chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 42.0
Sex: F
Vaccine: MMR
Symptoms: Cold sweat, Dizziness, Seizure, Unresponsive to stimuli
Clinical narrative: I administered the vaccine and patient sat in the lobby for a few minutes while I was filling out her paperwork. Patient become clammy and dizzy. Patient begin having seizure. I was going to stick her with the EPIPEN if she stopped breathing but patient became response. She was transported to the emergency room.
Age: 1.0
Sex: F
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a office manager and refers to a 12-months-old female patient. On 12-APR-2018, the patient was vaccinated for prophylaxis with improperly stored dose of VARIVAX (lot number N029631, expiration date 23-OCT-2019) (dose and route of administration were not provided), reconstituted with properly stored sterile diluent. The vaccine underwent a temperature excursion of 12 degrees Fahrenheit for 30 minutes. There was no previous temperature of excursion reported. Digital data logger was involved. No adverse effects were reported. This is one of several reports received from the same reporter.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. On 03-MAY-2018, the patient was vaccinated with an expired dose of M-M-R II lot # M022408, expiration date 02-MAY-2018. Concomitant therapies included properly stored sterile diluent (STERILE DILUENT) lot # M013219, expiration date 15-NOV-2018. There was no temperature excursion. No adverse effect was reported.
Sex: U
Vaccine: VARZOS
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Information has received from a medical assistant, concerning a patient of unknown age and gender. The patient's medical history, drug allergies, previously drug reactions, concurrent conditions and concomitant medication were not reported. On 21-MAR-2018, the patient was vaccinated with ZOSTAVAX, lot number reported: N025698 with expiration date on 16-DEC-2018 (strength, dose, route of administration and anatomical location were not provided) for prophylaxis, reconstituted with sterile diluent (DILUENT MRK), instead of VARIVAX, which the patient was supposed to receive (wrong drug administered); due to human error. No adverse effects were reported.
Age: 12.0
Sex: M
Vaccine: HPV9, MEN, TDAP
Symptoms: Syncope
Clinical narrative: This spontaneous report was received from a physician via company representative and refers to a 12 year old male patient. The patient's concomitant medications, pertinent medical history, drug reactions or allergies were not reported. On an unknown date, the patient was vaccinated with GARDASIL 9 first dose (lot #, expiration date, dose, strength and route of administration were not provided) for prophylaxis. In February 2018, the patient was vaccinated with GARDASIL 9 second dose (lot #, expiration date, dose, strength and route of administration were not provided) for prophylaxis. Other suspect therapies administered on the same date as second dose of GARDASIL 9 included (unspecified), TDAP vaccination and an unspecified meningitis vaccination. In February 2018, immediately after receiving the second dose of GARDASIL 9, the patient fainted and went to the hospital. It was unknown if the patient was hospitalized or if the patient went to the emergency department. The patient sought medical attention. The outcome of the event was reported as recovered on an unknown date. The causal relationship between the event and suspected therapy was not provided by the reporter.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to a patient of unknown age and gender. On 30-APR-2018, the patient was vaccinated with improperly stored dose of ROTATEQ (lot number N011651, expiration date 02-DEC-2018), 1 tube once, orally for prophylaxis. The vaccine underwent an excursion of 47 degrees Fahrenheit to 77 degrees Fahrenheit for 1 min and range at or above 32 degrees Fahrenheit up to 35 degrees Fahrenheit for 12 minutes. There was no previous temperature excursion. The digital data logger was involved.
Sex: U
Vaccine: HPV9
Symptoms: Product storage error
Clinical narrative: This spontaneous report as received from a medical assistant referring to an patient of unknown age and gender. The patients' pertinent medical history, drug reactions/allergies, concurrent conditions and concomitant medications were not reported. On an unknown date in 2017 (reported as: 06-APR-2017 to 08-NOV-2017), the patient was vaccinated with improperly stored dose of GARDASIL 9 (dose, frequency and route of administration were not reported) (lot # N003703 expiry date: 29-OCT-2019) for prophylaxis. The GARDASIL 9 was exposed to a total time in the range at or above 0 degrees C to 1 degrees C for 8.25 hours. It was reported the exact temperature and time below 0 degrees C was: -1.9 degrees C for 15 minutes, -1.2 degrees C for 15 minutes, -1.0 degrees C for 15 minutes, -0.8 degrees C for 15 minutes, -0.4 degrees C for 15 minutes and -0.2 degrees C for 1 hour 15 minutes. There was no previous temperature excursion. A "data logger" was involved. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Rash, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. In 2014, the patient was vaccinated with ZOSTAVAX, (lot# and route unknown) as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of shingles. On or about 03-JUL-2016, the patient was treated by a physician at a hospital, for the onset of a severe and painful vesicular rash, which was diagnosed as a shingles outbreak. The patient has been prescribed famciclovir (FAMVIR) for management of her painful symptoms. As a direct and proximate result of the defective ZOSTAVAX vaccine and/or as a result of the tenuous efficacy of the vaccine, the patient suffered painful injuries and damages, and required extensive medical care and treatment. Further, the patient has suffered and will continue to suffer significant medical expenses, pain and suffering, and other damages. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received on 14-MAY-2018 regarding a case in litigation from a lawyer and a male consumer of unknown age. The patient's concurrent conditions, medical history and concomitant medications are unknown. In 2014, the patient was inoculated with ZOSTAVAX (lot number and expiration unknown) unknown route, at a pharmacy. The inoculation was recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended. Rather the patient contracted a persistent strain of herpes zoster. On or about 01-JUN-2016, the patient was treated at an urgent care for the onset of a rash and was diagnosed as herpes zoster or shingles. As a direct and proximate result of the defective ZOSTAVAX, and/or as a result of the tenuous efficacy of the vaccine, the patient suffered painful injuries and damages, and required extensive medical care and treatment. Further, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Age: 1.0
Sex: F
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a office manager and refers to a 12-months-old female patient. On 17-APR-2018, the patient was vaccinated for prophylaxis with improperly stored dose of VARIVAX (lot number N029631, expiration date 23-OCT-2019) (dose and route of administration were not provided), reconstituted with properly stored sterile diluent. The vaccine underwent a temperature excursion of 12 degrees Fahrenheit for 30 minutes. There was no previous temperature of excursion reported. Digital data logger was involved. No adverse effects were reported. This is one of several reports received from the same reporter.
Age: 1.75
Sex: M
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a office manager and refers to a 21-months-old male patient. On 23-APR-2018, the patient was vaccinated for prophylaxis with improperly stored dose of VARIVAX lot # N029631, expiration date 23-OCT-2019 (dose and route of administration were not provided), reconstituted with properly stored sterile diluent (STERILE DILUENT). The vaccine underwent a temperature excursion of 12 degrees Fahrenheit for 30 minutes. There was no previous temperature of excursion reported. Digital data logger was involved. No adverse effects were reported. This is one of several reports received from the same reporter.
Age: 4.0
Sex: F
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a office manager and refers to a currently 4-year-old female patient. On 26-APR-2018, the patient was vaccinated for prophylaxis with improperly stored dose of VARIVAX lot # N029631, expiration date 23-OCT-2019 (dose and route of administration were not provided), reconstituted with properly stored sterile diluent (STERILE DILUENT). The vaccine underwent a temperature excursion of 12 degrees Fahrenheit for 30 minutes. There was no previous temperature of excursion reported. Digital data logger was involved. No adverse effects were reported. This is one of several reports received from the same reporter.
Age: 0.75
Sex: F
Vaccine: DTAPIPVHIB, PNC13
Symptoms: Pyrexia, Urticaria
Clinical narrative: Fever and hives. BENADRYL given. This was patient's first dose of PENTACEL, she had received a dose of PEDIARIX prior.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site pain, Vaccination site swelling
Clinical narrative: Mom noted small amount of redness at the vaccine site on his left thigh on 5/11/18. On 5/12/18 mom took the band aid off of the vaccine site on his left thigh and notes a reddened, tender, raised area the size of a deck of cards. Mom gave ibuprofen and BENADRYL and the site began to improve. Mom contacted the office on 5/14/18 to notify us of the reaction and she said that the reaction had almost resolved by that time.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia
Clinical narrative: Muscle soreness starting in hand day after vaccination. Has now spread throughout the body.  Patient now complains of muscle pain all over.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Chills, Headache, Pain, Pyrexia
Clinical narrative: The morning after the injection I have low grade fever (99.4), chills, body aches, stomach ache, and head ache.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP
Symptoms: Swelling
Clinical narrative: Small bump not going away after 2 weeks.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Incorrect route of drug administration, Pain, Swelling
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of swelling in a 65-year-old female patient who received SHINGRIX. On 3rd May 2018, the patient received the 1st dose of SHINGRIX (subcutaneous) .5 ml. On 3rd May 2018, unknown after receiving SHINGRIX, the patient experienced intramuscular formulation administered by other route. On an unknown date, the patient experienced swelling, erythema and pain. On an unknown date, the outcome of the swelling, erythema, pain and intramuscular formulation administered by other route were unknown. It was unknown if the reporter considered the swelling, erythema and pain to be related to SHINGRIX. Additional information was reported as follows: The case was reported by contacting a GlaxoSmithKline employee that was a Medical Science Liaison (MSL). The patient was vaccinated with SHINGRIX by subcutaneous route instead of Intramuscular route, which led to inappropriate route of vaccination.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling, Throat irritation
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site swelling in a 52-year-old female patient who received SHINGRIX (batch number CH2X7, expiry date 25th April 2020). The patient's past medical history included cancer (unknown type). Concurrent medical conditions included esophageal acid reflux. Concomitant products included Levothyroxine. On 9th April 2018, the patient received the 1st dose of SHINGRIX. In April 2018, 2 hrs after receiving SHINGRIX, the patient experienced itchy throat. On an unknown date, the patient experienced injection site swelling (serious criteria disability). On 10th April 2018, the outcome of the itchy throat was recovered/resolved. On an unknown date, the outcome of the injection site swelling was recovered/resolved. The reporter considered the injection site swelling and itchy throat to be almost certainly related to SHINGRIX. Additional details were reported as follows: The pharmacist stated that the patient was taking levothyroxine. The patient received the SHINGRIX vaccine in the left deltoid and she experienced throat itchiness two hours after receiving the vaccine, and it resolved by the end of the day. Less than a month after vaccination, the patient experienced injection site swelling, which lasted for 3 to 5 days. The pharmacist did not know the onset of that symptom. The pharmacist stated that the patient's arm swelling was a little bit disabling. The reporter was not aware of any medical intervention taken because of patient's experiences.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Influenza like illness, Injection site nodule
Clinical narrative: Patient has flu like symptoms. Patient has a knot at injection site.
Age: 74.0
Sex: M
Vaccine: VARZOS
Symptoms: Dizziness, Laboratory test, Mobility decreased, Scan, Tremor
Clinical narrative: Roughly 1 hour after receiving SHINGRIX patient was dizzy, shaking, and unable to lift arm. He went to ER and tests/scans were performed. He was discharged home with muscle relaxants and anti-inflammatory meds.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash generalised
Clinical narrative: A rash developed from neck down to ankles. Dr. instructed patient to take ZANTAC and CLARITIN OTC products daily as well as BENADRYL at bedtime. Rash lasted for roughly 5 days according to patient.
Age: 33.0
Sex: F
Vaccine: HEP
Symptoms: Haematuria, Urine analysis abnormal
Clinical narrative: The patient noticed hematuria the next day (5/5/18), which was confirmed by her PCP on 5/9/18.
Sex: M
Vaccine: VARCEL
Symptoms: Malaise
Clinical narrative: This spontaneous report has been received from a pharmacist, concerning a male patient of unknown age. The patient's medical history, concurrent conditions and concomitant medications were unknown by reporter. On an unknown date, the patient was vaccinated with the second dose of VARIVAX (frequency, route, lot number and expiration date were not provided) for prophylaxis. On an unknown date, the reporter stated that the patient received a mutated VARIVAX for the second dose and got very sick. The outcome of got very sick was unknown and the causal relationship between the adverse event and the therapy was not assessed. This is one of two reports received from the same reporter.; Sender's Comments: US-009507513-1805USA005879:
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a certified medical assistant referring to multiple unspecified patients of unknown age. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. On or after 02-MAY-2018, on multiple unspecified dates, the patients were vaccinated with improperly stored ROTATEQ, oral for prophylaxis (dose, route of administration, lot number and expiration date were not reported). No adverse events were reported. The vaccine was exposed to a temperature excursion of 47°F to 77°F with a time frame of 2 hours and 10 minutes. There was no previous temperature excursion. A "data logger" was involved.
Sex: F
Vaccine: VARZOS
Symptoms: Burning sensation, Herpes zoster, Rash
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. In 2007, the patient was vaccinated with ZOSTAVAX, (lot# and route unknown) as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended. Instead, the patient contracted a persistent strain of herpes zoster, or shingles. During 2016, the patient was treated by a physician, for the onset of a burning rash, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the defective ZOSTAVAX vaccine and/or as a result of the tenuous efficacy of the vaccine, the patient suffered painful injuries and damages, and required extensive medical care and treatment. Further, the patient has suffered and will continue to suffer significant medical expenses, pain and suffering. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Nervous system disorder, Pain, Rash
Clinical narrative: Information has been received on 14-MAY-2018 regarding a case in litigation from a lawyer and a male consumer of unknown age. The patient's concurrent conditions, medical history and concomitant medications are unknown. On or about 21-AUG-2013, the patient was inoculated with ZOSTAVAX (lot number and expiration unknown) unknown route, at a pharmacy. The inoculation was recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended. Instead, the patient contracted a persistent strain of shingles, or herpes zoster. On or about 09-MAY-2015, the patient was treated by a health care provider at an urgent care for the onset of a severe, painful rash and was diagnosed as severe herpes zoster with unspecified nervous system complication. The patient has been prescribed valacyclovir to manage his painful symptoms and chronic pain. As a direct and proximate result of the defective ZOSTAVAX, and/or as a result of the tenuous efficacy of the vaccine, 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. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash, Rash vesicular
Clinical narrative: Information was received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received concerning the patient's past medical history, concurrent conditions, or concomitant medication. In 2012, the patient was inoculated at a pharmacy with ZOSTAVAX (lot number, dosage, and route of administration not provided), as recommended for routine adult health maintenance and for the prevention of shingles. The ZOSTAVAX vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. During 2016, the patient was treated by a physician for the onset of a severe, painful vesicular rash, which was diagnosed as herpes zoster, or shingles. As a direct and proximate result of the defective ZOSTAVAX vaccine and/or because of the tenuous efficacy of the vaccine, the patient suffered painful injuries and damages, and required extensive medical care and treatment. Further, the patient has suffered and will continue to suffer significant medical expenses, pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was considered related. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash, Rash pruritic
Clinical narrative: Information was received from a lawyer regarding a case in litigation concerning a patient of unknown gender and age. No information was received concerning the patient's past medical history, concurrent conditions, or concomitant medication. On or about 08-NOV-2013, the patient was inoculated at a pharmacy with ZOSTAVAX (lot number, dosage, and route of administration not provided), as recommended for routine adult health maintenance and for the prevention of shingles. The ZOSTAVAX vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of shingles, or herpes zoster. On or about 21-NOV-2013, the patient was treated by a Family Nurse Practitioner for the onset of a painful and pruritic rash, which was diagnosed as shingles. As a direct and proximate result of the defective ZOSTAVAX vaccine and/or because of the tenuous efficacy of the vaccine, the patient suffered painful injuries and damages, and required extensive medical care and treatment.  Further, the patient has suffered and will continue to suffer significant medical expenses, pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was considered related. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash vesicular
Clinical narrative: Information was received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received concerning the patient's past medical history, concurrent conditions, or concomitant medication. During 2015, the patient was inoculated at a pharmacy with ZOSTAVAX (lot number, dosage, and route of administration not provided), as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. During 2016, the patient was treated by a physician for a vesicular outbreak, which was diagnosed as herpes zoster, or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX vaccine 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. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash vesicular
Clinical narrative: Information was received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received concerning the patient's past medical history, concurrent conditions, or concomitant medication. During 2014, the patient was inoculated at a pharmacy with ZOSTAVAX (lot number, dosage, and route of administration not provided), as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. During 2016, the patient was treated by a physician for  a vesicular rash, which was diagnosed as herpes zoster, or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX vaccine 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. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash vesicular
Clinical narrative: Information was received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received concerning the patient's past medical history, concurrent conditions, or concomitant medication. On or about 01-JAN-2009, the patient was inoculated by a physician with ZOSTAVAX (lot number, dosage, and route of administration not provided), as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently persistent strain of herpes zoster, also known as shingles. On or about 01-JUN-2009, the patient was treated by the same physician for the onset of a vesicular rash, which was diagnosed as herpes zoster, or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX vaccine 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. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash vesicular
Clinical narrative: Information was received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received concerning the patient's past medical history, concurrent conditions, or concomitant medication. During 2016, the patient was inoculated at a pharmacy with ZOSTAVAX (lot number, dosage, and route of administration not provided) as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles, and the patient subsequently contracted a persistent strain of herpes zoster. Later in 2016, the patient was treated at a health clinic for the onset of a vesicular rash, which was diagnosed as herpes zoster, or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX vaccine 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 was unknown. Causality assessment was considered related. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash vesicular
Clinical narrative: Information was received from a lawyer regarding a case in litigation. A patient, gender and age unspecified, was inoculated with ZOSTAVAX on 02-MAY-2016 at a pharmacy as recommended for routine adult health maintenance and for prevention of shingles. The vaccine did not prevent shingles as intended and subsequently the patient contracted a persistent strain condition of herpes zoster. On or about 09-JUN-2016 the patient was treated (by an unspecified health care professional) at a medical group office for the onset of a vesicular rash, which was diagnosed as shingles. On or about 14-FEB-2017, the patient sought subsequent treatment by a physician at a dermatology office for a further diagnosis of continued and worsening shingles. As a direct and proximate result of ZOSTAVAX vaccine, 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 reporter considered the events to be related to ZOSTAVAX. Additional information has been requested.
Age: 4.0
Sex: U
Vaccine: MMRV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report was received from a nurse referring to a 4 year old patient of unknown gender. The patient's pertinent medical history, concurrent conditions, concomitant therapies and past drug reactions/allergies were not reported. On 14-MAY-2018 the patient was inadvertently vaccinated with an additional dose (third dose) of PROQUAD lot # N023966 with expiration date: 28-FEB-2019 (strength, route, therapy type and anatomical location were not reported) for prophylaxis. The patient had previously been vaccinated with the second dose of PROQUAD in September 2017. Other suspect therapies included sterile diluent (strength, dose, route, anatomical location and indication were not reported). No adverse effects reported. No further adverse event  information provided.
Sex: M
Vaccine: VARZOS
Symptoms: Eye disorder, Herpes zoster
Clinical narrative: This initial spontaneous report was received from the wife of a male patient of unspecified age. The wife did not provide any information regarding medical history, concurrent conditions, or concomitant medications. On an unspecified date, the patient was vaccinated with ZOSTAVAX (dose, route, and lot number not provided). The wife reported that on an unspecified date, her husband still developed shingles. The patient was now experiencing "eye problems" (not further specified). The outcome of the events were not recovered. Causality assessment was not specified. The wife would like compensation for her husband (for medical bills and other). She also wanted to know if she should get an attorney and wanted to know if she should join the class action law suit. She stated she would like to settle without an attorney. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash vesicular
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient of unknown age and gender. No information was provided regarding concomitant medications, concurrent conditions or medical history. During 2015, the patient was inoculated with ZOSTAVAX at a pharmacy as recommended for routine adult health maintenance and for the prevention of shingles(dose, route, and lot # not provided). The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. On or about 03-JUN-2016, the patient was treated at an Internal Medicine office for the onset of severe vesicular rash, which was diagnosed as severe herpes zoster, or shingles. As a direct and proximate result of the ZOSTAVAX vaccine 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 was unknown. Causality assessment was related. Additional information has been requested.
Sex: M
Vaccine: VARCEL
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report has been received from a pharmacist, concerning a 23 year old male patient. The patient's medical history, concurrent conditions and concomitant medications were unknown by reporter. On 09-MAY-2018 (reported as today), the patient was vaccinated with the second dose of VARIVAX (frequency, route, lot number and expiration date were not provided) for prophylaxis. No adverse effects reported. On an unknown date, the reporter stated that the patient previously received one dose of VARIVAX when the patient was child (inappropriate schedule of drug administration). The reporter stated that the patient did not receive the second dose when was a child because the patient's mother would not allow him, because the patient's brother received a mutated VARIVAX (MARRS# 1805USA004364) and got very sick. This is one of two reports received from the same reporter.; Sender's Comments: US-009507513-1805USA004364:
Sex: U
Vaccine: PNC13, PNC13, PNC13
Symptoms: Antibody test positive, Extra dose administered, Product use issue, Therapy non-responder
Clinical narrative: This is a spontaneous report from a contactable physician via a Pfizer sales representative. This physician reported similar events for four patients. This is first of four reports. A patient of unspecified age ethnicity and gender received fifth dose of PREVNAR 13, via an unspecified route of administration on an unspecified date at a single dose for immunisation. The patient's medical history and concomitant medications were not reported. It was reported that the patient did not seroconvert after the fourth administration of pneumococcal 13-valent conjugate vaccine (diphtheria CRM197 protein). On an unspecified date, the patient experienced after the 5th dosage, titers increased significantly. It was also reported that checking titers was necessary after a complete immune work up due to frequent illnesses. Outcome of the event was unknown. Information on lot number, batch number and expiration date has been requested. Sender's Comments: Linked Report(s) : US-PFIZER INC-2018194075 same reporter, product and event, different patient; US-PFIZER INC-2018194076 same reporter, product and event, different patient; US-PFIZER INC-2018194077 same reporter, product and event, different patient.
Sex: U
Vaccine: PNC13, PNC13, PNC13
Symptoms: Antibody test negative, Autoantibody test
Clinical narrative: This is a spontaneous report from a contactable physician via a Pfizer sales representative. This physician reported similar events for four patients. This is first of four reports. A patient of unspecified age ethnicity and gender received fifth dose of PREVNAR 13, via an unspecified route of administration on an unspecified date at a single dose for immunisation. The patient's medical history and concomitant medications were not reported. It was reported that the patient did not seroconvert after the fourth administration of pneumococcal 13-valent conjugate vaccine (diphtheria CRM197 protein). On an unspecified date, the patient experienced after the 5th dosage, titers increased significantly. It was also reported that checking titers was necessary after a complete immune work up due to frequent illnesses. Outcome of the event was unknown. Information on lot number, batch number and expiration date has been requested. Sender's Comments: Linked Report(s) : US-PFIZER INC-2018194075 same reporter, product and event, different patient; US-PFIZER INC-2018194076 same reporter, product and event, different patient; US-PFIZER INC-2018194077 same reporter, product and event, different patient.
Sex: U
Vaccine: PNC13, PNC13, PNC13
Symptoms: Antibody test positive, Extra dose administered, Immune complex assay, Product use issue, Therapy non-responder
Clinical narrative: This is a spontaneous report from a contactable physician via a Pfizer sales representative. This physician reported similar events for four patients. This is first of four reports. A patient of unspecified age ethnicity and gender received fifth dose of PREVNAR 13, via an unspecified route of administration on an unspecified date at a single dose for immunisation. The patient's medical history and concomitant medications were not reported. It was reported that the patient did not seroconvert after the fourth administration of pneumococcal 13-valent conjugate vaccine (diphtheria CRM197 protein). On an unspecified date, the patient experienced after the 5th dosage, titers increased significantly. It was also reported that checking titers was necessary after a complete immune work up due to frequent illnesses. Outcome of the event was unknown. Information on lot number, batch number and expiration date has been requested. Sender's Comments: Linked Report(s) : US-PFIZER INC-2018194075 same reporter, product and event, different patient; US-PFIZER INC-2018194076 same reporter, product and event, different patient; US-PFIZER INC-2018194077 same reporter, product and event, different patient.
Sex: U
Vaccine: PNC13, PNC13, PNC13
Symptoms: Antibody test positive, Extra dose administered, Product use issue, Therapy non-responder
Clinical narrative: This is a spontaneous report from a contactable physician (pediatrician) via company representative. This Physician reported similar events for 4 patients. This is 2nd of 4 reports. A patient of unspecified age ethnicity and gender received fourth dose of PREVNAR 13 on an unspecified date at single dose for immunisation. The patient medical history and concomitant medications were not reported. The patient did not seroconvert after the 4th administration of pneumococcal 13-val conj vaccine. Checking titers was necessary after a complete immune work up due to frequent illnesses. After the 5th dosage, titers increased significantly. Information on batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2018193889 same reporter product event, different patient;US-PFIZER INC-2018194077 same reporter product event, different patient.
Sex: U
Vaccine: PNC13, PNC13, PNC13
Symptoms: Antibody test negative, Autoantibody test
Clinical narrative: This is a spontaneous report from a contactable physician (pediatrician) via company representative. This Physician reported similar events for 4 patients. This is 2nd of 4 reports. A patient of unspecified age ethnicity and gender received fourth dose of PREVNAR 13 on an unspecified date at single dose for immunisation. The patient medical history and concomitant medications were not reported. The patient did not seroconvert after the 4th administration of pneumococcal 13-val conj vaccine. Checking titers was necessary after a complete immune work up due to frequent illnesses. After the 5th dosage, titers increased significantly. Information on batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2018193889 same reporter product event, different patient;US-PFIZER INC-2018194077 same reporter product event, different patient.
Sex: U
Vaccine: PNC13, PNC13, PNC13
Symptoms: Antibody test positive, Extra dose administered, Immune complex assay, Product use issue, Therapy non-responder
Clinical narrative: This is a spontaneous report from a contactable physician (pediatrician) via company representative. This Physician reported similar events for 4 patients. This is 2nd of 4 reports. A patient of unspecified age ethnicity and gender received fourth dose of PREVNAR 13 on an unspecified date at single dose for immunisation. The patient medical history and concomitant medications were not reported. The patient did not seroconvert after the 4th administration of pneumococcal 13-val conj vaccine. Checking titers was necessary after a complete immune work up due to frequent illnesses. After the 5th dosage, titers increased significantly. Information on batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2018193889 same reporter product event, different patient;US-PFIZER INC-2018194077 same reporter product event, different patient.
Sex: U
Vaccine: PNC13
Symptoms: Antibody test positive, Extra dose administered
Clinical narrative: This is a spontaneous report from a contactable physician via a Pfizer sales representative. This physician reported similar events for four patients. This is fourth of four reports. A patient of unspecified age ethnicity and gender received fifth dose of PREVNAR 13, via an unspecified route of administration on an unspecified date at a single dose for immunisation. The patient's medical history and concomitant medications were not reported. It was reported that the patient did not seroconvert after the fourth administration of pneumococcal 13-valent conjugate vaccine (diphtheria CRM197 protein). On an unspecified date, the patient experienced after the 5th dosage, titers increased significantly. It was also reported that checking titers was necessary after a complete immune work up due to frequent illnesses. Outcome of the event was unknown. Information on lot number, batch number and expiration date has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2018193889 same reporter, product and event, different patient;US-PFIZER INC-2018194075 same reporter product event, different patient.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of injection site erythema in a female patient who received SHINGRIX. On 3rd May 2018, the patient received the 1st dose of SHINGRIX (intramuscular). In May 2018, 5 days after receiving SHINGRIX, the patient experienced injection site erythema, injection site itching and injection site pain. On an unknown date, the outcome of the injection site erythema, injection site itching and injection site pain were not recovered/not resolved. The reporter considered the injection site erythema, injection site itching and injection site pain to be almost certainly related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The reporter was the nurse at a health clinic reporting an adverse event on behalf of a patient. The reporter stated that the patient received the SHINGRIX vaccine and 5 days later had a red, sore, itchy area at the injection site. The reporter stated that they would have the patient come back in to see the doctor. The reporter had limited information regarding the patient and the event during the call.
Age: 25.0
Sex: F
Vaccine: TDAP
Symptoms: Infection, Injection site pain, Injection site swelling, Injection site warmth, Musculoskeletal stiffness
Clinical narrative: Pt presented came in to our clinic and for an infection and mentioned that she had an adverse reaction to her shot from may 1, 2018. She said it was fine for 2 days, then woke up and injection site was swollen and sore and warm to touch. Symptoms have not improved and arm is stiff.
Age: 25.0
Sex: F
Vaccine: TDAP
Symptoms: Vaccination complication
Clinical narrative: Pt presented came in to our clinic and for an infection and mentioned that she had an adverse reaction to her shot from may 1, 2018. She said it was fine for 2 days, then woke up and injection site was swollen and sore and warm to touch. Symptoms have not improved and arm is stiff.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Grip strength decreased, Headache, Influenza like illness, Injection site pain
Clinical narrative: In the evening following the injection pt noticed significant pain at injection site- thought it was normal- no bruising or changes in color or swelling noted. The next day pt had significant headache, lethargy, and achiness "like having the flu". Pain continued in arm but started to travel from injection site down to elbow "its like a straight line from injection site to the outside bone of the elbow", pt started to have difficulty opening jars and lifting heavy objects- injection was not in dominant arm-sometimes wakes at night from stiffness and achiness- still has localized pain in deltoid at injection site but also pain down to elbow and localized pain at elbow as well- made appt with her MD-oh-ibuprofen does take care of the pain.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Lethargy, Loss of personal independence in daily activities, Middle insomnia, Musculoskeletal stiffness, Product administered at inappropriate site
Clinical narrative: In the evening following the injection pt noticed significant pain at injection site- thought it was normal- no bruising or changes in color or swelling noted. The next day pt had significant headache, lethargy, and achiness "like having the flu". Pain continued in arm but started to travel from injection site down to elbow "its like a straight line from injection site to the outside bone of the elbow", pt started to have difficulty opening jars and lifting heavy objects- injection was not in dominant arm-sometimes wakes at night from stiffness and achiness- still has localized pain in deltoid at injection site but also pain down to elbow and localized pain at elbow as well- made appt with her MD-oh-ibuprofen does take care of the pain.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Weight bearing difficulty
Clinical narrative: In the evening following the injection pt noticed significant pain at injection site- thought it was normal- no bruising or changes in color or swelling noted. The next day pt had significant headache, lethargy, and achiness "like having the flu". Pain continued in arm but started to travel from injection site down to elbow "its like a straight line from injection site to the outside bone of the elbow", pt started to have difficulty opening jars and lifting heavy objects- injection was not in dominant arm-sometimes wakes at night from stiffness and achiness- still has localized pain in deltoid at injection site but also pain down to elbow and localized pain at elbow as well- made appt with her MD-oh-ibuprofen does take care of the pain.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Musculoskeletal stiffness, Nausea, Pain, Pain in extremity
Clinical narrative: Severe headache, severe body aches, stiff neck, and arm swollen and painful. Some nausea.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Peripheral swelling
Clinical narrative: Severe headache, severe body aches, stiff neck, and arm swollen and painful. Some nausea.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pyrexia, Skin warm
Clinical narrative: Patient's arm was red and hot and she got a fever. She went to doctor after 1 week of no relief and he prescribed BACTRIM DS.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Chills, Influenza like illness, Malaise, Pain
Clinical narrative: Flu like symptoms 4 hours after shot continuing up to today 5/15/18 at 4 pm when I checked in with the patient. Taking ALEVE per MD. Body aches, chills, stomach ache, malaise.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, HEP, MMRV
Symptoms: Injection site erythema, Injection site swelling, Local reaction
Clinical narrative: Large local reaction of redness/swelling at injection site.
Age: 0.17
Sex: M
Vaccine: RV1
Symptoms: Abdominal pain, Crying, Diarrhoea, Pyrexia, Ultrasound scan
Clinical narrative: Fever, abdominal pain, crying pain, diarrhea.
Age: 42.0
Sex: F
Vaccine: HEP
Symptoms: Headache, Injection site pain, Nausea, Vomiting
Clinical narrative: Nausea, one episode of vomiting and headache. Arm has pain at the injection site.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a male patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. In 2016, the patient was vaccinated with ZOSTAVAX, (lot# and route unknown) as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. Later in 2016, the patient was treated by a physician, for the onset of a severe vesicular rash, 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. Additional information has been requested.