chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 40.0
Sex: F
Vaccine: RAB
Symptoms: Asthenia, Body temperature increased, Culture stool negative, Dehydration, Diarrhoea
Clinical narrative: Initial unsolicited report received from a consumer (friend of patient) on 31-Jul-2017. Additional information was received on 01-Aug-2017. This case involves a 40-year-old female patient who was vaccinated with fourth dose of RABIES (HDC) VACCINE (IMOVAX) (Batch number, route and site of administration were unknown, dose and expiry date were not reported) on an unknown day in Jun 2017. Patient's pre-existing physician diagnosed allergies, birth defects, medical conditions was reported as unknown and patient's illness at the time of vaccination was none as per reporter. Patient's other vaccinations within 4 weeks of vaccinations was reported as unknown. Concomitant medications were not reported. On an unknown day in Jun-2017, about one week after the vaccination, patient had diarrhea, nausea, vomiting,aches and pains, dehydration, slightly elevated temp, dizziness, general weakness in body, pain, tingling, numbness in hands and feet. On an unknown date, following the vaccination, the patient had pain in hands and feet and tiredness had persisted and she could not go to work. Patient's friend would be taking her to a neurologist Previous doses indicated that the patient was previously vaccinated with three doses of IMOVAX on an unknown date. On 17 Jul 2017, patient required visit to the emergency room (ER) few weeks after. Laboratory investigations were negative for a "virus" and she had a stool culture done that was also negative. Corrective treatment was not reported. The outcome of the events aches and pains, dehydration, pain in hands and feet, nausea, dizziness, general weakness in body, tiredness, tingling in hands and feet, and numbness in hands and feet were reported as not recovered, and the outcome of slightly elevated temperature, diarrhea and vomiting were reported as recovering. List of documents held by sender: none.
Age: 40.0
Sex: F
Vaccine: RAB
Symptoms: Dizziness, Fatigue, Hypoaesthesia, Loss of personal independence in daily activities, Nausea
Clinical narrative: Initial unsolicited report received from a consumer (friend of patient) on 31-Jul-2017. Additional information was received on 01-Aug-2017. This case involves a 40-year-old female patient who was vaccinated with fourth dose of RABIES (HDC) VACCINE (IMOVAX) (Batch number, route and site of administration were unknown, dose and expiry date were not reported) on an unknown day in Jun 2017. Patient's pre-existing physician diagnosed allergies, birth defects, medical conditions was reported as unknown and patient's illness at the time of vaccination was none as per reporter. Patient's other vaccinations within 4 weeks of vaccinations was reported as unknown. Concomitant medications were not reported. On an unknown day in Jun-2017, about one week after the vaccination, patient had diarrhea, nausea, vomiting,aches and pains, dehydration, slightly elevated temp, dizziness, general weakness in body, pain, tingling, numbness in hands and feet. On an unknown date, following the vaccination, the patient had pain in hands and feet and tiredness had persisted and she could not go to work. Patient's friend would be taking her to a neurologist Previous doses indicated that the patient was previously vaccinated with three doses of IMOVAX on an unknown date. On 17 Jul 2017, patient required visit to the emergency room (ER) few weeks after. Laboratory investigations were negative for a "virus" and she had a stool culture done that was also negative. Corrective treatment was not reported. The outcome of the events aches and pains, dehydration, pain in hands and feet, nausea, dizziness, general weakness in body, tiredness, tingling in hands and feet, and numbness in hands and feet were reported as not recovered, and the outcome of slightly elevated temperature, diarrhea and vomiting were reported as recovering. List of documents held by sender: none.
Age: 40.0
Sex: F
Vaccine: RAB
Symptoms: Pain, Pain in extremity, Paraesthesia, Vomiting
Clinical narrative: Initial unsolicited report received from a consumer (friend of patient) on 31-Jul-2017. Additional information was received on 01-Aug-2017. This case involves a 40-year-old female patient who was vaccinated with fourth dose of RABIES (HDC) VACCINE (IMOVAX) (Batch number, route and site of administration were unknown, dose and expiry date were not reported) on an unknown day in Jun 2017. Patient's pre-existing physician diagnosed allergies, birth defects, medical conditions was reported as unknown and patient's illness at the time of vaccination was none as per reporter. Patient's other vaccinations within 4 weeks of vaccinations was reported as unknown. Concomitant medications were not reported. On an unknown day in Jun-2017, about one week after the vaccination, patient had diarrhea, nausea, vomiting,aches and pains, dehydration, slightly elevated temp, dizziness, general weakness in body, pain, tingling, numbness in hands and feet. On an unknown date, following the vaccination, the patient had pain in hands and feet and tiredness had persisted and she could not go to work. Patient's friend would be taking her to a neurologist Previous doses indicated that the patient was previously vaccinated with three doses of IMOVAX on an unknown date. On 17 Jul 2017, patient required visit to the emergency room (ER) few weeks after. Laboratory investigations were negative for a "virus" and she had a stool culture done that was also negative. Corrective treatment was not reported. The outcome of the events aches and pains, dehydration, pain in hands and feet, nausea, dizziness, general weakness in body, tiredness, tingling in hands and feet, and numbness in hands and feet were reported as not recovered, and the outcome of slightly elevated temperature, diarrhea and vomiting were reported as recovering. List of documents held by sender: none.
Age: 42.0
Sex: F
Vaccine: RAB
Symptoms: Muscle twitching, Paraesthesia
Clinical narrative: Initial unsolicited case received from a nurse on 31 Jul 2017. This case involves 42-years-old female patient who was vaccinated with dose one of IMOVAX, and a dose of IMMUNOGLOBULINS (Manufacturer also reported as unknown) (Batch number, expiry date, dose, route, and site of administration were not reported for both vaccines) on 24 Jul 2017, and dose two of IMOVAX (Batch number: M131142M, expiry date, dose not reported, site of administration unknown) via intramuscularly on 27 Jul 2017. The patient illness at the time of vaccination was unknown, and the patient had sulfa allergy. Concomitant medications were not reported. On 31 Jul 2017, seven days after the vaccination with first dose of IMOVAX, and immunoglobulins, and four days after the second dose of IMOVAX, the patient had developed muscle twitches and pins and needles in her legs. It was reported as the patient required to visit doctor and ER (emergency room). The patient relevant lab tests and corrective treatment were not reported. As of 31 Jul 2017, the patient was not recovered from the events. List of documents held by sender: none.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Rash pruritic
Clinical narrative: Approximately 30 minutes after administering the vaccine the patient developed a rash to her right outer forearm and to her right inner shin. She stated that she all of a sudden felt this area itching and looked down and saw the rash. She went to her car and sat there for a minute and then when the area presented to her right lower extremity she came back into the office for evaluation. She did not have any symptoms of an anaphylaxis reaction.
Age: 19.0
Sex: F
Vaccine: MENB
Symptoms: Headache, Injection site induration, Injection site pain, Injection site warmth, Lip swelling
Clinical narrative: 30 minutes after receiving Trumemba patient felt pain at the injection site and also warm and hard. She also had swelling of her lips which lasted 10 minutes, in additions she reported a constant headache that responded to Advil but persisted for 36 hours.
Age: 18.0
Sex: F
Vaccine: JEV1, RAB, YF
Symptoms: Injection site bruising, Injection site erythema, Injection site pruritus, Injection site swelling, Nausea
Clinical narrative: Within 24 hours after vaccine patient observed that right arm near YF-Vax injection site became red and swollen and that the area became itchy, especially in the sun. She also reported nickel- or quarter-sized bruise near YF-Vax injection site. Seven days after vaccine, injection site was still red and slightly swollen and bruise was starting to fade. Patient also noted some nausea during the past week which she states may or may not be due to the vaccine.
Age: 40.0
Sex: F
Vaccine: TDAP
Symptoms: Eyelid oedema, Eyelids pruritus, Pruritus, Urticaria
Clinical narrative: History of Present Illness: The symptoms began 1 week ago. Had immunization on 8/3/17 which was a tetanus shot. Had hives that started the night of the shot and eye lids were swollen. She was very itchy. She denies new detergents, soaps or  lotions since then. Prozac is new but that was started after the rash and itching came on. Things are starting to get better. She has taken Benadryl at night to see if that would help and it has things are getting better but her eyelids are still itchy. Hives to body have gone away. Swelling to eyelids has improved but still itchy. Denies throat swelling or itching, denies DIB. She had hives the last time that she had a tetanus shot but that was a long time ago. Assessment:  Allergic reaction, initial encounter (T78.40XA). Patient Plan:  I do think this could be an allergic reaction possibly to the tetanus, I will document it on your allergies with the reactions that you have had.  Take the Claritin as we discussed that will not cause drowsiness. You can use Aquaphor but nothing else on your eye lids.  Call me if things are not getting better.
Age: 5.0
Sex: M
Vaccine: HEPA
Symptoms: Local reaction
Clinical narrative: LOCAL.
Age: 1.0
Sex: M
Vaccine: CHOL
Symptoms: Fatigue
Clinical narrative: Got tired.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site mass, Injection site pruritus, Injection site urticaria
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a 72-year-old female patient with penicillin, cephalosporin, COMPAZINE and iodine allergy. On 26-JUL-2017, the patient was vaccinated with ZOSTAVAX lot # M042851, 0.65 ml, subcutaneous for prophylaxis. Other suspect therapies included sterile diluent lot# L034399. In July 2017, the patient experienced injection site mass, injection site erythema, mass, pruritus, injection site pruritus and injection site urticaria. The outcome of the events was reported as recovering/resolving. The relatedness between the events and ZOSTAVAX and sterile diluent was not reported.
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant referring to multiple unspecified number of patients of unknown age and gender. On unknown dates, the patients were vaccinated with improperly stored doses of VAQTA, lot # N016805 with expiration date 04-SEP-2018, lot# N012324 with expiration date 05-APR-2018, lot# N014945 with expiration date 31-AUG-2018, and lo# N008823 with expiration date 26-MAY-2018, for prophylaxis. No adverse event was reported. The doses of VAQTA were exposed to a temperature excursion of 47 degrees Fahrenheit (°F) to 77 °F during a time frame of 2 hours 45 minutes which was detected by the data logger. Previous temperature excursion was reported as 47 °F to 77 °F for 45 minutes. This is one of several reports from the same reporter. Sender's Comments: US-009507513-1708USA002993: US-009507513-1708USA002994: US-009507513-1708USA002995: US-009507513-1708USA002863.
Age: 17.0
Sex: U
Vaccine: HEPA
Symptoms: Incorrect dose administered, No adverse event, Product name confusion
Clinical narrative: This spontaneous report as received from a pharmacy student and refers to a patient of unknown age and gender. Information on medical history, past drugs, concurrent conditions and concomitant medications were not provided. Pharmacy student reported that multiple unspecified pediatric patients received adult doses of VAQTA 25/0.5, (N016805, 04-SEP-2018) and multiple unspecified adult patients received pediatric doses of VAQTA injection 25/0.5, (N014945, 31-AUG-2018), (Captured in MARRS 1708USA003180). All doses were administered on unspecified dates. Pharmacy student reported that product confusion was the cause of error (Product name confusion). No adverse effects were reported (No adverse event). All fields apply to all unspecified patients and all doses of VAQTA. No further information was provided. No product quality compliant (PQC) was present. Outcome of events was unknown. This is one of the several reports received from the same reporter.; Sender's Comments:  US-009507513-1708USA003180:
Sex: U
Vaccine: MMRV
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report received from a registered nurse referred to an unspecified patient in their 20s of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patient was administered PROQUAD (lot: M041084, expiry date: 04-APR-2018) (drug administered to patient of inappropriate age) alone with sterile diluent. No adverse effects reported. No further information provided.
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a physician refers to multiple patients of unknown age and gender. On unknown dates, the patients were vaccinated with doses of improperly stored M-M-R II lot#M008588 (dose, expiration date, route of administration and anatomical location were not reported) for prophylaxis. From an unknown date in October 2016, the vaccines underwent multiple temperature excursions (details to be determined) which were detected by a digital data logger. No adverse effects were reported. This is one of several reports form the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1708USA003935: US-009507513-1708USA004394: US-009507513-1708USA004395: US-009507513-1708USA004393: US-009507513-1708USA004408: US-009507513-1708USA004409:
Sex: F
Vaccine: VARZOS
Symptoms: Decreased immune responsiveness, Herpes zoster, Neuralgia, Post herpetic neuralgia, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient was inoculated with ZOSTAVAX (lot number, dosage, and route of administration not provided) on or about 05-JUL-2014 at a drug store as recommended for routine adult health maintenance and 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 28-APR-2016, the patient was treated by a physician for the onset of a severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as herpes zoster, or shingles with post-herpetic neuralgia resulting in long term nerve pain. The patient was prescribed valacyclovir and gabapentin 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: M
Vaccine: VARZOS
Symptoms: Decreased immune responsiveness, Herpes zoster, Nerve injury, Pain, Post herpetic neuralgia
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient was inoculated with ZOSTAVAX (lot number, dosage, and route of administration not provided) on or about 06-AUG-2012 at a pharmacy as recommended for routine adult health maintenance and 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 17-AUG-2015, the patient was treated by a physician for the onset of a severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed at herpes zoster, or shingles and post-herpetic neuralgia resulting in severe residual pain and nerve damage. The patient has been prescribed gabapentin and acyclovir for management of his 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: M
Vaccine: VARZOS
Symptoms: Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient was inoculated with ZOSTAVAX (lot number, dosage, and route of administration not provided) on or about 06-AUG-2012 at a pharmacy as recommended for routine adult health maintenance and 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 17-AUG-2015, the patient was treated by a physician for the onset of a severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed at herpes zoster, or shingles and post-herpetic neuralgia resulting in severe residual pain and nerve damage. The patient has been prescribed gabapentin and acyclovir for management of his 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: VARZOS
Symptoms: Decreased immune responsiveness, Herpes zoster, Pain, Rash vesicular
Clinical narrative: Information was received from a lawyer 08-AUG-2017 regarding a case in litigation concerning a plaintiff of unspecified age and gender. It was claimed the plaintiff was inoculated with ZOSTAVAX on or about 06-OCT-2009 at a Health unit, as recommended for routine adult health maintenance and for the prevention of shingles. It was claimed the vaccine did not prevent shingles as intended, but rather caused the plaintiff to contract a persistent strain of herpes zoster. On or about 07-AUG-2016 the plaintiff was treated by a physician at a hospital emergency department for the onset of a severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as herpes zoster, or shingles. The plaintiff had been prescribed acyclovir for management of the painful symptoms. As a direct and proximate result of these malfunctions, the plaintiff suffered painful injuries and damages and required extensive medical care and treatment. As a further proximate result, the plaintiff has suffered and will continue to suffer significant medical expenses, pain and suffering and other damages. Additional information was requested.
Sex: U
Vaccine: HPV9
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a other health professional refers to a patient of unknown age and gender. Patient's concurrent condition, pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On 09-AUG-2017 the patient was vaccinated with an expired dose of GARDASIL 9 (lot # K026246 expiry date: 28-JAN-2017) for prophylaxis (expired product administered). Dosing details and route of administration were not reported. No adverse effects were reported. No product quality complaint (PQC) was involved.
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from an Office Manager and refers to an unspecified number of patients of unknown age and gender. No information regarding the patient's medical history or concurrent conditions was provided. On 08-AUG-2017, the patients were vaccinated with improperly stored doses of PEDVAXHIB injection with lot number: N000236 and expiry date: 24-OCT-2019 (exact dose, route of administration, were not reported) for prophylaxis. The vaccine was reconstituted with sterile diluent (lot number and expiration date not reported). There were no concomitant therapies reported. The administered doses of the vaccine were exposed to a temperature between 47 degrees Fahrenheit to 77 degrees Fahrenheit on an unspecified date, for a time frame of 16 hours. A digital data logger was not involved. There were no previous temperature excursions recorded. No adverse experiences were reported. There was no product quality complaint involved. This is one of the several reports received from the same reporter. Sender's Comments: US-009507513-1708USA005224: US-009507513-1708USA004174.
Age: 17.0
Sex: F
Vaccine: HEPA, MENB
Symptoms: Feeling hot, Injection site erythema, Injection site pain, Nausea
Clinical narrative: Client become immediately nauseated and hot. Injection hurt at the site. At 0930 the next day received a call from mom stating client is still nauseated, site is red and painful.
Age: 38.0
Sex: F
Vaccine: FLU4, HEPAB, PPV, TDAP
Symptoms: Injection site erythema, Injection site rash, Injection site reaction, Pain in extremity, Peripheral swelling
Clinical narrative: Pt reported chills, fever, flu symptoms and also pt has injection site reaction with rash/redness spread around 3-4 inches on the left arm and very sore arm. Pt did not feel good and visited the emergency room on 08/09/2017. The Dr Prescribed Ibuprofen 600 mg and Pseudoephedrine 30 mg around the clock. After medication patient reported that she is felling better so far but still has a swollen and sore arm with rash.
Age: 38.0
Sex: F
Vaccine: FLU4, HEPAB, PPV, TDAP
Symptoms: Rash
Clinical narrative: Pt reported chills, fever, flu symptoms and also pt has injection site reaction with rash/redness spread around 3-4 inches on the left arm and very sore arm. Pt did not feel good and visited the emergency room on 08/09/2017. The Dr Prescribed Ibuprofen 600 mg and Pseudoephedrine 30 mg around the clock. After medication patient reported that she is felling better so far but still has a swollen and sore arm with rash.
Age: 68.0
Sex: M
Vaccine: PPV
Symptoms: Arthralgia, Asthenia, Cough, Dizziness, Dysphagia
Clinical narrative: The next day, pt c/o asthenia, dizziness, dysphagia, burning tongue, fever, cough, arthralgia, myalgia, insomnia.
Age: 68.0
Sex: M
Vaccine: PPV
Symptoms: Insomnia, Myalgia, Pyrexia, Tongue discomfort
Clinical narrative: The next day, pt c/o asthenia, dizziness, dysphagia, burning tongue, fever, cough, arthralgia, myalgia, insomnia.
Age: 76.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site rash
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a 76-year-old male patient. No information regarding the patient's medical history, concomitant medications and concurrent conditions was provided. On 24-JUL-2017, the patient was vaccinated with ZOSTAVAX lot # N012492, expiration date 17-MAR-2018 (dose and route of administration were not provided) for vaccination, which was reconstituted with sterile diluent, lot # N001534, expiration date 30-JUL-2019. On an unknown date in 2017 (reported as after receiving ZOSTAVAX, the patient experienced an unspecified rash at the injection site. The patient did not receive any treatment for the event. The outcome of the event was reported as not recovered/not resolved. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Disseminated varicella zoster vaccine virus infection, Immunology test, Rash maculo-papular, Rash vesicular, Varicella virus test positive
Clinical narrative: This literature marketed report as received from the authors of a published literature article. Refers to a 51-year-old male patient. The patient reported that he did not have varicella (chickenpox) as a child, and he did not recall previous vaccination against varicella. The patient's concurrent conditions included rheumatoid factor-negative spondyloarthropathy for which he received a weekly 10 mg dose of methotrexate (manufacturer unknown) for 10 months. On unknown dates, the patient was vaccinated with 2 doses of ZOSTAVAX injection, (dose, route of administration, injection site, lot number and expiration date were not provided) for prophylaxis. On postvaccination day 21, the patient was evaluated in an outpatient clinic at which time physical exam revealed a nonpainful, nonpruritic, mixed maculopapular and vesicular rash (approximately 50 total lesions) involving the patient's face, torso, groin, and arms (date unspecified). The patient reported he had no contact with persons known or suspected to have active varicella or zoster and had no cough or other constitutional symptoms. On an unknown date, valacyclovir hydrochloride, an oral antiviral medication, was prescribed, and the patient was instructed to remain at home and avoid outside contacts until the lesions crusted over. All household contacts of the patient had documented evidence of receipt of 2 doses of varicella vaccine. Direct immunofluorescence testing and culture of vesicular fluid were positive for varicella zoster virus (VZV) on postvaccination day 24 (date unspecified). The outcome of the adverse event was unknown at the time of the report. The authors considered disseminated varicella zoster vaccine virus infection to be related to therapy with ZOSTAVAX. Upon internal review, disseminated varicella zoster vaccine virus infection was considered to be medically significant. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a nurse and refers to multiple patients of unknown demographics. No information regarding the patients' pertinent medical history, concomitant medications, drug reactions or allergies was provided. On unknown dates, the patients were vaccinated with improperly stored doses of M-M-R II (recombinant human albumin (rHA)), injection, lot # M042846 with expiration date of 21-OCT-2018, lot # M036544 with expiration date of 15-AUG-2018 (dose and route of administration were not reported). Administered doses of vaccines experienced the temperature excursion of 47 degrees Fahrenheit to 77 degrees Fahrenheit for 1 hour and 10 minutes. There was a previous temperature excursion of 47 degrees Fahrenheit to 77 degrees Fahrenheit for 3 hours and 8 minutes. Digital data logger was involved in recording the excursion. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments:  US-009507513-1708USA005079: US-009507513-1708USA005079:
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from an office manager refers to unspecified patients of unknown age and gender. No information regarding the patients' pertinent medical histories, drug reactions or allergies and concomitant therapies was provided. On unspecified dates beginning "sometime in June 2017", the patients were vaccinated with improperly stored doses of ROTATEQ lot # M042169, expiry date 22-JUN-2017; lot # M044397, expiry date 20-JUN-2018; lot # M042822, expiry date 19-JUN-2018, orally (dose was not reported). No symptoms were reported. Administered doses of vaccines experienced the temperature excursion of 32 degrees Fahrenheit to 35 degrees Fahrenheit for 17 hours. Data logger was involved. There were no previous excursions reported. This is one of two reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1708USA004649:
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a physician refers to multiple patients of unknown age and gender. On unknown dates, the patients were vaccinated with doses of improperly stored PROQUAD lot# M031568 with expiration date of 24-DEC-2017, lot# N001489 with expiration date of 12-JUL-2018, lot# M035143, lot# M041082, lot# M042501 (expiration dates were not reported) (dose, route of administration and anatomical location were not reported) for prophylaxis. From an unknown date in October 2016, the vaccines underwent multiple temperature excursions (details to be determined) which were detected by a digital data logger. No adverse effects were reported.  This is one of several reports form the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1708USA004395: US-009507513-1708USA003935: US-009507513-1708USA004392: US-009507513-1708USA004394: US-009507513-1708USA004408: US-009507513-1708USA004409.
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a physician refers to multiple patients of unknown age and gender. On unknown dates, the patients were vaccinated with doses of improperly stored LIQUID PEDVAXHIB lot# M025192, lot# M027884, lot# M036612, lot# M046133 (expiration dates were not reported) and lot# N000237 with expiration date of 25-OCT-2019 (dose, route of administration and anatomical location were not reported) for prophylaxis. From an unknown date in October 2016, the vaccines underwent multiple temperature excursions (details to be determined) which were detected by a digital data logger. No adverse effects were reported. This is one of several reports form the same reporter. Additional information has been requested.; Sender's Comments:  US-009507513-1708USA004408: US-009507513-1708USA004409: US-009507513-1708USA004393: US-009507513-1708USA004392: US-009507513-1708USA004394: US-009507513-1708USA003935:
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from an office manager refers to unspecified patients of unknown age and gender. No information regarding the patients' pertinent medical histories, drug reactions or allergies and concomitant therapies was provided. On unspecified dates beginning "sometime in June 2017", the patients were vaccinated with improperly stored doses of VAQTA lot # N005796, expiry date 26-MAY-2018; lot # N008823, expiry date 26-MAY-2018; lot # N005274, expiry date 03-APR-2018, orally (dose was not reported). No symptoms were reported. Administered doses of vaccines experienced the temperature excursion of 32 degrees Fahrenheit to 35 degrees Fahrenheit for 17 hours. Data logger was involved. There were no previous excursions reported. This is one of two reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1708USA003990:
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a nurse and refers to multiple patients of unknown demographics. No information regarding the patients' pertinent medical history, concomitant medications, drug reactions or allergies was provided. On unknown dates, the patients were vaccinated with improperly stored doses of PNEUMOVAX 23 injection, lot # M032635 with expiration date of 05-MAY-2018, lot # N010105 with expiration date of 15-NOV-2018 (dose and route of administration were not reported). Administered doses of vaccines experienced the temperature excursion of 47 degrees Fahrenheit to 77 degrees Fahrenheit for 1 hour and 10 minutes. There was a previous temperature excursion of 47 degrees Fahrenheit to 77 degrees Fahrenheit for 3 hours and 8 minutes. Digital data logger was involved in recording the excursion. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1708USA005079: US-009507513-1708USA002718:
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a nurse and refers to multiple patients of unknown demographics. No information regarding the patients' pertinent medical history, concomitant medications, drug reactions or allergies was provided. On unknown dates, the patients were vaccinated with improperly stored doses of VAQTA injection, lot # L017757 with expiration date of 08-APR-2018 (dose and route of administration were not reported). Administered doses of vaccines experienced the temperature excursion of 47 degrees Fahrenheit to 77 degrees Fahrenheit for 1 hour and 10 minutes. There was a previous temperature excursion of 47 degrees Fahrenheit to 77 degrees Fahrenheit for 3 hours and 8 minutes. Digital data logger was involved in recording the excursion. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1708USA002718: US-009507513-1708USA005078.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a other health professional refers to two patients of unknown age. On an unknown date the patients were vaccinated with VARIVAX lot # M005973 for prophylaxis. Concomitant therapies included sterile diluent. On an unknown date the patients experienced incorrect product storage and no adverse event. The outcome of incorrect product storage and no adverse event is unknown. The reporter considered incorrect product storage and no adverse event to be not related to VARIVAX. This is one of two reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1708USA005305.
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a Registered Nurse refers to a patient of unknown age. On 09-AUG-2017 the patient was vaccinated with GARDASIL 9 dose 3 for prophylaxis. On an unknown date the patient experienced inappropriate schedule of drug administration and no adverse event. The outcome of inappropriate schedule of drug administration and no adverse event is unknown. The reporter considered inappropriate schedule of drug administration and no adverse event to be not related to GARDASIL 9.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a other health professional refers to a three patients of unknown age. On an unknown date the patients were vaccinated with PROQUAD lot # M042501 for prophylaxis. Concomitant therapies included sterile diluent. On an unknown date the patients experienced incorrect product storage and no adverse event. The outcome of incorrect product storage and no adverse event is unknown. The reporter considered incorrect product storage and no adverse event to be not related to PROQUAD. This is one of two reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1708USA005227.
Age: 17.0
Sex: F
Vaccine: TYP
Symptoms: Back pain, Chills, Feeding disorder, Feeling abnormal, Headache
Clinical narrative: 48 hours after receiving first dose of VIVOTIF, client reported nausea, could not eat. Later that day felt chills, feverish (no temp taken), slept for several hours. Took second dose at 10 pm that night despite feeling badly. Next day, client could not go to work, slept off and on all day, fever, headache, backache, called clinic for advice. Told to stop VIVOTIF, go to Urgent Care if symptoms worsen, see physician in am. Next morning saw physician, who also said stop VIVOTIF, do not take any antimalarials. Called Clinic to report events.
Age: 17.0
Sex: F
Vaccine: TYP
Symptoms: Nausea, Pyrexia
Clinical narrative: 48 hours after receiving first dose of VIVOTIF, client reported nausea, could not eat. Later that day felt chills, feverish (no temp taken), slept for several hours. Took second dose at 10 pm that night despite feeling badly. Next day, client could not go to work, slept off and on all day, fever, headache, backache, called clinic for advice. Told to stop VIVOTIF, go to Urgent Care if symptoms worsen, see physician in am. Next morning saw physician, who also said stop VIVOTIF, do not take any antimalarials. Called Clinic to report events.
Age: 0.42
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Irritability, Pyrexia, Seizure like phenomena
Clinical narrative: Fever within 1 day of immunization. Increased fussiness since immunization lasting approximately 1 week to the extent that the parents described him as "not my child." 2 seizure-like events lasting up to 3 minutes unassociated with feeding (note that the child has had similar seizure-like events prior to receiving the immunizations and has a past history of gastroesophageal reflux and aspiration).
Age: 26.0
Sex: M
Vaccine: SMALL
Symptoms: Chills, Dizziness, Eye pain, Headache, Injection site discharge
Clinical narrative: Patient stated has had symptoms of headache, painful vision upon movement, lymph pain, erythema of injection site, oozing of injection site, cross inoculation, swelling, feverish, shivers, and lightheadedness.
Age: 26.0
Sex: M
Vaccine: SMALL
Symptoms: Injection site erythema, Lymph node pain, Post vaccination autoinoculation, Pyrexia, Swelling
Clinical narrative: Patient stated has had symptoms of headache, painful vision upon movement, lymph pain, erythema of injection site, oozing of injection site, cross inoculation, swelling, feverish, shivers, and lightheadedness.
Age: 5.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Mother reports swollen, red, hot to touch upper arm; just below injection site. No fever, SOB or other respiratory reaction. Symptoms noticed later the evening 8/10/17.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, VARZOS
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Pt was given ZOSTAVAX instead of Varicella for his 4 year imms., no adverse reaction at this time.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Computerised tomogram head normal, Crying, Fall, Headache, Hypopnoea
Clinical narrative: Patient received her vaccinations at 3:30pm. She stood beside her mom who was holding her 2 month old brother. She watched his vaccines being given. After the last vaccine given, (3:45pm)she fell to the floor. Very pale, shallow breathing, good pulse, not responding. 1 minute after falling she started to cry and said her head hurt. Rescue squad was called at 3:46pm. She continued to cry. Color improving. Alert and oriented. BP at 3:50 was 110/64. Normal respirations and breathing. No bruising on head or injury to tongue, teeth or mouth. She squeezed hands without difficulty. Followed the command of sticking out her tongue. At 3:57 the rescue squad arrived.  Parent carried her to the rescue squad who transported her to the ER.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Laboratory test normal, Pallor, Unresponsive to stimuli
Clinical narrative: Patient received her vaccinations at 3:30pm. She stood beside her mom who was holding her 2 month old brother. She watched his vaccines being given. After the last vaccine given, (3:45pm)she fell to the floor. Very pale, shallow breathing, good pulse, not responding. 1 minute after falling she started to cry and said her head hurt. Rescue squad was called at 3:46pm. She continued to cry. Color improving. Alert and oriented. BP at 3:50 was 110/64. Normal respirations and breathing. No bruising on head or injury to tongue, teeth or mouth. She squeezed hands without difficulty. Followed the command of sticking out her tongue. At 3:57 the rescue squad arrived.  Parent carried her to the rescue squad who transported her to the ER.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site pain, Injection site reaction, Urticaria
Clinical narrative: Mother called and reported child has 3x4 cm welts on left leg around injection sites. States child c/o pain at site. Mother states no fever, swelling or respiratory distress.
Age: 13.0
Sex: M
Vaccine: HPV9
Symptoms: Urticaria
Clinical narrative: Hives on lower extremities about 4h after receiving vaccination and about 20 min following ingestion of calamari (food that patient has only had a few times prior in life, with no reaction). Given oral antihistamine by parent and hives subsided substantially. Re-evaluated the next day in office and only 2-3 remained. No trouble breathing, swelling or vomiting. Injection site appeared normal.
Age: 10.0
Sex: M
Vaccine: DTAPIPVHIB, PNC13
Symptoms: Blood culture, Chest X-ray, Cough, Full blood count, Respiratory tract congestion
Clinical narrative: Congestion on day of 03/28/17. Was seen in office 03/28/2017 at 2:45 P.M., imm. given at 3:30 P.M. Mother took child to E.R. that night., due to stridor and admission with DECADRON injection given. Discharged 03/29/17 with Albuterol. 7:00 P.M. on, 3-28-17 child started with stridor cough. He went to E.R. and 1st vitals are documented at 22:41 on 03-28-17.
Age: 10.0
Sex: M
Vaccine: DTAPIPVHIB, PNC13
Symptoms: Stridor
Clinical narrative: Congestion on day of 03/28/17. Was seen in office 03/28/2017 at 2:45 P.M., imm. given at 3:30 P.M. Mother took child to E.R. that night., due to stridor and admission with DECADRON injection given. Discharged 03/29/17 with Albuterol. 7:00 P.M. on, 3-28-17 child started with stridor cough. He went to E.R. and 1st vitals are documented at 22:41 on 03-28-17.
Sex: U
Vaccine: HIBV
Symptoms: Injection site discolouration
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of injection site discoloration in a 16-month-old patient who received HIBERIX. Co-suspect products included HIBERIX. In September 2016, the patient received HIBERIX. In November 2016, the patient received HIBERIX. On an unknown date, less than a year after receiving HIBERIX and not applicable after receiving HIBERIX, the patient experienced injection site discoloration and injection site discoloration. On an unknown date, the outcome of the injection site discoloration and injection site discoloration were unknown. It was unknown if the reporter considered the injection site discoloration to be related to HIBERIX. It was unknown if the reporter considered the injection site discoloration to be related to HIBERIX. Additional details were reported as follows: The patient's age was 16 months at the time of reporting. The age at vaccination was not reported. Less than a year after receiving a dose of HIBERIX in November 2016 (unspecified dose number), the patient experienced injection site discoloration. The physician believed that in September and November 2016, after administration with HIBERIX, the patient experienced 2 black dots. On 2nd August 2017, the patient received another dose of HIBERIX. The physician found a way to change the needle so the patient would not have a black dot. There was no black dot with the administration on 2nd August 2017 because the physician used a different needle for the reconstitution step. The reporter denied permission to be contacted for follow up.
Age: 12.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: Induration and redness at the site of injections.
Age: 34.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Erythema, Injected limb mobility decreased, Pain in extremity, Spinal pain, Urticaria
Clinical narrative: Patient called pharmacy at approximately 12 pm the day following the immunization administration. She was given the vaccine at about 3 pm on 08/10/17. Patient reports redness and a whelp on left arm that radiates downward. She endorses pain and limited movement in her arm. Patient also reported pain in her spine after she received the vaccination and was waiting in store, but this was not reported before leaving. Pharmacist recommendations are for the patient to take diphenhydramine and acetaminophen and use cold compress. Counseled patient to see primary physician if symptoms worsen or if additional symptoms present such as body aches or fever. She indicated that she does not currently have a doctor, so she has been directed to go to the ED if necessary.
Age: 18.0
Sex: F
Vaccine: HEPA, MENB, MNQ
Symptoms: Diarrhoea haemorrhagic, Nausea, Pain in extremity, Pyrexia
Clinical narrative: One hour after vaccine administration at 2;15pm client experienced fever 100.3oF progressed to bloody diarrhea X 3 and nausea with increasing fever to 102.4oF given Ibuprofen and by 7pm temperature down to 99oF no further diarrhea. next morning felt better with sore right arm no redness or swelling at injection sites.
Age: 58.0
Sex: M
Vaccine: PNC13
Symptoms: Injection site pain, Vomiting
Clinical narrative: By evening my arm around injection site was very sore, on the second day my entire upper arm up into my neck was so sore I didn't want to move the arm. The next morning I was stricken with sudden onset vomiting.
Age: 12.0
Sex: F
Vaccine: DTAP, MNQ
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: Client was given DTaP vaccine on this date. Based on clients age, the Tdap should have been administered instead.
Sex: U
Vaccine: VARZOS
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a pharmacist referring to an unspecified number of unspecified patients of unknown age and gender. On an unknown date, an unspecified number of patients were vaccinated with improperly stored doses of ZOSTAVAX, 19400 plaque forming units (PFU),(dose, route of administration were not reported), lot # N011366, expiration date 12-MAR-2018, for prophylaxis. Concomitant therapies included sterile diluent (manufacturer unknown). No adverse event was reported. The doses of ZOSTAVAX were exposed to a temperature excursion of 15 degrees Fahrenheit (°F) to 46°F (19 °F) during a time frame of 1 hour 15 minutes. Digital data logger was not involved. No previous temperature excursion was reported.
Sex: F
Vaccine: VARZOS
Symptoms: Decreased immune responsiveness, Herpes zoster, Pain, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. On or about 01-SEP-2015, the patient was vaccinated with ZOSTAVAX, (lot# and route unknown), as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. During March of 2016, the patient was treated by a physician for the onset of a severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as herpes zoster, or shingles. As a direct and proximate result of 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.