chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from an administrator referring to an unspecified patient (age and gender unknown). No information regarding the patient's concurrent conditions, medical history, drug reactions or allergies, and concomitant therapies was provided. The reporter stated that, on an unspecified date, the patient was vaccinated with an improperly stored dose (incorrect product storage) of M-M-R II (lot# M029229 with albumin status of rHA (recombinant human albumin), but unknown expiration date) (strength, dose, frequency, route of administration and anatomical location were not reported) for prophylaxis. Reportedly, the reporter could not provide the lot number and expiration date for the properly stored sterile diluent to reconstitute M-M-R II. The vaccine dose was exposed to a temperature excursion of 48 Fahrenheit degrees for 30 minutes; no digital data logger was involved or previous temperature excursions. No adverse effects were reported. This is one of three reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1704USA001661:US-009507513-1704USA001660.
Sex: U
Vaccine: VARCEL
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. No information regarding the patient's pertinent medical history, concomitant medications, drug reactions, or allergies was provided. On an unspecified date, the patient was vaccinated with improperly stored dose of VARIVAX injection (dose and route of administration were not provided; lot # M033214, expiration date: 17-JUL-2018) reconstituted in sterile diluent (manufacturer unknown). No adverse event was reported. The medical assistant stated, that a duration of the minimum/maximum temperature excursions were documented as the worst possible times due to the fact that they did not use a data logger thermometer and therefore from around 5:00 pm to 9:00 am each day they had no way to know how long the temperature excursion lasted. Generally, the excursions took place since 10-NOV-2016 to 05-APR-2017. The doses of vaccine experienced temperature excursions in the range 6 degrees Fahrenheit to 14 degrees Fahrenheit and 15 degrees Fahrenheit to 46 degrees Fahrenheit. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site bruising, Injection site erythema, Injection site induration
Clinical narrative: This spontaneous report was received from a physician via a company employee and refers to a 63 year old female patient. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 07-APR-2017, the patient was subcutaneously vaccinated with a dose of ZOSTAVAX (dose, lot# and expiration date were not reported) for prevention of shingles.   On an unknown date in April 2017, the patient experienced bruising, redness and hardness at the injection site. The patient sought medical attention. No treatment was given for the adverse events. The outcome of the events of bruising, redness and hardness at the injection site was unknown. The relatedness between the events of bruising, redness and hardness at the injection site and ZOSTAVAX was not reported.   Additional information is not expected, because there was no consent to contact the reporter.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. The patient's concomitant medications, pertinent medical history and drug reactions or allergies were not provided. On 30-MAR-2017, the patient was vaccinated an improperly stored dose of PROQUAD injection (albumin status: recombinant human albumin (rHA)), lot # M022402 with expiry date 01-NOV-2017, subcutaneously (exact dose was not reported) and properly stored sterile diluent (DILUENT MRK). PROQUAD dose was exposed to the temperature between 6 and 14 degrees Fahrenheit (F) for 1 hour 20 minutes and between 15 and 46 F for 50 minutes. Previous temperature excursions included temperature between 6 and 14 F (11.1 F) for 40 minutes. Digital data logger was involved. No adverse effects were reported. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site mass
Clinical narrative: Information was received from a nurse practitioner via a company representative concerning a 60 year old female patient.  No information was provided regarding the patient's past medical history, concurrent conditions, or concomitant medication. On 12-APR-2017, the patient was vaccinated with ZOSTAVAX 19400 PFU, 0.65 ml single dose (lot number not provided), subcutaneously for the prevention of herpes zoster.  The same day, the patient visited a tanning salon. On the following morning, 13-APR-2017, the patient woke to a "golf ball" size reddish lump on the ZOSTAVAX injection site. After she noticed the lump, the patient immediately sought medical attention from the nurse practitioner on 13-APR-2017. Information was not provided as to what type of medical attention was provided to the patient or if the patient had recovered from the golf ball size reddish lump. Additional information has been requested.
Age: 0.5
Sex: M
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant concerning a 6 month old male patient. The patients' medical history, concurrent conditions, concomitant medications and drug reactions/allergies were not reported. On 08-DEC-2016, the patient was vaccinated with an improperly stored dose of ROTATEQ dose 2, lot # L029617, orally, as prophylaxis (Strength, dose and expiration date were not reported), which experienced a temperature excursion (temperature and timeframe were no reported). It was not reported if there were previous temperature excursions. 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-009507513-1704USA006956: US-009507513-1704USA006957: US-009507513-1704USA006958: US-009507513-1701USA005974: US-009507513-1704USA007655: US-009507513-1704USA007664: US-009507513-1704USA007665: US-009507513-1704USA007666: US-009507513-1704USA007667: US-009507513-1704USA007669: US-009507513-1704USA007670: US-009507513-1704USA007671: US-009507513-1704USA007672: US-009507513-1704USA007673:
Age: 0.17
Sex: F
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant concerning a 10 weeks old female patient. The patients' medical history, concurrent conditions, concomitant medications and drug reactions/allergies were not reported. On 01-DEC-2016, the patient was vaccinated with an improperly stored dose of ROTATEQ dose 1, lot # L029617, orally, as prophylaxis (Strength, dose and expiration date were not reported), which experienced a temperature excursion (temperature and timeframe were no reported). It was not reported if there were previous temperature excursions. 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-009507513-1704USA006956: US-009507513-1704USA006957: US-009507513-1704USA006958: US-009507513-1701USA005974: US-009507513-1704USA007655: US-009507513-1704USA007664: US-009507513-1704USA007665: US-009507513-1704USA007666: US-009507513-1704USA007667: US-009507513-1704USA007668: US-009507513-1704USA007670: US-009507513-1704USA007671: US-009507513-1704USA007672: US-009507513-1704USA007673.
Age: 0.33
Sex: F
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant concerning a 4 month old female patient. The patients' medical history, concurrent conditions, concomitant medications and drug reactions/allergies were not reported. On 01-DEC-2016, the patient was vaccinated with an improperly stored dose of ROTATEQ dose 1, lot # L029617, orally, as prophylaxis (Strength, dose and expiration date were not reported), which experienced a temperature excursion (temperature and timeframe were no reported). It was not reported if there were previous temperature excursions. 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-009507513-1704USA006956: US-009507513-1704USA006957: US-009507513-1704USA006958: US-009507513-1701USA005974: US-009507513-1704USA007655: US-009507513-1704USA007664: US-009507513-1704USA007665: US-009507513-1704USA007666: US-009507513-1704USA007667: US-009507513-1704USA007668: US-009507513-1704USA007669: US-009507513-1704USA007671: US-009507513-1704USA007672: US-009507513-1704USA007673.
Age: 0.42
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Pyrexia
Clinical narrative: This is a spontaneous report from a contactable physician via a Pfizer sales representative and via a nurse. A child female patient of an unspecified age, race and ethnicity received the second dose of PREVNAR 13 (lot L04914) intramuscular in the right thigh at 0.5 ml single on 05Jun2015 at 15:06 at the age of 5 months for immunisation. Relevant medical history included allergic rhinitis and allergic cough (better on cetirizine hydrochloride, ZYRTEC) and chronic otitis media (better after PE tubes placed). Concomitant vaccines given for immunisation on 05Jun2015 along with suspect vaccine included the second dose of PENTACEL (Sanofi Pasteur, lot L4878AA) intramuscular in the left thigh and the third dose of rotavirus vaccine (Merck & Co., Inc., lot K013861) oral. Other concomitant vaccines administered for immunisation on 08May2015 included the second dose of  diphtheria vaccine, pertussis vaccine, tetanus vaccine (DTAP, Sanofi Pasteur, lot L4646AA) intramuscular in the left thigh , the second dose of polio vaccine (POLIO, Sanofi Pasteur, lot K13330-1) intramuscular in the left thigh, and the second dose of rotavirus vaccine (Merck & Co., Inc., lot K007912) oral. The patient had previously received for immunisation the first single dose of pneumococcal 13-val conj vac (dipht crm197 protein) on 09Mar2015, the first dose of diphtheria vaccine, haemophilus influenza type b vaccine, pertussis vaccine, polio vaccine, tetanus vaccine, the first dose of diphtheria vaccine, pertussis vaccine, tetanus vaccine, the first dose of polio vaccine and  the first dose of rotavirus vaccine on an unspecified date. The patient experienced high fever on an unspecified date. No emergency room or physician visit were needed. No specific tests and/or treatment were required. The patient recovered on an unspecified date. The event high fever was considered related to the vaccine. Follow-up (10Jun2016): Follow-up attempts are completed. No further information is expected. Follow-up (10Apr2017): New information reported from the same contactable physician includes: patient gender and age at time of vaccination, suspect vaccine details (lot, dose, frequency, route and anatomical location of vaccination, administration date), medical history, concomitant and past vaccines, absence of visits, tests and treatment, updated event outcome. Follow-up attempts are completed. No further information is expected.; Sender's Comments: Linked Report(s) : 2016243367 Legacy paper report number.
Age: 1.5
Sex: M
Vaccine: DTAPHEPBIP, PNC13
Symptoms: Decreased appetite, Impaired healing, Increased tendency to bruise, Muscular weakness, Pain in extremity
Clinical narrative: Sores in mouth Not healing, bruising without injury, respiratory issues, weakness and pain in legs, loss of appetite, possible siezures, falls and stroke.
Age: 1.5
Sex: M
Vaccine: DTAPHEPBIP, PNC13
Symptoms: Respiratory disorder, Stomatitis
Clinical narrative: Sores in mouth Not healing, bruising without injury, respiratory issues, weakness and pain in legs, loss of appetite, possible siezures, falls and stroke.
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Blood glucose decreased, Condition aggravated, Dizziness, Headache, Metabolic function test normal
Clinical narrative: Intensification of mild headache. Lightheadedness. Fingers tingling.
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Paraesthesia
Clinical narrative: Intensification of mild headache. Lightheadedness. Fingers tingling.
Age: 38.0
Sex: M
Vaccine: VARCEL
Symptoms: Electrocardiogram, Facial paralysis, Speech disorder, Swollen tongue
Clinical narrative: TONGUE SWELLING, SPEECH IMPACTED, RIGHT SIDE FACIAL DROOPING. PATIENT WENT TO EMERGENCY ROOM. EMERGENCY ROOM DOCTOR RULED OUT STROKE. PATIENT DIAGNOSED WITH BELLS PALSY OF RIGHT SIDE OF FACE.
Age: 22.0
Sex: F
Vaccine: HPV9
Symptoms: Lymphadenopathy, Nausea
Clinical narrative: This spontaneous report was received from a nurse referring to a 22-year-old female patient. The patient did not have any pertinent medical history, concurrent conditions or drug reactions/allergies. Concomitant medication included unspecified birth control. On 21-MAR-2017, the patient was vaccinated with GARDASIL 9 (lot # M018810), intramuscularly for human papillomavirus (HPV) vaccination (dose and expiration date were not reported). The nurse reported that a few hours after the vaccination (approximately on 21-MAR-2017) the patient experienced nausea which lasted for three days (until 23-MAR-2017). It was also reported that the patient developed a swollen lymph node on her neck (lymphadenopathy) that appeared on 24-MAR-2017. The patient did not receive treatment for the adverse events and no laboratory tests were performed. The patient did not seek medical attention. At the time of the report, the patient had not recovered from lymphadenopathy and the causality regarding both adverse events was not reported. No further information was provided. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report has been received from a medical assistant and refers to a patient of an unknown age and gender. The patient's medical history, concurrent conditions, drug allergies/reactions, and concomitant therapies were not reported. The medical assistant reported that on 20-MAR-2017, the patients was vaccinated with an improperly stored dose of GARDASIL 9 (lot # M026306, expiration date 30-APR-2018; dose and frequency were not reported) intramuscularly, for prophylaxis. This information was discovered as a digital data logger measured temperatures 47.5 °F, 47°F to 77°F for a total time frame of 30 hours. There was no previous temperature excursion. No adverse side effects were reported, and no product quality complaint (PQC) was involved. This is one of several reports from the same reporter. Additional information has been requested.; Sender's Comments:  US-009507513-1703USA013287: US-009507513-1703USA013286:
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report has been received from a medical assistant and refers to a patient of an unknown age and gender. The patient's medical history, concurrent conditions, drug allergies/reactions, and concomitant therapies were not reported. The medical assistant reported that on 16-MAR-2017, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 (lot # M029680, expiration date 17-JAN-2018; dose and frequency were not reported) intramuscularly, for prophylaxis. This information was discovered as a digital data logger measured temperatures 47.5 °F, 47°F to 77°F for a total time frame of 16 hours. There was no previous temperature excursion. No adverse side effects were reported, and no product quality complaint (PQC) was involved. This is one of several reports from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1703USA013277: US-009507513-1703USA013287.
Age: 0.17
Sex: U
Vaccine: HIBV
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report was received from the patient's mother, concerning a 10 month-old patient of an unknown gender. There were no concurrent conditions, medical history, drug reactions or allergies or concomitant medications reported. On unspecified dates (reported as the 2 and 4 months of the patient's age), the patient was intramuscularly vaccinated with PEDVAXHIB injection (dose, frequency, lot # and expiration date were not reported) and an unspecified date (reported as the 10 months of the patient's age), the patient received a booster intramuscular injection of PEDVAXHIB (dose, frequency, lot # and expiration date were not reported), all for prophylaxis. No adverse effects were reported. Additional information is not expected, as no consent to contact the reporter was granted.
Age: 22.0
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a 22 year old patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 17-JAN-2017, the patient was vaccinated with an improperly stored dose of GARDASIL 9 (route and site of administration, lot # and expiration date were not reported). There was no adverse effect reported. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1704USA002249: US-009507513-1704USA002250:
Age: 20.0
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a 20 year old patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 17-JAN-2017, the patient was vaccinated with an improperly stored dose of GARDASIL 9 (route and site of administration, lot # and expiration date were not reported). There was no adverse effect reported. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1704USA002250: US-009507513-1704USA001506.
Age: 22.0
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a 22 year old patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 17-JAN-2017, the patient was vaccinated with an improperly stored dose of GARDASIL 9 (route and site of administration, lot # and expiration date were not reported). There was no adverse effect reported. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1704USA001506: US-009507513-1704USA002249:
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant referring to multiple unspecified patients (age and gender unknown). No information regarding the patients' concurrent conditions, medical history, drug reactions or allergies, and concomitant therapies was provided. The reporter stated that, on unspecified dates, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB (lot# L039660, expiration date 04-FEB-2018) (strength, dose, frequency, route of administration and anatomical location were not reported) for prophylaxis. The vaccine doses were exposed to a temperature excursion between 32 and 35 Fahrenheit degrees (also reported as 34.2 F) for a time frame of 4 hours and 45 minutes; digital data logger was involved. There was not previous temperature excursion for the vaccine. No adverse effects were reported. This is one of three reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1704USA003209: US-009507513-1704USA003208:
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant referring to multiple unspecified patients (age and gender unknown). No information regarding the patients' concurrent conditions, medical history, drug reactions or allergies, and concomitant therapies was provided. The reporter stated that, on unspecified dates, the patients were vaccinated with improperly stored doses of LIQUID PEDVAXHIB (lot# L042835, expiration date 19-AUG-2018; and lot# M001814, expiration date 15-OCT-2018) (strength, dose, frequency, route of administration and anatomical location were not reported) for prophylaxis. The vaccine doses were exposed to a temperature excursion between 32 and 35 Fahrenheit degrees (also reported as 34.2 F) for a time frame of 4 hours and 45 minutes; digital data logger was involved. There was not previous temperature excursion for the vaccine. No adverse effects were reported. This is one of three reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1704USA002328: US-009507513-1704USA003209:
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant referring to multiple unspecified patients (age and gender unknown). No information regarding the patients' concurrent conditions, medical history, drug reactions or allergies, and concomitant therapies was provided. The reporter stated that, on unspecified dates, the patients were vaccinated with improperly stored doses of ROTATEQ orally (lot# M006111, expiration date 18-NOV-2017) (strength, dose, frequency, anatomical location were not reported) for prophylaxis. The vaccine doses were exposed to a temperature excursion between 32 and 35 Fahrenheit degrees (also reported as 34.2 F) for a time frame of 4 hours and 45 minutes; digital data logger was involved. There was not previous temperature excursion for the vaccine. No adverse effects were reported. This is one of three reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1704USA002328: US-009507513-1704USA003208:
Sex: U
Vaccine: VARZOS, DTAPIPV, VARZOS
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 4-year-old patient of unknown gender. No information regarding the patient's pertinent medical history, concomitant medications, drug reactions, or allergies was provided. On 10-APR-2017, the patient was inadvertently vaccinated with ZOSTAVAX 19400 plaque-forming units (PFU) (dose and route of administration were not provided; lot # M032360, expiration date: 18-AUG-2017) instead of VARIVAX. The dose of ZOSTAVAX was reconstituted with sterile diluent (manufacturer unknown) (lot# and expiration date were not provided). No adverse effect was reported. Additional information has been requested.
Sex: U
Vaccine: VARZOS, DTAPIPV, VARZOS
Symptoms: Injection site erythema, No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 4-year-old patient of unknown gender. No information regarding the patient's pertinent medical history, concomitant medications, drug reactions, or allergies was provided. On 10-APR-2017, the patient was inadvertently vaccinated with ZOSTAVAX 19400 plaque-forming units (PFU) (dose and route of administration were not provided; lot # M032360, expiration date: 18-AUG-2017) instead of VARIVAX. The dose of ZOSTAVAX was reconstituted with sterile diluent (manufacturer unknown) (lot# and expiration date were not provided). No adverse effect was reported. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Burning sensation, Gait disturbance, General physical health deterioration, Limb discomfort, Mental disorder
Clinical narrative: This spontaneous social media report was received from an article published in newspaper and refers to a 12-year-old female patient. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On an unknown date (reported as in September), the patient was vaccinated at school with a dose of GARDASIL (dose, route of administration and lot number were not provided) for prophylaxis. Next day, her legs felt heavy and she had a burning sensation in her spine. The straight student went on to lose all sensation in her legs, body and arms. On an unknown date, the patient found herself unable to move and just weeks later she was paralyzed from the neck down and in the hospital. The patient's family claimed she had suffered an alleged reaction to the HPV vaccine. However, her doctors claimed that her problem was completely psychological and the only help they offered was to section the patient. The patient's health deteriorated rapidly. At the time of the reporting, she shuffled before lying in her adapted bed at home, unable to move. The outcome of the events was unknown. The relatedness between vaccination with GARDASIL and the events was not reported. Upon internal review, the event of paralysis was considered to be medically significant. This is one of two reports received from the same source, as no contact details were provided. Additional information is not expected. Sender's Comments: US-009507513-1704USA006347.
Sex: F
Vaccine: HPV4
Symptoms: Mobility decreased, Paralysis, Sensory loss
Clinical narrative: This spontaneous social media report was received from an article published in newspaper and refers to a 12-year-old female patient. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On an unknown date (reported as in September), the patient was vaccinated at school with a dose of GARDASIL (dose, route of administration and lot number were not provided) for prophylaxis. Next day, her legs felt heavy and she had a burning sensation in her spine. The straight student went on to lose all sensation in her legs, body and arms. On an unknown date, the patient found herself unable to move and just weeks later she was paralyzed from the neck down and in the hospital. The patient's family claimed she had suffered an alleged reaction to the HPV vaccine. However, her doctors claimed that her problem was completely psychological and the only help they offered was to section the patient. The patient's health deteriorated rapidly. At the time of the reporting, she shuffled before lying in her adapted bed at home, unable to move. The outcome of the events was unknown. The relatedness between vaccination with GARDASIL and the events was not reported. Upon internal review, the event of paralysis was considered to be medically significant. This is one of two reports received from the same source, as no contact details were provided. Additional information is not expected. Sender's Comments: US-009507513-1704USA006347.
Age: 0.17
Sex: M
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant concerning a 8 weeks old male patient. The patients' medical history, concurrent conditions, concomitant medications and drug reactions/allergies were not reported. On 05-DEC-2016, the patient was vaccinated with an improperly stored dose of ROTATEQ dose 1, lot # L029617, orally, as prophylaxis (Strength, dose and expiration date were not reported), which experienced a temperature excursion (temperature and timeframe were no reported). It was not reported if there were previous temperature excursions. 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-009507513-1704USA006956: US-009507513-1704USA006957: US-009507513-1704USA006958: US-009507513-1701USA005974: US-009507513-1704USA007655: US-009507513-1704USA007664: US-009507513-1704USA007665: US-009507513-1704USA007666: US-009507513-1704USA007667: US-009507513-1704USA007668: US-009507513-1704USA007669: US-009507513-1704USA007670: US-009507513-1704USA007672: US-009507513-1704USA007673.
Age: 0.5
Sex: M
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant concerning a 6 month old male patient. The patients' medical history, concurrent conditions, concomitant medications and drug reactions/allergies were not reported. On 06-DEC-2016, the patient was vaccinated with an improperly stored dose of ROTATEQ dose 2, lot # L029617, orally, as prophylaxis (Strength, dose and expiration date were not reported), which experienced a temperature excursion (temperature and timeframe were no reported). It was not reported if there were previous temperature excursions. 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-009507513-1704USA006956: US-009507513-1704USA006957: US-009507513-1704USA006958: US-009507513-1701USA005974: US-009507513-1704USA007655: US-009507513-1704USA007664: US-009507513-1704USA007665: US-009507513-1704USA007666: US-009507513-1704USA007667: US-009507513-1704USA007668: US-009507513-1704USA007669: US-009507513-1704USA007670: US-009507513-1704USA007671: US-009507513-1704USA007673.
Age: 0.25
Sex: F
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant concerning a 3 month old female patient. The patients' medical history, concurrent conditions, concomitant medications and drug reactions/allergies were not reported. On 01-DEC-2016, the patient was vaccinated with an improperly stored dose of ROTATEQ dose 2, lot # L029617, orally, as prophylaxis (Strength, dose and expiration date were not reported), which experienced a temperature excursion (temperature and timeframe were no reported). It was not reported if there were previous temperature excursions. 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-009507513-1704USA006956: US-009507513-1704USA006957: US-009507513-1704USA006958: US-009507513-1701USA005974: US-009507513-1704USA007655: US-009507513-1704USA007664: US-009507513-1704USA007665: US-009507513-1704USA007666: US-009507513-1704USA007667: US-009507513-1704USA007668: US-009507513-1704USA007669: US-009507513-1704USA007670: US-009507513-1704USA007671: US-009507513-1704USA007672:
Age: 1.08
Sex: F
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 12-APR-2017, the patient was vaccinated with an improperly stored dose of ZOSTAVAX lot # M043308 expiration date 24-APR-2018 (dose was not reported), for prophylaxis. The ZOSTAVAX was reconstituted with properly stored diluent (lot# M024781 and expiration date 21-FEB-2019). No symptoms were reported. Administered dose of vaccine was improperly stored for 1 hour and 38 minutes in a temperature range between 6 degrees Fahrenheit and 14 degrees Fahrenheit and for 7 minutes in a temperature range between 15 degrees Fahrenheit to 46 degrees Fahrenheit. Data logger was involved. There were no previous excursions reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter.  Additional information has been requested.; Sender's Comments:  US-009507513-1704USA008355: US-009507513-1704USA006447:
Age: 1.17
Sex: M
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 12-APR-2017, the patient was vaccinated with an improperly stored dose of ZOSTAVAX lot # M043308 expiration date 24-APR-2018 (dose was not reported), for prophylaxis. The ZOSTAVAX was reconstituted with properly stored diluent (lot# M024781 and expiration date 21-FEB-2019). No symptoms were reported. Administered dose of vaccine was improperly stored for 1 hour and 38 minutes in a temperature range between 6 degrees Fahrenheit and 14 degrees Fahrenheit and for 7 minutes in a temperature range between 15 degrees Fahrenheit to 46 degrees Fahrenheit. Data logger was involved. There were no previous excursions reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1704USA008354: US-009507513-1704USA006447.
Sex: F
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: Initial unsolicited report received from a consumer (patient's husband) via other company (Pfizer) on 02 MAR 2017. This case involves a female patient (age was not reported) who was vaccinated with a dose INFLUENZA VACCINE (FLU SHOT) (batch number, dose in series, dose, route and site of administration was not reported) on an unspecified date (reported as 3 weeks ago). The patient's medical history and concomitant medications were not reported. On an unspecified date, following the vaccination, the patient had experienced flu. Laboratory data and corrective treatment not reported. Outcome of the event was not reported. List of documents held by sender: none.
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Nausea, Peripheral swelling
Clinical narrative: Left arm swollen, 33 cm around, parents applied heat which seemed to make it worse, had some nausea. Right arm was 29.5 cm, so Left arm was significantly more swollen.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Decreased appetite, Emotional disorder, Lethargy, Somnolence
Clinical narrative: Lethargy, Emotional changes, Decrease appetite. Increased drowsiness x 1 week.
Age: 0.33
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC13
Symptoms: Crying, Peripheral swelling
Clinical narrative: UNCONSOLABLE CRYING AND LEG SWELLING.
Age: 11.0
Sex: M
Vaccine: VARCEL, VARCEL
Symptoms: Abdominal pain, Pyrexia, Rash vesicular, Varicella post vaccine, Varicella virus test positive
Clinical narrative: Patient with evolving liver failure on oral steroids, Budesonide 6 mg PO OD, being prepped for transplant. Not previously vaccinated against VZV (parental preference). VZV vaccine required by transplant protocol presented to hospital 2/27 with abdominal pain, fever and rash that appeared classic varicella. No wild type exposure. IV acyclovir required.
Age: 11.0
Sex: M
Vaccine: VARCEL, VARCEL
Symptoms: Abdominal pain upper, Central venous catheterisation, Condition aggravated, Liver disorder, Liver transplant
Clinical narrative: Patient with evolving liver failure on oral steroids, Budesonide 6 mg PO OD, being prepped for transplant. Not previously vaccinated against VZV (parental preference). VZV vaccine required by transplant protocol presented to hospital 2/27 with abdominal pain, fever and rash that appeared classic varicella. No wild type exposure. IV acyclovir required.
Age: 11.0
Sex: M
Vaccine: VARCEL, VARCEL
Symptoms: Malaise, Polymerase chain reaction positive, Rash generalised, Rash pruritic, Rash vesicular
Clinical narrative: Patient with evolving liver failure on oral steroids, Budesonide 6 mg PO OD, being prepped for transplant. Not previously vaccinated against VZV (parental preference). VZV vaccine required by transplant protocol presented to hospital 2/27 with abdominal pain, fever and rash that appeared classic varicella. No wild type exposure. IV acyclovir required.
Age: 11.0
Sex: M
Vaccine: VARCEL, VARCEL
Symptoms: Varicella post vaccine, Varicella virus test positive, Viraemia
Clinical narrative: Patient with evolving liver failure on oral steroids, Budesonide 6 mg PO OD, being prepped for transplant. Not previously vaccinated against VZV (parental preference). VZV vaccine required by transplant protocol presented to hospital 2/27 with abdominal pain, fever and rash that appeared classic varicella. No wild type exposure. IV acyclovir required.
Age: 12.0
Sex: U
Vaccine: HPV9
Symptoms: Seizure
Clinical narrative: Patient was experiencing seizures.
Age: 69.0
Sex: M
Vaccine: PNC13
Symptoms: Brain oedema, Concussion, Hand fracture, Road traffic accident, Syncope
Clinical narrative: Rec'd PREVENAR 13 shot, left clinic and shortly afterwards, fainted on the expressway while driving motorcycle.
Age: 55.0
Sex: F
Vaccine: HEP
Symptoms: Injected limb mobility decreased, Injection site pain, Myalgia
Clinical narrative: Patient experienced severe muscle pain and temporary loss of mobility of injected arm, not just pain at injection site. Self limiting without treatment within 14 days. No reaction on previous dosage.
Age: 67.0
Sex: M
Vaccine: HEP
Symptoms: Chills, Diarrhoea, Migraine, Pyrexia
Clinical narrative: Dosed at 1430 on 4/4/2017. Migraine onset at 1900 and persisted for 36 hours. Diarrhea onset at 1930 and persisted for 12 hours. Fever/chills onset at 2100 and persisted for 14 hours.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a certified medical assistant referring to multiple unspecified patients (age and gender unknown). No information regarding the patients' concurrent conditions, medical history, drug reactions or allergies, and concomitant therapies was provided. The reporter stated that, on unspecified dates, the patients were vaccinated with improperly stored doses of PROQUAD (lot# M014301 with expiration date 22-SEP-2017 and albumin status of rHA (recombinant human albumin); and lot number reported as M025186 with expiration date 15-MAY-2018) (strength, dose, frequency, route of administration and anatomical location were not reported) for prophylaxis. The vaccine doses were exposed to a temperature excursion between 15 and 46 Fahrenheit degrees for 7 hours (also reported as "23.9 F"); and between 6 and 14 Fahrenheit degrees for 8 hours and 30 minutes; digital data logger was involved. No adverse effects were reported. Reportedly, the reporter did not know which improperly stored vaccines were administered. Additionally, it was reported that the sterile diluent (unspecified) used to reconstitute the administered vaccine did not undergo a temperature excursion (Lot # M015992 with expiration date 26-NOV-2018; Lot # L037795 with expiration date 04-MAY-2018; Lot # L019306 with expiration date 04-MAR-2018; Lot # L006552 with expiration date 12-NOV-2017; Lot # M001834 with expiration date 08-MAR-2018; Lot # M022946 with expiration date 17-DEC-2018; Lot # M024781 with expiration date 21-FEB-2019). There was not product quality complain (PQC) reported. This is one of three reports received from the same reporter. Lot number M025186 is an invalid lot number for Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live. Additional information has been requested. Sender's Comments: US-009507513-1704USA001189: US-009507513-1704USA001190.
Sex: M
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received 14-APR-2017 from a medical assistant regarding a male patient of unknown age. The patient's concurrent conditions, medical history and concomitant therapy were not reported. On 11-APR-2017 the patient was vaccinated with a dose of ROTATEQ lot # M038724 expiration 24-APR-2018, oral for prophylaxis which was improperly stored. No adverse effects were reported. The vaccine was stored between 32 degree Fahrenheit and 35 degree Fahrenheit for 1 hour.  There were no previous temperature excursions. The call was made due to a data logger. No additional information was provided.  Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Interchange of vaccine products, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistance and refers to an unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patients were vaccinated with the first dose of GARDASIL (dose, route, lot # and expiration date were not reported) for prophylaxis. Then, for the second dose the patient was vaccinated with the GARDASIL 9 (dose, route, lot # and expiration date were not reported) for prophylaxis. There were no adverse effects. This is one of two reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1611USA007845.
Sex: F
Vaccine: PNC13
Symptoms: Peripheral swelling
Clinical narrative: This is a spontaneous report from a contactable physician via Pfizer sales representative. A currently 77-year-old female patient of an unspecified race/ethnicity received PREVNAR 13, via an unspecified route of administration at single dose in the arm on an unspecified date for immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient developed swelling in the hand (of the vaccinated arm) over the course of 24 hours. The outcome of the event was recovering.
Sex: F
Vaccine: PNC13
Symptoms: Blood pressure increased, Injection site erythema, Injection site rash
Clinical narrative: This is a spontaneous report from a contactable nurse via a Pfizer Company representative. This nurse reported similar events for two patients. This is the second of two reports. A female patient of an unspecified age and race/ethnicity received PREVNAR 13 via an unspecified route of administration in the right arm on an unspecified date at 0.5 ml single for immunisation. The patient medical history and concomitant medications were not reported. The patient experienced red spots on the arm where she got the pneumonia shot two days before. The patient did not have any other symptoms like fever, she was not warm or anything like that. The patient had a full checkup, the patient's blood pressure was slightly elevated (150/80 mmgHg) but everything else was fine, they examined her arm and it showed some redness on her right upper arm where she got the injection and it did not appear to be cellulitis, so the treatment that they gave to her for red spots was prednisone 20 mg, 3 tablets daily, for 3 days. Outcome of the events was unknown. Causality assessment was unknown.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2017165913 same reporter/suspect product, similar event, different patient.
Sex: M
Vaccine: MNQ
Symptoms: Dizziness, Injection site erythema, Injection site pain, Injection site swelling, Nausea
Clinical narrative: Initial unsolicited report received from a consumer (patient's parent) on 06-APR-2017. This case involves a 14 years old male patient who was vaccinated with a first dose of MENACTRA (batch number, expiry date, dose was not reported) intramuscularly in an unknown site on 03-APR-2017. Patient's medical history as pre-existing physician diagnosed allergies, birth defects, medical conditions (specify) was reported as refused to provide and Illness at the time of vaccination was reported as denied. Concomitant medications were not reported. Any other vaccinations within four weeks of vaccinations were also not reported. On 03-APR-2017, same day of following the vaccination, the patient had developed pain at the injection site with redness and swelling which is accompanied by High fever, nausea and dizziness. The patient required emergency room (ER) or doctor visit on an unknown date. Laboratory investigations were reported as none. The patient received analgesics and took rest as corrective treatment. The outcome of the event was reported as not recovered. List of documents held by sender: none.
Sex: M
Vaccine: MNQ
Symptoms: Pyrexia
Clinical narrative: Initial unsolicited report received from a consumer (patient's parent) on 06-APR-2017. This case involves a 14 years old male patient who was vaccinated with a first dose of MENACTRA (batch number, expiry date, dose was not reported) intramuscularly in an unknown site on 03-APR-2017. Patient's medical history as pre-existing physician diagnosed allergies, birth defects, medical conditions (specify) was reported as refused to provide and Illness at the time of vaccination was reported as denied. Concomitant medications were not reported. Any other vaccinations within four weeks of vaccinations were also not reported. On 03-APR-2017, same day of following the vaccination, the patient had developed pain at the injection site with redness and swelling which is accompanied by High fever, nausea and dizziness. The patient required emergency room (ER) or doctor visit on an unknown date. Laboratory investigations were reported as none. The patient received analgesics and took rest as corrective treatment. The outcome of the event was reported as not recovered. List of documents held by sender: none.
Sex: U
Vaccine: TTOX
Symptoms: Vaccination complication
Clinical narrative: Initial unsolicited report received from a nurse via partner company Pfizer (manufacturer reference Number: 2017126010) on 06-APR-2017. This case involves a patient (onset age and gender were unknown) who was vaccinated with dose of TETANUS TOXOID (TETANUS VACCINE) (batch number, expiry date, dose and dose in series were not reported) in an unknown site on an unknown date. Patient's medical history and concomitant medications were not reported. On an unknown date, following the vaccination, the patient had experienced a reaction to a tetanus vaccine. Laboratory investigations and corrective treatment were not reported. The outcome of the event was not reported. List of documents held by sender: none.
Age: 34.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site swelling
Clinical narrative: 4/10/17 - vaccine administered on 1/25/17 (TDaP) to (L) Deltoid. Today, 4/10/17, patient reports ongoing pain to (L) upper arm. Initial reaction on 1/25/17 - Redness, swelling at site. No redness or swelling noted. Small marble size, firmness to area on palpation noted.
Age: 4.0
Sex: F
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site swelling, Injection site vesicles
Clinical narrative: Patient developed redness, swelling and scattered blisters at injection site (left thigh) approx. 24 hours post injection. Presented to Urgent Care on 4/14/2017 (same location as shot given). Return call pending.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain of skin, Rash erythematous, Rash vesicular
Clinical narrative: Developed red, blistering rash. Skin was seemingly raw and painful to the touch.
Age: 0.5
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Eye movement disorder, Febrile convulsion, Postictal state, Pyrexia, Tonic clonic movements
Clinical narrative: Patient had a fever of 102 with tonic-clonic movements of hands, eye rolling and was post-ictal. Taken to hospital by ambulance. Diagnosed febrile seizure.
Age: 46.0
Sex: M
Vaccine: HEP, VARZOS
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: None stated.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, HEPA, MMRV
Symptoms: Anger, Autism spectrum disorder, Blood magnesium decreased, Blood zinc decreased, Obsessive-compulsive disorder
Clinical narrative: Within just a couple short weeks of being vaccinated patient now has significant issues ranging from low vitamin D, zinc, B12, magnesium and behavior issues that are autistic in nature. She has obsessions and outbursts that were not present prior to receiving so many vaccines at once. We are now spending a fortune to correct these things by diet, supplements, and multiple therapies.