chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a physician via an unspecified reporter, refers to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On 16-SEP-2014, the patient was vaccinated with a dose of improperly stored PNEUMOVAX 23 "10 Single dose 0.5mLVls 10SDV" and lot number J011998 with expiration date of 12-FEB-2015 (route of administration was unknown), which was stored at 0.55 Celsius Degrees for 200 hours, 1.11 Celsius Degrees for 208 hours, -0.55 Celsius Degrees for 32 hours and 0 Celsius Degrees for 152 hours. The type of excursion was refrigerator and the vaccine status in excursion. No concomitant therapies nor adverse effect were reported. No product quality complaint was involved. This is one of several cases from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a physician via an unspecified reporter, refers to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On 28-JUL-2014, the patient was vaccinated with a dose of improperly stored PNEUMOVAX 23 "10 Single dose 0.5mLVls 10SDV" and lot number J011998 with expiration date of 12-FEB-2015 (route of administration was unknown), which was stored at 0.55 Celsius Degrees for 200 hours, -0.55 Celsius Degrees for 32 hours, 1.11 Celsius Degrees for 40 hours and 0 Celsius Degrees for 152 hours. The type of excursion was refrigerator and the vaccine status in excursion. No concomitant therapies nor adverse effect were reported. No product quality complaint was involved. This is one of several cases from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a physician via an unspecified reporter, refers to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On 24-APR-2014, the patient was vaccinated with a dose of improperly stored PNEUMOVAX 23 "10 single dose 0.5mLVls 10SDV" and lot number J011998 with expiration date of 12-FEB-2015 (route of administration was unknown), which was stored at -6.66 Celsius Degrees for 552 hours. The type of excursion was refrigerator and the vaccine status in excursion. No concomitant therapies nor adverse effect were reported. No product quality complaint was involved. This is one of several cases from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions and allergies were not reported. On 26-SEP-2016, the patient was administered with an expired M-M-R II, subcutaneous in the left arm (lot# K016154, expiration date 24-SEP-2016). There were no concomitant medications reported. No adverse reaction was reported. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to a patient of unknown age and gender. On 30-AUG-2016, the patient received a dose of improperly stored ROTATEQ (lot # M019691, expiry date: 02-NOV-2017). Excursion: 1.3C for 77 minutes cumulatively. Data logger was involved. No adverse effects reported. The outcome was unknown. No product quality complaint was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to 29 patients of unknown demographics. On unknown dates, the patients received doses of improperly stored ROTATEQ (lot # M019691, expiry date: 02-NOV-2017). Excursion: 1.3C for 77 minutes cumulatively. Data logger was involved. No adverse effects reported. The outcome was unknown. No product quality complaint was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. Information on the patient's concurrent conditions, medical history or concomitant therapy was not reported. The pharmacist reported that on unspecified date, the patient might have been administered a dose of PROQUAD (dose, route of administration, lot# and expiration date were not reported) that was improperly stored (exposed to 82F). The vaccine was still out of range at the time of the call, so the total time out of range was unspecified. No adverse effects were reported. Additional information has been requested.
Age: 68.0
Sex: F
Vaccine: TDAP
Symptoms: Mass, Nodule
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of mass is a 68-year-old female patient who received BOOSTRIX (batch number TX34X, expiry date 14 May 2017). On 21st September 2016, the patient received BOOSTRIX .5 ml. On 28th September 2016, 7 days after receiving BOOSTRIX, the patient experienced mass and nodule. On an unknown date, the outcome of the mass and nodule were not recovered/not resolved. The reporter considered the mass and nodule to be almost certainly related to BOOSTRIX. Additional details were provided as follows: The patient noticed lump or nodule 7 days after receiving BOOSTRIX vaccine.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a physician via an unspecified reporter, refers to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On 02-MAY-2014, the patient was vaccinated with a dose of improperly stored PNEUMOVAX 23 "10 Single dose 0.5mLVls 10SDV" and lot number J011998 with expiration date of 12-FEB-2015 (route of administration was unknown), which was stored at -6.66 Celsius Degrees for 744 hours. The type of excursion was refrigerator and the vaccine status in excursion. No concomitant therapies nor adverse effect were reported. No product quality complaint was involved. This is one of several cases from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On unknown dates, the patients were vaccinated with the incorrectly stored (33.1 F for 90 minutes) doses of RECOMBIVAX HB (lot # M023718, expiration date 09-AUG-2018; dose and route of administration were not reported). No previous excursion was reported. The call was made because of the data logger. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a certified medical assistant and refers to an unspecified number of patients of unknown age and gender. Information on the patients' concurrent conditions, medical history or concomitant therapy was not reported. The medical assistant reported that an unspecified number of doses of VAQTA (lot# M030598, expiration date: 13-OCT-2017, dose and route of administration were not reported) were administered to the patients on unknown dates following a temperature excursion of 32.9F for 22 hours and 17 minutes. No adverse effects were reported for any patients receiving doses. This is one of three reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a physician via an unspecified reporter, refers to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On 20-MAY-2014, the patient was vaccinated with a dose of improperly stored PNEUMOVAX 23 "10 Single dose 0.5 mLVIs 10SDV" and lot number J011998 with expiration date of 12-FEB-2015 (route of administration was unknown), which was stored at -6.66 Celsius Degrees for 1176 hours. The type of excursion was refrigerator and the vaccine status in excursion. No concomitant therapies nor adverse effect were reported. No product quality complaint was involved. This is one of several cases from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a physician via an unspecified reporter, refers to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On 09-APR-2014, the patient was vaccinated with a dose of improperly stored PNEUMOVAX 23 "10 Single dose 0.5mLVls 10SDV" and lot number J011998 with expiration date of 12-FEB-2015 (route of administration was unknown), which was stored at -6.66 Celsius Degrees for 192 hours. The type of excursion was refrigerator and the vaccine status in excursion. No concomitant therapies nor adverse effect were reported. No product quality complaint was involved. This is one of several cases from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a physician via an unspecified reporter, refers to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On 09-JUL-2014, the patient was vaccinated with a dose of improperly stored PNEUMOVAX 23 and a lot number J011998 with expiration date of 12-FEB-2015 (route of administration was unknown), which was stored at -0.55 Celsius Degrees for 32 hours, 1.11 Celsius Degrees for 40 hours, 0.55 Celsius Degrees for 176 hours and 0 Celsius Degrees for 152 hours. The type of excursion was refrigerator and the vaccine status in excursion. No concomitant therapies were nor adverse effect were reported. No product quality complaint was involved. This is one of several cases from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a physician via an unspecified reporter, refers to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On 27-AUG-2014, the patient was vaccinated with a dose of improperly stored PNEUMOVAX 23 "10 Single dose 0.5mLVls 10SDV" and lot number J011998 with expiration date of 12-FEB-2015 (route of administration was unknown), which was stored at 1.11 Celsius Degrees for 208 hours, 0.55 Celsius Degrees for 200 hours, 0 Celsius Degrees for 152 hours and -0.55 Celsius Degrees for 32 hours. The type of excursion was refrigerator and the vaccine status in excursion. No concomitant therapies nor adverse effect were reported. No product quality complaint was involved. This is one of several cases from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On unknown dates, the patients were vaccinated with the incorrectly stored (33.1 F for 90 minutes) doses of GARDASIL 9 (lot # reported as M028323, expiration date 26-SEP-2018; dose and route of administration were not reported). No previous excursion was reported. The call was made because of the data logger. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a physician via an unspecified reporter, refers to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On 02-APR-2014, the patient was vaccinated with a dose of improperly stored PNEUMOVAX 23 "10 Single dose 0.5 mLVIs 10SDV" and lot number J011998 with expiration date of 12-FEB-2015 (route of administration was unknown), which was stored at -6.66 Celsius Degrees for 24 hours. The type of excursion was refrigerator and the vaccine status in excursion. No concomitant therapies nor adverse effect were reported. No product quality complaint was involved. This is one of several cases from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a physician via an unspecified reporter, refers to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On 10-APR-2014, the patient was vaccinated with a dose of improperly stored PNEUMOVAX 23 "10 Single dose 0.5mLVls 10SDV" and lot number J011998 with expiration date of 12-FEB-2015 (route of administration was unknown), which was stored at -6.66 Celsius Degrees for 216 hours. The type of excursion was refrigerator and the vaccine status in excursion. No concomitant therapies nor adverse effect were reported. No product quality complaint was involved. This is one of several cases from the same reporter. Additional information has been requested.
Age: 12.0
Sex: M
Vaccine: HPV9
Symptoms: Urticaria
Clinical narrative: Urticaria.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a physician via company representative and an unspecified reporter, refers to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On 18-APR-2014, the patient was vaccinated with a dose of improperly stored PNEUMOVAX 23 "10 Single dose 0.5mLVIs 10SDV" and lot number J011998 with expiration date of 12-FEB-2015 (route of administration was unknown), which was stored at -6.66 Celsius Degrees for 408 hours. The type of excursion was refrigerator and the vaccine status in excursion. No concomitant therapies nor adverse effect were reported. No product quality complaint was involved. This is one of several cases from the same reporter. Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist, refers to a female patient of unknown age. No information on the patient's concomitant medications, concurrent conditions, pertinent medical history, drug reactions or allergies was reported. Since an unknown date, the patient was vaccinated intramuscularly or subcutaneously (not specified) with the PNEUMOVAX 23 (dose, lot # and expiration date were not reported) every year, as per her doctor, because of her chronic lung disease. 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 a certified medical assistant and refers to an unspecified number of patients of unknown age and gender. Information on the patients' concurrent conditions, medical history or concomitant therapy was not reported. The medical assistant reported that an unspecified number of doses of GARDASIL 9 (lot# M005714 with expiration date: 03-OCT-2017 and lot# M021407 with expiration date: 30-APR-2018, dose and route of administration were not reported) were administered to the patients on unknown dates following a temperature excursion of 32.9F for 22 hours and 17 minutes. No adverse effects were reported for any patients receiving doses. This is one of three reports received from the same source. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse, concerning to a 12 year old female patient. Her medical history and concurrent conditions were not reported. On 02-FEB-2016 at 13:15, the patient was vaccinated for the second time with an improperly stored dose of VARIVAX subcutaneously, lot number L013826 and expiration date of 21-APR-2017 (dose was not provided). No concomitant therapies were reported. It was reported that the vaccines were stored at 26.5F for 3 hours and previously stored at 46F for 50 hours and at 46F for 20 minutes (dates unspecified). The temperature excursion was captured via a Data Logger. No adverse effects were reported. This is one of several reports received from the same source. Additional information is not expected as all scheduled follow up was received.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Fatigue, Headache, Injection site pain, Neck pain, Pain
Clinical narrative: Pt complained of pain/soreness as site on evening of 10/10/16. Pt complained of headache, neck pain, fatigue/exhaustion, achiness and photosensitivity since 10/11/16. Pt taking Ibuprofen and Acetaminophen prn.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Photosensitivity reaction
Clinical narrative: Pt complained of pain/soreness as site on evening of 10/10/16. Pt complained of headache, neck pain, fatigue/exhaustion, achiness and photosensitivity since 10/11/16. Pt taking Ibuprofen and Acetaminophen prn.
Age: 49.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site pain, Injection site swelling, Ultrasound scan abnormal
Clinical narrative: Pain, swelling left deltoid.
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP, FLU4, HIBV, PNC13, RV5
Symptoms: Injection site erythema, Injection site swelling, Injection site vesicles
Clinical narrative: Blister, redness and swelling at injection site on (L) thigh. Rx given for amoxicillin, BACTROBAN ointment and continue CLARITIN for seasonal allergies. This was the initial dose of FLUZONE that we think he reacted to, as he had other immunizations in past.
Age: 15.0
Sex: F
Vaccine: IPV, VARCEL
Symptoms: Cellulitis
Clinical narrative: Local cellulitis requiring PO antibiotics.
Age: 1.0
Sex: M
Vaccine: VARCEL
Symptoms: Urticaria
Clinical narrative: Patient given vaccine, mother nursed after administration about 5 minutes after admin. mom notice rash on leg. Mom came out of exam room and got nurse. Nurse removed bandaids of both legs. Provider made aware. BENADRYL dose given. Pt stayed in office for observation for 45 minutes single urticarial lesion measuring 2x4cm.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pruritus, Injection site warmth
Clinical narrative: 10 days after vaccine administered patient developed redness, warmth, and itching at injection site of left arm. No pain or swelling. On exam, 6 cm x 4.5 cm area of mild erythema, and warmth. No induration or drainage. Blanchable to the touch. This could be possible allergic reaction or developing cellulitis. Patient was placed on TRIAMCINOLONE cream to help with itching. Cephalexin BID x 7 days to cover for bacterial in reaction with this. OTC ZYRTEC once daily as well.
Age: 79.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Injection site erythema, Pyrexia, Swelling face
Clinical narrative: 10/11/16- pt received FLUZONE in right arm and PREVNAR 12 in left arm (site of reaction). Pt contacted MD pm of 10/13/16 complain of fever and mild puffiness of left side of face. Came to pharmacy 10/12/16 to ask about reaction. Red area around site of Admin revealed to be approximately 6"x5". Suggested ice packs and antihistamine. (Spoke to MD and she attributed to normal reaction to vaccine).
Age: 69.0
Sex: U
Vaccine: PPV
Symptoms: Head discomfort, Injection site rash, Pruritus
Clinical narrative: Patient came in on 10/14/16 complaining that few hours after receiving vaccine had a rash at injection site and heavy head felt like itching upper torso. No visible rash anywhere other than injection site area.
Age: 16.0
Sex: F
Vaccine: MENB
Symptoms: Injection site urticaria
Clinical narrative: Hives - large around injection area.
Age: 16.0
Sex: M
Vaccine: HPV9
Symptoms: Dizziness, Pain in extremity, Pyrexia, Swelling
Clinical narrative: Patient reported fever greater than 100, arm pain, swelling and dizziness approx 24 hours after vaccine. Vaccine given on 10/11/2016 in office on 10/14/2016 with complaints called office on 10/13/16 to report.
Age: 34.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Erythema, Feeling hot
Clinical narrative: Redness, warmth.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a physician via company employees and a practice manager referring to a patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant therapy were not provided. On 31-MAR-2015 the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 0.5 ml Prefilled Syringe (PFS) (lot # K020795, expiration date 19-MAR-2016, dose and route were unspecified). This specified lot number vaccine was exposed to temperature excursion twice. The total cumulative excursion time of the first time was 16 hours with the lowest recorded temperature of 33 Fahrenheit degree. The total cumulative excursion time of the second time was 64 hours with the lowest recorded temperature of 34 Fahrenheit degree. The storage criteria and the type of excursion for this vaccine was refrigerator (R). No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 06-JUN-2016 the patient was vaccinated with an improperly stored dose of (wistar ra 27-3) M-M-R II single 0.5ml dose (rHA, lot # L007577, expiration date 05-MAR-2017, dose and route unknown). This specified lot number vaccine was exposed to temperature excursion once. The total cumulative excursion time was 24 hours with the highest recorded temperature of 47 Fahrenheit degree. The storage criteria and the type of excursion for this vaccine was refrigerator (R). No adverse effects were reported. This is one of several reports received form the same source. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 13-JUN-2016 the patient was vaccinated with an improperly stored dose of GARDASIL (lot # L040460, expiration date 27-MAY-2017, dose and route were unspecified). This specified lot number vaccine was exposed to temperature excursion once. The total cumulative excursion time was 256 hours with the lowest recorded temperature of 1 Fahrenheit degree. The storage criteria and the type of excursion for this vaccine was refrigerator (R). No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a physician and a practice manager via two company representatives referring to a patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant medication were unknown. On 06-JAN-2016 the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 0.5 ml (lot # L010598, expiration date 06-AUG-2016, route unknown). This specified lot number vaccine was exposed to temperature excursion fifteen times. The total cumulative excursion time (hour) and lowest recorded temperature (Fahrenheit degree) for each time were as below: (216, 29.3); (144, 34.2); (24, 33.6); (24, 33.4); (52, 33.1); (72, 32.9); (144, 32.4); (100, 34.5); (28, 30); (24, 34.3); (104, 29.1); (48, 34.9); (36, 31.1); (40, 34); (24, 34.8). The storage criteria and the type of excursion for this vaccine was refrigerator (R). No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 20-JUN-2016 the patient was vaccinated with an improperly stored dose of GARDASIL (lot # L040460, expiration date 27-MAY-2017, dose and route were unspecified). This specified lot number vaccine was exposed to temperature excursion once. The total cumulative excursion time was 80 hours with the lowest recorded temperature of 34 Fahrenheit degree. The storage criteria and the type of excursion for this vaccine was refrigerator (R). No adverse event was reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 06-JUL-2016 the patient was vaccinated with an improperly stored dose of GARDASIL  single-dose vial (SDV) lot # L035105 expiration date 14-MAY-2017, dose and route were unspecified). This specified lot number vaccine was exposed to temperature excursion. The total cumulative excursion time was 24 hours with highest recorded temperature of 30.8 temperature of 30.8 Fahrenheit degree. The storage criteria and the type of excursion for this vaccine was refrigerator (R). No adverse effect was reported. This is one of several reported received from the same source. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 19-JAN-2016 the patient was vaccinated with an improperly stored dose of ROTATEQ oral dose, 10-pack (lot # K010224, expiration date 13-MAY-2016). This specified lot number vaccine was exposed to temperature excursion once. The total cumulative excursion time was 536 hours with the lowest recorded temperature of 1.11 Fahrenheit degree. The storage criteria and the type of excursion for this vaccine was refrigerator (R). No adverse effect was reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 13-MAY-2015 the patient was vaccinated with an improperly stored dose of ROTATEQ oral dose, 10-pack (lot # K010224, expiration date 13-MAY-2016) orally. This specified lot number vaccine was exposed to temperature excursion once. The total cumulative excursion time was 64 hours with the lowest recorded temperature of 1.11 Fahrenheit degree. The storage criteria and the type of excursion for this vaccine was refrigerator (R). No adverse effect was reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 06-JUN-2016 the patient was vaccinated with an improperly stored dose of GARDASIL (lot # L040460, expiration date 27-MAY-2017, dose and route were unspecified). This specified lot number vaccine was exposed to temperature excursion once. The total cumulative excursion time was 80 hours with the lowest recorded temperature of 34 Fahrenheit degree. The storage criteria and the type of excursion for this vaccine was refrigerator (R). No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a physician and a practice manager via company representative referring to a patient of unknown age and gender. On 18-MAR-2015 the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23-10PK-0.5mlSD-PFS LLokwTip) (lot # K019386, expiration date 09-JUN-2016). This specified lot number vaccine was exposed to temperature excursion once. The total cumulative excursion time was 216 hours with the lowest recorded temperature of 27 Fahrenheit degree. The storage criteria and the type of excursion for this vaccine was refrigerator (R). No adverse effect was reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a physician and a practice manager via company representative referring to a patient of unknown age and gender. On 02-APR-2015 the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 (10PK-0.5mlSD-PFS LLokw Tip) (lot # L019386, expiration date 09-JUN-2016). This specified lot number vaccine was exposed to temperature excursion once. The total cumulative excursion time was 576 hours with the lowest recorded temperature of 27 Fahrenheit degree. The storage criteria and the type of excursion for this vaccine was refrigerator (R). No adverse effect was reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 19-MAY-2015, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 0.5ml (lot # K012424, expiration date 05-JUN-2016). This specified lot number vaccine was exposed to temperature excursion twice. The total cumulative excursion time of the first time was 48 hours with the lowest recorded temperature of 0 Fahrenheit degree. The total cumulative excursion time of the second time was 24 hours with the lowest recorded temperature of -1 Fahrenheit degree. The storage criteria and the type of excursion for this vaccine was refrigerator (R). No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 15-SEP-2015 the patient was vaccinated with an improperly stored dose of ROTATEQ oral dose, 10-pack (lot # K010224, expiration date 13-MAY-2016) orally. This specified lot number vaccine was exposed to temperature excursion once. The total cumulative excursion time was 120 hours with the lowest recorded temperature of 1.11 Fahrenheit degree. The storage criteria and the type of excursion for this vaccine was refrigerator (R). No adverse effect was reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 11-MAY-2016 the patient was vaccinated with an improperly stored dose GARDASIL 9 0.5 ml (lot # L038917, expiration date 20-FEB-2018, route unspecified). This specified lot number vaccine was exposed to temperature excursion twice. The total cumulative excursion time of the first time was 112 hours with the lowest recorded temperature of 34 Fahrenheit degree. The total cumulative excursion time of the second time was 48 hours with the lowest recorded temperature of 32 Fahrenheit degree. The storage criteria and the type of excursion for this vaccine was refrigerator (R). No adverse effect reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a physician via company employees and a practice manager referring to a patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant therapy were not provided. On 02-APR-2015 the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 0.5ml Prefilled Syringe (PFS) (lot # K020795, expiration date 19-MAR-2016, dose and route were unspecified). This specified lot number vaccine was exposed to temperature excursion twice. The total cumulative excursion time of the first time was 16 hours with the lowest recorded temperature of 33 Fahrenheit degree. The total cumulative excursion time of the second time was 64 hours with the lowest recorded temperature of 34 Fahrenheit degree. The storage criteria and the type of excursion for this vaccine was refrigerator (R). No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 26-MAY-2016 the patient was vaccinated with an improperly stored dose of GARDASIL 9 0.5ml (lot # L038917, expiration date 20-FEB-2018, route unspecified). This specified lot number vaccine was exposed to temperature excursion twice. The total cumulative excursion time for the first time was 72 hours with the lowest recorded temperature of 32 Fahrenheit degree. The total cumulative excursion time of the second time was 144 hours with the lowest recorded temperature of 34 Fahrenheit degree. The storage criteria and the type of excursion for this vaccine was refrigerator (R). No adverse effect reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 21-JAN-2016 the patient was vaccinated with an improperly stored dose of (wistar ra 27-3) M-M-R-II single 0.5ml dose (rHA, Lot # L007577, expiration date 05-MAR-2017, dose and route unknown). This specified lot number vaccine was exposed to temperature excursion once. The total cumulative excursion time was 40 hours with the lowest recorded temperature of 34 Fahrenheit degree. The storage criteria and the type of excursion for this vaccine was refrigerator (R). No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 14-MAR-2016 the patient was vaccinated with an improperly stored dose of VAQTA 50U/1ml (lot # L018498, expiration 28-APR-2016, dose and route were unspecified). This specified lot number vaccine was exposed to temperature excursion twice. The total cumulative excursion time of the first time was 840 hours with the lowest recorded temperature of 34 Fahrenheit degree. The total cumulative excursion time of the second time was 168 hours with the lowest recorded temperature of 32 Fahrenheit degree. The storage criteria and the type of excursion for this vaccine was refrigerator (R). No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage
Clinical narrative: Information has been received from a physician and a practice manger referring to a patient of unknown age and gender. On 28-SEP-2015, the patient was vaccinated with an improperly stored dose of GARDASIL (lot # K014191, expiration date 10-MAY-2017). This specified lot number vaccine was exposed to temperature excursion once. The total cumulative excursion time of the first time was 56 hours with the lowest recorded temperature of 34 Fahrenheit degree (the highest recorded temperature was not reported). The storage criteria and the type of excursion for this vaccine was refrigerator (R). This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 31-MAR-2016 the patient was vaccinated with an improperly stored dose of VAQTA 50U/1ml (lot # L018498, expiration date 28-APR-2016, dose and route were unspecified). This specified lot number vaccine was exposed to temperature excursion twice. The total cumulative excursion time of the first time was 840 hours with the lowest recorded temperature of 34 Fahrenheit degree. The total cumulative excursion time of the second time was 168 hours with the lowest recorded temperature of 32 Fahrenheit degree. The storage criteria and the type of excursion for this vaccine was refrigerator (R). No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage
Clinical narrative: Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 31-AUG-2015, the patient was vaccinated with an improperly stored dose of GARDASIL (lot # K014191, expiration date 21-MAY-2017). This specified lot number vaccine was exposed to temperature excursion once. The total cumulative excursion time of the first time was 32 hours with the lowest recorded temperature of 34 Fahrenheit degree (the highest recorded temperature was not reported). The storage criteria and the type of excursion for this vaccine was refrigerator (R). This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 17-MAY-2016 the patient was vaccinated with an improperly stored dose of M-M-R II single 0.5ml dose (rHA, lot # L007577, expiration date 05-MAR-2017, dose and route unknown). This specified lot number vaccine was exposed to temperature excursion three times. The total cumulative excursion time of the first time was 88 hours with the lowest recorded temperature of 33 Fahrenheit degree. The total cumulative excursion time of the second time was 96 hours with the lowest recorded temperature of 34 Fahrenheit degree. The total cumulative excursion time of the third time was 16 hours with the highest recorded temperature of 49 Fahrenheit degree. The storage criteria and the type of excursion for this vaccine was refrigerator (R). No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 28-DEC-2015 the patient was vaccinated with an improperly stored dose of ROTATEQ oral dose, 10-pack (lot # K010224, expiration date 13-MAY-2016). This specified lot number vaccine was exposed to temperature excursion once. The total cumulative excursion time was 288 hours with the lowest recorded temperature of 1.11 Fahrenheit degree. The storage criteria and the type of excursion for this vaccine was refrigerator (R). No adverse effect was reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 23-MAY-2016 the patient was vaccinated with an improperly stored dose of GARDASIL 9 0.5ml (lot # L038917, expiration date 20-FEB-2018, route unspecified). This specified lot number vaccine was exposed to temperature excursion twice. The total cumulative excursion time of the first time was 144 hours with the lowest recorded temperature of 34 Fahrenheit degree. The total cumulative excursion time of the second time was 72 hours with the lowest recorded temperature of 32 Fahrenheit degree. The storage criteria and the type of excursion for the vaccine was refrigerator (R). No adverse effect reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage
Clinical narrative: Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 16-SEP-2015, the patient was vaccinated with an improperly stored dose GARDASIL (lot # K014191, expiration date 10-MAY-2017). This specified lot number vaccine was exposed to temperature excursion once. The total cumulative excursion time of the first time was 56 hours with the lowest recorded temperature of 34 Fahrenheit degree (the highest recorded temperature was not reported). The storage criteria and the type of excursion for the vaccine was refrigerator (R). This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 17-FEB-2016 the patient was vaccinated with an improperly stored dose of VAQTA 50U/1ml (lot # L018498, expiration date 28-APR-2016, dose and route were unspecified). This specified lot number vaccine was exposed to temperature excursion twice. The total cumulative excursion time of the first time was 168 hours with the lowest recorded temperature of 32 Fahrenheit degree. The total cumulative excursion time of the second time was 696 hours with the lowest recorded temperature of 34 Fahrenheit degree. The storage criteria and the type of excursion for this vaccine was refrigerator (R). No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Age: 69.0
Sex: F
Vaccine: FLU3, PPV, PPV
Symptoms: Pain, Pyrexia
Clinical narrative: Severe pain in left shoulder and down entire arm, impaired movement of arm, fever in excess of 103.
Age: 69.0
Sex: F
Vaccine: FLU3, PPV, PPV
Symptoms: Injected limb mobility decreased, Injection site pain, Pain in extremity, Pyrexia
Clinical narrative: Severe pain in left shoulder and down entire arm, impaired movement of arm, fever in excess of 103.
Age: 63.0
Sex: F
Vaccine: FLU4
Symptoms: Asthenia, Chills, Decreased appetite, Fatigue, Pain
Clinical narrative: Fever, chills, loss of appetite, weakness, fatigue, body aches.
Age: 63.0
Sex: F
Vaccine: FLU4
Symptoms: Pyrexia
Clinical narrative: Fever, chills, loss of appetite, weakness, fatigue, body aches.
Age: 58.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site discharge, Injection site erythema, Injection site pruritus, Injection site vesicles
Clinical narrative: Red, itchy and many congregated blisters at the injection site. Oozing fluid at injection site.
Age: 0.17
Sex: M
Vaccine: HIBV, PPV
Symptoms: Pyrexia, Screaming
Clinical narrative: Screaming for over 3 hours with high pitched uncontrollable screaming, fever over 102.
Age: 38.0
Sex: M
Vaccine: FLU4
Symptoms: Burning sensation, Rash, Rash erythematous, Rash pruritic
Clinical narrative: She got her flu vaccine yesterday. Then she devloped a rash, she states it is really itchy. She states it is in her scalp down her face and now on her butt. She took benedryl last night that didn't help. No difficulty breathing or swallowing. No throat swelling. Has had the flu shot before, without reaction. She has several red spots on her Right hip area that burn; the rest of the spots on her scalp, face and legs only itch. Works in the NICU. Patient got her flu vaccine yesterday afternoon and then developed a rash that is very itchy, on her scalp, face, neck and now his bottom.
Age: 59.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Injection site pain, Skin warm, Swelling
Clinical narrative: It was a red hot area raised or swollen.
Age: 32.0
Sex: M
Vaccine: TD
Symptoms: Asthenia, Chills, Fatigue, Headache, Odynophagia
Clinical narrative: Extreme pain, tightness and weakness all over, especially in arms, legs, back and face. Tingling sensation like goose bumps, headache, fever, chills, sore throat w/ painful swallowing, fatigue. Taking Ibuprofen and TYLENOL, warm bath, heating pad, rest. Have not seen doctor and symptoms persisting through 10/15/16 (today).
Age: 32.0
Sex: M
Vaccine: TD
Symptoms: Oropharyngeal pain, Pain, Paraesthesia, Pyrexia
Clinical narrative: Extreme pain, tightness and weakness all over, especially in arms, legs, back and face. Tingling sensation like goose bumps, headache, fever, chills, sore throat w/ painful swallowing, fatigue. Taking Ibuprofen and TYLENOL, warm bath, heating pad, rest. Have not seen doctor and symptoms persisting through 10/15/16 (today).
Age: 55.0
Sex: F
Vaccine: FLU4, PNC10
Symptoms: Erythema, Nausea, Peripheral swelling, Pyrexia, Skin warm
Clinical narrative: Patient was nauseous, throwing up, running a high fever and had a warm red swollen arm.
Age: 55.0
Sex: F
Vaccine: FLU4, PNC10
Symptoms: Vomiting
Clinical narrative: Patient was nauseous, throwing up, running a high fever and had a warm red swollen arm.
Age: 66.0
Sex: F
Vaccine: FLUR3
Symptoms: Middle insomnia, Pruritus
Clinical narrative: Patient woke up in the middle of the night with severe itch.  Negative hives or shortness of breath.
Age: 0.0
Sex: F
Vaccine: HEP
Symptoms: Apnoea, Blood calcium, Blood culture, Blood gases, Blood magnesium
Clinical narrative: Apnea and suspicious seizure activity requiring intubation, and transfer to NICU.
Age: 0.0
Sex: F
Vaccine: HEP
Symptoms: Chest X-ray, Endotracheal intubation, Full blood count, Intensive care, Metabolic function test
Clinical narrative: Apnea and suspicious seizure activity requiring intubation, and transfer to NICU.
Age: 0.0
Sex: F
Vaccine: HEP
Symptoms: Seizure
Clinical narrative: Apnea and suspicious seizure activity requiring intubation, and transfer to NICU.
Age: 25.0
Sex: F
Vaccine: FLUX
Symptoms: Injection site pain, Pain, Pyrexia
Clinical narrative: Soreness around injection site, body aches, low-grade fever (100-101°F).
Age: 37.0
Sex: F
Vaccine: FLUX
Symptoms: Discomfort, Erythema, Headache, Injection site pain, Nausea
Clinical narrative: Pain at injection site which turned into my arm being covered in large red hot painful welts. They don't itch, but feel bruised. I am also now nauseous and have a bad headache. Waiting to see my doctor on Monday.