chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, Interchange of vaccine products, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On an unspecified date in 2011, the patient was vaccinated with the first dose of GARDASIL (dose, frequency, route of administration, lot number and expiration date were not reported). On 06-JUN-2016, the patient was administered with the second dose of series GARDASIL 9 (lot L013429, expiration date 21-JUL-2017). No adverse effect was reported. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to multiple unspecified patients of unknown age and gender. On unknown dates the patients were vaccinated with improperly stored M-M-R II (lot number L012479 expiration date 10-APR-2017 and lot number L009545 expiration date 19-MAR-2017). The vaccines were exposed to 9.7 degrees centigrade for a cumulative time frame of 4 hours and 41 minutes. There was no previous excursion. This report was for data logger. No adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical history provided. On an unknown dates, the patients were vaccinated with an improperly stored dose of ZOSTAVAX (lot# L003215 with expiration date 30-APR-2016; lot# L029485 with expiration date 06-NOV-2016; dose, anatomical location and route of administration were not reported). The vaccines were exposed to 4 hours 30 minutes at 47.5 Fahrenheit (F) on the fifth of April (year unspecified), 1 hour 30 minutes at 51.3 F, 2 hours at 56.3 F and 30 minutes at 6.1 F on the seventh of April (year unspecified), 1 hour and 30 minutes at 48.9 F on the fifth of May (year unspecified) and 1 hours at 51.6 F on the sixth of May (year unspecified). No adverse events were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a certified medical assistant and refers to a patient of unknown age and gender. There was no information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies provided. On 08-JUL-2016, the patient was vaccinated with an expired dose of ROTATEQ (lot# K010222, expiration date 31-MAY-2-16, dose was not reported; orally). No adverse events were reported. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from an unspecified reporter and refers to a 2 patients of unknown age and gender. On 23-JUN-2016, the patients were vaccinated with improperly stored doses of PROQUAD (dose, frequency, route of administration and indication were not reported lot # L014401 with expiration date improperly stored 23-OCT-2016). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to multiple unspecified patients of unknown age and gender. On unknown dates the patients were vaccinated with unspecified improperly stored LIQUID PEDVAXHIB. Reported lot number/expiration dates included valid L012837/11-MAR-2018, L006545/16-NOV-2017 and non-valid one J011272/21-APR-2016. The vaccines were exposed to 9.7 degrees centigrade for a cumulative time frame of 4 hours and 41 minutes. There was no excursion. This report was for data logger. No adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 28.0
Sex: F
Vaccine: HEPAB, JEV, TYP, HEPAB, JEV, TYP
Symptoms: Asthenia, Computerised tomogram head normal, Dehydration, Full blood count normal, Headache
Clinical narrative: The patient is a 28 year old female. Patient referred from allergy clinic for severe prolonged (>4 hours) vomiting after receiving the typhoid, TWINRIX # 3 and JEV vaccines. Pt reports that prior to receiving vaccination she ate in the cafeteria with her spouse and child. Neither had the same food that she did. 10 min after the vaccine receipt she began to feel "weak". She went home and approx 1 hour after vaccines she began to vomit repeatedly, resulting in dry heaves for the next 4 hours and a severe headache from the wretching. She states she does not have headaches regularly. She then went to the ER and a CT head and blood work was normal, showing only dehydration. She was given IV fluids and antiemetics and released. She began to take sips of liquids when she went home. By the next day she was asymptomatic and began to eat and drink normally.
Age: 28.0
Sex: F
Vaccine: HEPAB, JEV, TYP, HEPAB, JEV, TYP
Symptoms: Metabolic function test abnormal, Retching, Vomiting
Clinical narrative: The patient is a 28 year old female. Patient referred from allergy clinic for severe prolonged (>4 hours) vomiting after receiving the typhoid, TWINRIX # 3 and JEV vaccines. Pt reports that prior to receiving vaccination she ate in the cafeteria with her spouse and child. Neither had the same food that she did. 10 min after the vaccine receipt she began to feel "weak". She went home and approx 1 hour after vaccines she began to vomit repeatedly, resulting in dry heaves for the next 4 hours and a severe headache from the wretching. She states she does not have headaches regularly. She then went to the ER and a CT head and blood work was normal, showing only dehydration. She was given IV fluids and antiemetics and released. She began to take sips of liquids when she went home. By the next day she was asymptomatic and began to eat and drink normally.
Age: 28.0
Sex: F
Vaccine: HEPAB, JEV, TYP, HEPAB, JEV, TYP
Symptoms: Headache, Vomiting
Clinical narrative: The patient is a 28 year old female. Patient referred from allergy clinic for severe prolonged (>4 hours) vomiting after receiving the typhoid, TWINRIX # 3 and JEV vaccines. Pt reports that prior to receiving vaccination she ate in the cafeteria with her spouse and child. Neither had the same food that she did. 10 min after the vaccine receipt she began to feel "weak". She went home and approx 1 hour after vaccines she began to vomit repeatedly, resulting in dry heaves for the next 4 hours and a severe headache from the wretching. She states she does not have headaches regularly. She then went to the ER and a CT head and blood work was normal, showing only dehydration. She was given IV fluids and antiemetics and released. She began to take sips of liquids when she went home. By the next day she was asymptomatic and began to eat and drink normally.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site mass, Injection site warmth, Rash
Clinical narrative: This spontaneous report as received from a pharmacist refers to a female patient in her 60's. The patient did not have pertinent medical history, drug reactions or allergies. On 23-JUN-2016, the patient was vaccinated with a dose of ZOSTAVAX subcutaneously (strength, dose, frequency, lot number and expiration date were unknown). There were no concomitant therapies reported. In June 2016, after she received her ZOSTAVAX injection, the patient experienced a red mark at the injection site, a minor rash, a lump at the injection site, and slight heat at the injection site. The patient did not seek medical attention except to call the pharmacist. No laboratory diagnostics studies were performed nor treatment was given for the adverse events. The outcome of the aforementioned events and the causality between ZOSTAVAX and all the events were unknown. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a physician via company representative, refers to two patients of unknown ages and genders. Medical history and concurrent conditions were not reported. On an unknown dates the patients were vaccinated with a dose of ZOSTAVAX 19400 PFU, subcutaneous. Dose, frequency, lot number and expiration date were not provided. No other suspect or concomitant therapy was reported. On an unknown dates the patients developed Shingles. The outcome of Shingles was unknown. The causality between vaccination with ZOSTAVAX and Shingles was unknown. Additional information has been requested.
Age: 0.26
Sex: F
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a certified medical assistant and refers to a 3 months old, female patient. The patient's concurrent conditions, medical history and concomitant medications were not reported. On 22-APR-2016 at 12:37, the patient was vaccinated with improperly stored first dose of ROTATEQ lot# L033543, expiry date 30-MAY-2017, orally (dose was not reported). No adverse symptoms were reported. Administered vaccine experienced temperature excursion of 34 Fahrenheit for a total time of 65 hours. There was no previous temperature excursion. Digital data logger was not involved. This is one of several reports received from the same source. Additional information is not expected, as all scheduled correspondence was received.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 15-JUN-2016, the patient was vaccinated with a first dose of VARIVAX immunization series (lot# L043624 with expiry date on 03-NOV-2017 or lot# L040419 with expiry date on 14-OCT-2017 or lot# reported as M000156 with expiry date on 06-JAN-2018 (it was not specified which lot# was used); exact dose and route of administration were not reported) that were improperly stored. The vaccine was exposed to a temperature of -10, 1 Celsius degrees for 90 minutes. Data logger was used. No adverse effects were reported. No product quality complaint was involved. Lot number M000156 is an invalid lot number for varicella virus vaccine live (Oka/Merck). This is one of two reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not provided. On 24-JUN-2016, the patient was intramuscularly vaccinated with one expired dose of GARDASIL (injection, lot number: K001502 with expiry date of 06-AUG-2015). No concomitant therapy was reported. No adverse effect was reported. No product quality complaint was involved. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 14-JUN-2016, the patient was vaccinated with a first dose (Oka/Merck) VARIVAX immunization series (lot# L043624 with expiry date on 03-NOV-2017 or lot# L040419 with expiry date on 14-OCT-2017 or lot# reported as M000156 with expiry date on 06-JAN-2018 (it was not specified which lot# was used); exact dose and route of administration were not reported), that were improperly stored. The vaccine was exposed to a temperature of -10.1 Celsius degrees for 90 minutes. Data logger was used. No adverse effects were reported. No product quality complaint was involved. Lot number M000156 is an invalid lot number for VARIVAX (Oka/Merck). This is one of two reports received from the same reporter. Additional information has been requested.
Age: 0.57
Sex: M
Vaccine: RV5
Symptoms: Inappropriate schedule of drug administration, Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a certified medical assistant and refers to a 6 month old (at the time of the report the patient was 8 month old) male patient. Information on the patient's concurrent conditions, medical history or concomitant medications was not reported. On 02-MAY-2016 at 16:00, at the age of 6 month old, the patient was vaccinated with his first dose of ROTATEQ (lot# number reported as L033543, expiration date 30-MAY-2017, orally, dose was not reported). The temperature of excursion was 34F and the time frame was 65 hours. There was no previous temperature excursion and the call was not because of a data logger. No adverse events, signs or symptoms were reported. No product quality complaint (PQC) was involved. The patient had no illness at the time of vaccination. This is one of several reports received from the same source. Lot number L033543 has been verified to be valid lot number ROTATEQ. Additional information is not expected as all required correspondence has been received.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to an unspecified number of patients of unknown age and gender. Information regarding relevant medical history and concurrent condition were not reported. On unknown dates, the patients were vaccinated with improperly stored oral ROTATEQ (lot # L033694, expiration date 16-JUN-2017, oral, dose unspecified). No adverse effects were reported. Additional information has been requested.
Age: 0.46
Sex: M
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a certified medical assistant and refers to a 5 months old, male patient. The patient's concurrent conditions, medical history and concomitant medications were not reported. On 15-APR-2016 at 17:02, the patient was vaccinated with improperly stored dose of ROTATEQ lot# L033543, expiry date 30-MAY-2017, orally (dose was not reported). No adverse symptoms were reported. Administered vaccine experienced temperature excursion of 34 degrees Fahrenheit for a total time of 65 hours. Digital data logger was not involved. This is one of several reports received from the same source. Additional information is not expected, as all scheduled correspondence was received.
Age: 38.0
Sex: M
Vaccine: PPV
Symptoms: Arthralgia, Diarrhoea, Headache, Injection site erythema, Injection site swelling
Clinical narrative: Swelling/redness at injection site - 3 inch diameter. Also joint pain, headache, nausea, diarrhea, fever.
Age: 38.0
Sex: M
Vaccine: PPV
Symptoms: Nausea, Pyrexia
Clinical narrative: Swelling/redness at injection site - 3 inch diameter. Also joint pain, headache, nausea, diarrhea, fever.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site inflammation, Injection site pain, Injection site swelling
Clinical narrative: There was inflamation, swelling, pain and redness of the injection site. Pt had to go to the doctor and was prescribed an antibiotic and a steroid.
Age: 71.0
Sex: M
Vaccine: PNC13
Symptoms: Cold sweat, Dizziness, Skin discolouration
Clinical narrative: PATIENT RETURNED TO PHARMACY AND SAT ON BENCH, REPORTED COLD SWEATS AND DIZZINESS.  TOOK BLOOD PRESSURE, 100/54. Sent associate to get pillow to prop up feet, took 2nd read before pt lay down: 95/56.  Patient elevated feet.  Took 3rd read: 124/72.  Had patient remain sitting for several minutes, took a 4th read 120/74.  Patient reported feeling much improved, color better, sweats and dizziness gone.  Patient elected to return to shopping and was advised to return to pharmacy or seek help if dizziness returns.
Age: 70.0
Sex: M
Vaccine: PNC13
Symptoms: Abdominal pain upper, Constipation, Diarrhoea, Nausea
Clinical narrative: Stomach cramps, Nausea, diarrhea and constipation.
Age: 75.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Red swelling at injection site and redness extending over area 6" long and 3" wide.
Age: 20.0
Sex: F
Vaccine: MMR, TDAP
Symptoms: Measles antibody negative, Rash generalised
Clinical narrative: Rash all over body.
Age: 11.0
Sex: M
Vaccine: HEPA, HPV9, MNQ, TDAP
Symptoms: Decreased appetite, Dizziness, Fatigue, Moaning, Pyrexia
Clinical narrative: High fever of 104.5, some shaking and moaning administered Motrin to reduce fever. Fever stayed above 103 for 48 hours, fever broke after 72 hours. Remained fatigued and light headed for another two days, has little interest in eating.
Age: 11.0
Sex: M
Vaccine: HEPA, HPV9, MNQ, TDAP
Symptoms: Tremor
Clinical narrative: High fever of 104.5, some shaking and moaning administered Motrin to reduce fever. Fever stayed above 103 for 48 hours, fever broke after 72 hours. Remained fatigued and light headed for another two days, has little interest in eating.
Age: 22.0
Sex: F
Vaccine: ANTH
Symptoms: Dizziness, Myalgia, Nausea, Pyrexia, Vomiting
Clinical narrative: Dizzy, vomiting, low grade fever, nausea, muscle soreness.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Cellulitis, Erythema, Induration, Injection site pain
Clinical narrative: Patient complained of pain in left thigh lower injection site, which was Varicella, on 07/08/16 AM, which resolved by 07/09/16.  However, redness and induration increased by 07/10/16, and mother took child into Urgent Care and was diagnosed with cellulitis.
Age: 63.0
Sex: M
Vaccine: PPV, TDAP, VARZOS
Symptoms: Generalised erythema, Skin discolouration
Clinical narrative: Red, white, and black discolorations over the entire body.
Age: 1.29
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Injection site swelling, Pyrexia
Clinical narrative: Received vaccine in left thigh. Developed fevers and leg swelling day after. Leg stayed swollen for 2-3 days after vaccine given.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema
Clinical narrative: Redness at injection site.
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: Information has been received from a pharmacist referring to a patient of unknown age and gender. On 23-JUN-2016 the patient was inadvertently vaccinated with an expired dose of ZOSTAVAX (lot # L003218, expiration date 30-APR-2016, strength and route were not reported). No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to an unknown number of unspecified patients. On unknown dates starting on or after 12-MAY-2016 the patients were vaccinated with PROQUAD lot # L045675 (expiration date 09-MAY-2017) and Lot # M003434 (rHA, expiration date 19-JUL-2017), which was improperly stored at 14 F for 1400 minutes. There was no previous temperature excursion. No adverse effect reported. This is one of several reports received from the same source. Additional information has been requested.
Age: 37.0
Sex: M
Vaccine: HEP
Symptoms: Abdominal pain, Anxiety, Blood test, Computerised tomogram, Dehydration
Clinical narrative: Nausea, vomiting, diarrhea, abdominal pain, dizziness, headaches, anxiety, dehydration, high blood pressure. 6-2-16 - 6-23-16. Prescribed ondansetron and promethazine as well as saline IV, blood work, X-Rays, CAT scan.
Age: 37.0
Sex: M
Vaccine: HEP
Symptoms: Diarrhoea, Dizziness, Headache, Hypertension, Nausea
Clinical narrative: Nausea, vomiting, diarrhea, abdominal pain, dizziness, headaches, anxiety, dehydration, high blood pressure. 6-2-16 - 6-23-16. Prescribed ondansetron and promethazine as well as saline IV, blood work, X-Rays, CAT scan.
Age: 37.0
Sex: M
Vaccine: HEP
Symptoms: Vomiting, X-ray
Clinical narrative: Nausea, vomiting, diarrhea, abdominal pain, dizziness, headaches, anxiety, dehydration, high blood pressure. 6-2-16 - 6-23-16. Prescribed ondansetron and promethazine as well as saline IV, blood work, X-Rays, CAT scan.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to an unspecified number of patients of unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant therapies were not provided. On an unknown date, the patients were vaccinated with and improperly stored ZOSTAVAX VIAL 19400 PFU (plaque-forming units) (lot # L035286, expiry date 15-DEC-2016, dose and route of administration were not reported). It was reported that the vaccine underwent a temperature excursion of 35 degrees Fahrenheit for 8 hours. Administered with "2 or 3 doses with one patient receiving this week" (20-JUN-2016 - 24-JUN-2016) but would have only been exposed to prior excursion (35 degrees Fahrenheit for 12 hours) and not included current excursion. The vaccine underwent prior temperature excursion of 35 degrees Fahrenheit for 12 hours. There was no data logger. No adverse effects reported. The outcome of incorrect product storage and no adverse event were considered to be unknown. There was no Product Quality Complaint (PQC). Additional information has been requested.
Age: 0.3
Sex: U
Vaccine: VARCEL
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Information was received from a physician referring to a 3 months old patient of unknown gender. The patient's medical history, concurrent condition and concomitant therapy were not reported. On an unknown date the patient was administered 0.5 ml VARIVAX (unspecified lot and expiration date) subcutaneously. No adverse effect was reported. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to an unspecified patient of unknown age and gender. On an unknown date the patient was vaccinated with one dose of improperly stored PROQUAD (lot # L051098, expiration date 17-JUN-2017, strength and route were not reported). The vaccine has been stored under temperature of -10.8 degree Celsius for 48 minutes before back in range. There was no previous temperature excursion and date logger involved. No adverse effects were reported. This is one of several reports received from same reporter. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Premature menopause
Clinical narrative: Information has been received from a physician referring to unspecified female patients of unknown age. The patients' pertinent medical history and drug reactions/allergies were not reported. The reporter heard from other colleagues that on unknown dates, the patients experienced "premature ovarian failure" after receiving GARDASIL (dose, dose number, lot# and route were not reported) on unknown dates. The outcome of the event and the causality were not reported. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse referring unspecified number of patients of unknown ages and genders. Medical history and concurrent conditions were not provided. On an unknown dates, the patients were vaccinated with an improperly stored doses of LIQUID PEDVAXHIB injection, one dose intramuscularly (lot # M001813, expiration date 14-OCT-2018). No adverse effects were reported. No product quality complaint was involved. Additional information has been requested.
Sex: F
Vaccine: VARCEL
Symptoms: Ear pain, Eye pain, Fatigue, Full blood count normal, Neuralgia
Clinical narrative: This spontaneous report was received from a pharmacist referring to a female patient of unknown age. The patient's concurrent conditions and medical history were not provided. The patient did not have drug reactions or allergies. On an unspecified date in 2000 the patient was vaccinated with dose VARIVAX (strength, dose number, route, anatomical location, lot number and expiration date were not provided). Concomitant therapies were not provided. On 26-JUN-2016 the patient experienced fatigue, ear pain, scalp and eye pain. The reporter stated that the pain was running along nerve pathways. It was reported that unspecified anti-viral medication was given as treatment. On 28-JUN-2016, the patient went to an unspecified Urgent Care facility, where the following lab studies were performed: Red blood sedimentation rate (normal), full blood count (normal) and bacterial test (negative for streptococcus). No product quality complaint was involved. The outcome of fatigue, neuralgia, ear pain, pain of skin and eye pain was unknown. The reporter did not assess the relatedness between the events and suspect therapy. Additional information has been requested.
Sex: F
Vaccine: VARCEL
Symptoms: Pain of skin, Red blood cell sedimentation rate normal, Streptococcus test negative
Clinical narrative: This spontaneous report was received from a pharmacist referring to a female patient of unknown age. The patient's concurrent conditions and medical history were not provided. The patient did not have drug reactions or allergies. On an unspecified date in 2000 the patient was vaccinated with dose VARIVAX (strength, dose number, route, anatomical location, lot number and expiration date were not provided). Concomitant therapies were not provided. On 26-JUN-2016 the patient experienced fatigue, ear pain, scalp and eye pain. The reporter stated that the pain was running along nerve pathways. It was reported that unspecified anti-viral medication was given as treatment. On 28-JUN-2016, the patient went to an unspecified Urgent Care facility, where the following lab studies were performed: Red blood sedimentation rate (normal), full blood count (normal) and bacterial test (negative for streptococcus). No product quality complaint was involved. The outcome of fatigue, neuralgia, ear pain, pain of skin and eye pain was unknown. The reporter did not assess the relatedness between the events and suspect therapy. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site pain
Clinical narrative: This solicited report as received from a non-healthcare professional refers to a 11 year old female patient who was enrolled in a Market Research. Patient's concurrent conditions, and medical history were not provided. Concomitant therapies included multiple unspecified vaccines administered on the same date. In approximately May 2016, the subject was vaccinated with first dose of GARDASIL (dose, route, lot # and expiration date were not provided). In May 2016, the patient experienced soreness at injection site (injection site pain). The patient recovered of the injection site pain 3 days after vaccination (approximately May 2016). The investigator considered the injection site pain to be related to GARDASIL. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information was received from a registered nurse referring to multiple patients of unknown age and gender. The patients' medical history, concurrent condition and concomitant therapy were not reported. It was reported the multiple patients were administered improperly stored VARIVAX (lot # L013827, expired on 21-APR-2017) (dose and route unknown) on multiple dates. The vaccines were previously exposed under 22.2 F for 4 hours and 25 minutes, and was exposed under 8.3 F for 50 minutes this time. Data logger was involved. No adverse effects were reported. Additional information has been requested.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a 69 years old female patient referring to herself. The patient had no medical history and no known drug allergy. On 02-DEC-2015 the patient was administered with a dose of ZOSTAVAX (lot#, dose, frequency were unknown; route reported as injection) for shingles. There was no concomitant therapy. On 02-JUL-2016 (also reported as 6 months after being administered of the vaccine), the patient developed "a bad case" of the shingles. The patient had sought medical attention via speaking with physician. Valacyclovir hydrochloride was given as treatment for adverse event. No lab diagnostics was performed. The patient was not recovered from shingles at the time of the report. The causality assessment between the event and ZOSTAVAX was not provided. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assessment referring to an unspecified patient of unknown age and gender. On an unknown date the patient was vaccinated with one dose of improperly stored VARIVAX (lot # L045955, expiration date 17-NOV-2017, strength and route were not reported). The vaccine had been stored under temperature of -10.8 degree Celsius for 48 minutes before back in range. There was no previous temperature excursion and data logger involved. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage
Clinical narrative: Information was received from a certified medical assistant referring to an unspecified number of patients of unknown age and gender. The patients' medical history, concurrent condition and concomitant therapy were not reported. It was reported that improperly stored PROQUAD (dose, frequency, route, lot# and expiry were not reported) doses had been administered to unspecified patients on unspecified dates. Number of doses administered were unspecified. This is one of 2 reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage
Clinical narrative: Information was received from a certified medical assistant referring to an unspecified number of patients of unknown age and gender. The patient's medical history, concurrent condition and concomitant therapy were not reported. It was reported that improperly stored (Oka/Merck) VARIVAX (dose, frequency, route, lot# and expiry were not reported) doses had been administered to unspecified patients for prophylaxis on unspecified dates. Number of doses administered were unspecified. This is one of 2 reports received from the same reporter. Additional information has been requested.
Age: 26.0
Sex: U
Vaccine: MMRV
Symptoms: Drug administered to patient of inappropriate age, Incorrect route of drug administration, No adverse event
Clinical narrative: Information was received from a registered nurse referring to a 26 years old patient of unknown gender. The patient's medical history, concurrent condition and concomitant therapy were not reported. On 22-JUN-2016 the 26 years old patient was inadvertently administered a dose of PROQUAD (lot # L006388, expired on 25-AUG-2016, human serum albumin (HSA)) via the intramuscular route instead of the recommended subcutaneous route. No adverse effect was reported. Additional information has been requested.
Age: 0.3
Sex: U
Vaccine: HPVX
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Information has been received from a physician via a field representative referring to a 4 month old patient of unknown gender. The patient's pertinent medical history and drug reactions/allergies were not reported. On 30-JUN-2016, the only four months old patient was vaccinated with a dose of human papillomavirus (HPV) vaccine  (manufacturer unknown) (dose, dose number and route were not reported (inappropriate schedule of drug administration). It was unknown if the patient received GARDASIL, GARDASIL 9 or another hpv vaccine (unspecified) (manufacturer unknown) (product origin unknown). The patient did not experience any effects. 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 Licensed Practical Nurse (L.P.N) concerning a patient of unknown age and gender. The patient's pertinent medical history and concurrent conditions were not reported. On 24-JUN-2016, the patient inadvertently was vaccinated with an unspecified expired dose of M-M-R II (Lot # K008815; expiration date on 16-JUN-2016. No adverse effects reported. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker/medical assistant refers to patients of unknown demographics. No pertinent medical history and drug reactions/allergies were reported. Since 31-MAY-2016, an unknown number of patients have been administered doses of VARIVAX (Lot#L034370, expiry date: 08-SEP-2017/Lot# M000761, expiry date: 06-JAN-2018/Lot# M004326, expiry date 25-JAN-2018) which were improperly stored. No adverse effects reported. Data Logger was yes and outcome was all supported. No product quality complaint was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 1.02
Sex: M
Vaccine: HEPA, MMR, PNC13
Symptoms: Cough, Decreased appetite, Diet refusal, Hypersensitivity, Injection site erythema
Clinical narrative: Patient seen 24 hrs after hep A, PCV13 given in (L) thigh. He had a 5 x 5 area of erythema surrounding needle puncture sites. No flocculence. Mother reported 3 episodes of emesis with 3 hrs that morning. No fever. He did have clear rhinorrhea on exam. Suspected allergic reaction. Recommended BENADRYL. Seen back the next day due to redness expanding to 9 x 9 cm - suspected cellulitis and treated with cephalexin. 07/08/2016. Vomiting/SD. 12 month old baby boy here with his mother/hmm. Had 12mo shots yesterday. Last night decreased appetite and cranky. Woke up around 6am and vomited. He has done it 3 times since. He is refusing food as well. This mother also noticed red area around where he got shots on the left leg. No fever at home. c/o runny nose for the last day. c/o cough a little junky when he first woke up today. Denies: fever, sick contacts. 07/09/2016. Re rash - seen 7/8/16. 12 month 10 day old boy here with his mom. Two days ago got his 1 year shots - got a hep A and a PREVNAR in his left thigh. Usually gets fevers after shots. By the next morning, no fever, but vomited several times and had an area of redness around the vaccination sites. Seen here, assumed reaction, measured at 5 cm diameter, given BENADRYL. Has been using BENADRYL and cool compresses ever since. Vomiting stopped, but rash is still growing. Getting larger ever since being in the office yesterday. Measuring 9 cm across. He isn't itching, it doesn't seem tender.
Age: 1.02
Sex: M
Vaccine: HEPA, MMR, PNC13
Symptoms: Irritability, Puncture site erythema, Rhinorrhoea, Vomiting
Clinical narrative: Patient seen 24 hrs after hep A, PCV13 given in (L) thigh. He had a 5 x 5 area of erythema surrounding needle puncture sites. No flocculence. Mother reported 3 episodes of emesis with 3 hrs that morning. No fever. He did have clear rhinorrhea on exam. Suspected allergic reaction. Recommended BENADRYL. Seen back the next day due to redness expanding to 9 x 9 cm - suspected cellulitis and treated with cephalexin. 07/08/2016. Vomiting/SD. 12 month old baby boy here with his mother/hmm. Had 12mo shots yesterday. Last night decreased appetite and cranky. Woke up around 6am and vomited. He has done it 3 times since. He is refusing food as well. This mother also noticed red area around where he got shots on the left leg. No fever at home. c/o runny nose for the last day. c/o cough a little junky when he first woke up today. Denies: fever, sick contacts. 07/09/2016. Re rash - seen 7/8/16. 12 month 10 day old boy here with his mom. Two days ago got his 1 year shots - got a hep A and a PREVNAR in his left thigh. Usually gets fevers after shots. By the next morning, no fever, but vomited several times and had an area of redness around the vaccination sites. Seen here, assumed reaction, measured at 5 cm diameter, given BENADRYL. Has been using BENADRYL and cool compresses ever since. Vomiting stopped, but rash is still growing. Getting larger ever since being in the office yesterday. Measuring 9 cm across. He isn't itching, it doesn't seem tender.
Age: 4.0
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, 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 and medical history were not reported. On 07-JUL-2016, the patient was vaccinated with an expired dose of PNEUMOVAX 23 lot # K021030; expiration date 22-JUN-2016 (dose, dose number and anatomical location were not reported). Concomitant medications were not reported. No adverse effects were reported. No Product Quality Complaint was involved. Additional information has been requested.
Age: 11.0
Sex: M
Vaccine: TDAP
Symptoms: Eye swelling, Rash pruritic, Vaccination site urticaria
Clinical narrative: Developed itchy rash and eye swelling a few hours after - TDAP vaccine given: taken to ER and required BENADRYL. No fever positive urticaria on deltoid muscle noted at site where vaccine given on Flu visit.
Age: 42.0
Sex: F
Vaccine: HEPAB, TDAP
Symptoms: Injection site pain
Clinical narrative: Intermittent, sharp pain 8/10 from site of injec. radiating from shoulder to elbow. No redness swelling or fever. RN consulted with Dr. - referred pt. to PCP for further eval.
Age: 18.0
Sex: M
Vaccine: MENB
Symptoms: Arthralgia, Chest pain, Chills, Hyperhidrosis
Clinical narrative: Patient reports aching in his hips, knees, ankles, elbows, left shoulder and wrist. He also started to complain of pain in his left side of his upper chest. Patient had chills and alternately felt sweaty.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Clostridium test negative, Culture stool negative, Diarrhoea, Polymerase chain reaction, Rotavirus test negative
Clinical narrative: Patient developed explosive, mucousy diarrhea approximately 3-4 hours after 1st dose of ROTARIX. Stool cultures, c. diff toxin by PCR, and Rotavirus Ag. were all negative. Three months of diarrhea, seen by Pedi GI who recommended probiotics and diarrhea resolved.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Vaccination site pain, Vaccination site swelling
Clinical narrative: Redness, swelling, soreness of vaccine site at (L) posterior upper arm 3" above elbow. Site was red, swollen after vaccine (1 day after) and recovered around Wednesday 6/14/16.
Age: 79.0
Sex: F
Vaccine: PNC
Symptoms: Infection, Pain in extremity
Clinical narrative: Patient reported sore arm 5 days after vaccine. Told patient to see if MD it does not get better or gets worse. pain did not get better patient saw MD and diagnosed with infection.
Age: 15.0
Sex: M
Vaccine: HEPA, HPV4, MNQ, TDAP
Symptoms: Bradycardia, Hypotension, Syncope
Clinical narrative: Fainting episode approximately 5 min following vaccination. Hypotensive and bradycardic . Resolved in 1 hour.
Age: 53.0
Sex: M
Vaccine: DTAP
Symptoms: Asthenia, Bedridden, Dizziness, Fall, Headache
Clinical narrative: I am still weak extremely weak. My headaches are better but I still have them. Soreness where shot and spine extremely sore. Ache all over dizzy, lightheaded, bedridden. Fall if walk. Too dizzy. My spine is hurting.
Age: 53.0
Sex: M
Vaccine: DTAP
Symptoms: Injection site pain, Pain, Spinal pain
Clinical narrative: I am still weak extremely weak. My headaches are better but I still have them. Soreness where shot and spine extremely sore. Ache all over dizzy, lightheaded, bedridden. Fall if walk. Too dizzy. My spine is hurting.
Age: 14.0
Sex: M
Vaccine: HPV9
Symptoms: Fall, Laceration, Suture insertion, Syncope
Clinical narrative: Pt fainted after receiving injection, fell and sustained laceration to chin. Received 6 sutures in clinic.
Sex: F
Vaccine: HEP
Symptoms: Blister
Clinical narrative: Had small blistery rash on thigh.
Age: 0.36
Sex: F
Vaccine: DTAPHEPBIP
Symptoms: Injection site pruritus, Injection site swelling, Injection site vesicles, Pyrexia
Clinical narrative: Vaccination was given in right thigh and developed a blistered rash from knee to hip, swelling, itching, and fever of 100.8 degrees F.
Age: 61.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Injection site rash
Clinical narrative: Patient got a PNEUMOVAX 23 and a shingles vaccine on 5/21/2016. Both given in the left arm. About 2 days later patient reported appox 6" circle rash on inside R elbow.
Age: 0.18
Sex: F
Vaccine: HEP
Symptoms: Rash erythematous, Rash vesicular, Vaccination site pain, Vaccination site reaction, Vaccination site swelling
Clinical narrative: Vaccination sight developed a red blistery rash, swelling and pain.
Age: 41.0
Sex: F
Vaccine: PPV
Symptoms: Local swelling, Neck pain, Rash, Rash erythematous
Clinical narrative: Red, bumpy arm. Swelling and pain up through neck.
Age: 71.0
Sex: F
Vaccine: PNC13
Symptoms: Cellulitis, Erythema, Pruritus, Skin warm, Swelling
Clinical narrative: Redness, swelling, hot to the touch, itching. DX: cellulitis.
Sex: U
Vaccine: PPV
Symptoms: Computerised tomogram, Lower respiratory tract infection bacterial, Positron emission tomogram
Clinical narrative: Received Pneumonia booster shot from pharmacy. I accumulated a bacterial infection of my lungs and a spot.
Age: 67.0
Sex: U
Vaccine: PNC13
Symptoms: Chills, Dizziness, Headache, Loss of consciousness, Pyrexia
Clinical narrative: Fever and chills the same day. Had dizziness. Passed out later that day and headaches. Claims still has headaches.
Age: 45.0
Sex: M
Vaccine: ANTH
Symptoms: Asthenia, Fatigue, Injection site erythema, Musculoskeletal discomfort, Vaccination site induration
Clinical narrative: Denied any problems with previous immunizations and was well at time of vaccination. He reported the onset of swelling to vaccination site on the same day. He stated the area was red, hard like a rock, painful and warm to touch. It reached a size 3 inches and did not extend below elbow. He also reported that he felt fatigued, weak and had multiple joint discomfort. He did take anything for the discomfort and all symptoms completely resolved within one week.
Age: 45.0
Sex: M
Vaccine: ANTH
Symptoms: Vaccination site pain, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Denied any problems with previous immunizations and was well at time of vaccination. He reported the onset of swelling to vaccination site on the same day. He stated the area was red, hard like a rock, painful and warm to touch. It reached a size 3 inches and did not extend below elbow. He also reported that he felt fatigued, weak and had multiple joint discomfort. He did take anything for the discomfort and all symptoms completely resolved within one week.
Age: 57.0
Sex: F
Vaccine: TD
Symptoms: Induration, Local reaction, Skin warm, Swelling
Clinical narrative: Local reaction in arm. Area of induration, warm and swelling. No other signs or symptoms of infection.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMRV
Symptoms: Generalised erythema, Urticaria
Clinical narrative: Patient came in around 1320 today 7/11/16 after his visit this morning with diffuse erythema and hives over his entire body after receiving MMRV, Dtap, Polio vaccines in clinic around 1200 today. We gave 8.5 ml of BENADRYL and monitored in office for 45 min. At time of discharge pt's hives were no longer visible and erythema had decreased. Pt d/c home with mom.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Hypotonia, Loss of consciousness
Clinical narrative: Upon receiving the vaccination the patient went limp and passed out. She was carefully moved to the ground. She came to after 10-15 second and never stopped breathing. She indicated afterwards that she had fainted before (after indicating on her paperwork that she had not). After 30 min. she left with a family member.
Age: 11.0
Sex: M
Vaccine: TDAP
Symptoms: Loss of consciousness
Clinical narrative: Patient given Tdap - passed out 5 minutes after administration.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Erythema, Skin warm, Swelling
Clinical narrative: Right arm red, swollen and warm to touch.
Age: 43.0
Sex: F
Vaccine: HIBV, PNC13
Symptoms: Erythema, Mouth ulceration, Nodule, Skin ulcer
Clinical narrative: Red swollen knot turned into open sore, then 2 more knots about 2 wks later turned into open sores. They all grew until they became one huge open sore on my arm and then the final knot is by my armpit that became an open sore.
Age: 8.0
Sex: M
Vaccine: DTAP, IPV
Symptoms: Injection site hypersensitivity
Clinical narrative: Allergic reaction to injection site ((L) deltoid).
Age: 11.0
Sex: M
Vaccine: HEPA
Symptoms: Head injury, Loss of consciousness, Syncope
Clinical narrative: 1-2 minutes after he received shot he had syncopal episode and hit his head on window sill. He regained consciousness within few seconds. He BP was 60/40. He improved with lying flat and drinking water.
Age: 22.0
Sex: F
Vaccine: TDAP
Symptoms: Diarrhoea, Exposure during pregnancy, Feeling hot, Injection site erythema, Injection site swelling
Clinical narrative: Patient had 6-7 cm red area at injection site. The next day area was raised, is now flat but continues to have redness. Patient is pregnant. Having warm feeling and loose stools.
Age: 11.0
Sex: M
Vaccine: TDAP
Symptoms: Injection site pain, Local swelling
Clinical narrative: Local swelling, pain at injection site.
Age: 75.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site oedema
Clinical narrative: Erythema, edema in arm at injection site.
Age: 0.54
Sex: F
Vaccine: DTAPHEPBIP, PNC, RV5
Symptoms: Injection site pruritus, Injection site rash
Clinical narrative: Mother noticed bilateral rash to anterior thighs surrounding injection site with itching 24 hours after receiving injections. Mother stated it has happened the last 2 times patient received vaccines but never reported. TX hydrocortisone/ZYRTEC.
Age: 40.0
Sex: F
Vaccine: HPV2
Symptoms: Arthralgia, Back pain, Constipation, Gait disturbance, Headache
Clinical narrative: This case was reported by a regulatory authority via regulatory authority and described the occurrence of malaise in a 40-year old female subject who received CERVARIX. In August 2010, the subject received the 1st dose of CERVARIX (intramuscular). In March 2011, the dose was an unknown dose. On an unknown date, unknown after receiving CERVARIX, the subject experienced malaise, constipation, arthralgia, sleep disorder, headache, low back pain and difficulty in walking. On an unknown date, the outcome of the malaise, constipation, arthralgia, sleep disorder, headache, low back pain and difficulty in walking were unknown. It was not reported if the reporter considered the malaise, constipation, arthralgia, sleep disorder, headache, low back pain and difficulty in walking to be related to CERVARIX.