chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.27
Sex: M
Vaccine: HIBV, PNC13
Symptoms: Aphasia, Decreased appetite, Dyspnoea, Injection site swelling, Lethargy
Clinical narrative: High fever-104 degrees. Withdrawn. Loss of appetite (48hrs.). Loss ov verbal communication. Loss of eye contact. Lethargy. Labored breathing. Injection site swelling.
Age: 0.27
Sex: M
Vaccine: HIBV, PNC13
Symptoms: Pyrexia, Social avoidant behaviour
Clinical narrative: High fever-104 degrees. Withdrawn. Loss of appetite (48hrs.). Loss ov verbal communication. Loss of eye contact. Lethargy. Labored breathing. Injection site swelling.
Age: 1.03
Sex: M
Vaccine: PNC13, VARCEL
Symptoms: Injection site bruising, Injection site cyst, Injection site pain, Injection site papule, Injection site scar
Clinical narrative: Bump on right thigh, pea-sized, tender when touched, but otherwise ambulating without difficulty. 2 cm area of bruising with a pea-sized papule just below the skin on the anterior medial part, movable and firm. Likely, walled-off cyst or scar tissue. No treatment required.
Age: 1.03
Sex: M
Vaccine: PNC13, VARCEL
Symptoms: Injection site swelling
Clinical narrative: Bump on right thigh, pea-sized, tender when touched, but otherwise ambulating without difficulty. 2 cm area of bruising with a pea-sized papule just below the skin on the anterior medial part, movable and firm. Likely, walled-off cyst or scar tissue. No treatment required.
Sex: U
Vaccine: MMR
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Information has been received from a healthcare worker referring to patients at 8 months of age or less than 12 months of age. On unknown dates the patients were vaccinated with MMR II (lot#, expiration date, dose and route unspecified). No adverse effects reported. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Loss of consciousness
Clinical narrative: This spontaneous report as received from a nurse via company representative refers to a female patient of unknown age (reported as adolescent). The patient's medical history and current conditions were not provided. On an unknown date, the patient was vaccinated with a first dose of GARDASIL (lot #, expiration date, strength, dose and frequency were not reported). Secondary suspects and concomitant therapies were not reported. On an unknown date, during a routine vaccination of GARDASIL the patient "passed-out". Therapy with GARDASIL was discontinued as it was reported that the patient will not receive any other doses of GARDASIL. The outcome of loss of consciousness was reported as recovered. The relatedness between "passed-out" and GARDASIL was not reported. Additional information is not expected due to no consent to contact Health Care Professional was given.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a patient of unknown age and unknown gender. The patient's pertinent medical history and drug allergies were not reported. On 15-APR-2015, the patient was inadvertently administered improperly stored dose of 0.5 ml PNEUMOVAX23 intramuscularly. No adverse effects were reported. No product quality was reported for PNEUMOVAX23. Additional information has been requested.
Age: 14.0
Sex: M
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a Licensed Practical Nurse refers to a 14 year old male patient. Medical history and concurrent conditions were not provided. On 15-FEB-2011, the patient was vaccinated with a dose of GARDASIL, received other dose on 09-FEB-2015 (inappropriate schedule of drug administration) and another dose on 11-APR-2015 (dose, route, lot number and expiry date were not reported). No adverse experience had been observed or reported. There was no concomitant medication provided. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to a patient of unknown age and gender. The patient's medical history and current conditions were not reported. On 07-APR-2015, the patient was vaccinated with an improperly stored dose of (Merck) VARIVAX (dose, frequency, route of administration, lot# and expiration date were not reported). No adverse effect was reported. Product quality complain (PQC) was not involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to a patient of unknown age and gender. The patient's medical history and current conditions were not reported. On 27-MAR-2015, the patient was vaccinated with an improperly stored dose of (Merck) VARIVAX (dose, frequency, route of administration, lot# and expiration date were not reported). No adverse effect was reported. Product quality complain (PQC) was not involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to a patient of unknown age and gender. The patient's medical history and current conditions were not reported. On 24-MAR-2015, the patient was vaccinated with an improperly stored dose of (Merck) VARIVAX (dose, frequency, route of administration, lot# and expiration date were not reported). No adverse effect was reported. Product quality complain (PQC) was not involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to a patient of unknown age and gender. The patient's medical history and current conditions were not reported. On 23-MAR-2015, the patient was vaccinated with an improperly stored dose of (Merck) VARIVAX (dose, frequency, route of administration, lot# and expiration date were not reported). No adverse effect was reported. Product quality complain (PQC) was not involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to a patient of unknown age and gender. The patient's medical history and current conditions were not reported. On 10-MAR-2015, the patient was vaccinated with an improperly stored dose of (Merck) VARIVAX (dose, frequency, route of administration, lot# and expiration date were not reported). No adverse effect was reported. Product quality complain (PQC) was not involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to a patient of unknown age and gender. The patient's medical history and current conditions were not reported. On 05-MAR-2015, the patient was vaccinated with an improperly stored dose of (Merck) VARIVAX (dose, frequency, route of administration, lot# and expiration date were not reported). No adverse effect was reported. Product quality complain (PQC) was not involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to a patient of unknown age and gender. The patient's medical history and current conditions were not reported. On 26-FEB-2015, the patient was vaccinated with an improperly stored dose of (Merck) VARIVAX (dose, frequency, route of administration, lot# and expiration date were not reported). No adverse effect was reported. Product quality complain (PQC) was not involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from the nurse and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. The nurse stated that on 06-JAN-2015 the patient was vaccinated with a dose of expired PROQUAD (Merck), lot # J006162, expiry date: 30-NOV-2014 (site and route of administration were not reported). No adverse events were reported. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a Registered Nurse referring to an unspecified number of patients of unknown age and gender. Information regarding concurrent conditions and medical history was not provided. On unknown dates the patients were vaccinated with doses of improperly stored ZOSTAVAX (dose, dose #, lot #, route and application site were not reported). Concomitant therapy was not reported. No adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to a patient of unknown age and gender. The patient's medical history and current conditions were not reported. On 20-FEB-2015, the patient was vaccinated with an improperly stored dose of (Merck) VARIVAX (dose, frequency, route of administration, lot# and expiration date were not reported). No adverse effect was reported. Product quality complain (PQC) was not involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a Registered Nurse referring to an unspecified number of patients of unknown age and gender. Information regarding concurrent conditions and medical history was not provided. On unknown dates the patients were vaccinated with doses of improperly stored (Merck) VARIVAX (dose, dose #, lot #, route and application site were not reported). Concomitant therapy was not reported. No adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to a patient of unknown age and gender. The patient's medical history and current conditions were not reported. On 25-FEB-2015, the patient was vaccinated with improperly stored doses of (Oka/Merck) VARIVAX (dose, frequency, route of administration, lot# and expiration date were not reported). No adverse effect was reported. Product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter. 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 healthcare worker refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 13-APR-2015 the patient was vaccinated with a dose of expired MMR II, therapy type: HSA, lot # J004201, expiry date: 12-APR-2015 (site, route of administration were not reported). No adverse event was reported. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to a patient of unknown age and gender. The patient's medical history and current conditions were not reported. On 18-FEB-2015, the patient was vaccinated with an improperly stored dose of (Merck) VARIVAX (dose, frequency, route of administration, lot# and expiration date were not reported). No adverse effect was reported. Product quality complain (PQC) was not involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: M
Vaccine: PPV
Symptoms: Gait disturbance, Inflammation
Clinical narrative: Information has been received from a consumer via Pfizer referring to her husband of unknown age. The reporter explained her husband had injuried to his back prior to the vaccination shot and now he had to have surgery this week. On an unknown date the patient was vaccinated with a dose of PNEUMOVAX 23 (strength, dose, dose number, lot #, route and application site were not reported). Concomitant therapy was not reported. On an unknown date the patient experienced inflammation which started a couple of days after he received the shot. The reporter said that the PNEUMOVAX 23 shot did not cause the back issues but the inflammation from the shot made it worse and made the inflammatory go crazy. The inflammation triggered this terrible condition. The patient could barely walk right now. The outcome of inflammation was unknown. The reporter considered inflammation to be related to PNEUMOVAX 23. Additional information has been requested.
Age: 19.0
Sex: U
Vaccine: HEPA
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to a 19 year old patient of unknown gender. On 11-APR-2007 the patient was vaccinated with a first 0.5 ml dose of VAQTA intramuscularly. On 07-AUG-2014, the patient was vaccinated with a second 0.5 ml dose of VAQTA intramuscularly (inappropriate schedule of vaccine administered). No adverse experience was reported. No product quality complaint (PQC) was involved. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to a patient of unknown age and gender. The patient's medical history and current conditions were not reported. On 17-FEB-2015, the patient was vaccinated with an improperly stored dose of (Merck) VARIVAX (dose, frequency, route of administration, lot# and expiration date were not reported). No adverse effect was reported. Product quality complain (PQC) was not involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse referring to an unspecified number of patients of unknown age and gender. On unknown dates the patients were vaccinated with a dose of PROQUAD (Merck) (lot#, expiration date, dose, strength and route were not reported) which was exposed to a maximum temperature of - 6.2C for a total time of 5.5 hours. No adverse effects were reported. It was unspecified if the patient sought medical attention. Telephone call was placed to the reporting nurse on 17-APR-2015. The nurse was not able to provide additional information at the time of call. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Dizziness, Feeling abnormal, Pallor
Clinical narrative: Information has been received from a medical assistant referring to unspecified number of male and female patients. No relevant medical history or current conditions were reported. For the past seven years, since an unknown date, these patients were vaccinated with GARDASIL (dose, route, lot# and expiration date not reported). On unknown dates, these patients had been getting dizzy, been very pale and "spaced out" after the vaccination of GARDASIL while lying down. The outcome of the events was unknown. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: Information has been received from a nurse referring to a patient of unknown age and gender. Medical history of the patient was not reported. On 20-APR-2015 the patient was inadvertently vaccinated with PNEUMOVAX (lot # K004930, 0.5 ml, intramuscular) that had expired on 06-MAR-2015. No adverse effects were reported. Additional information is not expected as the reporter asked not to be contacted.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse referring to an unknown number of patients of unknown age and gender. Information about concurrent conditions and medical history were not provided. On unknown dates the patients were vaccinated with GARDASIL (lot # K007264, expiration date 02-MAR-2017, dose, dose# and route not reported) which were improperly stored. The temperature excursion for GARDASIL was supported with in-house stability data. No information regarding concomitant therapy was provided. No adverse symptoms reported. The outcome of the event was not reported. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker referring to unspecified patients of unknown age and gender. On unknown dates the patients were vaccinated with doses of ROTATEQ (strength, lot# and dose were unknown) orally, which were exposed to temperatures outside of the recommended range. No adverse effect had been reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Information has been received from a nurse concerning a patient of unknown age and gender. The patient's medical history and concurrent condition were not provided. On 03-MAR-2013, the patient was vaccinated with the first dose of GARDASIL (lot#, dose and route not provided). On 21-APR-2015, the patient was in the office in order to receive the second dose of GARDASIL (inappropriate schedule of the vaccine administration). No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker referring to unspecified patients of unknown age and gender. On unknown dates the patient were vaccinated with doses of RECOMBIVAX HB )route, strength, lot# and dose were unknown), which were exposed to temperature outside of the recommended range. No adverse effect had been reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker referring to unspecified patients of unknown age and gender. On unknown dates the patients were vaccinated with doses of GARDASIL (route, strength, lot# and dose were unknown), which were exposed to temperatures outside of the recommended range. No adverse effect had been reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Hepatitis B surface antibody negative
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to a patient of unknown age and gender who is also a physician. Concurrent conditions, medical history and allergies were not reported. On an unknown dates in approximately 2009 (reported as about 5 or 6 years ago), the patient was vaccinated with series of hepatitis b vaccine (manufacturer unknown), (strength, dose, frequency, route, anatomical location, lot number and expiration date were not reported). Other suspect and concomitant therapies were not reported. On an unknown date, the patient experienced hepatitis b surface antibody negative. It was reported that the patient had titers measured by a blood test prior to going on an international trip on an unknown date. The outcome of hepatitis b surface antibody negative was unknown. The relatedness between hepatitis b surface antibody negative and therapy with hepatitis b vaccine (manufacturer unknown) was not reported. This is one of two reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse refers to an unspecified number of unknown age and gender. Concurrent conditions, medical history and allergies were not reported. On an unknown dates, an unspecified number of patients were vaccinated with PROQUAD (strength, dose, route, anatomical location, lot number and expiration date were not reported), which were improperly stored. No adverse effects were reported and no product quality complaint (PQC) was involved. This is one of two reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product quality issue, Wrong technique in drug usage process
Clinical narrative: This spontaneous report as received from a nurse refers to an unspecified number of patients. On an unknown dates, the patients were vaccinated with an unspecified number of doses of (Merck) VARIVAX (lot#, dose, route and site of administration were not reported) that were reconstituted with sterile diluent (manufacturer unknown). The doses were reconstituted with 0.6 ml of sterile diluent (manufacturer unknown) and were not reconstituted with the entire volume of the supplied sterile diluent (manufacturer unknown) as recommended in the prescribing information. 0.5 ml of vaccine was drawn up for administration after reconstitution. No adverse events were reported. Product quality complaint was involved. This is one of several reports from the same reporter. Additional information has been requested.
Age: 1.0
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a mother of patient refers to her daughter who is now 14 months old received her first dose of (Merck) VARIVAX (dose, route, lot # were not reported) 1 single shot when she was 12 months old. The reporter received a letter from physicians office informing the first dose of (Merck) VARIVAX the patient received was improperly stored and she will need to be revaccinated. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified number of patients of an unknown age and an unknown gender. The unspecified number of patients of an unknown age and an unknown gender. The unspecified patients pertinent medical history was not reported. On an unknown date, the unspecified number of patients were vaccinated with improperly stored GARDASIL. No adverse effects were reported. No product quality complaint (PQC) was reported. This is one of the several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. medical history and concurrent conditions were not reported. On 13-APR-2015, the patient was vaccinated with improperly stored PROQUAD lot # K018142, expiration date 10-APR-2016 (dose and route were not reported). No adverse symptoms reported. No co-suspect and concomitant therapies were reported. This is one of several reports from the same source. Additional information has been requested.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Crying, Cyanosis, Diet refusal, Flatulence, Vomiting
Clinical narrative: Vomiting - about 3 times. Inconsolable crying - mom reports 3 episodes of crying. Gas that resulted in baby turning blue. Will not take pacifier or breastfeed at all.
Age: 1.03
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Contusion, Immunoglobulin therapy, Petechiae, Platelet count decreased
Clinical narrative: Petechiae and bruising noted.  Petechiae on trunk noted in the morning and bruises over bones.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Varicella
Clinical narrative: Developed mild case of chicken pox. Approximately 20 lesions have developed on arms and legs.
Age: 78.0
Sex: F
Vaccine: HEPA, PNC13, TDAP, TYP, YF
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: 4 inches X 2 inches red, raised, hot area on outer aspect Right arm between shoulder and elbow.
Age: 58.0
Sex: M
Vaccine: TDAP
Symptoms: Dizziness, Nausea
Clinical narrative: Persistent dizziness & nausea - almost gone after 24 hours.
Age: 30.0
Sex: F
Vaccine: IPV, PPV
Symptoms: Chills, Erythema, Hyperhidrosis, Pain, Pyrexia
Clinical narrative: Day 1: Received MENACTRA and Tdap. Day 2: Received IPV and PNEUMOVAX developed chills 2-2.5 hrs later; Returned to clinic. BP 128/89, T 98.1F oral. HR 89 RR 16, O2 sat 100>. Pt had gatorade. Warm tea, rest and monitoring, felt much better in a late day 3: Developed 2 areas soreness and erythema below vaccine sites. Day 4-5: developed subjective feeling of fever, but did not take temp, and sweating. Day 9: +/check at clinic-doing well.
Age: 0.57
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Vomiting
Clinical narrative: Vomiting.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Eye swelling, Ocular hyperaemia, Peripheral swelling, Rash, Rash macular
Clinical narrative: At 5:23 PM patients mom spoke with on call doctor and reported that patient had swelling up and down arm and a welt on abdomen. No lip swelling or difficulty breathing. On call doctor advised to give 2 teaspoons of Benadryl and go to ER. Mom verbalized understanding. Patient seen in ER at 7:00 PM. Rash had improved, no further treatment/medication given at ER. Instructed to follow up with allergist in 2-3 days or return to ER if worse in any way.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Urticaria
Clinical narrative: At 5:23 PM patients mom spoke with on call doctor and reported that patient had swelling up and down arm and a welt on abdomen. No lip swelling or difficulty breathing. On call doctor advised to give 2 teaspoons of Benadryl and go to ER. Mom verbalized understanding. Patient seen in ER at 7:00 PM. Rash had improved, no further treatment/medication given at ER. Instructed to follow up with allergist in 2-3 days or return to ER if worse in any way.
Age: 1.0
Sex: F
Vaccine: VARCEL
Symptoms: Induration, Rash
Clinical narrative: 3 SMALL BULLA BUMPS INDURATION OF 15MM.
Age: 1.13
Sex: M
Vaccine: VARCEL
Symptoms: Adverse reaction, Laboratory test, Ultrasound scan
Clinical narrative: LARGE 40MM ROUND BULLA.
Age: 76.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Swelling, pain, hot, injection site red and spread around arm.
Age: 63.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Erythema, Injection site swelling
Clinical narrative: Large oval shape (approx. 10cm in length x 5cm) local redness and looked raised around the injection site.  No pain and no fever confirmed but patient is a limited English speaker. Left a message on daughter's phone number and asked to follow up with us.
Age: 63.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site warmth, Local swelling
Clinical narrative: Large oval shape (approx. 10cm in length x 5cm) local redness and looked raised around the injection site.  No pain and no fever confirmed but patient is a limited English speaker. Left a message on daughter's phone number and asked to follow up with us.
Age: 11.0
Sex: M
Vaccine: HPV4, TDAP
Symptoms: Injection site erythema, Type III immune complex mediated reaction, Vaccination site swelling
Clinical narrative: Redness and swelling at vaccination site. Likely Arthus reaction.
Age: 31.0
Sex: F
Vaccine: TTOX
Symptoms: Abdominal discomfort, Myalgia, Pain in extremity
Clinical narrative: When I first received the Tetanus shot I had muscle aches-a feeling of pins in my stomach-and arm pain-IT HAS BEEN WELL OVER TWO YEARS AND THE ARM PAIN HAS NEVER WENT AWAY.
Sex: F
Vaccine: MEA
Symptoms: Adverse reaction
Clinical narrative: This spontaneous report as received from a pharmacist refers to a female patient of about 55 to 60 years old who on an unspecified date in 1960 received a dose of (Enders-Edmonston) ATTENUVAX (dose, route, anatomical location, lot number and expiration date not reported). The pharmacist reported that the patient experienced an unspecified severe reaction to the vaccine. The patient recovered on an unspecified date. No further information was reported. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to 2 patients of unknown age and gender. Medical history and concurrent conditions were not reported. On 25-MAR-2015, the patients were vaccinated with improperly stored PROQUAD (Merck) lot # K018142, expiration date 10-APR-2016 (dose and route were not reported). No adverse symptoms reported. No co-suspect and concomitant therapies were reported. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker referring to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On 21-APR-2015, the patient was vaccinated with an expired dose of M-M-R II, subcutaneously, (lot # J006135, expiry date 17-APR-2015). No adverse experience reported. Additional information has been requested.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Burning sensation, Herpes zoster
Clinical narrative: This spontaneous report as received from a consumer refers to himself, a 71 year old male patient with seasonal allergy. Patient with no pertinent medical history. In early September 2014 the patient was vaccinated with ZOSTAVAX 1 standard dose (route, lot number and expiration date unspecified by the reporter). There was no concomitant medication reported. On an unknown date in September 2014 the patient experienced a slight burning sensation on the buttocks and developed shingles after receiving ZOSTAVAX. The patient sought medical attention was seen in office visit and was treated with ELOCON cream. The outcome of herpes zoster was reported as recovering. The reporter did not assess the causal relationship between ZOSTAVAX and herpes zoster. Additional information is not expected since no contact details and permission for follow up was given.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a health worker refers to an unspecified number of patients of unknown age and gender. No concurrent or historical conditions were reported. On an unknown date, the patients were vaccinated with a dose of varicella virus vaccine live (Merck) (lot # and expiration date were not reported) (route and dose were not reported) which was improperly stored. No concomitant medication was reported. No adverse effect was reported at the time of this report. Additional information has been requested. This is one of several reports from the same source.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a Licensed Practical Nurse, refers to a patient of unknown age and gender. Medical history and concurrent conditions were not reported. The Licensed Practical Nurse informed that on 03-APR-2015, the patient received a dose of GARDASIL (dosage, route, lot# and expiration date were not reported) and on 20-APR-2015 received a second dose of GARDASIL, (dosage, route, lot# and expiration date were not reported). Concomitant therapy was not reported. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report was received from a Licensed Practical Nurse, refers to an unspecified patients, of an unknown age and gender. Medical history and concurrent conditions were not reported. The licensed practical nurse informed that on an unknown date the patients received an extra dose of RECOMBIVAX HB, (route, dosage,  lot# and expiration date were not reported). Concomitant therapy was not reported. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a health worker to an unspecified number of patients of unknown age and gender. No concurrent or historical conditions were reported. On an unknown date, the patients were vaccinated with a dose of VAQTA (lot # and expiration date were not reported) (route and dose were not reported) which was improperly stored. No concomitant medication was reported. No adverse effect was reported at the time of this report. Additional information has been requested. This is one of several reports from the same source.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a health worker refers to an unspecified number of patients of unknown age and gender. No concurrent or historical conditions were reported. On an unknown date, the patients were vaccinated with a dose of RECOMBIVAX HB (lot # and expiration date were not reported) (route and dose were not reported) which was improperly stored. No concomitant medication was reported. No adverse effect was reported at the time of this report. Additional information has been requested. This is one of several reports from the same source.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to unspecified number of patients of unknown age and gender. On unknown dates, an unspecified number of doses of improperly stored (Merck) VARIVAX (lot number K015946, expiration date 23-SEP-2016, dose and route were unknown) were administered to the patients. No adverse effects were reported. This is one of the two reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to unspecified number of patients of unknown age and gender. On unknown dates, an unspecified number of doses of improperly stored PROQUAD (lot number K025766, expiration date 08-JUN-2016, dose and route were unknown) were administered to the patients. No adverse effects were reported. This is one of the two reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a health worker refers to an unspecified number of patients of unknown age and gender. No concurrent or historical conditions were reported. On an unknown date, the patients were vaccinated with a dose of GARDASIL (lot # and expiration date were not reported) (route and dose were not reported) which was improperly stored. No concomitant medication was reported. No adverse effect was reported at the time of this report. Additional information has been requested. This is one of several reports from the same source.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a health worker refers to an unspecified number of patients of unknown age and gender. No concurrent or historical conditions were reported. On an unknown date, the patients were vaccinated with a dose of ROTATEQ (lot # and expiration date were not reported) (route and dose were not reported) which was improperly stored. No concomitant medication was reported. No adverse effect was reported at the time of this report. Additional information has been requested. This is one of several reports from the same source.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site mass
Clinical narrative: This spontaneous report was received from a pharmacist via company representative refers to unspecified number of patients (maybe 17 or 18) of unknown age and gender. Medical history and concurrent conditions were not provided. On an unspecified date, between February and March 2015, all these patients received ZOSTAVAX, 0.65 ml once, subcutaneous. No concomitant medications were reported. Some of the patients got a bump at site, not described as blister (Injection site mass). Reporting pharmacist stated that the symptoms dissipated over time and there were no details on any treatment. On 17-APR-2015, another pharmacist during a phone call confirmed the lot number and expiration date for the ZOSTAVAX: K020186 and expiry date: 27-JAN-2016. The pharmacist provided that patient identification information was not readily available at the time of the call and that there were no additional adverse events reported. The outcome of the injection site mass was recovering at the time of the report. Causality assessment was not provided. this is one of two reports received from the same reporter. Additional information has been requested.
Age: 12.0
Sex: M
Vaccine: HPV4
Symptoms: Eye movement disorder, Headache, Loss of consciousness, Muscle twitching, Musculoskeletal stiffness
Clinical narrative: Patient given HPV immunization. Patient was sitting approximately 3-4 minutes after patient experienced episode with LOC, stiffened, eyes rolled, twitching complained of headache after which cleared after lying down app 5 min.
Age: 40.0
Sex: F
Vaccine: TDAP
Symptoms: Hypoaesthesia, Hypoaesthesia oral, Urticaria
Clinical narrative: Received Tdap vaccine at 1130. Called to report hive on face and numbness to face and tongue at 1310. Referred to ER now. BENADRYL P.O.
Age: 11.0
Sex: M
Vaccine: HPV4, MNQ
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Received HPV on left deltoid, redness and swelling covering majority of upper extremity. No other symptoms/fever.
Age: 28.0
Sex: M
Vaccine: FLU3, FLUC3
Symptoms: Arthralgia, Full blood count, Influenza like illness, Metabolic function test, Pain
Clinical narrative: Explosive onset of rheumatoid arthritis.
Age: 28.0
Sex: M
Vaccine: FLU3, FLUC3
Symptoms: Pyrexia, Rheumatoid arthritis, Urine analysis
Clinical narrative: Explosive onset of rheumatoid arthritis.
Age: 28.0
Sex: M
Vaccine: FLU3, FLUC3
Symptoms: Laboratory test, Rheumatoid arthritis
Clinical narrative: Explosive onset of rheumatoid arthritis.
Age: 70.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Gait disturbance, Grimacing, Musculoskeletal pain, Myalgia, Pain in extremity
Clinical narrative: Pt had pain in the buttocks, legs, ankles, that started 1 day after administration of vaccine. Got progressively worse, so went to DR 4 days later, still not better on steroids and pain meds, so went to hospital on day 6. Discharged a few days later w/pain improving but no medical diagnosis for pain.
Age: 70.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Arthralgia, Musculoskeletal pain, Pain in extremity
Clinical narrative: Pt had pain in the buttocks, legs, ankles, that started 1 day after administration of vaccine. Got progressively worse, so went to DR 4 days later, still not better on steroids and pain meds, so went to hospital on day 6. Discharged a few days later w/pain improving but no medical diagnosis for pain.
Age: 4.0
Sex: U
Vaccine: MMR, VARZOS, VARCEL, VARZOS
Symptoms: Wrong drug administered
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 4,5 year old patient of unknown gender. The patient's concurrent conditions and medical history were not provided. IT was reported, that the patient received an initial dose of (Oka/Merck) VARIVAX on 08-FEB-2012 as intended. The patient then inadvertently received a dose of ZOSTAVAX, subcutaneously (dose, lot# and expiration dale were not reported) instead of the intended second dose of (Oka/Merck) VARIVAX on 03-APR-2015 at 4,5 years old. Additional information has been requested.
Age: 4.0
Sex: U
Vaccine: MMR, VARZOS, VARCEL, VARZOS
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 4,5 year old patient of unknown gender. The patient's concurrent conditions and medical history were not provided. IT was reported, that the patient received an initial dose of (Oka/Merck) VARIVAX on 08-FEB-2012 as intended. The patient then inadvertently received a dose of ZOSTAVAX, subcutaneously (dose, lot# and expiration dale were not reported) instead of the intended second dose of (Oka/Merck) VARIVAX on 03-APR-2015 at 4,5 years old. Additional information has been requested.
Age: 1.05
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Injection site vesicles
Clinical narrative: Blister noted at injection site. Now has 3 blisters.
Age: 1.17
Sex: F
Vaccine: HEPA, MMR
Symptoms: Injection site rash, Injection site swelling, Pyrexia
Clinical narrative: Fever, rash and swelling at injection site.
Age: 0.55
Sex: M
Vaccine: PNC13
Symptoms: Body temperature increased, Crying, Screaming, Streptococcus test negative, Vaccination complication
Clinical narrative: Baby began crying and was inconsolable. When baby was put down he would scream, when he was being held he whimpered constantly. Baby was walked, held, offered food, changed, bathed, but nothing comforted him. At about 3:30 his temperature was checked it was 101.8 pediatrician was called I was advised he was having a reaction to the shot. Give Tylenol and a dose of Benadryl. Both were given. After giving Tylenol an hour earlier his temperature was checked it was 102.1 @4:30pm given a luke warm bath. At 6pm temperature was checked again it was 101.5. At 8pm temperature was 103.9 given a dose of Motrin and a luke warm bath. At 8:45 temperature was 104.2. Taken to emergency room at that time. Upon arriving at emergency room was given a Tylenol suppository. Strep test was done as well as ear exam both were negative.  Left hospital at 11:15pm with instructions to give Motrin and Tylenol alternating.
Age: 0.76
Sex: M
Vaccine: DTAP, HIBV, IPV
Symptoms: Blood test normal, Irritability, Pyrexia, Urine analysis normal
Clinical narrative: Fussy, then developing fever of 102. Fever reduced the following day. Second night the fever shot up to 105. Went to ER, did blood work and urine sample to eliminate risk of bacterial infection. Third night fever at 104. Fourth night fever gone. Still fussy and irritable.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site bruising, Injection site erythema, Injection site mass
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a female patient of unknown age. On an unknown date, the patient was vaccinated with ZOSTAVAX (route of administration, dose, lot number and expiry date were not reported) for prevention of shingles. On an unknown date, a couple of days after the vaccination, a couple of months ago, the patient experienced redness, bruising and a lump at the injection site. The patient sought medical attention. No rash was reported. No rash was reported. No treatment was given for the adverse events and no lab diagnostic test was performed. The pharmacist reported that the patient was seen in the pharmacy about a week later and the symptoms had completely gone away (recovered on an unknown date). The relatedness between the vaccination and the adverse events was not reported. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to an unspecified number of the patients of unknown age and gender. On an unknown date the patient was vaccinated with improperly stored ROTATEQ (route of administration defaulted to oral, dosage schedule and lot# were not reported) (exposed to 52F to 48 horus). No adverse event. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist refers to a patient of unknown age. On 03-APR-2015, the patient was vaccinated inadvertently with an expirted dose of ZOSTAVAX lot # J014567, expiry date 18-FEB-2015. No adverse events were reported. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker referring to unspecified patients of unknown age and gender. No information about medical history, concurrent conditions were reported for the patients. On unknown dates, the patients were administered with unknown number of doses of improperly stored ROTATEQ (dose strength, lot # unspecified, orally). No adverse effects reported. This is one of the several reports received from the same souce. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site mass, Injection site pain
Clinical narrative: This spontaneous report was received from a female patient of unknown age regarding herself. The medical history, concurrent history and concomitant medications were not reported. On an unknown date, the patient was vaccinated with ZOSTAVAX. On an unknown date, the patient experienced painful, hard, red lump at the injection site after receiving ZOSTAVAX. The outcome of the events were unknown. Additional information is not expected.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a nurse via company representative refers to a twins patients of unknown age and gender. On 15-APR-2014, the patients were intramuscularly vaccinated with the first dose of GARDASIL (dose, lot # and expiration date were not reported).On 25-SEP-2014, the patients were intramuscularly vaccinated with the second dose of GARDASIL (dose, lot # and expiration date were not reported). On 15-OCT-2014, the patients were intramuscularly vaccinated with a third dose of GARDASIL (dose, lot # and expiration date were not reported). Patients received the doses of GARDASIL outside of recommended dosing interval. No adverse effects were reported. Additional information has been requested.
Age: 1.22
Sex: M
Vaccine: MMR
Symptoms: Generalised tonic-clonic seizure, Pyrexia
Clinical narrative: Patient was running a fever. Mom took him to MD. After seeing MD mom put him in his car seat and he had a grand mal seizure. An MD was in the parking lot - he call EMS and patient was transported to hospital.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Dyspnoea, Vomiting
Clinical narrative: Became lightheaded, SOB and vomiting. Told the pt. to lay down, applied ice to back of neck and cool compress to forehead. Got Dr. to check Pt.
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Herpes zoster
Clinical narrative: SHINGLES ACUTELY IN THE SAME ARM THAT THE VACCINE WAS ADMINISTERED.