chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Cough, Ocular hyperaemia
Clinical narrative: Pt received high dose flu vaccine at OV on 1/29/16 at 1117am. Pt returned to health center at 440 pm with coughing and red eyes, Pt declined IM SOLU-MEDROL or epinephrine; administered albuterol nebulizer x 1 and 50 mg BENADRYL given; instructions give to seek emergent care if symptoms worsen.
Age: 2.0
Sex: F
Vaccine: DTAP, IPV
Symptoms: Anaphylactic reaction, Respiratory distress
Clinical narrative: ADPT, IPV given. 30 minutes later child developed full blown anaphylaxis. With respiratory distress. Epipen given and transported to hospital.
Age: 33.0
Sex: F
Vaccine: HEP, HEPA, MMR, TDAP
Symptoms: Unevaluable event
Clinical narrative: No symptoms no signs, advised to return is 6 months.
Age: 46.0
Sex: F
Vaccine: FLU3, HEP, MMRV, TDAP
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: None stated.
Age: 75.0
Sex: M
Vaccine: FLU3
Symptoms: Diverticulitis, Erythema, Injection site pain, Injection site swelling, Myalgia
Clinical narrative: I received FLUZONE HD PF 15-16 Inj on September 28, 2015. It was given in the left deltoid. It was administered correctly. Within an hour aching began. Swelling and redness was apparent within 2 hours. Aching, swelling, and redness persisted for 2 days. Muscle soreness with pain on movement involving the deltoid muscle lasted until the end of October, 2015. The pain was initially 3 on a scale of 1 to 10. I have not had this extended period of pain previously with this vaccine. Beginning November 22, 2015, I experienced onset of acute diverticulitis. I was seen by my primary care physician, 11-24-2015, and treated with a combination of levofloxacin and metronidazole. On November 25, 2015, the injection site of the influenza immunization once again became painful with slight swelling and no redness. The patient was again 3 on a scale of 1 to 10. The left deltoid pain is still present today, but now has decreased to 1 or 2 on the scale of 1 to 10. I have received the high dose influenza vaccine previously with only minimal soreness for 1 day. I believe that the recurrence coinciding with an acute infection is unusual, and could be connected to this particular vaccine type or lot. I am enclosing records of these immunizations and a summary of my medical history.
Age: 75.0
Sex: M
Vaccine: FLU3
Symptoms: Pain, Swelling
Clinical narrative: I received FLUZONE HD PF 15-16 Inj on September 28, 2015. It was given in the left deltoid. It was administered correctly. Within an hour aching began. Swelling and redness was apparent within 2 hours. Aching, swelling, and redness persisted for 2 days. Muscle soreness with pain on movement involving the deltoid muscle lasted until the end of October, 2015. The pain was initially 3 on a scale of 1 to 10. I have not had this extended period of pain previously with this vaccine. Beginning November 22, 2015, I experienced onset of acute diverticulitis. I was seen by my primary care physician, 11-24-2015, and treated with a combination of levofloxacin and metronidazole. On November 25, 2015, the injection site of the influenza immunization once again became painful with slight swelling and no redness. The patient was again 3 on a scale of 1 to 10. The left deltoid pain is still present today, but now has decreased to 1 or 2 on the scale of 1 to 10. I have received the high dose influenza vaccine previously with only minimal soreness for 1 day. I believe that the recurrence coinciding with an acute infection is unusual, and could be connected to this particular vaccine type or lot. I am enclosing records of these immunizations and a summary of my medical history.
Age: 26.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Injection site erythema, Injection site induration, Injection site rash
Clinical narrative: Flu vaccine (L) deltoid - redness, induration at time of injection already resolved when patient returned to clinic for another visit. Tdap (R) deltoid - skin colored bumpy, non-itchy rash around injection site. Pt made us aware on 1/20/16.
Age: 0.19
Sex: M
Vaccine: DTAPIPV, HEP, HIBV, PNC13
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: None stated.
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Drug administered at inappropriate site, Injected limb mobility decreased, Injection site pain, Laboratory test, Nuclear magnetic resonance imaging
Clinical narrative: Person who administered shot gave the shot in a place very high up on my left arm. I asked why so high. I had never gotten a flu shot that high up. It also hurt a lot. Never had that happen before. That night I could not move my arm.
Age: 65.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Cellulitis, Erythema, Peripheral swelling
Clinical narrative: Cellulitis. Swelling and redness of arm.
Age: 0.33
Sex: F
Vaccine: DTAPIPV
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: None stated.
Age: 71.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Synovial cyst
Clinical narrative: Synovial cyst. Ibuprofen 800 TID, cold compress.
Age: 4.0
Sex: F
Vaccine: DTAPIPVHIB, MMRV, PNC13
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth, Pyrexia
Clinical narrative: Patient returned to clinic 2 days later experiencing fever since vaccine administered. Vaccine sites (Left and Right deltoids) are red, swollen, warm, and painful.
Age: 61.0
Sex: M
Vaccine: FLUX
Symptoms: Ageusia, Headache, Myalgia
Clinical narrative: Cae number PHHY2014US159804, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 545659) website on 28 Nov 2014. This report refers to a 61-year-old male patient. He was vaccinated with Seasonal Influenza vaccine (manufacturer and batch number: not reported) on 26 Sep 2014. On the same date, after vaccination he experienced complete loss of sense of taste, severe muscle soreness and headaches. The outcome of the events reported as not recovered. The events reported as non-serious. The causality of the events was not reported.
Age: 33.0
Sex: F
Vaccine: FLUX
Symptoms: Extensive swelling of vaccinated limb, Lymph node pain, Lymphadenopathy, Pain in extremity, Rash
Clinical narrative: Case number PHEH2014US020355, is a spontaneous report initially received from a radiologist (also patient) on 07 Oct 2014. This report refers to a 33-year-old female patient (age at the time of report). Her concurrent condition included allergy to latex. Concomitant medications were not reported. She was vaccinated with seasonal influenza vaccine (manufacturer and batch number unknown) on an unknown date. On an unknown date after vaccination, her whole arm and lymph nodes on that entire side swelled up and was very painful. One year it was minor and rashy and each year it got increasingly worse. It was reported that it has been a long time since she got a flu vaccine due to these events. She was pregnant at the time of this report. Outcome of lymphadenopathy, lymph node pain, extensive swelling of vaccinated limb and pain in arm were assessed as non-serious. Seriousness criteria of rash were not reported. Causality of the events was not reported. Follow-up information received from radiologist (also patient) on 02 Nov 2015: New events (lymph node pain and pain in arm), patient's demographics, outcome, seriousness criteria and other clinically relevant information updated in the narrative.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a physician referring to unspecified number of patients of unknown age and gender. On unspecified dates the patients were vaccinated with improperly stored doses of oral, ROTATEQ (lot # L020865, expiration date 09-FEB-2017, dose unknown) orally, which were under the temperature of 24 degree with time frame reported as 838 hours. The temperature was back in range at the time of the report. No previous temperature excursion was reported. No adverse effects was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: M
Vaccine: PPV
Symptoms: Abdominal distension, Arthralgia, Chest pain, Diarrhoea, Myalgia
Clinical narrative: Information has been received from a male patient of unknown age with high blood pressure, gout and diverticulitis, referring to himself. On 15-JAN-2016 the patient was vaccinated with a dose of PNEUMOVAX 23, on time injection, (dose, dose #, lot #, route and application site were not reported). Concomitant medications included unspecified medications to treat high blood pressure, gout, and diverticulitis. On 15-JAN-2016 the patient experienced joint pain, muscle aches, and pain in his upper chest. The patient also experienced diarrhea and a "bloating" feeling. No medical attention was sought. No treatment was given for events. No lab tests were performed. The outcome of the events was reported as not recovered/not resolved. The causality was not reported. Additional information is not expected because patient wishes to remain anonymous and did not disclose the name of the physician.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to an unspecified number of patients of unknown age and gender. On 19-OCT-2015, doses of VARIVAX (Merck) (lot # L023588, expiration date: 26-JUN-2017) were excursion in temperature for 69 F for 12 hours but they were not administered. On 16-NOV-2015, the doses of vaccine were excursion again in temperature of 80 F for 12 hours. On unknown dates, the patients were vaccinated with the doses of VARIVAX (Merck) (route and dose were unknown) (incorrect product storage). No adverse effects were reported. Additional information has been requested.
Age: 45.0
Sex: F
Vaccine: VARZOS
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 45 year old female patient. No concurrent conditions, medical history or allergy/drug reactions were reported. On 12-JAN-2016 the patient was inadvertently vaccinated with ZOSTAVAX lot L034724 with expiry: 09-DEC-2016, in the right arm (dose, frequency and route not reported) instead of VARIVAX (Merck) (wrong drug administered). No adverse effects were reported. There were no product quality complaint (PQC) involved. Additional information is not expected as the reporter did not wish further contact.
Sex: F
Vaccine: HPV4
Symptoms: Feeling abnormal, Vaccination complication
Clinical narrative: This spontaneous report was received from a female patient of unknown age. Patient's current conditions and pertinent medical history was not provided. On an unknown date in July 2015, the patient received unidentified Merck HVP vaccine administered (name and lot number not provided). It was unspecified if the patient was vaccinated with "GARDASIL" or "GARDASIL 9". The strength, dosage, dose number, route, lot# and expiration date of the vaccine administered was unknown. Concomitant medication was not provided. The patient enquired how to get the vaccine administered out of her system. After vaccination the patient reported that lots had happened to her, she has also experienced awful side effects. The patient did not elaborate on the actual side effects because she was too upset to continue. The outcome of events were unknown. There was no product quality complaints. No further information was provided. The causality was not reported. Additional information is expected, no contact details were provided.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a physician referring to unspecified number of patients of unknown age and gender. On unspecified dates the patients were vaccinated with improperly stored dose of RECOMBIVAX HB (lot# L038018, expiration date 13-SEP-2017, dose and route unknown), which were under the temperature of 24 Centigrade degree with time frame reported as 838 hours. The temperature was back in range at the time of the report. No previous temperature excursion was reported. No adverse effects was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 55.0
Sex: M
Vaccine: PPV, VARZOS
Symptoms: Guttate psoriasis, Medication error
Clinical narrative: This spontaneous report was received from a registered nurse regarding an approximately 55 year old male patient. The concurrent conditions included an unspecified neoplasm, allergy to cat dander and allergy to dust. Information on the medical history of the patient was not reported. On 23-SEP-2015 the patient was vaccinated with PNEUMOVAX 23, (lot expiry date, dose #, anatomical location were not specified) intramuscularly. Other suspect therapies included ZOSTAVAX lot # L035285, expiry date- 15-DEC-2016, (dose # and anatomical location were not specified) subcutaneously. Concomitant therapies included amlodipine, lorazepam, triamcinolone acetonide, clobetasol propionate, calcipotriene, mometasone furoate (oral), VIAGRA, Lisinopril (manufacturer unknown), LEVITRA, PRAVACHOL, fluticasone propionate, ADVAIR, FLONASE, albuterol, CLARITIN, PROVENTIL, vitamin E and ascorbic acid. On 02-OCT-2015, the patient was vaccinated with ZOSTAVAX subcutaneously after being administered a dose of PNEUMOVAX 23. Approximately in the year 2015 (an unspecified amount of time after receiving ZOSTAVAX), the potent experienced guttate psoriasis and began visiting a dermatologist for his condition since an unknown date in December 2015 and treatment of phototherapy was given for the adverse event. Reporting nurse stated that the patient's brother, who was a dentist, felt that the patient ha developed shingles from ZOSTAVAX and that this was the cause of the guttate psoriasis. The patient had sought medical attention by visiting the physician. There were no lab diagnostics performed. There was no intervention to prevent serious criteria. Outcome of guttate psoriasis was reported as not recovered/not resolved at the time of reporting. There was no Product Quality Complaint (PQC) filed. Reporting nurse did not provide the causal relationship of the event guttate psoriasis with PNEUMOVAX 23 and ZOSTAVAX. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Abnormal behaviour
Clinical narrative: Information has been received from a consumer referring his/her daughter, a female patient of unknown age. The patient's concurrent conditions and medical history were not reported. On an unknown date the patient was vaccinated with a dose of GARDASIL (lot #, dose and route were unknown). The patient's concomitant medication was not reported. On an unknown date, the patient was "a shadow of her former self". The outcome of the adverse event was unknown. The causality between the event and GARDASIL was not reported. Additional information is not expected.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant refers to multiple unspecified patients of unknown age and gender. The medical history, concurrent conditions and concomitant medications were not reported. On an unknown dates, the patients were vaccinated with improperly stored (temperature excursion was 48 Fahrenheit, time frame 20 minutes, because of data logger) RECOMBIVAX HB injection, lot # L029361, expiry date 14-AUG-2017, (dose, frequency and route of administration were not reported). Previous temperature excursion was reported as no. No adverse effects reported. The outcome of events was unknown. No product quality complaint (PQC) was involved. No further information was provided. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a Registered Nurse and refers to multiple unspecified patients of unknown age and gender. Patient's concurrent conditions, medical history and concomitant medications were unknown. It was reported that doses of GARDASIL 9 Lot # L08083, expiry date 03-SEP-2017 (dose and route were not reported) that had been exposed to 34.4F for 2 hours and then back in the range, were given to unspecified patients on unspecified dates. It was also confirmed that the vaccine had not had previous temperature excursion. It was unknown if the patients sought medical attention. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a Registered Nurse and refers to multiple unspecified patients of unknown age and gender. Patient's concurrent condition, medical history and concomitant medications were unknown. It was reported that doses of PEDVAXHIB Lot # L030870, expiry date 10-AUG-2018 (dose and route were not reported) that had been exposed to 34.4F for 2 hours and then back in the range, were given to unspecified patients on unspecified dates. It was also confirmed that the vaccine had not had previous temperature excursion. It was unknown if the patients sought medical attention. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same source. Lot number L030870 has been verified to be a valid lot number for PEDVAXHIB. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report has been received from a healthcare worker via Company Representative concerning unspecified number of patients of unknown age and gender. Patient's concomitant medication, pertinent medical history and drug reactions/allergies were not reported. On unknown dates, the patients were vaccinated with doses of GARDASIL 9 (strength, frequency, route, lot # and Exp. date not reported) outside the recommended time frame. No adverse effects were reported. This is one of two reports received from the same reporter. 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 unspecified patients of unknown age and gender. The patient's medical history, concomitant therapy and drug reactions were not reported. The primary reporter reported that improperly stored doses of ZOSTAVAX (lot # L029484, expiry date 06-NOV-2016, lot # L032184, expiry date 25-NOV-2016) were administered to unspecified patients. One unspecified patient received ZOSTAVAX (lot # L032184, expiry date 25-NOV-2016) on 22-DEC-2015 and two unspecified patients received ZOSTAVAX (lot numbers unspecified) on 21-JAN-2016. The ZOSTAVAX was exposed to 40 Fahrenheit for 912 hours (38 days). Back in range was reported as "Yes". There was no previous temperature excursion. No adverse effects were reported. Additional information has been requested.
Age: 26.0
Sex: F
Vaccine: HPV9
Symptoms: Drug administered at inappropriate site, No adverse event
Clinical narrative: Information has been received from a Licensed Practical Nurse referring to a 26 year old female patient. Information about medical history and concurrent condition were unspecified. On 27-JAN-2016 the patient was vaccinated with her first dose of GARDASIL 9 (lot # L045711, expiration date 08-MAY-2017, 0.5 ml, intramuscular in the gluteal muscle) (Vaccine administered at inappropriate site). No adverse effects were reported. Additional information is not expected because the reporter did not want to be contacted.
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Syncope
Clinical narrative: Information has been received from a physician via company representative referring to a 12 year old female patient. On unspecified dates, the patients was vaccinated with GARDASIL 9 (dose 1 and 2 timely, lot number and route not provided). The patient did not experienced adverse reactions with the first two doses. In January 2016 ("sometime last week"), the patient was vaccinated with the third dose of GARDASIL 9 (lot number and route not provided). The patient fainted after administration of GARDASIL 9. The patient was not injured and "kept down" as well as monitored for an unspecified amount of time by the physician. The patient recovered not long after being monitored. There was no product quality issue (PQC) involved. Additional information is not expected as we could not contact the physician.
Age: 75.0
Sex: M
Vaccine: FLUX
Symptoms: Cough, Dyspnoea, Eye pruritus, Fatigue, Pain
Clinical narrative: Case number PHHY2015US010817 is an initial spontaneous report received from a health care professional via the Vaccine Adverse Events Reporting System website on 06 Jan 2015. This report refers to a 75 year old male patient. His current conditions included high blood pressure and chronic obstructive pulmonary disease. His past medical history included glaucoma. His concomitant medications included losartan/HCTZ at a dose of 50/12.5 mg, clopidogrel at a dose of 75 mg, dorzolamide, TRAVATAN Z, SPIRIVA, Tamsulosin and Low dose aspirin. On 17 Oct 2014, he was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported). On the same day, after the vaccination, he developed cough, itchy eyes, aches, fatigue, vomiting and restricted breathing. The final outcome of the events was complete recovery. The events were reported as non serious and causality of the events was not reported.
Age: 75.0
Sex: M
Vaccine: FLUX
Symptoms: Vomiting
Clinical narrative: Case number PHHY2015US010817 is an initial spontaneous report received from a health care professional via the Vaccine Adverse Events Reporting System website on 06 Jan 2015. This report refers to a 75 year old male patient. His current conditions included high blood pressure and chronic obstructive pulmonary disease. His past medical history included glaucoma. His concomitant medications included losartan/HCTZ at a dose of 50/12.5 mg, clopidogrel at a dose of 75 mg, dorzolamide, TRAVATAN Z, SPIRIVA, Tamsulosin and Low dose aspirin. On 17 Oct 2014, he was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported). On the same day, after the vaccination, he developed cough, itchy eyes, aches, fatigue, vomiting and restricted breathing. The final outcome of the events was complete recovery. The events were reported as non serious and causality of the events was not reported.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site rash, Syncope
Clinical narrative: Patient had primary rash around injection site on right upper arm, about 4 inches diameter. Secondary redness spread to elbow and erythema; faint. No further complications; patient seen by MD.
Sex: U
Vaccine: MENB
Symptoms: Injection site pain
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of injection site pain in a patient who received BEXSERO. In December 2015, the patient received BEXSERO .5 ml. On an unknown date, less than a month after receiving BEXSERO, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was recovered/resolved. It was unknown if the reporter considered the injection site pain to be related to BEXSERO. Additional details provided were as follows: The physician's office had called the sales representative to report this case. The patient had been vaccinated with BEXSERO within the last month or so who had about 5 days of pain at the injection site after vaccination with BEXSERO. The patient's gender, lot number and expiration date of the vaccine were unknown.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a unspecified number of patients of unknown age and gender. The patient's pertinent medical history and concurrent conditions were not reported. No previous drug reactions or allergies were reported. On an unknown date the unspecified number of patients were vaccinated with improperly stored PEDVAXHIB (dosing details were not reported) (lot # K015462 with an expiry date of 10-JUL-2017 exposed to 30 F for 40.18 hours), (lot # K026532 with an expiry date of 07-AUG-2017 exposed to 30 F for 37.68 hours), (lot # L006545 with an expiry date of 16-NOV-2017 exposed to 30 F for 27.68 hours), (lot # L012837 with an expiry date of 08-MAR-2018 exposed to 30.4 F for 10 hours) and (lot # L014426 with an expiry date of 08-MAR-2018 exposed to 30.4 F for 20.75 hours). No concomitant medications were reported. No adverse effects were reported. There was no product quality complaint involved. This is one of the several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a unspecified number of patients of unknown age and gender. The patient's pertinent medical history and concurrent conditions were not reported. No previous drug reactions or allergies were reported. On an unknown date the unspecified number of patients were vaccinated with improperly stored VARIVAX (Merck) (dosing details were not reported) (lot # K016132 with an expiry date of 24-SEP-2016 exposed to 27.7 F for 252.57 hours), (lot # L017142 with an expiry date of 13-MAY-2017 exposed to 24.3 F for 133 hours) and (lot # L026410 with an expiry date of 15-FEB-2017 exposed to 19.9 F for 10.25 hours). No concomitant medications were reported. No adverse effects were reported. There was no product quality complaint involved. This is one of the several reports received from the same reporter. 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 worker refers to a unspecified number of patients of unknown age and gender. The patient's pertinent medical history and concurrent conditions were not reported. No previous drug reactions or allergies were reported. On an unknown date the unspecified number of patients were vaccinated with improperly PROQUAD (Merck) (dosing details were not reported) (lot # K022447 with an expiry date of 13-MAY-2016 exposed to 30 F for 50.43 hours and 27.7 F for 164.82 hours), (lot # L009207 with an expiry date of 17-SEP-2016 exposed to 30 F for 24.68 hours and 27 F for 79.75 hours), (lot # L023112 with an expiry date of 24-DEC-2016 exposed to 30.2 F for 10.75 hours and 24.3 for 133 hours) and (lot # L030591 with an expiry date of 10-FEB-2017 exposed to 30.4 F for 10.50 hours and 24.3 F for 53.25 hours). No concomitant medications were reported. No adverse effects were reported. There was no product quality complaint involved. This is one of the 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: This spontaneous report as received from a healthcare worker refers to a unspecified number of patients of unknown age and gender. The patient's pertinent medical history and concurrent conditions were not reported. No previous drug reactions or allergies were reported. On an unknown date the unspecified number of patients were vaccinated with improperly stored GARDASIL (dosing details were not reported) (lot # K007264 with an expiry date of 02-MAR-2017 exposed to 31.8 F for 8.75 hours) and (lot # K009482 with an expiry date of 06-MAR-2017 exposed to 31.8 F for 10.75 hours). No concomitant medications were reported. No adverse effects were reported. There were no product quality complaint involved. This is one of the several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a unspecified number of patients of unknown age and gender. The patient's pertinent medical history and concurrent conditions were not reported. No previous drug reactions or allergies were reported. On an unknown date the unspecified number of patients were vaccinated with improperly stored GARDASIL 9 (dosing details were not reported) (lot # K026242 with an expiry date of 28-JAN-2017 exposed to 30 F for 37.68 hours), (lot # L004014 with an expiry date of 04-MAR-2017 exposed to 30 F for 16.93 hours) and (lot # L007560 with an expiry date of 15-JUN-2017 exposed to 30 F for 20.75 hours). No concomitant medications were reported. No adverse effects were reported. There was no product quality complaint involved. This is one of the several reports received from the same reporter. Additional information has been requested.
Age: 50.0
Sex: M
Vaccine: RAB
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Case number PHEH2015US020733, is an initial spontaneous report received from healthcare professional on 08 Oct 2015. This report refers to a 60 year old male patient. Medical history and concomitant medication was not reported. His vaccination history included post exposure treatment with first dose of RABAVERT (batch number: unknown) on 10 Sep 2015 (day 0), second dose on 13 Sep 2015 (day 3), third dose on 17 Sep 2015 (day 7). The patient was scheduled to get the fourth dose of RABAVERT on 24 Sep 2015 (day 14) but did not receive it until 26 Sep 2015. The lot numbers and expiry dates not available at time of this report. No adverse event was reported following the medication error. No further information was reported. Follow-up information received on 26 January 2016: This case was reported by a other health professional and described the occurrence of drug dose administration interval too long in a 50-year-old male patient who received RABAVERT. On 26th September 2015, the patient received the 4th dose of RABAVERT (injection) which led to a drug dose administration interval too long.
Age: 9.0
Sex: F
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to unspecified number of patients of unknown age and gender. No information regarding their current condition and medical history was provided by the reporter. On an unknown date since 30-DEC-2015, the patients were vaccinated with improperly stored VARIVAX (Merck) (strength, dose, route and indication not reported) of lot # L015048 and expiry date: 29-APR-2017. Concomitant medications were not mentioned. The vaccine was stored at 26 degree Fahrenheit for a time frame of 18 hours which was outside of the recommended range (incorrect product storage) and administered to patients. There was no previous temperature excursion. No adverse effects have been reported. No additional information was provided. Product Quality complaint was not filed. Additional information has been requested. This is one of the five reports received from the same reporter.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to unspecified number of patients of unknown age and gender. No information regarding their current conditions and medical history was provided by the reporter. On an unknown date since 30-DEC-2015, the patients were vaccinated with improperly stored GARDASIL (strength, dose, route and indication not reported) of lot # K011325 and expiry date: 08-APR-2017. Concomitant medications were not mentioned. The vaccine was stored at 58.5 degree Fahrenheit for a time frame of 24 hours which was outside of the recommended range (incorrect product storage) and administered to patients. There was no previous temperature excursion. No adverse effects have been reported. No additional information was provided. Product Quality complaint was not filed. Additional information has been requested. This is one of the five reports received from the same reporter.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to unspecified number of patients of unknown age and gender. No information regarding their current conditions and medical history was provided by the reporter. On an unknown date since 30-DEC-2015, the patients were vaccinated with improperly stored RECOMBIVAX HB (strength, dose, route and indication not reported) of lot # J012567 and expiry date: 30-JAN-2016. Concomitant medications were not mentioned. The vaccine was stored at 58.5 degree Fahrenheit for a time frame of 24 hours which was outside of the recommended range (incorrect product storage) and administered to patients. There was no previous temperature excursion. No adverse events have been reported. No additional information was provided. Product Quality complaint was not filed. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to unspecified number of patients of unknown age and gender. No information regarding their current conditions and medical history was provided by the reporter. On an unknown date since 30-DEC-2015, the patients were vaccinated with improperly stored ROTATEQ (strength, dose, route and indication not reported) of lot # L020859 and expiry date: 19-JAN-2017. Concomitant medications were not mentioned. The vaccine was stored at 58.5 degree Fahrenheit for a time frame of 24 hours which was outside of the recommended range (incorrect product storage) and administered to patients. There was no previous temperature excursion. No adverse effects have been reported. No additional information was provided. Product Quality complaint was not filed. Additional information has been requested. This is one of the five reports received from the same reporter.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a Certified Medical Assistant regarding multiple unspecified patients of unknown demographics. There was no information about concurrent condition and historical medication. In between 18-NOV-2015 and 15-DEC-2015, the patients were vaccinated with improperly stored doses of VAQTA lot # L039659, expiration date- 15-MAR-2017, (incorrect product storage). No concomitant medication was reported. No adverse event was reported. The outcome of the event was unknown. Temperature was 35F, Time frame was 3 hours, 10 minutes, it was not out of range before and Data logger was Yes. Additional information has been requested.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: This spontaneous report as received from a pharmacist via company representative refers to a 66 year old female patient. The patient's pertinent medical history and concurrent conditions were not reported. On an unknown date the patient was vaccinated with ZOSTAVAX, subcutaneous. Concomitant medications were not provided. The pharmacist stated that the patient had called on Sunday night (date unknown) to report swelling, soreness, tenderness, and redness around the injection after receiving ZOSTAVAX. As a treatment patient was advised to apply ice in the injection site area. Patient did not seek medical attention. Causality assessment was not provided. No further AE information was provided. Product quality complaint was not filed. Additional information has been requested.
Age: 79.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling, Platelet count decreased
Clinical narrative: This spontaneous report was received from a 79 year old female patient reporting on herself. The patient's concurrent conditions and medical history were not provided. On an unknown date in 2015, the patient was vaccinated with a dose of PNEUMOVAX 23, (dose, route, lot number and expiration date were not provided). Concomitant therapies were not provided. The patient stated that on 18-NOV-2015 her upper arm "swelled and was red for a couple days" after receiving a dose of PNEUMOVAX 23. She also said "I had a low blood platelet count when I had my routine blood work during my doctor's visit". The patient sought medical attention by pharmacist visit and no treatment was received for the adverse events. The outcome of platelet count decreased, injection site swelling and injection site erythema was unknown. The relatedness between the events and suspect therapy was unknown. Additional information is not expected since no permission for further contact was given.
Age: 66.0
Sex: M
Vaccine: HEPAB, IPV, TDAP
Symptoms: Pruritus, Rash
Clinical narrative: 1/26/16 Pt. came to the Imm. clinic to update immunizations related to his annual physical and job description. Pt. stated he began itching that evening and developed a rash on his rt. lower leg and left ankle. 1/28/16 Pt. alerted Imms clinic about the rash and itching. Pt. chose to see personal PCP after 1/28/16.
Age: 36.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Pain, Swelling
Clinical narrative: Redness, swelling, pain.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: Pt developed varicella after 2 doses of vaccine.
Age: 86.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site pruritus, Pain, Pain in extremity
Clinical narrative: Rt upper arm red firm at injection site itches, 8 out of 10 pain with arm movement. Referred to PMD.
Age: 60.0
Sex: F
Vaccine: HEPA, TYP
Symptoms: Nasopharyngitis, Oropharyngeal pain, Pyrexia, Rash
Clinical narrative: Vaccine administration yesterday. Today she feels like she is getting a cold (sore throat). No trouble breathing, fever. Asked if she could take COLD-EEZE. 1-18-16 - pt. called today feeling back to normal but noticed rash on back. No pain. No itching. Encouraged her to see PMD.
Age: 0.33
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Crying, Irritability
Clinical narrative: Prolonged uncontrollable crying and irritability greater than or equal to 3 hrs.
Age: 53.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Skin irritation
Clinical narrative: Pt. was given Tdap on 1/11/16 - arm started having redness and irritation 5 days post shot peaked at 7 days post shot - warm compresses. Advised to call if worse.
Age: 66.0
Sex: F
Vaccine: PNC13
Symptoms: Contusion, Eyelid oedema, Lip swelling, Urticaria
Clinical narrative: Hives and bruising on legs. Hives on arms - back - breast - face. Eyelids and lips had some swelling. 3 time on prednisone 10 mg. - 1 ZANTAC - 1 all day allergy pill in A.M. and 1-2 BENADRYL in P.M. Saw dermatologist Dec. 30/15. Said hives were from shot. Prescribed - fluocinonide cream .05%. Ongoing.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Rash erythematous
Clinical narrative: Pt develops red bumps about 3 quarters. A little painful at the site.
Age: 0.58
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Crying
Clinical narrative: Patient cries inconsolably for 3 or more nights after receiving her childhood vaccinations. It has worsened after each round. This happens 3-5 days after immunizations, and lasts for 3-5 hours every night.
Age: 55.0
Sex: M
Vaccine: HEPAB
Symptoms: Mobility decreased, Pain, Sleep disorder, X-ray normal
Clinical narrative: Could not lift arm from side, pain affected sleep (amount and duration). X-ray revealed no fractures, separation. After 7 days no improvement received cortisone shot, one day later pain much better and could raise arm 90 degrees from body.
Sex: U
Vaccine: MMR
Symptoms: Seroconversion test negative, Vaccination failure
Clinical narrative: Information has been received from the authors in a published literature article, regarding 5 (also reported as 17% of 28 patients) adolescent or young adult patients of unknown age and gender with perinatally acquired human immunodeficiency virus (PAH). On an unknown date, the patients were vaccinated with a dose of MMR (Manufacturer unknown) (Lot number, expiration date, strength, dose and frequency were not provided). Concomitant medication was not reported. On an unknown date, despite appropriate prior vaccination, the patient experienced measles non-immunity which was defined as IgG titers < 120 miU by plaque reduction neutralization (PRN) assay and < 0.70 IU by measles enzyme immunoassay (EIA) (vaccination failure and seroconversion test negative). The outcome of vaccination failure and seroconversion test negative was unknown at the time of the report. The reporter considered vaccination failure and seroconversion test negative to be related to MMR (manufacturer unknown). This is one of several reports from the same source (MARRS# 1601USA010845, 1601USA010935, 1601USA010936). Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Seroconversion test negative, Serology test, Vaccination failure
Clinical narrative: Information has been received from the authors in a published literature article, title as above, regarding 16 (also reported as 55% of 28 patients) adolescent or young adult patients of unknown age (between 13 to 26 years) and gender with perinatally acquired human immunodeficiency virus (PAH). On an unknown date, the patients were vaccinated with a dose of MMR II (Manufacturer unknown) (Lot number, expiration date, strength, dose and frequency were not provided). Concomitant medication was not reported. On an unknown date, Despite appropriate prior vaccination, the patient experienced measles non-immunity which was defined as IgG titers < 120 miU by plaque reduction neutralization (PRN) assay and <0.7o IU by measles enzyme immunoassay (EIA) (vaccination failure and seroconversion test negative). The outcome of vaccination failure and Seroconversion test negative was unknown at the time of the report. The reporter considered vaccination failure and Seroconversion test negative to be related to MMR II (manufacturer unknown). A copy of the published article is attached as further documentation of the patient's experience. This is one of several reports from the same source (MARRS#1601USA010845, 1601USA01937, 1601USA010935). 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 registered nurse refers to an multiple unspecified patients of unknown age. Patient's medical history and concurrent conditions were not reported. On unspecified dates in January 2016 multiple unspecified patients was vaccinated with VARIVAX (Merck) (L026405, exp.date: 15-JUL-2017; L034370, exp.date: 08-SEP-2017; L029471, exp.date: 06-UAG-2017; L033138, exp.date: 31-AUG-2017; L034366, exp.date: 08-SEP-2017) and these doses were exposed to -5.8C in a time frame of 1 hour and 40 minutes. The previous temperature excursion was reported as -1.4C for 4hours and 12 minutes. No adverse effects was reported. No product quality complaint (PQC) was involved. No additional information was provided. Additional information has been requested.
Age: 52.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pruritus, Injection site rash, Injection site swelling
Clinical narrative: Raised reddened rash at injection site, with itching x1 week, "48 hours after" used hydrocortisone cream to site.
Age: 57.0
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a licensed practical nurse and refers to a 57 year old patient of unknown gender. The patient's medical history, concurrent conditions and drug reactions/allergies were not reported. On 27-JAN-2016, the patient was vaccinated with an expired dose of PNEUMOVAX 23 lot # K007262, expiration date 25-NOV-2015, (dose, frequency and route were not reported). The patient had not reported any adverse experience. No concomitant medications were reported. No product quality complaint was involved. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a health care worker who was a certified medical assistant regarding a patient of unknown age and gender. Patient demographics were not provided. Information on concurrent condition, medical history and drug allergies were not reported. On 25-JAN-2016 the patient was vaccinated with an expired dose of PROQUAD (Merck) lot # K007157, expiry date- 12-NOV-2015, subcutaneously. Concomitant medication were not reported. No adverse effects were reported. There was no Product Quality Complaint (PQC) filed. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Seroconversion test negative, Vaccination failure
Clinical narrative: Information has been received from the authors in a published literature article, title as above, regarding one (also reported as 4% of 28 patients) adolescent or young adult patient of unknown age (between 13 to 26 years) and gender with perinatally acquired human immunodeficiency virus (PAH). On an unknown date, the patient was vaccinated with a dose of MMR vaccine (Manufacturer unknown) (Lot number, expiration date, strength, dose and frequency were not provided). Concomitant medication was not reported. On an unknown date, despite appropriate prior vaccination, the patient experienced measles non-immunity which was defined as IgG titers < 120 miU by plaque reduction neutralization (PRN) assay and < 0.79 IU by measles enzyme immunoassay (EIA) (vaccination failure and seroconversion test negative). The outcome of vaccination failure and Seroconversion test negative was unknown at the time of the report. The reporter considered vaccination failure and Seroconversion test negative to be related to MMR (manufacturer unknown). A copy of the published article is attached as further documentation of the patient's experience. This is one of several reports from the same source. Additional information has been requested.
Sex: M
Vaccine: VARCEL
Symptoms: Premature baby
Clinical narrative: This spontaneous case report was received from a nurse practitioner regarding a male child currently with a current age of 3 years. It was reported that the child was exposed to the VARIVAX (Merck) via, transplacental route as the patient's mother received the vaccine during her 1st trimester. The baby was born at 35-36 week (Premature baby 33 to 36 weeks) (medically significant). The child weight was reported as 3130 grams and height was 18 3/3 inches at the time of birth. No congenital anomalies were reported. The outcome of premature baby was reported as recovered. The relatedness of the event "premature baby 33 to 36 weeks" with the suspect product was unknown. The case was linked to another case via parent-child link. Additional information is not expected as no further information was available.
Age: 2.0
Sex: F
Vaccine: VARCEL
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a patient of unknown age and gender. The patient's current condition and medical history were not reported. On 05-JAN-2016 the patient was vaccinated with VARIVAX (Merck) (dose# and route not reported) of lot # K002921, expiry date: 26-FEB-2016. On 26-JAN-2016, the same unspecified patient was again administered VARIVAX (Merck) (route not reported) of same lot # K002921, expiry date: 26-FEB-2016. Hence the patient experienced inappropriate schedule of drug administration on 26-JAN-2016. No adverse event was reported. Product quality complaint was not filed. Additional information has been requested.