chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 32.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Acne cystic, Biopsy, Biopsy skin, Ear disorder, Echocardiogram
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 32-year-old male patient received BNT162b2 (BNT162B2), on 29Apr2021 as dose 1, single (Lot number: EW0171) at the age of 32 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MALAISE (non-serious) with onset 2021, outcome "unknown", described as "did not feel well."; FATIGUE (non-serious) with onset 2021, outcome "unknown"; FEELING ABNORMAL (non-serious) with onset 2021, outcome "unknown", described as "felt like something was wrong"; HEADACHE (non-serious) with onset 2021, outcome "unknown"; PALPITATIONS (non-serious) with onset 2021, outcome "unknown", described as "heart palpitations"; WEIGHT DECREASED (non-serious) with onset 2021, outcome "unknown", described as "his weight used to be 160 pounds and now is 134 pounds/ weight loss occurred after the vaccine". Relevant laboratory tests and procedures are available in the appropriate section. Additional information: It was reported that everything started with heart palpitations, fatigue and headache; kept telling everyone that right after he got the vaccine he felt like something was wrong and made sure he was eating and sleeping enough and did not feel well, was so fatigued and it did not make sense but got a headache at the same time every afternoon and it was uncanny. Height was 5'10'' or 5'11'' and his weight used to be 160 pounds and was then 134 pounds and he was always a solid 160 pounds and the weight loss occurred after the vaccine.
Age: 32.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Electrocardiogram abnormal, Eye oedema, Eye swelling, Face oedema, Fatigue
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 32-year-old male patient received BNT162b2 (BNT162B2), on 29Apr2021 as dose 1, single (Lot number: EW0171) at the age of 32 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MALAISE (non-serious) with onset 2021, outcome "unknown", described as "did not feel well."; FATIGUE (non-serious) with onset 2021, outcome "unknown"; FEELING ABNORMAL (non-serious) with onset 2021, outcome "unknown", described as "felt like something was wrong"; HEADACHE (non-serious) with onset 2021, outcome "unknown"; PALPITATIONS (non-serious) with onset 2021, outcome "unknown", described as "heart palpitations"; WEIGHT DECREASED (non-serious) with onset 2021, outcome "unknown", described as "his weight used to be 160 pounds and now is 134 pounds/ weight loss occurred after the vaccine". Relevant laboratory tests and procedures are available in the appropriate section. Additional information: It was reported that everything started with heart palpitations, fatigue and headache; kept telling everyone that right after he got the vaccine he felt like something was wrong and made sure he was eating and sleeping enough and did not feel well, was so fatigued and it did not make sense but got a headache at the same time every afternoon and it was uncanny. Height was 5'10'' or 5'11'' and his weight used to be 160 pounds and was then 134 pounds and he was always a solid 160 pounds and the weight loss occurred after the vaccine.
Age: 32.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Fear, General physical health deterioration, Headache, Inflammation, Laboratory test
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 32-year-old male patient received BNT162b2 (BNT162B2), on 29Apr2021 as dose 1, single (Lot number: EW0171) at the age of 32 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MALAISE (non-serious) with onset 2021, outcome "unknown", described as "did not feel well."; FATIGUE (non-serious) with onset 2021, outcome "unknown"; FEELING ABNORMAL (non-serious) with onset 2021, outcome "unknown", described as "felt like something was wrong"; HEADACHE (non-serious) with onset 2021, outcome "unknown"; PALPITATIONS (non-serious) with onset 2021, outcome "unknown", described as "heart palpitations"; WEIGHT DECREASED (non-serious) with onset 2021, outcome "unknown", described as "his weight used to be 160 pounds and now is 134 pounds/ weight loss occurred after the vaccine". Relevant laboratory tests and procedures are available in the appropriate section. Additional information: It was reported that everything started with heart palpitations, fatigue and headache; kept telling everyone that right after he got the vaccine he felt like something was wrong and made sure he was eating and sleeping enough and did not feel well, was so fatigued and it did not make sense but got a headache at the same time every afternoon and it was uncanny. Height was 5'10'' or 5'11'' and his weight used to be 160 pounds and was then 134 pounds and he was always a solid 160 pounds and the weight loss occurred after the vaccine.
Age: 32.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Middle ear effusion, Oedema, Oedema mouth, Pain, Palpitations
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 32-year-old male patient received BNT162b2 (BNT162B2), on 29Apr2021 as dose 1, single (Lot number: EW0171) at the age of 32 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MALAISE (non-serious) with onset 2021, outcome "unknown", described as "did not feel well."; FATIGUE (non-serious) with onset 2021, outcome "unknown"; FEELING ABNORMAL (non-serious) with onset 2021, outcome "unknown", described as "felt like something was wrong"; HEADACHE (non-serious) with onset 2021, outcome "unknown"; PALPITATIONS (non-serious) with onset 2021, outcome "unknown", described as "heart palpitations"; WEIGHT DECREASED (non-serious) with onset 2021, outcome "unknown", described as "his weight used to be 160 pounds and now is 134 pounds/ weight loss occurred after the vaccine". Relevant laboratory tests and procedures are available in the appropriate section. Additional information: It was reported that everything started with heart palpitations, fatigue and headache; kept telling everyone that right after he got the vaccine he felt like something was wrong and made sure he was eating and sleeping enough and did not feel well, was so fatigued and it did not make sense but got a headache at the same time every afternoon and it was uncanny. Height was 5'10'' or 5'11'' and his weight used to be 160 pounds and was then 134 pounds and he was always a solid 160 pounds and the weight loss occurred after the vaccine.
Age: 32.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Rash, Staphylococcal infection, Stomatitis, Thrombosis, Weight decreased
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 32-year-old male patient received BNT162b2 (BNT162B2), on 29Apr2021 as dose 1, single (Lot number: EW0171) at the age of 32 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MALAISE (non-serious) with onset 2021, outcome "unknown", described as "did not feel well."; FATIGUE (non-serious) with onset 2021, outcome "unknown"; FEELING ABNORMAL (non-serious) with onset 2021, outcome "unknown", described as "felt like something was wrong"; HEADACHE (non-serious) with onset 2021, outcome "unknown"; PALPITATIONS (non-serious) with onset 2021, outcome "unknown", described as "heart palpitations"; WEIGHT DECREASED (non-serious) with onset 2021, outcome "unknown", described as "his weight used to be 160 pounds and now is 134 pounds/ weight loss occurred after the vaccine". Relevant laboratory tests and procedures are available in the appropriate section. Additional information: It was reported that everything started with heart palpitations, fatigue and headache; kept telling everyone that right after he got the vaccine he felt like something was wrong and made sure he was eating and sleeping enough and did not feel well, was so fatigued and it did not make sense but got a headache at the same time every afternoon and it was uncanny. Height was 5'10'' or 5'11'' and his weight used to be 160 pounds and was then 134 pounds and he was always a solid 160 pounds and the weight loss occurred after the vaccine.
Age: 32.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Fatigue, Feeling abnormal, Headache, Malaise, Palpitations
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 32-year-old male patient received BNT162b2 (BNT162B2), on 29Apr2021 as dose 1, single (Lot number: EW0171) at the age of 32 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MALAISE (non-serious) with onset 2021, outcome "unknown", described as "did not feel well."; FATIGUE (non-serious) with onset 2021, outcome "unknown"; FEELING ABNORMAL (non-serious) with onset 2021, outcome "unknown", described as "felt like something was wrong"; HEADACHE (non-serious) with onset 2021, outcome "unknown"; PALPITATIONS (non-serious) with onset 2021, outcome "unknown", described as "heart palpitations"; WEIGHT DECREASED (non-serious) with onset 2021, outcome "unknown", described as "his weight used to be 160 pounds and now is 134 pounds/ weight loss occurred after the vaccine". Relevant laboratory tests and procedures are available in the appropriate section. Additional information: It was reported that everything started with heart palpitations, fatigue and headache; kept telling everyone that right after he got the vaccine he felt like something was wrong and made sure he was eating and sleeping enough and did not feel well, was so fatigued and it did not make sense but got a headache at the same time every afternoon and it was uncanny. Height was 5'10'' or 5'11'' and his weight used to be 160 pounds and was then 134 pounds and he was always a solid 160 pounds and the weight loss occurred after the vaccine.
Age: 32.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Weight, Weight decreased
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 32-year-old male patient received BNT162b2 (BNT162B2), on 29Apr2021 as dose 1, single (Lot number: EW0171) at the age of 32 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MALAISE (non-serious) with onset 2021, outcome "unknown", described as "did not feel well."; FATIGUE (non-serious) with onset 2021, outcome "unknown"; FEELING ABNORMAL (non-serious) with onset 2021, outcome "unknown", described as "felt like something was wrong"; HEADACHE (non-serious) with onset 2021, outcome "unknown"; PALPITATIONS (non-serious) with onset 2021, outcome "unknown", described as "heart palpitations"; WEIGHT DECREASED (non-serious) with onset 2021, outcome "unknown", described as "his weight used to be 160 pounds and now is 134 pounds/ weight loss occurred after the vaccine". Relevant laboratory tests and procedures are available in the appropriate section. Additional information: It was reported that everything started with heart palpitations, fatigue and headache; kept telling everyone that right after he got the vaccine he felt like something was wrong and made sure he was eating and sleeping enough and did not feel well, was so fatigued and it did not make sense but got a headache at the same time every afternoon and it was uncanny. Height was 5'10'' or 5'11'' and his weight used to be 160 pounds and was then 134 pounds and he was always a solid 160 pounds and the weight loss occurred after the vaccine.
Age: 36.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Exposure during pregnancy, Wrong product administered
Clinical narrative: No additional AEs were reported.; a patient inadvertently received GARDASIL 9 instead of Tdap due to human error.; This spontaneous report was received from a registered nurse referring to a 36-year-old female patient. No information regarding the patient's pertinent medical history, drug reactions or allergies, or concomitant therapies was provided.   On 28-JUL-2022, the patient was inadvertently vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) 1 dose (lot # U036586 is valid for hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9), expiration date: 21-OCT-2023, strength and route of administration were unknown) for prophylaxis instead of diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid (TDAP) due to human error (wrong vaccine administered). No additional adverse events (AEs) were reported.
Age: 36.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No additional AEs were reported.; a patient inadvertently received GARDASIL 9 instead of Tdap due to human error.; This spontaneous report was received from a registered nurse referring to a 36-year-old female patient. No information regarding the patient's pertinent medical history, drug reactions or allergies, or concomitant therapies was provided.   On 28-JUL-2022, the patient was inadvertently vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) 1 dose (lot # U036586 is valid for hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9), expiration date: 21-OCT-2023, strength and route of administration were unknown) for prophylaxis instead of diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid (TDAP) due to human error (wrong vaccine administered). No additional adverse events (AEs) were reported.
Age: 66.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Chest X-ray normal, Chills, Dehydration, Electrocardiogram normal
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 66-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 09Jan2021 as dose 1, single (Lot number: EL3246), in left arm, on 30Jan2021 as dose 2, single (Lot number: PAA 156051), in left arm, on 09Oct2021 as dose 3 (booster), single (Lot number: 30T55BA), in left arm and on 20May2022 as dose 4 (booster), single (Lot number: FK9896) at the age of 66 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Barrett's" (unspecified if ongoing); "seasonal allergies" (unspecified if ongoing). Concomitant medication(s) included: ATORVASTATIN, start date: Mar2022, stop date: 15Aug2022; CLARITIN ALLERGIC, start date: Jan2002, stop date: 15Aug2022; PREVACID, start date: Jan2012. Past drug history included: Prevacid, start date: Jan2012. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of vaccination failure, covid-19 which included paxlovid from 15Aug2022 to 16Aug2022.
Age: 66.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Oropharyngeal pain, Pyrexia, SARS-CoV-2 test positive
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 66-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 09Jan2021 as dose 1, single (Lot number: EL3246), in left arm, on 30Jan2021 as dose 2, single (Lot number: PAA 156051), in left arm, on 09Oct2021 as dose 3 (booster), single (Lot number: 30T55BA), in left arm and on 20May2022 as dose 4 (booster), single (Lot number: FK9896) at the age of 66 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Barrett's" (unspecified if ongoing); "seasonal allergies" (unspecified if ongoing). Concomitant medication(s) included: ATORVASTATIN, start date: Mar2022, stop date: 15Aug2022; CLARITIN ALLERGIC, start date: Jan2002, stop date: 15Aug2022; PREVACID, start date: Jan2012. Past drug history included: Prevacid, start date: Jan2012. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of vaccination failure, covid-19 which included paxlovid from 15Aug2022 to 16Aug2022.
Age: 66.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 66-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 09Jan2021 as dose 1, single (Lot number: EL3246), in left arm, on 30Jan2021 as dose 2, single (Lot number: PAA 156051), in left arm, on 09Oct2021 as dose 3 (booster), single (Lot number: 30T55BA), in left arm and on 20May2022 as dose 4 (booster), single (Lot number: FK9896) at the age of 66 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Barrett's" (unspecified if ongoing); "seasonal allergies" (unspecified if ongoing). Concomitant medication(s) included: ATORVASTATIN, start date: Mar2022, stop date: 15Aug2022; CLARITIN ALLERGIC, start date: Jan2002, stop date: 15Aug2022; PREVACID, start date: Jan2012. Past drug history included: Prevacid, start date: Jan2012. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of vaccination failure, covid-19 which included paxlovid from 15Aug2022 to 16Aug2022.
Age: 67.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Cough, Pyrexia
Clinical narrative: patient felt sick like she was about to die; cough with blood; loss of voice; loss of appetite; she felt so severely weak and was unable to do anything/she was in bed; dizziness; This spontaneous case was reported by a patient and describes the occurrence of MALAISE (patient felt sick like she was about to die), HAEMOPTYSIS (cough with blood), APHONIA (loss of voice), DECREASED APPETITE (loss of appetite) and ASTHENIA (she felt so severely weak and was unable to do anything/she was in bed) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011B22A and 013F21A) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     Previously administered products included for COVID-19 prophylaxis: PFIZER VACCINE (First dose - EN6204, route: intramuscular.) on 02-Mar-2021, PFIZER VACCINE (Second dose -ET6955 and Expiration date: 30-Jun-2021.) on 25-Mar-2021. Past adverse reactions to the above products included No adverse event with PFIZER VACCINE and PFIZER VACCINE. Concurrent medical conditions included Drug allergy (Sulfa), Drug allergy (Lipitor), Drug allergy (Morphine), COPD (since 20 years ago.), Heart failure, Renal failure (Stage 3 (since 3 years ago).), Polyneuropathy (since 20 years ago) and Diabetes (since 20 years ago. She felts very sick). Concomitant products included ROSUVASTATIN CALCIUM (CRESTOR) for Blood cholesterol abnormal, TRAZODONE for Disorder sleep, CLOPIDOGREL BISULFATE (PLAVIX) and METOPROLOL for Heart disease, unspecified, ACETYLSALICYLIC ACID (ASPIRIN), ISOSORBIDE and HYDROCODONE for an unknown indication. On 18-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Aug-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Aug-2022, the patient experienced MALAISE (patient felt sick like she was about to die), HAEMOPTYSIS (cough with blood), APHONIA (loss of voice), DECREASED APPETITE (loss of appetite), ASTHENIA (she felt so severely weak and was unable to do anything/she was in bed) and DIZZINESS (dizziness). At the time of the report, MALAISE (patient felt sick like she was about to die), HAEMOPTYSIS (cough with blood), APHONIA (loss of voice), DECREASED APPETITE (loss of appetite), ASTHENIA (she felt so severely weak and was unable to do anything/she was in bed) and DIZZINESS (dizziness) had not resolved. Patient reported she will visit to her cardiologist and her kidney doctor on 19-Aug-2022. No treatment medications were reported.  This case was linked to MOD-2022-630420 (Patient Link).
Age: 67.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Aphonia, Asthenia, Decreased appetite, Dizziness, Haemoptysis
Clinical narrative: patient felt sick like she was about to die; cough with blood; loss of voice; loss of appetite; she felt so severely weak and was unable to do anything/she was in bed; dizziness; This spontaneous case was reported by a patient and describes the occurrence of MALAISE (patient felt sick like she was about to die), HAEMOPTYSIS (cough with blood), APHONIA (loss of voice), DECREASED APPETITE (loss of appetite) and ASTHENIA (she felt so severely weak and was unable to do anything/she was in bed) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011B22A and 013F21A) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     Previously administered products included for COVID-19 prophylaxis: PFIZER VACCINE (First dose - EN6204, route: intramuscular.) on 02-Mar-2021, PFIZER VACCINE (Second dose -ET6955 and Expiration date: 30-Jun-2021.) on 25-Mar-2021. Past adverse reactions to the above products included No adverse event with PFIZER VACCINE and PFIZER VACCINE. Concurrent medical conditions included Drug allergy (Sulfa), Drug allergy (Lipitor), Drug allergy (Morphine), COPD (since 20 years ago.), Heart failure, Renal failure (Stage 3 (since 3 years ago).), Polyneuropathy (since 20 years ago) and Diabetes (since 20 years ago. She felts very sick). Concomitant products included ROSUVASTATIN CALCIUM (CRESTOR) for Blood cholesterol abnormal, TRAZODONE for Disorder sleep, CLOPIDOGREL BISULFATE (PLAVIX) and METOPROLOL for Heart disease, unspecified, ACETYLSALICYLIC ACID (ASPIRIN), ISOSORBIDE and HYDROCODONE for an unknown indication. On 18-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Aug-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Aug-2022, the patient experienced MALAISE (patient felt sick like she was about to die), HAEMOPTYSIS (cough with blood), APHONIA (loss of voice), DECREASED APPETITE (loss of appetite), ASTHENIA (she felt so severely weak and was unable to do anything/she was in bed) and DIZZINESS (dizziness). At the time of the report, MALAISE (patient felt sick like she was about to die), HAEMOPTYSIS (cough with blood), APHONIA (loss of voice), DECREASED APPETITE (loss of appetite), ASTHENIA (she felt so severely weak and was unable to do anything/she was in bed) and DIZZINESS (dizziness) had not resolved. Patient reported she will visit to her cardiologist and her kidney doctor on 19-Aug-2022. No treatment medications were reported.  This case was linked to MOD-2022-630420 (Patient Link).
Age: 67.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Malaise
Clinical narrative: patient felt sick like she was about to die; cough with blood; loss of voice; loss of appetite; she felt so severely weak and was unable to do anything/she was in bed; dizziness; This spontaneous case was reported by a patient and describes the occurrence of MALAISE (patient felt sick like she was about to die), HAEMOPTYSIS (cough with blood), APHONIA (loss of voice), DECREASED APPETITE (loss of appetite) and ASTHENIA (she felt so severely weak and was unable to do anything/she was in bed) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011B22A and 013F21A) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     Previously administered products included for COVID-19 prophylaxis: PFIZER VACCINE (First dose - EN6204, route: intramuscular.) on 02-Mar-2021, PFIZER VACCINE (Second dose -ET6955 and Expiration date: 30-Jun-2021.) on 25-Mar-2021. Past adverse reactions to the above products included No adverse event with PFIZER VACCINE and PFIZER VACCINE. Concurrent medical conditions included Drug allergy (Sulfa), Drug allergy (Lipitor), Drug allergy (Morphine), COPD (since 20 years ago.), Heart failure, Renal failure (Stage 3 (since 3 years ago).), Polyneuropathy (since 20 years ago) and Diabetes (since 20 years ago. She felts very sick). Concomitant products included ROSUVASTATIN CALCIUM (CRESTOR) for Blood cholesterol abnormal, TRAZODONE for Disorder sleep, CLOPIDOGREL BISULFATE (PLAVIX) and METOPROLOL for Heart disease, unspecified, ACETYLSALICYLIC ACID (ASPIRIN), ISOSORBIDE and HYDROCODONE for an unknown indication. On 18-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Aug-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Aug-2022, the patient experienced MALAISE (patient felt sick like she was about to die), HAEMOPTYSIS (cough with blood), APHONIA (loss of voice), DECREASED APPETITE (loss of appetite), ASTHENIA (she felt so severely weak and was unable to do anything/she was in bed) and DIZZINESS (dizziness). At the time of the report, MALAISE (patient felt sick like she was about to die), HAEMOPTYSIS (cough with blood), APHONIA (loss of voice), DECREASED APPETITE (loss of appetite), ASTHENIA (she felt so severely weak and was unable to do anything/she was in bed) and DIZZINESS (dizziness) had not resolved. Patient reported she will visit to her cardiologist and her kidney doctor on 19-Aug-2022. No treatment medications were reported.  This case was linked to MOD-2022-630420 (Patient Link).
Age: 49.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Anaphylactic reaction, Dyspnoea, Nausea, Vomiting
Clinical narrative: Systemic: Allergic: Anaphylaxis-Medium, Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Medium, Systemic: Flushed / Sweating-Medium
Age: 49.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Anaphylactic reaction, Dysphagia, Dyspnoea, Flushing, Hyperhidrosis
Clinical narrative: Systemic: Allergic: Anaphylaxis-Medium, Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Medium, Systemic: Flushed / Sweating-Medium
Age: 49.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Throat tightness
Clinical narrative: Systemic: Allergic: Anaphylaxis-Medium, Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Medium, Systemic: Flushed / Sweating-Medium
Age: 2.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Incorrect dose administered, Medication error, No adverse event, Product administration error, Product preparation error
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP), Program ID:. The reporter is the parent. A 2-year-old male patient received BNT162b2 (BNT162B2), on 23Aug2022 at 11:20 as dose 2 (maroon cap), single (Lot number: FT9142) at the age of 2 years intramuscular, in left leg for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: BNT162b2 (DOSE 1, SINGLE, Lot Number:  FT9142, Dosage text: Undiluted 0.2 equivalent to 6 doses intramuscular injection to she thinks left leg at about 11:20, Pharmaceutical form (Dosage form): Maroon), administration date: 28Jun2022, when the patient was 2-year-old, for COVID-19 immunization. The following information was reported: PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (non-serious) with onset 23Aug2022 at 11:20, outcome "unknown", described as "intramuscular injection to she thinks left leg"; ABNORMAL BEHAVIOUR (non-serious) with onset 24Aug2022, outcome "not recovered", described as "a little clingy"; INFANT IRRITABILITY (non-serious) with onset 24Aug2022, outcome "not recovered", described as "a little more fussy". Additional Information: Caller reported regarding her son as her son received Pfizer Covid-19 vaccine and they notified her that the vaccine that was given to her son was not diluted. She asked if there were any side effects because of the vaccine being not diluted. Caller clarified that on 23Aug2022, her son was administered undiluted dose of Pfizer Covid-19 Vaccine, maroon formulation. She verified that she received the call to notify her of this on 23Aug2022. The doctor said he received the equivalent of 6 doses at that time. She was trying to find out if there were any potential other side effects she should be looking out for or anything in the future or if she should take him in to get a second opinion. The patient did not undergo any investigations. The patient did not any relevant Tests. The patient did not receive any other vaccinations within four weeks prior administration of the suspect vaccine. The vaccine facility type was medical office.
Age: 2.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Abnormal behaviour, Infant irritability, Product administered at inappropriate site
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP), Program ID:. The reporter is the parent. A 2-year-old male patient received BNT162b2 (BNT162B2), on 23Aug2022 at 11:20 as dose 2 (maroon cap), single (Lot number: FT9142) at the age of 2 years intramuscular, in left leg for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: BNT162b2 (DOSE 1, SINGLE, Lot Number:  FT9142, Dosage text: Undiluted 0.2 equivalent to 6 doses intramuscular injection to she thinks left leg at about 11:20, Pharmaceutical form (Dosage form): Maroon), administration date: 28Jun2022, when the patient was 2-year-old, for COVID-19 immunization. The following information was reported: PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (non-serious) with onset 23Aug2022 at 11:20, outcome "unknown", described as "intramuscular injection to she thinks left leg"; ABNORMAL BEHAVIOUR (non-serious) with onset 24Aug2022, outcome "not recovered", described as "a little clingy"; INFANT IRRITABILITY (non-serious) with onset 24Aug2022, outcome "not recovered", described as "a little more fussy". Additional Information: Caller reported regarding her son as her son received Pfizer Covid-19 vaccine and they notified her that the vaccine that was given to her son was not diluted. She asked if there were any side effects because of the vaccine being not diluted. Caller clarified that on 23Aug2022, her son was administered undiluted dose of Pfizer Covid-19 Vaccine, maroon formulation. She verified that she received the call to notify her of this on 23Aug2022. The doctor said he received the equivalent of 6 doses at that time. She was trying to find out if there were any potential other side effects she should be looking out for or anything in the future or if she should take him in to get a second opinion. The patient did not undergo any investigations. The patient did not any relevant Tests. The patient did not receive any other vaccinations within four weeks prior administration of the suspect vaccine. The vaccine facility type was medical office.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Fatigue, Feeling abnormal, Respiratory tract congestion, SARS-CoV-2 test positive
Clinical narrative: Breakthrough case. I didn't feel good, I was really tired and congested. Took a Home COVID-19 test and it was positive. I had a telehealth appointment with my Dr and he prescribed Paxlovid. I finished the prescription and started to feel better slowly. I retook the Home COVID-19 test on 08/01/2022 and it was negative.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccine breakthrough infection
Clinical narrative: Breakthrough case. I didn't feel good, I was really tired and congested. Took a Home COVID-19 test and it was positive. I had a telehealth appointment with my Dr and he prescribed Paxlovid. I finished the prescription and started to feel better slowly. I retook the Home COVID-19 test on 08/01/2022 and it was negative.
Age: 23.0
Sex: M
Vaccine: SMALLMNK
Symptoms: Chills, Pharyngitis streptococcal, Rash, Streptococcus test, Viral test
Clinical narrative: Spoke with patient regarding symptoms on 8/23/22. Per client symptoms presented on 8/19/22 patient states thought he had strep throat. Patient states first went to urgent care on 8/22/22 but was told to go to emergency room. Patient stated was tested for Strep throat. Per patient strep test was negative. Patient stated he was tested for monkey pox. Per patient was informed it would take 5 to 6 day for monkey pox results. Patient stated has sores/dots all over his body. Per patient has dots on his  feet, hands, and ears.  Patient stated had chills that started Friday and stopped on Sunday. Patient denied having any fever. Patient wanted further instructions regarding care. Encouraged to contact PCP for further medical advice. Patient verbalized understanding. Called patient on 8/24/22. Patient followed up with PCP and was informed to use itch cream. Per patient called the emergency location to follow up on monkey pox results. Per patient awaiting results of monkey pox swab. Patient encouraged to follow up with primary care physcian as needed. Patient verbalized understanding.
Age: 5.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Chills, Pyrexia, Vomiting
Clinical narrative: Woke with extreme stomach pain and vomiting. Shivering and fever. Had to go to the ER
Age: 33.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Biopsy skin abnormal, Cellulitis, Depression, Dermatitis, Dermatitis contact
Clinical narrative: Approximately 3 days after second shot I noticed  small various sizes of circular lesions on the right hand -approximately 6 later the lesions began to increase in size and started to cause panful itching and sever skin hardening- I attempted various OTC lotions and ointments to alleviate my pain and itching to no avail - now panic and depression started and I immediately sought professional medical attention both phycological and physical attention - the condition has worsened and spread to entire body from head to toe - and as of today I am still seeking and resolution to my chronic condition- I am under the care of a dermatologist who has given me multiple diagnoses such :  Psoriasis, Eczema , contact Dermatitis and neurological  dermatitis amount
Age: 33.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Eczema, Induration, Oedema peripheral, Pain in extremity, Panic disorder
Clinical narrative: Approximately 3 days after second shot I noticed  small various sizes of circular lesions on the right hand -approximately 6 later the lesions began to increase in size and started to cause panful itching and sever skin hardening- I attempted various OTC lotions and ointments to alleviate my pain and itching to no avail - now panic and depression started and I immediately sought professional medical attention both phycological and physical attention - the condition has worsened and spread to entire body from head to toe - and as of today I am still seeking and resolution to my chronic condition- I am under the care of a dermatologist who has given me multiple diagnoses such :  Psoriasis, Eczema , contact Dermatitis and neurological  dermatitis amount
Age: 33.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pruritus, Psoriasis
Clinical narrative: Approximately 3 days after second shot I noticed  small various sizes of circular lesions on the right hand -approximately 6 later the lesions began to increase in size and started to cause panful itching and sever skin hardening- I attempted various OTC lotions and ointments to alleviate my pain and itching to no avail - now panic and depression started and I immediately sought professional medical attention both phycological and physical attention - the condition has worsened and spread to entire body from head to toe - and as of today I am still seeking and resolution to my chronic condition- I am under the care of a dermatologist who has given me multiple diagnoses such :  Psoriasis, Eczema , contact Dermatitis and neurological  dermatitis amount
Age: 73.0
Sex: M
Vaccine: SMALLMNK
Symptoms: Injection site nodule, Injection site pain, Rash erythematous
Clinical narrative: On 08/18/2022, approximately 50 hours following receiving 0.5 mL of the Bavarian Nordic A/S Jynneos (PF) (Stockpile) vaccine via the subcutaneous route in the posterior left upper arm, I noticed pain at the site of the injection, along with a tender 2 cm subcutaneous firm nodule. At the same time, a pruritic well-marginated erythematous rash developed that lasted approximately 3 days and then resolved. At the time of this report, 08/27/2022, the tender subcutaneous nodule persists and the pain has improved greatly, although the nodule is still tender to touch.
Age: 1.67
Sex: F
Vaccine: COVID19
Symptoms: Angiogram, Blood test, Computerised tomogram, Electrocardiogram, Electroencephalogram
Clinical narrative: Extensive  Meningitis  Sepsis Infected CSF   Please contact Hospital for completely information
Age: 1.67
Sex: F
Vaccine: COVID19
Symptoms: Magnetic resonance imaging, Meningococcal sepsis, Ultrasound Doppler, Venogram
Clinical narrative: Extensive  Meningitis  Sepsis Infected CSF   Please contact Hospital for completely information
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Cold sweat, Fatigue, Headache
Clinical narrative: Starting 8/19 and lasting through 8/22 Chills (24 hours) Fever (6 hours) - max fever 102 Cold sweats (24 hours) Headache (72 hours) Joint pain (12 hours) Muscle pain (48 hours) Nausea (48 hours) - prescribed zofran Fatigue (72 hours)
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Nausea, Pyrexia
Clinical narrative: Starting 8/19 and lasting through 8/22 Chills (24 hours) Fever (6 hours) - max fever 102 Cold sweats (24 hours) Headache (72 hours) Joint pain (12 hours) Muscle pain (48 hours) Nausea (48 hours) - prescribed zofran Fatigue (72 hours)
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Muscle twitching, Tremor
Clinical narrative: Systemic: Lymph Node Swelling-Mild, Systemic: Shakiness-Mild, Additional Details: Patient reports nodule on right side of collar bone and right toe/foot twitch. Symptoms have not worsened and gradually getting better. Reported on day 3 after vaccine. Symptoms to not inhibit ability to perform daily activities.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site bruising, Injection site pain
Clinical narrative: Site: Bruising at Injection Site-Severe, Site: Pain at Injection Site-Severe
Age: 65.0
Sex: F
Vaccine: PNC20
Symptoms: Axillary pain, Erythema, Injection site erythema, Rash
Clinical narrative: Site: Redness at Injection Site-Medium, Systemic: rash/redness on upper arm, under arm soreness-Medium
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Psoriasis
Clinical narrative: My whole body broke out with Psoriasis
Sex: F
Vaccine: DTAP
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Adacel, which is approved for 7 years old and older was given to a 2 year old female.  No known reactions
Age: 1.33
Sex: F
Vaccine: COVID19
Symptoms: Stress, Urticaria, Urticaria contact
Clinical narrative: Patient seems to be experiencing hives. The hives seem to appear with contact/stress and then often go away with an hour or 2. The hives were discussed with our pediatrician and she recommended it may or may not be connected to the COVID vaccine, but we should report the potentially adverse reaction.
Age: 55.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Amnesia, Confusional state, Feeling abnormal, Magnetic resonance imaging head normal, Neurological examination abnormal
Clinical narrative: Short term memory loss, foggy brain, confusion.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Angina pectoris, Dizziness
Clinical narrative: Mild pain in the heart area. I got my third vaccine COVID19 Moderna (booster) at 6 pm on 08/26/22.  I started to feel dizziness and mild pain in the heart area around 9 pm on 08/26/22. I didn't go to a doctor but this kind of pain is very unusual for me. I am a healthy person, who runs almost every day 2-3 miles.
Age: 53.0
Sex: F
Vaccine: PNC20, TDAP
Symptoms: Extra dose administered
Clinical narrative: PATINET RECEIVED TDAP AND PREVANAR 20 ON 05/22/22. PATIENT CAME TO GET SECOND DOSE OF SINGLES AND TECHNICIAN ASKED ABOUT PREVNAR 20 AND TETANUS AGAIN AND PATIENT GAVE APPROVAL TO GIVE IT. VISITING PHARMACIST DID NOT REALIZE PATIENT HAD IT 3 MONTHS AGO AND GAVE ALL VACCINES AGAIN. PATIENT HAS NO SYMPTOMS AND DOING FINE.
Age: 67.0
Sex: M
Vaccine: SMALLMNK
Symptoms: Syringe issue, Underdose
Clinical narrative: Patient was asked pre-screening questions, no contra-indications to vaccine. while vaccinating patient, needle got disconnected from syringe causing most of the vaccine to leak out. Patient was vaccinated with a new dose  vaccine, 2-inches away from the site, team lead was made aware. Patient did not c/o of any discomfort.
Age: 51.0
Sex: F
Vaccine: FLU4
Symptoms: Computerised tomogram, Electrocardiogram, Magnetic resonance imaging, Pneumonia
Clinical narrative: In hospital with pneumonia
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Costochondritis
Clinical narrative: This was my first booster. I had gotten Moderna for my vaccine. I got Costochondritis. I went to the ER and was given a dose of anti inflammatory meds. It went away after that.
Age: 87.0
Sex: F
Vaccine: COVID19
Symptoms: Alanine aminotransferase normal, Albumin globulin ratio, Anion gap, Aspartate aminotransferase normal, Atrial fibrillation
Clinical narrative: Admit Date:  7/1/2022   Discharge Date: 7/5/22   Principal Dx/ Final Dx: Hyponatremia   Relevant Inpt Dx: Principal Problem:   Hyponatremia Active Problems:   COVID-19 virus detected   Benign essential HTN       HPI:   Hospital Course:   This elderly woman was admitted with hyponatremia.  She was seen by nephrology.  Sodium level is improved.  She is eating well and says she is going home today.  Will discharge on oral meds and with follow up arranged.      She did test positive for covid but did not require any treatment for this        Consults:   IP CONSULT TO NEPHROLOGY       Disposition:  home   Discharge Condition:  fair
Age: 87.0
Sex: F
Vaccine: COVID19
Symptoms: Bacterial test, Basophil count decreased, Basophil percentage decreased, Bilirubin urine, Bladder catheterisation
Clinical narrative: Admit Date:  7/1/2022   Discharge Date: 7/5/22   Principal Dx/ Final Dx: Hyponatremia   Relevant Inpt Dx: Principal Problem:   Hyponatremia Active Problems:   COVID-19 virus detected   Benign essential HTN       HPI:   Hospital Course:   This elderly woman was admitted with hyponatremia.  She was seen by nephrology.  Sodium level is improved.  She is eating well and says she is going home today.  Will discharge on oral meds and with follow up arranged.      She did test positive for covid but did not require any treatment for this        Consults:   IP CONSULT TO NEPHROLOGY       Disposition:  home   Discharge Condition:  fair
Age: 87.0
Sex: F
Vaccine: COVID19
Symptoms: Blood albumin normal, Blood alkaline phosphatase normal, Blood bilirubin normal, Blood calcium normal, Blood chloride decreased
Clinical narrative: Admit Date:  7/1/2022   Discharge Date: 7/5/22   Principal Dx/ Final Dx: Hyponatremia   Relevant Inpt Dx: Principal Problem:   Hyponatremia Active Problems:   COVID-19 virus detected   Benign essential HTN       HPI:   Hospital Course:   This elderly woman was admitted with hyponatremia.  She was seen by nephrology.  Sodium level is improved.  She is eating well and says she is going home today.  Will discharge on oral meds and with follow up arranged.      She did test positive for covid but did not require any treatment for this        Consults:   IP CONSULT TO NEPHROLOGY       Disposition:  home   Discharge Condition:  fair
Age: 87.0
Sex: F
Vaccine: COVID19
Symptoms: Blood creatinine increased, Blood glucose normal, Blood magnesium normal, Blood osmolarity decreased, Blood potassium normal
Clinical narrative: Admit Date:  7/1/2022   Discharge Date: 7/5/22   Principal Dx/ Final Dx: Hyponatremia   Relevant Inpt Dx: Principal Problem:   Hyponatremia Active Problems:   COVID-19 virus detected   Benign essential HTN       HPI:   Hospital Course:   This elderly woman was admitted with hyponatremia.  She was seen by nephrology.  Sodium level is improved.  She is eating well and says she is going home today.  Will discharge on oral meds and with follow up arranged.      She did test positive for covid but did not require any treatment for this        Consults:   IP CONSULT TO NEPHROLOGY       Disposition:  home   Discharge Condition:  fair
Age: 87.0
Sex: F
Vaccine: COVID19
Symptoms: Blood sodium decreased, Blood urea increased, Blood urea nitrogen/creatinine ratio, Blood urine absent, COVID-19
Clinical narrative: Admit Date:  7/1/2022   Discharge Date: 7/5/22   Principal Dx/ Final Dx: Hyponatremia   Relevant Inpt Dx: Principal Problem:   Hyponatremia Active Problems:   COVID-19 virus detected   Benign essential HTN       HPI:   Hospital Course:   This elderly woman was admitted with hyponatremia.  She was seen by nephrology.  Sodium level is improved.  She is eating well and says she is going home today.  Will discharge on oral meds and with follow up arranged.      She did test positive for covid but did not require any treatment for this        Consults:   IP CONSULT TO NEPHROLOGY       Disposition:  home   Discharge Condition:  fair
Age: 87.0
Sex: F
Vaccine: COVID19
Symptoms: Carbon dioxide normal, Chromaturia, Differential white blood cell count, Electrocardiogram abnormal, Eosinophil count normal
Clinical narrative: Admit Date:  7/1/2022   Discharge Date: 7/5/22   Principal Dx/ Final Dx: Hyponatremia   Relevant Inpt Dx: Principal Problem:   Hyponatremia Active Problems:   COVID-19 virus detected   Benign essential HTN       HPI:   Hospital Course:   This elderly woman was admitted with hyponatremia.  She was seen by nephrology.  Sodium level is improved.  She is eating well and says she is going home today.  Will discharge on oral meds and with follow up arranged.      She did test positive for covid but did not require any treatment for this        Consults:   IP CONSULT TO NEPHROLOGY       Disposition:  home   Discharge Condition:  fair