chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature decreased, Off label use
Clinical narrative: off label use; Low temperature 93.9 F to 94 F after booster shot; This spontaneous case was reported by a consumer and describes the occurrence of BODY TEMPERATURE DECREASED (Low temperature 93.9 F to 94 F after booster shot) and OFF LABEL USE (off label use) in a 37-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 059E21A, 036B21A and 047A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 14-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Aug-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced BODY TEMPERATURE DECREASED (Low temperature 93.9 F to 94 F after booster shot). On an unknown date, the patient experienced OFF LABEL USE (off label use). At the time of the report, BODY TEMPERATURE DECREASED (Low temperature 93.9 F to 94 F after booster shot) outcome was unknown and OFF LABEL USE (off label use) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 19-Aug-2021, Body temperature decreased: 93.9 f to 94 f (Low) Low.         No Concomitant medications were reported.  No Treatment information was reported.     This case was linked to MOD-2021-292888 (Patient Link).
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia, Vaccination site erythema, Vaccination site pruritus, Vaccination site warmth
Clinical narrative: she started to develop itching in the arm a little bit right at the injection site, it was hot, red around it.; she started to develop itching in the arm a little bit right at the injection site, it was hot, red around it.; she started to develop itching in the arm a little bit right at the injection site, it was hot, red around it.; low grade fever, under 100 degrees Fahrenheit; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (she started to develop itching in the arm a little bit right at the injection site, it was hot, red around it.), VACCINATION SITE PRURITUS (she started to develop itching in the arm a little bit right at the injection site, it was hot, red around it.), VACCINATION SITE ERYTHEMA (she started to develop itching in the arm a little bit right at the injection site, it was hot, red around it.) and PYREXIA (low grade fever, under 100 degrees Fahrenheit) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006D21A) for COVID-19 vaccination.     No medical history information was reported.  Concomitant products included ROSUVASTATIN CALCIUM (CRESTOR), OMEPRAZOLE, MULTIVITAMINS [VITAMINS NOS] and PROBIOTICS NOS for an unknown indication.    On 04-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Aug-2021, the patient experienced VACCINATION SITE WARMTH (she started to develop itching in the arm a little bit right at the injection site, it was hot, red around it.), VACCINATION SITE PRURITUS (she started to develop itching in the arm a little bit right at the injection site, it was hot, red around it.), VACCINATION SITE ERYTHEMA (she started to develop itching in the arm a little bit right at the injection site, it was hot, red around it.) and PYREXIA (low grade fever, under 100 degrees Fahrenheit). On 21-Aug-2021, VACCINATION SITE ERYTHEMA (she started to develop itching in the arm a little bit right at the injection site, it was hot, red around it.) had resolved. At the time of the report, VACCINATION SITE WARMTH (she started to develop itching in the arm a little bit right at the injection site, it was hot, red around it.), VACCINATION SITE PRURITUS (she started to develop itching in the arm a little bit right at the injection site, it was hot, red around it.) and PYREXIA (low grade fever, under 100 degrees Fahrenheit) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 17-Aug-2021, Body temperature: under 100 degrees fahrenheit (High) low grade fever, under 100 degrees Fahrenheit.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information were not provided by the reporter. It was reported that the pinkness had gone.   Most recent FOLLOW-UP information incorporated above includes: On 23-Aug-2021: Follow up information received included event outcome updated (Resolved) .
Sex: U
Vaccine: COVID19
Symptoms: Asthenia, Dizziness
Clinical narrative: Feeling dizzy and weak after vaccine.; Feeling dizzy and weak after vaccine.; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Feeling dizzy and weak after vaccine.) and ASTHENIA (Feeling dizzy and weak after vaccine.) 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 DIZZINESS (Feeling dizzy and weak after vaccine.) and ASTHENIA (Feeling dizzy and weak after vaccine.). At the time of the report, DIZZINESS (Feeling dizzy and weak after vaccine.) and ASTHENIA (Feeling dizzy and weak after vaccine.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No  concomitant medication information was provided by the reporter.  No treatment information was provided by the reporter.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy, Intentional product use issue, Product storage error
Clinical narrative: she is pregnant; She states that she was given the vaccine right from the refrigerator, it wasn't thawed at all to room temperature, Caller states it had been 3 minutes since they left to get the vaccine, until she received the dose/not thawed at room temperature; Caller stated the second dose was delayed because she got pregnant and wanted to wait until after the first trimester; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (she is pregnant), PRODUCT STORAGE ERROR (She states that she was given the vaccine right from the refrigerator, it wasn't thawed at all to room temperature, Caller states it had been 3 minutes since they left to get the vaccine, until she received the dose/not thawed at room temperature) and INTENTIONAL PRODUCT USE ISSUE (Caller stated the second dose was delayed because she got pregnant and wanted to wait until after the first trimester) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014M20A and 014M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. The patient's last menstrual period was on 15-Feb-2021 and the estimated date of delivery was 25-Nov-2021. On 25-Feb-2021, the patient experienced INTENTIONAL PRODUCT USE ISSUE (Caller stated the second dose was delayed because she got pregnant and wanted to wait until after the first trimester). On 06-Aug-2021, the patient experienced EXPOSURE DURING PREGNANCY (she is pregnant) and PRODUCT STORAGE ERROR (She states that she was given the vaccine right from the refrigerator, it wasn't thawed at all to room temperature, Caller states it had been 3 minutes since they left to get the vaccine, until she received the dose/not thawed at room temperature). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  twenty-fourth week of the pregnancy.  At the time of the report, EXPOSURE DURING PREGNANCY (she is pregnant), PRODUCT STORAGE ERROR (She states that she was given the vaccine right from the refrigerator, it wasn't thawed at all to room temperature, Caller states it had been 3 minutes since they left to get the vaccine, until she received the dose/not thawed at room temperature) and INTENTIONAL PRODUCT USE ISSUE (Caller stated the second dose was delayed because she got pregnant and wanted to wait until after the first trimester) had resolved.            Concomitant medication was not provided Treatment information was not reported  Caller did not want to enroll to the pregnancy registry at the moment.   Most recent FOLLOW-UP information incorporated above includes: On 20-Aug-2021: Follow up received on 20-AUG-2021 contains No new information.
Sex: U
Vaccine: COVID19
Symptoms: Abdominal pain, Chest discomfort, Malaise, Pneumonitis, Vaccination complication
Clinical narrative: I still have chest inflammation; I still have lung inflammation; I still feel very sick; Have some odd side effects/Inability to sneeze; Painful sensation in abdomen; 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 CHEST DISCOMFORT (I still have chest inflammation), PNEUMONITIS (I still have lung inflammation), MALAISE (I still feel very sick), VACCINATION COMPLICATION (Have some odd side effects/Inability to sneeze) and ABDOMINAL PAIN (Painful sensation in abdomen) 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced CHEST DISCOMFORT (I still have chest inflammation), PNEUMONITIS (I still have lung inflammation), MALAISE (I still feel very sick), VACCINATION COMPLICATION (Have some odd side effects/Inability to sneeze) and ABDOMINAL PAIN (Painful sensation in abdomen). The patient was treated with IBUPROFEN for Adverse event, at a dose of 600 mg, every 8 hours. At the time of the report, CHEST DISCOMFORT (I still have chest inflammation), PNEUMONITIS (I still have lung inflammation), VACCINATION COMPLICATION (Have some odd side effects/Inability to sneeze) and ABDOMINAL PAIN (Painful sensation in abdomen) outcome was unknown and MALAISE (I still feel very sick) had not resolved.            No relevant concomitant medications were reported.
Sex: U
Vaccine: COVID19
Symptoms: Device connection issue, Underdose
Clinical narrative: some liquid spills out; some liquid spills out; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional and describes the occurrence of UNDERDOSE (some liquid spills out) and DEVICE CONNECTION ISSUE (some liquid spills out) 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced UNDERDOSE (some liquid spills out) and DEVICE CONNECTION ISSUE (some liquid spills out). At the time of the report, UNDERDOSE (some liquid spills out) and DEVICE CONNECTION ISSUE (some liquid spills out) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported by reporter Treatment information was not provided
Sex: U
Vaccine: COVID19
Symptoms: Cough
Clinical narrative: Cough; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (Cough) 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced COUGH (Cough). At the time of the report, COUGH (Cough) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant products were reported.  No treatment information provided.  The reporter did not mention any adverse events but did cough a few times during the call.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Hypoaesthesia oral, Lip swelling
Clinical narrative: Swollen Lips; Numb Lips; Diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of LIP SWELLING (Swollen Lips), HYPOAESTHESIA ORAL (Numb Lips) and DIARRHOEA (Diarrhea) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Aug-2021, the patient experienced LIP SWELLING (Swollen Lips), HYPOAESTHESIA ORAL (Numb Lips) and DIARRHOEA (Diarrhea). At the time of the report, LIP SWELLING (Swollen Lips), HYPOAESTHESIA ORAL (Numb Lips) and DIARRHOEA (Diarrhea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications was not reported. Treatment information was not provided.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: I got vaccine and I'm feeling iller; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (I got vaccine and I'm feeling iller) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (I got vaccine and I'm feeling iller). At the time of the report, VACCINATION COMPLICATION (I got vaccine and I'm feeling iller) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant products were reported.  No treatment information provided.
Sex: U
Vaccine: COVID19
Symptoms: Chest pain
Clinical narrative: Chest pain; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (Chest pain) 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced CHEST PAIN (Chest pain). At the time of the report, CHEST PAIN (Chest pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant products were reported. No treatment information provided.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Migraine
Clinical narrative: Chronic migraines since she received second dose/Has several episodes every week; This spontaneous case was reported by a consumer and describes the occurrence of MIGRAINE (Chronic migraines since she received second dose/Has several episodes every week) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 045B21A and 018B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-May-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced MIGRAINE (Chronic migraines since she received second dose/Has several episodes every week). The patient was treated with VITAMIN B2 [RIBOFLAVIN] for Adverse event, at an unspecified dose and frequency. At the time of the report, MIGRAINE (Chronic migraines since she received last dose/Has several episodes every week) had not resolved.            Concomitant product use was not provided by the reporter.  Treatment medications also included  medication for pain relief.
Age: 25.0
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus, Vertigo
Clinical narrative: Ringing in ears constantly causing vertigo; Ringing in ears constantly causing vertigo; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (Ringing in ears constantly causing vertigo) and VERTIGO (Ringing in ears constantly causing vertigo) in a 25-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunisation.     Concurrent medical conditions included Penicillin allergy and Allergy to antibiotic (Amoxicillin).   On 19-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 17-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 milliliter. On 20-Apr-2021, the patient experienced TINNITUS (Ringing in ears constantly causing vertigo) and VERTIGO (Ringing in ears constantly causing vertigo). On 18-May-2021, TINNITUS (Ringing in ears constantly causing vertigo) and VERTIGO (Ringing in ears constantly causing vertigo) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Concomitant product use was not provided by the reporter.  Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 21-Aug-2021: Follow up received contains no new information.
Sex: U
Vaccine: COVID19
Symptoms: Asthenia, Fatigue, Nausea
Clinical narrative: weak/tired Covid-19 feeling; weak/tired Covid-19 feeling; very nauseated; This spontaneous case was reported by a non-health professional and describes the occurrence of ASTHENIA (weak/tired Covid-19 feeling), FATIGUE (weak/tired Covid-19 feeling) and NAUSEA (very nauseated) 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 ASTHENIA (weak/tired Covid-19 feeling), FATIGUE (weak/tired Covid-19 feeling) and NAUSEA (very nauseated). At the time of the report, ASTHENIA (weak/tired Covid-19 feeling), FATIGUE (weak/tired Covid-19 feeling) and NAUSEA (very nauseated) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product was not provided by the reporter. Treatment information was not provided.   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Erythema
Clinical narrative: Two red area; This spontaneous case was reported by a non-health professional and describes the occurrence of ERYTHEMA (Two red area) 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 ERYTHEMA (Two red area). At the time of the report, ERYTHEMA (Two red area) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. Treatment information was not provided.  The patient had redness, disappeared after 7 days.   This case was linked to MOD-2021-293079 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Feeling hot, Gait disturbance, Hyperhidrosis, Muscular weakness
Clinical narrative: sweating a lot/she was sock and wet; her walking gait was affected; her legs feel very weak; feels hot; she doesn't feel and it was horrible last night; muscle pain; This spontaneous case was reported by a non-health professional and describes the occurrence of HYPERHIDROSIS (sweating a lot/she was sock and wet), GAIT DISTURBANCE (her walking gait was affected), MUSCULAR WEAKNESS (her legs feel very weak), FEELING HOT (feels hot) and FEELING ABNORMAL (she doesn't feel and it was horrible last night) 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 19-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In August 2021, the patient experienced HYPERHIDROSIS (sweating a lot/she was sock and wet), GAIT DISTURBANCE (her walking gait was affected), MUSCULAR WEAKNESS (her legs feel very weak), FEELING HOT (feels hot), FEELING ABNORMAL (she doesn't feel and it was horrible last night) and MYALGIA (muscle pain). The patient was treated with IBUPROFEN for Adverse event, at an unspecified dose and frequency and PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. At the time of the report, HYPERHIDROSIS (sweating a lot/she was sock and wet), GAIT DISTURBANCE (her walking gait was affected), MUSCULAR WEAKNESS (her legs feel very weak), FEELING HOT (feels hot), FEELING ABNORMAL (she doesn't feel and it was horrible last night) and MYALGIA (muscle pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not reported by reporter.
Sex: F
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: sweating a lot/she was sock and wet; her walking gait was affected; her legs feel very weak; feels hot; she doesn't feel and it was horrible last night; muscle pain; This spontaneous case was reported by a non-health professional and describes the occurrence of HYPERHIDROSIS (sweating a lot/she was sock and wet), GAIT DISTURBANCE (her walking gait was affected), MUSCULAR WEAKNESS (her legs feel very weak), FEELING HOT (feels hot) and FEELING ABNORMAL (she doesn't feel and it was horrible last night) 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 19-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In August 2021, the patient experienced HYPERHIDROSIS (sweating a lot/she was sock and wet), GAIT DISTURBANCE (her walking gait was affected), MUSCULAR WEAKNESS (her legs feel very weak), FEELING HOT (feels hot), FEELING ABNORMAL (she doesn't feel and it was horrible last night) and MYALGIA (muscle pain). The patient was treated with IBUPROFEN for Adverse event, at an unspecified dose and frequency and PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. At the time of the report, HYPERHIDROSIS (sweating a lot/she was sock and wet), GAIT DISTURBANCE (her walking gait was affected), MUSCULAR WEAKNESS (her legs feel very weak), FEELING HOT (feels hot), FEELING ABNORMAL (she doesn't feel and it was horrible last night) and MYALGIA (muscle pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not reported by reporter.
Sex: U
Vaccine: COVID19
Symptoms: Peripheral swelling
Clinical narrative: one other arm used has large swollen area; This spontaneous case was reported by a non-health professional and describes the occurrence of PERIPHERAL SWELLING (one other arm used has large swollen area) 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 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 PERIPHERAL SWELLING (one other arm used has large swollen area). At the time of the report, PERIPHERAL SWELLING (one other arm used has large swollen area) outcome was unknown.            The concomitant history was not reported. The treatment information was not provided.   This case was linked to MOD-2021-293060 (Patient Link).
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes simplex
Clinical narrative: She has had 2 outbreaks after the Moderna vaccines; This spontaneous case was reported by a non-health professional and describes the occurrence of HERPES SIMPLEX (She has had 2 outbreaks after the Moderna vaccines) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 008B21A and 062G20A) for COVID-19 vaccination.     No Medical History information was reported.   On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced HERPES SIMPLEX (She has had 2 outbreaks after the Moderna vaccines). At the time of the report, HERPES SIMPLEX (She has had 2 outbreaks after the Moderna vaccines) outcome was unknown.            Concomitant medications were not reported. Treatment medications were not reported.   This case was linked to MOD-2021-293061 (Patient Link).
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Device connection issue, Exposure via skin contact, Underdose
Clinical narrative: This spontaneous case was reported by an other health care professional and describes the occurrence of EXPOSURE VIA SKIN CONTACT (a big portion of the liquid came out of her arm), UNDERDOSE (patient received less than the recommended dose of the Moderna COVID-19 vaccine: a big portion of the liquid came out of her arm if not the entire dose) and DEVICE CONNECTION ISSUE (patient received less than the recommended dose of the Moderna COVID-19 vaccine: a big portion of the liquid came out of her arm if not the entire dose) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017E21A and 091D21A) for COVID-19 vaccination. No Medical History information was reported. On 21-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Aug-2021, the patient experienced EXPOSURE VIA SKIN CONTACT (a big portion of the liquid came out of her arm) and UNDERDOSE (patient received less than the recommended dose of the Moderna COVID-19 vaccine: a big portion of the liquid came out of her arm if not the entire dose). On an unknown date, the patient experienced DEVICE CONNECTION ISSUE (patient received less than the recommended dose of the Moderna COVID-19 vaccine: a big portion of the liquid came out of her arm if not the entire dose). At the time of the report, EXPOSURE VIA SKIN CONTACT (a big portion of the liquid came out of her arm) outcome was unknown and UNDERDOSE (patient received less than the recommended dose of the Moderna COVID-19 vaccine: a big portion of the liquid came out of her arm if not the entire dose) and DEVICE CONNECTION ISSUE (patient received less than the recommended dose of the Moderna COVID-19 vaccine: a big portion of the liquid came out of her arm if not the entire dose) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Concomitant product was not provided by the reporter. Treatment information was not provided.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Headache, Nasopharyngitis, Off label use, Pyrexia
Clinical narrative: cold like symptoms.; Around 11a or noon, I had severe chills; Fever; Headache; severe headache woke me up Friday morning; received my 3rd injection; This spontaneous case was reported by a consumer and describes the occurrence of NASOPHARYNGITIS (cold like symptoms.), OFF LABEL USE (received my 3rd injection), HEADACHE (severe headache woke me up Friday morning), CHILLS (Around 11a or noon, I had severe chills) and PYREXIA (Fever) in a  patient of an unknown age and gender 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 19-Aug-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 19-Aug-2021, the patient experienced OFF LABEL USE (received my 3rd injection). On 20-Aug-2021, the patient experienced HEADACHE (severe headache woke me up Friday morning). On an unknown date, the patient experienced NASOPHARYNGITIS (cold like symptoms.), CHILLS (Around 11a or noon, I had severe chills), PYREXIA (Fever) and HEADACHE (Headache). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. At the time of the report, NASOPHARYNGITIS (cold like symptoms.), HEADACHE (severe headache woke me up Friday morning), CHILLS (Around 11a or noon, I had severe chills), PYREXIA (Fever) and HEADACHE (Headache) outcome was unknown and OFF LABEL USE (received my 3rd injection) had resolved.            No Concomitant medication information was reported.   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: (side effect); This spontaneous case was reported by a non-health professional and describes the occurrence of VACCINATION COMPLICATION (side effect) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (side effect). At the time of the report, VACCINATION COMPLICATION (side effect) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product was not provided by the reporter  Treatment information was not provided
Sex: U
Vaccine: COVID19
Symptoms: Anxiety
Clinical narrative: Anxiety 24 hours after my vaccine; This spontaneous case was reported by a consumer and describes the occurrence of ANXIETY (Anxiety 24 hours after my vaccine) 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 ANXIETY (Anxiety 24 hours after my vaccine). At the time of the report, ANXIETY (Anxiety 24 hours after my vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not reported.  Treatment medications were not reported.  It was stated that the patient Can I take 0.25 Xanax for anxiety 24 hours after my vaccine.   Reporter did not allow further contact
Age: 82.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Interchange of vaccine products
Clinical narrative: received the first dose of  Pfizer's COVID-19 vaccine and 5 months later (today) took the Moderna COVID-19 Vaccine; This spontaneous case was reported by a consumer and describes the occurrence of INTERCHANGE OF VACCINE PRODUCTS (received the first dose of  Pfizer's COVID-19 vaccine and 5 months later (today) took the Moderna COVID-19 Vaccine) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017C21A) for COVID-19 vaccination.    Co-suspect product included non-company product TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) injection for COVID-19 vaccination.    No Medical History information was reported.   On 21-Mar-2021, the patient started TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) at an unspecified dose. On 20-Aug-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (received the first dose of  Pfizer's COVID-19 vaccine and 5 months later (today) took the Moderna COVID-19 Vaccine). At the time of the report, INTERCHANGE OF VACCINE PRODUCTS (received the first dose of  Pfizer's COVID-19 vaccine and 5 months later (today) took the Moderna COVID-19 Vaccine) had resolved.            Patient received the first dose of Pfizer's COVID-19 vaccine and 5 months later (today) took the Moderna COVID-19 Vaccine. Patient received the first dose of the Pfizer on march 22nd.  No concomitant medications was provided.  No treatment medications was provided.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Inappropriate schedule of product administration
Clinical narrative: gave second vaccine dose from the expired vial; first dose of the Moderna COVID-19 vaccine on 07Jul2021 and the second on 20Aug2021; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (gave second vaccine dose from the expired vial) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (first dose of the Moderna COVID-19 vaccine on 07Jul2021 and the second on 20Aug2021) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 052E211A. and 051C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 07-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Aug-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 EXPIRED PRODUCT ADMINISTERED (gave second vaccine dose from the expired vial) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (first dose of the Moderna COVID-19 vaccine on 07Jul2021 and the second on 20Aug2021). At the time of the report, EXPIRED PRODUCT ADMINISTERED (gave second vaccine dose from the expired vial) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (first dose of the Moderna COVID-19 vaccine on 07Jul2021 and the second on 20Aug2021) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant Medications were provided. No Treatment Medications were provided.   This case was linked to MOD-2021-133589 (Patient Link).
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Fatigue, Vaccination site erythema, Vaccination site pain, Vaccination site rash
Clinical narrative: Gastrointestinal upset; Redness left arm; Puffiness left arm; Rash left arm; Tiredness; soreness in left arm at injection site; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL DISCOMFORT (Gastrointestinal upset), FATIGUE (Tiredness), VACCINATION SITE PAIN (soreness in left arm at injection site), VACCINATION SITE ERYTHEMA (Redness left arm) and VACCINATION SITE SWELLING (Puffiness left arm) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 088D21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Irritable bowel syndrome, Crohn's disease and COPD.    On 07-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Aug-2021, the patient experienced FATIGUE (Tiredness) and VACCINATION SITE PAIN (soreness in left arm at injection site). On 17-Aug-2021, the patient experienced VACCINATION SITE ERYTHEMA (Redness left arm), VACCINATION SITE SWELLING (Puffiness left arm) and VACCINATION SITE RASH (Rash left arm). On an unknown date, the patient experienced ABDOMINAL DISCOMFORT (Gastrointestinal upset). The patient was treated with HYDROCORTISONE ACETATE (CORTIZONE [HYDROCORTISONE ACETATE]) for Vaccination site rash, at an unspecified dose and frequency. At the time of the report, ABDOMINAL DISCOMFORT (Gastrointestinal upset), VACCINATION SITE ERYTHEMA (Redness left arm), VACCINATION SITE SWELLING (Puffiness left arm) and VACCINATION SITE RASH (Rash left arm) outcome was unknown and FATIGUE (Tiredness) and VACCINATION SITE PAIN (soreness in left arm at injection site) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided by reporter. Treatment medication includes essential oils.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site swelling
Clinical narrative: Gastrointestinal upset; Redness left arm; Puffiness left arm; Rash left arm; Tiredness; soreness in left arm at injection site; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL DISCOMFORT (Gastrointestinal upset), FATIGUE (Tiredness), VACCINATION SITE PAIN (soreness in left arm at injection site), VACCINATION SITE ERYTHEMA (Redness left arm) and VACCINATION SITE SWELLING (Puffiness left arm) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 088D21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Irritable bowel syndrome, Crohn's disease and COPD.    On 07-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Aug-2021, the patient experienced FATIGUE (Tiredness) and VACCINATION SITE PAIN (soreness in left arm at injection site). On 17-Aug-2021, the patient experienced VACCINATION SITE ERYTHEMA (Redness left arm), VACCINATION SITE SWELLING (Puffiness left arm) and VACCINATION SITE RASH (Rash left arm). On an unknown date, the patient experienced ABDOMINAL DISCOMFORT (Gastrointestinal upset). The patient was treated with HYDROCORTISONE ACETATE (CORTIZONE [HYDROCORTISONE ACETATE]) for Vaccination site rash, at an unspecified dose and frequency. At the time of the report, ABDOMINAL DISCOMFORT (Gastrointestinal upset), VACCINATION SITE ERYTHEMA (Redness left arm), VACCINATION SITE SWELLING (Puffiness left arm) and VACCINATION SITE RASH (Rash left arm) outcome was unknown and FATIGUE (Tiredness) and VACCINATION SITE PAIN (soreness in left arm at injection site) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided by reporter. Treatment medication includes essential oils.
Sex: F
Vaccine: COVID19
Symptoms: Product administration error, Product temperature excursion issue
Clinical narrative: Greater than 12 hours at room temperature; product administration error; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Greater than 12 hours at room temperature) and PRODUCT ADMINISTRATION ERROR (product administration error) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Aug-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Aug-2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Greater than 12 hours at room temperature) and PRODUCT ADMINISTRATION ERROR (product administration error). On 20-Aug-2021, PRODUCT TEMPERATURE EXCURSION ISSUE (Greater than 12 hours at room temperature) and PRODUCT ADMINISTRATION ERROR (product administration error) 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 medication of the patient was not reported.  No treatment information was provided by the reporter.  The pharmacist stated that they administered Moderna COVID-19 vaccine that had undergone a temperature excursion to 3 patients. The punctured vial was placed at room temperature on previous day at 3:58 pm and was administered next day at 10:09 am 11:17 am and 11:22 am.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Mobility decreased, Myalgia, Pain in extremity
Clinical narrative: within 30 minutes of receiving the first dose her left leg was hurting with muscle pains and says she could not walk without assistance for 3 days; says she could not walk without assistance; within 30 minutes of receiving the first dose her left leg was hurting with muscle pains and says she could not walk without assistance for 3 days; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (within 30 minutes of receiving the first dose her left leg was hurting with muscle pains and says she could not walk without assistance for 3 days), MOBILITY DECREASED (says she could not walk without assistance) and MYALGIA (within 30 minutes of receiving the first dose her left leg was hurting with muscle pains and says she could not walk without assistance for 3 days) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017E21A) for COVID-19 vaccination.     The patient's past medical history included Polio.    On 13-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (within 30 minutes of receiving the first dose her left leg was hurting with muscle pains and says she could not walk without assistance for 3 days), MOBILITY DECREASED (says she could not walk without assistance) and MYALGIA (within 30 minutes of receiving the first dose her left leg was hurting with muscle pains and says she could not walk without assistance for 3 days). The patient was treated with TRAMADOL for Adverse event, at a dose of 1 dosage form and IBUPROFEN for Adverse event, at a dose of 1 dosage form. At the time of the report, PAIN IN EXTREMITY (within 30 minutes of receiving the first dose her left leg was hurting with muscle pains and says she could not walk without assistance for 3 days), MOBILITY DECREASED (says she could not walk without assistance) and MYALGIA (within 30 minutes of receiving the first dose her left leg was hurting with muscle pains and says she could not walk without assistance for 3 days) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication information was provided by the reporter.  The patient also reported treatment of "ibuprofen with something else in it".
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Eye pain, Fatigue, Feeling abnormal, Ocular discomfort, Photophobia
Clinical narrative: discomfort in her eyes; Take naps/slept 10 hours last night; Gained 10 lbs after the 2nd dose in this 6 months.; Brain fog; Cannot handle stress anymore; Real bad side effects ever since the 2nd dose; Fatigue which is still ongoing after 6 months/severe fatigue; stabbing pain in both her eyes/feels like strain in eyes all the time/wears reading glasses a lot now/eye pain; developed photophobia; This spontaneous case was reported by a consumer and describes the occurrence of EYE PAIN (stabbing pain in both her eyes/feels like strain in eyes all the time/wears reading glasses a lot now/eye pain), PHOTOPHOBIA (developed photophobia), OCULAR DISCOMFORT (discomfort in her eyes), SOMNOLENCE (Take naps/slept 10 hours last night) and WEIGHT INCREASED (Gained 10 lbs after the 2nd dose in this 6 months.) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 12-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, the patient experienced EYE PAIN (stabbing pain in both her eyes/feels like strain in eyes all the time/wears reading glasses a lot now/eye pain) and PHOTOPHOBIA (developed photophobia). On an unknown date, the patient experienced OCULAR DISCOMFORT (discomfort in her eyes), SOMNOLENCE (Take naps/slept 10 hours last night), WEIGHT INCREASED (Gained 10 lbs after the 2nd dose in this 6 months.), FEELING ABNORMAL (Brain fog), STRESS (Cannot handle stress anymore), VACCINATION COMPLICATION (Real bad side effects ever since the 2nd dose) and FATIGUE (Fatigue which is still ongoing after 6 months/severe fatigue). The patient was treated with PREDNISOLONE at an unspecified dose and frequency. At the time of the report, EYE PAIN (stabbing pain in both her eyes/feels like strain in eyes all the time/wears reading glasses a lot now/eye pain), PHOTOPHOBIA (developed photophobia), OCULAR DISCOMFORT (discomfort in her eyes), SOMNOLENCE (Take naps/slept 10 hours last night), WEIGHT INCREASED (Gained 10 lbs after the 2nd dose in this 6 months.), FEELING ABNORMAL (Brain fog), STRESS (Cannot handle stress anymore), VACCINATION COMPLICATION (Real bad side effects ever since the 2nd dose) and FATIGUE (Fatigue which is still ongoing after 6 months/severe fatigue) outcome was unknown.            The concomitant medications were not reported   This case was linked to MOD-2021-293207 (Patient Link).