chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARZOS
Symptoms: No adverse event, Product packaging quantity issue
Clinical narrative: This spontaneous report as received from a pharmacist refers to an unspecified number of patients of unknown age and gender. On an unknown date the patients were vaccinated with an incorrect measuring of ZOSTAVAX less than 0.65 ml, one shot route not reported, (lot# and expiration date were not reported). The reporter stated that the full 0.65 ml volume could not be prepared due to a product underfill (pqc filled). No adverse effects reported. Additional information has been requested.
Age: 27.0
Sex: F
Vaccine: TDAP
Symptoms: Exposure during pregnancy
Clinical narrative: This is a prospective pregnancy case. This female subject was enrolled in an open label study. The subject received BOOSTRIX .5 ml on 22nd January 2015. On an unknown date, an unknown time after receiving BOOSTRIX the subject developed drug exposure during pregnancy (Non-serious). The outcome of drug exposure during pregnancy was unknown. The pregnancy was ongoing. Additional details provided: Due date and gestational age were unknown.
Age: 35.0
Sex: F
Vaccine: TDAP
Symptoms: Exposure during pregnancy
Clinical narrative: This is a prospective pregnancy case. This 36-year-old female subject was enrolled in an open label study. The subject received the 1st dose of BOOSTRIX .5 ml on 21st January 2015 16:00. The subject received BOOSTRIX at week 34 of the pregnancy and during the third trimester of pregnancy. On 21st January 2015 16:00, an unknown time after receiving BOOSTRIX the subject developed vaccine exposure during pregnancy (Non-serious). The outcome of vaccine exposure during pregnancy was unknown. The pregnancy was ongoing.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report received from a licensed practical nurse refers two unspecified patients of unknown ages and genders who on unknown dates were vaccinated with two improperly stored doses (Incorrect product storage) of VARIVAX (Merck) (dose, lot #, expiration date and route were not reported). No adverse effects reported. It was unknown if the patients sought medical attention. Additional information has been requested.
Age: 25.0
Sex: F
Vaccine: MMR
Symptoms: Chills, Cough, Diarrhoea, Face oedema, Pyrexia
Clinical narrative: Diffuse rash that started on face and spread to the rest of her body, coughing, diarrhea, low-grade fever, chills, facial edema.
Age: 25.0
Sex: F
Vaccine: MMR
Symptoms: Rash generalised, Rubivirus test positive
Clinical narrative: Diffuse rash that started on face and spread to the rest of her body, coughing, diarrhea, low-grade fever, chills, facial edema.
Sex: U
Vaccine: HEP, HEPA, HEPAB
Symptoms: Incorrect product storage
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of incorrect storage of drug in a unk patient who received ENGERIX B. Co-suspect products included HAVRIX and TWINRIX. On an unknown date, the patient received ENGERIX B at an unknown dose, HAVRIX at an unknown dose and TWINRIX at an unknown dose. On an unknown date, an unknown time after receiving ENGERIX B, HAVRIX and TWINRIX, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown. Reporter is a representative from distributor. He reported that some of the HAVRIX, ENGERIX and TWINRIX product have been recalled because they were not kept at the right temperature range by the time the customer received the order. However, some of his customers have already given some of these vaccines to their patients. Reporter did not clarify whether some or all three brands of vaccines were given to different patients. Reporter did not mention any symptoms.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Injection site pain, Injection site swelling
Clinical narrative: -injection site reaction. raised skin around injection. Swollen. Sore. -headache
Sex: U
Vaccine: HEPAB, TDAP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of incorrect storage of drug in a unk patient who received BOOSTRIX (batch number 5TN9R, expiry date unknown) and (batch number 3P9CL, expiry date unknown). Co-suspect products included ENGERIX B (batch number 7K5T4, expiry date unknown), (batch number 54RS5, expiry date unknown) and (batch number 797K7, expiry date unknown), HAVRIX (batch number 7K5T4, expiry date unknown) and TWINRIX (batch number 797K7, expiry date unknown).  On an unknown date, the patient received BOOSTRIX. On an unknown date, the dose was an unknown dose. On an unknown date, the patient received ENGERIX B. On an unknown date, the dose was an unknown dose. On an unknown date, the patient received HAVRIX and TWINRIX. On an unknown date, an unknown time after receiving BOOSTRIX, ENGERIX B, HAVRIX and TWINRIX, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown. The reporter considered the incorrect storage of drug to be unrelated to BOOSTRIX and TWINRIX. Additional information: Seven different HCP's reported to a regularly associate at a wholesale distributor that GSK vaccines were stored outside recommended temperature range. Some (or all) of the vaccines had been administered to patients. No adverse events had been reported to the wholesale distributor.
Sex: F
Vaccine: MMR
Symptoms: Antibody test negative
Clinical narrative: This spontaneous report as received from a physician via a company representative refers to a female patient of unknown age. Concurrent conditions or medical history were not reported. On an unknown date, the patient was vaccinated with M-M-R II (dose number, anatomical location, route, lot number and expiration date were not reported). On an unknown date, the patient had an antibody test that was negative, the patient sought for medical attention but was not treated for the event.  The patient was not recovered from antibody test negative at the tine of the report. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from other health professional (registered nurse) refers to a patient of unknown age, gender and ethnicity. On 23-JAN-2014, an expired dose PNEUMOVAX23, lot # J005071, expiration date: 19-JAN-2015 (dose, route of administration and indication not reported) was administered to the patient. No adverse effects were reported. No further information was provided. Additional information has been requested.
Sex: M
Vaccine: TDAP
Symptoms: Extra dose administered, Wrong drug administered
Clinical narrative: This case was reported by a other health professional and describ4ed the occurrence of extra dose administered in a 15-year-old male patient received BOOSTRIX.  Previously administered products included BOOSTRIX with an associated reaction of no adverse event (1st dose). On 13th NOVEMBER 2014, the patient received the 2nd dose of BOOSTRIX (unknown). On an unknown date, an unknown time after receiving BOOSTRIX, the patient experienced extra dose administered and wrong vaccine administered. On an unknown date, the outcome of the extra dose administered and wrong vaccine administered were unknown. Additional information was provided. The patient had received a 1st dose of BOOSTRIX in SEPTEMBER 2014 and was vaccinated with a 2nd dose of BOOSTRIX instead of Sanofi Flu vaccine. No adverse event was reported.
Age: 48.0
Sex: F
Vaccine: HEP
Symptoms: Drug administered to patient of inappropriate age, Incorrect dose administered, Wrong drug administered
Clinical narrative: This case was reported by a other health professional and described the occurrence of vaccine overdose in a 48-year-old female patient who received ENGERIX B pediatric (batch number: AHBVC200BA expiry date 8th FEBRUARY 2015). ON an unknown date, the patient received ENGERIX B pediatric. On an unknown date, an unknown time after receiving ENGERIX B pediatric, the patient experienced vaccine overdose, in appropriate age at vaccine administration and wrong vaccine administered. On an unknown date, the outcome of the vaccine overdose, inappropriate age at vaccine administration and wrong vaccine administered were unknown.
Sex: M
Vaccine: VARZOS
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a Licensed Practical Nurse, who is also the patient's grandmother, refers to a male patient of unknown age. Medical history and concurrent conditions were not report4ed. On 29-JAN-2015, the patient was inadvertently vaccinated with a dose of ZOSTAVAX (route, lot number and expiration date were not reported), instead of VARIVAX (Merck). No concomitant therapies were reported, neither was any adverse effect. 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 register nurse refers to unspecified number of patient (age and gender were not reported), that on an unknown date were vaccinated with RECOMBIVAX HB (dose, strength,  route and lot number were not reported). which on an unknown date experienced an incorrect product storage. No adverse effects reported. This is one of several reports received from the same source. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site inflammation, Injection site swelling, Injection site warmth, Pain in extremity
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 60 year old female patient with Diabetes and "Epstein Barre". On 13-JAN-2015 the patient was vaccinated with a dose of ZOSTAVAX, dose of 0.65 ml, subcutaneous, lot # K016326 and expiration date of 24-DEC-2015. On 14-JAN-2015, the patient experienced pain in extremity, his arm was sore. She also experienced injection site erythema, injection site inflammation referred as "raised", and injection site warmth about the size of a half dollar. The patient sought medical attention by calling the pharmacist. No treatment was given and no lab diagnostics were performed. At the time of the report the outcome of the events was unknown. Additional information has been requested.
Age: 75.0
Sex: F
Vaccine: PNC13
Symptoms: Anaphylactic reaction, Injection site swelling
Clinical narrative: Severe swelling of arm injection given in and mild anaphylaxis.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a register nurse refers to unspecified number of patient (age and gender were not reported), that on an unknown date were vaccinated with VAQTA (dose, strength, route and lot number were not reported), which on an unknown date, experienced an incorrect product storage. No adverse effects reported. This is one of several reports received from the same source. Additional information has been requested.
Age: 1.51
Sex: F
Vaccine: MMR
Symptoms: Erythema, Hypophagia, Injection site rash, Macule, Rash
Clinical narrative: Lacy reticulated rash on arms/legs/Abdomen. Few salmon colored macules. Decreased PO intake, Cheeks are more red than normal. Emesis x 2 regurgitation non-bloody.
Age: 1.51
Sex: F
Vaccine: MMR
Symptoms: Regurgitation, Vomiting
Clinical narrative: Lacy reticulated rash on arms/legs/Abdomen. Few salmon colored macules. Decreased PO intake, Cheeks are more red than normal. Emesis x 2 regurgitation non-bloody.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a register nurse refers to unspecified number of patient (age and gender were not reported), that on an unknown date were vaccinated with GARDASIL (dose, strength, route and lot number were not reported) which on an unknown date experienced an incorrect product storage. No adverse effects reported. This is one of several reports received from the same source. Additional information has been requested.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site reaction, Injection site warmth, Urticaria
Clinical narrative: Tenderness at injection sight followed by redness, feverish skin, pain and finally pancake-sized welts on the underside of arm (L); symptoms increased until 4th day when doctor was contacted; medication was given. Above symptoms lasted abt. one week.
Age: 38.0
Sex: M
Vaccine: HEP, TDAP
Symptoms: Chills, Diarrhoea, Dyspnoea, Impaired work ability, Influenza virus test
Clinical narrative: Sore arm and hugely swollen lymph nodes under arm1st then neck, and groin. Lumps appeared on 1/22/15. On 1/23/15 came home from work-node under arm bigger than fist. On 1/4 started vomiting, diarrhea, chills, SOB, fever, finally went to ER. Sat eve. at 10:00- Did breathing tx, IV, BENADRYL, steroid (Prednisone) and something for stomach. Still off work 1/26 and 1/27. O2 level still down to 91.
Age: 38.0
Sex: M
Vaccine: HEP, TDAP
Symptoms: Lymphadenopathy, Mass, Pain in extremity, Pyrexia, Vomiting
Clinical narrative: Sore arm and hugely swollen lymph nodes under arm1st then neck, and groin. Lumps appeared on 1/22/15. On 1/23/15 came home from work-node under arm bigger than fist. On 1/4 started vomiting, diarrhea, chills, SOB, fever, finally went to ER. Sat eve. at 10:00- Did breathing tx, IV, BENADRYL, steroid (Prednisone) and something for stomach. Still off work 1/26 and 1/27. O2 level still down to 91.
Sex: U
Vaccine: RAB
Symptoms: Drug administered at inappropriate site, No adverse event
Clinical narrative: Initial misuse report received from a healthcare professional on 12 AUGUST 2013. A patient (no information regarding the patient) was administered dose 1 and dose 1 of post exposure series of IMOVAX rabies at gluteal region and dose 2 was administered at deltoid region. No adverse event was reported. Documents held by sender: none
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Feeling hot, Vomiting
Clinical narrative: Patient stated felt "hot" then dizzy and had vomiting.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Autoimmune disorder, Rash erythematous, Rash generalised
Clinical narrative: Developed red rash over entire body beginning 5 days after vaccination with ZOSTAVAX. Saw doctor on 1/19/2015. Dx: Autoimmune reaction to vaccine. Treated with prednisone 40mg BID x 5 days. Improving.
Age: 1.07
Sex: F
Vaccine: HEPA, HIBV, MMRV, PNC13
Symptoms: Abasia, Pyrexia, Tremor
Clinical narrative: Fever, refuse to walk, tremulousness.
Sex: U
Vaccine: RAB
Symptoms: Drug administered at inappropriate site, No adverse event
Clinical narrative: Initial misuse report received from a healthcare professional on 13 AUGUST 2013. A patient (no information was provided regarding the patient) had received first and third dose of IMOVAX in the gluteal muscle. No information was provided regarding the site of second dose. No adverse event was reported. Documents held by sender:  none
Age: 38.0
Sex: F
Vaccine: RAB
Symptoms: Chills, Electrocardiogram normal, Feeling cold, Heart rate increased, Myalgia
Clinical narrative: Initial report received from a consumer (the patient) on 22 August 2013. A 38-year-old female patient had received a dose of Rabies vaccine (manufacturer unknown) (batch number, route of administration was not reported) in the left deltoid on 17 August 2013. On 17 August 2013, the patient had received first dose of IMOGAM vaccine (batch number, route and site of administration not reported). The patient had no illness at the time of vaccination. The patient had medical history of gall stones, varicose veins and sensitivities. Concomitant medications were not reported. On 17 August 2013, after vaccination the patient developed cold sensation up her arm, spread to across chest and teeth was chattering, heart was beating fast, achy muscles in legs and felt more sleepy. On an unspecified date, EKG (Electrocardiography) was done, the results of which was reported as 'ok'. Corrective treatment was not reported. On an unspecified date, the patient had recovered from the events. Documents held by sender: none.
Age: 38.0
Sex: F
Vaccine: RAB
Symptoms: Peripheral coldness, Somnolence
Clinical narrative: Initial report received from a consumer (the patient) on 22 August 2013. A 38-year-old female patient had received a dose of Rabies vaccine (manufacturer unknown) (batch number, route of administration was not reported) in the left deltoid on 17 August 2013. On 17 August 2013, the patient had received first dose of IMOGAM vaccine (batch number, route and site of administration not reported). The patient had no illness at the time of vaccination. The patient had medical history of gall stones, varicose veins and sensitivities. Concomitant medications were not reported. On 17 August 2013, after vaccination the patient developed cold sensation up her arm, spread to across chest and teeth was chattering, heart was beating fast, achy muscles in legs and felt more sleepy. On an unspecified date, EKG (Electrocardiography) was done, the results of which was reported as 'ok'. Corrective treatment was not reported. On an unspecified date, the patient had recovered from the events. Documents held by sender: none.
Sex: F
Vaccine: RAB
Symptoms: Complement factor decreased
Clinical narrative: This case is linked to case number 2013-08217 (same reproter and same product for different patient). Initial report received from a healthcare professional on 30 July 2013. A female patient, whose medical history and concomitant medications were not reported, had received pre-exposure rabies vaccine series with IMOVAX rabies vaccine (lot number: D0869 for 2 doses and lot number D1101 for 1 dose, (dose number, route and anatomical site of administration not reported), June 2010 date not specified. On an unspecified date of July 2013, the patient had undergone titer level test and was found titers less than 0.1. Other laboratory details and corrective treatments were not reported. At the time of this report, the outcome was not reported. Documents held by sender: none.
Sex: U
Vaccine: RAB
Symptoms: Drug administered at inappropriate site, No adverse event
Clinical narrative: Initial misuse report received from a healthcare professional on 29 JULY 2013. A patient had received first dose of post exposure IMOVAX in the gluteal muscle (buttock region). No information was provided regarding the patient. No adverse event was reported. List of documents held by sender: none
Age: 23.0
Sex: F
Vaccine: RAB
Symptoms: Antibody test negative
Clinical narrative: Follow-up case was received from a healthcare provider (nurse) on 05 AUGUST 2013. The additional information provided includes patient identifiers for two cases. This case now pertains to one of the thirteen patients. Information for the other patients is captured in case number 2013-008318 and 2013-06998. This case involves of a cluster of thirteen unidentified patients who had received intramuscular injections of IMOVAX, lot number D1177-1. This 23 year old female patient was vaccinated with the first dose into the left deltoid, the second into the right deltoid and the third into the left deltoid. Dates of administration were not reported for this patient Titers were checked on 14 MAY 2013 and 15 MAY 2013 and were low. Laboratory test results were not reported. The patient had received a first dose of Tdap batch U4088A intramuscularly into the left deltoid on 14 SEPTEMBER 2013. The patients pre-existing allergies and medical conditions were reported as UKDA, Lutera, Alopecia Areata. No further information was available at the time of this report. The patient outcome was reported as unknown. Documents held by sender: none
Age: 31.0
Sex: M
Vaccine: RAB
Symptoms: Bradycardia, Electrocardiogram, Fatigue, Muscle contractions involuntary, Muscle spasms
Clinical narrative: Initial report received from a non-health care professional on 28 August 2013. A 31-year-old male patient had received first dose of IMOVAX vaccine (lot number, route of vaccination and dose number not reported, in the right forearm into wound, right deltoid) and Rabies vaccine of unknown manufacturer (lot number, route and dose number not reported) in the left deltoid, on 17 July 2013. The patient had no medical history. It was reported that the patient was bit by dog on 4 July 2013, and was recommended to take RIG and the post exposure series. On 24 July 2013, the patient had severe bradycardia to 30's and severe fatigue. The patient also had fasciculations, spasms of the right 5th finger and right forearm at IMOVAX injection site. It was reported that the symptoms were not observed every-day. Electrocardiogram was done on an unspecified date and corrective treatment was not reported. At the time of this report the events were ongoing. Documents held by sender: none.
Sex: M
Vaccine: RAB
Symptoms: Complement factor decreased
Clinical narrative: This case is linked to case number 2013-08216 (same reporter and same product for different patient). Initial report received from a healthcare professional on 30 July 2013. A male patient, whose medical history and concomitant medications were not reported, had received pre-exposure Rabies vaccine series with IMOVAX Rabies vaccine (lot number: D1101 for 2 doses and lot number B0292 (lot not valid) for 1 dose, (dose number, route and anatomical site of administration not reported), June 2010 date not specified. On an unspecified date of July 2013, the patient had undergone titer level test and was found titers less than 0.1. Other laboratory details and corrective treatments were not reported. At the time of this report, the outcome was not reported. Documents held by sender: none.
Age: 37.0
Sex: M
Vaccine: RAB
Symptoms: Dry mouth
Clinical narrative: Initial report received from a healthcare professional on 03 SEPTEMBER 2013. A 37-year-old male patient had received IMOGAM (batch number H1290-2, dose number, route and site of administration not reported) and first dose of IMOVAX (batch number H1091-1, route and site of administration not reported) on 03 SEPTEMBER 2013.  The patient's illness at the time of vaccination and pre-existing physician diagnosed allergies, birth defects, medical conditions were not reported. On 02 SEPTEMBER 2013, same day after vaccination, the patient had experienced dry or waxy mouth Complimentary investigation and corrective treatments were not reported. The outcome of the event was unknown. List of document held by sender: none.  Follow up information received from a healthcare professional on 10 OCTOBER 2013. Updates made to patient demographics product details and event ongoing.
Age: 32.0
Sex: M
Vaccine: RAB
Symptoms: Viral titre decreased
Clinical narrative: Initial report received from a healthcare professional on 11 September 2013. A 35-year-old male patient whose medical history and concomitant medications were not reported, received a dose of IMOVAX (batch number, route and site of administration were not reported) on 24 August 2010. The patient had 3 doses of pre-exposure series of Rabies vaccine 5 years ago. The patient worked closed with bats, had lost his titer on 06 July 2013, the titer was reported as 0.2. The RABAVERT vaccine was to be administered today but till the time of this report, no vaccine had been administered. Documents held by sender: none. Additional information received on 02-Dec-2013: Patient did not have any side effects from vaccination.
Sex: U
Vaccine: RAB
Symptoms: Drug administered at inappropriate site, No adverse event
Clinical narrative: Initial misuse report received from a healthcare professional on 27 JUNE 2013. It was reported that one dose of IMOVAX was administered into the gluteal area. No information was provided regarding the patient. No adverse event was reported. List of documents held by sender: none
Age: 25.0
Sex: F
Vaccine: RAB
Symptoms: Beta haemolytic streptococcal infection, Blood test, Maternal exposure before pregnancy, Ultrasound antenatal screen
Clinical narrative: Initial report received on 31 DECEMBER 2013 (Pregnancy report) from an investigator. A 26-year-old female subject had vaccine exposure before pregnancy. The subject had received first intramuscular dose of IMOVAX in the left thigh on 25 JUNE 2013 (batch number not reported). The subject's current pregnancy history with risk factors (e.g. alcohol, tobacco or recreational drugs) was not reported. The last menstrual period date was 11 SEPTEMBER 2013. The mother's (subject's) health status was not reported. The father's health status was not reported. The father's age was 27 years at the time of report. The subject had two previous pregnancies. The subject had no births with congenital abnormality, 1 live birth without congenital abnormality, no pre-term birth, no elective abortions, one spontaneous abortion prior to 20 weeks gestation in JULY 2010 and no fetal death (>20 weeks gestation). She did not receive any treatment for infertility. The subject had no family history of congenital abnormalities. The subject had no maternal drug exposure. The subject had no relevant non-serious adverse event. The prenatal testing (including amniocentesis, alpha foetal protein, serologies, ultrasound, genetic screening and any other tests) was not reported. She had no reported pregnancy complications. Her estimate date of delivery was 18  JUNE 2014. The pregnancy was ongoing at the time of report. List of documents held by sender: none.  Unblinding information received on 20 DECEMBER 2013: The subject received INOVAX on 25 JUNE 2013. Follow up information received on 02 FEBRUARY 2014. The subject's current pregnant history included group B strep diagnosed on an unspecified date in JANUARY 2014 with 7 days of unknown antibiotic use. The mother (subject) was relatively healthy, other than bicuspid aortic valve (birth). The father's age was 27 years and health status was healthy. The subject had no reported pregnancy complications. Follow up information received on 03 FEBRUARY 2014. It was reported that the conception date was determined by ultrasound, and subject had regular menstrual cycle before pregnancy, pre-natal testing-ultrasounds, routine blood work, ultrasound dates as 13 NOVEMBER 2013, 11 DECEMBER 2013, regular heartbeats, another was scheduled on 05 FEBRUARY 2014.
Sex: U
Vaccine: TD, TDAP
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Initial misuse report received from a healthcare professional on 20-NOV-2013. An adult patient (no other information was provided regarding patient) had administered of ADACEL and TENIVAC. Both vaccines administered within 6 weeks of each other to an adult patient. No adverse event was reported. List of documents held by sender: none
Sex: U
Vaccine: RAB
Symptoms: Adverse reaction
Clinical narrative: Initial report received from a healthcare professional on 22 January 2014. A patient, whose date of birth, age, gender, medical history illness at the time of vaccination and concomitant medication were not reported, had received a first dose of IMOVAX vaccine (lot number, route and anatomical site of administration were not reported) and also received Rabies vaccine for next dose (manufacturer: other, lot number, route and anatomical site of administration were not reported) both vaccines on an unspecified date. On an unspecified date, after vaccination, the patient experienced unspecified "reaction". Laboratory investigations and corrective treatments were not reported. At the time of this report, the outcome was unknown. Documents held by sender: none.
Age: 1.6
Sex: U
Vaccine: DTAP
Symptoms: Immunisation, No adverse event, Wrong drug administered
Clinical narrative: Initial misuse report received from a healthcare professional on 21-AUG-2013 and at GPV on 21-MAR-2014. An 18-months-old patient had received the dose of TENIVAC instead of DTAP, i.e. wrong vaccine administered. The patient re immunized with DTAP. Infant not adequately protected against Diptheria and Pertussis. No adverse event was reported. List of documents held by sender: none
Sex: F
Vaccine: TD
Symptoms: Injected limb mobility decreased, Pain, Pain in extremity
Clinical narrative: Initial report received from a consumer on 24 MAY 2013. A female patient, whose age, medical history was not reported and concomitant medications included DURICEF, had received an intramuscular dose of TD vaccine from unknown manufacturer (batch number and dose number were not reported) in left arm on an unspecified date in 1995. On an unspecified date in 1995 after vaccination, the patient's left arm was sore. The patient could not move her left arm for 2 weeks, movement was painful. Corrective treatment and laboratory investigations were not reported. On an unspecified date, the patient had recovered from the events. Documents held by the sender: none
Sex: U
Vaccine: TD
Symptoms: Expired product administered
Clinical narrative: Initial case was received from a healthcare professional on 14 MARCH 2014. A patient (whose gender and date of birth was not reported) had received an expired dose of TENIVAC, (batch number and expiry date not reported) on an unspecified date.
Sex: U
Vaccine: TDAP
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Initial misuse report received from a healthcare professional on 20 June 2013. An adult patient had received TENIVAC vaccine in error instead of ADACEL. No adverse event was reported. Documents held by sender: None.
Sex: U
Vaccine: TDAP
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Initial misuse report received from a healthcare professional on 14 AUGUST 2013. On 05 AUGUST 2013 at patient was in advertently administered TENIVAC instead of ADACEL. No information was provided regarding the patient. No adverse event was reported. List of documents held by sender: none
Sex: U
Vaccine: TDAP
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Initial misuse report received from a healthcare professional on 10 September 2013. It was reported that, the patient recieved TENIVAC instead of ADACEL. No information was provided regarding the patient. No adverse event was reported. List of documents held by sender: none.
Sex: U
Vaccine: TD
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Initial misuse report received from a healthcare professional on 12 September 2013. This case is a summary case of some patients (number and individual patient identifiers were not reported). Some patients' received TENIVAC vaccine which was stored at temperature more than 8 degree Celsius for 173 hours. No information was provided regarding the patients. No adverse event was reported. List of documents held by sender: none.
Sex: U
Vaccine: TDAP
Symptoms: Adverse reaction, Rubber sensitivity
Clinical narrative: Initial report received from a non healthcare professional on 09-Oct-2013. A female patient was given TENIVAC (Lot # U4503AA) (route, dose, frequency unknown) on an unknown date. ON an unknown date the patient had latex allergy and experienced some form of reaction. Reported stated if the vaccine or the possibility of the tip cap containing latex was the cause of the reaction. List of documents held by sender: none.
Age: 27.0
Sex: F
Vaccine: TD
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: Initial report received from healthcare professional on 18 November 2013. A 27-year female patient, who has no relevant medical history and concomitant medications were not reported, had received intradermal dose of TENIVAC vaccine, batch number C4403AA in left forearm on 18 November 2013. It was reported that on 18 November, after receiving TENIVAC vaccine, the patient experienced site reaction of redness and itching. The patient received steroids as a corrective treatment and laboratory investigations were not reported. At the time of this report, the outcome was unknown. Documents held by sender: none. Follow up information was received on 17 January 2014: On an unspecified date, the events of vaccination site redness and vaccinations site pruritus was recovered.
Age: 50.0
Sex: F
Vaccine: TDAP
Symptoms: Abasia, Arthralgia, Chills, Delirium, Pyrexia
Clinical narrative: Initial report received from a non-health care professional on 06 DECEMBER 2013. A 50-year-old female patient had received a dose of TENIVAC lot number U4591AA, intramuscularly in the left deltoid, on 5 DECEMBER 2013. It was reported that, 30 minutes after vaccination the patient experienced delirium, chills and fever to 103 F, bilateral knee pain and could not walk these events was started at 1 AM. The patient had received Ibuprofen 200 mg as corrective treatment. Laboratory details were not reported. At the time of this report the patient was not recovered. Documents held by sender: none
Sex: U
Vaccine: RAB
Symptoms: Expired product administered, No adverse event
Clinical narrative: Initial misuse report received from a healthcare professional on 09 MAY 2013. It was reported that 1 year ago, a patient was given first pre-exposure dose of IMOVAX 1 day after expiration date (expiration date: 13 MAY 2013). No information was provided regarding the patient. No adverse event was reported. Documents held by sender: None
Sex: U
Vaccine: RAB
Symptoms: Musculoskeletal stiffness
Clinical narrative: Initial report received from other company (Novartis) on 13 May 2013. This case was initially reported by a healthcare professional. Other company reference number: PUS2013US040764. A patient, whose gender, age, medical history and concomitant medications were not reported, had received a dose of IMOVAX rabies vaccination (batch number, route and site of vaccination were not reported) on 22 April 2013. On an unspecified date, post vaccination, the patient experienced stiffness in the neck. Complementary investigations and corrective treatments were not reported. At the time of this report, the outcome of the event was not reported. Document Held by Sender: None.
Age: 44.0
Sex: F
Vaccine: RAB
Symptoms: Urticaria
Clinical narrative: Initial report received from healthcare professional on 21 JUNE 2013. A 44-year-old female patient who had hives prior to vaccination on an unspecified date with no known drug allergies had received an intramuscular dose one of IMOVAX in left deltoid (batch number H1258) and RIG dose one from other manufacturer (Talecris) in right glut (lot number 26NL431, route of vaccination; not reported) on 10 MAY 2013 at 22:45. The concomitant medications were not reported. The patient had no illness at time of vaccination. The patient had not received any vaccines within 4 weeks of IMOVAX and RIG administration. On 11 MAY 2013, 8 hours after vaccination, the patient experienced hives which lasted for couple of days, waxing and waning. The patient had received Benadryl as corrective treatment and laboratory test were not reported. At the time of this report, the patient recovered from adverse events on an unspecified date. Documents held by sender: none.  Follow up information received from a healthcare professional on 12 AUGUST 2013. The adverse event of hives was not reported previously. The patient had history of hives with prior vaccination. IT was reported that the frequent hives was unrelated to the prior vaccination.
Age: 20.0
Sex: F
Vaccine: RAB
Symptoms: Diarrhoea, Hypoaesthesia, Muscle spasms, Pain in extremity, Urticaria
Clinical narrative: Initial report received from other company (NOVARTIS) on 13 May 2013. this case was initially reported by a healthcare professional (who was patient's mother) other company reference number: PUS2013US041604. A 20-year-old female patient, whose medical history and concomitant medications were not reported, had received a dose of IMOVAX Vaccine (IPOL) (lot number, dose number, route and site of vaccination were not reported) on an unspecified date. It was reported that the patient experienced diarrhea, hives on trunk, vomiting, muscle cramping and numbness down her arm, shooting pain down her finger tips on an unspecified date in March 2012. Laboratory data and corrective treatment were not reported. At the time of this report, the outcome of patient was not reported. Follow-up information received a healthcare professional (patient's mother) on 19 June 2013 and 21 June 2013 The patient's responsible physician details were updated. List of documents held by sender: none
Age: 20.0
Sex: F
Vaccine: RAB
Symptoms: Vomiting
Clinical narrative: Initial report received from other company (NOVARTIS) on 13 May 2013. this case was initially reported by a healthcare professional (who was patient's mother) other company reference number: PUS2013US041604. A 20-year-old female patient, whose medical history and concomitant medications were not reported, had received a dose of IMOVAX Vaccine (IPOL) (lot number, dose number, route and site of vaccination were not reported) on an unspecified date. It was reported that the patient experienced diarrhea, hives on trunk, vomiting, muscle cramping and numbness down her arm, shooting pain down her finger tips on an unspecified date in March 2012. Laboratory data and corrective treatment were not reported. At the time of this report, the outcome of patient was not reported. Follow-up information received a healthcare professional (patient's mother) on 19 June 2013 and 21 June 2013 The patient's responsible physician details were updated. List of documents held by sender: none
Sex: U
Vaccine: RAB
Symptoms: Vaccination complication
Clinical narrative: Initial information received from another manufacturer (service request number 1-6634173946) on 18 March 2013. The information was originally provided to the other manufacturer from a healthcare professional. A patient whose age, gender, medical history and concomitant medications were not reported, received a dose of were not reported) on an unspecified date. It was reported that the patient experienced a reaction to Rabies Vaccine. The laboratory detail and corrective medications were not reported. The patient's outcome was not reported. Documents held by sender: none.
Age: 3.0
Sex: U
Vaccine: RAB
Symptoms: Expired product administered, No adverse event
Clinical narrative: Initial misuse report received from a healthcare professional on 19 March 2013. A 3-year-old patient received IMOVAX that had expired on an unspecified date. No adverse event was reported. List of documents held by sender: none.
Sex: U
Vaccine: RAB
Symptoms: Hypersensitivity
Clinical narrative: Initial information received from another manufacturer (service request number 1-6874826669) on 15 April 2013. The information was originally provided to the other manufacturer by a healthcare professional (pharmacist). A patient, whose age, gender, medical history and concomitant medications were not reported, had received a dose of Rabies vaccine from a unknown manufacturer (batch number, route, dose number and anatomical site of administration were not reported) on an unspecified date in 1999. It was reported that, the patient experienced an allergic reaction to Rabies vaccine in 1999. The corrective treatments and laboratory investigations were not reported. The patient's outcome was recovered. Documents held by sender: none.
Age: 31.0
Sex: F
Vaccine: RAB
Symptoms: Burning sensation, Injection site pain, Musculoskeletal stiffness
Clinical narrative: Initial report received from a healthcare professional on 23 April 2013. A 31-year-old female patient, had received an intramuscular 2nd dose of IMOVAX (lot number H1180-1) in left deltoid on 22 April 2013. The patient's illness at the time of vaccination, allergies, and medical condition were reported as unknown and concomitant medication was not reported. On 23 April 2013 i.e. one day post vaccination, the patient's had complained of neck stiffness, burning and pain in shoulder on the left side. Corrective treatments and complimentary investigations were not reported. The patient's outcome was not recovered. List of documents held by sender: none
Sex: U
Vaccine: RAB
Symptoms: Adverse reaction
Clinical narrative: Initial report received from a healthcare professional via other company (Merck) on 23 April 2013. Other company reference number: 1-6910404548. This is a non-valid case as individual patient identifiers are missing. An unspecified number of patients, whose medical history and concomitant medications were not reported, had received a dose of IMOVAX on unspecified date (batch number, dose number, route and site of administration were not reported). On unspecified date, unspecified number of patients experienced adverse reaction (not specified). Complementary investigations and corrective treatments were not reported. At the time of this report, the outcome of event was not reported. List of documents held by sender: none.
Age: 29.0
Sex: M
Vaccine: FLU3
Symptoms: Swelling
Clinical narrative: Per pharmacy manager of store patient alleged flu shot given caused swelling that did not go away.
Sex: U
Vaccine: PPV
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. Information concerning patient's medical history was not provided. On 21-JAN-2015, the patient was vaccinated with expired dose of PNEUMOVAX 23 (dose, frequency and route of administration were not specified) (lot # J010332, expiration date: 14-JAN-2015). No adverse experience has been reported. No product quality complaint (PQC) was involved. Additional information has been requested.
Age: 24.0
Sex: F
Vaccine: FLU3
Symptoms: Cellulitis, Peripheral swelling, Skin warm
Clinical narrative: Case number PHHY2014US170185 is an initial spontaneous report received via Vaccine Adverse Event Reporting System (VAERS ID: 544888) on 29 Dec 2014 and with the follow-up information received from Quality Assurance Department (reference number: 345068) on 29 Jan 2015. This report refers to a 24 years old female patient. Her medical history and concomitant medications were not reported. She was vaccinated with FLUVIRIN (batch number: 1413301) intramuscularly in the right arm on 16 Sep 2014. On 16 Sep 2014, she developed swollen arm. She went to emergency room. Nurse practitioner at health care clinic called and reported that her arm was swollen and the event was diagnosed as cellulitis and was treated. Arm was hot to touch. She had no fever. The final outcome of events was reported as complete recovery. The events were reported as non-serious, but the event cellulitis was upgraded as medically significant based on the information available in the NVS-IME list. The causality of the events was not reported. Based on the investigation performed, the QA department stated that, FLUVIRIN (batch number: 1413301) was manufactured in accordance with the approved internal procedures and it was in compliance with the cGMP requirements. Non-significant follow up information received from the Quality Assurance Department (reference number: 345068) on 06 Jan 2015: Updated QA reference number. Follow-up information received from the Quality Assurance Department (reference number: 345068) on 29 Jan 2015: Updated FLUVIRIN vaccine batch review report.
Age: 67.0
Sex: F
Vaccine: FLU3, PPV, VARZOS
Symptoms: Cellulitis, Erythema, Pyrexia, Rash
Clinical narrative: Case number PHHY2014US170680 is an initial spontaneous report received from a healthcare professional via the Vaccine Adverse Event Reporting System (VAERS ID: 545723) website on 29 Dec 2014 and with the follow-up information received from Quality Assurance Department (reference number: 345284) on 29 Jan 2015. This report refers to a 67 year old female patient. Her past medical history was not reported and concomitant medications included CIPRO. On 18 Sep 2014, she was vaccinated with FLUVIRIN (batch number: 1411001) intramuscularly, with PNEUMOVAX (other manufacturer, batch number: J004332) intramuscularly and with ZOSTAVAX (other manufacturer, batch number: K000328) subcutaneously. On 19 Sep 2014, she developed a rash, had redness and fever. She was diagnosed with cellulitis. The events were reported as non serious but the seriousness of cellulitis, fever, rash and redness was upgraded based on the information available in the source documents and causality of the events was not reported. Based on the investigation performed, the QA department stated that, FLUVIRIN vaccine (batch number: 1411001) was manufactured in accordance with the approved internal procedures and it was in compliance with the cGMP requirements. Non-significant follow up information received from the quality assurance department (reference number: 345284) on 07 Jan 2015: Updated QA reference number. Follow-up information received from the Quality Assurance Department (reference number: 345284) on 29 Jan 2015: Updated FLUVIRIN vaccine batch review report.
Age: 68.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Blister, Cellulitis, Erythema, Pyrexia, Rash
Clinical narrative: Case number PHHY2014US170193, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS, reference number: 545762) website on 29 Dec 2014 and with the follow-up information received from Quality Assurance Department (reference number: 345074) on 29 Jan 2015. This report refers to a 68 year old male patient. Historical condition and concomitant medication were none. He was vaccinated with FLUVIRIN (batch number: 1411001) and PNEUMOVAX (other manufacturer, batch number: J004332) both intramuscularly on 18 Sep 2014. On 19 Sep 2014, he developed rash, redness, fever and blister. The patient was taken to emergency room for medical support. Final diagnosis was made as cellulitis. Outcome of the events was reported as condition ongoing (not recovered). Events were reported as non-serious. Seriousness assessment of cellulitis was upgraded based on the NVS-IME list. Causality of the events was not reported. Based on the investigation performed, the QA department stated that, FLUVIRIN vaccine (batch number: 1411001) was manufactured in accordance with the approved internal procedures and it was in compliance with the cGMP requirements. Non-significant follow up information received from the quality assurance department (QA reference number: 345074) on 06 Jan 2015: Updated QA reference number. Follow-up information received from the Quality Assurance Department (reference number: 345074) on 29 Jan 2015: Updated FLUVIRIN vaccine batch review report.
Age: 33.0
Sex: F
Vaccine: FLU3, PPV, TDAP
Symptoms: Cellulitis, Influenza like illness, Injection site pain, Nuclear magnetic resonance imaging, Pain in extremity
Clinical narrative: Case number PHHY2014US170083, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 546681) website on 29 Dec 2014 and with the follow-up information received from Quality Assurance Department (reference number: 345066) on 29 Jan 2015. This report refers to a 33 year old female patient. Her medical history and concomitant medication was not reported. On 18 Sep 2014, she was vaccinated with FLUVIRIN (batch number: 1413301) IM into right arm. On the same day she also received PNEUMOVAX (batch number: K009809, other manufacturer) IM into right arm and BOOSTRIX (batch number: 3H432, other manufacturer) IM into left arm. On 19 Sep 2014, she experienced painful right arm at site of injection with flu-like symptoms. On 20 Sep 2014, she went to emergency room (ER) and discharged same night with arm sling. She returned to ER on 22 Sep 2014, due to increased arm pain and swelling. MRI of right humerus was taken on 22 Sep 2014 but results were not reported. She was admitted and treated for cellulitis with IV antibiotics. She was discharged on 25 Sep 2014. Final outcome of the events was recovered. Causality assessment was not reported. Events were reported as serious (hospitalization). Based on the investigation performed, the QA department stated that, FLUVIRIN vaccine (batch number: 1413301) was manufactured in accordance with the approved internal procedures and it was in compliance with the cGMP requirements. Non-significant follow up information received from the quality assurance department (reference number: 345066) on 06 Jan 2015: Updated QA reference number. Follow-up information received from the Quality Assurance Department (reference number: 345066) on 29 Jan 2015: Updated FLUVIRIN vaccine batch review report.