chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: HEPA
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a nurse and refers to a pediatric patient of unknown age and gender. The patient's concomitant medications, pertinent medical history and drug reactions or allergies were not reported. On 23-NOV-2016, the patient was vaccinated with the first dose of VAQTA injection, lot # reported as M022526 with expiation date 26-MAY-2017 (exact dose and route of administration were not reported). Subsequently, on 24-APR-2017, the patient received a booster dose of VAQTA injection, lot # M047658 with expiration date 28-OCT-2017 (exact dose and route of administration were not reported). No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Extra dose administered, No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On an unknown date, the patient was inadvertently vaccinated with the fourth dose of RECOMBIVAX HB 5/0.5 microgram/milliliter (dose and route of administration were unknown) with lot number reported as M045653 and expiration date of 03-JUL-2019 for prophylaxis instead of a dose of VAQTA (strength, dose, route of administration, lot number and expiration date were unknown) for the same indication. No adverse effects were reported. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Post herpetic neuralgia, Rash
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was provided regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient was inoculated with ZOSTAVAX vaccine (lot number, dosage, and route of administration not provided) on or about 18-APR-2012 by a physician as recommended for routine adult health maintenance for the prevention of shingles. It is alleged that the vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 14-AUG-2014, the patient was treated for a painful rash that was diagnosed as shingles. The patient was prescribed valacyclovir and gabapentin to manage his symptoms. On or about 26-AUG-2014, the patient was diagnosed with post herpetic neuralgia and was prescribed "tryptylline," gabapentin, and capsaicin cream to manage his symptoms. On or about 02-SEP-2014, the patient was again diagnosed with post herpetic neuralgia and was prescribed amitriptyline cream 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. The outcome of the shingles is unknown.  Additional information has been requested.
Age: 1.33
Sex: M
Vaccine: HIBV, MMR
Symptoms: Seizure
Clinical narrative: Seizure within 24hrs of receiving MMR and HIB vaccines.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Peripheral swelling, Tenderness
Clinical narrative: Swelling of arm, Redness, tenderness.
Age: 0.17
Sex: F
Vaccine: HEP, IPV, TDAP
Symptoms: Wrong drug administered
Clinical narrative: Wrong vaccine given.
Age: 1.08
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Eczema, Erythema, Rash
Clinical narrative: Eczema flared up. Very red and bumpy.
Age: 15.0
Sex: F
Vaccine: MENB
Symptoms: Chills, Immediate post-injection reaction, Malaise, Nausea, Pallor
Clinical narrative: Immediately stated, "I don't feel well." Requested back brace be removed due to tightness of Velcro strap around abdomen. Reported nausea, began shaking which continually progressed into full body shaking/shivering, denied chills. Had pallor, upon asked stated throat may have felt like it was swelling, no dyspnea witnessed. Was tachycardic. Within 10 minutes, mother transported patient to Urgent Care Clinic next door to Health Department while RN called ahead to advise patient was coming. Clinic then had patient transported to local ER for further treatment.
Age: 15.0
Sex: F
Vaccine: MENB
Symptoms: Pharyngeal oedema, Tachycardia, Tremor
Clinical narrative: Immediately stated, "I don't feel well." Requested back brace be removed due to tightness of Velcro strap around abdomen. Reported nausea, began shaking which continually progressed into full body shaking/shivering, denied chills. Had pallor, upon asked stated throat may have felt like it was swelling, no dyspnea witnessed. Was tachycardic. Within 10 minutes, mother transported patient to Urgent Care Clinic next door to Health Department while RN called ahead to advise patient was coming. Clinic then had patient transported to local ER for further treatment.
Sex: M
Vaccine: HEP
Symptoms: Hepatitis B antibody negative
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a currently 7 years old male patient. The patient's concurrent conditions included elevated liver enzymes, developmental delay, attention deficit disorder (ADD), retinal disorder and proteinuria. It was also reported that the patient had allergy to sulfonamides (Sulfa (unspecified)) and atomoxetine hydrochloride (STRATTERA). On an unknown dates, the patient received hepatitis B vaccine series (manufacturer unknown) (exact doses, units, frequency, route of administration, lot numbers and expiration dates were not provided) for prophylaxis. Concomitant therapies included clonidine. On an unknown date, it was found that the patient had hepatitis B titre that was nonreactive. Lab diagnostic studies performed included hepatitis A, B and C panel. The patient sought medical attention (unspecified). The outcome of the event was unknown. The relatedness between the event and vaccination with hepatitis B vaccine (manufacturer unknown) was not reported. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information was received from a registered nurse who reported that on unknown dates, multiple unknown patients received improperly stored VARIVAX lot # M036292, expiration date 17-AUG-2018 and lot #M042858, expiration date 21-JAN-2018; diluent lot #N007932, expiration date 06-MAY-2018 (dosages and routes of administration not provided). Temperature: 12F-15F Time frame: once every 24 hours for < 60 minutes for an unspecified number of days. Previous temperature excursion: No Data logger involved: No. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a multiple unspecified patients of unknown age and gender. The patients' concurrent conditions, medical history and concomitant medications were not reported. On 09-OCT-2015, the patients received an improperly stored doses of VARIVAX (lot#L009205, expiration date 17-MAR-2017, lot reported as L624124 expiration date 06-MAR-2016, lot#J013734 expiration date 30-OCT-2015) (doses, routes of administration and anatomical locations were not reported). No adverse effects reported. It was stated that all vaccines underwent a temperature excursion at 7.7 Fahrenheit for 15 min, date of temperature excursion as of 09-OCT-2015. The digital data logger was involved. The product quality complaint was not involved. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1705USA004383: US-009507513-1705USA004379: US-009507513-1705USA004380: US-009507513-1705USA004381: US-009507513-1705USA004382: US-009507513-1705USA004377: US-009507513-1705USA004376: US-009507513-1704USA008135:
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information was received on 10-MAY-2017 from an attorney in the form of an initial legal complaint regarding a female patient (age not reported). Medical history, concurrent conditions and concomitant medications were not reported. On 24-SEP-2012 the patient was vaccinated with ZOSTAVAX vaccine, 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 17-AUG-2015 the patient was treated for a rash that was diagnosed as shingles. She was prescribed acyclovir and hydrocodone-acetaminophen 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 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
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was provided regarding the patient's past medical history, concurrent condition, or concomitant medication. The patient was inoculated with ZOSTAVAX vaccine on or about 26-JUL-2013 at a pharmacy as recommended for routine adult health maintenance for the prevention of shingles (lot number, dosage, and route of administration not provided). It is alleged that the ZOSTAVAX did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 13-OCT-2015, the patient was treated by a physician for a painful rash that was diagnosed as shingles. The patient was prescribed acyclovir and ibuprofen (MOTRIN) for management of her severe 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. The outcome of the shingles is unknown. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was provided regarding the patient's past medical history, concurrent condition, or concomitant medication. The patient was inoculated with ZOSTAVAX vaccine on or about 15-OCT-2014 at a pharmacy as recommended for routine adult health maintenance for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 05-NOV-2014, the patient was treated by a physician for a painful vesicular rash that was diagnosed as shingles. The patient was prescribed famciclovir (FAMVIR) to manage her persistent 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. The outcome of the shingles is unknown. Additional information has been requested.
Sex: U
Vaccine: MENB
Symptoms: Erythema, Pain, Rash
Clinical narrative: This is a spontaneous report from a contactable consumer (patient) via a Pfizer sales representative. A 16-year-old patient of unspecified race/ethnicity and gender received TRUMENBA, via an unspecified route of administration, on an unspecified date, at single dose, for immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced pain and redness/rash on an unspecified date with outcome of unknown.
Age: 16.0
Sex: M
Vaccine: MENB
Symptoms: Chills, Musculoskeletal stiffness, Tremor
Clinical narrative: This is a spontaneous report from a contactable nurse. A 16-years-old male patient (weight 59cm, height 170 cm) received TRUMENBA (lot R45100), intramuscular on 08May2017 at 0.5 ml, single for immunisation.  Relevant medical history was none. There were no concomitant medications. On 08May2017 the patient experienced chills, stiff neck, like shaking all with outcome of recovered.  Therapeutic measures were taken as a result of events and included diphenhydramine hydrochloride (BENADRYL), Epinephrine and dexamethasone (DECADRON).
Age: 19.0
Sex: M
Vaccine: ANTH, TYP
Symptoms: Syncope
Clinical narrative: Fainted/Syncope episode shortly after receiving vaccination and getting up to check out. Had already received a blood draw and did not eat breakfast prior to coming to the site. Patient immediately recovered after fainting, alert and oriented, was aware of his surroundings. Did not remember falling to the floor.
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Pain, Pain in extremity
Clinical narrative: Arm pain and feeling achy.
Age: 1.0
Sex: M
Vaccine: MMR, PNC13, VARCEL
Symptoms: Blood test, Computerised tomogram, Electroencephalogram, Lumbar puncture, Nuclear magnetic resonance imaging
Clinical narrative: Seizure lasting 10 minutes followed by second seizure 3 hours later and high fevers lasting days.
Age: 1.0
Sex: M
Vaccine: MMR, PNC13, VARCEL
Symptoms: Pyrexia, Seizure, Urine analysis
Clinical narrative: Seizure lasting 10 minutes followed by second seizure 3 hours later and high fevers lasting days.
Age: 50.0
Sex: M
Vaccine: FLU4
Symptoms: Blood test, Gait disturbance, Hypoaesthesia, Immunoglobulin therapy, Lumbar puncture
Clinical narrative: Received influenza vaccine on 11-21-16. 11-29-16 I began to feel numbness and tingling in both feet. 12-2-16 I began to have difficulty walking. 12-20-16 IV/IG treatment began.
Age: 50.0
Sex: M
Vaccine: FLU4
Symptoms: Paraesthesia
Clinical narrative: Received influenza vaccine on 11-21-16. 11-29-16 I began to feel numbness and tingling in both feet. 12-2-16 I began to have difficulty walking. 12-20-16 IV/IG treatment began.
Age: 70.0
Sex: F
Vaccine: PNC
Symptoms: Rash macular
Clinical narrative: Blotchy rash near injection site, about 4 inches in length and 3 inches in width. Patient said it did not itch and the rash did not look to be raised.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Local redness, swelling, and warmth with mild pain over the right deltoid area.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a multiple unspecified patients of unknown age and gender. The patients' concurrent conditions, medical history and concomitant medications were not reported. On an unknown dates, the patients were vaccinated with an unspecified doses of GARDASIL (doses, lot numbers, expiration dates, routes of administration were not reported), that had undergone multiple unspecified temperature excursions. The information regarding temperature, time frame and previous temperature excursions were unknown. The digital data logger was involved. There were no adverse effects reported. The product quality complaint was not involved. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1705USA004383: US-009507513-1705USA004379: US-009507513-1705USA004380: US-009507513-1705USA004381: US-009507513-1705USA004382: US-009507513-1705USA004377: US-009507513-1705USA004376: US-009507513-1705USA004378:
Sex: U
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On an unknown date, the patient was vaccinated with expired dose of VARIVAX lot # L003775, expiration date: 04-FEB-2017 for prophylaxis (route and site of administration were not reported). No adverse effects were reported. Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Injection site mass, Injection site pain, Mobility decreased
Clinical narrative: This spontaneous report was received from a pharmacist via a company representative and refers to a non-pregnant female patient of unknown age. There was no information about the patient's pertinent medical history, concomitant medications and drug reactions or allergies provided. On an unknown date in October 2016, the patient was vaccinated with a dose of PNEUMOVAX23 intramuscular (dose, lot # and expiry date were not provided) for preventing against pneumococcal. On an unknown date, the patient experienced limited motion with her hand, lingering pain and a slight lump where she received the PNEUMOVAX23. The patient sought medical attention, she talked with pharmacist. No product quality complaint was involved. The outcome of the events was reported as not recovered. Causality assessment was not provided. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a licensed practical nurse and refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates in 2017 (reported as since 28-FEB-2017), the patients were vaccinated with improperly stored doses of VARIVAX lot # M023384, expiration date 11-MAY-2018 (dose, route and site of administration were not reported). There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion from -14 degrees Celsius to -10 degrees Celsius for 2 hours. Data logger was not involved. There were no previous excursions reported. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a multiple unspecified patients of unknown age and gender. The patients' concurrent conditions, medical history and concomitant medications were not reported. On an unknown dates, the patients were vaccinated with an unspecified doses of PNEUMOVAX 23 (doses, lot numbers, expiration dates, routes of administration were not reported), that had undergone multiple unspecified temperature excursions. The information regarding temperature, time frame and previous temperature excursions were unknown. The digital data logger was involved. There were no adverse effects reported. The product quality complaint was not involved. Additional information has been requested. Sender's Comments: US-009507513-1705USA004383: US-009507513-1705USA004379: US-009507513-1705USA004380: US-009507513-1705USA004381: US-009507513-1705USA004382: US-009507513-1704USA008135: US-009507513-1705USA004376: US-009507513-1705USA004378.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a multiple unspecified patients of unknown age and gender. The patients' concurrent conditions, medical history and concomitant medications were not reported. On an unknown dates, the patients were vaccinated with an unspecified doses of PROQUAD (Albumin status: recombinant human albumin or human serum albumin) (doses, lot numbers, expiration dates, routes of administration were not reported), that had undergone multiple unspecified temperature excursions. The information regarding temperature, time frame and previous temperature excursions were unknown. The digital data logger was involved. There were no adverse effects reported. The product quality complaint was not involved. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1705USA004383: US-009507513-1704USA008135: US-009507513-1705USA004380: US-009507513-1705USA004381: US-009507513-1705USA004382: US-009507513-1705USA004377: US-009507513-1705USA004376: US-009507513-1705USA004378:
Sex: U
Vaccine: HBHEPB
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a multiple unspecified patients of unknown age and gender. The patients' concurrent conditions, medical history and concomitant medications were not reported. On an unknown dates, the patients were vaccinated with an unspecified doses of COMVAX (doses, lot numbers, expiration dates, routes of administration were not reported), that had undergone multiple unspecified temperature excursions. The information regarding temperature, time frame and previous temperature excursions were unknown. The digital data logger was involved. There were no adverse effects reported. The product quality complaint was not involved. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1705USA004383: US-009507513-1705USA004379: US-009507513-1705USA004380: US-009507513-1705USA004381: US-009507513-1705USA004382: US-009507513-1705USA004377: US-009507513-1705USA004376: US-009507513-1705USA004378:
Sex: U
Vaccine: HPVX
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report was received from an office manager via a company representative who refers to a patient of unknown age and gender. The patient's medical history, concurrent condition, drug and allergy history were not reported. The reporter stated that on 08-MAY-2017 the patient was vaccinated with a 4th dose of unidentified Merck hpv vaccine administered (name, strength, route, dose, lote number and expiration date were not provided) for prophylaxis (product use issue). The reporter did not specify if it was GARDASIL or GARDASIL 9. The patient's concomitant therapy was not reported. No adverse effects were reported. Additional information has been requested.
Sex: F
Vaccine: UNK
Symptoms: Injury associated with device, No adverse event
Clinical narrative: This spontaneous report was received from a consumer and refers to her sister, a female nurse of an unknown age. Her concomitant medications, pertinent medical history and drug reactions or allergies were not reported. On an unknown date, the nurse pricked herself with an unspecified hepatitis vaccine (manufacturer unknown) (lot # and expiry date were not reported) before giving it to a patient. The reporter did not know the name of the hepatitis vaccine. No adverse effects were reported. Product quality complaint was not involved. Additional information is not expected as no consent to contact the physician was granted.
Sex: U
Vaccine: MMR
Symptoms: Adverse event, Incontinence
Clinical narrative: This spontaneous report was received from a consumer referring to a teenage patient of unknown age and demographics. There was no information about the patient's concurrent conditions, medical history concomitant or therapies provided. On an unknown date, the patient was vaccinated with M-M-R II for prophylaxis (the lot #, expiration date, route, frequency, dose, and strength were not reported). On an unknown date, the patient experienced an unspecified adverse event regarding to the M-M-R II vaccine. Reportedly, the patient was sent to the hospital after receiving the vaccine. It was also reported that the patient was in a diaper as a result of the reaction they had from the MMR II. The outcome of the event was unknown. The reporter considered the event to be related to M-M-R II. Additional information is not expected since the healthcare professional's contact details were not provided.
Sex: M
Vaccine: MMR
Symptoms: Death, Seizure
Clinical narrative: This spontaneous report was received from a physician via a company representative and refers to a male child patient. The patient's concurrent conditions, medical history and concomitant therapies were not reported. Approximately in 1997 (reported as "about 20 years"), the patient was vaccinated with a dose of M-M-R II frequency reported as "one injection", parenteral route reported as "injection" (anatomical place of vaccination was not provided), for Measles, Mumps, and Rubella  prophylaxis. Approximately in 1997 (reported as "two weeks after the vaccine was administered"), the patient experienced seizures and for an unspecified reason and the child passed away (death), subsequently on an unspecified date, the child passed away for an unspecified reason. At the time of reporting, the outcome of seizure was unknown. The reporter did not provide a causality assessment between M-M-R II, seizures and death. Upon internal review, seizures and the death were determined to be medically significant. Additional information is not expected, as the reporter did not provide consent to follow up.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Wrong drug administered
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 21-APR-2017, the patient was vaccinated with VARIVAX lot number M024683, expiration date 18-MAY-2018 (dose and route were not reported) for prophylaxis, instead ZOSTAVAX due to human error. No adverse effects were reported. Additional information has been requested.
Age: 5.0
Sex: U
Vaccine: HEP
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report was received from a Medical Assistant concerning a 5 year old patient of unknown gender. The patient's concurrent conditions, medical history, historical drugs and concomitant therapies were not reported. On 10-MAY-2017, the patient was inadvertently vaccinated with the fourth dose of RECOMBIVAX HB due to human error (lot number M045653, expiration date 03-JUL-2019) (dose and route were not reported) for prophylaxis. No adverse effects were reported. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash, Vaccination failure
Clinical narrative: Information was received on 10-MAY-2017 from an attorney in the form of an initial legal complaint regarding a female patient (age not reported). Medical history, concurrent conditions and concomitant medications were not reported. On 18-MAY-2015 the patient was vaccinated with ZOSTAVAX vaccine, as recommended for routine adult health maintenance for the prevention of shingles. The vaccine did not prevent shingles as intended (considered vaccination failure), but rather caused the patient to contract a persistent strain of herpes zoster. On or about 13-AUG-2016 the patient was treated at a medical center for a painful rash that was diagnosed as shingles. She was prescribed acyclovir 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 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, Neuralgia
Clinical narrative: Information was received on 10-MAY-2017 from an attorney in the form of an initial legal complaint regarding a female patient (age not reported). Medical history, concurrent conditions and concomitant medications were not reported. On 28-SEP-2012 the patient was vaccinated with ZOSTAVAX vaccine, as recommended for routine adult health maintenance for the prevention of shingles. The vaccine did not prevent shingles as intended (considered vaccination failure), but rather caused the patient to contract a persistent strain of herpes zoster. On or about 11-MAR-2015 the patient was treated for a painful rash that was diagnosed as a severe case of shingles. On or about 23-MAR-2015 the patient was treated for vesicular outbreaks, which were diagnosed as shingles. On or about 29-AUG-2015 the patient was treated at the emergency room for painful, worsening symptoms which were diagnosed as neuralgia. She was prescribed acyclovir and hydrocodone for 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 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 pruritic
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation referring to a male patient of unknown age.  Medical history and concomitant medications were not provided.  On or about 21-FEB-2014, the patient was vaccinated with ZOSTAVAX at a hospital as recommended for routine health maintenance for the prevention of shingles (route and lot # not provided).  The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster.  On or about 04-JUN-2015, the patient was treated for an itchy rash that was diagnosed as shingles.  He was prescribed lidocaine 5% ointment 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, pain and suffering, and other damages.  The outcome was unknown. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Ophthalmic herpes zoster, Pain
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation referring to a female patient of unknown age. Medical history and concomitant medications were not provided. On or about 10-DEC-2011, the patient was vaccinated with ZOSTAVAX at a pharmacy as recommended for routine health maintenance for the prevention of shingles (route and lot # not provided). The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 14-JAN-2015, the patient was treated for a painful condition called herpes "keratis", which is shingles in the eye and can cause vision loss and permanent blindness. She was prescribed acyclovir to help manage 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, pain and suffering, and other damages. The outcome of the events were unknown. Upon internal review, ophthalmic herpes simplex was considered medically significant. Additional information has been requested.
Age: 70.0
Sex: F
Vaccine: PNC13
Symptoms: Immediate post-injection reaction, Injection site pain
Clinical narrative: This is a spontaneous report from a contactable medical assistant reporting on behalf of a physician. The medical assistant reported similar events for 2 patients. This is the 2nd of 2 cases. A 70-year-old female patient received PREVNAR 13, via an unspecified route of administration, on 08May2017, at 0.5 ml single, for immunisation.  Medical history included ongoing hyperlipidaemia, ongoing depression, ongoing vitamin d deficiency, ongoing osteoporosis, ongoing glucose tolerance impaired. Concomitant medication included ongoing VOLTAREN, ongoing calcium (unspecified trade name), ongoing hydrochlorothiazide (HCTZ), ongoing losartan (unspecified trade name), ongoing LIPITOR, ongoing PAXIL, ongoing fexofenadine (unspecified trade name). The patient experienced burning when the medication went in on 08May2017 with outcome of unknown. Sender's Comments: Linked Report(s) : US-PFIZER INC-2017207726 Same reporter/drug/event, different patient.
Sex: F
Vaccine: FLU4
Symptoms: Guillain-Barre syndrome, Rash
Clinical narrative: Initial unsolicited report received from a non-health care professional on 08-May-2017. This case involves a female patient (age not reported) who was vaccinated with a dose of FLUZONE QIV (Batch number, expiration date, dose, dose in series, route and site of administration were not reported) on 14-Oct-2016. Medical history and concomitant medications were not reported. On an unknown date, following the vaccination, the patient developed rash and ultimately was hospitalized on 02-Nov-2016 with a Guillain-Barre syndrome (Hospital reported diagnosis). Laboratory investigations and corrective treatment were not reported. The outcome of events were not reported. List of documents held by sender: none. Sender's Comments: This case concerns female patient who received INFLUENZA QUADRIVAL A-B VACCINE and developed rash and Guillain Barre syndrome. Time to onset is not reported for rash while it is not compatible for Guillain Barre syndrome. However, this case is poorly documented and further information regarding etiological work up, concurrent condition at the time of vaccination, concomitant medication, and investigation results to rule out the alternative cause are needed for a complete assessment of the case.
Age: 22.0
Sex: F
Vaccine: TDAP
Symptoms: Arthralgia, Fatigue, Injection site pain, Injection site rash, Myalgia
Clinical narrative: Fatigue started at 8:30 PM. Fever at 12:30 AM with muscle and joint pain in arm of injection site. Fever resided at 1:00 PM on 05/11/2017. Muscle pain and rash around injection site present morning of 05/12/2017.
Age: 22.0
Sex: F
Vaccine: TDAP
Symptoms: Pyrexia
Clinical narrative: Fatigue started at 8:30 PM. Fever at 12:30 AM with muscle and joint pain in arm of injection site. Fever resided at 1:00 PM on 05/11/2017. Muscle pain and rash around injection site present morning of 05/12/2017.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Dry mouth, Headache, Lip dry, Paraesthesia, Peripheral coldness
Clinical narrative: Patient reported tingle in the hands and feet, also her hands were cold. I took her blood pressure and it was 143/86 and her heart rate was 82. She also said she had drymouth and dry lips. I made her stay longer. I also called her doctor. She wasn't having any breathing issues, so the doctor said to send her home and have her call. She also reported having a headache. She called her son and he picked her up. She didn't want an ambulance called.
Age: 67.0
Sex: F
Vaccine: HEP, MMR
Symptoms: Antinuclear antibody positive, Arthralgia, Complement factor C3, Complement factor C4 decreased, Rheumatoid factor negative
Clinical narrative: Bilateral progressive arthralgia  3/20/2017. Resolved 4/10/2017.
Age: 69.0
Sex: F
Vaccine: PNC
Symptoms: No adverse event
Clinical narrative: Client reports no signs and symptoms. No concerns at all.
Age: 71.0
Sex: M
Vaccine: PNC13
Symptoms: No adverse event
Clinical narrative: No signs and Symptoms. Client reports no concerns at all.
Age: 15.0
Sex: M
Vaccine: FLU4, HPV9
Symptoms: Injected limb mobility decreased, Injection site pain
Clinical narrative: Initially with left shoulder pain following both influenza quadrivalent vaccine and HPV9 vaccine. Over time he had decreased ability to lift his arm above parallel to the ground. He did not report until 4/24/17 at visit. Has been referred to physiatry, but as yet has not been evaluated.
Age: 0.92
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report was received from a registered nurse referring to a 1 year old patient of unknown gender. The patient's pertinent medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not provided. On an unknown date, in May 2017, the patient was in the office for a routine dose of PREVNAR 13 (strength, dose, Lot # and expiration date were not reported) for prophylaxis and inadvertently received the first dose of PNEUMOVAX 23 Lot # N003993 with an expiration date on 31-OCT-2018, intramuscularly (strength and dose were not reported) for prophylaxis instead of PREVNAR 13. However, there was no report of adverse effects. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was provided regarding the patient's past medical history, concurrent condition, or concomitant medication. The patient was inoculated with ZOSTAVAX vaccine (lot number not reported) on or about 15-MAY-2014 at a pharmacy as recommended for routine adult health maintenance for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 18-JUL-2016, the patient was treated by a nurse practitioner for a painful vesicular rash that was diagnosed as shingles. The patient was prescribed avalacyclovir (VALTREX) and lidocaine 4%  to manage her excruciating 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. The outcome of the shingles is unknown. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Post herpetic neuralgia, Rash, Rash vesicular
Clinical narrative: Information has been received from a lawyer on regarding a case in litigation concerning a female patient of unknown age. No information was provided regarding the patient's past medical history, concurrent condition, or concomitant medication. The patient was inoculated with ZOSTAVAX vaccine (lot number not reported) on unknown date at a pharmacy as recommended for routine adult health maintenance for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 01-JAN-2016, the patient was treated by a physician for a painful vesicular rash that was diagnosed as shingles. On or about 02-JAN-2016, the patient was treated for ongoing and worsening herpes zoster symptoms. On or about 28-MAR-2016 the patient was treated by a physician for conditions identified as postherpeutic neuralgia, a chronic condition of nerve pain and damage as a residual effect of severe shingles. On or about 13-OCT-2016 was seen at emergency room for new and worsening shingles. For the spectrum of her painful symptoms the patient was prescribed gabapentin and acyclovir to manage and attempt to mitigate 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 has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the shingles is unknown. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation referring to a male patient of unknown age.  Medical history and concomitant medications were not provided.  On or about 14-JUN-2014, the patient was vaccinated with ZOSTAVAX at a county health department as recommended for routine health maintenance for the prevention of shingles (route and lot # not provided). 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-NOV-2015, the patient was treated at a Family Practice for a painful rash that was diagnosed as shingles. On or about 20-NOV-2015 (note this is same date as before), the patient was treated at the same facility for worsening symptoms. He was prescribed acyclovir, MEDROL and capsaicin cream for management of 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, pain and suffering, and other damages. The outcome was unknown. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: Information was received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received regarding the patient's past medical history, concurrent condition, or concomitant medication. The patient was inoculated with ZOSTAVAX vaccine on or about 20-MAR-2015 at a pharmacy as recommended for routine adult health maintenance for the prevention of shingles (lot number, dosage and route of administration not provided). The ZOSTAVAX did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 31-MAY-2016, the patient was treated by a physician for a painful rash that was diagnosed as severe shingles. The patient was 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. The outcome of the shingles is unknown. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Deafness, Herpes zoster, Herpes zoster oticus, Rash
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation referring to a male patient of unknown age. Medical history and concomitant medications were not provided. On or about 29-SEP-2014, the patient was vaccinated with ZOSTAVAX at a pharmacy as recommended for routine health maintenance for the prevention of shingles (route and lot # not provided). The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 02-MAY-2016, the patient was treated by Nurse Practitioner for a painful rash that had spread into the ear and caused hearing loss. The condition was diagnosed as shingles. He was evaluated by an Audiology specialist to confirm the hearing loss. On or about 14-SEP-2016, the patient was treated at a facility for a shingles attack that was treated by two physicians. 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 was unknown. Upon internal review, shingles that caused hearing loss was considered medically significant. Additional information has been requested.
Age: 0.17
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13, RVX
Symptoms: Diarrhoea haemorrhagic
Clinical narrative: Initial unsolicited report received from a consumer (mother of patient) on 03-may-2017. This case involves a two months old (also reported as 9 weeks) female patient who was vaccinated with a dose of PENTACEL and HEPATITIS B VACCINE and PREVNAR and ROTAVIRUS VACCINE (batch number, expiry date, dose, dose in series, route and site of administration was not reported for all four vaccines) on 18-Apr-2017. The patient had a possible milk allergy. Patient has history of bloody diarrhea, was being breastfed, switched to a special formula and bloody diarrhea resolved. It was also reported that illness at time of vaccination was reported as none. Concomitant medications and any other vaccinations within 4 weeks of vaccinations noted above were not reported. On an unknown date, following the vaccination, the patient experienced bloody diarrhea. The patient's laboratory data and corrective treatment was not reported. On an unknown date, patient recovered from the event, which lasted for about a week. Upon internal review the case was considered as serious because of important medical event: bloody diarrhea. List of documents held by sender: none. Sender's Comments: Sanofi company comment dated 05-May-2017: Patient was vaccinated with PENTACEL, Hepatitis B, PREVNAR, Rotavirus vaccines. Following which patient experience bloody diarrhea unlisted as per PENTACEL. Patient's medical history such as allergies: possible milk allergy and concurrent administration of rotavirus vaccine can be alternative explanation. However need additional information of concurrent infection, past vaccination history and its tolerance are needed to further assess the case. Based on available information the role of vaccine cannot be excluded.
Age: 4.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Injection site erythema, Injection site induration, Injection site swelling, Injection site warmth
Clinical narrative: Redness, slight swelling, induration on right upper arm at site of injection with warmth to touch.