chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Fatigue, Heart rate, Heart rate abnormal, Nausea
Clinical narrative: Arm hurt; Diarrhea; Irregular heart rate; Palpitations; Nausea; Vomiting; Little bit tired; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm hurt), DIARRHOEA (Diarrhea), HEART RATE ABNORMAL (Irregular heart rate), PALPITATIONS (Palpitations) and NAUSEA (Nausea) in a 59-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 was reported by the reporter.  Concomitant products included ATORVASTATIN from 2019 to an unknown date, CURCUMA LONGA (TURMERIC [CURCUMA LONGA]) from 2020 to an unknown date, CHONDROITIN SULFATE, GLUCOSAMINE HYDROCHLORIDE, METHYLSULFONYLMETHANE (TRIPLEFLEX) from 2019 to an unknown date, ZINC from 2021 to an unknown date and VITAMIN C [ASCORBIC ACID] from 2021 to an unknown date for an unknown indication.   On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-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 PAIN IN EXTREMITY (Arm hurt), DIARRHOEA (Diarrhea), HEART RATE ABNORMAL (Irregular heart rate), PALPITATIONS (Palpitations), NAUSEA (Nausea), VOMITING (Vomiting) and FATIGUE (Little bit tired). On 30-Apr-2021, DIARRHOEA (Diarrhea), HEART RATE ABNORMAL (Irregular heart rate), PALPITATIONS (Palpitations), NAUSEA (Nausea) and VOMITING (Vomiting) had resolved. At the time of the report, PAIN IN EXTREMITY (Arm hurt) and FATIGUE (Little bit tired) had resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Heart rate: abnormal (abnormal) Irregular heart rate.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment information was not provided.   This case was linked to MOD-2021-066517 (Patient Link).
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Palpitations, Vomiting
Clinical narrative: Arm hurt; Diarrhea; Irregular heart rate; Palpitations; Nausea; Vomiting; Little bit tired; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm hurt), DIARRHOEA (Diarrhea), HEART RATE ABNORMAL (Irregular heart rate), PALPITATIONS (Palpitations) and NAUSEA (Nausea) in a 59-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 was reported by the reporter.  Concomitant products included ATORVASTATIN from 2019 to an unknown date, CURCUMA LONGA (TURMERIC [CURCUMA LONGA]) from 2020 to an unknown date, CHONDROITIN SULFATE, GLUCOSAMINE HYDROCHLORIDE, METHYLSULFONYLMETHANE (TRIPLEFLEX) from 2019 to an unknown date, ZINC from 2021 to an unknown date and VITAMIN C [ASCORBIC ACID] from 2021 to an unknown date for an unknown indication.   On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-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 PAIN IN EXTREMITY (Arm hurt), DIARRHOEA (Diarrhea), HEART RATE ABNORMAL (Irregular heart rate), PALPITATIONS (Palpitations), NAUSEA (Nausea), VOMITING (Vomiting) and FATIGUE (Little bit tired). On 30-Apr-2021, DIARRHOEA (Diarrhea), HEART RATE ABNORMAL (Irregular heart rate), PALPITATIONS (Palpitations), NAUSEA (Nausea) and VOMITING (Vomiting) had resolved. At the time of the report, PAIN IN EXTREMITY (Arm hurt) and FATIGUE (Little bit tired) had resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Heart rate: abnormal (abnormal) Irregular heart rate.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment information was not provided.   This case was linked to MOD-2021-066517 (Patient Link).
Age: 41.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: For this patient, the number of days that have passed were 26. Patient received second dose on 29Jul2021; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (For this patient, the number of days that have passed were 26. Patient received second dose on 29Jul2021) in a 41-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 29-Jul-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (For this patient, the number of days that have passed were 26. Patient received second dose on 29Jul2021). At the time of the report, EXPIRED PRODUCT ADMINISTERED (For this patient, the number of days that have passed were 26. Patient received second dose on 29Jul2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications and no treatment medications were reported.  CROSSLINK TO ORIGINAL CASE MOD21-126929   This case was linked to MOD-2021-278394 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Intentional dose omission
Clinical narrative: Had covid; Not necessary to take the second one; 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 COVID-19 (Had covid) and INTENTIONAL DOSE OMISSION (Not necessary to take the second one) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (Had covid) and INTENTIONAL DOSE OMISSION (Not necessary to take the second one). At the time of the report, COVID-19 (Had covid) outcome was unknown and INTENTIONAL DOSE OMISSION (Not necessary to take the second one) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product information was not provided. Treatment information was not provided.
Age: 35.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: For this patient, the number of days that have passed were 26. Patient received second dose on 29Jul2021; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (For this patient, the number of days that have passed were 26. Patient received second dose on 29Jul2021) in a 35-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 29-Jul-2021, the patient 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 received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Jul-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (For this patient, the number of days that have passed were 26. Patient received second dose on 29Jul2021). At the time of the report, EXPIRED PRODUCT ADMINISTERED (For this patient, the number of days that have passed were 26. Patient received second dose on 29Jul2021) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant and treatment medications were provided by reporter.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Antibody test, Coronavirus test, Feeling hot, Neuralgia, Product dose omission issue
Clinical narrative: Neuropathic Pain; She did not get the 2nd dose of the vaccine because of these side effects; Eperienced hot sensation on the right side of her head continued and worsened; Nerve pain which starts on the right side of her head and goes to the left side but the pain can start anywhere/neuropathic pain; This spontaneous case was reported by a consumer and describes the occurrence of FEELING HOT (Eperienced hot sensation on the right side of her head continued and worsened), NEURALGIA (Nerve pain which starts on the right side of her head and goes to the left side but the pain can start anywhere/neuropathic pain), NEURALGIA (Neuropathic Pain) and PRODUCT DOSE OMISSION ISSUE (She did not get the 2nd dose of the vaccine because of these side effects) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In January 2021, the patient experienced NEURALGIA (Nerve pain which starts on the right side of her head and goes to the left side but the pain can start anywhere/neuropathic pain). On 22-Jan-2021, the patient experienced FEELING HOT (Eperienced hot sensation on the right side of her head continued and worsened). On an unknown date, the patient experienced NEURALGIA (Neuropathic Pain) and PRODUCT DOSE OMISSION ISSUE (She did not get the 2nd dose of the vaccine because of these side effects). The patient was treated with GABAPENTIN for Neuropathic pain, at an unspecified dose and frequency; AMITRIPTYLINE at an unspecified dose and frequency; PREDNISONE at an unspecified dose and frequency; METHYLPREDNISOLONE ACETATE (MEDROL) at an unspecified dose and frequency and LEVOCETIRIZINE DIHYDROCHLORIDE (XYZAL) at an unspecified dose and frequency. At the time of the report, FEELING HOT (Eperienced hot sensation on the right side of her head continued and worsened) and NEURALGIA (Nerve pain which starts on the right side of her head and goes to the left side but the pain can start anywhere/neuropathic pain) had not resolved, NEURALGIA (Neuropathic Pain) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (She did not get the 2nd dose of the vaccine because of these side effects) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-Feb-2021, Coronavirus test: negative (Negative) Negative. In February 2021, Antibody test: 38.29 (Inconclusive) 38.29 per millilitre. In May 2021, Antibody test: 104.9 (Inconclusive) 104.9 per millilitre. In July 2021, Antibody test: 58.8 (Inconclusive) 58.8 per millilitre.     mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was withdrawn on an unknown date.       No concomitant medications were provided by the reporter.   Reporter did not allow further contact
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling
Clinical narrative: Swelling in their left foot; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Swelling in their left foot) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027L20A and 013M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In January 2021, the patient experienced PERIPHERAL SWELLING (Swelling in their left foot). At the time of the report, PERIPHERAL SWELLING (Swelling in their left foot) had not resolved.            No Concomitant medication were reported.  No treatment medication were reported.  Patient has seen several doctors, and X-rays and ultrasound studies were performed but no explanations was found. Patient is concerned about medical expenses. Patient state they do not take any medication regularly.
Sex: U
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: a patient who received the first shot in February and wants to get the second shot; 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 PRODUCT DOSE OMISSION ISSUE (a patient who received the first shot in February and wants to get the second shot) 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.    In February 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 (a patient who received the first shot in February and wants to get the second shot). At the time of the report, PRODUCT DOSE OMISSION ISSUE (a patient who received the first shot in February and wants to get the second shot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant Medication was provided.  No treatment medication was provided.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Off label use, Pain, Vaccination complication
Clinical narrative: Aches and pains (second dose); Second dose produced more severe side effects; he and his wife both received booster shots; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Aches and pains (second dose)), VACCINATION COMPLICATION (Second dose produced more severe side effects) and OFF LABEL USE (he and his wife both received booster shots) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010M20A, 037K20 and 0881021A) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised.   On 19-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 14-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN (Aches and pains (second dose)), VACCINATION COMPLICATION (Second dose produced more severe side effects) and OFF LABEL USE (he and his wife both received booster shots). At the time of the report, PAIN (Aches and pains (second dose)) and VACCINATION COMPLICATION (Second dose produced more severe side effects) outcome was unknown and OFF LABEL USE (he and his wife both received booster shots) had resolved.       No treatment medications were reported by reporter.  No concomitant medications were reported by reporter.  The patient experienced a few aches and pains with each of the first two doses but was fine so far after the booster dose. The second dose produced more severe side effects for the patient. It was unsure if the patient was currently on any concomitant medications. His wife experienced a few aches and pains with each of the first two doses but is fine so far after the booster dose. The caller mentioned that her second dose produced more severe side effects. It is unsure if the wife is currently on any concomitant medications at this time.  Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   This case was linked to MOD-2021-286836 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal, Myalgia
Clinical narrative: felt like I was hit by a bat; arm soreness felt like I was hit by a bat; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (felt like I was hit by a bat) and MYALGIA (arm soreness felt like I was hit by a bat) in a 54-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 067M20A) for COVID-19 vaccination.     Concomitant products included TAMSULOSIN, TESTOSTERONE, SERTRALINE, LISINOPRIL, GLYCERYL TRINITRATE (NITROGLYCERIN), AMIODARONE, ISOSORBIDE MONONITRATE, CARVEDILOL, ROSUVASTATIN, RIVAROXABAN (XARELTO) and ACETYLSALICYLIC ACID (BABY ASPIRIN) for an unknown indication.    On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Feb-2021, the patient experienced FEELING ABNORMAL (felt like I was hit by a bat) and MYALGIA (arm soreness felt like I was hit by a bat). At the time of the report, FEELING ABNORMAL (felt like I was hit by a bat) outcome was unknown and MYALGIA (arm soreness felt like I was hit by a bat) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment details reported.  Company comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. However the serious criteria Hospitalization is not captured. As the hospitalization occurred after 2nd dose.   This case was linked to MOD-2021-286939 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. However the serious criteria Hospitalization is not captured. As the hospitalization occurred after 2nd dose.
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: rash on his arm; This spontaneous case was reported by a consumer and describes the occurrence of RASH (rash on his arm) in a 36-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Aug-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 RASH (rash on his arm). At the time of the report, RASH (rash on his arm) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Expiration date is unknown for both doses. Both doses received in his upper arm muscle. First one in his left arm (non dominant arm) and second one in the right arm (dominant arm).  The patient does not take concomitant medications.  No treatment medications were provided.   This case was linked to MOD-2021-286925 (Patient Link).
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: rash across his chest and under his arms; This spontaneous case was reported by a consumer and describes the occurrence of RASH (rash across his chest and under his arms) in a 36-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 11-Aug-2021, the patient experienced RASH (rash across his chest and under his arms). At the time of the report, RASH (rash across his chest and under his arms) had resolved.            No concomitant medication were provided by the reporter.  Patient used cerave cream  as treatment medication for the rash and it worked.   This case was linked to MOD-2021-286916 (Patient Link).   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: patients who received a vaccine which was more than 30 days in the refrigerator (30 days were on 03Jul2021); This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patients who received a vaccine which was more than 30 days in the refrigerator (30 days were on 03Jul2021)) in a 57-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (patients who received a vaccine which was more than 30 days in the refrigerator (30 days were on 03Jul2021)). At the time of the report, EXPIRED PRODUCT ADMINISTERED (patients who received a vaccine which was more than 30 days in the refrigerator (30 days were on 03Jul2021)) 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.   Concomitant medications were not provided.  Treatment information was not reported.
Age: 34.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Inappropriate schedule of product administration, Interchange of vaccine products
Clinical narrative: Mixed series of vaccine; First dose (01-jul-2021) ,Second dose (13-aug-2021); This spontaneous case was reported by a pharmacist and describes the occurrence of INTERCHANGE OF VACCINE PRODUCTS (Mixed series of vaccine) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose (01-jul-2021) ,Second dose (13-aug-2021)) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018B21A) for COVID-19 vaccination.    Co-suspect product included non-company product TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for an unknown indication.    No Medical History information was reported.   On 01-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Aug-2021, the patient received first dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1 dosage form. On 13-Aug-2021, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (Mixed series of vaccine) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose (01-jul-2021) ,Second dose (13-aug-2021)). At the time of the report, INTERCHANGE OF VACCINE PRODUCTS (Mixed series of vaccine) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose (01-jul-2021) ,Second dose (13-aug-2021)) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications were not provided by reporter. Treatment information was not provided by reporter.
Age: 51.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: patients who received a vaccine which was more than 30 days in the refrigerator; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patients who received a vaccine which was more than 30 days in the refrigerator) in a 51-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Jul-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (patients who received a vaccine which was more than 30 days in the refrigerator). At the time of the report, EXPIRED PRODUCT ADMINISTERED (patients who received a vaccine which was more than 30 days in the refrigerator) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not provided. Treatment information was not provided.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: now has atrial fibrillation; patient was having a heart attack/an active heart attack; dripping sweat; couldn't breath; pressure on their chest/ elephant was sitting on their chest; arm soreness/ felt like my arm was broken; This spontaneous case was reported by a consumer and describes the occurrence of MYOCARDIAL INFARCTION (patient was having a heart attack/an active heart attack) and ATRIAL FIBRILLATION (now has atrial fibrillation) in a 54-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A2114) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.   Concomitant products included TAMSULOSIN, TESTOSTERONE, SERTRALINE, LISINOPRIL, GLYCERYL TRINITRATE (NITROGLYCERIN), AMIODARONE, ISOSORBIDE MONONITRATE, CARVEDILOL, ROSUVASTATIN, RIVAROXABAN (XARELTO) and ACETYLSALICYLIC ACID (BABY ASPIRIN) for an unknown indication.  On 11-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Mar-2021, the patient experienced PAIN IN EXTREMITY (arm soreness/ felt like my arm was broken). On 13-Mar-2021, the patient experienced MYOCARDIAL INFARCTION (patient was having a heart attack/an active heart attack) (seriousness criteria hospitalization and medically significant), HYPERHIDROSIS (dripping sweat), DYSPNOEA (couldn't breath) and CHEST DISCOMFORT (pressure on their chest/ elephant was sitting on their chest). On an unknown date, the patient experienced ATRIAL FIBRILLATION (now has atrial fibrillation) (seriousness criteria hospitalization and medically significant). At the time of the report, MYOCARDIAL INFARCTION (patient was having a heart attack/an active heart attack), ATRIAL FIBRILLATION (now has atrial fibrillation), HYPERHIDROSIS (dripping sweat), DYSPNOEA (couldn't breath), CHEST DISCOMFORT (pressure on their chest/ elephant was sitting on their chest) and PAIN IN EXTREMITY (arm soreness/ felt like my arm was broken) outcome was unknown.  Treatment medications were not reported. The reporter states that the patient after receiving the second dose experienced arm soreness. On 13 March 2021 patient started dripping sweat, said couldn't breathe, and felt pressure on the chest. The test confirms that patient was having a heart attack. On 15 March 2021 the patient went to different hospital and they ran test and confirming that the patient is having active heart attack. The patient went to the Cath lab and was at the hospital for 4 days. The patient now had atrial fibrillation and the patient never took anything on their own to help treat the symptoms experienced.  Company comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   This case was linked to MOD-2021-286915 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Chills, Ear pain, Fatigue
Clinical narrative: Felt hot and cold; Ear ache; Neck ache; knot at the injection site; weakness; Red at injection site; Injection site soreness; Tiredness; Joint pain in leg and hand; Headache; chills; This spontaneous case was reported by a consumer and describes the occurrence of FEELING OF BODY TEMPERATURE CHANGE (Felt hot and cold), EAR PAIN (Ear ache), NECK PAIN (Neck ache), VACCINATION SITE NODULE (knot at the injection site) and ASTHENIA (weakness) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 052E21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 (had Covid over a month prior to this report and was treated with Regeneron then) in 2021.    On 14-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Aug-2021 at 1:00 PM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced CHILLS (chills). On 15-Aug-2021 at 4:00 PM, the patient experienced FEELING OF BODY TEMPERATURE CHANGE (Felt hot and cold), EAR PAIN (Ear ache), NECK PAIN (Neck ache), VACCINATION SITE NODULE (knot at the injection site), ASTHENIA (weakness), INJECTION SITE ERYTHEMA (Red at injection site), INJECTION SITE PAIN (Injection site soreness), FATIGUE (Tiredness), ARTHRALGIA (Joint pain in leg and hand) and HEADACHE (Headache). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) 15-Aug-2021 for Adverse event, at a dose of 2 dosage form. At the time of the report, FEELING OF BODY TEMPERATURE CHANGE (Felt hot and cold), EAR PAIN (Ear ache), NECK PAIN (Neck ache), VACCINATION SITE NODULE (knot at the injection site), ASTHENIA (weakness), INJECTION SITE ERYTHEMA (Red at injection site), INJECTION SITE PAIN (Injection site soreness), FATIGUE (Tiredness), ARTHRALGIA (Joint pain in leg and hand), HEADACHE (Headache) and CHILLS (chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported by the reporter.  It was reported that the patient waited until she was Covid negative for 2 weeks before getting the vaccine like her physician recommended. Moreover, the patient reported that her symptoms were very similar to when she had Covid-19.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling of body temperature change, Headache, Injection site erythema, Injection site pain, Neck pain
Clinical narrative: Felt hot and cold; Ear ache; Neck ache; knot at the injection site; weakness; Red at injection site; Injection site soreness; Tiredness; Joint pain in leg and hand; Headache; chills; This spontaneous case was reported by a consumer and describes the occurrence of FEELING OF BODY TEMPERATURE CHANGE (Felt hot and cold), EAR PAIN (Ear ache), NECK PAIN (Neck ache), VACCINATION SITE NODULE (knot at the injection site) and ASTHENIA (weakness) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 052E21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 (had Covid over a month prior to this report and was treated with Regeneron then) in 2021.    On 14-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Aug-2021 at 1:00 PM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced CHILLS (chills). On 15-Aug-2021 at 4:00 PM, the patient experienced FEELING OF BODY TEMPERATURE CHANGE (Felt hot and cold), EAR PAIN (Ear ache), NECK PAIN (Neck ache), VACCINATION SITE NODULE (knot at the injection site), ASTHENIA (weakness), INJECTION SITE ERYTHEMA (Red at injection site), INJECTION SITE PAIN (Injection site soreness), FATIGUE (Tiredness), ARTHRALGIA (Joint pain in leg and hand) and HEADACHE (Headache). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) 15-Aug-2021 for Adverse event, at a dose of 2 dosage form. At the time of the report, FEELING OF BODY TEMPERATURE CHANGE (Felt hot and cold), EAR PAIN (Ear ache), NECK PAIN (Neck ache), VACCINATION SITE NODULE (knot at the injection site), ASTHENIA (weakness), INJECTION SITE ERYTHEMA (Red at injection site), INJECTION SITE PAIN (Injection site soreness), FATIGUE (Tiredness), ARTHRALGIA (Joint pain in leg and hand), HEADACHE (Headache) and CHILLS (chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported by the reporter.  It was reported that the patient waited until she was Covid negative for 2 weeks before getting the vaccine like her physician recommended. Moreover, the patient reported that her symptoms were very similar to when she had Covid-19.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site nodule
Clinical narrative: Felt hot and cold; Ear ache; Neck ache; knot at the injection site; weakness; Red at injection site; Injection site soreness; Tiredness; Joint pain in leg and hand; Headache; chills; This spontaneous case was reported by a consumer and describes the occurrence of FEELING OF BODY TEMPERATURE CHANGE (Felt hot and cold), EAR PAIN (Ear ache), NECK PAIN (Neck ache), VACCINATION SITE NODULE (knot at the injection site) and ASTHENIA (weakness) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 052E21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 (had Covid over a month prior to this report and was treated with Regeneron then) in 2021.    On 14-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Aug-2021 at 1:00 PM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced CHILLS (chills). On 15-Aug-2021 at 4:00 PM, the patient experienced FEELING OF BODY TEMPERATURE CHANGE (Felt hot and cold), EAR PAIN (Ear ache), NECK PAIN (Neck ache), VACCINATION SITE NODULE (knot at the injection site), ASTHENIA (weakness), INJECTION SITE ERYTHEMA (Red at injection site), INJECTION SITE PAIN (Injection site soreness), FATIGUE (Tiredness), ARTHRALGIA (Joint pain in leg and hand) and HEADACHE (Headache). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) 15-Aug-2021 for Adverse event, at a dose of 2 dosage form. At the time of the report, FEELING OF BODY TEMPERATURE CHANGE (Felt hot and cold), EAR PAIN (Ear ache), NECK PAIN (Neck ache), VACCINATION SITE NODULE (knot at the injection site), ASTHENIA (weakness), INJECTION SITE ERYTHEMA (Red at injection site), INJECTION SITE PAIN (Injection site soreness), FATIGUE (Tiredness), ARTHRALGIA (Joint pain in leg and hand), HEADACHE (Headache) and CHILLS (chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported by the reporter.  It was reported that the patient waited until she was Covid negative for 2 weeks before getting the vaccine like her physician recommended. Moreover, the patient reported that her symptoms were very similar to when she had Covid-19.
Age: 47.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: patients who received a vaccine which was more than 30 days in the refrigerator (30 days were on 03Jul2021); This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patients who received a vaccine which was more than 30 days in the refrigerator (30 days were on 03Jul2021)) in a 47-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 14-Jul-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Jul-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (patients who received a vaccine which was more than 30 days in the refrigerator (30 days were on 03Jul2021)). On 14-Jul-2021, EXPIRED PRODUCT ADMINISTERED (patients who received a vaccine which was more than 30 days in the refrigerator (30 days were on 03Jul2021)) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided. Treatment information was not provided.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Gait disturbance, Pain in extremity, Pyrexia
Clinical narrative: Hard time walking; Fever (100.3 degrees fahrenheit); legs are sore (both left and right) / leg pain; leg pain; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (legs are sore (both left and right) / leg pain), GAIT DISTURBANCE (Hard time walking), PAIN IN EXTREMITY (leg pain) and PYREXIA (Fever (100.3 degrees fahrenheit)) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 088D21A) for COVID-19 vaccination.     Concurrent medical conditions included Pacemaker syndrome.    On 14-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Aug-2021, the patient experienced PAIN IN EXTREMITY (legs are sore (both left and right) / leg pain) and PAIN IN EXTREMITY (leg pain). On 15-Aug-2021, the patient experienced GAIT DISTURBANCE (Hard time walking) and PYREXIA (Fever (100.3 degrees fahrenheit)). On 15-Aug-2021, PAIN IN EXTREMITY (leg pain) had resolved. At the time of the report, PAIN IN EXTREMITY (legs are sore (both left and right) / leg pain), GAIT DISTURBANCE (Hard time walking) and PYREXIA (Fever (100.3 degrees fahrenheit)) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  No treatment information was provided.
Sex: U
Vaccine: COVID19
Symptoms: Haematochezia
Clinical narrative: bleeding in stool; This spontaneous case was reported by a consumer and describes the occurrence of HAEMATOCHEZIA (bleeding in stool) 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 HAEMATOCHEZIA (bleeding in stool) (seriousness criterion medically significant). At the time of the report, HAEMATOCHEZIA (bleeding in stool) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication were not reported. Treatment medication were not reported. The reported states that the patient experienced bleeding in stool after vaccination.  Company Comment: Very limited information regarding this event has been provided at this time. Further information has been requested.; Sender's Comments: Very limited information regarding this event has been provided at this time. Further information has been requested.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Faeces discoloured
Clinical narrative: stool was dark red; stool was very bright after flushing; This spontaneous case was reported by a consumer and describes the occurrence of FAECES DISCOLOURED (stool was very bright after flushing) and FAECES DISCOLOURED (stool was dark red) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 0S4C21A and 002F21A) for COVID-19 vaccination.     Concomitant products included ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) for an unknown indication.   On 07-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 14-Aug-2021, the patient experienced FAECES DISCOLOURED (stool was very bright after flushing). On 15-Aug-2021, the patient experienced FAECES DISCOLOURED (stool was dark red). At the time of the report, FAECES DISCOLOURED (stool was very bright after flushing) and FAECES DISCOLOURED (stool was dark red) outcome was unknown.            The patient reported that he doesn't take any treatment for event but took  just water and orange juice.   Most recent FOLLOW-UP information incorporated above includes: On 15-Aug-2021: Follow up received on 15-Aug-2021 contains initial additional information-Updated the batch/Lot num of second dose.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Vaccine administered  after it was stored beyond 12 hours at room temperature; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine administered  after it was stored beyond 12 hours at room temperature) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Aug-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Aug-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine administered  after it was stored beyond 12 hours at room temperature). On 13-Aug-2021, EXPIRED PRODUCT ADMINISTERED (Vaccine administered  after it was stored beyond 12 hours at room temperature) 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.
Sex: F
Vaccine: COVID19
Symptoms: Psoriatic arthropathy, Vaccination complication
Clinical narrative: Multiple flares from psoriatic arthritis; Bad reaction after each shot; This spontaneous case was reported by a consumer and describes the occurrence of PSORIATIC ARTHROPATHY (Multiple flares from psoriatic arthritis) in a female patient of an unknown age 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.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PSORIATIC ARTHROPATHY (Multiple flares from psoriatic arthritis) (seriousness criterion medically significant) and VACCINATION COMPLICATION (Bad reaction after each shot). At the time of the report, PSORIATIC ARTHROPATHY (Multiple flares from psoriatic arthritis) and VACCINATION COMPLICATION (Bad reaction after each shot) outcome was unknown.            Concomitant product was not provided by the reporter.  Patient reported that after receiving 2nd dose she experienced multiple flares from psoriatic arthritis.  Treatment information was not provided Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   This case was linked to MOD-2021-052726 (Patient Link).   Reporter did not allow further contact; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Pain in extremity, Product dose omission issue, Pyrexia
Clinical narrative: sought guidance on whether they can still receive the second dose, as they are now also past the 28 day interval.; Patient diagnosed with COVID-19 infection after receiving first dose of Moderna COVID-19 vaccine.; sore arm; Fever; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Patient diagnosed with COVID-19 infection after receiving first dose of Moderna COVID-19 vaccine.), PAIN IN EXTREMITY (sore arm), PYREXIA (Fever) and PRODUCT DOSE OMISSION ISSUE (sought guidance on whether they can still receive the second dose, as they are now also past the 28 day interval.) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 07862119) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Jul-2021, the patient experienced PAIN IN EXTREMITY (sore arm) and PYREXIA (Fever). On 15-Jul-2021, the patient experienced COVID-19 (Patient diagnosed with COVID-19 infection after receiving first dose of Moderna COVID-19 vaccine.). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (sought guidance on whether they can still receive the second dose, as they are now also past the 28 day interval.). At the time of the report, COVID-19 (Patient diagnosed with COVID-19 infection after receiving first dose of Moderna COVID-19 vaccine.) outcome was unknown and PAIN IN EXTREMITY (sore arm), PYREXIA (Fever) and PRODUCT DOSE OMISSION ISSUE (sought guidance on whether they can still receive the second dose, as they are now also past the 28 day interval.) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       No concomitant medications were reported. No treatment medications were reported.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Product dose omission issue, Vaccination site pain
Clinical narrative: More than 35 days in between Moderna Covid-19 vaccinations.; tenderness in right arm injection site/ soreness in right arm injection site; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (More than 35 days in between Moderna Covid-19 vaccinations.) and VACCINATION SITE PAIN (tenderness in right arm injection site/ soreness in right arm injection site) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     No Medical History information was reported.    On 31-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (More than 35 days in between Moderna Covid-19 vaccinations.) and VACCINATION SITE PAIN (tenderness in right arm injection site/ soreness in right arm injection site). At the time of the report, PRODUCT DOSE OMISSION ISSUE (More than 35 days in between Moderna Covid-19 vaccinations.) had resolved and VACCINATION SITE PAIN (tenderness in right arm injection site/ soreness in right arm injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.     No concomitant medications were reported.   Treatment medication were not reported.   Reporter did not allow further contact