chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal, Headache, Inappropriate schedule of product administration, Influenza like illness, Myalgia
Clinical narrative: stronger reaction than after the first one; headache; Achy; felt a little bit like fluish; felt really bad; 1st dose on 06May2021 and 2nd dose on 17Jun2021; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (felt a little bit like fluish), FEELING ABNORMAL (felt really bad ), VACCINATION COMPLICATION (stronger reaction than after the first one), HEADACHE (headache) and MYALGIA (Achy) in a 35-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 054L21A and 038A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 06-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Jun-2021, the patient experienced FEELING ABNORMAL (felt really bad ) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose on 06May2021 and 2nd dose on 17Jun2021). On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (felt a little bit like fluish), VACCINATION COMPLICATION (stronger reaction than after the first one), HEADACHE (headache) and MYALGIA (Achy). On 17-Jun-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose on 06May2021 and 2nd dose on 17Jun2021) had resolved. At the time of the report, INFLUENZA LIKE ILLNESS (felt a little bit like fluish), FEELING ABNORMAL (felt really bad ), VACCINATION COMPLICATION (stronger reaction than after the first one), HEADACHE (headache) and MYALGIA (Achy) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not reported. Treatment information was not reported.  Patient had felt really bad the first night, they were achy and had headache and a stronger reaction than after the first one, but lasted less than 2 days.   This case was linked to MOD-2021-339360 (Patient Link).
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: stronger reaction than after the first one; headache; Achy; felt a little bit like fluish; felt really bad; 1st dose on 06May2021 and 2nd dose on 17Jun2021; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (felt a little bit like fluish), FEELING ABNORMAL (felt really bad ), VACCINATION COMPLICATION (stronger reaction than after the first one), HEADACHE (headache) and MYALGIA (Achy) in a 35-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 054L21A and 038A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 06-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Jun-2021, the patient experienced FEELING ABNORMAL (felt really bad ) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose on 06May2021 and 2nd dose on 17Jun2021). On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (felt a little bit like fluish), VACCINATION COMPLICATION (stronger reaction than after the first one), HEADACHE (headache) and MYALGIA (Achy). On 17-Jun-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose on 06May2021 and 2nd dose on 17Jun2021) had resolved. At the time of the report, INFLUENZA LIKE ILLNESS (felt a little bit like fluish), FEELING ABNORMAL (felt really bad ), VACCINATION COMPLICATION (stronger reaction than after the first one), HEADACHE (headache) and MYALGIA (Achy) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not reported. Treatment information was not reported.  Patient had felt really bad the first night, they were achy and had headache and a stronger reaction than after the first one, but lasted less than 2 days.   This case was linked to MOD-2021-339360 (Patient Link).
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Illness
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of illness (sick) and asthenia (no energy/laid in bed/could not get out of bed) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch/lot# 024M20A and 041L20A) for COVID-19 immunization. Concurrent medical conditions included immunocompromised. On Jan 22, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Feb 17, 2021, patient received the second dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Feb 17, 2021, patient experienced illness (sick) and asthenia (no energy/laid in bed/could not get out of bed). On Feb 18, 2021, illness (sick) and asthenia (no energy/laid in bed/could not get out of bed) resolved. No concomitant medication or treatment information provided.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Systemic lupus erythematosus
Clinical narrative: Diagnosed with Lupus in August; This spontaneous case was reported by a consumer and describes the occurrence of SYSTEMIC LUPUS ERYTHEMATOSUS (Diagnosed with Lupus in August) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031B21A and 003B21A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension and Hypothyroidism. Concomitant products included AMLODIPINE BESILATE (AMLODIPINE [AMLODIPINE BESILATE]) for Hypertension, LEVOTHYROXINE SODIUM (LEVOTHYROXINE [LEVOTHYROXINE SODIUM]) for Thyroid function abnormal, ATORVASTATIN CALCIUM (ATORVASTATIN [ATORVASTATIN CALCIUM]) for an unknown indication.   On 21-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In August 2021, the patient experienced SYSTEMIC LUPUS ERYTHEMATOSUS (Diagnosed with Lupus in August) (seriousness criterion medically significant). The patient was treated with HYDROXYCHLOROQUINE SULFATE (HYDROXYCHLOROQUINE [HYDROXYCHLOROQUINE SULFATE]) for Lupus erythematosus, at a dose of 200 milligram 1 tab twice a day. At the time of the report, SYSTEMIC LUPUS ERYTHEMATOSUS (Diagnosed with Lupus in August) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Company Comment: This case concerns a 60-year-old, male with a history of hypothyroidism and hypertension, who experienced the unexpected serious (medically significant) event of Lupus erythematosus. The event occurred approximately 4 months after the second dose of mRNA-1273 Moderna vaccine (Spikevax). The rechallenge was not applicable since the event hasn´t resolved.  The events were considered related to the study drug per the reporter's assessment. The benefit-risk relationship of mRNA-1273 Moderna vaccine in not affected by this report   This case was linked to MOD-2021-339211 (Patient Link).; Sender's Comments: This case concerns a 60-year-old, male with a history of hypothyroidism and hypertension, who experienced the unexpected serious (medically significant) event of Lupus erythematosus. The event occurred approximately 4 months after the second dose of mRNA-1273 Moderna vaccine (Spikevax). The rechallenge was not applicable since the event hasn´t resolved.  The events were considered related to the study drug per the reporter's assessment. The benefit-risk relationship of mRNA-1273 Moderna vaccine in not affected by this report
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Low density lipoprotein increased
Clinical narrative: LDL-P was 1219 and her regular cholesterol was 202; This spontaneous case was reported by a consumer and describes the occurrence of LOW DENSITY LIPOPROTEIN INCREASED (LDL-P was 1219 and her regular cholesterol was 202) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 015M20A and 013L20A) for COVID-19 vaccination.     Concurrent medical conditions included Hypercholesteraemia since 22-Oct-2020. Concomitant products included EVOLOCUMAB (REPATHA) from September 2020 to an unknown date for Hypercholesterolemia.   On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Sep-2021, the patient experienced LOW DENSITY LIPOPROTEIN INCREASED (LDL-P was 1219 and her regular cholesterol was 202). At the time of the report, LOW DENSITY LIPOPROTEIN INCREASED (LDL-P was 1219 and her regular cholesterol was 202) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 22-Oct-2020, Blood cholesterol: 171 (normal) 171. On 22-Oct-2020, Low density lipoprotein: 528 (abnormal) LDL P was 528. On 28-Sep-2021, Blood cholesterol: 202 (High) 202. On 28-Sep-2021, Low density lipoprotein: 1219 (High) LDL P was 1219.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient states that she started the medication,repatha in September of 2020  and her numbers were good, she had both doses of the vaccine early this year, had her numbers checked again, and they were  way up again.Her NMR lipoprofile blood test on 22 Oct 2020 and her LDL P was 528 and her regular cholesterol was 171. She had another NMR test on 28 Sep 2021 and her LDL P was 1219 and her regular cholesterol was 202.  Treatment information was not provided.
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Interchange of vaccine products
Clinical narrative: First dose Moderna, second dose Pfizer; This spontaneous case was reported by a pharmacist and describes the occurrence of INTERCHANGE OF VACCINE PRODUCTS (First dose Moderna, second dose Pfizer) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 053E21A) for COVID-19 vaccination.    Co-suspect product included non-company product TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for COVID-19 vaccination.    No Medical History information was reported.   On 24-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Sep-2021, the patient received second dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1 dosage form. On 30-Sep-2021, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (First dose Moderna, second dose Pfizer). On 30-Sep-2021, INTERCHANGE OF VACCINE PRODUCTS (First dose Moderna, second dose Pfizer) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment and concomitant medications were provided.
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Inappropriate schedule of product administration
Clinical narrative: After the booster, she only had funkiness for one day; Booster dose was after 7 months of her first vaccination; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (After the booster, she only had funkiness for one day) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Booster dose was after 7 months of her first vaccination) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high.   In September 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In September 2021, the patient experienced FEELING ABNORMAL (After the booster, she only had funkiness for one day) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Booster dose was after 7 months of her first vaccination). In September 2021, FEELING ABNORMAL (After the booster, she only had funkiness for one day) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Booster dose was after 7 months of her first vaccination) had resolved.            No relevant concomitant medications were reported.  No treatment information was provided.  Patient got the booster dose after 7 months past her first vaccination.   This case was linked to MOD-2021-339239 (Patient Link).
Age: 21.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: sore right injection site arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (sore right injection site arm) in a 21-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025A21A) for COVID-19 vaccination.     Concurrent medical conditions included Arthritis and Immunocompromised. Concomitant products included METHOTREXATE for an unknown indication.    On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Mar-2021, the patient experienced VACCINATION SITE PAIN (sore right injection site arm). At the time of the report, VACCINATION SITE PAIN (sore right injection site arm) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Treatment information was not reported. Patient received his flu shot at the same time he received his 3rd dose of Moderna vaccine.   This case was linked to MOD-2021-339391, MOD-2021-339390 (Patient Link).
Age: 23.0
Sex: M
Vaccine: COVID19
Symptoms: Seizure
Clinical narrative: Seizure for 1-2minutes; This spontaneous case was reported by a pharmacist and describes the occurrence of SEIZURE (Seizure for 1-2minutes) in a 23-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039D21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Oct-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced SEIZURE (Seizure for 1-2minutes) (seriousness criterion medically significant). On 03-Oct-2021, SEIZURE (Seizure for 1-2minutes) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication details were reported.  The patient had experienced seizure 5 minutes after he got his first dose of the Moderna covid19 vaccine. The patient does not have any known allergies or any history of seizure. The seizure lasted for 1 to 2 minutes.  No treatment medication details was reported.  Company Comment: This case concerns a 23 year-old, male subject whose medical history was not provided, who experienced the serious unexpected event of Seizure. The event occurred approximately 5 minutes after the first dose of mRNA-1273. The rechallenge is unknow, as the events happened immediately after the first dose of mRNA-1273 and since no information from the second dose is provided. The benefit-risk relationship of drug x in not affected by this report.; Sender's Comments: This case concerns a 23 year-old, male subject whose medical history was not provided, who experienced the serious unexpected event of Seizure. The event occurred approximately 5 minutes after the first dose of mRNA-1273. The rechallenge is unknow, as the events happened immediately after the first dose of mRNA-1273 and since no information from the second dose is provided. The benefit-risk relationship of drug x in not affected by this report.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Dyspnoea, Headache, Nausea, Pyrexia
Clinical narrative: Shortness of breath; Headache; Diarrhea; Fever; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea), DYSPNOEA (Shortness of breath), PYREXIA (Fever), NAUSEA (Nausea) and HEADACHE (Headache) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Sep-2021, the patient experienced DIARRHOEA (Diarrhea), PYREXIA (Fever) and NAUSEA (Nausea). On 30-Sep-2021, the patient experienced DYSPNOEA (Shortness of breath) and HEADACHE (Headache). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, DIARRHOEA (Diarrhea), DYSPNOEA (Shortness of breath), PYREXIA (Fever), NAUSEA (Nausea) and HEADACHE (Headache) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) Negative.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided.   Most recent FOLLOW-UP information incorporated above includes: On 01-Oct-2021: The followup contains No new information
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: Shortness of breath; Headache; Diarrhea; Fever; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea), DYSPNOEA (Shortness of breath), PYREXIA (Fever), NAUSEA (Nausea) and HEADACHE (Headache) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Sep-2021, the patient experienced DIARRHOEA (Diarrhea), PYREXIA (Fever) and NAUSEA (Nausea). On 30-Sep-2021, the patient experienced DYSPNOEA (Shortness of breath) and HEADACHE (Headache). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, DIARRHOEA (Diarrhea), DYSPNOEA (Shortness of breath), PYREXIA (Fever), NAUSEA (Nausea) and HEADACHE (Headache) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) Negative.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided.   Most recent FOLLOW-UP information incorporated above includes: On 01-Oct-2021: The followup contains No new information
Age: 21.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache
Clinical narrative: felt fatigued; Dull headache; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (felt fatigued) and HEADACHE (Dull headache) in a 21-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003B21A and 025A21A) for COVID-19 vaccination.     Concurrent medical conditions included Arthritis and Immunocompromised.  Concomitant products included METHOTREXATE for an unknown indication.   On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Mar-2021, the patient experienced FATIGUE (felt fatigued) and HEADACHE (Dull headache). On 30-Mar-2021, FATIGUE (felt fatigued) and HEADACHE (Dull headache) had resolved.      The patient felt fatigued with a dull headache which lasted about 24 hours after the second dose of vaccination.  No treatment medication was provided.   This case was linked to MOD-2021-339391, MOD-2021-339370 (Patient Link).
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Urticaria
Clinical narrative: hives that come and go; started to have hives that is itchy; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (hives that come and go) and PRURITUS (started to have hives that is itchy) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 076C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Sep-2021, the patient experienced URTICARIA (hives that come and go) and PRURITUS (started to have hives that is itchy). At the time of the report, URTICARIA (hives that come and go) and PRURITUS (started to have hives that is itchy) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  No treatment information was provided.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Insomnia, Pain in extremity, Vaccination site movement impairment
Clinical narrative: cannot sleep on my right arm; losing range of motion in my right arm/ having trouble raising my right arm / have trouble stretching my right arm/ I cannot sleep on my right arm/ I cannot move my right arm straight out; pain in her right arm / right arm remains painful sometimes hurts down to my finger tips; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (cannot sleep on my right arm), VACCINATION SITE MOVEMENT IMPAIRMENT (losing range of motion in my right arm/ having trouble raising my right arm / have trouble stretching my right arm/ I cannot sleep on my right arm/ I cannot move my right arm straight out) and PAIN IN EXTREMITY (pain in her right arm / right arm remains painful sometimes hurts down to my finger tips) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced INSOMNIA (cannot sleep on my right arm), VACCINATION SITE MOVEMENT IMPAIRMENT (losing range of motion in my right arm/ having trouble raising my right arm / have trouble stretching my right arm/ I cannot sleep on my right arm/ I cannot move my right arm straight out) and PAIN IN EXTREMITY (pain in her right arm / right arm remains painful sometimes hurts down to my finger tips). At the time of the report, INSOMNIA (cannot sleep on my right arm), VACCINATION SITE MOVEMENT IMPAIRMENT (losing range of motion in my right arm/ having trouble raising my right arm / have trouble stretching my right arm/ I cannot sleep on my right arm/ I cannot move my right arm straight out) and PAIN IN EXTREMITY (pain in her right arm / right arm remains painful sometimes hurts down to my finger tips) had not resolved.            No concomitant medication was reported.  No treatment medication was reported.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Hypersensitivity, Pruritus, Rash erythematous, Urticaria
Clinical narrative: red bumps that itched and felt like they were burning; red bumps that itched and felt like they were burning; red bumps that itched and felt like they were burning; hives; allergic reaction spread throughout the torso, neck, behind the ears and down the arms; This spontaneous case was reported by a consumer and describes the occurrence of RASH ERYTHEMATOUS (red bumps that itched and felt like they were burning), PRURITUS (red bumps that itched and felt like they were burning), BURNING SENSATION (red bumps that itched and felt like they were burning), URTICARIA (hives) and HYPERSENSITIVITY (allergic reaction spread throughout the torso, neck, behind the ears and down the arms) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939902) for COVID-19 vaccination.     Concurrent medical conditions included Nail infection and Sleep problem. Concomitant products included HYDROCHLOROTHIAZIDE for Blood pressure management, TERBINAFINE for Nail infection, GABAPENTIN for Sleep problem, ETANERCEPT (ENBREL) for an unknown indication.   On 29-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 30-Sep-2021, the patient experienced RASH ERYTHEMATOUS (red bumps that itched and felt like they were burning), PRURITUS (red bumps that itched and felt like they were burning), BURNING SENSATION (red bumps that itched and felt like they were burning), URTICARIA (hives) and HYPERSENSITIVITY (allergic reaction spread throughout the torso, neck, behind the ears and down the arms). The patient was treated with PREDNISONE for Hives, at an unspecified dose and frequency. At the time of the report, RASH ERYTHEMATOUS (red bumps that itched and felt like they were burning), PRURITUS (red bumps that itched and felt like they were burning), BURNING SENSATION (red bumps that itched and felt like they were burning), URTICARIA (hives) and HYPERSENSITIVITY (allergic reaction spread throughout the torso, neck, behind the ears and down the arms) had not resolved.            Patient started getting red bumps that itched and felt like they were burning. This allergic reaction spread throughout the torso, neck, behind the ears and down the arms. Those symptoms are ongoing.
Sex: U
Vaccine: COVID19
Symptoms: Influenza
Clinical narrative: Flu; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA (Flu) 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 INFLUENZA (Flu). At the time of the report, INFLUENZA (Flu) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant and Treatment was not specified.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Feeling hot, Induration, Pain in extremity, Vaccination complication
Clinical narrative: side effects; 1 inch by 1 inch area of redness/one can visibly see the area of redness; That area was also hard/the tissue in that area feels hard; hot to the touch/the tissue in that area feels hot; pain in the whole arm; This spontaneous case was reported by a nurse and describes the occurrence of VACCINATION COMPLICATION (side effects), ERYTHEMA (1 inch by 1 inch area of redness/one can visibly see the area of redness), INDURATION (That area was also hard/the tissue in that area feels hard), FEELING HOT (hot to the touch/the tissue in that area feels hot) and PAIN IN EXTREMITY (pain in the whole arm) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048C21A) for COVID-19 vaccination.     Concurrent medical conditions included Psoriasis and Psoriatic arthritis. Concomitant products included APREMILAST (OTEZLA) for Psoriasis and Psoriatic arthritis.    On 30-Sep-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Sep-2021, the patient experienced PAIN IN EXTREMITY (pain in the whole arm). On 01-Oct-2021, the patient experienced ERYTHEMA (1 inch by 1 inch area of redness/one can visibly see the area of redness). 01-Oct-2021, the patient experienced INDURATION (That area was also hard/the tissue in that area feels hard) and FEELING HOT (hot to the touch/the tissue in that area feels hot). On an unknown date, the patient experienced VACCINATION COMPLICATION (side effects). At the time of the report, VACCINATION COMPLICATION (side effects), INDURATION (That area was also hard/the tissue in that area feels hard), FEELING HOT (hot to the touch/the tissue in that area feels hot) and PAIN IN EXTREMITY (pain in the whole arm) outcome was unknown and ERYTHEMA (1 inch by 1 inch area of redness/one can visibly see the area of redness) was resolving.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The 1 inch by 1 inch area of redness, was not exactly at the injection site but adjacent to it. The redness was still there but fading now.  No treatment information was provided by the reporter.   This case was linked to MOD-2021-340988 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 04-Oct-2021: Additional events, concomitant medication and medical history were added. Dosing details, reporter details and patient details were updated.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Feeling abnormal, Myalgia, Pyrexia
Clinical narrative: Foggy vision after 3rd dose/Vision has change after 3rd dose; Feeling crappy after 3rd dose; Body aches after 3rd dose; Chills after 3rd dose; Fever 102F after 3rd dose,Fever keeps coming back; This spontaneous case was reported by a consumer and describes the occurrence of VISION BLURRED (Foggy vision after 3rd dose/Vision has change after 3rd dose), FEELING ABNORMAL (Feeling crappy after 3rd dose), MYALGIA (Body aches after 3rd dose), CHILLS (Chills after 3rd dose) and PYREXIA (Fever 102F after 3rd dose,Fever keeps coming back) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In June 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Oct-2021, the patient experienced FEELING ABNORMAL (Feeling crappy after 3rd dose), MYALGIA (Body aches after 3rd dose), CHILLS (Chills after 3rd dose) and PYREXIA (Fever 102F after 3rd dose,Fever keeps coming back). On 04-Oct-2021, the patient experienced VISION BLURRED (Foggy vision after 3rd dose/Vision has change after 3rd dose). The patient was treated with IBUPROFEN for Adverse event, at an unspecified dose and frequency. At the time of the report, VISION BLURRED (Foggy vision after 3rd dose/Vision has change after 3rd dose) had not resolved and FEELING ABNORMAL (Feeling crappy after 3rd dose), MYALGIA (Body aches after 3rd dose), CHILLS (Chills after 3rd dose) and PYREXIA (Fever 102F after 3rd dose,Fever keeps coming back) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-Oct-2021, Body temperature: 102 (High) Fever 102F.         No concomitant medications were provided.   This case was linked to MOD-2021-339821 (Patient Link).
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Vision blurred
Clinical narrative: Foggy vision after 3rd dose/Vision has change after 3rd dose; Feeling crappy after 3rd dose; Body aches after 3rd dose; Chills after 3rd dose; Fever 102F after 3rd dose,Fever keeps coming back; This spontaneous case was reported by a consumer and describes the occurrence of VISION BLURRED (Foggy vision after 3rd dose/Vision has change after 3rd dose), FEELING ABNORMAL (Feeling crappy after 3rd dose), MYALGIA (Body aches after 3rd dose), CHILLS (Chills after 3rd dose) and PYREXIA (Fever 102F after 3rd dose,Fever keeps coming back) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In June 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Oct-2021, the patient experienced FEELING ABNORMAL (Feeling crappy after 3rd dose), MYALGIA (Body aches after 3rd dose), CHILLS (Chills after 3rd dose) and PYREXIA (Fever 102F after 3rd dose,Fever keeps coming back). On 04-Oct-2021, the patient experienced VISION BLURRED (Foggy vision after 3rd dose/Vision has change after 3rd dose). The patient was treated with IBUPROFEN for Adverse event, at an unspecified dose and frequency. At the time of the report, VISION BLURRED (Foggy vision after 3rd dose/Vision has change after 3rd dose) had not resolved and FEELING ABNORMAL (Feeling crappy after 3rd dose), MYALGIA (Body aches after 3rd dose), CHILLS (Chills after 3rd dose) and PYREXIA (Fever 102F after 3rd dose,Fever keeps coming back) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-Oct-2021, Body temperature: 102 (High) Fever 102F.         No concomitant medications were provided.   This case was linked to MOD-2021-339821 (Patient Link).
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Chills, Cough, Drug ineffective, Dyspnoea
Clinical narrative: flu-like symptoms; cough; difficulty breathing; Hot; Chills; COVID-19; lack of drug effect; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (flu-like symptoms), COUGH (cough), DYSPNOEA (difficulty breathing), FEELING HOT (Hot) and DRUG INEFFECTIVE (lack of drug effect) in a 27-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.   In April 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In May 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Sep-2021, the patient experienced DRUG INEFFECTIVE (lack of drug effect) and COVID-19 (COVID-19). On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (flu-like symptoms), COUGH (cough), DYSPNOEA (difficulty breathing), FEELING HOT (Hot) and CHILLS (Chills). The patient was treated with AMOXICILLIN for COVID-19, at a dose of 500 mg twice a day. At the time of the report, INFLUENZA LIKE ILLNESS (flu-like symptoms), COUGH (cough), DYSPNOEA (difficulty breathing), FEELING HOT (Hot), CHILLS (Chills) and COVID-19 (COVID-19) was resolving and DRUG INEFFECTIVE (lack of drug effect) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   It was reported that second was taken 30 days after the first dose. No concomitant medication information were reported.; Sender's Comments: This case concerns a 77 year old male with no reported history who experienced the non-serious unlisted events of Flu like illness and COVID-19 and the Drug ineffective. The patient reports having dose 1 and dose 2 thirty days apart and the events occurred greater than 15 days after the second dose of mRNA-1273. Re-challenge is not applicable as this was the second dose and unknown for the first dose as no information is reported. Benefit-risk of mRNA-1273 is not affected by this report.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Feeling hot, Influenza like illness
Clinical narrative: flu-like symptoms; cough; difficulty breathing; Hot; Chills; COVID-19; lack of drug effect; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (flu-like symptoms), COUGH (cough), DYSPNOEA (difficulty breathing), FEELING HOT (Hot) and DRUG INEFFECTIVE (lack of drug effect) in a 27-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.   In April 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In May 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Sep-2021, the patient experienced DRUG INEFFECTIVE (lack of drug effect) and COVID-19 (COVID-19). On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (flu-like symptoms), COUGH (cough), DYSPNOEA (difficulty breathing), FEELING HOT (Hot) and CHILLS (Chills). The patient was treated with AMOXICILLIN for COVID-19, at a dose of 500 mg twice a day. At the time of the report, INFLUENZA LIKE ILLNESS (flu-like symptoms), COUGH (cough), DYSPNOEA (difficulty breathing), FEELING HOT (Hot), CHILLS (Chills) and COVID-19 (COVID-19) was resolving and DRUG INEFFECTIVE (lack of drug effect) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   It was reported that second was taken 30 days after the first dose. No concomitant medication information were reported.; Sender's Comments: This case concerns a 77 year old male with no reported history who experienced the non-serious unlisted events of Flu like illness and COVID-19 and the Drug ineffective. The patient reports having dose 1 and dose 2 thirty days apart and the events occurred greater than 15 days after the second dose of mRNA-1273. Re-challenge is not applicable as this was the second dose and unknown for the first dose as no information is reported. Benefit-risk of mRNA-1273 is not affected by this report.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: dizzy; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizzy) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003c21a and 003c21a) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included IRON, VITAMINS NOS (MULTIVIT [VITAMINS NOS]) and CYANOCOBALAMIN (B12 [CYANOCOBALAMIN]) for an unknown indication.   On 01-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Sep-2021, the patient experienced DIZZINESS (dizzy). The patient was treated with IBUPROFEN (ADVIL 12 HOUR) for Adverse event, at an unspecified dose and frequency. At the time of the report, DIZZINESS (dizzy) had not resolved.            On the 30th Sep patient started to feel dizzy and now she continues to feel dizzy but "not the same as before.
Sex: M
Vaccine: DTPPVHBHPB
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: A 16 year old patient received a VAXELIS vaccination in the office on 08SEP2021; This non-serious spontaneous safety report was received by a partner on 15-SEP-2021 and forwarded to Agency on 16-SEP-2021 from a nurse.  The causal relationship between Vaxelis and the reported event: A 16-year-old patient received a VAXELIS vaccination in the office on 08-SEP-2021 is assessed as not applicable due to the nature of the event.  No further information is expected
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Chest discomfort, Feeling abnormal, Gait inability, Gout, Insomnia
Clinical narrative: Severe foot pain; could not walk; pain even upon laying down.Excruciating; Could not sleep; Brain fog; Tightness in chest; Went to podiatrist , diagnosed me with acute gout; This is a spontaneous report from a contactable consumer (patient). A 43-years-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE Batch/Lot Number and expiration date were not reported) via an unspecified route of administration in the Left arm on 10Jul2021 15:30 (at the age of 43-years-old) at single dose for covid-19 immunisation. The patient medical history included tendon pain in legs, Back discs bulging and small arthritis in back, had tendonitis in foot once, all form an unspecified date. The patient concomitant medication was reported as none. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient had no list of any other medications received within 2 weeks of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination. The patient experienced severe foot pain 6 hours after vaccine on 10Jul2021 21:30; on 10Jul2021 could not walk, pain even upon laying down. Excruciating. Could not sleep. Advil did not take it away. Brain fog. Tightness in chest. Went to the ER, tests came back fine. Went to podiatrist, diagnosed me with acute gout. Never had gout before. Have a history with tendon pain in my legs. The patient had not been tested for COVID-19 since the vaccination. AE resulted in Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. Gout medication was received for the events and the outcome of the events was Not Recovered.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Investigation, Pain, Pain in extremity
Clinical narrative: Severe foot pain; could not walk; pain even upon laying down.Excruciating; Could not sleep; Brain fog; Tightness in chest; Went to podiatrist , diagnosed me with acute gout; This is a spontaneous report from a contactable consumer (patient). A 43-years-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE Batch/Lot Number and expiration date were not reported) via an unspecified route of administration in the Left arm on 10Jul2021 15:30 (at the age of 43-years-old) at single dose for covid-19 immunisation. The patient medical history included tendon pain in legs, Back discs bulging and small arthritis in back, had tendonitis in foot once, all form an unspecified date. The patient concomitant medication was reported as none. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient had no list of any other medications received within 2 weeks of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination. The patient experienced severe foot pain 6 hours after vaccine on 10Jul2021 21:30; on 10Jul2021 could not walk, pain even upon laying down. Excruciating. Could not sleep. Advil did not take it away. Brain fog. Tightness in chest. Went to the ER, tests came back fine. Went to podiatrist, diagnosed me with acute gout. Never had gout before. Have a history with tendon pain in my legs. The patient had not been tested for COVID-19 since the vaccination. AE resulted in Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. Gout medication was received for the events and the outcome of the events was Not Recovered.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 32.0
Sex: U
Vaccine: COVID19
Symptoms: Burning sensation, Diarrhoea, Vaccination site vesicles
Clinical narrative: Some diarrhea; Blister at injection site; slight burning sensation; This is a spontaneous report from a contactable consumer (patient). A 32-years-old patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE Batch/Lot Number and expiration date were not reported) via an unspecified route of administration in the Left arm on 15Jul2021 11:00 AM (at the age of 32-years-old) at single dose for covid-19 immunisation. The patient medical history included allergy to Amoxycillin, covid-19, both from an unspecified date. The patient was diagnosed with COVID-19 prior to vaccination. The patient concomitant medication was reported as none. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient had no list of any other medications received within 2 weeks of vaccination. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE Batch/Lot Number and expiration date were not reported) via an unspecified route of administration in the Left arm on 24Jun2021 12:00 AM (at the age of 32-years-old) at single dose for covid-19 immunisation. On 16Jul2021 03:00 AM, the patient experienced Blister at injection site, slight burning sensation still as of 7/18 (18Jul2021), some diarrhea, unsure if related. No treatment was received for the events. The patient had not been tested for COVID-19 since the vaccination. The outcome of the events was not recovered.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Headache, Lethargy
Clinical narrative: pain behind my left knee in the bend; severe headache; lethargy; This is a spontaneous report from a contactable consumer (patient). This consumer reported similar events for two doses. This is the second of two reports for second dose. A 33-years-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE Batch/Lot Number and expiration date were not reported) via an unspecified route of administration in the Left arm on 16Jul2021 14:30 (at the age of 33-years-old) at single dose for covid-19 immunisation. The patient was not pregnant. The patient was not pregnant at time of vaccination. The patient medical history included Anemia from an unspecified date. The patient had no known allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient had no list of any other medications received within 2 weeks of vaccination. The patient concomitant medication was reported as none. The patient was not diagnosed with COVID-19 prior to vaccination. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE Batch/Lot Number and expiration date were not reported) via an unspecified route of administration in the Left arm on 25Jun2021 (at the age of 33-years-old) at single dose for covid-19 immunisation and experienced pain behind left knee in the bend on 26Jun2021. The patient experienced after second dose, metal sticks to the patient's injection site she was not too worried about it. Just reporting what she observed. Both post injections she had pain behind her left knee in the bend. After second dose she had severe headache and lethargy. No treatment was received for the events. The patient had not been tested for COVID-19 since the vaccination. The outcome of the events was not recovered.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202100909585 same patient, different dose vaccine and similar event.