chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 1.0
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse concerning a currently 1 year old patient of unknown gender. The patient's medical history, concurrent conditions, concomitant medications and drug reactions/allergies were not provided. On an unknown date, the patient was vaccinated with VARIVAX (lot #: M033906 with expiration date: 28-JUL-2018) (dosage schedule, route of administration and anatomical location were not reported), for prophylaxis. The administered vaccine was improperly stored at temperature greater than 15°F but less than 46 °F  (15.5 °F) for 30 minutes and at temperature greater than 6 °F but less than 14 °F (10.1 °F) for 1.5 hours without any previous temperature excursion; this information was registered in a digital data logger. No adverse effects were reported. This is one of several reports from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1704USA001065: US-009507513-1704USA001070: US-009507513-1704USA001067: US-009507513-1704USA001068: US-009507513-1703USA012554: US-009507513-1704USA001064: US-009507513-1704USA001066:
Age: 8.0
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse concerning a currently 8 year old patient of unknown gender. The patient's medical history, concurrent conditions, concomitant medications and drug reactions/allergies were not provided. On an unknown date, the patient was vaccinated with VARIVAX (lot #: M033906 with expiration date: 28-JUL-2018) (dosage schedule, route of administration and anatomical location were not reported), for prophylaxis. The administered vaccine was improperly stored at temperature greater than 15°F but less than 46 °F  (15.5 °F) for 30 minutes and at temperature greater than 6 °F but less than 14 °F (10.1 °F) for 1.5 hours without any previous temperature excursion; this information was registered in a digital data logger. No adverse effects were reported. This is one of several reports from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1704USA001065: US-009507513-1703USA012554: US-009507513-1704USA001067: US-009507513-1704USA001068: US-009507513-1704USA001069: US-009507513-1704USA001064: US-009507513-1704USA001066.
Sex: U
Vaccine: HPVX
Symptoms: Vaccination complication
Clinical narrative: This spontaneous report was received from an unspecified reporter  concerning a less than 30.000 patients of unknown ages and genders. The patients' concurrent conditions, medical history, historical drugs and concomitant medication were not reported. On unknown dates, the patients were vaccinated with Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (manufacturer unknown) or HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (manufacturer unknown) (dose, route, lot number and expiration date were not reported) for prophylaxis. On unknown dates, the patients had complications (adverse event), most of the complications were minor.  At the time of reporting, the outcome of adverse event was not reported. The causal relationship between the event and Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (manufacturer unknown) or HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (manufacturer unknown) was not reported.  Additional information is not expected as there is no consent to contact the reporter. The correct Initial Receipt Date is 27-MAR-2017 and not 28-MAR-2017 as previously reported. Due to a technical limitation in which the system does not allow to distribute a case with an initial aware date that is earlier to the one previously entered, the safety report is US-009507513-1704USA001016 being deleted from our files and all the information is being captured under this new case US-009507513-1704USA001620. This is an amended report, as corrected. The Initial Receipt Date was changed from 28-MAR-2017 to 27-MAR-2017.; Sender's Comments: US-009507513-1702USA010584: US-009507513-1704USA000707: US-009507513-1704USA000702: US-009507513-1704USA000708: US-009507513-1704USA000709:
Sex: F
Vaccine: TTOX
Symptoms: Allergy to vaccine
Clinical narrative: Initial unsolicited report received from a Physician via partner company Pfizer (manufacturer reference Number: 2017107597) on 22-MAR-2017. This case involves a female patient (onset age was unknown) who was vaccinated with dose of TETANUS TOXOID (batch number, expiry date, dose and dose in series were not reported) in an unknown site on an unknown date. Patient's medical history and concomitant medications were not reported. On an unknown date, following the vaccination, the patient had developed allergy to Tetanus Vaccine and Toxoids. Laboratory investigations and corrective treatment were not reported. The outcome of events was not reported. List of documents held by sender: none.
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Electrocardiogram abnormal, Erythema, Headache, Hyperhidrosis, Local reaction
Clinical narrative: Initial unsolicited report received from a nurse on 23-Mar-2017. This case involves a female patient (age not reported) who was vaccinated with a dose of INFLUENZA VACCINE (Batch number, expiration date, dose, dose in series, route and site of administration were not reported) on an unknown date (reported as 10 years ago). Patient's medical history as pre-existing physician diagnosed allergies, birth defects, medical conditions (specify) and illness at the time of vaccination were unknown. Any other vaccinations within four weeks of vaccinations were also not reported. On an unknown date (reported as 10 years ago), following the vaccination, the patient developed a large local red reaction (vaccination site reaction) and headache with sweating. Patient required emergency room (ER)/ doctor visit with systolic BP in 80s and PVCs on a rhythm strip. Laboratory investigations were not reported. Corrective treatment were not reported. The outcome of events were unknown. List of documents held by sender: none.
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Ventricular extrasystoles
Clinical narrative: Initial unsolicited report received from a nurse on 23-Mar-2017. This case involves a female patient (age not reported) who was vaccinated with a dose of INFLUENZA VACCINE (Batch number, expiration date, dose, dose in series, route and site of administration were not reported) on an unknown date (reported as 10 years ago). Patient's medical history as pre-existing physician diagnosed allergies, birth defects, medical conditions (specify) and illness at the time of vaccination were unknown. Any other vaccinations within four weeks of vaccinations were also not reported. On an unknown date (reported as 10 years ago), following the vaccination, the patient developed a large local red reaction (vaccination site reaction) and headache with sweating. Patient required emergency room (ER)/ doctor visit with systolic BP in 80s and PVCs on a rhythm strip. Laboratory investigations were not reported. Corrective treatment were not reported. The outcome of events were unknown. List of documents held by sender: none.
Age: 25.0
Sex: F
Vaccine: HIBV, MENB, MNQ, PNC13
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: The injection site is hot, rock hard, painful, swollen and red.  Patient did get PREVNAR in the same arm, albeit lower on the arm.  That immunization is not causing a reaction.
Age: 13.0
Sex: M
Vaccine: HPV9
Symptoms: Dizziness, Face and mouth X-ray, Full blood count, Headache, Laboratory test
Clinical narrative: HEADACHES DIZZY FEELS FAINT UPON EXERCTION HAPPENS MID MORNING.
Age: 13.0
Sex: M
Vaccine: HPV9
Symptoms: Metabolic function test, Mononucleosis heterophile test
Clinical narrative: HEADACHES DIZZY FEELS FAINT UPON EXERCTION HAPPENS MID MORNING.
Age: 17.0
Sex: M
Vaccine: MENB
Symptoms: Injected limb mobility decreased, Injection site erythema, Injection site pain, Loss of personal independence in daily activities, Pain
Clinical narrative: Redness at injection site, region surrounding injection site very tender and sensitive. Excruciating pain that made me tear up whenever I attempted to lift my arm more than 1 1/2 inches. Unable to use right arm for any activities due to pain.
Age: 17.0
Sex: M
Vaccine: MENB
Symptoms: Pain in extremity
Clinical narrative: Redness at injection site, region surrounding injection site very tender and sensitive. Excruciating pain that made me tear up whenever I attempted to lift my arm more than 1 1/2 inches. Unable to use right arm for any activities due to pain.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse and refers to an multiple unspecified patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates, the patients were vaccinated with improperly stored doses of ROTATEQ orally (dose, lot # and expiration date were not reported). Other improperly stored vaccination was PEDVAXHIB (dose, route of administration, lot # and expiration date were not reported). There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion of 50.4 degrees Fahrenheit for 30 minutes. Data logger was involved. There were no previous excursions reported. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a Registered Nurse concerning an unspecified number of patients of unknown age and gender. The patients' concurrent conditions, medical history, historical drugs and concomitant therapies were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of ZOSTAVAX (dose, route, lot number and expiration date were not reported) for prophylaxis. The temperature involved were from 6° F to 14° F for 72 hours. It was not previous temperature excursion, and a data logger was not involved. No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested. Sender's Comments: US-009507513-1704USA002217:Original Case : 1704USA001049; US-009507513-1704USA002218:Original Case : 1704USA001049.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a certified medical assistant referring to multiple unspecified patients (age and gender unknown). No information regarding the patients' concurrent conditions, medical history, drug reactions or allergies, and concomitant therapies was provided. The reporter stated that, on unspecified dates, the patients were vaccinated with improperly stored doses of ZOSTAVAX (lot# M036296 with expiration date 14-NOV-2017; and lot# M037013 with expiration date 22-NOV-2017) (strength, dose, frequency, route of administration and anatomical location were not reported) for prophylaxis. The vaccine doses were exposed to a temperature excursion between 15 and 46 Fahrenheit degrees (also reported as "23.9 F") for a time frame of 7 hours and between 6 and 14 Fahrenheit degrees for a time frame of 8 hours and 30 minutes; digital data logger was involved. There were not previous temperature excursion for the vaccine. No adverse effects were reported. Additionally, it was reported that the sterile diluent (unspecified) used to reconstitute the administered vaccine did not undergo a temperature excursion (Lot # M015992 with expiration date 26-NOV-2018; Lot # L037795 with expiration date 04-MAY-2018; Lot # L019306 with expiration date 04-MAR-2018; Lot # L006552 with expiration date 12-NOV-2017; Lot # M001834 with expiration date 08-MAR-2018; Lot # M022946 with expiration date 17-DEC-2018; Lot # M024781 with expiration date 21-FEB-2019). There was not product quality complain (PQC) reported. This is one of three reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1703USA010175: US-009507513-1704USA001189.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a Registered Nurse concerning an unspecified number of patients of unknown age and gender. The patients' concurrent conditions, medical history, historical drugs and concomitant therapies were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of VARIVAX (dose, route, lot number and expiration date were not reported) for prophylaxis. The temperature involved were from 6° F to 14° F for 72 hours. It was not previous temperature excursion, and a data logger was not involved. No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested. Sender's Comments: US-009507513-1704USA002218: Original Case : 1704USA001049; US-009507513-1704USA001049: Original Case : 1704USA001049.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a Registered Nurse concerning an unspecified number of patients of unknown age and gender. The patients' concurrent conditions, medical history, historical drugs and concomitant therapies were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of PROQUAD (dose, route, lot number and expiration date were not reported) for prophylaxis. The temperature involved were from 6° F to 14° F for 72 hours. It was not previous temperature excursion, and a data logger was not involved. No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.; Sender's Comments: US-009507513-1704USA001049: Original Case : 1704USA001049 US-009507513-1704USA002217: Original Case : 1704USA001049.
Age: 46.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Malaise, Musculoskeletal stiffness
Clinical narrative: Right arm (injection site) became red, swollen, painful. C/O right sided neck pain and stiffness. Feeling of malaise. Symptoms persisted almost 5 days. 4 weeks later, neck still feels stiff and right arm is sensitive to sunlight.
Age: 46.0
Sex: F
Vaccine: VARCEL
Symptoms: Neck pain, Photosensitivity reaction
Clinical narrative: Right arm (injection site) became red, swollen, painful. C/O right sided neck pain and stiffness. Feeling of malaise. Symptoms persisted almost 5 days. 4 weeks later, neck still feels stiff and right arm is sensitive to sunlight.
Age: 40.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site warmth
Clinical narrative: Small redness around injection site, little hard, warm to touch 4/6/17- Redness area doubled in size, heat and hardness, sore to touch.
Age: 9.0
Sex: F
Vaccine: HEP, HEPA, IPV, MMR
Symptoms: Fall, Head injury
Clinical narrative: Patient was sitting up when vaccine administered and then rose a few seconds after to stand from the exam table. She got up, and then fell face forward onto the floor hitting her forehead. Patient did not lose consciousness.
Age: 29.0
Sex: F
Vaccine: HEP, VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Redness, pain and warm to touch at injection site.  Pt states size was around 3inches long.  No fever noted.
Age: 64.0
Sex: M
Vaccine: PPV
Symptoms: Pain in extremity, Pyrexia, Swelling
Clinical narrative: Severe arm pain, swelling, fever.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: 2 days after DTaP administered on Rt thigh on 3/3/17 pt began with redness on Rt thigh. On 3/6/17 induration and erythema measured 15x14cm on Rt thigh.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a Nurse Practitioner refers to a female patient of unknown age. The patient's medical history, concurrent conditions and concomitant medication use were not provided. "Three years ago" (2014) the patient was vaccinated with ZOSTAVAX, (lot#, route and dosage not specified) for prophylaxis.  The Nurse Practitioner reported that "recently" (onset date not specified) the patient developed shingles. The patient was seen by the Nurse Practitioner and was prescribed an antiviral medication (NOS) for treatment. The outcome of shingles was unknown. Additional information has been requested.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Cardiac operation, Pain, Rash, Rash erythematous
Clinical narrative: This spontaneous report as received from a nurse practitioner via a company representative refers to a 61 year old male patient. No medical history, concomitant medication, drug reactions or allergies were reported. On 21-DEC-2016, the patient was vaccinated with ZOSTAVAX (lot #, expiration date were not reported), one unspecified dose, for shingles. On 24-DEC-2016, the patient experienced pain. On 25-DEC-2016, the patient experienced red spots on chest and left arm. On an unspecified date in late January 2017, the patient had heart surgery. No treatment was given for the adverse events. The outcome of heart surgery, pain and red spots on patient's chest and left arm was not reported. The relatedness between the events and the ZOSTAVAX  was not reported. Upon internal review, the event of heart surgery was considered medically significant. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to unspecified patients of unknown age and gender. The patients' concurrent conditions, medical history and concomitant medications were not reported. In March 2017, reported as on 15-MAR-2017 and 16-MAR-2017, the patients were vaccinated with improperly stored GARDASIL 9 lot # M009378, expiry date 23-APR-2018, lot # M031557, expiry date 07-APR-2019 (dose, route and site of administration were not reported) for prophylaxis. No adverse effects noted. Administered doses of vaccines underwent a temperature excursion of 32 to 35 degrees Fahrenheit for 10 hours. Data logger was involved. Previous temperature excursion reported was between 32 to 35 degrees Fahrenheit for 18 hours. This is one of several cases received from the same reporter. Additional information is not expected, as there was no consent given for further contact.; Sender's Comments: US-009507513-1703USA008776: US-009507513-1704USA000918: US-009507513-1704USA000916:
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to unspecified patients of unknown age and gender. The patients' concurrent conditions, medical history and concomitant medications were not reported. In March 2017, reported as on 15-MAR-2017 and 16-MAR-2017, the patients were vaccinated with improperly stored ROTATEQ, orally, lot # M033338, expiry date 15-APR-2018 (dose was not reported) for prophylaxis. No adverse effects noted. Administered doses of vaccines underwent a temperature excursion of 32 to 35 degrees Fahrenheit for 10 hours. Data logger was involved. Previous temperature excursion reported was between 32 to 35 degrees Fahrenheit for 18 hours. This is one of several cases received from the same reporter. Additional information is not expected, as there was no consent given for further contact.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patient was vaccinated with improperly stored doses of PEDVAXHIB (lot # M036058 and expiration date 19-MAY-2019; dose and route of administration were not reported), for prophylaxis. There were no adverse effects reported. Administered doses of vaccines experienced a temperature excursion greater than 46 degrees Fahrenheit but less than 77 degrees Fahrenheit for 30minutes and another temperature excursion greater than 32 degrees Fahrenheit and less than 36 degrees Fahrenheit for 1 hour and 15 minutes. Data logger was involved. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1702USA002396.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse and refers to an multiple unspecified patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates, the patients were vaccinated with improperly stored doses of PEDVAXHIB (dose, route and site of administration, lot # and expiration date were not reported) for prophylaxis. There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion of 50.4 degrees Fahrenheit for 30 minutes. Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1703USA014425.
Age: 0.33
Sex: M
Vaccine: DTAPHEPBIP, PNC13, RV1
Symptoms: Incorrect product storage, Irritability
Clinical narrative: The Initial case was missing the following minimum criteria: unspecified number of patients. Upon receipt of follow-up information on 31Mar2017, this case now contains all required information to be considered valid. This is a spontaneous report from a contactable nurse and then from a contactable Physician. A 4-month-old male patient of unknown race/ethnicity received on 07Mar2017 14:44 PREVNAR 13 (lot number N05078, expiration date Sep2017, NDC number 0005-1971-02) at 0.5 ml single dose intramuscular for vaccination. Medical history was none. On 07Mar2017 the patient received also PEDIARIX at 0.5 ml single intramuscular and ROTARIX at 1 ml, both for immunization. It was reported that the patient was administered a vaccine after a temperature excursion (at 34 degree Fahrenheit for 2 minutes). On 08Mar2017 11:30 am the patient experienced also fussiness irritability that recovered on the same date without treatment.
Age: 62.0
Sex: F
Vaccine: PNC13
Symptoms: Nausea
Clinical narrative: This is a spontaneous report from a contactable pharmacist who reported the same event for 2 patients (husband and wife). This is the 1st of 2 reports. A 62-year-old female patient received the first dose of PREVNAR 13 (Lot number R41774, Expire date Apr 2018, NDC number 0005-1971-01), via an unspecified route of administration at 0.5 ml single in the left deltoid on 04Mar2017 for immunisation. No other vaccines were administered on the same date. The patient medical history and concomitant medications were not reported.  The patient previously took Z-pak in Jan2017. Within 24 hours, on an unspecified date in Mar2017, the patient experienced nausea. It was mentioned to her doctor and to the pharmacy on 14Mar2017 and when the pharmacist was able to get back in touch with her on 24Mar2017 the nausea had abated. The reporter stated that it sounded as though she just spoke to her doctors office over the phone and did not receive care or treatment for the nausea. No physician office or emergency room visit were required. The event resolved on an unknown date in Mar2017. The reporting pharmacist did not believe that the nausea was related to Prevnar 13. He believed that it sounded more as though the patient picked up a GI bug.; Sender's Comments: Though the event nausea is possibly related to the suspect product based on the know safety profile, per reporting HCP company agrees that nausea may not be related to prevnar 13,Linked Report(s) : US-PFIZER INC-2017143842 Same reporter/drug/AE, different patient.
Sex: F
Vaccine: PNC13
Symptoms: Swelling
Clinical narrative: This is a spontaneous report from a contactable physician received via a sales representative. An elderly female patient of an unspecified age (over 65 years old) and race/ethnicity received PREVNAR 13 on an unspecified date, at single dose, for immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced 12 cm by 12 cm large raised area showed up one week after injection, on an unspecified date, with unknown outcome.
Age: 1.25
Sex: F
Vaccine: DTAP, HIBV, VARCEL
Symptoms: Injection site urticaria
Clinical narrative: 2 cm welt at site of injection (Varicella).
Age: 81.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Neuralgia, Vaccination site reaction
Clinical narrative: Pt 5 days after vaccine, in area of vaccination began experiencing "nerve pain" radiating to (L) shoulder and occipital area. Waxes and wane. Reports H/O shingles in 2005 in the same area, describes it as similar pain.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: No adverse reaction. Vaccine was spoiled due to fridge temps too cold several days previous. Clinic did not know the temps had dropped until days later.
Sex: U
Vaccine: HEP
Symptoms: Autism spectrum disorder
Clinical narrative: This case was reported in a literature article and described the occurrence of atypical autism in a subject who received Hepatitis B vaccine. On an unknown date, unknown after receiving Hepatitis B vaccine, the subject developed atypical autism. Serious criteria included GSK medically significant. The outcome of atypical autism was unknown. The investigator considered that there was a reasonable possibility that the atypical autism may have been caused by Hepatitis B vaccine. Additional information was provided. This case was reported in a literature article and described the occurrence of atypical autism in a patient of unspecified age and gender who was vaccinated with unspecified hepatitis B virus (HBV) vaccine (manufacturer unknown). This case corresponds to table 4 of this literature article. The patient was a part of the study that examined the relationship between infant mercury (Hg) exposure from Thimerosal-containing hepatitis b vaccines and the long-term risk of a child being diagnosed with atypical autism. The patient was born between 1991 and 1998. No information on patient's medical or family history or concurrent condition or concomitant vaccine was provided. On an unspecified date, the patient received 1 dose of unspecified HBV vaccine (administration route and site unknown; batch number not provided). The patient was exposed to 12.5 ug of mercury within first 6 months. (In  this study, the vaccine administered contained 12.5 micrograms (ug) Hg per dose of hepatitis B vaccine. The Advisory Committee on Immunization Practices (ACIP) recommendations called for the administration of the first dose of hepatitis B vaccine between birth and 2 months of age, the second dose between 1 and 4 months of age, and the third dose between 6 and 18 months of age). On an unspecified date, an unknown period after vaccination, the patient developed atypical autism. Treatment was unknown. The outcome of the event was not reported. The authors considered that event of atypical autism significantly associated with thimerosal in unspecified HBV vaccine. The authors concluded, "The use of routine childhood vaccination is an important public health tool to significantly help reduce the morbidity and mortality associated with infectious disease. The results of this hypothesis-testing, prospective longitudinal, case-control study suggest that the mercurial component, Thimerosal, used as a preservative in many multi-dose vial preparations of vaccines worldwide, is significantly associated with overall and dose-dependent increased risk for atypical autism diagnoses. It is recommended that Thimerosal should be eliminated from all vaccines as soon as possible." This is 1 of the 2 valid cases in the same literature article.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Injection site rash
Clinical narrative: 2" x 4" rash at site of injection x 4 days and intense headache 4 days after injection of vaccine.
Age: 16.0
Sex: M
Vaccine: MENB, MNQ
Symptoms: Confusional state, Dysarthria, Headache, Inappropriate affect
Clinical narrative: The morning after MENACTRA and BEXSERO were given the patient awoke feeling confused and with slurred speech. He also had inappropriate affect and a headache. He was seen at urgent care and referred to ER. He did not go however and the symptoms resolved by the next morning.
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: No adverse reaction. Several days later the vaccine was deemed spoiled due to fridge temps dipped below proper temp levels.
Age: 17.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Dyspnoea, Erythema, Peripheral swelling
Clinical narrative: Arm is red, swollen about the size of her neck and shortness of breath.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant referring to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. The reporter stated that improperly stored doses of PNEUMOVAX 23 lot # M038359 expiration date 13-MAY-2018 (dose and route of administration were not reported), were administered to the patients from "09-MAR-2017-21-MAR-2017" for prophylaxis. No adverse reactions. Administered doses of vaccines experienced the temperature excursion of 47 degrees Fahrenheit to 77 degrees Fahrenheit for 15 hours. Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1704USA002263.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On an unknown date, the patient was vaccinated with an improperly stored dose of PEDVAXHIB lot # L030865, expiration date 07-JUN-2018 (dose and route of administration were not reported) for prophylaxis. There were no adverse symptoms reported. Administered dose of vaccine experienced the temperature excursion of 47 degrees Fahrenheit to 77 degrees Fahrenheit and 32 degrees Fahrenheit to 35 degrees. The Medical assistant also reported, that other vaccines, that were not PEDVAXHIB, were also improperly stored (case # 1703USA010647). There was no product quality complaint (PQC) involved. Additional information has been requested. Sender's Comments: US-009507513-1703USA010647.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site haemorrhage
Clinical narrative: This is a spontaneous report received from a pharmacist regarding a 54-year-old female who received a dose of ZOSTAVAX on 23-Mar-2017 subcutaneously (lot # M035694, exp. 07-NOV-2017) for prophylaxis. The pharmacist reported that the patient had a small amount of bleeding, "a few small drops at injection site". The pharmacist stated that the bleeding stopped and a Band-Aid was applied to the injection site. Causality was not reported. No further information was reported. Additional information is not expected.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from registered nurse and refers to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, concomitant medications and drug reactions/allergies were not reported. On 17-MAR-2017, the patient was inadvertently vaccinated with an expired dose of M-M-R II (dose, route and anatomical location were not reported) (lot # L008684 and expiration date 13-MAR-2017) for prophylaxis. Additionally, a dose of sterile diluent (manufacturer unknown) was administered (dose, route, lot # and expiration date were not reported). No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapies were not provided. On an unknown date, the patient was vaccinated with improperly stored dose of PROQUAD lot number M036294, expiry date 13-FEB-2018 (dose, frequency and route, were not provided) for prophylaxis. No adverse effects were reported. No product quality complaint (PQC) was involved. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant referring to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. The reporter stated that improperly stored doses of ZOSTAVAX lot # M038864 expiration date 12-DEC-2019 (dose and route of administration were not reported), were administered to the patients from "09-MAR-2017-21-MAR-2017" for prophylaxis. No adverse reactions. Administered doses of vaccines experienced the temperature excursion of 6 degrees Fahrenheit to 14 degrees Fahrenheit for 15 hours. Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1703USA010052.
Sex: M
Vaccine: MENB
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: This is a spontaneous report from a contactable MA calling on behalf of a physician who reported for a 12-year-old male patient. A 12-year-old male patient of an unspecified ethnicity received TRUMENBA  (Lot # M77282, Expiry Date Jun2017, NDC # 0005-100-10) intramuscular at 0.5ml, single in left deltoid on 31Mar2017 for immunisation. The patient medical history and concomitant medications were not reported. The patient experienced red, swelling, hot to touch and ring at injection site on an unspecified date in 2017 with outcome of unknown.
Age: 11.0
Sex: M
Vaccine: MENB, MNQ
Symptoms: Extra dose administered, Vomiting, Wrong drug administered
Clinical narrative: Initial unsolicited misuse report received from a physician and consumer on 23-Mar-2017. This case involves an 11-year-old male patient who was vaccinated with a first dose of MENACTRA (batch number: U5556BA, expiry date, dose form frequency not reported ) intramuscularly in the left deltoid and inadvertently administered a first dose of TRUMENBA (manufacturer: Pfizer, batch number R45100, expiry date, dose form frequency not reported) intramuscularly in the right deltoid instead of a dose of DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE (TDAP) (Batch number, expiry date, dose form, frequency, route and site of administration not reported) on 22-Mar-2017. Patient's medical history as pre-existing physician diagnosed allergies, birth defects, medical conditions (specify) and Illness at the time of vaccination were reported as none. Concomitant medications were not reported. Any other vaccinations within four weeks of vaccinations were also not reported. On 23-Mar-2017, at 4 am, one day following the vaccination, the patient experienced 2 episodes of vomiting. It was also a case of wrong vaccine administered and extra dose administered. Relevant laboratory investigations and corrective treatment were not reported. The outcome of the event vomiting was unknown. List of documents held by the sender: None
Age: 34.0
Sex: F
Vaccine: IPV, YF
Symptoms: Conjunctival oedema, Erythema, Induration, Skin warm
Clinical narrative: Conjunctival swelling bilaterally - Loratadine 10 mg daily #30  right arm-15 min induration/25mm erythema, warm to touch - ice pack left arm-0mm induration/30mm erythema, warm to touch-ice pack.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Pyrexia, Rash, Rash morbilliform, Rash pruritic
Clinical narrative: Measles-like rash on back and chest with pruritic qualities, fevers 103*F.
Age: 20.0
Sex: F
Vaccine: FLU3, HEP, IPV, MNQ, TDAP
Symptoms: Feeling hot, Heart rate increased, Injection site swelling
Clinical narrative: Local swelling on left arm at injection site. Pt complained of being hot. Elevated heart rate. Swelling went down within 30 minutes along with heart rate.
Age: 0.58
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Rash
Clinical narrative: Circular rash on torso and neck area, one hour after shots given. Referred her to her PCP for treatment.
Age: 2.0
Sex: M
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: NO ADVERSE EVENT. THE FRIDGE UNIT WENT OUT OF RANGE SO THE VACCINES WERE SPOILED.
Age: 95.0
Sex: F
Vaccine: VARCEL
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to an elderly female patient of unknown age. There was no information about the patient's concurrent conditions, medical history, concomitant medications or any known allergies or reactions. On 30-MAR-2017, the patient was vaccinated inadvertently with a dose of VARIVAX (lot # M023380, expiration date: 11-MAY-2018), for prophylaxis (dose and route of administration were not reported), reconstituted with sterile diluent (lot # M042852, expiration date: 30-MAY-2019; dose not provided), instead of a dose of ZOSTAVAX. No symptoms reported. The reporter did not provide additional details. No further information provided. No product quality complaint was involved. Additional information has been requested.
Age: 0.75
Sex: U
Vaccine: HIBV
Symptoms: No adverse event
Clinical narrative: This spontaneous report was received from a nurse and refers to a 9 month old patient of unknown gender. No pertinent medical history, drug reactions, allergies or concurrent conditions were reported. On an unknown date, when the patient was 6 months old  was vaccinated with the first dose of PEDVAXHIB for prophylaxis (dosage schedule, route, anatomical location, lot number and expiration date were not reported). Then, when they was 9 months old was again vaccinated with the second dose of PEDVAXHIB for prophylaxis (dosage schedule, route, anatomical location, lot number and expiration date were not reported). Other suspect and concomitant medications were not provided.  No adverse effects were reported. Additional information has been requested.
Age: 3.0
Sex: F
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: No adverse reaction. vaccines were spoiled due to fridge temps were found on log to be below zero.
Age: 0.42
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: No adverse reaction. Fridge temps went out of range; found out several days when checking hitek logs.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: No adverse reaction. Fridge temps were found to be below zero prior to work day.
Age: 0.5
Sex: F
Vaccine: DTAPHEPBIP, PNC
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: No adverse reaction. Fridge temps dropped below zero spoiling all vaccines. Temp log identified the loss.
Age: 0.75
Sex: M
Vaccine: PNC
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: No adverse reaction. Fridge temps dropped down below acceptable ranges during middle of the night.
Age: 0.58
Sex: M
Vaccine: DTAPHEPBIP, PNC, RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: No adverse reaction; fridge temps were out of acceptable range which caused spoilage of vaccines. Need to revaccinate.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Crying, Lethargy, Pyrexia, White blood cell count increased
Clinical narrative: Fever of 102.4, lethargic, whimpering, doctor visit, blood draw, WBC 16,300.
Age: 56.0
Sex: F
Vaccine: TDAP
Symptoms: Pruritus, Rash
Clinical narrative: After getting the immunization in store, once patient arrived home a couple of hours later she started ti getting itching and a rash on the face.
Age: 47.0
Sex: F
Vaccine: TDAP
Symptoms: Chest discomfort, Dysphonia, Dyspnoea, Nasal congestion
Clinical narrative: Reported feeling SOB, Chest Tightness, Hoarseness, Stuffy nose.
Age: 73.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Injection site erythema, Injection site pain, Injection site warmth, Skin burning sensation
Clinical narrative: Pt had burning hot redness over the bilateral bicep area spreading to the upper extermities.
Age: 73.0
Sex: F
Vaccine: PPV
Symptoms: Skin warm
Clinical narrative: Pt had burning hot redness over the bilateral bicep area spreading to the upper extermities.
Age: 0.75
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13
Symptoms: Abnormal behaviour, Mobility decreased
Clinical narrative: Patients mother describes patient not moving as usual, not holding up bottle at feeding, not crawling as usual. Not moving as usual smiling or moving arms or legs. Not responding as usual.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site cellulitis, Injection site swelling, Injection site warmth
Clinical narrative: Swelling and warmness at injection site.
Age: 35.0
Sex: F
Vaccine: MNQ, VARCEL
Symptoms: Injection site erythema, Pain, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Patient said back of her arm at vaccination site was red and raised and "feverish" about 1.5 inches in diameter. She did not have any other symptoms. She was taking OTC ibuprofen for the pain and swelling.
Age: 63.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Arthralgia, Erythema, Injection site erythema, Injection site swelling, Myalgia
Clinical narrative: 3 chicken pox on face, shot site swollen small egg size and bright red around it, face swollen red with itchy blotches  itch was 8 on scale of 10. Extreme joint pain and muscle pain.
Age: 63.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Pruritus, Rash macular, Swelling face, Varicella
Clinical narrative: 3 chicken pox on face, shot site swollen small egg size and bright red around it, face swollen red with itchy blotches  itch was 8 on scale of 10. Extreme joint pain and muscle pain.
Age: 63.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Blister, Erythema, Injection site erythema, Injection site induration, Injection site mass
Clinical narrative: 3 chicken pox on face, shot site swollen small egg size and bright red around it, face swollen red with itchy blotches  itch was 8 on scale of 10. Extreme joint pain and muscle pain.
Age: 63.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site swelling, Injection site warmth, Local reaction, Pain, Pruritus
Clinical narrative: 3 chicken pox on face, shot site swollen small egg size and bright red around it, face swollen red with itchy blotches  itch was 8 on scale of 10. Extreme joint pain and muscle pain.
Age: 63.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Pyrexia, Rash pustular
Clinical narrative: 3 chicken pox on face, shot site swollen small egg size and bright red around it, face swollen red with itchy blotches  itch was 8 on scale of 10. Extreme joint pain and muscle pain.
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site rash, Injection site swelling, Injection site warmth
Clinical narrative: Warm, erythematous, tender rash with swelling of right arm from the shoulder to elbow where he had MENVEO and HPV vaccine. Small local reaction 5cm diameter with swelling, erythema and tenderness left deltoid where TDaP given. Instructed to do ZYRTEC 10mg daily, BENADRYL Q6H PRN, cold packs, and MOTRIN/TYLENOL per physician.
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Local reaction
Clinical narrative: Warm, erythematous, tender rash with swelling of right arm from the shoulder to elbow where he had MENVEO and HPV vaccine. Small local reaction 5cm diameter with swelling, erythema and tenderness left deltoid where TDaP given. Instructed to do ZYRTEC 10mg daily, BENADRYL Q6H PRN, cold packs, and MOTRIN/TYLENOL per physician.
Age: 44.0
Sex: F
Vaccine: TDAP
Symptoms: Dermatitis, Pruritus
Clinical narrative: Pt. developed pruritic progressive dermatitis approximately 6 to 12 hrs. after vaccine administered. She was treated with SOLU MEDROL 40mg x1 dose, VISTARIL 25mg as needed for itching.
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: Patient had shooting pain from site of injection down to elbow in left arm -Pt has been getting the pain constantly from time she got vaccine. Pt called PCP and was told to take ALEVE.
Age: 28.0
Sex: F
Vaccine: VARCEL, VARCEL
Symptoms: Eye pain, Injection site inflammation, Injection site swelling, Iritis, Malaise
Clinical narrative: Iritis, vesicular rash on mouth and nose. Inflammation in Left eye about 8-9 days after vaccine administration. Started antiviral medication. Her Provider then diagnosed it as shingles.
Age: 28.0
Sex: F
Vaccine: VARCEL, VARCEL
Symptoms: Ocular discomfort, Ocular hyperaemia, Ophthalmic herpes zoster, Ophthalmological examination, Oral mucosal eruption
Clinical narrative: Iritis, vesicular rash on mouth and nose. Inflammation in Left eye about 8-9 days after vaccine administration. Started antiviral medication. Her Provider then diagnosed it as shingles.
Age: 28.0
Sex: F
Vaccine: VARCEL, VARCEL
Symptoms: Photophobia, Pyrexia, Rash, Rash vesicular, Slit-lamp examination
Clinical narrative: Iritis, vesicular rash on mouth and nose. Inflammation in Left eye about 8-9 days after vaccine administration. Started antiviral medication. Her Provider then diagnosed it as shingles.
Age: 28.0
Sex: F
Vaccine: VARCEL, VARCEL
Symptoms: Eye inflammation, Herpes zoster, Iritis, Oral mucosal eruption, Rash vesicular
Clinical narrative: Iritis, vesicular rash on mouth and nose. Inflammation in Left eye about 8-9 days after vaccine administration. Started antiviral medication. Her Provider then diagnosed it as shingles.
Age: 2.0
Sex: M
Vaccine: FLU4, HEPA, FLU4, HEPA
Symptoms: Abasia, Bladder dysfunction, Guillain-Barre syndrome, Immunoglobulin therapy, Muscular weakness
Clinical narrative: A few days after receiving his vaccine, patient began to show signs of head cold/ upper respiratory infection. 20 days post vaccine, patient woke up unable to walk or put any weight on his legs & was admitted to Hospital. The illness spread wakening upper body muscles, facial muscles, and shutting down his bladder functions. Patient was treated with IGIV & steroids. He was diagnosed with Guillain Barre Syndrome. As of Dec. 2015 he is in inpatient rehab, still unable to sit up or use his legs at all.
Age: 2.0
Sex: M
Vaccine: FLU4, HEPA, FLU4, HEPA
Symptoms: Nasopharyngitis, Posture abnormal, Upper respiratory tract infection, Weight bearing difficulty
Clinical narrative: A few days after receiving his vaccine, patient began to show signs of head cold/ upper respiratory infection. 20 days post vaccine, patient woke up unable to walk or put any weight on his legs & was admitted to Hospital. The illness spread wakening upper body muscles, facial muscles, and shutting down his bladder functions. Patient was treated with IGIV & steroids. He was diagnosed with Guillain Barre Syndrome. As of Dec. 2015 he is in inpatient rehab, still unable to sit up or use his legs at all.