chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: VARZOS
Symptoms: Injection site rash
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site rash in a female patient who received SHINGRIX (batch number G47M2, expiry date 11th October 2020) and (batch number 5NY3B, expiry date 13th July 2020). On 27th April 2018, the patient received SHINGRIX (intramuscular) .5 ml. On an unknown date, the dose was an unknown dose. On 29th April 2018, 2 days after receiving SHINGRIX, the patient experienced injection site rash. On an unknown date, the outcome of the injection site rash was not recovered/not resolved. The reporter considered the injection site rash to be possibly related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The pharmacist reported that they had a SHINGRIX clinic on Friday (27th April 2018). Three of her patients returned to her pharmacy on reporting date with the same symptoms. All three patients were female. The reporter did not have additional details to differentiate one patient from the other. They used two different lot numbers of SHINGRIX. This case has been linked with case US2018GSK080995 and US2018075831, reported by the same reporter.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Injected limb mobility decreased, Injection site pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 76-year-old female patient who received SHINGRIX (batch number 5NY3B, expiry date unknown). Previously administered products included Shingles vaccine (In 2012, the patient received original Shingles vaccine). Concurrent medical conditions included blood pressure high. On 30th April 2018 10:30, the patient received the 1st dose of SHINGRIX. On 30th April 2018, 2 hrs after receiving SHINGRIX, the patient experienced injection site pain and injected limb mobility decreased. On an unknown date, the outcome of the injection site pain and injected limb mobility decreased were not recovered/not resolved. The reporter considered the injection site pain and injected limb mobility decreased to be related to SHINGRIX. Additional details were provided as follows: Concomitant medication included high blood pressure medications. The patient received SHINGRIX on the left arm. The patient experienced pain at injection site which described as going from elbow to shoulder and due to pain, the patient was unable to lift arm. The patient had denied permission to contact their physician.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site rash
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site rash in a female patient who received SHINGRIX (batch number G47M2, expiry date 11th October 2020) and (batch number 5NY3B, expiry date 13th July 2020). On 27th April 2018, the patient received SHINGRIX (intramuscular) .5 ml. On an unknown date, the dose was an unknown dose. On 29th April 2018, 2 days after receiving SHINGRIX, the patient experienced injection site rash. On an unknown date, the outcome of the injection site rash was not recovered/not resolved. The reporter considered the injection site rash to be possibly related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. Pharmacist reported that they had a SHINGRIX clinic on Friday (27th April 2018). Three of her patients returned to her pharmacy on reporting date with the same symptoms. All three patients were female. The reporter did not have additional details to differentiate one patient from the other. They used two different lot numbers of SHINGRIX. This case has been linked with case US2018GSK080994 and US2018075831, reported by the same reporter.
Age: 70.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Incorrect route of drug administration, Pain in extremity, Peripheral swelling, Rash
Clinical narrative: Rash developed, painful and swollen left arm from subq. injection of SHINGRIX.
Age: 70.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Extensive swelling of vaccinated limb, Incorrect route of drug administration, Injection site erythema, Injection site swelling, Off label use
Clinical narrative: Rash developed, painful and swollen left arm from subq. injection of SHINGRIX.
Age: 55.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Reddened, raised area at injection site, warm to the touch. Area reddened is 40mm by 40mm.
Age: 56.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site swelling in a 56-year-old female patient who received SHINGRIX (batch number 9AS39, expiry date 13th July 2020). Concurrent medical conditions included anxiodepressive syndrome, blood pressure and cholesterol. On 28th April 2018, the patient received the 1st dose of SHINGRIX .5 ml. On 30th April 2018, 2 days after receiving SHINGRIX, the patient experienced injection site swelling, injection site erythema and injection site warmth. On an unknown date, the outcome of the injection site swelling, injection site erythema and injection site warmth were not recovered/not resolved. The reporter considered the injection site swelling, injection site erythema and injection site warmth to be related to SHINGRIX. Additional details were provided as follows: Concomitant product included anti inflammatory drugs. At 17:00 hours, the patient received the SHINGRIX vaccine on Saturday. On Monday, they came back with a red or swollen or hot injection site reaction. The patient didn't have any itching or pain and it wasn't bothering them. On 3rd May 2018, Thursday, it appears the redness got larger. The patient drew a circle around the reaction and it got larger and seems to be getting worse. The reported batch number 9A539 does not exists and was updated to 9AS39, as per sales data sheet.
Age: 56.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site swelling in a 56-year-old female patient who received SHINGRIX (batch number 9AS39, expiry date 13th July 2020). Concurrent medical conditions included anxiodepressive syndrome, blood pressure and cholesterol. On 28th April 2018, the patient received the 1st dose of SHINGRIX .5 ml. On 30th April 2018, 2 days after receiving SHINGRIX, the patient experienced injection site swelling, injection site erythema and injection site warmth. On an unknown date, the outcome of the injection site swelling, injection site erythema and injection site warmth were not recovered/not resolved. The reporter considered the injection site swelling, injection site erythema and injection site warmth to be related to SHINGRIX. Additional details were provided as follows: Concomitant product included anti inflammatory drugs. At 17:00 hours, the patient received the SHINGRIX vaccine on Saturday. On Monday, they came back with a red or swollen or hot injection site reaction. The patient didn't have any itching or pain and it wasn't bothering them. On 3rd May 2018, Thursday, it appears the redness got larger. The patient drew a circle around the reaction and it got larger and seems to be getting worse. The reported batch number 9A539 does not exists and was updated to 9AS39, as per sales data sheet.
Sex: U
Vaccine: PPV, RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse, referring to an unspecified number of patients of unknown demographics. The patients' medical history, concurrent conditions and concomitant medications were not reported. On unspecified dates, the patients were vaccinated with an improperly stored dose of PNEUMOVAX 23 lot # N034525 with expiration date 13-SEP-2019 (dose, route, and anatomical location were not provided) or could have received a dose of ROTATEQ orally,  lot # reported as N012751 with expiration date 27-JAN-2019, (dose and anatomical location were not provided); both used for prophylaxis. The vaccines experienced a temperature excursion of 47 degrees Fahrenheit (°F) to 77 degrees Fahrenheit (°F) with an average temperature of 59.2 degrees Fahrenheit (°F) for 5 hours and 35 minutes. There was no previous temperature excursion. There were no adverse effects reported. It was reported that this call was due to a digital data logger. Lot number N012751 is an invalid lot number for rotavirus vaccine, live, oral, pentavalent.
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: This spontaneous report was received via company representative from a pharmacist who refers to a female patient of unknown age. The patient's concomitant medications, pertinent medical history, drug reactions or allergies were not reported. On an unknown date, the patient was vaccinated with PNEUMOVAX 23 (lot #, expiration date, dose, strength and route of administration were not provided) for prophylaxis. On an unknown date (one day after vaccination), the patient experienced injection site injection site redness and swelling. The outcome of injection site injection site redness and swelling was unknown. The relatedness between the event and suspect vaccine was not defined by reporter.
Age: 71.0
Sex: F
Vaccine: PPV
Symptoms: Dizziness, Injection site erythema, Injection site pain, Injection site swelling, Joint effusion
Clinical narrative: This spontaneous report was received from a 71 years old female patient, who was reporting on herself. The patient's pertinent medical history included scoliosis. The patient had drug reactions or allergies to COMPAZINE, sulfa, clindamycin and amoxicillin. On approximately 16-APR-2018 (reported as "2 weeks ago"), the patient was vaccinated with PNEUMOVAX 23 injection (dose, route of administration, lot # and expiration date were not reported). The patient's concomitant medications were not provided. On the same day, five minutes after receiving the PNEUMOVAX 23 injection, the patient experienced dizziness and pain, redness and swelling at the injection site. On an unknown date in April 2018, she also developed a "pocket of fluid below her elbow" and subsequently went to the emergency room for unspecified treatment. Then, on an unknown date in April 2018, the patient developed stiffness in her fingers and dizziness (reported also "and hand"), and returned to the emergency room for unspecified treatment. She was treated in the emergency room (ER) with BENADRYL and other medication for the swelling. All treatments were received via the ER. Unspecified laboratory diagnostics were performed. The outcome of the events was reported to be recovered/resolved at the time reporting time (on an unknown date in 2018). The relatedness between the events and PNEUMOVAX 23 was not reported. No further information is available.
Age: 71.0
Sex: F
Vaccine: PPV
Symptoms: Musculoskeletal stiffness
Clinical narrative: This spontaneous report was received from a 71 years old female patient, who was reporting on herself. The patient's pertinent medical history included scoliosis. The patient had drug reactions or allergies to COMPAZINE, sulfa, clindamycin and amoxicillin. On approximately 16-APR-2018 (reported as "2 weeks ago"), the patient was vaccinated with PNEUMOVAX 23 injection (dose, route of administration, lot # and expiration date were not reported). The patient's concomitant medications were not provided. On the same day, five minutes after receiving the PNEUMOVAX 23 injection, the patient experienced dizziness and pain, redness and swelling at the injection site. On an unknown date in April 2018, she also developed a "pocket of fluid below her elbow" and subsequently went to the emergency room for unspecified treatment. Then, on an unknown date in April 2018, the patient developed stiffness in her fingers and dizziness (reported also "and hand"), and returned to the emergency room for unspecified treatment. She was treated in the emergency room (ER) with BENADRYL and other medication for the swelling. All treatments were received via the ER. Unspecified laboratory diagnostics were performed. The outcome of the events was reported to be recovered/resolved at the time reporting time (on an unknown date in 2018). The relatedness between the events and PNEUMOVAX 23 was not reported. No further information is available.
Age: 24.0
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: Information has been received from a medical assistant, concerning a 24 year old patient of unknown gender. The patient's medical history, drug allergies, previously drug reactions, concurrent conditions and concomitant medication were not reported. On 23-APR-2018, the patient was vaccinated with a first expired dose of the series VAQTA 50U/1ml injection, lot number N005605 with expiration date on 08-APR-2018 (route of administration and anatomical location were not provided), for prophylaxis. No prior excursion and no adverse effects were reported.
Sex: F
Vaccine: PPV
Symptoms: Chills, Immediate post-injection reaction, Injection site swelling, Mobility decreased, Nausea
Clinical narrative: This spontaneous report as received from an unspecified reporter via a company representative, and refers to a female patient possibly in her 50s. The patient's vaccination history included an unspecified Influenza vaccine and other unspecified vaccines with which she had unspecified reactions. Other historical vaccines also included PREVNAR 13. Information regarding the patient's concurrent conditions was not reported. On either 01-MAY-2018 or 02-MAY-2018, the patient was vaccinated with PNEUMOVAX 23 in the left arm (dose, route of administration, lot number and expiration date were not reported) for prophylaxis. In May 2018, immediately after vaccination, the patient started to have bad swelling at the injection site, so much pain in her left arm that she could barely lift her arm. She also had a high fever, felt nauseous, and had chills. The patient called to her doctor's office for medical attention and received an unspecified treatment for the adverse events. At the reporting time, the patient had not recovered from the adverse events. Causality assessment was not provided.
Sex: F
Vaccine: PPV
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: This spontaneous report as received from an unspecified reporter via a company representative, and refers to a female patient possibly in her 50s. The patient's vaccination history included an unspecified Influenza vaccine and other unspecified vaccines with which she had unspecified reactions. Other historical vaccines also included PREVNAR 13. Information regarding the patient's concurrent conditions was not reported. On either 01-MAY-2018 or 02-MAY-2018, the patient was vaccinated with PNEUMOVAX 23 in the left arm (dose, route of administration, lot number and expiration date were not reported) for prophylaxis. In May 2018, immediately after vaccination, the patient started to have bad swelling at the injection site, so much pain in her left arm that she could barely lift her arm. She also had a high fever, felt nauseous, and had chills. The patient called to her doctor's office for medical attention and received an unspecified treatment for the adverse events. At the reporting time, the patient had not recovered from the adverse events. Causality assessment was not provided.
Sex: U
Vaccine: HPVX
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist referring to a patient of unknown age. The patient's concurrent conditions, medical history and concomitant medications were not provided. On an unknown date in approximately 2016 (reported as two years earlier), the patient was vaccinated with the first and the second dose of GARDASIL 9 or GARDASIL (unidentified Merck HPV vaccine administered (name and lot number not provided)) for prophylaxis (strength, dose, route, frequency were not provided). The patient was in the pharmacy to receive the third dose (Inappropriate schedule of vaccine administered). No adverse effects were reported and no further information was provided.
Age: 0.33
Sex: F
Vaccine: RV5
Symptoms: Haematochezia
Clinical narrative: This spontaneous report has been received from a pharmacist, concerning a 4 month old female patient. The patient's concurrent condition included a possibly milk protein allergy. There were no medical history or concomitant medications reported. On 20-FEB-2018, the patient was vaccinated with the first dose of ROTATEQ; furthermore, on 24-APR-2018, the patient was vaccinated with the second dose of ROTATEQ, both doses were administered orally with a lot # N004815 and expiration date 07-OCT-2018 for prophylaxis (frequency was not provided). On an unknown date in 2018 (reported as after received second dose of ROTATEQ) (discrepant information reported as on 11-APR-2018), the patient experienced hematochezia. The patient sought medical attention in the emergency room and subsequently followed up with unspecified physician. The reporter stated that the patient's mother drank a lot of milk while breastfeeding the patient. The patient did not receive any treatment and no laboratories were performed. The outcome of hematochezia was reported as recovering. The causal relationship between hematochezia and ROTATEQ was not assessed. Upon internal review, hematochezia was considered to be medically significant.
Sex: F
Vaccine: HPV9
Symptoms: Contusion
Clinical narrative: This spontaneous report was received from a nurse practitioner concerning a female patient of unknown age. There was no information about the patient's concurrent conditions, medical history or concomitant medication. On an unspecified date in 2018 (reported as "within the last 7 to 10 days"), the patient was vaccinated with GARDASIL 9, intramuscular for prevention of human papillomavirus infection (HPV) (dose, anatomical location, lot number and expiration date were not reported). On an unspecified date in 2018, the patient developed 5 quarter sized bruises distributed across her body, but none were at the injection site (contusion). The outcome of contusion and the causal relationship between the event and therapy with GARDASIL 9 were not reported.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. On 12-JAN-2018, the patient was vaccinated with GARDASIL 9 lot number N021475 with expiration date on 31-JAN-2020 (strength, dose, route of administration and anatomical location were not reported) for prophylaxis. The administered dose of the vaccine experienced a temperature excursion in the range between 32°F up to 35°F for 270 minutes and 47°F to 77°F for 75 minutes, as recorded by a data logger. The vaccine had not had any previous temperature excursions.  There was no adverse effect reported. No product quality complaint was involved. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1805USA003097: US-009507513-1805USA003098: US-009507513-1805USA003099: US-009507513-1805USA003100: US-009507513-1805USA003101: US-009507513-1805USA003102: US-009507513-1805USA003103: US-009507513-1805USA003104: US-009507513-1805USA003105: US-009507513-1805USA003106: US-009507513-1805USA003107: US-009507513-1805USA003108: US-009507513-1805USA003109: US-009507513-1805USA003110: US-009507513-1805USA003111: US-009507513-1805USA003112: US-009507513-1805USA003096: US-009507513-1805USA003095: US-009507513-1805USA003094:
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report has been received from a medical assistant referring to a patient of unknown age and gender. Information regarding the patient's medical history, drug reactions or allergies, concurrent conditions and concomitant medications was not reported. On an unspecified day in May 2017, the patient was vaccinated with the first dose of GARDASIL 9 (strength, dose, route, anatomical location, lot # and expiration date were not provided) for prophylaxis. On an unspecified day in November 2017, the patient was vaccinated with the second dose of GARDASIL 9 (strength, dose, route, anatomical location, lot # and expiration date were not provided) for prophylaxis. On 07-MAY-2018, the patient was vaccinated with the third dose of GARDASIL 9 lot # N021572 with expiration date of 01-MAY-2020 (strength, dose, route and anatomical location were not provided) for prophylaxis (inappropriate schedule of drug administration).  No adverse effects were reported.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. On 15-JAN-2018, the patient was vaccinated with GARDASIL 9 lot number N021475 with expiration date on 31-JAN-2020 (strength, dose, route of administration and anatomical location were not reported) for prophylaxis. The administered dose of the vaccine experienced a temperature excursion in the range between 32°F up to 35°F for 270 minutes and 47°F to 77°F for 75 minutes, as recorded by a data logger. The vaccine had not had any previous temperature excursions.  There was no adverse effect reported. No product quality complaint was involved. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1805USA003078:
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. On 17-JAN-2018, the patient was vaccinated with GARDASIL 9 lot number N021475 with expiration date on 31-JAN-2020 (strength, dose, route of administration and anatomical location were not reported) for prophylaxis. The administered dose of the vaccine experienced a temperature excursion in the range between 32°F up to 35°F for 270 minutes and 47°F to 77°F for 75 minutes, as recorded by a data logger. The vaccine had not had any previous temperature excursions.  There was no adverse effect reported. No product quality complaint was involved. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1805USA003078:
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. On 05-MAR-2018, the patient was vaccinated with GARDASIL 9 lot number N021475 with expiration date on 31-JAN-2020 (strength, dose, route of administration and anatomical location were not reported) for prophylaxis. The administered dose of the vaccine experienced a temperature excursion in the range between 32°F up to 35°F for 270 minutes and 47°F to 77°F for 75 minutes, as recorded by a data logger. The vaccine had not had any previous temperature excursions.  There was no adverse effect reported. No product quality complaint was involved. This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1805USA003078:
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. On 06-MAR-2018, the patient was vaccinated with GARDASIL 9 lot number N021475 with expiration date on 31-JAN-2020 (strength, dose, route of administration and anatomical location were not reported) for prophylaxis. The administered dose of the vaccine experienced a temperature excursion in the range between 32°F up to 35°F for 270 minutes and 47°F to 77°F for 75 minutes, as recorded by a data logger. The vaccine had not had any previous temperature excursions.  There was no adverse effect reported. No product quality complaint was involved. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1805USA003078:
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. On 06-MAR-2018, the patient was vaccinated with GARDASIL 9 lot number N021475 with expiration date on 31-JAN-2020 (strength, dose, route of administration and anatomical location were not reported) for prophylaxis. The administered dose of the vaccine experienced a temperature excursion in the range between 32°F up to 35°F for 270 minutes and 47°F to 77°F for 75 minutes, as recorded by a data logger. The vaccine had not had any previous temperature excursions.  There was no adverse effect reported. No product quality complaint was involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1805USA003078.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. On 08-MAR-2018, the patient was vaccinated with GARDASIL 9 lot number N021475 with expiration date on 31-JAN-2020 (strength, dose, route of administration and anatomical location were not reported) for prophylaxis. The administered dose of the vaccine experienced a temperature excursion in the range between 32°F up to 35°F for 270 minutes and 47°F to 77°F for 75 minutes, as recorded by a data logger. The vaccine had not had any previous temperature excursions.  There was no adverse effect reported. No product quality complaint was involved. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1805USA003078:
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. On 13-MAR-2018, the patient was vaccinated with GARDASIL 9 lot number N021475 with expiration date on 31-JAN-2020 (strength, dose, route of administration and anatomical location were not reported) for prophylaxis. The administered dose of the vaccine experienced a temperature excursion in the range between 32°F up to 35°F for 270 minutes and 47°F to 77°F for 75 minutes, as recorded by a data logger. The vaccine had not had any previous temperature excursions.  There was no adverse effect reported. No product quality complaint was involved. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1805USA003078:
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. On 13-MAR-2018, the patient was vaccinated with GARDASIL 9 lot number N021475 with expiration date on 31-JAN-2020 (strength, dose, route of administration and anatomical location were not reported) for prophylaxis. The administered dose of the vaccine experienced a temperature excursion in the range between 32°F up to 35°F for 270 minutes and 47°F to 77°F for 75 minutes, as recorded by a data logger. The vaccine had not had any previous temperature excursions.  There was no adverse effect reported. No product quality complaint was involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1805USA003078.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. On 14-MAR-2018, the patient was vaccinated with GARDASIL 9 lot number N021475 with expiration date on 31-JAN-2020 (strength, dose, route of administration, anatomical location, lot number and expiration date were not reported) for prophylaxis. The administered dose of the vaccine experienced a temperature excursion in the range between 32°F up to 35°F for 270 minutes and 47°F to 77°F for 75 minutes, as recorded by a data logger. The vaccine had not had any previous temperature excursions. There was no adverse effect reported. No product quality complaint was involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1805USA003078.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. On 28-MAR-2018, the patient was vaccinated with GARDASIL 9 lot number N021475 with expiration date on 31-JAN-2020 (strength, dose, route of administration and anatomical location were not reported) for prophylaxis. The administered dose of the vaccine experienced a temperature excursion in the range between 32°F up to 35°F for 270 minutes and 47°F to 77°F for 75 minutes, as recorded by a data logger. The vaccine had not had any previous temperature excursions.  There was no adverse effect reported. No product quality complaint was involved. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1805USA003078:
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. On 05-APR-2018, the patient was vaccinated with GARDASIL 9 lot number N021475 with expiration date on 31-JAN-2020 (strength, dose, route of administration and anatomical location were not reported) for prophylaxis. The administered dose of the vaccine experienced a temperature excursion in the range between 32°F up to 35°F for 270 minutes and 47°F to 77°F for 75 minutes, as recorded by a data logger. The vaccine had not had any previous temperature excursions.  There was no adverse effect reported. No product quality complaint was involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1805USA003078.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. On 05-APR-2018, the patient was vaccinated with GARDASIL 9 lot number N021475 with expiration date on 31-JAN-2020 (strength, dose, route of administration and anatomical location were not reported) for prophylaxis. The administered dose of the vaccine experienced a temperature excursion in the range between 32°F up to 35°F for 270 minutes and 47°F to 77°F for 75 minutes, as recorded by a data logger. The vaccine had not had any previous temperature excursions.  There was no adverse effect reported. No product quality complaint was involved. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1805USA003078:
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. On 16-APR-2018, the patient was vaccinated with GARDASIL 9 lot number N021475 with expiration date on 31-JAN-2020 (strength, dose, route of administration and anatomical location were not reported) for prophylaxis. The administered dose of the vaccine experienced a temperature excursion in the range between 32°F up to 35°F for 270 minutes and 47°F to 77°F for 75 minutes, as recorded by a data logger. The vaccine had not had any previous temperature excursions.  There was no adverse effect reported. No product quality complaint was involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1805USA003078.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. On 17-APR-2018, the patient was vaccinated with GARDASIL 9 lot number N021475 with expiration date on 31-JAN-2020 (strength, dose, route of administration and anatomical location were not reported) for prophylaxis. The administered dose of the vaccine experienced a temperature excursion in the range between 32°F up to 35°F for 270 minutes and 47°F to 77°F for 75 minutes, as recorded by a data logger. The vaccine had not had any previous temperature excursions.  There was no adverse effect reported. No product quality complaint was involved. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1805USA003078:
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. On 19-APR-2018, the patient was vaccinated with GARDASIL 9 lot number N021572 with expiration date on 01-MAY-2020 (strength, dose, route of administration and anatomical location were not reported) for prophylaxis. The administered dose of the vaccine experienced a temperature excursion in the range between 32°F up to 35°F for 270 minutes and 47°F to 77°F for 75 minutes, as recorded by a data logger. The vaccine had not had any previous temperature excursions.  There was no adverse effect reported. No product quality complaint was involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1805USA003078.
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. On 13-MAR-2018, the patient was vaccinated with PEDVAXHIB lot number N003700 with expiration date on 01-NOV-2019 (strength, dose, route of administration and anatomical location were not reported) for prophylaxis. The administered dose of the vaccine experienced a temperature excursion in the range between 32°F up to 35°F for 270 minutes and 47°F to 77°F for 75 minutes, as recorded by a data logger. The vaccine had not had any previous temperature excursions. There was no adverse effect reported. No product quality complaint was involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1805USA003078.
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. On 22-MAR-2018, the patient was vaccinated with PEDVAXHIB lot number N003700 with expiration date on 01-NOV-2019 (strength, dose, route of administration and anatomical location were not reported) for prophylaxis. The administered dose of the vaccine experienced a temperature excursion in the range between 32°F up to 35°F for 270 minutes and 47°F to 77°F for 75 minutes, as recorded by a data logger. The vaccine had not had any previous temperature excursions. There was no adverse effect reported. No product quality complaint was involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1805USA003078.
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. On 27-APR-2018, the patient was vaccinated with PEDVAXHIB lot number N003700 with expiration date on 01-NOV-2019 (strength, dose, route of administration and anatomical location were not reported) for prophylaxis. The administered dose of the vaccine experienced a temperature excursion in the range between 32°F up to 35°F for 270 minutes and 47°F to 77°F for 75 minutes, as recorded by a data logger. The vaccine had not had any previous temperature excursions. There was no adverse effect reported. No product quality complaint was involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1805USA003078.
Sex: U
Vaccine: MMR, VARCEL
Symptoms: Incorrect route of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist, regarding a patient of unknown age. The patient's medical history, concurrent conditions, drug reactions, allergies and concomitant medications were not reported. On 04-MAY-2018, the patient was vaccinated with VARIVAX intramuscularly instead of subcutaneously, for prophylaxis (strength, dose, frequency, lot number and expiration date were not reported); and with M-M-R II, intramuscularly instead of subcutaneously, for prophylaxis (strength, dose, frequency, lot number and expiration date were not reported). No adverse effect was reported.
Age: 74.0
Sex: M
Vaccine: VARZOS
Symptoms: Asthenia, Decreased appetite, Erythema, Injection site erythema, Injection site pain
Clinical narrative: Pain, redness and swelling on the entire length of the left arm, loss of appetite, weakness, somnolence.
Age: 74.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site swelling, Pain in extremity, Peripheral swelling, Somnolence
Clinical narrative: Pain, redness and swelling on the entire length of the left arm, loss of appetite, weakness, somnolence.
Age: 83.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Insomnia, Pain, Rash
Clinical narrative: Patient received his first SHINGRIX vaccination at pharmacy on 3 /26 /2018. Patient began to have pain along the left side of his waist on 5/3/2018. Pain progressed and was having trouble sleeping because of it. He scheduled an appointment with his PCP for 5/8/2018 at which time a rash was identified along the left waist area. Patient was diagnosed with Shingles on 5/8/2018. Patient did receive a ZOSTAVAX in the past  on 6/21/2012.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site nodule, Injection site pain
Clinical narrative: Patient had large knot (the size of a egg) at in injection site that was sore.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Influenza like illness, Myalgia
Clinical narrative: Intense muscle pain - all over during the night - aches similar to flu.
Age: 16.0
Sex: F
Vaccine: MENB
Symptoms: Confusional state, Cyanosis, Dyskinesia, Headache, Hypotension
Clinical narrative: This case was reported by a other health professional via sales rep and described the occurrence of headache in a 16-year-old female patient who received BEXSERO (batch number 16D501, expiry date 31st march 2019). On 1st May 2018 13:00, the patient received the 2nd dose of BEXSERO. On 1st May 2018 17:00, 4 hrs after receiving BEXSERO, the patient experienced headache, blue lips, jerkiness, confusion and low blood pressure. On an unknown date, the outcome of the headache, blue lips jerkiness, confusion and low blood pressure were unknown. It was unknown if the reporter considered the headache, blue lips, jerkiness, confusion and low blood pressure to be related to BEXSERO. Additional details were provided as follows: The patient was vaccinated at 1:00 pm. Symptoms started at 5:00 pm which included headache, lips blue, jerky, confused and the patient had blood pressure 80/40 mm Hg. The patient was transported by ambulance to hospital (further details not provided). Information was also sent to VAERS reporting system on 1st May 2018. The reporter agreed to be contacted for follow up.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Influenza like illness
Clinical narrative: Felt like i had the flu for several days.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Chills, Heart rate increased, Influenza like illness, Influenza virus test negative
Clinical narrative: Patient stated that she started to have flu like symptoms several hours after administration of SHINGRIX (chills, fever, muscle aches "felt like knives stabbing her in every joint", severe nausea, increased heart rate ->130BPM). After only being able to sleep less than 2 hours, she went to ER where they ran multiple tests including a negative flu test. She stated that they ruled out everything and attributed her reaction to the vaccine. Her symptoms were treated and she covered in the next day or so.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Insomnia, Myalgia, Nausea, Pyrexia
Clinical narrative: Patient stated that she started to have flu like symptoms several hours after administration of SHINGRIX (chills, fever, muscle aches "felt like knives stabbing her in every joint", severe nausea, increased heart rate ->130BPM). After only being able to sleep less than 2 hours, she went to ER where they ran multiple tests including a negative flu test. She stated that they ruled out everything and attributed her reaction to the vaccine. Her symptoms were treated and she covered in the next day or so.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Dry mouth
Clinical narrative: Dry mouth, it lasted about 30 minutes, then subsided.
Sex: U
Vaccine: MMR
Symptoms: Incorrect route of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. On an unknown date, the patient was vaccinated with M-M-R II (rHA) injection 0.5mL, lot number N023149 with expiration date on 24-AUG-2019 (dose was not reported) for prophylaxis with sterile diluent (MERCK) lot number N027783 with expiration date on 17-NOV-2019. It was stated that the patient inadvertently received a dose via the intramuscular route instead of the intended subcutaneous route. No adverse effects reported. Lot number N027783 has been verified to be a valid lot number for sterile diluent (MERCK).
Age: 1.5
Sex: U
Vaccine: RV5
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a 18 month old child of an unknown gender. No information was provided regarding the patient's concurrent conditions, medical history or concomitant medications. On an unknown date, the patient was vaccinated with the first dose (1 vial/once) in the three dose ROTATEQ for prophylaxis (route of administration, anatomical location, lot number and expiration date were not reported) at 18 months which was later than the recommended starting age, for ROTATEQ. No adverse effects reported.
Sex: U
Vaccine: RV5
Symptoms: Gastroenteritis, Gastroenteritis rotavirus, Polymerase chain reaction positive, Rotavirus test positive, Vaccination failure
Clinical narrative: This literature marketed report was received from the authors in a published literature article title as stated below, concerning 6 child of unknown age and gender. On an unknown dates, 4 of 6 patients were fully vaccinated with rotavirus vaccine, live, oral, pentavalent (manufacturer unknown) orally (dose, frequency, lot# and the expiration date were not reported) for prophylaxis. 2 of 6 patients were vaccinated with rotavirus vaccine, live, oral, pentavalent (manufacturer unknown)orally (dose, frequency, lot# and the expiration date were not reported) for prophylaxis. On an unknown date, the patients experienced an outbreak of acute gastroenteritis (AGE) at a child care center (Vaccination failure). On an unknown date, stool specimens tested positive by reverse-transcription polymerase chain reaction (RT-PCR) for Gastroenteritis rotavirus. At the time of reporting, the outcome of vaccination failure and Gastroenteritis rotavirus was unknown. Current rotavirus vaccines were highly effective against severe diarrheal illness, but they did not necessarily prevent infection or milder disease. Thus, rotavirus disease and outbreaks could occur even in populations where vaccination coverage was high. Upon internal review the Gastroenteritis rotavirus was considered as medically significant.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On or about 18-OCT-2013, the patient was inoculated with ZOSTAVAX (lot number, dosage and route of administration not provided) for routine adult health maintenance and the intended purpose for the prevention of shingles. ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster, the very virus the zoster vaccine live (ZOSTAVAX) is intended to prevent. On or about 02-JUN-2016, the patient was treated for a vesicular outbreak, which was diagnosed as herpes zoster, or shingles. As a direct and proximate result of the ZOSTAVAX, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events is unknown. Additional information has been requested.