chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 1.0
Sex: M
Vaccine: HEPA, HIBV, VARCEL
Symptoms: Red blood cell sedimentation rate increased, Skin lesion, Varicella post vaccine
Clinical narrative: Began to have Chicken Pox lesions (6-8) on various body parts 4 days after vaccination. 2 weeks later he continued having new lesions appear. On 06/08/17 he was admitted for right hand cellulitis and varicella rash.
Age: 76.0
Sex: F
Vaccine: PNC
Symptoms: Dizziness, Erythema, Peripheral swelling, Vision blurred
Clinical narrative: Patient experienced swelling/redness all down her arm into her hand along with dizziness and blurred vision for a period of 2-3 days.
Age: 61.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Injection site rash, Rash, Rash pruritic
Clinical narrative: Patient got a rash at injection site on 6/9/17 in the afternoon and then on 6/11/17 she noticed an itchy rash on her back at which point she went to urgent care and her provider diagnosed the rash as zoster icd-10 B02.9.
Age: 61.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: Patient got a rash at injection site on 6/9/17 in the afternoon and then on 6/11/17 she noticed an itchy rash on her back at which point she went to urgent care and her provider diagnosed the rash as zoster icd-10 B02.9.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Polymerase chain reaction positive, Rash, Varicella virus test positive
Clinical narrative: Right sided rash consistent with shingles.
Age: 53.0
Sex: F
Vaccine: YF
Symptoms: Pain, Rash erythematous, Rash pruritic
Clinical narrative: Patient has red rash which is stingy and quite itchy and had it for a week.
Age: 73.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Peripheral swelling, Skin atrophy, Skin warm
Clinical narrative: Swelling of arm (tricep area), redness, hot to the touch, hanging skin. Started Friday 6/9/17. No treatment. Called doctor who said prednisone was not necessary.
Age: 27.0
Sex: F
Vaccine: HEP, HEP
Symptoms: Abdominal pain upper, Diarrhoea
Clinical narrative: Stomach Pain and diarrhea lasting 12 hrs. No treatment. Recovered after 12 hrs.
Age: 27.0
Sex: F
Vaccine: HEP, HEP
Symptoms: Diarrhoea, Gastrointestinal pain
Clinical narrative: Stomach Pain and diarrhea lasting 12 hrs. No treatment. Recovered after 12 hrs.
Age: 38.0
Sex: F
Vaccine: TDAP
Symptoms: Asthenia, Burning sensation, Dizziness, Hypoaesthesia, Nerve injury
Clinical narrative: Pain, swelling, numbness, tingling, burning, dizziness, weakness.
Age: 38.0
Sex: F
Vaccine: TDAP
Symptoms: Pain, Paraesthesia, Swelling
Clinical narrative: Pain, swelling, numbness, tingling, burning, dizziness, weakness.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Contusion, Erythema, Skin warm
Clinical narrative: Red, warm to touch, still looks bruised.
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Allergy to vaccine, Specialist consultation, Urticaria
Clinical narrative: Covered in major hives head to toe, front to back. Given BENADRYL, taken to the emergency dept., given steroids for 3 days and then again went back to ER and put back on steroids for another 5 days on top of BENADRYL for 2 weeks. Cool showers and also re-checked by his pediatrician and referred to allergy specialist who confirmed he is severely allergic to the meningitis vaccine. This reaction lasted two weeks.
Age: 0.75
Sex: M
Vaccine: HEPA
Symptoms: Inappropriate schedule of drug administration, Wrong drug administered
Clinical narrative: A pediatrician practicing at clinic did not follow the Recommended Immunization Schedule for Children and Adolescents Aged 18 Years or Younger, 2017 for my son. He was expected to receive the 3rd dose of HepB but instead, the pediatrician gave him the 1st dose of Hep A. A board certified pediatrician gave a 10-month-old Hep A instead of the expected Hep B!
Age: 36.0
Sex: F
Vaccine: HEP, TDAP
Symptoms: Pain, Swelling, Vomiting
Clinical narrative: Patient vaccinated 6/7/17 with TDaP (R delt.), Hep B (Left delt.). RTC to HU 6/13/17, stated had reaction to vaccine given in (R) arm. C/O of pain, swelling, and vomiting fizzy substance after injection.
Age: 16.0
Sex: F
Vaccine: MENB, MNQ, MENB, MNQ
Symptoms: Injection site pain, Rash
Clinical narrative: Pt received vaccines on 06/01/17. Were given in legs and a rash broke out a few days later on both deltoids. Denies pain/fever/itching. Has had MENACTRA in past with no reaction. States this is the 1st TRUMENBA vaccine. States (L) leg is sore but no rash.
Age: 16.0
Sex: F
Vaccine: MENB, MNQ, MENB, MNQ
Symptoms: Injection site pain, Rash pustular, Rash vesicular
Clinical narrative: Pt received vaccines on 06/01/17. Were given in legs and a rash broke out a few days later on both deltoids. Denies pain/fever/itching. Has had MENACTRA in past with no reaction. States this is the 1st TRUMENBA vaccine. States (L) leg is sore but no rash.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Patient fainted after receiving 2nd dose of HPV.
Age: 21.0
Sex: F
Vaccine: HEP
Symptoms: Urticaria
Clinical narrative: Pt. developed hives approx. 2 hrs after receiving vaccine. Tried BENADRYL - no improvement. Went to Urgent Care on 6/7/17. Treated with Prednisone. Follow up at Clinic on 6/12/17. Hives resolving.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: The day after receiving immunization pt had a lot of redness and pain at injection site. Saw Dr on 6/9/17 and was prescribed Azithromycin for possible cellulitis. Symptoms were resolved by 6/12/17.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Body temperature, Diarrhoea, Gastrointestinal bacterial infection, Injection site erythema, Injection site pain
Clinical narrative: States injection site was red and raised and extensive area around site was red. Was also painful. Had diarrhea following day-not sure if linked or if viral. Also had temp on day but only overnight.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Injection site swelling
Clinical narrative: States injection site was red and raised and extensive area around site was red. Was also painful. Had diarrhea following day-not sure if linked or if viral. Also had temp on day but only overnight.
Age: 53.0
Sex: F
Vaccine: MNQ
Symptoms: Dizziness, Dysgeusia, Fatigue, Headache, Injection site erythema
Clinical narrative: Dizziness, headache, nausea, fever, moderate - severe redness and irritation to vaccine site, right deltoid area, also, bitter taste in mouth, fatigue.
Age: 53.0
Sex: F
Vaccine: MNQ
Symptoms: Nausea, Pyrexia, Vaccination site irritation
Clinical narrative: Dizziness, headache, nausea, fever, moderate - severe redness and irritation to vaccine site, right deltoid area, also, bitter taste in mouth, fatigue.
Age: 1.08
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Pyrexia, Rash
Clinical narrative: Fever 6/8/17, Rash 6/12/17.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Cellulitis, Dizziness, Injection site erythema, Injection site pain, Injection site pruritus
Clinical narrative: The patient visited her Dr. presenting erythema at the site of injection, pruritus and pain. Also dizziness. The Dr: diagnosed cellulitis and prescribed her ROCEPHIN inj. 1 g. daily for six days. The patient has already two shots of ROCEPHIN.
Age: 22.0
Sex: F
Vaccine: TYP, YF
Symptoms: Incorrect route of drug administration, No adverse event
Clinical narrative: Yellow fever vaccine given via IM route, should have been given SQ, no adverse events reported this was a vaccine route administration error.
Age: 44.0
Sex: F
Vaccine: MMR
Symptoms: Injection site cellulitis, Injection site warmth
Clinical narrative: Cellulitis of (L) upper arm; heat. Follow-up was done at Urgent Care 6/6/17.
Age: 0.58
Sex: M
Vaccine: DTAPHEPBIP, PNC13
Symptoms: Injection site bruising
Clinical narrative: Left thigh contusion. No erythema. Rx: warm compress, supportive care.
Age: 17.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Bradycardia, Eye movement disorder, Hypotension, Posturing
Clinical narrative: Patient had eyes roll back, slumped to the right side on exam table, some posturing of feet. Episode lasted 30-45 seconds and received occurred 4 minutes after vaccine was given. Bradycardia to 49 after event and hypotensive x15-20 minutes.
Age: 36.0
Sex: F
Vaccine: TDAP
Symptoms: Pain in extremity
Clinical narrative: TDaP given 6/5/17 patient C/O pain left arm on 6/12/17. Patient seen by provided on 6/13/17 Referral to neurology. Rx Prednisone 40 mg PO x5 days 7/6 in 1 wk.
Age: 73.0
Sex: M
Vaccine: TDAP, TDAP
Symptoms: Asthenia, CSF protein increased, Fatigue, Hypoaesthesia, Paraesthesia
Clinical narrative: Patient had Guillain Barre Syndrome while out of town, with muscle weakness, numbness and tingling, difficulty swallowing, urosepsis from indwelling Foley catheter.
Age: 73.0
Sex: M
Vaccine: TDAP, TDAP
Symptoms: Bladder catheterisation, Dysphagia, Guillain-Barre syndrome, Hypoaesthesia, Muscular weakness
Clinical narrative: Patient had Guillain Barre Syndrome while out of town, with muscle weakness, numbness and tingling, difficulty swallowing, urosepsis from indwelling Foley catheter.
Age: 73.0
Sex: M
Vaccine: TDAP, TDAP
Symptoms: Paraesthesia, Urosepsis
Clinical narrative: Patient had Guillain Barre Syndrome while out of town, with muscle weakness, numbness and tingling, difficulty swallowing, urosepsis from indwelling Foley catheter.
Sex: F
Vaccine: HPV4
Symptoms: Asthenia, Dizziness, Fatigue, Injection site pain, Mobility decreased
Clinical narrative: This spontaneous report has been received from a consumer, via the Agency (413519) on 08-JUN-2017, concerning a 21 year-old female patient who, on 01-JAN-2010 underwent the administration of one dose of GARDASIL intramuscular (dose, frequency, lot #, expiration date and anatomical location were not reported) for prophylaxis, as per section above. On 01-JAN-2010, the patient experienced extreme pain at injection site (coded by the Agency as "pain") with temporary impaired mobility of the injected limb (not coded by the Agency in the dedicated section of the Regulatory form), dizziness, vertigo, myoclonus, asthenia, chronic fatigue (coded by the Agency as "fatigue"). The outcome of the adverse events was not available. The reported impact on the patients life quality was 8/10. The patient was contacted by the Local Health Unit by e-mail but she did not respond. At the time of reporting the patient was not a resident of the health district that received the report and the vaccination was not performed in the public vaccination health clinic. The reporter considered the events to be medically significant and the causality assessment between GARDASIL and the events to be related. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Myoclonus, Vertigo
Clinical narrative: This spontaneous report has been received from a consumer, via the Agency (413519) on 08-JUN-2017, concerning a 21 year-old female patient who, on 01-JAN-2010 underwent the administration of one dose of GARDASIL intramuscular (dose, frequency, lot #, expiration date and anatomical location were not reported) for prophylaxis, as per section above. On 01-JAN-2010, the patient experienced extreme pain at injection site (coded by the Agency as "pain") with temporary impaired mobility of the injected limb (not coded by the Agency in the dedicated section of the Regulatory form), dizziness, vertigo, myoclonus, asthenia, chronic fatigue (coded by the Agency as "fatigue"). The outcome of the adverse events was not available. The reported impact on the patients life quality was 8/10. The patient was contacted by the Local Health Unit by e-mail but she did not respond. At the time of reporting the patient was not a resident of the health district that received the report and the vaccination was not performed in the public vaccination health clinic. The reporter considered the events to be medically significant and the causality assessment between GARDASIL and the events to be related. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report was received from a medical assistant and refers to an unspecified number of patients of unknown demographics. No information regarding the patients' pertinent medical history, concomitant medications, drug reactions or allergies was provided. On unknown dates in 2017, the patients were possibly vaccinated with improperly stored stoses of GARDASIL 9 injection, lot # M034780 with expiration date 15-APR-2019 (dose, route and site of administration were not reported). GARDASIL 9 was stored between 32 and 35 degrees Fahrenheit for 11 hours and 5 minutes, and between 47 and 77 degrees Fahrenheit for 40 minutes. There was previous temperature excursion. The digital data logger was involved in recording the excursion. There was no product quality complaint involved in this case. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments:  US-009507513-1705USA015617: US-009507513-1705USA015615: US-009507513-1705USA015613: US-009507513-1705USA015612: US-009507513-1705USA015614:
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: This spontaneous report was received from a physician referring to a female patient of unknown age.  There was no information about the patient's concurrent conditions, medical history or concomitant medication. On an unknown date, prior to 65 years of age, the patient was vaccinated with PNEUMOVAX 23 dose 1 (dose, route of administration, lot number and expiration date were not reported) for prophylaxis. On an unspecified date, the patient experienced swelling and redness at the injection site for approximately one week after the vaccine was administered;  Patient also received a second dose of PNEUMOVAX 23 (dose, route of administration, lot number and expiration date were not reported) at 65 years of age but did not experienced any adverse effects after second dose. At the time of reporting, the patient recovered from swelling and redness at injection site. The causal relationship between the event and therapy with PNEUMOVAX 23 was not reported. Additional information has been requested.
Age: 2.0
Sex: F
Vaccine: DTAP, HEPA, HIBV, PNC13
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant(also reported as office manager) referring to a 2 year old patient of unknown gender. The patient's concurrent condition, medical history and concomitant therapy were not provided. On 09-MAY-2017, the patient was vaccinated with the second improperly stored dose of VAQTA (lot # M039202, expiration date: 11-MAR-2018; dose and route of administration were not provided) for prophylaxis. No adverse effects were reported. The vaccine was involved in Vaccines For Children Program(VFC) stock and the VFC status appointment was reported as 1. The patient received the vaccine with the temperature excursion of 17.6 degrees Celsius for 74 hours and 8 minutes (also reported as 1 hour and 38 minutes). The vaccine was previously exposed to a temperature excursion in 13 degrees Celsius for 72 hours 30 minutes. Data logger was involved. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information is not expected as all correspondence was received.; Sender's Comments:  US-009507513-1704USA014784:
Age: 4.0
Sex: M
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a licensed vocational nurse (LVN) and refers to a patient of unknown age and gender. There was no information about the patient;s concurent donditios, concomitant therapies or medcical history provided. On 23-MAY-2017 the patient was vaccinated with improperly stored dose of PROQUAD recombinant human albumin (rHA) lot # M036158 with an expiration date 12-FEB-2018 for prophylaxis (dose and route of administration were not reported). No adverrse effect was reported. Administered dose of PROQUAD experienced temperature excursion from 6 degrees Fahrenheit to 14 degrees Fahrenheit for 6 hours and 48 minutes.  There was no previous temperature excursion. A digital data logger was involved. This is one of two reports received from the same reporter. Additional information has been requested.; Sender's Comments:  US-009507513-1706USA005346:
Sex: F
Vaccine: PPV
Symptoms: Erythema, Mobility decreased, Peripheral swelling
Clinical narrative: Information was received from a nurse via field employee, concerning herself and her concurrent conditions included diabetes. The patient's concomitant therapy was reported as "diabetes".. There was no information about the patient's age. In approximately 2007 (also reported as about 10 years) the patient was vaccinated with PNEUMOVAX 23  for prophylaxis (dose, route of administration, lot number and expiration date were not reported). On an unspecified date in 2007, for about a week after vaccination, the patient experienced redness, could not rest her arm down by her side and had to keep it elevated (Injected limb mobility decreased) and swelling of the arm all the way into the armpit (peripheral swelling). The patient sought unspecified medical attention at the time of the experience and it was unknown if treatment was given for adverse events. The outcome of the events erythema, Injected limb mobility decreased, and peripheral swelling and the causal relationship between the event and therapy with PNEUMOVAX 23 were not reported. There was no PQC involved. Additional information is not expected because there was no consent to contact reporter.
Sex: U
Vaccine: VARCEL
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report has been received from a registered nurse and refers to a patient of an unknown age and gender. The patient's relevant medical history, concurrent conditions, and concomitant therapies were not reported. On 05-MAY-2017, the patient was vaccinated with the first dose of VARIVAX subcutaneously (strength, dose, frequency, lot number and expiration date were not reported) for prophylaxis, that were reconstituted with sterile diluent (DILUENT MRK) (lot number and expiration date were not reported). Subsequently, on 24-MAY-2017, the patient received the second dose of VARIVAX subcutaneously (strength, dose, and frequency were not reported; lot number reported as M004437 with an expiration date 04-NOV-2018) that was reconstituted with sterile diluent (DILUENT MRK) (lot number N007932 with an expiration date 06-MAY-2018). There were no adverse effects reported. Additional information has been requested.
Sex: F
Vaccine: HPV9
Symptoms: Pain in extremity, Peripheral swelling
Clinical narrative: This spontaneous report was received from a registered nurse referring to a female patient of unknown age. The patient's medical history, concurrent conditions, drug and allergy history were not reported.  On an unknown date, the patient was vaccinated in the physician office with GARDASIL 9 on her arm (dose route, lot #, and expiration date were not provided) for prophylaxis. The patient's concomitant therapy was not reported. On an unspecified date, 2 weeks after vaccination, the patient came back to the office because the arm in which she received GARDASIL 9 was "very swollen, very sore, and very sensitive." Patient was told to return to the office in 2 to 3 days if the symptoms did not resolve and patient never returned to the office, so the registered nurse assumed the patient had recovered. At the reporting time the final outcome of the events was unknown. The causality assessment between GARDASIL 9 and the adverse events was unknown. Additional information has been requested.
Age: 34.0
Sex: M
Vaccine: PPV
Symptoms: Injection site induration, Injection site swelling
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a 34 year old male patient. The patient was a smoker and did not have any drug reactions or allergies. No other information regarding the patient's pertinent medical history and concomitant medications was provided. On 26-MAY-2017, the patient was vaccinated with PNEUMOVAX 23, injection in the upper right extremity, lot # N005597 with expiration date on 19-OCT-2018 (dose and route of administration were not reported) due to smoking. On 26-May 2017, following the administration of the vaccine, the patient developed a large hard bump at the injection (reported as "insertion") site. The patient did not seek medical attention for the adverse events and did not receive any treatment. There were no laboratory diagnostic studies performed. At the time of the report, the patient did not recover from the adverse events. There was no product quality complaint involved. The relatedness between the adverse events and PNEUMOVAX 23 was not reported. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Papilloma viral infection, Smear cervix abnormal
Clinical narrative: This spontaneous report was received from a consumer (the patient's mother) and refers to a currently 27-year-old female patient. No information about the patient's pertinent medical history, concomitant medications, drug reactions or allergies was reported. On unspecified dates in 2007, at the age of 16, the patient was vaccinated with the series (number of doses was not specified) of GARDASIL, intramuscular injections (dose, frequency, strength, lot number or expiration dates were not reported), for prevention of Human Papilloma Virus (HPV). On an unknown date (reported as "recently"), the patient had a pap smear and was diagnosed with a high risk HPV types 16 and 18. The patient sought medical attention by contacting an unspecified physician. The outcome of high risk HPV (types 16 and 18) was reported as not recovered. The causality assessment between the event and GARDASIL was not provided. Additional information is not expected as the reporter did not wish to contact the patient's physician.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report was received from a medical assistant and refers to an unspecified number of patients of unknown demographics. No information regarding the patients' pertinent medical history, concomitant medications, drug reactions or allergies was provided. On unknown dates in 2017, the patients were possibly vaccinated with improperly stored doses of ROTATEQ liquid orally, lot # M040270 with expiration date 29-APR-2018 and lot # M038744 with expiration date 26-APR-2018 (dose was not reported). ROTATEQ was stored between 32 and 35 degrees Fahrenheit for 11 hours and 5 minutes, and between 47 and 77 degrees Fahrenheit for 40 minutes. There was previous temperature excursion. The digital data logger was involved in recording the excursion. There was no product quality complaint involved in this case. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1705USA015613: US-009507513-1705USA015614: US-009507513-1705USA015615: US-009507513-1705USA015617: US-009507513-1705USA007801:
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report was received from a medical assistant and refers to an unspecified number of patients of unknown demographics. No information regarding the patients' pertinent medical history, concomitant medications, drug reactions or allergies was provided. On unknown dates in May 2017, the patients were possibly vaccinated with improperly stored doses of VAQTA injection, lot # N005274 with expiration date 03-APR-2018 (dose, route and site of administration were not reported). VAQTA was stored between 32 and 35 degrees Fahrenheit for 4 hours and 40 minutes. There was previous temperature excursion and the digital data logger was involved in recording the excursion. There was no product quality complaint involved in this case. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1705USA015612: US-009507513-1705USA015614: US-009507513-1705USA015615: US-009507513-1705USA015617: US-009507513-1705USA007801:
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report was received from a medical assistant and refers to an unspecified number of patients of unknown demographics. No information regarding the patients' pertinent medical history, concomitant medications, drug reactions or allergies was provided. On unknown dates in 2017, the patients were possibly vaccinated with improperly stored doses of RECOMBIVAX HB injection, lot # N002913 with expiration date 23-FEB-2019 and lot # M037248 with expiration date 21-FEB-2019 (dose, route and site of administration were not reported). RECOMBIVAX HB was stored between 32 and 35 degrees Fahrenheit for 11 hours and 5 minutes, and between 47 and 77 degrees Fahrenheit for 40 minutes. There was previous temperature excursion. The digital data logger was involved in recording the excursion. There was no product quality complaint involved in this case. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1705USA015612: US-009507513-1705USA015613: US-009507513-1705USA015615: US-009507513-1705USA015617: US-009507513-1705USA007801:
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report was received from a medical assistant and 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 12-MAY-2017, the patient was vaccinated with an incorrectly stored dose of GARDASIL 9 injection, lot # M034780 with expiration date 15-APR-2019 (dose, route and site of administration were not reported). GARDASIL 9 was stored in temperature 34 degrees Fahrenheit for 4 hours and 40 minutes. There was previous temperature excursion and the digital data logger was involved in recording the excursion. There was no product quality complaint involved in this case. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1705USA015612: US-009507513-1705USA015613: US-009507513-1705USA015614: US-009507513-1705USA015617: US-009507513-1705USA007801:
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report was received from a medical assistant and 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 12-MAY-2017, the patient was vaccinated with an incorrectly stored dose of VAQTA injection, lot # N005274 with expiration date 03-APR-2018 (dose, route and site of administration were not reported). VAQTA was stored in temperature 34 degrees Fahrenheit for 4 hours and 4 minutes. There was previous temperature excursion and the digital data logger was involved in recording the excursion. There was no product quality complaint involved in this case. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1705USA015612: US-009507513-1705USA015613: US-009507513-1705USA015614: US-009507513-1705USA015615: US-009507513-1705USA007801:
Age: 18.0
Sex: M
Vaccine: HPVX
Symptoms: Abdominal discomfort, Disturbance in attention, Fatigue, Weight decreased
Clinical narrative: This spontaneous report was received from a patient's mother who was referring to her 18 year old son. The patient had no medical history, concomitant medications, drug reactions or allergies. On 16-MAR-2016, the patient was vaccinated with GARDASIL or GARDASIL 9 dose 1, intramuscularly for prophylaxis (lot number and expiration date were not provided). In March 2016 (reported as within a week), the patient experienced extreme fatigue and upset stomach. Over the course of the past 14 months, the patient lost over 30 pounds and continued to feel tired. It was also reported that the patient had trouble with concentrating on school work. The reporter did not provide demographics for a physician, as the patient no longer visited the pediatrician who administered the vaccine injection. It was also reported that the patient received only first dose of three doses of GARDASIL or GARDASIL 9. The patient sought medical attention and was seen by several specialists. He had many unspecified types of tests done and was scheduled for a few more tests. There was no treatment given for an adverse events. The patient's present status was not recovered. The relatedness between the events and GARDASIL or GARDASIL 9 was not reported. Additional information is not expected as there was no consent for follow-up.
Age: 70.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Erythema
Clinical narrative: This spontaneous report was received from a 70 year old female patient with cardiomyopathy, who was reporting on herself. The patient did not have any known drug reactions or allergies.  On 29-SEP-2016, the patient was vaccinated with a dose of ZOSTAVAX injection, one time via subcutaneous route (reported as under the skin) (exact dose, lot number and expiration date were not reported). On the same day, the patient was vaccinated with pneumococcal a dose of an unspecified "pneumonia shot" (manufacturer unknown) injection (dose, route of administration, lot number and expiration date were not reported). Concomitant therapies included Asian ginseng (+) acetylcarnitine (+) ascorbic acid (+) bacopa (+) biotin (+) choline (+) cyanocobalamin (+) docosahexaenoic acid (+) folic acid (+) ginkgo (+) glutamine (+) phosphatidyl choline (+) phosphatidyl serine (+) resveratrol (+) tyrosine (COGNETIX LABS PROVASIL) and quinapril hydrochloride.  On an unknown date in 2016, reported as a day and a half after receiving ZOSTAVAX and the unspecified pneumonia shot, the patient experienced redness that was 3 and 1/2 inches in size. The patient did not seek medical attention and did not receive treatment for the adverse event. There were no laboratory diagnostic studies performed. There was no product quality complaint involved. The outcome of the event was not reported. The relatedness between the event and the suspect vaccines was not provided. Additional information is not expected as no consent to contact the physician was granted.
Sex: U
Vaccine: HPV4
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from an office manager referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions, concomitant medications, and historical drugs were not reported. On 30-MAY-2017, the patient was vaccinated with and expire dose of GARDASIL (route, dose, dose number, frequency and anatomical location were unknown) with Lot # M014929 and expiration date 27-MAY-2017 for prophylaxis. No adverse effects were reported. There was no product quality complaint involved. Additional information has been requested.
Sex: U
Vaccine: HEP, HEPA, HPV9, PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a licensed practical nurse referring to an unspecified patient of unknown age and gender. The patient's medical history, concurrent conditions, drug and allergy history were not reported. The patient's concomitant therapy was not reported.  On an unknown date, the patient may have received one of the improperly stored lots of GARDASIL 9 lot # M035486 and expiration date on 05-JUN-2019 or lot # reported as M018626 and expiration date on 11-MAR-2018, or PNEUMOVAX 23 lot # N005096 and expiration date on 22-OCT-2018 or lot # N003993, expiration date on 22-OCT-2018 or lot # M042599, expiration date on 17-JUN-2018, or with VAQTA lot # M031806 and expiration date on 30-MAR.-2018, or RECOMBIVAX HB lot # M041384 and expiration date on 09-JUN-2019, or lot # M033096, expiration date on 31-MAY-2018, or lot # M041384 and expiration date on 07-JUL-2019. (neither the dose nor the route were provided for any of the vaccines) for prophylaxis. The reporter was not sure which of the vaccines the patient received. On an unspecified day, the data logger registered that during 6 hours and 52 minutes, the temperature under the vaccines were stored, was in the range (9°C to 25°C) and there was a prior temperature excursion in the range (9°C to 25°C) for 10 hours and 15 minutes. no adverse events were reported. Lot number M018626 is an invalid lot number for hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast). Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Dizziness, Dyspnoea, Feeling hot, Injection site pain, Insomnia
Clinical narrative: This spontaneous report was received from a physician and refers to a 15 year old female patient. The patient did not have any pertinent medical history, drug reactions or allergies. She did not take any concomitant medications. On 25-APR-2017 the patient was vaccinated with a dose of GARDASIL 9 injection, intramuscularly in the left upper arm (dose, lot number and expiration date were not reported) for Human Papillomavirus (HPV) prevention. On 25-APR-2017 (reported as "within minutes"), the patient began to feel light-headed, hot, developed difficulty breathing and had pain at the injection site. She was given ibuprofen as treatment for the events and was monitored at the office for 40 minutes. The symptoms resolved "in that time she was in the office" (on 25-APR-2017) and the patient left the office. On 05-JUN-2017, she was seen in the office again. The patient was complaining of chronic pain in her left arm, which was worse at night and she was unable to sleep at times (since an unknown date in 2017). It was reported that "while the patient stated that symptoms resolved in the office on 25-APR-2017, the physician reported that the pain in her arm came back and persisted." No lab diagnostic studies were performed. The events were treated with ibuprofen, which as "effective at times". The reporter stated that strength and sensation was normal in the left arm and referred the patient to a pain management center for further treatment. At the time of reporting, the event of chronic pain in the left arm was not resolved. The outcome of being unable to sleep was not reported. Action taken with GARDASIL 9 was considered to be not applicable. The relatedness between the events and the vaccination with GARDASIL 9 was not reported. Product quality complaint was not involved. No further information was available. The reporting physician considered the event of chronic pain in the left arm to be disabling.  Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Pain in extremity
Clinical narrative: This spontaneous report was received from a physician and refers to a 15 year old female patient. The patient did not have any pertinent medical history, drug reactions or allergies. She did not take any concomitant medications. On 25-APR-2017 the patient was vaccinated with a dose of GARDASIL 9 injection, intramuscularly in the left upper arm (dose, lot number and expiration date were not reported) for Human Papillomavirus (HPV) prevention. On 25-APR-2017 (reported as "within minutes"), the patient began to feel light-headed, hot, developed difficulty breathing and had pain at the injection site. She was given ibuprofen as treatment for the events and was monitored at the office for 40 minutes. The symptoms resolved "in that time she was in the office" (on 25-APR-2017) and the patient left the office. On 05-JUN-2017, she was seen in the office again. The patient was complaining of chronic pain in her left arm, which was worse at night and she was unable to sleep at times (since an unknown date in 2017). It was reported that "while the patient stated that symptoms resolved in the office on 25-APR-2017, the physician reported that the pain in her arm came back and persisted." No lab diagnostic studies were performed. The events were treated with ibuprofen, which as "effective at times". The reporter stated that strength and sensation was normal in the left arm and referred the patient to a pain management center for further treatment. At the time of reporting, the event of chronic pain in the left arm was not resolved. The outcome of being unable to sleep was not reported. Action taken with GARDASIL 9 was considered to be not applicable. The relatedness between the events and the vaccination with GARDASIL 9 was not reported. Product quality complaint was not involved. No further information was available. The reporting physician considered the event of chronic pain in the left arm to be disabling.  Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Myalgia, Pain, Pain in extremity
Clinical narrative: This spontaneous report was received from a physician and refers to a 15 year old female patient. The patient did not have any pertinent medical history, drug reactions or allergies. She did not take any concomitant medications. On 25-APR-2017 the patient was vaccinated with a dose of GARDASIL 9 injection, intramuscularly in the left upper arm (dose, lot number and expiration date were not reported) for Human Papillomavirus (HPV) prevention. On 25-APR-2017 (reported as "within minutes"), the patient began to feel light-headed, hot, developed difficulty breathing and had pain at the injection site. She was given ibuprofen as treatment for the events and was monitored at the office for 40 minutes. The symptoms resolved "in that time she was in the office" (on 25-APR-2017) and the patient left the office. On 05-JUN-2017, she was seen in the office again. The patient was complaining of chronic pain in her left arm, which was worse at night and she was unable to sleep at times (since an unknown date in 2017). It was reported that "while the patient stated that symptoms resolved in the office on 25-APR-2017, the physician reported that the pain in her arm came back and persisted." No lab diagnostic studies were performed. The events were treated with ibuprofen, which as "effective at times". The reporter stated that strength and sensation was normal in the left arm and referred the patient to a pain management center for further treatment. At the time of reporting, the event of chronic pain in the left arm was not resolved. The outcome of being unable to sleep was not reported. Action taken with GARDASIL 9 was considered to be not applicable. The relatedness between the events and the vaccination with GARDASIL 9 was not reported. Product quality complaint was not involved. No further information was available. The reporting physician considered the event of chronic pain in the left arm to be disabling.  Additional information has been requested.
Age: 1.08
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse referring to a 13 month old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On an unknown date, the patient was inadvertently vaccinated with a dose of PROQUAD and a dose of VARIVAX (dose, route, lot numbers and expiration dates for both therapies were not provided) reconstituted with sterile diluent, for prophylaxis. There were no adverse effects reported. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant, referring to an unspecified number of  patients (ages and genders not reported). The patients' medical history, concurrent conditions and concomitant therapies were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of LIQUID PEDVAXHIB lot number reported as "M0245206" with expiration date on 27-JUN-2019; lot number M046133 with expiration date on 26-SEP-2019; lot number M047666 with expiration date on 24-OCT-2019 or lot number reported as "N000237" with expiration date on 25-OCT-2019 (strength, dose, anatomical location and administration route were not reported) for prophylaxis. No adverse effects were reported and no additional information was provided. The vaccines had a temperature excursion of 9 Celsius (C) to 25 C during 20 minutes,also was confirmed that the vaccines did not have previous temperature excursions and a digital data logger was involved. This is one of several reports received from the same source. Additional information has been requested. Sender's Comments:  US-009507513-1706USA005670: US-009507513-1706USA005671: US-009507513-1706USA005672: US-009507513-1706USA005673:
Sex: U
Vaccine: VARZOS
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On an unspecified date in 2014, the patient received a dose of ZOSTAVAX and on 08-JUN-2017, the patient received another dose of ZOSTAVAX reconstituted with sterile diluent (dose, route, lot numbers and expiration dates for both doses were not provided) for prophylaxis. There were no adverse effects reported. Additional information is not expected because there was no consent to contact the reporter.
Sex: F
Vaccine: VARCEL
Symptoms: Rash pustular
Clinical narrative: This spontaneous report was received from a consumer (via a registered nurse) reporting on her daughter, a 2-year-old female patient. No information was provided regarding the patient's concurrent conditions, concomitant medications, drug reactions or allergies. On an unknown date in the past, the patient was vaccinated with VARIVAX (dose, frequency, lot number or expiration date were not reported), as chickenpox prevention. The vaccine was reconstituted with the Merck (MRK) sterile diluent (lot # and expiration date were not reported). On an unknown date in May 2017 (reported as "over the following weekend"), the patient developed a bumpy, pox-like rash on her body. The patient's mother stated that the rash might actually be mosquito bites, but she was not certain. She reported the event as potential transmission of VARIVAX virus from the patient's sister. The outcome of the events and the causality assessment between the events and therapy with VARIVAX was not reported. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1706USA004798: US-009507513-1705USA012785:
Age: 2.0
Sex: F
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant(also reported as office manager) referring to a 2 year old patient of unknown gender. The patient's concurrent condition, medical history and concomitant therapy were not provided. On 27-APR-2017, the patient was vaccinated with the second improperly stored dose of VAQTA (lot # M039202, expiration date: 11-MAR-2018; dose and route of administration were not provided) for prophylaxis. No adverse effects were reported. The vaccine was involved in Vaccines For Children Program(VFC) stock and the VFC status appointment was reported as 1. The patient received the vaccine with the temperature excursion of 17.6 degrees Celsius for 74 hours and 8 minutes (also reported as 1 hour and 38 minutes). The vaccine was previously exposed to a temperature excursion in 13 degrees Celsius for 72 hours 30 minutes. Data logger was involved. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information is not expected as all correspondence was received.; Sender's Comments:  US-009507513-1704USA014784:
Age: 2.0
Sex: M
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant(also reported as office manager) referring to a 2 year old patient of unknown gender. The patient's concurrent condition, medical history and concomitant therapy were not provided. On 18-MAY-2017, the patient was vaccinated with the second improperly stored dose of VAQTA (lot # M039202, expiration date: 11-MAR-2018; dose and route of administration were not provided) for prophylaxis(Incorrect product storage). No adverse effects were reported. The vaccine was involved in Vaccines For Children Program(VFC) stock and the VFC status appointment was reported as 1. The patient received the vaccine with the temperature excursion of 17.6 degrees Celsius for 74 hours and 8 minutes (also reported as 1 hour and 38 minutes). The vaccine was previously exposed to a temperature excursion in 13 degrees Celsius for 72 hours 30 minutes. Data logger was involved. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information is not expected as all correspondence was received.; Sender's Comments: US-009507513-1704USA014784:
Age: 2.0
Sex: M
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant(also reported as office manager) referring to a 2 year old patient of unknown gender. The patient's concurrent condition, medical history and concomitant therapy were not provided. On 26-APR-2017, the patient was vaccinated with the second improperly stored dose of VAQTA (lot # M039202, expiration date: 11-MAR-2018; dose and route of administration were not provided) for prophylaxis(Incorrect product storage). No adverse effects were reported. The vaccine was involved in Vaccines For Children Program(VFC) stock and the VFC status appointment was reported as 2. The patient received the vaccine with the temperature excursion of 17.6 degrees Celsius for 74 hours and 8 minutes (also reported as 1 hour and 38 minutes). The vaccine was previously exposed to a temperature excursion in 13 degrees Celsius for 72 hours 30 minutes. Data logger was involved. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information is not expected as all correspondence was received.; Sender's Comments: US-009507513-1704USA014784:
Age: 2.0
Sex: F
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant(also reported as office manager) referring to a 2 year old patient of unknown gender. The patient's concurrent condition, medical history and concomitant therapy were not provided. On 12-MAY-2017, the patient was vaccinated with the second improperly stored dose of VAQTA (lot # M039202, expiration date: 11-MAR-2018; dose and route of administration were not provided) for prophylaxis(Incorrect product storage). No adverse effects were reported. The vaccine was involved in Vaccines For Children Program(VFC) stock and the VFC status appointment was reported as 1. The patient received the vaccine with the temperature excursion of 17.6 degrees Celsius for 74 hours and 8 minutes (also reported as 1 hour and 38 minutes). The vaccine was previously exposed to a temperature excursion in 13 degrees Celsius for 72 hours 30 minutes. Data logger was involved. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information is not expected as all correspondence was received.; Sender's Comments: US-009507513-1704USA014784: