chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: UNK
Symptoms: Product storage error
Clinical narrative: This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions/allergies, concurrent conditions and concomitant medications were not reported. In 2017 (reported as "on or after 05-JUL-2017"), the patient was vaccinated with an improperly stored dose of RECOMBIVAX HB lot # M040423 with expiration date 03-JUL-2019; an improperly stored dose of ROTATEQ per oral, lot # M044396 with expiration date 19-JUN-2018; or an improperly stored dose of VAQTA lot # N005274 with expiration date 03-APR-2018, for prophylaxis (dose and route of administration were not reported). It was stated that the vaccine was exposed to a temperature of 32 to 35 Fahrenheit degrees with a time frame of 1 hour. No previous temperature excursion was reported. The reporter did not know which vaccine was administered to the patient. This is one of several reports from the same reporter. Sender's Comments: US-009507513-1711USA008229: US-009507513-1711USA008230: US-009507513-1711USA008231: US-009507513-1711USA008232: US-009507513-1711USA008233: US-009507513-1711USA008234.
Age: 59.0
Sex: F
Vaccine: HEPA
Symptoms: No adverse event, Underdose
Clinical narrative: This spontaneous report was received from a nurse, regarding to a 59 year old female patient. The patient's concurrent conditions, medical history and concomitant medications were not reported. It was reported that on 13-APR-2017, an adult patient received a pediatric dose of VAQTA which had a lot # M039055 with expiration date on 22-JUL-2018 (dose, concentration and anatomical location were not mentioned). At the reporting time, No adverse effects  were reported.
Sex: F
Vaccine: PPV
Symptoms: Injection site reaction, Local reaction, Rash erythematous
Clinical narrative: This spontaneous report was received from a consumer referring to her mother, a 70 year old female patient The patient had no pertinent medical history, drug reactions/allergies or concomitant medication. On 07-OCT-2017 the patient was vaccinated with PNEUMOVAX 23 for prophylaxis (route, strength, dose schedule and lot number were not reported). In October 2017, shortly after receiving PNEUMOVAX 23 the patient experienced local injection site reaction and a red flat rash around her arm and elbow. The patient reported the incident to her physician but no treatment was given for the adverse events. No studies or laboratory tests were performed. The reporter stated that the reaction subsided after a few days (October 2017). Causality assessment was not provided.
Sex: U
Vaccine: VARZOS
Symptoms: Product storage error
Clinical narrative: Information has been received from a pharmacist reporting on a patient of unknown age and gender. There was no information about the patient's concurrent conditions, medical history or concomitant medication. On 13-SEP-2017, the patient received an improperly stored dose of ZOSTAVAX lot # M040146, expiration date 26-DEC-2017, 0.65 ml for prophylaxis (dose number, anatomical location and route of administration were not reported), reconstituted with properly stored sterile diluent (STERILE DILUENT). On 04-SEP-2017, the administered vaccine was exposed to a temperature between 6 Fahrenheit degrees and 14 Fahrenheit degrees for 15 hours and 45 minutes. The pharmacist reported that there was no previous temperature excursion. The call was placed because of a Digital Data logger report. This is one of two reports received from the same reporter.; Sender's Comments:  US-009507513-1711USA008257:
Sex: U
Vaccine: MMR, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's concomitant medications, pertinent medical history, concurrent conditions, drug reactions or allergies were not reported. On 30-OCT-2017, the patient was vaccinated with improperly stored doses of VARIVAX (lot # N021315, expiration date 07-AUG-2019) and M-M-R II (lot # M049212, expiration date 16-DEC-2018) (strength, dose and route were not provided for the vaccines) for prophylaxis. The reporter also stated that the sterile diluent (MERCK STERILE DILUENT) used to reconstitute the vaccines did not undergo a temperature excursion. The vaccines were exposed to a temperature excursion of 6 degrees Fahrenheit (°F) to 14°F (6F) for 7 minutes which was detected by the data logger. Prior temperature excursion from 6°F to 14°F for 38 minutes was also reported. No adverse effects were reported.
Sex: U
Vaccine: MMR, VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, concomitant therapies and past drug reactions/allergies were not reported. On 03-AUG-2017, the patient was vaccinated with a dose of M-M-R II 0.5 ml, subcutaneously, lot # N014485 with expiration date: 10-MAY-2019 (anatomical location was not reported) for prophylaxis; and with a dose of VARIVAX  0.5 ml, lot # N020016 with expiration date: 17-JUL-2019 (route and anatomical location were not reported) for prophylaxis. Other suspect therapies included sterile diluent (MERCK STERILE DILUENT). The reporter stated that on 02-NOV-2017, the patient inadvertently received an extra dose of M-M-R II; and an extra dose of VARIVAX. No adverse effects were reported.
Age: 4.0
Sex: F
Vaccine: MMRV, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from a nurse, referring to a 4 year old female patient. The patient's medical drug included FLUZONE, intramuscularly, lot number UI810AA (4 previous doses). As concurrent conditions was reported mild asthma persistent and as concomitant therapies were reported: FLOVENT, PROAIR, CLARITIN, FLONASE and sterile diluent (MERCK). On 02-NOV-2017, the patient was vaccinated with an improperly stored dose of with VARIVAX lot number reported as "N020616" with expiration date reported on 22-JAN-2019 (anatomical location and administration route were not reported) for prophylaxis. On the same date (02-NOV-2017), the patient also received and improperly stored dose of PROQUAD second dose, subcutaneously, lot number N020616 (expiration date and anatomical location were not reported) for prophylaxis. (It was unknown if the patient received two different vaccines on the same date VARIVAX and PROQUAD or if was discrepant information regarding the vaccine administered). No adverse effects were reported. It was reported that the vaccines had a temperature excursion of 6-14 Fahrenheit (F) during a time frame of 3 hours and 47 minutes. It was confirmed that no previously temperature excursions occurred and a digital data logger was involved. Lot number N020616 is an invalid lot number for [generic name of varicella virus vaccine live (oka/merck).
Age: 7.0
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a nurse and refers to a 7 years old patient of unknown gender. No information regarding the patient's medical history, concurrent conditions and concomitant medications was provided. On 21-OCT-2017, the patient was vaccinated with improperly stored VAQTA lot # N019924 with expiration date on 02-SEP-2018 for prophylaxis (strength, dose and route were not reported). On an unknown date, the VAQTA was stored in temperature of 48.9 Fahrenheit degrees for 6 minutes. Previous temperature excursion was reported as 48.9 Fahrenheit degrees for 24 minutes and 47.4 Fahrenheit degrees for 15 minutes. No adverse effect was provided. Data logger was involved. No product quality complaint was reported. This is the one of several case reports received from the same reporter.; Sender's Comments: US-009507513-1711USA004812: US-009507513-1711USA004813: US-009507513-1710USA013033:
Age: 4.0
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a nurse and refers to a 4 years old patient of unknown gender. No information regarding the patient's medical history, concurrent conditions and concomitant medications was provided. On 21-OCT-2017, the patient was vaccinated with improperly stored  VAQTA lot # N017094 with expiration date on 31-AUG-2018 for prophylaxis (strength, dose and route were not reported). On an unknown date, the VAQTA was stored in temperature of 48.9 Fahrenheit degrees for 6 minutes. Previous temperature excursions were reported as 48.9 Fahrenheit degrees for 24 minutes and 47.4 Fahrenheit degrees for 15 minutes. No adverse effect was provided. Data logger was involved. No product quality complaint was reported. This is the one of several case reports received from the same reporter.; Sender's Comments: US-009507513-1710USA013033: US-009507513-1711USA004813: US-009507513-1711USA004811:
Age: 2.0
Sex: F
Vaccine: VARCEL
Symptoms: Herpes zoster, Pain
Clinical narrative: This initial spontaneous report was received from the father of a three year old female patient. The patient was taking no concomitant medication and had no pertinent medical history or allergies. On 03-APR-2017, the patient was administered "routine" VARIVAX, "0.5 dose" (route and lot # not provided). On 15-NOV-2017, the patient was diagnosed with shingles. The father stated she "got shingles from varicella vaccine". She currently has shingles on half her body. She was seen in the Emergency Room (ER) on an unspecified date and released. Unspecified labs/diagnostics were done described as "studied to see what was wrong with her". She was prescribed acyclovir "five times a day" and ibuprofen "whenever she cries". The patient was still experiencing pain at the time of the report. The outcome of the event was not recovered. Causality assessment was related. The father stated he wants to sue the company for giving his daughter shingles. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Anxiety, Death, Emotional distress, Herpes zoster, Pain
Clinical narrative: Information has been received on 16-NOV-2017 from a lawyer and the executor of the estate of a deceased consumer (date of death and cause of death was not reported.) The patient was reported to be a male patient of unknown age. The patient's prior concurrent conditions, medical history and concomitant medications are unknown. On or about On 26-JUN-2015, the patient received ZOSTAVAX(lot number and expiration unknown), subcutaneous for its intended purpose: the prevention of shingles. As a direct result of the vaccine, the patient suffered from a Shingles outbreak, in addition to chronic pain, rash and lesions to various parts of his body. The patient did not have a Shingles outbreak until 11-NOV-2016. As a direct result of the vaccine, the patient suffered mental and emotional distress due to resulting physical limitations and seriousness of his condition. As a result of ZOSTAVAX, the patient sustained severe and permanent personal injuries. Further, as a tragic consequence of 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. The patient has incurred medical expenses and other economic harm as a direct result of use of ZOSTAVAX. As a direct and proximate consequence of ZOSTAVAX, the patient sustained serious personal injuries and related losses including, but not limited to, mental anguish, physical pain and suffering, diminished capacity for the enjoyment of life, a diminished quality of life, medical and related expenses, and other losses and damages. Upon internal review, deceased was considered to be medically significant. Additional information has been requested. Reported Cause(s) of Death: deceased.
Sex: M
Vaccine: VARZOS
Symptoms: Physical disability, Quality of life decreased, Rash, Skin lesion
Clinical narrative: Information has been received on 16-NOV-2017 from a lawyer and the executor of the estate of a deceased consumer (date of death and cause of death was not reported.) The patient was reported to be a male patient of unknown age. The patient's prior concurrent conditions, medical history and concomitant medications are unknown. On or about On 26-JUN-2015, the patient received ZOSTAVAX(lot number and expiration unknown), subcutaneous for its intended purpose: the prevention of shingles. As a direct result of the vaccine, the patient suffered from a Shingles outbreak, in addition to chronic pain, rash and lesions to various parts of his body. The patient did not have a Shingles outbreak until 11-NOV-2016. As a direct result of the vaccine, the patient suffered mental and emotional distress due to resulting physical limitations and seriousness of his condition. As a result of ZOSTAVAX, the patient sustained severe and permanent personal injuries. Further, as a tragic consequence of 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. The patient has incurred medical expenses and other economic harm as a direct result of use of ZOSTAVAX. As a direct and proximate consequence of ZOSTAVAX, the patient sustained serious personal injuries and related losses including, but not limited to, mental anguish, physical pain and suffering, diminished capacity for the enjoyment of life, a diminished quality of life, medical and related expenses, and other losses and damages. Upon internal review, deceased was considered to be medically significant. Additional information has been requested. Reported Cause(s) of Death: deceased.
Sex: U
Vaccine: HEP, HEPA, RV5
Symptoms: Product storage error
Clinical narrative: This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions/allergies, concurrent conditions and concomitant medications were not reported. In 2017 (reported as "on or after 05-JUL-2017"), the patient was vaccinated with an improperly stored dose of RECOMBIVAX HB lot # M040423 with expiration date 03-JUL-2019; an improperly stored dose of ROTATEQ per oral, lot # M044396 with expiration date 19-JUN-2018; or an improperly stored dose of VAQTA lot # N005274 with expiration date 03-APR-2018, for prophylaxis (dose and route of administration were not reported). It was stated that the vaccine was exposed to a temperature of 32 to 35 Fahrenheit degrees with a time frame of 1 hour. No previous temperature excursion was reported. The reporter did not know which vaccine was administered to the patient. This is one of several reports from the same reporter.; Sender's Comments: US-009507513-1710USA015406: US-009507513-1711USA008230: US-009507513-1711USA008231: US-009507513-1711USA008232: US-009507513-1711USA008233: US-009507513-1711USA008234:
Sex: U
Vaccine: HEP, HEPA, RV5
Symptoms: Product storage error
Clinical narrative: This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions/allergies, concurrent conditions and concomitant medications were not reported. In 2017 (reported as "on or after 05-JUL-2017"), the patient was vaccinated with an improperly stored dose of RECOMBIVAX HB lot # M040423 with expiration date 03-JUL-2019; an improperly stored dose of ROTATEQ per oral, lot # M044396 with expiration date 19-JUN-2018; or an improperly stored dose of VAQTA lot # N005274 with expiration date 03-APR-2018, for prophylaxis (dose and route of administration were not reported). It was stated that the vaccine was exposed to a temperature of 32 to 35 Fahrenheit degrees with a time frame of 1 hour. No previous temperature excursion was reported. The reporter did not know which vaccine was administered to the patient. This is one of several reports from the same reporter.; Sender's Comments: US-009507513-1710USA015406: US-009507513-1711USA008229: US-009507513-1711USA008231: US-009507513-1711USA008232: US-009507513-1711USA008233: US-009507513-1711USA008234:
Sex: U
Vaccine: HEP, HEPA, RV5
Symptoms: Product storage error
Clinical narrative: This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions/allergies, concurrent conditions and concomitant medications were not reported. In 2017 (reported as "on or after 05-JUL-2017"), the patient was vaccinated with an improperly stored dose of RECOMBIVAX H) lot # M040423 with expiration date 03-JUL-2019; an improperly stored dose of ROTATEQ per oral, lot # M044396 with expiration date 19-JUN-2018; or an improperly stored dose of VAQTA lot # N005274 with expiration date 03-APR-2018, for prophylaxis (dose and route of administration were not reported). It was stated that the vaccine was exposed to a temperature of 32 to 35 Fahrenheit degrees with a time frame of 1 hour. No previous temperature excursion was reported. The reporter did not know which vaccine was administered to the patient. This is one of several reports from the same reporter.; Sender's Comments: US-009507513-1710USA015406: US-009507513-1711USA008229: US-009507513-1711USA008230:  US-009507513-1711USA008232: US-009507513-1711USA008233: US-009507513-1711USA008234:
Sex: U
Vaccine: HEP, HEPA, RV5
Symptoms: Product storage error
Clinical narrative: This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions/allergies, concurrent conditions and concomitant medications were not reported. In 2017 (reported as "on or after 05-JUL-2017"), the patient was vaccinated with an improperly stored dose of RECOMBIVAX HB lot # M040423 with expiration date 03-JUL-2019; an improperly stored dose of ROTATEQ per oral, lot # M044396 with expiration date 19-JUN-2018; or an improperly stored dose of VAQTA lot # N005274 with expiration date 03-APR-2018, for prophylaxis (dose and route of administration were not reported). It was stated that the vaccine was exposed to a temperature of 32 to 35 Fahrenheit degrees with a time frame of 1 hour. No previous temperature excursion was reported. The reporter did not know which vaccine was administered to the patient. This is one of several reports from the same reporter.; Sender's Comments: US-009507513-1710USA015406: US-009507513-1711USA008229: US-009507513-1711USA008230: US-009507513-1711USA008231: US-009507513-1711USA008232: US-009507513-1711USA008234:
Sex: U
Vaccine: HEP, HEPA, RV5
Symptoms: Product storage error
Clinical narrative: This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions/allergies, concurrent conditions and concomitant medications were not reported. In 2017 (reported as "on or after 05-JUL-2017"), the patient was vaccinated with an improperly stored dose of RECOMBIVAX HB lot # M040423 with expiration date 03-JUL-2019; an improperly stored dose of ROTATEQ per oral, lot # M044396 with expiration date 19-JUN-2018; or an improperly stored dose of VAQTA lot # N005274 with expiration date 03-APR-2018, for prophylaxis (dose and route of administration were not reported). It was stated that the vaccine was exposed to a temperature of 32 to 35 Fahrenheit degrees with a time frame of 1 hour. No previous temperature excursion was reported. The reporter did not know which vaccine was administered to the patient. This is one of several reports from the same reporter.; Sender's Comments:  US-009507513-1710USA015406: US-009507513-1711USA008229: US-009507513-1711USA008230: US-009507513-1711USA008231: US-009507513-1711USA008232: US-009507513-1711USA008233:
Sex: U
Vaccine: VARZOS
Symptoms: Product storage error
Clinical narrative: Information has been received from a pharmacist reporting on a patient of unknown age and gender. There was no information about the patient's concurrent conditions, medical history or concomitant medication. On 13-OCT-2017, the patient received an improperly stored dose of ZOSTAVAX lot # M040146, expiration date 26-DEC-2017, 0.65 ml for prophylaxis (dose number, anatomical location and route of administration were not reported), reconstituted with properly stored sterile diluent (STERILE DILUENT). On 05-OCT-2017, the administered vaccine was exposed to a temperature between 15 Fahrenheit degrees and 46 Fahrenheit degrees for 22 hours and 44 minutes. On 04-SEP-2017, the administered vaccine was exposed to a temperature between 6 Fahrenheit degrees and 14 Fahrenheit degrees for 15 hours and 45 minutes. On 28-SEP-2017, the administered vaccine was exposed to a temperature between 6 Fahrenheit degrees and 14 Fahrenheit degrees for 8 hours and 15 minutes. The pharmacist reported that there was no previous temperature excursion. The call was placed because of a Digital Data logger report. This is one of two reports received from the same reporter.; Sender's Comments:  US-009507513-1710USA016231:
Age: 70.0
Sex: M
Vaccine: FLU4
Symptoms: Acute respiratory failure, Bilevel positive airway pressure, Cough, Dyspnoea, Endotracheal intubation
Clinical narrative: Initial solicited report received on 09 November 2017 from an investigator participating in the study. This case involves a 70-year-old male subject who developed respiratory arrest during the study participation. The subject's medical history and concomitant therapies were not reported. On 03 November 2017, same day after receiving a single dose of intramuscular dose of blinded therapy on 03 November 2017 (batch number unknown), the subject developed respiratory arrest. This subject was admitted with acute HF and afib on 02 November 2017. On 03 November 2017 subject was randomized in Invested. At this time the subject was not decompensated HF. Subject reported no previous flu vaccine. At the conclusion of the 20-minute monitoring period the subject reported coughing and sniffling and then within hours of vaccination fever of 101.4 was noted. Per hospital staff subject was given Tylenol for fever. On 04 November 2017, subject developed dyspnea which was treated with bipap as well as transfer to ICU. Once in ICU subject became unresponsive requiring intubation. Per pulmonology consult, the subject was not in decompensated HF rather acute respiratory failure. Pulmonology and nephrology consults were also uploaded with hospitalization form. At this time the subject remained in ICU on ventilator. Classified as possibly related. According to the investigator, the seriousness of event was considered as life threating due to prolonged hospitalization. Other lab data was not reported. The subject had corrective treatment with (Paracetamol) Tylenol. The event of respiratory arrest was resolving at the time of the report. According to the investigator, the event was related to the study vaccine or trial procedures. Relationship to investigational product according to company: associated. List of documents held by sender: none. Sender's Comments: A 70-year-old male subject had respiratory arrest on the day of receiving study vaccination. He was admited for acute heart failure and atrial fibrillation and next day received study dose. Within hours of vaccination he had fever evolving to acute respiratory failure next day. Based on time to onset and morbid condition of subject, the possibility of event due to study vaccine can not be ruled out.
Age: 70.0
Sex: M
Vaccine: FLU4
Symptoms: Intensive care, Mechanical ventilation, Pyrexia, Respiratory arrest, Rhinorrhoea
Clinical narrative: Initial solicited report received on 09 November 2017 from an investigator participating in the study. This case involves a 70-year-old male subject who developed respiratory arrest during the study participation. The subject's medical history and concomitant therapies were not reported. On 03 November 2017, same day after receiving a single dose of intramuscular dose of blinded therapy on 03 November 2017 (batch number unknown), the subject developed respiratory arrest. This subject was admitted with acute HF and afib on 02 November 2017. On 03 November 2017 subject was randomized in Invested. At this time the subject was not decompensated HF. Subject reported no previous flu vaccine. At the conclusion of the 20-minute monitoring period the subject reported coughing and sniffling and then within hours of vaccination fever of 101.4 was noted. Per hospital staff subject was given Tylenol for fever. On 04 November 2017, subject developed dyspnea which was treated with bipap as well as transfer to ICU. Once in ICU subject became unresponsive requiring intubation. Per pulmonology consult, the subject was not in decompensated HF rather acute respiratory failure. Pulmonology and nephrology consults were also uploaded with hospitalization form. At this time the subject remained in ICU on ventilator. Classified as possibly related. According to the investigator, the seriousness of event was considered as life threating due to prolonged hospitalization. Other lab data was not reported. The subject had corrective treatment with (Paracetamol) Tylenol. The event of respiratory arrest was resolving at the time of the report. According to the investigator, the event was related to the study vaccine or trial procedures. Relationship to investigational product according to company: associated. List of documents held by sender: none. Sender's Comments: A 70-year-old male subject had respiratory arrest on the day of receiving study vaccination. He was admited for acute heart failure and atrial fibrillation and next day received study dose. Within hours of vaccination he had fever evolving to acute respiratory failure next day. Based on time to onset and morbid condition of subject, the possibility of event due to study vaccine can not be ruled out.
Age: 70.0
Sex: M
Vaccine: FLU4
Symptoms: Unresponsive to stimuli
Clinical narrative: Initial solicited report received on 09 November 2017 from an investigator participating in the study. This case involves a 70-year-old male subject who developed respiratory arrest during the study participation. The subject's medical history and concomitant therapies were not reported. On 03 November 2017, same day after receiving a single dose of intramuscular dose of blinded therapy on 03 November 2017 (batch number unknown), the subject developed respiratory arrest. This subject was admitted with acute HF and afib on 02 November 2017. On 03 November 2017 subject was randomized in Invested. At this time the subject was not decompensated HF. Subject reported no previous flu vaccine. At the conclusion of the 20-minute monitoring period the subject reported coughing and sniffling and then within hours of vaccination fever of 101.4 was noted. Per hospital staff subject was given Tylenol for fever. On 04 November 2017, subject developed dyspnea which was treated with bipap as well as transfer to ICU. Once in ICU subject became unresponsive requiring intubation. Per pulmonology consult, the subject was not in decompensated HF rather acute respiratory failure. Pulmonology and nephrology consults were also uploaded with hospitalization form. At this time the subject remained in ICU on ventilator. Classified as possibly related. According to the investigator, the seriousness of event was considered as life threating due to prolonged hospitalization. Other lab data was not reported. The subject had corrective treatment with (Paracetamol) Tylenol. The event of respiratory arrest was resolving at the time of the report. According to the investigator, the event was related to the study vaccine or trial procedures. Relationship to investigational product according to company: associated. List of documents held by sender: none. Sender's Comments: A 70-year-old male subject had respiratory arrest on the day of receiving study vaccination. He was admited for acute heart failure and atrial fibrillation and next day received study dose. Within hours of vaccination he had fever evolving to acute respiratory failure next day. Based on time to onset and morbid condition of subject, the possibility of event due to study vaccine can not be ruled out.
Age: 39.0
Sex: M
Vaccine: ANTH
Symptoms: Fatigue, Flushing, Myalgia, Skin warm
Clinical narrative: Approximately 12-24 hrs after receiving vaccine patient developed hrs after vaccine patient noted subjective warmth/myalgias/fatigue. Greater than 48 hrs after vaccine patient noted flushing to trunk/axilla/groin. Resolved within 48 hrs without treatment.
Age: 1.08
Sex: F
Vaccine: FLU4
Symptoms: Extra dose administered
Clinical narrative: Child received a 2 dose of this year's flu vaccine even though she had previously received the two dose amounts last season. She only needed one vaccine this year and received two.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Chills, Headache, Injection site pain, Nausea, Pain
Clinical narrative: Headache, pain at site not able to use shoulder, nausea, chills, aches.
Age: 1.08
Sex: M
Vaccine: FLU4
Symptoms: Extra dose administered
Clinical narrative: Child received two doses of the 2017-18 flu vaccine after receiving two doses last year for the 2016-17 vaccine. He should have only received one but was inadvertently given two.
Sex: U
Vaccine: FLU4
Symptoms: Loss of consciousness
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of passed out in a child patient who received FLULAVAL Quadrivalent (batch number Z39X5, expiry date unknown). In November 2017, the patient received FLULAVAL Quadrivalent .5 ml. In November 2017, less than a week after receiving FLULAVAL Quadrivalent, the patient experienced passed out (serious criteria GSK medically significant). On an unknown date, the outcome of the passed out was unknown. It was unknown if the reporter considered the passed out to be related to FLULAVAL Quadrivalent. Additional details were provided as follows: This case was not reported to anyone previously. The age at vaccination was not reported. It was reported that, five school-age patients passed out following vaccination with FLULAVAL QIV at different sites, during the week of 6th to 10th November 2017. No further information was provided. This is 1 of 5 cases reported by the same reporter.
Age: 0.25
Sex: F
Vaccine: FLU4
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: Was given to a 3 month baby.
Age: 18.0
Sex: M
Vaccine: HEPA
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Administered Adult Hep A vaccine to a 18 year old male. Patient did not have any adverse reaction while at clinic.
Age: 37.0
Sex: F
Vaccine: PPV
Symptoms: Chest discomfort, Dyspnoea, Erythema, Lymphadenopathy, Pain in extremity
Clinical narrative: The day after she started to have lots of pain and redness around her arm but there were no issues at the injection site. She states that she has a swollen lymph node in her shoulder now. Since she has had the shot she has been short of breath and feels like she has something on her chest.
Age: 54.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema
Clinical narrative: Redness about the size of a softball around injection site on day 2 after injection. No treatment.
Age: 70.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site induration, Injection site swelling, Injection site warmth
Clinical narrative: Patient said her arm was fine for the first 2 days after the vaccine was given, then it started to swell a little and get a hard spot when injection was given, then it continued to swell and get red and fevered.  The redness kept spreading so she went to the doctor and he gave her an antibiotic
Age: 6.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site swelling, Pruritus
Clinical narrative: Fever: None; Location: Left; Onset: 3 -7 days; Duration: Acute; Severity: Moderate; Quality: Worsening. L. arm swelling and redness has moved. Received flu shot 11/18/17. Reaction was noted the following day. Child has had a flu shot every year and never had a reaction. Mom noted the arm was getting swollen yesterday and was red, starting a finger's width below where the shot was given. Patient had a normal day yesterday and today. Moved his arms normally and no complaints of pain. He reports itching. Mom gave him BENADRYL and ibuprofen before bed and he slept fine last night. Today mom thinks the redness has improved, swelling seems the same. Plan: I'm not worried at this point about a compartment syndrome-type reaction, as he has full ROM and no pain. Since mom thinks redness has improved, I hope we're trending toward improvement. Mom is comfortable watching, but knows to have a low threshold to seek care urgently if swelling increases or child is complaining of pain. Ibuprofen and BENADRYL is fine before bed.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Discomfort, Influenza, Injection site erythema
Clinical narrative: Similar generalized symptoms with flu vaccine 2 weeks ago without skin reaction - antihistamine worked to control symptoms. Since patient has the next day or two off from work I have recommended BENADRYL 25mg- 50mg every 6-8 hours for the next 24 hours, then resume daily CLARITIN. Ice to area of erythema to LUA. Ibuprofen or TYLENOL for discomfort. Should area of erythema worsen, please call office will need to consider treatment for cellulitis. Similar systemic reactions with last two vaccines - consider premedication with BENADRYL for future immunizations.
Sex: U
Vaccine: DTAP
Symptoms: Bordetella test positive, Cough, Pertussis, Vaccination failure
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of vaccination failure in a patient who received DTaP vaccine. On an unknown date, the patient received DTaP vaccine at an unknown dose. On an unknown date, unknown after receiving DTaP vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), Pertussis (serious criteria GSK medically significant) and cough. On an unknown date, the outcome of the vaccination failure, Pertussis and cough were unknown. It was unknown if the reporter considered the vaccination failure, Pertussis and cough to be related to DTaP vaccine. Additional details were provided as follows: The age at vaccination was not reported. The reporter stated that, in 2014, there was an outbreak of Pertussis in a patient. The patient tested positive, but had no symptoms to minimum symptoms with less coughing. When tested the patient's were pertactin lacking. The reporter was not sure which brand of DTaP that was provided. This case was considered as the suspected vaccination failure since the details regarding basic immunization schedule, time to onset for the event were not reported. This case is 1 of the 5 cases, as reported by same reporter.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a 72-year-old female patient of unknown race. The patient's concurrent conditions, medical history, and concomitant medications were not reported. The patient had not had any reaction to any previous vaccination. The patient had not illness at the time of vaccination. On 23-OCT-2017, the patient was vaccinated at a pharmacy with an expired dose of ZOSTAVAX (lot number: M033335, expiration date: 11-OCT-2017; the dose was not provided) on sterile diluent (DILUENT MRK) (lot number: M046372, expiration date: 08-JUL-2019) applied on the left arm subcutaneously for prophylaxis. The patient had normal inoculation and no adverse reaction was reported. There was no temperature excursion regarding the digital data logger.  No other vaccine was administrated within the 4 weeks prior to the vaccination with ZOSTAVAX. The patient's physician was notified.
Age: 14.0
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a nurse and refers to a 14 years old patient of unknown gender. No information regarding the patient's medical history, concurrent conditions and concomitant medications was provided. On 21-OCT-2017, the patient was vaccinated with improperly stored VAQTA lot # N017094 with expiration date on 31-AUG-2018 for prophylaxis (strength, dose and route were not reported). On an unknown date, the VAQTA was stored in temperature of 48.9 Fahrenheit degrees for 6 minutes. Previous temperature excursions were reported as 48.9 Fahrenheit degrees 24 minutes and 47.4 Fahrenheit degrees for 15 minutes. No adverse effect was provided. Data logger was involved. No product quality complaint was reported. This is the one of several case reports received from the same reporter.; Sender's Comments: US-009507513-1711USA004812:  US-009507513-1710USA013033: US-009507513-1711USA004811:
Age: 64.0
Sex: F
Vaccine: FLU4
Symptoms: Inflammatory marker increased, Injection site pain, Myalgia
Clinical narrative: Soreness at injection site. No problems until approx. 7-10 days later. Extreme muscle pain in both shoulders extending down to elbow and left hip to back of knee. Took ibuprofen and TYLENOL to try and ease pain. Continued until 11/6 when I went to express clinic. Was told possible reaction to flu vaccine and continue with ibuprofen and TYLENOL. Pain continued so went to family doctor on 11/15 and Dr. ordered bloodwork. After results of bloodwork said possible serum sickness and prescribed MOBIC. Called Dr. office today 11/21 to tell Dr. that pain is no better. Waiting on call back at this time.
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Injection site erythema
Clinical narrative: PATIENT CALLING BECAUSE SHE DEVELOPED REDNESS DOWN HER ARM. THIS ALSO BANDED OUT ALONG THE AREA OF INJECTION. PATIENT TOOK OTC MEDICATIONS.
Age: 51.0
Sex: F
Vaccine: FLU4
Symptoms: Cough, Dyspnoea, Fatigue, Nausea, Oropharyngeal pain
Clinical narrative: Sore Throat, cough, nauseas, Shortness of Breath, fatigue.
Age: 20.0
Sex: F
Vaccine: MENB
Symptoms: Asthenia, Chills, Decreased appetite, Feeling abnormal, Feeling cold
Clinical narrative: Exactly seven and a half hours after the vaccine, I started to shake uncontrollably, similar to extreme shivering. I then started to feel as though someone injected ice into my veins and tried to sleep with my winter coat on in addition to many blankets, but I was unable to get warm. My arm was in so much pain I could not move or use it from the injection. It was incredibly weak and essentially useless. For the next two days, I had a four-degree fever, my temperature is usually 96.5 and it rose to 100, significant for me. I didn't eat and slept for approximately 48 hours. This lasted for two days then I started to feel better. However a week later, I still don't feel as though I'm at 100%. I have never in my life felt this horrible, it was as if I had a severe flu, I would have gone to the hospital but I was too weak to drive there.
Age: 20.0
Sex: F
Vaccine: MENB
Symptoms: Hypersomnia, Influenza, Injected limb mobility decreased, Muscular weakness, Pain in extremity
Clinical narrative: Exactly seven and a half hours after the vaccine, I started to shake uncontrollably, similar to extreme shivering. I then started to feel as though someone injected ice into my veins and tried to sleep with my winter coat on in addition to many blankets, but I was unable to get warm. My arm was in so much pain I could not move or use it from the injection. It was incredibly weak and essentially useless. For the next two days, I had a four-degree fever, my temperature is usually 96.5 and it rose to 100, significant for me. I didn't eat and slept for approximately 48 hours. This lasted for two days then I started to feel better. However a week later, I still don't feel as though I'm at 100%. I have never in my life felt this horrible, it was as if I had a severe flu, I would have gone to the hospital but I was too weak to drive there.
Age: 20.0
Sex: F
Vaccine: MENB
Symptoms: Pyrexia, Tremor
Clinical narrative: Exactly seven and a half hours after the vaccine, I started to shake uncontrollably, similar to extreme shivering. I then started to feel as though someone injected ice into my veins and tried to sleep with my winter coat on in addition to many blankets, but I was unable to get warm. My arm was in so much pain I could not move or use it from the injection. It was incredibly weak and essentially useless. For the next two days, I had a four-degree fever, my temperature is usually 96.5 and it rose to 100, significant for me. I didn't eat and slept for approximately 48 hours. This lasted for two days then I started to feel better. However a week later, I still don't feel as though I'm at 100%. I have never in my life felt this horrible, it was as if I had a severe flu, I would have gone to the hospital but I was too weak to drive there.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Burning sensation, Erythema, Rash pruritic
Clinical narrative: Pt got a severe raised rash on chest that was itchy, burning and red. it lasted 6 weeks. It is now spotted. She said it did not weep or have liquids. The doctor told her it is most likely from the ZOSTAVAX.
Age: 29.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Redness and tenderness in area of pneumonia vaccine.
Age: 41.0
Sex: M
Vaccine: FLU4
Symptoms: Oedema peripheral, Tenderness
Clinical narrative: Tenderness in left armpit started on 11/17/17. Noted tennis ball sized swelling and tenderness under the left armpit the next morning.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Injection site rash, Rash, Rash erythematous, Rash pruritic
Clinical narrative: Rash started on left shoulder at injection site then rash spread down the left side of chest and back red raised and itchy patient was given script for predisone, triamcinolone and suggested to take benadryl and Zyrtec.
Age: 43.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site hypersensitivity, Vaccination site discomfort, Vaccination site pain, Vaccination site vesicles
Clinical narrative: Pt was here yesterday for her annual immunization of influenza vaccine, after immunization pt tolerated well with no problem or reaction. Today pt came back to the office with severe discomfort and burning sensation in the vaccine area, after I checked it, I can observe several blisters in the vaccine area as an allergic reaction. Dr. states this is a reaction to the trivalent Flu vaccine not to the administration. Pt is coming tomorrow for follow up.
Age: 24.0
Sex: M
Vaccine: RAB
Symptoms: Asthenia, Dyspnoea, Eyelid oedema, Gait disturbance, Urticaria
Clinical narrative: Contacted by patient's wife 8 days post vaccination, 2nd rabies. First vaccine given 11-6-2017, 2nd 11-13-17. Wife of patient stated on 11-17-17 patient woke up with hives, went to ED, had difficulty breathing and was given several medications and sent home. "A while later" after leaving the ED the patient's wife stated he started having the same type of reaction with weakness and difficulty walking and patient was taken back to the ED. Since patient does still have "hives off and on and puffy eyes."
Age: 41.0
Sex: M
Vaccine: FLUC4
Symptoms: Cough, Oropharyngeal pain, Pain, Pyrexia
Clinical narrative: Body aches, sore throat, fever and cough noted 3 days after vaccination. Took Ibuprofen 800 mg oral TID as needed. Got better after 3 days.
Age: 0.75
Sex: F
Vaccine: FLU4
Symptoms: Product storage error
Clinical narrative: Storage unit temperature excursion, vaccines deemed non viable by manufacturer. Contacting patients for re-vaccination.
Age: 0.33
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13
Symptoms: Diarrhoea, Haematochezia, Laboratory test, Polymerase chain reaction
Clinical narrative: Diarrhea and bloody stools.
Age: 22.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Blood culture negative, Chest X-ray normal, Immunodeficiency, Injection site erythema, Myalgia
Clinical narrative: Approximately 10 hours after receiving the vaccines (11/17), she developed generalized myalgias and fever. Continued to have fever until the following day and presented to the hospital due to immunocompromised state. Had fevers from 11/17-11/19. Treated with very broad spectrum antibiotics but all infectious studies were negative. Developed erythema over the R deltoid (location of pneumovax, but not influenza vaccine) on 11/20.
Age: 22.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Pyrexia, Urine analysis normal, White blood cell count increased
Clinical narrative: Approximately 10 hours after receiving the vaccines (11/17), she developed generalized myalgias and fever. Continued to have fever until the following day and presented to the hospital due to immunocompromised state. Had fevers from 11/17-11/19. Treated with very broad spectrum antibiotics but all infectious studies were negative. Developed erythema over the R deltoid (location of pneumovax, but not influenza vaccine) on 11/20.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Pyrexia, Rash
Clinical narrative: Large rash, approximately 2-3cm, and fevers/fatigue.
Age: 57.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Redness, swelling, pain & warmth in 4x4cm area left deltoid. Seen by PCP.
Age: 24.0
Sex: F
Vaccine: MMR
Symptoms: Pruritus, Rash, Rash morbilliform, Urticaria
Clinical narrative: 11/8/17-Employee received MMR subcutaneously left arm. 11/18/17-Itchy, hive-like rash presented on both arms. Took Claritin & Benadryl for relieve. 11/20/17-Employee made Employee Health aware; evaluated by doctor. Diagnosed with morbilliform eruption and advised to continue symptomatic care. No further MMR injections.
Age: 73.0
Sex: M
Vaccine: PPV
Symptoms: Chills, Injection site pain, Mobility decreased, Pyrexia
Clinical narrative: Progressive pain at injection site moving to high fever and chills during the night. Treated with acetaminophen. Fever went down but arm remained somewhat immobile -- (severe pain when touched or moved) -- slowly getting better as the day went on.
Age: 48.0
Sex: M
Vaccine: FLU4
Symptoms: Erythema
Clinical narrative: Reddened area right arm approx 20 x 6 cm. Referred to PCP for F/U.
Age: 34.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site pain, Joint range of motion decreased, Pain in extremity
Clinical narrative: Reports felt pain at site of Flu vaccination injection site. Reports site was about 1" below boney prominence. (L) arm continued to be painful and for the last 4 weeks has had reduced range of motion in raising and reaching. Refer to occupational medicine.
Age: 13.0
Sex: F
Vaccine: FLU4, HPV4
Symptoms: Product storage error
Clinical narrative: Storage unit temperature excursion, vaccines deemed non viable my manufacturer. Contacting patients for re-vaccination.
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Mobility decreased, Musculoskeletal pain, Musculoskeletal stiffness, Neck pain, Pain
Clinical narrative: I couldn't lift my arm after a few hours, the pain went to my neck and shoulder. It has been over 7 days and my arm still hurts to raise it. My neck is still stiff and my shoulder still hurts.
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Pain in extremity
Clinical narrative: I couldn't lift my arm after a few hours, the pain went to my neck and shoulder. It has been over 7 days and my arm still hurts to raise it. My neck is still stiff and my shoulder still hurts.
Age: 15.0
Sex: F
Vaccine: FLU4, HPV4
Symptoms: Product storage error
Clinical narrative: Storage unit temperature excursion, vaccines deemed non viable by manufacturer. Contacting patients for re-vaccination.
Age: 2.0
Sex: F
Vaccine: FLU4
Symptoms: Product storage error
Clinical narrative: Storage unit temperature excursion, vaccines deemed non viable by manufacturer, contacting patients for re-vaccination.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Product storage error
Clinical narrative: Storage unit temperature excursion, vaccines deemed non viable by manufacturer, contacting patients for re-vaccination.
Age: 3.0
Sex: F
Vaccine: FLU4
Symptoms: Product storage error
Clinical narrative: Storage unit temperature excursion, vaccines deemed non viable by manufacturer, contacting patients for re-vaccination.