chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: HPV9
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a nurse practitioner and refers to a female patient of unknown age. The patient's pertinent medical history, drug reactions and allergies were not reported. Concomitant therapies were not provided. On an 17-MAY-2018, the nurse noticed that 2 syringes in the GARDASIL 9 box (NDC 0006-4121-02, lot# N029069 with an expiration date 17-MAY-2020) had a different unknown NDC, lot and expiration date (NDC 000064121-01, lot# M743R56 with an expiration date 02-JAN-2003). On the same day, the patient received GARDASIL 9 with correct NDC number, lot# and expiration date (dose, route of administration was not reported) for prophylaxis. The GARDASIL 9 with the incorrect NDC, lot#/expiration date was not administered, and the remaining 8 doses in the box that had the correct NDC, lot# and expiration date were administered. No adverse effects was reported. Product quality complaint (PQC) was reported. Lot number M743R56 is an invalid lot number for GARDASIL 9. This is one of two reports received from the same reporter.; Sender's Comments:  US-009507513-1806USA005991:
Age: 0.33
Sex: U
Vaccine: MMRV
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report was received from a Nurse referring to a 4 month old patient of unknown gender. The patient's medical history, concurrent conditions, concomitant medications, and historical drugs were not reported. On an unknown date, the patient was vaccinated with PROQUAD (route, dose, frequency, anatomical location, indication, lot # and expiration date were unknown) with lot # N025927, and expiration date 18-MAR-2019 for prophylaxis. No adverse effects were reported.
Sex: M
Vaccine: HPV9
Symptoms: Immediate post-injection reaction, Rash generalised
Clinical narrative: This spontaneous report was received from a nurse, via a company representative; and it refers to a male patient that, according to the reporter was 11 or 12 years old at the time of event. Information regarding the patient's pertinent medical history, concurrent conditions and concomitant medications was not provided. On approximately 29-MAY-2015, reported as 2 to 3 years ago, the patient was vaccinated with 1 injection of GARDASIL 9, for Human papillomavirus (HPV) prevention (dose, route of administration, lot number and expiration date were not reported), and that immediately after receiving the GARDASIL 9 injection, the boy develop a rash all over his body (Rash generalized), for what the vaccination center personal sent the boy to the neighboring hospital for treatment. The nurse reported that the patient recovered (date was not provided), but was contraindicated to receive further doses of GARDASIL 9. It was also reported that the event did not represent a significant disability or incapacity for the patient, and there was no patient overdose involved. The reporter did not assess the causal relationship between therapy with GARDASIL 9 and the Rash generalized.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, 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. On or about 12-MAR-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 herpes zoster. On or about 31-JUL-2016, the patient was treated by a physician for the onset of a vesicular rash, which was diagnosed as zoster dermatitis. The patient has been prescribed VALTREX and prednisone 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. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Decreased immune responsiveness, 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. On or about 01-DEC-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, and the patient subsequently contracted a persistent strain of herpes zoster. On or about 16-JUN-2016, the patient was treated by a physician for the onset of a severe vesicular rash accompanied by weakened immune symptoms, which was 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. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Post herpetic neuralgia, 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. On or about 18-APR-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, and the patient subsequently contracted a persistent strain of herpes zoster. On or about 16-MAY-2016, the patient was treated at a medical facility for the onset of a vesicular rash, which was diagnosed as herpes zoster. On or about 16-MAY-2016, the patient sought subsequent treatment at the medical facility for a persistent vesicular rash, which was diagnosed as post-herpetic neuralgia, a chronic condition of pain and nerve damage secondary to herpes zoster infections. The patient has been prescribed amitriptyline, acyclovir and tramadol to manage her 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. Additional information has been requested.
Sex: F
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 female patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. In 2008, the patient was inoculated with ZOSTAVAX at a physician's office 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. In 2011, the patient was treated at the same physician's office for a persistent and severe vesicular rash, which was diagnosed as 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: Herpes zoster
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On or about 11-AUG-2016, the patient was prescribed and inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided), at physician office as recommended for routine adult health maintenance and for the long-term prevention of shingles. The ZOSTAVAX did not prevent shingles as intended. Instead the patient contracted a persistent strain of shingles, or herpes zoster. On or about 11-JUL-2016, the patient was treated by a physician for the development of herpes zoster. As a direct and proximate result of the defective ZOSTAVAX, 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, pain and suffering, and other damages. The outcome of the events is unknown. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash
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. Her physician recommended and prescribed the ZOSTAVAX to the patient for long-term prevention against shingles. On or about 12-MAR-2014, the patient was inoculated with the ZOSTAVAX at a pharmacy, as recommended for routine adult health maintenance and for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended. Instead, the patient contracted a persistent strain of shingles, or severe herpes zoster. On or about 16-JUN-2016, the patient was treated by a physician for the onset of a rash, which was diagnosed as herpes zoster, or shingles. As a direct and proximate result of the defective ZOSTAVAX, the patient suffered and continues to suffer painful and ongoing injuries and damages, and required and continues to require extensive medical care and treatment. As a further proximate result of the ZOSTAVAX vaccine, 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, Rash, Rash erythematous
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 28-MAR-2012, the patient was prescribed by his physician and inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided), at physician office as recommended for long-term prevention of shingles. The ZOSTAVAX did not prevent shingles as intended. On or about 27-JUN-2016, the patient was treated by a physician for the sudden onset of a red rash in his upper rib cage area, which was diagnosed as herpes zoster or shingles. The patient was prescribed valacyclovir and lidocaine for management of his symptoms. As a direct and proximate result of the ZOSTAVAX, the patient suffered and will continue to suffer significant medical expenses, pain and suffering, and other damages. The outcome of the events is unknown. The outcome of the events is unknown. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
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. In November 2010, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided), at a hospital as recommended by his physician for the long-term prevention of shingle and as preventative measure prior to having surgery. The ZOSTAVAX did not prevent shingles as intended. Instead the patient contracted a persistent strain of shingles, or herpes zoster. In approximately July 2016, the patient was treated by a physician for the onset of herpes zoster or shingles. As a direct and proximate result of the defective ZOSTAVAX, 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, pain and suffering, and other damages. The outcome of the events is unknown. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On or about 07-NOV-2012, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided), at a pharmacy as recommended by her physician for routine adult health maintenance and for the long-term prevention of shingles. The ZOSTAVAX did not prevent shingles as intended. Instead the patient contracted a persistent strain of shingles, or herpes zoster. On or about 11-JUL-2016, the patient was admitted at a hospital for the development of zoster and was prescribed VALTREX. On 12-JUL-2016 the patient was diagnosed by the physician with herpes zoster, or shingles. The patient was prescribed VALTREX, and zolpidem for the management of her shingles related symptoms. As a direct and proximate result of the defective ZOSTAVAX, 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, pain and suffering, and other damages. The outcome of the events is unknown. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
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 26-MAR-2014, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided), as recommended by his physicians for the long-term prevention of shingles during a routine adult health appointment. The ZOSTAVAX did not prevent shingles as intended. Instead the patient contracted a persistent strain of shingles, or herpes zoster. On or about 07-FEB-2016, the patient was treated at medical center for the development of herpes zoster and was prescribed acyclovir for management of his shingles-related symptoms. The outcome of the events is unknown. As a direct and proximate result of the defective ZOSTAVAX, 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, pain and suffering, and other damages. Additional information has been requested.
Sex: F
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 female patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about 13-OCT-2014, 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. In 2016, the patient was treated by a physician for a persistent and severe vesicular rash, which was diagnosed as 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: Herpes zoster, Nervous system disorder, Pain, Post herpetic neuralgia, 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 the ZOSTAVAX (lot number, dosage and route of administration not provided) at a pharmacy, for routine adult health maintenance and the intended purpose for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended. The patient subsequently contracted a persistent strain of herpes zoster. On or about 21-JUL-2015, the patient was treated by a physician for a vesicular outbreak, which was diagnosed as herpes zoster with unspecified nervous complication. The patient was prescribed acyclovir and hydrocodone for management of her painful symptoms and chronic pain. On or about 12-AUG-2015, the patient sought subsequent treatment for a vesicular outbreak, which was diagnosed as herpes zoster with unspecified nervous complication and postherpetic neuralgia, a chronic condition of pain and nerve damage secondary to herpes zoster infections. The patient was prescribed gabapentin for management of her painful symptoms and excruciating pain. 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: Burning sensation, Herpes zoster, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On or about 18-JUL-2011, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided), for routine adult health maintenance and the intended purpose for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended. The patient subsequently contracted a persistent strain of herpes zoster. On or about 07-JUL-2016, the patient was treated for a burning vesicular outbreak, which was diagnosed as 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, Pain, 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 the ZOSTAVAX (lot number, dosage and route of administration not provided), administered by a physician, for routine adult health maintenance and the intended purpose for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended. The patient subsequently contracted a persistent strain of herpes zoster. On or about 30-JUN-2015, the patient was treated for a blistering vesicular outbreak, which was diagnosed as shingles. The patient was prescribed acyclovir, gabapentin, and MEDROL for management of her painful symptoms and chronic pain. 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: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. Information regarding medical history, concurrent conditions or concomitant medication was not provided. On 07-JUN-2018, the patient was vaccinated with VAQTA 25/0.5 DF, lot # N002921, expiration date 08-APR-2018, for prophylaxis (dosage information, and route of vaccination were not informed). No adverse effects were reported in the patient.
Age: 16.0
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a Nurse, concerning a 16 year old patient of unknown gender. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. On an unspecified date in December 2016, the patient was vaccinated with the first dose of GARDASIL 9 for prophylaxis (route of administration, anatomical location, lot number and expiration date were not reported). The nurse stated that the patient received the second dose of GARDASIL 9 on an unspecified date in April 2018. No adverse effects were reported for the patient.
Sex: M
Vaccine: MENB
Symptoms: Injected limb mobility decreased, Injection site pain, Pyrexia
Clinical narrative: This is a spontaneous report from a contactable physician through a Pfizer sales representative. An adolescent male patient of an unspecified age received TRUMENBA on an unknown date, at single dose, for immunization. Relevant medical history and concomitant medications were unknown. On an unspecified date, the patient experienced fever like symptoms and injection site pain with difficulty moving. Clinical outcome of the events was unknown at time of this report. No follow-up attempts are possible, information about lot number cannot be obtained.
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Bradyphrenia, Headache, Influenza like illness, Lymphadenopathy, Myalgia
Clinical narrative: Patient states that she is having flu like symptoms, primarily on the left side. Lymph nodes swollen, sore muscles, headache, son states that she was somewhat slow with her thoughts for a day or two after the symptoms began.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pain, Tenderness
Clinical narrative: She received her first SHINGRIX vaccine in her L deltoid on 6/12 at 12 pm. It was administered at Clinic by her pharmacist who used sterile technique including gloves and alcohol. A little sore. After 1-2 hours, she noticed increased pain. Later that day, she noticed redness. Over the last 2 days, the redness has faded slightly. Tenderness and when palpated, 8/10 Denies constitutional sxs.  Managing with NSAIDS, ice.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Influenza like illness, Injection site erythema, Pain, Pyrexia
Clinical narrative: Flu like symptoms: body aches, 101 fever, tired. I stayed in bed all day and felt better after about ten hours. My vaccine site was swollen, huge and red for about a week.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Vaccination site swelling
Clinical narrative: Flu like symptoms: body aches, 101 fever, tired. I stayed in bed all day and felt better after about ten hours. My vaccine site was swollen, huge and red for about a week.
Age: 13.0
Sex: M
Vaccine: HPV9
Symptoms: Seizure
Clinical narrative: Patient had first dose of HPV-9 vaccine at 4:56pm on 6/7/18 and had a seizure episode at 10:30pm that night per mom. Patient have a history of seizure and last seizure episode was April 2018 per mom.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, RV1
Symptoms: Dermatitis, Erythema, Scab
Clinical narrative: Left cheek was extremely red and  crusted the following morning. Infant has had dermatitis on legs, arms, back, stomach, head, and face since vaccine.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Nausea, Pain, Pyrexia
Clinical narrative: Aches, nausea, headache, fever and chills.
Age: 20.0
Sex: F
Vaccine: MENB
Symptoms: Dyspnoea, Pain in extremity, Pyrexia
Clinical narrative: PT REPORTED FEVER, DIFFICULTY CATCHING HER BREATH, ACHEY AND SORE ARM.
Sex: M
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 male patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. In 2015, the patient was inoculated with ZOSTAVAX at a pharmacy as recommended for routine adult health maintenance and for the prevention of shingles (lot #, dose and route not provided). The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. On or about 25-MAR-2016, the patient was treated by a physician for a persistent and severe vesicular rash, which was diagnosed as severe herpes zoster. 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 or about 18-JUL-2016, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided) at a pharmacy, for routine adult health maintenance and the intended purpose for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended. The patient subsequently contracted a persistent strain of herpes zoster. On or about 20-JUL-2016, the patient was treated for a blistering vesicular outbreak, which was diagnosed as 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: 0.5
Sex: M
Vaccine: PNC13
Symptoms: Ear infection, Inappropriate schedule of drug administration
Clinical narrative: This is a spontaneous report from a contactable nurse. A 6-month-old patient received PREVNAR 13 the second dose at the age of 6 months (lot number: S74423, expiration date: 28Nov2019) via an unspecified route of administration as an injection on 28Nov2017 in the left thigh at a single dose and the third dose at the age of 7 months (lot number: unknown, expiration date: 28Nov2019) via an unspecified route of administration as an injection on 10Jan2018 at a single dose, both for vaccination for pneumonia. The patient's medical history and concomitant medications were not reported. The patient previously received the first dose of PREVNAR 13, (lot number: S31257, expiration date: 31Jul2018) on 21Aug2017 in the right thigh as an injection for vaccination for pneumonia. On 28Nov2017, it was realized that the patient experienced inappropriate schedule of vaccine administered. This was further elaborated as the patient received pneumococcal 13-valent conjugate vaccine (diphtheria CRM197 protein) the 1st dose date: 21Aug2017, 2nd dose date: 28Nov2017 and 3rd dose date: 10Jan2018. The patient presented with an ear infection, no fever reported- before the administration of the fourth dose on 06Jun2018. The outcome of the events was unknown.
Sex: U
Vaccine: PNC13
Symptoms: Product storage error
Clinical narrative: This is a spontaneous report from a contactable Health Care Professional. This Health Care Professional reported similar events for 64 patients. This is the 62nd of 64 reports. A patient of unspecified gender received PREVNAR 13, (Lot. T62565, Expiration date: 29Feb2020) at 0.5 ml single, on 01May2018, for immunization. The patient medical history and concomitant medications were not reported. On 01May2018, the patient received the vaccine after that it was exposed to a temperature excursion (the excursion occurred on an unspecified date with temperature of 32 degrees Fahrenheit for 11 hours 20 minutes). Sender's Comments: Linked Report(s): US-PFIZER INC-2018239213 Same reporter/event/ product, different patient.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Patient presents with red, slightly raised area measuring 2 inch x 1 inch circular area at injection site. No symptoms associated - no streaks, warmth, fever, itch, or pain.
Age: 30.0
Sex: F
Vaccine: HPV9
Symptoms: Drug administered to patient of inappropriate age, Product administered at inappropriate site
Clinical narrative: This spontaneous report was received from an other reporter via a company representative refers to a female patient of unknown age (reported as in her 30's) with cervix carcinoma (several times). On an unknown date, when the patient was 30 years old, she was vaccinated with GARDASIL 9 (concentration, dose, frequency, lot #, expiration date and indication were not reported) directly into her cervix (incorrect route of drug administration). It was reported, that after the patient received GARDASIL 9 this way, she had not cervical cancer again (pre-existing condition improved). The outcome of the event was not reported. The relatedness between the event and GARDASIL 9 was not provided.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash vesicular
Clinical narrative: Information has been received on 06-JUN-2018 regarding a case in litigation from a lawyer and a female consumer of unknown age. The patient's concurrent conditions, medical history and concomitant medications are unknown. On or about 26-MAR-2010, the patient was inoculated with ZOSTAVAX (lot number and expiration unknown) unknown route at a pharmacy 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. In 2015, the patient was treated by a physician for a persistent and 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 has 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 has been received on 06-JUN-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 2013, the patient was inoculated with ZOSTAVAX (lot number and expiration unknown) unknown route by a physician 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. In 2014, the patient was treated by a physician for a persistent and 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 has 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 has been received on 06-JUN-2018 regarding a case in litigation from a lawyer and a female consumer of unknown age. The patient's concurrent conditions, medical history and concomitant medications are unknown. On or about 31-AUG-2012, the patient was inoculated with ZOSTAVAX (lot number and expiration unknown) unknown route at a pharmacy 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. In 2015, the patient was treated by a physician for a persistent and 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 has 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: Discomfort, Herpes zoster, Pruritus generalised, Scar
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 medical history, concurrent conditions, or concomitant medications. The patient was inoculated with ZOSTAVAX in or about 2012 at the county health department for routine health maintenance and for the prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles, but rather caused the patient to contract a persistent strain of herpes zoster. In 2012 (reported as shortly after receiving ZOSTAVAX), the patient began to experience a feeling of itchiness and discomfort throughout her body. Thereafter, she was diagnosed as suffering from an outbreak of shingles, which led to significant and severe scarring throughout her body. As a direct and proximate result of these malfunctions, 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 were unknown at the time of this report. Causality assessment was considered related to ZOSTAVAX. Additional information has been requested.
Sex: F
Vaccine: PNC13
Symptoms: Malaise
Clinical narrative: This is a spontaneous report from a Pfizer sponsored program, Monthly Tracker, received from a contactable consumer. A female patient of an unspecified age received PREVNAR 13, (batch/lot number and expiration date were not reported), via an unspecified route of administration on an unspecified date at a single dose for immunization. The patient's medical history and concomitant medications were not reported. The patient experienced got sick from the shot on an unspecified date. The outcome of the event was unknown.  No follow-up attempts are possible, information about batch number cannot be obtained.
Sex: M
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: This is a spontaneous report from a contactable nurse via a Pfizer-sales representative. A male patient of an unspecified age received PREVNAR 13, via an unspecified route of administration on an unspecified date at a single dose for immunization at the physician office. The patient's medical history and concomitant medications were not reported. The patient had some pain, redness, and swelling at the injections site on an unspecified date. The outcome of the events, pain, redness, and swelling at the injection site, was unknown. Information on batch number has been requested.
Age: 5.0
Sex: F
Vaccine: MMR
Symptoms: Hypersensitivity, Injection site erythema, Injection site urticaria, Pruritus, Rash generalised
Clinical narrative: (6.12.18) Pt had an allergic reaction to the vaccine within 15 mins of injection. Pt R thing broke out into hives with redness. Pt given 2 tsp of BENADRYL based on her weight. Pt was kept in the office for an additional 40 mins, responded well the BENADRYL and pulse ox was 100 the whole time, no resp distress, or facial/tongue/lip swelling, no itch. Pt was also given ice to the area after 20 mins. Rash had improved after 40 mins, pt feeling well. Pt was able to go home, informed that if it comes back, spreads, to give more BENADRYL and take pt to the ER. 1:30 am (6.13.18) the rash came back, this time all over pt body, itchy, BENADRYL was given and 911 called. EMS arrived and assessed pt and stayed with patient for 15 mins, decided pt was doing better and was OK to stay home.  9:00 Am (6.13.18) mom called the office stating her rash had returned, still in no distress, just itchy.  Mom did not want to give another dose of Benadryl.  At this time mom was recommended to take pt to CHOA ER. mom agrees and called was ended.  10:00am (6.14.18) Follow up to mom , left message to call  office.
Age: 56.0
Sex: M
Vaccine: VARZOS
Symptoms: Hypoaesthesia, Injection site pain, Pain, Pain in extremity, Pyrexia
Clinical narrative: Significant pain at injection site and entire left arm, overall body pain, numbness in extremities  and fever up too 101.4. Took ibuprofen to reduce fever. All symptoms but numbness still persist as of 11:22a 6/14/2018. Fever is now 99.8.
Age: 0.42
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Rash generalised
Clinical narrative: Mother stated baby broke out in a rash from head to toe on 6/9/18 morning. He had also finished some prednisolone approx. 4 days before receiving vaccines.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: 3 spots of shingles on right hip.
Sex: F
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a physician and refers to a female patient of unknown age. Concurrent conditions, medical history, historical and concomitant medications were not reported. The reporting physician informed that on 21-JUL-2015, 22-SEP2015 and 09-FEB-2016, the patient was vaccinated with the first, second and third doses respectively, of GARDASIL 9 Injection, for prophylaxis (strength, dose, route and anatomical location were not reported). The lot numbers and expiration dates of the first and second doses were not reported, while the lot number of the third dose was L045711, and the expiration date was 08-MAY-2017. The physician stated that the doses may had been improperly stored, but the temperatures of storage, time frames and previous temperature excursions were unknown at the time of this report. No adverse events were reported.
Age: 2.0
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Extra dose administered
Clinical narrative: This spontaneous report was received from a license practical nurse referring to a 27 month old patient of unknown gender. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. In approximately March 2018, (also reported as "2 months ago") the patient was inadvertently vaccinated with PROQUAD lot number N019250 and expiration date of 20-DEC-2018 and a dose of VARIVAX lot number M049126 and expiration date of 15-DEC-2018 both for prophylaxis (dose, route of administration, lot number and expiration date were not reported).
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash vesicular
Clinical narrative: Information has been received on 06-JUN-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 2013, the patient was inoculated with ZOSTAVAX (lot number and expiration unknown) unknown route at a clinic 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. In 2016, the patient was treated at a medical office for a persistent and 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 has 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: 85.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Pain, Rash, Skin exfoliation
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain in a 85-year-old female patient who received SHINGRIX for prophylaxis. Concomitant products included acetylsalicylic acid (Aspirin), diltiazem hydrochloride (Diltiazem), pravastatin sodium (Pravachol), ascorbic acid (Vitamin C), cinnamomum cassia extract (Cinnamon Capsules), alendronate sodium (Fosamax) and omeprazole (Prilosec). On 14th May 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. In May 2018, less than a month after receiving SHINGRIX, the patient experienced pain, injection site erythema and rash. On 21st May 2018, the patient experienced skin peeling. The patient was treated with diphenhydramine hydrochloride (Benadryl (Usa)). On 19th May 2018, the outcome of the rash was recovered/resolved. On an unknown date, the outcome of the pain and injection site erythema were recovered/resolved and the outcome of the skin peeling was not recovered/not resolved. The reporter considered the pain, skin peeling, injection site erythema and rash to be almost certainly related to SHINGRIX. Additional details were provided as follows: The patient's concomitant medication included Immune booster medication and Centrum Silver for women. The patient's medical history diagnoses prior to receiving vaccine were unknown. The patient received SHINGRIX vaccine in the left deltoid. The patient stated that she received the SHINGRIX vaccine and it hurt like the dickens. Two days after receiving the vaccine around 9 a.m. the patient noticed that her left shoulder was very red. On the inner aspect of her upper arm, abdomen, and chest, there were also rashes. The patient was informed by her pharmacist to take Benadryl that she did take. Two days after that on Friday, the rashes were fading and by Saturday, they were completely gone. The patient stated that by that following Monday, she had a lot of skin peeling on her hands and feet but it was not itchy or sore. The patient was informed by the physician at the pharmacist not to get the 2nd dose of the SHINGRIX vaccine. The permission to contact MD was obtained.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site mass, Injection site swelling, Pyrexia
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site lump in a female patient who received SHINGRIX for prophylaxis. In April 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a month after receiving SHINGRIX, the patient experienced injection site lump, injection site swelling and fever. On an unknown date, the outcome of the injection site lump, injection site swelling and fever were recovered/resolved. It was unknown if the reporter considered the injection site lump, injection site swelling and fever to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The health care professional (HCP) reported that 2 months ago from the day of reporting, the patient received a dose of SHINGRIX different pharmacy location. The patient experienced baseball size lump and swelling at injection site. The patient also experienced severe fever. The reporter stated that the symptoms resolved a few days after the administration of vaccine. The reporter was not sure to administer the 2nd dose based on these symptoms.