chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Eye swelling, Influenza like illness, Rash, Swelling face, Vomiting
Clinical narrative: Patient reported adverse symptoms after receiving her shingles vaccine last month. Symptoms included, severe vomiting, rash around eyes, flu like symptoms and swelling to eyes and face. Pt was seen at UC and ER for these symptoms.
Age: 4.0
Sex: F
Vaccine: UNK
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Pyrexia
Clinical narrative: Fever 101.3 lasting around 36 hours; no treatment, resolved Redness/swelling/warmth on right anterior thigh around injection site; approximately the size of a half dollar, has gotten slightly bigger after 48 hours.
Sex: U
Vaccine: PPV
Symptoms: Antibody test positive, Blood immunoglobulin G normal, Respiratory tract infection, Sinusitis
Clinical narrative: This literature marketed report was received from the authors of the published literature article and refers to a 8 patients between 2 and 15 year old (reported as children) of unknown gender. On unknown dates, the patients were vaccinated with PNEUMOVAX 23 (dose, route of administration, lot # and expiration date were not reported) and had appropriate rise in pneumococcal antibody titers following immunization and had normal response to immunization. On unknown dates, the patients experienced recurrent sinopulmonary infections with discordant pneumococcal antibody and avidity results. The mean number of serotypes with a normal antibody response (above 1.3 migrogram/ml) among 8 children following immunization with pneumococcal vaccine polyvalent was 18.1 of 23 serotypes while the mean number of serotypes with a normal avidity response (1.0) was 4.4 of 23 serotypes. IgG replacement was administered subcutaneously. The mean IgG level was 720 mg/dL. Local reactions were all mild and observed in 4/8 children. All 8 children experienced a marked reduction in respiratory illnesses while on IgG replacement therapy. The outcome recurrent sinopulmonary infections was recovering and of poor pneumococcal antibody function was unknown. The reporter considered the events to be related to PNEUMOVAX 23. Upon internal review, the event of recurrent sinopulmonary infections was considered to be medically significant.
Sex: F
Vaccine: HEP
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a consumer refers to her daughter, a female patient of unknown age. On an unknown date the patient was vaccinated with one dose of improperly stored RECOMBIVAX HB (dose, frequency, route, lot # and expiry date were not reported)(product storage error) for prophylaxis. No adverse effects reported. Temperature was reported as "29 point something". Time frame, previous temperature excursion, data logger involvement were unknown by reporter. No product quality complaint was involved.
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Rash vesicular
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history.  On or about 01-MAR-2014, the patient was inoculated with ZOSTAVAX at an Urgent Care as recommended for routine adult health maintenance 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, also known as shingles. On or about 01-APR-2014, the patient was treated at the same Urgent Care for a blistering vesicular outbreak that was diagnosed as severe herpes zoster or 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 outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Rash vesicular
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about 09-JUN-2008, the patient was inoculated with ZOSTAVAX at a family medicine office as recommended for routine adult health maintenance 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, also known as shingles and other complications. On or about 02-JUL-2012, the patient was treated at the same family medicine office for a blistering vesicular outbreak that was diagnosed as severe herpes zoster or 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 outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On an unknown date in 2013, the patient was inoculated with ZOSTAVAX (lot number, dosage and route of administration not provided), as recommended for routine adult health maintenance for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster, also known as shingles and other complications. On or about 15-MAY-2016, the patient was treated for a blistering vesicular outbreak that was diagnosed as severe herpes zoster or shingles. The outcome of the events is unknown. 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. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Pain, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On or about 31-JAN-2014, the patient was inoculated with ZOSTAVAX (lot number, dosage and route of administration not provided), as recommended for routine adult health maintenance for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster, also known as shingles and other complications. On or about 23-JUL-2016, the patient was treated by a physician for a blistering vesicular outbreak that was diagnosed as severe herpes zoster. The patient was prescribed acyclovir for management of his painful symptoms. The outcome of the events is unknown. 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. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Malaise, Mass, Rash, Rhinorrhoea, Skin warm
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of rash in a adult patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced rash, runny nose, feeling unwell, mass and skin warm. On an unknown date, the outcome of the rash, runny nose, feeling unwell, mass and skin warm were unknown. The reporter considered the rash, runny nose, feeling unwell and mass to be related to SHINGRIX. It was unknown if the reporter considered the skin warm to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The events were told to this reporter by a pharmacist. The pharmacist told this reporter that several patients experienced a softball size rash that was warm to touch but not itchy with a lump underneath that lasted 2 weeks or so. Some patient's also experienced a running nose and just felt crummy. The reporter repeated the information that was provided by her pharmacist to her. She would not give her pharmacist name but said she would tell her to call GSK to report the events the pharmacist had observed.
Sex: U
Vaccine: VARZOS
Symptoms: White blood cell count increased
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of white blood cell count increased in a adult patient who received SHINGRIX for prophylaxis. Concurrent medical conditions included chronic lymphocytic leukemia. On 1st April 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced white blood cell count increased. On an unknown date, the outcome of the white blood cell count increased was unknown. It was unknown if the reporter considered the white blood cell count increased to be related to SHINGRIX. Additional details were provided as follows: This case was reported by Hospital administration. The age at vaccination was not reported. The hospital administrator stated on online chat that, could SHINGRIX cause an increase in white blood count. The patient with chronic lymphocytic leukaemia and not sure increase was due to chronic lymphocytic leukaemia or shot of SHINGRIX. The hospital administrator closed online chat before any contact information or any other information was obtained.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Incorrect route of drug administration, Swelling
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of erythema in a 65-year-old female patient who received SHINGRIX (batch number C523T, expiry date 4th July 2020) for prophylaxis. On 5th June 2018, the patient received SHINGRIX (subcutaneous) .5 ml. On 5th June 2018, unknown after receiving SHINGRIX, the patient experienced intramuscular formulation administered by other route. On an unknown date, the patient experienced erythema and swelling. On an unknown date, the outcome of the erythema and swelling were not recovered/not resolved and the outcome of the intramuscular formulation administered by other route was unknown. It was unknown if the reporter considered the erythema, swelling and intramuscular formulation administered by other route to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The health care professional reported that the patient received SHINGRIX subcutaneously, which led to inappropriate route of vaccination. One to two days after injection, the patient experienced redness and swelling. The health care professional stated that the redness and swelling was getting better but now on 12th June 2018, it was starting to swell up again.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site induration, Injection site mass, 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 64-year-old female patient who received SHINGRIX for prophylaxis. On 11th June 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 12th June 2018, 1 days after receiving SHINGRIX, the patient experienced injection site pain, injection site induration and injection site lump. On an unknown date, the outcome of the injection site pain, injection site induration and injection site lump were not recovered/not resolved. It was unknown if the reporter considered the injection site pain, injection site induration and injection site lump to be related to SHINGRIX. Additional details were provided as follows: The patient reported only partial information. The patient received SHINGRIX in the left deltoid. The patient experienced soreness at the injection site and hard knot at the injection site. The patient was transferred from GlaxoSmithKline's vaccine patient assistance program. The patient had denied permission to contact their physician.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Joint lock, Musculoskeletal pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of joint lock in a adult female patient who received SHINGRIX for prophylaxis. In April 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On an unknown date, 21 days after receiving SHINGRIX, the patient experienced joint lock and shoulder pain. On an unknown date, less than a month after receiving SHINGRIX, the patient experienced injection site pain. On an unknown date, the outcome of the joint lock, shoulder pain and injection site pain were not recovered/not resolved. It was unknown if the reporter considered the joint lock, shoulder pain and injection site pain to be related to SHINGRIX. Additional details were reported as follows: This case was previously not reported to anyone. The age at vaccination was not reported. The patient received SHINGRIX on the left arm. In 2018, less than a month after vaccination the patient had injection site pain. In 2018, about 3 weeks to a month after receiving the SHINGRIX, the patient's shoulder would lock up on occasion. She stated, the locking up was like a pain in her shoulder that would resolve once she moved it around a little. The patient also stated that, there was still a small amount of pain at the injection site and she compared it to a mosquito bite.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Pain, Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of chills in a 62-year-old female patient who received SHINGRIX for prophylaxis. Concomitant products included CRESTOR, CYMBALTA, DIOVAN, Metformin, GLYBURIDE, INVOKANA, SYNTHROID and VICTOZA. In March 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On an unknown date, less than a year after receiving SHINGRIX, the patient experienced chills, pain and fever. On an unknown date, the outcome of the chills, pain and fever were recovered/resolved. The reporter considered the chills, pain and fever to be related to SHINGRIX. Additional details were provided as follows: This case was reported by the patient for herself. The patient reported that she and her husband had the SHINGRIX. The patient's body temperature was recorded as 100 degree F. The patient had chills, fever, and achiness and lasted about 48 hour. This was 1 of 2 cases, reported by the same reporter.
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Pain, Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of fever in a adult male patient who received SHINGRIX for prophylaxis. Concomitant products included FLOMAX and gabapentin. In March 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On an unknown date, less than a year after receiving SHINGRIX, the patient experienced fever, pain and chills. On an unknown date, the outcome of the fever, pain and chills were recovered/resolved. The reporter considered the fever, pain and chills to be related to SHINGRIX. Additional details were provided as follows: The case was reported for reporter's husband. The patient reported that she and her husband had the SHINGRIX. The patient had chills, fever, and achiness and lasted about 5 days. This was 1of 2 cases, reported by the same reporter.
Sex: U
Vaccine: VARZOS
Symptoms: Influenza like illness
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of influenza-like symptoms in a adult patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced influenza-like symptoms. On an unknown date, the outcome of the influenza-like symptoms was unknown. The reporter considered the influenza-like symptoms to be related to SHINGRIX. Additional information was received as follows: The age group was not reported but was selected as adult as per vaccine indication. This case is one of 8 cases, reported by the same reporter.
Sex: U
Vaccine: VARZOS
Symptoms: Influenza like illness
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of influenza-like symptoms in a adult patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced influenza-like symptoms. On an unknown date, the outcome of the influenza-like symptoms was unknown. The reporter considered the influenza-like symptoms to be related to SHINGRIX. Additional information was received as follows: The age group was not reported but was selected as adult as per vaccine indication. This case is one of 8 cases reported by the same reporter.
Age: 44.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site induration, Injection site pruritus, Injection site urticaria
Clinical narrative: Developed a wheal and flare reaction approx. 1 inch in diameter with associated induration and itchiness at the site of the injection. Noticed it the day after the reaction.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Confusional state, Dizziness, Dysstasia
Clinical narrative: Severe dizziness and inability to stand without support, some confusion for the past few months, but slowly subsiding over time. All other causes ruled out by MD.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Injection site erythema, Injection site pain, Insomnia, Myalgia
Clinical narrative: Patient began to complain of soreness and redness at injection site within 15-20 minutes of administration. Patient returned to work and by the time she got home that evening of 6/18 (6-8 PM), she complained of generalized whole body pain, a low grade fever (approximately 101-102 F), and headache. She mentioned her intense muscle soreness in her arms had progressed to the point that she could not lift her arms above her shoulders without extreme pain. Patient reported no nausea, vomiting, rash, or symptoms of an anaphylactic reaction. Patient reported she took some TYLENOL and an ALEVE OTC, which helped with the headache. Patient reported she barely slept that night due to the symptoms. Patient reported back to work the next day on 6/19. Generalized whole body pain was still present but other symptoms had subsided. All symptoms had ceased by the time patient called the pharmacy on 6/20. Patient reported that she intended to complete the series, and would pretreat herself to minimize/prevent the same reaction from reoccurring.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pyrexia
Clinical narrative: Patient began to complain of soreness and redness at injection site within 15-20 minutes of administration. Patient returned to work and by the time she got home that evening of 6/18 (6-8 PM), she complained of generalized whole body pain, a low grade fever (approximately 101-102 F), and headache. She mentioned her intense muscle soreness in her arms had progressed to the point that she could not lift her arms above her shoulders without extreme pain. Patient reported no nausea, vomiting, rash, or symptoms of an anaphylactic reaction. Patient reported she took some TYLENOL and an ALEVE OTC, which helped with the headache. Patient reported she barely slept that night due to the symptoms. Patient reported back to work the next day on 6/19. Generalized whole body pain was still present but other symptoms had subsided. All symptoms had ceased by the time patient called the pharmacy on 6/20. Patient reported that she intended to complete the series, and would pretreat herself to minimize/prevent the same reaction from reoccurring.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Pyrexia
Clinical narrative: Patient had a very large (larger than softball) sized redness around the injection site as well as a 101 degree fever the two days after receiving the immunization.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site pain, Injection site pruritus, Injection site swelling, Pyrexia
Clinical narrative: Patients first KINRIX and second PROQUAD, but it is his 5th dtap and 4th polio. Patient began experiencing pain and ithching and swelling of the left arm as well as fever last night around 2 am according to mother. Mother gave child Tylenol for pain and fever. When child came to clinic arm was swollen with no hard lumps and very mild tenderness of the area. gave the child benadryl in clinic, Dr.  gave the child a prescription of ibuprofen and benadryl to take at home, we will follow up with him 1 week and for the meantime gave mother ER precautions.
Sex: F
Vaccine: HPV9
Symptoms: Infectious mononucleosis
Clinical narrative: This spontaneous report was received from an office manager and refers to a female patient of unknown age. No information regarding the patient's medical history, concurrent conditions or concomitant medications was provided. On an unknown date, the patient was vaccinated with the first dose of GARDASIL 9 injection via intramuscular route (dose, lot number and expiration date were not reported) as an human papillomavirus (HPV) prevention. On 24-APR-2018, the patient was diagnosed with mononucleosis. The outcome of the event was unknown. The relatedness between the event and GARDASIL 9 was not reported.
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: Information has been received from a certified medical assistant (also reported as nurse) reporting on a patient of unknown age and gender. There was no information about the patient's concurrent conditions, medical history or concomitant medication. On 29-MAY-2018, the patient received inadvertently an expired dose of VAQTA, lot number reported as N022979, expiration date 26-MAY-2018, for prophylaxis (strength, dose and route of administration were not reported). Lot number N022979 is an invalid lot number for hepatitis a vaccine, inactivated.
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information has been received regarding the patient's past medical history, concurrent conditions, or concomitant medication. In 2015, the patient was inoculated with ZOSTAVAX (lot number, dosage and route of administration not provided), at a medical center/hospital (by an unspecified healthcare professional) as recommended for routine adult health maintenance for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain condition of herpes zoster. On or about 08-JUL-2016, the patient was treated (by an unspecified health care professional) at the medical center/hospital for a blistering vesicular outbreak, which was then diagnosed as 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 reporter considered the events to be related to ZOSTAVAX. The outcome of the events is unknown. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Blister, 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 has been received regarding the patient's past medical history, concurrent conditions, or concomitant medication. In March 2015, the patient was inoculated with ZOSTAVAX (lot number, dosage and route of administration not provided), at physician's office (by an unspecified healthcare professional) as recommended for routine adult health maintenance for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain condition of herpes zoster. On or about 09-JUL-2016, the patient was treated (by an unspecified health care professional) at a hospital for a blistering vesicular outbreak, 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 reporter considered the events to be related to ZOSTAVAX. The outcome of the events is unknown. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 14-MAY-2018, the patient was vaccinated with an improperly stored dose of LIQUID PEDVAXHIB, lot # N022167, expiration date: 08-FEB-2020 (dose and route of administration were not reported). There was no adverse effect reported. Administered dose of vaccine experienced the temperature excursion of 47 to 77 degrees Fahrenheit for 5 hours. Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1806USA001505; US-009507513-1806USA009026; US-009507513-1806USA009027; US-009507513-1806USA009028; US-009507513-1806USA009029; US-009507513-1806USA009030; US-009507513-1806USA009031; US-009507513-1806USA009032; US-009507513-1806USA009033; US-009507513-1806USA009034; US-009507513-1806USA009035; US-009507513-1806USA009036; US-009507513-1806USA009037; US-009507513-1806USA009038; US-009507513-1806USA009039; US-009507513-1806USA009040; US-009507513-1806USA009041; US-009507513-1806USA009043; US-009507513-1806USA009044; US-009507513-1806USA009045; US-009507513-1806USA009046; US-009507513-1806USA009047; US-009507513-1806USA009048; US-009507513-1806USA009049; US-009507513-1806USA009050; US-009507513-1806USA009051; US-009507513-1806USA009052; US-009507513-1806USA009053; US-009507513-1806USA009054; US-009507513-1806USA009055; US-009507513-1806USA009056.
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Rash vesicular
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about 24-NOV-2014, the patient was inoculated with ZOSTAVAX at a pharmacy as recommended for routine adult health maintenance 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, also known as shingles and other complications. In 2015, the patient was treated by a physician for a blistering vesicular outbreak that was diagnosed as severe herpes zoster or 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 outcome of the events was unknown.  Causality assessment was related. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Blister, 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 an unknown date in 2010, the patient was inoculated with ZOSTAVAX (lot number, dosage and route of administration not provided), as recommended for routine adult health maintenance for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster, also known as shingles and other complications. On an unknown date later in 2010, the patient was treated for a blistering vesicular outbreak that was diagnosed as severe herpes zoster or shingles. The outcome of the events is unknown. 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. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Blister, 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 an unknown date in 2012, the patient was inoculated with ZOSTAVAX (lot number, dosage and route of administration not provided), by a physician, as recommended for routine adult health maintenance for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster, also known as shingles and other complications. On an unknown date in 2014, the patient was treated by a physician for a blistering vesicular outbreak that was diagnosed as severe herpes zoster or shingles. The outcome of the events is unknown. 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. Additional information has been requested.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in a 73-year-old female patient who received SHINGRIX (batch number CH2X7, expiry date unknown) for prophylaxis. Concurrent medical conditions included drug allergy (sulfa allergy). Concomitant products included Atorvastatin, Losartan, omeprazole, verapamil and hydrochlorothiazide. On 31st May 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 31st May 2018, less than a day after receiving SHINGRIX, the patient experienced injection site erythema, injection site swelling and injection site pain. On 4th June 2018, the outcome of the injection site erythema, injection site swelling and injection site pain were recovered/resolved. The reporter considered the injection site erythema, injection site swelling and injection site pain to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX vaccine on the left arm. The symptoms started the evening of the day of vaccination, according to the reporting pharmacist. The reporting pharmacist stated that the patient had denied any symptoms of allergy after vaccination.
Sex: U
Vaccine: VARZOS
Symptoms: Adverse reaction
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of adverse reaction in a adult patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX. On 14th June 2018, 7 days after receiving SHINGRIX, the patient experienced adverse reaction. On an unknown date, the outcome of the adverse reaction was unknown. It was unknown if the reporter considered the adverse reaction to be related to SHINGRIX. Additional details were provided as follows: This case was reported via click to chat. The age group was not reported but was selected as adult as per vaccine indication. A week after receiving SHINGRIX, the patient experienced the reaction. The reporter was wondering about reactions to SHINGRIX vaccine. No additional information could be obtained. The healthcare professional ended the chat.
Age: 75.0
Sex: M
Vaccine: HEPA
Symptoms: Alanine aminotransferase increased, Aspartate aminotransferase increased
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of alanine aminotransferase increased in a 75-year-old male patient who received HAVRIX for prophylaxis. Concurrent medical conditions included stroke. On 31st May 2018, the patient received HAVRIX. On 1st June 2018, 1 days after receiving HAVRIX, the patient experienced alanine aminotransferase increased and aspartate aminotransferase increased. On an unknown date, the outcome of the alanine aminotransferase increased and aspartate aminotransferase increased were unknown. It was unknown if the reporter considered the alanine aminotransferase increased and aspartate aminotransferase increased to be related to HAVRIX. Additional details were reported as follows: The healthcare professional reported that, the patient had a normal liver function test on 14th May 2018. The next day after receiving HAVRIX, the patient's alanine aminotransferase and aspartate aminotransferase were increased. No additional information was provided.
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Mood altered
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of fatigue in a female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced fatigue and mood change. SHINGRIX was discontinued. On an unknown date, the outcome of the fatigue and mood change were unknown. It was unknown if the reporter considered the fatigue and mood change to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The healthcare professional reported that, the patient received one dose of SHINGRIX and was still complained of fatigue and mood was different up to 30 days after receiving the first dose. The patient did not want to receive the 2nd dose. The healthcare professional did not have any other information at the time of call. This case has been linked with case US2018107242, reported by same reporter.
Sex: F
Vaccine: VARZOS
Symptoms: Malaise
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of feeling unwell in a female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, 1 day after receiving SHINGRIX, the patient experienced feeling unwell. On an unknown date, the outcome of the feeling unwell was recovered/resolved. It was unknown if the reporter considered the feeling unwell to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. Next day, after receiving SHINGRIX, the patient did not felt well. The patient felt yucky but she was fine afterwards. The reporter did not have any details of the patient.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a 64-year-old female patient who received SHINGRIX for prophylaxis. On 9th May 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. In June 2018, 30 days after receiving SHINGRIX, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown. It was unknown if the reporter considered the shingles to be related to SHINGRIX. Additional details were provided as follows: The batch number of SHINGRIX was not reported. The pharmacist notified by a patient that her physician had diagnosed her with Shingles. The patient had denied permission to contact their physician, as physician information was not known by the pharmacist.
Age: 62.0
Sex: M
Vaccine: TDAP, VARZOS
Symptoms: Fatigue, Myalgia, Pain, Vertigo positional
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of myalgia in a 62-year-old male patient who received SHINGRIX for prophylaxis. Co-suspect products included dTpa vaccine for prophylaxis. On 21st May 2018, the patient received SHINGRIX and dTpa vaccine. On an unknown date, less than a month after receiving SHINGRIX and dTpa vaccine, the patient experienced myalgia, vertigo positional, fatigue and pain localized. On an unknown date, the outcome of the myalgia, vertigo positional, fatigue and pain localized were unknown. It was unknown if the reporter considered the myalgia, vertigo positional, fatigue and pain localized to be related to SHINGRIX and dTpa vaccine. Additional details were provided as follows: The patient reported the feeling of normal myalgia, fatigue and local pain as indicated in the PI and cleared up in 1 to 2 days but also reported a positional vertigo which was persisted for 3 weeks since vaccination. The reporter would like to discuss with GlaxoSmithKline if this patient should receive the 2nd dose or not.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Diarrhoea, Urticaria
Clinical narrative: Initial unsolicited report received from a consumer (patient herself) on 07-Feb-2018. This case involves a female patient (age not reported), who was vaccinated with 0.5 ml dose of FLUZONE HIGH-DOSE once (batch number, expiration date, dose in series and site of administration were not reported) via intramuscularly on 07-Nov-2017. Medical history and concomitant medications were not reported. On an unknown day, five to six weeks post vaccination, the patient experienced diarrhea and some localized hives on her arms. On an unknown day, patient visited doctor. Laboratory investigations was not reported and other corrective treatment include DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL). The outcome of all the events were recovered on an unknown day. List of documents held by sender: none Follow up received fom a nurse on 14-JUN-2018. Patient received corrective treatment. List of documents held by sender: none.
Age: 12.0
Sex: F
Vaccine: HEPA, HPV9
Symptoms: Blood glucose, Bruxism, Electrocardiogram, Fatigue, Full blood count
Clinical narrative: Clenching jaw and rigid body, lasted about 2-3 seconds and then opened eyes and felt tired. Positive urine incontinence. Pt was tired after for about 3-5 minutes but able to answer questions. Concern for syncope vs. seizure --- transferred to ED for evaluation and discharged home, referred to pediatric neurology for possible seizure.
Age: 12.0
Sex: F
Vaccine: HEPA, HPV9
Symptoms: Metabolic function test, Muscle rigidity, Urinary incontinence
Clinical narrative: Clenching jaw and rigid body, lasted about 2-3 seconds and then opened eyes and felt tired. Positive urine incontinence. Pt was tired after for about 3-5 minutes but able to answer questions. Concern for syncope vs. seizure --- transferred to ED for evaluation and discharged home, referred to pediatric neurology for possible seizure.
Age: 81.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Patient reports redness close to the injection site (on the upper arm) but not at the injection site. Site affected has a circular redness that the patient reports is warm and sore. Patient reports the site has become more red since yesterday.
Age: 84.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Injected limb mobility decreased, Pain in extremity
Clinical narrative: Arm into which vaccine was given was painful and not movable for 24 hours. Patient also had chills lasting 24 hours. Patient reported being fine after 24 hours.
Age: 54.0
Sex: M
Vaccine: VARZOS
Symptoms: Altered state of consciousness, Asthenia, Dizziness, Headache, Impaired work ability
Clinical narrative: PATIENT WOKE UP AND FELT VERY DIZZY, ALMOST PASSED OUT, VERY WEAK, HAD A HEADACHE. FELT LIKE GETTING THE FLU, HAD TO LEAVE WORK D/T SEVERITY. AFTER 1ST DOSE ONLY HAD SORE ARM.
Age: 54.0
Sex: M
Vaccine: VARZOS
Symptoms: Influenza like illness
Clinical narrative: PATIENT WOKE UP AND FELT VERY DIZZY, ALMOST PASSED OUT, VERY WEAK, HAD A HEADACHE. FELT LIKE GETTING THE FLU, HAD TO LEAVE WORK D/T SEVERITY. AFTER 1ST DOSE ONLY HAD SORE ARM.
Age: 2.0
Sex: F
Vaccine: HIBV
Symptoms: Injection site reaction, Rash papular
Clinical narrative: Patient presented 11 days post immunization with an Id like reaction to R anterior thigh. Rash initially appeared to be insect bites on R lateral aspect but quickly turned into papulovesicular lesions covering R anterior thigh.
Age: 12.0
Sex: U
Vaccine: HEPA
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report was received from a clinic manager/vaccine coordinator and refers to a 12-year-old patient of unknown gender. No information regarding the patient's pertinent medical history, concomitant medications, drug reactions or allergies was provided. On 25-APR-2016, the patient as an adolescent was vaccinated with an adult dose of VAQTA, 50/1.0 U/ml, an adult dose, intramuscularly, lot # M009786 and expiration date: 26-MAY-2017 (frequency was not reported). The error was discovered on 08-JUN-2018, during a routine audit. No adverse effects were reported in the patient. The outcome of event of of incorrect dose administered was unknown. No causality assessment was provided.
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Pain, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information has been received regarding the patient's past medical history, concurrent conditions, or concomitant medication. In 2009, the patient was inoculated with ZOSTAVAX (lot number, dosage and route of administration not provided), at a medical center/hospital (by an unspecified healthcare professional) as recommended for routine adult health maintenance for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain condition of herpes zoster. On or about 07-AUG-2015, the patient was treated (by an unspecified health care professional) at a healthcare facility(hospital/clinic) for a blistering vesicular outbreak, which was diagnosed as herpes zoster. The patient was prescribed valacyclovir for management of his painful symptoms and chronic pain. 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 reporter considered the events to be related to ZOSTAVAX. The outcome of the events is unknown. Additional information has been requested.
Sex: F
Vaccine: HPV9
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a nurse refers to a 22 year old female patient. There was no information about the patient's concurrent conditions, medical history or concomitant medications. On 19-JAN-2018, the patient was vaccinated with the first dose of GARDASIL 9, for prophylaxis (dose, route of administration, lot number and expiration date were not reported). Later on 19-MAR-2018, she would receive the second dose of GARDASIL 9 dose 2 for prophylaxis (dose, route of administration, lot number and expiration date were not reported); however, the reporter was not sure if the patient received DEPO-MEDROL (dose, route of administration, lot number and expiration date were not reported) instead of GARDASIL 9. No adverse effect reported.
Sex: F
Vaccine: VARZOS
Symptoms: Blister, 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 an unknown date in 2014, the patient was inoculated with ZOSTAVAX (lot number, dosage and route of administration not provided) at a pharmacy, as recommended for routine adult health maintenance for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster, also known as shingles and other complications. On an unknown date in 2015, the patient was treated by a physician for a blistering vesicular outbreak that was diagnosed as severe herpes zoster or shingles. The outcome of the events is unknown. 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. Additional information has been requested.