chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 87.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: got second dose more than 35 days since the first dose; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (got second dose more than 35 days since the first dose) in an 87-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 022M20 and 030L20A) for COVID-19 vaccination.     No medical history were reported by reporter.  Concomitant products included CARBIDOPA, LEVODOPA (CARBIDOPA AND LEVODOPA) and PROBENECID for an unknown indication.   On 22-Jan-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 02-Mar-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (got second dose more than 35 days since the first dose). On 02-Mar-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (got second dose more than 35 days since the first dose) had resolved.            No treatment information were reported  by the reporter.   This case was linked to MOD-2021-327740 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Administered with expired vaccine; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered with expired vaccine) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Sep-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered with expired vaccine). On 22-Sep-2021, EXPIRED PRODUCT ADMINISTERED (Administered with expired vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication information was not provided by the reporter.  Treatment information was not provided by the reporter.
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Chest discomfort, Diarrhoea, Musculoskeletal discomfort, Myalgia
Clinical narrative: groin discomfort; diarrhea; abdominal cramping; left side chest discomfort; 99.8 fever which had a high of 100.1 degrees F; body aches; This spontaneous case was reported by a nurse and describes the occurrence of MUSCULOSKELETAL DISCOMFORT (groin discomfort), DIARRHOEA (diarrhea), ABDOMINAL PAIN (abdominal cramping), CHEST DISCOMFORT (left side chest discomfort) and PYREXIA (99.8 fever which had a high of 100.1 degrees F) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 062E21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 (Undocumented history of COVID19.).    On 12-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In September 2021, the patient experienced MUSCULOSKELETAL DISCOMFORT (groin discomfort), DIARRHOEA (diarrhea), ABDOMINAL PAIN (abdominal cramping), CHEST DISCOMFORT (left side chest discomfort), PYREXIA (99.8 fever which had a high of 100.1 degrees F) and MYALGIA (body aches). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency; IBUPROFEN at an unspecified dose and frequency; BISMUTH SUBSALICYLATE (PEPTO-BISMOL) at an unspecified dose and frequency and CALCIUM CARBONATE, MAGNESIUM CARBONATE (TUMS [CALCIUM CARBONATE;MAGNESIUM CARBONATE]) at an unspecified dose and frequency. At the time of the report, MUSCULOSKELETAL DISCOMFORT (groin discomfort), DIARRHOEA (diarrhea), ABDOMINAL PAIN (abdominal cramping), CHEST DISCOMFORT (left side chest discomfort) and PYREXIA (99.8 fever which had a high of 100.1 degrees F) had resolved and MYALGIA (body aches) had not 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.   Concomitant medication was not provided by the  reporter.  Patient tested positive for antibodies in 2 antibody blood tests.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: groin discomfort; diarrhea; abdominal cramping; left side chest discomfort; 99.8 fever which had a high of 100.1 degrees F; body aches; This spontaneous case was reported by a nurse and describes the occurrence of MUSCULOSKELETAL DISCOMFORT (groin discomfort), DIARRHOEA (diarrhea), ABDOMINAL PAIN (abdominal cramping), CHEST DISCOMFORT (left side chest discomfort) and PYREXIA (99.8 fever which had a high of 100.1 degrees F) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 062E21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 (Undocumented history of COVID19.).    On 12-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In September 2021, the patient experienced MUSCULOSKELETAL DISCOMFORT (groin discomfort), DIARRHOEA (diarrhea), ABDOMINAL PAIN (abdominal cramping), CHEST DISCOMFORT (left side chest discomfort), PYREXIA (99.8 fever which had a high of 100.1 degrees F) and MYALGIA (body aches). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency; IBUPROFEN at an unspecified dose and frequency; BISMUTH SUBSALICYLATE (PEPTO-BISMOL) at an unspecified dose and frequency and CALCIUM CARBONATE, MAGNESIUM CARBONATE (TUMS [CALCIUM CARBONATE;MAGNESIUM CARBONATE]) at an unspecified dose and frequency. At the time of the report, MUSCULOSKELETAL DISCOMFORT (groin discomfort), DIARRHOEA (diarrhea), ABDOMINAL PAIN (abdominal cramping), CHEST DISCOMFORT (left side chest discomfort) and PYREXIA (99.8 fever which had a high of 100.1 degrees F) had resolved and MYALGIA (body aches) had not 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.   Concomitant medication was not provided by the  reporter.  Patient tested positive for antibodies in 2 antibody blood tests.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Pneumothorax
Clinical narrative: Collapsed lungs after first shot; COVID-19 disease after first shot; This spontaneous case was reported by a consumer and describes the occurrence of PNEUMOTHORAX (Collapsed lungs after first shot) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   In December 2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PNEUMOTHORAX (Collapsed lungs after first shot) (seriousness criterion medically significant) and COVID-19 (COVID-19 disease after first shot). At the time of the report, PNEUMOTHORAX (Collapsed lungs after first shot) and COVID-19 (COVID-19 disease after first shot) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   No relevant concomitant medications were reported  No treatment information was provided.  Company comment: This case concerns a 30 year-old female patient with no reported medical history, who experienced the unexpected serious event of Pneumothorax and the non-serious AESI of COVID-19. The events occurred an unknown number of days after the first 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 30 year-old female patient with no reported medical history, who experienced the unexpected serious event of Pneumothorax and the non-serious AESI of COVID-19. The events occurred an unknown number of days after the first dose of mRNA-1273 vaccine. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Dose given past the 12 hour post puncture time; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose given past the 12 hour post puncture time) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Sep-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose given past the 12 hour post puncture time). On 03-Sep-2021, EXPIRED PRODUCT ADMINISTERED (Dose given past the 12 hour post puncture time) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications was not provided by the reporter.  On 31-Aug-2021, Vial was put into fridge and opened on 01-Sep-2021.  Vaccine was kept a the appropriate refrigerated temperature the entire time.  Patient reported having no adverse events  Treatment information was not provided   This case was linked to MOD-2021-327879 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 27-Sep-2021: Follow-up non-significant information added in narrative.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Seizure
Clinical narrative: Sore arm; Seizures; This spontaneous case was reported by a consumer and describes the occurrence of SEIZURE (Seizures) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048F21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Seizures since an unknown date. Concurrent medical conditions included Epilepsy. Concomitant products included CARBAMAZEPINE (TEGRETOL) and PHENYTOIN (DILANTIN [PHENYTOIN]) for an unknown indication.    On 06-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Sep-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced SEIZURE (Seizures) (seriousness criterion medically significant). On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore arm). At the time of the report, SEIZURE (Seizures) and PAIN IN EXTREMITY (Sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient had 1 seizure on 07-Sep-2021, 5 seizures on 10-Sep-2021 and another seizure on 18-Sep-2021. Patient had no other adverse event or pre-existing condition. No allergy was reported. Patient had not visited primary care yet regarding this event.  No treatment information was provided.  Company Comment: This case concerns a 61-year-old, female patient with previous relevant medical history of seizures, epilepsy and use of concomitant medication, who experienced the unexpected event of seizure. The event occurred 1 days after the first dose of mRNA-1273. The rechallenge was unknown since no information about the outcome of the events was disclosed. The medical history of seizures, epilepsy and use of concomitant medication remains a confounder. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This case concerns a 61-year-old, female patient with previous relevant medical history of seizures, epilepsy and use of concomitant medication, who experienced the unexpected event of seizure. The event occurred 1 days after the first dose of mRNA-1273. The rechallenge was unknown since no information about the outcome of the events was disclosed. The medical history of seizures, epilepsy and use of concomitant medication remains a confounder. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Age: 22.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Dose given past the 12 hour post puncture time; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 22-Sep-2021 and was forwarded to Moderna on 22-Sep-2021.    This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose given past the 12 hour post puncture time) in a 22-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Sep-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose given past the 12 hour post puncture time). On 06-Sep-2021, EXPIRED PRODUCT ADMINISTERED (Dose given past the 12 hour post puncture time) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The reporter stated that dose was given past the 12hour post puncture time.  No concomitant medications were reported.  No treatment information was reported.   This case was linked to MOD-2021-327879 (Patient Link).
Age: 21.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Dose given past the 12 hour post puncture time; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 22-Sep-2021 and was forwarded to Moderna on 22-Sep-2021.    This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose given past the 12 hour post puncture time) in a 21-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Sep-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose given past the 12 hour post puncture time). On 08-Sep-2021, EXPIRED PRODUCT ADMINISTERED (Dose given past the 12 hour post puncture time) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication details was reported. No treatment medication details was reported.   This case was linked to MOD-2021-327879.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation
Clinical narrative: mild, moderate to intense burning sensation/strong burning/ burning sensation thorough out her whole body/; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 22-Sep-2021 and was forwarded to Moderna on 22-Sep-2021.    This spontaneous case was reported by a consumer and describes the occurrence of BURNING SENSATION (mild, moderate to intense burning sensation/strong burning/ burning sensation thorough out her whole body/) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 053E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Aug-2021, the patient experienced BURNING SENSATION (mild, moderate to intense burning sensation/strong burning/ burning sensation thorough out her whole body/). The patient was treated with IBUPROFEN in August 2021 for Burning sensation, at an unspecified dose and frequency. At the time of the report, BURNING SENSATION (mild, moderate to intense burning sensation/strong burning/ burning sensation thorough out her whole body/) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.  Patient informed that in the evening after the vaccination of her first dose, she experienced burning sensation thorough out her whole body which lasted a little bit. Next morning, it returned in her entire body including legs, face, arms and it was very intense which went on for the whole day. Patient went to a clinic and they told her to take Ibuprofen which helped her and the burning subsided.  On the following Monday, the burning sensation was present but was not that intense. During the following week, she kept experiencing mild to intense burning sensation which lasted sometimes 1 hour or so. Caller took Ibuprofen and the burning subsided. Last week, the caller started experiencing mild, moderate to intense burning sensation again in her whole body and she still experiencing the same as of today.  The strong burning sensation kept coming back.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: dose given past the 12 hour post puncture time; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (dose given past the 12 hour post puncture time) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Sep-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (dose given past the 12 hour post puncture time). On 15-Sep-2021, EXPIRED PRODUCT ADMINISTERED (dose given past the 12 hour post puncture time) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication information was not provided by the reporter.  Treatment information was not provided by the reporter.   This case was linked to MOD-2021-328674, MOD-2021-328946, MOD-2021-327829, MOD-2021-327835, MOD-2021-327839, MOD-2021-327846, MOD-2021-328129, MOD-2021-328125.
Sex: F
Vaccine: COVID19
Symptoms: Death
Clinical narrative: Passed away; This spontaneous case was reported by a consumer and describes the occurrence of DEATH (Passed away) 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. Death occurred on 28-Aug-2021 The patient died on 28-Aug-2021. The cause of death was not reported. It is unknown if an autopsy was performed.            Concomitant product use was not provided by the reporter. No treatment information was provided.  This report concerns a female patient with no relevant medical history who died (unexpected event) due to an unknown cause. The event occurred after an unknown duration following vaccination with the first dose of mRNA-1273. The rechallenge was assessed as not applicable as the patient passed away. The benefit-risk relationship of mRNA-1273 is not affected by this report.   This case was linked to MOD-2021-327538 (Patient Link).; Sender's Comments: This report concerns a female patient with no relevant medical history who died (unexpected event) due to an unknown cause. The event occurred after an unknown duration following vaccination with the first dose of mRNA-1273. The rechallenge was assessed as not applicable as the patient passed away. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Reported Cause(s) of Death: Unknown cause of death
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: sore right injection site arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (sore right injection site arm) in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Aug-2021, the patient experienced VACCINATION SITE PAIN (sore right injection site arm). At the time of the report, VACCINATION SITE PAIN (sore right injection site arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. No treatment medications were reported.   This case was linked to MOD-2021-327938 (Patient Link).
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Cold sweat, Confusional state, Decreased appetite
Clinical narrative: swelling in the shoulder; discombobulated; sweating with 70°F and a fan on / sweating profusely; most extreme case chills ever experienced in my life; continued headache; continued joint pain. Every joint, from hands to feet; redness in injection site; cold sweats; no appetite; numbness in my joints (specially in right elbow); This spontaneous case was reported by a consumer and describes the occurrence of COLD SWEAT (cold sweats), DECREASED APPETITE (no appetite), HYPOAESTHESIA (numbness in my joints (specially in right elbow)), SWELLING (swelling in the shoulder) and CONFUSIONAL STATE (discombobulated) in a 53-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017E21A and 062E21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 22-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 22-Sep-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced HYPOAESTHESIA (numbness in my joints (specially in right elbow)). On an unknown date, the patient experienced COLD SWEAT (cold sweats), DECREASED APPETITE (no appetite), SWELLING (swelling in the shoulder), CONFUSIONAL STATE (discombobulated), HYPERHIDROSIS (sweating with 70°F and a fan on / sweating profusely), CHILLS (most extreme case chills ever experienced in my life), HEADACHE (continued headache), ARTHRALGIA (continued joint pain. Every joint, from hands to feet) and VACCINATION SITE ERYTHEMA (redness in injection site). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency; NAPROXEN SODIUM (ALEVE) at an unspecified dose and frequency and PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, COLD SWEAT (cold sweats), DECREASED APPETITE (no appetite), HYPOAESTHESIA (numbness in my joints (specially in right elbow)), SWELLING (swelling in the shoulder), CONFUSIONAL STATE (discombobulated), HYPERHIDROSIS (sweating with 70°F and a fan on / sweating profusely), CHILLS (most extreme case chills ever experienced in my life), HEADACHE (continued headache), ARTHRALGIA (continued joint pain. Every joint, from hands to feet) and VACCINATION SITE ERYTHEMA (redness in injection site) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. It was reported that patient also covered with a blank for chills and used light clothes for the sweating and lost 7 pounds since the second dose.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Hyperhidrosis, Hypoaesthesia, Swelling, Vaccination site erythema
Clinical narrative: swelling in the shoulder; discombobulated; sweating with 70°F and a fan on / sweating profusely; most extreme case chills ever experienced in my life; continued headache; continued joint pain. Every joint, from hands to feet; redness in injection site; cold sweats; no appetite; numbness in my joints (specially in right elbow); This spontaneous case was reported by a consumer and describes the occurrence of COLD SWEAT (cold sweats), DECREASED APPETITE (no appetite), HYPOAESTHESIA (numbness in my joints (specially in right elbow)), SWELLING (swelling in the shoulder) and CONFUSIONAL STATE (discombobulated) in a 53-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017E21A and 062E21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 22-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 22-Sep-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced HYPOAESTHESIA (numbness in my joints (specially in right elbow)). On an unknown date, the patient experienced COLD SWEAT (cold sweats), DECREASED APPETITE (no appetite), SWELLING (swelling in the shoulder), CONFUSIONAL STATE (discombobulated), HYPERHIDROSIS (sweating with 70°F and a fan on / sweating profusely), CHILLS (most extreme case chills ever experienced in my life), HEADACHE (continued headache), ARTHRALGIA (continued joint pain. Every joint, from hands to feet) and VACCINATION SITE ERYTHEMA (redness in injection site). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency; NAPROXEN SODIUM (ALEVE) at an unspecified dose and frequency and PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, COLD SWEAT (cold sweats), DECREASED APPETITE (no appetite), HYPOAESTHESIA (numbness in my joints (specially in right elbow)), SWELLING (swelling in the shoulder), CONFUSIONAL STATE (discombobulated), HYPERHIDROSIS (sweating with 70°F and a fan on / sweating profusely), CHILLS (most extreme case chills ever experienced in my life), HEADACHE (continued headache), ARTHRALGIA (continued joint pain. Every joint, from hands to feet) and VACCINATION SITE ERYTHEMA (redness in injection site) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. It was reported that patient also covered with a blank for chills and used light clothes for the sweating and lost 7 pounds since the second dose.
Age: 85.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: sore left injection site arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (sore left injection site arm) in an 85-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036A21A and 042120A) for COVID-19 vaccination.     No Medical History information was reported.   On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 22-Feb-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VACCINATION SITE PAIN (sore left injection site arm). At the time of the report, VACCINATION SITE PAIN (sore left injection site arm) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication were reported. No treatment information were provided.   This case was linked to MOD-2021-327913, MOD-2021-327671 (Patient Link).
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Hyperhidrosis, Inappropriate schedule of product administration, Lymphadenopathy
Clinical narrative: More than 35 days between Moderna Covid-19 vaccinations.; fatigued; swollen lymph node under his lymph node; vomited; chills; nausea; shaking; sweating; This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (shaking), HYPERHIDROSIS (sweating), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (More than 35 days between Moderna Covid-19 vaccinations.), CHILLS (chills) and NAUSEA (nausea) in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 048F21A and 002F21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 07-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Sep-2021, the patient experienced TREMOR (shaking), HYPERHIDROSIS (sweating), CHILLS (chills) and NAUSEA (nausea). On 20-Sep-2021, the patient experienced VOMITING (vomited). On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (More than 35 days between Moderna Covid-19 vaccinations.), FATIGUE (fatigued) and LYMPHADENOPATHY (swollen lymph node under his lymph node). At the time of the report, TREMOR (shaking), HYPERHIDROSIS (sweating), CHILLS (chills), NAUSEA (nausea), FATIGUE (fatigued), VOMITING (vomited) and LYMPHADENOPATHY (swollen lymph node under his lymph node) outcome was unknown and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (More than 35 days between Moderna Covid-19 vaccinations.) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was not applicable  No concomitant medications reported. No treatment reported On an unknown date lab data includes Bloodwork and an Ultrasound results were pending.   This case was linked to MOD-2021-327904 (Patient Link).
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Nausea, Tremor, Vomiting
Clinical narrative: More than 35 days between Moderna Covid-19 vaccinations.; fatigued; swollen lymph node under his lymph node; vomited; chills; nausea; shaking; sweating; This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (shaking), HYPERHIDROSIS (sweating), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (More than 35 days between Moderna Covid-19 vaccinations.), CHILLS (chills) and NAUSEA (nausea) in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 048F21A and 002F21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 07-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Sep-2021, the patient experienced TREMOR (shaking), HYPERHIDROSIS (sweating), CHILLS (chills) and NAUSEA (nausea). On 20-Sep-2021, the patient experienced VOMITING (vomited). On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (More than 35 days between Moderna Covid-19 vaccinations.), FATIGUE (fatigued) and LYMPHADENOPATHY (swollen lymph node under his lymph node). At the time of the report, TREMOR (shaking), HYPERHIDROSIS (sweating), CHILLS (chills), NAUSEA (nausea), FATIGUE (fatigued), VOMITING (vomited) and LYMPHADENOPATHY (swollen lymph node under his lymph node) outcome was unknown and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (More than 35 days between Moderna Covid-19 vaccinations.) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was not applicable  No concomitant medications reported. No treatment reported On an unknown date lab data includes Bloodwork and an Ultrasound results were pending.   This case was linked to MOD-2021-327904 (Patient Link).
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Somnolence
Clinical narrative: sleepy after second shot; tired after second shot; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (sleepy after second shot) and FATIGUE (tired after second shot) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003A21A and 030M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Mar-2021, the patient experienced SOMNOLENCE (sleepy after second shot) and FATIGUE (tired after second shot). At the time of the report, SOMNOLENCE (sleepy after second shot) and FATIGUE (tired after second shot) outcome 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.
Sex: U
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: Full of blood clots; 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 THROMBOSIS (Full of blood clots) 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 THROMBOSIS (Full of blood clots). At the time of the report, THROMBOSIS (Full of blood clots) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided. Treatment medications was not provided.   Reporter did not allow further contact; Sender's Comments: This case concerns a patient of unknown age and gender with no reported medical history, who experienced the unexpected non-serious AESI of Thrombosis. The event occurred an unknown number of days after an unspecified dose of mRNA-1273 vaccine. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Manual override done to remove seriousness criteria of Medically significant from event of Thrombosis based on medical judgement and review of source document that does not support seriousness criteria.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Asthma
Clinical narrative: Patient started with symptoms of asthma. she has asthma but doesn't need to use nebulizer or any other medication for it. But since the first dose, patient has been going through daily asthma attacks; This spontaneous case was reported by a consumer and describes the occurrence of ASTHMA (Patient started with symptoms of asthma. she has asthma but doesn't need to use nebulizer or any other medication for it. But since the first dose, patient has been going through daily asthma attacks) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014F21A) for COVID-19 vaccination.     Concurrent medical conditions included Asthma.    On 17-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Sep-2021, the patient experienced ASTHMA (Patient started with symptoms of asthma. she has asthma but doesn't need to use nebulizer or any other medication for it. But since the first dose, patient has been going through daily asthma attacks). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Asthma, at an unspecified dose and frequency. At the time of the report, ASTHMA (Patient started with symptoms of asthma. she has asthma but doesn't need to use nebulizer or any other medication for it. But since the first dose, patient has been going through daily asthma attacks) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported by the reporter.  Within 30 minutes of administration, patient started with symptoms of asthma.  Patient has also seen a doctor and was prescribed with corticoids too. She was better now than at the beginning, but still not good.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Maternal exposure during pregnancy
Clinical narrative: Pregnant; second dose on  the 22 nd day from her first dose; This spontaneous prospective pregnancy case was reported by a nurse and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Pregnant) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dose on  the 22 nd day from her first dose) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Pregnant.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On an unknown date, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Pregnant) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dose on  the 22 nd day from her first dose). At the time of the report, MATERNAL EXPOSURE DURING PREGNANCY (Pregnant) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dose on  the 22 nd day from her first dose) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. Treatment medication use was not provided by the reporter.  This case concerns a 34 year-old female patient with no reported medical history, who experienced the unexpected events of Maternal exposure during pregnancy and Inappropriate schedule of product administration. The event s occurred an unknown number of days after the second dose of mRNA-1273 vaccine. The seriousness criteria of the event Maternal exposure during pregnancy was downgraded from Medically significant to non-serious based on medical judgement and review of available report without information supporting seriousness criteria. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This case concerns a 34 year-old female patient with no reported medical history, who experienced the unexpected events of Maternal exposure during pregnancy and Inappropriate schedule of product administration. The event s occurred an unknown number of days after the second dose of mRNA-1273 vaccine. The seriousness criteria of the event Maternal exposure during pregnancy was downgraded from Medically significant to non-serious based on medical judgement and review of available report without information supporting seriousness criteria. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Muscle fatigue, Muscle spasms
Clinical narrative: Muscle fatigue; Muscle cramps; Joint ache; This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE FATIGUE (Muscle fatigue), MUSCLE SPASMS (Muscle cramps) and ARTHRALGIA (Joint ache) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 019821A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Mar-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 MUSCLE FATIGUE (Muscle fatigue), MUSCLE SPASMS (Muscle cramps) and ARTHRALGIA (Joint ache). At the time of the report, MUSCLE FATIGUE (Muscle fatigue), MUSCLE SPASMS (Muscle cramps) and ARTHRALGIA (Joint ache) 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 information was reported. No treatment information was reported.  After the first dose of vaccination, the patient had severe muscle cramps which seemed to be like broken rib. On an unknown date, the x-ray was performed but nothing was noticed for cramping. The joint was hurting with fatigued muscle.   This case was linked to MOD-2021-331113.   Most recent FOLLOW-UP information incorporated above includes: On 24-Sep-2021: Follow up include updated reporter details. updated patient demographics. updated suspect product details. updated events outcome.
Sex: M
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (More than 35 days passed since the first dose and he did not get the second dose) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 23-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (More than 35 days passed since the first dose and he did not get the second dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (More than 35 days passed since the first dose and he did not get the second dose) had resolved. Concomitant medication was not reported. Treatment information was not reported.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: Covid infection after full vaccination. /positive COVID-19 cases for individuals who have been fully vaccinated; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Covid infection after full vaccination. /positive COVID-19 cases for individuals who have been fully vaccinated) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (Covid infection after full vaccination. /positive COVID-19 cases for individuals who have been fully vaccinated). At the time of the report, COVID-19 (Covid infection after full vaccination. /positive COVID-19 cases for individuals who have been fully vaccinated) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive (Positive) positive.         No concomitant product use was provided. No treatment information was provided.; Sender's Comments: This case concerns a female patient with no age and  medical history reported  who experienced the unexpected event of COVID-19.  The time that this event happened from the time of vaccination with the 2nd dose of Moderna is unknown , no details were reported. The benefit-risk relationship of Moderna  is not affected by this report.
Age: 85.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: patient involved in the doses given past the 12 hour post puncture time; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patient involved in the doses given past the 12 hour post puncture time) in an 85-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Sep-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (patient involved in the doses given past the 12 hour post puncture time). On 03-Sep-2021, EXPIRED PRODUCT ADMINISTERED (patient involved in the doses given past the 12 hour post puncture time) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Vaccine was kept at the appropriate refrigerated temperature the entire time  No concomitant and treatment information were reported by the reporter.
Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: Alopecia, Back pain, Chills, Decreased appetite, Headache
Clinical narrative: Hair loss; Fever; Chills; Headache; Pain at injection site; Lethargy; Back pain; no apettite; This spontaneous case was reported by a consumer and describes the occurrence of LETHARGY, BACK PAIN, DECREASED APPETITE, ALOPECIA, and PYREXIA in a 27-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 055E21A and 056D21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 PCR test positive on 02-Aug-2020.   On 11-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 09-Sep-2021, the patient experienced LETHARGY, BACK PAIN, DECREASED APPETITE, PYREXIA, CHILLS, HEADACHE, and VACCINATION SITE PAIN. On 10-Sep-2021, the patient experienced ALOPECIA. On 12-Sep-2021, LETHARGY, BACK PAIN, DECREASED APPETITE, PYREXIA, CHILLS, HEADACHE, and VACCINATION SITE PAIN had resolved. At the time of the report, ALOPECIA outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available) on 02-Aug-2020, SARS-CoV-2 test positive PCR test.         No concomitant medications were reported. No treatment medications were reported.
Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: Lethargy, Pyrexia, SARS-CoV-2 test, Vaccination site pain
Clinical narrative: Hair loss; Fever; Chills; Headache; Pain at injection site; Lethargy; Back pain; no apettite; This spontaneous case was reported by a consumer and describes the occurrence of LETHARGY, BACK PAIN, DECREASED APPETITE, ALOPECIA, and PYREXIA in a 27-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 055E21A and 056D21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 PCR test positive on 02-Aug-2020.   On 11-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 09-Sep-2021, the patient experienced LETHARGY, BACK PAIN, DECREASED APPETITE, PYREXIA, CHILLS, HEADACHE, and VACCINATION SITE PAIN. On 10-Sep-2021, the patient experienced ALOPECIA. On 12-Sep-2021, LETHARGY, BACK PAIN, DECREASED APPETITE, PYREXIA, CHILLS, HEADACHE, and VACCINATION SITE PAIN had resolved. At the time of the report, ALOPECIA outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available) on 02-Aug-2020, SARS-CoV-2 test positive PCR test.         No concomitant medications were reported. No treatment medications were reported.