chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 75.0
Sex: M
Vaccine: COVID19, COVID19, UNK, COVID19
Symptoms: Blood urea, COVID-19, Drug ineffective, Dyspnoea, Electrocardiogram
Clinical narrative: he woke up and his sugars were in the 90s; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 75-year-old male patient received BNT162b2 (BNT162B2), on 26Oct2021 as dose 3 (booster), single (Lot number: FG3527) at the age of 75 years, in left arm for covid-19 immunisation; insulin detemir (LEVEMIR), (Batch/Lot number: unknown). The patient's relevant medical history included: "SIBO" (unspecified if ongoing); "High Blood Urea Nitrogen" (unspecified if ongoing); "Type 1 diabetes mellitus" (unspecified if ongoing); "Diabetes" (unspecified if ongoing). Concomitant medication(s) included: NOVOLOG taken for diabetes mellitus; HUMALOG taken for diabetes mellitus. Vaccination history included: BNT162b2 (Dose 1, single, Batch/Lot: EN6208), administration date: 15Mar2021, when the patient was 74-year-old, for COVID-19 immunization; BNT162b2 (Dose 2, single, Batch/Lot: ER8737), administration date: 05Apr2021, when the patient was 74-year-old, for COVID-19 immunization, reaction(s): "Blood Sugar in 20s; Diabetic Coma", "in May2021 he started having the following side effect of totally random plunges in his blood sugars after taking his Levemir", "he didn't go to the ER after his car accident on 14Aug2021", "irregular heart beat". The following information was reported: BLOOD GLUCOSE DECREASED (medically significant), outcome "unknown", described as "he woke up and his sugars were in the 90s". The events "he woke up and his sugars were in the 90s" required physician office visit. The patient underwent the following laboratory tests and procedures: Blood glucose abnormal: (unspecified date) 40, notes: go down to 40; (unspecified date) 20, notes: blood sugar of 20; (unspecified date) 117, notes: blood sugar was 117; (May2021) Random piunges; Electrocardiogram: (unspecified date) 44 bpm. The action taken for insulin detemir was unknown. Therapeutic measures were taken as a result of blood glucose decreased.  Clinical Course: Reported as, patient stated in October it happened another time, he woke up and his sugars were in the 90s and he took his 24 hour insulin and he had been stable over night as determined by his every 5 minute continuous monitor and at about 7:10a.m. he was standing in line at buffet and the next thing he knows the paramedics are giving him sugar through an IV because his blood sugar was just below 20. Caller states he is used to well controlled sugars and he tries to keep them in the 70s, but he can tolerate down to 40. Patient stated they gave him the IV sugar feed and then he was fine.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200809903 Same patient, different event/drug;US-PFIZER INC-202200811600 Same patient, different event/dose;
Age: 75.0
Sex: M
Vaccine: COVID19, COVID19, UNK, COVID19
Symptoms: Nasopharyngitis, SARS-CoV-2 test
Clinical narrative: he woke up and his sugars were in the 90s; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 75-year-old male patient received BNT162b2 (BNT162B2), on 26Oct2021 as dose 3 (booster), single (Lot number: FG3527) at the age of 75 years, in left arm for covid-19 immunisation; insulin detemir (LEVEMIR), (Batch/Lot number: unknown). The patient's relevant medical history included: "SIBO" (unspecified if ongoing); "High Blood Urea Nitrogen" (unspecified if ongoing); "Type 1 diabetes mellitus" (unspecified if ongoing); "Diabetes" (unspecified if ongoing). Concomitant medication(s) included: NOVOLOG taken for diabetes mellitus; HUMALOG taken for diabetes mellitus. Vaccination history included: BNT162b2 (Dose 1, single, Batch/Lot: EN6208), administration date: 15Mar2021, when the patient was 74-year-old, for COVID-19 immunization; BNT162b2 (Dose 2, single, Batch/Lot: ER8737), administration date: 05Apr2021, when the patient was 74-year-old, for COVID-19 immunization, reaction(s): "Blood Sugar in 20s; Diabetic Coma", "in May2021 he started having the following side effect of totally random plunges in his blood sugars after taking his Levemir", "he didn't go to the ER after his car accident on 14Aug2021", "irregular heart beat". The following information was reported: BLOOD GLUCOSE DECREASED (medically significant), outcome "unknown", described as "he woke up and his sugars were in the 90s". The events "he woke up and his sugars were in the 90s" required physician office visit. The patient underwent the following laboratory tests and procedures: Blood glucose abnormal: (unspecified date) 40, notes: go down to 40; (unspecified date) 20, notes: blood sugar of 20; (unspecified date) 117, notes: blood sugar was 117; (May2021) Random piunges; Electrocardiogram: (unspecified date) 44 bpm. The action taken for insulin detemir was unknown. Therapeutic measures were taken as a result of blood glucose decreased.  Clinical Course: Reported as, patient stated in October it happened another time, he woke up and his sugars were in the 90s and he took his 24 hour insulin and he had been stable over night as determined by his every 5 minute continuous monitor and at about 7:10a.m. he was standing in line at buffet and the next thing he knows the paramedics are giving him sugar through an IV because his blood sugar was just below 20. Caller states he is used to well controlled sugars and he tries to keep them in the 70s, but he can tolerate down to 40. Patient stated they gave him the IV sugar feed and then he was fine.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200809903 Same patient, different event/drug;US-PFIZER INC-202200811600 Same patient, different event/dose;
Age: 75.0
Sex: M
Vaccine: COVID19, COVID19, UNK, COVID19
Symptoms: Blood glucose abnormal, Blood glucose decreased, Electrocardiogram
Clinical narrative: he woke up and his sugars were in the 90s; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 75-year-old male patient received BNT162b2 (BNT162B2), on 26Oct2021 as dose 3 (booster), single (Lot number: FG3527) at the age of 75 years, in left arm for covid-19 immunisation; insulin detemir (LEVEMIR), (Batch/Lot number: unknown). The patient's relevant medical history included: "SIBO" (unspecified if ongoing); "High Blood Urea Nitrogen" (unspecified if ongoing); "Type 1 diabetes mellitus" (unspecified if ongoing); "Diabetes" (unspecified if ongoing). Concomitant medication(s) included: NOVOLOG taken for diabetes mellitus; HUMALOG taken for diabetes mellitus. Vaccination history included: BNT162b2 (Dose 1, single, Batch/Lot: EN6208), administration date: 15Mar2021, when the patient was 74-year-old, for COVID-19 immunization; BNT162b2 (Dose 2, single, Batch/Lot: ER8737), administration date: 05Apr2021, when the patient was 74-year-old, for COVID-19 immunization, reaction(s): "Blood Sugar in 20s; Diabetic Coma", "in May2021 he started having the following side effect of totally random plunges in his blood sugars after taking his Levemir", "he didn't go to the ER after his car accident on 14Aug2021", "irregular heart beat". The following information was reported: BLOOD GLUCOSE DECREASED (medically significant), outcome "unknown", described as "he woke up and his sugars were in the 90s". The events "he woke up and his sugars were in the 90s" required physician office visit. The patient underwent the following laboratory tests and procedures: Blood glucose abnormal: (unspecified date) 40, notes: go down to 40; (unspecified date) 20, notes: blood sugar of 20; (unspecified date) 117, notes: blood sugar was 117; (May2021) Random piunges; Electrocardiogram: (unspecified date) 44 bpm. The action taken for insulin detemir was unknown. Therapeutic measures were taken as a result of blood glucose decreased.  Clinical Course: Reported as, patient stated in October it happened another time, he woke up and his sugars were in the 90s and he took his 24 hour insulin and he had been stable over night as determined by his every 5 minute continuous monitor and at about 7:10a.m. he was standing in line at buffet and the next thing he knows the paramedics are giving him sugar through an IV because his blood sugar was just below 20. Caller states he is used to well controlled sugars and he tries to keep them in the 70s, but he can tolerate down to 40. Patient stated they gave him the IV sugar feed and then he was fine.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200809903 Same patient, different event/drug;US-PFIZER INC-202200811600 Same patient, different event/dose;
Age: 75.0
Sex: M
Vaccine: COVID19, COVID19, UNK, COVID19
Symptoms: Cardiac flutter, Dyspnoea
Clinical narrative: he woke up and his sugars were in the 90s; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 75-year-old male patient received BNT162b2 (BNT162B2), on 26Oct2021 as dose 3 (booster), single (Lot number: FG3527) at the age of 75 years, in left arm for covid-19 immunisation; insulin detemir (LEVEMIR), (Batch/Lot number: unknown). The patient's relevant medical history included: "SIBO" (unspecified if ongoing); "High Blood Urea Nitrogen" (unspecified if ongoing); "Type 1 diabetes mellitus" (unspecified if ongoing); "Diabetes" (unspecified if ongoing). Concomitant medication(s) included: NOVOLOG taken for diabetes mellitus; HUMALOG taken for diabetes mellitus. Vaccination history included: BNT162b2 (Dose 1, single, Batch/Lot: EN6208), administration date: 15Mar2021, when the patient was 74-year-old, for COVID-19 immunization; BNT162b2 (Dose 2, single, Batch/Lot: ER8737), administration date: 05Apr2021, when the patient was 74-year-old, for COVID-19 immunization, reaction(s): "Blood Sugar in 20s; Diabetic Coma", "in May2021 he started having the following side effect of totally random plunges in his blood sugars after taking his Levemir", "he didn't go to the ER after his car accident on 14Aug2021", "irregular heart beat". The following information was reported: BLOOD GLUCOSE DECREASED (medically significant), outcome "unknown", described as "he woke up and his sugars were in the 90s". The events "he woke up and his sugars were in the 90s" required physician office visit. The patient underwent the following laboratory tests and procedures: Blood glucose abnormal: (unspecified date) 40, notes: go down to 40; (unspecified date) 20, notes: blood sugar of 20; (unspecified date) 117, notes: blood sugar was 117; (May2021) Random piunges; Electrocardiogram: (unspecified date) 44 bpm. The action taken for insulin detemir was unknown. Therapeutic measures were taken as a result of blood glucose decreased.  Clinical Course: Reported as, patient stated in October it happened another time, he woke up and his sugars were in the 90s and he took his 24 hour insulin and he had been stable over night as determined by his every 5 minute continuous monitor and at about 7:10a.m. he was standing in line at buffet and the next thing he knows the paramedics are giving him sugar through an IV because his blood sugar was just below 20. Caller states he is used to well controlled sugars and he tries to keep them in the 70s, but he can tolerate down to 40. Patient stated they gave him the IV sugar feed and then he was fine.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200809903 Same patient, different event/drug;US-PFIZER INC-202200811600 Same patient, different event/dose;
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Headache, Pain in extremity
Clinical narrative: Soreness in the left arm; Headache; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (Soreness in the left arm) and HEADACHE (Headache) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for COVID-19 vaccination.     The patient had no allergies and patient never had COVID positive test or diagnosis.     On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Soreness in the left arm) and HEADACHE (Headache). At the time of the report, PAIN IN EXTREMITY (Soreness in the left arm) and HEADACHE (Headache) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No concomitant medication was reported. The patient received Moderna COVID-19 Vaccine second dose on 12-Apr-2021 with lot number 036B21A. No treatment medications was reported.   This case was linked to MOD-2022-586322, MOD-2022-586329, MOD-2022-586331 (Patient Link).
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Neck pain, Swelling, Vaccination site swelling
Clinical narrative: Soreness in the left arm; Headache; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (Soreness in the left arm) and HEADACHE (Headache) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for COVID-19 vaccination.     The patient had no allergies and patient never had COVID positive test or diagnosis.     On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Soreness in the left arm) and HEADACHE (Headache). At the time of the report, PAIN IN EXTREMITY (Soreness in the left arm) and HEADACHE (Headache) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No concomitant medication was reported. The patient received Moderna COVID-19 Vaccine second dose on 12-Apr-2021 with lot number 036B21A. No treatment medications was reported.   This case was linked to MOD-2022-586322, MOD-2022-586329, MOD-2022-586331 (Patient Link).
Age: 53.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Headache, Pain in extremity
Clinical narrative: swollen on the left side of the neck; soreness on the left side of their neck; swollen is on the side where she got the shot; This spontaneous case was reported by a patient and describes the occurrence of SWELLING (swollen on the left side of the neck), NECK PAIN (soreness on the left side of their neck) and VACCINATION SITE SWELLING (swollen is on the side where she got the shot) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 058A222A, 034F21A, 036B21A and 038A21A) for COVID-19 prophylaxis.     The patient had no know allergies (medications, food and other products). The patient never had COVID positive test or diagnosis. The patient did not have both acute and chronic illnesses at the time of vaccination. The patient did not receive any other vaccines within 1 month prior to Moderna COVID-19 vaccine.    On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Jun-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Jun-2022, the patient experienced SWELLING (swollen on the left side of the neck), NECK PAIN (soreness on the left side of their neck) and VACCINATION SITE SWELLING (swollen is on the side where she got the shot). At the time of the report, SWELLING (swollen on the left side of the neck), NECK PAIN (soreness on the left side of their neck) and VACCINATION SITE SWELLING (swollen is on the side where she got the shot) outcome was unknown.            Concomitant medication of the patient was not reported.  The patient reported that those events were different from the other vaccination because they did not have a headache. The patient did not seek medical care (office visit, urgent care, ER visit and hospitalized) as well the patient did not experience a similar event in the past. It was not known if the symptoms of the patient were improved or worsened  No treatment information was provided by the reporter.
Age: 53.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Neck pain, Swelling, Vaccination site swelling
Clinical narrative: swollen on the left side of the neck; soreness on the left side of their neck; swollen is on the side where she got the shot; This spontaneous case was reported by a patient and describes the occurrence of SWELLING (swollen on the left side of the neck), NECK PAIN (soreness on the left side of their neck) and VACCINATION SITE SWELLING (swollen is on the side where she got the shot) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 058A222A, 034F21A, 036B21A and 038A21A) for COVID-19 prophylaxis.     The patient had no know allergies (medications, food and other products). The patient never had COVID positive test or diagnosis. The patient did not have both acute and chronic illnesses at the time of vaccination. The patient did not receive any other vaccines within 1 month prior to Moderna COVID-19 vaccine.    On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Jun-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Jun-2022, the patient experienced SWELLING (swollen on the left side of the neck), NECK PAIN (soreness on the left side of their neck) and VACCINATION SITE SWELLING (swollen is on the side where she got the shot). At the time of the report, SWELLING (swollen on the left side of the neck), NECK PAIN (soreness on the left side of their neck) and VACCINATION SITE SWELLING (swollen is on the side where she got the shot) outcome was unknown.            Concomitant medication of the patient was not reported.  The patient reported that those events were different from the other vaccination because they did not have a headache. The patient did not seek medical care (office visit, urgent care, ER visit and hospitalized) as well the patient did not experience a similar event in the past. It was not known if the symptoms of the patient were improved or worsened  No treatment information was provided by the reporter.
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Headache, Pain in extremity
Clinical narrative: With all the other vaccines they did got a headache and soreness in the left arm.; With all the other vaccines they did got a headache and soreness in the left arm.; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (With all the other vaccines they did got a headache and soreness in the left arm.) and HEADACHE (With all the other vaccines they did got a headache and soreness in the left arm.) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 034F21A, 036B21A and 038A21A) for COVID-19 vaccination.     The patient had no allergies to medications, food, and other products.  The patient never ever had COVID + test or diagnosis. The patient had no medical history relating to the mentioned adverse event and both Acute and Chronic illnesses at the time of vaccination. No other vaccines were given within 1 month prior to Moderna COVID-19 vaccine.    On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (With all the other vaccines they did got a headache and soreness in the left arm.) and HEADACHE (With all the other vaccines they did got a headache and soreness in the left arm.). At the time of the report, PAIN IN EXTREMITY (With all the other vaccines they did got a headache and soreness in the left arm.) and HEADACHE (With all the other vaccines they did got a headache and soreness in the left arm.) outcome was unknown.            No Concomitant product use was reported.  It was reported that the adverse event didn't cause the patient to seek medical care and the patient had not experienced a similar event in the past. On 01-Dec-2021, the patient received their first booster dose.  No treatment information was provided.   This case was linked to MOD-2022-586334, MOD-2022-586331, MOD-2022-586322 (Patient Link).
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Neck pain, Swelling, Vaccination site swelling
Clinical narrative: With all the other vaccines they did got a headache and soreness in the left arm.; With all the other vaccines they did got a headache and soreness in the left arm.; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (With all the other vaccines they did got a headache and soreness in the left arm.) and HEADACHE (With all the other vaccines they did got a headache and soreness in the left arm.) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 034F21A, 036B21A and 038A21A) for COVID-19 vaccination.     The patient had no allergies to medications, food, and other products.  The patient never ever had COVID + test or diagnosis. The patient had no medical history relating to the mentioned adverse event and both Acute and Chronic illnesses at the time of vaccination. No other vaccines were given within 1 month prior to Moderna COVID-19 vaccine.    On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (With all the other vaccines they did got a headache and soreness in the left arm.) and HEADACHE (With all the other vaccines they did got a headache and soreness in the left arm.). At the time of the report, PAIN IN EXTREMITY (With all the other vaccines they did got a headache and soreness in the left arm.) and HEADACHE (With all the other vaccines they did got a headache and soreness in the left arm.) outcome was unknown.            No Concomitant product use was reported.  It was reported that the adverse event didn't cause the patient to seek medical care and the patient had not experienced a similar event in the past. On 01-Dec-2021, the patient received their first booster dose.  No treatment information was provided.   This case was linked to MOD-2022-586334, MOD-2022-586331, MOD-2022-586322 (Patient Link).
Age: 59.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Back pain, Impaired work ability, Injection site pain, Neck pain, Oedema peripheral
Clinical narrative: moderna x2 followed by pfizer. Pain swelling of arm  and axilla after vaccination followed by flair of arthritis and frozen shoulder
Age: 59.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Pain, Pain in extremity, Periarthritis, Peripheral swelling, Rash
Clinical narrative: moderna x2 followed by pfizer. Pain swelling of arm  and axilla after vaccination followed by flair of arthritis and frozen shoulder
Age: 59.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Sleep disorder, Swelling
Clinical narrative: moderna x2 followed by pfizer. Pain swelling of arm  and axilla after vaccination followed by flair of arthritis and frozen shoulder
Age: 59.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Arthritis, Interchange of vaccine products, Oedema peripheral, Pain in extremity, Periarthritis
Clinical narrative: moderna x2 followed by pfizer. Pain swelling of arm  and axilla after vaccination followed by flair of arthritis and frozen shoulder
Age: 59.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Peripheral swelling, Ultrasound Doppler, X-ray limb
Clinical narrative: moderna x2 followed by pfizer. Pain swelling of arm  and axilla after vaccination followed by flair of arthritis and frozen shoulder
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Joint range of motion decreased, Neck pain, Pain in extremity
Clinical narrative: Patient stated start having pain in arm after received vaccine, severity is increasing with limited range of motion, pain now spread to her neck all the way to hand. Referred pt to see primary care physician .
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Pain in extremity, Pyrexia
Clinical narrative: Fever 100.6 and rising. Sore arm. Tired
Age: 25.0
Sex: M
Vaccine: COVID19
Symptoms: Axillary pain, Blood test, Chest X-ray, Chest pain, Chills
Clinical narrative: Among classic COVID-19 vaccine symptoms (fever, chills, body aches), chest pain showed up on 3/18/22.  Got worse and peaked on 3/19/22.  Felt well enough (with heavy aspirin and acetaminophen dose) to go skiing on 3/20/22, which must have aggregated it.  Felt much worse on 3/21/22 and felt bad enough to to into ER thinking it could be pericarditis.  Diagnosed as likely costochondritis likely caused by vaccine by physicians at ER.  Pain concentrated around sternum around to under left armpit.
Age: 25.0
Sex: M
Vaccine: COVID19
Symptoms: Costochondritis, Feeling abnormal, Malaise, Pain, Pyrexia
Clinical narrative: Among classic COVID-19 vaccine symptoms (fever, chills, body aches), chest pain showed up on 3/18/22.  Got worse and peaked on 3/19/22.  Felt well enough (with heavy aspirin and acetaminophen dose) to go skiing on 3/20/22, which must have aggregated it.  Felt much worse on 3/21/22 and felt bad enough to to into ER thinking it could be pericarditis.  Diagnosed as likely costochondritis likely caused by vaccine by physicians at ER.  Pain concentrated around sternum around to under left armpit.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Headache, Pain in extremity
Clinical narrative: Slight headache and sore arm in the evening, and lower backache the following day.  Pain lessening on the fourth day.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Oropharyngeal pain, Rhinorrhoea, SARS-CoV-2 test positive
Clinical narrative: No adverse event per se. had sore throat and funny nose. Rapid antigen test was positive so had to notify medical staff on cruise ship.  They confirmed positivity via PCR test and immediately initiated my isolation for 6 days with release after negative test
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Amenorrhoea, Ovulation disorder
Clinical narrative: Loss of period, slowed ovulation cycle persistent for at least 1 year
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse event; Vaccine coordinator is reporting the administration of improperly stored vaccines to unknown patients after the temperature excursion on 20JAN2022.; This spontaneous report was received from a vaccine coordinator and refers to a patient of unknown age and gender.  The patient's pertinent medical history, drug reactions or allergies, and concomitant therapies were not reported.  On 20-JAN-2022, the patient was vaccinated with varicella virus vaccine live (Oka/Merck) (VARIVAX) dose 1, lot #U020244, expiration date: 28-JUN-2023, (strength, route of administration and anatomical location were not provided) that underwent a temperature excursion in -14 degree Celsius (C)  for 7 hours (Product storage error). No additional adverse event (AE) was reported.   This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2205USA004997:02167739 US-009507513-2205USA005084:02167789 US-009507513-2205USA005067:02167643 US-009507513-2205USA005130:02167643 US-009507513-2205USA004990:02167746 US-009507513-2205USA005126:02167756 US-009507513-2205USA005023:02167763 US-009507513-2205USA005071:02167774 US-009507513-2205USA005229:02167797
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported; Vaccine coordinator is reporting the administration of improperly stored vaccines to unknown patients after the temperature excursion on 20JAN2022.; This spontaneous report was received from a vaccine coordinator and refers to a patient of unknown age and gender  The patient's pertinent medical history, drug reactions or allergies, and concomitant therapies were not reported.   On an unknown date in 2022,  the patient was vaccinated with measles, mumps, rubella, and varicella (oka-merck) virus vaccine live (recombinant human albumin - rHA) (PROQUAD) subcutaneous injection, lot #U017138, expiration date: 28-NOV-2022, administered for prophylaxis (strength, and route of administration were not provided) that was improperly stored on 20-JAN-2022, and had a temperature excursion of -14C for 7 hours. No additional adverse events reported.   This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2205USA004997: US-009507513-2205USA005002:02167763 US-009507513-2205USA005067:02167763 US-009507513-2205USA005084: US-009507513-2205USA005130: US-009507513-2205USA005071: US-009507513-2205USA005126: US-009507513-2205USA005229:
Age: 1.0
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AEs reported; two doses of an expired vaccine were administered to two different patients; This spontaneous report was received from a nurse referring to a 12-month-old patient of unknown gender. Information regarding the patient's pertinent medical history, concomitant medications, concurrent conditions, and previous drug reactions or allergies was not applicable.  On 11-MAY-2022, the patient was vaccinated with the expired hepatitis A vaccine, inactivated (VAQTA) intramuscular injection, (lot #T033304, expiration date: 02-APR-2022; strength, dose, and route of administration were not provided), administered for prophylaxis (Expired product administered). No adverse effects were noted (No adverse event). No additional AEs reported. No product quality compliant (PQC).  This is one of two reports received from the same reporter. ; Sender's Comments:  US-009507513-2205USA005489:
Age: 23.0
Sex: F
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported; improperly stored vaccines were administered.; This spontaneous report was received from a nurse concerning a 23-year-old female patient. The patient's medical history, concurrent conditions, and concomitant medications were not provided.   On 16-MAY-2022, there was a temperature excursion reported for measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rHA) (M-M-R II), which was improperly stored at 13.8 Celcius degrees, for 7 hours and 30 minutes. There was no previous temperature excursion.  On 20-MAY-2022, the patient was vaccinated with improperly stored measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rHA) (M-M-R II) subcutaneous injection,  lot # U007684, expiration date 09-MAR-2023 (strength, dose, route of administration, and anatomical location were not provided) administered for prophylaxis (product storage error). No additional adverse events were reported.   This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2205USA007635: US-009507513-2205USA007943:
Age: 4.0
Sex: F
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: Device or device component malfunction; No adverse event; Temperature excursion occurred 23-MAR-2022/given to patient; This spontaneous report was received from a medical assistant and refers to a 4-year-old female patient. No information regarding the patient's concurrent conditions, medical history and concomitant medications was provided.  On 28-MAR-2022, the patient was vaccinated with the second, improperly stored (product storage error) dose of varicella virus vaccine live (oka/merck) (VARIVAX) lot #: U025790, expiration date: 19-AUG-2023, administered subcutaneously(sq) (exact dose, site of administration were not provided) for prophylaxis. Malfunction of device or device component was reported (device malfunction), however no device was involved. Temperature excursion information: -14 degree Celsius up to -10 degrees Celsius for 3 hours. There was no previous temperature excursion. Temperature excursion occurred as a result of a reading from a Data Logger. No additional adverse event was reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2204USA009330:
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: No adverse event, Overdose
Clinical narrative: Per caller the patient has not reported any issues or concerns.; Customer called to report that a patient was administered PROQUAD and VARIVAX in the same day about two weeks ago.; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's medical history, concomitant therapies and concurrent conditions were not provided.  On approximately 13-MAY-2022, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) subcutaneous injection and varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection (strength, dose, dose number, route of administration, anatomical location, lot # and expiration date were not provided for both) for prophylaxis (overdose). The patient had not reported any issues or concerns (no adverse event).
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects or symptoms following administration; VARIVAX was administered following temperature excursion.; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. Information regarding the patient's pertinent medical history, concomitant medications, and drug reactions or allergies was not provided by the reporter.  On 15-MAY-2022, the vaccine underwent a temperature excursion of 6 Fahrenheit (F) during 7 minutes. There was no previous temperature excursion. Following the temperature excursion, on 27-MAY-2022, the patient received a dose of varicella virus vaccine live (oka/merck) (VARIVAX) 0.5 mL, lot# U020244 with expiration date 28-JUN-2023 (strength and route of administration was not reported), administered for prophylaxis. No adverse effects or symptoms following administration.; Sender's Comments:  US-009507513-2206USA001318: US-009507513-2206USA001331: US-009507513-2206USA001347: US-009507513-2206USA001555: US-009507513-2206USA001558: US-009507513-2206USA001561:
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: VARIVAX was administered following temperature excursion.; No adverse effects or symptoms following administration; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. Information regarding the patient's pertinent medical history, concomitant medications, and drug reactions or allergies was not provided by the reporter.  On 15-MAY-2022, the vaccine underwent a temperature excursion of 6 Fahrenheit (F) for 7 minutes. There was no previous temperature excursion. Following the temperature excursion, on 23-MAY-2022, the patient received a dose of varicella virus vaccine live (oka/merck) (VARIVAX) 0.5 mL, lot# U020244 with expiration date 28-JUN-2023 (strength and route of administration was not reported), administered for prophylaxis. No adverse effects or symptoms following administration.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2206USA001549: US-009507513-2206USA001561: US-009507513-2206USA001318: US-009507513-2206USA001331: US-009507513-2206USA001347: US-009507513-2206USA001558:
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: VARIVAX was administered following temperature excursion.; No adverse effects or symptoms following administration; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. Information regarding the patient's pertinent medical history, concomitant medications, and drug reactions or allergies was not provided by the reporter.  On 15-MAY-2022, the vaccine underwent a temperature excursion of 6 Fahrenheit (F) for 7 minutes. There was no previous temperature excursion. Following the temperature excursion, on 26-MAY-2022, the patient received a dose of varicella virus vaccine live (oka/merck) (VARIVAX) 0.5 mL, lot# U020244 with expiration date 28-JUN-2023 (strength and route of administration was not reported), administered for prophylaxis. No adverse effects or symptoms following administration.  This is one of several reports received from the same reporter. ; Sender's Comments:  US-009507513-2206USA001561: US-009507513-2206USA001549: US-009507513-2206USA001318: US-009507513-2206USA001331: US-009507513-2206USA001347: US-009507513-2206USA001555:
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: VARIVAX was administered following temperature excursion; No adverse effects or symptoms following administration; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. Information regarding the patient's pertinent medical history, concomitant medications, and drug reactions or allergies was not provided by the reporter.  On 15-MAY-2022, the vaccine underwent a temperature excursion of 6 Fahrenheit (F) for 7 minutes. There was no previous temperature excursion. Following the temperature excursion, on 02-JUN-2022, the patient received a dose of varicella virus vaccine live (oka/merck) (VARIVAX) 0.5 mL, lot# U020244 with expiration date 28-JUN-2023 (strength and route of administration was not reported), administered for prophylaxis. No adverse effects or symptoms following administration.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2206USA001549: US-009507513-2206USA001318: US-009507513-2206USA001331: US-009507513-2206USA001347: US-009507513-2206USA001555: US-009507513-2206USA001558:
Sex: U
Vaccine: MMR
Symptoms: Expired product administered
Clinical narrative: Medical assistant calling to report an expired MMRII dose that was administered to a patient. Date of administration: 6Jun2022, date of expiration: 21Apr2022. Vaccine has not undergone any temperature excursions. No PQC. No additional information.; This spontaneous report was received from a medical assistant and referred to a patient of unspecified age and gender. The patient's medical, concurrent conditions and concomitant therapies were not reported.  On 06-JUN-2022, the patient was vaccinated with an expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (recombinant human albumin (rHA)) (M-M-R II) 0.5 ml, lot number T013725, expiration date: 21-APR-2022, administered as prophylaxis (strength, vaccination schedule, and route of administration were not provided) (expired product administered). Vaccine had not undergone any temperature excursions. At the time of reporting, the outcome of expired product administered was unknown.
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: No other adverse events reported.; A patient received a pediatric dose of VAQTA today that was expired.; This spontaneous report was received from physician referring to a patient of unknown age and gender.  The patient's current conditions, pertinent medical history, past drug reactions or allergies and concomitant medications were not reported. On 07-JUN-2022, the patient received an expired pediatric dose of hepatitis A vaccine inactivated (VAQTA) (strength, exact dose, vaccination scheme frequency, route of administration and anatomical site of application were not provided; lot number T023913 has been verified to be a valid lot number for syringe formulation with and expiration date reported and established as 31-MAR-2022), administered for prophylaxis (expired product administered). It was reported that the dose was properly stored up through time of administration.  No other adverse events reported (no adverse event).
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Post herpetic neuralgia
Clinical narrative: postherpetic neuralgia; multiple outbreaks of herpes zoster; Information has been received from a lawyer regarding a case in litigation and refers to a patient of unknown age and gender. Information about concurrent condition, history condition and concomitant medication was not reported. On an unknown date, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (strength, dose, route, lot# and expiration date unknown) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). After receiving zoster vaccine live (ZOSTAVAX), the patient suffered multiple outbreaks of herpes zoster and postherpetic neuralgia. As a result of these symptoms, the patient was seen and treated by medical providers and was still under their care. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient's symptoms had resulted in physical limitations not present prior to using the vaccine. The patient also experienced mental and emotional distress due to resulting physical limitations and seriousness of the condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), the patient sustained severe and permanent personal injuries. Further, as a tragic consequence of zoster vaccine live (ZOSTAVAX), the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient had suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the events multiple outbreaks of herpes zoster and postherpetic neuralgia was considered to be not recovered and causal relationship was assessed as related.     The lawyer considered the events multiple outbreaks of herpes zoster and postherpetic neuralgia to be disability.
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE details or PQC; PNEUMOVAX 23 was inadvertently administered after a non-supported temp excursion; This spontaneous report was received from a healthcare business professional (HBP) and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies, drug reactions, allergies or medical history provided.  On 11-APR-2022, the patient was vaccinated with improperly stored pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) prefilled syringe, lot # U022819, expiration date 14-JAN-2023, for prophylaxis (exact dose, route of administration and anatomical site were not provided). Vaccine was improperly stored for 96 hours in temperature of 70 F (Product storage error). Data logger was not used to capture the temperature excursion. There was no previous temperature excursion. No additional adverse event or product quality complaint was provided (No adverse event).
Sex: U
Vaccine: PPV
Symptoms: Product storage error
Clinical narrative: No additional AE details or PQC.; Inbound call from HBP who stated PNEUMOVAX 23 was inadvertently administered after a non-supported temp excursion; This spontaneous report was received from a healthcare business professional (HBP) referring to a patient of unknown age and gender. Information about the patient's pertinent medical history, concomitant medications, concurrent conditions and drug reactions/ allergies was not provided.  On 12-APR-2022, the patient was vaccinated with an improperly stored dose of pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) pre-filled syringe, lot number: U022819, expiration date: 14-JAN-2023 (dose, dose number, route of administration and anatomical location was not reported) for prophylaxis (product storage error). No additional adverse event (AE) details or product quality complaint (PQC) was reported (no adverse event).  The administered dose of the vaccine experienced a non-supported temperature excursion of 70 degrees Fahrenheit for 96 hours. There were no previous reported temperature excursions. It was unknown, whether a digital data logger was involved.
Sex: U
Vaccine: VARZOS
Symptoms: Fatigue, Feeling hot, Flushing, Food intolerance, Hypersensitivity
Clinical narrative: Flushing of face and chest; Tingling in lips and arms; feeling warm; Most pronounced after combination of Athletic Greens and chai latte; Numb lips; allergic reaction; This case was reported by a consumer via call center representative and described the occurrence of allergic reaction in a 58-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of fatigue (1st dose received on an unknown date, refer case US2022AMR081860).   On 29th April 2022, the patient received the 2nd dose of Shingrix. On 2nd May 2022, 3 days after receiving Shingrix, the patient experienced allergic reaction. On an unknown date, the patient experienced flushing, tingling, feeling of warmth, food interaction and numb lips. The patient was treated with benadryl (nos) (Benadryl). Rechallenge with Shingrix was positive. On an unknown date, the outcome of the allergic reaction was recovered/resolved and the outcome of the flushing was recovering/resolving and the outcome of the tingling and numb lips were not recovered/not resolved and the outcome of the feeling of warmth and food interaction were unknown.   It was unknown if the reporter considered the allergic reaction, flushing, tingling, feeling of warmth, food interaction and numb lips to be related to Shingrix.     Linked case(s) involving the same patient:  US2022AMR081860   Additional Information: GSK Receipt Date: 19-MAY-2022 Reporter's Comment: The patient self-reported this case. The patient received dose of Shingrix vaccine and was feeling a little tired and flu like symptoms. The patient also experienced flushing of his/her face, tingling in his/her lips and arms and feeling warm. Most pronounced was after the combination of Athletic Greens and a chai latte. However, even later in the day, his/her face and chest were flushed for no apparent reason. The patient separated out the chai from the AG, which reduced some of this, but the numb lips continue.  On 5th May 2022 the also experienced worst of the apparent allergic reaction, . It subsided after he/she took some benadryl. The patient discontinued the AG and as of today (day of reporting) the tingling/numbness in his/her lips and on his/her face persists. The patient asked for advice. Additional supportive information: The follow-up would not possible, as no contact, details were available.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR081860:Same reporter