chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 53.0
Sex: F
Vaccine: PPV
Symptoms: Chest pain, Computerised tomogram normal, Hypoaesthesia, Limb discomfort
Clinical narrative: This spontaneous report was received from a 53 year old female patient, regarding himself. Patient's pertinent medical history was reported as acid reflux, hepatitis c and prediabetes with no changes. Patient was allergic to novacaine, since it caused her heart rate to increase. On 10-FEB-2015 the patient vaccinated with PNEUMOVAX 23 for the prevention of pneumonia. Concomitant therapies included temazepam, oxybutynin (Manufacturer unknown) and pantoprazole. After receiving the PNEUMOVAX 23, the patient experienced her left leg became numb. Consumer sought medical attention and went to emergency room, and was seen by an unspecified physician. Computerised tomography (CT) scan was performed on an unspecified date in February 2015 and after the review of CT scan, physician informed consumer, that she did not have a stroke. Consumer was discharged to follow up with primary care physician and a neurologist. On an unspecified date, consumer reported that the numbness had improved. However, she had intermittent left calf discomfort and the intensity of the left leg numbness varied and occasionally extended to the ankle. On 17-FEB-2015, she experienced slight chest pain when she resumed exercise at the gym. Chest pain resolved, with no treatment. The outcome of the left leg numbness and intermittent left calf discomfort was unknown. No product quality complaint (PQC) was involved. Causality assessment was not provided. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to unspecified number of patients of unknown age and unknown gender. The unspecified patients pertinent medical history was not reported. On an unknown date the, unspecified number of patients were vaccinated with GARDASIL (Lot # J007264 and expiry date: 02-MAR-2017) which was improperly stored. No product quality complaint was reported for GARDASIL. Reporter provided that there have been no reported adverse events following administration of the vaccinations. There has been no need for revaccination. This is one of the several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to unspecified patients of unknown ages and genders. Since October 2014 the patients were vaccinated with doses of improperly stored VAQTA (route, lot#, dose and frequency were unknown). No adverse effects were noted. It was unspecified if the patients sought medical attention. This is one of the several reports received from the same reporter. Additional information has been requested.
Age: 57.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Injection site erythema, Injection site swelling, Pyrexia
Clinical narrative: Information has been received from a registered nurse referring to a 57 year old female patient. The patient was allergic to FLUZONE. On 07-OCT-2013, the patient receivd a dose of FLUZONE intradermally. Due to eggs being in the vaccine, she developed redness at the injection site and subsequently, was recovered from this event on an unknown date. The patient had no other pertinent medical history. On 18-JAN-2015, "around 1:00 PM", the patient was vaccinated with her first dose of PNEUMOVAX 23, lot # k019386, expiry date: 09-JUN-2016, 0.5 ml, subcutaneously. There was no concomitant medication reported. On that day at around "4:00 pm", the patient developed swelling and redness at the injection site. On approximately 19-FEB-2015 (reported as "yesterday"), the patient also developed fevers with body temperature as high as 100.2 (unit unknown) and chills. The patient sought medical attention via calling and speaking with the nurse on the phone. There was no treatment given for the events. No intervention and lab diagnostics studies were performed. At the time of reporting, the patient was not recovered from all the events. The causality between of PNEUMOVAX 23 an all events were not reported. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from two Licensed Practical Nurses referring to unspecified number of patients (age and gender were unknown). Information regarding concurrent conditions and medical history was not provided. On 09-JUL-2014, VAQTA was improperly exposed to 10.9C for 17 hours. On unspecified dates after this, unspecified number of patients were vaccinated with doses of the improperly stored VAQTA, intramuscularly (strength, dose, dose number and lot # were not reported). Concomitant therapy was not reported. No known adverse effects. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a health professional refers to a patient of unknown age and gender. On an unknown date, the patient was vaccinated with the first dose of GARDASIL. On an unknown date, the patent inadvertently received their second dose of GARDASIL 0.5 ml, intramuscular, outside the prescribing information. No adverse effects was reported. Additional information has been requested.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Lymph node palpable, Lymphadenopathy
Clinical narrative: This spontaneous report was received from a registered nurse concerning a 25 year old female patient with chronic idiopathic purpura disorder, drug reaction/allergy to aspirin and sulfa. The patient's medical history included stroke. On 26-JAN-2015, the patient was vaccinated with the first dose of GARDASIL (dose number not reported), lot # K009482, expiration date 06-MAR-2017, 0.5 ml, intramuscular. Co-suspect and concomitant therapies were not reported. The registered nurse reported that on 28-JAN-2015, the patient called to report pain at the injection site. The nurse practitioner advised patient to take an unspecified dose of BENADRYL. The registered nurse reported that on 29-JAN-2015, she/he examined the patient and found a small swollen, red area at the site of injection and found a palpable, swollen, left subclavicular lymph node. The patient also reported pain at the site of injection and tenderness around the left clavicular area. The nurse practitioner advised patient to take an unspecified dose of TYLENOL. At the time of the report the outcome of the events were reported as unknown. The patient seeks medical attention with the registered nurse. No diagnostics lab tests were performed. Additional information has been requested.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Tenderness
Clinical narrative: This spontaneous report was received from a registered nurse concerning a 25 year old female patient with chronic idiopathic purpura disorder, drug reaction/allergy to aspirin and sulfa. The patient's medical history included stroke. On 26-JAN-2015, the patient was vaccinated with the first dose of GARDASIL (dose number not reported), lot # K009482, expiration date 06-MAR-2017, 0.5 ml, intramuscular. Co-suspect and concomitant therapies were not reported. The registered nurse reported that on 28-JAN-2015, the patient called to report pain at the injection site. The nurse practitioner advised patient to take an unspecified dose of BENADRYL. The registered nurse reported that on 29-JAN-2015, she/he examined the patient and found a small swollen, red area at the site of injection and found a palpable, swollen, left subclavicular lymph node. The patient also reported pain at the site of injection and tenderness around the left clavicular area. The nurse practitioner advised patient to take an unspecified dose of TYLENOL. At the time of the report the outcome of the events were reported as unknown. The patient seeks medical attention with the registered nurse. No diagnostics lab tests were performed. Additional information has been requested.
Age: 14.0
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a other health professional refers to an approximately 14 year old patient. On 10-FEB-2015 the patient was vaccinated with an improperly stored GARDASIL (dosing regimen and frequency unknown) (lot number and expiry date unknown). No concomitant medications were reported. No adverse events were reported. The action taken with the therapy with GARDASIL was unknown. The outcome of the events was unknown. The relatedness of the events to the therapy with GARDASIL was unknown. There was no product quality issue reported. This is one of the many reports from the same source. Additional information has been requested.
Age: 16.0
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a other health professional refers to an approximately 16 year old patient. On 10-FEB-2015 the patient was vaccinated with an improperly stored GARDASIL (dosing regimen and frequency unknown) (lot number and expiry date unknown). No concomitant medications were reported. No adverse events were reported. The action taken with the therapy with GARDASIL was unknown. The outcome of the events was unknown. The relatedness of the events to the therapy with GARDASIL was unknown. There was no product quality issue reported. This is one of the many reports from the same source. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and unknown gender. On 02-JUL-2014, the patient was vaccinated with first dose of GARDASIL 0.5 ml intramuscularly. The patient received second dose of GARDASIL on 18-DEC-2014 and third dose on 18-FEB-2015 (inappropriate schedule of drug administration). No adverse effects were reported. No product quality complaint (PQC) was reported for GARDASIL. Additional information has been requested.
Age: 18.0
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a other health professional refers to an approximately 18 year old patient. On 10-FEB-2015 the patient was vaccinated with an improperly stored GARDASIL (dosing regimen and frequency unknown) (lot number and expiry date unknown). No concomitant medications were reported. No adverse events were reported. The action taken with the therapy with GARDASIL was unknown. The outcome of the events was unknown. The relatedness of the events to the therapy with GARDASIL was unknown. There was no product quality issue reported. This is one of the many reports from the same source. Additional information has been requested.
Sex: F
Vaccine: VARCEL
Symptoms: Exposure during pregnancy, Pregnancy test positive
Clinical narrative: Information has been received from a register nurse referring to a female patient of unknown age. The patient was vaccinated with her first dose and second dose of VARIVAX (Merck) (lot#, expiration date, route, dose unknown) for pre-employment vaccination on 20-NOV-2014 and 06-JAN-2015, respectively. On 03-FEB-2015, the patient returned to the office of the nurse and stated she was pregnant. Pregnancy was determined by the patient at home with a home pregnancy test. None lab diagnostics studied performed. The last menstrual period (LMP) was estimated date of delivery (EDD) were unknown. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse refers to an unspecified patients of unknown age and gender. On 05-FEB-2015, the patients were vaccinated with MMR II INJ (strength, dose and route were not reported) (lot # K0054431 and expiration date 15-APR-2016) which were exposed to an unsupported temperature excursion. No adverse effect was reported. No product Quality Complaint (PQC) was involved. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to unspecified number of patients of unknown age and unknown gender. The unspecified patients pertinent medical history was not reported. On an unknown date the unspecified number of patients were vaccinated with PROQUAD (Merck) (Lot # K001854 and expiry date: 06-AUG-2015) which was improperly stored. Reporter provided that there have been no reported adverse events following administration of the vaccinations. There has been no need for revaccination. This is one of the several reports from the same reporter. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: PPV
Symptoms: Expired product administered, Lymphadenopathy, Nasopharyngitis, Oropharyngeal pain, Upper respiratory tract infection
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 12 year old non-pregnant female patient. The patient's pertinent medical history included: the removal of tonsils, "tubes" at 13 months, asthma and heart murmurs. The patient had no drug reactions/allergies. On 03-FEB-2015 the patient was vaccinated with PNEUMOVAX 23, lot # J004196, expiry date: 06-DEC-2014 because she was "only immune to 3 of the 14 strains of pneumonia". Concomitant therapies included ACTIFED, QVAR, SINGULAIR and FLONASE. The nurse reported that the patient was inadvertently administered an expired PNEUMOVAX 23 and after the injection, the patient experienced swollen lymph nodes in the left arm. The swollen lymph nodes went away on an unknown date, but now the patient had an upper respiratory infection and symptoms of a cold such as a sore throat. The patient did not seek a medical attention, there were no lab diagnostics studies performed and no treatment was given for the events. The outcome of the event: swollen lymph nodes was recovered/resolved. The outcome of the event: an upper respiratory infection and symptoms of a cold such as a sore throat was not recovered/not resolved. The relationship between the events and PNEUMOVAX 23 was not reported. Additional information has been requested.
Sex: U
Vaccine: VARZOS
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 age and gender. No medical history, drug allergy and concurrent condition was reported. In 2013, the patient received first dose of ZOSTAVAX. Again on 23-FEB-2015, the patient was vaccinated with the second dose of ZOSTAVAX .65 ml, subcutaneous. No adverse effects were reported. No product quality complaint was involved. Additional information has been requested.
Age: 51.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Information has been received from a pharmacist referring to a male patient of unknown age. The patient had no pertinent medical history or drug reactions/allergies. On 03-AUG-2014 the patient was vaccinated with a dose of ZOSTAVAX (subcutaneous, 0.65 ml, lot# and expiry date were unspecified). Concomitant therapies included atorvastatin, valsartan and hydrochlorothiazide (HCTZ). On an unknown date the patient developed swelling and erythema at the injection site after receiving ZOSTAVAX. On an unspecified date, the patient informed the pharmacist in an unspecified way for medical attention and didn't receive any treatment for the adverse events. No lab diagnostics study was performed. The outcome of the events was not provided. This is one of several reports received from the same source. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site vesicles
Clinical narrative: This spontaneous report as received from a pharmacist refers to a female patient of unknown age. The patient's pertinent medical history, drug reactions and allergies were not reported. The pharmacist reported that, on 20-FEB-2015, the patient was vaccinated with ZOSTAVAX, lot # K020801, expiration date: 31-JAN-2016 (dose and route of administration were not provided). No concomitant medication was reported. On an unspecified date in February 2015, the patient experienced injection site reaction described as localized blisters at injection site only. The patient sought medical attention by calling pharmacy. The outcome of the event was unknown. The relatedness between the event and the vaccination with ZOSTAVAX was not provided. Additional information has been requested.
Age: 32.0
Sex: M
Vaccine: HEP
Symptoms: Abdominal pain upper, Nausea, Pyrexia, Salivary hypersecretion
Clinical narrative: This spontaneous report as received from a physician refers to a 32 year old male patient. Pertinent medical history was unknown. On 08-JAN-2015 the patient was vaccinated with first dose of RECOMBIVAX HB 10/1.0 microgram/ml (1 ml, once, intramuscular) due to occupation (courier). Concomitant medications were unspecified by reporter. On 08-JAN-2015, the patient experienced nausea, stomach pain, fever and was salivating. The patient medicated himself with PEPTO BISMOL. The outcome of nausea, stomach pain, fever and salivation was reported as recovered/resolved within 3 weeks after first vaccination. On 10-FEB-2015, the patient received second dose of RECOMBIVAX HB 10/1.0 microgram/ml (1 ml, once, intramuscular, lot# K014190, expiry date: 24-OCT-2016) and experienced severe nausea, which was not constant but came in waves and lasted for 5 hours. The reporter explained that the symptoms came more quickly but did not last as long as first vaccination. The patient again medicated himself with PEPTO BISMOL. The reporter stated that 4 days after second vaccination the patient was feeling fine. The patient did not seek any care. The causal relationship between the events and RECOMBIVAX HB was unknown. No further information was provided. Additional information has been requested.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Injection site urticaria
Clinical narrative: This spontaneous report was received from a pharmacist refers to a 67 year old male patient with drug allergy to penicillin (manufacturer unknown). No medical history and concomitant medication was reported. On 21-FEB-2015, the patient was vaccinated with ZOSTAVAX, .65 ml, subcutaneous with the lot # K015310 and expiration date of 17-DEC-2015, based on a script from his doctor. On 22-FEB-2015, 2 days after onset of therapy the patient experienced 2 by 3 inch welt that was red and swollen at the injection site. No lab diagnostics studies were performed. Patient sought medical attention by been to pharmacy on 23-FEB-2015. No product quality complaint (PQC) was involved. The outcome of "2 by 3 inch welt that was red and swollen" was reported as not recovered/not resolved. Causality assessment was not provided. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: Information has been received from a pharmacist via a company representative, concerning an unspecified amount of patients of unknown age and gender. On unknown dates the patient was vaccinated with doses of ZOSTAVAX (subcutaneous, 0.65 ml, lot# and expiry date were not provided) and the patients experienced pain at the injection site during administration of ZOSTAVAX. The outcome of pain at the injection site was reported as recovered on unspecified dates. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse refers to an unspecified patients of unknown age and gender. On 07-JAN-2015, the patients were vaccinated with M-M-R II inj (strength, dose and route were not reported) (lot # K005431 and expiration date 15-APR-2016) which were exposed to an unsupported temperature excursion. No adverse effect was reported. No product Quality Complaint (PQC) was involved. This is one of the several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to unspecified number of patients of unknown age and unknown gender. The unspecified patients pertinent medical history was not reported. On an unknown date the unspecified number of patients were vaccinated with GARDASIL (Lot # J007354 and expiry date: 20-FEB-2016, reported as 12-FEB-2016) which was improperly stored. No adverse events were reported. No product quality complaint was reported for GARDASIL. Reporter provided that there have been no reported adverse events following administration of the vaccinations. There has been no need for revaccination. This is one of the several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to unspecified number of patients of unknown age and unknown gender. The unspecified patients pertinent medical history was not reported. On an unknown date the, unspecified number of patients were vaccinated with GARDASIL (Lot # J013324 and expiry date: 12-FEB-2016) which was improperly stored. No product quality complaint was reported for GARDASIL. Reporter provided that there have been no reported adverse events following administration of the vaccinations. There has been no need for revaccination. This is one of the several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to unspecified number of patients of unknown age and unkonwn gender. On an unknown date, unspecified number of patients were inadvertently vaccinated with improperly stored GARDASIL. No adverse effect was reported. No product quality complaint (PQC) was reported for GARDASIL. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Unevaluable event
Clinical narrative: This spontaneous report as received from a health professional refers to an unspecified number of patients of unknown age and gender. Concurrent conditions and medical history were not reported for any of them. The reporter informed that on unknown dates, an unspecified number of patients were vaccinated with a dose of VAQTA intramuscular injection (dose number, route, anatomical location, batch/lot # and expiration date not reported). No adverse effects were reported. This is one of several reports coming from the same source. Additional information is not expected because neither the reporter nor the responsible physician wished to be contacted for further follow-up.
Sex: U
Vaccine: MMRV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to the seventeen patients of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On an unknown date the seventeen patients were vaccinated with an expired PROQUAD (Merck) (doses, routes of administration, lot numbers were not reported). No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a health professional refers to an unspecified number of patients of unknown age and gender. Concurrent conditions and medical history were not reported for any of them. The reporter informed that on unkonwn dates, an unspecified number of patients were vaccinated with a dose of RECOMBIVAX HB Intramuscular injection (dose number, route, anatomical location, batch/lot # and expiration date not reported). No adverse effects were reported. This is one of several reports coming from the same source. Additional information is not expected because neither the reporter nor the responsible physician wished to be contacted for further follow-up.
Sex: U
Vaccine: HPV4
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and unknown gender. On 23-FEB-2015 the patient was inadvertently administered an expired dose of GARDASIL (lot # H010649 and expiry date: 20-FEB-2015). No adverse effect reported. No product quality complaint (PQC) was reported for GARDASIL. Additional information has been requested.
Age: 4.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: This case was reported by a consumer and described the occurrence of ever in a 5-year-old female patient who received KINRIX (batch number T325H, expiry date 17th February 2017). Concomitant products included PROQUAD. On 21st January 2015 16:30, the patient received KINRIX (intramuscular) .5 ml. On an unknown date, the dose was an unknown dose. On 22nd January 2015, 1 days after receiving KINRIX, the patient experienced fever and pain in arm. On an unknown date, the outcome of the fever and pain in arm were not recovered/not resolved. The reporter considered the fever and pain in arm to be related to KINRIX. Additional information: Caller reports that her daughter received a KINRIX and PROQUAD vaccination yesterday. This morning she was complaining that her arm hurt and she didn't look very good. She was given TYLENOL to treat the pain and she went to daycare. While at daycare she just laid on the floor. When she was picked up from daycare she was burning up with fever. The caller has not had a chance to take her daughter's temperature, but she feels in is greater than 102 F, just based upon touch. The caller feels the fever is more likely caused by KINRIX because she has had a previous Merck MMR vaccine with no reaction. Her daughter has a history of running high fevers when ill.
Age: 15.0
Sex: F
Vaccine: HEPAB
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a female patient who received TWINRIX adult (batch number HZ9Z9, expiry date 3rd March 2017). Co-suspect products included TWINRIX adult (batch number HZ9Z9, expiry date 3rd March 2017). On an unknown date, the patient received the 1st dose of TWINRIX adult 1 ml. On an unknown date, the dose was an unknown dose. On an unknown date, the patient received the 2nd dose of TWINRIX adult 1 ml. On an unknown date, an unknown time after receiving TWINRIX adult, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown. Additional information: The caller reports that this patient received two doses of the TWINRIX vaccine (have same lot number/expiration date). The patient was 15 years old when they received the vaccine doses (under recommended age for TWINRIX). No other AEs were reported.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a Medical Assistant refers to an unknown number of patients of unknown gender and ages. On an unspecified dates, since 06-FEB-2015, the patient were vaccinated with an inappropriate storage included GARDASIL (route, dose, lot # and expiration date were not reported). No adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 11.0
Sex: M
Vaccine: DTAP
Symptoms: Conjunctivitis, Wrong drug administered
Clinical narrative: This case was reported by a consumer and described the occurrence of pinkeye in a 12-year-old male patient who received DTaP vaccine. Previously administered products included DTaP, DTaP, DTaP, DTaP and DTaP with an associated reaction of prophylaxis (DTA). Concurrent medical conditions included slow speech development. (He was okay but he was not trying to talk at 18 months of age) and attention deficit/hyperactivity disorder. On 20th January 2015, the patient received the 5th dose of DTaP vaccine. On 20th January 2015, an unknown time after receiving DTaP vaccine, the patient experienced wrong vaccine administered. On 21st January 2015, the patient experienced pinkeye. On an unknown date, the outcome of the pinkeye was not recovered/not resolved and the outcome of the wrong vaccine administered was unknown. It was unknown if the reporter considered the pinkeye to be related to DTaP vaccine. Additional information: The patient is the caller's son. He received DTaP vaccinations on 3/8/2004, 5/11/2004, 7/2004, 1/22/2008 and a DTaP/HIB on 04/27/2005. He was supposed to get a TDAP vaccination on 2/20/15, but was given another DTaP by mistake. The hospital told her over the phone that the last DTaP was a GSK product.
Sex: U
Vaccine: TDAP
Symptoms: Expired product administered
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a unk patient who received BOOSTRIX (batch number AC52B099AA, expiry date 19th January 2015). On an unknown date, the patient received BOOSTRIX. On an unknown date, an unknown time after receiving BOOSTRIX, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown. Additional information: the reporter did not know the patient's DOB, sex or initials.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from medical assistant (M.A) concerning a patient of unknown age and gender. On 04-FEB-2015 the patient was vaccinated with the first dose of GARDASIL (0.5 ml, intermuscular), and the dose administered underwent an unsupported temperature excursion. No adverse experience reported and no concomitant therapies were reported. Also it was reported that the therapy with GARDASIL was continued. Additional information has been requested.
Age: 0.5
Sex: M
Vaccine: DTAP
Symptoms: Musculoskeletal stiffness, Screaming
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of screaming in a 6-month-old male patient who received INFANRIX. On an unknown date, the patient received the 1st dose of INFANRIX. On an unknown date, several hours after receiving INFANRIX, the patient experienced screaming and stiffness. INFANRIX was discontinued. On an unknown date, the outcome of the screaming and stiffness were recovered/resolved. The reporter considered the screaming and stiffness to be almost certainly related to INFANRIX. Additional information: Patient reported that at 6 months he received "DTT" - vaccine containing Pertussis. He described a reaction of two days screaming and stiff body which he said occurred a few hours after vaccine or possible starting the next day. No intervention was required. Physician informed mother that he should not receive vaccine again. He has never received another pertussis containing vaccine since then. Patient did not know any other information regarding the incident.
Age: 14.0
Sex: M
Vaccine: HEP
Symptoms: Accidental overdose, Drug administered to patient of inappropriate age
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 14-year-old male patient who received ENGERIX B adult (batch number AHBVC207AB, expiry date 28th February 2015). On an unknown date, the patient received ENGERIX B adult. On an unknown date, an unknown time after receiving ENGERIX B adult, the patient experienced inappropriate age at vaccine administration and accidental overdose. On an unkonwn date, the outcome of the inappropriate age at vaccine administration and accidental overdose were unknown. Additional information: An adult dose of ENGERIX-B was inadvertently given to a pediatric patient. Reporter refused to provide DOB but did say the patient was 14 years old.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a Medical Assistant refers to an unknown number of patients of unknown ages and gender. On an unspecified dates since 06-FEB-2015 the patients were vaccinated with an inappropriate storage of RECOMBIVAX HB, (route, dose, lot# and expiration date were not reported). No adverse effects reported. This is one of several reports received front he same reporter. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a Healthcare Worker refers to an unknown number of patients of unknown ages and gender. On an unspecified dates since 06-FEB-2015 the patients were vaccinated with an inappropriate storage of VAQTA, (route, dose, lot# and expiration date were not reported). No adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: F
Vaccine: HEP
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a female patient who received ENGERIX B adult (batch number Unknown, expiry date unknown). On an unknown date, the patient received the 2nd dose of ENGERIX B adult. On an unknown date, an unknown time after receiving ENGERIX B adult, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown. Additional information: Dose 2 of the 0, 1 and 6 month schedule was approx 1 month late. Lot and expiration unknown.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker reporting on an unknown number of patients of an unknown age and gender, that since 13-JAN-2015, had bene vaccinated with a dose of VARIVAX (Merck) (dose, dose umber, lot number, expiration date and route were not reported), which underwent supported temperature excursions. No adverse effects reported. Co-suspect and concomitant therapies were not reported. Additional information has been requested. This is one (1) of two (2) reports from the same source.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker reporting on an unknown number of patients of an unkonwn age and gender, that since 13-JAN-2015, had been vaccinated with a dose of ZOSTAVAX (dose, dose number, lot number, expiration date and route were not reported), which underwent supported temperature excursions. No adverse effects reported. Co-suspect and concomitant therapies were not reported. Additional information has been requested. This is one (1) of two (2) reports from the same source.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker concerning unspecified number of patients of unknown age and gender. On unknown dates the patients received GARDASIL (lot#, expiration date, dose and route not reported), after being improperly stored for one month. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: Information has been received from a healthcare worker referring to a patient of unknown age and gender. On 30-JAN-2015 the patient was vaccinated with an expired dose of PNEUMOVAX23 (lot# J009833, expire date 25-JAN-2015, 0.5 ml, intramuscular). No adverse experience was reported. Additional information has been requested.
Age: 15.0
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a other health professional refers to an approximately 15 year old patient. On 11-FEB-2015 the patient was vaccinated with an improperly stored GARDASIL (dosing regimen and frequency unknown) (lot number and expiry date unknown). No concomitant medications were reported. No adverse events were reported. The action taken with the therapy with GARDASIL was unknown. The outcome of the events was unknown. The relatedness of the events to the therapy with GARDASIL was unknown. There was no product quality issue reported. This is one of the many reports from the same source. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site rash, Injection site reaction
Clinical narrative: Information has been received from a pharmacist via a field representative referring to a female patient of unknown age. On an unspecified date in October 2014 (reported as 3 months ago), the patient was vaccinated with a dose of ZOSTAVAX (dosage and lot# unspecified), subcutaneous. On an unspecified date in October 2014 (reported as 3 months ago), the patient experienced injection site reaction-mainly a rash after receiving ZOSTAVAX. The patient did not seek medical attention. The outcome of the events was unknown. Additional information has been requested.
Age: 81.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain
Clinical narrative: This spontaneous report was received from a physician, via a company representative, reporting on his 81 year old mother. Medical history and concurrent conditions were not reported. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX (dose, dose number, lot number, expiration date and route were not reported). Co-suspect and concomitant therapies were not reported. The physician reported that on an unknown date, his mother developed shingles "2 weeks" after receiving ZOSTAVAX. The patient developed shingles on the "right side of her head". The first three days of this was "quite painful" for the patient; however, the patient "feels like it is getting better." At the time of the report the outcome of the shingles and the pain was reported as recovering. The patient seeks medical attention and received an unspecified anti-viral medication as treatment. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On 12-FEB-2015, the patient was vaccinated with a dose of ZOSTAVAX (administration route and lot number were not provided) which expired on 29-AUG-2014. No concomitant medication was reported, neither was any adverse effect. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Pneumonia
Clinical narrative: This spontaneous report as received from a pharmacist via Pfizer, refers to an elderly patient of unknown age and gender. No medical history or concurrent conditions were provided. On an unknown date, several years ago, the patient was vaccinated with PNEUMOVAX23 (dose, route and lot number not provided). No co-suspect or concomitant therapies were reported. On an unspecified date, the patient experienced pneumonia. At the time of the report, the outcome of the event was recovering/resolving (reported as "recently getting over pneumonia"). The causality was not provided. Additional information is not expected because the reporter details were not provided.
Sex: U
Vaccine: MMR
Symptoms: Rash
Clinical narrative: Information has been received from a physician concerning a pediatric patient of unknown gender and exact age. On an unknown date the patient was vaccinated with a dose of M-M-R II injection (lot#, expiration date, strength, dose and route were not reported). On an unspecified date, 8-12 days after vaccination, the patient experienced rash. The outcome of the event was unknown. It was unspecified if the patient sought medical attention. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a Medical Assistant refers to an unknown number of patients of unknown gender and ages. On unspecified dates, since 06-FEB-2015, the patients were vaccinated with an inappropriate storage of M-M-R II 0.5 ml, intramuscular, (lot# and expiration date were not reported). No adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 1.0
Sex: F
Vaccine: HEPA
Symptoms: Accidental overdose
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of accidental overdose in a female patient who received HAVRIX 1441 (batch number 2F559, expiry date 20th march 2017). On an unknown date, the patient received HAVRIX 1440. On an unknown date, an unknown time after receiving HAVRIX 1440, the patient experienced accidental overdose. On an unknown date, the outcome of the accidental overdose was unknown. Additional information: the RN states that a 1 year old patient was inadvertently administered HAVRIX 1440.
Sex: U
Vaccine: VARZOS
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report was received from a pharmacist concerning a patient of unknown age and gender, who on 23-FEB-2015 received a dose of ZOSTAVAX, 0.65 ml, subcutaneous, but the patient was prescribed to receive VARIVAX (Merck). No adverse events were reported. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from licensed practical nurse refers to a patient of unknown age and gender who on 09-FEB-2015 was vaccinated with an improperly stored dose of M-M-R II (dose, lot #, expiration date and route were not reported). No adverse effects reported. It was unknown if the patient sought medical attention. Additional information has been requested.
Age: 0.53
Sex: M
Vaccine: DTAPIPV
Symptoms: Drug administered to patient of inappropriate age, No adverse event, Wrong drug administered
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of wrong vaccine administered in a 6-month-old male patient who received KINRIX (batch number AC20B235AA, expiry date unknown). On 12th February 2014, the patient received KINRIX .5 ml. On an unknown date, the dose was an unknown dose. On 12th February 2014, an unknown time after receiving KINRIX, the patient experienced wrong vaccine administered and inappropriate age at vaccine administration. On an unknown date, the outcome of the wrong vaccine administered and inappropriate age at vaccine administration were unknown. Additional information: a 6 month old patient was administered KINRIX by mistake. The patient should have received the individual DTAP and IPV vaccines instead. No adverse event occurred.
Age: 63.0
Sex: F
Vaccine: PPV
Symptoms: Malaise
Clinical narrative: Information has been received from an unspecified reporter, concerning a 63 year old female patient. On an unknown date the patient was vaccinated with PNEUMOVAX (dose, lot number, route not reported). On an unknown date the patient stated that the product made her sick. The outcome of the event was unknown. Causality between PNEUMOVAX (manufacturer unknown) and the event was not reported.
Age: 0.6
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker (reported as medical assistant) refers to a 7 month old patient of unknown gender. Pertinent medical history was unknown. It was reported that due to human error a medication error occurred resulting a 7 year old patient received one dose of GARDASIL (dose, route of administration, anatomical location and lot number was unknown) on 20-FEB-2015 (inappropriate schedule of drug administration). Concomitant medications were unspecified by reporter. It was clarified  that there was no labeling or product confusion happened. No adverse effects were reported. The outcome of the events was unknown. The causal relationship between the events and GARDASIL was not reported. No additional information was reported. Additional information has been requested.
Age: 37.0
Sex: F
Vaccine: DTAP
Symptoms: Drug administered to patient of inappropriate age, Wrong drug administered
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of wrong vaccine administered in a 37-year-old female patient who received INFANRIX (batch number 9D7CM, expiry date 27th February 2017). On 21st January 2015, the patient received INFANRIX. On an unknown date, the dose was an unknown dose. On an unknown date, an unknown time receiving INFANRIX, the patient experienced wrong vaccine administered and inappropriate age at vaccine administration. On an unknown date, the outcome of the wrong vaccine administered and inappropriate age at vaccine administration were unknown. Additional information: INFANRIX mistakenly administered to a 37 year old female instead of Tdap.
Age: 19.0
Sex: F
Vaccine: HEP
Symptoms: Expired product administered
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 19-year-old female patient who received ENGERIX B pediatric (batch number AHBVC188AA, expiry date 15th January 2015). On an unknown date, the patient received ENGERIX B pediatric .5 ml. On an unknown date, the dose was an unknown dose. On an unknown date, an unknown time after receiving ENGERIX B pediatric, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown. Additional information: 19 year old female received an expired ENGERIX-B Ped dose. This was an accident.
Sex: M
Vaccine: HEPAB
Symptoms: Expired product administered
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a male patient who received TWINRIX (batch number AHABB251AA, expiry date 30th May 2014). On an unknown date, the patient received TWINRIX. On an unknown date, an unknown time after receiving TWINRIX, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown. Additional information: MD office reports that a patient was inadvertently administered an expired dose of TWINRIX.
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: Information has been received from a healthcare worker referring to a patient of unknown age and gender. On 23-FEB-2015 the patient was vaccinated with an expired dose of ZOSTAVAX (lot # J014566, expiration date 18-FEB-2015, 0.65 ml, subcutaneous) (Expired drug administered). No adverse effect was reported. Additional information has been requested.
Age: 0.24
Sex: M
Vaccine: HIBV
Symptoms: Extra dose administered
Clinical narrative: Gave patient Hibalong with PENTACEL which has Hib in it.