chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.35
Sex: F
Vaccine: HBHEPB, HIBV, PNC13
Symptoms: Incorrect dose administered, Pyrexia
Clinical narrative: Patient was given two doses of Hib vaccine. One was a single Hib vaccine. The other was Comvax (Hib/Hepatitis B). On f/u call 8/18/14, mother noted infant had a fever starting late in the day of 8/14/14 with a maximum temp of 102F. Mother called triage nurse. She was advised to give infant acetaminophen, cool compresses and tepid baths. The infant was in stable condition as of 8/17/14, afebrile, feeding well, voiding well, stools normal, alert per mother.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Induration, Injection site urticaria, Pyrexia, Urticaria
Clinical narrative: Hives on face, spread to ear, foot, cheeks were rock hard. After Benadryl it went down. Came back next day twice as bad in different locations. administered Benadryl.  Within an hour both arms were completely covered in a matter of 10 minutes.  After given drugs at hospital next day came back again while at doctors office, treated again, still has hives. Also has maintained a low grade fever throughout.
Age: 5.0
Sex: F
Vaccine: DTAP, MMRV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Pain, Pruritus
Clinical narrative: Paitents mother c/o rednes, swelling & heat on left thigh where the vaccine were given on 08/15/14. Child also c/o itching and pain.  Complaints started at bedtime.
Age: 73.0
Sex: M
Vaccine: FLUX
Symptoms: Arthralgia, Chills, Decreased appetite, Feeling hot, Hyperhidrosis
Clinical narrative: Shaking for about 6 hours; extreme cold and chills 2 hours; then hot and sweaty 12 hours; lost of appetite 36 hours; all joints ached 36 hours.
Age: 73.0
Sex: M
Vaccine: FLUX
Symptoms: Nasopharyngitis, Tremor
Clinical narrative: Shaking for about 6 hours; extreme cold and chills 2 hours; then hot and sweaty 12 hours; lost of appetite 36 hours; all joints ached 36 hours.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Local swelling, Mobility decreased, Pain, Rash macular
Clinical narrative: Chills, face, neck shoulder, arm, hand extreme swelling, face blotches, extreme pain, could not move or lift arm. Saw the nurse partitioner at Dr.s office on 08/11/2014 given a super shot of antihistamines in the buttocks. Shot helped alleviate some of the pain but by 6:30 PM the pain returned full force.  Called the office 08/12/2014 and was prescribed a 6 day graduated prescription of prednisone.  Although this 1st course of prednisone helped with the swelling and pain I was still not able to lift my arm above my head and still had swelling and pain.  I called the Dr again on 08/18/2014 and again meet with the nurse practitioner and was given a 2nd prescription of prednisone that was a 9 day course.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Swelling face
Clinical narrative: Chills, face, neck shoulder, arm, hand extreme swelling, face blotches, extreme pain, could not move or lift arm. Saw the nurse partitioner at Dr.s office on 08/11/2014 given a super shot of antihistamines in the buttocks. Shot helped alleviate some of the pain but by 6:30 PM the pain returned full force.  Called the office 08/12/2014 and was prescribed a 6 day graduated prescription of prednisone.  Although this 1st course of prednisone helped with the swelling and pain I was still not able to lift my arm above my head and still had swelling and pain.  I called the Dr again on 08/18/2014 and again meet with the nurse practitioner and was given a 2nd prescription of prednisone that was a 9 day course.
Age: 5.0
Sex: M
Vaccine: HEPA
Symptoms: Injection site erythema, Injection site pain, Pyrexia
Clinical narrative: Tenderness of the muscle and erythema over injection site and adjacent shoulder.  Persistent fever of 102 for two days.
Age: 17.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Grand mal convulsion
Clinical narrative: Tonic Clonic Grand Mal Seizure.
Age: 57.0
Sex: F
Vaccine: FLU3
Symptoms: Mastication disorder, Pain in jaw
Clinical narrative: The day following administration of flu shot, about 12 hours later, awoke with extreme lower left jaw pain, a muscular event. It prevented me from chewing on that side of the mouth for 3 days. The site of the pain was the lower jaw rear muscle/conjunction towards the back of the skull. After about three days of acute pain it dissipated as quickly as its onset.
Age: 59.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: SWELLING, REDNESS, PAIN IN AREA OF ARM WHERE VACCINE WAS ADMINISTERED.
Age: 36.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site induration, Injection site swelling, Malaise, Oral herpes
Clinical narrative: Site of injection hard red and swollen, pt developed fever and overall feeling of illness as well as a cold sore on her lip.
Age: 36.0
Sex: F
Vaccine: TDAP
Symptoms: Pyrexia
Clinical narrative: Site of injection hard red and swollen, pt developed fever and overall feeling of illness as well as a cold sore on her lip.
Age: 17.0
Sex: F
Vaccine: HPV4, MNQ, TDAP, HPV4, MNQ, TDAP
Symptoms: Loss of consciousness, Malaise, Nausea, Seizure like phenomena, Somnolence
Clinical narrative: Pt was given Tdap, Menactra, and Gardasil. After the last injection was given the patient said she didn't feel well and thought she might pass out. She then passed out. I broke an ammonia capsule but that didn't help and she began having a seizure like episode. This lasted about 30 to 60 seconds. Then  patient came to but wasn't sure where she was at first. Then once we told her she started to remember. After checking vital signs and giving patient some juice we asked patient and mother to wait 15 minutes and we would recheck the patient. During this time she began to complain of nausea and seemed very sleepy. So we decided to call 911 so patient could be evaluated by a doctor in the ER. Mother agreed to this. I have tried to contact mother to check on patient but she has not answered or returned phone calls.
Age: 17.0
Sex: F
Vaccine: HPV4, MNQ, TDAP, HPV4, MNQ, TDAP
Symptoms: Convulsion, Immediate post-injection reaction, Loss of consciousness, Malaise, Unresponsive to stimuli
Clinical narrative: Pt was given Tdap, Menactra, and Gardasil. After the last injection was given the patient said she didn't feel well and thought she might pass out. She then passed out. I broke an ammonia capsule but that didn't help and she began having a seizure like episode. This lasted about 30 to 60 seconds. Then  patient came to but wasn't sure where she was at first. Then once we told her she started to remember. After checking vital signs and giving patient some juice we asked patient and mother to wait 15 minutes and we would recheck the patient. During this time she began to complain of nausea and seemed very sleepy. So we decided to call 911 so patient could be evaluated by a doctor in the ER. Mother agreed to this. I have tried to contact mother to check on patient but she has not answered or returned phone calls.
Age: 41.0
Sex: M
Vaccine: ANTH, TYP
Symptoms: Amnesia, Confusional state, Dizziness, Fatigue, Nuclear magnetic resonance imaging brain
Clinical narrative: FATIGUE, DIZZINESS, CONFUSION, MEMORY LAPSE.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Erythema, Herpes zoster, Pruritus, Skin lesion
Clinical narrative: Pt noticed itch lesion on back. She came in today and she has a cluster of vesicles on an erythematous base, thus Herpes Zoster.
Age: 11.0
Sex: M
Vaccine: MNQ, VARCEL
Symptoms: Injection site pruritus
Clinical narrative: Mother and patient state patient developed itching at vaccine administration site, left upper outer arm.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Shingles outbreak despite vaccination.
Age: 37.0
Sex: F
Vaccine: FLUX
Symptoms: Hypoaesthesia, Injection site anaesthesia
Clinical narrative: Numbness progressing from right deltoid (site of injection), down into right flank of abdomen, then up right side of neck, and facial numbness covering all of face. This lasted for three hours, then all numbness went away.
Age: 18.0
Sex: F
Vaccine: MNQ, VARCEL
Symptoms: Presyncope
Clinical narrative: Pt experience vasovagal event following administration of meningococcal conjugate vaccine and varicella live virus vaccine.
Age: 36.0
Sex: M
Vaccine: PPV
Symptoms: Computerised tomogram head normal, Headache, Malaise, Nausea, Vomiting
Clinical narrative: Headache, malaise, nausea, vomiting.
Age: 63.0
Sex: M
Vaccine: PPV
Symptoms: Computerised tomogram, Pain in extremity, Pyrexia, Swelling, X-ray limb
Clinical narrative: Pt reports receiving vaccine afternoon 8/19/14. Went to work that night, noted slight arm pain. At work second night, started running fever, noted swelling, increased pain left arm. Unable to break fever w/ antipyretics. To emergency dept 8/22, admitted to hosp for IV antibiotics. Discharged 6PM 8/23 on po HTB. Details obtained per phone w/ patient.
Age: 37.0
Sex: F
Vaccine: TDAP
Symptoms: Formication, Hypoaesthesia, Immunoglobulin therapy, Laboratory test, Myelitis transverse
Clinical narrative: This case was reported by a consumer and described the occurrence of transverse myelitis in a 37-year-old female subject who was vaccinated with BOOSTRIX, (GlaxoSmithKline). A physician or other health care professional has not verified this report. Concurrent medical conditions included seasonal allergy (the subject had no allergies to medication). Concurrent medications included ORTHO TRI-CYCLEN. On 26 March 2014, the subject received an unspecified dose of BOOSTRIX (0.5 ml, unknown route, left arm). On 20 April 2014, 25 days after vaccination with BOOSTRIX, the subject experienced constant humming and swimming sensation under the skin, pins and needles sensations, tingling sensation, numbing and stabbing sensation. These symptoms occurred in arms and legs. The subject also experienced complete acute bilateral neuropathy through arms and legs. On 23 April 2014, she was seen by her doctor. She had numerous testing and lab work done over the last 3 months and was diagnosed with post infection vaccine related transverse myelitis. This case was assessed as medically serious by GSK. On 18 August 2014, the subject started treatment with normal immunoglobulin (IVIG). She had 4 infusions so far. She could not pin point whether it was working yet. She was slated for 6 cycles (6 months). At the time of reporting, the events were unresolved.
Age: 37.0
Sex: F
Vaccine: TDAP
Symptoms: Neuropathy peripheral, Paraesthesia, Sensory disturbance
Clinical narrative: This case was reported by a consumer and described the occurrence of transverse myelitis in a 37-year-old female subject who was vaccinated with BOOSTRIX, (GlaxoSmithKline). A physician or other health care professional has not verified this report. Concurrent medical conditions included seasonal allergy (the subject had no allergies to medication). Concurrent medications included ORTHO TRI-CYCLEN. On 26 March 2014, the subject received an unspecified dose of BOOSTRIX (0.5 ml, unknown route, left arm). On 20 April 2014, 25 days after vaccination with BOOSTRIX, the subject experienced constant humming and swimming sensation under the skin, pins and needles sensations, tingling sensation, numbing and stabbing sensation. These symptoms occurred in arms and legs. The subject also experienced complete acute bilateral neuropathy through arms and legs. On 23 April 2014, she was seen by her doctor. She had numerous testing and lab work done over the last 3 months and was diagnosed with post infection vaccine related transverse myelitis. This case was assessed as medically serious by GSK. On 18 August 2014, the subject started treatment with normal immunoglobulin (IVIG). She had 4 infusions so far. She could not pin point whether it was working yet. She was slated for 6 cycles (6 months). At the time of reporting, the events were unresolved.
Age: 0.39
Sex: F
Vaccine: DTAPIPVHIB, PNC13
Symptoms: Injection site rash
Clinical narrative: Rash at site. Mom first noticed 24 hrs after administration of vaccine. No treatment needed.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Dysphagia, Dysphonia, Localised oedema, Oedema mouth, Pharyngeal oedema
Clinical narrative: Pt R/cd ZOSTAVAX on 8/19/14, 8/20/14 early AM noticed mouth swelling progressing to neck edema, hoarseness and throat swelling (dysphagia).
Age: 69.0
Sex: M
Vaccine: PPV
Symptoms: Blood test, Dyspnoea, Increased upper airway secretion, Malaise, Pneumonia
Clinical narrative: This spontaneous report as received from a 69  year old male patient refers to himself. The patient was being treated with chemotherapy also suffers from depression, high blood pressure, multi-myeloma and thyroid disorder. There were no drug reactions/allergies. Between 2008 and 2009 the patient was vaccinated with a dose of PNEUMOVAX23 (dose, route and lot # not reported) in the arm. Concomitant therapies included REVLLIMID, dexamethasone (manufacturer unknown), ADVAIR and LEVOXYL. it was reported that on 13-AUG-2014 the patient was diagnosed with pneumonia. Pneumonia consisted of "yellowish phlegm." The patient also noted that he "got sicker" and "had more difficulty breathing". The patient treated with azithromycin, 5 day round, 2 tablets on 18-AUG-2014 followed by a pill each day after that. X-ray and blood test were performed (result unspecified). The outcome of pneumonia was reported as recovering/resolving at the time of reporting. The patient sought medical attention by talking with physician. Additional information has been requested.
Age: 69.0
Sex: M
Vaccine: PPV
Symptoms: X-ray
Clinical narrative: This spontaneous report as received from a 69  year old male patient refers to himself. The patient was being treated with chemotherapy also suffers from depression, high blood pressure, multi-myeloma and thyroid disorder. There were no drug reactions/allergies. Between 2008 and 2009 the patient was vaccinated with a dose of PNEUMOVAX23 (dose, route and lot # not reported) in the arm. Concomitant therapies included REVLLIMID, dexamethasone (manufacturer unknown), ADVAIR and LEVOXYL. it was reported that on 13-AUG-2014 the patient was diagnosed with pneumonia. Pneumonia consisted of "yellowish phlegm." The patient also noted that he "got sicker" and "had more difficulty breathing". The patient treated with azithromycin, 5 day round, 2 tablets on 18-AUG-2014 followed by a pill each day after that. X-ray and blood test were performed (result unspecified). The outcome of pneumonia was reported as recovering/resolving at the time of reporting. The patient sought medical attention by talking with physician. Additional information has been requested.
Age: 4.0
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a health professional refers to a 4 year old patient. On 29-JUL-2014 the patient was vaccinated with a dose of M-M-R II (HS, lot # K000174, EXP date: 11-JUN-2015, dose and route not reported) which was stored improperly. There was no adverse effect reported. This is one of several reports received from the same source. Additional information is not expected.
Age: 21.0
Sex: F
Vaccine: MNQ, VARCEL
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Patient had swelling, redness, itching around injection site. Patient was advised to take OTC BENADRYL and return to clinic if reaction persists or worsens, right subq area.
Sex: F
Vaccine: VARCEL
Symptoms: Antibody test negative
Clinical narrative: This spontaneous report was received from a pharmacist refers to a female patient of unknown age. On unknown date the patient was vaccinated with 10-11 doses of (Oka/Merck) VARIVAX (dose, lot # and route of administration were not reported). It was reported that the patient remained negative for titers. The outcome of the event was not recovered/not resolved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: F
Vaccine: VARCEL
Symptoms: No therapeutic response, Seroconversion test
Clinical narrative: This spontaneous report was received from a approximately 40 years old female patient (pharmacist) reporting on herself. In approximately August 2004 (also reported as 5 or 10 years ago) the patient was vaccinated with at least 5 doses of (Oka/Merck) VARIVAX (dose, lot # and route of administration were not reported). It was reported that the patient never seroconverted. The outcome of the event was not recovered/resolved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to an unspecified number of patients of unknown age and gender. No pertinent medical history or drug reactions/allergies were provided. The reporter stated that, since 08-JUL-2014 (exact dates not provided), VAQTA 25/0.5 (units not provided) was administered to patients after improper storage (dose, route, lot number and expiration date not reported0. No adverse effects were noted. The case is linked to case MARRS # 1407USA004179, 1408USA013888 and 1408USA013889 (same reporter link). Additional information is not expected because the reporter declined any further contact regarding the report.
Sex: U
Vaccine: RV5
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to an unspecified number of patients of unknown age and gender. No pertinent medical history or drug reactions/allergies were provided. The reporter stated that, since 08-JUL-2014 (exact dates not provided), ROTATEQ was administered to patients after improper storage, orally (dose, lot number and expiration date not reported). No adverse effects were noted. This case is linked to case MARRS# 1407JSA004179, 1408USA013887 and 1408USA013889 (same reporter link). Additional information is not expected because the reporter declined any further contact regarding this report.
Age: 28.0
Sex: F
Vaccine: MMR
Symptoms: Antibody test abnormal, Antibody test negative, Exposure during pregnancy
Clinical narrative: This spontaneous prospective pregnancy report as received from a consumer refers to his 28 year old wife with no pertinent medical history and drug reactions or allergies who in 2008, was vaccinated with the first dose of M-M-R II (dose, route and lot number not reported). For unspecified reason, titer was drawn for this patient on 15-JUL-2014 and titer measles was borderline and patient received another dose of M-M-R II (dose, route and lot number not reported) on 22-JUL-2014 at health department. On 05-AUG-2014, the patient's wife found out to be pregnant. At the time of the report, the patient had not recovered from the experience. The patient did not see medical attention. The relatedness for titer was drawn for the patient on 15-JUL-2014 and titer for measles was borderline and M-M-R II was unknown. Additional information is not expected.
Sex: U
Vaccine: PPV
Symptoms: Expired drug administered, No adverse event
Clinical narrative: Information has been received from a pharmacist regarding a patient of unknown age and gender. The patient's medical history, drug reactions or allergies were not provided. On 22-AUG-2014, the patient was vaccinated with expired PNEUMAVAX23 (dose and lot number were not provided, expiration date 10-AUG-2014). Pharmacist stated the PNEUMOVAX23 did not have any previous temperature excursions. No adverse symptoms reported. Additional information has been requested.
Age: 4.0
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a health professional refers to a 4 year old patient. On 02-MAY-2014 the patient was vaccinated with M-M-R II (lot# J010993, expiration date 06-SEP-2015, dose and route not reported) which was stored improperly. There was no adverse effect reported. This is one of several reports received from the same source. Additional information is not expected.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a Register Nurse refers to an unspecified amount patients of unknown age and gender. Concomitant medication, pertinent medical history, drug reaction and allergies were not reported. On an unknown date, unspecified amount of patients were vaccinated with GARDASIL, which underwent a temperature excursion, 0.5 ml, intramuscular (lot number was not provided). No adverse effect reported. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: No adverse event, Product quality issue, Wrong technique in drug usage process
Clinical narrative: This spontaneous report was received from a pharmacist via company representative refers to a patient of unknown age and gender. Medical history was not reported. On an unknown date, the patient was vaccinated with ZOSTAVAX 1 vial or 1, almost 0.6 ml, lot number, expiration date and route were not reported. Concomitant therapy was reported. The pharmacist informed that on an unknown date, she reconstituted ZOSTAVAX with sterile water diluent and ZOSTAVAX vial which resulted in an under filled vial of almost 0.6 instead of the required 0.65. The vaccination was still given to the patient. No adverse symptoms were reported. The patient did not seek medical attention. A PQC was filled. This is one of several reports from the same source. Additional information has been requested.
Age: 64.0
Sex: F
Vaccine: PPV
Symptoms: Pain in extremity, Rash pruritic
Clinical narrative: This spontaneous report as received from a physician refers to a 64 year old female patient with allergies, irritable bowel syndrome, cataracts, satty liver disease, impaired glucose tolerance, joint disease, tremor, tobacco use, obesity, sleep apnea, hypertension, depression, peptic ulcer disease and iodine contrast allergy. patient had previous allergic reaction with iodine contrast. On 11-AUG-2014 the patient was vaccinated with PNEUMOVAX 23 injection 0.05 ml single dose with lot # J010396, expiry date 16-FEB-2015 intramuscular. Concomitant therapies included LEXAPRO, WELLBUTRIN SR, ranitidine (manufacturer unknown), losartan, hydrochlorothiazide (manufacture unknown) and FLONASE. On 12-AUG-2014, the patient experienced a series of adverse events that included pain in her arm when she was trying to raise it and was decreased by next day. Patient developed rashes on her arms, neck and upper chest, rashes described as itchy. Patient sought for medical attention and was prescribed with ADVIL and hydrocortisone (manufacture unknown) cream. No laboratory test was performed. Therapy with PNEUMOVAX 23 was discontinued and was not reintroduced. The outcome of pain in her arm when trying to raise it, develop rashes on her arms, neck and upper chest was reported as recovering/resolving. The reporter did not provide the causality of pain in her arm when trying to raise it, develop rashes on her arms, neck and upper chest was reported as recovering/resolving. The reporter did not provide the causality of pain in her arm when trying to raise it, develop rashes on her arms, neck and upper chest to PNEUMOVAX 23. No further information was provided. Additional information has been requested.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site rash, Rash vesicular, Skin warm
Clinical narrative: This spontaneous report was received from a 50 year old female patient who is also a company representative regarding herself. On 08-AUG-2014, the patient was vaccinated with a dose of ZOSTAVAX (lot# and expiration date unknown) in the arm. On 09-AUG-2014, the patient first noticed the rush because her arm felt warm to touch and then she looked into the mirror and saw the rash. She described it as a herpes zoster like rash at the injection site that was 3 inches long by one and half inch wide. The outcome of arm felt warm to tough and herpes zoster like rash at the injection site was unknown. Causality was not reported. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: MNQ
Symptoms: Angioedema, Full blood count normal, Lip swelling, Local reaction, Local swelling
Clinical narrative: After MENACTRA facial angioedema - 8/19/14 lip swelling. Arm swelling and itching - 8/13/14. Arm swelling - local reaction 8-5-14.
Age: 14.0
Sex: F
Vaccine: MNQ
Symptoms: Pruritus
Clinical narrative: After MENACTRA facial angioedema - 8/19/14 lip swelling. Arm swelling and itching - 8/13/14. Arm swelling - local reaction 8-5-14.
Age: 13.0
Sex: M
Vaccine: MNQ
Symptoms: Swelling face, Urticaria, Vaccination complication, Viral infection
Clinical narrative: Hives, urticaria, MENVEO vaccine given 8-18-14 and pt developed hives 8-24-14; face looked swollen to mom on 8-23-14. Gave BENADRYL po at home in pm. ZYRTEC in am; saw Dr in office 8-25-14 Dx with virus vs reaction to MENACTRA.
Age: 15.0
Sex: F
Vaccine: HPV4, MNQ, TDAP, VARCEL
Symptoms: Eye movement disorder, Heart rate increased, Loss of consciousness, Muscle contractions involuntary, Opisthotonus
Clinical narrative: After the 4th and final imm given, which was the HPV vaccine, client, who was placed on exam table and lying down during vaccine administration, her eyes rolled back and she made a deep snoring noise. Her back began to arch and her arms drew up and tightened like with seizure activity. Client was unconscious. Client had rapid pulse. After 30 sec or so, client came to and answered to her name. Cool rags were applied to her chest and forehead, she was fanned with paper RN had in her hand. A Coke was given to client once consciousness gained. After 2-3 minutes client stated she felt fine. She was observed 15-20 minutes after losing consciousness and walked out of Health Dept without assistance with her mother and 2 brothers. Mother states she has a history of passing out and having seizure like activity after vaccines or the sight of blood.
Age: 15.0
Sex: F
Vaccine: HPV4, MNQ, TDAP, VARCEL
Symptoms: Seizure like phenomena, Snoring
Clinical narrative: After the 4th and final imm given, which was the HPV vaccine, client, who was placed on exam table and lying down during vaccine administration, her eyes rolled back and she made a deep snoring noise. Her back began to arch and her arms drew up and tightened like with seizure activity. Client was unconscious. Client had rapid pulse. After 30 sec or so, client came to and answered to her name. Cool rags were applied to her chest and forehead, she was fanned with paper RN had in her hand. A Coke was given to client once consciousness gained. After 2-3 minutes client stated she felt fine. She was observed 15-20 minutes after losing consciousness and walked out of Health Dept without assistance with her mother and 2 brothers. Mother states she has a history of passing out and having seizure like activity after vaccines or the sight of blood.
Age: 62.0
Sex: F
Vaccine: TDAP, VARZOS
Symptoms: Chest discomfort, Flushing, Injection site pruritus, Paraesthesia oral, Swollen tongue
Clinical narrative: About 2 minutes after vaccines given, Tdap first, then shingles vaccine, client c/o itching at shingles site. Within about 5 minutes client c/o "tightness in chest like big dog sitting on chest: "Got client some water and she sat in waiting area. Talked with client about total of seven minutes since vaccine. Client flushed stated chest tightness worse. Got another PHN and took client to room. About 10 minutes after vaccines, client stated "Tongue feeling funny and a little swollen." Employee gave 0.5 mg IM Epi, at 5 minutes after vaccines, HR 68 SBP 148/70, before Epi 150/70, after Epi 158/80. Client stated "Feeling better," after Epi, about 5 minutes after Epi, client c/o chest tightness. Call 911 and client went to ER in ambulance to further assess client.
Age: 83.0
Sex: F
Vaccine: FLU3
Symptoms: Immediate post-injection reaction, Injection site pain, Injection site swelling
Clinical narrative: Immediately after shot - swelling at site of injection site and pain and continued for over 15 min. No dizziness or fainting. No allergies to eggs or latex.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Wrong drug administered
Clinical narrative: Patient was given Varicella vaccine which was not ordered or indicated at time of appointment Nurse error.
Age: 0.38
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Culture stool negative, Haematochezia, Irritability, Ultrasound abdomen normal
Clinical narrative: Blood in stool 4 days after vaccines, fussy. Seen in the ER, abdomina U/S ruled out intussusception. Stool cultures sent.
Age: 59.0
Sex: M
Vaccine: VARZOS
Symptoms: Induration, Local swelling, Pruritus, Skin warm
Clinical narrative: Local swelling, Hardness and very warm, a little itchy.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Injection site reaction, Injection site swelling, Injection site vesicles, Rash erythematous
Clinical narrative: Chills night after vaccine administered. Red rash, swelling from injection site up back of arm, worsened over several days. Blisters developed at site of injection.
Age: 13.0
Sex: M
Vaccine: VARCEL
Symptoms: Asthenia, Blood glucose normal, Dizziness
Clinical narrative: Dizziness and weakness. Onset was sudden 4 hrs go, onset followed Varicella vax given at 0900. Faint feeling.
Age: 1.26
Sex: F
Vaccine: DTAP, HIBV, VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: DTaP given in (L) upper arm on 8/15 - within x1 days area for (L) elbow to shoulder was red, warm, tender to touch/swollen. By day 3 arm looking better - area 2-3 in diameter redness and 8/20 quarter size area. By 8/22 area resolved. Rx'ed with Ibuprofen and cool compresses.
Age: 23.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Blood test, Chills, Cutaneous lupus erythematosus, Dizziness
Clinical narrative: One day after vaccine had soreness at injection site, mild fever, chills, dizziness. Seen by administering clinic with not treatment given. One week later, weakness and hoarseness. Resolved with time. 2 weeks after injection developed face lesion subsequently diagnosed by dermatologist as discoid lupus - being treated topically.
Age: 23.0
Sex: F
Vaccine: FLU3
Symptoms: Dysphonia, Injection site pain, Pyrexia, Skin lesion
Clinical narrative: One day after vaccine had soreness at injection site, mild fever, chills, dizziness. Seen by administering clinic with not treatment given. One week later, weakness and hoarseness. Resolved with time. 2 weeks after injection developed face lesion subsequently diagnosed by dermatologist as discoid lupus - being treated topically.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Abdominal pain upper, Pruritus, Rash
Clinical narrative: Mom brought patient back to clinic from pharmacy on 1st floor, itching, rash, c/o stomach ache - gave 6 ml BENADRYL PO, O2 Sat - 99%, vital signs WNL.
Sex: U
Vaccine: PPV
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 22-AUG-2014 the patient was vaccinated with an expired dose of PNEUMOVAX23 lot # H021941, expiration date 11-JUL-2014 (route and strength not reported). No adverse effect reported. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Human papilloma virus test positive, Papilloma viral infection, Smear cervix abnormal
Clinical narrative: This spontaneous report was received from a physician via a company representative refers to a female patient of unknown age. On an unknown date the patient was vaccinated with GARDASIL (dose, lot # and route of administration were not reported). On an unknown date the patient had positive Pap Smear exam for HPV included the type 18 in high risk range. It was reported that before having this exam on unknown date, the patient had completed the three dose series of GARDASIL. It was also reported that the HPV cleared on its own without the need of treatment. The patient did not seek medical attention. The outcome of the event was reported as recovered/resolved on unknown date. Additional information is not expected due to the reporter did not want to be contacted again.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site swelling, Injection site urticaria
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 62 year old male patient. No concomitant medication, pertinent medical history, pertinent drug reactions or allergies were reported. On 11-AUG-2014 the patient was vaccinated with ZOSTAVAX lot# K000995, subcutaneous (strength and route not reported). On 12-AUG-2014, the patient developed a 3 inch welt/swelling at the site of ZOSTAVAX. Patient sought medical attention and no treatment was given for the reported adverse events. No laboratories were performed. At the time of the report the outcome of the events was reported as recovered. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site induration, Injection site nodule, Injection site swelling, Rash erythematous, Rash pruritic
Clinical narrative: This spontaneous report as received from a 60 year old female consumer reported on herself with low thyroid. The patient's medical history included that she went into a coma and almost died on an unknown date of 2010. On 02-AUG-2014, the patient was vaccinated with ZOSTAVAX, subcutaneous, dose reported as 1 injection (strength, frequency, lot number and expiration date were not reported). Concomitant therapies included lithium, Synthroid, Ticlodone, Xanax and hydroxyzine pamoate. On 02-AUG-2014, the patient experienced injection site swelling and a really "hard knot" at the injection site of ZOSTAVAX. On 13-AUG-2014 (also reported as last night), the patient noticed an outbreak of itchy red bumps on each of her ankles. The outcome of the events were not reported. No treatment was given for the adverse events. Patient did not seek medical attention. Additional information has been requested.
Age: 82.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Injection site erythema, Injection site induration, Injection site mass, Injection site pain
Clinical narrative: This spontaneous report as received from the patient's daughter, reporting on her mother, a 82 year old female patient. Medical history and concurrent conditions were not reported. On 11-AUG-2014, the patient was vaccinated with a dose of ZOSTAVAX (dose and frequency reported as one time vaccine) (route reported as injection) (lot number and expiration date were not reported) for prevent shingles. Concomitant therapies included LISINOPRIL, LEXAPRO and FOSAMAX. The daughter stated her mother got ZOSTAVAX vaccine on Monday, 11-AUG-2014 and experienced "redness, pain, itching, swelling hard lump at site of injection, headache, body aches, muscle aches, which all started same day she got vaccine". At the time of the report outcome was unknown. The patient seek medical attention and the physician suggest as treatment BENADRYL for itching, hard lump, and ibuprophen for aches pain and ice pack for swelling. No labs diagnostics studies were performed. Additional information has been requested.
Age: 82.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pruritus, Injection site swelling, Myalgia, Pain
Clinical narrative: This spontaneous report as received from the patient's daughter, reporting on her mother, a 82 year old female patient. Medical history and concurrent conditions were not reported. On 11-AUG-2014, the patient was vaccinated with a dose of ZOSTAVAX (dose and frequency reported as one time vaccine) (route reported as injection) (lot number and expiration date were not reported) for prevent shingles. Concomitant therapies included LISINOPRIL, LEXAPRO and FOSAMAX. The daughter stated her mother got ZOSTAVAX vaccine on Monday, 11-AUG-2014 and experienced "redness, pain, itching, swelling hard lump at site of injection, headache, body aches, muscle aches, which all started same day she got vaccine". At the time of the report outcome was unknown. The patient seek medical attention and the physician suggest as treatment BENADRYL for itching, hard lump, and ibuprophen for aches pain and ice pack for swelling. No labs diagnostics studies were performed. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a registered pharmacist refers to a patient of unknown age and gender. On 22-AUG-2014, the patient was vaccinated with an expired dose of PNEUMOVAX23 (Lot# J009827, expiration date 10-AUG-2014). No adverse effects were reported. Additional information is not expected. The reporter did not want to be contacted.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report was received from a pharmacist refers to a female patient of unknown age. On an unknown date the patient was vaccinated with ZOSTAVAX (dose, lot # and route of administration were not reported). It was reported that the patient had experienced a case of shingles in the past on unknown date. After the patient was vaccinated with ZOSTAVAX she was diagnosed with a recurrence of shingles. The outcome of the event was reported as recovered/resolved on unknown date. This is one of several reports received from the same reporter. Additional information is not expected due to the reporter did not want to be contacted again.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain
Clinical narrative: This spontaneous report as received from a pharmacist refers to a friend of his wife of unknown age. On 2010 (reported as 3 or 4 years), the patient was vaccinated with ZOSTAVAX. On an unknown date she developed painful case of shingles on her face. The outcome of painful case of shingles on her face was unknown. This case is linked to 1408USA008634 due to same reporter link. Additional information has been requested.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site rash, Injection site reaction, Urticaria
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 71 year old female patient. The patient's medical history included history of shingles. The patient had no drug reactions/allergies. On 18-AUG-2014, reported as "2 days ago", the patient was vaccinated with ZOSTAVAX (lot # J014812, expiry date 20-FEB-2015, dose, route not provided) 19400 PFU for prevention of shingles recurrence. Concomitant therapies included omeprazole (manufacturer unknown), LAMISIL and pharmacist reports that the patient received a dose of acyclovir, 1 week prior to the ZOSTAVAX administration. The patient came back to the pharmacy today, 20-AUG-2014, with a "red, itchy welt with rash present around the injection site". Pharmacist reports that the patient reports that the symptoms began "later on in the evening, the same day that the vaccine was administered on 18-AUG-2014. There was no product quality complaint. No lab diagnostics studies were performed. No treatment was given for the event. The patient sought medical attention by contacting the pharmacy. There was no intervention done to prevent serious criteria. The outcome was reported as not recovered/not resolved. The causality of the event was not specified by the reporter. Additional information has been requested.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: This spontaneous report as received from a pharmacist refers to himself (male patient of unknown age). The patient current condition includes hypertension and arthritis (due to running). The patient is reported as non diabetic. On an unknown date in May or June of 2012, the patient was vaccinated with ZOSTAVAX. Concomitant therapies included ibuprofen and antihypertensive agent. On an unknown date the patient developed shingles. On an unspecified date, the patient began to feel like he had mosquito bites on his back. He stated that the next day he had a rash on the side of his body, and the rash extended from his back to his armpit. Patient sought medical attention. The patient was treated with ZOVIRAX. No lab diagnostics were performed. He did notify his healthcare provider, who prescribed ZOVIRAX for him. The pharmacist declined receipt of VZVIP for two reasons: he is taking ZOVIRAX, and he does not want to involve his healthcare provider. He states that his condition of the shingles has improved drastically since he started using ZOVIRAX. The outcome of shingles was reported as recovering/resolving. 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 an unspecified number of patients of unknown demographics. No concurrent conditions or medical history were provided. The nurse reported that (Oka/Merck) VARIVAX underwent a temperature excursions on 31-JUL-2014, stability was supported. An unspecified number of patients received doses of these vaccines on unspecified dates after 31-JUL-2014 (in August 2014) (dose, frequency, route and lot # unknown). No adverse effects reported. This is one of several reports from the same source. Additional information has been requested.
Age: 66.0
Sex: M
Vaccine: PPV
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report was received from a nurse regarding an approximately 66 year old male patient. There was no information on pertinent medical history and drug reactions or allergies. On 21-AUG-2014, the patient was vaccinated with PNEUMOVAX 23 Product lot # J015868, Expiry date: 25-FEB-2015, dose 1.5 ml (milliliter), intramuscularly in the right arm (reported as right delt). The nurse stated that she inadvertently drew up 1.5 ml of PNEUMOVAX 23 from multi dose vial and administrated to patient on 21-AUG-2014. No adverse effects reported at this time. There was no product quality complaint involved. The outcome of the event was unknown. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an unspecified number of patients of unkown demographics. No concurrent conditions or medical history were provided. The nurse reported that PROQUAD (Merck) underwent a temperature excursion on 31-JUL-2014, stability was supported. An unspecified number of patients received doses of these vaccines on unspecified dates after 31-JUL-2014 (in August 2014) (dose, frequency and lot # unknown) subcutaneously. No adverse effects reported. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report was received from a Registered Nurse refers to twin 4 year old female patients Vaccinated with VARIVAX (Merck), vaccine. On 20-JUN-2014, the patient was vaccinated with VARIVAX (Merck), subcutaneous. This is the second dose in the series. On an 20-JUN-2014, the patient received VARIVAX that was exposed to a maximum of 17.2 Fahrenheit for cumulative 41.5 hours (supported). The Nurse also reported there were other patients (an unspecified number) who received improperly stored VARIVAX Patient data not presently available. The Outcome of receiving VARIVAX that was exposed to a maximum of 17.2 Fahrenheit for cumulative 41.5 hours is unknown. Additional information is not expected. This case is linked to 1408USA009865 due to twin patients who were vaccinated on the same date 20-JUN-2014. This case is linked to 1407USA012109 due to twin patients who were vaccinated on the same date 20-JUN-2014.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a Certified Medical Assistant refers to an unspecified number of patients of unknown age and gender. The Medical Assistant stated that "a few (Oka/Merck) VARIVAX" were administered to patients since being improperly stored in approximately July 2014" about one month ago". No adverse effects were noted. Additional information has been requested (corresponding containing a request for additional information is scheduled).
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown demographics. No concurrent conditions or medical history were provided. The nurse reported that ZOSTAVAX underwent a temperature excursion on 31-JUL-2014, stability was supported. An unspecified number of patients received doses of these vaccines on unspecified dates after 31-JUL-2014 (in August 2014) (dose, frequency, route and lot # unknown). No adverse effects reported. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist refers to a patient of unknown age and genger who on 22-AUG-2014 was vaccinated with a dose of ZOSTAVAX that had expired on 14_JUL-2014 (lot number and route were not reported). No adverse events were reported. Additional information has been requested.
Sex: U
Vaccine: FLUN4
Symptoms: Influenza, Influenza A virus test positive
Clinical narrative: A report has been received from a Physician concerning a Child, of unknown gender and age. No relevant history and concomitant medications of the patient were reported. The patient received nasal FLUMIST quadrivalent (intranasal), in mid September, on an unknown date. The patient experienced flu in March and was found to be H1N1 test positive. Action taken with FLUMIST was unknown. The outcome of the event of Flu was unknown. The report was considered to be non-serious by the reporter. The report was considered to be non-serious by the reporter. Corrected report 26-May-2014: Key ingredient of suspect drug correct to Q/LAIV from FLUMIST.
Sex: U
Vaccine: FLUN4
Symptoms: Expired drug administered
Clinical narrative: A report has been received from a Health Professional concerning a, subject of unknown gender, who had been receiving Nasal FLUMIST QUADRIVALENT. FLUMIST QUADRIVALENT started on an unknown date. It was reported few patients received expired FLUMIST QUADRIVALENT. The outcome of the event a few patients received expired FLUMIST QUADRIVALENT is unknown. The report was considered to be non-serious.
Age: 3.0
Sex: F
Vaccine: FLUN4
Symptoms: Influenza, Influenza virus test positive
Clinical narrative: A report has been received from a Physician concerning a 3 year old, Female patient. No information regarding relevant history, concomitant disease and concomitant medications were provided. The patient received nasal FLUMIST Quadrivalent on 01-Oct-2013. Medical representative reported that patient got FLUMIST Quadrivalent then got the flu on 15-Dec-2013. The doctor told the Medirep that child was only minorly ill, but got better. The patient recovered from the event of patient got the flu / tested positive for flu on an unspecified date. The reporter considered the event to be non-serious.
Sex: F
Vaccine: FLUN4
Symptoms: Expired drug administered
Clinical narrative: A report has been received from a Health Professional concerning a patient, Female subject, who had been receiving Nasal FLUMIST QUADRIVALENT. FLUMIST QUADRIVALENT started on an unknown date. The patient was administered expired FLUMIST QUADRIVALENT. The outcome of the event of administered expired FLUMIST QUADRIVALENT is unknown. The report was considered to be non-serious.
Sex: M
Vaccine: FLUN4
Symptoms: Exposure via direct contact
Clinical narrative: A report has been received from a Health Professional concerning an adult, male subject, who had been receiving FLUMIST (Intranasal). FLUMIST (Intranasal) started on 01-Nov-2014. It was reported that, the Nurse informed medirep while on a office visit the afternoon, that she administered FLUMIST to her husband in november 2013 and some of the medication went into his eye which started on 01-Nov-2013. The patient recovered from the event of THAT SHE ADMINISTERED FLUMIST TO HER HUSBAND IN NOVEMBER 2013 AND SOME OF THE MEDICATION WENT INTO HIS EYE on an unspecified date. The report was considered to be non-serious.