chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 1.58
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 19 month old patient of unknown gender. The patient's concurrent condition, medical history and concomitant therapy were not provided. On 02-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.; Sender's Comments: US-009507513-1704USA014784:
Age: 1.58
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 19 month 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(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: 1.5
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 18 month old patient of unknown gender. The patient's concurrent condition, medical history and concomitant therapy were not provided. On 17-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 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: 1.33
Sex: F
Vaccine: DTAP, HEPA, HIBV
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 16 month 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: 1.25
Sex: F
Vaccine: HEPA, MMR, PNC13, VARCEL
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(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. Sender's Comments: US-009507513-1704USA014784:
Age: 56.0
Sex: M
Vaccine: HEPA
Symptoms: Cerebral disorder, Disorientation, Mobility decreased, Transient ischaemic attack, Vertigo positional
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of ministroke in a 56-year-old male patient who received HAVRIX (batch number 5354D, expiry date 17th November 2018). Concomitant products included CRESTOR. On 5th June 2017, the patient received HAVRIX (intramuscular) 1 ml. On 5th June 2017, 6 hrs after receiving HAVRIX, the patient experienced ministroke (serious criteria GSK medically significant), mobility decreased (serious criteria GSK medically significant), cerebral disorder, disorientation and vertigo positional. On an unknown date, the outcome of the ministroke, cerebral disorder and vertigo positional were recovering/resolving and the outcome of the mobility decreased and disorientation were unknown. The reporter considered the ministroke, mobility decreased, cerebral disorder, disorientation and vertigo positional to be possibly related to HAVRIX. Additional details were reported as follows: At 12:00, the patient received HAVRIX on left arm and stated that experienced serious cerebral event. The patient required emergency room visit and was diagnosed with positional vertigo, but required no overnight hospitalization. The patient felt like he was having a mini stroke and was not able to move for a 2 hours period and was also completely disoriented during that time.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Patient was brought in by mother. Left Deltoid where shots were administered had localized redness was warm to touch, site was about 5x4 in length and width. Per mom no fever or sign of illness.  Was told to take IBU for pain. A circle was drawn on patients arm over the area, Mom was told to watch the site and if it gets bigger or if other illness occurs to call the office or go to the ED. Follow up will be made on 06/15/2017 by phone call if mom has not returned to office.
Sex: U
Vaccine: HPV9
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. No information on patient's medical history, concurrent conditions and concomitant medications was provided. On 28-MAY-2017, the patient was vaccinated with an expired dose of GARDASIL 9) (lot # M014929, expiry date: 27-MAY-2017) (dose, route of administration not provided). No adverse event was reported. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to multiple patients of unknown age and gender. No information regarding the patients' concurrent conditions, medical history and concomitant therapies was reported. On unknown dates, the patients received incorrectly stored doses of RECOMBIVAX HB (dose and route of administration were not reported) lot # M003658, expiration date: 02-JUN-2018. No adverse effects were reported. The vaccines were stored in the temperature between 47 and 77 degrees Fahrenheit for 4 hours. Digital Data Logger was not involved. The vaccines underwent a previous temperature excursion for 45 minutes in the temperature between 47 and 77 degrees Fahrenheit. This is one of several reports received from the same reporter. Additional information is not expected as there was no consent to contact the reporter.; Sender's Comments: US-009507513-1706USA005334:
Age: 0.17
Sex: M
Vaccine: MMR
Symptoms: Full blood count normal, Petechiae, Pyrexia, Rash
Clinical narrative: This spontaneous report received from a nurse referred to a currently 7 month old male patient. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 13-JAN-2017, the patient received a dose of M-M-R II (lot: L043702, expiry date: 03-NOV-2017) for an unspecified indication. The nurse reported that the patient was seen back in the office on 15-FEB-2017 because "he had developed a fever and rash for 1 week and had moderate petechia on both (facial) cheeks, arms and legs. The nurse stated a complete blood count test was performed (on 15-FEB-2017) which showed borderline normal. The nurse stated the patient was seen back in the office on 20-MAR-2017 for follow up and had another blood test performed which showed normal. The nurse stated "no rash was noted" on 20-MAR-2017. When asked the current status, the nurse stated that he was doing well. No treatment was given to the patient. Outcome of rash was recovered and other events were resolving. Causality assessment was not reported.  This is one of the two reports received associated with the same patient. Additional information has been requested.; Sender's Comments: US-009507513-1706USA005492:
Sex: U
Vaccine: VARZOS
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. No concurrent conditions, medical history or allergy/drug reactions were reported. On 03-MAY-2017, the patient was vaccinated with ZOSTAVAX vial 19400 PFU (plaque-forming units), lot# M041086, expiry date: 03-JAN-2018 (dosing details, route unknown) instead of VARIVAX, for prophylaxis. ZOSTAVAX was reconstituted with sterile diluent(MERCK STERILE DILUENT) lot# N007932, expiry date: 06-MAY-2018 (dosing details, route unknown).  No adverse effects were reported. There were no product quality complaints (PQC) involved. Additional information has been requested.
Age: 4.0
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to 4-year-old patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 16-MAY-2017, the patient was vaccinated with improperly stored dose of PROQUAD lot # L046506, expiration date of 17-MAY-2017 (dose and route of administration were not reported). The vaccine was reconstituted with properly stored sterile diluent (DILUENT MRK). Administered dose of vaccine experienced the temperature excursion between 6 and 14 degrees F for 30 minutes on 03-FEB-2017. No previous temperature excursion occurred. No product quality complaint was involved. No adverse effects were reported. Digital Data logger was involved. This is one of several reports received from the same source. Additional information is not expected as all relevant information has already been received.; Sender's Comments:  US-009507513-1704USA010916:
Age: 4.0
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to 4-year-old patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 08-MAR-2017, the patient was vaccinated with improperly stored dose of PROQUAD lot # L046506, expiration date of 17-MAY-2017 (dose and route of administration were not reported). The vaccine was reconstituted with properly stored sterile diluent (DILUENT MRK). Administered dose of vaccine experienced the temperature excursion between 6 and 14 degrees F for 30 minutes on 03-FEB-2017. No previous temperature excursion occurred. No product quality complaint was involved. No adverse effects were reported. Digital Data logger was involved. This is one of several reports received from the same source. Additional information is not expected as all relevant information has already been received.; Sender's Comments:  US-009507513-1704USA010916: Original Case : 1704USA010916
Age: 4.0
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to 4-year-old patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 29-MAR-2017, the patient was vaccinated with improperly stored dose of PROQUAD lot # L046506, expiration date of 17-MAY-2017 (dose and route of administration were not reported). The vaccine was reconstituted with properly stored sterile diluent (DILUENT MRK). Administered dose of vaccine experienced the temperature excursion between 6 and 14 degrees F for 30 minutes on 03-FEB-2017. No previous temperature excursion occurred. No product quality complaint was involved. No adverse effects were reported. Digital Data logger was involved. This is one of several reports received from the same source. Additional information is not expected as all relevant information has already been received.; Sender's Comments:  US-009507513-1704US A010916:
Age: 4.0
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to 4-year-old patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 11-MAY-2017, the patient was vaccinated with improperly stored dose of PROQUAD lot # L046506, expiration date of 17-MAY-2017 (dose and route of administration were not reported). The vaccine was reconstituted with properly stored sterile diluent (DILUENT MRK). Administered dose of vaccine experienced the temperature excursion between 6 and 14 degrees F for 30 minutes on 03-FEB-2017. No previous temperature excursion occurred. No product quality complaint was involved. No adverse effects were reported. Digital Data logger was involved. This is one of several reports received from the same source. Additional information is not expected as all relevant information has already been received.; Sender's Comments:  US-009507513-1704USA010916:
Sex: F
Vaccine: PPV
Symptoms: Injection site cellulitis, Injection site reaction
Clinical narrative: This spontaneous report was received from a nurse practitioner via a company representative and refers to a 72- or 73-year-old female patient. No information regarding the patient's concurrent conditions, medical history and concomitant therapies was reported. On an unknown date, the patient was vaccinated with PNEUMOVAX23, 0.5 ml (route of administration, lot# and expiration date were not reported). On an unknown date in June 2017 (reported as "within the last day or two"), the patient developed an injection site reaction and cellulitis after receiving the vaccine. The patient sought medical attention by visiting the nurse practitioner. An unspecified treatment was given to the patient for the events, on an unknown date. The outcome of the events was unknown. The relatedness between the events and PNEUMOVAX23 was no reported. Upon internal review, the event of cellulitis was determined to be medically significant. Additional information has been requested.
Age: 0.17
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Blister, Scab
Clinical narrative: This spontaneous report received from a nurse referred to a currently 7 month old male patient. The patient's historical condition included rash and concurrent conditions included fever and moderate petechia. On 13-JAN-2017, the patient received a dose of M-M-R II (lot: L043702, expiry date: 03-NOV-2017) for an unspecified indication. The patient was seen in the office on 10-MAY-2017 and received a dose of VARIVAX (lot: M037643; expiry date: 01-SEP-2018) subcutaneously for an unspecified indication. The patients mother called the office on 30-MAY-2017 stated, a couple of days prior the patient developed multiple blisters in his groin area and under his arms that were then crusting over. When asked the current status, the nurse stated that he was doing well. No treatment was given to the patient. Outcome of blister was resolving. Causality assessment was not reported. This is one of the two reports received associated with the same patient. Additional information has been requested.; Sender's Comments: US-009507513-1706USA001656:
Age: 19.0
Sex: F
Vaccine: HPV4, MENB
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: This is a spontaneous report from a contactable other health care professional. A 20-year-old female patient received TRUMENBA (Lot# M95612, Exp date Jul2017), via an unspecified route of administration in arm left, on 07Jul2016, at single dose, for immunisation and the 3rd dose of GARDASIL (Lot# N000326, Exp date Oct2019), via an unspecified route of administration in arm left, on 07Jul2016, at unspecified dose, for immunisation. The patient's medical history was not reported. Concomitant medications were not reported. The patient previously took 1st and 2nd dose of GARDASIL on unspecified date, for immunisation. The patient experienced injection site swollen, painful and red on an unspecified date with outcome of unknown. Sender's Comments: Linked Report(s): US-PFIZER INC-2017252924 Same drug/event, different patient.
Age: 71.0
Sex: F
Vaccine: PNC13, TDAP
Symptoms: Erythema, Malaise, Pain in extremity, Peripheral swelling
Clinical narrative: This is a spontaneous report from a contactable Nurse. A 71-year-old female patient received PREVNAR 13 (lot Number: R49357, Expire Date: 31May2018) as routine prevention on 31May2017 10:00 via intramuscular route in the left deltoid, at 0,5ml single dose for immunization. On the same date the patient also received the first dose of TDAP IMMUN (lot U5626AA, exp. date 05Apr2019, Manufacturer: Sanofi) via intramuscular route in the right thigh. Concomitant medication included Fish oil at 1000 mg, 3x/day for High cholesterol, ongoing, glucosamine for joint issues at 50 mg, 1x/day, loratadine for Allergy at 10 mg, daily, ongoing and calcium as supplement, ongoing. Relevant medical history included Diabetes, Hypertension, High cholesterol diagnosed for at least 5 years, kidney cancer. On an unspecified date in Jun2017 the patient experienced acute left arm redness, swelling and pain and she did not feel well. The outcome of the events was not recovered.
Age: 1.0
Sex: F
Vaccine: DTAPHEPBIP, HEPA, HIBV, MMR, PNC13, VARCEL
Symptoms: Haemoglobin normal, Rash generalised
Clinical narrative: On 6/5/2017 Mom of client called to report that the child started a rash on 6/2/2017, time of onset unknown. She took her to the Emergency room on 6/4/2017 where they told the mother that it might be strep or a reaction to her vaccines. No testing was done and they told her to follow up with her doctor. When she talked to me on 6/5/2017 I also told her to follow up with her doctor. The mother called me back later on the afternoon of 6/5/2017 and reported that she saw a doctor and he told her that it was a rash related to the MMR vaccine. Mom reports that the child is covered head to toe in a rash but that no other signs or symptoms are present, denies any fevers. The doctor that she saw told her that it would go away and that no treatment was necessary. Mother of child also reports the child only having 1 set of vaccines in January 2017 at a free clinic, unable to obtain records.
Age: 4.0
Sex: F
Vaccine: DTAP
Symptoms: Erythema, Headache, Injection site erythema, Injection site swelling
Clinical narrative: Redness and swelling at injection site. 6/14/17 parent noted redness extending up into shoulder with some red streaks under arm. Child c/o headache.
Age: 1.33
Sex: M
Vaccine: HEPA, MMR
Symptoms: Ear infection, Pyrexia
Clinical narrative: Double ear infection/fever.
Sex: U
Vaccine: VARZOS
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report was received from a registered pharmacist reporting on a patient of unknown age or gender. No information was provided regarding the patient's pertinent medical history, concomitant medications, drug reactions or allergies. Approximately in 2015, reported as two years ago, the patient was vaccinated with the first dose of ZOSTAVAX injection (exact dose, route of administration, lot# and expiry date were not reported). On 24-MAY-2017, the patient was inadvertently vaccinated with the second dose of ZOSTAVAX injection, subcutaneously (lot# M0338863, expiry date 12-DEC-2017; exact dose was not reported). The pharmacist discovered that the patient had already been vaccinated two years before only after the second dose of the vaccine was administered. No adverse effects were reported. There was no product quality complaint involved. Additional information has been requested.
Sex: F
Vaccine: HPV9
Symptoms: Exposure during pregnancy
Clinical narrative: This prospective pregnancy report was received from a healthcare worker via a company representative and refers to a female of unspecified age. The patient's concurrent conditions, medical history and concomitant therapies were not provided. On an unspecified date, the patient was vaccinated with 1 dose of GARDASIL 9 1 dose (route of administration, lot# and expiration date were not reported). An unspecified time after receiving GARDASIL 9, it was determined by an unspecified method that the patient was pregnant. The last menstrual period (LMP) and estimated date of delivery (EDD) were not reported and could not be calculated. The pregnancy outcome was pending. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report was received from a nurse 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 08-JUL-2014, the patient was vaccinated with the first dose of GARDASIL 9. On 02-FEB-2015, the patient received the second dose of GARDASIL 9. On 05-NOV-2015, the patient was vaccinated with the third dose of GARDASIL 9. On 05-JUN-2017, the patient inadvertently received the fourth dose of GARDASIL 9 injection, lot # M011117 with expiration date on 07-DEC-2017 (route and site of administration were not reported). No adverse effects were reported. There was no product quality complaint involved. Additional information has been requested.
Sex: U
Vaccine: HEPA, HPV9
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a Licensed Practical Nurse referring to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported. The patient was vaccinated, on 11-JAN-2017, with the first doses of VAQTA intramuscularly, for prophylaxis, lot number M036458 with expiration date of 02-MAR-2018 (dose and anatomical location were not reported) and GARDASIL 9 for prophylaxis, lot number M034195 with expiration date of 14-APR-2019 (route, dose and anatomical location were not reported). It was reported that the patient inadvertently received the "immunization series too early compared with the recommended schedule", on 30-MAY-2017. He received, on that date, the second doses of VAQTA intramuscularly, for prophylaxis, lot number N005274 with expiration date of 03-APR-2018 (dose and anatomical location were not reported) and GARDASIL 9 for prophylaxis, lot number N001533 with expiration date of 16-OCT-2019 (route, dose and anatomical location were not reported). No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist referring to an unspecified number of patients of unknown age and gender. The patients' concurrent conditions, medical history and concomitant therapies were not reported. It was reported that, on unspecified dates since August 2016, the patients were vaccinated with improperly stored doses of VARIVAX lot # M023384 with expiration date of 11-MAY-2018, for prophylaxis (dose, route, anatomical location and frequency were not reported). The sterile diluent (manufacturer unknown) used to reconstitute the VARIVAX was properly stored, but the pharmacist was not sure which sterile diluent lot numbers were used to reconstitute VARIVAX, but one of the lot numbers was possibly M046371 with expiration date 07/06/2019.  No symptoms were reported. It was stated that the vaccines underwent a temperature excursion of 34.52 degrees Fahrenheit for 7 hours and 34 degrees Fahrenheit for 2 hours and 15 minutes. No previous temperature excursion was done. The call was not because of a "data logger". No further information was provided. Additional information is not expected because there is no consent to contact the reporter.
Age: 57.0
Sex: M
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported. It was reported that, on 05-JUN-2017, the patient received an expired dose of VAQTA intramuscularly, for prophylaxis, lot# M022556 with expiration date of 26-MAY-2017 (dose, frequency and anatomical location were not reported). No adverse effects were 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 an administrator reporting on multiple patients of unknown age or gender. No information regarding the patients' pertinent medical history, concurrent conditions, concomitant medications, drug reactions or allergies was provided. On unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL 9 (doses, route of administration, lot numbers or expiration dates were not reported), for prophylaxis. The temperature excursion ranged from 0 to 1 degree Celsius and lasted for 57 hours 25 minutes. It occurred once on an unspecified date and was detected by a Digital Data Logger. There was no previous excursion reported. No adverse effects were reported. This was one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1706USA004567: US-009507513-1706USA004568.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist referring to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 03-JUN-2017, the patient was vaccinated with an improperly stored dose of RECOMBIVAX HB intramuscularly in the left upper leg (lot number and expiration date were not provided) for prophylaxis. There was no adverse effect reported. Administered dose of RECOMBIVAX HB experienced the temperature excursion of 55 degrees Fahrenheit for 3 hours. Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same source. Additional information has been requested.; Sender's Comments: US-009507513-1706USA006113: US-009507513-1706USA006114:
Sex: F
Vaccine: MMR
Symptoms: Maternal exposure before pregnancy
Clinical narrative: This spontaneous prospective pregnancy report was received from a pharmacist referring to a female patient of unknown age. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On an unknown date, the patient received a dose of M-M-R II (route, lot number and expiration date were not provided) for prophylaxis. On an unknown date, the patient became pregnant less than 30 days after receiving the vaccine (maternal exposure before pregnancy). The patient's last menstrual period, estimated date of conception and estimated date of delivery were not reported. The patient visited the physician's office on an unspecified date. At the time of the report, the pregnancy outcome was pending. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from an administrator reporting on multiple patients of unknown age or gender. No information regarding the patients' pertinent medical history, concurrent conditions, concomitant medications, drug reactions or allergies was provided. On unknown dates, the patients were vaccinated with improperly stored doses of VAQTA (doses, route of administration, lot numbers or expiration dates were not reported), for prophylaxis. The temperature excursion ranged from 0 to 1 degree Celsius and lasted for 57 hours 25 minutes. It occurred once on an unspecified date and was detected by a Digital Data Logger. There was no previous excursion reported. No adverse effects were reported. This was one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1706USA004568: US-009507513-1706USA002610:
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from an administrator reporting on multiple patients of unknown age or gender. No information regarding the patients' pertinent medical history, concurrent conditions, concomitant medications, drug reactions or allergies was provided. On unknown dates, the patients were vaccinated with improperly stored doses of ROTATEQ (doses, lot numbers or expiration dates were not reported), for prophylaxis. The temperature excursion ranged from 0 to 1 degree Celsius and lasted for 57 hours 25 minutes. It occurred once on an unspecified date and was detected by a Digital Data Logger. There was no previous excursion reported. No adverse effects were reported. This was one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments:  US-009507513-1706USA004567: US-009507513-1706USA002610:
Sex: U
Vaccine: HPV9
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 GARDASIL 9 lot number M028323 with expiration date on 26-SEP-2018 (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-009507513-1706USA005672: US-009507513-1706USA005673: US-009507513-1706USA004421.
Sex: U
Vaccine: MMR
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 M-M-R II lot number M034856 with expiration date on 27-JUL-2018 (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-009507513-1706USA005673: US-009507513-1706USA004421:
Sex: U
Vaccine: PPV
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 PNEUMOVAX 23 syringes, lot number M023460 with expiration date on 12-NOV-2017 (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-009507513-1706USA004421:
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist referring to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 04-JUN-2017, the patient was vaccinated with an improperly stored dose of RECOMBIVAX HB intramuscularly in the right upper leg (lot number and expiration date were not provided) for prophylaxis. There was no adverse effect reported. Administered dose of RECOMBIVAX HB experienced the temperature excursion of 55 degrees Fahrenheit for 3 hours. Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same source. Additional information has been requested.; Sender's Comments: US-009507513-1706USA002776: US-009507513-1706USA006114:
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist referring to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 05-JUN-2017, the patient was vaccinated with an improperly stored dose of RECOMBIVAX HB intramuscularly in the right upper leg (lot number and expiration date were not provided) for prophylaxis. There was no adverse effect reported. Administered dose of RECOMBIVAX HB experienced the temperature excursion of 55 degrees Fahrenheit for 3 hours. Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same source. Additional information has been requested.; Sender's Comments: US-009507513-1706USA002776: US-009507513-1706USA006113:
Age: 0.5
Sex: F
Vaccine: DTAPHEPBIP
Symptoms: Irritability, Pyrexia, Rash, Rhinorrhoea, Tremor
Clinical narrative: High fever. Runny nose. Shaking. Irritable. Rash.
Age: 12.0
Sex: M
Vaccine: TYP
Symptoms: Regurgitation
Clinical narrative: Patient burped up partially intact capsule.
Age: 29.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Localized L. Arm swelling and skin reddening (1" circumference around injection site), Warm-to-touch, Moderate Pain at injection site.
Age: 1.08
Sex: M
Vaccine: MMR
Symptoms: Cough, Croup infectious, Immune thrombocytopenic purpura, Immunoglobulin therapy, Petechiae
Clinical narrative: Pt. seen 5/2/17 for MMR #1. Pt. seen 6/4/17 w/croupy cough and cold x 10 days, petechiae and ITP symptoms. Sent to ER.
Age: 1.08
Sex: M
Vaccine: MMR
Symptoms: Platelet count decreased, Viral upper respiratory tract infection
Clinical narrative: Pt. seen 5/2/17 for MMR #1. Pt. seen 6/4/17 w/croupy cough and cold x 10 days, petechiae and ITP symptoms. Sent to ER.
Age: 78.0
Sex: F
Vaccine: FLU3
Symptoms: Abasia, Abdominal discomfort, Blood test, Chills, Diarrhoea
Clinical narrative: Onset of fever and chills for one week-then unable to walk-weakness in legs-could not feed myself or go to the bathroom by myself-weakness in hands. To further explain the adverse event of my flu shot----I was diagnosed by three doctors as having Guillain Barre syndrome as a result of the flu shot administered late last year at the drug store. I was diagnosed first of February 2017 and am still sick (five months expected to last at least 6 months or more). I first walked with a walker now with a cane. I am unable to do very much and Have great pain a great deal of the time. I have lost 20 pounds. Often unable to sleep because of pain. Upset stomach. Diarrhea. I have trembling in my hands as well as in my legs. I was in acute rehab care in a hospital for two weeks and am receiving physical therapy. How can you administer a vaccine that can cause such damage? Patient 6-5-17.
Age: 78.0
Sex: F
Vaccine: FLU3
Symptoms: Guillain-Barre syndrome, Insomnia, Loss of personal independence in daily activities, Muscular weakness, Pain
Clinical narrative: Onset of fever and chills for one week-then unable to walk-weakness in legs-could not feed myself or go to the bathroom by myself-weakness in hands. To further explain the adverse event of my flu shot----I was diagnosed by three doctors as having Guillain Barre syndrome as a result of the flu shot administered late last year at the drug store. I was diagnosed first of February 2017 and am still sick (five months expected to last at least 6 months or more). I first walked with a walker now with a cane. I am unable to do very much and Have great pain a great deal of the time. I have lost 20 pounds. Often unable to sleep because of pain. Upset stomach. Diarrhea. I have trembling in my hands as well as in my legs. I was in acute rehab care in a hospital for two weeks and am receiving physical therapy. How can you administer a vaccine that can cause such damage? Patient 6-5-17.
Age: 78.0
Sex: F
Vaccine: FLU3
Symptoms: Pyrexia, Tremor, Walking aid user, Weight decreased
Clinical narrative: Onset of fever and chills for one week-then unable to walk-weakness in legs-could not feed myself or go to the bathroom by myself-weakness in hands. To further explain the adverse event of my flu shot----I was diagnosed by three doctors as having Guillain Barre syndrome as a result of the flu shot administered late last year at the drug store. I was diagnosed first of February 2017 and am still sick (five months expected to last at least 6 months or more). I first walked with a walker now with a cane. I am unable to do very much and Have great pain a great deal of the time. I have lost 20 pounds. Often unable to sleep because of pain. Upset stomach. Diarrhea. I have trembling in my hands as well as in my legs. I was in acute rehab care in a hospital for two weeks and am receiving physical therapy. How can you administer a vaccine that can cause such damage? Patient 6-5-17.
Age: 81.0
Sex: M
Vaccine: PPV
Symptoms: Muscular weakness, Pyrexia
Clinical narrative: Muscle weakness, fever.
Age: 57.0
Sex: F
Vaccine: PNC
Symptoms: Anaphylactic reaction, Chest X-ray, Dysphonia, Electrocardiogram, Full blood count
Clinical narrative: Urticaria on right side and 3 hives on right scalp on same day of vaccine. Symptoms progressed over next 4 days resulting in anaphylaxis on 6/10 and requiring ER visit. Pt. took Benadryl on 6/6. Hives developed on 6/7 to left arm, increased on scalp and bilateral hands. Pt took Benadryl on 6/7 PM. Continued with more hives on 6/8 and added Zyrtec to Benadryl regimen. On 6/9 pt. took Prednisone 10mg. Awakened early on 6/10 with lip and facial swelling, hoarse, hives covering scalp/neck/left arm and reported to EUH ER. Given IV decadron/Benadryl/famotidine and IV fluids; required monitoring for 6 hrs. until discharged. Sent home with Zantac BID and Medrol Dose Pak. Hives and facial swelling returned on 6/12 and pt. started on high doses of prednisone with Benadryl/Zyrtec/Zantac.
Age: 57.0
Sex: F
Vaccine: PNC
Symptoms: Laboratory test, Lip swelling, Swelling face, Urine analysis, Urticaria
Clinical narrative: Urticaria on right side and 3 hives on right scalp on same day of vaccine. Symptoms progressed over next 4 days resulting in anaphylaxis on 6/10 and requiring ER visit. Pt. took Benadryl on 6/6. Hives developed on 6/7 to left arm, increased on scalp and bilateral hands. Pt took Benadryl on 6/7 PM. Continued with more hives on 6/8 and added Zyrtec to Benadryl regimen. On 6/9 pt. took Prednisone 10mg. Awakened early on 6/10 with lip and facial swelling, hoarse, hives covering scalp/neck/left arm and reported to EUH ER. Given IV decadron/Benadryl/famotidine and IV fluids; required monitoring for 6 hrs. until discharged. Sent home with Zantac BID and Medrol Dose Pak. Hives and facial swelling returned on 6/12 and pt. started on high doses of prednisone with Benadryl/Zyrtec/Zantac.
Age: 1.5
Sex: M
Vaccine: HEPA
Symptoms: Peripheral swelling, Urticaria
Clinical narrative: Follow up at 19Mo old for well child visit. Vaccination ordered by Dr.  DTap 0.5mg given in the LVL by IM injection Manufacturer Sanofi-Pasteur Lot#65065AA Exp 10/8/18. After vaccine, patients left thigh swell up into large hive. Mom brought him back from parking lot to be checked. No respiratory problems, lungs-clear. Benadryl 7.5 ml given in office. Follow up call at 12:26 baby is sleeping and hive is a little smaller. The following medication was given: Medication: Diphenhist, hcl  Dose: 12.5mg/5mL Quantity: 7.5mL.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a register nurse referring to unspecified number of patients of unknown age and gender. The patients' pertinent medical history, drug reactions/allergies and concomitant medication were not reported. The nurse reported that improperly stored doses of RECOMBIVAX HB lot # M031574 with expiration date of 11-NOV-2018; lot # L048848 with expiration date 09-AUG-2018; lot # M036156 with expiration date 23-FEB-2019; and lot #M037248 with expiration date 21-FEB-2019 (dose, frequency and route were not reported) for prophylaxis, were administered to patients from 01-MAY-2017 to 30-MAY-2017. The vaccines were exposed to temperature excursion of 9° Celsius (°C) to 25°C for a time frame of 1 hour 9 minutes because of data logger. The vaccines had a previous temperature excursion of 9°C to 25°C, for a time frame of 7 hours 50 minutes. Nurse stated that no adverse effects had been reported by any patient and that she was unable to provide any additional patient information for patient who had received supported vaccines. This is one of the several reports from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-706USA006155: US-009507513-1706USA006156:
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a licensed practical nurse referring to a multiple unspecified patients of unknown age and gender. The patients' concomitant therapy, medical history, concurrent conditions, drug and allergy history were not reported. On multiple unspecified dates, the patients were vaccinated with improperly stored GARDASIL 9 lot # N002720 and expiration date on 12-MAY-2019 (dose and route were not provided) for prophylaxis. No adverse effects were reported. On an unspecified day, the data logger registered that during 30 minutes, the temperature under the vaccine stored was 47° to 77° Fahrenheit (9° to 25° Celsius), there was previous temperature excursion during 7 hours under the same temperatures. This is one of the two reports received from the same source. Additional information has been requested. Sender's Comments: US-009507513-1706USA001166.
Sex: M
Vaccine: VARZOS
Symptoms: Headache
Clinical narrative: Information was received on 07-JUN-2017 from a 66 year old male patient who reported he received a ZOSTAVAX subcutaneous injection for prevention of shingles (dose and lot#/expiration not reported) through a pharmacy in February 2017 (date unspecified). Patient stated that two days later (unspecified date) he began having headaches which started off very mild. Patient stated that as time went on he began to have more frequent headaches (unspecified dates) and they became progressively worse. Patient stated that he was still presently having headaches. Patient asked his unspecified pharmacist if this was normal and was told that headaches were a possible side effect from the ZOSTAVAX injection but they should not last this long. Patient stated he has had numerous unspecified vaccines over the years, because he travels to various countries, but has never had this happen before, so he could only assume that the headaches may be caused by the ZOSTAVAX injection. Patient stated he has not had any other symptoms besides the headaches. Patient also stated that he takes losartan, atorvastatin calcium (LIPITOR), morniflumate (FLOMAX), vitamin D3 and loratadine (CLARITIN) (dates of use, dose, frequency and indications unspecified). Patient noted he was scheduled to see and consult with his physician on 12-JUN-2017 for further evaluation. No other information provided. Adverse event was filed as precaution as it cannot be determined if ZOSTAVAX is the cause of the patient's headaches. Patient's present status was not recovered. Additional information has been requested.