anything). On 29-Nov-2021, INFLUENZA LIKE ILLNESS (felt like he had the normal flu, not the COVID flu), CONDITION AGGRAVATED (Same side effect with booster but worse), ASTHENIA (He had no energy), VACCINATION SITE PRURITUS (Itching injection site), FATIGUE (Fatigue), FATIGUE (Tired) and VACCINATION SITE SWELLING (Swollen injection site) had resolved. At the time of the report, PRURITUS (ITCHING), VACCINATION SITE SWELLING (arm is swollen) and FATIGUE (he does not feel like doing anything) had not resolved.            There are no treatment or concomitant medications provided. The patient reported With the Booster dose, he had the same side effect, but it was worse this time.   This case was linked to MOD-2021-403070 (Patient Link).
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pruritus, Vaccination site swelling
Clinical narrative: ITCHING; arm is swollen; he does not feel like doing anything; Fatigue; Tired; Swollen injection site; He had no energy; Itching injection site; felt like he had the normal flu, not the COVID flu; Same side effect with booster but worse; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (felt like he had the normal flu, not the COVID flu), CONDITION AGGRAVATED (Same side effect with booster but worse), PRURITUS (ITCHING), ASTHENIA (He had no energy) and VACCINATION SITE PRURITUS (Itching injection site) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039909) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 27-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In November 2021, the patient experienced INFLUENZA LIKE ILLNESS (felt like he had the normal flu, not the COVID flu), CONDITION AGGRAVATED (Same side effect with booster but worse), ASTHENIA (He had no energy), VACCINATION SITE PRURITUS (Itching injection site), FATIGUE (Fatigue), FATIGUE (Tired) and VACCINATION SITE SWELLING (Swollen injection site). On 30-Nov-2021, the patient experienced PRURITUS (ITCHING), VACCINATION SITE SWELLING (arm is swollen) and FATIGUE (he does not feel like doing anything). On 29-Nov-2021, INFLUENZA LIKE ILLNESS (felt like he had the normal flu, not the COVID flu), CONDITION AGGRAVATED (Same side effect with booster but worse), ASTHENIA (He had no energy), VACCINATION SITE PRURITUS (Itching injection site), FATIGUE (Fatigue), FATIGUE (Tired) and VACCINATION SITE SWELLING (Swollen injection site) had resolved. At the time of the report, PRURITUS (ITCHING), VACCINATION SITE SWELLING (arm is swollen) and FATIGUE (he does not feel like doing anything) had not resolved.            There are no treatment or concomitant medications provided. The patient reported With the Booster dose, he had the same side effect, but it was worse this time.   This case was linked to MOD-2021-403070 (Patient Link).