chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Erythema
Clinical narrative: Case number PHHY2016US162033, is an initial spontaneous report received from a health care professional via Vaccine Adverse Event Reporting System (VAERS reference number: 644823 and 644838) website on 21 Nov 2016 (combined report). This report refers to an adult female patient. Prior vaccination history included as, patient was vaccinated with first dose of seasonal influenza vaccine INN (manufacturer and batch number: not reported) and had reaction of erythema and redness down her arm on an unknown date (see case US2016GSK098540/PHHY2016US162066). Past medical history and concomitant medications were not reported. The patient was vaccinated with second dose of seasonal influenza vaccine INN (manufacturer and batch number: not reported) on an unspecified date. On an unknown date after vaccination, the patient experienced generalized urticaria and hives all over her body. The outcome of the event was reported as complete recovery on an unknown date. The seriousness of the event was reported as non serious. The causality of the event was not reported. Seriousness assessment of urticaria was upgraded to serious (medically significant) based on the information available in the source document.
Age: 40.0
Sex: M
Vaccine: FLUX, PPV
Symptoms: Chills, Pain in extremity, Pyrexia
Clinical narrative: Case number PHHY2016US162731, is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 655490) website on 21 Nov 2016. This report refers to a 40 years old male patient. Past medical history included as polycythemia vera, antiphospholipid syndrome and long QT. Current condition included as sulfa drug allergy. Concomitant medications included as LOVENOX, nadolol and PEGASYS. The patient was vaccinated with seasonal influenza vaccine INN (manufacturer and batch number: not reported) into left arm, intramuscularly on 26 Sep 2016. The patient also vaccinated with pneumococcal vaccine (other manufacture, batch number: not reported) (reported as Pneumo vaccine) into right arm, intramuscularly on 26 Sep 2016. On the same day after vaccination, the patient experienced extremely high fever with body temperature 104.2 (unit unspecified) and chills, severe arm pain in injection-site arm. The outcome of the events was reported as complete recovery on an unknown date. The seriousness of the events was reported as non serious. The causality of the events was not reported. Seriousness assessment of chills and pyrexia was upgraded to serious (medically significant) based on the information available in the source document.
Age: 12.0
Sex: M
Vaccine: FLUX
Symptoms: Urticaria
Clinical narrative: Case number PHHY2016US161665, is an initial spontaneous report received from a Vaccine Adverse Event Reporting System (VAERS reference number: 656509) website on 21 Nov 2016. This report refers to a 12 years old male patient. Past medical history and concomitant medications were not reported. The patient was vaccinated with seasonal influenza vaccine INN (manufacturer and batch number: not reported) into right arm, intramuscularly on 01 Oct 2016. On the same day after vaccination, the patient experienced hives all over body, no trouble breathing and treated with oral cetirizine 10 mg. The outcome of the event was reported as condition unchanged. The seriousness of the event was reported as non serious. The causality of the event was not reported. Seriousness assessment of urticaria was upgraded to serious (medically significant) based on the information available in the source document.
Sex: M
Vaccine: FLUX
Symptoms: Facial paralysis
Clinical narrative: Case number PHHY2016US161570, an initial spontaneous report received from a Vaccine Adverse Event Reporting System (VAERS reference number: 657495) website on 21 Nov 2016. This report refers to an  unknown age of male patient. Past medical history and concomitant medications were not reported. The patient was vaccinated with seasonal influenza vaccine INN (manufacturer and batch number: not reported) on an unspecified date in 2013. The patient experienced Bell's Palsy on an unknown date in 2013. The outcome, seriousness and causality of the event were not reported. Seriousness assessment of facial paralysis was upgraded to serious (medically significant) based on the NVS IME list.
Sex: M
Vaccine: FLU3
Symptoms: Abdominal pain upper, Chills, Myalgia, Oropharyngeal pain, Pyrexia
Clinical narrative: Initial unsolicited report received from physician on 23-Jan-2017. This case involves a male patient (age not reported) vaccinated with dose of FLUZONE HD (Batch number, expiration date, dose in series, route and site of administration were not reported) on an unspecified date. Patient's medical history and concomitant medications were not reported. On an unknown date, six hours following the vaccination, the patients experienced chills, myalgia, low grade fever, sore throat and stomach ache. Laboratory examinations were not reported. Corrective treatment were not reported. On an unknown date patient got recovered from the events which lasted for 12 hours. List of documents held by sender: none.
Age: 51.0
Sex: F
Vaccine: FLU4
Symptoms: CSF test, Myelitis transverse, Nervous system disorder, Nuclear magnetic resonance imaging spinal
Clinical narrative: Admitted to hospital on 9-26-15 Eventually DX with Transverse Myelitis with Marked neurological impairment.
Age: 62.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Bone pain, Chest pain, Chills, Dyspnoea, Electrocardiogram
Clinical narrative: Information was received on 12-JAN-2017 from a licensed practical nurse regarding a 62 year old female patient with a medical history of hypertension, dyslipidemia, tinea corporis, carotid artery disease and weakened immune system. The patient had drug allergies to ROCEPHIN; codeine, KEFLEX; sulfa; and SUDAFED. Concomitant medications included losartan and pravastatin. The nurse reported that the patient received PNEUMONIA 23 (lot # L038669, expiration date 11-AUG-2017) on 08-DEC-2016. The nurse was not sure but she did not think the patient received any previous doses of received PNEUMONIA 23. The nurse reported that on 09-DEC-2016 the patient experienced chest pain. Additionally, the vaccinated arm was sore, weak, had edema and had limited range of motion. The patient also experienced "delayed fever", chills, bone pain, fatigue and "foot discoloration" of both feet. The patient went to the office on 13-DEC-2016 because of her symptoms. The patient had a physical exam and electrocardiogram (EKG) by the physician. The patient was instructed to treat herself with over-the-counter BENADRYL. The office had not heard from the patient since her appointment on 13-DEC-2016. No further information was provided. Additional information has been requested.
Age: 62.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Eye pain, Fatigue, Injected limb mobility decreased, Muscular weakness, Oedema peripheral
Clinical narrative: Information was received on 12-JAN-2017 from a licensed practical nurse regarding a 62 year old female patient with a medical history of hypertension, dyslipidemia, tinea corporis, carotid artery disease and weakened immune system. The patient had drug allergies to ROCEPHIN; codeine, KEFLEX; sulfa; and SUDAFED. Concomitant medications included losartan and pravastatin. The nurse reported that the patient received PNEUMONIA 23 (lot # L038669, expiration date 11-AUG-2017) on 08-DEC-2016. The nurse was not sure but she did not think the patient received any previous doses of received PNEUMONIA 23. The nurse reported that on 09-DEC-2016 the patient experienced chest pain. Additionally, the vaccinated arm was sore, weak, had edema and had limited range of motion. The patient also experienced "delayed fever", chills, bone pain, fatigue and "foot discoloration" of both feet. The patient went to the office on 13-DEC-2016 because of her symptoms. The patient had a physical exam and electrocardiogram (EKG) by the physician. The patient was instructed to treat herself with over-the-counter BENADRYL. The office had not heard from the patient since her appointment on 13-DEC-2016. No further information was provided. Additional information has been requested.
Age: 62.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Pain in extremity, Pyrexia, Skin discolouration
Clinical narrative: Information was received on 12-JAN-2017 from a licensed practical nurse regarding a 62 year old female patient with a medical history of hypertension, dyslipidemia, tinea corporis, carotid artery disease and weakened immune system. The patient had drug allergies to ROCEPHIN; codeine, KEFLEX; sulfa; and SUDAFED. Concomitant medications included losartan and pravastatin. The nurse reported that the patient received PNEUMONIA 23 (lot # L038669, expiration date 11-AUG-2017) on 08-DEC-2016. The nurse was not sure but she did not think the patient received any previous doses of received PNEUMONIA 23. The nurse reported that on 09-DEC-2016 the patient experienced chest pain. Additionally, the vaccinated arm was sore, weak, had edema and had limited range of motion. The patient also experienced "delayed fever", chills, bone pain, fatigue and "foot discoloration" of both feet. The patient went to the office on 13-DEC-2016 because of her symptoms. The patient had a physical exam and electrocardiogram (EKG) by the physician. The patient was instructed to treat herself with over-the-counter BENADRYL. The office had not heard from the patient since her appointment on 13-DEC-2016. No further information was provided. Additional information has been requested.
Age: 62.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Bone pain, Chest pain, Chills, Electrocardiogram, Fatigue
Clinical narrative: Information was received on 12-JAN-2017 from a licensed practical nurse regarding a 62 year old female patient with a medical history of hypertension, dyslipidemia, tinea corporis, carotid artery disease and weakened immune system. The patient had drug allergies to ROCEPHIN; codeine, KEFLEX; sulfa; and SUDAFED. Concomitant medications included losartan and pravastatin. The nurse reported that the patient received PNEUMONIA 23 (lot # L038669, expiration date 11-AUG-2017) on 08-DEC-2016. The nurse was not sure but she did not think the patient received any previous doses of received PNEUMONIA 23. The nurse reported that on 09-DEC-2016 the patient experienced chest pain. Additionally, the vaccinated arm was sore, weak, had edema and had limited range of motion. The patient also experienced "delayed fever", chills, bone pain, fatigue and "foot discoloration" of both feet. The patient went to the office on 13-DEC-2016 because of her symptoms. The patient had a physical exam and electrocardiogram (EKG) by the physician. The patient was instructed to treat herself with over-the-counter BENADRYL. The office had not heard from the patient since her appointment on 13-DEC-2016. No further information was provided. Additional information has been requested.
Age: 62.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Injected limb mobility decreased, Muscular weakness, Oedema peripheral, Pain in extremity, Pyrexia
Clinical narrative: Information was received on 12-JAN-2017 from a licensed practical nurse regarding a 62 year old female patient with a medical history of hypertension, dyslipidemia, tinea corporis, carotid artery disease and weakened immune system. The patient had drug allergies to ROCEPHIN; codeine, KEFLEX; sulfa; and SUDAFED. Concomitant medications included losartan and pravastatin. The nurse reported that the patient received PNEUMONIA 23 (lot # L038669, expiration date 11-AUG-2017) on 08-DEC-2016. The nurse was not sure but she did not think the patient received any previous doses of received PNEUMONIA 23. The nurse reported that on 09-DEC-2016 the patient experienced chest pain. Additionally, the vaccinated arm was sore, weak, had edema and had limited range of motion. The patient also experienced "delayed fever", chills, bone pain, fatigue and "foot discoloration" of both feet. The patient went to the office on 13-DEC-2016 because of her symptoms. The patient had a physical exam and electrocardiogram (EKG) by the physician. The patient was instructed to treat herself with over-the-counter BENADRYL. The office had not heard from the patient since her appointment on 13-DEC-2016. No further information was provided. Additional information has been requested.
Age: 62.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Skin discolouration
Clinical narrative: Information was received on 12-JAN-2017 from a licensed practical nurse regarding a 62 year old female patient with a medical history of hypertension, dyslipidemia, tinea corporis, carotid artery disease and weakened immune system. The patient had drug allergies to ROCEPHIN; codeine, KEFLEX; sulfa; and SUDAFED. Concomitant medications included losartan and pravastatin. The nurse reported that the patient received PNEUMONIA 23 (lot # L038669, expiration date 11-AUG-2017) on 08-DEC-2016. The nurse was not sure but she did not think the patient received any previous doses of received PNEUMONIA 23. The nurse reported that on 09-DEC-2016 the patient experienced chest pain. Additionally, the vaccinated arm was sore, weak, had edema and had limited range of motion. The patient also experienced "delayed fever", chills, bone pain, fatigue and "foot discoloration" of both feet. The patient went to the office on 13-DEC-2016 because of her symptoms. The patient had a physical exam and electrocardiogram (EKG) by the physician. The patient was instructed to treat herself with over-the-counter BENADRYL. The office had not heard from the patient since her appointment on 13-DEC-2016. No further information was provided. Additional information has been requested.
Age: 23.0
Sex: F
Vaccine: HEP, VARCEL
Symptoms: Cyst, Lymphadenopathy
Clinical narrative: Either a small cyst or swollen lymph node that last for more than three weeks, worsened after the second dose of HepB and Varicella on 1/30/2017; observing for 4 more weeks.
Sex: U
Vaccine: FLU4
Symptoms: Asthma, Bronchitis, Cardiac disorder, Influenza, Osteoporosis
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a patient who received Seasonal Influenza vaccine. Co-suspect products included ADVAIR DISKUS inhalation powder for drug use for unknown indication. On an unknown date, the patient received Seasonal Influenza vaccine at an unknown dose and ADVAIR DISKUS 250/50 ug at an unknown dose and frequency. On an unknown date, the dose was changed to an unknown dose and frequency. In December 2016, an unknown time after receiving Seasonal Influenza vaccine and not applicable after starting ADVAIR DISKUS, the patient experienced vaccination failure (serious criteria GSK medically significant) and influenza. On an unknown date, the patient experienced pneumonia (serious criteria GSK medically significant), osteoporosis, heart disorder, bronchitis and asthma. The patient was treated with Albuterol. ADVAIR DISKUS was discontinued (Dechallenge was unknown). Rechallenge with ADVAIR DISKUS was unknown. On an unknown date, the outcome of the vaccination failure, pneumonia, osteoporosis, influenza, heart disorder, bronchitis and asthma were unknown. It was unknown if the reporter considered the vaccination failure, influenza, bronchitis and asthma to be related to Seasonal Influenza vaccine. It was unknown if the reporter considered the pneumonia, osteoporosis and heart disorder to be related to ADVAIR DISKUS. Additional details were provided as follows: The age at vaccination was not reported. The patient had been receiving ADVAIR 100/50 and also 250/50 since the mid 1990's. Over time the patient have developed an electrical heart problem and last year she was diagnosed with osteoporosis. It had worked well for her most of the time, but she have had bouts of pneumonia several times and resorted to using her home nebulizer with Albuterol. The patient voluntarily decided to quit using ADVAIR about a month before reporting date (was on the 100) and since had the flu (even though she had received the flu shot) and eventually bronchitis. At the reporting time, the patient was at a point where she cannot differentiate between if she had bronchitis or asthma. The patient's pulmonologist cannot see her until 14th February 2017. The patient inquired if she had used ADVAIR for too long. The patient would like to be armed with some information before she have her appointment with pulmonologist doctor. This case was considered suspected vaccination failure for influenza vaccine since the time to onset of the events and confirmatory lab test details were not provided.
Sex: U
Vaccine: FLU4
Symptoms: Pneumonia, Vaccination failure
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a patient who received Seasonal Influenza vaccine. Co-suspect products included ADVAIR DISKUS inhalation powder for drug use for unknown indication. On an unknown date, the patient received Seasonal Influenza vaccine at an unknown dose and ADVAIR DISKUS 250/50 ug at an unknown dose and frequency. On an unknown date, the dose was changed to an unknown dose and frequency. In December 2016, an unknown time after receiving Seasonal Influenza vaccine and not applicable after starting ADVAIR DISKUS, the patient experienced vaccination failure (serious criteria GSK medically significant) and influenza. On an unknown date, the patient experienced pneumonia (serious criteria GSK medically significant), osteoporosis, heart disorder, bronchitis and asthma. The patient was treated with Albuterol. ADVAIR DISKUS was discontinued (Dechallenge was unknown). Rechallenge with ADVAIR DISKUS was unknown. On an unknown date, the outcome of the vaccination failure, pneumonia, osteoporosis, influenza, heart disorder, bronchitis and asthma were unknown. It was unknown if the reporter considered the vaccination failure, influenza, bronchitis and asthma to be related to Seasonal Influenza vaccine. It was unknown if the reporter considered the pneumonia, osteoporosis and heart disorder to be related to ADVAIR DISKUS. Additional details were provided as follows: The age at vaccination was not reported. The patient had been receiving ADVAIR 100/50 and also 250/50 since the mid 1990's. Over time the patient have developed an electrical heart problem and last year she was diagnosed with osteoporosis. It had worked well for her most of the time, but she have had bouts of pneumonia several times and resorted to using her home nebulizer with Albuterol. The patient voluntarily decided to quit using ADVAIR about a month before reporting date (was on the 100) and since had the flu (even though she had received the flu shot) and eventually bronchitis. At the reporting time, the patient was at a point where she cannot differentiate between if she had bronchitis or asthma. The patient's pulmonologist cannot see her until 14th February 2017. The patient inquired if she had used ADVAIR for too long. The patient would like to be armed with some information before she have her appointment with pulmonologist doctor. This case was considered suspected vaccination failure for influenza vaccine since the time to onset of the events and confirmatory lab test details were not provided.
Age: 40.0
Sex: F
Vaccine: VARZOS
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Information has been received on 06-JAN-2017 from a medical assistant regarding a 40 year old female patient. The patient's concurrent conditions, medical history and concomitant medications were not reported. The medical assistant reported that the patient, currently 52 years old, stated that she received ZOSTAVAX, (lot number and expiration not reported) reported as "zoster vaccine" for prophylaxis when she was 40 years old on an unspecified date (approximately 2005) at an unspecified medical facility. No adverse effects reported. No further information was reported. Additional information has been requested.
Age: 86.0
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a 86 year old patient of unknown gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On an unspecified date, the patient was to receive an unspecified injection for an unspecified coexisting condition which may caused shingles. On 09-JAN-2017, the patient was vaccinated with an expired dose of ZOSTAVAX lot # L006392, expiration date 25-MAY-2016. No adverse effects were reported. Additional information has been requested.
Sex: F
Vaccine: HPVX
Symptoms: Injection site pain
Clinical narrative: Information was identified on the internet, from the mother of an 11 year old female patient with a family history of ovarian, uterine, and cervical issues.  The mother reported that her daughter "just got hers this year," referring to being vaccinated with an unspecified human papillomavirus vaccine (manufacturer, lot number, dosage, and route of administration not provided).  The mother reported that her daughter had no issue other than some lingering injection site soreness.  The outcome of the lingering injection site soreness was not provided.  No further adverse event information was reported. Additional information is not expected.
Sex: M
Vaccine: PNC13
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a 66-year-old male patient. The patient medical history included vaccination with a dose of PREVNAR 13 on an unknown date in 2015. There was no information about his concurrent conditions, drug reactions or allergies provided. On an unknown date in 2016, the patient was vaccinated with a dose of PREVNAR 13 instead of prescribed PNEUMOVAX 23 (dose, route of administration, anatomical location, lot# and expiration date were not reported) as an effect of miscommunication between the physician and medical assistant. No symptoms were reported. Product quality complaint (PQC) was not reported. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Contraindication to vaccination, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist technician referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not reported. On January 2017 (reported as " a couple hours ago), the patient who was on therapy with ixekizumab (TALTZ) 80 mg (lot number, expiration date, strength, frequency, route of administration were not reported) an immunosuppressant injection, was administered a dose of ZOSTAVAX 19400 PFU lot # M033910, expiration date: 17-OCT-2017 (dose, strength, frequency and route of administration were not reported) for prophylaxis. No untoward effects noted. Additional information has been requested.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: No adverse event, Syringe issue, Underdose
Clinical narrative: This spontaneous report was received from a registered pharmacist and refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions, allergies and concomitant medications were not reported. On unknown date, the patient was vaccinated with less than a full dose of ZOSTAVAX injection (dose, route of administration, lot# and expiration date were not reported). The vaccine leaked out of the syringe during administration. No adverse symptoms were reported. Product quality complaint (PQC) was not involved. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a physician and refers to a 17-year-old female patient. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On an unknown date approximately in January 2016 (reported as "a year ago") and on 13-JAN-2017, the patient was vaccinated respectively with the first and second dose of GARDASIL injection (lot # of second dose of vaccine M014929 with expiry date of 27-MAY-2016, dose and route of administration were not reported). There were no adverse effects reported. No product quality complaint was involved. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a Licensed Practical Nurse referring to an unspecified number of patients of unknown age and gender. The patients medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not reported. On an unknown date, the patients were vaccinated with improperly stored dose of GARDASIL 9, Lot number reported as M026306, expiration date: 30-APR-2018 (strength, dose, frequency and route of administration were not reported), for prophylaxis with a temperature excursion of >0 but < 2 degrees Celsius for 49 hours and 5 minutes. Additionally, this excursion was detected due to a digital data logger and there was no previous temperature excursion reported. No adverse symptoms reported. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1701USA006813: US-009507513-1701USA006818.
Sex: U
Vaccine: HEP, HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant refers to 9 adult patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On 17-JAN-2017, the patients were vaccinated with improperly stored doses of VAQTA from lot # M039055  with expiry: 22-JUL-2018 and lot# M034893 with expiry: 26-MAY-2017 and RECOMBIVAX HB from lot# M040422 with expiry: 07-JUL-2019 and lot# M033096 with expiry: 31-MAY-2018. It was unable to determine what specific lots were administered. No adverse effect reported. The vaccines lots were exposed to a temperature of 35 degree Fahrenheit for 40 minutes and they did not have previous temperature excursion. The temperature excursion was determined by data logger. No product quality compliant (PQC) involved. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant, referring to a patient of unknown age and gender. The patient's medical history or concurrent conditions were not reported. On 20-JAN-2017, the patient was vaccinated with VAQTA (which had the lot # L030442, expiration date 19-DEC-2016 (expired product administered)) for prophylaxis (dosage details, route or strength were not informed). Information regarding concomitant medication was not provided.  No adverse effects were reported. There was no product quality complaint involved. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions, drug reactions/allergies and concomitant therapies were not reported. On an unknown date, the patient was vaccinated with GARDASIL 9 lot # M013636, expiration date: 15-FEB-2018, intramuscularly route per reporter (strength, dose and frequency were not reported) for prophylaxis, which was improperly stored at 32 and 36 Farenheit degrees for an unknown time. This excursion was detected due to a digital data logger, however no previous temperature excursion was reported.  No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1701USA013133: US-009507513-1701USA013134: US-009507513-1701USA013139: US-009507513-1701USA013136: US-009507513-1701USA013137: US-009507513-1701USA013138: US-009507513-1701USA010177: US-009507513-1701USA013135.
Sex: F
Vaccine: VARZOS
Symptoms: Expired product administered, Injection site reaction, Rash pruritic
Clinical narrative: This spontaneous report was received from a pharmacist via a company representative and refers to a female patient. The patient had no concomitant medications, pertinent medical history, drug reactions nor allergies. On 25-JAN-2017, the patient was vaccinated with a dose of ZOSTAVAX injection, in arm, lot# reported as M036296, expiry date 14-NOV-2014 (dose and route of administration were not reported) for shingles prevention. On the same date, the patient experienced an injection site reaction: she developed an itchy rash and bumps on the arm vaccinated. The pharmacist advised the patient to follow up with her primary physician however it was not known if the patient contacted her physician for treatment or not. At the time of the report, no treatment was given for the events. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Wrong drug administered
Clinical narrative: This spontaneous report was received from a physician via a company representative referring to a 25 year old female patient.  No information about the patient's medical history, concurrent conditions or concomitant medications was provided. On an unknown date, the patient was supposed to receive a dose of VARIVAX but accidentally was vaccinated with a dose of ZOSTAVAX (wrong drug administered), subcutaneously, for prophylaxis (dose, frequency, lot number and expiration date were not provided) (product use issue). No product quality complaint (PQC) was involved. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On 27-JAN-2017, the patient was vaccinated with an improperly stored dose of RECOMBIVAX HB injection, lot # L042846, expiration date 15-SEP-2017 (route and site of administration were not reported). No adverse effects were reported. The administered dose of RECOMBIVAX HB was stored in the temperature above 46 degrees Fahrenheit but below 77 degrees Fahrenheit for 5 hours and 45 minutes. Data logger was involved. There were no previous temperature excursions reported. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant and refers to 24 unspecified patients of unknown ages and genders. No pertinent medical history, drug reactions/ allergies or concurrent conditions were reported. On an unknown date, the patients were vaccinated with a dose of improperly stored LIQUID PEDVAXHIB which had a lot  # M027883 and an expiration date of 15-APR-2019; however, dosage number and route of administration were not reported), for prophylaxis. Nevertheless, no adverse effects were reported. The vaccines experienced the following temperature excursions during 5 minutes: 9 grades centigrade. Reportedly, there had been no previous temperature excursions and the aforementioned ones were identified due to a data logger. Furthermore, no product quality complaint was involved. This is one of several reports received from the same source.  Additional information has been requested.; Sender's Comments: US-009507513-1701USA006026: US-009507513-1701USA014268:
Age: 0.33
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report has been received from a licensed practical nurse refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies, drug reactions or allergies and medical history provided. On 31-JAN-2017, the patient was inadvertently administered improperly stored ROTATEQ oral liquid, lot # M031807, expiration date 02-APR-2018 (dose was not reported). No adverse effects were reported. The vaccine experienced a temperature excursion of 50 Fahrenheit degrees (F) for 20 minutes, which was detected by a digital data logger. There was no previous temperature excursion. No product quality complaint was involved. Additional information has been requested.
Age: 40.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Initial unsolicited report received from a patient on 19 January 2017. This case involves a female patient (onset age unknown) who was vaccinated with 0.5 ml dose of TETANUS TOXOID (TETANUS TOXOID) (batch number: USS21BA, expiry date: 10 December 2018, dose in series were not reported) in the left arm on 26 December 2016. Concomitant medications were not reported. On an unknown date, unspecified timeframe following the vaccination, the patient had developed swelling at the injection site which was red warm to touch and very sore and covered half of the arm. The patient required emergency room (ER)/ doctor visit on an unknown date. Laboratory investigations were not reported. Corrective treatment was prescribed as antibiotic. The outcome of event was reported as unknown. List of documents held by sender: none.
Age: 23.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site bruising, Injection site erythema
Clinical narrative: Initial unsolicited report received from a Nurse on 23 January 2017. This case involves a 24-year-old female patient who was vaccinated with a first dose of ADACEL (batch number: U5521BA, expiry date: 10 December 2018, dose and dose in series were not reported) in left deltoid on 17 January 2016. Patient's medical history as pre-existing physician diagnosed allergies, birth defects, medical conditions (specify) and Illness at the time of vaccination were reported as none. Concomitant medications were not reported. Any other vaccinations within four weeks of vaccinations were reported as none. On 22 January 2016, 5 days of following the vaccination, the patient's left arm was bruised and had a large red area of 4.5 inches long and about 3 inches wide with bruising at the injection site. The patient required emergency room (ER)/ doctor visit. Laboratory investigations was reported as none. The patient had received CLARITIN and BENADRYL and apply cool compresses as a corrective treatment. The outcome of the events were reported as not recovered. List of documents held by sender: none.
Age: 18.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Discomfort, Erythema, Injection site erythema, Injection site pain, Injection site reaction
Clinical narrative: Intense pain and heaviness on right deltoid the injection site starting on 1/24/17 7pm, noted large patch of redness around injection site as well as a erythematous streak radiated from right deltoid to right axilla.
Age: 45.0
Sex: F
Vaccine: HEP, HEPA
Symptoms: Dyspnoea, Fatigue, Ill-defined disorder, Pain, Pharyngeal oedema
Clinical narrative: Client reports tongue and throat swollen. Slight difficulty breathing. White spots in back of throat. Client took one Benadryl with no effect and then took 2 more Benadryl 1 hour later. Reports tiredness and fatigue, overall body aches. client reports sleeping for 10 hours. This morning symptoms of tongue swelling ,"not as bad as yesterday, but still swollen", and "breathing is not that bad" per client. Otherwise unchanged and client took 1 more Benadryl this morning 2/1/2017. Referred client to an Urgent Care or primary doctor. Advised some side effects could possibly be from vaccines or possibly from other sources. Also advised if she were truly having difficulty breathing to call 911.
Age: 45.0
Sex: F
Vaccine: HEP, HEPA
Symptoms: Swollen tongue
Clinical narrative: Client reports tongue and throat swollen. Slight difficulty breathing. White spots in back of throat. Client took one Benadryl with no effect and then took 2 more Benadryl 1 hour later. Reports tiredness and fatigue, overall body aches. client reports sleeping for 10 hours. This morning symptoms of tongue swelling ,"not as bad as yesterday, but still swollen", and "breathing is not that bad" per client. Otherwise unchanged and client took 1 more Benadryl this morning 2/1/2017. Referred client to an Urgent Care or primary doctor. Advised some side effects could possibly be from vaccines or possibly from other sources. Also advised if she were truly having difficulty breathing to call 911.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Pruritus, Rash, Skin warm, Swelling
Clinical narrative: Swelling, rash, itching, warm worsened for 3 days, then started to go away.  5th day, almost gone, still red and itches a bit, still swollen a bit.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical histories provided. On an unknown date, the patient was vaccinated with an improperly stored PNEUMOVAX 23 lot # M037533 with an expiration date of 17-MAY-2018 (dose and route of administration were not reported). No adverse effects were reported. Administered vaccine underwent the temperature excursion between 8 degrees Celsius to below 25 degrees Celsius (reported as ">8°C but <25°C") for 10 minutes which was detected by a data logger. There were no previous excursions reported. 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 pharmacist and refers to multiple, unspecified patients of unknown age and gender. No information about the patients' medical history, concurrent conditions, drug reactions or allergies and concomitant therapies was provided.   On unknown dates, the patients were vaccinated with improperly stored VARIVAX injection (lot#, expiration date, dose and route of administration were not reported). The vaccine underwent previous temperature excursions. The number of previous excursions, time frames and values of incorrect temperature were unknown. No adverse effects were reported. Digital data logger was used. Product quality complaint was not involved. This is one of two reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1702USA000237:
Age: 25.0
Sex: M
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a nurse and refers to a 25 year old male patient. No information about the patient's medical history, concurrent conditions, drug reactions or allergies and concomitant therapies was provided. On 14-DEC-2016, the patient was vaccinated with the first dose of GARDASIL 9 injection (lot#, expiration date, dose and route of administration were not provided). On 17-JAN-2017, the patient was vaccinated with the second dose of GARDASIL 9 injection (lot#, expiration date, dose and route of administration were not provided). No adverse effect was reported. Product quality complaint was not involved. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This is a spontaneous case received from a male consumer of unknown age who received his first dose of  ZOSTAVAX on and unknown date. The patient reported that he had received the ZOSTAVAX vaccine about 3 years ago and then three years later he developed shingles. No further information was reported. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a state vaccine official concerning a patient of unknown age and gender. The patient's medical history, concurrent conditions, allergies and concomitant therapies were not reported. On an unknown date, the patient was vaccinated with an improperly stored dose of GARDASIL 9 for prophylaxis (lot # M023169) (dose, frequency, route of administration, expiration date, and batch # were not reported). There were no adverse effects reported. The dose of the vaccine was exposed to a temperature of -4 degree Celsius (C) (below 32 degrees Fahrenheit/0 degree C) for a time frame of 78 hours. There were no previous temperature excursions. A digital data logger was involved. Furthermore, No product quality complaint (PQC) was involved. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Vulvovaginal warts
Clinical narrative: This spontaneous report was received from a nurse prescriber via a company representative and refers to a 20 year old non-pregnant female patient. There was no information about the patient's concomitant medications, allergies and pertinent medical history reported. On an unknown dates in 2008, the patient was vaccinated with all three doses in the GARDASIL series, injection, (dose, route of administration, lot#, expiry date and anatomical location were not reported) to prevent human papillomavirus. On an unknown date, the patient experienced vaginal warts. On 26-JAN-2017, the patient sought medical attention in the nurse prescriber's office. At the time of the report, the patient did not recover and was still experiencing the warts. The relatedness between the event and GARDASIL was not reported. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist and refers to multiple, unspecified patients of unknown age and gender. No information about the patients' medical history, concurrent conditions, drug reactions or allergies and concomitant therapies was provided.   On unknown dates, the patients were vaccinated with improperly stored ZOSTAVAX injection (lot#, expiration date, dose and route of administration were not reported). The vaccine underwent previous temperature excursions. The number of previous excursions, time frames and values of incorrect temperature were unknown. No adverse effects were reported. Digital data logger was used. Product quality complaint was not involved. This is one of two reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1701USA008441:
Sex: U
Vaccine: FLU3
Symptoms: Injection site pain
Clinical narrative: Initial unsolicited report received from a pharmacist on 20 January 2017. This case involves three patients (onset age and gender was unknown) who were vaccinated with an unknown dose of FLUZONE HD (batch number reported as UI666AB and UI692AA, expiry date was unknown, dose in series were not reported) in an unknown site on an unknown date. Concomitant medications were not reported. On an unknown date, unspecified timeframe following the vaccination, the patients had developed pain in the injection site. The patients required emergency room (ER)/ doctor visit was not reported. Laboratory investigations and corrective treatment were not reported. The outcome of event was reported as ongoing (not recovered). List of documents held by sender: none.
Age: 0.75
Sex: F
Vaccine: FLU4
Symptoms: Laboratory test, Malaise, Type 1 diabetes mellitus
Clinical narrative: Very sick, almost lost her life was diagnosed with Type 1 Diabetes on January 1st. Does not run in family. I know vaccine triggered this, since she was perfectly healthy.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV
Symptoms: Crying, Decreased activity, Decreased appetite, Vomiting
Clinical narrative: Started crying for no reason for about 30mins then sat very still as if about to fall asleep. Loss of appetite. Woke at 2AM 1/27/17 vomiting 5 times in first hour and a half then every 20 mins following until 7:40AM then again 3:30PM then again 9:35PM and 10PM. Appetite returned 1/29/17. Patient had never vomited before this.
Age: 2.0
Sex: M
Vaccine: FLU4, FLU4
Symptoms: Agitation, Polydipsia, Thirst, Type 1 diabetes mellitus
Clinical narrative: Thirsty, drinking a lot, agitated.
Age: 2.0
Sex: M
Vaccine: FLU4, FLU4
Symptoms: Blood glucose increased, Type 1 diabetes mellitus
Clinical narrative: Thirsty, drinking a lot, agitated.
Age: 30.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Lymphadenopathy, Peripheral swelling, Pyrexia
Clinical narrative: SWOLLEN LYMPH NODES, SWOLLEN ARM, FEVER, ERYTHEMA
Age: 85.0
Sex: F
Vaccine: PNC
Symptoms: Back pain, Sleep disorder
Clinical narrative: PATIENT WAS AWAKEN AT NIGHT TIME WITH PAIN IN BACK FROM SHOULDER TO SHOULDER. THE PAIN WAS RELIEVED BY 3 TYLENOL TABLETS HOWEVER WHEN SHE WOKE UP, THE PAIN RETURNED.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site reaction
Clinical narrative: Large, localized injection site reaction. Told patient to apply cold compresses.
Age: 15.0
Sex: F
Vaccine: FLU4
Symptoms: Contusion, Depressed level of consciousness, Face injury, Fall, Lip discolouration
Clinical narrative: Patient was sitting on exam table in room 1. She had received a TB test placement without difficulty, also received influenza vaccine injection into left deltoid without difficulty. Patient exhibited no symptoms and was talking to mom. Patient did not state that she was feeling faint. Patient suddenly fell from exam table from sitting position and hit face on floor. Patient was unable to be aroused to consciousness for approximately 30-60 seconds. Palpable carotid pulse, breathing was visible via chest movements, color pale, lips dusky. Patient aroused to verbal commands at 4:19 PM, oriented to person, place and situation. Reported nasal pain and on forehead upon arousal. Erythema of nasal bridge noted and mild nasal bruising. Denied pain other locations, Moving head freely. 911 called immediately at 4:20 PM with arrival at 4:25 PM. Patient able to stand and walk to EMS cart. Conversation appropriate. Taken by EMS personnel to ER for evaluation. Mom present with patient during entire situation. EMS squad updated on events.
Age: 15.0
Sex: F
Vaccine: FLU4
Symptoms: Pallor
Clinical narrative: Patient was sitting on exam table in room 1. She had received a TB test placement without difficulty, also received influenza vaccine injection into left deltoid without difficulty. Patient exhibited no symptoms and was talking to mom. Patient did not state that she was feeling faint. Patient suddenly fell from exam table from sitting position and hit face on floor. Patient was unable to be aroused to consciousness for approximately 30-60 seconds. Palpable carotid pulse, breathing was visible via chest movements, color pale, lips dusky. Patient aroused to verbal commands at 4:19 PM, oriented to person, place and situation. Reported nasal pain and on forehead upon arousal. Erythema of nasal bridge noted and mild nasal bruising. Denied pain other locations, Moving head freely. 911 called immediately at 4:20 PM with arrival at 4:25 PM. Patient able to stand and walk to EMS cart. Conversation appropriate. Taken by EMS personnel to ER for evaluation. Mom present with patient during entire situation. EMS squad updated on events.
Age: 23.0
Sex: F
Vaccine: SMALL
Symptoms: Rash generalised, Viral test negative
Clinical narrative: Diffuse rash after smallpox inoculation.
Age: 0.33
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Abdominal X-ray, Barium double contrast, Haematochezia, Intussusception, Obstruction
Clinical narrative: Intussusception diagnosed on ultrasound after patient passed bloody stools. Obstruction reduced in emergency room via air barium enema.
Age: 0.33
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Ultrasound abdomen abnormal
Clinical narrative: Intussusception diagnosed on ultrasound after patient passed bloody stools. Obstruction reduced in emergency room via air barium enema.