chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 42.0
Sex: F
Vaccine: FLU4, PPV, FLU4, PPV
Symptoms: Neutrophil count normal, Pain in extremity, Rhinorrhoea, Tenderness, Tobacco abuse
Clinical narrative: Vaccine given at 4PM, that evening developed nausea, emesis, diarrhea, arm became painful, today ongoing nausea, sense of "heat" but no fever, right upper arm hot, red, tender.
Age: 42.0
Sex: F
Vaccine: FLU4, PPV, FLU4, PPV
Symptoms: Vomiting, Wheezing, White blood cell count increased, White blood cell count normal
Clinical narrative: Vaccine given at 4PM, that evening developed nausea, emesis, diarrhea, arm became painful, today ongoing nausea, sense of "heat" but no fever, right upper arm hot, red, tender.
Age: 42.0
Sex: F
Vaccine: FLU4, PPV, FLU4, PPV
Symptoms: C-reactive protein, Diarrhoea, Feeling hot, Full blood count, Injection site erythema
Clinical narrative: Vaccine given at 4PM, that evening developed nausea, emesis, diarrhea, arm became painful, today ongoing nausea, sense of "heat" but no fever, right upper arm hot, red, tender.
Age: 42.0
Sex: F
Vaccine: FLU4, PPV, FLU4, PPV
Symptoms: Injection site pain, Injection site warmth, Nausea, Pain in extremity, Red blood cell sedimentation rate
Clinical narrative: Vaccine given at 4PM, that evening developed nausea, emesis, diarrhea, arm became painful, today ongoing nausea, sense of "heat" but no fever, right upper arm hot, red, tender.
Age: 42.0
Sex: F
Vaccine: FLU4, PPV, FLU4, PPV
Symptoms: Vomiting
Clinical narrative: Vaccine given at 4PM, that evening developed nausea, emesis, diarrhea, arm became painful, today ongoing nausea, sense of "heat" but no fever, right upper arm hot, red, tender.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 08-NOV-2016, the patient was vaccinated with an improperly stored dose of VARIVAX (lot # M023380, expiration date: 11-MAY-2016) (dose, route of administration and injection site were not provided) at the ambulatory care center. No adverse reaction was reported. Product quality complaint (PQC) was not involved. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. The patient's concurrent conditions, pertinent medical history and concomitant medication were not reported. On an unknown date, the patient was vaccinated with an improperly stored dose of GARDASIL 9 lot # M018810, expiry date 28-MAY-2016 (route and site of administration, dose and strength were not reported). The temperature was 0.9 Celsius degrees for 20 hours 47 minutes. Previous temperature excursion was no performed. Data logger was involved. Additional information has been requested.
Age: 21.0
Sex: F
Vaccine: HPV9
Symptoms: Flushing, Nausea
Clinical narrative: This spontaneous report received from a nurse referred to a 21-year old female patient. The patient's current conditions included seasonal allergies, attention deficit disorder, depression, anxiety and asthma, allergies with latex and nickel. Concomitant medications included amphetamine aspartate, amphetamine sulfate, dextroamphetamine saccharate, ADDERALL, alprazolam, DULERA, LEXAPRO, SINGULAIR, ethinyl estradiol, SPRINTEC, ZYRTEC, XOPENEX, vitamin B12 and vitamin C. On 09-NOV-2016, the patient was vaccinated with GARDASIL 9 intramuscular injection as a HPV vaccination (lot number: M017983, expiry date: 30-MAY-2018). The nurse reported that about an hour of so after administration, the patient experienced nausea that lasted until the end of the day (09-NOV-2016), flushing of the chest and face that lasted until the next morning (10-NOV-2016). The patient did not take any treatment for the events. Outcome of both the events was resolved. Causality assessment was not reported. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant refers to an unknown number of patients of unknown age. The medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patients were vaccinated with ROTATEQ lot # M007124, 05-OCT-2017, temperature 49.6F for 108 hours 4mins. It was administered and there was no previous temperature excursion. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: HPVX
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not known. One year ago, in approximately 2015, the patient was vaccinated with the first dose of either GARDASIL or GARDASIL 9. The patient would now like to receive a second dose of GARDASIL or GARDASIL 9 now, on 23-NOV-2016 (inappropriate schedule of drug administration). No adverse symptoms were reported. Additional information has been requested.
Sex: M
Vaccine: HPV9
Symptoms: Lymphadenopathy
Clinical narrative: This spontaneous report was received from a consumer (patient's mother) and refers to a 16 year old male patient. Information on medical history and concurrent conditions were not reported. On an unknown date, the patient was vaccinated with GARDASIL 9 intramuscularly. On an unknown date, the patient developed swollen lymph node near his collar bone. The physician was contacted for treatment, however he did not believe that the event was a side effect of the vaccine. No treatment was given for the event. The outcome of the event was reported as not recovered/not resolved. The reporter did not assess the causality of the event with GARDASIL 9. Additional information is not expected as no physician or reporter contact details were provided.
Sex: F
Vaccine: PPV
Symptoms: Nasopharyngitis
Clinical narrative: This spontaneous report was received from a dietitian, a female consumer of unknown age referring on herself. The patient's medical history, concurrent conditions and drug reactions/allergies were not reported. On an unknown date, the patient was vaccinated with a dose of PNEUMOVAX 23 (Lot #, expiration date, strength, dose, frequency and route of administration were not reported). Additionally, it was stated by the patient that "about a week" on an unspecified date after receiving the dose of PNEUMOVAX 23, she developed a "terrible cold" (nasopharyngitis). Concomitant therapies were not reported. No Product Quality Complaint (PQC) was involved. At the time of the report, the outcome of nasopharyngitis was reported as not recovered. The causality between the event and therapy with PNEUMOVAX 23 was not reported. Additional information is not expected since the reporter did not provide any contact information.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to multiple unspecified patients of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On unknown dates, reported as multiple unspecified dates, the patients were vaccinated with improperly stored doses of PNEUMOVAX 23 (strength, dose, anatomical location, lot# and expiration date were not reported). Administered doses of PNEUMOVAX 23 experienced temperature excursion of 0.4 degrees Celsius for 89 hours and 5 minutes, on an unknown date. Temperature was logged with a data logger, and there were no previous temperature excursions. No adverse effects were reported. 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 was received from a pharmacy student referring to an unspecified number of patients, of unknown age and gender. Medical history, concurrent condition and concomitant therapy were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of ROTATEQ orally, lot # M004890 (expiration date 10-NOV-2017), (dose and frequency were not reported). The vaccine was exposed to temperature of -2.1 C, during 4 hours, 6 cycles. The call was because of data logger. No previous temperature excursions and no adverse effects were reported. There was no Product Quality Complaint (PQC). This is one of several reports received from the same reporter. Additional information is not expected as there was no consent to contact the physician.
Sex: F
Vaccine: PPV
Symptoms: Erythema, Injection site pain, Peripheral swelling
Clinical narrative: This solicited report was received from a pharmacist concerning five unspecified female patients of unknown age enrolled in a market research program. The patients' concurrent condition, medical history and concomitant therapy were not provided. On an unknown date in 2015 (reported as last year), the patients were vaccinated with unspecified doses of PNEUMOVAX 23 intramuscularly (dosage schedule, anatomical location, lot number and expiration date were not reported). Other suspect and concomitant medications were not provided. After received the PNEUMOVAX 23 vaccine, the patients experienced injection site pain and a red swelling arm. The outcome of the injection site pain, injection site swelling and injection site erythema was reported as recovered with sequelae on an unspecified date. The reporter considered the events to be related to PNEUMOVAX 23 and considered the events to be medically significant. Additional information has been requested. This case was created in order to correct the aware date of 1611USA010878 which was entered incorrectly as 22-NOV-2016 instead of 21-NOV-2016.
Sex: U
Vaccine: HPV4, RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions and drug reactions/allergies were not reported. On an unknown date, the patient was vaccinated with a dose of GARDASIL Lot # M011117, expiration date: 12-JUL-2017 (strength, dose, frequency and route of administration were not reported), or with a dose of ROTATEQ orally, Lot # L033549, expiration date: 05-JUN-2017 (strength, dose and frequency were not reported), which underwent a temperature excursion of 35 Fahrenheit degrees, for 20 minutes and was administered to the patient. No adverse effects were reported by the patient. Additional information is not expected, because no consent for follow-up was provided or physician's contact details.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to unspecified number of patients of unknown age and gender. The patients' medical history, current conditions and concomitant medications were not reported. On 16-NOV-2016 the patients were vaccinated with improperly stored dose of RECOMBIVAX HB (lot# L020157 and expiry date: 12-MAR-2018, lot# M010671 and expiry date: 02-JUN-2018, lot# M029233 and expiry date: 09-AUG-2018, lot# M010212 and expiry date: 21-JAN-2019). The vaccine was exposed to a temperature of 53 Fahrenheit for 1 hour and 45 minutes. There were no previous temperature excursions. The call was because of a data logger. No adverse events were reported. There was no product quality complaint involved. This is one of the several reports 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 nurse refers to unspecified number of patients of unknown age and gender. The patients' medical history, current conditions and concomitant medications were not reported. ON 16-NOV-016 the patients were vaccinated with improperly stored dose of ROTATEQ (lot # L028645 and expiry date: 25-MAY-2017, lot # M031802 and expiry date: 09-NOV-2017, lot# M007301 and 19-NOV-201, lot # M004885 and expiry date: 23-OCT-2017). The vaccine was exposed to a temperature of 53 Fahrenheit for 1 hour and 45 minutes. There were no previous temperature excursions. The call was because of a data logger. No adverse events were reported. There was no product quality complaint involved. This is one of the several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse and refers to unspecified number of patients with unknown demographics. Information about the patients' pertinent medical history, drug reactions allergies and concomitant medications was not reported. On an unknown date, the patients were vaccinated with improperly stored doses of (Oka/Merck) VARIVAX, lot # L006385 with expiration date 25-FEB-2017, (dose number and route of administration were not provided). No adverse effects were reported. On 26-JUL-2016, the vaccines experienced a initial temperature excursion of 16.2 F for 12 hours. The aforementioned one was identified due to a data logger. No doses were given following the recent excursion reported on 14-NOV-2016. Furthermore, no product quality complaint was involved. Additional information has been requested.
Age: 19.0
Sex: M
Vaccine: FLU4, VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a nurse concerning a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 25-NOV-2016, the patient was vaccinated with an expired dose of VARIVAX, lot # reported as K018944, expiration date: 15-OCT-2016, (dose number, route and anatomical location of administration were unknown). No adverse effect was reported. Additional information has been requested.
Age: 1.25
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to unspecified number of patients of unknown age and gender. The patients' medical history, current conditions and concomitant medications were not reported. On 16-NOV-2016 the patients were vaccinated with improperly stored doses of M-M-R II (lot # L032044, expiry date: 24-AUG-2017; lot # L032181, expiry date: 25-AUG-2017; lot # L043703, expiry date: 03-NOV-2017; lot # M008588, expiry date: 16-FEB-2018; lot # M016234, expiry date: 31-MAR-2018). The vaccine was exposed to a temperature of 53 Fahrenheit for 1 hour and 45 minutes. There were no previous temperature excursions. The call was because of a data logger. No adverse events were reported. There was no product quality complaint involved. This is one of the several reports from the same reporter. Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Erythema, Myalgia, Pain, Swelling
Clinical narrative: This spontaneous report was received from a pharmacist regarding a female patient of unknown age. There was no information about concurrent condition, historical medication and concomitant medication. On an unknown date the patient was vaccinated with PNEUMOVAX 23. On an unknown date the patient experienced swelling and pain, not at the injection site. The redness and swelling was not associated with the injection site, but it seems to be painful, not just on the skin, but a muscle-type pain that goes down to bicep muscle (as reported same type of adverse experience). The outcome of the event swelling, redness, muscle-type pain and pain was unknown. Causality was unknown. This is one of several reports received from the same reporter. Additional information is not expected as reporter does not want to get contacted.
Sex: U
Vaccine: HEP, HEPA, HPV9, RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received on 01-NOV-2016 from an immunization official/coordinator who reported that improperly stored doses of ROTATEQ (lot# K022992, expiration date 30-JUN-2016), VAQTA (lot# L007559, expiration date 01-JUN-2017), GARDASIL 9 (lot# K005881, expiration date 14-JAN-2017) and RECOMBIVAX HB (lot# J013394, expiration date 25-AUG-2016) were administered to unspecified patients on an unspecified date. Temperature was 31.8 Fahrenheit for a time frame of 170 minutes. There was no previous temperature excursion. Call was because of a data logger. No adverse effects reported. No further information provided. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist referring to an unspecified patient of unknown age and gender. The patient's medical history, concurrent conditions and drug reactions/allergies were not reported. On 07-NOV-2016, the patient was inadvertently administered an expired dose of ZOSTAVAX lot # L029485, expiration date: 06-NOV-2016 (strength, dose, frequency and route were not reported. Concomitant therapies were not reported. No adverse effect were reported and no Product Quality Complaint was involved. Additional information has been requested.
Age: 1.0
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to a 12 month old patient of unknown gender. The patient's medical history, concurrent condition and concomitant medication were unknown. On 26-OCT-2016, the patient was vaccinated with a dose of VARIVAX (dose unknown, lot # M015731, expiration date: 30-MAR-2018, subcutaneously) in the right leg and PROQUAD (dose and route unknown, lot# M031566, expiration date: 24-DEC-2017) in left leg (overdose). The patient had not experienced an adverse effect. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 10-NOV-2016, the patient was vaccinated with an expired dose of PNEUMOVAX 23 injection (lot # L008664 with an expiration date of 03-NOV-2016; exact dose was not reported), intramuscularly. No adverse effects were reported. There was no product quality complaint involved. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to unspecified number of patients of unknown age and gender. The patients' medical history, current conditions and concomitant medications were not reported. On 16-NOV-2016 the patients were vaccinated with improperly stored dose of VAQTA (lot # M017982, expiry date: 13-SEP-2017; lot # M030598, expiry date: 13-OCT-2017; lot # M003011, expiry date: 15-NOV-2017; lot # M036459, expiry date: 18-JAN-2018; lot # M012261, expiry date 01-FEB-2018). The vaccine was exposed to a temperature of 53 Fahrenheit for 1 hour and 45 minutes. There were no previous temperature excursions. The call was because of a data logger. No adverse events were reported. There was no product quality complaint involved. This is one of the several reports from the same reporter. Additional information has been requested.
Age: 81.0
Sex: M
Vaccine: PNC13
Symptoms: Erythema, Pain in extremity, Pruritus, Pyrexia, Rash
Clinical narrative: Vaccine was charted as given in right arm. From 8/1/16 nursing note: pt was here on 07/29 and was given an injection and had a reaction. Redness, itching and had a fever like hot pain on the left arm. When he got home, a few hours later - felt that he was shaking and went to bed. Asked pt if wife called advise nurse at that time, he refused. He also refused at the time to go to ER - because he was too tired to go. He has some slight redness - refused to wait to be seen by RN as walk in and refused to call TCP. He still has some redness and rash to the left arm as he came in today. Asked pt if he would like to be seen by RN as walk in - STILL REFUSED. Symptoms: Fever and Urticaria Pruritus.
Age: 81.0
Sex: M
Vaccine: PNC13
Symptoms: Tremor, Urticaria, Vaccination complication
Clinical narrative: Vaccine was charted as given in right arm. From 8/1/16 nursing note: pt was here on 07/29 and was given an injection and had a reaction. Redness, itching and had a fever like hot pain on the left arm. When he got home, a few hours later - felt that he was shaking and went to bed. Asked pt if wife called advise nurse at that time, he refused. He also refused at the time to go to ER - because he was too tired to go. He has some slight redness - refused to wait to be seen by RN as walk in and refused to call TCP. He still has some redness and rash to the left arm as he came in today. Asked pt if he would like to be seen by RN as walk in - STILL REFUSED. Symptoms: Fever and Urticaria Pruritus.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a physician refers to an unknown number patients of unknown age. The medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patients were vaccinated with VAQTA lot # M011839 13-SEP-2107, M017982 13-SEP-2017, M002268, 20-SEP-2017, M015290 20-SEP-2017, M022924 24-SEP-2018, L018499 25-FEB-2017, L036300 04-NOV-2016. No adverse effects were not reported. Temperature excursion 28.0F for 222.75 hours. Additional information has been requested.
Age: 4.0
Sex: F
Vaccine: PNC13
Symptoms: Extra dose administered
Clinical narrative: Pt. given 2 extra PCV 13. Only needed 1 dose because of delayed start.
Age: 17.0
Sex: U
Vaccine: HPV9
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 17 year old patient of unknown gender. The patient's concurrent conditions, medical history and concomitant medications were not known. On 19-MAY-2014, the patient was vaccinated with the first dose of GARDASIL 9 (lot number J009788 (invalid lot number), expiry 17-MAR-2016), intramuscularly. On 28-JUL-2014, the patient was vaccinated with the second dose (lot number K001500 (invalid lot number), expiry 06-NOV-2016). On 02-DEC-2014, patient was vaccinated with the third dose (lot number K009482 (invalid lot number), expiry 06-MAR-2017) and on 22-NOV-2016, patient was vaccinated with the fourth dose (lot number M023169, expiry 13-JUN-2018). The patient had not experienced an adverse effect. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a physician refers to an unknown number of patients of unknown age. The medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patients were vaccinated with RECOMBIVAX HB lot # L025738, 14-AUG-2017, M008551 02-SEP-2018, M023718 09-AUG-2018. No adverse effects were reported. Temperature excursion 29.4F for 132.75 hours, 31.5 F for 40.25 hours, 46.3 F for 15 mins, 29.6 F for 58.5 hours. There was no previous temperature excursion. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not known. On 23-SEP-2016 the patient was vaccinated with the yellow fever virus vaccine and then on 11-OCT-2016, patient was with M-M-R II. No adverse effect was reported. The outcome of inappropriate schedule of drug administration was unknown. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: Information has been received from a licensed practical nurse referring to a patient of unknown age and gender. The patient's concomitant medication, medical history and drug reactions/allergies were not reported. On 21-NOV-2016, the patient received an expired dose of PNEUMOVAX 23 (prefilled syringe, lot # K022886 with expiration date 09-JUN-2016; dose unknown) intramuscularly. No adverse effects were reported. Additional information has been requested.
Age: 11.0
Sex: M
Vaccine: HPV4
Symptoms: Headache, Nausea, Pyrexia, Vomiting
Clinical narrative: This spontaneous report was received from a patient's mother and refers to an 11 year old male patient. The patient's concurrent conditions included attention deficit/hyperactivity disorder (ADHD). He did not have any drug reactions or allergies. On 16-NOV-2016, the patient was intramuscularly vaccinated with a dose of GARDASIL injection (site of administration, dose, lot number and expiration date were not reported). Concomitant therapies included unspecified medication for ADHD. On 16-NOV-2016 (also reported as 16-NOV-2017), within a half an hour after receiving the vaccine, the patient developed headache. On 17-NOV-2016, he developed vomiting overnight and nausea. The patient was also having a fever of 100.5 (units not reported) (onset date approximately in November 2016). The patient did not seek medical attention (the reporter stated that she did not contact the responsible physician for treatment). Apart from body temperature, no other lab diagnostic studies were performed. No treatment was given for the events. The outcome of headache, vomiting, nausea and fever was reported as not recovered. The relatedness between these events and the vaccination with GARDASIL was not reported. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: Information has been received from a nurse practitioner referring to a patient of unknown age and gender. The patient's concomitant medication, medical history and drug reactions/allergies were not reported. On 19-NOV-2016, the patient was vaccinated with a dose of PNEUMOVAX 23 (lot # unknown, expiration date 18-NOV-2016, once) intramuscularly (expired product administered. No side effects were reported. Additional information has been requested.
Age: 68.0
Sex: M
Vaccine: PPV
Symptoms: Injection site haemorrhage
Clinical narrative: Information has been received from a pharmacist concerning a male patient of unknown age. The patient had no concomitant medications, pertinent medical history or drug reactions/allergies. On 09-NOV-2016, the patient was vaccinated with one dose of PNEUMOVAX 23 (lot # M026317, expiration date 11-JAN-2018) intramuscularly. "After withdrawing needle, some blood ran down the arm about 4-5 inches. It did not look like vaccine was mixed in the blood". No treatment was given for the event. No lab diagnostics studies were performed. At the time of the reporting, the outcome of the event was unknown. 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 assistant concerning unspecified patients. The patients' concomitant medications, pertinent medical history, and concurrent conditions were not provided. On 10-NOV-2016, 3 doses of improperly stored (Oka/Merck) VARIVAX (dose and frequency unknown) (lot # M014309, expiration date 21-MAR-2018, subcutaneous) were inadvertently administered to the patients. The (Oka/Merck) VARIVAX was exposed to temperature excursion of 8.6 Fahrenheit degree (F) for a time frame of 5 hours. Data logger was involved but there was no previous temperature excursion. No adverse effects were reported. This is one of several reports from the same reporter. Additional information is not expected as the reporter did not wish to further contact.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant concerning unspecified patients. The patients' concomitant medications, pertinent medical history and concurrent conditions were not provided. On 10-NOV-2016, 3 doses of improperly stored M-M-R II (dose and frequency unknown) (lot # L040960, expiration date 16-OCT-2017, subcutaneous) were inadvertently administered to the patients. The M-M-R II was exposed to temperature excursion of 8.6 Fahrenheit degree (F) for 5 hours. Data logger was involved but there was no previous temperature excursion. No adverse effects were reported. This is one of several reports 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 was received from a medical assistant refers to an unknown number of patients of unknown age. The medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patients were vaccinated with GARDASIL 9 lot # L019297, 18-AUG-2017, L043214 30-AUG-2017, M003659 20-SEP-2017, M005717 03-OCT-2017. No adverse effects were reported. Temperature excursion 9 C for 9 hours, 0.3 C for 837 hours and 30 F for 542 hours. There were no prior excursions. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a physician via a company representative refers to a patient of an unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patient was vaccinated with an extra dose of GARDASIL 9 (dose, lot#, expiration and route of administration were not reported). The patient did not experience an adverse event. Product quality complaint (PQC) was not involved. Additional information is not expected as no contact details were provided.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a physician refers to an unknown number of patients of unknown age. On an unknown date, the patients were vaccinated with GARDASIL lot # M014929 27-MAY-2017, K010215, 05-MAY-2017, L040459 06-JUN-2017. Temperature excursion 46.6F for 30 minutes, 46.6F for 15mins, 46.3F for 15mins, 28.9F for 150 hours. No adverse effects were reported. Additional information has been requested.
Age: 4.0
Sex: U
Vaccine: MMR, VARCEL
Symptoms: Extra dose administered
Clinical narrative: This spontaneous report received from a nurse practitioner refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies and medical history provided. On unknown date (reported as the patient was 1 year old), the patient was vaccinated with the first dose of M-M-R II injection (dose, route of administration, lot # and expiry date were not reported) and with the first dose of VARIVAX injection (dose, route of administration, lot # and expiry date were not reported). On unknown date (reported as the patient was 2 years old), the patient was vaccinated with the second dose of M-M-R II injection (dose, route of administration, lot # and expiry date were not reported) and with the second dose of VARIVAX injection (dose, route of administration, lot # and expiry date were not reported). On 08-NOV-2016 (reported also as the patient was 4 years old), the patient was vaccinated with the third dose of M-M-R II injection (dose, route of administration, lot # and expiry date were not reported) and with the third dose of VARIVAX injection (dose, route of administration, lot # and expiry date were not reported). Additional information is not expected because there was no consent to contact the reporter.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to multiple unspecified patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical history provided. On unknown dates, reported as multiple unspecified dates, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB (strength, dose, anatomical location, lot# and expiration date were not reported). Administered doses of RECOMBIVAX HB experienced temperature excursion of 0.4 degrees Celsius for 89 hours and 5 minutes on an unknown date. Temperature was logged with a data logger, and there were no previous temperature excursions. 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 registered nurse and refers to multiple unspecified patients of unknown age and gender. There was no information about the patients' concurrent conditions concomitant therapies or medical history provided. On unknown dates, reported as multiple unspecified dates, the patients were vaccinated with improperly stored doses of VAQTA (strength, dose, anatomical location, lot# and expiration date were not reported). Administered doses of VAQTA experienced temperature excursion of 0.4 degrees Celsius for 89 hours and 5 minutes, on an unknown date. Temperature was logged with a data logger, and there were no previous temperature excursions. No adverse effects were reported. This is one of several reports received 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 was received from a registered nurse and refers to multiple unspecified patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical history provided. On unknown dates, reported as multiple unspecified dates, the patients were vaccinated with improperly stored doses of GARDASIL 9 (strength, dose, anatomical location, lot# and expiration date were not reported). Administrated doses of GARDASIL 9 experienced temperature excursion of 0.4 degrees Celsius for 89 hours and 5 minutes, on an unknown date. Temperature was logged with a data logger, and there were no previous temperature excursions. No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse via a company representative and refers to multiple (about seven), unspecified adult patients of unknown age and gender. The patients' medical history, concomitant medications and concurrent conditions were not reported. On unknown dates, about seven adult patients were vaccinated with pediatric doses of RECOMBIVAX HB injection (dose, route of administration, lot# and expiration date were not reported) instead of the adult doses of the vaccines. The medical practice bought pediatric RECOMBIVAX HB accidentally. It could not have been confirmed which dose in the series of RECOMBIVAX HB any of the patients received. No adverse effects were reported. Additional information has been requested.
Sex: F
Vaccine: HPV9
Symptoms: Feeling abnormal
Clinical narrative: This solicited report was received from a patient's mother regarding her 13-year-old daughter who was enrolled in a market research. On an unknown date the patient was vaccinated with GARDASIL 9 (lot number, expiration date, dose, route of administration and anatomical location were not reported). On response to the question "For which of the following reasons has your child not received an additional dose of the HPV vaccine?", the mother selected the option 'Other' and described that as, on an unknown date, she thought the vaccine was making her daughter her feel funny when she got it (feeling abnormal). The outcome of feeling abnormal was unknown. The reporter considered the event to be related to GARDASIL 9. Additional information is expected.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from an allied health worker referring to multiple unspecified patients of unknown age and gender. Information regarding concomitant medications, pertinent medical histories and drug reactions/allergies was not reported. On unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL 9 (lot # L036301 with expiration date 20-DEC-2017, and lot# L037554 with expiration date 25-DEC-2017; dose and route were not reported). There were no prior excursions. Temperature/Time Frame as follow: 29.5 Fahrenheit (F) for 1 hour, 23 minutes; 32 F for 3 hours, 47 minutes; 33.6 F for 2 hours, 47 minutes; 33.6 F for 1 hour, 2 minutes 32.1 F for 1 hour, 2 minutes; 32.1 F for 5 hours, 44 minutes; 33.8 F for 1 hours, 46 minutes. No adverse effects were reported. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Cough, Dysphonia, Enuresis, Nightmare
Clinical narrative: This spontaneous report was received from a pharmacist regarding an approximately 17 years old non-pregnant female patient. It was reported that patient was very healthy and had none drug allergies or reactions. On 19-JUL-2016, the patient was vaccinated with GARDASIL. Patient was on none concomitant medication. The following week on an unknown date in 2016 the patient developed a cough and a hoarse voice and then she had really bad dreams in which she was sitting on the toilet, and she would wet the bed. No treatment was given for the adverse event and she did not seek any medical attention. No laboratory diagnostic tests were performed. The pharmacist reports that these symptoms went away within 7 to 10 days of the onset of these symptoms and the outcome of the events were reported as resolved. Causality was unknown. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified patient. Patient's pertinent medical history, concurrent condition, drug reactions/allergies and concomitant medication were not reported. On 15-MAY-2016, the patient was vaccinated with GARDASIL 9 (lot # and expiry date unspecified) dose 1 (dosage regimen, frequency and route of administration was not reported). Subsequently, on 15-AUG-2016, the patient was vaccinated with GARDASIL 9 dose 2 (inappropriate schedule of drug administration). No adverse effects were reported. No product quality complaint (PQC) was involved. No further information was provided. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site rash, Injection site warmth
Clinical narrative: This spontaneous report was received from a female patient of an unknown age, who was reporting on herself. No information regarding the patient's medical history or concurrent conditions was provided. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX injection (dose, route of administration, lot # and expiration date were not reported). There were no concomitant therapies reported. On an unknown date, the patient got experienced a spot at the site where she got the vaccine, which also felt warm. The outcome of the events was not reported. The relatedness between the events and ZOSTAVAX was not reported. Additional information is not expected as there was no consent to contact the patient's physician.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Pain in extremity, Peripheral swelling
Clinical narrative: Left arm swelling and pain. Went to ER and received steroids.
Age: 1.75
Sex: M
Vaccine: DTAPIPVHIB, HEPA, MMRV, PNC13
Symptoms: Lip swelling, Swelling face
Clinical narrative: Patient received vaccines around 10:00 am and called around 11am stating his face and lips were swollen. Dr advised to give BENADRYL and come in, mom had no BENADRYL so she came in to office.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Rash erythematous
Clinical narrative: Baby had red rash spots on legs.
Age: 86.0
Sex: F
Vaccine: FLU4
Symptoms: Arthralgia, Blood test, Insomnia, Limb mass, Myalgia
Clinical narrative: Large sore lump-upper (L) arm (lasted 2 wks) after flu vac. Severe and worsening joint and muscle pain in both shoulders/upper arms, also hips to knees (both) unable to sleep thru night, ALEVE gave some temp. relief. Saw PAC on 11/16/16. She ordered blood tests twice and prescribed 15mg/day prednisone.
Age: 86.0
Sex: F
Vaccine: FLU4
Symptoms: Pain in extremity
Clinical narrative: Large sore lump-upper (L) arm (lasted 2 wks) after flu vac. Severe and worsening joint and muscle pain in both shoulders/upper arms, also hips to knees (both) unable to sleep thru night, ALEVE gave some temp. relief. Saw PAC on 11/16/16. She ordered blood tests twice and prescribed 15mg/day prednisone.
Sex: F
Vaccine: HPV9
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: This solicited report was received from an "MR" moderator concerning a 43 year old female patient enrolled in a market research. The patient's medical history, concurrent conditions and concomitant medications were not reported. On an unspecified date, the patient was vaccinated with GARDASIL 9 (dose, strength, frequency and lot number were not reported). On an unspecified date, the patient experienced an adverse event reported as a "negative published articles" that the reporter received in her social media account. At the reporting time, the outcome of the adverse event was unknown. The reporter stated that therapy was discontinued for reasons other than the adverse event. The reporter did not assess the causal relationship between the adverse event and vaccination with GARDASIL 9. Additional information has been requested.
Age: 66.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site pain
Clinical narrative: Severe right shoulder pain with any abduction of the right arm. Treated with IM TORADOL and has started.
Sex: U
Vaccine: HEP
Symptoms: Extra dose administered, Hepatitis B antibody negative
Clinical narrative: This spontaneous report was received from a physician refers to a patient of unknown age and gender. Information about the patient's medical history, concurrent conditions and concomitant medication was not reported. On an unknown date, the patient was vaccinated with 6 doses of RECOMBIVAX HB (route of administration, lot # and expiration date were not provided). On an unknown date, the patient experienced hepatitis B antibody negative. The patient had tiers drawn on unspecified dates and it was found to had not seroconverted. The outcome of hepatitis B antibody negative was unknown. This is one of the several reports received from the same reporter. Additional information has been requested.
Age: 13.0
Sex: M
Vaccine: MENB
Symptoms: Injection site erythema, Injection site oedema, Injection site warmth
Clinical narrative: Edema, area warm to touch, pink discoloration to site of injection.
Age: 64.0
Sex: F
Vaccine: PPV
Symptoms: Blister, Pain, Pruritus, Rash erythematous, Skin warm
Clinical narrative: 3 hours post: itch/warm/sore. White ring w/red rash. Sunday AM (next morning) Hot to touch red very swollen blisters (pin pop) went to ER - given KEFLEX.
Age: 64.0
Sex: F
Vaccine: PPV
Symptoms: Swelling, White blood cell count increased
Clinical narrative: 3 hours post: itch/warm/sore. White ring w/red rash. Sunday AM (next morning) Hot to touch red very swollen blisters (pin pop) went to ER - given KEFLEX.
Age: 90.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site induration, Injection site pruritus, Injection site swelling
Clinical narrative: PREVNAR 13 vaccination given in left deltoid 11/21/2016. (L) arm erythema and itching, induration at site 4 cm and slightly raised. Erythema involved entire upper arm. No systemic reaction-no fever/chills/hives/difficulty breathing.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Back pain, Musculoskeletal pain, Neck pain, Swelling
Clinical narrative: Came week after shot had low back pain with a little swelling, then neck, shoulders, and elbows, thinks it might be polymyalgia rheumatica. Taking ALEVE and using hot packs but getting worse.
Age: 0.5
Sex: F
Vaccine: DTAPIPVHIB, HIBV, PNC13, RV5
Symptoms: Extra dose administered
Clinical narrative: Nurse administered 2 HIB vaccines in error.
Age: 76.0
Sex: M
Vaccine: TDAP
Symptoms: Arthralgia
Clinical narrative: Pain in both knees (right knee more so). L, began about 2 hours after shot and continues. No pain in any other joints.
Age: 19.0
Sex: M
Vaccine: ANTH, HEPAB, JEV1, SMALL, ANTH, HEPAB, JEV1
Symptoms: Activated partial thromboplastin time normal, Anion gap normal, Back pain, Band neutrophil count increased, Band neutrophil percentage increased
Clinical narrative: The following information was downloaded from VAERS webpage on 21 Nov 2016 (available as of 16 Nov 2016). A 19 year old healthy male received a dose of IXIARO (batch number JEV15D92E) on 04 Aug 2016. Co-suspect vaccination included TWINRIX I.M., and BIOTHRAX I.M.  on the same day; as well as ACAM2000 I.D. into the  left arm on 05 Aug 2016. He had received a new tattoo on his left upper arm on 04-AUG 2016.  On 11 Aug 2016 the vaccinee felt ill; on 12 Aug 2016 he woke up with a rash over his new tattoo site. He developed fever, chills, nausea, headache with photophobia (severity described as 3/10; intermittent throbbing pain across forehead; 'mostly associated with fever'), lower back pain (dull pain in the middle of his lower back), and neck / neck flexion pain (associated with fever). On 12 Aug 2016 he was hospitalised for vaccinia spread into recent tattoo, for four days. For treatment he received IV fluids, TYLENOL and Ibuprofen, and improved significantly within 24 hours of admission  -  with ongoing lesions within tattoo and additional lesions on abdomen and chest. Haematology  [most likely of 12 Aug 2016] was without significantly abnormal values, including  blood culture and staph test, except for mean platelet volume 10.6 fL (increased), neutrophils 84.8%  (8.83 x 1000/microL, increased), lymphocytes 8.0 % (0.8 x 1000/microL, decreased), chloride 95 mmol/L (decreased), and phosphate 2.1 mg/dL (decreased). [Please note that additional lab values were considered abnormal as per VAERS, however, not so as per reporter.] During hospitalisation,  existing lesions erupted, drained and crusted. He had not recovered by time of report to VAERS.