chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Cardiovascular disorder, Chills, Fatigue, Hypoaesthesia
Clinical narrative: Circulatory problems; Numbness in feet; Lockjaw; Weakness; Tiredness; Cold chills; This spontaneous case was reported by a consumer and describes the occurrence of CARDIOVASCULAR DISORDER (Circulatory problems), HYPOAESTHESIA (Numbness in feet), TRISMUS (Lockjaw), ASTHENIA (Weakness) and FATIGUE (Tiredness) in a 42-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 048A21A and 022M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included MONTELUKAST SODIUM (SINGULAIR), MONTELUKAST and ALBUTEROL [SALBUTAMOL] for an unknown indication.   On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Apr-2021, the patient experienced CARDIOVASCULAR DISORDER (Circulatory problems), HYPOAESTHESIA (Numbness in feet), TRISMUS (Lockjaw), ASTHENIA (Weakness), FATIGUE (Tiredness) and CHILLS (Cold chills). At the time of the report, CARDIOVASCULAR DISORDER (Circulatory problems), HYPOAESTHESIA (Numbness in feet), TRISMUS (Lockjaw), ASTHENIA (Weakness), FATIGUE (Tiredness) and CHILLS (Cold chills) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment medication details was provided.  The patient experienced tiredness, weakness, cold chills and circulatory problems after receiving the first and second dose. Patient also had some numbness in feet as well as lockjaw. These side effects seemed to last for a while. It took 2-3 weeks and maybe about a month to resolve.   This case was linked to MOD-2021-390859, MOD-2021-056268 (Patient Link).
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Trismus
Clinical narrative: Circulatory problems; Numbness in feet; Lockjaw; Weakness; Tiredness; Cold chills; This spontaneous case was reported by a consumer and describes the occurrence of CARDIOVASCULAR DISORDER (Circulatory problems), HYPOAESTHESIA (Numbness in feet), TRISMUS (Lockjaw), ASTHENIA (Weakness) and FATIGUE (Tiredness) in a 42-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 048A21A and 022M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included MONTELUKAST SODIUM (SINGULAIR), MONTELUKAST and ALBUTEROL [SALBUTAMOL] for an unknown indication.   On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Apr-2021, the patient experienced CARDIOVASCULAR DISORDER (Circulatory problems), HYPOAESTHESIA (Numbness in feet), TRISMUS (Lockjaw), ASTHENIA (Weakness), FATIGUE (Tiredness) and CHILLS (Cold chills). At the time of the report, CARDIOVASCULAR DISORDER (Circulatory problems), HYPOAESTHESIA (Numbness in feet), TRISMUS (Lockjaw), ASTHENIA (Weakness), FATIGUE (Tiredness) and CHILLS (Cold chills) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment medication details was provided.  The patient experienced tiredness, weakness, cold chills and circulatory problems after receiving the first and second dose. Patient also had some numbness in feet as well as lockjaw. These side effects seemed to last for a while. It took 2-3 weeks and maybe about a month to resolve.   This case was linked to MOD-2021-390859, MOD-2021-056268 (Patient Link).
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Chills, Cold burn, Pain in extremity, Pain of skin
Clinical narrative: Pain in the arm , both arms; Burning sensation from the shoulder all the way to the elbow of both arms/a burning sensation from the hip down and is getting close to the knees; Cold sensation from the shoulder all the way to the elbow of both arms/a cold sensation from the hip down and is getting close to the knees.; Skin hurt; Cold burn; Shivery feeling from the shoulder all the way to the elbow of both arms/shivery feeling from the hip down and is getting close to the knees/ shivering; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Pain in the arm , both arms), BURNING SENSATION (Burning sensation from the shoulder all the way to the elbow of both arms/a burning sensation from the hip down and is getting close to the knees), PERIPHERAL COLDNESS (Cold sensation from the shoulder all the way to the elbow of both arms/a cold sensation from the hip down and is getting close to the knees.), PAIN OF SKIN (Skin hurt) and COLD BURN (Cold burn) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013F21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Previously administered products included for COVID-19 vaccination: J and J COVID-19 Vaccine on 30-Mar-2021. Past adverse reactions to the above products included No adverse event with J and J COVID-19 Vaccine. Concomitant products included VITAMINS NOS for an unknown indication.    On 17-Nov-2021 at 5:30 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Nov-2021, the patient experienced PAIN IN EXTREMITY (Pain in the arm , both arms), BURNING SENSATION (Burning sensation from the shoulder all the way to the elbow of both arms/a burning sensation from the hip down and is getting close to the knees), PERIPHERAL COLDNESS (Cold sensation from the shoulder all the way to the elbow of both arms/a cold sensation from the hip down and is getting close to the knees.), PAIN OF SKIN (Skin hurt), COLD BURN (Cold burn) and CHILLS (Shivery feeling from the shoulder all the way to the elbow of both arms/shivery feeling from the hip down and is getting close to the knees/ shivering). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) on 18-Nov-2021 for Adverse event, at a dose of At morning. At the time of the report, PAIN IN EXTREMITY (Pain in the arm , both arms), BURNING SENSATION (Burning sensation from the shoulder all the way to the elbow of both arms/a burning sensation from the hip down and is getting close to the knees), PERIPHERAL COLDNESS (Cold sensation from the shoulder all the way to the elbow of both arms/a cold sensation from the hip down and is getting close to the knees.), PAIN OF SKIN (Skin hurt), COLD BURN (Cold burn) and CHILLS (Shivery feeling from the shoulder all the way to the elbow of both arms/shivery feeling from the hip down and is getting close to the knees/ shivering) outcome was unknown.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral coldness
Clinical narrative: Pain in the arm , both arms; Burning sensation from the shoulder all the way to the elbow of both arms/a burning sensation from the hip down and is getting close to the knees; Cold sensation from the shoulder all the way to the elbow of both arms/a cold sensation from the hip down and is getting close to the knees.; Skin hurt; Cold burn; Shivery feeling from the shoulder all the way to the elbow of both arms/shivery feeling from the hip down and is getting close to the knees/ shivering; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Pain in the arm , both arms), BURNING SENSATION (Burning sensation from the shoulder all the way to the elbow of both arms/a burning sensation from the hip down and is getting close to the knees), PERIPHERAL COLDNESS (Cold sensation from the shoulder all the way to the elbow of both arms/a cold sensation from the hip down and is getting close to the knees.), PAIN OF SKIN (Skin hurt) and COLD BURN (Cold burn) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013F21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Previously administered products included for COVID-19 vaccination: J and J COVID-19 Vaccine on 30-Mar-2021. Past adverse reactions to the above products included No adverse event with J and J COVID-19 Vaccine. Concomitant products included VITAMINS NOS for an unknown indication.    On 17-Nov-2021 at 5:30 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Nov-2021, the patient experienced PAIN IN EXTREMITY (Pain in the arm , both arms), BURNING SENSATION (Burning sensation from the shoulder all the way to the elbow of both arms/a burning sensation from the hip down and is getting close to the knees), PERIPHERAL COLDNESS (Cold sensation from the shoulder all the way to the elbow of both arms/a cold sensation from the hip down and is getting close to the knees.), PAIN OF SKIN (Skin hurt), COLD BURN (Cold burn) and CHILLS (Shivery feeling from the shoulder all the way to the elbow of both arms/shivery feeling from the hip down and is getting close to the knees/ shivering). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) on 18-Nov-2021 for Adverse event, at a dose of At morning. At the time of the report, PAIN IN EXTREMITY (Pain in the arm , both arms), BURNING SENSATION (Burning sensation from the shoulder all the way to the elbow of both arms/a burning sensation from the hip down and is getting close to the knees), PERIPHERAL COLDNESS (Cold sensation from the shoulder all the way to the elbow of both arms/a cold sensation from the hip down and is getting close to the knees.), PAIN OF SKIN (Skin hurt), COLD BURN (Cold burn) and CHILLS (Shivery feeling from the shoulder all the way to the elbow of both arms/shivery feeling from the hip down and is getting close to the knees/ shivering) outcome was unknown.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Feeling cold, Feeling jittery, Illness, Malaise
Clinical narrative: Feel really sick; Really freezing/ Really cold; Feeling lousy/ Do not feel well; Jittery; Tired; Body aches; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Feel really sick), FEELING COLD (Really freezing/ Really cold), MALAISE (Feeling lousy/ Do not feel well), FEELING JITTERY (Jittery) and FATIGUE (Tired) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 065F21A, 025A21A and 020E21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 (Was sick for almost 8 months; was constantly on low dose Medrol pack and doxycycline) in 2020 and Wheezing (Still experiencing wheezing, after recovering from COVID).   On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Nov-2021, the patient experienced ILLNESS (Feel really sick), FEELING COLD (Really freezing/ Really cold), MALAISE (Feeling lousy/ Do not feel well), FEELING JITTERY (Jittery), FATIGUE (Tired) and MYALGIA (Body aches). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) for Adverse event, at a dose of 1 dosage form. At the time of the report, ILLNESS (Feel really sick), FEELING COLD (Really freezing/ Really cold), MALAISE (Feeling lousy/ Do not feel well), FEELING JITTERY (Jittery), FATIGUE (Tired) and MYALGIA (Body aches) had not resolved.            No concomitant medications was provided by reporter.  After getting the booster dose, patient was feeling really sick, really freezing, really cold, jittery, tired, having body aches, feeling lousy, do not feel well and tired. Patient had taken Advil which may have alleviated the symptoms little but not completely.   This case was linked to MOD-2021-390907, MOD-2021-390908 (Patient Link).
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: Feel really sick; Really freezing/ Really cold; Feeling lousy/ Do not feel well; Jittery; Tired; Body aches; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Feel really sick), FEELING COLD (Really freezing/ Really cold), MALAISE (Feeling lousy/ Do not feel well), FEELING JITTERY (Jittery) and FATIGUE (Tired) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 065F21A, 025A21A and 020E21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 (Was sick for almost 8 months; was constantly on low dose Medrol pack and doxycycline) in 2020 and Wheezing (Still experiencing wheezing, after recovering from COVID).   On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Nov-2021, the patient experienced ILLNESS (Feel really sick), FEELING COLD (Really freezing/ Really cold), MALAISE (Feeling lousy/ Do not feel well), FEELING JITTERY (Jittery), FATIGUE (Tired) and MYALGIA (Body aches). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) for Adverse event, at a dose of 1 dosage form. At the time of the report, ILLNESS (Feel really sick), FEELING COLD (Really freezing/ Really cold), MALAISE (Feeling lousy/ Do not feel well), FEELING JITTERY (Jittery), FATIGUE (Tired) and MYALGIA (Body aches) had not resolved.            No concomitant medications was provided by reporter.  After getting the booster dose, patient was feeling really sick, really freezing, really cold, jittery, tired, having body aches, feeling lousy, do not feel well and tired. Patient had taken Advil which may have alleviated the symptoms little but not completely.   This case was linked to MOD-2021-390907, MOD-2021-390908 (Patient Link).
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Received expired booster shot; This spontaneous case was reported by a consumer and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received expired booster shot) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026C21A, 020A21A and 006M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Oct-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Received expired booster shot). On 26-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Received expired booster shot) had resolved.            Concomitant product use was not provided by the reporter.  No treatment information was provided.  Patient stated that a week after the booster shot, he received a letter informing him that the booster vaccine he received was in fact expired.
Age: 32.0
Sex: U
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: Experiencing a Herpes zoster infection shortly after the vaccination; This spontaneous case was reported by a consumer and describes the occurrence of HERPES ZOSTER (Experiencing a Herpes zoster infection shortly after the vaccination) in a 32-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received 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 an unknown date, the patient experienced HERPES ZOSTER (Experiencing a Herpes zoster infection shortly after the vaccination). At the time of the report, HERPES ZOSTER (Experiencing a Herpes zoster infection shortly after the vaccination) outcome was unknown.            Concomitant medications were not reported. Treatment details were not provided.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: soreness in left injection site arm after first Moderna Covid-19 injection; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (soreness in left injection site arm after first Moderna Covid-19 injection) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In February 2021, the patient experienced VACCINATION SITE PAIN (soreness in left injection site arm after first Moderna Covid-19 injection). At the time of the report, VACCINATION SITE PAIN (soreness in left injection site arm after first Moderna Covid-19 injection) had not resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Concomitant medications were not provided Treatment medications were not provided   This case was linked to MOD-2021-390870 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: Covid-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Covid-19) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-May-2021, the patient experienced COVID-19 (Covid-19) (seriousness criterion hospitalization). The patient was hospitalized from 25-May-2021 to sometime in June 2021 due to COVID-19. At the time of the report, COVID-19 (Covid-19) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided.  On both hospital admissions, the patient was given plasma treatment along with other unspecified medications. She was discharged after one week but was re admitted in another hospital because she was not doing well. She stayed for another week and was transported to an in-house rehabilitation for OT, PT and nursing care. She was eventually discharged on 28Jun2021. It was reported that their son died due to Covid on 18-May-2021 and patient was exposed to him..  Company comment: This spontaneous case concerns a female patient with no relevant medical history who experienced serious unexpected event of COVID-19. The event occurred approximately 2 days after the first dose of the Moderna COVID-19 vaccine, respectively. The patient was hospitalized due to COVID-19 and discharged however, the patient was hospitalized again due to not doing well. The patient was on rehabilitation. Rechallenge was not applicable since due to nature of the event of COVID-19, unknown outcome and lack of information on the second dose, no rechallenge was done and recurrence was not applicable.  The benefit-risk relationship of drug is not affected by this report.; Sender's Comments: This spontaneous case concerns a female patient with no relevant medical history who experienced serious unexpected event of COVID-19. The event occurred approximately 2 days after the first dose of the Moderna COVID-19 vaccine, respectively. The patient was hospitalized due to COVID-19 and discharged however, the patient was hospitalized again due to not doing well. The patient was on rehabilitation. Rechallenge was not applicable since due to nature of the event of COVID-19, unknown outcome and lack of information on the second dose, no rechallenge was done and recurrence was not applicable.  The benefit-risk relationship of drug is not affected by this report.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: 39 patients administered with the Moderna COVID 19 vaccine that have past the expiration date; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (39 patients administered with the Moderna COVID 19 vaccine that have past the expiration date) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037A21B) 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 EXPIRED PRODUCT ADMINISTERED (39 patients administered with the Moderna COVID 19 vaccine that have past the expiration date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (39 patients administered with the Moderna COVID 19 vaccine that have past the expiration date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication of the patient was not reported.   Number of doses/vials: As per reporter if it was 14 doses per vial, there would be 3 vials impacted. Date(s) of administration of vaccine: 01-Sep-2021 and 08-Sep-2021. There was no prior excursion episode that the reporter was aware of.  No treatment information was provided by the reporter.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: soreness in left injection site arm after second Moderna Covid-19 injection; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (soreness in left injection site arm after second Moderna Covid-19 injection) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (soreness in left injection site arm after second Moderna Covid-19 injection). At the time of the report, VACCINATION SITE PAIN (soreness in left injection site arm after second Moderna Covid-19 injection) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications and treatment information were not provided by reporter.   This case was linked to MOD-2021-390866 (Patient Link).
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Fungal skin infection
Clinical narrative: fungal infection after the first dose on the skin of her abdomen, both legs legs, and both arms; This spontaneous case was reported by a consumer and describes the occurrence of FUNGAL SKIN INFECTION (fungal infection after the first dose on the skin of her abdomen, both legs legs, and both arms) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In January 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 FUNGAL SKIN INFECTION (fungal infection after the first dose on the skin of her abdomen, both legs legs, and both arms). At the time of the report, FUNGAL SKIN INFECTION (fungal infection after the first dose on the skin of her abdomen, both legs legs, and both arms) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       Concomitant medications details were not reported by the reporter. Treatment details was not reported by the reporter. Reporter reported that Patient had chest pain since 2019, Patient stated chest pain is getting worse since the summer of 2021. Patient stated she has low potassium, low sodium, and is anemic.   This case was linked to MOD-2021-048169, MOD-2021-377107 (Patient Link).
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Feeling cold, Therapeutic response unexpected
Clinical narrative: similar reaction after 2nd dose; freezing and tired; with wheezing that he was experiencing and helped further more when he took the 2nd dose.; similar reaction after 2nd dose; freezing and tired; This spontaneous case was reported by a patient and describes the occurrence of FEELING COLD (similar reaction after 2nd dose; freezing and tired), THERAPEUTIC RESPONSE UNEXPECTED (with wheezing that he was experiencing and helped further more when he took the 2nd dose.) and FATIGUE (similar reaction after 2nd dose; freezing and tired) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 020E21A, 025A21A and 065F21A) for COVID-19 vaccination.     No Medical History information was reported.   On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced FEELING COLD (similar reaction after 2nd dose; freezing and tired), THERAPEUTIC RESPONSE UNEXPECTED (with wheezing that he was experiencing and helped further more when he took the 2nd dose.) and FATIGUE (similar reaction after 2nd dose; freezing and tired). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) for Adverse event, at an unspecified dose and frequency. At the time of the report, FEELING COLD (similar reaction after 2nd dose; freezing and tired), THERAPEUTIC RESPONSE UNEXPECTED (with wheezing that he was experiencing and helped further more when he took the 2nd dose.) and FATIGUE (similar reaction after 2nd dose; freezing and tired) outcome was unknown.            Concomitant medications details were not reported by the reporter.   This case was linked to MOD-2021-390907, MOD-2021-390861 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Received Expired Booster Vaccine; 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 EXPIRED PRODUCT ADMINISTERED (Received Expired Booster Vaccine) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received Expired Booster Vaccine). On 17-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Received Expired Booster Vaccine) had resolved.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Received expired vaccine beyond 12 hours post puncture; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received expired vaccine beyond 12 hours post puncture) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received expired vaccine beyond 12 hours post puncture). On 18-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Received expired vaccine beyond 12 hours post puncture) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medication was reported.     No treatment medications were reported.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Received expired vaccine beyond 12 hours post puncture; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received expired vaccine beyond 12 hours post puncture) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received expired vaccine beyond 12 hours post puncture). On 18-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Received expired vaccine beyond 12 hours post puncture) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   On 04-Nov-2021, the vial was initially stored in the refrigerator. On 17-Nov-2021 at 10:00, the vial was first punctured. On 17-Nov-2021 at 10:53 until 18-Nov-2021 11:00, the vial was exposed to room temperature range ( 46° to 77°F).   This case was linked to MOD-2021-391046 (Patient Link).
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Received expired vaccine beyond 12 hours post puncture; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received expired vaccine beyond 12 hours post puncture) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033F21A) 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 18-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received expired vaccine beyond 12 hours post puncture). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Received expired vaccine beyond 12 hours post puncture) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant and treatment medications were reported.
Sex: F
Vaccine: COVID19
Symptoms: Cough, Fatigue, Oropharyngeal pain, Pyrexia
Clinical narrative: Coughing; Sore throat; Fever; Extreme fatigue; This spontaneous case was reported by a nurse and describes the occurrence of COUGH (Coughing), OROPHARYNGEAL PAIN (Sore throat), PYREXIA (Fever) and FATIGUE (Extreme fatigue) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced COUGH (Coughing), OROPHARYNGEAL PAIN (Sore throat), PYREXIA (Fever) and FATIGUE (Extreme fatigue). At the time of the report, COUGH (Coughing), OROPHARYNGEAL PAIN (Sore throat), PYREXIA (Fever) and FATIGUE (Extreme fatigue) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant and treatment medications were provided by the reporter.The patient experiencing sore throat, coughing, fever and extreme fatigue. The symptoms were ongoing.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Administration of expired vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administration of expired vaccine) in a 51-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administration of expired vaccine). On 18-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Administration of expired vaccine) 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  Source document stated that patient had not experienced any symptoms.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Administration of expired vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administration of expired vaccine) in a 40-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administration of expired vaccine). On 18-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Administration of expired vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Date the vial was initially stored in the refrigerator: 04-Aug-2021.   No concomitant medication was provided.  No treatment medication was  given.
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Administration of expired vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administration of expired vaccine) in a 33-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Nov-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administration of expired vaccine). On 18-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Administration of expired vaccine) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported.  No treatment information was provided.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Administered expired Moderna COVID-19 vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered expired Moderna COVID-19 vaccine) in a 47-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047C21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included BUSPIRONE, FLUOXETINE, ALBUTEROL [SALBUTAMOL], FENOFIBRATE, OMEPRAZOLE, CAFFEINE, PARACETAMOL (EXCEDRIN [CAFFEINE;PARACETAMOL]) and MIRTAZAPINE for an unknown indication.    On 18-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered expired Moderna COVID-19 vaccine). On 18-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Administered expired Moderna COVID-19 vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant information was not provided.   Treatment information was not provided.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: expired vaccine used; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired vaccine used) in a 26-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired vaccine used). On 10-Nov-2021, EXPIRED PRODUCT ADMINISTERED (expired vaccine used) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication information was not provided by the reporter. Treatment information was not provided by the reporter.  Company Comment: This case concerns a 26-year-old female patient, with no known medical history, who experienced the non-serious event of expired product administered. The event occurred  on the same day after unspecified dose of mRNA 1273 vaccine. The benefit-risk relationship of mRNA 1273 vaccine is not affected by this report.; Sender's Comments: This case concerns a 26-year-old female patient, with no known medical history, who experienced the non-serious event of expired product administered. The event occurred  on the same day after unspecified dose of mRNA 1273 vaccine. The benefit-risk relationship of mRNA 1273 vaccine is not affected by this report.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered, Syringe issue
Clinical narrative: Solution came out the side of needle,the needle on the syringe was faulty; didn't receive full booster dose (0.25 ml),liquid came out of injection site; This spontaneous case was reported by a pharmacist and describes the occurrence of SYRINGE ISSUE (Solution came out the side of needle,the needle on the syringe was faulty) and INCORRECT DOSE ADMINISTERED (didn't receive full booster dose (0.25 ml),liquid came out of injection site) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 069F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Nov-2021, the patient experienced SYRINGE ISSUE (Solution came out the side of needle,the needle on the syringe was faulty) and INCORRECT DOSE ADMINISTERED (didn't receive full booster dose (0.25 ml),liquid came out of injection site). On 18-Nov-2021, SYRINGE ISSUE (Solution came out the side of needle,the needle on the syringe was faulty) and INCORRECT DOSE ADMINISTERED (didn't receive full booster dose (0.25 ml),liquid came out of injection site) 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.  It was reported that the patient was re vaccinated with Moderna during the same session. The HCP stated that again the patient did not receive the entire 0.25 ml dose as some of the liquid came out of injection site. The HCP also stated that some fluid may have been entered into patients fatty arm tissue.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: A patient received a booster dose from a vial that was opened yesterday (post 12 hours puncture).; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (A patient received a booster dose from a vial that was opened yesterday (post 12 hours puncture).) 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 18-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (A patient received a booster dose from a vial that was opened yesterday (post 12 hours puncture).). On 18-Nov-2021, EXPIRED PRODUCT ADMINISTERED (A patient received a booster dose from a vial that was opened yesterday (post 12 hours puncture).) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant and treatment information were reported by the reporter
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine used; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 09-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant products were not provided. Treatment medication were not reported.  Company comment- This case concerns a 59-year-old, male patient, with no known medical history, who experienced the non-serious event of expired product administered. The event occurred  on the same day after unspecified dose of mRNA 1273 vaccine. The benefit-risk relationship of mRNA 1273 vaccine is not affected by this report; Sender's Comments: This case concerns a 59-year-old, male patient, with no known medical history, who experienced the non-serious event of expired product administered. The event occurred  on the same day after unspecified dose of mRNA 1273 vaccine. The benefit-risk relationship of mRNA 1273 vaccine is not affected by this report
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Antibody test, Arthralgia, Myalgia, Neck pain, Pain in extremity
Clinical narrative: soreness of neck; it was painful/soreness in arm; soreness in wrist and arm,soreness in shoulders; soreness in arm,muscles in upper torso sore; This spontaneous case was reported by a consumer and describes the occurrence of NECK PAIN (soreness of neck), PAIN IN EXTREMITY (it was painful/soreness in arm), ARTHRALGIA (soreness in wrist and arm,soreness in shoulders) and MYALGIA (soreness in arm,muscles in upper torso sore) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 11-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced NECK PAIN (soreness of neck), PAIN IN EXTREMITY (it was painful/soreness in arm), ARTHRALGIA (soreness in wrist and arm,soreness in shoulders) and MYALGIA (soreness in arm,muscles in upper torso sore). In 2021, NECK PAIN (soreness of neck), PAIN IN EXTREMITY (it was painful/soreness in arm), ARTHRALGIA (soreness in wrist and arm,soreness in shoulders) and MYALGIA (soreness in arm,muscles in upper torso sore) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 30-Jul-2021, Antibody test: levels of the antibody was 2070 (Inconclusive) levels of the antibody was 2070, done through . On 07-Oct-2021, Antibody test: count was 2291, antibody levels went up (High) count was 2291, antibody levels went up.         No Concomitant medications were provided.  No treatment medications were provided.  The events lasted for 8-9hrs.  Patient also mentioned that he heard that younger people had a more intense response to vaccination because their immune system was more rigorous, and older people had less of a response, but he said had response was pretty vigorous.   This case was linked to MOD-2021-051636 (Patient Link).
Age: 88.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patients received an expired vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patients received an expired vaccine) in an 88-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047C21A) for COVID-19 vaccination.     No Medical History information was reported.  On 09-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patients received an expired vaccine). On 09-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Patients received an expired vaccine) had resolved. Not Provided    For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.     No treatment information was provided.