chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Pruritus
Clinical narrative: This spontaneous report was received from a consumer refers to his wife a 76 year old female patient. The patient's medical history included shingles virus, chicken pox from head to toe, measles, outbreak of mumps and polio. The patient's husband reported that his wife experienced an outbreak of shingles after receiving ZOSTAVAX, 0.65 ml, subcutaneous (date and lot not reported) for prophylaxis on an unspecified date. His wife initially had the shingles virus 4 years ago at the age of 72 years, on an unspecified date. The patient then received ZOSTAVAX, on an unspecified date after the first case of shingles had abated. Since then the patient had had 3 more outbreaks of the shingles virus. She was currently experiencing her 3rd outbreak after receiving the vaccine. The patient was in a lot of pain and was very slow to recover that time. The patient was taking VALTREX, codeine and administering lidocaine cream prescribed by an unspecified physician, to assist with the pain and itching. The outcome of the event was reported as not recovered/not resolved. The relatedness between the event and ZOSTAVAX was not reported. Additional information has been requested.
Age: 10.0
Sex: M
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Eye swelling, Swollen tongue
Clinical narrative: Swollen eyes and tongue went to ER. Treatment Benadryl Zytec no epi steroid no breathing difficulties.
Age: 24.0
Sex: M
Vaccine: ANTH, HEP, TYP
Symptoms: Papule
Clinical narrative: Rash like lesion (papules) on both hands.  Possible smallpox vaccinia, 6-7 papules on both hands.
Age: 1.45
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Convulsion, Febrile convulsion, Pyrexia
Clinical narrative: Simple febrile seizure.  Patient with a generalized seizure lasting 2 minutes 1 day after receiving MMR and Varivax vaccines.  Patient's fever following seizure was found to be 105. Patient evaluated in the emergency department.
Age: 60.0
Sex: M
Vaccine: HEP
Symptoms: Blood test, Cardiac stress test, Faecal incontinence, Immunoglobulin therapy, Intensive care
Clinical narrative: Initial onset of paralysis evening of 05/19/2013; within eight hours was paralyzed from waist down, including bowels and bladder. Put in ICU at hospital at midnight. Two MRIs, lumbar puncture, etc early morning 05/20/2013.  Received five doses of IVIG beginning AM on 05/20/2013.  Hospitalized for 16 days, with final diagnosis as Transverse Myelitis (initially thought to be Guillain Barre Syndrome).
Age: 60.0
Sex: M
Vaccine: HEP
Symptoms: Lumbar puncture, Myelitis transverse, Nuclear magnetic resonance imaging, Paralysis, Paraplegia
Clinical narrative: Initial onset of paralysis evening of 05/19/2013; within eight hours was paralyzed from waist down, including bowels and bladder. Put in ICU at hospital at midnight. Two MRIs, lumbar puncture, etc early morning 05/20/2013.  Received five doses of IVIG beginning AM on 05/20/2013.  Hospitalized for 16 days, with final diagnosis as Transverse Myelitis (initially thought to be Guillain Barre Syndrome).
Age: 60.0
Sex: M
Vaccine: HEP
Symptoms: Ultrasound scan, Urinary incontinence
Clinical narrative: Initial onset of paralysis evening of 05/19/2013; within eight hours was paralyzed from waist down, including bowels and bladder. Put in ICU at hospital at midnight. Two MRIs, lumbar puncture, etc early morning 05/20/2013.  Received five doses of IVIG beginning AM on 05/20/2013.  Hospitalized for 16 days, with final diagnosis as Transverse Myelitis (initially thought to be Guillain Barre Syndrome).
Age: 22.0
Sex: M
Vaccine: ANTH, SMALL
Symptoms: Arthralgia, Convulsion, Hypertonia, Loss of consciousness, Pallor
Clinical narrative: Pt in Immunizations section, received Anthrax vaccination to R arm and Smallpox vaccination to L arm.  Upon completion of smallpox vaccination pt began to turn pale and had a loss of consciousness x1-2 minutes.  Pt body seized and bilateral upper and lower extremities adducted inward w full body tension.  Pt awoke and took about 2 minutes to regain full orientation to person, place, time and event.  Pt BP's taken beginning at 0958 every 5 minutes as follows: 152/92, 125/79, 118/78, 119/79, 121/73.  Pt blood glucose taken at 1010 found to be 114.  Pt stated no medical issues, pt had surgery to L shoulder in Nov 2012, pt stated allergy to SULFA based medications.  Pt states extreme pain localized to L ankle at 8 out of 10 and spreading from posterior aspect of ankle to foot and upper posterior aspect of calf.  Pt stated last meal at 1830 yesterday, pt did not eat breakfast and did not participate in PT this am.  No other issues at persent, provider OIC saw PT and disposition in process.
Age: 63.0
Sex: F
Vaccine: TDAP
Symptoms: Diarrhoea, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Diarrhea, significant right upper arm swelling redness, tenderness (at site of injection).
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Erythema, Skin warm, Swelling
Clinical narrative: 3x3 inch redness with swelling and warm to touch with no streaking. Treating with keflex.
Age: 0.51
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC13, RV5
Symptoms: Blepharospasm, Bruxism, Dyskinesia, Erythema, Seizure like phenomena
Clinical narrative: Jerking of right arm, redness to right side of face, twitching of eye and grinding of teeth seizure-like but responsive.
Age: 1.83
Sex: F
Vaccine: DTAP
Symptoms: Gait disturbance, Injection site induration, Injection site mass, Injection site pain
Clinical narrative: Patient limped on her leg and experienced severe pain at the injection site lasting a few days. There was a very hard, large lump at the injection site that was painful to the touch and lasted several months.
Age: 44.0
Sex: F
Vaccine: PPV
Symptoms: Abdominal pain upper, Arthralgia, Chills, Cough, Headache
Clinical narrative: Fever, chills. cough, headache, vomiting, body aches, joint aches, racing heart, stomach pains.
Age: 44.0
Sex: F
Vaccine: PPV
Symptoms: Pain, Palpitations, Pyrexia, Vomiting
Clinical narrative: Fever, chills. cough, headache, vomiting, body aches, joint aches, racing heart, stomach pains.
Age: 62.0
Sex: F
Vaccine: TDAP
Symptoms: Joint range of motion decreased, Pain in extremity
Clinical narrative: Patient has continuing soreness in arm and cannot lift arm above head.
Age: 2.0
Sex: M
Vaccine: DTAP, HIBV, MMRV
Symptoms: Erythema, Skin warm
Clinical narrative: Mother states child had vaccination on 7/16/13. On 7/17/13 he woke up warm, red at thigh. 7/18/13 area enlarged to 5 inches x 5.5 inches.
Age: 1.0
Sex: M
Vaccine: VARCEL
Symptoms: Herpes zoster
Clinical narrative: Herpes zoster (L) axilla to back dermatome s/p VARIVAX 2/4/13. No pain or morbidity < 24h sx --> treated with acyclovir.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Induration, Swelling
Clinical narrative: 2" area, red, swollen, hard.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site discolouration
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 65 year old female patient. There was reported none concomitant medications, pertinent medical history, drug reactions or allergies. On 28-JUN-2013 the patient was vaccinated with ZOSTAVAX (lot # J000432, exp. date 28-JUN-2014) (dose and route were not reported). Concomitant medications were not reported. The pharmacist reported that on 28-JUN-2013, a patient had a small black dot at the ZOSTAVAX injection site (no rash). The pharmacist reported that the small black dot appeared shortly after vaccination with the ZOSTAVAX and it has not changed or gone away. Patient was not treated for small black dot. No lab diagnostics studies were performed. Patient seek unspecified medical attention. The outcome of black dot at the ZOSTAVAX injection site was reported as not recovered/not resolved. The relationship between ZOSTAVAX and the small black dot was not reported. Additional information is not expected.
Age: 1.0
Sex: F
Vaccine: MMRV
Symptoms: Antibody test abnormal, Blood immunoglobulin G increased, Blood immunoglobulin M increased, Pyrexia, Rash
Clinical narrative: This spontaneous report was received from a physician regarding a 12.5 month old female patient with no pertinent medical history or drug reactions or allergies. On 20-JUN-2013 the patient was vaccinated with (merck) PROQUAD. The physician was unsure if the doses were administered as a dose of (merck) PROQUAD or as individual concomitant doses both MMR and (Merck) VARIVAX. On 21-JUN-2013 reported as "a day later" the patient developed a fever and broke out in a vesicular rash on the face and upper chest. The physician reported that "no culture was performed of the vesicular rash" however "titer studies were performed" when the patient visited the physician's office approximately on 27-JUN-2013 (reported as "a week later"). The physician reported that "chicken pox/varicella titers were low" and there was "a positive IgG and IgM to Herpes I". The physician reported that the patient could possibly be exposed to herpes I before receiving the vaccination. The physician reported that the patient is completely recovered at this time (date of recovery not reported). The physician did not assess the relatedness between fever, vesicular rash and positive to Herpes I and PROQUAD. VZVIP packet was sent. Additional information has been requested.
Age: 1.0
Sex: F
Vaccine: MMRV
Symptoms: Rash vesicular, Simplex virus test positive
Clinical narrative: This spontaneous report was received from a physician regarding a 12.5 month old female patient with no pertinent medical history or drug reactions or allergies. On 20-JUN-2013 the patient was vaccinated with (merck) PROQUAD. The physician was unsure if the doses were administered as a dose of (merck) PROQUAD or as individual concomitant doses both MMR and (Merck) VARIVAX. On 21-JUN-2013 reported as "a day later" the patient developed a fever and broke out in a vesicular rash on the face and upper chest. The physician reported that "no culture was performed of the vesicular rash" however "titer studies were performed" when the patient visited the physician's office approximately on 27-JUN-2013 (reported as "a week later"). The physician reported that "chicken pox/varicella titers were low" and there was "a positive IgG and IgM to Herpes I". The physician reported that the patient could possibly be exposed to herpes I before receiving the vaccination. The physician reported that the patient is completely recovered at this time (date of recovery not reported). The physician did not assess the relatedness between fever, vesicular rash and positive to Herpes I and PROQUAD. VZVIP packet was sent. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Fall, Feeling abnormal, Gaze palsy, Pallor
Clinical narrative: 0859 child stated to father she "did not feel good." 0900 pt. eyes rolled back, and child started to fall forward from exam table. She was caught by M.A. and she was laid down on exam table. Pt. was pallor, and M.D. was called. 0901 SaO2 was requested and saturation was 100%, pulse 98 BPM. 0902 Pt. was given apple juice and crackers and was instructed to stay laying. Blood pressure was checked at 0910am 99/69, and 67 pulse.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Injection site bruising, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Bruise at injection site. Redness/swelling - 2" diameter at injection. Headache/nausea. Pain at injection site and deep into arm.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Nausea, Pain in extremity
Clinical narrative: Bruise at injection site. Redness/swelling - 2" diameter at injection. Headache/nausea. Pain at injection site and deep into arm.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a consumer regarding his daughter, a 15 year old female patient with no pertinent medical history reported. In December 2009 the patient was vaccinated with the first dose of GARDASIL (lot number and expiration date not reported), (dose and route not reported). The reporter stated that the patient received the second dose of GARDASIL on 25-MAY-2013. No adverse effect reported. Additional information has been requested.
Age: 19.0
Sex: M
Vaccine: ANTH
Symptoms: Chest discomfort, Dyspnoea, Myalgia
Clinical narrative: Pt. c/o chest tightness, shortness of breath and generalized muscle aches.
Sex: F
Vaccine: MMR
Symptoms: Hypersensitivity
Clinical narrative: This spontaneous report as received from a female consumer of unknown age refers to herself. On an unknown date, the patient ws vaccinated with a dose of M-M-R II (route, lot # and expiration date were not provided). On an unknown date, the patient experienced an unspecified allergic reaction after receiving the M-M-R II. The outcome of allergic reaction was unknown. The relationship between therapy with M-M-R II and the event was unknown. It was unknown if the patient sought medical attention. Additional information is not expected.
Sex: M
Vaccine: HPV4
Symptoms: Vomiting
Clinical narrative: This spontaneous report as received from a physician refers to a male patient of unknown age. On an unknown date the patient was vaccinated with a dose of GARDASIL (Lot # not reported) (dose and route not reported). Concomitant therapy was not reported. On an unknown date, following administration of a dose of GARDASIL the patient vomited. At the time of the report the patient's outcome was unknown. This case is linked to MARRS 1307USA009233 and 1307USA010388. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: This spontaneous report as received from a physician refers to 2 unspecified patients. On an unknown date the patients were vaccinated with a dose of GARDASIL (Lot # not reported) (dose and route not reported). Concomitant therapy was not reported. On an unknown date, following vaccination of GARDASIL the patients fainted. At the time of the report the outcome for the patients was unknown. This case is linked to MARRS 1307USA009233 and 1307USA010389. Additional information has been requested.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Injection site erythema, Injection site pruritus, Injection site warmth, Pyrexia
Clinical narrative: This spontaneous report was received from a registered nurse refers to a 61 year old female patient with allergy to PERCOCET, sulfa and latex and a history of Herpes Simplex. On 08-JUL-2013 the patient was vaccinated with ZOSTAVAX, (lot number and expiration date not reported0 (0.65 ml, subcutaneous, once). It was reported that on 09-JUL-2013 (reported as 24 hours after) the patient experienced joint aches all over her body and a fever that "lasted for about a day and then subsided" (10-JUL-2013). It was reported that the patient saw her unspecified primary care provider on 11-JUL-2013 (reported as "today"), and the injection site was red, hot to the touch and itchy. The outcome for joint aches and all over her body and injection site red, hot to the touch and itchy, was reported as  not recovered. No treatment ws given for the above mentioned events. No laboratory diagnostic tests were performed. The reporter did not assess the causality between joint aches all over her body, fever, and injection site red, hot to the touch and itchy. Additional information is not expected.
Sex: M
Vaccine: PPV
Symptoms: Injection site cellulitis, Injection site erythema
Clinical narrative: This spontaneous report as received from a physician via a company representative refers to a 50-59 year old male patient (exact age unspecified). "A year ago", in approximately July 2012 the patient was vaccinated with PNEUMOVAX23 (lot # not reported) (strength and total daily dose not reported). On an unknown date the patient developed redness in his arm where he received the PNEUMOVAX23 vaccine. The physician believed it might have been cellulitis. The patient sought for medical attention by seeing the physician. Unspecified treatment was given. The outcome was reported as recovered. Additional information has been requested.
Age: 46.0
Sex: F
Vaccine: VARCEL, PPV
Symptoms: Antibody test negative, Contusion, Injection site rash, Skin lesion, Swelling
Clinical narrative: This spontaneous report was received from a 46 year old female patient with asthma, regarding herself. The patient had no known drug reactions/allergies. On 08-JUN-2013, the patient was vaccinated with a dose of PNEUMOVAX23, in the right arm, to prevent pneumonia (Lot number, expiration date, and route were not provided). Co-suspect therapy was not provided. Concomitant therapies included SYMBICORT, CLARITIN-D, SINGULAIR and DYMISTA. On 18-JUN-2013, 10 days after she received the dose of PNEUMOVAX23, she experienced swelling and bruising  around the injection site. The swelling had reduced and seemed to be going away, but the bruising was still there. The patient had not received any treatment for the events and had not performed any laboratory test. The patient sought medical attention by speaking to the clinician. The relatedness of the adverse events and PNEUMOVAX23 was unknown. Additional information has been requested.
Age: 46.0
Sex: F
Vaccine: VARCEL, PPV
Symptoms: Injection site bruising, Injection site swelling
Clinical narrative: This spontaneous report was received from a 46 year old female patient with asthma, regarding herself. The patient had no known drug reactions/allergies. On 08-JUN-2013, the patient was vaccinated with a dose of PNEUMOVAX23, in the right arm, to prevent pneumonia (Lot number, expiration date, and route were not provided). Co-suspect therapy was not provided. Concomitant therapies included SYMBICORT, CLARITIN-D, SINGULAIR and DYMISTA. On 18-JUN-2013, 10 days after she received the dose of PNEUMOVAX23, she experienced swelling and bruising  around the injection site. The swelling had reduced and seemed to be going away, but the bruising was still there. The patient had not received any treatment for the events and had not performed any laboratory test. The patient sought medical attention by speaking to the clinician. The relatedness of the adverse events and PNEUMOVAX23 was unknown. Additional information has been requested.
Age: 12.0
Sex: M
Vaccine: HEPA, HPV4, MNQ, TDAP, HPV4, MNQ, TDAP
Symptoms: Chest discomfort, Dyspnoea, Local swelling, Swelling face, Throat tightness
Clinical narrative: Swelling of cheeks and lips. Mom took to ER, received Epinephrine shots and pt was sent home. After about 2 hours pt felt like throat was swelling and was taken back to ER. Given Epinephrine shots and admitted over night.
Age: 12.0
Sex: M
Vaccine: HEPA, HPV4, MNQ, TDAP, HPV4, MNQ, TDAP
Symptoms: Lip swelling, Pharyngeal oedema, Swelling face
Clinical narrative: Swelling of cheeks and lips. Mom took to ER, received Epinephrine shots and pt was sent home. After about 2 hours pt felt like throat was swelling and was taken back to ER. Given Epinephrine shots and admitted over night.
Age: 9.0
Sex: M
Vaccine: TYP
Symptoms: Urticaria
Clinical narrative: Patient developed hives on chest and back.
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a Licensed Practical Nurse refers to a patient of unknown age. On 14-JUN-2013 the patient was vaccinated with M-M-R II (lot# H10135, expired date 17-MAY-2014), route, dose and frequency unspecified. The M-M-R II was improperly stored at 8.5 degrees C. -9.1 degrees C for 720 hours. There was no adverse effect reported. The outcome of the patient was unknown. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a Licensed Practical Nurse refers to a patient of unknown age. On 11-JUN-2013 the patient was vaccinated with oral ROTATEQ (lot # H011439, expired date 01-DEC-2013), route, dose and frequency unspecified. The oral ROTATEQ was improperly stored at 8.5 degrees C. -9.1 degrees C for 720 hours. There was no adverse effect reported. The outcome of the patient was unknown. This is one of several reports received from the same source. Additional information has been requested.
Age: 53.0
Sex: F
Vaccine: PPV
Symptoms: Urticaria
Clinical narrative: This spontaneous report as received from a consumer refers to a 53 year old female patient with chronic sinusitis. On 09-JUL-2013 the patient was vaccinated with PNEUMOVAX 23 (lot # unknown) once intramuscular for physician recommended. Concomitant therapies included ZOLOFT, BYSTOLIC, WELLBUTRIN, SYNTHROID, ARMOUR THYROID TABLETS, pravastatin sodium, MIRAPEX, "water pill", estradiol and progesterone. Consumer reported that on 09-JUL-2013 after received PNEUMOVAX 23 she developed a small hive on her abdomen. Consumer stated she self medicated with ADVIL and the hive "went away after a couple of days". The consumer stated when she took Codeine (manufacturer unspecified) she hallucinates, when she takes CIPRO (manufacturer unspecified) she got a rash and when she takes BACTRIM (manufacturer unspecified) or SUDAFED (manufacturer unspecified) she developed a purple, blotchy rash and her whole body turns red. There was no lab performed for the event. The patient also did not sought medical attention. Additional information is not expected.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Blood creatine phosphokinase increased, Malaise
Clinical narrative: This spontaneous report as received from a physician refers to a 64 year old male patient. On 09-MAY-2013 the patient was vaccinated with a 0.65ml dose of ZOSTAVAX (lot number not reported) subcutaneously. The patient experienced a dramatic rise in his creatine phosphokinase(CPK) after being administered ZOSTAVAX. On 17-MAY-2013 the patient began to feel very ill. Ill was enough to go to hospital to be evaluated. The patient spent 3 days in the hospital receiving supportive care which included intravenous fluids and serial laboratory studies, specifically creatine phosphokinase(CPK). Initially the patient's CPK rose dramatically and over the course of the patient's 3 day hospital stay, the CPK's returned to normal levels. The outcome of feel very ill was reported as recovering. Additional information has been requested.
Age: 41.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Erythema, Local swelling, Pain, Pyrexia, Skin warm
Clinical narrative: Left arm swelling, redness, pain, low grade fever, body ache, arm hot to touch.
Age: 41.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Injection site erythema, Injection site streaking, Injection site swelling, Injection site warmth, Pain
Clinical narrative: Left arm swelling, redness, pain, low grade fever, body ache, arm hot to touch.
Age: 41.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Pyrexia
Clinical narrative: Left arm swelling, redness, pain, low grade fever, body ache, arm hot to touch.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Allergy test positive, Anaphylactic reaction, Inappropriate schedule of drug administration, Oedema mouth, Pharyngeal oedema
Clinical narrative: This spontaneous report as received from a pharmacist refers to her daughter with allergy to augmentin no pertinent medical history. The pharmacist reported that her daughter received a dose of GARDASIL (date unspecified, sometime in 2010). Other suspect therapy included IBUPROFEN and later the same day with the vaccine administered, the patient went to the emergency room for an anaphylactic reaction described as swelling of the mouth and throat. The pharmacist reported that allergy testing (unspecified type of allergy testing) determined that the anaphylactic reaction was to ibuprofen (manufacturer unspecified). The patient received the treatment including epinephrine, unspecified steroid and BENADRYL. The patient recovered from the event within two or three days. The pharmacist reported that the patient received the second dose of GARDASIL about 4 month after the first dose of GARDASIL (date unspecified) and then third dose of GARDASIL was administered about two to three months after the second dose of GARDASIL (no adverse event reported after the second or third doses of GARDASIL). Anaphylactic reaction (swelling of mouth and throat) was considered to be life threatening by the reporter. Upon internal review, anaphylactic reaction (treated with Epinephrine) was determined to be medically significant. Additional information has been requested.
Sex: F
Vaccine: MMR
Symptoms: Measles antibody negative, Mumps antibody test positive, Rubella antibody positive
Clinical narrative: This spontaneous report as received from a physician refers to a female patient of unknown age. On an unknown date the patient was vaccinated with M-M-R II HSA (dosage, concentration, route and lot number unknown). On an unknown date the patient had titers drawn. The Rubella and Mumps titers came back as positive however the Measles results were equivocal. Physician was unsure if the patient had received both required MMR vaccines as a younger person. No vaccination documentation was provided to the physician. No adverse effect reported. The patient didn't seek for medical attention. The outcome of the event was reported as unknown. Additional information has been requested.
Age: 39.0
Sex: F
Vaccine: VARCEL
Symptoms: Blister, Rash erythematous, Rash generalised
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 39 year old female patient. On an unknown date, the patient was vaccinated with VARIVAX (Merck) injection (dose, route and lot number were not reported). On 30-JUN-2013, the patient experienced red rash of "size of large man's hand" and "possibly a few vesicles", after the patient received VARIVAX (Merck). On a call back, the patient reported "bumps randomly over body" and blister under arm of injection site. The patient contacted the pharmacist. The patient's outcome was unknown. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Alopecia, Metal poisoning
Clinical narrative: This spontaneous report as received from a physician via company representative refers to a female patient of unknown age. On an unknown date the patient was vaccinated with GARDASIL dose, route and lot# not reported. The patient believed that on an unknown date she had aluminum poisoning and her hair was thinning. The outcome of adverse events was unknown. The relatedness between GARDASIL and adverse events was unknown. It was unknown if the patient sought medical attention. 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 Licensed Practical Nurse refers to a patient of unknown age. On 25-JUN-2013 the patient was vaccinated with GARDASIL (lot # H012973, expired date 05-MAR-2015), route, dose, and frequency unspecified. The GARDASIL was improperly stored at 8.5 degrees C. -9.1 degrees C for 720 hours. There was no adverse effect reported. The outcome of the patient was unknown. This one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Antibody test negative, Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age. On 10-JUL-2013 The medical assistant reported patient was administered an expired dose of M-M-R II (0.5 ml, subcutaneous, lot # reported as 0870AA, exp 06-JUN-2013). The medical assistant was unsure if the patient had any previous doses of M-M-R II administered, however the patient had "negative titers for MMR antibodies" on an unspecified date prior to the expired dose of MMR being administered. No adverse effect reported. Additional information has been requested.
Sex: F
Vaccine: VARCEL
Symptoms: Foetal exposure during pregnancy, Jaundice neonatal, Meconium stain
Clinical narrative: Information has been received from a registered nurse for VARIVAX (Merck), a Pregnancy Registry product, concerning a female neonate. The neonate's 21 year old mother on approximately 10-JAN-2012 was vaccinated with VARIVAX (Merck) (dose, route and lot number not reported). The mother at the time of receipt of the VARIVAX (Merck) she was not pregnant. At the follow-up visit the patient was tested positive for pregnancy, and further data collection revealed that her last menstrual period was 26-NOV-2011. Estimated Delivery Date was 01-SEP-2012. Follow-up information reported that the mother delivered a healthy baby girl on 12-Sep-2012 at 39 weeks' gestation (LMP previously reported as 26-NOV-2011 which would count as 41 weeks' gestation age). The vaginal delivery was without complications. The infant weighed 3203 grams, APGAR scores were 9/9. It was reported there was meconium stained fluid upon delivery. No fetal congenital anomalies were reported. The infant had neonatal jaundice post delivery (approximately in September 2012, exact date not reported). Outcome of the neonatal jaundice was not reported. Additional information is not expected.
Sex: U
Vaccine: VARZOS
Symptoms: Product quality issue
Clinical narrative: This spontaneous report as received from a registered pharmacist reporting that a patient of an unknown age, on 30-MAY-2013, was vaccinated with a dose of ZOSTAVAX (lot # J000445, Exp. Date: 11-APR-2014) (dose and route not reported) with diluent, when the solution sprayed onto pharmacist skin due to elevated pressure in the ZOSTAVAX vial. This is one of several reports from the same source.  Follow up information was received via a vaccine adverse experience report. The reporter stated that the patient did not had an under dose, because he used a new vial of diluent. Their was no adverse event. Information of the vaccine administrator was provided. The vaccine was administered on 30-MAY-2013 AM. The route was also reported, but illegible. Back pressure filling diluent into ZOSTAVAX vial. It was also reported that "Diluent back flushed from ZOSTAVAX vial on diluent ...(illegible)".  Additional information is not expected.
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a Licensed Practical Nurse refers to a patient of unknown age. On 11-JUN-2013 the patient was vaccinated with M-M-R II (lot# H10135, expired date 17-MAY-2014), route, dose and frequency unspecified. The M-M-R II was improperly stored at 8.5 degrees C. -9.1 degrees C for 720 hours. There was no adverse effect reported. The outcome of the patient was unknown. This is one of several reports received from the same source. Additional information has been requested.
Age: 17.0
Sex: U
Vaccine: HEPA
Symptoms: Drug administered to patient of inappropriate age, No adverse event, Wrong drug administered
Clinical narrative: Information has been received from a licensed practical nurse concerning a 17 year-old (pediatric) patient who, on 02-JUL-2013, was inadvertently vaccinated with an adult dose of VAQTA, 50/1.0 U/ml, 1 ml, intramuscularly (lot # reported as J000145, expiry date 25-SEP-2015). This was the patient's first dose of VAQTA. No adverse effect was reported. Additional information has been requested.
Age: 21.0
Sex: F
Vaccine: VARCEL
Symptoms: Delivery, Exposure during pregnancy, Meconium stain, No adverse event, Pregnancy test positive
Clinical narrative: Information has been received from a registered nurse for VARIVAX (Merck), a Pregnancy Registry product, concerning a 21 year old female patient who on approximately 10-JAN-2012 ("approximately two weeks ago"), was vaccinated with  VARIVAX (Merck) (dose, route and lot number not reported). The registered nurse reported, that the patient stated that at the time of receipt of the VARIVAX (Merck) she was not pregnant. At the follow-up visit the patient was tested positive for pregnancy, and further data collection revealed that her last menstrual period was 26-NOV-2011. The patient had a physical exam. The patient was scheduled to be seen by responsible physician 13-FEB-2012. No adverse effect has been reported or observed. Estimated Delivery date would be 01-SEP-2012.  Follow up information has been received from the nurse. The patient delivered a  healthy baby girl on 12-SEP-2102 at 39 weeks' gestation (LMP previously reported as 26-NOV-2011 which would count as 41 week gestational age). The vaginal delivery was without complications. The infant weighed 3203 grams, APGAR scores were 9/9. It was reported there was meconium stained fluid upon delivery. No fetal congenital anomalies were reported. The infant had neonatal jaundice post delivery (captured in Case # 1307USA010527). Additional information is not expected.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Condition aggravated, Oral herpes
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 72 year old female patient. The patient had a previous history of cold sores. The patient had no drug allergy. On 11-JUL-2013 the patient was vaccinated with ZOSTAVAX lot # H022152, exp. 18-MAR-2013. There was no concomitant medication. On 11-JUL-2013, The patient received ZOSTAVAX in the morning and then developed cold sore later in the same day. No lab test was done. The outcome of cold sore was reported as not recovered/not resolved. The patient contacted pharmacist for medical attention. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Exposure to vaccinated person, Herpes zoster
Clinical narrative: This spontaneous report was received from a registered pharmacist concerning a female patient of unknown age. On 05-JUL-2013, the patients husband was vaccinated with 0.65 milliliter (ml) of ZOSTAVAX (lot number and expiry date reported as J000435 and 10_APR-2014 respectively), subcutaneously. Concomitant medications of the patients husband included several medications (unspecified) and he had no drug reactions or allergies. On 08-JUL-2013 (also reported as on an unknown date), the patient (wife) was diagnosed with shingles by an unspecified physician. No further information was provided regarding the patient (wife). Outcome of the events was unknown. The relatedness for the events was unknown for ZOSTAVAX. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report has been received from a Nurse Practitioner via Company Representative who was referring to her sister, a female patient of unknown age. Information on medical history, drug reactions or allergies not provided. On an unknown date the patient was vaccinated with ZOSTAVAX (lot number, expiry date, dose, route, dosage not reported). It was reported that Nurse Practitioner's sister received ZOSTAVAX and then developed a rash described as shingles (dates not provided). The outcome of rash described as shingles was unknown. It was unknown if the patient sought medical attention. The relatedness was not assessed by the reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a nurse. No patient identifiers were provided. The nurse reported that the VARIVAX (Merck) in her facility had been stored in a 'dorm style' freezer unit with no thermometer for an unknown amount of time. The nurse stated that she was not sure if any of these doses have been administered to patients. No adverse effects were reported. Additional information has been requested.
Age: 24.0
Sex: F
Vaccine: ANTH, TYP
Symptoms: Activities of daily living impaired, Allergy to vaccine, Blindness transient, Cataract, Chills
Clinical narrative: 32 yo female who felt well when she received AVA dose #1 in Aug 2005. The next day she developed headache, fever to 102.0 and chills. On post vaccine day (PVD) 2-3 fatigue and nausea began in addition to the initial symptoms. She was seen, told to consider herself allergic to AVA with permanent exemption and given 2 weeks in quarters. On PVD 3 the sensation of burning skin began, "like a sunburn", but without the redness of rash. It was over her entire body. She stayed in quarters for the two weeks when all of the symptoms had progressively resolved to where she felt well again. She deployed the following month. Upon return from deployment in Mar 2006 she began having ocular migraines where she had episodes of blindness lasting 15-20 minutes, occurring about once a month. She was diagnosed with ocular migraine and has learned behaviors that have decreased the frequency. In 2006 she also developed episodes of diplopia unrelated to the ocular migraines. It increased in severity until she could not see to drive. She has recently seen a neuro ophthalmologist who diagnosed optic neuritis and cataracts and suggested that AVA might have caused it. She was informed that optic neuritis can preceded autoimmune disease such as MS. Her rheumatology workup was negative. She is concerned though, because her grandmother developed MS at age 32, the same age as the patient. She suffered a head injury as well prior to onset of diplopia. Lasik surgery could treat her conditions, but the VA does not cover it.
Age: 24.0
Sex: F
Vaccine: ANTH, TYP
Symptoms: Diplopia, Fatigue, Head injury, Headache, Laboratory test normal
Clinical narrative: 32 yo female who felt well when she received AVA dose #1 in Aug 2005. The next day she developed headache, fever to 102.0 and chills. On post vaccine day (PVD) 2-3 fatigue and nausea began in addition to the initial symptoms. She was seen, told to consider herself allergic to AVA with permanent exemption and given 2 weeks in quarters. On PVD 3 the sensation of burning skin began, "like a sunburn", but without the redness of rash. It was over her entire body. She stayed in quarters for the two weeks when all of the symptoms had progressively resolved to where she felt well again. She deployed the following month. Upon return from deployment in Mar 2006 she began having ocular migraines where she had episodes of blindness lasting 15-20 minutes, occurring about once a month. She was diagnosed with ocular migraine and has learned behaviors that have decreased the frequency. In 2006 she also developed episodes of diplopia unrelated to the ocular migraines. It increased in severity until she could not see to drive. She has recently seen a neuro ophthalmologist who diagnosed optic neuritis and cataracts and suggested that AVA might have caused it. She was informed that optic neuritis can preceded autoimmune disease such as MS. Her rheumatology workup was negative. She is concerned though, because her grandmother developed MS at age 32, the same age as the patient. She suffered a head injury as well prior to onset of diplopia. Lasik surgery could treat her conditions, but the VA does not cover it.
Age: 24.0
Sex: F
Vaccine: ANTH, TYP
Symptoms: Migraine, Nausea, Optic neuritis, Pyrexia, Skin burning sensation
Clinical narrative: 32 yo female who felt well when she received AVA dose #1 in Aug 2005. The next day she developed headache, fever to 102.0 and chills. On post vaccine day (PVD) 2-3 fatigue and nausea began in addition to the initial symptoms. She was seen, told to consider herself allergic to AVA with permanent exemption and given 2 weeks in quarters. On PVD 3 the sensation of burning skin began, "like a sunburn", but without the redness of rash. It was over her entire body. She stayed in quarters for the two weeks when all of the symptoms had progressively resolved to where she felt well again. She deployed the following month. Upon return from deployment in Mar 2006 she began having ocular migraines where she had episodes of blindness lasting 15-20 minutes, occurring about once a month. She was diagnosed with ocular migraine and has learned behaviors that have decreased the frequency. In 2006 she also developed episodes of diplopia unrelated to the ocular migraines. It increased in severity until she could not see to drive. She has recently seen a neuro ophthalmologist who diagnosed optic neuritis and cataracts and suggested that AVA might have caused it. She was informed that optic neuritis can preceded autoimmune disease such as MS. Her rheumatology workup was negative. She is concerned though, because her grandmother developed MS at age 32, the same age as the patient. She suffered a head injury as well prior to onset of diplopia. Lasik surgery could treat her conditions, but the VA does not cover it.
Age: 24.0
Sex: F
Vaccine: ANTH, TYP
Symptoms: Vision blurred
Clinical narrative: 32 yo female who felt well when she received AVA dose #1 in Aug 2005. The next day she developed headache, fever to 102.0 and chills. On post vaccine day (PVD) 2-3 fatigue and nausea began in addition to the initial symptoms. She was seen, told to consider herself allergic to AVA with permanent exemption and given 2 weeks in quarters. On PVD 3 the sensation of burning skin began, "like a sunburn", but without the redness of rash. It was over her entire body. She stayed in quarters for the two weeks when all of the symptoms had progressively resolved to where she felt well again. She deployed the following month. Upon return from deployment in Mar 2006 she began having ocular migraines where she had episodes of blindness lasting 15-20 minutes, occurring about once a month. She was diagnosed with ocular migraine and has learned behaviors that have decreased the frequency. In 2006 she also developed episodes of diplopia unrelated to the ocular migraines. It increased in severity until she could not see to drive. She has recently seen a neuro ophthalmologist who diagnosed optic neuritis and cataracts and suggested that AVA might have caused it. She was informed that optic neuritis can preceded autoimmune disease such as MS. Her rheumatology workup was negative. She is concerned though, because her grandmother developed MS at age 32, the same age as the patient. She suffered a head injury as well prior to onset of diplopia. Lasik surgery could treat her conditions, but the VA does not cover it.
Age: 41.0
Sex: F
Vaccine: HEPA
Symptoms: Wrong drug administered
Clinical narrative: Wrong vaccine given. Hep B order. Hep A given.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site rash
Clinical narrative: Patient experienced a rash on vaccine arm near injection site.
Age: 72.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Fatigue, Skin warm
Clinical narrative: Red in the area, "moved down the arm", warm and feel tired.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Redness 2.25" in diameter around injection site, warm to touch. 1" in diameter around injection site slightly swollen. Tx. apply cold compress -24-48 hours for clearing of reaction.
Age: 30.0
Sex: F
Vaccine: TDAP
Symptoms: Chills, Headache, Pain, Pyrexia
Clinical narrative: Patient states approximately 3 hrs after injection she had headache, body aches, chills. States she had 101-102 degree fever, responsive to TYLENOL (99).
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5, DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Hypotonic-hyporesponsive episode
Clinical narrative: Patient had hypotonic hyporesponsive episode within 5 minutes of receiving the vaccine. Episode lasted for approx 5 min and patient was fine thereafter.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5, DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Hypotonia
Clinical narrative: Patient had hypotonic hyporesponsive episode within 5 minutes of receiving the vaccine. Episode lasted for approx 5 min and patient was fine thereafter.
Age: 80.0
Sex: U
Vaccine: UNK
Symptoms: Asthenia, Headache, Increased upper airway secretion, Productive cough, Respiratory tract irritation
Clinical narrative: Cough from bad lung irritation. Keep bring up mucous, also headache and weakness still not better.
Age: 80.0
Sex: M
Vaccine: PPV
Symptoms: Convulsion, Dizziness, Dysphonia, Fatigue, Headache
Clinical narrative: Had a seizure, headache, tiredness and dizziness and hoarseness.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash vesicular
Clinical narrative: ZOSTAVAX administered SC on 07/11/13. Patient developed a varicella-like rash on legs and back on 07/13/13 - confirmed on exam 07/15/13. No fevers.
Age: 16.0
Sex: M
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Dyspnoea, Muscle spasms, Pyrexia
Clinical narrative: Fever 103.7, violent body spasms, serious difficulty breathing. Body spasms lasted for several hours, breathing improved after treatment at hospital. Remained unavailable.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site reaction, Injection site warmth, Rash, Rash erythematous, Skin warm
Clinical narrative: Warm red rash on left upper arm and left thigh. This resolved, then had red warm to touch rash on (R+) forearm..
Age: 0.22
Sex: M
Vaccine: DTAPHEPBIP
Symptoms: Apnoea, Apnoea test, Bradycardia, Injection site nodule, Intensive care
Clinical narrative: This case was reported by a pharmacist and described the occurrence of apnea (infant) in a 3-month-old male subject who was vaccinated with PEDIARIX (GlaxoSmithKline). Concurrent medical conditions included prematurity. Concurrent medications included PRILOSEC, EES, Iron salt and Vitamin with iron and simethicone. On 2 July 2013 at 11:43 the subject received 1st dose of PEDIARIX (.5 ml, unknown route, left thigh). On 3 July 2013, 1 day after vaccination with PEDIARIX, the subject experienced apnea (infant), nodule injection site (described as large), bradycardia and decreased oxygen saturation. At the time of reporting, the premature infant was in the neonatal intensive care unit. The pharmacist reported that the subject experienced increased apnea and decreased oxygen saturation. The pharmacist reported that it was unknown if the immunization series was discontinued or delayed. The pharmacist considered the events were disabling and clinically significant (or requiring intervention). Relevant test results included apnea test with results of increased and oxygen saturation levels with result of decreased on 3 July 2013. The subject was treated with warm compress and oxygen. At the time of reporting the event of large injection site nodule was unresolved. The events of apnea (infant). bradycardia, and decreased oxygen saturation had improved. The pharmacist reported 4 other cases. See cases A1033994A, A1033995A, A1033996A, and A1033997A for details on the other cases.
Age: 0.22
Sex: M
Vaccine: DTAPHEPBIP
Symptoms: Laboratory test abnormal, Oxygen saturation decreased
Clinical narrative: This case was reported by a pharmacist and described the occurrence of apnea (infant) in a 3-month-old male subject who was vaccinated with PEDIARIX (GlaxoSmithKline). Concurrent medical conditions included prematurity. Concurrent medications included PRILOSEC, EES, Iron salt and Vitamin with iron and simethicone. On 2 July 2013 at 11:43 the subject received 1st dose of PEDIARIX (.5 ml, unknown route, left thigh). On 3 July 2013, 1 day after vaccination with PEDIARIX, the subject experienced apnea (infant), nodule injection site (described as large), bradycardia and decreased oxygen saturation. At the time of reporting, the premature infant was in the neonatal intensive care unit. The pharmacist reported that the subject experienced increased apnea and decreased oxygen saturation. The pharmacist reported that it was unknown if the immunization series was discontinued or delayed. The pharmacist considered the events were disabling and clinically significant (or requiring intervention). Relevant test results included apnea test with results of increased and oxygen saturation levels with result of decreased on 3 July 2013. The subject was treated with warm compress and oxygen. At the time of reporting the event of large injection site nodule was unresolved. The events of apnea (infant). bradycardia, and decreased oxygen saturation had improved. The pharmacist reported 4 other cases. See cases A1033994A, A1033995A, A1033996A, and A1033997A for details on the other cases.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site irritation, Injection site pruritus, Injection site swelling
Clinical narrative: Patient reported increased swelling, itching, and irritation at site of injection. Patient went to her PCP 3 days after injection and received a prescription for a steroid type cream.