chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.17
Sex: M
Vaccine: DTAP, HEP, HIBV, HPV9, IPV, PPV
Symptoms: Wrong drug administered
Clinical narrative: This spontaneous report as received from the patient's mother referring to her son, a 2 month old male patient. The patient's pertinent medical history, concurrent conditions, and drug reactions/allergies were not reported. Concomitant therapies included diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid, poliovirus vaccine live oral (Opv), poliovirus vaccine inactivated (Ipv), hib conj vaccine (unspecified) (HIB) and Hepatitis B Vaccine (Recombinant) (manufacturer unknown); all given on 10-APR-2017. On 10-APR-2017, the patient was vaccinated with GARDASIL 9, (dose,lot # and expiration date were not reported) intramuscularly for prophylaxis by accident. The physician, mistakenly gave the patient GARDASIL 9 thinking it was the pneumococcal conj vaccine (unspecified) (PCV) instead. It was also reported that the pneumococcal conj vaccine (unspecified) (PCV) was administered on the same date. Additional information has been requested.
Age: 17.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a nurse practitioner via a company representative refers to a 17-year-old male patient. On 08-MAR-2017, the patient was vaccinated with PROQUAD (dose, route of administration, lot # and expiration date were not reported). Other suspect therapies included properly stored sterile diluent (manufacturer unknown) (lot # and expiration date were not reported) used to reconstitute the dose of PROQUAD. On 05-APR-2017, the patient inadvertently received VARIVAX and M-M-R II (dose, route of administration, lot # and expiration date were not reported for both) reconstituted with properly stored sterile diluent (manufacturer unknown) (lot # and expiration date were not reported). No adverse events were reported. Additional information has been requested.
Age: 1.17
Sex: U
Vaccine: PPV
Symptoms: Drug administered to patient of inappropriate age, No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report was received from a nurse and refers to a 14-month-old patient of an unknown gender. The patient's concurrent conditions, medical  history and concomitant medications were not reported. On 11-APR-2017, the patient was inadvertently vaccinated with a dose of PNEUMOVAX 23 lot # M043424, expiration date 06-JUN-2018 (dose, route of administration, frequency were not reported) instead of PREVNAR 13 (PT: interchange of vaccine products, drug administered to patient of inappropriate age and wrong drug administered). There was no adverse event reported. The product quality complaint was not involved. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a phlebotomist and refers to an unspecified patient of unknown age and gender. The patient's pertinent medical history, drug reactions and allergies and concomitant therapy were not reported. The phlebotomist reported that the patient received GARDASIL 9 outside the recommended dosing schedule. On an unspecified date in 2013, the patient received the first dose of GARDASIL 9 (dose, route of administration, lot # and expiration date were not reported). On 05-APR-2015 and 15-JUN-2015, the patient was vaccinated with the second and the third dose of GARDASIL 9 (dose and route of administration were not reported, lot # reported as K009902, expiration date 06-MAR-2017), respectively. No adverse effects were reported. Additional information has been requested.
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a licensed practical nurse and refers to multiple patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On unknown dates. the patients were vaccinated with improperly stored doses of VARIVAX subcutaneously, lot # M028553 and expiration date 07-JUN-2018 (doses and anatomical locations were not reported) for prophylaxis. No adverse effects were reported. The doses of VARIVAX were stored in the temperatures from 15 Fahrenheit degrees (F) to 46 F (23.2 F) for 96 hours (dates were not reported). There were no previous temperature excursions. The digital data logger was not involved. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Needle issue, No adverse event, Underdose
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions, allergies and concomitant medications were not reported. On 06-FEB-2017, the patient was inadvertently vaccinated with a partial dose of ZOSTAVAX vial, subcutaneously, lot # M033336, expiration date 01-OCT-2017 (dose was not provided) which was diluted by sterile diluent (STERILE DILUENT) injection, once, subcutaneously (strength, dose, indication, lot# and expiration date were not reported), due to leakage from the needle connection to the syringe. No adverse effects were reported. Product quality complaint was not involved. Additional information is not expected, as there was no consent to contact the reporter.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a physical therapist refers to 19 patients of unknown age and gender. There was no information about the patients' concomitant medications, allergies and pertinent medical history reported. On an unknown dates, between 23-FEB-2017 and 12-APR-2017, the patients were vaccinated with improperly stored VARIVAX lot # M039318, expiry date 20-SEP-2018 (dose, route of administration and anatomical location were not reported). VARIVAX was reconstituted with properly stored sterile diluent (manufacturer unknown). No adverse events reported. No previous temperature excursion was performed. No data logger was involved. Additional information has been requested.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: Information was received from a medical assistant concerning a patient of unknown age or gender. No information was reported regarding the patient's past medical history, concurrent conditions, or concomitant medication. The medical assistant reported that on 11-APR-2017, the unspecified patient received an expired dose of M-M-R II (recombinant human albumin) (lot #L012482, expiration date 10-APR-2017) (route of administration not provided) and sterile water diluent (unknown lot #, unknown expiration). No adverse effects reported. No further details provided. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a physician assistant, concerning a patient of an unknown age and gender. There were no concurrent conditions, medical history, drug reactions or allergies or concomitant medications reported. On 19-APR-2017, the patient was vaccinated with an expired dose of VARIVAX injection (dose, frequency and route were not reported) lot # L013395 with expiration date of 16-APR-2017, for prophylaxis. No adverse effects were reported. There was no product quality complaint involved. Additional information has been requested.
Sex: F
Vaccine: HPV9
Symptoms: Arthralgia
Clinical narrative: This spontaneous report was received from a registered nurse, concerning a female patient of an unknown age. There were no concurrent conditions, medical history, drug reactions or allergies or concomitant medications reported. On an unspecified date, the patient was vaccinated with the first dose of GARDASIL 9 (dose, frequency, route, lot # and expiration date were not reported) for prophylaxis (reported as "vaccine"). It was unknown whether she experienced side effects from this first dose. On an unspecified date, the patient was vaccinated with the second dose of GARDASIL 9 (dose, frequency, route, lot # and expiration date were not reported) for prophylaxis (reported as "vaccine"). On an unspecified date, the patient experienced joint pain (arthralgia), so she was hospitalized for an unspecified time period and the reporter could not provide any details about treatment specifics during the hospital admission. At the time of the report, the outcome of the arthralgia was unknown. There was no product quality complaint (PQC) involved. The causality between the adverse event and GARDASIL 9 was unknown. Additional information is not expected, as the reporter did not wish further contact.
Sex: U
Vaccine: VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant, concerning a patient of an unknown age and gender. There were no concurrent conditions, medical history, drug reactions or allergies or concomitant medications reported. On unspecified dates in 2004 and 2013, the patient was vaccinated with the first and second doses of VARIVAX injection (dose, frequency, route, lot # and expiration date were not reported), respectively, for prophylaxis. On 10-MAR-2017, the patient was inadvertently vaccinated with a third dose of VARIVAX injection (dose, frequency, route and lot # were not reported) with expiration date of 23-NOV-2017, for prophylaxis. The medical assistant did not know the lot number of any of the diluents (manufacturer unknown) that were used to prepare the doses of VARIVAX. No adverse effect was reported. There was no product quality complaint involved. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Neuralgia, Rash
Clinical narrative: Information has been received on 20-APR-2017 regarding a case in litigation from a lawyer and a female consumer of unknown age. The patient's concurrent conditions, medical history and concomitant medications were not reported. The patient was inoculated with ZOSTAVAX (lot number and expiration not reported) subcutaneous on or about 06-APR-2015, as recommended for routine adult health maintenance for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 16-JUL-2016, the patient was treated by a physician for a painful rash that was diagnosed as a severe case of shingles with nerve pain and neuralgia. Although the shingles virus is an incurable condition and neuralgia is a chronic residual effect of nerve damage cause by shingles, the patient was prescribed acyclovir, sulfadiazine, silver (SILVADENE 1% TOPICAL CREAM), hydrocodone and gabapentin (reported as "Gabapentic") for the management of her symptoms. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Anxiety, Balance disorder, Cervical spinal stenosis, Emotional distress, Guillain-Barre syndrome
Clinical narrative: Information was received on 24-APR-2017 from a lawyer regarding a case in litigation concerning a female of unknown age. On 13-MAR-2015 the patient received a dose of ZOSTAVAX for its intender purpose: the prevention of shingles. On 30-MAR-2015 the patient went to the hospital with complaints of lower extremity pain and symptoms of paresthesias. The patient was admitted to the hospital. A neurological work-up showed cervical spinal stenosis and large posterior disc herniation. Lumbar puncture was performed and the results, along with her symptoms, led to a diagnosis of Guillain-Barre plus Syndrome. The patient's Guillain-Barre plus Syndrome was caused by the ZOSTAVAX vaccine. The patient was hospitalized until 09-APR-2015. The patient subsequently went to a rehabilitation hospital for approximately two weeks and underwent outpatient rehabilitation. The patient suffered nerve damage and continues to suffer from loss of balance and leg pain. As a direct and proximate result of the defective ZOSTAVAX vaccine, the patient continues to experience ongoing symptoms, including imbalance and leg pain. The patient's symptoms have resulted in physical limitations not present prior to using the vaccine. The patient also experiences mental and emotional distress due to resulting physical limitations and seriousness of her condition. As a result of manufacture, marketing, advertising, promotion, distribution and/or sale of ZOSTAVAX, the patient suffered severe and permanent injures. Further, as a tragic consequence, 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 has incurred and will continue to occur medical expenses and other economic harm as a direct result of use of ZOSTAVAX. As a direct and proximate consequence of negligence, the patient sustained serious personal injuries and related losses including but not limited to the following: The patient required and will continue to require healthcare and services; the patient incurred and will continue to incur medical and related expense; and the patient has suffered, and will continue to suffer mental anguish, physical pain and suffering, diminished capacity for the enjoyment of life, a diminished quality of life and other losses and damages. Upon internal review, Guillain-Barre syndrome and cervical spinal stenosis were considered medically significant. Guillain-Barre syndrome was considered disabling. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injury, Intervertebral disc protrusion, Lumbar puncture abnormal, Nerve injury, Neurological examination abnormal
Clinical narrative: Information was received on 24-APR-2017 from a lawyer regarding a case in litigation concerning a female of unknown age. On 13-MAR-2015 the patient received a dose of ZOSTAVAX for its intender purpose: the prevention of shingles. On 30-MAR-2015 the patient went to the hospital with complaints of lower extremity pain and symptoms of paresthesias. The patient was admitted to the hospital. A neurological work-up showed cervical spinal stenosis and large posterior disc herniation. Lumbar puncture was performed and the results, along with her symptoms, led to a diagnosis of Guillain-Barre plus Syndrome. The patient's Guillain-Barre plus Syndrome was caused by the ZOSTAVAX vaccine. The patient was hospitalized until 09-APR-2015. The patient subsequently went to a rehabilitation hospital for approximately two weeks and underwent outpatient rehabilitation. The patient suffered nerve damage and continues to suffer from loss of balance and leg pain. As a direct and proximate result of the defective ZOSTAVAX vaccine, the patient continues to experience ongoing symptoms, including imbalance and leg pain. The patient's symptoms have resulted in physical limitations not present prior to using the vaccine. The patient also experiences mental and emotional distress due to resulting physical limitations and seriousness of her condition. As a result of manufacture, marketing, advertising, promotion, distribution and/or sale of ZOSTAVAX, the patient suffered severe and permanent injures. Further, as a tragic consequence, 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 has incurred and will continue to occur medical expenses and other economic harm as a direct result of use of ZOSTAVAX. As a direct and proximate consequence of negligence, the patient sustained serious personal injuries and related losses including but not limited to the following: The patient required and will continue to require healthcare and services; the patient incurred and will continue to incur medical and related expense; and the patient has suffered, and will continue to suffer mental anguish, physical pain and suffering, diminished capacity for the enjoyment of life, a diminished quality of life and other losses and damages. Upon internal review, Guillain-Barre syndrome and cervical spinal stenosis were considered medically significant. Guillain-Barre syndrome was considered disabling. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, Paraesthesia, Physical disability, Quality of life decreased
Clinical narrative: Information was received on 24-APR-2017 from a lawyer regarding a case in litigation concerning a female of unknown age. On 13-MAR-2015 the patient received a dose of ZOSTAVAX for its intender purpose: the prevention of shingles. On 30-MAR-2015 the patient went to the hospital with complaints of lower extremity pain and symptoms of paresthesias. The patient was admitted to the hospital. A neurological work-up showed cervical spinal stenosis and large posterior disc herniation. Lumbar puncture was performed and the results, along with her symptoms, led to a diagnosis of Guillain-Barre plus Syndrome. The patient's Guillain-Barre plus Syndrome was caused by the ZOSTAVAX vaccine. The patient was hospitalized until 09-APR-2015. The patient subsequently went to a rehabilitation hospital for approximately two weeks and underwent outpatient rehabilitation. The patient suffered nerve damage and continues to suffer from loss of balance and leg pain. As a direct and proximate result of the defective ZOSTAVAX vaccine, the patient continues to experience ongoing symptoms, including imbalance and leg pain. The patient's symptoms have resulted in physical limitations not present prior to using the vaccine. The patient also experiences mental and emotional distress due to resulting physical limitations and seriousness of her condition. As a result of manufacture, marketing, advertising, promotion, distribution and/or sale of ZOSTAVAX, the patient suffered severe and permanent injures. Further, as a tragic consequence, 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 has incurred and will continue to occur medical expenses and other economic harm as a direct result of use of ZOSTAVAX. As a direct and proximate consequence of negligence, the patient sustained serious personal injuries and related losses including but not limited to the following: The patient required and will continue to require healthcare and services; the patient incurred and will continue to incur medical and related expense; and the patient has suffered, and will continue to suffer mental anguish, physical pain and suffering, diminished capacity for the enjoyment of life, a diminished quality of life and other losses and damages. Upon internal review, Guillain-Barre syndrome and cervical spinal stenosis were considered medically significant. Guillain-Barre syndrome was considered disabling. Additional information has been requested.
Sex: U
Vaccine: PPV, VARZOS
Symptoms: No adverse event, Vaccination error
Clinical narrative: This spontaneous report was received from a pharmacist concerning a patient of an unknown age and gender. The patient's concurrent conditions, medical history, historical drugs and concomitant therapies were not reported. On 24-APR-2017, the patient was vaccinated with ZOSTAVAX 19400 pfu, subcutaneosly, lot number M037013, expiration date 22-NOV-2017 (dose and anatomical location were not reported) for prophylaxis, and with PNEUMOVAX 23 lot number M032635, expiration date 05-MAY-2018 (dose, route and anatomical location were not reported) for prophylaxis. The patient's concomitant medication included sterile diluent (STERILE DILUENT), lot number reported as M013218 and expiration date 08-NOV-2018. No adverse effects were reported. Additional information has been requested.
Age: 49.0
Sex: M
Vaccine: MMR
Symptoms: Parotid gland enlargement
Clinical narrative: RIGHT PAROTID SWELLING.
Age: 13.0
Sex: F
Vaccine: HPV9
Symptoms: Crying, Feeling abnormal, Mobility decreased, Pain in extremity, Slow response to stimuli
Clinical narrative: A FEW MINUTES AFTER RECIEVING HPV VACCINE, PATIENT CRYING C/O SEVERE LT ARM PAIN AND STATING SHE COULDN'T MOVE IT. IMMEDIATELY AFTER RECEIVING TYLENOL, PATIENT BECAME DAZED AND WAS RESPONDING VERY SLOW.
Age: 0.17
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5, DTAPIPVHIB, PNC13, RV5
Symptoms: Abdominal distension, Enema administration, Intussusception, Urinary system X-ray, X-ray abnormal
Clinical narrative: 1 week after ROTATEQ #1 given (4/17/17) patient with intussusception (4/24/17).
Age: 0.17
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5, DTAPIPVHIB, PNC13, RV5
Symptoms: Abdominal X-ray, Haematochezia, Intestinal obstruction, Intussusception, Irritability
Clinical narrative: 1 week after ROTATEQ #1 given (4/17/17) patient with intussusception (4/24/17).
Age: 0.17
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5, DTAPIPVHIB, PNC13, RV5
Symptoms: Vomiting, X-ray abnormal
Clinical narrative: 1 week after ROTATEQ #1 given (4/17/17) patient with intussusception (4/24/17).
Age: 78.0
Sex: M
Vaccine: PPV
Symptoms: Rash
Clinical narrative: Patient had rash down left arm. Treated with IM dexamethasone at urgent care facility. Patient speaks little English and would not wait for translation, could not verify any other information.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Injury, Musculoskeletal discomfort, Musculoskeletal pain, Pain in extremity, Ultrasound scan
Clinical narrative: Gradually developed Left arm and shoulder pain, which progressively became very severe, leading to a trip to the emergency room for evaluation and pain medication. At this juncture, a subscapular injury exists, which is requiring rehabilitation due to persistent shoulder discomfort and arm aching.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Erythema, Feeling hot, Swelling
Clinical narrative: Redness, warmth swelling, diagnosed with cellulitis.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Pain in extremity, Peripheral swelling, Skin warm
Clinical narrative: Arm became painful, swollen and hot to the touch.
Age: 63.0
Sex: F
Vaccine: RUB, TDAP
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Redness on and around injection site. Sever arm swelling around injection site.
Age: 63.0
Sex: F
Vaccine: RUB, TDAP
Symptoms: Cellulitis, Erythema, Pain in extremity
Clinical narrative: Redness on and around injection site. Sever arm swelling around injection site.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pain, Skin warm
Clinical narrative: Pt called pharmacy 4/25/2017 stating that she had pain and redness "a little larger than a 50 cent piece".  She also complained it was hot to the touch.  She also stated that is was improving a lot today.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Anaphylactic reaction, Autopsy, Sudden infant death syndrome
Clinical narrative: SIDS.
Age: 1.42
Sex: M
Vaccine: DTAPHEPBIP, PNC13
Symptoms: Erythema, Hypersensitivity, Lip swelling, Ocular hyperaemia, Rash
Clinical narrative: Pt presented to ED carried by mom, states pt had an immunization 1 hour PTA and now she noted a rash and spots around his mouth and lips, mom reports lip and face swelling as well. Respirations are regular, non labored. Provider notes from ER record are as follows: "Patient is a 17 month old male presenting today with mom who reports patient began with facial and lip swelling after receiving his hepatitis B, pneumococcal, D-tap and Polio vaccinations around 9:20 AM today. Mom states patient is behind on his immunizations for his age, reporting shortly after receiving his vaccinations today, patient started with a rash on his face. She denies patient having known allergies or similar reactions in the past. She denies patient having any vomiting, diarrhea or appearing SOB. Patient is reported otherwise healthy without medical problems." Pt was given the medications prednisolone sod- phos 15 mg/5 mL oral solution 13.5 mg and diphenhydramine 12.5 mg/5 mL liquid 6.25 mg once at approximately 10:32 AM and 10:33 AM. Pt was kept in the ER and at 10:54 AM nurse noted a few more spots on arms and redness right face and eye. At 11:25 AM nurse notes "Improved rash. Redness right eye. Child is resting. Do not have a time that patient left the ER. On 4/24/17 at 2:50 PM, mom called the provider office to notify that patient had a severe allergic reaction 30 minutes after leaving office.
Age: 1.42
Sex: M
Vaccine: DTAPHEPBIP, PNC13
Symptoms: Swelling face
Clinical narrative: Pt presented to ED carried by mom, states pt had an immunization 1 hour PTA and now she noted a rash and spots around his mouth and lips, mom reports lip and face swelling as well. Respirations are regular, non labored. Provider notes from ER record are as follows: "Patient is a 17 month old male presenting today with mom who reports patient began with facial and lip swelling after receiving his hepatitis B, pneumococcal, D-tap and Polio vaccinations around 9:20 AM today. Mom states patient is behind on his immunizations for his age, reporting shortly after receiving his vaccinations today, patient started with a rash on his face. She denies patient having known allergies or similar reactions in the past. She denies patient having any vomiting, diarrhea or appearing SOB. Patient is reported otherwise healthy without medical problems." Pt was given the medications prednisolone sod- phos 15 mg/5 mL oral solution 13.5 mg and diphenhydramine 12.5 mg/5 mL liquid 6.25 mg once at approximately 10:32 AM and 10:33 AM. Pt was kept in the ER and at 10:54 AM nurse noted a few more spots on arms and redness right face and eye. At 11:25 AM nurse notes "Improved rash. Redness right eye. Child is resting. Do not have a time that patient left the ER. On 4/24/17 at 2:50 PM, mom called the provider office to notify that patient had a severe allergic reaction 30 minutes after leaving office.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report was received from an administrator and refers to an unspecified number of patients of an unknown age and gender. There was no information about the patients' pertinent medical history, concurrent conditions, concomitant therapies, and drug reactions or allergies. The reporter stated that improperly stored doses of GARDASIL 9 (strength, anatomical location, dose, frequency, route of administration, lot number, and expiration date were not provided), were administered to an unspecified number of patients on an unspecified date, for prophylaxis. The vaccine had multiple unspecified excursions due to a data logger issue. The reporter provided information relevant to the temperature at which the vaccines were maintained, however it was explicitly stated that such vaccines were not administered to any patient. There was no product quality complaint involved. This is one of three reports received from the same source. Additional information is not expected as there was no information and consent to contact the physician.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: Information has been received on 20-APR-2017 regarding a case in litigation from a lawyer and a female consumer of unknown age. The patient's concurrent conditions, medical history and concomitant medications were not reported. The patient was inoculated with ZOSTAVAX (lot number and expiration not reported) subcutaneous on or about 13-NOV-2012 by a physician, as recommended for routine adult health maintenance for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 29-APR-2016, the patient was treated by a physician for a painful rash that was diagnosed as shingles. While shingles is an incurable condition, the patient has been prescribed VALTREX to manage her outbreaks. 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 suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash, Viral test positive
Clinical narrative: Information has been received on 20-APR-2017 regarding a case in litigation from a lawyer and a female consumer of unknown age. The patient's concurrent conditions, medical history and concomitant medications were not reported. The patient was inoculated with ZOSTAVAX (lot number and expiration not reported) subcutaneous on or about 21-OCT-2013, as recommended for routine adult health maintenance for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 20-SEP-2014, the patient was treated for an ongoing painful rash which was diagnosed by a physician as the shingles. On or about 16-SEP-2014, the patient was swabbed for a culture that came back positive as a zoster culture, confirming that the patient has a strain of shingles that was classified as "abnormal" based on the culture results. Although shingles is an incurable viral condition, the patient was prescribed oxycodone for management of her painful symptoms. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report was received from an administrator and refers to an unspecified number of patients of an unknown age and gender. There was no information about the patients' pertinent medical history, concurrent conditions, concomitant therapies, and drug reactions or allergies. The reporter stated that improperly stored doses of RECOMBIVAX HB (strength, anatomical location, dose, frequency, route of administration, lot number, and expiration date were not provided), were administered to an unspecified number of patients on an unspecified date, for prophylaxis. The vaccine had multiple unspecified excursions due to a data logger issue. The reporter provided information relevant to the temperature at which the vaccines were maintained, however it was explicitly stated that such vaccines were not administered to any patient. There was no product quality complaint involved. This is one of three reports received from the same source. Additional information is not expected as there was no information and consent to contact the physician.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report was received from an administrator and refers to an unspecified number of patients of an unknown age and gender. There was no information about the patients' pertinent medical history, concurrent conditions, concomitant therapies, and drug reactions or allergies. The reporter stated that improperly stored doses of M-M-R II (strength, anatomical location, dose, frequency, route of administration, lot number, and expiration date were not provided), were administered to an unspecified number of patients on an unspecified date, for prophylaxis. The vaccine had multiple unspecified excursions due to a data logger issue. The reporter provided information relevant to the temperature at which the vaccines were maintained, however it was explicitly stated that such vaccines were not administered to any patient. There was no product quality complaint involved. This is one of three reports received from the same source. Additional information is not expected as there was no information and consent to contact the physician.
Age: 80.0
Sex: F
Vaccine: FLU4, PNC13
Symptoms: Fall, Guillain-Barre syndrome, Hypoaesthesia, Immunoglobulin therapy, Muscular weakness
Clinical narrative: 2wks after vaccine started with weakness and pain to bilateral lower extremities and numbness to hands and feet. on 1/11/17 reported increased falls, increased numbness and weakness to extremities. 1/17/17 was seen in ER and diagnosed with Guillain Barre Syndrome then transferred to hospital were treated with Gammaglobulin q6hrs then discharged home 1/24/17 with home PT/OT.
Age: 80.0
Sex: F
Vaccine: FLU4, PNC13
Symptoms: Pain in extremity
Clinical narrative: 2wks after vaccine started with weakness and pain to bilateral lower extremities and numbness to hands and feet. on 1/11/17 reported increased falls, increased numbness and weakness to extremities. 1/17/17 was seen in ER and diagnosed with Guillain Barre Syndrome then transferred to hospital were treated with Gammaglobulin q6hrs then discharged home 1/24/17 with home PT/OT.
Age: 0.5
Sex: M
Vaccine: DTAPIPVHIB, HEP, RV5
Symptoms: Expired product administered
Clinical narrative: Patient was given a expired dose (4-6-17) of Rotavirus vaccine. Patient is scheduled to return one month to repeat dose.
Age: 60.0
Sex: M
Vaccine: PPV, VARZOS
Symptoms: Diarrhoea, Ear pain, Fatigue, Hyperhidrosis, Pain of skin
Clinical narrative: Swelling of face, decreased vision, fatigue, diaphoresis, diarrhea, vomiting, bilateral ear pain and tenderness, scalp tenderness. Optometrist diagnosed increased retinal leakage.
Age: 60.0
Sex: M
Vaccine: PPV, VARZOS
Symptoms: Retinal disorder, Swelling face, Tenderness, Visual impairment, Vomiting
Clinical narrative: Swelling of face, decreased vision, fatigue, diaphoresis, diarrhea, vomiting, bilateral ear pain and tenderness, scalp tenderness. Optometrist diagnosed increased retinal leakage.
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Computerised tomogram head normal, Craniocerebral injury, Eye movement disorder, Immediate post-injection reaction, Loss of consciousness
Clinical narrative: Called to the treatment room after patient was witnessed to have her eyes roll back in her head and lose consciousness immediately after receiving her immunizations today (first doses of HPV9/GARDASIL, Meningococcal/MCV4/MENACTRA, and Tdap). On arrival to the room patient was noted to be unresponsive in a lateral recumbent position with her eyes open, and was noted to have a tonic posture with blinking and lip smacking. She appeared to have lost bladder control. After approximately 30 seconds she was spontaneously responsive to voice and was oriented to person, place, and time with fluent speech. On questioning patient and her mother indicated she was in her usual state of health today, but patient admitted to not eating any breakfast today. Patient's mother denies recent illness, prior adverse reaction to vaccines (although she stated patient is very "scared of needles"), prior episodes of fainting, and chest pain/palpitations. No rhinoconjunctival, cutaneous, pulmonary, or GI symptoms. Patient's mother reports a recent closed head injury in January of this year associated with a loss of consciousness (CT head obtained in the ER at that time was negative).
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Tardive dyskinesia, Tonic posturing, Urinary incontinence
Clinical narrative: Called to the treatment room after patient was witnessed to have her eyes roll back in her head and lose consciousness immediately after receiving her immunizations today (first doses of HPV9/GARDASIL, Meningococcal/MCV4/MENACTRA, and Tdap). On arrival to the room patient was noted to be unresponsive in a lateral recumbent position with her eyes open, and was noted to have a tonic posture with blinking and lip smacking. She appeared to have lost bladder control. After approximately 30 seconds she was spontaneously responsive to voice and was oriented to person, place, and time with fluent speech. On questioning patient and her mother indicated she was in her usual state of health today, but patient admitted to not eating any breakfast today. Patient's mother denies recent illness, prior adverse reaction to vaccines (although she stated patient is very "scared of needles"), prior episodes of fainting, and chest pain/palpitations. No rhinoconjunctival, cutaneous, pulmonary, or GI symptoms. Patient's mother reports a recent closed head injury in January of this year associated with a loss of consciousness (CT head obtained in the ER at that time was negative).
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a pharmacist, via a company representative, concerning a female patient of an unknown age. The patient's concomitant medications included donepezil (ARICEPT). Her medical history, concurrent conditions and drug reactions/allergies were not provided. On an unknown date, the patient was vaccinated with ZOSTAVAX (dose, strength, frequency, route of administration, anatomical location, lot # and expiration date were not provided), for prophylaxis. On an unknown date, the patient experienced shingles (herpes zoster). The patient reported this reaction to the pharmacist on 30-MAR-2017. It was unknown if a treatment was given for the adverse event and if a laboratory diagnostics studies were performed. No product quality complaint was involved. The patient's outcome and the causality assessment between ZOSTAVAX and herpes zoster were unknown. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: Information was received from a physician regarding an unspecified patient (unknown age and gender). No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The physician reported that an expired dose of PNEUMOVAX 23 (lot # L018503, expiration date 16-MAR-2017) was administered to the unspecified patient on 07-APR-2017 (dosage and route of administration not provided). No temperature excursion was reported. No adverse effects reported. No further information to report. Additional information has been requested.
Age: 68.0
Sex: U
Vaccine: HEP
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On 03-JUN-2015, the patient received their first dose of RECOMBIVAX HB (concentration, dose and lot#, expiration date were not provided), for prophylaxis. Then, on 08-JAN-2016, the patient received their second dose of RECOMBIVAX HB (concentration, dose and lot#, expiration date were not provided), for prophylaxis and on 23-FEB-2016, the patient received their third dose of RECOMBIVAX HB (concentration, dose and lot#, expiration date were not provided), for prophylaxis, instead of the recommended schedule (0-, 1-, and 6-month schedule). No adverse effect reported. Additional information has been requested.
Age: 0.42
Sex: F
Vaccine: DTAPIPVHIB, PPV
Symptoms: Interchange of vaccine products, No adverse event
Clinical narrative: Information was received on 14-APR-2017 via a licensed practical nurse regarding a 5 month old baby. Medical history, concurrent conditions and concomitant medications were not reported. On 14-APR-2017 the nurse inadvertently administered a dose of PNEUMOVAX 23 (lot # M026317, expiration date 11-JAN-2018), (dose not provided) instead of an intended dose of PREVNAR 13. The nurse reported this occurred because she looked at the patient's chart and saw the patient was due for "PCV", which she knew meant PREVNAR 13; however, she inadvertently selected and administered PNEUMOVAX 23 in error. No adverse effects were reported. No additional information was provided. The nurse did not rate the causal relationship. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: Information has been received on 19-APR-2017 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 were not reported. The patient was inoculated with ZOSTAVAX (lot number and expiration not reported) subcutaneous on or about 16-DEC-2015, as recommended for routine adult health maintenance for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 21-JAN-2011, the patient was treated by a physician for a painful rash that was diagnosed as shingles. While shingles is an incurable condition, the patient has been prescribed acyclovir to manage his symptoms. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering and other damages. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: Information has been received on 20-APR-2017 regarding a case in litigation from a lawyer and a consumer of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not reported. The patient was inoculated with ZOSTAVAX (lot number and expiration not reported) subcutaneous on or about 07-AUG-2013, as recommended for routine adult health maintenance for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 26-AUG-2013, the patient was treated for a painful rash that was diagnosed as shingles. Although shingles is an incurable viral condition, the patient was prescribed valacyclovir hydrochloride (VALTREX) and pregabalin (LYRICA) to manage her symptoms. 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. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Measles, Vaccination failure
Clinical narrative: This spontaneous report was received from a registered nurse via a company representative referring to a 11 year old patient of unknown gender. The patient's concurrent conditions, medical history or concomitant medication were not reported. On an unspecified date in 2008 or 2009, the patient was vaccinated with an unspecified dose of M-M-R II (strength, dose, route of administration, lot number and expiration date were not reported) as routine vaccination (prophylaxis). On an unspecified date, the patient developed measles even though he/she had received the vaccine in the past. The registered nurse called back with additional information regarding to the lot number of second dose of the M-M-R II series of vaccination related to the adverse event. At the time of reporting the outcome for the event measles and vaccination failure was not reported.  Upon internal review measles was considered to be a medically significant event. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from an office manager, concerning a multiple unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions, drug allergies or concomitant therapies were not reported. On unknown dates in 2017 (reported as "on or after 09-MAR-2017"), patients were vaccinated with improperly stored doses of ROTATEQ oral liquid (strength and dose were not reported) lot number: M019707, expiration date: 25-OCT-2017, orally for prophylaxis. According to the reporter, ROTATEQ dose were exposed to the following temperature excursions: 3 1 hour and 30 minutes at 31 degrees Fahrenheit (F) or below (30.2F); and 24 hours and 10 minutes between 32F to 35F. No previous temperature excursions were reported. No adverse effects were reported. A digital data logger was involved. This is one of two reports from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1704USA012789:
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from an office manager, concerning a multiple unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions, drug allergies or concomitant therapies were not reported. On unknown dates in 2017 (reported as "on or after 09-MAR-2017"), patients were vaccinated with improperly stored doses of GARDASIL 9 injection (strength, dose, anatomical location and route were not reported) lot number: M031557, expiration date: 07-APR-2019, for prophylaxis. According to the reporter, GARDASIL 9 doses were exposed to the following temperature excursions: 1 hour and 30 minutes at 31 degrees Fahrenheit (F) or below (30.2F); and 24 hours and 10 minutes between 32F to 35F. No previous temperature excursions were reported. No adverse effects were reported. A digital data logger was involved. This is one of two reports from the same reporter. Additional information has been requested.; Sender's Comments:  US-009507513-1704USA012729:
Age: 4.0
Sex: F
Vaccine: DTAP
Symptoms: Dyskinesia, Tic
Clinical narrative: My daughter started to develop severe spastic tic like movements of her arms, face and shoulders after receiving the DTaP shot. This worsened over a few months and made it hard to her to eat and perform simple tasks and slowly started getting better around December. The tics and spastic movements have now resolved.
Age: 0.58
Sex: M
Vaccine: DTAPHEPBIP, FLU4, HIBV, PNC13
Symptoms: Cough, Pyrexia, Rhinorrhoea, Upper respiratory tract infection
Clinical narrative: URI symptoms of cough and runny nose.  TMax: 104 relieved with Tylenol 2.5 milliliters. Fever returns in 4-5 hours.
Age: 55.0
Sex: F
Vaccine: TDAP
Symptoms: Discomfort, Mobility decreased, Musculoskeletal pain, Pain in extremity
Clinical narrative: Extreme soreness in arm and shoulder. Extreme difficulty in movement of arm  e.g. when dressing/undressing. Strong pain and discomfort when sleeping. Pain peaked a few days after vaccination. Slowly subsiding; however still quite relevant after 12 days, and some rotational movement of arms are not feasible yet. Treated with painkiller.
Age: 15.0
Sex: F
Vaccine: HPV9
Symptoms: Menstruation delayed
Clinical narrative: Has not has a period since she had her 3rd HPV GARDASIL shot.
Age: 18.0
Sex: F
Vaccine: MNQ, MNQ
Symptoms: Injection site swelling
Clinical narrative: Swelling of upper left arm below injection site.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, VARZOS
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: No adverse event by patient. Reporting that Zoster was inadvertently given instead of Varicella. Patient had not had any Varicella before.
Age: 18.0
Sex: F
Vaccine: HEPA, MENB
Symptoms: Confusional state, Headache, Lumbar puncture, Neck pain, Pain
Clinical narrative: Headaches and body aches since the day of 4/14/17, started with fever, neck pain and confusion 04/17/2017.
Age: 18.0
Sex: F
Vaccine: HEPA, MENB
Symptoms: Pyrexia
Clinical narrative: Headaches and body aches since the day of 4/14/17, started with fever, neck pain and confusion 04/17/2017.