chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 69.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Cerebrovascular accident, Inappropriate schedule of product administration, Pain in extremity
Clinical narrative: didn't feel good,felt crappy; laid around and fatigue.; This spontaneous case was reported by a patient and describes the occurrence of FEELING ABNORMAL (didn't feel good,felt crappy) and FATIGUE (laid around and fatigue.) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included FLUOXETINE HYDROCHLORIDE (PROZAC), MULTIVITAMIN [VITAMINS NOS] and ROSUVASTATIN CALCIUM (CRESTOR) for an unknown indication.    On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced FEELING ABNORMAL (didn't feel good,felt crappy) and FATIGUE (laid around and fatigue.). At the time of the report, FEELING ABNORMAL (didn't feel good,felt crappy) and FATIGUE (laid around and fatigue.) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No treatment details were reported.   This case was linked to MOD-2022-577184, MOD-2022-577206, MOD-2022-577207 (Patient Link).
Age: 69.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Fatigue, Feeling abnormal
Clinical narrative: didn't feel good,felt crappy; laid around and fatigue.; This spontaneous case was reported by a patient and describes the occurrence of FEELING ABNORMAL (didn't feel good,felt crappy) and FATIGUE (laid around and fatigue.) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included FLUOXETINE HYDROCHLORIDE (PROZAC), MULTIVITAMIN [VITAMINS NOS] and ROSUVASTATIN CALCIUM (CRESTOR) for an unknown indication.    On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced FEELING ABNORMAL (didn't feel good,felt crappy) and FATIGUE (laid around and fatigue.). At the time of the report, FEELING ABNORMAL (didn't feel good,felt crappy) and FATIGUE (laid around and fatigue.) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No treatment details were reported.   This case was linked to MOD-2022-577184, MOD-2022-577206, MOD-2022-577207 (Patient Link).
Age: 69.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Fatigue, Feeling abnormal, Inappropriate schedule of product administration
Clinical narrative: didn't feel good,felt crappy; laid around and fatigue.; This spontaneous case was reported by a patient and describes the occurrence of FEELING ABNORMAL (didn't feel good,felt crappy) and FATIGUE (laid around and fatigue.) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included FLUOXETINE HYDROCHLORIDE (PROZAC), MULTIVITAMIN [VITAMINS NOS] and ROSUVASTATIN CALCIUM (CRESTOR) for an unknown indication.    On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced FEELING ABNORMAL (didn't feel good,felt crappy) and FATIGUE (laid around and fatigue.). At the time of the report, FEELING ABNORMAL (didn't feel good,felt crappy) and FATIGUE (laid around and fatigue.) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No treatment details were reported.   This case was linked to MOD-2022-577184, MOD-2022-577206, MOD-2022-577207 (Patient Link).
Age: 69.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Cerebrovascular accident, Inappropriate schedule of product administration, Pain in extremity
Clinical narrative: didn't feel good,felt crappy; laid around and fatigue; first dose: 02April2021 and second dose: 02Nov2021; This spontaneous case was reported by a patient and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (first dose: 02April2021 and second dose: 02Nov2021), FEELING ABNORMAL (didn't feel good,felt crappy) and FATIGUE (laid around and fatigue) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939905) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included FLUOXETINE HYDROCHLORIDE (PROZAC), MULTIVITAMINS [VITAMINS NOS] and ROSUVASTATIN CALCIUM (CRESTOR) for an unknown indication.   On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Nov-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Nov-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (first dose: 02April2021 and second dose: 02Nov2021). On an unknown date, the patient experienced FEELING ABNORMAL (didn't feel good,felt crappy) and FATIGUE (laid around and fatigue). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (first dose: 02April2021 and second dose: 02Nov2021), FEELING ABNORMAL (didn't feel good,felt crappy) and FATIGUE (laid around and fatigue) outcome was unknown.            No treatment medications was reported.   This case was linked to MOD-2022-577184, MOD-2022-577205, MOD-2022-577207 (Patient Link).
Age: 69.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Fatigue, Feeling abnormal
Clinical narrative: didn't feel good,felt crappy; laid around and fatigue; first dose: 02April2021 and second dose: 02Nov2021; This spontaneous case was reported by a patient and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (first dose: 02April2021 and second dose: 02Nov2021), FEELING ABNORMAL (didn't feel good,felt crappy) and FATIGUE (laid around and fatigue) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939905) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included FLUOXETINE HYDROCHLORIDE (PROZAC), MULTIVITAMINS [VITAMINS NOS] and ROSUVASTATIN CALCIUM (CRESTOR) for an unknown indication.   On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Nov-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Nov-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (first dose: 02April2021 and second dose: 02Nov2021). On an unknown date, the patient experienced FEELING ABNORMAL (didn't feel good,felt crappy) and FATIGUE (laid around and fatigue). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (first dose: 02April2021 and second dose: 02Nov2021), FEELING ABNORMAL (didn't feel good,felt crappy) and FATIGUE (laid around and fatigue) outcome was unknown.            No treatment medications was reported.   This case was linked to MOD-2022-577184, MOD-2022-577205, MOD-2022-577207 (Patient Link).
Age: 69.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Fatigue, Feeling abnormal, Inappropriate schedule of product administration
Clinical narrative: didn't feel good,felt crappy; laid around and fatigue; first dose: 02April2021 and second dose: 02Nov2021; This spontaneous case was reported by a patient and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (first dose: 02April2021 and second dose: 02Nov2021), FEELING ABNORMAL (didn't feel good,felt crappy) and FATIGUE (laid around and fatigue) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939905) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included FLUOXETINE HYDROCHLORIDE (PROZAC), MULTIVITAMINS [VITAMINS NOS] and ROSUVASTATIN CALCIUM (CRESTOR) for an unknown indication.   On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Nov-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Nov-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (first dose: 02April2021 and second dose: 02Nov2021). On an unknown date, the patient experienced FEELING ABNORMAL (didn't feel good,felt crappy) and FATIGUE (laid around and fatigue). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (first dose: 02April2021 and second dose: 02Nov2021), FEELING ABNORMAL (didn't feel good,felt crappy) and FATIGUE (laid around and fatigue) outcome was unknown.            No treatment medications was reported.   This case was linked to MOD-2022-577184, MOD-2022-577205, MOD-2022-577207 (Patient Link).
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Poor quality product administered, Product temperature excursion issue
Clinical narrative: Vaccine administered after more than 1 temperature excursion; Vaccine administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) in a 55-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 035C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Nov-2021 at 11:09 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 03-Nov-2021 at 11:09 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The patient age was reported as 55.84   Concomitant products were not provided.  On 03-Nov-2021, Excursion time were at 10 AM was 35, total doses given for the day was 117 , condition of vaccine prior to vaccination was not frozen, vaccine was moved to fridge on 05-Oct-2021, vial was moved to clinic on 03-Nov-2021. 6 vials was moved to clinic. Vaccine BUD date was 05-Nov-2021.  It was reported that unknown number of patients were administered with vaccines that experienced more than 1 temperature excursion during 33 weeks in 2021. The explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 hour and a half approximately, when the temperature data logger registered 34- or 35-degree F.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic. Temperature recordings were taken by using a  traceable temperature monitor at every hour. After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  No treatment information was provided.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Treatment of COVID-19 - Sneezing and nasal congestion, runny nose; Lack of drug effect; This spontaneous case was reported by a physician and describes the occurrence of COVID-19 (Treatment of COVID-19 - Sneezing and nasal congestion, runny nose) and DRUG INEFFECTIVE (Lack of drug effect) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017F21A, 022C21A, 012M21A and 011L20A) for COVID-19 vaccination.     The patient's past medical history included Allergy NOS (Name of Drug as Reported-No).   On 01-Jan-2021 at 1:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Jan-2021 at 1:00 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Nov-2021 at 1:00 PM, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Apr-2022 at 1:00 PM, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced COVID-19 (Treatment of COVID-19 - Sneezing and nasal congestion, runny nose) and DRUG INEFFECTIVE (Lack of drug effect). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 10-May-2022 to 15-May-2022 for COVID-19 treatment, at an unspecified dose and frequency. At the time of the report, COVID-19 (Treatment of COVID-19 - Sneezing and nasal congestion, runny nose) and DRUG INEFFECTIVE (Lack of drug effect) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.  Company comment: This case concerns a 75-year-old male patient with no relevant medical history reported, who experienced the adverse event of special interest of COVID-19 an unknown date after the second dose of mRNA-1273. The patient received treatment with NIRMATRELVIR, RITONAVIR. Outcome was reported as unknown. The benefit-risk relationship of mRNA-1273 is not affected by this report. Sender's Comments: This case concerns a 75-year-old male patient with no relevant medical history reported, who experienced the adverse event of special interest of COVID-19 an unknown date after the second dose of mRNA-1273. The patient received treatment with NIRMATRELVIR, RITONAVIR. Outcome was reported as unknown. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Poor quality product administered, Product temperature excursion issue
Clinical narrative: Vaccine administered after more than 1 temperature excursion; Vaccine administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Jun-2021 at 11:08 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 22-Jun-2021 at 11:08 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The patient age was reported as 55.80  Concomitant products were not provided.  On 22-Jun-2021, Excursion time were at 08 AM was 35, total doses given for the day was 36 , condition of vaccine prior to vaccination was not frozen, vaccine was moved to fridge on 27-May-2021, vial was moved to clinic on 22-Jun-2021. 4 vials was moved to clinic. Vaccine BUD date was 26-Jun-2021.  It was reported that unknown number of patients were administered with vaccines that experienced more than 1 temperature excursion during 33 weeks in 2021. The HCP explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 hour and a half approximately, when the temperature data logger registered 34- or 35-degree F.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic. Temperature recordings were taken by using a traceable temperature monitor at every hour. After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  No treatment information was provided.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Fatigue, Feeling abnormal, Feeling cold, Immunisation reaction
Clinical narrative: She states that today, 26MAY2022, she still does not feel up to her normal self; Tired; Eight hours after the 2nd booster, she felt sick and she was sick all day; She was feeling Cold; Shaking inside and outside; No energy; Slept all day; This spontaneous case was reported by a patient and describes the occurrence of IMMUNISATION REACTION (Eight hours after the 2nd booster, she felt sick and she was sick all day), FEELING COLD (She was feeling Cold), TREMOR (Shaking inside and outside), ASTHENIA (No energy) and SOMNOLENCE (Slept all day) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004M21A, 031A21A, 014M20A and 031H21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Apr-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 24-May-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-May-2022, the patient experienced IMMUNISATION REACTION (Eight hours after the 2nd booster, she felt sick and she was sick all day), FEELING COLD (She was feeling Cold), TREMOR (Shaking inside and outside), ASTHENIA (No energy), SOMNOLENCE (Slept all day) and FATIGUE (Tired). On 26-May-2022, the patient experienced FEELING ABNORMAL (She states that today, 26MAY2022, she still does not feel up to her normal self). On 25-May-2022, IMMUNISATION REACTION (Eight hours after the 2nd booster, she felt sick and she was sick all day) had resolved. At the time of the report, FEELING COLD (She was feeling Cold), TREMOR (Shaking inside and outside), ASTHENIA (No energy), SOMNOLENCE (Slept all day), FEELING ABNORMAL (She states that today, 26MAY2022, she still does not feel up to her normal self) and FATIGUE (Tired) had not resolved.            No concomitant medication reported.  Eight hours after the 2nd booster, patient felt sick and was sick all day. Patient was feeling cold, shaking inside and outside, tired, no energy and slept all day. Patient stated that today ,26MAY2022. Patient still did not feel up to the normal self. The patient reported that due to event experienced could not celebrate birthday which was on 26-May-2022. Patient did not contacted the doctor.  No treatment medication details reported.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Somnolence, Tremor
Clinical narrative: She states that today, 26MAY2022, she still does not feel up to her normal self; Tired; Eight hours after the 2nd booster, she felt sick and she was sick all day; She was feeling Cold; Shaking inside and outside; No energy; Slept all day; This spontaneous case was reported by a patient and describes the occurrence of IMMUNISATION REACTION (Eight hours after the 2nd booster, she felt sick and she was sick all day), FEELING COLD (She was feeling Cold), TREMOR (Shaking inside and outside), ASTHENIA (No energy) and SOMNOLENCE (Slept all day) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004M21A, 031A21A, 014M20A and 031H21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Apr-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 24-May-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-May-2022, the patient experienced IMMUNISATION REACTION (Eight hours after the 2nd booster, she felt sick and she was sick all day), FEELING COLD (She was feeling Cold), TREMOR (Shaking inside and outside), ASTHENIA (No energy), SOMNOLENCE (Slept all day) and FATIGUE (Tired). On 26-May-2022, the patient experienced FEELING ABNORMAL (She states that today, 26MAY2022, she still does not feel up to her normal self). On 25-May-2022, IMMUNISATION REACTION (Eight hours after the 2nd booster, she felt sick and she was sick all day) had resolved. At the time of the report, FEELING COLD (She was feeling Cold), TREMOR (Shaking inside and outside), ASTHENIA (No energy), SOMNOLENCE (Slept all day), FEELING ABNORMAL (She states that today, 26MAY2022, she still does not feel up to her normal self) and FATIGUE (Tired) had not resolved.            No concomitant medication reported.  Eight hours after the 2nd booster, patient felt sick and was sick all day. Patient was feeling cold, shaking inside and outside, tired, no energy and slept all day. Patient stated that today ,26MAY2022. Patient still did not feel up to the normal self. The patient reported that due to event experienced could not celebrate birthday which was on 26-May-2022. Patient did not contacted the doctor.  No treatment medication details reported.
Age: 20.0
Sex: M
Vaccine: COVID19
Symptoms: Mechanical urticaria
Clinical narrative: Dermatographia; This spontaneous case was reported by a patient and describes the occurrence of MECHANICAL URTICARIA (Dermatographia) in a 20-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013H21B, 033B21A and 004C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 01-May-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 05-Jan-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Jan-2022, the patient experienced MECHANICAL URTICARIA (Dermatographia). At the time of the report, MECHANICAL URTICARIA (Dermatographia) had not resolved.            No concomitant medications were taken at the time of event onset. Patient states that now he is on regular medication. Patient was given antiallergic medication for this symptom. He does not remember the name of this medication, but he only took it for one week because he did not see improvement. He is experiencing the symptoms since 4 months.
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Fatigue, Hypertension
Clinical narrative: Blood pressure high; Tired/Tiredness; This spontaneous case was reported by a consumer and describes the occurrence of HYPERTENSION (Blood pressure high) and FATIGUE (Tired/Tiredness) in a female patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Rheumatoid arthritis.    Concurrent medical conditions included Rheumatoid arthritis.   On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form On an unknown date, received first dose of mRNA-1273 (Spikevax) (Intramuscular) dosage was changed to 1 dosage form. and ADALIMUMAB (HUMIRA) (Subcutaneous) UNK, Solution for injection in pre-filled pen citrate free. On an unknown date, the patient experienced HYPERTENSION (Blood pressure high) and FATIGUE (Tired/Tiredness). At the time of the report, HYPERTENSION (Blood pressure high) and FATIGUE (Tired/Tiredness) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: high (High) High.     The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown.       It was unknown if patient was enrolled in a COVID-19 vaccine trial.  No concomitant medication was reported by reporter.  No treatment medication was reported by reporter.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Poor quality product administered, Product temperature excursion issue
Clinical narrative: Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 55-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Apr-2021 at 11:47 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 15-Apr-2021 at 11:47 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Age of patient was reported as 55.44 for dose administered on 15-Apr-2021.  No concomitant medications were reported.  Batch number 044B21A underwent temperature excursion on 15-Apr-2021 with temperature 34 degrees Fahrenheit at 09:00 AM. This vial was moved to fridge on 06-Apr-2021 and beyond use date for the vial was reported as 09-May-2021. Product moved to clinic on 15-Apr-2021.  Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination at around 2021. Vials were only punctured right before administration. Vaccines were not frozen at time of administration. It was reported that each time a vial was put into a cooler, sometimes there was a period of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34- or 35-degree Fahrenheit. Temperature recordings were taken using a traceable temperature monitor at every hour.  No treatment medications were reported.   This case was linked to MOD-2022-566976 (Patient Link).
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pruritus, Vaccination site rash, Vaccination site warmth
Clinical narrative: Warm; Itchy; Small, patch mark or rash that appeared about 1 inch down her arm from her injection site; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE WARMTH (Warm), VACCINATION SITE PRURITUS (Itchy) and VACCINATION SITE RASH (Small, patch mark or rash that appeared about 1 inch down her arm from her injection site) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038A22A, 065F21A, 007C21A and 042B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 24-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 50 microgram. On 23-May-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 50 microgram. On 24-May-2022, the patient experienced VACCINATION SITE WARMTH (Warm), VACCINATION SITE PRURITUS (Itchy) and VACCINATION SITE RASH (Small, patch mark or rash that appeared about 1 inch down her arm from her injection site). At the time of the report, VACCINATION SITE WARMTH (Warm), VACCINATION SITE PRURITUS (Itchy) and VACCINATION SITE RASH (Small, patch mark or rash that appeared about 1 inch down her arm from her injection site) was resolving.            No concomitant medication was reported.  Patient did not experience any symptoms after the first 3 doses of the vaccine.   The day after the dose on 23-May-2022, patient started to experience a warm, itchy, small, patch mark or rash that appeared about 1 inch down arm from injection site. Patient has not taken any medications or treatments to try and help with that. It has been getting smaller since it started, but has not resolved.
Sex: F
Vaccine: COVID19
Symptoms: Ocular discomfort
Clinical narrative: Sensation of pressure in eye; This spontaneous case was reported by a consumer and describes the occurrence of OCULAR DISCOMFORT (Sensation of pressure in eye) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Ankylosing spondylitis.    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, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. and ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate Free,Solution for injection in pre filled pen. On an unknown date, the patient experienced OCULAR DISCOMFORT (Sensation of pressure in eye). At the time of the report, OCULAR DISCOMFORT (Sensation of pressure in eye) was resolving.     Concomitant product use was not provided by the reporter.  Treatment information was not provided.  It was unknown if patient was enrolled in a COVID-19 Vaccine trail.
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Accidental underdose
Clinical narrative: A patient received a booster dose instead of the first dose of the Moderna Vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of ACCIDENTAL UNDERDOSE (A patient received a booster dose instead of the first dose of the Moderna Vaccine) in a 28-year-old male patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) .25 milliliter. On an unknown date, the patient experienced ACCIDENTAL UNDERDOSE (A patient received a booster dose instead of the first dose of the Moderna Vaccine). At the time of the report, ACCIDENTAL UNDERDOSE (A patient received a booster dose instead of the first dose of the Moderna Vaccine) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown.   For mRNA-1273 (Spikevax) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication were given. No treatment information were given.  A patient received a booster dose instead of the first dose of the Moderna Vaccine, the nurse gave the patient a .25 mL dose instead of a .5 mL dose. HCP just wants to confirm if patient had to be administered with.25 mL so the 2 doses can count as one.  No adverse events were reported as a result of this misadministration.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Pityriasis rosea
Clinical narrative: Pityriasis Rosea; This spontaneous case was reported by a pharmacist and describes the occurrence of PITYRIASIS ROSEA (Pityriasis Rosea) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003K21-2A, 050E21A, 027A21A and 029L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 18-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 milliliter. On 31-Mar-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-Apr-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PITYRIASIS ROSEA (Pityriasis Rosea). The patient was treated with PREDNISONE (oral) for Pityriasis rosea, at a dose of tapering dose for up to 12 days. At the time of the report, PITYRIASIS ROSEA (Pityriasis Rosea) was resolving.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant product use was provided.  The patient noticed a rash(spot), which was later diagnosed as Pityriasis Rosea (a viral immune related rash) which presented on his chest. This "multiplied" throughout his trunk to his chest and back. It had continued up until at the time of reporting. The patient spoked to his primary care doctor and a dermatologist. Following the dermatologist appointment 3 days ago, he was prescribed a tapering dose of oral prednisone for up to 12 days. The taper was as follows 40mg for 3 days, 30mg for 3 days, 20mg for 3 days, and 10 mg for 3 days. He started the 30mg for 3 day dosage at the time of reporting. His rash has been improving after taking this medication. He also tried some over the counter lotions and creams that did not provide improvement prior to taking the prednisone.   This case was linked to MOD-2021-353240, MOD-2021-353257 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Interchange of vaccine products
Clinical narrative: COVID-19; Interchange of vaccine products; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19) and INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: J & J (Dose 1 with unknown batch number). Past adverse reactions to the above products included No adverse event with J & J. Concurrent medical conditions included Hypercholesterolemia and Drug allergy. Concomitant products included SIMVASTATIN for an unknown indication.    On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (COVID-19) and INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from May 2022 to May 2022 for COVID-19 treatment, at an unspecified dose and frequency. At the time of the report, COVID-19 (COVID-19) had not resolved and INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products) outcome was unknown.            The patient was on other medications/products within 2 weeks of starting COVID-19 treatment. The patient had previously received COVID-19 Vaccine. It was stated as, 48 hours after finishing Paxlovid, Covid-19 symptoms returned and were much more severe than initial symptoms.  Company Comment: This spontaneous case concerns a patient of an unknown age and gender with no relevant medical history reported, who experienced the unexpected non-serious AESI event of COVID-19 unspecified days after receiving second dose of mRNA-1273 vaccine. It was reported that patient started with Paxlovid and 48 hours after finishing Paxlovid, Covid symptoms returned and were much more severe than initial symptoms. Patient was noted to have received a dose with J & J prior to current vaccination (Interchange of vaccine products). The current pandemic situation of COVID-19 may remain as confounder to the event Covid-19. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a patient of an unknown age and gender with no relevant medical history reported, who experienced the unexpected non-serious AESI event of COVID-19 unspecified days after receiving second dose of mRNA-1273 vaccine. It was reported that patient started with Paxlovid and 48 hours after finishing Paxlovid, Covid symptoms returned and were much more severe than initial symptoms. Patient was noted to have received a dose with J & J prior to current vaccination (Interchange of vaccine products). The current pandemic situation of COVID-19 may remain as confounder to the event Covid-19. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Dysgeusia, Fall, Feeding disorder
Clinical narrative: I ate a saltine cracker & the taste blew me away. It tasted so salty. I could taste salt again.; It knocked me flat; I couldn't eat; This spontaneous case was reported by a patient and describes the occurrence of FALL (It knocked me flat), FEEDING DISORDER (I couldn't eat) and DYSGEUSIA (I ate a saltine cracker & the taste blew me away. It tasted so salty. I could taste salt again.) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037A22B) for COVID-19 vaccination.     Concurrent medical conditions included Environmental allergy.    On 23-May-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-May-2022, the patient experienced FALL (It knocked me flat) and FEEDING DISORDER (I couldn't eat). On 25-May-2022, the patient experienced DYSGEUSIA (I ate a saltine cracker & the taste blew me away. It tasted so salty. I could taste salt again.). At the time of the report, FALL (It knocked me flat) and FEEDING DISORDER (I couldn't eat) had resolved and DYSGEUSIA (I ate a saltine cracker & the taste blew me away. It tasted so salty. I could taste salt again.) was resolving.            Other relevant medical history information included patient received the shingles shot on 23-MAY-2022. No concomitant medications were reported. No treatment information was provided.   This case was linked to MOD-2022-577824 (Patient Link).
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Dysgeusia
Clinical narrative: Metallic taste in mouth; Diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of DYSGEUSIA (Metallic taste in mouth) and DIARRHOEA (Diarrhea) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product NIRMATRELVIR, RITONAVIR (PAXLOVID) for COVID-19 treatment.    Previously administered products included for Drug use for unknown indication: Codeine. Past adverse reactions to the above products included Allergy with Codeine. Concurrent medical conditions included Psoriasis and Psoriatic arthritis.   On 08-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-May-2022, the patient started NIRMATRELVIR, RITONAVIR (PAXLOVID) (unknown route) at an unspecified dose. On 22-May-2022, the patient experienced DYSGEUSIA (Metallic taste in mouth) and DIARRHOEA (Diarrhea). At the time of the report, DYSGEUSIA (Metallic taste in mouth) and DIARRHOEA (Diarrhea) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant drug reported.  Patient was taking Paxlovid for COVID-19 Treatment.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Ankylosing spondylitis, Vaccination site pain
Clinical narrative: ANKYLOSING SPONDYLITIS FLARE UP; Sore arm from Covid vaccine; This spontaneous case was reported by a consumer and describes the occurrence of ANKYLOSING SPONDYLITIS (ANKYLOSING SPONDYLITIS FLARE UP) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Ankylosing spondylitis.    No Medical History information was reported.   In May 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In June 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In December 2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate free. On an unknown date, the patient experienced ANKYLOSING SPONDYLITIS (ANKYLOSING SPONDYLITIS FLARE UP) (seriousness criterion medically significant) and VACCINATION SITE PAIN (Sore arm from Covid vaccine). At the time of the report, ANKYLOSING SPONDYLITIS (ANKYLOSING SPONDYLITIS FLARE UP) had not resolved and VACCINATION SITE PAIN (Sore arm from Covid vaccine) outcome was unknown.            No concomitant medications were reported.  The daily dose of HUMIRA (Solution for injection in pre-filled pen) (ADALIMUMAB) was reported as Citrate free.  The daily dose of Moderna Covid-19 Vaccine was reported as 1 in 1 once.  The reporter's causality for the events of ankylosing spondylitis flare up and sore arm from COVID Vaccine with HUMIRA (ADALIMUMAB)was not provided.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  No treatment medications were reported. COMPANY COMMENT: This is an spontaneous case concerning a female patient born in 1964 with medical history of Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Ankylosing spondylitis, vaccinated with Moderna COVID-19 Vaccine on May, June and December 2021 who experienced the unexpected  event of ANKYLOSING SPONDYLITIS (seriousness criterion medically significant) and other expected event unknown days of 3rd  dose of  mRNA-1273 vaccine. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: COMPANY COMMENT: This is an spontaneous case concerning a female patient born in 1964 with medical history of Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Ankylosing spondylitis, vaccinated with Moderna COVID-19 Vaccine on May, June and December 2021 who experienced the unexpected  event of ANKYLOSING SPONDYLITIS (seriousness criterion medically significant) and other expected event unknown days of 3rd  dose of  mRNA-1273 vaccine. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Sex: M
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Rash on stomach/Rash trunk/rash; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Rash on stomach/Rash trunk/rash) in an elderly male patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.    Co-suspect product included non-company product RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) for Plaque psoriasis, Psoriasis and Psoriatic arthritis.    Concurrent medical conditions included Plaque psoriasis (MODERATE TO SEVERE CHRONIC PLAQUE), Psoriasis and Psoriatic arthritis.   On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form and RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) (unknown route) at an unspecified dose. On an unknown date, the patient experienced RASH (Rash on stomach/Rash trunk/rash). At the time of the report, RASH (Rash on stomach/Rash trunk/rash) had not resolved.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       Concomitant medications were not reported.  It was unknown if the patient was enrolled in clinical trail.  Treatment information was not reported.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Taste disorder
Clinical narrative: I couldn't taste salt anymore.; This spontaneous case was reported by a consumer and describes the occurrence of TASTE DISORDER (I couldn't taste salt anymore.) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 064H21A) for COVID-19 vaccination.     Concurrent medical conditions included Environmental allergy.    On 01-Dec-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced TASTE DISORDER (I couldn't taste salt anymore.). At the time of the report, TASTE DISORDER (I couldn't taste salt anymore.) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No concomitant medications were reported. The patient stated that the AE has recovered and the symptoms had been improved. No treatment medications were provided.   This case was linked to MOD-2022-577298, MOD-2022-577829 (Patient Link).
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Patient administered first dose on 01-Dec-2020 and second dose on 16-Mar-2021/Extended period between 1st & 2nd doses.; This spontaneous case was reported by a patient and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient administered first dose on 01-Dec-2020 and second dose on 16-Mar-2021/Extended period between 1st & 2nd doses.) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040A21A and 064H21A) for COVID-19 vaccination.     Concurrent medical conditions included Environmental allergy.   On 01-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Mar-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient administered first dose on 01-Dec-2020 and second dose on 16-Mar-2021/Extended period between 1st & 2nd doses.). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient administered first dose on 01-Dec-2020 and second dose on 16-Mar-2021/Extended period between 1st & 2nd doses.) outcome was unknown.            No information on concomitant medication was reported. No information on treatment medications was reported.   This case was linked to MOD-2022-577298, MOD-2022-577824 (Patient Link).