chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant referring to an unspecified number of patients of unknown age and gender. The patients' concurrent conditions, medical history and concomitant therapies were not provided. On unknown dates, the patients were vaccinated with improperly stored doses of VARIVAX lot number M039318, expiration date 20-SEP-2018 (dose and route not reported) for prophylaxis. The vaccines were exposed to Total time in the range 15°F to 46°F (-9°C to 8°C) (7°C actual temperature) for 24 hours and 50 minutes. The vaccine doses had been exposed to a previous temperature excursion of a total time in the range 15°F to 46°F (-9°C to 8°C) (7°C actual temperature) for 5 hours and 47 minutes. The call was placed because of a Digital data logger. No adverse experiences were reported. This is one of several reports received from the same source. Additional information has been requested.; Sender's Comments: US-009507513-1703USA011935: US-009507513-1703USA011934: US-009507513-1703USA011932: US-009507513-1703USA011933:
Age: 15.0
Sex: M
Vaccine: MMRV, VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse, referring to a 15 year old male patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 13-MAR-2017 at a physician practice office, the patient was vaccinated with a dose of VARIVAX lot number reported as "M036293 with an expiration date on 17-AUG-2018 (strength, dose, administration route and anatomical location were not reported) for prophylaxis; and on the same date, the patient was also vaccinated with a dose of PROQUAD lot number M007963, with an expiration date on 05-AUG-2017 (strength, dose, administration route and anatomical location were not reported) for prophylaxis. No adverse effects were reported. No product quality complaint (PQC) was involved. Additional information is not expected because there was no consent to contact for follow-up.
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On an unknown date, the patient was inadvertently vaccinated with an expired dose of ZOSTAVAX (lot # L035283, expiration date:15-DEC-2016) for prophylaxis. There was no adverse event reported. The outcome of the event was unknown. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. No information about the patient's medical history, concurrent conditions and drug reactions or allergies was provided. On 13-MAR-2017, the patient was vaccinated with an expired dose VAQTA 50/1 units(U)/ml injection, lot # L023232 , expiration date: 25-FEB-2017 (dose and route of administration were not reported). No adverse effects were reported. Product quality complaint was not involved. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a physician in the format of a medical record refers to a patient of unknown age and gender. No medical history, concurrent conditions and concomitant medications were reported. Reportedly, GARDASIL 9 was inferred to have experienced the following temperature excursions: 36.9 F for 10 minutes on 24-DEC-2016, at 00:31 hours; 38.6 F for 20 minutes on 27-DEC-2016, at 07:51 hours; and 44.9 F for 20 minutes on 31-DEC-2016 at 03:41 hours. They were called out because of a digital data logger. On 31-DEC-2016, at 11:41 hours, the patient was vaccinated with the first, improperly stored, 0.5 ml dose of this vaccine (which had a lot # of M021407 with an expiration date of 30-APR-2018), intramuscularly, in the left arm, for prophylaxis. Despite this, no adverse symptoms were reported. All available medical records will be provided upon request. This is one of the several reports received from the same source. Additional information has been requested. Sender's Comments: US-009507513-1701USA002579: US-009507513-1703USA011160: US-009507513-1703USA011162: US-009507513-1703USA011159: US-009507513-1703USA011158: US-009507513-1703USA011161.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a physician in the format of a medical record refers to a patient of unknown age and gender. No medical history, concurrent conditions and concomitant medications were reported. Reportedly, hepatitis a vaccine, inactivated (manufacturer unknown) was inferred to have experienced the a temperature excursions of 36.9 F for 10 minutes on 24-DEC-2016, at 00:31 hours and it was called out because of a digital data logger. On the same date, at 11:56 hours, the patient was vaccinated with the second, improperly stored, 0.5 ml dose of this vaccine (which had a lot # of M002268 with an expiration date of 20-SEP-2017), intramuscularly, in the left thigh, for prophylaxis. Despite this, no adverse symptoms were reported. All available medical records will be provided upon request. This is one of the several reports received from the same source. Additional information has been requested. Sender's Comments: US-009507513-1701USA002579: US-009507513-1703USA011159: US-009507513-1703USA011160: US-009507513-1703USA011161: US-009507513-1703USA011162: US-009507513-1703USA010731.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a physician in the format of a medical record refers to a patient of unknown age and gender. No medical history, concurrent conditions and concomitant medications were reported. Reportedly, GARDASIL 9 was inferred to have experienced the following temperature excursions: 36.9 F for 10 minutes on 24-DEC-2016, at 00:31 hours; and 38.6  F for 20 minutes on 27-DEC-2016, at 07:51 hours. They were called out because of a digital data logger. On 27-DEC-2016, at 15:08 hours, the patient was vaccinated with the second, improperly stored, 0.5 ml dose of this vaccine (which had a lot # of M021407 with an expiration date of 30-APR-2018), intramuscularly, in the left arm, for prophylaxis. Despite this, no adverse symptoms were reported. All available medical records will be provided upon request. This is one of the several reports received from the same source. Additional information has been requested. Sender's Comments: US-009507513-1701USA002579: US-009507513-1703USA010731: US-009507513-1703USA011161: US-009507513-1703USA011162: US-009507513-1703USA011158: US-009507513-1703USA011159.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a physician in the format of a medical record refers to a patient of unknown age and gender. No medical history, concurrent conditions and concomitant medications were reported. Reportedly, GARDASIL 9 was inferred to have experienced the following temperature excursions: 36.9 F for 10 minutes on 24-DEC-2016, at 00:31 hours; and 38.6 F for 20 minutes on 27-DEC-2016, at 07:51 hours. They were called out because of a digital data logger. On 27-DEC-2016, at 14:13 hours, the patient was vaccinated with the first, improperly stored, 0.5 ml dose of this vaccine (which had a lot # of M021407 with an expiration date of 30-APR-2018), intramuscularly, in the left deltoid, for prophylaxis. Despite this, no adverse symptoms were reported. All available medical records will be provided upon request. This is one of the several reports received from the same source. Additional information has been requested. Sender's Comments: US-009507513-1701USA002579: US-009507513-1703USA011160: US-009507513-1703USA010731: US-009507513-1703USA011162: US-009507513-1703USA011158: US-009507513-1703USA011159.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a physician in the format of a medical record refers to a patient of unknown age and gender. No medical history, concurrent conditions and concomitant medications were reported. Reportedly, PROQUAD was inferred to have experienced the following temperature excursions: 36.9 F for 10 minutes on 24-DEC-2016, at 00:31 hours; and 38.6 F for 20 minutes on 27-DEC-2016, at 07:51 hours. They were called out because of a digital data logger. On 30-DEC-2016, at 15:54 hours, the patient was vaccinated with the second, improperly stored, 0.5 ml dose of this vaccine (which had a lot # of M035143 with an expiration date of 30-JUN-2018), subcutaneously, in the left thigh, for prophylaxis. Despite this, no adverse symptoms were reported. All available medical records will be provided upon request. This is one of the several reports received from the same source. Additional information has been requested. Sender's Comments: US-009507513-1701USA002579: US-009507513-1703USA011160: US-009507513-1703USA011161: US-009507513-1703USA010731: US-009507513-1703USA011158: US-009507513-1703USA011159.
Age: 48.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Loss of personal independence in daily activities, Pain, Rash
Clinical narrative: This spontaneous report was received from a 48 year old female patient, reporting on herself. The patient had a prior history of getting shingles on her spine every three months since she was 30 years old. The patient's concurrent conditions included compromised immune system. The patient did not have any drug reaction, allergy or concomitant therapy. On an unknown date, at the age of 48 years, the patient was vaccinated with a dose of ZOSTAVAX subcutaneously (lot #, expiration date, site and dose were not reported). On an unknown date, the patient experienced a breakout. The pain she experienced put her down for days. She was unable to wear clothes because the pain was so bad. The patient sought medical attention and was hospitalized due to the event (start date and duration of hospitalization were not reported). She was treated with acyclovir, FAMVIR and VALTREX for the event. However, according to the patient, none of these drugs worked. The outcome of herpes zoster was reported as recovered on an unknown date. The relatedness between the event and ZOSTAVAX was not reported. Additional information is not expected as the patient refused to provide her physician's contact details.
Sex: M
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report has been received from a nurse referring to a 21 month old male patient. The patient's medical history, concurrent conditions or concomitant medication were not reported. On 22-MAR-2017, the patient was vaccinated with an expired dose of M-M-R II (which had the lot number reported as L0939213, expiration date 17-MAR-2017) (dosage information, route or anatomical site of vaccination were not informed) for prophylaxis. No adverse effects were noted. And there was no product quality complaint involved. This is one of two cases from the same reporter. Additional information is not expected, since the physician cannot be contacted.; Sender's Comments:  US-009507513-1703USA011956:
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant referring to an unspecified number of patients of unknown age and gender. The patients' concurrent conditions, medical history and concomitant therapies were not provided. On unknown dates, the patients were vaccinated with refrigerated improperly stored doses of ROTATEQ lot number M033338, expiration date 15-APR-2018 (dose and route not reported) for prophylaxis. The vaccines were exposed to a total time in the range 47°F to 77°F (9° C to 25 °C) (15.8°C actual temperature) for 1 hour and 34 minutes. The vaccine doses had previous temperature excursions for a total time in the range 47°F to 77°F (9°C to 25"C ) (17.5C actual temperature) for 6 hours and 20 minutes. The call was placed because of a Digital data logger. No adverse experiences were reported. This is one of several reports received from the same source. Additional information has been requested.; Sender's Comments: US-009507513-1703USA011935: US-009507513-1703USA011934: US-009507513-1703USA006822: US-009507513-1703USA011933:
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant referring to an unspecified number of patients of unknown age and gender. The patients' concurrent conditions, medical history and concomitant therapies were not provided. On unknown dates, the patients were vaccinated with refrigerated improperly stored doses of RECOMBIVAX HB lot number M026309, expiration date 11-NOV-2018 (dose and route not reported) for prophylaxis. The vaccines were exposed to a total time in the range 47°F to 77°F (9° C to 25 °C) (15.8°C actual temperature) for 1 hour 34 minutes. The vaccine doses had previous temperature excursions for a total time in the range 47°F to 77°F (9°C to 25°C ) (17.5° C actual temperature) for 6 hours, 20 minutes. The call was placed because of a Digital data logger. No adverse experiences were reported. This is one of several reports received from the same source. Additional information has been requested. Sender's Comments: US-009507513-1703USA011935: US-009507513-1703USA011934: US-009507513-1703USA011932: US-009507513-1703USA006822.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant referring to an unspecified number of patients of unknown age and gender. The patients' concurrent conditions, medical history and concomitant therapies were not provided. On unknown dates, the patients were vaccinated with refrigerated improperly stored doses of GARDASIL 9 lot number M031557, expiration date 07-APR-2019 (dose and route not reported) for prophylaxis. The vaccines were exposed to a total time in the range 47°F to 77°F (9° C to 25 °C) (15.8°C actual temperature) for 1 hour 34 minutes. The vaccine doses had previous temperature excursions for a total time in the range 47°F to 77°F (9°C to 25°C ) (17.5° C actual temperature) for 6 hours, 20 minutes. he call was placed because of a Digital data logger. No adverse experiences were reported. This is one of several reports received from the same source. Additional information has been requested. Sender's Comments: US-009507513-1703USA011935: US-009507513-1703USA006822: US-009507513-1703USA011932: US-009507513-1703USA011933.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant referring to an unspecified number of patients of unknown age and gender. The patients' concurrent conditions, medical history and concomitant therapies were not provided. On unknown dates, the patients were vaccinated with refrigerated improperly stored doses of M-M-R II lot number M029919, expiration date 13-JUN-2018 (dose and route not reported) for prophylaxis. The vaccines were exposed to temperature of 47°F to 77°F (9° C to 25 °C) (15.8°C actual temperature) for 1 hour 34 minutes. The vaccine doses were not exposed to a previous temperature excursion. The call was placed because of a Digital data logger. No adverse experiences were reported. This is one of several reports received from the same source. Additional information has been requested. Sender's Comments: US-009507513-1703USA006822: US-009507513-1703USA011934: US-009507513-1703USA011932: US-009507513-1703USA011933.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report as received from a registered nurse who is an immunization official refers to unspecified patients of an unknown age and gender. The patients' concurrent conditions, medical history and concomitant therapies were not provided. On an unknown date in 2017, the patients were vaccinated with improperly stored doses of VARIVAX (dose, frequency, route, lot # and expiration date were not provided) for prophylaxis. The vaccines were improperly stored in January 2017 with a temperature excursion of - 14 °C to - 10 °C for a time frame of 16 hours. There was no data logger involved. There were no previous temperature excursions. No product quality complaint was involved. This is one of two reported received from the same source. Additional information has been requested.; Sender's Comments:  US-009507513-1703USA005228:
Sex: M
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report has been received from a nurse referring to a 23 month old male patient. The patient's medical history, concurrent conditions or concomitant medication were not reported. On 22-MAR-2017, the patient was vaccinated with an expired dose of M-M-R II (which had the lot number reported as L0939213, expiration date 17-MAR-2017) (dosage information, route or anatomical site of vaccination were not informed) for prophylaxis. No adverse effects were noted. And there was no product quality complaint involved. This is one of two cases from the same reporter. Additional information is not expected, since the physician cannot be contacted.; Sender's Comments:  US-009507513-1703USA011903:
Sex: M
Vaccine: SMALL
Symptoms: Electrocardiogram normal, Pericarditis
Clinical narrative: Initial solicited report on 13 March 2017 from an investigator (Defense Health Agency/Immunization Healthcare Branch) in the trial. A 24 year-old male subject with no significant medical history. The subject's concomitant medication was not reported. The subject received a dose of ACAM2000 (lot number and route, site of administration not reported) on 10 November 2016. On 16 November 2016, 06 days after vaccination the subject was diagnosed with I30.9 acute pericarditis, unspecified. The subject's lab data included, on 16 November 2016 ECG was normal. Treatments were not reported. The subject's outcome was not reported. Relationship to investigational product according to company: associated Additional information will be requested from the investigator. Note: There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study. List of documents held by sender: none.; Sender's Comments: This case involves a healthy 24-year-old male who developed acute pericarditis with favorable temporal association post vaccination with ACAM2000. Pericarditis is a listed adverse event that may occur following vaccination with live vaccinia virus smallpox vaccines. Alternative etiologies could be Myocardial infarction, pulmonary embolism, Pneumonia, Costochondritis or pneumothorax. History of allergies or trauma was not reported. In the absence of additional information on confirmation of diagnosis with CK-MB assays, biopsy, role of study vaccine can not be ruled out.
Sex: M
Vaccine: SMALL
Symptoms: Echocardiogram normal, Electrocardiogram normal, Pericarditis, Troponin I increased
Clinical narrative: Initial solicited report on 13 March 2017 from an investigator (Defense Health Agency/Immunization Healthcare Branch) in the trial. A 22 year-old male subject with no significant medical history. The subject's concomitant medication was not reported. The subject received a dose of ACAM2000 (lot number and route, site of administration not reported) on 28 November 2016. On 12 December 2016, 14 days after vaccination the subject was diagnosed with I30.9 acute pericarditis, unspecified. The subject's lab data included, on 07 December 2016 ECG and Echocardiogram was normal. Troponin I result - 03.11, Abnormal. Treatments were not reported. The subject's outcome was not reported. Relationship to investigational product according to company: associated. Additional information will be requested from the investigator. Note: There is no reporter causality assessment as this is a safety urveillance (data mining, non-interventional) study. List of documents held by sender: none. Sender's Comments: This case involves a healthy 22-year-old male who developed acute pericarditis with favorable temporal association post vaccination with ACAM2000. Pericarditis is a listed adverse event that may occur following vaccination with live vaccinia virus smallpox vaccines. Alternative etiologies could be Myocardial infarction, pulmonary embolism, Pneumonia, Costochondritis or pneumothorax. History of allergies or trauma was not reported. In the absence of additional information on confirmation of diagnosis with CK-MB assays, biopsy, role of study vaccine can not be ruled out.
Age: 67.0
Sex: M
Vaccine: PPV, TDAP
Symptoms: Pain in extremity, Wrong drug administered
Clinical narrative: Initial unsolicited misuse report received from a consumer (patient herself) via other company Pfizer (manufacturer reference Number: 2017094549) on 13-MAR-2017. This case involves a 67 years old male patient who was vaccinated with dose of DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE (TDAP) (batch number, expiry date, dose and dose in series for both the vaccines were not reported) and a dose of PNEUMOCOCCAL VACCINE (PNEUMOCOCCAL POLYSACCHARIDE 23 VALENT) (batch number, expiry date, dose and dose in series for both the vaccines were not reported) in the right upper deltoid instead of PNEUMOCOCCAL CONJUGATE VACCINE (PNEUMOCOCCAL CONJUGATE 13) on 03-OCT-2016. Illness at the time of vaccination was reported none and the patients mother past away in sleep at 95 years old. Concomitant medications were reported as the patient had Vitamin one a day, Astaxanthin 4 mg gel oil and Super Green capsule every other day. It was a case of Wrong vaccine administered where the patient was supposed to get pneumococcal conjugate 13 first but accidently vaccinated with pneumococcal polysaccharide 23 valent. On 03-OCT-2016, shortly after vaccination, the patient had developed pain in right arm which got worse shortly after receiving the TDap. Patient's medical history was reported as the patient was previously vaccinated with DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE (TETANUS, reported as TETANUS/TDap) (batch number, expiry date, dose and dose in series for both the vaccines were not reported) in the left upper deltoid on 12-SEP-2016 and also received another vaccine within two months of the first vaccine also the patient had hip operation an unknown date (reported as 27 Oct 2016). Laboratory investigations were reported none. The patient received Naproxen sodium and Aleve as corrective treatment. The patient had no emergency visit. The outcome of event was reported as recovered on an unknown date. List of documents held by sender: none.
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP, HPV9, HPV9, MNQ, TDAP
Symptoms: Rash, Rash erythematous, Skin warm
Clinical narrative: Initial unsolicited report received from a consumer (patient's parent) on 13-MAR-2017. This case involves an 11-year-old female patient who was vaccinated with a first dose of MENACTRA (batch number, expiry date, dose and dose in series were not reported) in the right deltoid, a first dose of GARDASIL9 (manufacture: Merck) (batch number, expiry date, dose and dose in series were not reported) and BOOSTRIX (manufacture: GSK) (batch number, expiry date, dose and dose in series were not reported) in the left deltoid on 01-MAR-2017. Patient's medical history as pre-existing physician diagnosed allergies, birth defects, medical conditions (specify) was reported as the patient had allergies to eggs, latex, many antibiotics, and had no Medical issues and Illness at the time of vaccination was reported as none. Concomitant medications were reported as none. Any other vaccinations within four weeks of vaccinations were also reported as none. On 07-MAR-2017, six day of following the vaccination, the patient had developed a small rashy spot on the left thumb that eventually over a few days developed on both hands some spots on arms and her chin which raised red not itchy and was warm to touch. The patient required emergency room (ER) or doctor visit on an unknown date. Laboratory investigations were reported as none. Corrective treatment were not reported. The outcome of event was reported as not recovered. List of documents held by sender: none.
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP, HPV9, HPV9, MNQ, TDAP
Symptoms: Rash
Clinical narrative: Initial unsolicited report received from a consumer (patient's parent) on 13-MAR-2017. This case involves an 11-year-old female patient who was vaccinated with a first dose of MENACTRA (batch number, expiry date, dose and dose in series were not reported) in the right deltoid, a first dose of GARDASIL9 (manufacture: Merck) (batch number, expiry date, dose and dose in series were not reported) and BOOSTRIX (manufacture: GSK) (batch number, expiry date, dose and dose in series were not reported) in the left deltoid on 01-MAR-2017. Patient's medical history as pre-existing physician diagnosed allergies, birth defects, medical conditions (specify) was reported as the patient had allergies to eggs, latex, many antibiotics, and had no Medical issues and Illness at the time of vaccination was reported as none. Concomitant medications were reported as none. Any other vaccinations within four weeks of vaccinations were also reported as none. On 07-MAR-2017, six day of following the vaccination, the patient had developed a small rashy spot on the left thumb that eventually over a few days developed on both hands some spots on arms and her chin which raised red not itchy and was warm to touch. The patient required emergency room (ER) or doctor visit on an unknown date. Laboratory investigations were reported as none. Corrective treatment were not reported. The outcome of event was reported as not recovered. List of documents held by sender: none.
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP, HPV9, HPV9, MNQ, TDAP
Symptoms: Labelled drug-drug interaction medication error, Rash
Clinical narrative: Initial unsolicited report received from a consumer (patient's parent) on 13-MAR-2017. This case involves an 11-year-old female patient who was vaccinated with a first dose of MENACTRA (batch number, expiry date, dose and dose in series were not reported) in the right deltoid, a first dose of GARDASIL9 (manufacture: Merck) (batch number, expiry date, dose and dose in series were not reported) and BOOSTRIX (manufacture: GSK) (batch number, expiry date, dose and dose in series were not reported) in the left deltoid on 01-MAR-2017. Patient's medical history as pre-existing physician diagnosed allergies, birth defects, medical conditions (specify) was reported as the patient had allergies to eggs, latex, many antibiotics, and had no Medical issues and Illness at the time of vaccination was reported as none. Concomitant medications were reported as none. Any other vaccinations within four weeks of vaccinations were also reported as none. On 07-MAR-2017, six day of following the vaccination, the patient had developed a small rashy spot on the left thumb that eventually over a few days developed on both hands some spots on arms and her chin which raised red not itchy and was warm to touch. The patient required emergency room (ER) or doctor visit on an unknown date. Laboratory investigations were reported as none. Corrective treatment were not reported. The outcome of event was reported as not recovered. List of documents held by sender: none.
Age: 0.17
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Crying, Screaming
Clinical narrative: Continuous screaming and crying.
Age: 63.0
Sex: F
Vaccine: PNC13
Symptoms: Injected limb mobility decreased, Injection site pain, Pain in extremity
Clinical narrative: Pain in the arm in which the shot was given (left deltoid), pain goes down the arm and also across the upper shoulder area. Movement is limited as well by the pain.
Age: 59.0
Sex: F
Vaccine: PNC13, VARZOS
Symptoms: Injection site erythema, Lip dry, Oral mucosal blistering, Oral pruritus, Paraesthesia oral
Clinical narrative: Patient had redness around the immunization site. On 3/23 her lips were dry. On 03/26 she developed itchy, tingly blisters around her mouth. On 3/27 she was examined by her husband's physician (while at an appt with him) and was told the blisters were not open or seeping.
Age: 0.33
Sex: M
Vaccine: HIBV, DTAP
Symptoms: Abdominal compartment syndrome, Acquired tracheo-oesophageal fistula, Bacterial test negative, Blood bicarbonate normal, Blood lactic acid normal
Clinical narrative: 4 month old former 36 5/7 week infant with h/o tracheoesophageal fistula and esophageal atresia, s/p repair with course complicated by anastomotic leak and prolonged ventilation. Multiple previous brief episodes of CPR due to difficult airway. Had recovered to point of being in room air and tolerating gastrostomy feeds. Developed fever to 38.8 and diarrhea (15 stools/24 hrs) after 3/8 DTaP. Cardiovascular collapse at about 7:45 PM, requiring CPR, intubation, with profound metabolic acidosis. Post code course complicated by newly discovered, acquired tracheoesophageal fistula at site of previous esophageal anastomotic breakdown. Developed abdominal compartment syndrome and required bowel resection. Left with severe, static encephalopathy with diffuse supra- and infra-tentorial brain volume loss on MRI.
Age: 0.33
Sex: M
Vaccine: HIBV, DTAP
Symptoms: Blood pH decreased, Circulatory collapse, Diarrhoea, Encephalopathy, Endotracheal intubation
Clinical narrative: 4 month old former 36 5/7 week infant with h/o tracheoesophageal fistula and esophageal atresia, s/p repair with course complicated by anastomotic leak and prolonged ventilation. Multiple previous brief episodes of CPR due to difficult airway. Had recovered to point of being in room air and tolerating gastrostomy feeds. Developed fever to 38.8 and diarrhea (15 stools/24 hrs) after 3/8 DTaP. Cardiovascular collapse at about 7:45 PM, requiring CPR, intubation, with profound metabolic acidosis. Post code course complicated by newly discovered, acquired tracheoesophageal fistula at site of previous esophageal anastomotic breakdown. Developed abdominal compartment syndrome and required bowel resection. Left with severe, static encephalopathy with diffuse supra- and infra-tentorial brain volume loss on MRI.
Age: 0.33
Sex: M
Vaccine: HIBV, DTAP
Symptoms: Intestinal resection, Metabolic acidosis, Nuclear magnetic resonance imaging brain abnormal, PCO2 normal, PO2 decreased
Clinical narrative: 4 month old former 36 5/7 week infant with h/o tracheoesophageal fistula and esophageal atresia, s/p repair with course complicated by anastomotic leak and prolonged ventilation. Multiple previous brief episodes of CPR due to difficult airway. Had recovered to point of being in room air and tolerating gastrostomy feeds. Developed fever to 38.8 and diarrhea (15 stools/24 hrs) after 3/8 DTaP. Cardiovascular collapse at about 7:45 PM, requiring CPR, intubation, with profound metabolic acidosis. Post code course complicated by newly discovered, acquired tracheoesophageal fistula at site of previous esophageal anastomotic breakdown. Developed abdominal compartment syndrome and required bowel resection. Left with severe, static encephalopathy with diffuse supra- and infra-tentorial brain volume loss on MRI.
Age: 0.33
Sex: M
Vaccine: HIBV, DTAP
Symptoms: Post procedural fistula, Pyrexia, Resuscitation, Rotavirus test negative, Viral test negative
Clinical narrative: 4 month old former 36 5/7 week infant with h/o tracheoesophageal fistula and esophageal atresia, s/p repair with course complicated by anastomotic leak and prolonged ventilation. Multiple previous brief episodes of CPR due to difficult airway. Had recovered to point of being in room air and tolerating gastrostomy feeds. Developed fever to 38.8 and diarrhea (15 stools/24 hrs) after 3/8 DTaP. Cardiovascular collapse at about 7:45 PM, requiring CPR, intubation, with profound metabolic acidosis. Post code course complicated by newly discovered, acquired tracheoesophageal fistula at site of previous esophageal anastomotic breakdown. Developed abdominal compartment syndrome and required bowel resection. Left with severe, static encephalopathy with diffuse supra- and infra-tentorial brain volume loss on MRI.
Age: 0.33
Sex: M
Vaccine: HIBV, DTAP
Symptoms: Brain injury, Chills, Dehydration, Diarrhoea, Gastrointestinal disorder
Clinical narrative: 4 month old former 36 5/7 week infant with h/o tracheoesophageal fistula and esophageal atresia, s/p repair with course complicated by anastomotic leak and prolonged ventilation. Multiple previous brief episodes of CPR due to difficult airway. Had recovered to point of being in room air and tolerating gastrostomy feeds. Developed fever to 38.8 and diarrhea (15 stools/24 hrs) after 3/8 DTaP. Cardiovascular collapse at about 7:45 PM, requiring CPR, intubation, with profound metabolic acidosis. Post code course complicated by newly discovered, acquired tracheoesophageal fistula at site of previous esophageal anastomotic breakdown. Developed abdominal compartment syndrome and required bowel resection. Left with severe, static encephalopathy with diffuse supra- and infra-tentorial brain volume loss on MRI.
Age: 0.33
Sex: M
Vaccine: HIBV, DTAP
Symptoms: Gastrointestinal injury, Heart rate increased, Intestinal operation, Nausea, Pyrexia
Clinical narrative: 4 month old former 36 5/7 week infant with h/o tracheoesophageal fistula and esophageal atresia, s/p repair with course complicated by anastomotic leak and prolonged ventilation. Multiple previous brief episodes of CPR due to difficult airway. Had recovered to point of being in room air and tolerating gastrostomy feeds. Developed fever to 38.8 and diarrhea (15 stools/24 hrs) after 3/8 DTaP. Cardiovascular collapse at about 7:45 PM, requiring CPR, intubation, with profound metabolic acidosis. Post code course complicated by newly discovered, acquired tracheoesophageal fistula at site of previous esophageal anastomotic breakdown. Developed abdominal compartment syndrome and required bowel resection. Left with severe, static encephalopathy with diffuse supra- and infra-tentorial brain volume loss on MRI.
Age: 0.33
Sex: M
Vaccine: HIBV, DTAP
Symptoms: Respiratory arrest, Surgery, Tremor
Clinical narrative: 4 month old former 36 5/7 week infant with h/o tracheoesophageal fistula and esophageal atresia, s/p repair with course complicated by anastomotic leak and prolonged ventilation. Multiple previous brief episodes of CPR due to difficult airway. Had recovered to point of being in room air and tolerating gastrostomy feeds. Developed fever to 38.8 and diarrhea (15 stools/24 hrs) after 3/8 DTaP. Cardiovascular collapse at about 7:45 PM, requiring CPR, intubation, with profound metabolic acidosis. Post code course complicated by newly discovered, acquired tracheoesophageal fistula at site of previous esophageal anastomotic breakdown. Developed abdominal compartment syndrome and required bowel resection. Left with severe, static encephalopathy with diffuse supra- and infra-tentorial brain volume loss on MRI.
Sex: M
Vaccine: VARZOS
Symptoms: Aphthous ulcer, Incorrect route of drug administration, Sinusitis
Clinical narrative: Information has been received from a 74 year old male patient reporting on himself. The patient's medical history, concurrent conditions, concomitant medications and drug reactions/allergies were not provided. On an unspecified date in March 2017 (reported as a week and half ago), the patient was vaccinated with ZOSTAVAX 19400 plaque-forming unit (PFU) (dose, frequency, anatomical location, lot# and expiration date were not provided), intramuscularly, for prevention of shingles. On an unspecified date in March 2017 (reported as approximately a week after the administration of the ZOSTAVAX, the patient experienced sinus infection and canker sores. The patient went to see his physician and was prescribed an unspecified medication. The patient's outcome was reported as not recovered. The causality assessment between ZOSTAVAX and the adverse events was not provided. Additional information has been requested.
Age: 75.0
Sex: M
Vaccine: PPV
Symptoms: Induration, Pain in extremity, Peripheral swelling
Clinical narrative: This is a spontaneous report received from a patient reporting on himself a 75-year-old male who was administered a dose of PNEUMOVAX vaccine on 17-MAR-2017, for the prevention of pneumococcal disease administered by a pharmacist (lot # unknown). Medical history included the following: "blood sugar", "cholesterol", kidney stones, insomnia, and high blood pressure. On 18-MAR-2017, the patient's arm swelled. He stated that "it is twice the size of the other arm." The next day, 19-MAR-2017, he developed hardness and pain in three spots on the same arm. The patient has been taking ADVIL and BENADRYL which he said are not helping his symptoms. The patient reported he has an appointment with his doctor today, 20-MAR-2017. No further information was provided. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a unspecified number of patients of unknown age and gender. There was no information about patient's concomitant medications and pertinent medical history reported. On unknown dates, the patients were vaccinated with a dose of improperly stored PROQUAD, lot number M034692 with expiration date 24-JAN-2018, (dose, route and anatomical location were not reported) for prophylaxis. The vaccine was exposed to temperatures between -14 (0 Celsius (C)) to -13 (0 Celsius (C)) at -12(0 Celsius (C)) during 1 hour and 15 minutes and also at -13(0 Celsius (C)) during 1 hour and 3 minutes. On unknown date, the vaccine was also exposed to -11(0 Celsius (C)) for 1 hour and 23 minutes. The storage type was reported as "data logger." No adverse effects were reported. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site rash
Clinical narrative: This spontaneous report was received from a pharmacist via company representative regarding a female patient of unknown age. There was no information about patient's concomitant medications and pertinent medical history reported. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX, (dose, route, anatomical location, lot number and expiration date were not reported) for prophylaxis. On unknown date shortly after the patient received the dose of ZOSTAVAX, she developed a "rash on the arm where the ZOSTAVAX was given." The patient sought medical attention by seeing the pharmacist and it was unknown if treatment or lab diagnostics studies were performed for the event. At the time of the report, the patient recovered from the rash on unspecified date described as "the patient was fine shortly after." The relatedness between the event and therapy with ZOSTAVAX was not reported. Additional information has been requested.
Sex: M
Vaccine: FLUN4
Symptoms: Malaise
Clinical narrative: A report has been received from a Health Professional concerning a Male patient, who had received Nasal FLUMIST (intranasal) on 07-Nov-2015. On 09-Nov-2015, it was reported that patient was not feeling great (Preferred Term: Malaise). Patient further stated that he had FLUMIST on Saturday and thinks this may be contributing. The outcome of the event of not feeling great was unknown. The report was considered to be non-serious by the company physician. Corrected Report 27-Mar-2017: Key ingredient corrected for FLUMIST from FLUMIST to Q/LAIV. Mandatory vaccine reporter and null flavor added. Product type corrected from drug to vaccine. Causality added on associations as per patient's statement. Narrative updated.
Sex: U
Vaccine: TTOX
Symptoms: Allergy to vaccine
Clinical narrative: Initial unsolicited report received from a Physician on 03-MAR-2017. This case is linked with 2016SA224325. This case involves a patient (onset age and gender were unknown) who was vaccinated with dose of TETANUS TOXOID (TETANUS) (batch number, expiry date, dose and dose in series were not reported) in an unknown site on an unknown date. Patient's medical history and concomitant medications were not reported. On an unknown date, following the vaccination, the patient had developed allergic to vaccine. Laboratory investigations and corrective treatment were not reported. The outcome of events was not reported. ist of documents held by sender: none.
Age: 50.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Pain, Skin warm, Swelling
Clinical narrative: Initial unsolicited case received from other non-health care professional on 13 Mar 2017. This case involves a 50 year old female patient who was vaccinated with dose one of FLUZONE ID (Batch number: UT5569BA, expiry date: 30 Jun 2017, dose , route and site of administration was unknown) on 05 Dec 2016. The patient had no illness at the time of vaccination, the patient had BACTRIM and Lisinopril allergies, any other vaccinations within 4 weeks of vaccinations was reported as none. Concomitant medications were not reported. On 06 Dec 2016, one day after the vaccination in the morning the patient experienced a softball size red raised area with heat and pain, the patient required ER/doctor visit and it was reported as on 07 Mar 2017, when the patient returned to office she still has a red area on her arm about the size of a dime. It's not raised red or itchy as this point. The patient lab tests were reported as none. Corrective treatment was not reported. The outcome of the events were reported as not recovered. List of documents held by sender: none.
Sex: F
Vaccine: FLUX
Symptoms: Loss of consciousness
Clinical narrative: Initial unsolicited report received from a Pharmacist via other company (Pfizer, Manufacturer report number: 2017092318) on 13 March 2017. This case involves a female patient who was vaccinated with a dose of INFLUENZA VACCINE (Flu Vaccine) on an unknown date in 1971 (while she was in hospital) and a dose of PREVENAR 13 (batch number, dose and expiration date unknown for both the vaccines) on an unknown date. Patient's medical history and concomitant medications were not reported. On an unknown date in 1971, following the vaccination, the patient passed out. Lab data and corrective treatment were not reported. On an unknown date, patient recovered completely from the event. Upon internal review the case was considered as serious because of important medical event passed out. Patient was instructed never to get flu vaccine by her physician and was told her the reason she passed out was probably due to the chicken feathers that was part of the vaccine (reported as related). List of documents held by sender: none. Sender's Comments: Time to onset is unknown. Loss of consciousness may occur as the result of traumatic brain injury, brain hypoxia, severe poisoning with drugs that depress the activity of the central nervous system, severe fatigue and other causes. It was suspected that patient unconscious due to chicken or chicken feathers that part of the vaccine. More details regarding exact time to onset, name of the vaccine administered, patient was in contact with chicken, history of allergy, concomitant medication and investigation reports are needed for complete assessment of the case. As 2 vaccines were administered before the onset of events, making it difficult to assess the role of each vaccine.
Age: 0.08
Sex: F
Vaccine: HEP, HIBV, PPV
Symptoms: Erythema, Rash generalised
Clinical narrative: Rash all over body that lasted two days. Red cheeks that come and go since 11/24/2016 still ongoing.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Pain, Rash, Swelling
Clinical narrative: She went to Urgent Care c/o swelling and pain while ambulating on 3/26/17 and was diagnosed as a rash and she was instructed to ice the area, use ibuprofen/TYLENOL as needed, and to encourage activity/walking.
Age: 4.0
Sex: M
Vaccine: HEP
Symptoms: Rash
Clinical narrative: Rash.
Age: 10.0
Sex: F
Vaccine: FLUC4
Symptoms: Abdominal pain upper, Blood test, Diarrhoea, Parasite blood test
Clinical narrative: Severe stomach pains, massive Diarrhea.
Sex: U
Vaccine: TDAP
Symptoms: Acute disseminated encephalomyelitis
Clinical narrative: This case was reported in a literature article and described the occurrence of acute disseminated encephalomyelitis in a adult subject who received dTpa vaccine. On an unknown date, 11 days after receiving dTpa vaccine, the subject developed acute disseminated encephalomyelitis. Serious criteria included GSK medically significant. The outcome of acute disseminated encephalomyelitis was unknown. The investigator considered the acute disseminated encephalomyelitis to be possibly related to dTpa vaccine. Additional information was provided. This case was reported in a literature article and described the occurrence of acute disseminated encephalomyelitis (ADEM) in an adult of unspecified gender who was vaccinated with unspecified Tdap vaccine (manufacturer unknown). The patient was part of the study that aimed to analyse the association of immunisation and subsequent development of transverse myelitis (TM) or ADEM. All cases of TM and ADEM in the Vaccine Safety Datalink (VSD) population were identified. The study used a case-centered, which compares vaccination patterns during an exposure interval prior to the outcome in cases vs the entire study population, matched by age, sex, and site. Study population included all children and adults of any age enrolled in the health plans at 6 VSD sites who received 1 or more vaccines during the period from 1 January 2007 through 31 December 2012. The patient was healthy. No information on patient's family history or concurrent condition or concomitant medication was provided. On an unspecified date, the patient received Tdap vaccine (administration route and site unspecified; dosages unknown; batch number not provided). The patient was routinely vaccinated. On an unspecified date between 1 January 2007 and 31 December 2012, 11 days after vaccination, the patient developed the symptoms of ADEM. (In this study, trained medical records analysts (MRAs) reviewed all identified cases to verify that a neurologist made the diagnosis within 3 months of the first electronic diagnosis, to validate the date of onset, to ensure the diagnosis did not change over time, and to abstract pertinent information. Following this, a neurologist with expertise in demyelinating illnesses reviewed each case. For ADEM, cases were confirmed using the Brighton Collaboration Criteria, and  accepted diagnostic levels of certainty 1, 2, and 3 as cases). Treatment was unknown. The outcome of the event was not reported. The authors commented "for ADEM, we found a possible association with the Tdap vaccine in the 5 to 28 day risk interval." The authors concluded "TM and ADEM are rarely, if ever, associated with vaccines. If there is an association of ADEM with Tdap, the excess risk is not likely to exceed 1.16 cases of ADEM per million doses of Tdap administered." This is 1 of the 5 valid cases reported in the same literature article.