chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to 18 patients of unknown age. On an unknown date the patients were vaccinated with VARIVAX (Merck) lot # H015940. The VARIVAX (Merck) had multiple excursions reaching the highest temperature of 15.5f. The nurse was unsure how many total hours of the excursions but reported that it was over 72 hours. No adverse effect was reported. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to 4 patients of unknown age. The case was linked to case 1305USA017051 (same reporter link). On an unknown date the patients were vaccinated with VARIVAX (Merck) lot # H009841. The VARIVAX (Merck) had multiple excursions reaching the highest temperature of 15.5f. The nurse was unsure how many total hours of the excursions but reported that it was over 72 hours. No adverse effect was reported. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Rash
Clinical narrative: This spontaneous report was received from a female patient of unknown age regarding herself. There was no pertinent medical history and no drug reactions or allergies. On 06-JUN-2013, the patient was vaccinated with a dose of ZOSTAVAX (lot number, expiry date, dose and route unspecified). Concomitant therapy included clonazepam (dosage and manufacturer unspecified). On 07-JUN-2013, the patient developed a rash, the size of a baseball and she became very fatigued. The patient sought medical attention (spoke to pharmacist). No treatment was given and no lab tests were performed. The patient was recovering from the events. The relatedness for the events was unknown for ZOSTAVAX. Additional information has been requested.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthritis, Condition aggravated
Clinical narrative: This spontaneous report was received from a 60 year old male patient who is also a pharmacist. Patient current condition included arthritis. No medical history was reported. Approximately on 15-OCT-2012(reported as middle of October 2012), the patient was vaccinated with a one time dose of ZOSTAVAX (lot#, expiry not reported), 0.65 ml, subcutaneously. No concomitant medications were reported. On 15-OCT-2012 (reported as middle of October 2012), the patient experienced exacerbation of arthritis after receiving ZOSTAVAX. Patient is taking ADVIL(unspecified manufacturer) as treatment. Patient sought medical attention(patient is the pharmacist). Laboratory diagnostics studies performed was none. The outcome of exacerbation of arthritis was unknown. Additional information has been requested.
Age: 1.2
Sex: F
Vaccine: MMRV, VARCEL
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report was received from a licensed practical nurse, regarding a 14 month old patient (gender not provided). Pertinent medical history and drug reactions/allergies were not provided. On 12-JUN-2013 the patient was vaccinated with a dose of PROQUAD (Merck) (route, lot number and expiration date were not provided). On the same date, the patient received a dose of VARIVAX (Merck), (route, lot number and expiration date were not provided). No adverse effect was reported. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender (no demographic details were provided). The patient medical history was unknown. On 04-JUN-2013 the patient was vaccinated with VARIVAX (Merck), lot number 0831AA. The medical assistant reported the administered dose of VARIVAX (Merck) was expired; the expiration date of the vaccine was reported to be 02-JUN-2013. No adverse event was reported. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HEPA, HPV4
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: No adverse reaction.
Age: 66.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Pt. had redness, swelling in right upper arm. Vaccine given in (R) deltoid. No fever or pain. Advised cold compresses today and warm compresses tomorrow.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMRV
Symptoms: Dysphemia
Clinical narrative: Parent reports patient stuttering after adminisration of vaccines, feels strongly it is because of MMR and wants "report filed".
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site discharge, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Pt was given KINRIX and PROQUAD for 4yr checkup. Redness - localized swelling, warm to touch - some drainage from where PROQUAD was given (RA).
Age: 4.0
Sex: M
Vaccine: DTAPIPV, HEPA, MMRV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: 5-29-13 - Day - Fever 101.0. That night Mom noticed (R) arm was swollen and red, with red lines coming away from injection site. No c/o's pain. 5-30-12 Instructed to go to ED. No fever. Symptoms same. Mom states that ED stated "It was something with his immune something...possibly an infection. Placed on 2 antibiotics: BACTRIM and Cephalexin. 6-4-13 Follow up. Mom states "He is way better". States he has finished his antibiotics".
Age: 17.0
Sex: F
Vaccine: HEPA, TYP
Symptoms: Pyrexia, Syncope, Vomiting
Clinical narrative: 5 minutes post vaccinations, patient fainted. Pt had fevers and vomiting. Pt left w/ EMT and went to the hospital.
Age: 15.0
Sex: M
Vaccine: HEPA, TDAP, VARCEL, VARCEL
Symptoms: Rash generalised, Varicella post vaccine
Clinical narrative: This spontaneous report as received from an other health professional refers to a 15 year old male patient. The patient's medical history included an unspecified skin problem. On an unknown date the patient was vaccinated with (merck) VARIVAX (dose 1; dosing, indication unknown). On 29-APR-2013 the patient was vaccinated with (merck) VARIVAX (dose 2, lot # H018451, exp date: 09-OCT-2014; dosing, indication unknown). Concomitant medication included a topical antifungal. On 04-MAY-2013 the patient developed chickenpox and a secondary infection. The patient had visited the Emergency Room several times. A biopsy of the secondary infection was performed. The outcome was reported as not recovered. Additional information has been requested.
Age: 15.0
Sex: M
Vaccine: HEPA, TDAP, VARCEL, VARCEL
Symptoms: Biopsy, Infection, Varicella post vaccine
Clinical narrative: This spontaneous report as received from an other health professional refers to a 15 year old male patient. The patient's medical history included an unspecified skin problem. On an unknown date the patient was vaccinated with (merck) VARIVAX (dose 1; dosing, indication unknown). On 29-APR-2013 the patient was vaccinated with (merck) VARIVAX (dose 2, lot # H018451, exp date: 09-OCT-2014; dosing, indication unknown). Concomitant medication included a topical antifungal. On 04-MAY-2013 the patient developed chickenpox and a secondary infection. The patient had visited the Emergency Room several times. A biopsy of the secondary infection was performed. The outcome was reported as not recovered. Additional information has been requested.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Pruritus, Rash
Clinical narrative: This spontaneous report was received from an adult patient of unknown age and gender with no pertinent medical history and drug reactions/allergies reported. On 10-MAY-2013, the patient was vaccinated with ZOSTAVAX (dose, frequency, route, lot number an expiration date were not reported). Concomitant medication was not reported. Approximately in May 2013, the patient had broken out with a rash across back and stomach. The patient had small red bumps across these areas. It was itchy and scabby. Not real severe yet. Much more scarred and in both sides of these areas. Did not look severe as many pictures the patient looked up, but worried it may become worse. The patient would be seeing the administering doctor (DR) around 10-JUN-2013 to have him look at it. The patient never had this problem before the vaccine. The outcome of rash across my back and stomach the patient had small red bumps across these areas, It was itchy, scarred and on both sides of back and stomach and scabby was unknown. Relatedness of events and ZOSTAVAX was unknown. Additional information has been requested.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Rash erythematous, Rash pruritic, Scab, Scar
Clinical narrative: This spontaneous report was received from an adult patient of unknown age and gender with no pertinent medical history and drug reactions/allergies reported. On 10-MAY-2013, the patient was vaccinated with ZOSTAVAX (dose, frequency, route, lot number an expiration date were not reported). Concomitant medication was not reported. Approximately in May 2013, the patient had broken out with a rash across back and stomach. The patient had small red bumps across these areas. It was itchy and scabby. Not real severe yet. Much more scarred and in both sides of these areas. Did not look severe as many pictures the patient looked up, but worried it may become worse. The patient would be seeing the administering doctor (DR) around 10-JUN-2013 to have him look at it. The patient never had this problem before the vaccine. The outcome of rash across my back and stomach the patient had small red bumps across these areas, It was itchy, scarred and on both sides of back and stomach and scabby was unknown. Relatedness of events and ZOSTAVAX was unknown. Additional information has been requested.
Age: 71.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Body temperature increased, Pain in extremity, Rash
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 71 year old female patient with no drug reactions or allergies and no pertinent medical history. On 10-JUN-2013 the patient was vaccinated with a dose of ZOSTAVAX subcutaneous (lot # J000432, expiration date 10-APR-2014) (dose not reported). There were no concomitant medications. On 11-JUN-2013, the patient developed allergic reaction of bumpy, itchy, painful rash at the injection site. There were no lab diagnostics studies performed. Steroid cream was given as a treatment for the adverse events. The patient sought medical attention by calling the pharmacist. The outcome of bumpy rash at the injection site, painful rash at the injection site and itchy rash at the injection site was reported as not recovered/not resolved. Additional information has been requested.
Age: 71.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Hypersensitivity, Injection site pain, Injection site pruritus, Injection site rash
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 71 year old female patient with no drug reactions or allergies and no pertinent medical history. On 10-JUN-2013 the patient was vaccinated with a dose of ZOSTAVAX subcutaneous (lot # J000432, expiration date 10-APR-2014) (dose not reported). There were no concomitant medications. On 11-JUN-2013, the patient developed allergic reaction of bumpy, itchy, painful rash at the injection site. There were no lab diagnostics studies performed. Steroid cream was given as a treatment for the adverse events. The patient sought medical attention by calling the pharmacist. The outcome of bumpy rash at the injection site, painful rash at the injection site and itchy rash at the injection site was reported as not recovered/not resolved. Additional information has been requested.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. On 12-JUN-2013 the patient was vaccinate with an expired vial of ZOSTAVAX (lot # 0423AE, expiration date 02-APR-2013), (dose, route and anatomical location unspecified). Concomitant medications were not reported. No adverse effect reported, no PQC reported. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HEPA
Symptoms: Injection site erythema, Injection site nodule, Injection site swelling
Clinical narrative: Redness, swelling, hard knot at injection site.
Age: 8.0
Sex: M
Vaccine: DTAP
Symptoms: Abasia, Blood test normal, Dystonia, Electroencephalogram normal, Injection site erythema
Clinical narrative: Initial report received from a consumer who is the patient's parent on 05 June 2013. A consumer reported that her 7 year old son who had medical history of Autism that was diagnosed in 2006 at age 2 years had received a 5th intramuscular right deltoid injection of either Tdap or Dtap vaccine on 18 July 2012. The following day after vaccination, the patient developed a local reaction of redness and swelling at the site and was evaluated by a physician the following day. He was prescribed corrective treatment with BENADRYL and ibuprofen. Four weeks later, the patient developed stiffness and contortion of the right hand that progressed to all 4 extremities and by September 2012 he was unable to walk. The patient was hospitalized (dates not reported) for 4 days for testing to rule out seizures. Blood work, an MRI and EEG were all normal. A spinal MRI was also performed in November 2012 (results not reported). Neurology evaluation diagnosed dystonia and the patient was treated with dopamine and muscle relaxants. No specific cause has been determined. The patient had been up to date on all immunizations by 2 years of age, but vaccination was ceased after he was diagnosed with Autism 2006. At the time of this report, the patient had not recovered. Documents held by sender: None.
Age: 8.0
Sex: M
Vaccine: DTAP
Symptoms: Injection site swelling, Local reaction, Musculoskeletal stiffness, Nuclear magnetic resonance imaging normal, Nuclear magnetic resonance imaging spinal
Clinical narrative: Initial report received from a consumer who is the patient's parent on 05 June 2013. A consumer reported that her 7 year old son who had medical history of Autism that was diagnosed in 2006 at age 2 years had received a 5th intramuscular right deltoid injection of either Tdap or Dtap vaccine on 18 July 2012. The following day after vaccination, the patient developed a local reaction of redness and swelling at the site and was evaluated by a physician the following day. He was prescribed corrective treatment with BENADRYL and ibuprofen. Four weeks later, the patient developed stiffness and contortion of the right hand that progressed to all 4 extremities and by September 2012 he was unable to walk. The patient was hospitalized (dates not reported) for 4 days for testing to rule out seizures. Blood work, an MRI and EEG were all normal. A spinal MRI was also performed in November 2012 (results not reported). Neurology evaluation diagnosed dystonia and the patient was treated with dopamine and muscle relaxants. No specific cause has been determined. The patient had been up to date on all immunizations by 2 years of age, but vaccination was ceased after he was diagnosed with Autism 2006. At the time of this report, the patient had not recovered. Documents held by sender: None.
Sex: F
Vaccine: PNC13
Symptoms: Death, Pneumococcal sepsis, Pneumonia pneumococcal
Clinical narrative: This is an initial spontaneous report by a contactable physician. A female patient received PREVNAR 13 (Lot number: G54897, Expiration Date: 09Jan2014) unknown dose unknown, frequency ,unknown anatomical location of the administration for an unknown indication in May2013. Relevant medical history was unknown. Relevant concomitant medications were unknown. Vaccines given on the same day was unknown. Vaccines taken within the last four weeks were unknown. In 2013 she experienced pneumococcal pneumonia, pneumococcal sepsis and an unspecified condition to which she passed away. Relevant lab data was unknown. It was unknown if an autopsy was performed. At the time of report she had not recovered from an unspecified condition. At the time of report the clinical outcome for the other events were unknown.
Age: 17.0
Sex: M
Vaccine: HPV4
Symptoms: Hyperhidrosis
Clinical narrative: This spontaneous report as received from a nurse refers to a 17 year old male patient with none pertinent medical history seasonal allergies. On an unknown date the patient was vaccinated with the first and the second dose of GARDASIL (lot #, doses and routes not reported). Concomitant medication included unspecified allergy medication (dosage and manufacturer unspecified). On an unknown date, after receiving his second dose, the patient experienced hyperhidrosis and extreme sweating. The nurse planned to give the patient the third dose of GARDASIL. The patient sought medical attention, he spoke to nurse. Unspecified treatment was given. None lab diagnostics was performed. The outcome of hyperhidrosis and extreme sweating was reported as not recovered/not resolved. Causality was not reported.
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: This spontaneous report was received from a registered nurse via company representative concerning a male patient of unknown age. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX (lot number, expiry date, dose and route unspecified). No concomitant therapy was reported. On an unknown date, the patient experienced a local injection site reaction of redness and hardness after receiving the vaccination. The patient sought medical attention (doctor visit). The patient was treated with BENADRYL (manufacturer unknown). It was unspecified if any lab tests were performed. On an unknown date, the patient recovered from the local injection site reaction of redness and hardness. The relatedness for the events was unknown for ZOSTAVAX. Additional information is not expected.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Diarrhoea, Weight decreased
Clinical narrative: This spontaneous report as received from the treating nurse practitioner refers to a 21 year old female patient, who "some time in the beginning of March 2013" was vaccinated with the first dose of GARDASIL (lot # not reported), "single standard dose taken", intramuscular. "Some time in the beginning of March 2013", after vaccination of the first dose, the patient begun having diarrhea and weight loss. The patient sought medical attention, by office visit. No lab diagnostic was performed. At the time of report, the outcome of weight loss and diarrhea was reported as not recovered/not resolved. Causality was not reported. Additional information has been requested.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Dizziness, Headache, Pyrexia
Clinical narrative: This spontaneous report as received from a physician refers to a 66 year old female patient with asthma and sulfur allergy (reaction unknown). On 13-JUN-2013 the patient was vaccinated with ZOSTAVAX (lot number was reported as J001009; expired date 24-APR-2014) in the left arm. Concomitant therapies included alendronate sodium/ cholecalciferol tablets 70 mg/once daily, QVAR nasal spray twice daily and NASONEZ 50 mcg/twice daily. On 13-JUN-2013 the patient experienced had a fever of 103 degrees Fahrenheit and experienced weakness, dizziness and headache after receiving ZOSTAVAX. The next day she still felt weak and had a headache but the other symptoms had subsided. The patient was also using NASONEX at the time of the adverse event. There was no laboratory diagnostics studies performed. The outcome of dizziness and had a fever of 103 degrees fahrenheit was reported as recovering/resolving. The outcome of weakness and headache was reported as not recovered/not resolved. The action taken was not provided. The patient had spoken with doctor for medical attention. Additional information has been requested.
Age: 0.9
Sex: U
Vaccine: HIBV
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report was received from a Licensed Practical Nurse refers to a 11 month old patient of unknown gender. No medical history was reported. On 23-JAN-2013, patient was vaccinated with dose 1 of PEDVAXHIB (lot#, expiry not reported) intramuscularly. The nurse reported that on an unknown date in 2013, the patient was vaccinated with dose 3 of PEDVAXHIB (lot#, expiry not reported) intramuscularly only one month after receiving the second dose of PEDVAXHIB (lot#, expiry not reported). No adverse events were reported. Additional information has been requested.
Age: 78.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from an approximately 78 year old male patient refers to himself, as a part of Post Marketing Active Surveillence. Medical history, drug reactions or allergies were not reported. The patient stated that he was in a study for the "shingles vaccine". The consumer did not have further information about the study. On an unknown date in approximately 2003 (reported as "about 10 years ago") the patient was vaccinated with a dose of ZOSTAVAX subcutaneous (dose, route and lot number were not reported). On an unknown date in approximately 2013 (reported as "recently") the patient was diagnosed with shingles. The outcome of shingles was unknown. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Burning sensation, Discomfort, Herpes zoster, Musculoskeletal discomfort
Clinical narrative: This spontaneous report as received from a consumer refers to a 61 year old female patient with no pertinent medical history and allergy to hay fever and penicillin. On an unspecified date in April 2013 the patient was vaccinated with a dose of ZOSTAVAX (dose, route and lot# not reported). Concomitant therapy included blood pressure medications (dose and manufacturer unknown). The patient stated she had a mild case of Shingles over 20 years and recognized the symptoms, so she got the ZOSTAVAX vaccine to prevent having an extremely bad case. The patient was experiencing burning and discomfort in her back and under her armpit. No distinction was made to which side of her body was being affected. The patient did not receive any treatment and did not seek any medical attention. Routine quarterly blood work was performed and no result was given. On approximately 07-JUN-2013 (currently), the patient was still experiencing the symptoms. Additional information is not expected.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a pharmacist refers to a female patient of unknown age. On an unknown date the patient was vaccinated with a dose of ZOSTAVAX (dose, route and lot # not reported). On an unknown date, the patient experienced a case of shingles after vaccination. It was unspecified if the patient had sought medical attention. The outcome of the patient's adverse event was unknown. This is one of several reports from the same source. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARCEL
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report was received from a registered pharmacist via a company representative concerning a 60 year old (also reported as 61 year old) female patient. On an unknown date, the patient was vaccinated with a dose of VARIVAX (Merck) (lot number, expiry date, dose and route unspecified) by accident instead of ZOSTAVAX. No concomitant therapy was reported. No side effects were reported. Additional information is not expected.
Sex: U
Vaccine: HIBV, PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: This literature marketed report as received from a other health professional refers to a pediatric patient of unknown age. the retrospective study objective was to develop a valid and reliable algorithm to identify ADRs (Adverse drug reactions) in the NICU (neonatal intensive care units). Algorithm development began with a 24-item questionnaire for data collection on 100 previously suspected Adverse Drug Reaction (ADR). Five pediatric pharmacologists independently rated cases as definite, probable, possible, and unlikely ADRs. On an unknown date, the patient was vaccinated with Hib (manufacturer unknown) and also pneumococcal vaccine (unspecified). No concomitant medications were reported. On an unknown date the patient experienced redness, swelling at injection site and redness, swelling at injection site. It was reported that in an adverse drug reactions by drug class for the cases from the neonatal intensive care units. The outcome of redness, swelling at injection site was unknown. The author considered redness, swelling at injection site to be related to Hib vaccine (manufacturer unknown). In conclusion the author stated that, the new algorithm was developed based on actual patient data using a novel mathematical approach. The resulting scoring system appeared to be significantly more valid and reliable compared with the Naranjo algorithm in an inborn NICU population. It was believed that with greater numbers of patients with varied demographics, diseases, and therapies, the validity and reliability of this ADR algorithm developed could be further improved. A similar approach could be used to develop and refine an algorithm for older pediatric patients. This retrospective study had demonstrated the advantage of using real patient data for the development of an ADR assessment algorithm and is an important first step toward eventually obtaining a valid and reliable ADR assessment algorithm for this very vulnerable population. The case is linked to 1306USA007154, 1306USA007153, 1306USA004473, 1306USA007336, 1306USA007337, 1306USA007338, 1306USA007339, 1306USA007340, 1306USA007341, 1306USA007342 via same reporter link. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a program manager (healthcare worker) refers to unspecified number of patients of unknown age. Program manager reported that patients might have been administered M-M-R II (injection, therapy type, strength, lot#, dose/frequency, route and duration were unspecified) that had been exposed to unspecified temperatures out of range for an unspecified length of time since an unspecified date in September 2012. No adverse effects reported. Outcome was unknown. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Unevaluable event
Clinical narrative: This spontaneous report as received from a pharmacist refers to two unspecified patients. On an unknown date the two unspecified patients received ZOSTAVAX at two separate unspecified pharmacies and developed a "baseball sized knot' at the injection site at an unspecified time. The pharmacist reported that the one patient was unable to move the arm that they received the ZOSTAVAX (captured in MARRS # 1306USA007036). The outcome of event was unknown. Lot number 000444 is an invalid lot number for ZOSTAVAX. This is one of two reports received from the same source. Additional information has been requested.
Age: 90.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Oedema peripheral, Ultrasound Doppler abnormal
Clinical narrative: C/p worsening redness and swelling of left arm.  Patient related recent vaccination in site but also history of multiple lab draws from the same arm with redness/swelling beginning at lab draw site but extending to entire are.  Began 5/29/13 pm (day of vaccine); went to PCP on 5/30/13 and place on po abx (Omnicef); seen in ED on 5/31/13- admitted to the hospital; IV abx given on admission plus US to r/o DVT which was negative.
Age: 18.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Asthenia, Dizziness, Lethargy, Loss of consciousness, Paraesthesia
Clinical narrative: Patient was given 2 vaccinations- HPV and Meningococcal Conjugate.  Within 15 seconds of immunizations patient passed out and fell to the floor.  She then exhibited seizure-like symptoms before coming to.  After this the nurse called for assistance and the Dr. came in to evaluate the situation.  She was then carefully placed on the table where she was having difficulty responding to questions.  She also exhibited loss of strength in her hands when the Dr. asked her to squeeze her hands.  Patient continued to lethargic and very dizzy.  She experienced tingling in her hands as well.  She was given IV fluids- and this did help- however she continued to be dizzy.  Patient vomited several times during this experience- basically every time she was asked to sit up.  After approximately 2 1/2 hours of being monitored and resting- patient was released.  When she arrived home- she continued to be extremely lethargic and vomited several times on 2 occasions.  She was monitored through out the day and night- and continued with her lethargy.  The second day she still remained dizzy and lethargic.
Age: 18.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Seizure like phenomena, Vomiting
Clinical narrative: Patient was given 2 vaccinations- HPV and Meningococcal Conjugate.  Within 15 seconds of immunizations patient passed out and fell to the floor.  She then exhibited seizure-like symptoms before coming to.  After this the nurse called for assistance and the Dr. came in to evaluate the situation.  She was then carefully placed on the table where she was having difficulty responding to questions.  She also exhibited loss of strength in her hands when the Dr. asked her to squeeze her hands.  Patient continued to lethargic and very dizzy.  She experienced tingling in her hands as well.  She was given IV fluids- and this did help- however she continued to be dizzy.  Patient vomited several times during this experience- basically every time she was asked to sit up.  After approximately 2 1/2 hours of being monitored and resting- patient was released.  When she arrived home- she continued to be extremely lethargic and vomited several times on 2 occasions.  She was monitored through out the day and night- and continued with her lethargy.  The second day she still remained dizzy and lethargic.
Age: 23.0
Sex: M
Vaccine: SMALL
Symptoms: Rash macular, Rash pruritic
Clinical narrative: Patient noted diffuse macular rash to arms bilat.  Presented to this facility on 06/18/2013 c/o rash spreading and itching. Diffuse macular type rash to face, neck a&p, torso a&p, and limbs X 4 a&p. Rash consistent with that seen in early onset vaccinia. Patient sent to ER. Final disposition was to home with a anti itching medication.  No follow up or referrals given.
Age: 0.01
Sex: F
Vaccine: HEP
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a female patient newborn patient. On the day the patient was born, 20-FEB-2013, she was vaccinated with her first dose of RECOMBIVAX HB (lot number not provided) 5 mcg/0.5 ml intramuscularly. On 22-FEB-2013, the second dose of RECOMBIVAX HB was administered. No adverse effect was reported. Medical attention was not sought. Additional information has been requested.
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Contusion
Clinical narrative: This spontaneous report was received from a consumer's wife regarding her husband, a 71 year old patient with no pertinent medical history reported. On 29-MAY-2013 (reported as two weeks ago) the patient was vaccinated with ZOSTAVAX (lot number and expiration date not provided) (dose and route not provided) as a prescription from primary physician for ZOSTAVAX. No other suspect therapies were reported. Concomitant medications included aspirin. On an unspecified date in 2013 (reported as a few days later) the patient's arm showed bruising down his elbow to his shoulders. The reporter stated that from their own Internet research it appeared like cellulitis. The reporter was encouraged to consult their healthcare provider. It was reported that the patient still has the bruising on his arm (which arm information was not distinguished). No treatment information was reported. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Body temperature increased, Pain, Rash, Wheezing
Clinical narrative: Rash onset: 10 min after vaccines. Temp 100, body aches, wheezing onset: over 12 hrs after vaccines.
Age: 18.0
Sex: M
Vaccine: MMRV, MNQ
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: None.
Age: 18.0
Sex: M
Vaccine: HEPA, HPV4, MNQ
Symptoms: Eye disorder, Nausea, Syncope, Vomiting
Clinical narrative: Pt. given MENACTRA, hep A and GARDASIL. Approx. 5 minutes after, Pt. fainted for approx 30 seconds, vomited 4 times (bile) c/o nausea. Called to patients mother. States vomited till 1800 - eyes looked funny. Pt. feeling better following day.
Age: 26.0
Sex: M
Vaccine: HEPA
Symptoms: Anaphylactic shock
Clinical narrative: Anaphylactic shock several minutes after vaccination. EPIPEN administered.
Age: 63.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain
Clinical narrative: Patient still has soreness in left arm where injection was given. Patient works for a medical supply company and recently attended a conference where she met an AFLURIA rep. The rep. told her to report her problem.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Cellulitis
Clinical narrative: Cellulitis.
Age: 45.0
Sex: F
Vaccine: MMR, TDAP
Symptoms: Erythema, Feeling hot, Injection site pruritus, Injection site swelling
Clinical narrative: 4-16-13- Tdap and MMR Vaccine- Lt. delt. area 4-21-13- c/o itching, swollen at inj. site. red patches and feels hot.- no pain.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Redness and swelling around injection site.
Age: 18.0
Sex: F
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Erythema, Skin swelling
Clinical narrative: 4cm x 2cm redness with slight raised skin. No pain, no itch.
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Erythema, Skin warm, Swelling
Clinical narrative: Red, swollen, hot, 3 1/2 inches in diameter.
Age: 0.16
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Injection site swelling
Clinical narrative: Entire left leg swollen from hip to mid-calf for 24 hrs. Mom did cool compress and TYLENOL and swelling resolved by next day.
Age: 0.09
Sex: F
Vaccine: HEP
Symptoms: Rash erythematous, Rash generalised, Rash macular
Clinical narrative: Child developed a red, blotchy rash to entire body less than 24 hours after getting Hep B vaccine. No resp involvement. Rash lessened with dose of BENADRYL.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Muscle tightness
Clinical narrative: Pt immediately felt lightheaded after inj. Lie pt down within a minute or so she stated her neck felt tight (not throat). Denies SOB. Denies dysphagia, dizzy/lightheaded resolved. After lying down, pt still with neck Sx - all over 30 min.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site pain, Injection site swelling, Local reaction
Clinical narrative: Swelling to right thigh area and painful to site (R) thigh area - localized reaction.
Age: 6.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pain, Injection site streaking, Injection site swelling
Clinical narrative: Erythema, swelling and tenderness (6 x 7 cm in diameter) over right deltoid; red streak into axilla - treated with pain relief, ice packs and antibiotics.
Age: 4.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Injection site cellulitis, Injection site swelling, Local reaction
Clinical narrative: Vaccine on 06/10/13. Patient seen in office 06/13/13 with swelling at Rt thigh 5 1/2" x 3". No regional lymphadenopathy. H/O allergy to egg white.
Age: 34.0
Sex: F
Vaccine: MMR, YF
Symptoms: Dysstasia, Erythema, Fatigue, Injection site rash, Pain
Clinical narrative: Pt states she woke up the morning after her injection aching all over, hurting to stand upright, and was very fatigued. 2 days later she noticed a slight rash to her left upper arm that looked like "where someone had grabbed her arm in a forceful manner". Over the next few days the reddened area became worse and reported it to us by coming by our clinic on 06/14/13 at 11:10 am.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMRV
Symptoms: Injection site erythema, Injection site induration, Injection site pain
Clinical narrative: Mother reports child woke up with leg red and painful, thought was normal but didn't go away so came to clinic today to get checked.  Assessment was 3x2 inch area with induration and smaller pea size (3-4) add'l indurations on lt thigh. Redness noted but not complete solid red. Not hot to touch, no blistering.  Denies itching.  Adv to use cold packs, ibuprofen, and Benadryl OTC x2 days. If no improvement or worsens to seek medical care with PCP.
Age: 71.0
Sex: M
Vaccine: FLU3
Symptoms: Asthenia, Pain
Clinical narrative: Pain and weakness all over body its been happening for 4 months Dr. administered prednisone.
Age: 30.0
Sex: M
Vaccine: ANTH
Symptoms: Headache
Clinical narrative: After shot 5 repetitive headaches of increasing strength and duration. First noted symptoms after Anthrax shot 3 on 29 Mar 2007, and follow-up shot 4 on 29 Aug 2007. 1-1/2 years after shot 5, symptoms occurred less frequently, and decreased in duration and strength.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Diarrhoea, Intestinal cyst, Intestinal operation, Intussusception, Pain
Clinical narrative: Mom reports in February, infant started having diarrhea 3-5x/day (none prior). This continued for several weeks but decreased to 1-2x/day. Dr initially thought maybe virus then considered several other possibilities. In early to mid April, infant started throwing up and clearly in pain. Surgery done 4-17-13 for intussusception and a cyst in the intestine per mom. Infant doing fine now.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Vomiting
Clinical narrative: Mom reports in February, infant started having diarrhea 3-5x/day (none prior). This continued for several weeks but decreased to 1-2x/day. Dr initially thought maybe virus then considered several other possibilities. In early to mid April, infant started throwing up and clearly in pain. Surgery done 4-17-13 for intussusception and a cyst in the intestine per mom. Infant doing fine now.
Age: 0.38
Sex: M
Vaccine: 6VAX-F, PPV, RVX
Symptoms: Body temperature increased, Decreased appetite, Injection site erythema, Injection site nodule, Injection site swelling
Clinical narrative: Temp 100.8F; extreme fussiness/irritability; swelling of left leg; redness, swelling at injection site; knot in leg at injection site; decreased appetite; trouble sleeping.
Age: 0.38
Sex: M
Vaccine: 6VAX-F, PPV, RVX
Symptoms: Insomnia, Irritability
Clinical narrative: Temp 100.8F; extreme fussiness/irritability; swelling of left leg; redness, swelling at injection site; knot in leg at injection site; decreased appetite; trouble sleeping.
Age: 46.0
Sex: F
Vaccine: TDAP
Symptoms: Lymphadenopathy, Rash
Clinical narrative: Rash, lymphadenopathy. Treated with prednisone, resolved.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Vertigo
Clinical narrative: Vertigo.
Age: 1.01
Sex: F
Vaccine: HEPA, VARCEL
Symptoms: Injection site reaction, Local reaction, Rash vesicular
Clinical narrative: Local vesicular reaction at site of injection. No fever.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site discolouration, Injection site erythema, Injection site urticaria
Clinical narrative: Large whelp with brown/red discoloration at injection site.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site mass, Injection site pain
Clinical narrative: Severe pain at injection site.  A large ring of red surrounded the injection site.  It became as large as 6" x 4".  A hard lump of app. 3" diameter also.
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Injection site erythema, Injection site induration, Local reaction
Clinical narrative: Local reaction of left arm deltoid to elbow with redness and induration and FULL mobility and no pain.
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Rash erythematous, Screaming, Vomiting
Clinical narrative: Mother reported vomiting, screaming and red rash. Mother was advised by this nurse to call Pediatric office and/or take child to Emergency Dept.
Age: 53.0
Sex: M
Vaccine: FLU3
Symptoms: Axillary pain, Musculoskeletal pain
Clinical narrative: Shoulder and armpit pain approximately 2 weeks after receiving flu shot. Pain is better but not resolved at six months after receiving shot.
Age: 47.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Injection site pain, Mobility decreased, Pain
Clinical narrative: Excruciating pain in left arm at injection site, unable to move arm because any movement of muscle caused extreme pain.  As of 6/19 at 1:38 PM, still having trouble moving the arm, and when I do I have moderate pain.
Age: 10.0
Sex: M
Vaccine: HEPA
Symptoms: Blister, Erythema, Inflammation, Local swelling
Clinical narrative: AREA WAS INFLAMED 2 X 2 INCHES WITH SOME SWELLING, FOLLOWING DAY AREA GREW WITH MORE REDNESS. ON SATURDAY AREA FORMED A BLISTER.
Age: 11.0
Sex: M
Vaccine: HEPA, TDAP
Symptoms: Chest X-ray, Full blood count, Upper extremity mass
Clinical narrative: Noted lump on right arm.
Age: 42.0
Sex: F
Vaccine: HEPA
Symptoms: Chest pain, Palpitations, Paraesthesia, Urticaria
Clinical narrative: Pt reports to ER by ambulance about 19 hours post Hepatitis A vaccination with c/o hives and heart palpitations, chest pain and tingling. Pt given Benadryl 25 mg IM, prednisone 60 mg PO, Pepcid 20 mg PO. Pt discharged in stable condition with rx for Benadryl 25 mg PO, prednisone 20 mg PO, and Pepcid 20 mg PO.
Age: 20.0
Sex: M
Vaccine: SMALL
Symptoms: Rash papular, Rash pruritic
Clinical narrative: 3 day history, starting on 15JUN2013, of multiple round, pruritic, erythematous, raised lesions on front of chest and abdomen. Lesions are all at the same stage.
Age: 13.0
Sex: M
Vaccine: HPV4
Symptoms: Nausea, Respiratory tract congestion, Vertigo
Clinical narrative: Vertigo, room spinning, nausea. Has suffered off and on ever since, with symptoms lasting over two months at a time.
Age: 1.0
Sex: M
Vaccine: DTAP
Symptoms: Delirium, Pyrexia, Speech disorder
Clinical narrative: High fever - 105F. Delirious and babbling. Continued overnight.
Age: 4.0
Sex: M
Vaccine: DTAP
Symptoms: Injection site induration, Injection site mass
Clinical narrative: Firm mass at leg. No erythema. Treatment - BACTROBAN ointment applied to site until clear.
Age: 4.0
Sex: M
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth, Skin reaction
Clinical narrative: Itchy at site, red, swollen at shot site, warm came to office 5/18/13. Treatment: cephalexin x 3 days. Localized reaction calmed down and resolved.
Age: 17.0
Sex: F
Vaccine: HEPA
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an appropriately 17 year old(currently 19 year old) female patient. On 20-JUN-2011 the patient was vaccinated with her first dose of VAQTA (strength, formulation, lot#, dose/frequency, route was unspecified), which was a adult dose. On 09-JUN-2013, patient received a pediatric dose of VAQTA (injection, 25/0.5 U/ML, lot#, dose/frequency, route were unspecified) as her second dose. On 20-JUN-2011, 1 day after onset of therapy the patient experienced currently 19 year old patient received an adult dose, on 06/20/2011. No adverse symptoms reported. Outcome was unknown. Additional information has been requested.
Age: 5.0
Sex: M
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Redness at site, warm. Treatment: BACTROBAN ointment.
Age: 1.45
Sex: M
Vaccine: DTAP
Symptoms: Cough, Pyrexia, Upper respiratory tract infection, Vomiting
Clinical narrative: URI symptoms, cough, vomiting. Went to hospital 5/10/2013. Treatment - TYLENOL for fever, URI resolved on it's own and with time.
Age: 0.34
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Injection site erythema, Injection site rash, Injection site swelling
Clinical narrative: After immunizations given mom called nurse back to the room. Child's legs were bright pink/red; dark, non blanching spots on both lower legs; some swelling of feet noted; 1/4 tsp BENADRYL given and 6ml prednisolone as prescribed by NP. Before leaving office redness faded, purplish red spots on lower legs yet.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Blood pressure decreased, Heart rate increased, Hyporesponsive to stimuli, Nausea, Pallor
Clinical narrative: Approx. 5 min. following injection, patient fainted, BP decreased 95/50, increased pulse, pale, nauseated. Responsive, but not totally. Pt. rested, drank juice and water, improved about 30-45 min. later.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Approx. 5 min. following injection, patient fainted, BP decreased 95/50, increased pulse, pale, nauseated. Responsive, but not totally. Pt. rested, drank juice and water, improved about 30-45 min. later.
Age: 15.0
Sex: F
Vaccine: HEPA, HPV4, MNQ
Symptoms: Fall, Loss of consciousness
Clinical narrative: About 5 min after immunizations pt was sitting and just slumped forward, passed out, as soon as her head touched the table she looked up and said "what happened?" We lay her down for 10 min and gave water.
Age: 26.0
Sex: F
Vaccine: MNQ, MNQ
Symptoms: Cellulitis, Dyspnoea, Erythema, Injection site rash, Nausea
Clinical narrative: Received vaccine rt-del on 6-11-2013 patient states she noticed a rash around the site day of. Ignored it. Extreme pain 6-13-13 edema erythema. Tood Ibuprofen, no relief. Returned to clinic 6-14-13 for care. Pt experienced N-V and SOB. Dx with cellulitis. Treated with BACTRIM DS #20, 800 mg/160mg bid x 10 days.
Age: 26.0
Sex: F
Vaccine: MNQ, MNQ
Symptoms: Oedema, Pain, Vomiting
Clinical narrative: Received vaccine rt-del on 6-11-2013 patient states she noticed a rash around the site day of. Ignored it. Extreme pain 6-13-13 edema erythema. Tood Ibuprofen, no relief. Returned to clinic 6-14-13 for care. Pt experienced N-V and SOB. Dx with cellulitis. Treated with BACTRIM DS #20, 800 mg/160mg bid x 10 days.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Skin lesion
Clinical narrative: This spontaneous report as received from a other health professional refers to a 69 year old male patient without a history of drug reactions/allergies. No further medical history provided. In 2009 the patient was vaccinated with ZOSTAVAX ("ZOSTAVAX vial 19400 PFU": dosing unknown). Concomitant therapies included quinapril hydrochloride (manufacturer unknown), CRESTOR, LOVAZA, TRILIPIX and Co-Enzyme Q10; manufacturer unknown). On 15-MAY-2013 ("about two weeks ago") the patient developed lesions on his abdomen. The patient sought medical attention by visiting the nurse's office on 29-MAY-2013. After a physical exam by a physician the patient was diagnosed with shingles on 29-MAY-2013. The patient described the lesions as being painful. Physician noted in chart that no fever or chills were present and there were about 3 lesions on the patient's upper right quadrant of abdomen. In addition the patient also has "3 or more" lesions that wrap around his waste. The patient's lesions are healing up and the VZV analysis most likely will not be completed. The patient had been taking aspirin (manufacturer unknown) and ADVIL to relieve the pain. No lab diagnostics were performed. The outcome was reported as not recovered. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HEPA, MNQ, VARCEL
Symptoms: Burning sensation, Erythema, Pain, Pain in extremity, Swelling
Clinical narrative: (L) arm pain, burns, red large bump size of quarter, body aches. No fever.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Injection site rash, Rash, Vaccination complication
Clinical narrative: Rash at injection site/and around arm area. Primary care physician diagnosed that vaccination caused shingles outbreak valacyclovir TID x 7 days.
Age: 76.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Rash erythematous
Clinical narrative: 6/14/13 patient came in pharmacy to report he stated noticing red rashes on shoulder, lower neck after receiving shingles vaccine (administered 3/12/13). Pt also stated he developed shingles in last week and was prescribed valacyclovir tablets on 6/13/13. Pt was informed shingles vaccine only decreases these evenly of the diseases.