chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: VARZOS
Symptoms: Erythema, Peripheral swelling
Clinical narrative: This spontaneous report as received from a pharmacist via company representative and refers to a male patient of unknown age. Patient's medical history and current conditions were not provided. On 30-JAN-2015 the patient was vaccinated with a dose of ZOSTAVAX (lot number and expiration date were not reported), 0.65 ml, subcutaneous, in arm. No concomitant medications were reported. On 02-FEB-2015, the patient experienced "softball sized" swelling with redness on the same arm that the patient received ZOSTAVAX. The outcome of "softball sized" swelling with redness was unknown. The relatedness between "softball sized" swelling with redness and ZOSTAVAX was not reported. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age and gender. The patient's pertinent medical history was not reported. On 09-FEB-2015, the patient was inadvertently administered an expired dose of M-M-R II lot # H018181, expiration date: 05-OCT-2014 (dose and route of administration were not provided). No adverse effect was reported. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a Medical Assistant (C.M.A.) (also reported as nurse) refers to a unspecified number of patients of unknown age and gender. On an unknown date the patients were vaccinated with a doses of VAQTA dose number, lot# and expiration date was not reported, which underwent a supported temperature excursion. No adverse effects reported. Follow-up information has been received. On 04-FEB-2015 several telephone attempts were placed to the certified medical assistant however she was unavailable at the time of calls. This one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a Medical Assistant (C.M.A.)(also reported as nurse) refers to a unspecified number of patients of unknown age and gender. On an unknown date the patients were vaccinated with a doses of PEDVAXHIB dose number, lot# and expiration date was not reported, which underwent a supported temperature excursion. No adverse effects reported. Follow-up information has been received. On 04-FEB-2015 several telephone attempts were placed to the certified medical assistant however she was unavailable at the time of calls. This is one of several reports from the same reporter. Additional information has been requested.
Sex: F
Vaccine: HEP
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of drug dose administration interval too long in a female patient who received ENGERIX B. Concomitant products included ENGERIX B. On an unknown date, the patient received 2nd dose of ENGERIX B. On an unknown date, an unknown time after receiving ENGERIX B, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown. Additional information received: HCP stated that a female patient over the age of 20 received the 1st dose of ENGERIX-B on 10/20/14 and is now presenting for the 2nd dose 12/19/14. Therefore, she is not getting the 2nd dose after the 1 month interval recommended in the package insert.
Age: 25.0
Sex: F
Vaccine: HEPAB
Symptoms: Expired product administered
Clinical narrative: This case was reported by a consumer and described the occurrence of expired vaccine used in a 25-year-old female patient who received TWINRIX (batch number AHABB260AB, expiry date 14th November 2014). On 19th December 2014, the patient received the 1st dose of TWINRIX .5 ml. On an unknown date, the dose was an unknown dose. On an unknown date, an unknown time after receiving TWINRIX, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown. Additional information received: 25 year-old female patient received today (12/19/2014) the first dose of a series of TWINRIX that had expired on 11/14/2014.
Sex: U
Vaccine: DTAP, DTAPHEPBIP, DTAPIPV, HEPA, RV1, TDAP
Symptoms: Incorrect product storage
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of incorrect storage of drug in a unk patient who received BOOSTRIX (batch number 41Y24, expiry date 10th April 2016) and (batch number HP4XT, expiry date 21st October 2016). Co-suspect products included HAVRIX (batch number 4B299, expiry date 17th December 2016), INFANRIX (batch number75853, expiry date 27th September 2016), (batch number MP293, expiry date 4th November 2016) and (batch number 5A425, expiry date 27th February 2017), KINRI (batch number 54LZR, expiry date 28th September 2016) and (batch number DR294, expiry date 23rd September 2016), PEDIARIX (batch number E2297, expiry date 1st July 2016) and (batch number 4233K, expiry date 5th September 2016) and ROTARIX (batch number A41FB421A, expiry date 6th September 2016) and (batch number A41FB460A, expiry date 4th February 2016). 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 HAVRIX and INFANRIX. On an unknown date, the dose was an unknown dose. On an unknown date, the dose was an unknown dose. On an unknown date, the patient received KINRIX. On an unknown date, the dose was an unknown dose. On an unknown date, the patient received PEDIARIX. On an unknown date, the dose was an unknown dose. On an unknown date, the patient received ROTARIX. On an unknown date, the dose was an unknown dose. On an unknown date, an unknown time after receiving BOOSTRIX, HAVRIX, INFANRIX, KINRIX, PEDIARIX and ROTARIX, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown. Additional information received: Vaccines were exposed to temps up to 51.8 degrees for 30mins. The have been administered to a "hand full" of patients. Reporter did not have patient charts.
Age: 65.0
Sex: M
Vaccine: TDAP
Symptoms: Erectile dysfunction
Clinical narrative: This case was reported by a consumer and described the occurrence of erection failure in a 65-year-old male patient who received BOOSTRIX. Concurrent medical conditions included high cholesterol. Concomitant products included ambiguous medication FLOMAX (Nos), Cholesterol medication (Unknown) and Flu seasonal TIV. In December 2014, the patient received BOOSTRIX (unknown). In December 2014, 1 day after receiving BOOSTRIX, the patient experienced erection failure. On an unknown date, the outcome of the erection failure was not recovered/not resolved. The reporter considered the erection failure to be possibly related to BOOSTRIX. Additional information received: The patient received BOOSTRIX about 1 to 1.5 weeks ago. Within a day or two after getting BOOSTRIX, the patient noticed that he was not getting an erection. He thinks it has gotten a little worse since first noticing it. The patient notified the nurse at the office and expect to speak with the physician on Monday.
Sex: M
Vaccine: HEPAB
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: This case was reported by a consumer and described the occurrence of drug dose administration interval too long in a male patient who received TWINRIX. Previously administered products included TWINRIX (dose 1), TWINRIX (dose 2) and TWINRIX (dose 3). On an unknown date, the patient received the 4th dose of TWINRIX. On an unknown date, an unknown time after receiving TWINRIX, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unkonwn. Additional information received: Patient reports he received 3 TWINRIX doses about 2 years ago but never received the 4th dose. Patient either disconnected or had a phone issue, and no further information was available at time of report. Information provided at time of repot has been documented.
Sex: U
Vaccine: MMR, MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. The patient's medical history was not provided. On 06-FEB-2015, the patient was inadvertently subcutaneously administered a dose of M-M-R II (albumin status and lot# were not reported), which expired on 18-OCT-2014. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: MMR, MMR
Symptoms: Expired product administered, No adverse event, Product expiration date issue, Product quality issue
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. The patient's medical history was not provided. On 06-FEB-2015, the patient was inadvertently subcutaneously administered a dose of M-M-R II (albumin status and lot# were not reported), which expired on 18-OCT-2014. No adverse effects were reported. Additional information has been requested.
Age: 0.17
Sex: M
Vaccine: DTAP, DTAPIPV, HIBV, PNC13
Symptoms: Extra dose administered, Wrong technique in drug usage process
Clinical narrative: Gave pt HIB vaccine with the wrong diluent not the one it comes with, and also gave pt a KINRIX DTaP/IPV so I gave pt double DTaP, what would be the outcome how can I take care of this, and can we revaccinate these vaccines.
Age: 0.52
Sex: M
Vaccine: DTAP, DTAPIPV, HIBV, PNC13
Symptoms: Extra dose administered, Wrong technique in drug usage process
Clinical narrative: Gave pt Hib vaccine but with wrong diluent not with diluent it comes with also gave pt a KINRIX DTaP/IPV and I gave pt double DTaP so would be the outcomes of this and can I revaccinate these vaccines.
Age: 1.01
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Rash papular
Clinical narrative: Sev papulovesicular lesions appearing more and more on face and extremities over after 24 hours. Otherwise seems ok. Injection site nml.
Age: 37.0
Sex: M
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: Information has been received from a pharmacist via facility referring to a 37 year old male patient. Information regarding concomitant therapy, concurrent conditions and medical history was not provided. On 06-FEB-2015 the patient was vaccinated with a dose of M-M-R II, lot # reported as H018945 that expired on 18-OCT-2014 (dose, dose number, application site and router were not reported)(expired vaccine used). The patient did not report any problems and no tests had been done. As of 06-FEB-2015 it was unknown if the patient will get another M-M-R II vaccine and the outcome of receiving an expired vaccine was unknown. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Information has been received from a pharmacist referring to 7 patients of unknown age and gender. Information about concurrent conditions and medical history were not provided. Pharmacist reported that the 7 patients received their second and third doses of RECOMBIVAX HB (strength 2.5mcg/0.5ml, dose, lot# and route not reported) at not the recommended schedule on an unspecified days described as "the second dose was given after 1 month and the 3rd dose was given after 6 months" (Inappropriate schedule of vaccine administered). No adverse effects reported. The outcome of the event was not reported. This is one of several reports received from the same source. Additional information has been requested.
Age: 85.0
Sex: F
Vaccine: PNC13
Symptoms: Chills, Dizziness, Night sweats, Peripheral coldness
Clinical narrative: Pt states she experienced bouts of lightheadedness and severe chills. Feet became very cold, took warm showers and used heater to stay warm from chills. Reports teeth chattering and night sweats. These effects began approximately 9 days after receiving vaccine. Lasted through Sunday 2/8/15. She stated symptoms were alleviated with ALEVE.
Sex: U
Vaccine: HEP
Symptoms: Inappropriate schedule of drug administration, Interchange of vaccine products, No adverse event
Clinical narrative: Information has been received from a pharmacist referring to a patient of unknown age and gender. Information about concurrent conditions and medical history were not provided. Pharmacist reported 8 patients received their second and third doses of RECOMBIVAX HB (strength 2.5mcg/0.5ml, dose, lot# and route not reported) at not the recommended schedule on an unspecified day described as "the second dose was given after 1 month and the 3rd dose was given after 6 months"(Inappropriate schedule of vaccine administered, captured in 1602USA001304). Pharmacist reported one of the patients also received RECOMBIVAX HB and the second dose was ENGERIX-B (dose, lot# and route not reported) and third dose was RECOMBIVAX HB (Interchange of vaccine products). No adverse effects reported. The outcome of the event was not reported. This is one of several reports received from the same source. Additional information has been requested.
Age: 71.0
Sex: F
Vaccine: PNC13
Symptoms: Bronchitis, Chills, Myalgia, Pyrexia
Clinical narrative: Fever, chills, muscle aches, bronchitis type symptoms 24 hours after vaccine administered. Symptoms started resolving 4 days later.
Age: 29.0
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: Information has been received from a Licensed Practical Nurse (LPN) concerning a 29 year old patient with unknown gender. On 12-JAN-2015, the patient was inadvertently vaccinated with an expired dose of PNEUMOVAX 23 (0.5 ml, once, lot # J013345, and expiration date: 11-JAN-2015, intramuscular) in the right deltoid (Expired vaccine administered). No adverse effects were reported. Additional information has been requested.
Age: 23.0
Sex: M
Vaccine: HEPA, MNQ
Symptoms: Dizziness, Loss of consciousness
Clinical narrative: Pt was given vaccines at approximately 6:40pm pt waited until approximately 7:00pm to leave when he stood up he felt lightheaded and passed out. Pt came to immediately with no injury.
Age: 49.0
Sex: F
Vaccine: MMR
Symptoms: Erythema, Pruritus, Rash papular
Clinical narrative: 36 hours post-injection developed profuse papular rash with erythema and itching over bil arms, legs, abdomen. Trunk/back/face/chest/palms were not involved. Pt was admin. BENADRYL PO, hydrocortisone topic al cream.
Age: 48.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Injection site erythema, Injection site oedema, Injection site pain, Injection site reaction
Clinical narrative: Patient came to clinic with reaction to PNEUMOVAX given three days previously. Right arm is red and edematous from approx 2 above elbow to shoulder. It has been painful and swollen - he applied cool compresses with minimal relief. Had fever and chills the 2nd day, along with malaise and muscle pain at injection site.
Age: 48.0
Sex: F
Vaccine: PPV
Symptoms: Injection site swelling, Malaise, Myalgia, Pyrexia
Clinical narrative: Patient came to clinic with reaction to PNEUMOVAX given three days previously. Right arm is red and edematous from approx 2 above elbow to shoulder. It has been painful and swollen - he applied cool compresses with minimal relief. Had fever and chills the 2nd day, along with malaise and muscle pain at injection site.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Pain at site of injection with marked erythema and swelling measuring 14 x 16 cm.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness
Clinical narrative: This spontaneous report as received from a physician (the patient's mother) via company representative refers to her daughter 13 year old female patient. In approximately 2008, when the patient was 13 years old the patient was vaccinated with a dose of GARDASIL (dose, lot# and expiration date were not reported). There was no concomitant medication reported. The physician stated that her daughter had a reaction to the GARDASIL, physician explained that after the vaccination, her daughter was dizzy and had to lay down in the car. The outcome of dizziness was reported as recovered/resolved on an unspecified date. Additional information is not expected since there is not permission to contact the physician.
Age: 26.0
Sex: F
Vaccine: TDAP
Symptoms: Exposure during pregnancy, Incorrect product storage
Clinical narrative: This is a pregnancy case. This 26-year-old female subject was enrolled in an open label study. The subject received the 1st dose of BOOSTRIX on 30th December 2014. The subject's past medical history included renal failure. On an unknown date, an unknown time after receiving BOOSTRIX the subject developed incorrect storage of drug (Non-serious). Additional event(s) included vaccine exposure during pregnancy. The outcome of incorrect storage of drug was unknown. The outcome(s) of the additional event(s) included vaccine exposure during pregnancy (unknown). The pregnancy outcome was unknown. Additional information received: Nurse reports that a 26 yo pregnant female and past medical history of kidney failure was administered BOOSTRIX today after it was stored at 28 degrees C. No additional information is known at this time.
Sex: F
Vaccine: HEP
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a adult female patient who received ENGERIX B pediatric. On an unknown date, the patient received the 1st dose of ENGERIX B pediatric. On an unknown date, an unknown time after receiving ENGERIX B pediatric, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker concerning unspecified patients (demographics unknown). The healthcare worker reproted that doses of VARIVAX (Merck) (Lot # not provided) which were exposed to unknown temperature conditions, had been administered to unspecified patients on unspecified dates since November 2014. No adverse effect had been reported. This is one of several reports received from the same source. Additional information has been requested.
Age: 78.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Skin warm
Clinical narrative: 1-27-15 started with a small red area under injection site and gradually increased to 9 cm x 11 cm on the day she presented at clinic. Area red and warm to touch. It is not raised or painful. She came to clinic on 2-2-15. Advised to try OTC BENADRYL and observe for changes. Area completely gone by 2-5-15.
Age: 0.3
Sex: F
Vaccine: DTAPIPV
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 4-month-old female patient who received KINRIX (batch number 3ZL2Y, expiry date 27th March 2016). In December 2014, the patient received KINRIX. On an unknown date, an unknown time after receiving KINRIX, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown. Additional information received: KINRIX administered to a 4 month old.
Sex: U
Vaccine: MMR
Symptoms: Autism
Clinical narrative: This spontaneous report has been received from a consumer refers to a patient of unknown age. On an unknown date the patient was vaccinated with M-M-R II (lot#, dose and route unknown). The reporter mentioned on an unspecified date an anonymous patient developed Autism after received M-M-R II. The outcome was unknown. Action taken was not provided. Additional information has been requested.
Age: 30.0
Sex: F
Vaccine: HEP
Symptoms: Drug administered to patient of inappropriate age, Inappropriate schedule of drug administration, Wrong drug administered
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 30-year-old female patient who received ENGERIX B pediatric (batch number UNKNOWN, expiry date unknown). Previously administered products included ENGERIX B adult (dose 1). On an unknown date, the patient received the 2nd dose of ENGERIX B pediatric 10 micrograms. On an unknown date, the dose was an unknown dose. On an unknown date, an unknown time after receiving ENGERIX B pediatric, the patient experienced drug dose administration interval too long, inappropriate age at vaccine administration and wrong vaccine administered. On an unknown date, the outcome of the drug dose administration interval too long, inappropriate age at vaccine administration and wrong vaccine administered were unknown. Additional information received: Pharmacist calling on behalf of LTC facility under their supervision for healthcare worker who works at risk for Hep B. She has little information on dates of vaccinations or ages when received or patient information. However, female healthcare worker now in 30s received an adult dose presumably at 20 yo or older of ENGERIX-B 20mcg, but then received a second dose at unknown time interval of the pediatric formulation of ENGERIX-B or 10mcg/0.5 mL. Now it has been some time since second dose and they want to know about the 3rd dose. They know of no titers drawn at this point. She is asking on behalf of this healthcare worker as to what they should do for succeeding doses. Sub-optimal/Age-inappropriate dose for this adult, presumably given previously, which is maladministration AE.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Vaccination site erythema, Vaccination site induration, Vaccination site warmth
Clinical narrative: Received shingles vaccine (ZOSTAVAX) 9/16/14. Developed itching and redness at vaccine site on 9/17/14. Had 5.0 cm induration, slight erythema and warmth. By 9/18/14 area grew to 8 x 10 cm induration. Pt treated with BACTRIM with complete resolution of symptoms.
Age: 23.0
Sex: F
Vaccine: MMR
Symptoms: Rash erythematous, Rash generalised, Rash macular, Skin warm
Clinical narrative: Whole body rash from head/neck to bilateral feet. Large red rash w/red splotches. Warm to touch. Afebrile. 98.5 today. Appeared 9 days after vaccines. Took 7 day steroid dose pack starting on 01/21/15-no improvement.
Age: 75.0
Sex: M
Vaccine: TDAP
Symptoms: Expired product administered
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 75-year-old male patient who received BOOSTRIX (batch number unknown, expiry date 16th April 2014) and (batch number unknown, expiry date 16th April 2014). On 14th May 2014, the patient received BOOSTRIX. On an unknown date, the dose was an unknown dose. On an unknown date, an unknown time after receiving BOOSTRIX, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown. Additional information received: On 5/14/2014 administered an injection of BOOSTRIX that, according to this ED record, had an expiration date of 4/16/2014. Now recognizing that the BOOSTRIX was 28 days past expiration date.
Age: 1.02
Sex: F
Vaccine: DTAPHEPBIP, HEPA, MMR, VARCEL
Symptoms: Cough, Pyrexia, Rash generalised, Rhinorrhoea
Clinical narrative: MMR vaccine administered 1/28/15. Pt. experienced low grade temp that PM. Rash appeared on 1/31/15-entire body. No illness noted at time of immunization. 2/3/15-c/o cough-non productive. Runny nose green/yellowish in color.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker concerning unspecified patients (demographics unknown). The healthcare worker reported that doses of VAQTA (Lot # not provided) which were exposed to an unsupported temperature excursion on 08-DEC-2014, had been administered for unspecified patients on unspecified dates since 08-DEC-2014. No adverse effect had been reported. This is one of several reports received from the same source. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Abasia, Activated partial thromboplastin time, Anti-platelet antibody, Antinuclear antibody positive, Arthralgia
Clinical narrative: Stiffness of body began 48 hours after HPV injection. She then developed severe arthralgias and myalgia. She was unable to walk and move without pain. 10-11/10 level of pain in back, fingers, shoulders, ankles and thighs. Went to ER 1/27/15. Developed petechia on feet.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Back pain, Blood creatine phosphokinase, Blood lactate dehydrogenase, C-reactive protein, Full blood count
Clinical narrative: Stiffness of body began 48 hours after HPV injection. She then developed severe arthralgias and myalgia. She was unable to walk and move without pain. 10-11/10 level of pain in back, fingers, shoulders, ankles and thighs. Went to ER 1/27/15. Developed petechia on feet.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Metabolic function test, Musculoskeletal pain, Musculoskeletal stiffness, Myalgia, Pain
Clinical narrative: Stiffness of body began 48 hours after HPV injection. She then developed severe arthralgias and myalgia. She was unable to walk and move without pain. 10-11/10 level of pain in back, fingers, shoulders, ankles and thighs. Went to ER 1/27/15. Developed petechia on feet.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Pain in extremity, Petechiae, Prothrombin time, Red blood cell sedimentation rate increased, Rheumatoid factor
Clinical narrative: Stiffness of body began 48 hours after HPV injection. She then developed severe arthralgias and myalgia. She was unable to walk and move without pain. 10-11/10 level of pain in back, fingers, shoulders, ankles and thighs. Went to ER 1/27/15. Developed petechia on feet.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Streptococcus test
Clinical narrative: Stiffness of body began 48 hours after HPV injection. She then developed severe arthralgias and myalgia. She was unable to walk and move without pain. 10-11/10 level of pain in back, fingers, shoulders, ankles and thighs. Went to ER 1/27/15. Developed petechia on feet.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site urticaria
Clinical narrative: Urticaria of left upper arm - BENADRYL.
Age: 56.0
Sex: M
Vaccine: PPV
Symptoms: Mobility decreased, Pain, Rash, Swelling
Clinical narrative: Patient presented with Rx for antibiotic and pain meds from PCP. He had rash on left arm (injection arm) and pain as well as swelling and limited mobility.
Age: 0.5
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13
Symptoms: Pyrexia
Clinical narrative: Per mother of child, patient had high fever of 102 degrees at 1245 A mother took patient to emergency room where temp. increased to 103 degrees, TYLENOL and MOTRIN administered. Attempted 4 times to straight cath the patient unsuccessfully. Upon discharge at 6 A this morning, patient's temp was 101. Mom to continue giving TYLENOL and MOTRIN.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker concerning unspecified patients (demographics unknown). The healthcare worker reported that doses of RECOMBIVAX HB (Lot # not provided) which were exposed to an unsupported temperature excursion on 08-DEC-2014, has been administered to unspecified patients on unspecified dates since 08-DEC-2014. No adverse effect had been reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker concerning unspecified patients (demographics unkonwn). The healthcare worker reported that doses of GARDASIL (Lot # not provided) which were exposed to an unsupported temperature excursion on 08-DEC-2014, had been administered to the unspecified patients on unspecified dates since 08-DEC-2014. No adverse effect had been reported. This is one of several reports received from the same source. Additional information has been requested.
Age: 27.0
Sex: F
Vaccine: ANTH
Symptoms: Abortion spontaneous, Exposure during pregnancy
Clinical narrative: Information received on 27JAN2015 from an assistant study coordinator of military facility. On an unspecified date in June 2014, a 27 year old female (gravida 2 para 1) received a primary dose of BIOTHRAX (lot unknown) at 1+3 estimated gestational age (EGA). In August 2014 the subject was determined to be pregnant (32 days after vaccination). In January 2015 she contacted the investigator for possible enrollment in an ongoing pregnancy registry. At that time she indicated that she had miscarried in September 2014 at 13+2 EGA. The outcome was unknown at the time of the report. No other information was provided regarding other vaccinations, treatments, concurrent medical conditions or medications, medical history, or relevant laboratory/diagnostic results. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Injection site rash, Pruritus, Reaction to preservatives, Skin warm
Clinical narrative: Case number PHHY2013US069470 is an initial spontaneous report received from Vaccine Adverse Event Reporting System website (VAERS reference number: 479803) on 03 Jul 2013: This report refers to an 11-year-old female child. Her medical history and concomitant medications were not reported. She was vaccinated with MENVEO (batch number: A12010) along with GARDASIL (batch number: H010649) and with ADACEL (batch number: U4383AA) on 26 Dec 2012. All the vaccines were administered intramuscularly. MENVEO and GARDASIL were administered in to the left arm and ADACEL was given in the right arm. On the same day, after vaccinations, she experienced rashes of bilateral deltoids, pruritic and warm to touch. Diagnosis was made for a probable reaction to vaccine preservative. Outcome of the events was reported as complete recovery of the patient on an unspecified date. No additional information about seriousness and causality was reported.
Age: 12.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Dizziness, Vision blurred
Clinical narrative: Case number PHHY2013US032433 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 480219) website on 04 APR 2013. This report refers to 12-year-old male patient.  His medical history included ADD, exercise induced bronchospasm, asthma and nephrolithiasis. His concomitant medication included Concerta, QVAR, and Albuterol inhaler. He was vaccinated with MENVEO (batch number A11046) intramuscularly into left arm and ADACEL (other manufacturer, batch number: C4137AA) intramuscularly into right arm on 14 DEC 2012. On the same day, approximately three minutes after vaccinations, he felt dizzy. His "CVR was clear", breathing was within normal limited (WNL), no color change, heart rate (HR) was WNL and regular , "VS monitoring q 5 minutes", stable oxygen saturation (100%) and respiratory rate was 20. He felt his vision was blurred and it had been increasing. He did not feel better with sealed or supine or after giving water. He was observed for 15 minutes and found no change, so he had an emergency visit. The outcome of the events was reported as recovered on an unspecified date. The seriousness and causality of the events were not reported.
Age: 16.0
Sex: F
Vaccine: MNQ
Symptoms: Dizziness, Hyperhidrosis, Hypotension, Pallor
Clinical narrative: Case number PHHY2013US020778 is an initial spontaneous report received from vaccine adverse event reporting system (VAERS reference number: 480221) web site on 04 Mar 2013. This report refers to a 16-year-old female patient. Her current condition included eczema and concomitant medications were Mometasone topical 0.1% cream for eczema. She was vaccinated with MENVEO (batch number: A11047) intramuscularly on to left arm on 31 Dec 2012. On the same day, she became pale, diaphoretic, dizzy and lightheaded after vaccination. She was laid on to a table and her blood pressure was 96/60 (units and normal values were not reported), heart rate was 71 (units and normal values were not reported) and oxygen saturation was 99%. She became well after 20 minutes and her blood pressure was 102/60 (units and normal values were not reported) later. The outcome of the events was reported as complete recovery.
Age: 23.0
Sex: M
Vaccine: MNQ
Symptoms: Dizziness, Feeling abnormal
Clinical narrative: Case number PHHY2013US032543 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 481193) website on 04 Apr 2013. This report refers to a 23-year-old male patient. He was vaccinated with MENVEO (batch number: M12024) on 09 Jan 2013 intramuscularly to the left arm. On the same date, after vaccination during 15 minute observation, he experienced a floating feeling toward his head and he felt lightheaded, but did not felt like he was going to faint. He laid down and stated that he felt better. The outcome of the events was reported recovered as of 10 Jan 2013. The seriousness and causality of the events were not reported. No further information was available.
Age: 25.0
Sex: F
Vaccine: HEP, MNQ
Symptoms: Asthenia, Chills, Muscle spasms, Vomiting
Clinical narrative: Case number PHHY2013US117533 is an initial spontaneous report received from a Vaccine Adverse Event Reporting System (reference number: 481949) on 15 Oct 2013: This report refers to a 25-year-old female patient. Her medical history and concomitant medications were not reported. she was vaccinated with seasonal meningococcal vaccine (manufacture and batch number unknown) intramuscularly on left arm on 20 Jan 2013. On the same day, she was also vaccinated with hepatitis B vaccine (manufacturer and batch number unknown) intramuscularly on right arm. On the same day, after vaccination she experienced vomiting, chills, weakness and cramps. Outcome of the events was reported as not recovered as of 21 Jan 2013. Seriousness and causality of the events was not reported.
Age: 13.0
Sex: M
Vaccine: MNQ
Symptoms: Communication disorder, Eye movement disorder, Musculoskeletal stiffness
Clinical narrative: Case number PHHY2013US032464 is an initial spontaneous report from Vaccine Adverse Event Reporting System (VAERS ID 482574) received on 04 Apr 2013. This report refers to a 13-year-old male patient. His medical history included attention deficit hyperactivity disorder (ADHD). He was vaccinated with MENVEO (batch number A11072) intramuscularly in his left arm on 24 Jan 2013. On the same day 1 to 2 minutes after the vaccination, his eyes rolled backwards of his head; he became very still and could not communicate. It lasted for about 45 seconds, and then he was back to normal and started talking. The doctor evaluated him and administered fluids orally, checked blood pressure and pulse which were normal. The outcome of the events was reported as complete recovery as of 25 Jan 2013. The seriousness and causality assessment of the events was not reported.
Sex: M
Vaccine: MNQ
Symptoms: Feeling abnormal, Headache, Paraesthesia
Clinical narrative: Case number PHHY2013US032784 is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS Ref: 482598) website on 04 Apr 2013: This report refers to am 18 year old male patient. The patient had no immediate illness. He was vaccinated with the first dose of MENVEO (batch number and expiry date: unknown) on 15 Jun 2012 (see case: PHHY2013US032544). The patient received second dose of MENVEO (batch number and expiry date: unknown) on 07 Aug 2012. He developed brain fog, symptoms of tingling in extremities and headaches. The patient received third dose of MENVEO (See case: PHHY2013US032787) on 27 Dec 2012. The outcome of the events was condition unchanged. Seriousness and causality assessment was not reported. Following an internal review on 18 Apr 2013, of the information received on 04 Apr 2013, following significant correction was done. Brain fog (feeling abnormal) was coded as an event.
Sex: F
Vaccine: MNQ
Symptoms: Erythema, Injection site erythema, Injection site oedema, Oedema peripheral, Red blood cell sedimentation rate increased
Clinical narrative: Case number PHHY2013US032568 is an initial spontaneous report from Vaccine Adverse Event Reporting System (VAERS ID 483366) received on 04 APR 2013. This report refers to a 42-year-old female patient. Her medical history and concomitant medications were not reported. She was vaccinated with MENVEO (batch number: M12013) intramuscularly in her left arm on 25 JAN 2013. On the same day post vaccination she had erythema and edema that progressively worsened extending below left elbow. It started receding after four days. On 01 FEB 2013 her edema and erythema were mild over lateral aspect of upper arm and above elbow. Her erythrocyte sedimentation rte was 47 and white blood cell count was normal. The outcome of the events was reported as complete recovery as of 04 FEB 2013. The seriousness and causality assessment of the events were not reported.
Sex: F
Vaccine: MNQ
Symptoms: White blood cell count normal
Clinical narrative: Case number PHHY2013US032568 is an initial spontaneous report from Vaccine Adverse Event Reporting System (VAERS ID 483366) received on 04 APR 2013. This report refers to a 42-year-old female patient. Her medical history and concomitant medications were not reported. She was vaccinated with MENVEO (batch number: M12013) intramuscularly in her left arm on 25 JAN 2013. On the same day post vaccination she had erythema and edema that progressively worsened extending below left elbow. It started receding after four days. On 01 FEB 2013 her edema and erythema were mild over lateral aspect of upper arm and above elbow. Her erythrocyte sedimentation rte was 47 and white blood cell count was normal. The outcome of the events was reported as complete recovery as of 04 FEB 2013. The seriousness and causality assessment of the events were not reported.
Age: 12.0
Sex: F
Vaccine: HEPA, HPV4, MNQ
Symptoms: Injection site haemorrhage, Injection site pain
Clinical narrative: Case number PHHY2013US044451, is an initial report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 483976) website on 06 May 2013. This report refers to 12-year-old female patient. Medical history included asthma. Current condition included UTI (urinary tract infection). She was vaccinated with MENVEO (batch number: M11081) on left arm and with HAVRIX (batch number: AHAVB536, other manufacturer) and GARDASIL (batch number: H014645, other manufacturer) both on right arm on 05 Feb 2013 via intramuscular route. On 07 Feb 2013, 2 days after vaccinations, the patient experienced tenderness and ecchymosis (2 cm) at the left deltoid region. The patient visited the emergency room. The outcome of the events was reported as not recovered as of 08 Feb 2013. The seriousness and causality of the events were not reported.
Age: 20.0
Sex: F
Vaccine: MNQ
Symptoms: Axillary pain
Clinical narrative: Case number PHHY2013US044457, is an initial report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 484113) website on 06 May 2013. This report refers to a 20-year-old female patient. She was vaccinated with MENVEO (batch number: M12023) on 29 Jan 2013 in the left arm. On 30 Jan 2013 in the morning, one day after vaccination, she noticed soreness/sore spot in the left arm pit. She had no other complaints, no redness or edema or felt warmth of fever. She was instructed to watch, use a warm cloth, take ibuprofen and if she was concerned or the event increased requested to seek the medical advice. The outcome of the event was reported as not recovered. The causality and seriousness of the event were not reported.
Age: 11.0
Sex: M
Vaccine: HPV4, MNQ, TDAP
Symptoms: Skin warm, Swelling
Clinical narrative: Case number PHHY2013US044464, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 484721) website on 06 May 2013. This report refers to an 11-year-old male patient. His medical history and concomitant medication was not reported. He was vaccinated with MENVEO (batch number: M11072) intramuscularly in the left arm, HPV4 (batch number: H016238) intramuscularly in the right arm on 13 Feb 2013. On the same day after vaccination, he experienced swelling and warm to touch. The event outcome was reported as condition unchanged as on 15 Feb 2013. The seriousness and causality of the events was not reported.
Sex: F
Vaccine: MNQ
Symptoms: Local reaction
Clinical narrative: Case number PHHY2013US044486, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System. (VAERS reference number: 485634) website on 06 MAY 2013. This report refers to 11-year-old female child patient. Her medical history and concomitant medications were not reported. She was vaccinated with MENVEO (batch number: M12006) intramuscularly into right arm on 20 FEB 2013. On 25 FEB 2013, she experienced 4cm local reaction (not specified). Outcome of the event was reported as condition unchanged. The causality and seriousness of the event were not reported. No other information was available at the time of this report.
Age: 10.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Administration site reaction, Erythema, Induration
Clinical narrative: Case number PHHY2013US056720 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 486164) website on 05 JUN 2013. This report refers to a 10-year-old male patient. His medical history and concomitant medication were not reported. He was vaccinated with MENVEO (batch number: A12004) into right arm and BOOSTRIX (other manufacturer, batch number: AC52B102AA) into right arm on 21 FEB 2013. On 22 FEB 2013, 24 hours after vaccination, he developed red indurated area of 6x6 cm (area unspecified). He also developed local reaction on right arm at MENVEO administration site. The outcome of the events was not reported. The causality and seriousness of the events were not reported.
Sex: M
Vaccine: MNQ, RAB
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus
Clinical narrative: Case number PHHY2013US056726 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 486729) website on 05 JUN 2013. This report refers to a 21 year old male patient. His medical history and concomitant medications were not reported. He was vaccinated with MENVEO (batch number: M1071) intramuscularly into left arm and RabAvert (batch number: 502011A) intramuscularly into right arm on 26 FEB 2013. On the same day, he developed erythema of upper arm with itching and tenderness, starting at 6 PM. He received one dose of diphenhydramine and the reaction was resolved in two days. The outcome of the events was recovered. The seriousness and causality were not reported.
Age: 18.0
Sex: M
Vaccine: MNQ
Symptoms: Altered state of consciousness, Dizziness, Feeling hot, Loss of consciousness
Clinical narrative: Case number PHHY2013US056696 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 486943) website on 05 Jun 2013. This report refers to a 18-year-old male patient. His medical history included IDDM (type 1 diabetes mellitus). Concomitant medications included insulin, LANTUS and NOVOLOG. He was vaccinated with MENVEO (batch number: M11078) on 14 Mar 2013 (3:10 pm) via intramuscular route on left arm. On the same date, after vaccination he blacked out for a second. He felt like he was going to black out and his mother guided him to a chair in waiting area. He felt hot and dizzy for about 10 minutes but felt better after sitting. It was reported that he did not fall to ground/no injuries. The outcome of the events was reported as recovered. The seriousness and causality of the event were not reported.
Sex: F
Vaccine: HEP, HEPA, HPV4, MNQ, PNC13, TDAP
Symptoms: Injection site warmth, Pain, Skin discolouration, Swelling, Tenderness
Clinical narrative: Case number PHHY2013US056707, is initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 487011) website on 05 JUN 2013. This report refers to an 11-year-old female patient. Her medical history and concomitant medication were not reported. She was vaccinated with first dose of MENVEO (batch number: A00182) intramuscularly in the left arm, first dose of HAVRIX (other manufacturer, batch number: AHAVB690BA) intramuscularly in the left arm, GARDASIL (other manufacturer, batch number: H017698) intramuscularly in the left arm, third dose of ENGERIX-B (other manufacturer, batch number: AHBVB982BB) intramuscularly in the right arm, third dose of PREVNAR 13 (other manufacturer, batch number: G73023) intramuscularly in the right arm and BOOSTRIX (other manufacturer, batch number: ACB087CB) intramuscularly in the right arm on 11 MAR 2013 respectively. On the same day of vaccination, her mother stated that, she experienced continued pain, swelling tenderness, discoloration and the site was not to touch for three days after injection. She visited the emergency room or physician. The provider prescribed KELFLEX, BENADRYL, and Ibuprofen and was recommended col compress to site and was also suggested to massaging the area. The patient appointment was made two day after for follow up symptoms. The outcome of the events was reported as complete recovery as on 15 MAR 2013. The seriousness and causality of the events were not reported.
Age: 12.0
Sex: M
Vaccine: HPV4, MNQ
Symptoms: Abdominal pain upper, Dizziness, Fatigue, Headache, Myalgia
Clinical narrative: Case number PHHY2013US116986. is an initial spontaneous report received from the Vaccine Adverse Event System (VAERS reference number: 487153) website on 15 Oct 2013, with the follow-up received on 20 Jan 2014. This report refers to a 12-year-old male patient. He was vaccinated with MENVEO (batch number: A12010) and GARDASIL (other manufacturer and batch number: 0101AE), on 15 Mar 2013. On the same day, after vaccination he had a horrible stomach ache, dizziness and headache. The following day, he had all the same symptoms plus fever and muscle aches. On the third day, he had fever up to 104, horrible headache, muscle aches and extreme fatigue. The patient visited the emergency room. The outcome of the events reported as not recovered as of 18 Mar 2013. The seriousness and causality of the events were not reported. Follow-up received from the Vaccine Adverse Event Reporting System (VAERS reference number: 487153) website on 20 Jan 2014: Suspect vaccines recoded from MENVEO INN to MENVEO, human papilloma vaccine to GARDASIL and updated both suspect vaccines batch numbers.