chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 12.0
Sex: M
Vaccine: HPV9
Symptoms: Presyncope, Pyrexia, Vomiting
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS ID-617591). This spontaneous report refers to a 12 year old male patient. The patient had no concurrent conditions and medical history. On 04-JAN-2016 the patient was vaccinated with GARDASIL 9 lot # L017407 dose 2 (unspecified dosage regimen), via intramuscular route in the right arm for prophylaxis. On the same day, the patient had near syncopal event, vomiting for one time and fever. The outcome of presyncope, vomiting and pyrexia was reported as unknown. Causality assessment was not provided. Additional information is not expected from the Agency as follow up information cannot be obtained.
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Extra dose administered
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS ID-617802). This spontaneous report refers to a 13 year old female patient. The patient had no historical and concurrent conditions. On 06-JAN-2016 the patient was vaccinated with GARDASIL 9 (lot # L023230) dose 1 (unspecified dosage regimen), intramuscular in the right arm for prophylaxis. Other suspect therapies included MENVEO (dose 1, right arm) and BOOSTRIX (dose 2, left arm), given on the same day intramuscularly. The registered nurse gave BOOSTRIX and the vaccinations were given in the same arm (left deltoid). Extra dose and wrong dose were administered. Additional information is not expected from the Agency as follow up information cannot be obtained.
Sex: F
Vaccine: FLUN4, HEPA, HPV9, MNQ
Symptoms: Dyskinesia, Loss of consciousness, Pallor, Unresponsive to stimuli
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS ID-618254). This spontaneous report refers to a 11 year old female patient. The patient had no medical history, concurrent conditions and concomitant medications. On 25-NOV-2015 the patient was vaccinated with GARDASIL 9 lot # L016429 dose 1 (unspecified dosage regimen), intramuscular in the right arm for prophylaxis. Other suspect therapies included FLUMIST (dose 1, unspecified dose and frequency), MENACTRA (dose 1, unspecified dose and frequency, intramuscular route), and HAVRIX (dose 1, unspecified dose and frequency, intramuscular route). After vaccines and blood draw patient appeared pale and also appeared to lose consciousness. Patient then proceeded to show signs of rhythmic jerking. The patient was made to lay down on table where she was already sitting. She was unresponsive to stimuli for less than 30 sec. She appeared to be aware of her surroundings. Vitals were taken and patient was monitored in lying position. The outcome of dyskinesia, unresponsive to stimuli, pallor and loss of consciousness was reported as recovered. Causality assessment was not provided. Additional information is not expected from the Agency as follow up information cannot be obtained.
Sex: F
Vaccine: FLUN4, HPV9
Symptoms: Injection site reaction, Muscle spasms, Muscle twitching
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 619303) on 04-APR-2017. This spontaneous report as received from a regulatory authority refers to a 12 year old female patient. The patient's medical history included attention deficit/hyperactivity disorder (ADHD) and dysfunctional uterine bleeding. The patient's other medications included CONCERTA and ORTHO-CYCLEN. The patient's concomitant therapies and concurrent illness were not reported. On 14-JAN-2016 the patient was vaccinated with the first dose of GARDASIL 9 intramuscularly in the right arm, lot # L025737 (dose, frequency and lot expiration date were not reported) for prophylaxis. Other suspect therapies included FLUMIST QUADRIVALENT. On 14-JAN-2016, the patient experienced upper right arm twitching and muscle cramping into elbow episodic. The outcome of muscle spasms and muscle twitching was unknown. Causality assessment was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Age: 4.0
Sex: F
Vaccine: VARZOS, DTAPIPV, VARZOS
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Wrong medication given no reaction. ZOSTAVAX given instead of varicella. Follow up phone call on 4/21/2017 No adverse reactions per mom. slight redness at site.
Age: 4.0
Sex: F
Vaccine: VARZOS, DTAPIPV, VARZOS
Symptoms: Injection site erythema, No adverse event, Wrong drug administered
Clinical narrative: Wrong medication given no reaction. ZOSTAVAX given instead of varicella. Follow up phone call on 4/21/2017 No adverse reactions per mom. slight redness at site.
Age: 0.42
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1, DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Abdominal pain, Blood test, Laboratory test, Lymphadenopathy, Ocular hyperaemia
Clinical narrative: FEVER, not feeding well and fussy. Patient is a 5 mos old female who presents with fever to 102-103F for 8 days, congestion, cough, bulbar conjunctivitis for 2 days. Fever started the day of vaccines on 3/31. She was seen at office on 4/3, 4/4 and 4/5 for evaluation. Case discussed last night regarding possible admission and echocardiogram set up for 4/7. Seen by Dr. in Peds who repeated labs. Labs done 4/5 showed pleocytosis, thrombocytosis, increased ESR and CRP, neg EBV, CMV and Mycoplasma, neg BC to date and confirmed no UTI. Albumin and ALT were also normal. ESR, CRP and WBC increased today. Dr. spoke with another Dr. from Peds ID who confirms we should admit and treat with IVIG for atypical Kawasaki's. Resp Viral Panel was sent yesterday, results pending. No rash, mucositis, lymphadenopathy, arthritis, or extremity changes. She has had slightly decreased input but normal output per mother. She has been noticeably fussy and has not slept well in 2 days. Associated symptoms: nasal symptoms for 8 day(s) and fever for 8 day(s). Patient is a 5 M female with likely atypical Kawasaki's vs viral etiology. S/p IVIG evening 4/7-4/8AM. Treated due to high fever x 8 days, bulbar conjunctivitis, pleocytosis, thrombocytosis and elevated CRP & ESR.
Age: 0.42
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1, DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Pyrexia, Respiratory syncytial virus test, Swollen tongue, Urine analysis, X-ray
Clinical narrative: FEVER, not feeding well and fussy. Patient is a 5 mos old female who presents with fever to 102-103F for 8 days, congestion, cough, bulbar conjunctivitis for 2 days. Fever started the day of vaccines on 3/31. She was seen at office on 4/3, 4/4 and 4/5 for evaluation. Case discussed last night regarding possible admission and echocardiogram set up for 4/7. Seen by Dr. in Peds who repeated labs. Labs done 4/5 showed pleocytosis, thrombocytosis, increased ESR and CRP, neg EBV, CMV and Mycoplasma, neg BC to date and confirmed no UTI. Albumin and ALT were also normal. ESR, CRP and WBC increased today. Dr. spoke with another Dr. from Peds ID who confirms we should admit and treat with IVIG for atypical Kawasaki's. Resp Viral Panel was sent yesterday, results pending. No rash, mucositis, lymphadenopathy, arthritis, or extremity changes. She has had slightly decreased input but normal output per mother. She has been noticeably fussy and has not slept well in 2 days. Associated symptoms: nasal symptoms for 8 day(s) and fever for 8 day(s). Patient is a 5 M female with likely atypical Kawasaki's vs viral etiology. S/p IVIG evening 4/7-4/8AM. Treated due to high fever x 8 days, bulbar conjunctivitis, pleocytosis, thrombocytosis and elevated CRP & ESR.
Age: 0.42
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1, DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Alanine aminotransferase normal, Blood albumin normal, Blood culture negative, C-reactive protein increased, Conjunctivitis
Clinical narrative: FEVER, not feeding well and fussy. Patient is a 5 mos old female who presents with fever to 102-103F for 8 days, congestion, cough, bulbar conjunctivitis for 2 days. Fever started the day of vaccines on 3/31. She was seen at office on 4/3, 4/4 and 4/5 for evaluation. Case discussed last night regarding possible admission and echocardiogram set up for 4/7. Seen by Dr. in Peds who repeated labs. Labs done 4/5 showed pleocytosis, thrombocytosis, increased ESR and CRP, neg EBV, CMV and Mycoplasma, neg BC to date and confirmed no UTI. Albumin and ALT were also normal. ESR, CRP and WBC increased today. Dr. spoke with another Dr. from Peds ID who confirms we should admit and treat with IVIG for atypical Kawasaki's. Resp Viral Panel was sent yesterday, results pending. No rash, mucositis, lymphadenopathy, arthritis, or extremity changes. She has had slightly decreased input but normal output per mother. She has been noticeably fussy and has not slept well in 2 days. Associated symptoms: nasal symptoms for 8 day(s) and fever for 8 day(s). Patient is a 5 M female with likely atypical Kawasaki's vs viral etiology. S/p IVIG evening 4/7-4/8AM. Treated due to high fever x 8 days, bulbar conjunctivitis, pleocytosis, thrombocytosis and elevated CRP & ESR.
Age: 0.42
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1, DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Cough, Culture urine negative, Cytomegalovirus test negative, Echocardiogram normal, Epstein-Barr virus test negative
Clinical narrative: FEVER, not feeding well and fussy. Patient is a 5 mos old female who presents with fever to 102-103F for 8 days, congestion, cough, bulbar conjunctivitis for 2 days. Fever started the day of vaccines on 3/31. She was seen at office on 4/3, 4/4 and 4/5 for evaluation. Case discussed last night regarding possible admission and echocardiogram set up for 4/7. Seen by Dr. in Peds who repeated labs. Labs done 4/5 showed pleocytosis, thrombocytosis, increased ESR and CRP, neg EBV, CMV and Mycoplasma, neg BC to date and confirmed no UTI. Albumin and ALT were also normal. ESR, CRP and WBC increased today. Dr. spoke with another Dr. from Peds ID who confirms we should admit and treat with IVIG for atypical Kawasaki's. Resp Viral Panel was sent yesterday, results pending. No rash, mucositis, lymphadenopathy, arthritis, or extremity changes. She has had slightly decreased input but normal output per mother. She has been noticeably fussy and has not slept well in 2 days. Associated symptoms: nasal symptoms for 8 day(s) and fever for 8 day(s). Patient is a 5 M female with likely atypical Kawasaki's vs viral etiology. S/p IVIG evening 4/7-4/8AM. Treated due to high fever x 8 days, bulbar conjunctivitis, pleocytosis, thrombocytosis and elevated CRP & ESR.
Age: 0.42
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1, DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Full blood count, Gamma-glutamyltransferase normal, Hypophagia, Immunoglobulin therapy, Irritability
Clinical narrative: FEVER, not feeding well and fussy. Patient is a 5 mos old female who presents with fever to 102-103F for 8 days, congestion, cough, bulbar conjunctivitis for 2 days. Fever started the day of vaccines on 3/31. She was seen at office on 4/3, 4/4 and 4/5 for evaluation. Case discussed last night regarding possible admission and echocardiogram set up for 4/7. Seen by Dr. in Peds who repeated labs. Labs done 4/5 showed pleocytosis, thrombocytosis, increased ESR and CRP, neg EBV, CMV and Mycoplasma, neg BC to date and confirmed no UTI. Albumin and ALT were also normal. ESR, CRP and WBC increased today. Dr. spoke with another Dr. from Peds ID who confirms we should admit and treat with IVIG for atypical Kawasaki's. Resp Viral Panel was sent yesterday, results pending. No rash, mucositis, lymphadenopathy, arthritis, or extremity changes. She has had slightly decreased input but normal output per mother. She has been noticeably fussy and has not slept well in 2 days. Associated symptoms: nasal symptoms for 8 day(s) and fever for 8 day(s). Patient is a 5 M female with likely atypical Kawasaki's vs viral etiology. S/p IVIG evening 4/7-4/8AM. Treated due to high fever x 8 days, bulbar conjunctivitis, pleocytosis, thrombocytosis and elevated CRP & ESR.
Age: 0.42
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1, DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Kawasaki's disease, Mycoplasma test negative, Nasal disorder, Pleocytosis, Poor quality sleep
Clinical narrative: FEVER, not feeding well and fussy. Patient is a 5 mos old female who presents with fever to 102-103F for 8 days, congestion, cough, bulbar conjunctivitis for 2 days. Fever started the day of vaccines on 3/31. She was seen at office on 4/3, 4/4 and 4/5 for evaluation. Case discussed last night regarding possible admission and echocardiogram set up for 4/7. Seen by Dr. in Peds who repeated labs. Labs done 4/5 showed pleocytosis, thrombocytosis, increased ESR and CRP, neg EBV, CMV and Mycoplasma, neg BC to date and confirmed no UTI. Albumin and ALT were also normal. ESR, CRP and WBC increased today. Dr. spoke with another Dr. from Peds ID who confirms we should admit and treat with IVIG for atypical Kawasaki's. Resp Viral Panel was sent yesterday, results pending. No rash, mucositis, lymphadenopathy, arthritis, or extremity changes. She has had slightly decreased input but normal output per mother. She has been noticeably fussy and has not slept well in 2 days. Associated symptoms: nasal symptoms for 8 day(s) and fever for 8 day(s). Patient is a 5 M female with likely atypical Kawasaki's vs viral etiology. S/p IVIG evening 4/7-4/8AM. Treated due to high fever x 8 days, bulbar conjunctivitis, pleocytosis, thrombocytosis and elevated CRP & ESR.
Age: 0.42
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1, DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Pyrexia, Red blood cell sedimentation rate increased, Respiratory tract congestion, Respiratory viral panel, Thrombocytosis
Clinical narrative: FEVER, not feeding well and fussy. Patient is a 5 mos old female who presents with fever to 102-103F for 8 days, congestion, cough, bulbar conjunctivitis for 2 days. Fever started the day of vaccines on 3/31. She was seen at office on 4/3, 4/4 and 4/5 for evaluation. Case discussed last night regarding possible admission and echocardiogram set up for 4/7. Seen by Dr. in Peds who repeated labs. Labs done 4/5 showed pleocytosis, thrombocytosis, increased ESR and CRP, neg EBV, CMV and Mycoplasma, neg BC to date and confirmed no UTI. Albumin and ALT were also normal. ESR, CRP and WBC increased today. Dr. spoke with another Dr. from Peds ID who confirms we should admit and treat with IVIG for atypical Kawasaki's. Resp Viral Panel was sent yesterday, results pending. No rash, mucositis, lymphadenopathy, arthritis, or extremity changes. She has had slightly decreased input but normal output per mother. She has been noticeably fussy and has not slept well in 2 days. Associated symptoms: nasal symptoms for 8 day(s) and fever for 8 day(s). Patient is a 5 M female with likely atypical Kawasaki's vs viral etiology. S/p IVIG evening 4/7-4/8AM. Treated due to high fever x 8 days, bulbar conjunctivitis, pleocytosis, thrombocytosis and elevated CRP & ESR.
Age: 0.42
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1, DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Urine analysis normal, Viral infection, White blood cell count increased
Clinical narrative: FEVER, not feeding well and fussy. Patient is a 5 mos old female who presents with fever to 102-103F for 8 days, congestion, cough, bulbar conjunctivitis for 2 days. Fever started the day of vaccines on 3/31. She was seen at office on 4/3, 4/4 and 4/5 for evaluation. Case discussed last night regarding possible admission and echocardiogram set up for 4/7. Seen by Dr. in Peds who repeated labs. Labs done 4/5 showed pleocytosis, thrombocytosis, increased ESR and CRP, neg EBV, CMV and Mycoplasma, neg BC to date and confirmed no UTI. Albumin and ALT were also normal. ESR, CRP and WBC increased today. Dr. spoke with another Dr. from Peds ID who confirms we should admit and treat with IVIG for atypical Kawasaki's. Resp Viral Panel was sent yesterday, results pending. No rash, mucositis, lymphadenopathy, arthritis, or extremity changes. She has had slightly decreased input but normal output per mother. She has been noticeably fussy and has not slept well in 2 days. Associated symptoms: nasal symptoms for 8 day(s) and fever for 8 day(s). Patient is a 5 M female with likely atypical Kawasaki's vs viral etiology. S/p IVIG evening 4/7-4/8AM. Treated due to high fever x 8 days, bulbar conjunctivitis, pleocytosis, thrombocytosis and elevated CRP & ESR.
Age: 1.25
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Abnormal behaviour, Developmental delay, Intelligence test abnormal, Loss of personal independence in daily activities, Pyrexia
Clinical narrative: Unable to keep down water. Threw up 7 times. Temperature went up to 105 degrees. Uncontrollable screaming and shaking. I gave her ibuprofen at 5PM to try and control the temperature. Took her to ER at 6PM. I told the intake nurse she just received vaccines. I was not made aware of VAERS at all. They dismissed me as a first time mother. Let me sit there with a feverish baby, they administered Motrin. An hour later they gave me a small bottle of nonflavored Pediasure. They told me to go home and wait it out, and to keep giving her motoring and Pediasure. That's it.
Age: 1.25
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Screaming, Tremor, Vomiting
Clinical narrative: Unable to keep down water. Threw up 7 times. Temperature went up to 105 degrees. Uncontrollable screaming and shaking. I gave her ibuprofen at 5PM to try and control the temperature. Took her to ER at 6PM. I told the intake nurse she just received vaccines. I was not made aware of VAERS at all. They dismissed me as a first time mother. Let me sit there with a feverish baby, they administered Motrin. An hour later they gave me a small bottle of nonflavored Pediasure. They told me to go home and wait it out, and to keep giving her motoring and Pediasure. That's it.
Age: 0.25
Sex: F
Vaccine: DTAP, RVX
Symptoms: Abnormal behaviour, Injection site erythema, Injection site induration, Injection site mass, Injection site swelling
Clinical narrative: Localized redness at injection site with hard palpable mass/swelling under the skin and under area of redness.  Extreme fussiness and change in usual behavior.
Age: 0.25
Sex: F
Vaccine: DTAP, RVX
Symptoms: Irritability
Clinical narrative: Localized redness at injection site with hard palpable mass/swelling under the skin and under area of redness.  Extreme fussiness and change in usual behavior.
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Urticaria
Clinical narrative: Rash more consistent with hives.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant and refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies, drug reactions, allergies or pertinent medical histories provided. On unknown dates, the patients were vaccinated with improperly stored doses of PROQUAD lot # L040414, expiration date 13-APR-2017, subcutaneously (dose was not reported). There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion of 21.18 degrees Fahrenheit for 10 minutes. A digital data logger was involved. There were no previous temperature excursions reported. Product quality complaint was not involved. This is one of two reports received from the same reporter. Additional information is not expected, as the reported was unable to provide any further information. Sender's Comments: US-009507513-1703USA001642.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a certified medical assistant and refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies, drug reactions, allergies or pertinent medical histories provided. On unknown dates, the patients were vaccinated with improperly stored doses of VARIVAX lot # L035129, expiration date 14-SEP-2017, subcutaneously (dose was not reported). There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion of 21.18 degrees Fahrenheit for 10 minutes. A digital data logger was involved. There were no previous temperature excursions reported. Product quality complaint was not involved. This is one of two reports received from the same reporter. Additional information is not expected, as the reported was unable to provide any further information.; Sender's Comments:  US-009507513-1702USA007303:
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect route of drug administration
Clinical narrative: This spontaneous report has been received from a pharmacist via Poison and Drug Center refers to a patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant medication was not reported. On an unknown date the patient was vaccinated with VARIVAX, intramuscular (dose and frequency unspecified) (lot number and expiry date unknown) for an unknown indication. On an unknown date, the patient was given VARIVAX intramuscularly rather than subcutaneously. As of 07-MAR-2017 it was unknown if the patient continued on the VARIVAX. Additional information is not expected as the attempt to contact the reporter has been unsuccessful.
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse concerning to a patient of unknown age and demographics. The patient's concurrent conditions, medical history drug reaction/allergies, and concomitant therapies were not reported. In September 2016, the patient was vaccinated with the first dose of GARDASIL 9 (strength, dose, route of administration, lot # and expiration date were not provided), and the second dose of GARDASIL 9 (strength, dose, route of administration, lot # and expiration date were not provided) was administered on 23-MAR-2017 both for prophylaxis. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist concerning to a patient of unknown age and demographics. The patient's concurrent conditions, medical history, drug reactions/allergies, and concomitant therapies were not provided. On 27-MAR-2017, the patient was vaccinated with an expired dose of VARIVAX with lot # L007225, and expiration date 27-MAR-2017, for prophylaxis (the strength, dose, route, and frequency were not provided). The vaccine was reconstituted with a Merck diluent. No adverse effects were reported. Additional information is not expected because there was no consent to contact physician.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to an unspecified number of patients of unknown age and gender. No information about the patient's pertinent medical history, concomitant medications and drug reactions or allergies was reported. On an unknown dates, the patients were vaccinated with improperly stored doses of LIQUID PEDVAXHIB injection, lot # M034188 with expiry date 20-MAY-2019, lot # M034189 with expiry date 23-MAY-2019 and lot # M036612 with expiry date 19-MAY-2019 (dose, route of administration and anatomical location were not specified) for prophylaxis. Administered doses of LIQUID PEDVAXHIB underwent a temperature excursion at 31 Fahrenheit degrees or colder (25 Fahrenheit degrees) for 29 hours. There was no previous temperature excursion. No adverse effects were reported. Product quality complaint (PQC) was not involved. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse, concerning an unspecified number of patients of an unknown gender and age. There were no concurrent conditions, medical history, drug reactions or allergies or concomitant medications reported. On unspecified dates, the patients were vaccinated with improperly stored doses VARIVAX (dose, frequency and route were not reported) lot # M027344 with expiration date of 01-JUN-2018. The temperature of the VARIVAX was between 6 °F and 14 °F for a time frame of 1 hour and 30 minutes; no previous temperature excursion was reported. No adverse effects were reported and no product quality complaint (PQC) was involved. Data logger was involved. This is one of two reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1704USA004588:
Age: 47.0
Sex: U
Vaccine: VARZOS
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a nurse via a company representative refers to a 47-year-old patient of unknown age. No information regarding the patient's pertinent medical history, concomitant medications, drug reactions or allergies was provided. On an unknown date, the 47-year-old patient was vaccinated with ZOSTAVAX (dose, route of administration, lot# and expiration date were not provided) reconstituted with sterile diluent (manufacturer unknown). No adverse event was reported. Additional information has been requested.
Age: 0.75
Sex: M
Vaccine: HEP
Symptoms: Extra dose administered, Wrong drug administered
Clinical narrative: This spontaneous report was received from a patient's grandmother and refers to a 2 year old male patient. The patient had no medical history, concomitant therapies, drug reactions or allergies. On 27-AUG-2015, the patient was vaccinated with first dose of RECOMBIVAX HB in injection, for prevention of hepatitis B. On 02-JAN-2016, the patient received second dose of vaccine and on 03-MAR-2016, the patient received third dose of vaccine. In June 2016 (unspecified date), the patient received fourth dose of vaccine, but there was no explanation why the fourth dose was given to the patient. In March 2017 (date unspecified), by a mistake the patient received the fifth dose of a vaccine. It was reported that a physician assistant stated that an unspecified nurse gave the injection, and then she realized it was the incorrect vaccine. The reporter stated that both she and a mother of the child were not able to get information from the physician assistant as to how or why there was a fourth injection or if they should be concerned about the additional injections the child was given. The grandmother stated that she is concerned about long term side effects her grandson could have as a result of the medical error made. The event made patient's grandmother to sought medical attention by speaking to physician's assistant. No lab tests were performed. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema
Clinical narrative: This spontaneous report was received from a pharmacist via a company representative, concerning a patient of an unknown age and gender. There were no concurrent conditions, medical history, drug reactions or allergies or concomitant medications reported. On an unspecified date, the patient was vaccinated with a dose of ZOSTAVAX vial (dose, frequency, route, lot # and expiration date were not reported) to prevent shingles. After administration of ZOSTAVAX, the patient developed a "large erythema on the back of the arm;" the type of erythema was unknown and it was not clear if it manifested as redness or as a rash. At the time of the report, the outcome of the event was unknown. No product quality complaint was involved (PQC). The causality between the adverse event and ZOSTAVAX was unknown.  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 a patient of unknown age and gender. No information about the patient's pertinent medical history, concomitant medications, drug reactions or allergies was provided. On an unknown date, the patient was vaccinated with a dose of improperly stored ZOSTAVAX lot # M018593, expiration date 28-JUN-2017 (dose and route of administration not reported). The vaccine underwent a temperature excursion of 6 to 14 degrees Fahrenheit for 45 minutes. Digital data logger was used. There was no previous excursions. No adverse effect was reported. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information was received from a pharmacist who reported that multiple unspecified patients were vaccinated with improperly stored ZOSTAVAX 19400 PFU (dosages and routes of administration not provided), (lot #M040145, expiration date 26-DEC-2017), reconstituted with properly stored sterile diluent (lot #M044952, expiration date 01-JUL-2019) on multiple unspecified dates. No adverse effects reported. Excursion information: Temperature: 24.8F Time frame: 1 hour 30 minutes Previous temperature excursion: Yes, 6F to 14F (8.6F) for 45 minutes. Call was because of a data logger. No further information provided. 20-APR-2017: Lot number M040145 has been verified to be a valid lot number for ZOSTAVAX. 20-APR-2017: Lot number M044952 has been verified to be a valid lot number for the sterile diluent. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: Information had been received on 19-APR-2017 regarding a case in litigation. It was alleged in litigation that a female patient of unknown age was vaccinated with ZOSTAVAX vaccine (dose, route, lot # and expiration date were not provided) on or about 12-MAR-2015 at a Drug store as recommended for routine adult health maintenance for the prevention of shingles. The patient's medical history, concurrent conditions and concomitant medication were not provided. It was reported, the ZOSTAVAX vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 20-NOV-2015, the patient was treated at a health center for a painful rash that was diagnosed as shingles. Again, on or about 04-DEC-2015, the patient was treated at the same facility for a severe outbreak of herpes zoster. While shingles is a chronic and incurable condition, the patient has been prescribed VALTREX to manage her symptoms. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, pain and suffering and other damages. This is one of several reports from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1704USA009664: US-009507513-1704USA009757: US-009507513-1704USA009812.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: Information had been received on 19-APR-2017 regarding a case in litigation. It was alleged in litigation that a male patient of unknown age was vaccinated at an outpatient clinic with ZOSTAVAX vaccine (dose, route, lot # and expiration date were not provided) on or about 23-FEB-2013 as recommended for routine adult health maintenance for the prevention of shingles. The patient's medical history, concurrent conditions and concomitant medication were not provided. It was reported, the ZOSTAVAX vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 16-MAR-2015, the patient was treated at a health center for a painful rash that was diagnosed as a severe case of shingles. While shingles is an incurable viral condition, the patient was prescribed valacyclovir to manage his symptoms. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, pain and suffering and other damages. This is one of several reports from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1704USA009595: US-009507513-1704USA009757: US-009507513-1704USA009812.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Ophthalmic herpes zoster, Pain, Post herpetic neuralgia, Rash
Clinical narrative: Information was received on 19-APR-2017 from a lawyer regarding a case in litigation concerning a female patient of unknown age. It is complained and alleged that the patient was inoculated with a dose of ZOSTAVAX vaccine, on or about 17-MAY-2012  at a health care facility, as recommended for routine adult health maintenance for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 12-NOV-2014, the patient was treated at a medical facility for a painful rash that was diagnosed as shingles that has spread into her eyes. On or about 18-NOV-2015, the patient was treated again for the shingles that had spread into her eyes, which is a more serious condition called herpes keratis (sic). On or about 16-DEC-2015, after experiencing continued severe pain, the patient was diagnosed with post herpetic neuralgia. While shingles and herpes keratis (sic) are incurable viral conditions, the patient has been prescribed  Gabapentin (manufacturer unknown) which has been ineffective in managing her symptoms. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses and pain and suffering and other damages. Upon internal review, shingles that had spread into her eyes/herpes keratitis was considered medically significant. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Neuralgia, Post herpetic neuralgia, Rash
Clinical narrative: Information had been received on 19-APR-2017 regarding a case in litigation. It was alleged in litigation that a female patient of unknown age was vaccinated with ZOSTAVAX vaccine (dose, route, lot # and expiration date were not provided) on or about 06-JUL-2007 at a facility as recommended for routine adult health maintenance for the prevention of shingles. The patient's medical history, concurrent conditions and concomitant medication were not provided. It was reported, the ZOSTAVAX vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 03-MAR-2013, the patient was treated at the same facility for an ongoing painful rash and persistent nerve pain which was diagnosed as shingles and the residual condition of post-herpetic neuralgia. Post-herpetic neuralgia is a painful and chronic condition caused by the residual nerve damage after the contracting shingles. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, pain and suffering and other damages. This is one of several reports from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1704USA009840: US-009507513-1704USA009757: US-009507513-1704USA009595: US-009507513-1704USA009664.
Sex: F
Vaccine: PNC13
Symptoms: Injection site pain, Urticaria
Clinical narrative: This is a spontaneous report from a contactable nurse communicated to a Pfizer sales representative. A contactable nurse reported that...Dates for Very painful at the injection site: (From: Unspecified To: Unspecified). Reporter seriousness for Very painful at the injection site: Unspecified. Dates for Left a welt on her arm, a bump: (From: Unspecified To: Unspecified). Reporter seriousness for Left a welt on her arm, a bump: Unspecified. Is PREVNAR 13 a Pfizer product? Yes PREVNAR 13 manufacturer: Unspecified Dates for PREVNAR 13: (Start: Unspecified Stop: Unspecified) NDC number of PREVNAR 13: Unknown UPC number of PREVNAR 13: Unknown Reason for no lot number: of PREVNAR 13: Other: LOT# was unknown as Pfizer Sales Representative did not have information. Expiry Date of PREVNAR 13: Unknown. Verbatim event relatedness: PREVNAR 13: Very painful at the injection site  - Related PREVNAR 13: Left a welt on her arm, a bump - Related Patient history: Asthma (From: Unspecified To: Unspecified). Additional Context: Pfizer Sales Representative stated, I wanted to report an adverse event that I heard yesterday. Pfizer Sales Representative provided the name of product as PREVNAR 13. Pfizer Sales Representative stated, She (nurse) said that it was very painful at the injection site and left a welt in her arm, a bump. Pfizer sales representative. PRD: Pfizer Sales Representative stated, It was yesterday at 2 O'clock pm, 4/18/2017. Reason of delay: Pfizer Sales Representative stated, I don't know I have to report within 24 hours. Pfizer Sales Representative did not know the last name of the nurse. Pfizer Sales Representative did not have the email address. In response to follow up, Pfizer Sales Representative stated, I don't know, I did not ask her. Causality: Yes. In response to consumers details Pfizer Sales Representative stated, It was actually the nurse herself. She received (PREVNAR 13) and telling me about. In response to nurse details (date of birth, height and weight and ethnicity), Pfizer Sales Representative stated, I don't know her date of birth she think she said she was, I don't know her age. She had asthma and doctor gave her a PREVNAR 13. Product details (LOT#, NDC# and UPC# and Expiration date) were unknown as Pfizer Sales Representative did not have information. In response to doctor's details Pfizer Sales Representative stated, I do not know that. In response to pharmacy details Pfizer Sales Representative stated, I do not know. Limited information was available as Pfizer Sales Representative did not have any further information.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a certified medical assistant and an office manager and refers to a patient of an unknown age and gender. The patient's pertinent medical history, drug reactions, allergies and concomitant medications were not provided. On an unknown date, the patient was vaccinated with a dose of PNEUMOVAX 23 lot # L012215 (dose and route of administration were not reported), which expired on 13-JAN-2017. No symptoms were reported. Product quality complaint was not involved. Additional information is not expected, as there was no consent to contact a physician.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant 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 improperly stored doses of VARIVAX (lot # M010485, expiration date 01-MAR-2018 and lot # M012990 expiration date 14-MAR-2018) dose and route of administration were not reported for prophylaxis. It was reported that the vaccine was reconstituted with a properly stored sterile diluent (manufacturer unknown). There were no adverse effects reported. Administered doses of vaccines experienced the temperature excursion of 6 to 14 degrees Fahrenheit for 74 hours. A previous temperature excursion of 6 to 14 degrees Fahrenheit for 11 hours was reported. No data logger was involved. This is one of two reports received from the same reporter. Additional information has been requested.; Sender's Comments:  US-009507513-1704USA010593:
Age: 53.0
Sex: M
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. On 29-MAR-2017, the patient was vaccinated with improperly stored dose of PNEUMOVAX23 lot # M043424, expiration date 16-JUN-2018 (dose and route of administration were not reported). No symptoms were reported. Administered doses of vaccines experienced the temperature excursion of 49.8 degrees Fahrenheit for 2 hours and 34.9 degrees Fahrenheit for 50 minutes. Data logger was involved. There were no previous excursions reported. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Papilloma viral infection
Clinical narrative: This spontaneous report was received from a 31-year-old female patient reporting on herself. The patient had no pertinent medical history and drug reactions or allergies. On an unknown dates, reported as "few years ago, maybe 2011 or 2012", the patient received series of all three doses of GARDASIL for prevention from human papilloma virus (HPV) (dose, route of administration, lot # and expiration date were not reported). Concomitant therapies included NUVARING. On 06-APR-2017, the patient was diagnosed with an unspecified HPV infection. She was treated on 06-APR-2017 by the physician and would need to follow up with the physician in two weeks. No lab diagnostic studies were performed. The outcome of the event and the relatedness between the event and GARDASIL were not 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 registered nurse and refers to multiple unspecified patients of unknown age and gender. No information about the patients' pertinent medical history, concomitant medications, drug reactions or allergies was provided. On unspecified dates, the patients were vaccinated with doses of improperly stored GARDASIL 9 lot # M034780 with expiration date 15-APR-2019 and lot # M036509 with expiration date 03-JUN-2019 (dose and route of administration not reported). The vaccine underwent a temperature excursion of 32 to 35 degrees Fahrenheit for 30 minutes. Digital data logger was used to record the excursion. The vaccine already underwent previous excursion of 32 to 35 degrees Fahrenheit for 185 hours and 45 minutes. No adverse effects were reported. This is one of three reports received from the same source. Additional information has been requested.; Sender's Comments: US-009507513-1704USA010519: US-009507513-1704USA010520:
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to multiple unspecified patients of unknown age and gender. No information about the patients' pertinent medical history, concomitant medications, drug reactions or allergies was provided. On unspecified dates, the patients were vaccinated with doses of improperly stored PNEUMOVAX 23 lot # M041394 with expiration date 23-MAY-2018 (dose and route of administration not reported). The vaccine underwent a temperature excursion of 32 to 35 degrees Fahrenheit for 30 minutes. Digital data logger was used to record the excursion. The vaccine already underwent previous excursion of 32 to 35 degrees Fahrenheit for 185 hours and 45 minutes. No adverse effects were reported. This is one of three reports received from the same source. Additional information has been requested. Sender's Comments: US-009507513-1704USA010520: US-009507513-1704USA005828.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to multiple unspecified patients of unknown age and gender. No information about the patients' pertinent medical history, concomitant medications, drug reactions or allergies was provided. On unspecified dates, the patients were vaccinated with doses of improperly stored  PEDVAXHIB lot # reported as M02784 with expiration date 19-APR-2019 (dose and route of administration not reported). The vaccine underwent a temperature excursion of 32 to 35 degrees Fahrenheit for 30 minutes. Digital data logger was used to record the excursion. The vaccine already underwent previous excursion of 32 to 35 degrees Fahrenheit for 185 hours and 45 minutes. No adverse effects were reported. This is one of three reports received from the same source. Additional information has been requested. Sender's Comments: US-009507513-1704USA005828: US-009507513-1704USA010519.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant 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 improperly stored doses of PROQUAD (lot # M006106, expiration date 01-AUG-2017 and lot # M035143 expiration date 30-JAN-2018) dose and route of administration were not reported for prophylaxis. It was reported that the vaccine was reconstituted with a properly stored sterile diluent (manufacturer unknown). There were no adverse effects reported. Administered doses of vaccines experienced the temperature excursion of 6 to 14 degrees Fahrenheit for 74 hours. A previous temperature excursion of 6 to 14 degrees Fahrenheit for 11 hours was reported. No data logger was involved. This is one of two reports received from the same reporter. Additional information has been requested.; Sender's Comments:  US-009507513-1704USA002366:
Age: 28.0
Sex: M
Vaccine: HEP, HEPA
Symptoms: Dizziness
Clinical narrative: Client received vaccines on 04/04/2017 at our clinic in the afternoon. Client states that on 04/05/2017 while playing a video game at 10:00PM, a "loud sound" came through his headphones and he began to feel dizzy. Client stated that he ate food, which did not help the dizziness. No other symptoms reported. Client called our clinic on 04/06/2017 around 10:00AM to report his symptoms, since they had not resolved. Client instructed to not drive and seek medical care. Client referred to urgent care locations in his area that accept his insurance since he reports not having a PCP.
Sex: U
Vaccine: VARCEL
Symptoms: Injection site reaction, Local reaction
Clinical narrative: This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. No information regarding the patient's medical history, concurrent conditions, concomitant therapies or drug reactions/allergies was provided. On an unknown date, the patient was vaccinated by a medical assistant with a dose of VARIVAX 0.5 ml, probably intramuscularly instead of subcutaneously (dose number, anatomical location, lot number and expiration date were not reported), for prophylaxis. It was reported that it could not be verified which size of needle was used to administer the vaccine, however no adverse events were reported. No product quality complaint was involved. Follow up information has been received from the registered nurse on 31-MAR-2017. The nurse reported that the patient developed "a localized reaction at the injection site" on 05-MAR-2017, which was treated with BENADRYL. Subsequently, on an unspecified date in March 2017 (reported as "took 2 to 3 weeks to resolve"), the patient recovered from the event. The causality assessment between VARIVAX and injection site reaction was not provided. Additional information has been requested.