chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Myalgia, Pruritus, Rash, Sinus headache
Clinical narrative: she has red dots all over; it started itching on her arms; she had a rash on her chest / arm / ankles; the injection site it started itching; the injection site it started getting red going down the arm; during the night she had a sinus headache; a sore arm; This spontaneous case was reported by a consumer and describes the occurrence of SINUS HEADACHE (during the night she had a sinus headache), ERYTHEMA (she has red dots all over), PRURITUS (it started itching on her arms), RASH (she had a rash on her chest / arm / ankles) and MYALGIA (a sore arm) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     "No medical history was provided by the reporter.".  Concomitant products included RABEPRAZOLE SODIUM (ACIPHEX) for an unknown indication.   On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 31-Aug-2021, the patient experienced MYALGIA (a sore arm). On 01-Sep-2021, the patient experienced SINUS HEADACHE (during the night she had a sinus headache), VACCINATION SITE PRURITUS (the injection site it started itching) and VACCINATION SITE ERYTHEMA (the injection site it started getting red going down the arm). On 02-Sep-2021, the patient experienced ERYTHEMA (she has red dots all over), PRURITUS (it started itching on her arms) and RASH (she had a rash on her chest / arm / ankles). The patient was treated with PARACETAMOL (TYLENOL) at a dose of UNK dosage form. At the time of the report, SINUS HEADACHE (during the night she had a sinus headache), ERYTHEMA (she has red dots all over), PRURITUS (it started itching on her arms), RASH (she had a rash on her chest / arm / ankles), MYALGIA (a sore arm), VACCINATION SITE PRURITUS (the injection site it started itching) and VACCINATION SITE ERYTHEMA (the injection site it started getting red going down the arm) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus
Clinical narrative: she has red dots all over; it started itching on her arms; she had a rash on her chest / arm / ankles; the injection site it started itching; the injection site it started getting red going down the arm; during the night she had a sinus headache; a sore arm; This spontaneous case was reported by a consumer and describes the occurrence of SINUS HEADACHE (during the night she had a sinus headache), ERYTHEMA (she has red dots all over), PRURITUS (it started itching on her arms), RASH (she had a rash on her chest / arm / ankles) and MYALGIA (a sore arm) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     "No medical history was provided by the reporter.".  Concomitant products included RABEPRAZOLE SODIUM (ACIPHEX) for an unknown indication.   On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 31-Aug-2021, the patient experienced MYALGIA (a sore arm). On 01-Sep-2021, the patient experienced SINUS HEADACHE (during the night she had a sinus headache), VACCINATION SITE PRURITUS (the injection site it started itching) and VACCINATION SITE ERYTHEMA (the injection site it started getting red going down the arm). On 02-Sep-2021, the patient experienced ERYTHEMA (she has red dots all over), PRURITUS (it started itching on her arms) and RASH (she had a rash on her chest / arm / ankles). The patient was treated with PARACETAMOL (TYLENOL) at a dose of UNK dosage form. At the time of the report, SINUS HEADACHE (during the night she had a sinus headache), ERYTHEMA (she has red dots all over), PRURITUS (it started itching on her arms), RASH (she had a rash on her chest / arm / ankles), MYALGIA (a sore arm), VACCINATION SITE PRURITUS (the injection site it started itching) and VACCINATION SITE ERYTHEMA (the injection site it started getting red going down the arm) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Body temperature, Chills, Fatigue, Gait disturbance
Clinical narrative: everyday getting weaker and weaker; legs cannot support weight for the first time in his life; can't get out of bed; Fever with a temperature range of  99.9-100.8 F intermittently; pain, hurting; headache; Chills; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (everyday getting weaker and weaker), GAIT DISTURBANCE (legs cannot support weight for the first time in his life), MOBILITY DECREASED (can't get out of bed), PYREXIA (Fever with a temperature range of  99.9-100.8 F intermittently) and MYALGIA (pain, hurting) in a 54-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.     No Medical History information was reported.    On 21-Aug-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Aug-2021, the patient experienced ASTHENIA (everyday getting weaker and weaker), GAIT DISTURBANCE (legs cannot support weight for the first time in his life), MOBILITY DECREASED (can't get out of bed), PYREXIA (Fever with a temperature range of  99.9-100.8 F intermittently), MYALGIA (pain, hurting), HEADACHE (headache), CHILLS (Chills) and FATIGUE (fatigue). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at a dose of UNK, q4h. At the time of the report, ASTHENIA (everyday getting weaker and weaker), GAIT DISTURBANCE (legs cannot support weight for the first time in his life), MOBILITY DECREASED (can't get out of bed), PYREXIA (Fever with a temperature range of  99.9-100.8 F intermittently), MYALGIA (pain, hurting), HEADACHE (headache), CHILLS (Chills) and FATIGUE (fatigue) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, SARS-CoV-2 test: negative (Negative) Negative. On 31-Aug-2021, Body temperature: 99.9-100.8 f (High) 99.9-100.8 F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Mobility decreased, Myalgia, Pyrexia, SARS-CoV-2 test
Clinical narrative: everyday getting weaker and weaker; legs cannot support weight for the first time in his life; can't get out of bed; Fever with a temperature range of  99.9-100.8 F intermittently; pain, hurting; headache; Chills; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (everyday getting weaker and weaker), GAIT DISTURBANCE (legs cannot support weight for the first time in his life), MOBILITY DECREASED (can't get out of bed), PYREXIA (Fever with a temperature range of  99.9-100.8 F intermittently) and MYALGIA (pain, hurting) in a 54-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.     No Medical History information was reported.    On 21-Aug-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Aug-2021, the patient experienced ASTHENIA (everyday getting weaker and weaker), GAIT DISTURBANCE (legs cannot support weight for the first time in his life), MOBILITY DECREASED (can't get out of bed), PYREXIA (Fever with a temperature range of  99.9-100.8 F intermittently), MYALGIA (pain, hurting), HEADACHE (headache), CHILLS (Chills) and FATIGUE (fatigue). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at a dose of UNK, q4h. At the time of the report, ASTHENIA (everyday getting weaker and weaker), GAIT DISTURBANCE (legs cannot support weight for the first time in his life), MOBILITY DECREASED (can't get out of bed), PYREXIA (Fever with a temperature range of  99.9-100.8 F intermittently), MYALGIA (pain, hurting), HEADACHE (headache), CHILLS (Chills) and FATIGUE (fatigue) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, SARS-CoV-2 test: negative (Negative) Negative. On 31-Aug-2021, Body temperature: 99.9-100.8 f (High) 99.9-100.8 F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chest pain, Chills, Dyspnoea, Headache
Clinical narrative: Bad reaction; Hard to breathe; Pain in the middle of her chest; Ached all over the body; Fever; Chills; Head exploded with a headache; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Bad reaction), DYSPNOEA (Hard to breathe), CHEST PAIN (Pain in the middle of her chest), PAIN (Ached all over the body) and PYREXIA (Fever) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 01M20A and 004M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Fibromyalgia, Kidney disorder and Allergy NOS (Allergies). Concomitant products included LOSARTAN, AMLODIPINE, EZETIMIBE (ZETIA), ASPIRIN [ACETYLSALICYLIC ACID] and PATIROMER SORBITEX CALCIUM (VELTASSA) for an unknown indication.   On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 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 VACCINATION COMPLICATION (Bad reaction), PAIN (Ached all over the body), PYREXIA (Fever), CHILLS (Chills) and HEADACHE (Head exploded with a headache). 26-Feb-2021, the patient experienced DYSPNOEA (Hard to breathe) and CHEST PAIN (Pain in the middle of her chest). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. On 27-Feb-2021, VACCINATION COMPLICATION (Bad reaction), DYSPNOEA (Hard to breathe), CHEST PAIN (Pain in the middle of her chest), PAIN (Ached all over the body), PYREXIA (Fever), CHILLS (Chills) and HEADACHE (Head exploded with a headache) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 26-Feb-2021, Body temperature: 101-102 degree fahrenheit (High) 101-102 degree Fahrenheit : fever.         Concomitant medication also included Lovaxacine 100 micrograms once daily and Pression vision for unknown indication. The patient had no history of pericarditis/myocarditis and COVID-19 infection. The treatment with Tylenol did not work for the patient. Going to the second day after the second dose vaccination, the patient felt normal. The patient asked whether it was safe for the patient to get the third or booster dose or not, even after having a bad reaction to the vaccine and having some allergies. The patient felt like vomiting but did not vomit.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia, Vaccination complication
Clinical narrative: Bad reaction; Hard to breathe; Pain in the middle of her chest; Ached all over the body; Fever; Chills; Head exploded with a headache; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Bad reaction), DYSPNOEA (Hard to breathe), CHEST PAIN (Pain in the middle of her chest), PAIN (Ached all over the body) and PYREXIA (Fever) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 01M20A and 004M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Fibromyalgia, Kidney disorder and Allergy NOS (Allergies). Concomitant products included LOSARTAN, AMLODIPINE, EZETIMIBE (ZETIA), ASPIRIN [ACETYLSALICYLIC ACID] and PATIROMER SORBITEX CALCIUM (VELTASSA) for an unknown indication.   On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 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 VACCINATION COMPLICATION (Bad reaction), PAIN (Ached all over the body), PYREXIA (Fever), CHILLS (Chills) and HEADACHE (Head exploded with a headache). 26-Feb-2021, the patient experienced DYSPNOEA (Hard to breathe) and CHEST PAIN (Pain in the middle of her chest). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. On 27-Feb-2021, VACCINATION COMPLICATION (Bad reaction), DYSPNOEA (Hard to breathe), CHEST PAIN (Pain in the middle of her chest), PAIN (Ached all over the body), PYREXIA (Fever), CHILLS (Chills) and HEADACHE (Head exploded with a headache) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 26-Feb-2021, Body temperature: 101-102 degree fahrenheit (High) 101-102 degree Fahrenheit : fever.         Concomitant medication also included Lovaxacine 100 micrograms once daily and Pression vision for unknown indication. The patient had no history of pericarditis/myocarditis and COVID-19 infection. The treatment with Tylenol did not work for the patient. Going to the second day after the second dose vaccination, the patient felt normal. The patient asked whether it was safe for the patient to get the third or booster dose or not, even after having a bad reaction to the vaccine and having some allergies. The patient felt like vomiting but did not vomit.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Received dose from Vial punctured more than 12 hours before; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received dose from Vial punctured more than 12 hours before) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 047B21A and 047B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 06-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Sep-2021 at 8:40 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 03-Sep-2021 at 8:40 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received dose from Vial punctured more than 12 hours before). On 03-Sep-2021, EXPIRED PRODUCT ADMINISTERED (Received dose from Vial punctured more than 12 hours before) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided. Treatment information was not  provided.   Most recent FOLLOW-UP information incorporated above includes: On 07-Sep-2021: Follow up received on 07-SEP-2021 contains Non-Significant information-Reporter information added, vaccine route of administration, specific anatomical site updated.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: pain in the arm; 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 PAIN IN EXTREMITY (pain in the arm) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (pain in the arm). At the time of the report, PAIN IN EXTREMITY (pain in the arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported.  No treatment information was provided.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Product dose omission issue
Clinical narrative: pharmacist would not give her the second dose; left hip joint pain (last 4 to 5 days); left hip joint pain is ongoing; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (pharmacist would not give her the second dose), ARTHRALGIA (left hip joint pain (last 4 to 5 days)) and ARTHRALGIA (left hip joint pain is ongoing) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 052C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Aug-2021, the patient experienced ARTHRALGIA (left hip joint pain (last 4 to 5 days)) and ARTHRALGIA (left hip joint pain is ongoing). On 02-Sep-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (pharmacist would not give her the second dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (pharmacist would not give her the second dose), ARTHRALGIA (left hip joint pain (last 4 to 5 days)) and ARTHRALGIA (left hip joint pain is ongoing) 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 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: Myalgia
Clinical narrative: A little sore arm after first dose; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (A little sore arm after first dose) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027A21A, 038A21A and 002F21A) for COVID-19 vaccination.     Concurrent medical conditions included Autoimmune disorder and Psoriasis. Concomitant products included RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) for an unknown indication.   On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Mar-2021, the patient experienced MYALGIA (A little sore arm after first dose). On 08-Mar-2021, MYALGIA (A little sore arm after first dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Skyrizi injection took by patient in Feb2021 600mg, and in May 2021 300mg and it is scheduled in SEP 2021.  No treatment information was reported by reporter.   This case was linked to MOD-2021-307235, MOD-2021-307237 (Patient Link).
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received a vaccine that had Expiration date Mar 06, 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received a vaccine that had Expiration date Mar 06, 2021) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 062G20A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Mar-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received a vaccine that had Expiration date Mar 06, 2021). On 10-Mar-2021, EXPIRED PRODUCT ADMINISTERED (Patient received a vaccine that had Expiration date Mar 06, 2021) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication is provided No treatment medication is provided  Reporter stated the vial was received on 19-Jan-2021 and on 10-Mar-2021 it was moved from  freezer to refrigerator.   This case was linked to MOD-2021-314646 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 09-Sep-2021: Updated reporter details, Patient information added, dose number added On 09-Sep-2021: Follow-up appended. Patient initials were updated..
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Muscle tightness, Ocular hyperaemia, Pain, Pain in extremity
Clinical narrative: Bloodshot eye; Pain in arm; Pain localised; Shoulder pain; Muscle tension; This spontaneous case was reported by a consumer and describes the occurrence of OCULAR HYPERAEMIA (Bloodshot eye), PAIN IN EXTREMITY (Pain in arm), PAIN (Pain localised), ARTHRALGIA (Shoulder pain) and MUSCLE TIGHTNESS (Muscle tension) in a 38-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 020F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Sep-2021, the patient experienced OCULAR HYPERAEMIA (Bloodshot eye), PAIN IN EXTREMITY (Pain in arm), PAIN (Pain localised), ARTHRALGIA (Shoulder pain) and MUSCLE TIGHTNESS (Muscle tension). At the time of the report, OCULAR HYPERAEMIA (Bloodshot eye), PAIN IN EXTREMITY (Pain in arm), PAIN (Pain localised), ARTHRALGIA (Shoulder pain) and MUSCLE TIGHTNESS (Muscle tension) 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 did not provide any causality assessments.   No concomitant medication was reported.  No treatment medication use was reported.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Body temperature, Chills, Decreased appetite, Diarrhoea
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of PAIN (severe aching), FEELING ABNORMAL (felt generally awful), MOBILITY DECREASED (strictly in bed all day), DIARRHEA (diarrea) and DECREASED APPETITE (no appetite) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 24-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 24-Aug-2021, the patient experienced PAIN (severe aching), FEELING ABNORMAL (felt generally awful), CHILLS (chills) and PYREXIA (woke up with a temperature of 100.5). On 25-Aug-2021, the patient experienced MOBILITY DECREASED (strictly in bed all day). 25-Aug-2021, the patient experienced DIARRHEA (diarrea), DECREASED APPETITE (no appetite), ILLNESS (the sickest I have ever been), FATIGUE (huge fatigue), HEADACHE (headache) and NAUSEA (nausea). On 31-Aug-2021, the patient experienced ASTHENIA (15 to 20 minutes of energy). On an unknown date, the patient experienced PALPITATIONS (heart racing), DIZZINESS (extremely light headed/dizzy) and DIZZINESS POSTURAL (worse with standing). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. On 25-Aug-2021, MOBILITY DECREASED (strictly in bed all day) had resolved. On 26-Aug-2021, PYREXIA (woke up with a temperature of 100.5) had resolved. On 29-Aug-2021, HEADACHE (headache) had resolved. At the time of the report, PAIN (severe aching), FEELING ABNORMAL (felt generally awful), DIARRHEA (diarrea), DECREASED APPETITE (no appetite), ILLNESS (the sickest I have ever been), PALPITATIONS (heart racing), DIZZINESS (extremely light headed/dizzy), DIZZINESS POSTURAL (worse with standing), ASTHENIA (15 to 20 minutes of energy), FATIGUE (huge fatigue), NAUSEA (nausea) and CHILLS (chills) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, SARS-CoV-2 test: negative (Negative) Negative. On 24-Aug-2021, Body temperature: 100.5 (High) 100.5. No relevant concomitant product were reported
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Dizziness postural, Fatigue, Feeling abnormal, Headache
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of PAIN (severe aching), FEELING ABNORMAL (felt generally awful), MOBILITY DECREASED (strictly in bed all day), DIARRHEA (diarrea) and DECREASED APPETITE (no appetite) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 24-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 24-Aug-2021, the patient experienced PAIN (severe aching), FEELING ABNORMAL (felt generally awful), CHILLS (chills) and PYREXIA (woke up with a temperature of 100.5). On 25-Aug-2021, the patient experienced MOBILITY DECREASED (strictly in bed all day). 25-Aug-2021, the patient experienced DIARRHEA (diarrea), DECREASED APPETITE (no appetite), ILLNESS (the sickest I have ever been), FATIGUE (huge fatigue), HEADACHE (headache) and NAUSEA (nausea). On 31-Aug-2021, the patient experienced ASTHENIA (15 to 20 minutes of energy). On an unknown date, the patient experienced PALPITATIONS (heart racing), DIZZINESS (extremely light headed/dizzy) and DIZZINESS POSTURAL (worse with standing). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. On 25-Aug-2021, MOBILITY DECREASED (strictly in bed all day) had resolved. On 26-Aug-2021, PYREXIA (woke up with a temperature of 100.5) had resolved. On 29-Aug-2021, HEADACHE (headache) had resolved. At the time of the report, PAIN (severe aching), FEELING ABNORMAL (felt generally awful), DIARRHEA (diarrea), DECREASED APPETITE (no appetite), ILLNESS (the sickest I have ever been), PALPITATIONS (heart racing), DIZZINESS (extremely light headed/dizzy), DIZZINESS POSTURAL (worse with standing), ASTHENIA (15 to 20 minutes of energy), FATIGUE (huge fatigue), NAUSEA (nausea) and CHILLS (chills) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, SARS-CoV-2 test: negative (Negative) Negative. On 24-Aug-2021, Body temperature: 100.5 (High) 100.5. No relevant concomitant product were reported
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Illness, Mobility decreased, Nausea, Pain, Palpitations
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of PAIN (severe aching), FEELING ABNORMAL (felt generally awful), MOBILITY DECREASED (strictly in bed all day), DIARRHEA (diarrea) and DECREASED APPETITE (no appetite) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 24-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 24-Aug-2021, the patient experienced PAIN (severe aching), FEELING ABNORMAL (felt generally awful), CHILLS (chills) and PYREXIA (woke up with a temperature of 100.5). On 25-Aug-2021, the patient experienced MOBILITY DECREASED (strictly in bed all day). 25-Aug-2021, the patient experienced DIARRHEA (diarrea), DECREASED APPETITE (no appetite), ILLNESS (the sickest I have ever been), FATIGUE (huge fatigue), HEADACHE (headache) and NAUSEA (nausea). On 31-Aug-2021, the patient experienced ASTHENIA (15 to 20 minutes of energy). On an unknown date, the patient experienced PALPITATIONS (heart racing), DIZZINESS (extremely light headed/dizzy) and DIZZINESS POSTURAL (worse with standing). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. On 25-Aug-2021, MOBILITY DECREASED (strictly in bed all day) had resolved. On 26-Aug-2021, PYREXIA (woke up with a temperature of 100.5) had resolved. On 29-Aug-2021, HEADACHE (headache) had resolved. At the time of the report, PAIN (severe aching), FEELING ABNORMAL (felt generally awful), DIARRHEA (diarrea), DECREASED APPETITE (no appetite), ILLNESS (the sickest I have ever been), PALPITATIONS (heart racing), DIZZINESS (extremely light headed/dizzy), DIZZINESS POSTURAL (worse with standing), ASTHENIA (15 to 20 minutes of energy), FATIGUE (huge fatigue), NAUSEA (nausea) and CHILLS (chills) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, SARS-CoV-2 test: negative (Negative) Negative. On 24-Aug-2021, Body temperature: 100.5 (High) 100.5. No relevant concomitant product were reported
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of PAIN (severe aching), FEELING ABNORMAL (felt generally awful), MOBILITY DECREASED (strictly in bed all day), DIARRHEA (diarrea) and DECREASED APPETITE (no appetite) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 24-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 24-Aug-2021, the patient experienced PAIN (severe aching), FEELING ABNORMAL (felt generally awful), CHILLS (chills) and PYREXIA (woke up with a temperature of 100.5). On 25-Aug-2021, the patient experienced MOBILITY DECREASED (strictly in bed all day). 25-Aug-2021, the patient experienced DIARRHEA (diarrea), DECREASED APPETITE (no appetite), ILLNESS (the sickest I have ever been), FATIGUE (huge fatigue), HEADACHE (headache) and NAUSEA (nausea). On 31-Aug-2021, the patient experienced ASTHENIA (15 to 20 minutes of energy). On an unknown date, the patient experienced PALPITATIONS (heart racing), DIZZINESS (extremely light headed/dizzy) and DIZZINESS POSTURAL (worse with standing). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. On 25-Aug-2021, MOBILITY DECREASED (strictly in bed all day) had resolved. On 26-Aug-2021, PYREXIA (woke up with a temperature of 100.5) had resolved. On 29-Aug-2021, HEADACHE (headache) had resolved. At the time of the report, PAIN (severe aching), FEELING ABNORMAL (felt generally awful), DIARRHEA (diarrea), DECREASED APPETITE (no appetite), ILLNESS (the sickest I have ever been), PALPITATIONS (heart racing), DIZZINESS (extremely light headed/dizzy), DIZZINESS POSTURAL (worse with standing), ASTHENIA (15 to 20 minutes of energy), FATIGUE (huge fatigue), NAUSEA (nausea) and CHILLS (chills) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, SARS-CoV-2 test: negative (Negative) Negative. On 24-Aug-2021, Body temperature: 100.5 (High) 100.5. No relevant concomitant product were reported
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Having a really bad headache last night; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Having a really bad headache last night) 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) 1 dosage form. On 02-Sep-2021, the patient experienced HEADACHE (Having a really bad headache last night). The patient was treated with IBUPROFEN on 02-Sep-2021 for Headache, at an unspecified dose and frequency. At the time of the report, HEADACHE (Having a really bad headache last night) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication were provided by the reporter.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Ear infection, Ear pain, Feeling abnormal, Heart rate increased, Tinnitus
Clinical narrative: weird symptoms; right ear started hurting bad/pain has been coming and going; swooshing sound; ended up being my heart rate which I could hear in my head; ear infection; This spontaneous case was reported by an other health care professional and describes the occurrence of FEELING ABNORMAL (weird symptoms), EAR PAIN (right ear started hurting bad/pain has been coming and going), TINNITUS (swooshing sound), HEART RATE INCREASED (ended up being my heart rate which I could hear in my head) and EAR INFECTION (ear infection) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced FEELING ABNORMAL (weird symptoms), EAR PAIN (right ear started hurting bad/pain has been coming and going), TINNITUS (swooshing sound), HEART RATE INCREASED (ended up being my heart rate which I could hear in my head) and EAR INFECTION (ear infection). At the time of the report, FEELING ABNORMAL (weird symptoms), EAR PAIN (right ear started hurting bad/pain has been coming and going), HEART RATE INCREASED (ended up being my heart rate which I could hear in my head) and EAR INFECTION (ear infection) outcome was unknown and TINNITUS (swooshing sound) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The patient experienced some weird symptoms since receiving the vaccine. A couple of days after the first dose her right ear started hurting bad. This was accompanied by a swooshing sound, which ended up being her heart rate which she could hear in her head, tinnitus and was worse with lying down, sitting or stress. The patient was treated for an ear infection with sulfatide or cephalosporin. The patient had vexing and weeing kind of pain. She also has had headaches which have been continuous since then feeling like pressure in her head. She has seen an ENT specialist and neurologist who did MRIs showing no brain tumor or blood flow issues. She saw neuro yesterday who concluded that her symptoms were due to intercranial hypertension. She is now scheduled to get a spinal tap on 14SEP2021.   This case was linked to MOD-2021-307252 (Patient Link).
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Rash pruritic
Clinical narrative: The rash is itchy; Mild rash developed in lower back area about 3x4 inches the size of the palm of hand above the butt crack and rash is bumpy; This spontaneous case was reported by a consumer and describes the occurrence of RASH PRURITIC (The rash is itchy) and RASH (Mild rash developed in lower back area about 3x4 inches the size of the palm of hand above the butt crack and rash is bumpy) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 088D22A) for COVID-19 vaccination.     No Medical History information was reported.   On 29-Aug-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 RASH PRURITIC (The rash is itchy) and RASH (Mild rash developed in lower back area about 3x4 inches the size of the palm of hand above the butt crack and rash is bumpy). At the time of the report, RASH PRURITIC (The rash is itchy) and RASH (Mild rash developed in lower back area about 3x4 inches the size of the palm of hand above the butt crack and rash is bumpy) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   No concomitant medication was given. No treatment medication was given.  It was reported that, patient was scared about getting the Moderna second vaccine.  She did state that her vaccine paperwork from where she went for her vaccine, was documented as the left arm, but said it was given in the right arm.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Bedridden, Diarrhoea, Feeling of body temperature change, Vomiting
Clinical narrative: All day in bed; All night long throwing up and it was coming from the other end too; All night long throwing up and it was coming from the other end too/ Threw up 25 times; Hot and cold; This spontaneous case was reported by a consumer and describes the occurrence of FEELING OF BODY TEMPERATURE CHANGE (Hot and cold), BEDRIDDEN (All day in bed), DIARRHOEA (All night long throwing up and it was coming from the other end too) and VOMITING (All night long throwing up and it was coming from the other end too/ Threw up 25 times) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 048C21A and 026P21A) for COVID-19 vaccination.     No medical history was reported.    On 03-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Aug-2021, the patient experienced FEELING OF BODY TEMPERATURE CHANGE (Hot and cold), DIARRHOEA (All night long throwing up and it was coming from the other end too) and VOMITING (All night long throwing up and it was coming from the other end too/ Threw up 25 times). On 04-Aug-2021, the patient experienced BEDRIDDEN (All day in bed). On 05-Aug-2021, BEDRIDDEN (All day in bed) had resolved. At the time of the report, FEELING OF BODY TEMPERATURE CHANGE (Hot and cold), DIARRHOEA (All night long throwing up and it was coming from the other end too) and VOMITING (All night long throwing up and it was coming from the other end too/ Threw up 25 times) was resolving.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications included cancer, heart medicine and 13 medicines every morning. No treatment drug was reported.  The patient went home after vaccination and felt hot and cold. After supper time, went to bed but that night was all night long throwing up and it was coming from the other end too.   On Thursday patient was also in bed.  On 03-Sep-2021, Friday, the patient was feeling a little bit better.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain, Vaccination site pruritus, Vaccination site swelling, Vaccination site warmth
Clinical narrative: sore arm; itching, swollen and hot to the touch at the injection site; itching, swollen and hot to the touch at the injection site; hot to the touch at the injection site; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE PAIN (sore arm), VACCINATION SITE PRURITUS (itching, swollen and hot to the touch at the injection site), VACCINATION SITE SWELLING (itching, swollen and hot to the touch at the injection site) and VACCINATION SITE WARMTH (hot to the touch at the injection site) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 49E21A) for COVID-19 vaccination.     No Medical History information was reported.   On 01-Sep-2021, the patient 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, the patient experienced VACCINATION SITE PAIN (sore arm), VACCINATION SITE PRURITUS (itching, swollen and hot to the touch at the injection site), VACCINATION SITE SWELLING (itching, swollen and hot to the touch at the injection site) and VACCINATION SITE WARMTH (hot to the touch at the injection site). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL ALLERGY [DIPHENHYDRAMINE HYDROCHLORIDE]) for Itching, at an unspecified dose and frequency and PARACETAMOL (TYLENOL) for Pain, at an unspecified dose and frequency. At the time of the report, VACCINATION SITE PAIN (sore arm), VACCINATION SITE PRURITUS (itching, swollen and hot to the touch at the injection site), VACCINATION SITE SWELLING (itching, swollen and hot to the touch at the injection site) and VACCINATION SITE WARMTH (hot to the touch at the injection site) outcome was unknown.            no concomitant medications are provided. patient used icepack for hot spot.  She stated both shots and only had sore arm with the 2nd shot.   This case was linked to MOD-2021-307222 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: First dose on 10-JUN-2021 and it's now 2-SEP-2021; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (First dose on 10-JUN-2021 and it's now 2-SEP-2021) 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 10-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Jun-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (First dose on 10-JUN-2021 and it's now 2-SEP-2021). On 10-Jun-2021, PRODUCT DOSE OMISSION ISSUE (First dose on 10-JUN-2021 and it's now 2-SEP-2021) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Relevant concomitant medications were not reported.  The treatment information was  not provided.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: COVID-19 positive; This spontaneous case was reported by a consumer and describes the occurrence of SARS-COV-2 TEST POSITIVE (COVID-19 positive) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 020F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Sep-2021, the patient experienced SARS-COV-2 TEST POSITIVE (COVID-19 positive). At the time of the report, SARS-COV-2 TEST POSITIVE (COVID-19 positive) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No patient treatment and concomitant medication were provided. Patient past medication history was not given. On 03-Sep-2021 she found out by rapid test she was COVID-19 positive. She was due for her second shot on 21-Sept-2021.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Heavy menstrual bleeding, Social problem
Clinical narrative: Bleeding/bled for almost a month straight/after that it was off and on; It almost ruined her marriage and broke a lot of her friendships; Turned her into the beast; This spontaneous case was reported by a consumer and describes the occurrence of HEAVY MENSTRUAL BLEEDING (Bleeding/bled for almost a month straight/after that it was off and on), SOCIAL PROBLEM (It almost ruined her marriage and broke a lot of her friendships) and FEELING ABNORMAL (Turned her into the beast) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. FA7484) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Aug-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HEAVY MENSTRUAL BLEEDING (Bleeding/bled for almost a month straight/after that it was off and on) (seriousness criterion hospitalization), SOCIAL PROBLEM (It almost ruined her marriage and broke a lot of her friendships) (seriousness criterion hospitalization) and FEELING ABNORMAL (Turned her into the beast) (seriousness criterion hospitalization). At the time of the report, HEAVY MENSTRUAL BLEEDING (Bleeding/bled for almost a month straight/after that it was off and on), SOCIAL PROBLEM (It almost ruined her marriage and broke a lot of her friendships) and FEELING ABNORMAL (Turned her into the beast) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was withdrawn on an unknown date.       The concomitant medications were not reported. The treatment information was not provided.  The patient reported that after the vaccine and the social circumstances she had been through she was admitted in the psychiatric hospital . She was drugged and was raped at the hospital . The patient also reported that she will not get second dose of moderna vaccine.  Company Comment: Very limited information regarding these events has been provided at this time. Further information has been requested; Sender's Comments: Very limited information regarding these events has been provided at this time. Further information has been requested