chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse practitioner referring to a patient of unknown age and gender. There was no concurrent condition or medical history reported. On 25-JAN-2016 the patient was administered improperly stored GARDASIL (lot # K011562, expiration date 08-APR-2017) (dosage, strength and route unknown) (temperature 30 degree Fahrenheit, time frame 4 hours). There was no concomitant medication reported. No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report has been received from a healthcare worker concerning a patient of unknown age and gender. The patient's concomitant medication pertinent history and drug reactions/allergies were not reported. On 07-JAN-2016 the patient was administered a dose of improperly stored ROTATEQ (strength, dose not reported, lot # L013202 and Exp. date 27-JAN-2017) orally. The vaccine was exposed to 34 F for 8 hours, and there was o previous temperature excursion. No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to an unspecified number of patients of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medication were not reported. On unknown dates, the patients were vaccination with improperly stored doses of ROTATEQ lot # K014826, expiration date 28-MAY-2016, orally (dose was not reported). No adverse symptoms were reported. Product quality complaint was not 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 has been received from a healthcare worker concerning a patient of unknown age and gender. The patient's concomitant medication, pertinent medical history and drug reactions/allergies were not reported. On 08-JAn-2016 the patient was administered a dose of improperly stored ROTATEQ (strength, dose not reported, lot # L016202 and Exp. date 27-JAN-2017) orally. The vaccine was exposed to 34 F for 8 hours, and there was no previous temperature excursion. No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Interchange of vaccine products, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse, referring to a patient of unknown age and gender. No medical history was reported. On an unknown date, the patient was vaccinated with the first dose of GARDASIL (lot # K023432, expiration date 18-JUN-2016) (route was not provided). No concomitant medication was reported. It was reported that 4 months after the first dose of GARDASIL, the patient was then vaccinated with a dose of GARDASIL 9 (dose and route were not provided) (lot # L007560, expiration date: 15-JUN-2017). No adverse effects were reported. It was also reported that no product quality complain was involved. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report has been received from a healthcare worker concerning a patient of unknown age and gender. The patient's concomitant medication, pertinent medical history and drug reactions/allergies were not reported. On 08-JAN-2016 the patient was administered a dose of improperly stored ROTATEQ (strength, dose not reported, lot # L016202 and Exp. date 27-JAN-2017) orally. The vaccine was exposed to 34 F for 8 hours, and there was no previous temperature excursion. No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report has been received from a healthcare worker concerning a patient of unknown age and gender. The patient's concomitant medication, pertinent medical history and drug reactions/allergies were not reported. On 11AN-2016 the patient was administered a dose of improperly stored ROTATEQ (strength, dose not reported, lot # L016202 and Exp. date 27-JAN-2017) orally. The vaccine was exposed to 34 F for 8 hours, and there was no previous temperature excursion. No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report has been received from a healthcare worker concerning a patient of unknown age and gender. The patient's concomitant medication, pertinent medical history and drug reactions/allergies were not reported. On 11-JAN-2016 the patient was administered a dose of improperly stored ROTATEQ (strength, dose not reported, lot # L016202 and Exp. date 27-JAN-2017) orally. The vaccine was exposed to 34 F for 8 hours, and there was no previous temperature excursion. No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 2.0
Sex: M
Vaccine: HEPA, HIBV, PNC13, TDAP
Symptoms: Wrong drug administered
Clinical narrative: Tdap given instead of DTaP as dose number 4 in the series.
Age: 63.0
Sex: F
Vaccine: PPV
Symptoms: Hypoaesthesia, Mobility decreased, Musculoskeletal pain, Nuclear magnetic resonance imaging, Pain in extremity
Clinical narrative: Within 24 hrs after pneumococcal vaccine, there was serious pain in right shoulder could not have full arm movement. Also pain in the forearm bicep area and numbness in the right hand and fingers. Treatment pending.
Sex: U
Vaccine: HPV9
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 patient medical history, concurrent conditions and concomitant medication were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL 9 (lot # L013429, expiration date 21-SEP-2017)(dose and route of administration were not reported). No adverse symptoms were reported. Product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse practitioner referring to a patient of unknown age and gender. There was no concurrent condition or medical history reported. On 25-JAN-2016 the patient was administered improperly stored GARDASIL (lot # K011562, expiration date 08-APR-2017) (dosage, strength and route unknown). There was no concomitant medication reported. No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse practitioner referring to a patient of unknown age and gender. There was no concurrent condition or medical history reported. On 23-JAN-2016 the patient was administered improperly stored GARDASIL (lot # K011562, expiration date 08-APR-2017) (dosage, strength and route unknown) (temperature 30 degree Fahrenheit, time frame 4 hours). There was no concomitant medication reported. No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: This spontaneous report was received f rom a 55 year old female consumer regarding herself. The patient's pertinent medical history included breast cancer. The patient did not have any drug reaction/allergies. On 22-JAN-2016, the patient was vaccinated with ZOSTAVAX (lot # unspecified), 0.65 ml/one injection, subcutaneously . Concomitant therapies included raloxifene, amlodipine, Lisinopril (manufacturer unknown), fish oil, Vitamin D3 and baby aspirin. On 22-JAN-2016, the patient experienced injection site pain, swelling and feverish feeling around the injection site. The patient did not seek medical attention. No Product Quality Complaint (PQC) was reported. No lab diagnostics studies were performed. The outcome of the events were reported as recovering. Causality assessment was not provided. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report has been received from a healthcare worker concerning a patient of unknown age and gender. The patient's concomitant medication, pertinent medical history and drug reactions/allergies were not reported. On 05-JAN-2016 the patient was administered a dose of improperly stored ROTATEQ (strength, dose not reported, lot # L013202 and Exp. date 27-JAN-2017) orally. The vaccine was exposed to 34 F for 8 hours, and there was no previous temperature excursion. No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Unevaluable event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. Patient's current conditions, medical history and concomitant medications was not provided. On an unknown date, the patient was vaccinated with ZOSTAVAX (strength, dose, frequency, route, lot # and expiration date was not specified). The reporter inquired on how long the patient what to wait before starting prednisone for an "unspecified reason" (adverse event) after receiving the ZOSTAVAX (circumstance or information capable of leading to medication error). The outcome of the adverse event was not known. Causality assessment was not provided. No further details were provided. There was no product quality complaints involved. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report has been received from a healthcare worker concerning a patient of unknown age and gender. The patient's concomitant medication, pertinent medical history and drug reactions/allergies were not reported. On 04-JAN-2016 the patient was administered a dose of improperly stored ROTATEQ (strength, dose not reported, lot # L013202 and Exp. date 27-JAN-2017) orally. The vaccine was exposed to 34 F for 8 hours, and there was no previous temperature excursion. No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR, VARCEL
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender.  No information regarding the patient's medical history or concurrent conditions was provided. On 08-AUG-2014, the patient was vaccinated with dose of M-M-R II, injection (dose, route of administration, lot # and expiry date were not reported). On 25-AUG-2014, also reported as 17 days later, the patient was vaccinated with a dose of (Oka/Merck) VARIVAX injection (dose, route of administration, lot # and expiry date were not reported). There were no concomitant therapies reported. No adverse effects were reported. There was no product quality complaint involved. Additional information is not expected as the reporter declined any further contact.
Age: 51.0
Sex: F
Vaccine: PPV
Symptoms: Injection site mass
Clinical narrative: This spontaneous report as received from an unspecified reporter, as part of a marketing research program, refers to a 51 year old female patient who enrolled in a marker research program entitled "HCC adult vaccine location journey", information regarding relevant medical history and concurrent condition were not reported. On an unknown date the patient was vaccinated with PNEUMOVAX23 (one dose in the arm, route and lot # not reported). Information regarding concomitant medications was not reported. Approximately on an unknown date in 2014, the patient had lump on arm at the injection site. It was reported that the lump "cleared" after 3 days at most and the patient recovered from the event on an unknown date in September 2015. The reporter considered the event to be related to PNEUMOVAX23. Additional information is not expected because the reporter refused to provide contact information.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report has been received from a healthcare worker concerning a patient of unknown age and gender. The patient's concomitant medication, pertinent medical history and drug reactions/allergies were not reported. On 19-JAN-2016 the patient was administered a dose of improperly stored ROTATEQ (strength, dose not reported, lot # L013202 and Exp. date 27-JAN-2017) orally. The vaccine was exposed to 34 F for 8 hours, and there was no previous temperature excursion. No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 24.0
Sex: F
Vaccine: HPV9
Symptoms: Lymphadenopathy
Clinical narrative: This spontaneous report as received from a physician via a company representative refers to a 24 year old female patient. The patient had no pertinent medical history and no known drug allergies. On 24-NOV-2015, the patient was vaccinated with the first dose of GARDASIL 9 (lot # L016429, expiration date 09-AUG-2017, intramuscularly in the left deltoid (dose and frequency were not reported). Concomitant therapies included XANAX and unspecified birth control pills (manufacturer unknown). On 25-NOV-2015, the patient experienced a swollen lymph node in the location of left supraclavicular. On 24-JAN-2016 (also reported as today), the patient came to the reporter's office to be administered the second dose of GARDASIL 9 in the series and stated she was still able to feel the swollen node if she turned her neck in a certain way (also reported that the swollen node went away on approximately 02-DEC-2015, reported as after a week). On 25-JAN-2016 (also reported as today), the reporter could not palpate any swollen lymph node on the patient and did not administer the second dose of GARDASIL 9 (also reported as the therapy with GARDASIL 9 was not discontinued. The patient sought medical attention as she called the reporting physician on 25-NOV-2015 and reported the event during the office visit on 25-JAN-2016. Apart from physician examination, no other lab diagnostic  studies were performed. No treatment was given for the event. Product quality complaint was not involved. The outcome of the event was considered unknown. The relatedness between the event and GARDASIL 9 was not reported. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report has been received from a healthcare worker concerning a patient of unknown age and gender. The patient's concomitant medication, pertinent medical history and drug reactions/allergies were not reported. On 20-JAN-2016 the patient was administered a dose of improperly stored ROTATEQ (strength, dose not reported, lot # L013202 and Exp. date 27-JAN-2017) orally. The vaccine was exposed to 34 F for 8 hours, and there was no previous temperature excursion. No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 19.0
Sex: M
Vaccine: MENB
Symptoms: Dizziness, Fatigue, Headache
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of headache in a 19-year-old male patient who received BEXSERO. In January 2016, the patient received BEXSERO. In January 2016, 3 days after receiving BEXSERO, the patient experienced headache, dizziness and fatigue. On an unknown date, the outcome of the headache was not recovered/not resolved and the outcome of the dizziness and fatigue were recovered/resolved. It was unknown if the reporter considered the headache, dizziness and fatigue to be related to BEXSERO. Additional details were provided as follows:  The patient was grandson of the reporting healthcare professional. The healthcare professional reported that the patient received BEXSERO 2 weeks before the time of reporting and began experiencing headache, fatigue and dizziness 3 days after receiving the vaccine. The healthcare professional reported that the patient has never experienced these types of symptoms before. The healthcare professional reported that the symptoms seemed to go away a few days before the time of reporting but the headache has come back. No further information was reported regarding this administration. The healthcare professional initially called for recommendations of clinical data regarding adverse reactions of BEXSERO. The call was escalated to Vaccine's Medical Information System.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report has been received from a healthcare worker concerning a patient of unknown age and gender. The patient's concomitant medication, pertinent medical history and drug reactions/allergies were not reported. On 15-JAN-2016 the patient was administered a dose of improperly stored ROTATEQ (strength, dose not reported, lot # L013202 and Exp. date 27-JAN-2017) orally. The vaccine was exposed to 34 F for 8 hours, and there was no previous temperature excursion. No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Feeling abnormal, Headache, Pyrexia
Clinical narrative: This spontaneous report as received from a registered nurse refers to one or two patients of unknown age and gender. The patients' relevant medical history, concurrent conditions or concomitant medications were not reported. On unknown dates, the patients were vaccinated with the first or second dose of GARDASIL (dose, route of administration, lot# and expiry date were not reported). In approximately 2014 (reported as "maybe a year and a half ago"), the patients did not feel good, complained of headache and fever. The patients might have treated their headaches at home with unspecified remedies. The patients did not complete GARDASIL series because of the events. The outcome of the events was unknown. The relatedness between the events and GARDASIL was not reported. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report has been received from a healthcare worker concerning a patient of unknown age and gender. The patient's concomitant medication, pertinent medical history and drug reactions/allergies were not reported. On 14-JAN-2016 the patient was administered a dose of improperly stored ROTATEQ (strength, dose not reported, lot # L013202 and Exp. date 27-JAN-2017) orally. The vaccine was exposed to 34 F for 8 hours, and there was no previous temperature excursion. No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report has been received from a healthcare worker concerning a patient of unknown age and gender. The patient's concomitant medication, pertinent medical history and drug reactions/allergies were not reported. On 13-JAN-2016 the patient was administered a dose of improperly stored ROTATEQ (strength, dose not reported, lot # L013202 and Exp. date 27-JAN-2017) orally. The vaccine was exposed to 34 F for 8 hours, and there was no previous temperature excursion. No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist refers to a patient of unknown gender and age. Information regarding patient's medical, history, concurrent condition, drug reactions/allergies and concomitant medication were not provided. Reporting pharmacist stated that the patient received first dose of RECOMBIVAX HB (dosing details unspecified) sometime during April 2015. They received the second dose sometime in December 2015 and dose 3 was not yet administered (inappropriate schedule of drug administration). No symptoms were reported. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report has been received from a healthcare worker concerning a patient of unknown age and gender. The patient's concomitant medication, pertinent medical history and drug reactions/allergies were not reported. On 12-JAN-2016 the patient was administered a dose of improperly stored ROTATEQ (strength, dose not reported, lot # L013202 and Exp. date 27-JAN-2017) orally. The vaccine was exposed to 34 F for 8 hours, and there was no previous temperature excursion. No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 85.0
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Injection site erythema, Injection site pain, Injection site scab
Clinical narrative: Jan 13, 2016 at 14:12. Reason for RN walk in visit: Patient c/o redness and pain at zoster injection site. Patient reports he broke out 2 weeks ago with blister like rash with pain. Patient received zoster injection December 15, 2015. At right upper posterior arm where injection was given area noted to be scabbed with jagged edges with redness surrounding the site. Dr. examined patient's right posterior arm dx localized shingles from zoster injection.
Age: 85.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: Jan 13, 2016 at 14:12. Reason for RN walk in visit: Patient c/o redness and pain at zoster injection site. Patient reports he broke out 2 weeks ago with blister like rash with pain. Patient received zoster injection December 15, 2015. At right upper posterior arm where injection was given area noted to be scabbed with jagged edges with redness surrounding the site. Dr. examined patient's right posterior arm dx localized shingles from zoster injection.
Age: 72.0
Sex: M
Vaccine: PPV
Symptoms: Chills, Injection site erythema, Injection site swelling, Pyrexia
Clinical narrative: Fever and swelling and redness at injection site, chills.
Sex: U
Vaccine: HEP, RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to a patient of unknown age and gender. Information about concurrent conditions, medical history and concomitant medication was not provided. On 20-JAN-2016 the patient was administered with  a dose of improperly stored ROTATEQ (lot # L008996 and expiration date 01-DEC-2016, dose, dose # and route not reported) and RECOMBIVAX HB (lot # L027733 and expiration date 13-SEP-2017, dose, dose # and route not reported). No adverse effects reported. This is one of several reports received from the same source. Additional information is not expected since there was no consent for follow up contact.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to a patient of unknown age and gender. Information about concurrent conditions, medical history and concomitant medication was not provided. On 20-JAN-2016 the patient was administered with a dose of improperly stored oral, ROTATEQ (lot# L008996 and expiration date 01-DEC-2016, dose, dose# and route not reported). No adverse effects reported. Additional information is not expected since there was no consent for follow up contact.
Sex: U
Vaccine: HEP, RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to a patient of unknown age and gender. Information about concurrent conditions, medical history and concomitant medication was not provided. On 25-JAN-2016 the patient was administered with a dose of improperly stored ROTATEQ (lot# L013203 and expiration date 28-JAN-2017, dose, dose# and route not reported) and RECOMBIVAX HB (lot# L027733 and expiration date 13-SEP-2017, dose, dose# and route not reported). No adverse effects reported. This is one of several reports received from the same source. Additional information is not expected since there was no consent for follow up contact.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to a patient of unknown age and gender. Information about concurrent conditions, medical history and concomitant medication was not provided. On 20-JAN-2016 the patient was administered with a dose of improperly stored ROTATEQ (lot# L008996 and expiration date 01-DEC-2016, dose, dose# and route not reported). No adverse effects reported. This is one of several reports received from the same source. Additional information is not expected since there was no consent for follow up contact.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report has been received from a healthcare worker concerning a patient of unknown age and gender. The patient's concomitant medication, pertinent medical history and drug reactions/allergies were not reported. On 19-JAN-2016 the patient was administered a dose of improperly stored oral, ROTATEQ (strength, dose not reported, lot # L013202 and Exp. date 27-JAN-2017) orally. The vaccine was exposed to 34 F for 8 hours, and there was no previous temperature excursion. No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. Patient's pertinent medical history, drug reactions, allergies and concomitant medications were not provided. In January 2015 (one year ago), the patient was vaccinated with the first dose of pneumococcal vaccine (manufacturer unknown); the second dose was administered on 26-JAN-2016 (dose, route of administration and lot number were not reported). The next day, on 27-JAN-2016, the patient was vaccinated with a dose of ZOSTAVAX lot # L026414, expiry date 15-OCT-2016. No adverse effect was reported. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a certified medical assistant and refers to an unspecified number of patients of unknown age and gender. Medical history and concomitant medications were unknown. On an unknown date, an unspecified number of patients were vaccinated with improperly stored doses of VARIVAX (Merck) Lot # L031065, expiration date 18-AUG-2017; Lot # L029467, expiration date 06-AUG-2017; Lot #, reported as L035127, expiration date 14-SEP-2017; Lot # L002217, expiration date 21-JAN-2017; Lot # L031065 expiration date 18-AUG-2017 and Lot # L034372 expiration date 08-SEP-2017, (route, dose and anatomical location were not reported), which were exposed to 5.7 degrees F temperature, outside of the recommended range during a time frame of 30 minutes. There was not a previous temperature excursion. No adverse effects were reported. No product quality complaint (PQC) was involved. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV9
Symptoms: Headache
Clinical narrative: This spontaneous report was received from a nurse practitioner and refers to a 16 year old female patient. The patient's current conditions, medical history and concomitant medications were not reported. On 22-JAN-2016, the patient was vaccinated with GARDASIL 9 injection 0.5 ml, lot # L027282 (expiry date 21-SEP-2017) intramuscularly. On 25-JAN-2016, the patient developed a headache. Treatment was not given for the event. Lab diagnostic studies were not performed. The patient sought medical attention. On 28-JAN-2016, the patient saw nurse practitioner for the ongoing headache. Product quality complaint (PQC) was not involved. No further information was provided. The event was not resolved. The reporter did not provide causal relationship between the event and suspect therapy. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: This spontaneous report as received from a registered nurse, who learned from their traveling nurse, refers to three patients of unknown age and gender. The patients' pertinent medical history and drug reactions or allergies were not reported. On unknown dates, the patient were vaccinated with unknown doses of PNEUMOVAX 23 (lot # L024129, expiry date January 2017; route was not reported). The travelling nurse used pre-filled syringes for the first time. Concomitant medications were not reported. In January 2016 (reported as "within the last two weeks"), the patients experienced extreme swelling and redness in their entire upper arm area after receiving the PNEUMOVAX 23 vaccine from the pre-filled syringes. The patients sought medical attention. No lab diagnostics studies were performed. It was reported that the swelling lasted "longer than usual (3) days". The outcome of the events was reported as recovered on unknown dates in January 2016. The relatedness between the events and PNEUMOVAX 23 was not reported. The reporter requested for a lot check. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Blister
Clinical narrative: This spontaneous report was received from a retired nurse refers to a male patient in his 70's. The patient's drug reaction/allergies include eggs, chicken, unspecified food and airborne allergies. His pertinent medical history and concomitant medications were not reported. Approximately in 2014 (reported as 15 to 16 months ago) the patient was vaccinated with ZOSTAVAX to prevent shingles. On an unspecified date in 2014 (reported as approximately 2 weeks) after receiving ZOSTAVAX, he developed 10 mm to 14 mm size blisters on his legs and feet. He sought medical attention by visiting the office and recovered from the event on an unspecified date. The reporter did not provide the relatedness of the event with ZOSTAVAX. No further information was provided. Additional information is not expected as the reporter did not want any further involvement pertaining to this case and refused tot provide the physician's name and contact information.
Sex: F
Vaccine: TDAP
Symptoms: Headache
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of headache in a adult female patient who received BOOSTRIX. On an unknown date, the patient received BOOSTRIX. On an unknown date, an unknown time after receiving BOOSTRIX, the patient experienced headache. On an unknown date, the outcome of the headache was unknown. It was unknown if the reporter considered the headache to be related to BOOSTRIX. Additional details provided were as follows: This case was reported by the patient herself. The reporter stated that she experience headache while using BOOSTRIX vaccine. The reporter declined to answer questions for the report.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, Product packaging confusion
Clinical narrative: This spontaneous report was received from a licensed practical nurse (L.P.N.) (also reported as Licensed Vocational Nurse - L.V.N.). On an unknown date, the L.P.N. stated that the packing of MMR II (Lot# L027591; expiration date 23-JUL-2017) and sterile diluent (unspecified lot/expiration) appeared too similar and products could be confuse. The reporter denied administration of MMR II doses to patients. Also, the MMR II was accidentally left out because practice staff thought it was diluent. Additional information has been requested.
Age: 81.0
Sex: F
Vaccine: VARZOS
Symptoms: Back pain, Myalgia, Palpitations
Clinical narrative: Back pain, muscle aches, heart palpitations starting the day after the injection.
Age: 79.0
Sex: M
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: C/O (L) arm itching and redness to injection site.
Age: 84.0
Sex: M
Vaccine: PNC13
Symptoms: Erythema
Clinical narrative: Erythema the following day for 7 days.
Sex: F
Vaccine: HPVX
Symptoms: Injection site nodule
Clinical narrative: This spontaneous report was received from a nurse practitioner via a company representative refers to a female patient of unknown age. The patient's pertinent medical history and concomitant medications were not reported. She had no known allergies/drug reactions. On an unknown date the patient was vaccinated with unidentified Merck HPV vaccine intramuscularly. The reporter could not confirm which vaccine was administered GARDASIL or GARDASIL 9. The patient developed "a pea sized nodule" at the injection site following the administration of vaccine on an unspecified date in November 2015. The patient has sought unspecified medical attention and warm compress was used as treatment. The nurse practitioner stated that the "nodule" at the injection site "has shrunk", but "it's still present upon palpation" (recovered with sequelae) on an unspecified date. No lab diagnostic tests were performed. The reporter did not provide the relatedness of the event with the suspect therapy. Additional information has been requested.
Sex: U
Vaccine: HEP, RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to a patient of unknown age and gender. Information about concurrent conditions, medical history and concomitant medication was not provided. On 25-JAN-2016 the patient was administered with a dose of improperly stored oral ROTATEQ (lot# L013203 and expiration date 28-JAN-2017, dose, dose# and route not reported) and RECOMBIVAX HB (lot# L027733 and expiration date 13-SEP-2017, dose, dose# and route not reported). No adverse effects reported. This is one of several reports received from the same source. Additional information it not expected since there was no consent for follow up contact.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to a patient of unknown age and gender. Information about concurrent conditions, medical history and concomitant medication was not provided. On 21-JAN-2016 the patient was administered with a dose of improperly stored GARDASIL 9 (lot # L004014 and expiration date 04-MAR-2016, dose, dose # and route not reported). No adverse effects reported. This is one of several reports received from the same source, Additional information it not expected since there was no consent for follow up contact.
Age: 64.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Injection site pain
Clinical narrative: Patient called 1/12/16 complaining about arm pain following the vaccine administration on 12/19/15. Suggested to patient to get evaluated by MD.
Age: 64.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Pain in extremity
Clinical narrative: Patient called 1/12/16 complaining about arm pain following the vaccine administration on 12/19/15. Suggested to patient to get evaluated by MD.
Age: 52.0
Sex: M
Vaccine: FLUX, FLU3, FLUX
Symptoms: Injected limb mobility decreased, Injection site discomfort, Injection site pain
Clinical narrative: Patient developed arm soreness at injection site after vaccination that seemed to be worse than he had ever experienced before.  Still having issues with sore arm at injection site now 4 months later.  Patient had stated they have been in for a doctor visit on 2 different occasions since vaccination for the soreness.  No other symptoms described at this time.
Age: 52.0
Sex: M
Vaccine: FLUX, FLU3, FLUX
Symptoms: Injection site pain
Clinical narrative: Patient developed arm soreness at injection site after vaccination that seemed to be worse than he had ever experienced before.  Still having issues with sore arm at injection site now 4 months later.  Patient had stated they have been in for a doctor visit on 2 different occasions since vaccination for the soreness.  No other symptoms described at this time.
Age: 52.0
Sex: M
Vaccine: FLUX, FLU3, FLUX
Symptoms: Injected limb mobility decreased, Injection site pain, Musculoskeletal discomfort
Clinical narrative: Patient developed arm soreness at injection site after vaccination that seemed to be worse than he had ever experienced before.  Still having issues with sore arm at injection site now 4 months later.  Patient had stated they have been in for a doctor visit on 2 different occasions since vaccination for the soreness.  No other symptoms described at this time.
Age: 51.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Palpitations, Throat irritation
Clinical narrative: Patient's throat was bothering her.  Patient went to ER and mentions that she was administered BENADRYL and a dilator for her bronchi and was given therapy. Patient left the pharmacy well.
Age: 51.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Throat irritation
Clinical narrative: Patient's throat was bothering her.  Patient went to ER and mentions that she was administered BENADRYL and a dilator for her bronchi and was given therapy. Patient left the pharmacy well.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Paraesthesia, Pruritus, Rash
Clinical narrative: Tingling of skin similar to getting a rash. Ongoing until going to Dr. office to determine cause. Anti viral tablets, 7 day supply, Calamine lotion and cream for the rash. Burning and itching of skin with lots of pain. Thermador for pain.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Skin burning sensation
Clinical narrative: Tingling of skin similar to getting a rash. Ongoing until going to Dr. office to determine cause. Anti viral tablets, 7 day supply, Calamine lotion and cream for the rash. Burning and itching of skin with lots of pain. Thermador for pain.
Age: 56.0
Sex: F
Vaccine: TDAP
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: Severe arm pain exacerbation 4 days after injection. Reports inability to use her arm for 24 hours. No fever, chills, erythema.  Normal exam 1 week later.
Age: 61.0
Sex: M
Vaccine: FLU4
Symptoms: Mobility decreased, Pain, Pain in extremity
Clinical narrative: Day of administration, could not lift arm, continued to ache randomly. Pain shoots down arm and up to neck. Pain comes and goes, still experiencing symptoms.
Age: 4.0
Sex: F
Vaccine: DTAP, FLU4, IPV, MMRV
Symptoms: Injection site erythema, Injection site induration, Injection site swelling, Injection site urticaria, Skin reaction
Clinical narrative: No treatment indicated. Well child check on 01/29/16. PROQUAD, influenza, DTaP, Polio given. Over the weekend father observed painless redness and swelling of the PROQUAD injection site. No distant rash, hives, itching, pain, fever. On 2/1/15 3 cm approximately 1.25" painless indurated central wheal surrounded by malar erythema at lateral aspect of left upper thigh. Minor local cutaneous skin reaction to PROQUAD vaccine. Lungs clear throughout with normal work of breathing.
Age: 50.0
Sex: F
Vaccine: TDAP
Symptoms: Grip strength decreased, Immune system disorder, Mobility decreased, Muscular weakness, Musculoskeletal pain
Clinical narrative: Right arm was very painful after receiving the tetanus vaccine on 10/29/2015 for the days leading up to 11/03/2015.  11/03/2015 I could not feel my arm, could barely move my arm, entire arm and shoulder hurt with pain down to my fingers, arm was very weak getting weaker each day, I started dropping light stuff when I tried to pick it up.  Notified my doctor who told me it sounded like Brachial Neuritis and to see a neurologist.  I saw Dr. who told me that my immune system was attacking my nerves due to the tetanus vaccine.  Presently in physical therapy.
Age: 50.0
Sex: F
Vaccine: TDAP
Symptoms: Pain in extremity, Sensory loss
Clinical narrative: Right arm was very painful after receiving the tetanus vaccine on 10/29/2015 for the days leading up to 11/03/2015.  11/03/2015 I could not feel my arm, could barely move my arm, entire arm and shoulder hurt with pain down to my fingers, arm was very weak getting weaker each day, I started dropping light stuff when I tried to pick it up.  Notified my doctor who told me it sounded like Brachial Neuritis and to see a neurologist.  I saw Dr. who told me that my immune system was attacking my nerves due to the tetanus vaccine.  Presently in physical therapy.
Age: 13.0
Sex: M
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2014US024326, is an initial spontaneous report received from a nurse on 02 Dec 2014. This report refers to a 13 year old male patient. Medical history and concomitant medication were not reported. He was vaccinated with FLUVIRIN, (batch number: 14511P, expiry date: Mar 2015) intramuscularly at a dose of 0.5 ml on 05 Nov 2014. Nurse reported that PFS of FLUVIRIN was stored at 49 degree F for 1 hour and 15 minutes. No adverse event was reported following this maladministration (Incorrect storage of drug). No further information was provided.
Age: 9.0
Sex: M
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2014US024332, is an initial spontaneous report received from a nurse on 02 Dec 2014 with a follow up information received from the nurse on 19 Jan 2015. This report refers to a 9 years old male patient. His medical history and concomitant medications were not reported. His vaccination history included administration of previous FLUVIRIN (batch number: not reported) which was previously tolerated. He was vaccinated with FLUVIRIN (batch number: 14511P expiry date: Mar 2015) intramuscularly at a dose of 0.5 ml in the left deltoid on 05 Nov 2014. It was reported that the patient received FLUVIRIN PFS that was stored at 49 degree F for 1 hour 15 minutes. No adverse event was reported following this maladministration. The reporter confirmed that the patient did not experience any adverse reaction following administration of incorrectly stored vaccine. Follow up information received from the nurse on 19 Jan 2015: Updated vaccination history, site of vaccination and reporter's comment.
Age: 15.0
Sex: F
Vaccine: HPV4, HPV4, HPV4, HPV4, HPV4, HPV4
Symptoms: Death, Myocardial infarction, Pain, Seizure, Tachycardia
Clinical narrative: Possible Lyme disease, 3 and a half years of pain with seizures and tachycardia. Seizure led to heart attack and death on 1/12/16.
Age: 15.0
Sex: F
Vaccine: HPV4, HPV4, HPV4, HPV4, HPV4, HPV4
Symptoms: Death, Feeding disorder, Generalised tonic-clonic seizure, Hyperacusis, Myocardial infarction
Clinical narrative: Possible Lyme disease, 3 and a half years of pain with seizures and tachycardia. Seizure led to heart attack and death on 1/12/16.
Age: 15.0
Sex: F
Vaccine: HPV4, HPV4, HPV4, HPV4, HPV4, HPV4
Symptoms: Pain, Parenteral nutrition, Photophobia, Seizure, Tachycardia
Clinical narrative: Possible Lyme disease, 3 and a half years of pain with seizures and tachycardia. Seizure led to heart attack and death on 1/12/16.
Age: 15.0
Sex: F
Vaccine: HPV4, HPV4, HPV4, HPV4, HPV4, HPV4
Symptoms: Vaccination complication
Clinical narrative: Possible Lyme disease, 3 and a half years of pain with seizures and tachycardia. Seizure led to heart attack and death on 1/12/16.
Age: 15.0
Sex: F
Vaccine: HPV4, HPV4, HPV4, HPV4, HPV4, HPV4
Symptoms: Death, Fatigue, Inappropriate schedule of drug administration
Clinical narrative: Possible Lyme disease, 3 and a half years of pain with seizures and tachycardia. Seizure led to heart attack and death on 1/12/16.
Age: 15.0
Sex: F
Vaccine: HPV4, HPV4, HPV4, HPV4, HPV4, HPV4
Symptoms: Death, Seizure
Clinical narrative: Possible Lyme disease, 3 and a half years of pain with seizures and tachycardia. Seizure led to heart attack and death on 1/12/16.
Age: 15.0
Sex: F
Vaccine: HPV4, HPV4, HPV4, HPV4, HPV4, HPV4
Symptoms: Death, Gastrointestinal tube insertion, Pain
Clinical narrative: Possible Lyme disease, 3 and a half years of pain with seizures and tachycardia. Seizure led to heart attack and death on 1/12/16.
Age: 18.0
Sex: F
Vaccine: HPV4, HPV4, HPV4, HPV4, HPV4, HPV4
Symptoms: Death, Myocardial infarction, Pain, Seizure, Tachycardia
Clinical narrative: Initial and follow up information has been received from a physician, referring to a 18 year old female patient. The patient's medical history, concurrent conditions and drug reactions/allergies were not reported. The physician obtained the information in a public post, which was posted by the mother of the patient. In approximately 2013 (reported as "about 3 years ago"), the patient was vaccinated with the first dose of GARDASIL (dose, route, lot # expiration date were not reported). Then, in approximately 2014 (reported as "about 2 years ago") the patient received the second dose of GARDASIL (dose, route, lot # and expiration date were not reported). There was no concomitant medication reported. It was reported that, on an unknown date, the patient experienced a "general fatigue" after receipt of the second dose of GARDASIL in approximately 2014. The patient did not seek for medical attention at this time. At the end, the reporter stated that 5 days after receiving the dose (unspecified dose number), the patient died on an unspecified date (discrepant information as it was also reported that the patient died "some time last week, January 2016"). The cause of death was not provided. The patient did not seek any medical attention. No product quality complaint was involved. It was reported that the patient's mother was blaming GARDASIL for causing her daughter's death. At the time of the report, the outcome of general fatigue was unknown. The relatedness between the events and GARDASIL was not provided. Additional information has been requested.