chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMRV, DTAP, IPV, MMRV
Symptoms: Rash erythematous, Varicella post vaccine
Clinical narrative: Information has been received from a registered nurse and a physician (through a completed questionnaire), concerning a 5 year old male patient with asthma and no known allergies who on 03-MAY-2011 was vaccinated with PROQUAD (Merck) (lot number 666885/0283Z) in the left thigh. Concomitant therapy included DAPTACEL administered on 03-MAY-2011, montelukast sodium (MSD), PROVENTIL and FLOVENT. On 03-MAY-2011 at the injection site the patient developed "red, raised rash, painful with blisters". On 04-May-2011 the patient developed chickenpox; more than 5 lesions (exact number unknown) and circular around injection site. The patient presented a maximum temperature of 100.7. It was reported that the patient had no recent exposure to chickenpox or shingles. The patient called the physician and was started on prednisone and either CLARITIN or ZYRTEC". On 05-MAY-2011, the patient recovered from red, raised rash, painful with blisters at the injection site. At the time of the report the patient's chickenpox status was unknown. The patient's blisters scab over. The patient was enrolled in the Varicella Zoster Virus Identification Program to identify if VZV is present and if it is present, to identify if it is associated with the wild-type (WT) VZV strain or with the Merck vaccine strain. A lesion sample was collected on 07-MAY-2011. The sample was taken from a scab (results pending). Additional information has been received and the PCR analysis revealed the sample was inadequate to process. Additional information has been received which stated that on 07-MAY-2011 a small scab from left thigh was taken, on 12-May-2011 the specimen arrived to the lab and a VZV amplification could not be done. A beta-globin DNA was also not amplified. The final PCR specimen result was inadequate specimen. Follow-up information has been received from a physician concerning the 5 year old male student with "none" illness at time of vaccination, who on 04-MAY-2011 (previously reported as 03-MAY-2011) at 14:10, was vaccinated with the first dose of PROQUAD (lot # 666885/0283Z) in the left leg. The same day, the patient received the sixth dose of DAPTACEL (Lot# C3358AA) in the right leg and the fifth dose of IPOL (lot # D0674-1) in the left leg. On 04-MAY-2011, the patient developed a 8 x 5.5 cm area of erythema and induration with tiny vesicles in center. Subsequently, the patient recovered from 8 x 5.5 cm area of erythema and induration with tiny vesicles in center on an unspecified date. The patient did not seek medical attention. Additional information has been requested.
Age: 0.25
Sex: M
Vaccine: DTP, HIBV, OPV
Symptoms: Blindness, Convulsion, Cyanosis, Encephalitis, Irritability
Clinical narrative: Child recieved vaccinations and approx 5 days later child was in critical condition. Prior to the actual incident my child was extremely cranky the day before it occurred. My Child was found by sitter not breathing and bluish color change to skin and lips. My child was rushed to hospital with seizures and not breathing. Finally after testing they diagnosed encephalitis. When asked if it could be from vaccinations they said "no", he must of caught it from someone in the public? He was on seizure medicine until 1 yrs old and has permanent optic nerve damage from the seizures & from stopping breathing until encephalitis was diagnosed. He is legally blind from the damage received from the encephalitis.
Age: 0.25
Sex: M
Vaccine: DTP, HIBV, OPV
Symptoms: Laboratory test abnormal, Optic nerve injury, Respiratory arrest
Clinical narrative: Child recieved vaccinations and approx 5 days later child was in critical condition. Prior to the actual incident my child was extremely cranky the day before it occurred. My Child was found by sitter not breathing and bluish color change to skin and lips. My child was rushed to hospital with seizures and not breathing. Finally after testing they diagnosed encephalitis. When asked if it could be from vaccinations they said "no", he must of caught it from someone in the public? He was on seizure medicine until 1 yrs old and has permanent optic nerve damage from the seizures & from stopping breathing until encephalitis was diagnosed. He is legally blind from the damage received from the encephalitis.
Age: 56.0
Sex: F
Vaccine: FLUX
Symptoms: Condition aggravated, Laboratory test, Myalgia
Clinical narrative: Severe muscle ache both legs pain still active today. Last year same reaction worse this year.
Age: 72.0
Sex: F
Vaccine: TTOX
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Red swollen arm at injection site about 12 hours after injection. Treatment given - Ice, BENADRYL.
Age: 1.12
Sex: F
Vaccine: PNC13
Symptoms: Febrile convulsion
Clinical narrative: Had febrile seizure. Was taken by ambulance to hospital for febrile seizure.
Sex: U
Vaccine: FLUX
Symptoms: Unevaluable event
Clinical narrative: This spontaneous literature report (initial receipt 28-Nov-2011) concerns children aged 2-17 years who received trivalent inactivated vaccine. The study included a total of 4245 and 10693 children who received 1 dose or greater of LAIV in year 1 of 6 TIV - controlled and 14 placebo-controlled studies, respectively. All reported adverse events considered to be wheezing, asthma, bronchial obstruction or bronchospasm (including bronchiolitis) were grouped into wheezing events of special interest. Lower respiratory or respiratory difficulty. Reactogenicity events included runny/stuffy nose, sore throat, cough, vomiting, headache, muscle ache, chills, decreased activity, irritability, abdominal pain, decreased appetite, and fever. In the 0-10 days post vaccination, it was reported that in year 1 of vaccination with TIV (dose 1), 755 patients reported >=1 events (1103 events in total); events of interest included 110 incidences of lower respiratory illness and 68 incidences of wheezing illness; and in year 1 (dose 2), 363 patients reported > 1 events (519 events in total); events of interest included 60 incidences of lower respiratory illness and 30 incidences of wheezing illness. In addition, it was reported that patients experienced reactogenicity events in the 0-10 days following TIV (dose 1 and 2), however absolute numbers were not reported. Outcome of patients is unknown.
Age: 48.0
Sex: F
Vaccine: MMR
Symptoms: Arthralgia, Pyrexia, Rash
Clinical narrative: 12/11/11 Fever between 102 degrees to 104 degrees (down to 100 degrees with ibuprofen) pain in all joints. Red non-raised, non-itchy rash over chest, bilateral upper arms. 12/19/11 "Im just fine now. Everything's gone."
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Contusion, Erythema
Clinical narrative: Onset redness, bruising (R) arm 24 hour after injection. Rx CLARITIN & CORTAID.
Age: 67.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site cellulitis, Injection site mass, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: 4 to 5 hrs after vaccination pt felt warm & itching at site of injection left arm. Swelled up & raised. Painful knot - feverish - seen day after - 11/11/11 noted cellulitis at site - treated with KEFLEX - pt better after 2 days - lasted total 5 days.
Age: 67.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site warmth, Pyrexia
Clinical narrative: 4 to 5 hrs after vaccination pt felt warm & itching at site of injection left arm. Swelled up & raised. Painful knot - feverish - seen day after - 11/11/11 noted cellulitis at site - treated with KEFLEX - pt better after 2 days - lasted total 5 days.
Age: 26.0
Sex: F
Vaccine: HPV4, PPV, TDAP
Symptoms: Differential white blood cell count, Erythema, Feeling of body temperature change, Full blood count, Oedema peripheral
Clinical narrative: Received pneumococcal & Tdap vaccine on 9/30/11. Since then, hot & cold, body aches, arm pain with increased redness, swelling & pain. Elevated WBC, fever, increased thirst. Sent from facility to ED and then hospitalized x4 days.
Age: 26.0
Sex: F
Vaccine: HPV4, PPV, TDAP
Symptoms: Pain, Pain in extremity, Platelet count, Pyrexia, Thirst
Clinical narrative: Received pneumococcal & Tdap vaccine on 9/30/11. Since then, hot & cold, body aches, arm pain with increased redness, swelling & pain. Elevated WBC, fever, increased thirst. Sent from facility to ED and then hospitalized x4 days.
Age: 26.0
Sex: F
Vaccine: HPV4, PPV, TDAP
Symptoms: White blood cell count increased
Clinical narrative: Received pneumococcal & Tdap vaccine on 9/30/11. Since then, hot & cold, body aches, arm pain with increased redness, swelling & pain. Elevated WBC, fever, increased thirst. Sent from facility to ED and then hospitalized x4 days.
Age: 0.44
Sex: M
Vaccine: DTAPIPVHIB, FLU3, PNC13
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Patient had received a flu vaccine at 5 months old. No adverse reactions.
Age: 1.01
Sex: M
Vaccine: FLU3, HIBV, MMR, VARCEL
Symptoms: Rash, Rash erythematous, Scab
Clinical narrative: Mom reports that 10-20 minutes after imms given that the baby developed rash on cheeks. Over the course of 3 hrs the "rash" changed from red spots, to red bumps & then finally the bumps "scabbed over like tiny chicken pox. Imms given at 1200 pm rash had scabbed over by 4pm. No anaphylaxis.
Sex: M
Vaccine: DTAP, FLU3
Symptoms: Injection site cellulitis, Injection site swelling, Pyrexia
Clinical narrative: Swelling of entire (Rt) leg. Dx in ER as cellulitis - IV antibiotic; fever mgmt.
Age: 73.0
Sex: F
Vaccine: FLUX
Symptoms: Chest X-ray, Headache, Immediate post-injection reaction, Malaise, Muscle spasms
Clinical narrative: Directly after receiving the flu shot patient instantly felt sick. Headaches, body aches, cramps, fever. This has been a week with the Sx. Pt received her EMBREL shot the day before getting her flu vx. Tx: Chest x-ray, TYLENOL.
Age: 73.0
Sex: F
Vaccine: FLUX
Symptoms: Pain, Pyrexia
Clinical narrative: Directly after receiving the flu shot patient instantly felt sick. Headaches, body aches, cramps, fever. This has been a week with the Sx. Pt received her EMBREL shot the day before getting her flu vx. Tx: Chest x-ray, TYLENOL.
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Large red, warm, swollen area at injection site, 1 day after injection.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site pruritus, Injection site swelling, Injection site vesicles
Clinical narrative: Injection site felt itchy, became red after a couple days and raised. Feels firm to the touch. Had vesicles at one point.
Age: 0.76
Sex: F
Vaccine: DT
Symptoms: Drug administered to patient of inappropriate age, Wrong drug administered
Clinical narrative: Physician ordered Hep B, medical assistant administered Adult Td in error. Administered to 9 mos. old vaccine intended for ages 7 yrs and above.
Age: 35.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site swelling
Clinical narrative: Pt complain swelling elbow up to shoulder. Per pt. 4 hrs. after the shots (FLUZONE & Pneumo) she had around 3" circle beneath pneumo shot. That night swelling was up to elbow. Then the next morning there was swelling up to shoulder. Pt had ibuprofen, BENADRYL & did cold compress. Told pt to to go MD.
Age: 65.0
Sex: F
Vaccine: FLU3, PPV, VARZOS
Symptoms: Full blood count normal, Injection site erythema, Injection site swelling, Injection site vesicles, Injection site warmth
Clinical narrative: Pt noted increased pain with in hours after injection, pain increased over 24 hrs then redness noted at ZOSTAVAX site, pt used ice, TYLENOL which help some. Pt then came to clinic presented with 13cm x 23cm redness with 5cm x 3cm center of raised blister center - area warm to touch - (L) arm where ZOSTAVAX was given - (R) arm also with redness & swelling at site of PPV/Flu 13cm x 19cm.
Age: 65.0
Sex: F
Vaccine: FLU3, PPV, VARZOS
Symptoms: Pain
Clinical narrative: Pt noted increased pain with in hours after injection, pain increased over 24 hrs then redness noted at ZOSTAVAX site, pt used ice, TYLENOL which help some. Pt then came to clinic presented with 13cm x 23cm redness with 5cm x 3cm center of raised blister center - area warm to touch - (L) arm where ZOSTAVAX was given - (R) arm also with redness & swelling at site of PPV/Flu 13cm x 19cm.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Redness, quarter size swelling (lil bigger) to (L) arm. TYLENOL for pain & cool compresses.
Age: 9.0
Sex: M
Vaccine: IPV
Symptoms: Blood test, Body temperature increased, Culture throat negative, Headache, Lymphadenopathy
Clinical narrative: Patient received an IPV on 11/16/11 with no adverse events following injection. On 12-11-11 he developed headache, neck pain, temp of 105 and swollen neck glands. Sx continued thru 12-13-11. Throat culture was negative. Dr suspected virus but advised H.D. be contacted re: IPV reaction.
Age: 9.0
Sex: M
Vaccine: IPV
Symptoms: Neck pain, Viral infection
Clinical narrative: Patient received an IPV on 11/16/11 with no adverse events following injection. On 12-11-11 he developed headache, neck pain, temp of 105 and swollen neck glands. Sx continued thru 12-13-11. Throat culture was negative. Dr suspected virus but advised H.D. be contacted re: IPV reaction.
Age: 79.0
Sex: M
Vaccine: FLU3
Symptoms: Hypoaesthesia, Neuropathy peripheral
Clinical narrative: After receiving FLUVIRIN on 10/5/11 - next day stood up from sitting and foot had no feeling - ER MD said was vaccine related neuropathy.
Age: 2.0
Sex: M
Vaccine: FLU3
Symptoms: Blood glucose normal, Chest X-ray, Dyspnoea, Full blood count normal, Respiratory tract congestion
Clinical narrative: 12-12-11 - Middle of night - awoke with chest congestion, difficulty breathing, seizure-like episode lasting several minutes. To Emergency Rm. evaluated. Admitted on 12-13-11 for observation; discharged home on 12-14-11.
Age: 2.0
Sex: M
Vaccine: FLU3
Symptoms: Seizure like phenomena, White blood cell count normal
Clinical narrative: 12-12-11 - Middle of night - awoke with chest congestion, difficulty breathing, seizure-like episode lasting several minutes. To Emergency Rm. evaluated. Admitted on 12-13-11 for observation; discharged home on 12-14-11.
Age: 1.02
Sex: M
Vaccine: DTAP, HIBV, MMR, PNC13, VARCEL
Symptoms: Blister, Cellulitis, Erythema, Induration, Rash maculo-papular
Clinical narrative: Lesion formed size of quarter maculopapular water-filled blister with some scabbing with induration erythema with cellulitis. Given cephalexin x 10 days.
Age: 1.02
Sex: M
Vaccine: DTAP, HIBV, MMR, PNC13, VARCEL
Symptoms: Scab, Skin lesion
Clinical narrative: Lesion formed size of quarter maculopapular water-filled blister with some scabbing with induration erythema with cellulitis. Given cephalexin x 10 days.
Age: 77.0
Sex: M
Vaccine: FLU3
Symptoms: Electromyogram, Guillain-Barre syndrome, Lumbar puncture, Muscular weakness, Nerve conduction studies
Clinical narrative: Developed weakness in extremities at 11 days after flu vaccine. Neurology diagnosed patient w/ Guillain Barre Syndrome. Undergoing PT per Neurology.
Age: 65.0
Sex: U
Vaccine: MMRV
Symptoms: Incorrect route of drug administration, No adverse event, Wrong drug administered
Clinical narrative: Information has been received from a medical assistant concerning a 65 year old patient who on 23-MAR-2011 was vaccinated with a 0.5 ml dose of PROQUAD (Merck), intramuscularly. (Lot number 667187/1413Z). The health professional reported that the patient was administered PROQUAD (Merck) instead of MMR II. No adverse effects were reported. Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: HEPA, IPV, MNQ, YF
Symptoms: Pain, Rash vesicular
Clinical narrative: Vesicular rash on (R) palm, wrist, middle finger/painful. Dx: ? shingles - Dx 12/9. Recheck on 12/12 - pain & slight worsening - tx with NEURONTIN & doxycycline. Rash not yet resolved but not worsening.
Age: 5.0
Sex: F
Vaccine: MMRV
Symptoms: Activities of daily living impaired, Exposure to communicable disease, Headache, Rash, Rash pruritic
Clinical narrative: Information has been received from a registered nurse (R.N.) concerning a 12 year old female patient with milk allergy and no pertinent medical history reported, who on 12-MAR-2003 was vaccinated subcutaneously in the left thigh with a dose of VARIVAX (Merck) (Lot # 644565/1149M, expiration date unknown) and on 21-SEP-2006 was vaccinated subcutaneously in the right deltoid with a dose of PROQUAD (Merck) (Lot # 655140/0832F, expiration date unknown). No concomitant medication was reported. It was reported that now the patient had breakthrough chickenpox and on 21-MAR-2011 experienced an itchy rash on face, arms and chest. Also the patient had a headache off and on for one day (specific date unknown). The patient was afebrile. It was reported that the patient had exposure to children at school that had chickenpox. It was unknown if these children at school were vaccinated. The patient was instructed to stay out of school until no new lesions or the lesions had crusted over. Patient was treated with BENADRYL over the counter as needed, TYLENOL as needed, calamine or hydrocortisone as needed for itching. No labs were performed. Patient sought medical attention (office visit). At the time of reporting the patient was recovering. Follow up information has been received from a physician concerning the now 10 year old female patient with no illness at time of vaccination who on 12-MAR-2003 at 15:45 was vaccinated subcutaneously in the left anterior thigh with the first dose of VARIVAX (Merck) (Lot # 644565/1149M, expiration date unknown) and on 21-SEP-2006 at 16:00 was vaccinated subcutaneously in the right deltoid with a dose of PROQUAD (Merck) (Lot # 655140/0832F, expiration date unknown). It was reported that on 22-MAR-2011 the patient had varicella disease breakthrough despite 2 doses of varicella vaccine (Merck). The patient recovered on an unknown date. This is one of several reports received from the same source regarding siblings (WAES# 1105USA02388). Additional information is not expected.
Age: 5.0
Sex: F
Vaccine: MMRV
Symptoms: Skin lesion, Varicella post vaccine
Clinical narrative: Information has been received from a registered nurse (R.N.) concerning a 12 year old female patient with milk allergy and no pertinent medical history reported, who on 12-MAR-2003 was vaccinated subcutaneously in the left thigh with a dose of VARIVAX (Merck) (Lot # 644565/1149M, expiration date unknown) and on 21-SEP-2006 was vaccinated subcutaneously in the right deltoid with a dose of PROQUAD (Merck) (Lot # 655140/0832F, expiration date unknown). No concomitant medication was reported. It was reported that now the patient had breakthrough chickenpox and on 21-MAR-2011 experienced an itchy rash on face, arms and chest. Also the patient had a headache off and on for one day (specific date unknown). The patient was afebrile. It was reported that the patient had exposure to children at school that had chickenpox. It was unknown if these children at school were vaccinated. The patient was instructed to stay out of school until no new lesions or the lesions had crusted over. Patient was treated with BENADRYL over the counter as needed, TYLENOL as needed, calamine or hydrocortisone as needed for itching. No labs were performed. Patient sought medical attention (office visit). At the time of reporting the patient was recovering. Follow up information has been received from a physician concerning the now 10 year old female patient with no illness at time of vaccination who on 12-MAR-2003 at 15:45 was vaccinated subcutaneously in the left anterior thigh with the first dose of VARIVAX (Merck) (Lot # 644565/1149M, expiration date unknown) and on 21-SEP-2006 at 16:00 was vaccinated subcutaneously in the right deltoid with a dose of PROQUAD (Merck) (Lot # 655140/0832F, expiration date unknown). It was reported that on 22-MAR-2011 the patient had varicella disease breakthrough despite 2 doses of varicella vaccine (Merck). The patient recovered on an unknown date. This is one of several reports received from the same source regarding siblings (WAES# 1105USA02388). Additional information is not expected.
Age: 19.0
Sex: M
Vaccine: HEP, MNQ, TDAP
Symptoms: Pallor, Syncope
Clinical narrative: Pt. became pale, and then fainted - after last vaccine was given (approx 5 min - after last given). Had pt. lay down. B.P. 124/71, pulse reg. 70 at 11:25. Gave juice & crkrs. At 11:32 B.P. 131/78 P. 80.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Cough, Dysphagia, Dysphonia, Pyrexia, Respiratory tract congestion
Clinical narrative: Per mom the child had fever, congestion, hoarseness, and kept on coughing, slight trouble in swallowing but no trouble breathing. Mom gave medicine from another country which included an antihistamine.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site reaction, Scratch
Clinical narrative: Information has been received from a Registered Nurse concerning a 5 year old female patient with no medical history or drug allergies, who on 05-APR-2011 was vaccinated with a dose of PROQUAD (Merck) (lot# 666752/0542Z, expiration date 07-OCT-2011) possibly via intramuscular route. Concomitant therapy included (reported as "DTaP IPV combination") on the same day. On 07-APR-2011 the patient developed redness at the site of injection. The patient's mother sent the nurse the photo of the child's injection site and the nurse noticed the approximately 2 inches diameter of redness with "scratch marks". No labs/diagnostics studies were performed. At the time of reporting, the patient's injection site redness with "scratch mark" persisted. The patient was not given treatment for the event. The patient sought unspecified medical attention. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: FLU3, HPV4, MNQ
Symptoms: Dyskinesia, Immediate post-injection reaction, Unresponsive to stimuli
Clinical narrative: HPV vaccine administered to left arm while patient sitting on exam table. Patient immediately leaned forward and was unresponsive. Patient was assisted to supine position. Involuntary movement noted of bilateral arms & legs. Lasting a few seconds. MD called for with prompt response and patient responsive at this time.
Age: 1.51
Sex: F
Vaccine: DTAP, FLUX, HEPA, MMRV
Symptoms: Varicella
Clinical narrative: Information has been received from a registered nurse concerning an 18 month old female patient with no known drug reactions, allergies and medical history who on 16-APR-2007, was vaccinated with the first dose of PROQUAD (Merck) (lot number, dose and site of administration not reported) and the second dose on 17-OCT-2007 of PROQUAD (Merck) (Lot number 657782/0612U, expiration date: 05-OCT-2008), subcutaneously (dose not reported). Secondary suspect vaccines also included Hepatitis A vaccine (manufacturer unknown) and influenza vaccine (manufacturer unknown) administered the same day of the second dose of PROQUAD (Merck). Concomitant vaccines included "DTaP", on the same date of the second dose of PROQUAD (Merck). On 21-MAR-2011, the patient developed chickenpox. The patient received unspecified medical attention. No treatment was given for the adverse event. No lab diagnostics were performed. At the time of the report, the patient was recovering. Additional information has been requested.
Sex: M
Vaccine: MMRV
Symptoms: Rash generalised
Clinical narrative: Information has been received from a nurse practitioner concerning a male patient, with no pertinent medical history or drug allergies, who in the year 2000 was vaccinated with a dose of PROQUAD (Merck) (manufacturer unknown), (dose, lot # and route not reported). There was no concomitant medication. The nurse practitioner reported that eleven years ago the patient received a dose of a combination of MMR and varicella (manufacturer unknown) and developed a rash on his body. She did not know if the product was PROQUAD (Merck) but knew that it was the same combination. The patient received the vaccine in another state and the nurse practitioner did not know the name of or contact information for the attending physician at the time. The patient received BENADRYL for the rash and recovered after a few days. No lab diagnostics were performed. No further information is available.
Age: 75.0
Sex: F
Vaccine: FLU3
Symptoms: Chest discomfort, Hypoaesthesia oral
Clinical narrative: FLUZONE given 1230 c/o "lips numb", progressing to "chest tightness" 1238 (no rash or hypotension, no wheezing) EPI given 1240. EMS called.
Age: 0.42
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Death, Pyrexia, Sudden infant death syndrome
Clinical narrative: Patient received vaccines in office on 12/08/2011.  Patient's mother stated he ran a low-grade fever of 100-101 that evening and was treated with Tylenol twice.  No fever after that.  Child passed away on 12/12/2011 of suspected SIDS.
Age: 61.0
Sex: M
Vaccine: FLU3
Symptoms: Pain in extremity, Tendonitis
Clinical narrative: Pt complains of upper arm hurting (tendonitis). I found out from drs office on 12/17/11. She said she was treating him with steroids.
Age: 4.0
Sex: M
Vaccine: DTAP
Symptoms: Decreased appetite, Vomiting
Clinical narrative: Loss of appetite followed by vomiting - multiple episodes. Unable to drink or eat for 20 hours.
Age: 56.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia
Clinical narrative: Shoulder joint pain after administration of flu vaccine. Patient stated that she does have arthritis, but feels this pain is from the vaccination.  Patient's symptoms did not improve and has since gone to see a physician for it.  Patient stated she is in therapy as a result.  She did not state a time course, just that it has been ongoing.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Asthenia, Dizziness, Pallor, Staring, Unresponsive to stimuli
Clinical narrative: Pt. Stood and became weak. Pale. Dizzy. Stare. Unable to tell nurse name or where she was. Assisted to chair by nurse. Ammonia capsule used and pt immediately able to respond to name and location. Pediatrician called for assesssment of child. Mom verbalizes child has history of light headedness when standing up too fast.
Age: 59.0
Sex: U
Vaccine: FLUN3
Symptoms: Allergic respiratory symptom, Rhinorrhoea, Sneezing
Clinical narrative: I was given the FLUMIST about 2:30 PM on Thurs. Dec 1st; after that I went home. I knew I had had a reaction from the injection over 10 yrs ago, but I said I was willing to try the nasal mist. Within several minutes, my nose started with allergic symptoms - running & some sneezing. I left about 3 PM, and they got worse on the way home. As the drippage was going down the back of my throat, I could feel the back of my throat.
Age: 15.0
Sex: F
Vaccine: HPV2
Symptoms: Abdominal pain
Clinical narrative: This case was reported by a physician, via a GSK representative, and described the occurrence of abdominal pain in a 15-year-old female subject who was vaccinated with CERVARIX (GlaxoSmithKline). On an unspecified date in the 2nd week of May (year unknown) the subject received 1st dose of CERVARIX (unknown route, unknown arm). A few hours after vaccination with CERVARIX, the subject experienced "severe" abdominal pain. At the time of reporting the event was resolved. The physician called the CDC and was told to restart the series with GARDASIL.
Age: 4.0
Sex: F
Vaccine: MMRV
Symptoms: Rash morbilliform, Rash vesicular
Clinical narrative: Information has been received from a family member concerning an "approximately 4 year old" female patient who on approximately 04-MAY-2011 ("about 12 days ago") was vaccinated subcutaneously with the first 0.5ml dose of PROQUAD (Merck) (lot # not reported). The consumer reported that on 16-MAY-2011 the patient "broke out in a measles or chickenpox like rash on the face and back." The patient sought unspecified medical attention. At the time of reporting, the patient did not recover. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Convulsion
Clinical narrative: Information has been received from GlaxoSmithKline and was assigned manufacturer report number: 2011-05840, concerning patients who on unspecified dates were vaccinated with doses of PROQUAD (Merck). There was an issue with seizures, so they went back to use MMR II separate from VARIVAX (Merck). At the time of reporting, the patients' outcomes were unknown. It was unspecified if the patients had sought medical attention. Upon internal interview, the seizures were determined to be other important medical events. This was originally reported by a physician. No further information is available.
Age: 4.0
Sex: M
Vaccine: MMRV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Information has been received from a nurse practitioner concerning a 4 year old male with no pertinent medical history and no drug allergy who on 06-JUN-2011 was vaccinated with the first dose of PROQUAD (Merck) (dose and route not reported, lot# 664339/0182Z). Concomitant therapy included DTaP-Polio. On 07-JUN-2011 the patient experienced injection site reaction after his first vaccination with PROQUAD (Merck). The site was swollen and red. The reaction was 3.75cm x 2.25cm in size. No rash. The patient was seen in the office on 09-JUN-2011 and was given BENADRYL and cool compresses. No lab diagnostics study was performed. At the time of reporting, the patient was recovering. Follow up information has been received from the nurse practitioner concerning a 4 year old male with gluten hypersensitivity who on 08-JUN-2011 experienced erythema with edema to injection site. On 09-JUN-2011, reaction site measured 3.75cm x 2.25cm on right thigh. The patient required doctor visit. On an unknown date, the patient recovered. Additional information is not expected.
Age: 15.0
Sex: M
Vaccine: MMRV
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Information has been received from a health professional concerning a 15 year old male who had already vaccinated with two doses of MMR II, 0.5ml subcutaneously injection prior to receiving a dose of PROQUAD (Merck) on 04-APR-2011 when the patient was given a dose of PROQUAD (Merck) instead of a dose of VARIVAX (Merck). Healthcare worker did not know the dates of administration of the two doses of MMR II. It was unknown if the patient sought medical attention. No adverse effects reported. Additional information has been requested.
Age: 1.0
Sex: F
Vaccine: MMRV
Symptoms: Pyrexia, Rash generalised, Vomiting
Clinical narrative: Information has been received from a registered nurse concerning her daughter, a 12 month old female with eczema and no drug reactions/allergies who on 14-JUL-2011 was vaccinated with the first dose of PROQUAD (Merck) (Lot # not reported). There was no concomitant medication. On 17-JUL-2011 the patient developed generalized rash. On 20-JUL-2011 the patient started intermittent fever. On 22-JUL-2011 the patient vomited. On 23-JUL-2011 the patient was seen by physician who described the rash as generalized, non-vesicular, and possibly viral in origin. No lab diagnostics study performed. No treatment given. At the time of reporting, the patient had not recovered. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV2
Symptoms: Dyskinesia, Gaze palsy, Hypoaesthesia, Musculoskeletal stiffness
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of arm numbness in a 18-year-old female subject who was vaccinated with CERVARIX (GlaxoSmithKline). Concurrent medical conditions included acne. Concurrent medications included BENZAMYCIN and CETAPHIL soap. On 16 June 2011 at 12:45 the subject received 1st dose of CERVARIX at 0.5 ml in the left arm. On 16 June 2011, 5 minutes after vaccination with CERVARIX, the subject experienced left arm numbness, eyes rolled back, stiffness and body jerks. It was reported that the subject was given oxygen and was laid down and her symptoms resolved.
Age: 12.0
Sex: F
Vaccine: HPV2, MNQ, TDAP
Symptoms: Dizziness, Nausea
Clinical narrative: This case was reported by a physician and a healthcare professional, via a GSK representative, and described the occurrence of nausea in a 12-year-old female subject who was vaccinated with CERVARIX (GlaxoSmithKline). Concurrent vaccination included MENACTRA (non-gsk); Sanofi Pasteur MSD given on 14 July 2011; ADACEL (non-gsk); Sanofi Pasteur MSD given on 14 July 2011. On 14 July 2011 (in the morning) the subject received 1st dose of CERVARIX (.5 ml, unknown route, right arm). On 14 July 2011, "a few minutes" after vaccination with CERVARIX, the subject experienced nausea and dizziness. The physician considered the events were clinically significant (or requiring intervention). On 14 July 2011, the events were resolved after a "short time" with the subject lying supine and drinking some water. Her blood pressure had been monitored. The physician considered the events were possibly related to vaccination with CERVARIX. Follow-up information was received via the physician on 10 August 2011. The subject's date of last menstrual period was 13 July 2011. She was not pregnant at the time of adverse events. Nausea and dizziness resolved on the day of CERVARIX administration, 14 July 2011, and no additional details were provided.
Age: 35.0
Sex: F
Vaccine: RUB
Symptoms: Arthritis
Clinical narrative: Information has been received from a doctor of pharmacy concerning a current 67 year old female patient with asthma, penicillin and sulfa allergy who, when she was approximately 35 year old "30 some years ago" was vaccinated with a dose of Rubella vaccine (manufacturer unknown) (Lot # and route not reported) and experienced severe arthritis type reaction that lasted for 6 months. On an unspecified date, the patient had recovered. Additional information has been requested.
Age: 13.0
Sex: M
Vaccine: MMRV
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Information has been received from a registered nurse concerning a 13 year old male patient who on an unspecified date was vaccinated with a dose of PROQUAD (Merck) (Lot # not provided), "back to school dose required by the state", instead of VARIVAX (Merck). It was reported that the patient had not experienced any known symptoms. It was unknown if the patient sought medical attention. This is one of several reports received from the same source. Additional information has been requested.
Age: 13.0
Sex: M
Vaccine: MMRV
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Information has been received from a registered nurse concerning a male patient who on an unspecified date was vaccinated with a dose of PROQUAD (Merck) (Lot # not provided), "back to school dose required by the state", instead of VARIVAX (Merck). It was reported that the patient had not experienced any known symptoms. It was unknown if the patient sought medical attention. This is one of several reports received from the same source. Additional information has been requested.
Sex: F
Vaccine: RUB
Symptoms: Hypersensitivity
Clinical narrative: Information has been received from a female consumer reporting on herself who on an unspecified date was vaccinated with a dose of MERUVAX II (Lot# and expiration not reported). Consumer reported that she had a hypersensitivity reaction after getting MERUVAX II over 20 years ago. It was unspecified if the patient sought medical attention. The outcome of the patient was unknown. No further information is available.
Age: 11.0
Sex: F
Vaccine: HPV2
Symptoms: Dysmenorrhoea
Clinical narrative: This case was reported by a healthcare professional via a sales representative and described the occurrence of menstrual cramping/pain in a 11-year-old female subject who was vaccinated with CERVARIX (GlaxoSmithKline). In February 2011 the subject received 1st dose of CERVARIX (unknown). Less than one year after vaccination with CERVARIX, and starting at some unspecified time prior to receiving the 2nd dose of CERVARIX on 28 April 2011, the subject developed painful menstrual cramps. The painful menstrual cramps continued following the 2nd dose of CERVARIX and were unresolved at the time of reporting. No further details were provided.
Age: 23.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Red round warm 1 in by 1 in round circumscribed area where immunization was given.
Age: 75.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Asthenia, Decreased appetite, Dysuria, Feeling hot, Headache
Clinical narrative: Evening of injection felt swelling, fever, pain, and warmth in entire right arm, headache difficulty urinating, loss of appetite extreme overall weakness.
Age: 75.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Injection site pain, Injection site swelling, Injection site warmth, Oedema peripheral, Pain in extremity
Clinical narrative: Evening of injection felt swelling, fever, pain, and warmth in entire right arm, headache difficulty urinating, loss of appetite extreme overall weakness.
Age: 75.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Pyrexia
Clinical narrative: Evening of injection felt swelling, fever, pain, and warmth in entire right arm, headache difficulty urinating, loss of appetite extreme overall weakness.
Age: 59.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Dyspnoea, Hypoaesthesia, Impaired work ability, Lethargy, Oedema peripheral
Clinical narrative: Painful, swollen right arm, numbness, lethargy, inability to work following day, some difficulty breathing - pt did not seek treatment.
Age: 59.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Pain in extremity
Clinical narrative: Painful, swollen right arm, numbness, lethargy, inability to work following day, some difficulty breathing - pt did not seek treatment.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Hyperhidrosis, Nausea, Vomiting
Clinical narrative: 30 minutes post injection patient broke out into a sweat.  Minutes after that patient was vomiting.  Repeated 30 minutes later.  Resolved.  Then was nauseous.
Age: 0.19
Sex: M
Vaccine: DPP
Symptoms: Crying, Erythema, Injection site discolouration, Injection site mass, Screaming
Clinical narrative: Received shot around 10:00 am. Around 1:45 pm woke up from nap screaming. Couldn't be comforted. Administered Pedia Care Acetaminophen for pain. Didn't work. Had golf ball sized knot where the injection was administered. Purple circle are site about an inch in diameter. Red patch, hot to the touch, about 4 inches in diameter.
Age: 0.19
Sex: M
Vaccine: DPP
Symptoms: Skin warm
Clinical narrative: Received shot around 10:00 am. Around 1:45 pm woke up from nap screaming. Couldn't be comforted. Administered Pedia Care Acetaminophen for pain. Didn't work. Had golf ball sized knot where the injection was administered. Purple circle are site about an inch in diameter. Red patch, hot to the touch, about 4 inches in diameter.
Age: 0.67
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Body temperature increased, Dyspnoea, Nasal congestion, Poor quality sleep
Clinical narrative: Clear nasal congestion. Difficulty breathing through nose. 99.3 temp. Can't sleep well, due to congestion.
Age: 10.0
Sex: M
Vaccine: FLU3
Symptoms: Cold sweat, Convulsion, Head injury, Loss of consciousness, Skin warm
Clinical narrative: Pt passed out, hit back of head & had a seizure approx 5 min post vaccination. Seizure lasted <1min. Pt's mother states they had been traveling that day or the day before and had been a long day for them.  Also mentioned that patient had been eating a lot of sugary foods recently.  Pt vomited approx 5 min after seizure & had warm clammy skin.  Left clinic with instructions to follow up immediately with pediatrician's call service and go to ER for follow up.
Age: 10.0
Sex: M
Vaccine: FLU3
Symptoms: Vomiting
Clinical narrative: Pt passed out, hit back of head & had a seizure approx 5 min post vaccination. Seizure lasted <1min. Pt's mother states they had been traveling that day or the day before and had been a long day for them.  Also mentioned that patient had been eating a lot of sugary foods recently.  Pt vomited approx 5 min after seizure & had warm clammy skin.  Left clinic with instructions to follow up immediately with pediatrician's call service and go to ER for follow up.
Age: 11.0
Sex: F
Vaccine: FLU3, HEPA, HPV4, TDAP, VARCEL
Symptoms: Abdominal pain, Activities of daily living impaired, Gastric emptying study, Impaired gastric emptying, Laboratory test
Clinical narrative: Nausea, abdominal pain, vomiting for several weeks.  Patient has missed 6 weeks of normal activity d/t this illness.  Patient was hospitalized for 7 days.  Patient is now diagnosed with Gastroparesis.  Thought patient caught a virus but realized after several days that something else was wrong.  Realized after a couple of weeks of patient being ill that the symptoms started the day after the vaccine.
Age: 11.0
Sex: F
Vaccine: FLU3, HEPA, HPV4, TDAP, VARCEL
Symptoms: Nausea, Vomiting, X-ray, X-ray gastrointestinal tract
Clinical narrative: Nausea, abdominal pain, vomiting for several weeks.  Patient has missed 6 weeks of normal activity d/t this illness.  Patient was hospitalized for 7 days.  Patient is now diagnosed with Gastroparesis.  Thought patient caught a virus but realized after several days that something else was wrong.  Realized after a couple of weeks of patient being ill that the symptoms started the day after the vaccine.
Age: 24.0
Sex: F
Vaccine: TTOX
Symptoms: Feeling hot, Loss of consciousness, Nausea
Clinical narrative: She donated plasma, then had tetanus shot, went to donor floor to sit and wait 15 min to see if reaction. She was on laptop sent e mail. Logged off. Started feeling hot, nauseated, got up and went to counter to tell staff, staff went to get nurse, staff got back, she was no longer at counter but had passed out on floor. She also states she has not eaten anything since 7pm 12/18/11.
Age: 0.19
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5, DTAP, HEP, HIBV, IPV, PPV, RVX
Symptoms: Dyskinesia, Electroencephalogram, Infantile spasms, Irritability, Nuclear magnetic resonance imaging
Clinical narrative: Child fussy evening post vaccine adm. On about 7-10 days later he had jerking of right cheek for few seconds occurring several times a day. Lasted 1-2 weeks with increased intervals and symptoms lasting for longer times. Saw neurologist who diagnosed Focal Seizures and ordered Trileptal medication Bid. In late Sept, one month later, childs hands and arms jerked along with facial symptoms. Referred to  Hospital Neurologist who diagnosed Infantile Spasms and prescribed Vigabatrin 5mg Bid along with the Trileptal.  Child has had no seizures for 2 months and so on 12/5 Neurologist stated he could continue all shots and sent along a Rx.
Age: 0.19
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5, DTAP, HEP, HIBV, IPV, PPV, RVX
Symptoms: Partial seizures
Clinical narrative: Child fussy evening post vaccine adm. On about 7-10 days later he had jerking of right cheek for few seconds occurring several times a day. Lasted 1-2 weeks with increased intervals and symptoms lasting for longer times. Saw neurologist who diagnosed Focal Seizures and ordered Trileptal medication Bid. In late Sept, one month later, childs hands and arms jerked along with facial symptoms. Referred to  Hospital Neurologist who diagnosed Infantile Spasms and prescribed Vigabatrin 5mg Bid along with the Trileptal.  Child has had no seizures for 2 months and so on 12/5 Neurologist stated he could continue all shots and sent along a Rx.
Age: 0.19
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5, DTAP, HEP, HIBV, IPV, PPV, RVX
Symptoms: Abnormal behaviour, Crying, Decreased appetite, Electroencephalogram, Facial asymmetry
Clinical narrative: Child fussy evening post vaccine adm. On about 7-10 days later he had jerking of right cheek for few seconds occurring several times a day. Lasted 1-2 weeks with increased intervals and symptoms lasting for longer times. Saw neurologist who diagnosed Focal Seizures and ordered Trileptal medication Bid. In late Sept, one month later, childs hands and arms jerked along with facial symptoms. Referred to  Hospital Neurologist who diagnosed Infantile Spasms and prescribed Vigabatrin 5mg Bid along with the Trileptal.  Child has had no seizures for 2 months and so on 12/5 Neurologist stated he could continue all shots and sent along a Rx.
Age: 0.19
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5, DTAP, HEP, HIBV, IPV, PPV, RVX
Symptoms: Infantile spasms, Irritability, Movement disorder, Nuclear magnetic resonance imaging brain, Partial seizures
Clinical narrative: Child fussy evening post vaccine adm. On about 7-10 days later he had jerking of right cheek for few seconds occurring several times a day. Lasted 1-2 weeks with increased intervals and symptoms lasting for longer times. Saw neurologist who diagnosed Focal Seizures and ordered Trileptal medication Bid. In late Sept, one month later, childs hands and arms jerked along with facial symptoms. Referred to  Hospital Neurologist who diagnosed Infantile Spasms and prescribed Vigabatrin 5mg Bid along with the Trileptal.  Child has had no seizures for 2 months and so on 12/5 Neurologist stated he could continue all shots and sent along a Rx.
Age: 0.19
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5, DTAP, HEP, HIBV, IPV, PPV, RVX
Symptoms: Posture abnormal, Shock, Skin warm, Vaccine positive rechallenge
Clinical narrative: Child fussy evening post vaccine adm. On about 7-10 days later he had jerking of right cheek for few seconds occurring several times a day. Lasted 1-2 weeks with increased intervals and symptoms lasting for longer times. Saw neurologist who diagnosed Focal Seizures and ordered Trileptal medication Bid. In late Sept, one month later, childs hands and arms jerked along with facial symptoms. Referred to  Hospital Neurologist who diagnosed Infantile Spasms and prescribed Vigabatrin 5mg Bid along with the Trileptal.  Child has had no seizures for 2 months and so on 12/5 Neurologist stated he could continue all shots and sent along a Rx.
Age: 39.0
Sex: M
Vaccine: FLU3
Symptoms: Activities of daily living impaired, Arthralgia, Body temperature increased, Chills, Cough
Clinical narrative: Achy joints, malaise, chills, as this progressed during the week day, barking cough (yellow sputum), temperature 102.4, sore throat, hoarse voice, missed a day of work. Cough still persist as of this report 12/19/11.
Age: 39.0
Sex: M
Vaccine: FLU3
Symptoms: Dysphonia, Malaise, Oropharyngeal pain, Productive cough, Sputum discoloured
Clinical narrative: Achy joints, malaise, chills, as this progressed during the week day, barking cough (yellow sputum), temperature 102.4, sore throat, hoarse voice, missed a day of work. Cough still persist as of this report 12/19/11.
Age: 3.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site mass, Injection site pain
Clinical narrative: Hard red lump formed at the site of injection, approximately the size of a quarter or slightly larger formed. Patient complained of pain at the site.
Age: 17.0
Sex: F
Vaccine: HPV2
Symptoms: Injection site erythema, Injection site swelling, Malaise
Clinical narrative: This case was reported by a physician and described the occurrence of injection site redness in a 17-year-old female subject who was vaccinated with CERVARIX (GlaxoSmithKline). Concurrent vaccination included HAVRIX; GlaxoSmithKline; unknown; unknown given on an unspecified date. There were no concurrent medications. On 28 June 2011 and 10 September 2011 the subject received 1st dose and 2nd dose of CERVARIX (unknown, left arm). On 28 June 2011, less than one day after vaccination with CERVARIX, the subject experienced injection site redness, swelling injection site and not feeling well. The subject did not feeling well for one day after the injection (details no provided). The subject improved. On an unspecified date in September 2011, within one week after the 2nd dose of CERVARIX, the subject experienced not feeling well for four days. The subject also experienced injection site redness and swelling injection site. At the time of reporting the injection site redness and swelling injection site were improved; not feeling well resolved. The physician considered the events of injection site redness, swelling injection site and not feeling well were probably related to vaccination with CERVARIX.