chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.49
Sex: F
Vaccine: VARCEL, VARCEL
Symptoms: Skin lesion, Varicella virus test positive
Clinical narrative: This spontaneous report as received from a physician refers to a 9 year old female patient with residual pain hypopituitary and sulfa and vancomycin allergies. The patient did not have recent Varicella Zoster Virus (VZV) exposure to chickenpox or shingles. On 27-APR-2006, at 5 months age, the patient was vaccinated with a first dose of VARIVAX (Merck) (route, lot # and expiration date were not provided). Then on 22-JUN-2011, at five years old, the patient was vaccinated with a second dose of VARIVAX (Merck) (also reported as PROQUAD) batch reported as "0141Z". Concomitant therapies included SYNTHROID, CORTEF, somatropin (manufacturer unknown) and DDAVP. On an unknown date in 2011, the patient had a remote history of brain cancer/tumor resected in 2011 and her last chemotherapy was in 2012. On 01-JUL-2015, the patient experienced herpes zoster referred as disseminated shingles, rash type "vesicles and papules", she was also afebrile. The patient presented less than 100 lesions distributed over the trunk, extremities, hands, palms and soles. On 04-JUL-2015, the immunocompromised child was hospitalized and a sample from a vesicle/lesion was collected. Direct Fluorescent Antibody (DFA) was done from lesion on "7.2" that was positive for varicella zoster virus (VZV) dermatome diffuse and discarded. The rash did not occur at the site of injection post-vaccination. It was also stated that the patient did not experience pneumonitis or hepatitis. The patient was intravenously treated with acyclovir (manufacturer unknown). On an unknown date in July 2015, the outcome of herpes zoster was recovered and the brain cancer was considered as recovered in 2012. The physician stated that the child may be discharged from the hospital on 06-JUL-2015 but it was unknown whether she was discharged or not. Upon internal review, the brain cancer/tumor was considered as other important medical event. Additional information has been requested.
Age: 0.49
Sex: F
Vaccine: VARCEL, VARCEL
Symptoms: Brain neoplasm, Herpes zoster, Immunology test abnormal, Pyrexia
Clinical narrative: This spontaneous report as received from a physician refers to a 9 year old female patient with residual pain hypopituitary and sulfa and vancomycin allergies. The patient did not have recent Varicella Zoster Virus (VZV) exposure to chickenpox or shingles. On 27-APR-2006, at 5 months age, the patient was vaccinated with a first dose of VARIVAX (Merck) (route, lot # and expiration date were not provided). Then on 22-JUN-2011, at five years old, the patient was vaccinated with a second dose of VARIVAX (Merck) (also reported as PROQUAD) batch reported as "0141Z". Concomitant therapies included SYNTHROID, CORTEF, somatropin (manufacturer unknown) and DDAVP. On an unknown date in 2011, the patient had a remote history of brain cancer/tumor resected in 2011 and her last chemotherapy was in 2012. On 01-JUL-2015, the patient experienced herpes zoster referred as disseminated shingles, rash type "vesicles and papules", she was also afebrile. The patient presented less than 100 lesions distributed over the trunk, extremities, hands, palms and soles. On 04-JUL-2015, the immunocompromised child was hospitalized and a sample from a vesicle/lesion was collected. Direct Fluorescent Antibody (DFA) was done from lesion on "7.2" that was positive for varicella zoster virus (VZV) dermatome diffuse and discarded. The rash did not occur at the site of injection post-vaccination. It was also stated that the patient did not experience pneumonitis or hepatitis. The patient was intravenously treated with acyclovir (manufacturer unknown). On an unknown date in July 2015, the outcome of herpes zoster was recovered and the brain cancer was considered as recovered in 2012. The physician stated that the child may be discharged from the hospital on 06-JUL-2015 but it was unknown whether she was discharged or not. Upon internal review, the brain cancer/tumor was considered as other important medical event. Additional information has been requested.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Chest pain, Musculoskeletal pain
Clinical narrative: This spontaneous report was received from a 65 year old male consumer who was reporting on himself. The patient's medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX (dose, route of administration, lot # and expiration date were not reported). On an unknown date, the patient experienced sharp pain in his shoulder and in his chest. The outcome of the adverse events was unknown. The relatedness between adverse events and the therapy with ZOSTAVAX was not reported. Additional information is not expected as there are no contact details.
Age: 11.0
Sex: M
Vaccine: VARCEL
Symptoms: Erythema, Rash pruritic, Skin warm
Clinical narrative: Very red raised rash about 2cm by 4cm. (day 1) Then a secondary rash grew around it (day 2 - 3) (unraised). Total size of rash at treatment was 4cm by 8 cm, hot to the touch. Saw Dr on 7/10, recieved steroid cream. Inner rash still visible on 7/13, not as red, no longer itchy.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site warmth, Pain in extremity
Clinical narrative: Injection site reaction (red, warm to touch) and sore arm.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Rash erythematous
Clinical narrative: Large red, raised rash that was approximately 8 inches in diameter and spreading across patient's arm.
Age: 70.0
Sex: F
Vaccine: PNC13
Symptoms: Activities of daily living impaired, Injection site pain, Joint range of motion decreased, Pain in extremity
Clinical narrative: Pain at injection site but also pain in upper arm - inside (just below the shoulder) and radiating down the forearm. Also top of shoulder. Pain became progressively worse for the next 3 days (very severe) even at rest - just sitting. Very limited range of motion. Still painful - but not the extreme pain - by Friday. June 18th I went back to the Dr. who ordered physiotherapy - which I started and have been doing exercises. Still painful but not as severe. Still limited range of motion. Interferes with lifestyle.
Age: 36.0
Sex: F
Vaccine: MMR
Symptoms: Fatigue, Headache, Musculoskeletal pain, Pain, Pain in extremity
Clinical narrative: Fatigue, headache, achiness, arm tingling. Arm/shoulder pain increasingly worse over time and continues to date.
Age: 36.0
Sex: F
Vaccine: MMR
Symptoms: Paraesthesia
Clinical narrative: Fatigue, headache, achiness, arm tingling. Arm/shoulder pain increasingly worse over time and continues to date.
Age: 20.0
Sex: M
Vaccine: MMR
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: No adverse effect reported by patient.  Patient left after vaccine was administered.
Age: 18.0
Sex: M
Vaccine: MNQ
Symptoms: Headache, Neck pain
Clinical narrative: Headache, neck was sore on the 10th.  Has a headache now and since he got his shot.  Going on the 4th day of headache.  Has been taking Tylenol with some relief but not a lot.  Relates nothing else has been going on and feels like he is pretty hydrated.
Age: 59.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Erythema, Inflammation, Pain in extremity, Skin exfoliation, Skin warm
Clinical narrative: Redness, tenderness, swelling, inflammation to include hot to the touch, peeling, arm pain x4 weeks. Patient prescribed antibiotic.
Age: 59.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Swelling, Tenderness
Clinical narrative: Redness, tenderness, swelling, inflammation to include hot to the touch, peeling, arm pain x4 weeks. Patient prescribed antibiotic.
Sex: U
Vaccine: HPV4
Symptoms: Expired product administered, Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a physician referring to 14 anonymous patients of unknown age and gender. Patients' concurrent conditions, concomitant medication and medical history were not provided. On unknown dates between 12-APR-2015 and 30-JUN-2015, the 14 patients were vaccinated with expired GARDASIL (lot # H016238, expiry date 11-APR-2015, dose and route were not provided). The physician reported that the GARDASIL had previous temperature excursions on unknown dates and was unable to provide the excursion details at this time. No adverse symptoms were reported. The physician called back on 09-JUL-2015 and provided the names of 14 patients administered improperly stored and expired doses of GARDASIL. Physician did not specify what dose in the GARDASIL series was administered to each patient. One of the patients was administered the vaccine on 02-APR-2015 (improperly stored only) and 29-JUN-2015. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report as received from a Medical Assistant refers to an adult patient of unknown age and gender who on 18-JUN-2015 was vaccinated with an improperly stored dose of GARDASIL lot #K006960 (exp date, dose and route of administration not provided). According to the reporter the vaccine dose administered underwent a temperature excursion for 63 hours. This is one of several reports from the same reporter. Additional information is not expected as all correspondence was received. Product and narrative were updated.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist refers to a patient of unknown age and gender. No pertinent medical history was reported. On 13-APR-2015, the patient was vaccinated with improperly stored ZOSTAVAX VIAL (lot # L000450 and expiration date 09-MAR-2015) 0.65 ml once, subcutaneous. No adverse effects reported. No Product Quality Complaint (PQC) was involved. This is one of the several reports received from the same source. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Fatigue, Headache, Insomnia, Musculoskeletal pain, Rash
Clinical narrative: Shoulder very sore - could not sleep on right side. Next day very tired with headache. Saturday am - splotchy rash on upper arm. Rash slowly moved downwards as day progressed - sore to the touch. Rash still apparent on Monday am but much improved in that soreness has almost gone.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Rash macular, Tenderness
Clinical narrative: Shoulder very sore - could not sleep on right side. Next day very tired with headache. Saturday am - splotchy rash on upper arm. Rash slowly moved downwards as day progressed - sore to the touch. Rash still apparent on Monday am but much improved in that soreness has almost gone.
Age: 0.35
Sex: F
Vaccine: DTAPIPV
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: No adverse. Wrong IZ given.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker and refers to an unspecified number of patients. Medical history and concomitant medications were unknown. It was reported that improperly stored doses of oral, ROTATEQ were given to unspecified patients on unspecified dates (Incorrect product storage). No adverse experiences were reported. No product quality complaint (PQC) was involved. The outcome was unknown. This is one of several reports from the same reporter. Follow up has been received from a healthcare worker on 06-JUL-2015: It was reported that, on 02-JAN-2014 the patient of unknown age and gender was vaccinated with improperly stored oral, ROTATEQ (Lot number: H015715, expiry date: 15-MAR-2014). This is one of several reprots from the same reporter. Additional information has been requested.
Age: 0.17
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to multiple unspecified patients of unknown age and gender. The patients' medical history, concurrent condition and concomitant therapy were not provided. On unknown dates, the patients were vaccinated with doses of LIQUID PEDVAXHIB (lot#, expiration date, dose and route not reported), which were improperly stored. No adverse effects were reported. Follow up information has been received from an other reporter on 07-JUL-2015 and refers to an 8 weeks old patient of unknown gender. On 03-JUN-2015, the patient was vaccinated with a dose of LIQUID PEDVAXHIB lot # K016965, expiration date 20-JUL-2017. This is one of several reports received from the same source. Additional information has been received. Patient demographics, product and event details and narrative were updated.
Age: 0.22
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to multiple unspecified patients of unknown age and gender. The patients' medical history, concurrent condition and concomitant therapy were not provided. On unknown dates, the patients were vaccinated with doses of PEDVAXHIB (lot#, expiration date, dose and route not reported), which were improperly stored. No adverse effects were reported. Follow up information has been received from an other reporter on 07-JUL-2015 and refers to an 11 week old patient of unknown gender. On 02-JUN-2015, the patient was vaccinated with a dose of PEDVAHXIB lot # K016965, expiration date 20-JUL-2017. This is one of several reprots received from the same source. Additional information has been requested. Patient demographics, product and event details and narrative were updated.
Sex: U
Vaccine: HPV4
Symptoms: Expired product administered, Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a physician referring to 14 anonymous patients of unknown age and gender. Patients' concurrent conditions, concomitant medication and medical history were not provided. On unknown dates between 12-APR-2015 and 30-JUN-2015, the 14 patients were vaccinated with expired GARDASIL (lot # H016238, expiry date 11-APR-2015, dose and route were not provided). The physician reported that the GARDASIL had previous temperature excursions on unknown dates and was unable to provide the excursion details at this time. No adverse symptoms were reported. The physician called back on 09-JUL-2015 and provided the names of 14 patients administered improperly stored and expired doses of GARDASIL. Physician did not specify what dose in the GARDASIL series was administered to each patient. One of the patients was administered the vaccine on 30-APR-2015. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Pt mother stated that the day after vaccines placement, she notice her daughter's upper right arm was, red and swollen, pt stated it hurt when she touches.
Age: 3.0
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to multiple unspecified patients of unknown age and gender. The patients' medical history, concurrent condition and concomitant therapy were not provided. On unknown dates, the patients were vaccinated with doses of PEDVAXHIB (lot#, expiration date, dose and route not reported), which were improperly stored. No adverse effects were reported. Follow up information has been received from an other reporter on 07-JUL-2015 and refers to a 3 year old patient of unknown gender. On 05-JUN-2015, the patient was vaccinated with a dose of PEDVAXHIB lot # K016965, expiration date 20-JUL-2017. This is one of several reports received from the same source. Additional information has been requested. Patient demographics, product and event details and narrative were updated.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker and a nurse refers to an unspecified number of patients. Medical history and concomitant medications were unknown. It was reported that improperly stored doses of oral, ROTATEQ were given to unspecified patients on unspecified dates (Incorrect product storage). No adverse experiences were reported. No product quality complaint (PQC) was involved. The outcome was unknown. This is one of several reprots from the same reporter. Follow up has been received from a healthcare worker on 06-JUL-2015: It was reported that, on 07-APR-2015, the patient of unknown age and gender was vaccinated with improperly stored oral, ROTATEQ (Lot number: K010219, expiry date: 02-JUN-2015). This is one of 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 healthcare worker (also reported as a nurse) refers to an unspecified number of patients. Medical history and concomitant medications were unknown. It was reported that improperly stored doses of oral, ROTATEQ were given to unspecified patients on unspecified dates (Incorrect product storage). No adverse experiences were reported. No product quality complaint (PQC) was involved. The outcome was unknown. This is one of several reprots from the same reporter. Follow up has been received from a healthcare worker on 06-JUL-2015: It was reported that, on 03-APR-2015, the patient of unknown age and gender was vaccinated with improperly stored oral, ROTATEQ (Lot number: K010219, expiry date: 02-JUN-2015). Additional information has been requested.
Age: 0.18
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to multiple unspecified patients of unknown age and gender. The patients' medical history, concurrent condition and concomitant therapy were not provided. On unknown dates, the patients were vaccinated with doses of PEDVAXHIB (lot#, expiration date, dose and route not reported), which were improperly stored. No adverse effects were reported. Follow up information has been received from an other reporter on 07-JUL-2015 and refers to a 9 weeks old patient of unknown gender. On 04-JUN-2015, the patient was vaccinated with a dose of PEDVAXHIB lot # K016965, expiration date 20-JUL-2017. This is one of several reports received from the same source. Additional information has been requested.
Age: 0.33
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Incorrect route of drug administration
Clinical narrative: ROTARIX vaccine given as IM rather than oral.
Sex: U
Vaccine: HPV4
Symptoms: Expired product administered, Incorrect product storage, No adverse event
Clinical narrative: Information has been recieved from a physician referring to 14 anonymous patients of unknown age and gender. Patients' concurrent conditions, concmitant medicationa nd medical hsitory were not reported. On unknown dates between 12-APR-2015 and 30-JUN-2015, the 14 patients were vaccinated with expired GARDASIL (lot # H016238, expiry date 11-APR-2015, dose and route were not provided). The physician reported that the GARDASIL had previous temperature excursions on unknown dates and was unable to provide the excursion details at this time. No adverse symptoms were reported. The physician called back on 09-JUL-2015 and provided the names of 14 patients administered improperly stored and expired doses of GARDASIL. Physician did not specify what dose in the GARDASIL series was administered to each patient. One of the patients was administered the vaccine on 07-MAY-2015. This is one of several reprots received from the same reproter. Additional information has been reuqested.
Age: 80.0
Sex: F
Vaccine: PNC13
Symptoms: Diarrhoea, Fatigue, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: 7/7/15 - Pt complaining of left upper arm redness, tenderness, swelling and warm to touch. On 7/10/15 - pt reports onset of fatigue and diarrhea, redness, swelling from shoulder to elbow and site warm to touch. Still present today. Saw Dr. no treatment needed.
Age: 80.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site warmth
Clinical narrative: 7/7/15 - Pt complaining of left upper arm redness, tenderness, swelling and warm to touch. On 7/10/15 - pt reports onset of fatigue and diarrhea, redness, swelling from shoulder to elbow and site warm to touch. Still present today. Saw Dr. no treatment needed.
Age: 18.0
Sex: F
Vaccine: MNQ, VARCEL
Symptoms: Immediate post-injection reaction, Injection site discomfort, Injection site erythema, Product preparation error
Clinical narrative: This spontaneous report was received from a registered nurse refers to an 18 year old female patient. No pertinent medical history was reported. On 29-JUN-2015, the patient was inadvertently vaccinated with a dose of VARIVAX (Merck) (dose and lot# were not reported) subcutaneous which had been inadvertently reconstituted with a dose of MENACTRA instead of Sterile Water Diluent. On 29-JUN-2015, the patient experienced injection site discomfort and injection site erythema immediately following administration, while still in the physician's office. No treatment was given to the patient. No Product Quality Complaint (PQC) was involved. Action taken was not applicable. The outcome of events was unknown. The reporter did not provide the causality between the event and the suspect therapy. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a pharmacist referring to an unspecified number of patients of unknown age and gender. There was no pertinent medical history or drug reaction/allergies reported. On unknown dates the patients were vaccinated with improperly stored ZOSTAVAX (0.65 ml, once, lot# K018176, expired date 10-JAN-2016; lot# L003218, expired date 30-MAR-2016) subcutaneously. No concomitant medication was reported. No adverse events were reported after improperly stored ZOSTAVAX was administered. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from two healthcare workers referring to an unspecified number of patients of unknown age and gender. Information about patients' concurrent conditions and medical history was not reported. On unspecified dates the patients were vaccinated with doses of improperly stored GARDASIL 9 (lot#, dose, route not reported). Concomitant mediations were not provided. No adverse symptoms were reported. This is one of several reports from the same reporter. Additional information has been requested.
Age: 5.0
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report was received from a physician and refers to a 5 year old patient of unknown gender. No medical history, current conditions and concomitant therapies were reported. On 07-JUL-2015, the patient was vaccinated with a dose of VARIVAX (Merck) (lot #, expiration date, dose and anatomical location were not reported) subcutaneously, in addition to a dose of PROQUAD (Merck) (lot #, expiration date, dose, route of administration and anatomical location were not reported) received on the same day. No adverse effects were 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 health care professional refers to an unspecified patient of unknown age and gender. On 15-JUN-2015 the patient was vaccinated with improperly stored GARDASIL lot # K008931; expiry: 04-MAR-2017 (dose, route and frequency unspecified) (incorrect product storage). No concomitant medications were reported. No adverse reactions have been reported. No further information was available. The outcome of the medication error was unknown. 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 healthcare professional refers to an unspecified number of patients. Concurrent conditions, medical history and allergies were not reported. In approximately 2015 (reported as since 13-MAR-2015), the patients were vaccinated with doses of ROTATEQ lot # K010221, K011663, K016313 and lot # reported as K015816 (expiration dates, dose, route and site of administrations were not reported) that were exposed to temperatures outside of the recommended range. No adverse effects had been observed or reported. Follow up information has been received from the medical assistant on 02-JUL-2015 concerning a patient of an unknown age and gender who on 07-MAY-2015 was vaccinated with a dose of ROTATEQ (lot # K015816) (dose and route not reported) that was 63 hours temperature excursion. This is one of several reports received from the same source. Additional information is not expected as all correspondence was received.
Sex: U
Vaccine: HPV4
Symptoms: Expired product administered, Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a physician referring to 14 anonymous patients of unknown age and gender. Patients' concurrent conditions, concomitant medication and medical history were not provided. On unknown dates between 12-APR-2015 and 30-JUN-2015, the 14 patients were vaccinated with expired GARDASIL (lot # H016238, expiry date 11-APR-2015, dose and route were not provided). The physician reported that the GARDASIL had previous temperature excursions on unknown dates and was unable to provide the excursion details at this time. No adverse symptoms were reported. The physician called back on 09-JUL-2015 and provided the names of 14 patients administered improperly stored and expired doses of GARDASIL. Physician did not specify what dose in the GARDASIL series was administered to each patient. One of the patients was administered the vaccine on 02-APR-2015 (improperly stored only) and 23-JUN-2015. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: M
Vaccine: PPV
Symptoms: Adverse reaction
Clinical narrative: This spontaneous report as received from a consumer refers to himself, a male patient of unknown age. The patient reported an unspecified adverse reaction on an unspecified date in DEC-2013 after receiving PNEUMOVAX 23 (start date not provided). The outcome of the unspecified adverse reaction is unknown. No further information was provided. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report as received from a Medical Assistant refers to an adult patient of unknown age and gender who on 16-JUN-2015 was vaccinated with an improperly stored dose of GARDASIL lot #K006960 (exp date, dose and route of administration not provided). According to the reporter the vaccine dose administered underwent a temperature excursion for 63 hours. This is one of several reports from the same reporter. Additional information is not expected as all correspondence was received. Product and narrative were updated.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, Pain in extremity
Clinical narrative: This spontaneous report was received from a Healthcare worker refers to an unspecified patients of unknown demographics. It was reported that on an unknown date since December 2014 the patients were vaccinated with improperly stored oral, ROTATEQ (dose, route, lot # and frequency unspecified). No concomitant medications were reported. Healthcare worker stated that on an unknown date, some complaints may have been made with regards to sore arms but that's nothing out of the ordinary. Healthcare worker could not provide information regarding any specific patient(s) who may have experienced the symptom. She stated that they "always" received complaints regarding sore arms after administration of vaccines. No further information was provided. The outcome of sore arm and incorrect product storage was unknown. Causality assessment for the event sore arm not reported. There was no product quality complaint involved. This is one of several reprots received from the same source. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Expired product administered, Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a physician referring to 14 anonymous patients of unknown age and gender. Patients' concurrent conditions, concomitant medication and medical history were not provided. On unknown dates between 12-APR-2015 and 30-JUN-2015, the 14 patients were vaccinated with expired GARDASIL (lot # H016238, expiry date 11-APR-2015, dose and route were not provided). The physician reported that the GARDASIL had previous temperature excursions on unknown dates and was unable to provide the excursion details at this time. No adverse symptoms were reported. The physician called back on 09-JUL-2015 and provided the names of 14 patients administered improperly stored and expired doses of GARDASIL. Physician did not specify what dose in the GARDASIL series was administered to each patient. One of the patients was administered the vaccine on 18-JUN-2015. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ
Symptoms: Erythema, Peripheral swelling, Skin irritation, Swelling, Vaccination complication
Clinical narrative: This spontaneous report was received from a physician via a company representative and refers to a 11 year old male patient. On 02-JUL-2015, the patient was vaccinated with the first dose of GARDASIL 9 (left arm, route of administration, dose, lot number and expiry date were not reported) and with a dose of MENACTRA (right arm, route of administration, dose, lot number and expiry date were not reported). On 03-JUL-2015, the patient developed swelling in the left arm (unspecified location of the arm), and then on 04-JUL-2015, the patient developed swelling and redness "along the left jaw side". On an unknown date, the patient was seen in an unspecified emergency room for the symptoms that he developed and two days later, the patient was seen by a physician for a check-up. It was reported that the patient was diagnosed with irritation from vaccine, possible cellulitis from the emergency room and treated with KEFLEX. On an unknown date, reported as two days later, the patient was seen in the physician's office and the site was notably improved. The relatedness between the suspect therapies and the adverse events was not reported. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report as received from a Medical Assistant refers to an adult patient of unknown age and gender who on 17-JUN-2015 was vaccinated with an improperly stored dose of GARDASIL lot #K006960 (exp date, dose and route of administration not provided). According to the reporter the vaccine dose administered underwent a temperature excursion for 63 hours. This is one of several reports from the same reporter. Additional information is not expected as all correspondence was received. Product and narrative were updated.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from two healthcare workers refers to an unspecified number patients of unknown age and gender. Information about patients' concurrent conditions and medical history was not reported. On unspecified dates the patients were vaccinated with doses of improperly stored ROTATEQ (lot#, dose not reported, orally). Concomitant medications were not provided. No adverse symptoms were reported. This is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from two healthcare workers referring to an unspecified number patients of unknown age and gender. Information about patients' concurrent conditions and medical history was not reported. On unspecified dates the patients were vaccinated with doses of improperly stored VAQTA (lot#, dose, route not reported). Concomitant medications were not provided. No adverse symptoms were reported. This is one of 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 healthcare worker and nurse refers to an unspecified number of patients. Medical history and concomitant medications were unknown. It was reported that improperly stored doses of oral, ROTATEQ were given to unspecified patients on unspecified dates (Incorrect product storage). No adverse experiences were reported. No product quality complaint (PQC) was involved. The outcome was unknown. This is one of sevearl reports from the same reporter. Follwo up has been received from healthcare worker on 06-JUL-2015. It was reported that on 17-MAR-2015, the patient of unknown age and gender was vaccinated with improperly stored oral, ROTATEQ (lot number: K010219, 02-JUN-2015). This is several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a Medical Assistant refers to a patient of unknown age and gender who on 25-JUN-2015 was vaccinated with a dose of GARDASIL lot # K006960 (dose and route were not provided) which were exposed to temperatures outside of the recommended range during 63 hours excursion. No adverse effects had been observed or reported. This is one of 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 healthcare professional refers to an unspecified number of patients. In approximately 2015 (reported as since 13-MAR-2015), the patients were vaccinated with doses of ROTATEQ lot # K010221, K011663, K016313 and lot # reported as K015816 (expiration dates, dose, route and site of administrations were not reported) that were exposed to temperatures outside of the recommended range. No adverse effects had been observed or reported. Follow up information has been received from a Medical assistant on 02-JUL-2015 concerning a patient of an unknown age and gender who on 14-APR-2015, the patient was vaccinated with a dose of ROTATEQ lot # K011663 (expiration date, dose, route and site of administration were not reported) that was exposed to temperatures outside of the recommended range. This is one of several reports received from the same reporter. Additional information is not expected as all correspondence was received. Product and narrative were updated.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare professional refers to an unknown number of patients (age and genders were not reported). On unknown dates, the patients were vaccinated with VARIVAX (Merck) (doses, routes of administration and lot numbers were not reported), that had been improperly stored. No adverse effect reported. A phone call was placed to the healthcare worker on 16-JUN-2015. A message was left with the receptionist requesting that the healthcare worker return the phone call. Additionally, a request was made for patient identifiers, lot number and expiration date and date of vaccination. All telephone attempts to obtain follow-up information have been unsuccessful. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare professional refers to an unknown number of patients (age and genders were not reported). On unknown dates, the patients were vaccinated with PROQUAD (Merck) (doses, routes of administration and lot numbers were not reported), that had been improperly stored. No adverse effect reported. A phonecall was placed to the healthcare worker on 16-JUN-2015. A message was left with the receptionist requesting that the healthcare worker return the phone call. Additionally, a request was made for patient identifiers, lot number and expiration date and date of vaccination. All telephone attempts to obtain a follow-up information have been unsuccessful. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Expired product administered, Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a physician referring to 14 anonymous patients of unknown age and gender. Patients' concurrent conditions, concomitant medication and medical history were not provided. On unknown dates between 12-APR-2015 and 30-JUN-2015, the 14 patients were vaccinated with expired GARDASIL (lot # H016238, expiry date 11-APR-2015, dose and route were not provided). The physician reported that the GARDASIL had previous temperature excursions on unknown dates and was unable to provide the excursion details at this time. No adverse symptoms were reported. The physician called back on 09-JUL-2015 and provided the names of 14 patients administered improperly stored and expired doses of GARDASIL. Physician did not specify what dose in the GARDASIL series was administered to each patient. One of the patients was administered the vaccine on 24-APR-2015. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: Information had been received from a healthcare worker referring to a patients of unknown age and gender. Information of pertinent medical history and drug reactions/allergies of the patient were not reported. On 25-JUN-2015 the patient was vaccinated with expired M-M-R II (dose, strength and route unknown), lot # H016132 with expiration date of 31-AUG-2014. Concomitant medication was not reported. The outcome of the event was unknown. No adverse symptoms were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: Information had been received from a healthcare worker referring to a patient of unknown age and gender. Information of pertinent medical history and drug reactions/allergies of the patient were not reported. On 06-JUL-2015 the patient was vaccinated with expired M-M-R II (dose, strength and route unknown), lot # H016132 with expiration date of 31-AUG-2014. Concomitant medication was not reported. No adverse symptoms were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: Information had been received from a healthcare worker referring to a patients of unknown age and gender. Information of pertinent medical history and drug reactions/allergies of the patient were not reported. On 12-JUN-2015 the patient was vaccinated with expired M-M-R II (dose, strength and route unknown), lot # H016132 with expiration date of 31-AUG-2014. Concomitant medication was not reported. No adverse symptoms were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: Information has been received from a healthcare worker referring to a patient of unknown age and gender. Information of pertinent medical history and drug reactions/allergies of the patient were not reported. On 22-JUN-2015 the patient was vaccinated with expired M-M-R II (dose, strength and route unknown), lot # H016132 with expiration date of 31-AUG-2014. Concomitant medication was not reported. No adverse symptoms were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Dysphagia, Lip swelling, Nausea, Vomiting
Clinical narrative: Information has been received from a register nurse referring to a patient of unknown age. On 25-JUN-2015, the patient was vaccinated with RECOMBIVAX HB (dose, route and lot number not provided). On 25-JUN-2015, the patient developed swollen lips shortly afterwards receiving the vaccine. The nurse reported that within 1 week the patient developed difficulty swallowing, nausea and vomiting. The patient might seek medical attention. At the time of reporting, the patient was still experiencing difficulty swallowing and the lip swelling had resolved. The outcome of vomiting was unknown. 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 healthcare professional refers to an unspecified number of patients. Concurrent conditions, medical history and allergies were not reported. In approximately 2015 (reported as since 13-MAR-2015), the patients were vaccinated with doses of oral, ROTATEQ lot # K010221, K011663, K016313 and lot # reported as K015816 (expiration dates, dose, route and site of administration were not reported) that were exposed to temperatures outside of the recommended range. No adverse effects had been observed or reported. Follow up information has been received from the medical assistant on 02-JUL-2015 concerning a patient of an unknown age and gender who on 06-MAY-2015 was vaccinated with a dose of oral, ROTATEQ (lot # K015816) (dose and route not reported) that was 63 hours temperature excursion. This is one of several reports received from the same source. Additional information is not expected as all correspondence was received.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare professional refers to a patient of an unknown age and gender. Medical history and concurrent conditions were not reported. On 05-MAY-2015, the patient was vaccinated with a dose of GARDASIL lot # K006960 (expiration date, dose, route and sites of administrations were not reported) that were exposed to temperatures outside of the recommended range. No adverse effects had been observed or reported. This is one of several repots from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Expired product administered, Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a physician referring to 14 anonymous patients of unknown age and gender. Patients' concurrent conditions, concomitant medication and medical history were not provided. On unknown dates between 12-APR-2015 and 30-JUN-2015, the 14 patients were vaccinated with expired GARDASIL (lot # H016238, expiry date 11-APR-2015, dose and route were not provided). The physician reported that the GARDASIL had previous temperature excursions on unknown dates and was unable to provide the excursion details at this time. No adverse symptoms were reported. The physician called back on 09-JUL-2015 and provided the names of 14 patients administered improperly stored and expired doses of GARDASIL. Physician did not specify what dose in the GARDASIL series was administered to each patient. One of the patients was administered the vaccine on 21-APR-2015 and 22-JUN-2015. 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 healthcare professional refers to an unspecified number of patients. Concurrent conditions, medical history and allergies were not reported. In approximately 2015 (reported as since 13-MAR-2015), the patients were vaccinated with doses of ROTATEQ lot # K010221, K011663, K016313 and lot # reported as K015816 (expiration dates, dose, route and site of administrations were not reported) that were exposed to temperatures outside of the recommended range. No adverse effects had been observed or reported. Follow up information has been received from the medical assistant on 02-JUL-2015 concerning a patient of an unknown age and gender who on 12-MAY-2015 was vaccinated with a dose of ROTATEQ (lot # K015816) (dose and route not reported) that was 63 hours temperature excursion. This is one of several reports received from the same source. Additional information is not expected as all correspondence was received.
Age: 24.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Bone pain, Headache
Clinical narrative: This spontaneous report was received from a healthcare worker refers to a 24 year old female patient. The patient's pertinent medical history, drug reactions/allergies and concomitant medication were reported as none. On 10-JUN-2015, the patient was vaccinated with first dose of GARDASIL lot # K023432, expiry date 18-JUN-2016, for Prevention of HPV, (dose not provided). On 12-JUN-2015 (two days later), the patient experienced headache and bone pain. Healthcare worker reported that the patient called her office 30-JUN-2015 (today) to report the symptoms and stated that they are "slowly getting better" and patient was currently "at a 5 out of 10 on the pain scale". Healthcare worker reported that the patient was told to administer TYLENOL 500 milligram (mg) every 8 hours as needed to treat the symptoms. Lab diagnostics studies performed was reported as none. The outcome of the bone pain and headache was recovering. No further information was provided. Causality was not provided. Patient sought medical attention by calling the physician's office. No product quality complaint (PQC) was involved. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: MNQ, TYP, MNQ
Symptoms: Injected limb mobility decreased, Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Patient had local swelling and pruritis of the left upper arm in the region of the deltoid where a meningococcal vaccine was administered.  No systemic effects.
Age: 11.0
Sex: F
Vaccine: MNQ, TYP, MNQ
Symptoms: Injection site pruritus, Injection site swelling
Clinical narrative: Patient had local swelling and pruritis of the left upper arm in the region of the deltoid where a meningococcal vaccine was administered.  No systemic effects.
Age: 71.0
Sex: U
Vaccine: PNC13, UNK
Symptoms: Bacterial infection
Clinical narrative: July 9/15 started with a red rash and itching when walking around 5:30 this morning. Saw the APRN at 9:45. She told me to stay on BENADRYL 3 time a day. Evening started to itch on both feet 7:15 PM stop itching around 8:30.
Age: 71.0
Sex: U
Vaccine: PNC13, UNK
Symptoms: Pruritus, Rash erythematous
Clinical narrative: July 9/15 started with a red rash and itching when walking around 5:30 this morning. Saw the APRN at 9:45. She told me to stay on BENADRYL 3 time a day. Evening started to itch on both feet 7:15 PM stop itching around 8:30.
Age: 70.0
Sex: F
Vaccine: PNC13
Symptoms: Body temperature, Pain in extremity, Peripheral swelling
Clinical narrative: Pain and swelling in arm.  Temp 8:00PM.