chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 62.0
Sex: M
Vaccine: FLU3
Symptoms: Contusion, Haemorrhage, Musculoskeletal pain, Paraesthesia
Clinical narrative: Pt said his shoulder sore, tingling of face, bruises, when vaccinated he was bleeding. He said he took TYLENOL but did not help.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Rash erythematous, Skin warm
Clinical narrative: Rash started Tues AM at 8 then down to elbow by Thurs. We contacted provider they recommended ice and TYLENOL. If gets worse pt. to go to urgent care. Rash is red and hot to touch.
Age: 0.33
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Endoscopy normal, Full blood count normal, Haematemesis, Ultrasound abdomen normal
Clinical narrative: 4 mo. old breastfed 50%/Enfamil formula 50% baby with GER (but "happy spitter") who developed moderately large amount of hematemesis 3 hrs. after rotavirus vaccine. Endoscopy nl and Abd U/S nl next day.
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS, VARZOS
Symptoms: Injection site pain, Pain, Pain in extremity, Paraesthesia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of tingling of extremity 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 tingling of extremity, nerve injury and injection site reaction. On an unknown date, the outcome of the tingling of extremity was not recovered/not resolved and the outcome of the nerve injury and injection site reaction were unknown. It was unknown if the reporter considered the tingling of extremity, nerve injury and injection site reaction to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient had an appointment with her dermatologist who stated that whomever administered the vaccine hit a nerve and triggered the tingling in her arm. She was planning to get the 2nd dose, but thought that she might receive it a week past the 6 month mark. She would talk to the person administering the product about using a smaller needle and/or an alternate dosing site.
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS, VARZOS
Symptoms: Chills, Injected limb mobility decreased, Injection site erythema, Injection site pain, Musculoskeletal pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of tingling of extremity 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 tingling of extremity, nerve injury and injection site reaction. On an unknown date, the outcome of the tingling of extremity was not recovered/not resolved and the outcome of the nerve injury and injection site reaction were unknown. It was unknown if the reporter considered the tingling of extremity, nerve injury and injection site reaction to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient had an appointment with her dermatologist who stated that whomever administered the vaccine hit a nerve and triggered the tingling in her arm. She was planning to get the 2nd dose, but thought that she might receive it a week past the 6 month mark. She would talk to the person administering the product about using a smaller needle and/or an alternate dosing site.
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS, VARZOS
Symptoms: Myalgia, Nerve injury, Pain in extremity, Paraesthesia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of tingling of extremity 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 tingling of extremity, nerve injury and injection site reaction. On an unknown date, the outcome of the tingling of extremity was not recovered/not resolved and the outcome of the nerve injury and injection site reaction were unknown. It was unknown if the reporter considered the tingling of extremity, nerve injury and injection site reaction to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient had an appointment with her dermatologist who stated that whomever administered the vaccine hit a nerve and triggered the tingling in her arm. She was planning to get the 2nd dose, but thought that she might receive it a week past the 6 month mark. She would talk to the person administering the product about using a smaller needle and/or an alternate dosing site.
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS, VARZOS
Symptoms: Hypoaesthesia, Neuritis, Pain in extremity, Paraesthesia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of tingling of extremity 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 tingling of extremity, nerve injury and injection site reaction. On an unknown date, the outcome of the tingling of extremity was not recovered/not resolved and the outcome of the nerve injury and injection site reaction were unknown. It was unknown if the reporter considered the tingling of extremity, nerve injury and injection site reaction to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient had an appointment with her dermatologist who stated that whomever administered the vaccine hit a nerve and triggered the tingling in her arm. She was planning to get the 2nd dose, but thought that she might receive it a week past the 6 month mark. She would talk to the person administering the product about using a smaller needle and/or an alternate dosing site.
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS, VARZOS
Symptoms: Injection site reaction, Nerve injury, Paraesthesia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of tingling of extremity 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 tingling of extremity, nerve injury and injection site reaction. On an unknown date, the outcome of the tingling of extremity was not recovered/not resolved and the outcome of the nerve injury and injection site reaction were unknown. It was unknown if the reporter considered the tingling of extremity, nerve injury and injection site reaction to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient had an appointment with her dermatologist who stated that whomever administered the vaccine hit a nerve and triggered the tingling in her arm. She was planning to get the 2nd dose, but thought that she might receive it a week past the 6 month mark. She would talk to the person administering the product about using a smaller needle and/or an alternate dosing site.
Age: 68.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Erythema
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of erythematous rash in a 68-year-old male patient who received SHINGRIX (batch number 524S7, expiry date 12th February 2021) for prophylaxis. On 31st August 2018, the patient received the 2nd dose of SHINGRIX (intramuscular) .5 ml. On 2nd September 2018, 2 days after receiving SHINGRIX, the patient experienced erythematous rash. On an unknown date, the outcome of the erythematous rash was unknown. It was unknown if the reporter considered the erythematous rash to be related to SHINGRIX. Additional details were provided as follows: The patient recevied SHINGRIX vaccine on left arm. The healthcare professional reported that the patient developed a red rash on their chest. The healthcare professional stated that unsure of red rash had resolved at this time of not. The healthcare professional reported that the patient to call her if the rash got worse stated she had not heard from the patient. The healthcare professional reported that the patient with a different rash at the same time. This case has been linked with US2018161574, reported by the same reporter.
Age: 68.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Rash erythematous
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of erythematous rash in a 68-year-old male patient who received SHINGRIX (batch number 524S7, expiry date 12th February 2021) for prophylaxis. On 31st August 2018, the patient received the 2nd dose of SHINGRIX (intramuscular) .5 ml. On 2nd September 2018, 2 days after receiving SHINGRIX, the patient experienced erythematous rash. On an unknown date, the outcome of the erythematous rash was unknown. It was unknown if the reporter considered the erythematous rash to be related to SHINGRIX. Additional details were provided as follows: The patient recevied SHINGRIX vaccine on left arm. The healthcare professional reported that the patient developed a red rash on their chest. The healthcare professional stated that unsure of red rash had resolved at this time of not. The healthcare professional reported that the patient to call her if the rash got worse stated she had not heard from the patient. The healthcare professional reported that the patient with a different rash at the same time. This case has been linked with US2018161574, reported by the same reporter.
Age: 4.0
Sex: F
Vaccine: VARCEL
Symptoms: Abdominal discomfort, Decreased appetite, Diarrhoea, Injection site erythema, Injection site hypersensitivity
Clinical narrative: Her right thigh swelled up and turned red. It was super hot to the touch and had two round circle areas around the injection site. My daughter also had diarrhea, upset stomach, nausea, fever of 101.1 and lethargic and not eating well. She complained of pain and itchiness on the area.
Age: 4.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site pain, Injection site pruritus, Injection site swelling, Injection site warmth, Lethargy
Clinical narrative: Her right thigh swelled up and turned red. It was super hot to the touch and had two round circle areas around the injection site. My daughter also had diarrhea, upset stomach, nausea, fever of 101.1 and lethargic and not eating well. She complained of pain and itchiness on the area.
Age: 4.0
Sex: F
Vaccine: VARCEL
Symptoms: Nausea, Pyrexia
Clinical narrative: Her right thigh swelled up and turned red. It was super hot to the touch and had two round circle areas around the injection site. My daughter also had diarrhea, upset stomach, nausea, fever of 101.1 and lethargic and not eating well. She complained of pain and itchiness on the area.
Age: 7.0
Sex: M
Vaccine: MNQ
Symptoms: Vaccination site erythema, Vaccination site induration, Vaccination site warmth
Clinical narrative: Right upper arm where vaccine was given, patient had 9x10 cm area of erythema, warm and firm to touch the next day. No signs of systemic reaction, no fever, no pain. Patient was given diphenhydramine liquid orally and triamcinolone to apply to affected area.
Age: 72.0
Sex: F
Vaccine: UNK
Symptoms: Asthenia, Chills, Headache
Clinical narrative: Chills, headache, weakness.
Sex: F
Vaccine: HPV9
Symptoms: Syncope
Clinical narrative: Information has been received from a front desk clerk from the office of a physician via a company representative, referring to a 12 year old female patient. Information of concurrent condition, medical history and concomitant therapy was not provided. On an unknown date, the patient was vaccinated with a dose of GARDASIL 9 (route, lot# and expiration date unknown) for prophylaxis. It was the only vaccine the patient was administered. On an unknown date, the patient experienced an episode of syncope at the front desk. The outcome of the event was unknown. The causality was not provided.
Age: 19.0
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Underdose
Clinical narrative: Information has been received from a nurse referring to a 19 year old patient of unknown gender. The patient's pertinent medical history, drug reactions/allergies, current condition and concomitant medication were not provided. On 17-AUG-2018, the patient was inadvertently administered a pediatric dose of VAQTA 25/0.5 (lot # R009954, expiration date 12-JUN-2019) intramuscularly for prophylaxis. No adverse effect reported.
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: This spontaneous report was received from a nurse via a company representative regarding a currently 23-year-old patient of an unknown gender. The patient's concurrent conditions, medical history and concomitant medications were not reported. On an unspecified date in 2010, the patient was vaccinated with the first dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (manufacturer unknown) or with HPV rL1 6 11 16 18 31 45 52 58 VLP vaccine (yeast) (manufacturer unknown) (lot#, expiration date, formulation, dose, route of administration were not reported) administered for prophylaxis. On 05-SEP-2018, the patient was vaccinated with the second dose in series of GARDASIL 9 (lot#, expiration date, exact dose, formulation and route of administration were not reported) administered for prophylaxis. No adverse events were reported. The outcome of the event of product origin unknown was not reported. The causality between the event and an unspecified HPV vaccine was not reported. The causality between the event and GARDASIL 9 was not related.
Age: 17.0
Sex: U
Vaccine: HPV9
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report was received from a Licensed Practical Nurse referring to a 17 year old patient of unknown gender. The patient's medical history, concurrent conditions, concomitant therapies and drug or allergy reactions were not provided. On unknown dates, the patient received 2 doses of an unspecified  Human papillomaviruses (HPV) vaccine. On 14-AUG-2018, the patient was vaccinated with a dose of GARDASIL 9 (lot number and expiration date were not reported). On 06-SEP-2018, inadvertently received an additional dose of GARDASIL 9 lot number R009614 with expiration date on 30-NOV-2020 (strength, dose, dose number and administration route were not reported), for prophylaxis. No adverse effects were reported.
Age: 15.0
Sex: F
Vaccine: MMRV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Information has been received from a nurse via a field representative referring to a 15 year old female patient. The patient's concomitant medication, pertinent medical history and drug reactions/allergies were not reported. On approximately 24-AUG-2018 (reported as about 2 weeks ago) the unspecified 15 year old patient was vaccinated with PROQUAD (subcutaneous, strength, dose, frequency, lot # and expiration date were not reported) for prophylaxis due to no history of mumps measles and rubella vaccination and varicella vaccination (Inappropriate age at vaccine administration). The reporter stated prior to PROQUAD administration the "patient tested negative for varicella titer and mumps measles and rubella titer" on unspecified date. No adverse effect was reported.
Sex: F
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from a nurse referring to unspecified patients of unknown age and gender. The patients' concomitant medication, pertinent medical history and drug reactions/allergies were not provided. On unknown dates the unspecified patients received doses of improperly stored PROQUAD (rHA) (strength, dose, frequency, route were not reported, lot # N031929, expiry date 12-MAY-2019) for prophylaxis. Concomitant therapy included sterile diluent (lot # and expiry date were unknown). Sterile diluent used to reconstitute PROQUAD was stored properly. The temperature and time frame were unknown. There were no previous excursions reported. The call was because of a data logger. No adverse effects were reported. Follow up information was received on 05-SEP-2018 from the nurse and later from the physician. The reporters stated that three female children and five male children between the ages of 1 year and 4 years received doses of PROQUAD on an unspecified date in the past 3 months in approximately 2018. The patient was 1 year old female. The patient's concomitant medication, pertinent medical history and drug reactions/allergies were not provided. There had been no adverse events following the administration of the improperly stored PROQUAD vaccinations. This was just temperature issue where temperature reached -12 Celsius degree. Sender's Comments: US-009507513-1808USA010810: US-009507513-1809USA004055: US-009507513-1809USA004056: US-009507513-1809USA004057: US-009507513-1809USA004061: US-009507513-1809USA004059: US-009507513-1809USA004060.
Sex: F
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from a nurse referring to unspecified patients of unknown age and gender. The patients' concomitant medication, pertinent medical history and drug reactions/allergies were not provided. On unknown dates the unspecified patients received doses of improperly stored PROQUAD (rHA) (strength, dose, frequency, route were not reported, lot # N031929, expiry date 12-MAY-2019) for prophylaxis. Concomitant therapy included sterile diluent (lot # and expiry date were unknown). Sterile diluent used to reconstitute PROQUAD was stored properly. The temperature and time frame were unknown. There were no previous excursions reported. The call was because of a data logger. No adverse effects were reported. Follow up information was received on 05-SEP-2018 from the nurse and later form the physician. The reporters stated that three female children and five male children between the ages of 1 year and 4 years received doses of PROQUAD on an unspecified date in the past 3 months in approximately 2018. The patient was 1 year old White female patient. The patient's concomitant medication, pertinent medical history and drug reactions/allergies were not provided. There had been no adverse events following the administration of the improperly stored PROQUAD vaccinations. This was just temperature issue where temperature reached -12 Celsius degree.; Sender's Comments: US-009507513-1808USA010810: US-009507513-1809USA004055: US-009507513-1809USA004056: US-009507513-1809USA004057: US-009507513-1809USA004058: US-009507513-1809USA004060: US-009507513-1809USA004061:
Sex: F
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from a nurse referring to unspecified patients of unknown age and gender. The patients' concomitant medication, pertinent medical history and drug reactions/allergies were not provided. On unknown dates the unspecified patients received doses of improperly stored PROQUAD (rHA) (strength, dose, frequency, route were not reported, lot # N031929, expiry date 12-MAY-2019) for prophylaxis. Concomitant therapy included sterile diluent (lot # and expiry date were unknown). Sterile diluent used to reconstitute PROQUAD was stored properly. The temperature and time frame were unknown. There were no previous excursions reported. The call was because of a data logger. No adverse effects were reported. Follow up information was received on 05-SEP-2018 from the nurse and later from the physician. The reporters stated that three female children and five male children between the ages of 1 year and 4 years received doses of PROQUAD on an unspecified date in the past 3 months in approximately 2018. The patient was 1 year old female patient. The patient's concomitant medication, pertinent medical history and drug reactions/allergies were not provided. There had been no adverse events following the administration of the improperly stored PROQUAD vaccinations. This was just temperature issue where temperature reached -12 Celsius degree. Sender's Comments: US-009507513-1808USA010810: US-009507513-1809USA004055: US-009507513-1809USA004056: US-009507513-1809USA004057: US-009507513-1809USA004058: US-009507513-1809USA004059: US-009507513-1809USA004061.
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. Information regarding medical history, concurrent conditions and concomitant medications was not provided. In 2012, the patient was inoculated with ZOSTAVAX at a doctor's office as recommended for routine adult health maintenance and for the long-term prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster or shingles. In 2016, the patient was treated at a doctor's office for the onset of a severe vesicular rash which was diagnosed as severe herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX vaccine and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, 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. Information regarding medical history, concurrent conditions and concomitant medications was not provided. On or about 23-JUL-2012, the patient was inoculated with ZOSTAVAX 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 or shingles. On or about 23-SEP-2016, the patient was treated at a doctor's office by a physician for the onset of a vesicular outbreak, which was diagnosed as herpes zoster. The patient was prescribed acyclovir and hydrocortisone for the management of 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: M
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Pain, Rash vesicular
Clinical narrative: Information has been received on 11-SEP-2018 regarding a case in litigation from a lawyer and a male consumer of unknown age. The patient's concurrent conditions, medical history and concomitant medications are unknown. In 2014, the patient was inoculated with ZOSTAVAX (lot number and expiration unknown) unknown route at a pharmacy 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 or shingles. On 03-AUG-2016, the patient was treated at a family practice for a blistering vesicular outbreak, which was diagnosed as herpes zoster.The patient was prescribed VALTREX for management of his painful symptoms and "chronic." As a direct and proximate result of the ZOSTAVAX and/or despite receiving the 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, Rash vesicular
Clinical narrative: Information has been received on 11-SEP-2018 regarding a case in litigation from a lawyer and a male consumer of unknown age. The patient's concurrent conditions, medical history and concomitant medications are unknown. On or about 17-DEC-2009, the patient was inoculated with ZOSTAVAX (lot number and expiration unknown) unknown route at a health care center 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 or shingles. On or about 30-AUG-2016, the patient was treated by a physician for a blistering vesicular outbreak, which was diagnosed as herpes zoster. On or about 12-SEP-2016, the patient sought subsequent care from the same physician for a blistering vesicular outbreak, which was diagnosed as herpes zoster. As a direct and proximate result of the ZOSTAVAX and/or despite receiving the 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 was received from a lawyer regarding a case in litigation involving a female patient, age and medical history not provided. In 2015 the patient was inoculated with ZOSTAVAX vaccine for routine adult health maintenance and the prevention of shingles at a pharmacy. The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain condition of herpes zoster. In 2017 the patient was treated by a physician for a blistering vesicular outbreak, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of ZOSTAVAX or despite receiving ZOSTAVAX for 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, pain, suffering and other damages. Additional information has been requested.
Age: 23.0
Sex: F
Vaccine: HPV9
Symptoms: Blood test, Fatigue, Laboratory test
Clinical narrative: This spontaneous report was received from a nurse practitioner concerning a 23 year old female patient. Her concurrent conditions included scoliosis. Other pertinent medical history was not reported. She did not have any drug reactions/allergies. Her concomitant medications included ethinyl estradiol, norgestimate(TRI LINYAH). On 11-JUN-2018, the patient was vaccinated with the first dose of GARDASIL 9 intramuscularly, lot # N021571, expiration date: 29-APR-2020 for Human papillomavirus (HPV) vaccination. On an unspecified date in June 2018 (reported as within 1 week after vaccination), the patient was complaining of excessive fatigue. No treatment was given for the events. A chemistry panel and a blood count were performed, however, no results were provided. She seek medical attention with the nurse practitioner. The outcome of fatigue was reported as not recovered.  The causality between fatigue and GARDASIL 9 was not reported.
Sex: F
Vaccine: VARZOS
Symptoms: Burning sensation, Deafness unilateral, Herpes zoster, Ophthalmic herpes zoster, Paralysis
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. On or about 28-SEP-2016, the patient was vaccinated with ZOSTAVAX, (lot# and route unknown). The vaccine did not prevent shingles but rather caused the patient to contract a persistent strain of herpes zoster. Shortly after receiving ZOSTAVAX the patient developed burning and itching in the mid-section of her body. This was followed by an outbreak of a zoster rash around her left eye, jaw, and along her forehead. Thereafter, the patient suffered from loss of hearing in one ear, and palsy. As a direct and proximate result the patient's symptoms and diagnoses have resulted in physical limitations not present prior to using ZOSTAVAX. As a result of the use of ZOSTAVAX the patient sustained severe and permanent personal injuries. Further, the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. The patient had incurred and will continue to incur medical and other economic harm as a direct result of use of ZOSTAVAX. Upon internal review loss of hearing in one ear, zoster rash around her left eye and palsy were considered medically significant events. Hearing loss in one ear, persistent strain of herpes zoster, the vaccine did not prevent shingles, zoster rash around her left eye, jaw, and along her forehead, and palsy were reported as disabling by the lawyer. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus, Rash
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. On or about 28-SEP-2016, the patient was vaccinated with ZOSTAVAX, (lot# and route unknown). The vaccine did not prevent shingles but rather caused the patient to contract a persistent strain of herpes zoster. Shortly after receiving ZOSTAVAX the patient developed burning and itching in the mid-section of her body. This was followed by an outbreak of a zoster rash around her left eye, jaw, and along her forehead. Thereafter, the patient suffered from loss of hearing in one ear, and palsy. As a direct and proximate result the patient's symptoms and diagnoses have resulted in physical limitations not present prior to using ZOSTAVAX. As a result of the use of ZOSTAVAX the patient sustained severe and permanent personal injuries. Further, the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. The patient had incurred and will continue to incur medical and other economic harm as a direct result of use of ZOSTAVAX. Upon internal review loss of hearing in one ear, zoster rash around her left eye and palsy were considered medically significant events. Hearing loss in one ear, persistent strain of herpes zoster, the vaccine did not prevent shingles, zoster rash around her left eye, jaw, and along her forehead, and palsy were reported as disabling by the lawyer. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Rash, Skin lesion
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age.  The patient's medical history, concurrent conditions and concomitant medication use were not provided. On or about 10-OCT-2014, the patient was vaccinated with ZOSTAVAX (dose, route of administration, site of administration and lot # were not provided) for its intended purpose:  the prevention of shingles. As a direct result of the vaccine, the patient suffered from a shingles outbreak, in addition to chronic pain, rash and lesions to various parts of his body. The patient did not have a shingles outbreak until 11-AUG-2017. As a direct result of the vaccine, the patient suffered mental and emotional distress due to resulting physical limitations and seriousness of his condition. As a result of ZOSTAVAX vaccine, the patient sustained severe and permanent personal injuries. Further, the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. The patient incurred medical expenses and other economic harm as a direct result of use of ZOSTAVAX. The reporter considered the events to be related to ZOSTAVAX. Shingles outbreak was reported to be disabling. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Rash, Skin lesion
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. The patient's medical history, concurrent conditions and concomitant medication use were not provided. On or about 30-JUL-2013, the patient was vaccinated with ZOSTAVAX (dose, route of administration, site of administration and lot # were not provided) for its intended purpose:  the prevention of shingles. As a direct result of the vaccine, the patient suffered from a shingles outbreak, in addition to chronic pain, rash and lesions to various parts of his (Conflicting information. Patient is reported as a female) body. The patient did not have a shingles outbreak until 16-MAR-2015 and a reoccurrence of Shingles on 05-OCT-2016. As a direct result of the vaccine, the patient suffered mental and emotional distress due to resulting physical limitations and seriousness of his (Conflicting information) condition. As a result of ZOSTAVAX vaccine, the patient sustained severe and permanent personal injuries. Further, the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. The reporter considered the events to be related to  ZOSTAVAX. The events of Shingles outbreak and Recurrence of shingles were considered to be disabling. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: This spontaneous report was received from a physician referring to an unspecified number of patients of unknown age and gender. The patients' pertinent medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not provided. On an unknown date, the patient was vaccinated with GARDASIL 9  (strength, dose, anatomical location, lot number and expiration date were not provided) for prophylaxis. On an unknown date, the patient experienced drug administered to patient of inappropriate age and no adverse event. This is a non valid case due to lack of patient identifiers.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Nasal congestion, Pain
Clinical narrative: Started with headache approx. 2pm that became massive. Progressed over next 4 hours to include fatigue, achiness, nasal congestion, 7 pm chills started. Arm soreness that started about 1 pm that increased in pain over next 6 hours to an extreme level of throbbing pain. Took Tylenol starting 7 pm and again at midnight. By morning chills were gone and nasal congestion started to subside.  Throughout second day remaining symptoms eventually subsided by that evening. Unable to go to work that day.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: Started with headache approx. 2pm that became massive. Progressed over next 4 hours to include fatigue, achiness, nasal congestion, 7 pm chills started. Arm soreness that started about 1 pm that increased in pain over next 6 hours to an extreme level of throbbing pain. Took Tylenol starting 7 pm and again at midnight. By morning chills were gone and nasal congestion started to subside.  Throughout second day remaining symptoms eventually subsided by that evening. Unable to go to work that day.
Age: 13.0
Sex: M
Vaccine: HPV9
Symptoms: Myalgia, Pain
Clinical narrative: Assmnt: No visible swelling over the left outer arm. Area of presumed vaccination well below AC joint and in upper deltoid. No echymosis. There is pain approx one inch below ac joint to palpation, pain worsened with active movement of arm upward. No skin induration, no warmth. A/P: Pt is a 13 yrs. old male with myalgia s/p immunization with HPV. Greater than one week s/p immunization, history and exam raises possibility of bursitis as well. Recommend advil 400mg bid x 3-5 days, if not getting better in 3 days will refer to ortho as may benefit from intra-articular steroids vs oral steroids. Discussed with father.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Chest discomfort, Cough, Dysphonia, Headache, Hyperhidrosis
Clinical narrative: Lethargic, Fever started that night lasted till Monday 9/10/18- high of 100.9, sweating, headache, body aches, I still have heaviness in my chest, cough, hoarseness. Lethargy is improved and body aches.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Lethargy, Pain, Pyrexia
Clinical narrative: Lethargic, Fever started that night lasted till Monday 9/10/18- high of 100.9, sweating, headache, body aches, I still have heaviness in my chest, cough, hoarseness. Lethargy is improved and body aches.
Age: 1.25
Sex: M
Vaccine: VARCEL
Symptoms: Emotional distress, Fatigue, Irritability, Lethargy, Pyrexia
Clinical narrative: Fever of 101-102.6 for 3 days now. Only will stay down with alternating Tylenol and Advil. Lathargic, clingy, tired, whiny.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Chest discomfort, Erythema, Musculoskeletal stiffness, Peripheral swelling
Clinical narrative: Patient reported muscle stiffness, tightness of chest, swelling and redness of injected arm.
Age: 21.0
Sex: F
Vaccine: MENB
Symptoms: Discomfort, Impaired driving ability, Injection site haemorrhage, Injection site pain, Musculoskeletal pain
Clinical narrative: She presents with pain in left upper arm which began 4 days ago, when she had 2nd Men B vaccine. Arm is increasingly painful with movement, as compared to soreness after first dose which resolved after 3 days. She was unable to drive herself home due to pain last night, and can't get comfortable. Associated symptoms include pain with moving arm, shoulder/neck pain, tingling sensation in hand, pain in lower arm. She did not have severe pain with injection, did not have significant bleeding from injection site. ROS negative for redness, swelling, bruising, increased warmth of arm. No lower extremity weakness, cough, difficulty breathing. ASSESSMENT: Postimmunization reaction. PLAN:  Hydrocodone for next 1-2 days only. Discussed in detail cannot take while taking Baclofen. Baclofen recently prescribed by neuro as adjunct to migraine treatment, and has not taken this medication at all. Rx discussed with MD. Alternate heat and ice. Elevate arm.
Age: 21.0
Sex: F
Vaccine: MENB
Symptoms: Neck pain, Pain, Pain in extremity
Clinical narrative: She presents with pain in left upper arm which began 4 days ago, when she had 2nd Men B vaccine. Arm is increasingly painful with movement, as compared to soreness after first dose which resolved after 3 days. She was unable to drive herself home due to pain last night, and can't get comfortable. Associated symptoms include pain with moving arm, shoulder/neck pain, tingling sensation in hand, pain in lower arm. She did not have severe pain with injection, did not have significant bleeding from injection site. ROS negative for redness, swelling, bruising, increased warmth of arm. No lower extremity weakness, cough, difficulty breathing. ASSESSMENT: Postimmunization reaction. PLAN:  Hydrocodone for next 1-2 days only. Discussed in detail cannot take while taking Baclofen. Baclofen recently prescribed by neuro as adjunct to migraine treatment, and has not taken this medication at all. Rx discussed with MD. Alternate heat and ice. Elevate arm.
Age: 64.0
Sex: M
Vaccine: FLU4, PPV
Symptoms: Injection site erythema, Injection site inflammation, Injection site warmth
Clinical narrative: Redness, warmth, inflammation at injection site. BENADRYL and prednisone ordered.
Age: 69.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Asthenia, Blood glucose increased, Chills, Myalgia, Nausea
Clinical narrative: 10 hours after the vaccines, 10 minutes after self injection of nightly insulin (Lantus Solostar insulin glargine, 23 units), experienced overall shaking (more intense than shivering) for 20 minutes followed by bouts of shivering for the next 30 minutes. I was able to get up and take blood glucose reading (218) and BP/pulse (141/74, 100) approximately 2 hr after episode began. Repeated readings the next morning were within normal ranges. Widespread muscle aches, weakness, occassional nausea continued for the next day. I have taken the insulin for years, a flu shot every year, and this was the second dose of SHINGRIX and I never experienced this type of reaction before.
Age: 69.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Tremor
Clinical narrative: 10 hours after the vaccines, 10 minutes after self injection of nightly insulin (Lantus Solostar insulin glargine, 23 units), experienced overall shaking (more intense than shivering) for 20 minutes followed by bouts of shivering for the next 30 minutes. I was able to get up and take blood glucose reading (218) and BP/pulse (141/74, 100) approximately 2 hr after episode began. Repeated readings the next morning were within normal ranges. Widespread muscle aches, weakness, occassional nausea continued for the next day. I have taken the insulin for years, a flu shot every year, and this was the second dose of SHINGRIX and I never experienced this type of reaction before.
Sex: F
Vaccine: PPV
Symptoms: Haemoptysis, Hypersensitivity, Pneumonia bacterial, Upper-airway cough syndrome
Clinical narrative: This spontaneous report was received from a female patient of unknown age. The patient's historical condition included a bacterial infection in the lungs, experienced in approximately 2013 (reported as about 5 years ago), severe enough to cause scarring to occur in the lungs. It was reported that as a result of the scarring in the patient's lungs, she became more prone to getting bacterial pneumonia. On an unknown date in approximately 2014 (reported as about 4 years ago), the patient was vaccinated with a dose of PNEUMOVAX 23 (dose, site and route of administration, lot # and expiration date were not provided) for prophylaxis. In January 2018, the patient developed a bacterial pneumonia infection. In June 2018, she experienced another bacterial related pneumonia infection. On an unknown date, she developed an unspecified allergies, which were reported as bad. On unknown dates (reported as sometimes), because of her bad allergies, the patient was experiencing nasal drips and coughing up blood. The patient sought medical attention via contacting her infectious disease physician. The outcome of the events was unknown. The relatedness between the events and PNEUMOVAX 23 was not reported. Upon internal review, the event of bacterial pneumonia infection was considered to be medically significant.
Sex: M
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from a nurse referring to unspecified patients of unknown age and gender. The patients' concomitant medication, pertinent medical history and drug reactions/allergies were not provided. On unknown dates the unspecified patients received doses of improperly stored PROQUAD (rHA) (strength, dose, frequency, route were not reported, lot # N031929, expiry date 12-MAY-2019) for prophylaxis. Concomitant therapy included sterile diluent (lot # and expiry date were unknown). Sterile diluent used to reconstitute PROQUAD was stored properly. The temperature and time frame were unknown. There were no previous excursions reported. The call was because of a data logger. No adverse effects were reported. Follow up information was received on 05-SEP-2018 from the nurse and from the physician. The reporters stated that three female children and five male children between the ages of 1 year and 4 years received doses of PROQUAD on an unspecified date in the past 3 months in approximately 2018. The patient was 4 year old male patient. The patient's concomitant medication, pertinent medical history and drug reactions/allergies were not provided. There had been no adverse events following the administration of the improperly stored PROQUAD vaccinations. This was just temperature issue where temperature reached -12 Celsius degree. Sender's Comments: US-009507513-1808USA010810: US-009507513-1809USA004055: US-009507513-1809USA004056: US-009507513-1809USA004058: US-009507513-1809USA004059: US-009507513-1809USA004060: US-009507513-1809USA004061.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, 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. Information regarding medical history, concurrent conditions and concomitant medications was not provided. On or about 13-FEB-2015, the patient was inoculated with ZOSTAVAX 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 or shingles. On or about 10-SEP-2016, the patient was treated at medical center for the onset of a vesicular outbreak, which was diagnosed as herpes zoster. The patient was prescribed FAMVIR for management of 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 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, Rash, Skin lesion
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. The patient's medical history, concurrent conditions and concomitant medication use were not provided. On or about 23-SEP-2013, the patient was vaccinated with ZOSTAVAX (dose, route of administration, site of administration and lot # were not provided) for its intended purpose: the prevention of shingles. As a direct result of the vaccine, the patient suffered from a shingles outbreak, in addition to chronic pain, rash and lesions to various parts of her body. The patient did not have a shingles outbreak until 10-APR-2017 and to date continues to have reoccurring outbreaks and permanent nerve damage. As a direct result of the vaccine, the patient suffered mental and emotional distress due to resulting physical limitations and seriousness of her condition. As a result of ZOSTAVAX vaccine, the patient sustained severe and permanent personal injuries. Further, the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. The patient incurred medical expenses and other economic harm as a direct result of use of ZOSTAVAX. The reporter considered the events to be related to ZOSTAVAX. The events of Shingles outbreak/continues to have reoccurring outbreaks and permanent nerve damage were considered to be disabling. Additional information has been requested.