chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: Incorrect dose administered, Myocarditis, Neuropathy peripheral
Clinical narrative: neuropathy; myocarditis; pharmacy for the 2nd dose (HCP termed it as the booster) they were given a full dose instead of half.; This spontaneous case was reported by a physician and describes the occurrence of NEUROPATHY PERIPHERAL (neuropathy) and MYOCARDITIS (myocarditis) in a male patient of an unknown age who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On an unknown date, the patient received second dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On an unknown date, received first dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced NEUROPATHY PERIPHERAL (neuropathy) (seriousness criterion medically significant), MYOCARDITIS (myocarditis) (seriousness criterion medically significant) and INCORRECT DOSE ADMINISTERED (pharmacy for the 2nd dose (HCP termed it as the booster) they were given a full dose instead of half.). At the time of the report, NEUROPATHY PERIPHERAL (neuropathy), MYOCARDITIS (myocarditis) and INCORRECT DOSE ADMINISTERED (pharmacy for the 2nd dose (HCP termed it as the booster) they were given a full dose instead of half.) outcome was unknown.        For SPIKEVAX NOS (SPIKEVAX NOS) (Unknown), the reporter did not provide any causality assessments.   A physician states that they have a patient who had myocarditis after getting the 1st 2 doses of the Moderna Covid-19 vaccine.  The patient was given the 1st dose and when the patient went back to the pharmacy for the 2nd dose (HCP termed it as the booster) they were given a full dose instead of half. Physician does not had the vaccination details at the time of the call.  HCP states that these doses were given when the vaccines just came out.  HCP states that the patient was currently debilitated, had neuropathy and was having frequent PVCs.  He still had mild myocarditis and was saw a cardiologist. Concomitant medications were not reported.  No treatment medication was provided by the reporter. Company Comment This spontaneous case concerns a male patient of unknown age with no medical history reported who experienced the seriousness criterion medically significant expected event of myocarditis; and the seriousness criterion medically significant unexpected events of neuropathy peripheral and incorrect dose administered unknown days after 1st. dose of SPIKEVAX NOS vaccine. Concomitant medication details nor Treatment details were reported. He still had mild myocarditis and was saw a cardiologist. The benefit-risk relationship of SPIKEVAX NOS vaccine is not affected by this report.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Feeling abnormal, Headache, Hyperhidrosis
Clinical narrative: felt real rotten; sweating; nausea; chills; bad headache; really tired/She's very active and lays flat; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (felt real rotten), HYPERHIDROSIS (sweating), NAUSEA (nausea), CHILLS (chills) and HEADACHE (bad headache) in a 39-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 22-Sep-2023, the patient received fifth dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On 22-Sep-2023, the patient experienced FEELING ABNORMAL (felt real rotten), HYPERHIDROSIS (sweating), NAUSEA (nausea), CHILLS (chills), HEADACHE (bad headache) and FATIGUE (really tired/She's very active and lays flat). At the time of the report, FEELING ABNORMAL (felt real rotten), HYPERHIDROSIS (sweating), NAUSEA (nausea), CHILLS (chills), HEADACHE (bad headache) and FATIGUE (really tired/She's very active and lays flat) outcome was unknown.        For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.  On 22-Sep-2023, patient received Spikevax, and had reactions on the first night. She had the same reaction on the same day of her 5 injections: she felt real rotten, sweating, nausea, chills, bad headache, really tired. She was very active and lays flat.  No treatment information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-742747 (Linked Report). This case was linked to MOD-2023-742931 (Patient Link).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-742747:Mother case
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: felt real rotten; sweating; nausea; chills; bad headache; really tired/She's very active and lays flat; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (felt real rotten), HYPERHIDROSIS (sweating), NAUSEA (nausea), CHILLS (chills) and HEADACHE (bad headache) in a 39-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 22-Sep-2023, the patient received fifth dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On 22-Sep-2023, the patient experienced FEELING ABNORMAL (felt real rotten), HYPERHIDROSIS (sweating), NAUSEA (nausea), CHILLS (chills), HEADACHE (bad headache) and FATIGUE (really tired/She's very active and lays flat). At the time of the report, FEELING ABNORMAL (felt real rotten), HYPERHIDROSIS (sweating), NAUSEA (nausea), CHILLS (chills), HEADACHE (bad headache) and FATIGUE (really tired/She's very active and lays flat) outcome was unknown.        For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.  On 22-Sep-2023, patient received Spikevax, and had reactions on the first night. She had the same reaction on the same day of her 5 injections: she felt real rotten, sweating, nausea, chills, bad headache, really tired. She was very active and lays flat.  No treatment information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-742747 (Linked Report). This case was linked to MOD-2023-742931 (Patient Link).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-742747:Mother case
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: Body aches; Fever; This spontaneous case was reported by a patient and describes the occurrence of PAIN (Body aches) and PYREXIA (Fever) in a female patient of an unknown age who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     No Medical History information was reported.    On 27-Sep-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN (Body aches) and PYREXIA (Fever). At the time of the report, PAIN (Body aches) and PYREXIA (Fever) outcome was unknown.        For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not provided. Treatment information was not reported.   Reporter did not allow further contact
Age: 1.83
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: No adverse event; 22-month-old patient received a first dose of Spikevax Moderna COVID-19 vaccine Single Dose Vial meant for 12 year old and up; This spontaneous case was reported by an other health care professional and describes the occurrence of INCORRECT DOSE ADMINISTERED (22-month-old patient received a first dose of Spikevax Moderna COVID-19 vaccine Single Dose Vial meant for 12 year old and up) and NO ADVERSE EVENT (No adverse event) in a 22-month-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. 8057456) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: FLU Shot. Past adverse reactions to the above products included No adverse event with FLU Shot. Concomitant products included INFLUENZA VACCINE (FLU [INFLUENZA VACCINE]) for an unknown indication.    On 28-Sep-2023, the patient received first dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) .5 milliliter. On 28-Sep-2023,  after starting mRNA-1273.815 (SPIKEVAX 2023-2024), the patient experienced INCORRECT DOSE ADMINISTERED (22-month-old patient received a first dose of Spikevax Moderna COVID-19 vaccine Single Dose Vial meant for 12 year old and up). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, INCORRECT DOSE ADMINISTERED (22-month-old patient received a first dose of Spikevax Moderna COVID-19 vaccine Single Dose Vial meant for 12 year old and up) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for INCORRECT DOSE ADMINISTERED (22-month-old patient received a first dose of Spikevax Moderna COVID-19 vaccine Single Dose Vial meant for 12 year old and up).    No treatment medications were provided.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect dose administered, No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No adverse event; Instead of the adult dose, he got the pediatric dose. He received the Moderna COVID19 Vaccine for 6 months-11 years old, single dose vial, 0.25 ml.; Instead of the adult dose, he got the pediatric dose; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Instead of the adult dose, he got the pediatric dose. He received the Moderna COVID19 Vaccine for 6 months-11 years old, single dose vial, 0.25 ml.), INCORRECT DOSE ADMINISTERED (Instead of the adult dose, he got the pediatric dose) and NO ADVERSE EVENT (No adverse event) in a 66-year-old male patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. AU5509B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 28-Sep-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) .25 milliliter. On 28-Sep-2023, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Instead of the adult dose, he got the pediatric dose. He received the Moderna COVID19 Vaccine for 6 months-11 years old, single dose vial, 0.25 ml.) and INCORRECT DOSE ADMINISTERED (Instead of the adult dose, he got the pediatric dose). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Instead of the adult dose, he got the pediatric dose. He received the Moderna COVID19 Vaccine for 6 months-11 years old, single dose vial, 0.25 ml.), INCORRECT DOSE ADMINISTERED (Instead of the adult dose, he got the pediatric dose) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Instead of the adult dose, he got the pediatric dose. He received the Moderna COVID19 Vaccine for 6 months-11 years old, single dose vial, 0.25 ml.) and INCORRECT DOSE ADMINISTERED (Instead of the adult dose, he got the pediatric dose).    Concomitant medication was not provided. Reporter stated that she had a customer that got a vaccination on morning of 28Sep2023. Instead of the adult dose, patient got the pediatric dose. He assumed he will need to be revaccinated in a couple of months. He received the Moderna COVID19 Vaccine for 6 months-11 years old, single dose vial, 0.25 ml. Treatment information was not reported.   Reporter did not allow further contact
Age: 70.0
Sex: F
Vaccine: UNK
Symptoms: Fatigue, Headache, Myalgia
Clinical narrative: headache; fatigue; muscle pain; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache), FATIGUE (fatigue) and MYALGIA (muscle pain) in a 70-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     No Medical History information was reported.    On 27-Sep-2023, the patient received fifth dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On 28-Sep-2023, the patient experienced HEADACHE (headache), FATIGUE (fatigue) and MYALGIA (muscle pain). At the time of the report, HEADACHE (headache), FATIGUE (fatigue) and MYALGIA (muscle pain) had not resolved.        For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. Patient did not receive any other vaccines in the 4 weeks prior to COVID-19 vaccine. Suspect product batch number reported as either 25E23A or 2ZE23A. Patient queried that if patient could take treatment medication Tylenol.
Age: 81.0
Sex: M
Vaccine: COVID19-2
Symptoms: Malaise
Clinical narrative: did not feel well the rest of the day; This spontaneous case was reported by a patient family member or friend and describes the occurrence of MALAISE (did not feel well the rest of the day) in an 81-year-old male patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. ASKU) for COVID-19 prophylaxis.     No Medical History information was reported.    On 20-Sep-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On 20-Sep-2023,  after starting mRNA-1273.815 (SPIKEVAX 2023-2024), the patient experienced MALAISE (did not feel well the rest of the day). At the time of the report, MALAISE (did not feel well the rest of the day) outcome was unknown.        The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown) was unknown.   For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-742771 (Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-742771:Wife Case
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Nausea, No reaction on previous exposure to drug, Oropharyngeal pain
Clinical narrative: sore throat; weakness; dizziness; nausea; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (sore throat), ASTHENIA (weakness), DIZZINESS (dizziness) and NAUSEA (nausea) in a 66-year-old male patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. ASKU) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: Pfizer (received all COVID-19 Pfizer shots .). Past adverse reactions to the above products included No adverse event with Pfizer. Concomitant products included INFLUENZA VACCINE (FLU VACCINE VII) for an unknown indication.    On 25-Sep-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On 25-Sep-2023, the patient experienced OROPHARYNGEAL PAIN (sore throat), ASTHENIA (weakness), DIZZINESS (dizziness) and NAUSEA (nausea). At the time of the report, OROPHARYNGEAL PAIN (sore throat), ASTHENIA (weakness), DIZZINESS (dizziness) and NAUSEA (nausea) had not resolved.        For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   Patient experienced a strong reaction and had been kind of sick for 3 days. Patent was unsure whether sore throat was related to the vaccine. Treatment information was not provided.   Reporter did not allow further contact
Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: Myocardial infarction, Myocarditis
Clinical narrative: Heart attack; Myocarditis/ Shortness of breath/ Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of MYOCARDIAL INFARCTION (Heart attack) and MYOCARDITIS (Myocarditis/ Shortness of breath/ Fatigue) in a 27-year-old male patient who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) 1 dosage form. On 11-Aug-2023, the patient experienced MYOCARDIAL INFARCTION (Heart attack) (seriousness criteria hospitalization and medically significant) and MYOCARDITIS (Myocarditis/ Shortness of breath/ Fatigue) (seriousness criteria hospitalization and medically significant). At the time of the report, MYOCARDIAL INFARCTION (Heart attack) and MYOCARDITIS (Myocarditis/ Shortness of breath/ Fatigue) had resolved with sequelae.        The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) was unknown.       Concomitant medication was not provided. Treatment information was not reported.  Company Comment This spontaneous case concerns a 27-year-old male patient with no medical history reported who experienced the seriousness criterion medically significant and hospitalization expected event of myocarditis; and the seriousness criterion medically significant and hospitalization unexpected event of myocardial infarction unknown days after a dose of SPIKEVAX NOS vaccine. Concomitant medication details nor Treatment details were reported. The events had resolved with sequelae. The benefit-risk relationship of SPIKEVAX NOS vaccine is not affected by this report.
Age: 72.0
Sex: M
Vaccine: UNK
Symptoms: No reaction on previous exposure to drug, Purpura
Clinical narrative: there is a huge place on his arm about 3 inches around that looks like blood comes to the surface.; This spontaneous case was reported by a patient and describes the occurrence of PURPURA (there is a huge place on his arm about 3 inches around that looks like blood comes to the surface.) in a 72-year-old male patient who received mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (batch no. 3031278) for COVID-19 prophylaxis.     The patient's past medical history included Heart attack in October 2022. Previously administered products included for Product used for unknown indication: Pfizer (First dose) on 08-Oct-2021, Pfizer (second dose) on 13-May-2022, Pfizer (3rd Booster dose) on 14-Sep-2022, HPV (3 to 4 weeks ago) and Flu vaccine (3 to 4 weeks ago). Past adverse reactions to the above products included No adverse event with Flu vaccine, HPV, Pfizer, Pfizer and Pfizer. Concomitant products included SACUBITRIL, VALSARTAN (ENTRESTO) for COVID-19 prophylaxis, CARVEDILOL, EZETIMIBE, ASPIRIN [ACETYLSALICYLIC ACID], HYDROCHLOROTHIAZIDE and ATORVASTATIN for an unknown indication.    On 28-Sep-2023, the patient received fourth dose of mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (unknown route) 1 dosage form. On 28-Sep-2023,  after starting mRNA-1273.815 (SPIKEVAX 2023-2024 PFS), the patient experienced PURPURA (there is a huge place on his arm about 3 inches around that looks like blood comes to the surface.). At the time of the report, PURPURA (there is a huge place on his arm about 3 inches around that looks like blood comes to the surface.) had not resolved.        For mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were provided.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Injection site warmth, Vaccination site bruising, Vaccination site erythema
Clinical narrative: the injection site is red and developed a bruise; her sister feels, chills, "weak feelin,"; the injection site is red and developed a bruise; her sister feels, chills, "weak feelin,"; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE BRUISING (the injection site is red and developed a bruise), ASTHENIA (her sister feels, chills, "weak feelin,"), VACCINATION SITE ERYTHEMA (the injection site is red and developed a bruise) and CHILLS (her sister feels, chills, "weak feelin,") in a 74-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. ASKU) for COVID-19 prophylaxis.     The patient's past medical history included COVID-19 (When first COVID came out (before received any covid vaccines)).    On 25-Sep-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE BRUISING (the injection site is red and developed a bruise), ASTHENIA (her sister feels, chills, "weak feelin,"), VACCINATION SITE ERYTHEMA (the injection site is red and developed a bruise) and CHILLS (her sister feels, chills, "weak feelin,"). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency. At the time of the report, VACCINATION SITE BRUISING (the injection site is red and developed a bruise), ASTHENIA (her sister feels, chills, "weak feelin,"), VACCINATION SITE ERYTHEMA (the injection site is red and developed a bruise) and CHILLS (her sister feels, chills, "weak feelin,") outcome was unknown.        For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. Reporter had no reactions with any of the Moderna doses, but reporter's sister (patient) always had a problem whether the patient received Moderna doses and the patient experienced a reaction with it. It has been reported that bruising was bigger than a half dollar for patient and which started from the injection site and went to the elbow and bruising was red and hot. Further bruising went a bit past the elbow, but was not as red. The patient felt like she had covid again.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Pyrexia
Clinical narrative: fever; chills; headache; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever), CHILLS (chills), HEADACHE (headache) and FATIGUE (fatigue) in a 46-year-old male patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     The patient's past medical history included COVID-19 in May 2023.    On 28-Sep-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use) 1 dosage form. On 29-Sep-2023, the patient experienced PYREXIA (fever), CHILLS (chills), HEADACHE (headache) and FATIGUE (fatigue). At the time of the report, PYREXIA (fever), CHILLS (chills), HEADACHE (headache) and FATIGUE (fatigue) was resolving.            No concomitant drug was reported.  The patient did not experience any additional symptoms/events.  No treatment drug was reported.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, No reaction on previous exposure to drug
Clinical narrative: sore arm in the site of injection; This spontaneous case was reported by a patient and describes the occurrence of INJECTION SITE PAIN (sore arm in the site of injection) in a 70-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     The patient's past medical history included Stroke (ended up disabled) in 2019. Previously administered products included for Product used for unknown indication: flu shot on 20-Sep-2023. Past adverse reactions to the above products included No adverse event with flu shot. Concomitant products included METOPROLOL for Blood pressure, ASPIRIN [ACETYLSALICYLIC ACID], CLOPIDOGREL and POTASSIUM for an unknown indication.    On 28-Sep-2023, the patient received fourth dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On 28-Sep-2023, after starting mRNA-1273.815 (SPIKEVAX 2023-2024), the patient experienced INJECTION SITE PAIN (sore arm in the site of injection). At the time of the report, INJECTION SITE PAIN (sore arm in the site of injection) had not resolved.        For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   On 21-Feb-2021, the patient received first dose of moderna covid-19 vaccine (batch/lot number: 006M20A), on 25-Mar-2021, second dose (batch/lot number: 040A21A) and on third dose was 2022 (batch/lot number: unknown). It was reported that with the last dose patient got sore arm in the site of injection and it is still a bit sore.  The patient received other vaccines in the 4 weeks prior to COVID-19 vaccine. No treatment medications were reported.   This case was linked to US-MODERNATX, INC.-MOD-2021-027802 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-027802:Dose 1, same reporter, different product
Age: 87.0
Sex: F
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: very sick; This spontaneous case was reported by a patient and describes the occurrence of ILLNESS (very sick) in an 87-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. ASKU) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On an unknown date, the patient experienced ILLNESS (very sick). At the time of the report, ILLNESS (very sick) outcome was unknown.        The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown) was unknown.   For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were provided.   Reporter did not allow further contact
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Blister, Lymphoedema, Peripheral swelling
Clinical narrative: Blisters on toes; felt swelling in arm and lymph; This spontaneous case was reported by a consumer and describes the occurrence of BLISTER (Blisters on toes) and LYMPHOEDEMA (felt swelling in arm and lymph) in a 53-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) for COVID-19 prophylaxis.     The patient had no medical history, concomitant disease or risk factor.     On 28-Sep-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (Intramuscular use) 1 dosage form. On 28-Sep-2023, the patient experienced BLISTER (Blisters on toes) and LYMPHOEDEMA (felt swelling in arm and lymph). At the time of the report, BLISTER (Blisters on toes) and LYMPHOEDEMA (felt swelling in arm and lymph) was resolving.        The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (Intramuscular use) was unknown.       Concomitant medication was not reported. Patient had blisters on toes that began around the time she felt swelling in arm and lymph. It was unknown if the patient experienced any additional symptoms/events. Treatment medication was not reported.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Photopsia, Pyrexia
Clinical narrative: flashes; fever; This spontaneous case was reported by a patient and describes the occurrence of PHOTOPSIA (flashes) and PYREXIA (fever) in a 73-year-old male patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. ASKU) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received fifth dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On 29-Sep-2023, the patient experienced PHOTOPSIA (flashes) and PYREXIA (fever). At the time of the report, PHOTOPSIA (flashes) and PYREXIA (fever) had not resolved.        For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not reported. Patient had fever and flashes in eyes. Treatment medication was not reported.
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Arthritis, Back pain, Disease recurrence, Systemic lupus erythematosus
Clinical narrative: Caused his lupus to reactivate; Caused his lupus to reactivate; Inflammation around the joints; Lower back pain; Severe hip pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 30-year-old male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 26Sep2023 at 12:30 as dose 1, single (Lot number: 1389554) at the age of 30 years, in right arm for COVID-19 immunisation. The patient's relevant medical history included: "hips replaced" (unspecified if ongoing), notes: 1 year prior to vaccine; "Lupus" (unspecified if ongoing). Concomitant medication(s) included: LOVENOX [LEVOFLOXACIN]. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The following information was reported: BACK PAIN (non-serious) with onset 27Sep2023 at 05:00, outcome "recovering", described as "Lower back pain"; ARTHRALGIA (non-serious) with onset 27Sep2023 at 05:00, outcome "recovering", described as "Severe hip pain"; SYSTEMIC LUPUS ERYTHEMATOSUS (medically significant), DISEASE RECURRENCE (medically significant), outcome "unknown" and all described as "Caused his lupus to reactivate"; ARTHRITIS (non-serious), outcome "unknown", described as "Inflammation around the joints". The events "caused his lupus to reactivate", "lower back pain", "severe hip pain" and "inflammation around the joints" required physician office visit. Therapeutic measures were not taken as a result of back pain, arthralgia. Additional information: The patient began to have hip and lower back pain on 27Sep2023 at 05:00. He woke up on 28Sep2023 to severe hip pain. He had both hips replaced 1 year prior to vaccine. He spoke to the doctor and the vaccine possibly caused inflammation around the joints or caused his lupus to reactivate.
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Acute kidney injury, Anaemia, Anticoagulation drug level above therapeutic, COVID-19, Chronic kidney disease
Clinical narrative: Brief Summary of Hospital Stay: (Include Significant Findings and Invasive Procedures)    Patient admitted with hypoxic respiratory failure related to COVID 19. She was also treated for possible bacterial coinfection. Noted also to have acute anemia thought likely due to supratherapeutic INR (on chronic warfarin therapy for afib and mechanical aortic valve replacement). She has a history of GI bleed, though this was not worked up as possible cause during this admission as her hgb stabilized without intervention, and INR is a known cause of anemia. Hgb monitored during hospitalization, she did not require transfusion.    Patient completed course of remdesivir,steroids, and a course of cefepime for possible CAP coinfection. Eventually weaned off of HFNC to nasal cannula. She was still very dyspneic with minimal exertion. Therapy teams recommended SNF for rehab; patient initially hesitant and wanting to go home, but did accept this as short term rehab. In the past few days she has continued to show marked improvement, I expect her to recover well from this. She is motivated to do well in therapy with the goal of home independently (lives with her son, though she has previously managed all her ADLs).    CKD3A with acute kidney injury noted, AKIN stage 1; resolved prior to discharge.
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea exertional, Haemoglobin abnormal, International normalised ratio abnormal, Respiratory failure, SARS-CoV-2 test positive
Clinical narrative: Brief Summary of Hospital Stay: (Include Significant Findings and Invasive Procedures)    Patient admitted with hypoxic respiratory failure related to COVID 19. She was also treated for possible bacterial coinfection. Noted also to have acute anemia thought likely due to supratherapeutic INR (on chronic warfarin therapy for afib and mechanical aortic valve replacement). She has a history of GI bleed, though this was not worked up as possible cause during this admission as her hgb stabilized without intervention, and INR is a known cause of anemia. Hgb monitored during hospitalization, she did not require transfusion.    Patient completed course of remdesivir,steroids, and a course of cefepime for possible CAP coinfection. Eventually weaned off of HFNC to nasal cannula. She was still very dyspneic with minimal exertion. Therapy teams recommended SNF for rehab; patient initially hesitant and wanting to go home, but did accept this as short term rehab. In the past few days she has continued to show marked improvement, I expect her to recover well from this. She is motivated to do well in therapy with the goal of home independently (lives with her son, though she has previously managed all her ADLs).    CKD3A with acute kidney injury noted, AKIN stage 1; resolved prior to discharge.
Age: 4.0
Sex: M
Vaccine: IPV, PNC13
Symptoms: Erythema, Pruritus
Clinical narrative: Patient received 2 vaccines, IPV and Prevnar 13 on 2/15/23 in office. On 2/17/23 mother brought the patient into the office to be seen due to patients right arm being red and itchy.   See below for chart notes from provider encounter: "Per mother child awoke with increased redness to his right arm Patient had vaccine placed 3 days ago Prevnar was placed to right arm and Polio was placed to left arm Patient has received these vaccines in the past without reaction Today the patient awoke with redness to arm. Mother did not notice a reaction right after the vaccine. Patient has also been outside and has had multiple insect bites to his arms."
Age: 56.0
Sex: F
Vaccine: FLUC4
Symptoms: Immediate post-injection reaction, Injection site pain, Loss of personal independence in daily activities, Shoulder injury related to vaccine administration, Sleep disorder
Clinical narrative: The pain started in the upper left arm right after the injection (which I felt was placed unusually high in the arm). I waited for it to stop after a couple of days, but 10 days later I was still in pain. It has not subsided ever since. The pain wakes me up several times every night. I can no longer perform normal tasks like looking at my wrist watch or putting my clothes on in a normal way or opening a car door with my shoulder. I can no longer do yoga or dancing. This has affected my health enormously.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Brain fog, Chills, Fatigue, Feeling hot
Clinical narrative: I woke up with a terrible back ache the 1st morning and I was extremely tired and lethargic. I continued to feel that way for 3 more days. On the 4th day, I was sneezing a lot and I am still sneezing a lot.  I have had chills, and then I am extremely hot.  My head felt very clouded throughout the 4 days after the vaccination.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Lethargy, Sneezing
Clinical narrative: I woke up with a terrible back ache the 1st morning and I was extremely tired and lethargic. I continued to feel that way for 3 more days. On the 4th day, I was sneezing a lot and I am still sneezing a lot.  I have had chills, and then I am extremely hot.  My head felt very clouded throughout the 4 days after the vaccination.
Age: 10.0
Sex: M
Vaccine: COVID19-2
Symptoms: Incorrect dose administered
Clinical narrative: 0.5ml dose instead of 0.25ml dose given to patient
Age: 73.0
Sex: F
Vaccine: COVID19-2
Symptoms: COVID-19
Clinical narrative: Was hospitalized for covid 09/24/2023
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 48-year-old female patient (not pregnant) received bnt162b2 (BNT162B2 NOS), on 09Oct2022 as dose number unknown, single (Batch/Lot number: unknown) at the age of 47 years for covid-19 immunisation. The patient's relevant medical history included: "Sulfa" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Sep2023, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Patient was treated with Paxlovid from 18Sep2023 to 22Sep2023.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 3.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect dose administered, Pain, Product preparation error, Pyrexia, Urine output decreased
Clinical narrative: Vaccine error: Patient received an undiluted dose of new covid booster. (3 times the dose) Per parents, patient developed a fever and some soreness, slight decreased urine output, but remained "largely ok"
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Expired product administered
Clinical narrative: Pt was given the vaccine on 10/03/23.    The expiration date  listed 010ct2023.  The vaccine given had expired
Age: 40.0
Sex: M
Vaccine: COVID19-2, FLU4
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: Developed Covid-19 8 days after vaccination
Age: 75.0
Sex: F
Vaccine: COVID19-2
Symptoms: Arthralgia, Blood test normal, Body temperature increased, Chills, Cough
Clinical narrative: She got her vaccine in her left wrist.  The following morning at 6:00 AM she noticed a grape sized lump inside her elbow on the left.  Slowly as the days, weeks and months have progressed the symptoms have exacerbated.  She initially noticed increased pain in the joints and muscles on the left.  Increased swelling that is increasing more and more.  At first she thought it was her post-polio.  She then started running low grade temps, chills, nausea, headaches which she never gets.  Also has coughing, red spots on her arm, red spots under the arm, and red spot on top of the wrist and under the wrist.  She went to her doctor for her symptoms, and he was most concerned for the swelling under the arm.  He sent her
Age: 75.0
Sex: F
Vaccine: COVID19-2
Symptoms: Erythema, Feeling hot, Gait disturbance, Headache, Incorrect route of product administration
Clinical narrative: She got her vaccine in her left wrist.  The following morning at 6:00 AM she noticed a grape sized lump inside her elbow on the left.  Slowly as the days, weeks and months have progressed the symptoms have exacerbated.  She initially noticed increased pain in the joints and muscles on the left.  Increased swelling that is increasing more and more.  At first she thought it was her post-polio.  She then started running low grade temps, chills, nausea, headaches which she never gets.  Also has coughing, red spots on her arm, red spots under the arm, and red spot on top of the wrist and under the wrist.  She went to her doctor for her symptoms, and he was most concerned for the swelling under the arm.  He sent her
Age: 75.0
Sex: F
Vaccine: COVID19-2
Symptoms: Joint swelling, Mammogram normal, Myalgia, Nausea, Swollen tongue
Clinical narrative: She got her vaccine in her left wrist.  The following morning at 6:00 AM she noticed a grape sized lump inside her elbow on the left.  Slowly as the days, weeks and months have progressed the symptoms have exacerbated.  She initially noticed increased pain in the joints and muscles on the left.  Increased swelling that is increasing more and more.  At first she thought it was her post-polio.  She then started running low grade temps, chills, nausea, headaches which she never gets.  Also has coughing, red spots on her arm, red spots under the arm, and red spot on top of the wrist and under the wrist.  She went to her doctor for her symptoms, and he was most concerned for the swelling under the arm.  He sent her
Age: 88.0
Sex: F
Vaccine: FLU4
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient presented to the office requesting a flu shot. Patient was given the Fluzone High-Dose vaccine. After administering the vaccine, while pulling records to provide the patient with information she was requesting about a prior vaccine, it was shown the patient to have just received a high-dose flu shot the month prior at a local pharmacy. No side effects have been reported at this time.
Age: 54.0
Sex: F
Vaccine: VARZOS, VARCEL
Symptoms: Skin infection
Clinical narrative: Patient report a skin infection, was seen at Doctor's office then reported this to us
Age: 54.0
Sex: F
Vaccine: VARZOS, VARCEL
Symptoms: Cellulitis, Chills, Erythema, Feeling hot, Headache
Clinical narrative: Patient report a skin infection, was seen at Doctor's office then reported this to us
Age: 54.0
Sex: F
Vaccine: VARZOS, VARCEL
Symptoms: Pain, Pain in extremity, Pyrexia, Swelling
Clinical narrative: Patient report a skin infection, was seen at Doctor's office then reported this to us
Age: 54.0
Sex: F
Vaccine: VARZOS, VARCEL
Symptoms: Skin infection
Clinical narrative: fever, chills, headache, body aches , arm pain, swelling, redness , heat , and. Diagnosed  with cellulitis on 10-3-2023
Age: 54.0
Sex: F
Vaccine: VARZOS, VARCEL
Symptoms: Cellulitis, Chills, Erythema, Feeling hot, Headache
Clinical narrative: fever, chills, headache, body aches , arm pain, swelling, redness , heat , and. Diagnosed  with cellulitis on 10-3-2023
Age: 54.0
Sex: F
Vaccine: VARZOS, VARCEL
Symptoms: Pain, Pain in extremity, Pyrexia, Swelling
Clinical narrative: fever, chills, headache, body aches , arm pain, swelling, redness , heat , and. Diagnosed  with cellulitis on 10-3-2023
Age: 86.0
Sex: F
Vaccine: FLU4, PNC20
Symptoms: Dizziness, Erythema, Injection site erythema, Injection site swelling, Night sweats
Clinical narrative: Left arm red from shoulder to wrist, swollen at immunization site, raised red at immunization site, night sweats, dizziness
Age: 8.0
Sex: F
Vaccine: FLU4
Symptoms: Loss of consciousness
Clinical narrative: CHILD RECEIVED VACCINE AND THEN PASSED OUT AFTER VACCINATION.  MOTHER LOWERED HER TO THE GROUND AT ENTRANCE OF CLINIC WHERE THE FLU CLINIC WAS BEING HELD AND CALLED FOR ASSISTANCE.  MOTHER REPORTED PER FORM THAT CHILD WAS ANXIOUS ABOUT GETTING VACCINATED TODAY.  CHILD AWAKENED AS SOON AS STAFF MADE IT OVER TO MOTHER TO ASSIST HER.  CHILD SAID SHE WAS FINE.  GIVEN APPLE JUICE AND A CRACKER.  BP 92/60.  SAT UP AND THEN STOOD UP WITHOUT ANY DIFFICULTY.  OFFERED TO CALL EMS, MOTHER DECLINED. TOLD MOTHER SHE COULD TAKE HER TO THE DOCTOR TO GET CHECKED OUT IF SHE WANTED BUT TO KEEP AN EYE ON CHILD AND FOLLOW UP WITH PCP IF NEEDED.  VOICED UNDERSTANDING.  ALSO TOLD MOTHER TO LET PROVIDERS KNOW OF FAINTING INCIDENT AT FUTURE APPTS.  ATTEMPTED TO CALL MOTHER NEXT DAY ON 10/3/23 AND LEFT VOICEMAIL TO CHECK IN ON CLIENT.
Age: 67.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Arthralgia, Chills, Decreased appetite, Dizziness, Dysstasia
Clinical narrative: She got her vaccines, left the doctors office afterwards and went to the grocery store.  Came home, unloaded and put away her groceries and said at the time to her sister who was there, told her that shd did not feel too good and was going to go upstairs and lay down, which she did for about an hour or so.  Her stomach was sort of queazy and did not feel good.  Already had a headache between the time of the vaccine and getting home.  She got up and came down the stairs (3), and walked into the kitchen and she took a bite of some chicken and mid chew she spit it into the sink as she felt really bad, and felt tht it was not right and tried to call out to her sister and fainted.  Her sister was trying to bring her arouaround, and her sister said that before she came to she was mumbling, garbled but her eyes rolled out and felt that she was going to pass out again.  Her sister let her lay there and come conscience.  Probably 1-2 minutes later she said that she was OK, but that she needed something as she was soaking wet from sweating.  She got her a cold wet rag to put around her neck, and she laid on the floor for 15 minutes before she could get her wits to get up.  She has had 2 knee replacements and did not want to kneel and she pulled herself up when she had a thick foam dog bed to get up.  She could not get her legs under her so sat in the chair for 15 minutes.  She does not know if when she fainted her knee overextended or her knee overextended and that she had pain.  Then her sister helped her walk into the living room and sit in her lazy boy.  She then got chills, and then around an hour later she took some Tylenol and went to bed.  She was then in bed for 3 full days.  Her muscles hurt, she was tired and lethargic and thought that her head was going to explode as it hurt so bad.  She did not want to eat as she felt so bad.  She did not call her doctor.  Her knee was doing fine until she fell, she had total knee replacements 2 years and 7 years ago and now they are in severe pain.    Her sister and herself could not figure out what caused her to faint.  She just happened to notice that Shingrix pamphlet and read it and knew that it was due to that vaccine as the literature mentionend it.  It showed all the issues that she had had, and how she felt before and after.  She has regained some of her appetite, but not really hungry.
Age: 67.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Eye movement disorder, Fall, Fatigue, Feeling abnormal, Headache
Clinical narrative: She got her vaccines, left the doctors office afterwards and went to the grocery store.  Came home, unloaded and put away her groceries and said at the time to her sister who was there, told her that shd did not feel too good and was going to go upstairs and lay down, which she did for about an hour or so.  Her stomach was sort of queazy and did not feel good.  Already had a headache between the time of the vaccine and getting home.  She got up and came down the stairs (3), and walked into the kitchen and she took a bite of some chicken and mid chew she spit it into the sink as she felt really bad, and felt tht it was not right and tried to call out to her sister and fainted.  Her sister was trying to bring her arouaround, and her sister said that before she came to she was mumbling, garbled but her eyes rolled out and felt that she was going to pass out again.  Her sister let her lay there and come conscience.  Probably 1-2 minutes later she said that she was OK, but that she needed something as she was soaking wet from sweating.  She got her a cold wet rag to put around her neck, and she laid on the floor for 15 minutes before she could get her wits to get up.  She has had 2 knee replacements and did not want to kneel and she pulled herself up when she had a thick foam dog bed to get up.  She could not get her legs under her so sat in the chair for 15 minutes.  She does not know if when she fainted her knee overextended or her knee overextended and that she had pain.  Then her sister helped her walk into the living room and sit in her lazy boy.  She then got chills, and then around an hour later she took some Tylenol and went to bed.  She was then in bed for 3 full days.  Her muscles hurt, she was tired and lethargic and thought that her head was going to explode as it hurt so bad.  She did not want to eat as she felt so bad.  She did not call her doctor.  Her knee was doing fine until she fell, she had total knee replacements 2 years and 7 years ago and now they are in severe pain.    Her sister and herself could not figure out what caused her to faint.  She just happened to notice that Shingrix pamphlet and read it and knew that it was due to that vaccine as the literature mentionend it.  It showed all the issues that she had had, and how she felt before and after.  She has regained some of her appetite, but not really hungry.