chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: like "getting a punch in the arm or something"/ went away; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (like "getting a punch in the arm or something"/ went away) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Aug-2021, the patient experienced VACCINATION SITE PAIN (like "getting a punch in the arm or something"/ went away). At the time of the report, VACCINATION SITE PAIN (like "getting a punch in the arm or something"/ went away) had resolved.            No relevant concomitant medications were reported. No treatment medication was  reported.
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age, Product dose omission issue
Clinical narrative: patient did not get the second dose yet; patient under 18 got the first dose of the vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (patient did not get the second dose yet) and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (patient under 18 got the first dose of the vaccine) in a 17-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.    In March 2021, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. In March 2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (patient under 18 got the first dose of the vaccine). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (patient did not get the second dose yet). In March 2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (patient under 18 got the first dose of the vaccine) had resolved. At the time of the report, PRODUCT DOSE OMISSION ISSUE (patient did not get the second dose yet) had resolved.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. No treatment information was provided. Patient is under 18 but over 12 years of age, got the first dose of the vaccine back in Mar-2021 in Portugal and was inquiring about getting the second dose.
Sex: U
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: ongoing dizzy spells since they received their Covid 19 vaccine; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (ongoing dizzy spells since they received their Covid 19 vaccine) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Allergy and Meniere's disease.    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 (ongoing dizzy spells since they received their Covid 19 vaccine). At the time of the report, DIZZINESS (ongoing dizzy spells since they received their Covid 19 vaccine) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided.   No treatment medications were provided.   Reporter did not allow further contact
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Extra dose administered
Clinical narrative: Received third dose , not immunocompromised; This spontaneous case was reported by a consumer and describes the occurrence of EXTRA DOSE ADMINISTERED (Received third dose , not immunocompromised) in an 81-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 9399243, 041L20A and 030M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Sep-2021, the patient experienced EXTRA DOSE ADMINISTERED (Received third dose , not immunocompromised). On 17-Sep-2021, EXTRA DOSE ADMINISTERED (Received third dose , not immunocompromised) had resolved.            No concomitant medications were reported. No treatment medications were reported.
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Sore Injection Site Arm; This spontaneous case was reported by a pharmacist and describes the occurrence of VACCINATION SITE PAIN (Sore Injection Site Arm) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Jan-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 VACCINATION SITE PAIN (Sore Injection Site Arm). At the time of the report, VACCINATION SITE PAIN (Sore Injection Site Arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications reported. No treatment reported.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Computerised tomogram, Deep vein thrombosis, Ultrasound scan
Clinical narrative: blood clots; This spontaneous case was reported by a consumer and describes the occurrence of DEEP VEIN THROMBOSIS (blood clots) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 023M20A and 001B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 18-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Mar-2021, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 2 dosage form. On 08-Mar-2021, the patient experienced DEEP VEIN THROMBOSIS (blood clots) (seriousness criterion medically significant). The patient was treated with RIVAROXABAN (XARELTO) for Adverse event, at a dose of 20 milligram. At the time of the report, DEEP VEIN THROMBOSIS (blood clots) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Computerised tomogram: blood clots blood clots. On an unknown date, Ultrasound scan: blood clots blood clots.         Concomitant product usage were not provided.  This case concerns a  73 year-old, male patient with no relevant medical history, who experienced the unexpected event of deep vein thrombosis. The event occurred approximately  19 days after the first dose of Spikevax. The rechallenge was unknown since no information regarding second dose.  The benefit-risk relationship of Spikevax in not affected by this report.; Sender's Comments: This case concerns a  73 year-old, male patient with no relevant medical history, who experienced the unexpected event of deep vein thrombosis. The event occurred approximately  19 days after the first dose of Spikevax. The rechallenge was unknown since no information regarding second dose.  The benefit-risk relationship of Spikevax in not affected by this report.
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Got an expired dose; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Got an expired dose) in a 36-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Sep-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Got an expired dose). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Got an expired dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication were provided. No treatment details were provided.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Is pain in my arm after getting the shot normal; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Is pain in my arm after getting the shot normal) 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 SITE PAIN (Is pain in my arm after getting the shot normal). At the time of the report, VACCINATION SITE PAIN (Is pain in my arm after getting the shot normal) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication information was provided.  No treatment medication information was provided.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pyrexia
Clinical narrative: fatigued; high temperature/temperature of 102 degrees Farenheight; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (fatigued) and PYREXIA (high temperature/temperature of 102 degrees Farenheight) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) 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. On 16-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced FATIGUE (fatigued) and PYREXIA (high temperature/temperature of 102 degrees Farenheight). At the time of the report, FATIGUE (fatigued) and PYREXIA (high temperature/temperature of 102 degrees Farenheight) had resolved.            No treatment medication was reported. No Concomitant medication was reported.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: head ache / massive headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (head ache / massive headache) in a 42-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 050E21A and 059E21A) for COVID-19 vaccination.     No Medical History information was reported.   On 15-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Sep-2021, the patient experienced HEADACHE (head ache / massive headache). On 14-Sep-2021, HEADACHE (head ache / massive headache) had resolved.            No concomitant treatment was provided.  No treatment medication was provided.  The patient had reported started maybe one day after got the second dose, had a head ache on the 13th and then on the 14th figured it would have go away by now.
Age: 66.0
Sex: U
Vaccine: COVID19
Symptoms: Headache, Vaccination complication
Clinical narrative: Moderna has destroyed my body; headaches; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Moderna has destroyed my body) and HEADACHE (headaches) in a 66-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 05-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Moderna has destroyed my body) and HEADACHE (headaches). At the time of the report, VACCINATION COMPLICATION (Moderna has destroyed my body) and HEADACHE (headaches) outcome was unknown.            No Concomitant medications were reported. No Treatment medications were reported.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia
Clinical narrative: low grade fever 100.1; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (low grade fever 100.1) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032B21A) for COVID-19 vaccination.     No medical history was reported.  Concomitant products included METOPROLOL and AMLODIPINE for Blood pressure, ZOLPIDEM TARTRATE (AMBIEN) for Disorder sleep, HYDROCODONE BITARTRATE, PARACETAMOL (NORCO) for Knee replacement, PREGABALIN (LYRICA) for Neuropathy, ESTRADIOL (ESTRADIOL 2 1 A PHARMA) for an unknown indication.    On 13-Apr-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 PYREXIA (low grade fever 100.1). At the time of the report, PYREXIA (low grade fever 100.1) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 100.1 (High) High.         No treatment medications are provided.   This case was linked to MOD-2021-323594 (Patient Link).
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Vaccination site rash, Vaccination site swelling
Clinical narrative: swollen left arm around her injection site area; itchy rash around her injection site area; Headache; chills; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (swollen left arm around her injection site area), VACCINATION SITE RASH (itchy rash around her injection site area), HEADACHE (headache) and CHILLS (chills) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 020F21A) for COVID-19 vaccination.     The medical history was not provided by the reporter.     On 14-Sep-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 VACCINATION SITE SWELLING (swollen left arm around her injection site area), VACCINATION SITE RASH (itchy rash around her injection site area), HEADACHE (headache) and CHILLS (chills). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL A) for Rash, at an unspecified dose and frequency. At the time of the report, VACCINATION SITE SWELLING (swollen left arm around her injection site area), VACCINATION SITE RASH (itchy rash around her injection site area), HEADACHE (headache) and CHILLS (chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not provided.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Asthma, Rhinorrhoea
Clinical narrative: Increased asthma attacks; Severe runny nose; This spontaneous case was reported by a physician and describes the occurrence of RHINORRHOEA (Severe runny nose) and ASTHMA (Increased asthma attacks) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 053E21A, 031M20A and 011J20A) for COVID-19 vaccination.     Concurrent medical conditions included Autoimmune disorder, Asthma and Drug allergy (Gabapentin makes her nauseated and have vertigo). Concomitant products included FLUTICASONE PROPIONATE, SALMETEROL XINAFOATE (ADVAIR) for an unknown indication.   On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Aug-2021, the patient experienced RHINORRHOEA (Severe runny nose). On an unknown date, the patient experienced ASTHMA (Increased asthma attacks). The patient was treated with LEVALBUTEROL [LEVOSALBUTAMOL] for Adverse event, at a dose of unk, Nebulizer; ITRACONAZOLE (ITRACONAZOLE EG) for Sinus infection, at an unspecified dose and frequency and AZITHROMYCIN (ZITHROMAX) for Adverse event, at an unspecified dose and frequency. At the time of the report, RHINORRHOEA (Severe runny nose) and ASTHMA (Increased asthma attacks) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient thought that might had react more to the vaccine this time around, felt like faucet, patient  was checking a box of Kleenex everyday. Other treatment medication included antihistamines.   This case was linked to MOD-2021-323634, MOD-2021-323615 (Patient Link).
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain, Vaccination site swelling
Clinical narrative: sore left injection site arm; some swelling in the injection site arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (sore left injection site arm) and VACCINATION SITE SWELLING (some swelling in the injection site arm) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Aug-2021, the patient experienced VACCINATION SITE PAIN (sore left injection site arm) and VACCINATION SITE SWELLING (some swelling in the injection site arm). At the time of the report, VACCINATION SITE PAIN (sore left injection site arm) and VACCINATION SITE SWELLING (some swelling in the injection site arm) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided. No treatment medication was provided.   This case was linked to MOD-2021-323677 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Myocardial infarction
Clinical narrative: multiple heart attack patients (4 to 5); 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 MYOCARDIAL INFARCTION (multiple heart attack patients (4 to 5)) 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 MYOCARDIAL INFARCTION (multiple heart attack patients (4 to 5)) (seriousness criterion medically significant). At the time of the report, MYOCARDIAL INFARCTION (multiple heart attack patients (4 to 5)) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications are provided by reporter. No treatment medications are provided by reporter.  company comment: This case concerns a patient of unknown gender and age, with no relevant medical history, who experienced the unexpected event of myocardial infarction. The events occurred after a dose of mRNA-1273. Very limited information regarding this case and this event has been provided. The benefit-risk relationship of mRNA-1273 is not affected by this report.   This case was linked to MOD-2021-323647, MOD21-144997, MOD-2021-323647 (Patient Link).; Sender's Comments: This case concerns a patient of unknown gender and age, with no relevant medical history, who experienced the unexpected event of myocardial infarction. The events occurred after a dose of mRNA-1273. Very limited information regarding this case and this event has been provided. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache, Influenza like illness, Myalgia
Clinical narrative: Very tired like the Flu; Very tired/ Spent the day after the second vaccine in bed.; Body aches; Headaches; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Very tired like the Flu), FATIGUE (Very tired/ Spent the day after the second vaccine in bed.), MYALGIA (Body aches) and HEADACHE (Headaches) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939906) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Sep-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 INFLUENZA LIKE ILLNESS (Very tired like the Flu), FATIGUE (Very tired/ Spent the day after the second vaccine in bed.), MYALGIA (Body aches) and HEADACHE (Headaches). At the time of the report, INFLUENZA LIKE ILLNESS (Very tired like the Flu), FATIGUE (Very tired/ Spent the day after the second vaccine in bed.), MYALGIA (Body aches) and HEADACHE (Headaches) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information was provided No treatment medication information was provided    This case was linked to MOD-2021-323655 (Patient Link).
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Insomnia, Vaccination site erythema, Vaccination site pain, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: Could not sleep last night; Pain on the Injection site/the pain is getting worst/Can not pick up her baby using her left arm; Red Injection site (2 quarters size); Swelling on the injection site; Itchiness on the Injection site; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (Could not sleep last night), VACCINATION SITE PRURITUS (Itchiness on the Injection site), VACCINATION SITE PAIN (Pain on the Injection site/the pain is getting worst/Can not pick up her baby using her left arm), VACCINATION SITE ERYTHEMA (Red Injection site (2 quarters size)) and VACCINATION SITE SWELLING (Swelling on the injection site) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939906) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Sep-2021, the patient experienced VACCINATION SITE PRURITUS (Itchiness on the Injection site). On 17-Sep-2021, the patient experienced INSOMNIA (Could not sleep last night), VACCINATION SITE PAIN (Pain on the Injection site/the pain is getting worst/Can not pick up her baby using her left arm), VACCINATION SITE ERYTHEMA (Red Injection site (2 quarters size)) and VACCINATION SITE SWELLING (Swelling on the injection site). The patient was treated with PARACETAMOL (TYLENOL) on 17-Sep-2021 for Adverse event, at an unspecified dose and frequency. At the time of the report, INSOMNIA (Could not sleep last night), VACCINATION SITE PRURITUS (Itchiness on the Injection site), VACCINATION SITE PAIN (Pain on the Injection site/the pain is getting worst/Can not pick up her baby using her left arm), VACCINATION SITE ERYTHEMA (Red Injection site (2 quarters size)) and VACCINATION SITE SWELLING (Swelling on the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The patient states that she could not sleep last night from the pain and she can not pick up her baby using her left arm.  No concomitant medication details were reported.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Alopecia, Anaemia, Blood test, Endoscopy
Clinical narrative: slight anemia.; Hair loss is everywhere on his body((eyebrows, chest, arms, legs); hair is so thin and light; he started losing hair on his head first./hair loss is progressively worse; This spontaneous case was reported by a consumer and describes the occurrence of ANAEMIA (slight anemia.), ALOPECIA (Hair loss is everywhere on his body((eyebrows, chest, arms, legs)), ALOPECIA (hair is so thin and light) and ALOPECIA (he started losing hair on his head first./hair loss is progressively worse) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included SIMVASTATIN, LISINOPRIL, COLLAGEN, ACETYLSALICYLIC ACID (BABY ASPIRIN), SERENOA REPENS (PROSTATE HEALTH [SERENOA REPENS]), TURMERIC [CURCUMA LONGA RHIZOME] and BIFIDOBACTERIUM INFANTIS, LACTOBACILLUS ACIDOPHILUS (PROBIOTIC [BIFIDOBACTERIUM INFANTIS;LACTOBACILLUS ACIDOPHILUS]) for an unknown indication.   On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In March 2021, the patient experienced ANAEMIA (slight anemia.), ALOPECIA (Hair loss is everywhere on his body((eyebrows, chest, arms, legs)), ALOPECIA (hair is so thin and light) and ALOPECIA (he started losing hair on his head first./hair loss is progressively worse). At the time of the report, ANAEMIA (slight anemia.), ALOPECIA (Hair loss is everywhere on his body((eyebrows, chest, arms, legs)), ALOPECIA (hair is so thin and light) and ALOPECIA (he started losing hair on his head first./hair loss is progressively worse) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood test: slight anemia (abnormal) SLIGHT ANEMIA and the blood work showed that the anemia is doing bet (normal) the blood work showed that the anemia is doing better, closer to normal ranges.. On an unknown date, Endoscopy: no bleeding (normal) no bleeding.         The patient was also taking Acu vitamin concomitantly. No treatment information was provided.
Sex: U
Vaccine: COVID19
Symptoms: Anosmia
Clinical narrative: Loss of my sense of  smell/ experiencing anosmia after receiving vaccine; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of ANOSMIA (Loss of my sense of  smell/ experiencing anosmia after receiving 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 09-Sep-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ANOSMIA (Loss of my sense of  smell/ experiencing anosmia after receiving vaccine). At the time of the report, ANOSMIA (Loss of my sense of  smell/ experiencing anosmia after receiving vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant medications were provided  No treatment medications were provided.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Cardiac disorder, Dyspnoea, Fatigue
Clinical narrative: very sick; Every time she stands, bends, or changes position she has breathing problems; Cardiac disorder / Every time she stands, bends, or changes position she has heart problems; lost all of her energy / hard to get up everyday; very bad joint pain; chronic fatigue; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (very sick), DYSPNOEA (Every time she stands, bends, or changes position she has breathing problems), CARDIAC DISORDER (Cardiac disorder / Every time she stands, bends, or changes position she has heart problems), ASTHENIA (lost all of her energy / hard to get up everyday) and ARTHRALGIA (very bad joint pain) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ILLNESS (very sick), DYSPNOEA (Every time she stands, bends, or changes position she has breathing problems), CARDIAC DISORDER (Cardiac disorder / Every time she stands, bends, or changes position she has heart problems), ASTHENIA (lost all of her energy / hard to get up everyday), ARTHRALGIA (very bad joint pain) and FATIGUE (chronic fatigue). At the time of the report, ILLNESS (very sick), DYSPNOEA (Every time she stands, bends, or changes position she has breathing problems), CARDIAC DISORDER (Cardiac disorder / Every time she stands, bends, or changes position she has heart problems), ASTHENIA (lost all of her energy / hard to get up everyday), ARTHRALGIA (very bad joint pain) and FATIGUE (chronic fatigue) outcome was unknown.            No treatment medications provided.  No Concomitant medications provided.  Spike protient antibody test was done with a score over 4000, of which passing score was 1.00 or 0.8.
Sex: F
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: very sick; Every time she stands, bends, or changes position she has breathing problems; Cardiac disorder / Every time she stands, bends, or changes position she has heart problems; lost all of her energy / hard to get up everyday; very bad joint pain; chronic fatigue; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (very sick), DYSPNOEA (Every time she stands, bends, or changes position she has breathing problems), CARDIAC DISORDER (Cardiac disorder / Every time she stands, bends, or changes position she has heart problems), ASTHENIA (lost all of her energy / hard to get up everyday) and ARTHRALGIA (very bad joint pain) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ILLNESS (very sick), DYSPNOEA (Every time she stands, bends, or changes position she has breathing problems), CARDIAC DISORDER (Cardiac disorder / Every time she stands, bends, or changes position she has heart problems), ASTHENIA (lost all of her energy / hard to get up everyday), ARTHRALGIA (very bad joint pain) and FATIGUE (chronic fatigue). At the time of the report, ILLNESS (very sick), DYSPNOEA (Every time she stands, bends, or changes position she has breathing problems), CARDIAC DISORDER (Cardiac disorder / Every time she stands, bends, or changes position she has heart problems), ASTHENIA (lost all of her energy / hard to get up everyday), ARTHRALGIA (very bad joint pain) and FATIGUE (chronic fatigue) outcome was unknown.            No treatment medications provided.  No Concomitant medications provided.  Spike protient antibody test was done with a score over 4000, of which passing score was 1.00 or 0.8.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: received a dose of the vaccine more than 12 hs after first puncture; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (received a dose of the vaccine more than 12 hs after first puncture) in a 35-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 an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (received a dose of the vaccine more than 12 hs after first puncture). At the time of the report, EXPIRED PRODUCT ADMINISTERED (received a dose of the vaccine more than 12 hs after first puncture) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications was not provided by the reporter Treatment information was not provided
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Did not receive 2nd dose 25-35 days after the 1st dose; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Did not receive 2nd dose 25-35 days after the 1st dose) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Did not receive 2nd dose 25-35 days after the 1st dose). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Did not receive 2nd dose 25-35 days after the 1st dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment medication was reported. No concomitant medication was reported.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: got sick; This spontaneous case was reported by a nurse and describes the occurrence of ILLNESS (got sick) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022B21A) for COVID-19 vaccination.     Concurrent medical conditions included Renal failure (The patient was hospitalized starting on 17Sep2021.).    On 29-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 ILLNESS (got sick). At the time of the report, ILLNESS (got sick) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered ILLNESS (got sick) to be possibly related.    Concomitant medications were not provided. No Treatment information was provided.  The patient received the first dose on 29Jul2021 and got sick. He is in the hospital currently for renal failure (unrelated to the vaccine) and would like to get the second dose. The reporter (nurse) would like to know if they should proceed to give him the second dose or start the series over. The patient was hospitalized starting on 17Sep2021.; Sender's Comments: This case concerns a 60-year-old, male subject with a medical history of renal failure, who experienced the unexpected event of illness. The event start date following administration of the first dose of the Moderna COVID-19 Vaccine was not provided. The rechallenge was not applicable as the event occurred after the first dose. The medical history of renal failure, which may cause the potential complication of decreased immune response that makes the patient more vulnerable to infection, remains a confounder. The benefit-risk relationship of the Moderna COVID-19 Vaccine is not affected by this report.
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Cardiac disorder, Dyspnoea, Fatigue
Clinical narrative: heart problems / She knows there are other people like her.; breathing problems / She knows there are other people like her.; very bad joint pain / She knows there are other people like her.; chronic fatigue / She knows there are other people like her.; lost their energy / She knows there are other people like her.; 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 CARDIAC DISORDER (heart problems / She knows there are other people like her.), DYSPNOEA (breathing problems / She knows there are other people like her.), ARTHRALGIA (very bad joint pain / She knows there are other people like her.), FATIGUE (chronic fatigue / She knows there are other people like her.) and ASTHENIA (lost their energy / She knows there are other people like her.) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No medical history was provided by the reporter.     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 CARDIAC DISORDER (heart problems / She knows there are other people like her.), DYSPNOEA (breathing problems / She knows there are other people like her.), ARTHRALGIA (very bad joint pain / She knows there are other people like her.), FATIGUE (chronic fatigue / She knows there are other people like her.) and ASTHENIA (lost their energy / She knows there are other people like her.). At the time of the report, CARDIAC DISORDER (heart problems / She knows there are other people like her.), DYSPNOEA (breathing problems / She knows there are other people like her.), ARTHRALGIA (very bad joint pain / She knows there are other people like her.), FATIGUE (chronic fatigue / She knows there are other people like her.) and ASTHENIA (lost their energy / She knows there are other people like her.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 93.0
Sex: U
Vaccine: COVID19
Symptoms: Dysstasia, Illness, Influenza, Product dose omission issue
Clinical narrative: Very sick; Could barely stand up without getting dizzy; Felt like she had a bad flu; Second shot on 18Apr2021 but she chickened out; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Very sick), DYSSTASIA (Could barely stand up without getting dizzy), INFLUENZA (Felt like she had a bad flu) and PRODUCT DOSE OMISSION ISSUE (Second shot on 18Apr2021 but she chickened out) in a 93-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 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ILLNESS (Very sick), DYSSTASIA (Could barely stand up without getting dizzy), INFLUENZA (Felt like she had a bad flu) and PRODUCT DOSE OMISSION ISSUE (Second shot on 18Apr2021 but she chickened out). At the time of the report, ILLNESS (Very sick) and DYSSTASIA (Could barely stand up without getting dizzy) was resolving, INFLUENZA (Felt like she had a bad flu) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (Second shot on 18Apr2021 but she chickened out) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication was not provided.  Treatment information was not provided.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: felt tired after the second vaccine; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (felt tired after the second vaccine) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939906) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Sep-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Sep-2021, the patient experienced FATIGUE (felt tired after the second vaccine). At the time of the report, FATIGUE (felt tired after the second vaccine) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. No treatment information was provided.   This case was linked to MOD-2021-323752.
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Off label use, Product administered to patient of inappropriate age
Clinical narrative: Off-label dosing to 16 year old patient; Off-label dosing to 16 year old patient; This spontaneous case was reported by a pharmacist and describes the occurrence of OFF LABEL USE (Off-label dosing to 16 year old patient) and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Off-label dosing to 16 year old patient) in a 16-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Sep-2021, the patient experienced OFF LABEL USE (Off-label dosing to 16 year old patient) and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Off-label dosing to 16 year old patient). On 17-Sep-2021, OFF LABEL USE (Off-label dosing to 16 year old patient) and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Off-label dosing to 16 year old patient) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Reporter confirmed that patient hadn't experienced any side effects by the time of reporting. No concomitant medication information were provided.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Chills
Clinical narrative: a little chilly; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (a little chilly) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032620A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced CHILLS (a little chilly). The patient was treated with PARACETAMOL (TYLENOL) 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, CHILLS (a little chilly) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  Patient took second dose on 25-FEB-2021 (left arm) (lot no. 002A21A).   This case was linked to MOD-2021-323799
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Dizziness, Insomnia, Musculoskeletal pain, Myalgia
Clinical narrative: her shoulder blade hurt/burns in between the shoulder blades; hurts all over; Her feet started to hurt; her feet tingle/face tingles/; sometimes a place in her face will burn; a lot of pain going on; tongue tingles; unable to sleep; dizzy; her whole left arm (which is the injection arm) started killing her; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (her whole left arm (which is the injection arm) started killing her), ARTHRALGIA (her shoulder blade hurt/burns in between the shoulder blades), MYALGIA (hurts all over), PAIN IN EXTREMITY (Her feet started to hurt) and PARAESTHESIA (her feet tingle/face tingles/) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006D21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 30-Jul-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Jul-2021, the patient experienced VACCINATION SITE PAIN (her whole left arm (which is the injection arm) started killing her). On an unknown date, the patient experienced ARTHRALGIA (her shoulder blade hurt/burns in between the shoulder blades), MYALGIA (hurts all over), PAIN IN EXTREMITY (Her feet started to hurt), PARAESTHESIA (her feet tingle/face tingles/), BURNING SENSATION (sometimes a place in her face will burn), PAIN (a lot of pain going on), PARAESTHESIA ORAL (tongue tingles), INSOMNIA (unable to sleep) and DIZZINESS (dizzy). At the time of the report, VACCINATION SITE PAIN (her whole left arm (which is the injection arm) started killing her), ARTHRALGIA (her shoulder blade hurt/burns in between the shoulder blades), MYALGIA (hurts all over), PAIN IN EXTREMITY (Her feet started to hurt), PARAESTHESIA (her feet tingle/face tingles/), BURNING SENSATION (sometimes a place in her face will burn), PAIN (a lot of pain going on), PARAESTHESIA ORAL (tongue tingles), INSOMNIA (unable to sleep) and DIZZINESS (dizzy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided by the reporter. No treatment information was provided by the reporter.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pain in extremity, Paraesthesia, Paraesthesia oral, Vaccination site pain
Clinical narrative: her shoulder blade hurt/burns in between the shoulder blades; hurts all over; Her feet started to hurt; her feet tingle/face tingles/; sometimes a place in her face will burn; a lot of pain going on; tongue tingles; unable to sleep; dizzy; her whole left arm (which is the injection arm) started killing her; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (her whole left arm (which is the injection arm) started killing her), ARTHRALGIA (her shoulder blade hurt/burns in between the shoulder blades), MYALGIA (hurts all over), PAIN IN EXTREMITY (Her feet started to hurt) and PARAESTHESIA (her feet tingle/face tingles/) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006D21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 30-Jul-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Jul-2021, the patient experienced VACCINATION SITE PAIN (her whole left arm (which is the injection arm) started killing her). On an unknown date, the patient experienced ARTHRALGIA (her shoulder blade hurt/burns in between the shoulder blades), MYALGIA (hurts all over), PAIN IN EXTREMITY (Her feet started to hurt), PARAESTHESIA (her feet tingle/face tingles/), BURNING SENSATION (sometimes a place in her face will burn), PAIN (a lot of pain going on), PARAESTHESIA ORAL (tongue tingles), INSOMNIA (unable to sleep) and DIZZINESS (dizzy). At the time of the report, VACCINATION SITE PAIN (her whole left arm (which is the injection arm) started killing her), ARTHRALGIA (her shoulder blade hurt/burns in between the shoulder blades), MYALGIA (hurts all over), PAIN IN EXTREMITY (Her feet started to hurt), PARAESTHESIA (her feet tingle/face tingles/), BURNING SENSATION (sometimes a place in her face will burn), PAIN (a lot of pain going on), PARAESTHESIA ORAL (tongue tingles), INSOMNIA (unable to sleep) and DIZZINESS (dizzy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided by the reporter. No treatment information was provided by the reporter.