chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 92.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Rash macular
Clinical narrative: Rash observed on her left arm/02Oct2021: Same rash observed on her left leg; Vaccinated observed a rash on her right arm, it was blotchy with dry patches; This spontaneous case was reported by a consumer and describes the occurrence of RASH MACULAR (Vaccinated observed a rash on her right arm, it was blotchy with dry patches) and RASH (Rash observed on her left arm/02Oct2021: Same rash observed on her left leg) in a 92-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 035C21A and 031C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 13-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Jun-2021, the patient experienced RASH MACULAR (Vaccinated observed a rash on her right arm, it was blotchy with dry patches). On an unknown date, the patient experienced RASH (Rash observed on her left arm/02Oct2021: Same rash observed on her left leg). At the time of the report, RASH MACULAR (Vaccinated observed a rash on her right arm, it was blotchy with dry patches) and RASH (Rash observed on her left arm/02Oct2021: Same rash observed on her left leg) outcome was unknown.            On 25-Jun-2021, Vaccinated observed a rash on her right arm, it was blotchy with dry patches.  On unknown dat,: Rash observed on her left arm.  On 02-Oct-2021, Same rash observed on her left leg.  No concomitant medications reported. No treatment medications reported.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: I found out that I had COVID-19 when I got the 2nd shot/I'd been having trouble taking deep breaths.; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of COVID-19 (I found out that I had COVID-19 when I got the 2nd shot/I'd been having trouble taking deep breaths.) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Feb-2021, the patient experienced COVID-19 (I found out that I had COVID-19 when I got the 2nd shot/I'd been having trouble taking deep breaths.) (seriousness criterion medically significant). At the time of the report, COVID-19 (I found out that I had COVID-19 when I got the 2nd shot/I'd been having trouble taking deep breaths.) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, SARS-CoV-2 test Positive.         No concomitant medication was mentioned.  Patient found out that she had Covid-19 when she got the 2nd shot. She had been going back and forth to the Doctor just before she got the shot. She had been having trouble taking deep breaths.  No treatment medication was mentioned.  Company Comment: This case concerns a 77-year-old female patient with no relevant medical history, who experienced the unexpected serious event of COVID-19 . The event occurred approximately 1 day after the second dose of Spikevax. The rechallenge is not applicable since the event occurred after the second dose and no details were provided about the first dose. The benefit-risk relationship of Spikevax is not affected by this report.   This case was linked to MOD-2021-340415 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired dose administered; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired dose administered) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Oct-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired dose administered). On 04-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Expired dose administered) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant and treatment information were reported by the reporter.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Vomiting
Clinical narrative: Diarrhea; vomiting after the first shot; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea) and VOMITING (vomiting after the first shot) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (Hospitalized and intubated). Concurrent medical conditions included Immunocompromised. Concomitant products included TOPIRAMATE, OMEPRAZOLE MAGNESIUM (PRILOSEC [OMEPRAZOLE MAGNESIUM]), PREDNISONE, HYOSCYAMINE, PILOCARPINE, TRAMADOL, QUETIAPINE, GABAPENTIN and URSODEOXYCHOLIC ACID (URSODIOL) for an unknown indication.   On 02-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Oct-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 DIARRHOEA (Diarrhea) and VOMITING (vomiting after the first shot). At the time of the report, DIARRHOEA (Diarrhea) and VOMITING (vomiting after the first shot) outcome was unknown.            No treatment was provided.   This case was linked to MOD-2021-340684 (Patient Link).
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Decreased appetite, Dyspnoea, Gait disturbance, Hallucination
Clinical narrative: hallucinating; difficulty breathing/shortness of breath; swelling around ankles; arm hurts; loss of appetite; coughing; Heart was pounding hard/Heart was beating fast, felt like it was going to come out of my chest.; difficulty speaking; hard to walk on feet; throat hurts; This spontaneous case was reported by a consumer and describes the occurrence of HALLUCINATION in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 (hospitalized and intubated). Concurrent medical conditions included Immunocompromised. Concomitant products included TOPIRAMATE, PRILOSEC, PREDNISONE, HYOSCYAMINE, PILOCARPINE, TRAMADOL, QUETIAPINE, GABAPENTIN, and URSODIOL for an unknown indication.    On 01-Oct-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 HALLUCINATION (seriousness criterion medically significant), DYSPNOEA, JOINT SWELLING, PAIN IN EXTREMITY, DECREASED APPETITE, COUGH, PALPITATIONS, SPEECH DISORDER, GAIT DISTURBANCE, and OROPHARYNGEAL PAIN. At the time of the report, HALLUCINATION, DYSPNOEA, JOINT SWELLING, PAIN IN EXTREMITY, DECREASED APPETITE, COUGH, SPEECH DISORDER, GAIT DISTURBANCE, and OROPHARYNGEAL PAIN was resolving and PALPITATIONS had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available) on an unknown date, fast heart rate.         Other concomitant medication included Mucus relief tablets.  Treatment medication was not provided.  This case concerns a 45-year-old, female patient with relevant medical history of Immunocompromised, who experienced, serious unlisted event of hallucination, among other non-serious events. The event occurred on an unspecified duration after the second dose of Moderna COVID-19 Vaccine. The rechallenge was not applicable as the event occurred after second dose of Moderna COVID-19 Vaccine. The patient's is on quetiapine probably for some psychiatric condition, which may remain a confounder, and patient should be followed-up to confirm. The benefit-risk relationship of Moderna COVID-19 Vaccine is not affected by this report.   This case was linked to MOD-2021-340634 (Patient Link).
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate, Joint swelling, Oropharyngeal pain, Pain in extremity, Palpitations
Clinical narrative: hallucinating; difficulty breathing/shortness of breath; swelling around ankles; arm hurts; loss of appetite; coughing; Heart was pounding hard/Heart was beating fast, felt like it was going to come out of my chest.; difficulty speaking; hard to walk on feet; throat hurts; This spontaneous case was reported by a consumer and describes the occurrence of HALLUCINATION in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 (hospitalized and intubated). Concurrent medical conditions included Immunocompromised. Concomitant products included TOPIRAMATE, PRILOSEC, PREDNISONE, HYOSCYAMINE, PILOCARPINE, TRAMADOL, QUETIAPINE, GABAPENTIN, and URSODIOL for an unknown indication.    On 01-Oct-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 HALLUCINATION (seriousness criterion medically significant), DYSPNOEA, JOINT SWELLING, PAIN IN EXTREMITY, DECREASED APPETITE, COUGH, PALPITATIONS, SPEECH DISORDER, GAIT DISTURBANCE, and OROPHARYNGEAL PAIN. At the time of the report, HALLUCINATION, DYSPNOEA, JOINT SWELLING, PAIN IN EXTREMITY, DECREASED APPETITE, COUGH, SPEECH DISORDER, GAIT DISTURBANCE, and OROPHARYNGEAL PAIN was resolving and PALPITATIONS had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available) on an unknown date, fast heart rate.         Other concomitant medication included Mucus relief tablets.  Treatment medication was not provided.  This case concerns a 45-year-old, female patient with relevant medical history of Immunocompromised, who experienced, serious unlisted event of hallucination, among other non-serious events. The event occurred on an unspecified duration after the second dose of Moderna COVID-19 Vaccine. The rechallenge was not applicable as the event occurred after second dose of Moderna COVID-19 Vaccine. The patient's is on quetiapine probably for some psychiatric condition, which may remain a confounder, and patient should be followed-up to confirm. The benefit-risk relationship of Moderna COVID-19 Vaccine is not affected by this report.   This case was linked to MOD-2021-340634 (Patient Link).
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Speech disorder
Clinical narrative: hallucinating; difficulty breathing/shortness of breath; swelling around ankles; arm hurts; loss of appetite; coughing; Heart was pounding hard/Heart was beating fast, felt like it was going to come out of my chest.; difficulty speaking; hard to walk on feet; throat hurts; This spontaneous case was reported by a consumer and describes the occurrence of HALLUCINATION in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 (hospitalized and intubated). Concurrent medical conditions included Immunocompromised. Concomitant products included TOPIRAMATE, PRILOSEC, PREDNISONE, HYOSCYAMINE, PILOCARPINE, TRAMADOL, QUETIAPINE, GABAPENTIN, and URSODIOL for an unknown indication.    On 01-Oct-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 HALLUCINATION (seriousness criterion medically significant), DYSPNOEA, JOINT SWELLING, PAIN IN EXTREMITY, DECREASED APPETITE, COUGH, PALPITATIONS, SPEECH DISORDER, GAIT DISTURBANCE, and OROPHARYNGEAL PAIN. At the time of the report, HALLUCINATION, DYSPNOEA, JOINT SWELLING, PAIN IN EXTREMITY, DECREASED APPETITE, COUGH, SPEECH DISORDER, GAIT DISTURBANCE, and OROPHARYNGEAL PAIN was resolving and PALPITATIONS had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available) on an unknown date, fast heart rate.         Other concomitant medication included Mucus relief tablets.  Treatment medication was not provided.  This case concerns a 45-year-old, female patient with relevant medical history of Immunocompromised, who experienced, serious unlisted event of hallucination, among other non-serious events. The event occurred on an unspecified duration after the second dose of Moderna COVID-19 Vaccine. The rechallenge was not applicable as the event occurred after second dose of Moderna COVID-19 Vaccine. The patient's is on quetiapine probably for some psychiatric condition, which may remain a confounder, and patient should be followed-up to confirm. The benefit-risk relationship of Moderna COVID-19 Vaccine is not affected by this report.   This case was linked to MOD-2021-340634 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: tired; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (tired) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028L20A, 039K20A and 037F21A) for COVID-19 vaccination.     No Medical History information was reported.   On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced FATIGUE (tired). At the time of the report, FATIGUE (tired) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant drug details were reported. No treatment details were reported.    This case was linked to MOD-2021-340745 (Patient Link).
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Facial discomfort, Joint swelling, Peripheral swelling, Pruritus, Rash macular
Clinical narrative: Skin rash (blotchy red on thighs and torso); Swelling of hands, feet and knees; Swelling of hands, feet and knees; Mild generalized pruritis; Sensation of facial "tightness; This spontaneous case was reported by a consumer and describes the occurrence of RASH MACULAR (Skin rash (blotchy red on thighs and torso)), PERIPHERAL SWELLING (Swelling of hands, feet and knees), JOINT SWELLING (Swelling of hands, feet and knees), PRURITUS (Mild generalized pruritis) and FACIAL DISCOMFORT (Sensation of facial "tightness) in a 31-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Surgery (Spinal surgery for Kyphosis a number of years ago) since an unknown date.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced RASH MACULAR (Skin rash (blotchy red on thighs and torso)), PERIPHERAL SWELLING (Swelling of hands, feet and knees), JOINT SWELLING (Swelling of hands, feet and knees), PRURITUS (Mild generalized pruritis) and FACIAL DISCOMFORT (Sensation of facial "tightness). The patient was treated with IBUPROFEN for Adverse event, at an unspecified dose and frequency and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency. At the time of the report, RASH MACULAR (Skin rash (blotchy red on thighs and torso)), PERIPHERAL SWELLING (Swelling of hands, feet and knees) and JOINT SWELLING (Swelling of hands, feet and knees) was resolving and PRURITUS (Mild generalized pruritis) and FACIAL DISCOMFORT (Sensation of facial "tightness) had not resolved.            No concomitant medication was provided.  The patient  was seen at a urgent care center on two occasions last week and was administered some kind of steroid injection on 29 Sep 2021 with mild improvement in his sympotms. Further evaluation(lab tests) were pending.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Headache, Inappropriate schedule of product administration, Malaise, Myalgia
Clinical narrative: felt warm; headache; body aches; nausea; Vaccines 52 days apart; felt so sick; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (felt so sick), FEELING HOT (felt warm), HEADACHE (headache), MYALGIA (body aches) and NAUSEA (nausea) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 048B21A and 048B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 08-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Oct-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Oct-1021, the patient experienced MALAISE (felt so sick). On 02-Oct-2021, the patient experienced FEELING HOT (felt warm), HEADACHE (headache), MYALGIA (body aches), NAUSEA (nausea) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Vaccines 52 days apart). On 04-Oct-2021, FEELING HOT (felt warm), HEADACHE (headache), MYALGIA (body aches), NAUSEA (nausea) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Vaccines 52 days apart) had resolved. At the time of the report, MALAISE (felt so sick) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-1 test: positiive (Positive) Her second injection was scheduled but she had a positive Covid-19 test 4 days before her shot was scheduled 4Sep2021..         Concomitant medication was not reported. Treatment information was not reported.  Patient called to report that she had her first Moderna injection on 8Aug2021.  Her second injection was scheduled but she had a positive Covid-19 test 4 days before her shot was scheduled 4Sep2021.  She had her second injection 1Oct2021 Lot# 048B21A  52 days after first injection.   This case was linked to MOD-2021-340751 (Patient Link).
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, SARS-CoV-1 test
Clinical narrative: felt warm; headache; body aches; nausea; Vaccines 52 days apart; felt so sick; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (felt so sick), FEELING HOT (felt warm), HEADACHE (headache), MYALGIA (body aches) and NAUSEA (nausea) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 048B21A and 048B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 08-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Oct-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Oct-1021, the patient experienced MALAISE (felt so sick). On 02-Oct-2021, the patient experienced FEELING HOT (felt warm), HEADACHE (headache), MYALGIA (body aches), NAUSEA (nausea) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Vaccines 52 days apart). On 04-Oct-2021, FEELING HOT (felt warm), HEADACHE (headache), MYALGIA (body aches), NAUSEA (nausea) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Vaccines 52 days apart) had resolved. At the time of the report, MALAISE (felt so sick) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-1 test: positiive (Positive) Her second injection was scheduled but she had a positive Covid-19 test 4 days before her shot was scheduled 4Sep2021..         Concomitant medication was not reported. Treatment information was not reported.  Patient called to report that she had her first Moderna injection on 8Aug2021.  Her second injection was scheduled but she had a positive Covid-19 test 4 days before her shot was scheduled 4Sep2021.  She had her second injection 1Oct2021 Lot# 048B21A  52 days after first injection.   This case was linked to MOD-2021-340751 (Patient Link).
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Epistaxis, Fatigue, Headache
Clinical narrative: body aches; bloody nose/ nose still hurts; chills; body aches; headches/ head is still hurting; joint pain; fatigued for a month; She received the 3rd dose despite not being immunocompromised; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (body aches), EPISTAXIS (bloody nose/ nose still hurts), CHILLS (chills), MYALGIA (body aches) and HEADACHE (headches/ head is still hurting) in a 7-decade-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037F221A, 039K20A and 028L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN (body aches), EPISTAXIS (bloody nose/ nose still hurts), CHILLS (chills), MYALGIA (body aches), HEADACHE (headches/ head is still hurting), ARTHRALGIA (joint pain), FATIGUE (fatigued for a month) and OFF LABEL USE (She received the 3rd dose despite not being immunocompromised). The patient was treated with ERYTHROMYCIN at an unspecified dose and frequency. At the time of the report, PAIN (body aches), CHILLS (chills) and MYALGIA (body aches) outcome was unknown, EPISTAXIS (bloody nose/ nose still hurts), HEADACHE (headches/ head is still hurting) and ARTHRALGIA (joint pain) had not resolved and FATIGUE (fatigued for a month) and OFF LABEL USE (She received the 3rd dose despite not being immunocompromised) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant informations were reported.   This case was linked to MOD-2021-340725 (Patient Link).
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Off label use, Pain
Clinical narrative: body aches; bloody nose/ nose still hurts; chills; body aches; headches/ head is still hurting; joint pain; fatigued for a month; She received the 3rd dose despite not being immunocompromised; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (body aches), EPISTAXIS (bloody nose/ nose still hurts), CHILLS (chills), MYALGIA (body aches) and HEADACHE (headches/ head is still hurting) in a 7-decade-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037F221A, 039K20A and 028L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN (body aches), EPISTAXIS (bloody nose/ nose still hurts), CHILLS (chills), MYALGIA (body aches), HEADACHE (headches/ head is still hurting), ARTHRALGIA (joint pain), FATIGUE (fatigued for a month) and OFF LABEL USE (She received the 3rd dose despite not being immunocompromised). The patient was treated with ERYTHROMYCIN at an unspecified dose and frequency. At the time of the report, PAIN (body aches), CHILLS (chills) and MYALGIA (body aches) outcome was unknown, EPISTAXIS (bloody nose/ nose still hurts), HEADACHE (headches/ head is still hurting) and ARTHRALGIA (joint pain) had not resolved and FATIGUE (fatigued for a month) and OFF LABEL USE (She received the 3rd dose despite not being immunocompromised) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant informations were reported.   This case was linked to MOD-2021-340725 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: She had to press hard to feel a little tenderness on the area of the injection; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (She had to press hard to feel a little tenderness on the area of the injection) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In August 2021, the patient 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 received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (She had to press hard to feel a little tenderness on the area of the injection). At the time of the report, VACCINATION SITE PAIN (She had to press hard to feel a little tenderness on the area of the injection) was resolving.            Patient was concerned whether she got the right dose as she barely did not feel any pain at all.  No relevant concomitant medications were reported. No treatment information was provided.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Feeling hot, Headache, Inappropriate schedule of product administration, Myalgia
Clinical narrative: She had her second injection 1Oct2021 Lot# 048B21A  52 days after first injection; felt warm; headache; body aches; nausea; Positive Covid-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Positive Covid-19), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (She had her second injection 1Oct2021 Lot# 048B21A  52 days after first injection), FEELING HOT (felt warm), HEADACHE (headache) and MYALGIA (body aches) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 08-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Sep-2021, the patient experienced COVID-19 (Positive Covid-19). On 02-Oct-2021, the patient experienced FEELING HOT (felt warm), HEADACHE (headache), MYALGIA (body aches) and NAUSEA (nausea). On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (She had her second injection 1Oct2021 Lot# 048B21A  52 days after first injection). On 04-Oct-2021, FEELING HOT (felt warm), HEADACHE (headache), MYALGIA (body aches) and NAUSEA (nausea) had resolved. At the time of the report, COVID-19 (Positive Covid-19) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (She had her second injection 1Oct2021 Lot# 048B21A  52 days after first injection) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 04-Sep-2021, SARS-CoV-2 test: positive (Positive) Positive.     mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No relevant concomitant medications were reported. Treatment information was unknown.   This case was linked to MOD-2021-340740 (Patient Link).; Sender's Comments: This case concerns a 62-year-old, female subject with no relevant medical  history reported, who experienced the unexpected event of COVID-19. The event occurred twenty-seven after the first dose of Spikevax. The rechallenge was negative. The benefit-risk relationship of Spikevax is not affected by this report.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, SARS-CoV-2 test
Clinical narrative: She had her second injection 1Oct2021 Lot# 048B21A  52 days after first injection; felt warm; headache; body aches; nausea; Positive Covid-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Positive Covid-19), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (She had her second injection 1Oct2021 Lot# 048B21A  52 days after first injection), FEELING HOT (felt warm), HEADACHE (headache) and MYALGIA (body aches) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 08-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Sep-2021, the patient experienced COVID-19 (Positive Covid-19). On 02-Oct-2021, the patient experienced FEELING HOT (felt warm), HEADACHE (headache), MYALGIA (body aches) and NAUSEA (nausea). On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (She had her second injection 1Oct2021 Lot# 048B21A  52 days after first injection). On 04-Oct-2021, FEELING HOT (felt warm), HEADACHE (headache), MYALGIA (body aches) and NAUSEA (nausea) had resolved. At the time of the report, COVID-19 (Positive Covid-19) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (She had her second injection 1Oct2021 Lot# 048B21A  52 days after first injection) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 04-Sep-2021, SARS-CoV-2 test: positive (Positive) Positive.     mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No relevant concomitant medications were reported. Treatment information was unknown.   This case was linked to MOD-2021-340740 (Patient Link).; Sender's Comments: This case concerns a 62-year-old, female subject with no relevant medical  history reported, who experienced the unexpected event of COVID-19. The event occurred twenty-seven after the first dose of Spikevax. The rechallenge was negative. The benefit-risk relationship of Spikevax is not affected by this report.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: sore arm for short period of time; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm for short period of time) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (sore arm for short period of time). At the time of the report, PAIN IN EXTREMITY (sore arm for short period of time) had resolved.        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 reported.  It was reported that patient experienced same kind of sore arm with any other vaccine.
Sex: U
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) 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 PAIN IN EXTREMITY (Sore arm). At the time of the report, PAIN IN EXTREMITY (Sore arm) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication and treatment information was reported.   This case was linked to MOD-2021-340870 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Chills, Decreased appetite, Dizziness, Headache, Loss of personal independence in daily activities
Clinical narrative: dizziness; no appetite; could not work; chills; fever; nausea; headache; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizziness), DECREASED APPETITE (no appetite), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (could not work), CHILLS (chills) and PYREXIA (fever) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037F21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 30-Sep-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Oct-2021, the patient experienced DIZZINESS (dizziness), DECREASED APPETITE (no appetite), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (could not work), CHILLS (chills), PYREXIA (fever), NAUSEA (nausea) and HEADACHE (headache). The patient was treated with PARACETAMOL (TYLENOL) on 02-Oct-2021 at a dose of 4 Tylenols. On 03-Oct-2021, CHILLS (chills) had resolved. On 04-Oct-2021, DIZZINESS (dizziness) and NAUSEA (nausea) had not resolved, DECREASED APPETITE (no appetite), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (could not work) and HEADACHE (headache) had resolved. At the time of the report, PYREXIA (fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication were reported.   This case was linked to MOD-2021-340861 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Nausea, Pyrexia
Clinical narrative: dizziness; no appetite; could not work; chills; fever; nausea; headache; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizziness), DECREASED APPETITE (no appetite), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (could not work), CHILLS (chills) and PYREXIA (fever) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037F21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 30-Sep-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Oct-2021, the patient experienced DIZZINESS (dizziness), DECREASED APPETITE (no appetite), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (could not work), CHILLS (chills), PYREXIA (fever), NAUSEA (nausea) and HEADACHE (headache). The patient was treated with PARACETAMOL (TYLENOL) on 02-Oct-2021 at a dose of 4 Tylenols. On 03-Oct-2021, CHILLS (chills) had resolved. On 04-Oct-2021, DIZZINESS (dizziness) and NAUSEA (nausea) had not resolved, DECREASED APPETITE (no appetite), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (could not work) and HEADACHE (headache) had resolved. At the time of the report, PYREXIA (fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication were reported.   This case was linked to MOD-2021-340861 (Patient Link).
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Product dose omission issue
Clinical narrative: He got COVID positive and hospitalized at the end of JAN2021or  beginning of FEB2021; The patient has not received the second dose yet; This spontaneous case was reported by a nurse and describes the occurrence of COVID-19 in a 30-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Previously administered products included for an unreported indication MONOCLONAL ANTIBODY 17-1A (He had Monoclonal antibody treatment > 90 days ago and after having COVID disease).    On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Oct-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE. On an unknown date, the patient experienced COVID-19 (seriousness criterion hospitalization). On 04-Oct-2021, PRODUCT DOSE OMISSION ISSUE had resolved. At the time of the report, COVID-19 outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication information was not reported.  Per reporter, the patient became COVID positive and hospitalized at the end of Jan-2021 or beginning of Feb-2021.   Treatment included monoclonal antibody received more than 90 days ago, after developing COVID disease.  A 30-year-old male hospitalized with a serious unexpected event of COVID-19, and product dose omission issue. Latency 1-2 months after first dose mRNA-1273. Events resolved with monoclonal antibody treatment. Rechallenge not applicable due to product dose omission. Reporter causality not provided. No confounders were reported. Causality possible from temporal association. Events consistent with known profile of mRNA-1273. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Inappropriate schedule of product administration
Clinical narrative: Got covid; more than 42 days for administration of second dose; This spontaneous case was reported by an other health care professional and describes the occurrence of COVID-19 (Got covid) in a male 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 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (Got covid) (seriousness criterion hospitalization) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (more than 42 days for administration of second dose). At the time of the report, COVID-19 (Got covid) outcome was unknown and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (more than 42 days for administration of second dose) 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 use information was not provided by reporter. Treatment medication mention treatment for COVID NOS.  Company Comment: This is a case of inappropriate schedule of product administra tion and concerns an unknown age male patient with no relevant medical history, who experienced the unexpected serious event of COVID-19 and was hospitalized. The event of COVID-19 occured unknown number of days after the first dose of Spivax vaccine. The event of inappropriate schedule of product administration was  more than 42 days for administration of second dose. The rechallenge was unknown since no information about the second dose was disclosed. The benefit-risk relationship of Spikevax in not affected by this report.   Reporter did not allow further contact; Sender's Comments: This is a case of inappropriate schedule of product administra tion and concerns an unknown age male patient with no relevant medical history, who experienced the unexpected serious event of COVID-19 and was hospitalized. The event of COVID-19 occured unknown number of days after the first dose of Spivax vaccine. The event of inappropriate schedule of product administration was  more than 42 days for administration of second dose. The rechallenge was unknown since no information about the second dose was disclosed. The benefit-risk relationship of Spikevax in not affected by this report.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Paraesthesia
Clinical narrative: Tingling sensations; Chills; Headache; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (Tingling sensations), CHILLS (Chills), HEADACHE (Headache) and FATIGUE (Fatigue) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In March 2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 27-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PARAESTHESIA (Tingling sensations), CHILLS (Chills), HEADACHE (Headache) and FATIGUE (Fatigue). At the time of the report, PARAESTHESIA (Tingling sensations) had not resolved, CHILLS (Chills) and FATIGUE (Fatigue) outcome was unknown and HEADACHE (Headache) had resolved.            No concomitant medication was reported.  No treatment medication use was reported. Patient reported after her 3hrd shot, her headache felt like she had 5 heads and when the headache subsided, she felt tingling above her right eye which hasn't gone away.   This case was linked to MOD-2021-340950, MOD-2021-340951 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Illness, Vaccination complication
Clinical narrative: got very violently sick; side effects; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (got very violently sick) and VACCINATION COMPLICATION (side effects) in a female patient of an unknown age 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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ILLNESS (got very violently sick) and VACCINATION COMPLICATION (side effects). At the time of the report, ILLNESS (got very violently sick) and VACCINATION COMPLICATION (side effects) outcome was unknown.            No concomitant medications provided. No treatment medications provided.
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site mass, Vaccination site pruritus, Vaccination site rash
Clinical narrative: Lumpy  Injection site; Rash on the injection site; Itching Injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MASS (Lumpy  Injection site), VACCINATION SITE RASH (Rash on the injection site) and VACCINATION SITE PRURITUS (Itching Injection site) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Sep-2021, the patient experienced VACCINATION SITE MASS (Lumpy  Injection site), VACCINATION SITE RASH (Rash on the injection site) and VACCINATION SITE PRURITUS (Itching Injection site). At the time of the report, VACCINATION SITE MASS (Lumpy  Injection site), VACCINATION SITE RASH (Rash on the injection site) and VACCINATION SITE PRURITUS (Itching Injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were not reported. No treatment medications were not provided. Patient has not seen a doctor.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Vaccination site swelling
Clinical narrative: swelling in my left injection site arm; very tired for 2 days; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (swelling in my left injection site arm) and FATIGUE (very tired for 2 days) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031BZIA) for COVID-19 vaccination.     Concomitant products included SPIRONOLACTONE (SPIRONOLACTON) and VITAMINS NOS for an unknown indication.    On 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Apr-2021, the patient experienced VACCINATION SITE SWELLING (swelling in my left injection site arm) and FATIGUE (very tired for 2 days). In April 2021, FATIGUE (very tired for 2 days) had resolved. At the time of the report, VACCINATION SITE SWELLING (swelling in my left injection site arm) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Lab data was not provided Treatment product was not provided by the reporter  This case refers only to the events of the first dose of the Moderna COVID-19 Vaccine.   This case was linked to MOD-2021-341010 (Patient Link).; Sender's Comments: This case concerns a  36-year-old, female patient with no relevant medical history, who experienced the unexpected events of Vaccination site swelling and Fatigue. The events occurred on the day of the first dose of Moderna CoviD-19 Vaccine. The rechallenge was unknown as the events occurred after the first dose and no information about second dose is available. The benefit-risk relationship of Moderna CoviD-19 Vaccine is not affected by this report. This case is downgraded to Non-serious because the events have resolved within 2 days and did not cause hospitalization, permanent disability or incapacity.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache
Clinical narrative: Chills; Headache; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills), HEADACHE (Headache) and FATIGUE (Fatigue) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In March 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 (Chills), HEADACHE (Headache) and FATIGUE (Fatigue). At the time of the report, CHILLS (Chills), HEADACHE (Headache) and FATIGUE (Fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported. No treatment reported.   This case was linked to MOD-2021-340922, MOD-2021-340951 (Patient Link).