chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Pruritus, Tendon discomfort
Clinical narrative: he felt his head burning; body itching; his neck tendons are tense, his back tendons are tense; he feels tingling on his left feet, he feels tingling on his left leg; he can't sleep; he stands up and feels dizzy; he can't work; This spontaneous case was reported by a consumer and describes the occurrence of BURNING SENSATION (he felt his head burning), PRURITUS (body itching), TENDON DISCOMFORT (his neck tendons are tense, his back tendons are tense), PARAESTHESIA (he feels tingling on his left feet, he feels tingling on his left leg) and INSOMNIA (he can't sleep) in a 39-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 054C211A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 26-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-May-2021, the patient experienced BURNING SENSATION (he felt his head burning), PRURITUS (body itching), TENDON DISCOMFORT (his neck tendons are tense, his back tendons are tense), PARAESTHESIA (he feels tingling on his left feet, he feels tingling on his left leg), INSOMNIA (he can't sleep), DIZZINESS (he stands up and feels dizzy) and LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (he can't work). At the time of the report, BURNING SENSATION (he felt his head burning), PRURITUS (body itching), TENDON DISCOMFORT (his neck tendons are tense, his back tendons are tense), PARAESTHESIA (he feels tingling on his left feet, he feels tingling on his left leg), INSOMNIA (he can't sleep), DIZZINESS (he stands up and feels dizzy) and LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (he can't work) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided by the reporter. No treatment information was provided by the reporter. patient was tested, a CT scan and a MRI and nothing was found.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Aphasia, Asthenia, Complement factor C3, Computerised tomogram, Confusional state
Clinical narrative: fasciculations spread to biceps, head and face/ fasciculations in his calf and feet; extreme dizziness; brain fog; weakness in legs; confusion; memory issues; cannot complete sentences; lost 25lbs; This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE CONTRACTIONS INVOLUNTARY (fasciculations spread to biceps, head and face/ fasciculations in his calf and feet), DIZZINESS (extreme dizziness), FEELING ABNORMAL (brain fog), ASTHENIA (weakness in legs) and CONFUSIONAL STATE (confusion) in a 38-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 16-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced MUSCLE CONTRACTIONS INVOLUNTARY (fasciculations spread to biceps, head and face/ fasciculations in his calf and feet), DIZZINESS (extreme dizziness), FEELING ABNORMAL (brain fog), ASTHENIA (weakness in legs), CONFUSIONAL STATE (confusion), MEMORY IMPAIRMENT (memory issues), APHASIA (cannot complete sentences) and WEIGHT DECREASED (lost 25lbs). At the time of the report, MUSCLE CONTRACTIONS INVOLUNTARY (fasciculations spread to biceps, head and face/ fasciculations in his calf and feet), DIZZINESS (extreme dizziness), FEELING ABNORMAL (brain fog), ASTHENIA (weakness in legs), CONFUSIONAL STATE (confusion), MEMORY IMPAIRMENT (memory issues), APHASIA (cannot complete sentences) and WEIGHT DECREASED (lost 25lbs) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Computerised tomogram: normal (normal) CT and MRI scans that have all come back negative.. In 2021, Magnetic resonance imaging: normal (normal) normal. On 09-Aug-2021, Complement factor C3: decreased (abnormal) antibody tests and his C3 levels were below 4MG..     mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was withdrawn on an unknown date.       Patient did not plan to take 2nd dose No Concomitant medications were reported No treatment medications were reported   Most recent FOLLOW-UP information incorporated above includes: On 15-Oct-2021: Significant Follow up- Event outcome & contact details updated; Sender's Comments: Limited information regarding the events has been provided at this time and a causal relationship cannot be excluded.  Patient reports multiple diagnostic imaging tests with no confirmation of pathology and does not report any specific treatments provided for the reported symptoms.  Therefore not considered medically significant and no report of specifically being disabled or hospitalized so events are considered non-serious.  Time period over which weight was lost not reported.Not confirmed if patient missed second dose of vaccine.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Feeling abnormal, Magnetic resonance imaging, Memory impairment, Muscle contractions involuntary
Clinical narrative: fasciculations spread to biceps, head and face/ fasciculations in his calf and feet; extreme dizziness; brain fog; weakness in legs; confusion; memory issues; cannot complete sentences; lost 25lbs; This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE CONTRACTIONS INVOLUNTARY (fasciculations spread to biceps, head and face/ fasciculations in his calf and feet), DIZZINESS (extreme dizziness), FEELING ABNORMAL (brain fog), ASTHENIA (weakness in legs) and CONFUSIONAL STATE (confusion) in a 38-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 16-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced MUSCLE CONTRACTIONS INVOLUNTARY (fasciculations spread to biceps, head and face/ fasciculations in his calf and feet), DIZZINESS (extreme dizziness), FEELING ABNORMAL (brain fog), ASTHENIA (weakness in legs), CONFUSIONAL STATE (confusion), MEMORY IMPAIRMENT (memory issues), APHASIA (cannot complete sentences) and WEIGHT DECREASED (lost 25lbs). At the time of the report, MUSCLE CONTRACTIONS INVOLUNTARY (fasciculations spread to biceps, head and face/ fasciculations in his calf and feet), DIZZINESS (extreme dizziness), FEELING ABNORMAL (brain fog), ASTHENIA (weakness in legs), CONFUSIONAL STATE (confusion), MEMORY IMPAIRMENT (memory issues), APHASIA (cannot complete sentences) and WEIGHT DECREASED (lost 25lbs) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Computerised tomogram: normal (normal) CT and MRI scans that have all come back negative.. In 2021, Magnetic resonance imaging: normal (normal) normal. On 09-Aug-2021, Complement factor C3: decreased (abnormal) antibody tests and his C3 levels were below 4MG..     mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was withdrawn on an unknown date.       Patient did not plan to take 2nd dose No Concomitant medications were reported No treatment medications were reported   Most recent FOLLOW-UP information incorporated above includes: On 15-Oct-2021: Significant Follow up- Event outcome & contact details updated; Sender's Comments: Limited information regarding the events has been provided at this time and a causal relationship cannot be excluded.  Patient reports multiple diagnostic imaging tests with no confirmation of pathology and does not report any specific treatments provided for the reported symptoms.  Therefore not considered medically significant and no report of specifically being disabled or hospitalized so events are considered non-serious.  Time period over which weight was lost not reported.Not confirmed if patient missed second dose of vaccine.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Weight decreased
Clinical narrative: fasciculations spread to biceps, head and face/ fasciculations in his calf and feet; extreme dizziness; brain fog; weakness in legs; confusion; memory issues; cannot complete sentences; lost 25lbs; This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE CONTRACTIONS INVOLUNTARY (fasciculations spread to biceps, head and face/ fasciculations in his calf and feet), DIZZINESS (extreme dizziness), FEELING ABNORMAL (brain fog), ASTHENIA (weakness in legs) and CONFUSIONAL STATE (confusion) in a 38-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 16-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced MUSCLE CONTRACTIONS INVOLUNTARY (fasciculations spread to biceps, head and face/ fasciculations in his calf and feet), DIZZINESS (extreme dizziness), FEELING ABNORMAL (brain fog), ASTHENIA (weakness in legs), CONFUSIONAL STATE (confusion), MEMORY IMPAIRMENT (memory issues), APHASIA (cannot complete sentences) and WEIGHT DECREASED (lost 25lbs). At the time of the report, MUSCLE CONTRACTIONS INVOLUNTARY (fasciculations spread to biceps, head and face/ fasciculations in his calf and feet), DIZZINESS (extreme dizziness), FEELING ABNORMAL (brain fog), ASTHENIA (weakness in legs), CONFUSIONAL STATE (confusion), MEMORY IMPAIRMENT (memory issues), APHASIA (cannot complete sentences) and WEIGHT DECREASED (lost 25lbs) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Computerised tomogram: normal (normal) CT and MRI scans that have all come back negative.. In 2021, Magnetic resonance imaging: normal (normal) normal. On 09-Aug-2021, Complement factor C3: decreased (abnormal) antibody tests and his C3 levels were below 4MG..     mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was withdrawn on an unknown date.       Patient did not plan to take 2nd dose No Concomitant medications were reported No treatment medications were reported   Most recent FOLLOW-UP information incorporated above includes: On 15-Oct-2021: Significant Follow up- Event outcome & contact details updated; Sender's Comments: Limited information regarding the events has been provided at this time and a causal relationship cannot be excluded.  Patient reports multiple diagnostic imaging tests with no confirmation of pathology and does not report any specific treatments provided for the reported symptoms.  Therefore not considered medically significant and no report of specifically being disabled or hospitalized so events are considered non-serious.  Time period over which weight was lost not reported.Not confirmed if patient missed second dose of vaccine.
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during breast feeding, Product administered to patient of inappropriate age
Clinical narrative: Received Moderna Covid-19 vaccine at age 17; Patient is Breast feeding received vaccine; This spontaneous case was reported by a health care professional and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Received Moderna Covid-19 vaccine at age 17) and MATERNAL EXPOSURE DURING BREAST FEEDING (Patient is Breast feeding received vaccine) in a 17-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Sep-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Received Moderna Covid-19 vaccine at age 17) and MATERNAL EXPOSURE DURING BREAST FEEDING (Patient is Breast feeding received vaccine). On 24-Sep-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Received Moderna Covid-19 vaccine at age 17) had resolved. At the time of the report, MATERNAL EXPOSURE DURING BREAST FEEDING (Patient is Breast feeding received vaccine) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications reported. No treatment information was provided.  Company Comment: This case concerns a 17-year-old, female patient with no relevant medical history reported, in which product administered to patient of inappropriate age and maternal exposure during breast feeding were reported with no associated adverse events. The patient received the first dose of Spikevax. The rechallenge was not applicable due to the nature of the events. The benefit-risk relationship of Spikevax is not affected by this report.   This case was linked to MOD-2021-342801 (Parent-Child Link).   See case MOD-2021-342801 for details regarding the child case.  Most recent FOLLOW-UP information incorporated above includes: On 07-Oct-2021: Follow up received on 08-Oct-2021 contains non new information .; Sender's Comments: This case concerns a 17-year-old, female patient with no relevant medical history reported, in which product administered to patient of inappropriate age and maternal exposure during breast feeding were reported with no associated adverse events. The patient received the first dose of Spikevax. The rechallenge was not applicable due to the nature of the events. The benefit-risk relationship of Spikevax is not affected by this report.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: mild headache after the second dose of her Moderna Covid-19 vaccine; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (mild headache after the second dose of her Moderna Covid-19 vaccine) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006B21A and 011A21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included METFORMIN, AMLODIPINE and ROSUVASTATIN for an unknown indication.   On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced HEADACHE (mild headache after the second dose of her Moderna Covid-19 vaccine). At the time of the report, HEADACHE (mild headache after the second dose of her Moderna Covid-19 vaccine) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   no treatment drug was reported
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pruritus, Vaccination site erythema
Clinical narrative: Area started itching really bad; readness started around the injection site/arm was red but it was about the size of a 50cent piece; Arm started feeling sore which i expected cause it happened with my second dose as well; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Area started itching really bad), VACCINATION SITE ERYTHEMA (readness started around the injection site/arm was red but it was about the size of a 50cent piece) and MYALGIA (Arm started feeling sore which i expected cause it happened with my second dose as well) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 024M20A and 026L20A) for COVID-19 vaccination.     Concurrent medical conditions included Hypersensitivity, Guttate psoriasis since November 2014, Diabetic since July 2020, Spice allergy (Paprika, Throat starts to seal), Drug allergy (Ibuprofen, nausea to the point of dehydration can't keep solids or liquids down) and Drug allergy (Meloxicam, nausea to the point of dehydration can't keep solids or liquids down).   On 25-Jan-2021 at 2:30 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Feb-2021 at 2:15 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PRURITUS (Area started itching really bad), VACCINATION SITE ERYTHEMA (readness started around the injection site/arm was red but it was about the size of a 50cent piece) and MYALGIA (Arm started feeling sore which i expected cause it happened with my second dose as well). At the time of the report, PRURITUS (Area started itching really bad), VACCINATION SITE ERYTHEMA (readness started around the injection site/arm was red but it was about the size of a 50cent piece) and MYALGIA (Arm started feeling sore which i expected cause it happened with my second dose as well) outcome was unknown.            No concomitant medications were reported.  No treatment medications were reported.   This case was linked to MOD-2021-340995 (Patient Link).
Age: 90.0
Sex: M
Vaccine: COVID19
Symptoms: Cardiac pacemaker replacement
Clinical narrative: Replace a pacemaker; This spontaneous case was reported by a consumer and describes the occurrence of CARDIAC PACEMAKER REPLACEMENT (Replace a pacemaker) in a 90-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Oct-2021, the patient experienced CARDIAC PACEMAKER REPLACEMENT (Replace a pacemaker). On 05-Oct-2021, CARDIAC PACEMAKER REPLACEMENT (Replace a pacemaker) had resolved.            No concomitant medications or treatment details were reported.  Patient had a surgery on 05-Oct-2021 to replace a pacemaker that was put in 5 years ago. He reported this has nothing to do with the vaccine.   Reporter did not allow further contact
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Vaccine that had been more than 30 days in the refrigerator was given to 16 patients, vaccinate past its expiration date of 10/1/21; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine that had been more than 30 days in the refrigerator was given to 16 patients, vaccinate past its expiration date of 10/1/21) in a 24-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine that had been more than 30 days in the refrigerator was given to 16 patients, vaccinate past its expiration date of 10/1/21). On 07-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Vaccine that had been more than 30 days in the refrigerator was given to 16 patients, vaccinate past its expiration date of 10/1/21) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was provided by the reporter.  No treatment information was provided by the reporter.  Reporter stated that they had a carton of vials in the fridge which was kept in there from the freezer on 01 Sep 2021. Vials were used on 05 Oct 2021, 07 Oct 2021, 08 Oct 2021, 11Oct2021 and 12 Oct 2021. In total, 16 patients were vaccinated in these dates using five vials. The vial was received in the refrigerator on 01 Sep 2021 and has been used to vaccinate past its expiration date of 01 Oct 2021.   This case was linked to MOD-2021-352746, MOD-2021-352860, MOD-2021-353006, MOD-2021-353022, MOD-2021-352843, MOD-2021-352625, MOD-2021-352822, MOD-2021-352833, MOD-2021-352837, MOD-2021-352948, MOD-2021-352955, MOD-2021-353005, MOD-2021-353227 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 18-Oct-2021: Follow-up information included no new information
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: A sore arm; This spontaneous case was reported by a nurse and describes the occurrence of PAIN IN EXTREMITY (A sore arm) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised.    On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (A sore arm). At the time of the report, PAIN IN EXTREMITY (A sore arm) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were provided. No treatment medications were reported.   This case was linked to MOD-2021-352622, MOD-2021-352623, MOD-2021-352994, MOD-2021-352991 (Patient Link).
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Sore arm after second dose; This spontaneous case was reported by a nurse and describes the occurrence of VACCINATION SITE PAIN (Sore arm after second dose) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012M20A and 025L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (Sore arm after second dose). At the time of the report, VACCINATION SITE PAIN (Sore arm after second dose) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications information was not reported No treatment medications were provided   This case was linked to MOD-2021-352613, MOD-2021-352623, MOD-2021-352994, MOD-2021-352991 (Patient Link).
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Got third dose from an expired vial; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Got third dose from an expired vial) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 049E21A, 012M20A and 025L20A) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised.   On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 ml. On 12-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 ml. On 13-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 ml. On 13-Oct-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Got third dose from an expired vial). On 13-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Got third dose from an expired vial) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were provided.  No treatment medications were provided.   This case was linked to MOD-2021-352622, MOD-2021-352613, MOD-2021-352994, MOD-2021-352991 (Patient Link).
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Vaccine that had been more than 30 days in the refrigerator was given to 16 patients/vaccinate past its expiration date of 10/1/21; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine that had been more than 30 days in the refrigerator was given to 16 patients/vaccinate past its expiration date of 10/1/21) in a 55-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine that had been more than 30 days in the refrigerator was given to 16 patients/vaccinate past its expiration date of 10/1/21). On 12-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Vaccine that had been more than 30 days in the refrigerator was given to 16 patients/vaccinate past its expiration date of 10/1/21) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   They had a carton of vials in the fridge which was put in there from the freezer on 01-Sep-2021.   No concomitant medication was provided.  No treatment medication was provided.   This case was linked to MOD-2021-352611 (Patient Link).
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: doses were kept in room temperature for greater than 12 hours; thought they had been newly drawn and administered them; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (doses were kept in room temperature for greater than 12 hours) and PRODUCT STORAGE ERROR (thought they had been newly drawn and administered them) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 009C21A and 037B21A) 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) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (doses were kept in room temperature for greater than 12 hours) and PRODUCT STORAGE ERROR (thought they had been newly drawn and administered them). At the time of the report, EXPIRED PRODUCT ADMINISTERED (doses were kept in room temperature for greater than 12 hours) and PRODUCT STORAGE ERROR (thought they had been newly drawn and administered them) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant information was not reported. Treatment information was not reported. Total amount of time the vial was exposed to room temperature range (8° to 25°C= 46° to 77°F): The vials were thawed by 9:30 AM EST yesterday morning.   This case was linked to MOD-2021-353230 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Alopecia
Clinical narrative: lot of hair was falling off; 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 ALOPECIA (lot of hair was falling off) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ALOPECIA (lot of hair was falling off). At the time of the report, ALOPECIA (lot of hair was falling off) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not provided.  Treatment information was not provided.
Sex: F
Vaccine: COVID19
Symptoms: Postmenopausal haemorrhage
Clinical narrative: Period after being menopausal for 1 year.; This spontaneous case was reported by a consumer and describes the occurrence of POSTMENOPAUSAL HAEMORRHAGE (Period after being menopausal for 1 year.) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Menopause since 2020.   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 POSTMENOPAUSAL HAEMORRHAGE (Period after being menopausal for 1 year.) (seriousness criterion medically significant). At the time of the report, POSTMENOPAUSAL HAEMORRHAGE (Period after being menopausal for 1 year.) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   No concomitant product information was provided.  Treatment information was not provided.  Company Comment: This spontaneous case concerns a female of unknown age who experience serious unexpected  postmenopausal heamorrahage after being menopausal for one year after being vaccinated with spikevax. Time to onset and dose number is unknown. The event was upgraded to serious as per IME list. The benefit-risk relationship of Spikevax in not affected by this report It was reported that patient got her period after being menopausal for one year.; Sender's Comments: This spontaneous case concerns a female of unknown age who experience serious unexpected  postmenopausal heamorrahage after being menopausal for one year after being vaccinated with spikevax. Time to onset and dose number is unknown. The event was upgraded to serious as per IME list. The benefit-risk relationship of Spikevax in not affected by this report
Sex: U
Vaccine: COVID19
Symptoms: Hypersensitivity, Pruritus, Vaccination complication
Clinical narrative: Had an adverse reaction; Itching; Severe allergic reaction; 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 VACCINATION COMPLICATION (Had an adverse reaction), PRURITUS (Itching) and HYPERSENSITIVITY (Severe allergic reaction) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.   No Medical History information was reported.  On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Had an adverse reaction), PRURITUS (Itching) and HYPERSENSITIVITY (Severe allergic reaction). At the time of the report, VACCINATION COMPLICATION (Had an adverse reaction), PRURITUS (Itching) and HYPERSENSITIVITY (Severe allergic reaction) outcome was unknown.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.  No concomitant medications was reported.  No treatment drug details was reported.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site mass, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Heat (where I got the shot); Feels like a big lump (where I got the shot); Large area of swelling (where I got the shot); Pretty red (where I got the shot); This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Heat (where I got the shot)), VACCINATION SITE MASS (Feels like a big lump (where I got the shot)), VACCINATION SITE SWELLING (Large area of swelling (where I got the shot)) and VACCINATION SITE ERYTHEMA (Pretty red (where I got the shot)) in a 27-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 076CZ1A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Oct-2021, the patient experienced VACCINATION SITE WARMTH (Heat (where I got the shot)), VACCINATION SITE MASS (Feels like a big lump (where I got the shot)), VACCINATION SITE SWELLING (Large area of swelling (where I got the shot)) and VACCINATION SITE ERYTHEMA (Pretty red (where I got the shot)). At the time of the report, VACCINATION SITE WARMTH (Heat (where I got the shot)), VACCINATION SITE MASS (Feels like a big lump (where I got the shot)), VACCINATION SITE SWELLING (Large area of swelling (where I got the shot)) and VACCINATION SITE ERYTHEMA (Pretty red (where I got the shot)) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant were reported.  No treatment were reported.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Influenza like illness
Clinical narrative: Tired; Chills; like the flu; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Tired), CHILLS (Chills) and INFLUENZA LIKE ILLNESS (like the flu) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 080M20A) for COVID-19 vaccination.     Concurrent medical conditions included Emphysema, COPD, Blood pressure, Aneurysm and Oxygen consumption.    On 11-Feb-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 FATIGUE (Tired), CHILLS (Chills) and INFLUENZA LIKE ILLNESS (like the flu). At the time of the report, FATIGUE (Tired), CHILLS (Chills) and INFLUENZA LIKE ILLNESS (like the flu) outcome was unknown.        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 medications were provided.  Second dose has taken on 11-Mar-2021.  No treatment medications were provided.   This case was linked to MOD-2021-352745 (Patient Link).
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Impaired work ability, Influenza like illness
Clinical narrative: like the flu; in bed for a day and a half; chills; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (like the flu), IMPAIRED WORK ABILITY (in bed for a day and a half) and CHILLS (chills) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030A21A, 080M20A and 037F21A) for COVID-19 vaccination.     Concurrent medical conditions included Emphysema, COPD, Blood pressure, Aneurysm and Oxygen consumption.   On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Sep-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 INFLUENZA LIKE ILLNESS (like the flu), IMPAIRED WORK ABILITY (in bed for a day and a half) and CHILLS (chills). At the time of the report, INFLUENZA LIKE ILLNESS (like the flu), IMPAIRED WORK ABILITY (in bed for a day and a half) and CHILLS (chills) outcome was unknown.        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.  Patient reported that his doctor did not recommend to take the third dose, but he decided to do so all the same because of his several underlying conditions.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: vaccinate past its expiration date/Vaccine that had been more than 30 days in the refrigerator; vaccinate past its expiration date/Vaccine that had been more than 30 days in the refrigerator; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (vaccinate past its expiration date/Vaccine that had been more than 30 days in the refrigerator) and PRODUCT STORAGE ERROR (vaccinate past its expiration date/Vaccine that had been more than 30 days in the refrigerator) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (vaccinate past its expiration date/Vaccine that had been more than 30 days in the refrigerator) and PRODUCT STORAGE ERROR (vaccinate past its expiration date/Vaccine that had been more than 30 days in the refrigerator). On 08-Oct-2021, EXPIRED PRODUCT ADMINISTERED (vaccinate past its expiration date/Vaccine that had been more than 30 days in the refrigerator) and PRODUCT STORAGE ERROR (vaccinate past its expiration date/Vaccine that had been more than 30 days in the refrigerator) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant information was reported. No treatment information was reported.   This case was linked to MOD-2021-352843 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 14-Oct-2021: Added patient initials, DOB and gender. Added suspect product start date, expiration date.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: tired; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (tired) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced FATIGUE (tired). At the time of the report, FATIGUE (tired) outcome was unknown.            No concomitant were reported.  No treatment were reported.   This case was linked to MOD-2021-352754 (Patient Link).
Age: 23.0
Sex: M
Vaccine: COVID19
Symptoms: Seizure
Clinical narrative: Seizure; This spontaneous case was reported by a physician and describes the occurrence of SEIZURE (Seizure) in a 23-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced SEIZURE (Seizure) (seriousness criterion medically significant). At the time of the report, SEIZURE (Seizure) outcome was unknown.        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. Patient stated that after first dose he had seizure. No treatment information was provided. It was reported that the doctor wants to see if that was a contraindication.  Company Comment: This case concerns a 23-year-old, male patient, with no known medical history, who experienced the serious, unexpected, AESI event of seizure. The event occurred  on unknown day after first dose of Moderna vaccine. The rechallenge is unknown as it is not confirmed if patient received the second dose. The benefit-risk relationship of Moderna vaccine is not affected by this report.; Sender's Comments: This case concerns a 23-year-old, male patient, with no known medical history, who experienced the serious, unexpected, AESI event of seizure. The event occurred  on unknown day after first dose of Moderna vaccine. The rechallenge is unknown as it is not confirmed if patient received the second dose. The benefit-risk relationship of Moderna vaccine is not affected by this report.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Vaccine that had been more than 30 days in the refrigerator was given to 16 patients/vaccinate past its expiration date of 10/1/21; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine that had been more than 30 days in the refrigerator was given to 16 patients/vaccinate past its expiration date of 10/1/21) in a 42-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048F21A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine that had been more than 30 days in the refrigerator was given to 16 patients/vaccinate past its expiration date of 10/1/21). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine that had been more than 30 days in the refrigerator was given to 16 patients/vaccinate past its expiration date of 10/1/21) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered EXPIRED PRODUCT ADMINISTERED (Vaccine that had been more than 30 days in the refrigerator was given to 16 patients/vaccinate past its expiration date of 10/1/21) to be not applicable.    Concomitant medication information not provided.  Treatment information not provided.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Vaccine that had been more than 30 days in the refrigerator was given to 16 patients, vaccinate past its expiration date of 10/1/21; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine that had been more than 30 days in the refrigerator was given to 16 patients, vaccinate past its expiration date of 10/1/21) in a 53-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Aug-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine that had been more than 30 days in the refrigerator was given to 16 patients, vaccinate past its expiration date of 10/1/21). On 07-Aug-2021, EXPIRED PRODUCT ADMINISTERED (Vaccine that had been more than 30 days in the refrigerator was given to 16 patients, vaccinate past its expiration date of 10/1/21) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Concomitant use were reported No Treatment were reported
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Vaccine that had been more than 30 days in the refrigerator was given to 16 patients/vaccinate past its expiration date of 10/1/21; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine that had been more than 30 days in the refrigerator was given to 16 patients/vaccinate past its expiration date of 10/1/21) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine that had been more than 30 days in the refrigerator was given to 16 patients/vaccinate past its expiration date of 10/1/21). On 07-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Vaccine that had been more than 30 days in the refrigerator was given to 16 patients/vaccinate past its expiration date of 10/1/21) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was reported. No treatment medication was reported
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: vaccinate past its expiration date of 10/1/21; Vaccine that had been more than 30 days in the refrigerator was given to 16 patients; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (vaccinate past its expiration date of 10/1/21) and PRODUCT STORAGE ERROR (Vaccine that had been more than 30 days in the refrigerator was given to 16 patients) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (vaccinate past its expiration date of 10/1/21) and PRODUCT STORAGE ERROR (Vaccine that had been more than 30 days in the refrigerator was given to 16 patients). On 07-Oct-2021, EXPIRED PRODUCT ADMINISTERED (vaccinate past its expiration date of 10/1/21) and PRODUCT STORAGE ERROR (Vaccine that had been more than 30 days in the refrigerator was given to 16 patients) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.   This case was linked to MOD-2021-352746, MOD-2021-352611, MOD-2021-352860, MOD-2021-353006 (Patient Link).
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Vaccine that had been more than 30 days in the refrigerator was given to 16 patients, vaccinate past its expiration date of 10/1/21; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine that had been more than 30 days in the refrigerator was given to 16 patients, vaccinate past its expiration date of 10/1/21) in a 42-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine that had been more than 30 days in the refrigerator was given to 16 patients, vaccinate past its expiration date of 10/1/21). On 08-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Vaccine that had been more than 30 days in the refrigerator was given to 16 patients, vaccinate past its expiration date of 10/1/21) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant and treatment medications was reported Cartons of vial was stored in from the freezer on 01Sep2021.   This case was linked to MOD-2021-352843 (Patient Link).