chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 72.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Flank pain, Herpes zoster, Rash
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of shingles in a 72-year-old female patient who received SHINGRIX. Previously administered products included ZOSTAVAX vaccine (received in 2010). Concomitant products included ADVAIR, CYTOMEL, sertraline, CELEXA, estradiol, hydrochlorothiazide, NASONEX and SYNTHROID. On 13th March 2018, the patient received the 1st dose of SHINGRIX. On 19th March 2018, 6 days after receiving SHINGRIX, the patient experienced shingles (serious criteria hospitalization and disability) and flank pain (serious criteria hospitalization and disability). On 21st March 2018, the patient experienced rash (serious criteria hospitalization and disability). On an unknown date, the outcome of the shingles, rash and flank pain were not recovered/not resolved. The reporter considered the shingles, rash and flank pain to be probably related to SHINGRIX. Additional details were provided as follows: The patient's concomitant medication included Citrulline and Allergy shots. The physician stated that she prescribed SHINGRIX for the patient. The patient received the vaccine at local pharmacy and she developed pain in her left flank. She was seen at the local emergency room and a full work up was performed and she was sent home. On 21st March 2018, 8 days after receiving SHINGRIX, a rash appeared and the patient was admitted to the hospital for 1 day for pain management. It was noted she had no other vaccines on the day of vaccination or 4 weeks prior was given. The physician had limited information on the actual vaccination administration since it was done at a local pharmacy. She doubted the patient would receive the 2nd dose given the circumstances with the 1st.
Age: 15.0
Sex: M
Vaccine: HPV9
Symptoms: Pruritus, Urticaria
Clinical narrative: Large hives started about 24 hours after vaccine given. BENADRYL given as needed and hives continued to appear and disappear. On day 4 after vaccine hives so large and thick all over body especially on abdomen went to emergency room. Received 125 mg methylprednisolone IV, PEPCID 20 mg IV, and BENADRYL 25 mg IV. Hives did improve and relief noted. Prescribed Prednisone 40 mg daily for 5 days and BENADRYL 25 mg orally every 4 hours as needed. Large itchy hives still appearing at this time despite prednisone and BENADRYL.
Age: 1.17
Sex: F
Vaccine: DTAP, HEPA, HIBV, PNC13
Symptoms: Appetite disorder, CSF culture negative, CSF glucose normal, CSF protein increased, Decreased activity
Clinical narrative: 15 month old with 2 week URI, recent catch up vaccines (DTaP, Hep A, Hib, PCV13) and was + enteroviral/rhinoviral infection with ascending paralysis-consistent with Guillain Barre syndrome CSF studies with high protein, nml glucose, cx negative, enteroviral CSF negative, herpes CSF negative, MRI normal, Child is now s/p 4/4 IVIG. With improvement in strength after 3rd dose. Before discharge child was stable on RA > 24 hours able to sit unassisted and stand unassisted.
Age: 1.17
Sex: F
Vaccine: DTAP, HEPA, HIBV, PNC13
Symptoms: Dysstasia, Enterovirus infection, Enterovirus test negative, Gait disturbance, Guillain-Barre syndrome
Clinical narrative: 15 month old with 2 week URI, recent catch up vaccines (DTaP, Hep A, Hib, PCV13) and was + enteroviral/rhinoviral infection with ascending paralysis-consistent with Guillain Barre syndrome CSF studies with high protein, nml glucose, cx negative, enteroviral CSF negative, herpes CSF negative, MRI normal, Child is now s/p 4/4 IVIG. With improvement in strength after 3rd dose. Before discharge child was stable on RA > 24 hours able to sit unassisted and stand unassisted.
Age: 1.17
Sex: F
Vaccine: DTAP, HEPA, HIBV, PNC13
Symptoms: Herpes simplex test negative, Immunoglobulin therapy, Mobility decreased, Nuclear magnetic resonance imaging normal, Rhinovirus infection
Clinical narrative: 15 month old with 2 week URI, recent catch up vaccines (DTaP, Hep A, Hib, PCV13) and was + enteroviral/rhinoviral infection with ascending paralysis-consistent with Guillain Barre syndrome CSF studies with high protein, nml glucose, cx negative, enteroviral CSF negative, herpes CSF negative, MRI normal, Child is now s/p 4/4 IVIG. With improvement in strength after 3rd dose. Before discharge child was stable on RA > 24 hours able to sit unassisted and stand unassisted.
Age: 59.0
Sex: M
Vaccine: VARZOS
Symptoms: Asthenia, Fatigue, Injection site discomfort, Injection site pain, Mental impairment
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of difficulty thinking in a 59-year-old male patient who received SHINGRIX. On 12th March 2018, the patient received SHINGRIX. On 12th March 2018, less than a day after receiving SHINGRIX, the patient experienced difficulty thinking (serious criteria GSK medically significant), injection site pain, tiredness and weakness. On 17th March 2018, the patient experienced generalized pruritus and general body pain. The patient was treated with BENADRYL and TYLENOL. On an unknown date, the outcome of the difficulty thinking, injection site pain, tiredness, weakness, generalized pruritus and general body pain were recovering/resolving. The reporter considered the difficulty thinking, injection site pain, tiredness, weakness, generalized pruritus and general body pain to be possibly related to SHINGRIX. Additional details were provided as follows: This case was previously not reported to anyone. This case was reported by the registered pharmacist. The patient experienced soreness at the injection site. The reporter did not know which arm the patient had the injection. That  evening, the patient reported he felt tired and weak. The patient reports that he could not think clearly. On Saturday 17th March 2018, the patient experienced itching all over his body and pain all over his body. On Sunday 18th March 2018, the patient took BENADRYL and TYLENOL. When the patient contacted the pharmacy today on 20th March 2018, all of the events were improved, but there was still some itching present.
Age: 59.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain, Pruritus generalised
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of difficulty thinking in a 59-year-old male patient who received SHINGRIX. On 12th March 2018, the patient received SHINGRIX. On 12th March 2018, less than a day after receiving SHINGRIX, the patient experienced difficulty thinking (serious criteria GSK medically significant), injection site pain, tiredness and weakness. On 17th March 2018, the patient experienced generalized pruritus and general body pain. The patient was treated with BENADRYL and TYLENOL. On an unknown date, the outcome of the difficulty thinking, injection site pain, tiredness, weakness, generalized pruritus and general body pain were recovering/resolving. The reporter considered the difficulty thinking, injection site pain, tiredness, weakness, generalized pruritus and general body pain to be possibly related to SHINGRIX. Additional details were provided as follows: This case was previously not reported to anyone. This case was reported by the registered pharmacist. The patient experienced soreness at the injection site. The reporter did not know which arm the patient had the injection. That  evening, the patient reported he felt tired and weak. The patient reports that he could not think clearly. On Saturday 17th March 2018, the patient experienced itching all over his body and pain all over his body. On Sunday 18th March 2018, the patient took BENADRYL and TYLENOL. When the patient contacted the pharmacy today on 20th March 2018, all of the events were improved, but there was still some itching present.
Age: 13.0
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a 15 and a half year old patient. No information about the patient's medical history, concurrent conditions and concomitant medications was reported. On an unknown date in approximately 2016 (reported as "at age 13"), the patient was vaccinated with the first dose of GARDASIL 9 intramuscularly (lot number and expiration date were unknown). On an unknown date in 2018 (reported as "currently"), the patient was about to be vaccinated with the second dose of GARDASIL 9 intramuscularly (lot number and expiration date were unknown). It is unknown whether the patient received the vaccine. There was no adverse event reported. No further information was available and all scheduled correspondence has been canceled.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This non-valid spontaneous report was received from a registered nurse and refers to an unspecified number of patients. No information regarding the patients' medical histories or concurrent conditions was provided. On unknown dates, the patients were vaccinated with improperly stored doses of ROTATEQ, lot # N013989 with expiration date on 30-JAN-2019. The vaccine underwent a temperature excursion of 32 to 35 degrees Fahrenheit for 15 minutes. Digital Data Logger was involved in recording of the excursion. No previous temperature excursions were reported. No adverse effects were reported.
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. There was no information about the patent's concurrent conditions, concomitant therapies or medical history provided. On 16-MAR-2018, the patient was inadvertently vaccinated with both dose of PROQUAD and dose of VARIVAX (exact dose, route of administration, lot# and expiry date were not reported) for prophylaxis reconstituted with sterile diluent (manufacturer unknown) (lot# and expiry date were not reported) which did not undergo a temperature excursion. No adverse effects were reported.
Age: 17.0
Sex: F
Vaccine: HEPA
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant, and refers to a 17 year old female patient. No information about the patient's medical history, concurrent conditions, concomitant medications and drug reactions/allergies was provided. On 15-FEB-2018, the patient was inadvertently administered 1 ml. dose of VAQTA, intramuscular, for prophylaxis, (frequency, lot number and expiration date were not provided). No adverse effects reported.
Age: 17.0
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist referring to an approximately 17 year old patient of unknown gender. The patient's pertinent medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not provided. On 23-SEP-2015, the patient received the first dose of the GARDASIL for prophylaxis (strength, route, lot # and expiration date were not reported. Almost 8 months after, on 03-MAY-2016, the patient received the second dose of the GARDASIL for prophylaxis (strength, route, lot # and expiration date were not reported). Two years after, on 03-JAN-2018, the patient received the last dose in the three dose HPV vaccination series late with GARDASIL 9 for prophylaxis (strength, route, lot # and expiration date were not reported). No adverse effects were reported.
Age: 15.0
Sex: M
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse regarding an unspecified 15 year old male patient. The patient's medical history, concurrent conditions and concomitant medications were not provided. On 13-JUL-2017, 29-DEC-2017 and 21-MAR-2018, the patient was vaccinated with GARDASIL 9 injection, for prophylaxis (dose, frequency, route, lot # and expiration date were not provided) (inappropriate schedule of drug administration). No adverse effect reported.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information was received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received concerning the patient's past medical history, concurrent conditions, or concomitant medication. On or about 01-FEB-2015, the patient was inoculated by the physician with ZOSTAVAX as recommended for routine adult health maintenance and for the prevention of shingles (dose, route of administration, site of administration and lot # were not provided). The vaccine did not prevent shingles as intended. On or about MAY-2016, the male patient was treated by the same physician who administered the vaccine, and was diagnosed with Herpes zoster, or shingles.  As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. The lawyer felt the events were related to ZOSTAVAX. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information was received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received concerning the patient's past medical history, concurrent conditions, or concomitant medication. On or about 29-MAY-2015, the patient was inoculated (by an unspecified health care professional) at a pharmacy with ZOSTAVAX as recommended for routine adult health maintenance and for the prevention of shingles (dose, route of administration, site of administration and lot # were not provided). The vaccine did not prevent shingles as intended. On or about MAY-2016, the female patient was treated (by an unspecified health care professional) at a medical center, and was diagnosed with Herpes zoster, or shingles.  As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. The lawyer felt the events were related to ZOSTAVAX. 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 (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. During 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 April 2016, the patient was treated by a physician and was diagnosed with 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: M
Vaccine: VARZOS
Symptoms: Herpes zoster
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. During 2015, 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 May 2016, the patient was treated by a physician and was diagnosed with 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, Neuropathy peripheral, Pain
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 29-JAN-2015, 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. On or about 17-MAY-2016, the patient was treated and was diagnosed with painful herpes zoster, or shingles. She was later diagnosed with peripheral neuropathy secondary to 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
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. During 2010, 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. During 2016, the patient was treated by a physician and was diagnosed with herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX, and/or despite receiving ZOSTAVAX, for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment.  As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received on 23-MAR-2018 from a lawyer and a male consumer of unknown age. The patient's concurrent conditions, medical history and concomitant medications are unknown. During 2013, the patient was inoculated with ZOSTAVAX (lot number and expiration unknown) unknown route, as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended but rather caused the patient to contract a persistent strain condition of herpes zoster. On or about 01-MAY-2016, the patient was treated by a physician and was diagnosed with herpes zoster, or shingles. As a direct and proximate result of the ZOSTAVAX, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: Information has been received on 23-MAR-2018 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 08-OCT-2013, the patient was inoculated with ZOSTAVAX (lot number and expiration unknown) unknown route, as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended. On or about 01-MAY-2016, the patient was treated by a physician for an outbreak that was diagnosed as herpes zoster, or shingles. As a direct and proximate result of the ZOSTAVAX, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HPV9
Symptoms: Asthenia, Disability, Gait disturbance, Inappropriate schedule of drug administration, Interchange of vaccine products
Clinical narrative: This spontaneous report was received from a nurse practitioner via a field representative regarding a 12 year old non-pregnant female patient. The patient's pertinent medical history, drug reactions/allergies, and concomitant medications were unknown. On 14-DEC-2013 and 10-JAN-2015, the patient was vaccinated with GARDASIL (route, dose, lot#, and expiration date unknown) for prophylaxis (inappropriate schedule of drug administration). On 09-DEC-2015, the patient experienced weakness and was not able to run (unable to clarify further). Patient was told it was postural related and to see neurologist. On 25-FEB-2016, the patient was vaccinated with GARDASIL 9 (dose, route, lot#, and expiration date not reported) as routine vaccination (interchange of vaccine products). The patient sought medical attention from physician visit and went to emergency room on an unknown date in 2016. She was diagnosed with muscular dystrophy. The event caused a significant disability or incapacity to the patient and patient became wheel chair bound. On an unknown date, the patient was hospitalized for the event. The patient was not treated for the adverse event. It was unknown if lab diagnostics/studies were performed. The outcome of the event muscular dystrophy was unknown. The reporter did not assess the causality of the event with suspect therapies. Product quality complaint was not involved.
Age: 13.0
Sex: F
Vaccine: HPV9
Symptoms: Muscular dystrophy, Wheelchair user
Clinical narrative: This spontaneous report was received from a nurse practitioner via a field representative regarding a 12 year old non-pregnant female patient. The patient's pertinent medical history, drug reactions/allergies, and concomitant medications were unknown. On 14-DEC-2013 and 10-JAN-2015, the patient was vaccinated with GARDASIL (route, dose, lot#, and expiration date unknown) for prophylaxis (inappropriate schedule of drug administration). On 09-DEC-2015, the patient experienced weakness and was not able to run (unable to clarify further). Patient was told it was postural related and to see neurologist. On 25-FEB-2016, the patient was vaccinated with GARDASIL 9 (dose, route, lot#, and expiration date not reported) as routine vaccination (interchange of vaccine products). The patient sought medical attention from physician visit and went to emergency room on an unknown date in 2016. She was diagnosed with muscular dystrophy. The event caused a significant disability or incapacity to the patient and patient became wheel chair bound. On an unknown date, the patient was hospitalized for the event. The patient was not treated for the adverse event. It was unknown if lab diagnostics/studies were performed. The outcome of the event muscular dystrophy was unknown. The reporter did not assess the causality of the event with suspect therapies. Product quality complaint was not involved.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a nurse concerning a patient of unknown age and gender. There was no information about the patient's concurrent conditions, medical history or concomitant medication. On 26-MAR-2018, the patient was vaccinated with M-M-R II lot # M011667 with expiration date of 08-MAR-2018, for prophylaxis (dose, route of administration and anatomical location were not reported). No adverse effects were reported.
Sex: M
Vaccine: MMRV
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report has been received from a nurse referring to a 32 year old male patient. Information regarding the patient's medical history, drug reactions or allergies and concurrent conditions. Concomitant therapies included sterile diluent (MERCK). On 26-FEB-2018, the patient was vaccinated with PROQUAD (strength, dose, route, anatomical location, lot number and expiration date were not provided) for prophylaxis (drug administered to patient of inappropriate age). No adverse effects were reported.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. Concomitant medication included a sterile diluent (manufacturer unknown). On 06-MAR-2018, the patient had received an improperly stored PROQUAD subcutaneously (lot: N012617, expiry date: 18-OCT-2018). The vaccine was exposed to 6°F to 14°F for 30 minutes. There were no previous temperature excursions. The call was because of a digital data logger. The sterile diluent (manufacturer unknown) used to reconstitute PROQUAD was properly stored. No adverse effects were reported.
Age: 12.0
Sex: M
Vaccine: HPV9
Symptoms: Fall, Syncope
Clinical narrative: This spontaneous report was received from a physician via field representative referring to a 12 year old male patient. The patient's medical history, concurrent conditions and concomitant medications were not reported. On an unspecified date, the patient was administered GARDASIL 9 intramuscularly (lot and expiry date not reported) as a prophylaxis. After administration of GARDASIL 9, the patient experienced syncope and fainted to the floor. The patient did not suffer any injuries as a result of the fall. Patient recovered from the events syncope and fall within the same office visit. It was unknown if the patient received any treatment. Causality assessment was not reported for the events.
Sex: U
Vaccine: MMR
Symptoms: Incorrect route of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On 15-MAR-2018 the patient was vaccinated with a dose of M-M-R II, (lot number and expiry date unknown) (dosing regimen and frequency unknown) intramuscularly in error for prophylaxis. No adverse events were reported. No product quality complaint was reported.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a patient of unknown age. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. On an unknown date, the patient was vaccinated with an improperly stored dose of PROQUAD, subcutaneous, lot number N014948 with expiration date on 11-NOV-2018 (strength, dose and anatomical location were not reported) for prophylaxis. The administered dose of the vaccine experienced a temperature excursion of 8.8°F for 51 minutes, as recorded by a data logger. The vaccine had not had any previous temperature excursions. There was no adverse effect reported. No product quality complaint was involved.
Sex: M
Vaccine: VARZOS
Symptoms: Guillain-Barre syndrome, Herpes zoster, Paraesthesia
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 medical history, concurrent conditions, or concomitant medications. On or about 14-AUG-2014, the patient was inoculated with ZOSTAVAX in his right deltoid for routine health maintenance and for the prevention of shingles (lot # and dose not provided). The vaccine was given by a Medical Assistant at his primary care physician's office. The vaccine did not prevent shingles, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 23-AUG-2014, the patient was diagnosed with paresthesia. On or about 15-SEP-2014, the patient was treated by his primary care physician and diagnosed with Guillain-Barre Syndrome and "post-traumatic syndrome."  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, pain and suffering, and other damages. Upon internal review, Guillain-Barre Syndrome was considered medically significant. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report has been received from a nurse referring to a patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions, drug, allergy history or concomitant medications. On 24-JUL-2007, the patient was vaccinated with the first dose of VARIVAX (strength, dose, frequency, lot# and expiration date were not provided) for prophylaxis. The second dose of VARIVAX was on 27-MAY-2011. It was reported that on 24-JUL-2007, the patient received the first dose of M-M-R II (strength, dose, frequency, Lot# and expiration date were not provided) for prophylaxis, and the second dose was on 17-MAY-2011. No adverse events were reported.
Age: 0.25
Sex: U
Vaccine: MMR
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a 3 month old patient of unknown gender. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On 27-MAR-2018 the 3 month old patient was vaccinated with a dose of M-M-R II (drug administered to patient of inappropriate age) (lot number and expiry date unknown) (dosing regimen and frequency unknown) subcutaneously for prophylaxis. No adverse events were reported. There was no product quality compliant reported.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 22-MAR-2018, the patient was vaccinated with one dose of improperly stored ROTATEQ (lot: N004812, expiry date: 04-OCT-2018). No adverse effects reported. The vaccine was exposed to 9°C to 25°C for 30 minutes. There was no previous temperature excursions. The call was because of a digital data logger.
Age: 22.0
Sex: M
Vaccine: SMALL
Symptoms: Discomfort, Erythema, Fatigue, Headache, Injection site erythema
Clinical narrative: Information from the review of scientific literature was received on 19MAR2018. A 22 year-old male experienced autoinoculation, post-vaccination nonviral pustulosis, fever, myalgia, headache and fatigue following immunization with ACAM2000. Nine days after receiving ACAM2000, the male presented with complaints of a pruritic rash on back, shoulders and right thigh; subjective fevers, generalized muscle aches, severe headache and fatigue. The patient reported a recent history of severe sunburn with blistering on back and shoulders just before vaccination; otherwise no significant medical history. Upon exam, his vital signs were within normal limits. He appeared uncomfortable with several 2-3 cm umbilicated pustules and surrounding erythema on his back and shoulders. He had several erythematous non-umbilicated 1 mm perifollicular papules on his right thigh. His inoculation site had become a 1.5 cm circular pustule with a central fissure weeping purulent material and a large area of surrounding erythema and induration. Real-time polymerase chain reaction (PCR) assays from two vesicular lesions detected orthopox DNA. Further analysis confirmed vaccinia in both specimens. Generalized vaccinia was considered due to the presence of systemic symptoms which suggested viremia. However the systemic symptoms could also be explained by post-vaccination immune response or the hematogenous spread of vaccinia. The author suggested that a strong argument could be made for autoinoculation versus generalized vaccinia due to the recent history of sunburn upon immunization which may have created the tendency to scratch pruritic areas with contaminated fingers causing the transfer of vaccinia to skin with poor epithelial barriers due to the sun damage. The case met criteria for confirmed inadvertent autoinoculation per CDC case definitions, but did not meet criteria for generalized vaccinia. Separately, the outbreak of small perifollicular papules and pustules on his thigh were most consistent with non-viral pustulosis. The patient was closely monitored and treated with symptomatic medications over the next 10 days; his fatigue, muscle aches, and headache resolved and his rash scabbed over and dissipated. Sender's Comments: This report was retrieved from a literature article describing a 22 year old male who experienced autoinoculation and pustulosis following sunburn and vaccination with ACAM2000.
Age: 22.0
Sex: M
Vaccine: SMALL
Symptoms: Injection site induration, Injection site pustule, Injection site rash, Injection site reaction, Myalgia
Clinical narrative: Information from the review of scientific literature was received on 19MAR2018. A 22 year-old male experienced autoinoculation, post-vaccination nonviral pustulosis, fever, myalgia, headache and fatigue following immunization with ACAM2000. Nine days after receiving ACAM2000, the male presented with complaints of a pruritic rash on back, shoulders and right thigh; subjective fevers, generalized muscle aches, severe headache and fatigue. The patient reported a recent history of severe sunburn with blistering on back and shoulders just before vaccination; otherwise no significant medical history. Upon exam, his vital signs were within normal limits. He appeared uncomfortable with several 2-3 cm umbilicated pustules and surrounding erythema on his back and shoulders. He had several erythematous non-umbilicated 1 mm perifollicular papules on his right thigh. His inoculation site had become a 1.5 cm circular pustule with a central fissure weeping purulent material and a large area of surrounding erythema and induration. Real-time polymerase chain reaction (PCR) assays from two vesicular lesions detected orthopox DNA. Further analysis confirmed vaccinia in both specimens. Generalized vaccinia was considered due to the presence of systemic symptoms which suggested viremia. However the systemic symptoms could also be explained by post-vaccination immune response or the hematogenous spread of vaccinia. The author suggested that a strong argument could be made for autoinoculation versus generalized vaccinia due to the recent history of sunburn upon immunization which may have created the tendency to scratch pruritic areas with contaminated fingers causing the transfer of vaccinia to skin with poor epithelial barriers due to the sun damage. The case met criteria for confirmed inadvertent autoinoculation per CDC case definitions, but did not meet criteria for generalized vaccinia. Separately, the outbreak of small perifollicular papules and pustules on his thigh were most consistent with non-viral pustulosis. The patient was closely monitored and treated with symptomatic medications over the next 10 days; his fatigue, muscle aches, and headache resolved and his rash scabbed over and dissipated. Sender's Comments: This report was retrieved from a literature article describing a 22 year old male who experienced autoinoculation and pustulosis following sunburn and vaccination with ACAM2000.
Age: 22.0
Sex: M
Vaccine: SMALL
Symptoms: Orthopoxvirus test positive, Papule, Polymerase chain reaction positive, Post vaccination autoinoculation, Purulent discharge
Clinical narrative: Information from the review of scientific literature was received on 19MAR2018. A 22 year-old male experienced autoinoculation, post-vaccination nonviral pustulosis, fever, myalgia, headache and fatigue following immunization with ACAM2000. Nine days after receiving ACAM2000, the male presented with complaints of a pruritic rash on back, shoulders and right thigh; subjective fevers, generalized muscle aches, severe headache and fatigue. The patient reported a recent history of severe sunburn with blistering on back and shoulders just before vaccination; otherwise no significant medical history. Upon exam, his vital signs were within normal limits. He appeared uncomfortable with several 2-3 cm umbilicated pustules and surrounding erythema on his back and shoulders. He had several erythematous non-umbilicated 1 mm perifollicular papules on his right thigh. His inoculation site had become a 1.5 cm circular pustule with a central fissure weeping purulent material and a large area of surrounding erythema and induration. Real-time polymerase chain reaction (PCR) assays from two vesicular lesions detected orthopox DNA. Further analysis confirmed vaccinia in both specimens. Generalized vaccinia was considered due to the presence of systemic symptoms which suggested viremia. However the systemic symptoms could also be explained by post-vaccination immune response or the hematogenous spread of vaccinia. The author suggested that a strong argument could be made for autoinoculation versus generalized vaccinia due to the recent history of sunburn upon immunization which may have created the tendency to scratch pruritic areas with contaminated fingers causing the transfer of vaccinia to skin with poor epithelial barriers due to the sun damage. The case met criteria for confirmed inadvertent autoinoculation per CDC case definitions, but did not meet criteria for generalized vaccinia. Separately, the outbreak of small perifollicular papules and pustules on his thigh were most consistent with non-viral pustulosis. The patient was closely monitored and treated with symptomatic medications over the next 10 days; his fatigue, muscle aches, and headache resolved and his rash scabbed over and dissipated. Sender's Comments: This report was retrieved from a literature article describing a 22 year old male who experienced autoinoculation and pustulosis following sunburn and vaccination with ACAM2000.
Age: 22.0
Sex: M
Vaccine: SMALL
Symptoms: Pyrexia, Rash, Rash pruritic, Rash pustular, Rash vesicular
Clinical narrative: Information from the review of scientific literature was received on 19MAR2018. A 22 year-old male experienced autoinoculation, post-vaccination nonviral pustulosis, fever, myalgia, headache and fatigue following immunization with ACAM2000. Nine days after receiving ACAM2000, the male presented with complaints of a pruritic rash on back, shoulders and right thigh; subjective fevers, generalized muscle aches, severe headache and fatigue. The patient reported a recent history of severe sunburn with blistering on back and shoulders just before vaccination; otherwise no significant medical history. Upon exam, his vital signs were within normal limits. He appeared uncomfortable with several 2-3 cm umbilicated pustules and surrounding erythema on his back and shoulders. He had several erythematous non-umbilicated 1 mm perifollicular papules on his right thigh. His inoculation site had become a 1.5 cm circular pustule with a central fissure weeping purulent material and a large area of surrounding erythema and induration. Real-time polymerase chain reaction (PCR) assays from two vesicular lesions detected orthopox DNA. Further analysis confirmed vaccinia in both specimens. Generalized vaccinia was considered due to the presence of systemic symptoms which suggested viremia. However the systemic symptoms could also be explained by post-vaccination immune response or the hematogenous spread of vaccinia. The author suggested that a strong argument could be made for autoinoculation versus generalized vaccinia due to the recent history of sunburn upon immunization which may have created the tendency to scratch pruritic areas with contaminated fingers causing the transfer of vaccinia to skin with poor epithelial barriers due to the sun damage. The case met criteria for confirmed inadvertent autoinoculation per CDC case definitions, but did not meet criteria for generalized vaccinia. Separately, the outbreak of small perifollicular papules and pustules on his thigh were most consistent with non-viral pustulosis. The patient was closely monitored and treated with symptomatic medications over the next 10 days; his fatigue, muscle aches, and headache resolved and his rash scabbed over and dissipated. Sender's Comments: This report was retrieved from a literature article describing a 22 year old male who experienced autoinoculation and pustulosis following sunburn and vaccination with ACAM2000.
Age: 22.0
Sex: M
Vaccine: SMALL
Symptoms: Skin fissures, Viraemia
Clinical narrative: Information from the review of scientific literature was received on 19MAR2018. A 22 year-old male experienced autoinoculation, post-vaccination nonviral pustulosis, fever, myalgia, headache and fatigue following immunization with ACAM2000. Nine days after receiving ACAM2000, the male presented with complaints of a pruritic rash on back, shoulders and right thigh; subjective fevers, generalized muscle aches, severe headache and fatigue. The patient reported a recent history of severe sunburn with blistering on back and shoulders just before vaccination; otherwise no significant medical history. Upon exam, his vital signs were within normal limits. He appeared uncomfortable with several 2-3 cm umbilicated pustules and surrounding erythema on his back and shoulders. He had several erythematous non-umbilicated 1 mm perifollicular papules on his right thigh. His inoculation site had become a 1.5 cm circular pustule with a central fissure weeping purulent material and a large area of surrounding erythema and induration. Real-time polymerase chain reaction (PCR) assays from two vesicular lesions detected orthopox DNA. Further analysis confirmed vaccinia in both specimens. Generalized vaccinia was considered due to the presence of systemic symptoms which suggested viremia. However the systemic symptoms could also be explained by post-vaccination immune response or the hematogenous spread of vaccinia. The author suggested that a strong argument could be made for autoinoculation versus generalized vaccinia due to the recent history of sunburn upon immunization which may have created the tendency to scratch pruritic areas with contaminated fingers causing the transfer of vaccinia to skin with poor epithelial barriers due to the sun damage. The case met criteria for confirmed inadvertent autoinoculation per CDC case definitions, but did not meet criteria for generalized vaccinia. Separately, the outbreak of small perifollicular papules and pustules on his thigh were most consistent with non-viral pustulosis. The patient was closely monitored and treated with symptomatic medications over the next 10 days; his fatigue, muscle aches, and headache resolved and his rash scabbed over and dissipated. Sender's Comments: This report was retrieved from a literature article describing a 22 year old male who experienced autoinoculation and pustulosis following sunburn and vaccination with ACAM2000.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Induration, Rash erythematous
Clinical narrative: LOCALIZED INDURATION 3X6 CM, RED SKIN RASH, TENDERNESS-STARTED WITHIN 24 HOURS, NO SYSTEMIC REACTION.
Age: 0.58
Sex: F
Vaccine: FLU4, HEP
Symptoms: Erythema, Injection site erythema, Injection site swelling, Injection site warmth, Skin warm
Clinical narrative: Starting about 24 hours after receiving her vaccines, patient's left thigh, at the injection site, was swollen, red in color and hot to the touch. Over the next 15 hours, these symptoms continued and spread to her other (right) leg, bottom, back, stomach, arms, hands, feet and face. She also had patchy redness and hives periodically for about three days after receiving her vaccines.
Age: 0.58
Sex: F
Vaccine: FLU4, HEP
Symptoms: Swelling, Urticaria
Clinical narrative: Starting about 24 hours after receiving her vaccines, patient's left thigh, at the injection site, was swollen, red in color and hot to the touch. Over the next 15 hours, these symptoms continued and spread to her other (right) leg, bottom, back, stomach, arms, hands, feet and face. She also had patchy redness and hives periodically for about three days after receiving her vaccines.
Age: 71.0
Sex: F
Vaccine: PNC13, PPV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient received the PNEUMOVAX from physician and then came to the pharmacy to receive the PNEUMOVAX, having forgotten she had received it earlier that day. After administration, the duplication was discovered and the physician was contacted. No adverse events have been reported at this time.
Age: 25.0
Sex: F
Vaccine: VARCEL
Symptoms: Pyrexia, Rash, Rash pruritic
Clinical narrative: Fever 100.2, pruritic non-vesicular rash on arms, legs, face and stomach 24 hours after receiving.
Sex: M
Vaccine: HEPA, MMR, PNC13
Symptoms: Pyrexia, Rash erythematous
Clinical narrative: 3/20/2018 Mom called the clinic stating patient had broken out with a red rash and fever of 100 degrees. Symptoms started Sunday, 3/18/18. His MMR had been given 3/06/18. She was advised to keep him home until the rash and fever were gone. She has been treating the fever with TYLENOL which brought it down. A return call was made 3/22/18 9:45 AM. Mom stated the rash was almost gone and patient had been fever free for about 24 hours now. No other problems mentioned.
Sex: F
Vaccine: VARZOS
Symptoms: Facial pain, Herpes zoster, Pain, Trigeminal neuralgia
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. The patient was inoculated with ZOSTAVAX on or about 17-OCT-2014 at a pharmacy 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. Shortly after receiving ZOSTAVAX (onset not further specified), the patient developed an intermittent, sharp throbbing pain on the left side of her face. Thereafter, she was diagnosed with trigeminal neuralgia. 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, pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.