chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: HPV4
Symptoms: Arthralgia, Immediate post-injection reaction
Clinical narrative: This spontaneous report was received from a nurse via company representative and refers to a patients of unknown age and gender. On an unknown dates, the patients was vaccinated with doses of GARDASIL (dose, frequency, route of administration were not reported). On an unknown date the unspecified number of patients experienced unspecified joint pain immediately after receiving the vaccine. It was also reported that there were some cases where it took an unspecified number of months for the joint pain to be under control. The outcome of the event was unknown. Causality assessment was not reported. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report was received from a healthcare worker, who reported that M-M-R II (lot number and expiry date were not reported) appeared on the product list as temperature stability questions were asked. However, no doses of improperly stored M-M-R II were administered to any patients. Temperature excursion was not reported. It was unknown, if data logger was involved. This is one of several reports from the same reporter. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a female patient of unknown age. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. The nurse reported that a patient received her first dose of GARDASIL on 18-NOV-2014, her second dose of GARDASIL on 02-MAR-2015, and her third dose of GARDASIL on 18-MAY-2015 (dose, site and route of administration, lot# and expiration date were not reported for all), which was outside of the recommendations in prescribing information. There was no adverse effect reported. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Full blood count normal, Injection site erythema, Injection site swelling
Clinical narrative: This spontaneous report has been received from a nurse referring to a 12 years old female patient who was sexually active. The patient had neither medical history nor drug reactions/allergies. On 06-JUN-2016 the patient was vaccinated with the first dose of GARDASIL 9 (0.5 ml, lot # L040164, expiration date 20-FEB-2018) via intramuscular. Concomitant therapies included CLARITIN. On 06-JUN-2016, the patient developed redness the "size of a nickel" at the injection site. On an unknown date in June 2016 (reported as "as the week progressed") after receiving the GARDASIL 9 the patient developed swelling alongside of the redness at the injection site. Currently, the redness and swelling were the "size of a baseball". On 13-JUN-2016, the patient was seen in the physician's office and the treatment was given for the events. On 13-JUN-2016 the complete blood count (CBC) was performed which resulted normal. The outcome of the events were not recovered/not resolved. 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 refers to 4 patients of unknown age and gender. No medical history and concurrent conditions were reported. On an unknown date the patients were vaccinated with a dose of improperly store VARIVAX (lot # L017142, expiry date 13-MAY-2017) (dosing regimen and frequency unknown). No concomitant medications were reported. It was reported that the VARIVAX experienced a temperature of 19.9 degrees Fahrenheit for a 525 hours time frame. It was also reported that there was no previous temperature excursion. It was also reported that the healthcare worker called to report because of a data logger. No adverse effects were reported. No product quality complaint was reported. The action taken with therapy with VARIVAX was unknown. The outcome of the events was unknown. This case is linked to case number 1606USA009455 via same reporter link. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. The patients' concurrent conditions, medical history and concomitant medications were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB lot # L048236, expiry date 31-MAR-2018, lot # L040458, expiry date 04-FEB-2018, lot # L045117, expiry date 06-OCT-2018, lot # L027733, expiry date 13-SEP-2017, (dose, route and site of administration were not reported). No adverse effect was reported. Administered doses of vaccines experienced the temperature excursion of 0.2 degrees Celsius for 48 hours. Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report 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, allergies or concomitant therapies was provided. On 29-FEB-2016, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 (lot # L002310, expiration date 20-JUL-2016, exact dose and route of administration were not reported). The reason of the call was temperature alarm received via Digital Data Logger. It was reported that the vaccine was exposed to temperature of 62 degree Fahrenheit for 165 hours before administration to the patient. No previous temperature excursion was reported. No adverse effects were reported. This is one of the several reports received from the same source. Additional information is not expected as there was no consent for follow-up.
Sex: U
Vaccine: HPV4
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. The patients' concurrent conditions and medical history were not reported. In approximately 2016 (reported as on or after 23-APR-2016), the patients were vaccinated with improperly stored doses of GARDASIL lot # reported as L044475, expiration date reported as 12-MAY-2017, lot # reported as M003659, expiration date reported as 20-SEP-2017 (dose, route and site of administration were not reported). There was no adverse effect reported. Administered doses of vaccine experienced the temperature excursion of 34.8 degrees Fahrenheit for 6 hours 43 minutes and 53.2 degrees Fahrenheit for 8 minutes. Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a nurse via company representative regarding a 13 year old female patient. Information on the concurrent conditions and medical history were not reported. On 15-OCT-2013, 17-DEC-2013 and 22-OCT-2014, the patient was vaccinated with dose 1, 2 and 3 of GARDASIL (lot, expiry date, dose, frequency, route and anatomical location were not specified) 1 dosage form respectively. On 03-JUN-2016, the patient was inadvertently administered a dose of GARDASIL 9 (lot# L043213, expiry date 28-AUG-2017) intramuscularly 1 dosage form. Concomitant medication were not reported. No adverse event was reported. There were no Product Quality Complaint (PQC) involved. 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 and refers to a patient of unknown age and gender. Concurrent conditions and medical history were not provided. On an unknown date, the patient was vaccinated with ROTATEQ, lot # L042216, expiration date: 13-JUN-2017, 1 ml, orally (strength and frequency were not provided). There were no concomitant medications reported. The reporter stated that on an unknown date, the ROTATEQ was improperly stored. It was exposed to a temperature of 30.79 Fahrenheit for 31 minutes, before being administrated to the patient. No adverse event was reported. This is one of two reports from the same reporter. Additional information is not expected as the reporter did not consent for follow-up attempts.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Malaise, Pruritus, Pyrexia
Clinical narrative: This spontaneous report concerning a female patient of an unknown age was received from the patient herself via company representative. Concurrent conditions an medical history were not provided. On unknown date, the patient was vaccinated with zoster vaccine live (manufacturer unknown) (strength, dose, frequency, route, lot and expiration date were not reported). There were no concomitant medications reported. On 01-JUN-2016, the patient experienced herpes zoster, reported as "the shot made her break out on her arm, had fever (result and units were not reported). On 12-JUN-2016, the patient broke out in shingles (herpes zoster) and itching. At the time of the report, the outcome of herpes zoster was no recovered (also reported as "still feels ill now") and the outcome of fever was unknown. The reporter considered herpes zoster and fever to be related to Zoster Vaccine Live (manufacturer unknown). Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant concerning an unspecified number of patients of unknown age and gender. Patients' concomitant medication, pertinent medical history and drug reactions/allergies were not reported. On an unknown dates, the patients were vaccinated with doses of improperly stored PEDVAXHIB (dose and route not reported, lot # L051123 and expiration date 13-OCT-2018). The vaccines were exposed to 46.9F for 1 hour 15 minutes. No previous temperature excursion was reported. No adverse events were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 37.0
Sex: F
Vaccine: HEPA
Symptoms: Erythema, Pruritus
Clinical narrative: Received 2nd Hepatitis vaccine 6/10/16. States Sunday had come erythema and pruritus.
Age: 16.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Urticaria
Clinical narrative: Urticaria.
Age: 75.0
Sex: M
Vaccine: PPV, TDAP
Symptoms: Erythema, Pain in extremity, Peripheral swelling
Clinical narrative: Pain, redness, and swelling of left arm.
Age: 7.0
Sex: M
Vaccine: HEPA, IPV, TDAP
Symptoms: Gait disturbance, Injection site erythema, Injection site swelling, Lethargy, Pain in extremity
Clinical narrative: Severe pain in leg. Swelling and redness at vaccine site on leg. Difficulty walking for several days. Lethargic. Tx: Epsom salt baths,   THUJA homeopathy milk thistle extract, Selenium drops, Chlorella.  5 days later able to walk. Weeks -> months later to date still expresses discomfort in leg and some movement difficulty.
Age: 4.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Injection site erythema, Injection site induration, Injection site pain
Clinical narrative: Redness. Firmness, tenderness around left thigh after KINRIX vaccine.
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. The patients' concurrent conditions and medical history were not reported. In approximately 2016 (reported as on or after 23-APR-2016), the patients were vaccinated with improperly stored doses of ROTATEQ lot # L029618, expiration date reported as 20-MAY-2017, lot # L033545, expiration date reported as 30-MAY-2017 (dose was not reported) oral. There was no adverse effect reported. Administered doses of vaccine experienced the temperature excursion of 34.8 degrees Fahrenheit for 6 hours 43 minutes and 53.2 degrees Fahrenheit for 8 minutes. Data logger was involved. There was no previous excursions reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
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, allergies or concomitant therapies was provided. On 29-FEB-2016, the patient was vaccinated with an improperly stored dose of M-M-R II (lot # K012472, expiration date 11-JUN-2016, exact dose and route of administration were not reported). The reason of the call was temperature alarm received via Digital Data Logger. It was reported that the vaccine was exposed to temperature of 62 degree Fahrenheit for 165 hours before administration to the patient. No previous temperature excursion was reported. No adverse effects were reported. This is one of the several reports received from the same source. Additional information is not expected as there was no consent for follow-up.
Sex: U
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On 09-JUN-2016, the patient was vaccinated with an expired dose of VARIVAX lot # K002919, expiration date 26-FEB-2016 (dose and route of administration were not reported). No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse regarding an unspecified number of patients of unknown demographics. There was no information about concurrent condition and historical medication. On an unknown date the patients were vaccinated with improperly stored PNEUMOVAX 23 Prefilled syringes lot # L019835/expiration date- 23-MAY-2017 (incorrect product storage). No adverse event. Excursion temperature was 31 F and timeframe was 152 days (worst case). There was no prior temperature excursion. Call was because of the data logger. No concomitant medication was reported. The outcome of the event was unknown. No PQC (product quality complaint) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 17.0
Sex: M
Vaccine: MENB
Symptoms: Pain in extremity
Clinical narrative: Very sore L arm, denies bruising or rash at injection site. Treated with OTC ibuprofen.
Age: 66.0
Sex: M
Vaccine: PPV
Symptoms: Pruritus, Pyrexia, Rash generalised, Urticaria
Clinical narrative: Pt had Pneumococcal 23 on 6/9/16 at 2:18 p.m., ran fever during night then developed rash all over his body and itching was sent home but returned again to ER with urticaria.
Age: 50.0
Sex: F
Vaccine: TDAP
Symptoms: Rash, Rash pruritic
Clinical narrative: 6-7 itchy rash on torso, chest, neck; started BENADRYL. 6-9 a little better.
Age: 0.16
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Blood glucose normal, Electrocardiogram normal, Pallor
Clinical narrative: Infant pale following administration of PENTACEL, PREVNAR, RECOMBIVAX, and ROTATEQ. O2 sat, BP, P, R all normal Blood sugar normal. Symptoms gradually resolved over a 30 minute time period.
Age: 18.0
Sex: F
Vaccine: HPV4, MNQ, VARCEL
Symptoms: Erythema, Local swelling, Tenderness
Clinical narrative: Vaccine given 6-10-16, red, swollen area appeared at 9:30 pm 6-10-16. Patient used BENADRYL, TYLENOL or ibuprofen for tenderness, 6-11 -> 6012016. When she woke up 6-13-16, she had developed a larger pink area around the initial red swelling. At clinic today, 6-16-16 - red, area measured 3.27 cm and surrounding pink area measured 5cm wide x 7.5 cm long, will cont. meds as needed.
Age: 23.0
Sex: F
Vaccine: VARZOS
Symptoms: Cellulitis, Injection site erythema, Injection site exfoliation, Peripheral swelling
Clinical narrative: Raised red spot at vac. site. Applied cold compress, swelling to approx. size of a lemon, arm red from shoulder down 48 hours post vac., med. attn. at urgent care, script for steroid and antibiotic, cellulitis suspected. Swelling reduced after 5 days post vac. 14 days post vac. swelling resolved. Some redness persists, skin peeling at inj. site.
Age: 12.0
Sex: M
Vaccine: HPV9
Symptoms: Nausea, Pallor
Clinical narrative: Following administration of GARDASIL 9 vaccine, patient reported nausea and appeared pale. Given 6 oz of orange juice and candy and water. Vital signs monitored. Initially BP 72/39 and pulse 58. Color improved, reported feeling better. VS improved to 100/59, pulse 58 and then 94/56 pulse 76 before going home. Seen by provider before leaving office. Called parent later in day who reported patient felt much better, nausea resolved, eating well.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received form a physician referring to unknown number of patients of unknown age and gender. Information about concurrent condition, medical history and concomitant medication was not provided. On unknown dates the patients were vaccinated with oral ROTATEQ (lot # L035511, expiration date 25-MAY-2017, dose, dose# and route unknown). The vaccines were stored under 34F for 13 hours and the vaccines were back in range without previous excursion. No adverse reactions reported. This is one of two reports received from the same source. Additional information has been requested.
Age: 1.11
Sex: M
Vaccine: HEPA, MMRV
Symptoms: Arthropod bite, Blister, Injection site erythema, Injection site rash, Injection site reaction
Clinical narrative: Received MMRV (Merck Lot L009210) on 5/9/2016 to left thigh and Hep A (SK Lot# X22P4) to right thigh. Mom advised day of vaccination there were 3 dots to his right leg (providers documented as 2 lesions/wheal). These dots were diagnosed as resembling insect bites vs urticaria and was to observe. (Pictures taken). The next day, 5/10/2016, mom advised there were some vesicle like red spots to both vaccine sites that were red but she took to daycare. Daycare called to report that this rash had spread to both legs, abdomen and face. Mom brought child to ER (workplace) where providers diagnosed as urticarial rash. Mom was treating with oral BENADRYL which did reduce the rash significantly prior to exam. The next day 5/11/2016 mom said rash gone but now had splotchy redness to left leg vaccine site (MMRV) that progressed up to his abdomen. This lasted less than 12 hours and resolved. Mom used BENADRYL every 6 hours x 2 days without return of reaction.
Age: 1.11
Sex: M
Vaccine: HEPA, MMRV
Symptoms: Rash erythematous, Rash macular, Urticaria
Clinical narrative: Received MMRV (Merck Lot L009210) on 5/9/2016 to left thigh and Hep A (SK Lot# X22P4) to right thigh. Mom advised day of vaccination there were 3 dots to his right leg (providers documented as 2 lesions/wheal). These dots were diagnosed as resembling insect bites vs urticaria and was to observe. (Pictures taken). The next day, 5/10/2016, mom advised there were some vesicle like red spots to both vaccine sites that were red but she took to daycare. Daycare called to report that this rash had spread to both legs, abdomen and face. Mom brought child to ER (workplace) where providers diagnosed as urticarial rash. Mom was treating with oral BENADRYL which did reduce the rash significantly prior to exam. The next day 5/11/2016 mom said rash gone but now had splotchy redness to left leg vaccine site (MMRV) that progressed up to his abdomen. This lasted less than 12 hours and resolved. Mom used BENADRYL every 6 hours x 2 days without return of reaction.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. The patients' concurrent conditions, medical history and concomitant medications were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of VAQTA lot # L046953, expiry date 14-JAN-2017, lot # 015460, expiry date 20-JUL-2017, lot # 045713, expiry date 14-JAN-2017, lot # L043209, expiry date 17-SEP-2017 (dose, route and site of administration were not reported). No adverse effect was reported. Administered doses of vaccines experienced the temperature excursion of 0.2 degrees Celsius for 48 hours. Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 0.25
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Cellulitis, Injection site mass, Injection site rash, Rash generalised, Urticaria
Clinical narrative: One week ago well check-had PENTACEL in left thigh-knot underneath and raised-was given a prescription for KEFLEX yesterday to treat it with a dx of cellulitis, initially rash was just over the leg-at basically the injection site-but before giving KEFLEX he started breaking out everywhere-every time he has gotten PENTACEL he has gotten a mild reaction-but nothing like this-NOW has hives multiple places-no new foods-no new detergent- have tried BENADRYL-but is has not helped much-rash for a couple of days-worse overnight so came back for a second eval.
Sex: F
Vaccine: HPV9
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: This spontaneous prospective pregnancy report was received from the patient's husband regarding his wife of unknown age. The patient's current conditions, medical history and concomitant medications were not reported. On an unknown date, the patient was vaccinated with GARDASIL 9. The patient's last menstrual period (LMP) was approximately 16-MAY-2016 (reported as almost a half month). The patient's estimated date of delivery (EDD) was 20-FEB-2017. The outcome of the pregnancy was unknown. No further adverse event (AE) information was provided. Product quality complaint (PQC) was not involved. Additional information is not expected, as the contact details were not provided.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from an other health professional referring to multiple unspecified patients of unknown age and gender. There was no pertinent medical history, concurrent conditions, concomitant medication or drug allergies/drug reactions described. On unspecified dates, the patients were vaccinated with improperly stored GARDASIL Lot#L007560 with expiration date of 15-JUN-2017 (or another unspecified Lot #) (dose and route were not reported), which were stored at 30 F for 30 minutes. The previous temperature excursion included 31 F to 35 F for 9.5 hours total cumulatively. No adverse effect was reported. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse regarding an unspecified number of patients of unknown demographics. There was no information about concurrent condition and historical medication. On an unknown date the patients were vaccinated with improperly stored GARDASIL lot # L035105/expiration date 14-MAY-2017. No adverse event. Excursion temperature was 31 F and timeframe was 152 days (worst case). There was no prior temperature excursion. Call was because of the data logger. No concomitant medication was reported. The outcome of the event was unknown. No PQC (product quality complaint) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a Registered Nurse, refers to a patient of unknown age and gender. No pertinent medical history, drug reactions/allergies or concurrent conditions were reported. On an unknown date, the patient was vaccinated with a dose of improperly stored PNEUMOVAX 23 (which had a lot # L040456 and expiration date of 10-MAY-2107; however, dosage number and route of administrations were not reported). Nonetheless, no adverse effects were reported and no product quality complaint was involved. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Polycystic ovaries
Clinical narrative: This spontaneous report was received from a physician via company representative, referring to two female patients who were about "20 plus" years old. Medical history and concurrent conditions of this two patients were not provided. On an unknown date, the patients were vaccinated with GARDASIL (dosage, frequency, route of administration, lot number and expiration date were not reported). No other suspect or concomitants therapies were provided. On an unknown date, both patients developed Polycystic ovarian syndrome. The reported referred that is unknown if both patients sought medical attention. No product quality complaint was involved. At the time of the report, the status of polycystic ovarian syndrome was unknown. The causality between GARDASIL and the adverse event were not provided. Additional information has been requested.
Age: 48.0
Sex: F
Vaccine: VARZOS
Symptoms: Condition aggravated, Herpes zoster
Clinical narrative: This spontaneous report was received from a 48 year old female patient regarding herself. The patient had a prior history of shingles. The patient's concurrent conditions included allergy to DARVOCET and penicillin and migraine headaches. One and a half years ago, in approximately December 2014, the patient was vaccinated with ZOSTAVAX 'one time vaccine' to lessen the spreading of future outbreaks of shingles, on the right arm, via the subcutaneous route. Concomitant therapy included VALTREX. About 4 days after vaccination, in approximately December 2014, the patient had shingles outbreaks on both hips, which currently (in approximately 2016) progressed to 2 circles on the right hip, and 3 on her left hip, about the size of "fifty cent pieces". She also stated after getting the vaccine, her migraines, had gotten worse. Patient sought medical attention and received treatment for the events. Outcome of the shingles that occurred in December 2014 was not known, while outcome of shingles that occurred 'currently' (2016) was considered 'not recovered'. The outcome of migraine was not known. Causality assessment was not provided. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse regarding an unspecified number of patients of unknown demographics. There was no information about concurrent condition and historical medication. On an unknown date the patients were vaccinated with improperly stored MMR II lot # L019989/expiration date 01-JUN-2017, lot # L028273/expiration date- 28-JUL-2017. No adverse event. Excursion temperature was 31 F and timeframe was 152 days (worst case). There was no prior temperature excursion. Call was because of the data logger. No concomitant medication was reported. The outcome of the event was unknown. No PQC (product quality complaint) was involved. 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 regarding an unspecified number of patients of unknown demographics. There was no information about concurrent condition and historical medication. On an unknown date the patients were vaccinated with improperly stored GARDASIL 9 lot # L007560/expiration date- 15-JUN-2017, (incorrect product storage). No adverse event. Excursion temperature was 31 F and timeframe was 152 days (worst case). There was no prior temperature excursion. Call was because of the data logger. No concomitant medication was reported. The outcome of the event was unknown. No PQC (product quality complaint) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. The patients' concurrent conditions, medical history and concomitant medications were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of ROTATEQ, orally, lot# L038536, expiry date 19-AUG-2017, lot # L039297, expiry date 19-JUN-2017, lot # L038534, expiry date 19-AUG-2017, lot # L037921, expiry date 31-MAY-2017 (dose and site of administration were not reported). No adverse effect was reported. Administered doses of vaccines experienced the temperature excursion of 0.2 degrees Celsius for 48 hours. Data logger was involved. There were no previous excursions reported. This is one of several reports received 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 as received from a medical assistant refers to an unspecified number of patients of unknown age and gender. The patients' concurrent conditions and medical history were not reported. In approximately 2016 (reported as on or after 08-APR-2016), the patients were vaccinated with improperly stored does of VARIVAX lot # L044527, expiration date reported as 09-NOV-2017 (dose, route and site of administration were not reported). There was no adverse effect reported. Administered doses of vaccine experienced the temperature excursion for 110 hours. Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a pharmacist via a field representative referring to a patient of unknown age and gender. There was no pertinent medical history, concomitant medication or drug allergies/drug reactions reported. On an unknown date the patient was vaccinated with a dose of ZOSTAVAX (lot #, dose and route unknown). The patient might currently have shingles (start date unspecified). The reporter did not provide the causal relationship of shingle and ZOSTAVAX. Additional information has been requested.
Age: 42.0
Sex: M
Vaccine: HEP
Symptoms: Wrong drug administered
Clinical narrative: The spontaneous report has been received from a nurse referring to a 42 year old male patient with hypertension. The patient had completed a three-dose series of an unspecified hepatitis B vaccine (manufacturer unknown) on an unspecified date many years ago. On 31-MAY-2016 the patient was inadvertently vaccinated with a 40 mcg dose of RECOMBIVAX HB 40 mcg (dialysis formulation) for prevention of hepatitis B instead of an intended dose RECOMBIVAX HB 10 mcg (adult formulation). No product confusion occurred. The nurse stated that the error occurred because her facility only carries ROCOMBIVAX HB 40 mcg and she was unaware that there was another formulation for which the patient was actually indicated. Additional information has been requested.
Sex: F
Vaccine: HEP
Symptoms: Hepatitis B antibody negative
Clinical narrative: This spontaneous report was received from a licensed practical nurse and refers to a female patient of unknown age. Pertinent medical history, concurrent conditions and drug reactions or allergies were unknown. On an unknown date, when the patient was a child (reported as "vaccinated as a child"), she was vaccinated with a dose series of hepatitis b vaccine (manufacturer unknown) (batch/lot number, expiration date, dose and frequency) intramuscularly. Other suspect therapies or concomitant medications were unknown. The reporter stated that on an unknown date the patient had a lab result of a negative titer for Hepatitis B. No adverse effects were reported. The outcome of the above mentioned event and the causality between the event and hepatitis b vaccine (manufacturer unknown) were unknown at the time of the report. It was reported that the patient did not seek medical attention. No product quality complaint was involved. Additional information has been requested.
Age: 0.3
Sex: F
Vaccine: RV5
Symptoms: Oral administration complication, Vomiting
Clinical narrative: This spontaneous report has been received from a licensed practitioner nurse referring to a 4 month old female patient. The patient had no pertinent medical history and no known drug reactions or allergies. On 28-MAY-2016, the patient was vaccinated with ROTATEQ, orally, lot # M002254, expiration date 15-NOV-2017 (dose and frequency were unknown by the reporter). Concomitant therapies included ZANTAC. On the same date of the vaccination the patient vomited "almost the entire dose of ROTATEQ shortly after receiving it" (accidental underdose). The licensed practitioner nurse stated that the patient did not receive treatment for the event and also none lab diagnostics studies were performed. Product quality complaint was not involved. It was reported that the patient sought medical attention and was at the doctor's office at the time of the event. The outcome of vomiting "almost the entire dose of ROTATEQ shortly after receiving it" was reported as recovered on the same date of the vaccination. The relatedness between the event and ROTATEQ was not reported. Additional information has been requested.
Age: 66.0
Sex: M
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a Licensed Practical Nurse (LPN) referring a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On an unknown date, the patient was vaccinated with an expired dose of PNEUMOVAX 23, with lot # K005402, expiration date 07-NOV-2015, (dose, frequency and route of administration were not reported). No other concomitant therapies were reported. A Product Quality Complaint (PQC) was filled because the reporter stated that the administered dose of PNEUMOVAX 23 was from a 10 pack with a different (current) expiration date. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse referring to multiple patients of unknown age and gender. On unknown dates the patients were vaccinated with improperly stored dose of GARDASIL 9 (lot # M005714 with expiration date of 03-OCT-2017; strength, dosage, frequency and route unspecified). No adverse effects were reported. This is one of two reports received from the same reporter.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse referring to multiple patients of unknown age and gender. On unknown dates the patients were vaccinated with improperly stored doses of ROTATEQ (lot # L033693 with expiration date of 31-MAY-2017; strength, dosage, frequency and route unspecified) (incorrect product storage). No adverse effects were reported. This is one of two reports received from the same reporter. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Headache, Mass, Syncope
Clinical narrative: This spontaneous report was received from a physician via field representative refers to a 12 year old female patient. The patient's relevant medical history, concurrent condition and concomitant medication were not reported. On 25-MAY-2016, the patient was vaccinated with first vaccine GARDASIL 9, one shot intramuscularly. On the same day, the patient had syncope. The physician's staff took the patient back to the exam room for observation and after drinking some water and rest she had recovered. None treatment was given for adverse events. Patient had a bump on her head and a headache but the symptoms had subsided. None lab diagnostics studies performed. The outcome of the events was recovered. The reporter did not provide any causality assessment between events and GARDASIL 9. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site inflammation
Clinical narrative: Local inflammatory reaction at deltoid injection site.
Age: 12.0
Sex: M
Vaccine: HEPA, TDAP
Symptoms: Pruritus, Rash, Urticaria
Clinical narrative: Developed hive rash on trunk and extremities itchy -6-15-16. Said he felt itchy on 6-14-16 afternoon after vaccines given but didn't mention to mom til 6-15. Mom gave BENADRYL 50mg at 12:30 p 6-15-16 and again at bedtime 6-15-16. Rash improving with BENADRYL.
Age: 1.07
Sex: F
Vaccine: HIBV, MMRV, PNC13, VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No adverse events or side effects.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Asthenia, Dizziness, Pain, Pain in extremity, Pyrexia
Clinical narrative: Day of vaccine c/o (R) hand pain. Day after vaccine c/o achey, weak, light headed, fever 100-102.
Age: 16.0
Sex: M
Vaccine: HPV9, MENB
Symptoms: Contusion, Fatigue, Headache, Pain in extremity, Peripheral swelling
Clinical narrative: L arm bruised, swollen, very sore. Patient felt fatigue, headache. Advised mom to give IBUPROFEN, use heat/ice PRN at injection site.
Age: 5.0
Sex: F
Vaccine: DTAP
Symptoms: Injection site erythema
Clinical narrative: (R) thigh with erythema- 4 inches or 10cm in diameter. No vesicles, no open skin, no petechia, no joint swelling, no fever.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Crying, Feeling abnormal, Nausea, Rash generalised, Rash pruritic
Clinical narrative: Rash all over body -no blisters- c/o of it itching. Day after vaccine - felt loopy, relaxed, and crying. Next day felt "gross", nauseous and rash onset.
Age: 72.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Blood pressure increased, Dizziness, Head discomfort
Clinical narrative: Dizziness, BP spike, pressure in base of skull (back on neck).
Age: 72.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Dizziness, Electrocardiogram normal, Hypertension, Immediate post-injection reaction
Clinical narrative: Dizziness, BP spike, pressure in base of skull (back on neck).
Age: 19.0
Sex: F
Vaccine: HPV4, MENB
Symptoms: Erythema, Pyrexia, Vaccination site rash
Clinical narrative: Administered vaccine on 6/16/16. Fever on 6/17/16 which resolved with ADVIL and TYLENOL. 6/20/16 rash started on vaccination site (L) deltoid then spread towards her (L) elbow, 2 sites. (1) 8cmx65cm (2)11cmx7cm. Red, not raised, not painful. Treatment with topical BENADRYL.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMRV
Symptoms: Injection site erythema, Vaccination site warmth
Clinical narrative: Redness and warmth at vaccine site noted several hours after injection.
Age: 1.3
Sex: F
Vaccine: HEPA, HIBV
Symptoms: Crying, Cyanosis
Clinical narrative: Turned blue from crying so hard.
Age: 28.0
Sex: M
Vaccine: TDAP
Symptoms: Diarrhoea, Fatigue, Feeling hot, Influenza like illness, Nausea
Clinical narrative: States had flu like symptoms-body aches, tired, nausea, felt warm but did not check temperature. Also has diarrhea. Symptoms lasted approx. 4 days. Did work during this.
Age: 28.0
Sex: M
Vaccine: TDAP
Symptoms: Pain
Clinical narrative: States had flu like symptoms-body aches, tired, nausea, felt warm but did not check temperature. Also has diarrhea. Symptoms lasted approx. 4 days. Did work during this.
Age: 14.0
Sex: U
Vaccine: HPV9
Symptoms: Urticaria, Wheezing
Clinical narrative: Patient received vaccine the morning of 6-13-16 that evening he woke with hives to chest and wheezing. Patient given 25mg BENADRYL and albuterol. Went to ED. Symptoms resolved. Monitored in ED.
Age: 54.0
Sex: F
Vaccine: HEPAB
Symptoms: Blister, Erythema, Rash
Clinical narrative: Patient described red, blistering rash in the arms, waist and legs the following evening after receiving the vaccine.
Sex: M
Vaccine: MNQ
Symptoms: Seizure
Clinical narrative: The patient received a MENVEO vaccination and convulsed for 20-30 seconds.
Age: 55.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: This spontaneous report as received from a pharmacist via company representative, refers to a 55 year old male patient. This patient was reported as smoker and his medical history was not provided. On 24- MAY-2016, the patient was vaccinated with a dose of PNEUMOVAX 23 (lot number M005287 and expiration date on 08-OCT-2017) intramuscular (dose and frequency were not reported). Concomitant therapies included vitamin D. Twelve hours after the injection, the patient called the clinic and complained redness, swelling and soreness at the injection site. Two days post injection, approximately on 26-MAY-2016, the patient sought medical attention by going to an unspecified urgent care facility for office visit and was diagnosed with cellulitis. Consequently, unspecified treatment was given for the adverse event. The pharmacist requested a lot check for PNEUMOVAX 23. The outcome of the injection site cellulitis was reported as recovered on an unspecified date in 2016. The causality between injection site cellulitis and PNEUMOVAX 23 was not provided. This is one of two reports from the same source. Additional information has been requested.
Age: 55.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Cellulitis, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: This spontaneous report as received from a pharmacist via company representative, refers to a 55 year old male patient. This patient was reported as smoker and his medical history was not provided. On 24- MAY-2016, the patient was vaccinated with a dose of PNEUMOVAX 23 (lot number M005287 and expiration date on 08-OCT-2017) intramuscular (dose and frequency were not reported). Concomitant therapies included vitamin D. Twelve hours after the injection, the patient called the clinic and complained redness, swelling and soreness at the injection site. Two days post injection, approximately on 26-MAY-2016, the patient sought medical attention by going to an unspecified urgent care facility for office visit and was diagnosed with cellulitis. Consequently, unspecified treatment was given for the adverse event. The pharmacist requested a lot check for PNEUMOVAX 23. The outcome of the injection site cellulitis was reported as recovered on an unspecified date in 2016. The causality between injection site cellulitis and PNEUMOVAX 23 was not provided. This is one of two reports from the same source. Additional information has been requested.
Age: 15.0
Sex: M
Vaccine: HPV4, HPV9
Symptoms: Chills, Headache, Pyrexia
Clinical narrative: Information has been received from a registered nurse (currently a stay at home mom) concerning her 15 year old son. On unknown dates, the patient was vaccinated with the first and second doses of GARDASIL 9, dose route and frequency unknown. On 15-JUN-2016, the patient received a third dose of GARDASIL 9 of unknown dose, route and frequency. The reporter mentioned that the patient felt fatigued, achy, lightheaded, had a fever of 102.1 Fahrenheit (F) and had a headache later in the day. The patient sought medical attention with physician and received unspecified treatment for the events. The reporter stated that on 16-JUN-2016 (in the morning) the patient's fever was down to 99.6 F and the patient told her that he felt a little bit better. The outcome of the events was reported as recovering. The reporter did not assess the causality of the events with GARDASIL 9. Additional information is not expected as the reporter denied consent for follow up.
Age: 15.0
Sex: M
Vaccine: HPV4, HPV9
Symptoms: Dizziness, Fatigue, Headache, Pain, Pyrexia
Clinical narrative: Information has been received from a registered nurse (currently a stay at home mom) concerning her 15 year old son. On unknown dates, the patient was vaccinated with the first and second doses of GARDASIL 9, dose route and frequency unknown. On 15-JUN-2016, the patient received a third dose of GARDASIL 9 of unknown dose, route and frequency. The reporter mentioned that the patient felt fatigued, achy, lightheaded, had a fever of 102.1 Fahrenheit (F) and had a headache later in the day. The patient sought medical attention with physician and received unspecified treatment for the events. The reporter stated that on 16-JUN-2016 (in the morning) the patient's fever was down to 99.6 F and the patient told her that he felt a little bit better. The outcome of the events was reported as recovering. The reporter did not assess the causality of the events with GARDASIL 9. Additional information is not expected as the reporter denied consent for follow up.
Age: 38.0
Sex: F
Vaccine: TDAP
Symptoms: Pain in extremity
Clinical narrative: PT HAS PAIN IN LEFT ARM (SCALE 7/10).
Age: 25.0
Sex: F
Vaccine: TYP, YF
Symptoms: Hypoaesthesia, Muscular weakness, Pain, Pain in extremity, Paraesthesia
Clinical narrative: Sharp shooting pain down arm; pins and needles on right side of hand/forearm which then became numbness; followed by severe muscle weakness.
Age: 32.0
Sex: F
Vaccine: TDAP
Symptoms: Fatigue, Injection site erythema, Injection site swelling, Injection site warmth, Mobility decreased
Clinical narrative: Redness, swelling, warmth at injection site; soreness of arm; limitation of arm movement; fatigue. The redness and swelling are still present, but this is improving each day.
Age: 32.0
Sex: F
Vaccine: TDAP
Symptoms: Pain in extremity
Clinical narrative: Redness, swelling, warmth at injection site; soreness of arm; limitation of arm movement; fatigue. The redness and swelling are still present, but this is improving each day.
Age: 72.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth, Insomnia
Clinical narrative: Redness, swelling, pain, and warmth to injection site. Difficulty sleeping. Pt instructed to use TYLENOL or MOTRIN and cool compresses.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV, DTAPIPV, MMRV
Symptoms: Dysphagia, Pyrexia, Rash generalised, Skin exfoliation
Clinical narrative: Full body rash, hard to swallow, high fever 104F, peeling skin days later. Went to ER for assistance.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV, DTAPIPV, MMRV
Symptoms: Hypersensitivity, Pyrexia, Throat irritation
Clinical narrative: Full body rash, hard to swallow, high fever 104F, peeling skin days later. Went to ER for assistance.
Age: 48.0
Sex: F
Vaccine: TDAP
Symptoms: Hypoaesthesia, Local swelling, Palpitations, Paraesthesia
Clinical narrative: Individual phoned HD on 6/10/2016 stating on the evening of 06/09/2016 her neck began to swell, the arm she reeived vaccine in was numb, her head was tingling, and she had heart palpetations. PHN suggested she go to ER for eval ASAP.
Age: 29.0
Sex: M
Vaccine: HEP, MMR, VARCEL
Symptoms: Lymphadenopathy, Rash vesicular
Clinical narrative: Swollen Lymph node under left armpit; shingle like rash about 6 inches in diameter between the tricep and bicep on the inner side of the left arm.
Age: 19.0
Sex: M
Vaccine: MENB
Symptoms: Discomfort, Injection site erythema, Injection site mass, Injection site swelling, Injection site warmth
Clinical narrative: SWELLING OF INJECTION SITE APPROXIMATELY 5 INCHES IN LENGTH WITH LARGE HARD LUMP IN THE AREA.  VERY RED AND HOT TO TOUCH; SWELLING RESOLVED FOUR DAYS AFTER VACCINATION; DISCOMFORT CONTINUES I WEEK AFTER INJECTION.
Age: 83.0
Sex: M
Vaccine: PNC13
Symptoms: Balance disorder, Blood test, Chest X-ray, Computerised tomogram abdomen, Computerised tomogram head
Clinical narrative: Fever of 103, bilateral muscle weakness, overall flu-like muscle aches, overall sense of feeling unwell, decreased mental acuity, confusion, decreased balance, electrolyte imbalance, shaking, and loss of appetite.