chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: ADEN_4_7, FLU3, IPV, MNQ, TDAP
Symptoms: Allergy test negative, Anaphylactic shock, Blood immunoglobulin E normal, Hypersensitivity, Laboratory test normal
Clinical narrative: A report was received from an observational study. This is a Phase IV safety study using Adenovirus Type 4 and Type 7 Vaccine, Live, Oral. This report is based on data abstracted from a retrospective review. This report is a follow up report to the master case 353398USA. A male patient between the ages of 19-24 years patient who experienced other anaphylactic shock, NEC (Serious, since 24-Nov-2011, until 24-Nov-2011) while enrolled in a study. Treatment medications included azithromycin (250mg, 2 tabs weekly for 6 weeks, oral) started on 16-Nov-2011 and stopped on 15-Dec-2011, indication unknown; epinephrine (0.3mg, injection, frequency and indication unknown) started on 24-Nov-2011 and stopped on 07-Dec-2011; prednisone (unknown frequency, dose, units, indication) started on 24-Nov-2011 and stopped on 24-Nov-2011; ZANTAC (unknown frequency, dose, units, indication) started on 24-Nov-2011 and stopped on 24-Nov-2011. Adverse events within 42 days of vaccination: Allergic reaction started on 01-Dec-2011, treated at outpatient visit, treatments medications included non-drug treatment medication included prescription and OTC, severity and seriousness were not assessed, outcome unknown, resolution date 01-Dec-2011; anaphylaxis follow up on 14-Dec-2011, at outpatient visit, treatments medications included non-drug treatment medication included prescription and OTC, severity, seriousness and outcome were not assessed, resolution date 14-Dec-2011. At the time of the report the outcome of the AEs were: Other anaphylactic shock, NEC: recovered/resolved. The medical history of the patient no alcohol or tobacco use within 30 days prior to Adenovirus vaccination. The patient's concomitant medication included Azithromycin (Tablet, Oral, since 16-Nov-2011, until 15-Dec-2011, 2 tabs weekly x 6 weeks, IPV, Diphtheria-tetanus-pertussis vaccine, Influenza vaccine, Meningococcal vaccine. The patient's past medication were unspecified. Action taken with suspect drug: Adenovirus vaccine - Not applicable. Lab tests 07-Dec-2011, Aero allergies-normal, 07-Dec-2011, Apple Ab IgE-normal, 07-Dec-2011, Pumpkin Ab IgE-normal, 07-Dec-2011, Tryptase-normal, 07-Dec-2011, Pulmonary function test-abnormal early obstructive pulmonary impairment. This case was considered serious based on the following criteria: (Other Serious (Important Medical Events). This event was assessed as "unknown" in severity. The medical monitor has assessed the causal relationship of the event as not related to the adenovirus vaccine.
Sex: M
Vaccine: ADEN_4_7, FLU3, IPV, MNQ, TDAP
Symptoms: Obstructive airways disorder, Pulmonary function test abnormal, Tryptase
Clinical narrative: A report was received from an observational study. This is a Phase IV safety study using Adenovirus Type 4 and Type 7 Vaccine, Live, Oral. This report is based on data abstracted from a retrospective review. This report is a follow up report to the master case 353398USA. A male patient between the ages of 19-24 years patient who experienced other anaphylactic shock, NEC (Serious, since 24-Nov-2011, until 24-Nov-2011) while enrolled in a study. Treatment medications included azithromycin (250mg, 2 tabs weekly for 6 weeks, oral) started on 16-Nov-2011 and stopped on 15-Dec-2011, indication unknown; epinephrine (0.3mg, injection, frequency and indication unknown) started on 24-Nov-2011 and stopped on 07-Dec-2011; prednisone (unknown frequency, dose, units, indication) started on 24-Nov-2011 and stopped on 24-Nov-2011; ZANTAC (unknown frequency, dose, units, indication) started on 24-Nov-2011 and stopped on 24-Nov-2011. Adverse events within 42 days of vaccination: Allergic reaction started on 01-Dec-2011, treated at outpatient visit, treatments medications included non-drug treatment medication included prescription and OTC, severity and seriousness were not assessed, outcome unknown, resolution date 01-Dec-2011; anaphylaxis follow up on 14-Dec-2011, at outpatient visit, treatments medications included non-drug treatment medication included prescription and OTC, severity, seriousness and outcome were not assessed, resolution date 14-Dec-2011. At the time of the report the outcome of the AEs were: Other anaphylactic shock, NEC: recovered/resolved. The medical history of the patient no alcohol or tobacco use within 30 days prior to Adenovirus vaccination. The patient's concomitant medication included Azithromycin (Tablet, Oral, since 16-Nov-2011, until 15-Dec-2011, 2 tabs weekly x 6 weeks, IPV, Diphtheria-tetanus-pertussis vaccine, Influenza vaccine, Meningococcal vaccine. The patient's past medication were unspecified. Action taken with suspect drug: Adenovirus vaccine - Not applicable. Lab tests 07-Dec-2011, Aero allergies-normal, 07-Dec-2011, Apple Ab IgE-normal, 07-Dec-2011, Pumpkin Ab IgE-normal, 07-Dec-2011, Tryptase-normal, 07-Dec-2011, Pulmonary function test-abnormal early obstructive pulmonary impairment. This case was considered serious based on the following criteria: (Other Serious (Important Medical Events). This event was assessed as "unknown" in severity. The medical monitor has assessed the causal relationship of the event as not related to the adenovirus vaccine.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Urticaria
Clinical narrative: Pt says she has welts on each side of her belly button similar area to where she had shingles rash last year.
Sex: F
Vaccine: FLU3, MNQ, TDAP
Symptoms: Encephalitis post immunisation, Encephalomyelitis
Clinical narrative: A report was received from an observational study. This is a Phase IV safety study using Adenovirus Type 4 and Type 7 Vaccine, Live, Oral. This report is based on data abstracted from a retrospective review. This report is a follow up report to the master case 353238USA. A female patient between the ages of 19-24 years, who experienced encephalitis and encephalomyelitis following immunization procedures (confirmed) (Serious, since 18-Feb-2012, until 23-Feb-2012) while enrolled in a study. The patient was an active recruit. Adenovirus vaccine was administered on 12-Dec-2011. The patient was seen in outpatient visit, treatment medications included prescription and OTC; diphenhydramine (25mg, QID, oral) started on 19-Feb-2012, stopped on 21-Feb-2012 for immunization reaction; sulfamethoxazole/trimethoprim (800/160mg, BID, oral) started on 21-Feb-2012, stopped on 02-Nov-2012 for unknown indication; ibuprofen (800mg, QID, oral) started on 21-Feb-2012, stopped on 25-Feb-2012, unknown indication; penicillin G benzathine 600,000 (2 mL, one time, IM) started on 27-Feb-2012, stopped 27-Feb-2012. The patient also received MCV4P on 17-Feb-2012 (lot#U4259AA manufacture PCM), Tdap on 17-Feb-2012 (lot#AC52B074BA manufacture SKB), and influenza on 17-Feb-2012 (lot#UT423AA, manufacture PMC); HAVRIX (hep A-child) on 22-Feb-2012 (lot#AHAVB541DA, manufacture SKB); IPV 22-Feb-2012 (lot#H1305, manufacturer PMC). At the time of the report the outcome of the AEs were: Encephalitis and encephalomyelitis following immunization procedures : recovered/resolved. The medical history of the patient was not specified. The medical history of the patient no alcohol or tobacco use within 30 days prior to Adenovirus vaccination. The patient's concomitant medication influenza vaccine, diphtheria-tetanus-pertussis vaccine, meningococcal vaccine, HAVRIX, IPV. The patient's past medication were unspecified. Action taken with suspect drug: - Not applicable. Lab tests were not reported. This event was assessed as moderate in severity, seriousness not assessed. The medical monitor has assessed the causal relationship of the event as possibly related to the Adenovirus vaccine. This case was considered serious based on the following criteria: medically serious.
Age: 52.0
Sex: F
Vaccine: DTAP
Symptoms: Dizziness, Headache, Musculoskeletal pain, Nausea, Neck pain
Clinical narrative: Headache, day of inj. Excruciating headache, the following morning with dizziness, nausea, neck, arm and shoulder pain.
Age: 52.0
Sex: F
Vaccine: DTAP
Symptoms: Nuclear magnetic resonance imaging, Pain in extremity, Prothrombin time
Clinical narrative: Headache, day of inj. Excruciating headache, the following morning with dizziness, nausea, neck, arm and shoulder pain.
Age: 80.0
Sex: F
Vaccine: PPV
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 28.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Hot flush, Injection site pain, Nausea, Neck pain
Clinical narrative: Approx within 30 minutes of administration, developed moderately-severe arm pain (where vaccine admin), and radiated to neck, and to fingertips. Nausea as well as light-headed, faintness, hot flashes. Resolved mostly by bedtime (1030 pm).
Age: 28.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity, Syncope
Clinical narrative: Approx within 30 minutes of administration, developed moderately-severe arm pain (where vaccine admin), and radiated to neck, and to fingertips. Nausea as well as light-headed, faintness, hot flashes. Resolved mostly by bedtime (1030 pm).
Sex: M
Vaccine: ADEN_4_7, FLU3, HEP, MNQ, TDAP
Symptoms: Anaphylactic shock, Headache
Clinical narrative: A report was received from an observational study. This is a Phase IV safety study using Adenovirus Type 4 and Type 7 Vaccine, Live, Oral. This report is based on data abstracted from a retrospective review. This report is a follow up report to the master case 353398USA. A male patient between the ages of 19-24 years, experienced other anaphylactic shock, NEC (confirmed) (since 21-Dec-2012, resolved on 21-Dec-2012), severity and seriousness were not assessed, while enrolled in a study. The patient was an active recruit. Adenovirus vaccine was administered on 20-Dec-2011. The patient was seen as outpatient visit treatment medications included: ibuprofen (600mg, TID, oral) started on 21-Dec-2012, stopped on 20-Jan-2012 (indication unknown); methylprednisone (62.5mg/mL, once, injection) started on 21-Dec-2012, stopped on 20-Jan-2012 (indication unknown). The patient also received RECOMBIVAX-HB on 20-Dec-2011 (lot#AHABB223DA, manufacture SKB); meningococcal (MCV4P) on 20-Dec-2011 (lot#U4052AD manufacture PCM), tetanus-diphtheria-pertussis (Tdap) on 20-Dec-2011 (lot#AC52B075AA manufacture SKB), and influenza on 20-Dec-2011 (lot#04949221A, manufacture CSL). At the time of the report the outcome of the AEs were: Other anaphylactic shock, NEC: recovered/resolved. Adverse events within 42 days of vaccination: headache F/U started on 22-Dec-2012, stopped on 22-Dec-2011, the patient was seen in outpatient visit, outcome, severity and seriousness were not assessed; headache F/U started on 23-Dec-2012, stopped on 23-Dec-2011, outcome, severity and seriousness were not assessed. The medical history of the patient was not specified. Concomitant medications within 42 days of vaccination: promethazine (25mg, Q6H, oral) started on 23-Dec-2012, stopped on 26-Dec-2012 (indication unknown); azithromycin (250mg, oral) started on 29-Dec-2012, stopped on 03-Jan-2012 (frequency and indication unknown); ibuprofen (800mg, TID, oral) started on 29-Dec-2012, stopped on 05-Jan-2012 (indication unknown). The patient's past medication were unspecified. The medical history of the patient no alcohol or tobacco use within 30 days prior to Adenovirus vaccination. Action taken with suspect drugs: Adenovirus vaccine - Not applicable. Lab tests were not reported. This case was considered serious based on the following criteria: (Other Serious (Important Medical Events)). This event was assessed as "unknown" in severity. The medical monitor has assessed the causal relationship of the event as possibly related to the Adenovirus vaccine.
Sex: M
Vaccine: HIBV, MNQ
Symptoms: Anaphylactic shock
Clinical narrative: A report was received from an observational study. This is a Phase IV safety study using Adenovirus Type 4 and Type 7 Vaccine, Live, Oral. This report is based on data abstracted from a retrospective review. This report is a follow up report to the master case 353398USA. A male patient between the ages of 19-24 years, experienced other anaphylactic shock, NEC (confirmed) (serious, since 01-Feb-2012, until 01-Feb-2012) while enrolled in the study. The patient was hospitalized for IV treatment which included: epinephrine (injection) started on 01-Feb-2012, stopped on 01-Feb-2012 (dose, unit, frequency and indication unknown); SOLU-MEDROL (IV) started on 01-Feb-2012, stopped on 01-Feb-2012 (dose, unit, frequency and indication unknown); BENADRYL (IV) started on 01-Feb-2012, stopped on 01-Feb-2012 (dose, unit, frequency and indication unknown). The patient also received MCV4P on 01-Feb-2012 (lot#U4259AA manufacture PCM), Tdap on 27-Jan-2012 (lot#AC52B075AA manufacture SKB), and influenza on 27-Jan-2012 (lot#UT423AA, manufacture PMC); PEDVAX on 01-Feb-2012 (lot#0231AA, manufacture MSD). At the time of the report the outcome of the AEs were: other anaphylactic shock, NEC: recovered/resolved. The medical history of the patient was not specified. The medical history of the patient no alcohol or tobacco use within 30 days prior to Adenovirus vaccination. Concomitant medications within 42 days of vaccination: calamine lotion (topical) started on 14-Feb-2012, stopped on 10-Mar-2012 (dose, unit, frequency and indication unknown), Influenza Vaccine, DTP vaccine, IPV, Meningococcal Vaccine, PEDVAX-HIB. The patient's past medication were unspecified. Action taken with suspect drugs: Adenovirus Vaccine - not applicable. Lab tests were not reported. This case was considered serious based on the following criteria: (Hospitalization Required, Other Serious  (Important Medical Events)).  This event was assessed as "unknown" in severity. The medical monitor has assessed the causal relationship of the event as not related to the Adenovirus Vaccine.
Age: 58.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Feeling abnormal, Flushing, Neck pain, Pain in extremity
Clinical narrative: Extreme pain in arm into neck, feels flushed, faint, just not feeling right. Pain starts 15 min after injection given.
Age: 20.0
Sex: F
Vaccine: FLUN4
Symptoms: Urticaria
Clinical narrative: Developed hives on arms and legs the day after FLUMIST was given.
Sex: M
Vaccine: ADEN_4_7, FLUN3, HEP, MNQ, TDAP
Symptoms: Anaphylactic shock
Clinical narrative: A report was received from an observational study. This is a Phase IV safety study using Adenovirus Type 4 and Type 7 Vaccine, Live, Oral. This report is based on data abstracted from a retrospective review. This report is a follow up report to the master case 353398USA. A male patient between the ages of 19-24 years experienced Other Anaphylactic Shock, NEC (confirmed), (Serious, since 02-Mar-2012, until 02-Mar-2012) while enrolled in the study, treatment was at outpatient visit, treatment medications included: BENADRYL (50mg, 2Q, oral) started on 02-Mar-2012, stopped on 09-Mar-2012, unknown indications; epinephrine (0.3mg, injection) started on 02-Mar-2012, stopped on 01-Apr-2012, unknown indication; prednisone (20mg, 2QDx2D, oral) started on 02-Mar-2012, stopped on 04-Mar-2012, unknown indication. The patient was an active recruit. Adenovirus vaccine was administered on 29-Feb-2012. The patient also received RECOMBIVAX-HB on 29-Feb-2012 (lot # AHABB23AA, manufacturer SKB); meningococcal (MCV4P) on 29-Feb-2012 (lot#U4259AA manufacturer PCM), Tdap on 29-Feb-2012 (lot#AC52B074AA manufacturer PMC), and influenza (intranasal) on 29-Feb-2012 (lot#YK2207, manufacturer MED). Adverse events within 42 days of vaccination: Anaphylaxis F/U at outpatient visit on 06-Mar-2012, severity not assessed, outcome not resolved on 06-Mar-2012, disability/incapacity seriousness, treated with non-drug treatment medication included prescription and OTC; anaphylaxis F/U outpatient visit, severity not assessed, outcome resolved on 09-Mar-2012, disability/incapacity seriousness, treated with non-drug treatment. At the time of the report the outcome of the AEs were: Other Anaphylactic Shock, NEC: Unknown. The medical history of the patient was not specified. The patient's concomitant medication were unspecified. The patient's past medication were unspecified. The medical history of the patient no alcohol or tobacco use within 30 days prior to Adenovirus vaccination. Action taken with suspect drugs: Adenovirus Type 4 and Type 7 Live Vaccine - Not applicable. Lab tests were not reported. This case was considered serious based on the following criteria: (Other Serious (Important Medical Events). This event was assessed as "unknown" in severity. The medical monitor has assessed the causal relationship of the event as not related to the adenovirus vaccine.
Age: 84.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Pain
Clinical narrative: Started to get severe pain at injection site 3 hrs after injection. Took aspirin and relieved pain a little. Pain worsened 2nd day. By 3rd day better. Reported to me around 5pm 3rd day.
Sex: F
Vaccine: ADEN_4_7, TDAP
Symptoms: Anaphylactic shock, Hypersensitivity
Clinical narrative: A report was received from an observational study. This is a Phase IV safety study using Adenovirus Type 4 and Type 7 Vaccine, Live, Oral. This report is based on data abstracted from a retrospective review. This report is a follow up report to the master case 353398USA. A report of the case of a female, aged 19-24 years old, patient who experienced Other Anaphylactic Shock, NEC (Serious, since 04-Jan-2012, until 04-Jan-2012) while enrolled in the study. Received Adenovirus vaccine 4-Jan-2012, Lot # 34600018. Event start date was 4-Jan-2012 and the patient was hospitalized for complications, which included medications (prescription and OTC and non-drug treatment, Non-drug treatment), severity was not assessed and outcome resolved and seriousness medically serious. Treatment provided: Epinephrine 0.5 mg x2 injection on 04-Jan-2012. Albuterol oral on 4-Jan-2012, SOLU-MEDROL 60 mg IV started 4-Jan-2012, BENADRYL 25 mg IV started 4-Jan-2012, Guaifenesin-Pseudoephrine 600/60 mg orally Q12H started 6-Jan-2012, Prednisone 10 mg 6 tabs x2 days orally started 5-Jan-2012 and last dose 8-Jan-2012, Ibuprofen 200 mg orally PRN started 14-Feb-2012 and last dose 9-Mar-2012, and Oxygen nasal on 4-Feb-2012. Adverse events within 42 days of vaccination: Evaluation for possible vaccination reaction on 13-Jan-2012- Treatment outpatient visit and medication-outcome, severity, seriousness not assessed; Allergic reactions to immunizations on 18-Jan-2012- treatment outpatient visit and medication-outcome, severity, seriousness not assessed; and history of anaphylaxis Tdap/Hep A- Tele consult on 24-Jan-2012-outcome, severity, seriousness not assessed. The patient also received meningococcal (MCV4P) on 30-Dec-2011 (lot#U4259AA manufacturer PMC), Tdap on 4-Jan-2012 (lot#AC52B075AA manufacture SKB) and influenza on 30-Dec-2011 (lot#UT423AA, manufacture PMC) and IPV on 30-Dec-2011 (lot #G1500 manufacture PMC). At the time of the report the outcome of the AEs were: Other Anaphylactic Shock, NEC: recovered/resolved. The medical history of the patient was not specified. The patient's concomitant medication included influenza vaccine, Diphtheria-Tetanus-Pertussis vaccine, IPV, Meningococcal vaccine. The patient's past medication were unspecified. Action taken with suspect drugs: Adenovirus vaccine - not applicable. Lab tests were not reported. This case was considered serious based on the following criteria: (Hospitalization Required, Other Serious (Important Medical Events)). The medical monitor noted that the causality for the case is Possibly Related to the Adenovirus Vaccine.
Age: 5.0
Sex: F
Vaccine: DTAP, MMR, VARCEL
Symptoms: Body temperature increased, Oral candidiasis, Rash generalised
Clinical narrative: 9/3/2013 MMR and VZV given. 9/5/13-9/6-/13 Temp of 104.1, rash on neck and body thrush to tongue. Reported by Mom. 9/7/13 ER visit and treatment.
Age: 11.0
Sex: F
Vaccine: MNQ
Symptoms: Arthralgia, Headache
Clinical narrative: Mom called stating child c/o of joint pain in all joints and headache. Took ibuprofen - improved per following call 9-12/13.
Age: 5.0
Sex: U
Vaccine: MMR
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker who refers to a 5 year old patient of unknown gender. On 29-AUG-2013 the patient was vaccinated with an expired dose of M-M-R II lot # 671320/1121AA (rHA), expiration date 17-JUL-2013. No adverse effect reported. The outcome and action taken were not reported. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker (medical assistant) concerning a patient of unknown age and gender. It was reported that on 30-APR-2012, the patient was vaccinated with the first dose of GARDASIL (lot number, expiry date, dose and route unspecified). On 29-JUN-2012, the patient was vaccinated with the second dose of GARDASIL (lot number, expiry date, dose and route unspecified). On 10-AUG-2012, the patient was vaccinated with the third dose of GARDASIL (lot number, expiry date, dose and route unspecified). On 15-OCT-2012 and on 03-SEP-2013, the patient was vaccinated with the extra doses (fourth and fifth doses respectively) of GARDASIL (lot number, expiry date, dose and route unspecified). No concomitant therapy was reported. No adverse symptoms were reported. Additional information has been requested.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. No information regarding the patient's medical history was provided. On 28-AUG-2013 the patient was vaccinated with ZOSTAVAX, valid lot # 0363AE, subcutaneously, which had been expired on 16-AUG-2013. No concomitant medication was reported. No adverse effect was reported. No outcome was reported. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: FLUN4, MEN, TDAP
Symptoms: Erythema, Local reaction, Skin irritation
Clinical narrative: LOCAL REACTION, REDNESS AND IRRITATION NOTED TO RIGHT ARM.
Sex: U
Vaccine: HPV4
Symptoms: Rash
Clinical narrative: This spontaneous report as received from a physician via company representative refers to a patient of unknown age. On an unknown date the patient was vaccinated with the first dose of GARDASIL (lot# unspecified) and developed a rash after vaccination. The outcome of rash was unknown. Additional information has been requested.
Age: 66.0
Sex: M
Vaccine: FLUX
Symptoms: Chills, Oropharyngeal pain, Pain, Respiratory tract congestion
Clinical narrative: Sore Throat - Congestion - body pains - severe chills & shivering Started letting up in 2 1/2 hours. 1 asprin.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Pyrexia
Clinical narrative: This spontaneous report as received from a nurse refers to a 20 years old female patient. The patient had no pertinent medical history and drug reactions/allergies. On 23-AUG-2013 the patient was vaccinated with her first 0.5ml dose of GARDASIL (lot# J002641, expiry date: 10-DEC-2015), intramuscular at an unspecified location. No concomitant therapy reported. On Friday 23-AUG-2013 the patient who was taking GARDASIL experienced a fever. The reporter stated that the fever was up to 103F over the weekend and the patient took TYLENOL and rested. The patient called the physician's office on Monday 26-AUG-2013, and the fever had resolved on 26-AUG-2013. No lab diagnostics studies performed. Additional information has been requested.
Age: 73.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Depressed level of consciousness, Loss of consciousness
Clinical narrative: Administered vaccine, pt requested receipt, left pt to retrieve paperwork, returned to pt within 5 min and pt appeared unconscious, difficult to arouse, then came around and stared off.  Unable to state where she was, lived, did not recall getting shots. BP was 147/76; called EMS--over 45min period she seemed to become more aware to her surroundings, released to EMS.
Age: 7.0
Sex: F
Vaccine: MMR
Symptoms: Breath sounds abnormal, Gaze palsy, Grunting, Respiration abnormal, Tic
Clinical narrative: Increased "tic" like episodes eg eye rolloing, forced exhalation from nose, phonation or grunting with exhalation.
Age: 1.54
Sex: M
Vaccine: DTAP, HEPA
Symptoms: Feeling abnormal, Muscle twitching
Clinical narrative: "Zoned out" and twitched. 3 separate episodes while father in law & his girl friend were watching (babysitting) him. On 9/6/13 similar espisode (x1) while in the care of mom's girlfriend, but she is not sure if he was just acting afraid because of the new environment and person he was with.
Age: 59.0
Sex: F
Vaccine: FLU3
Symptoms: Anaphylactic reaction, Hypersensitivity, Pruritus, Throat tightness, Urticaria
Clinical narrative: Employee states h/o receiving influenza vaccination 0900hrs 5 Sept 2013, then at approximately 1100hrs she began experiencing a mild pruritis of the skin of her back, then at approximately 2100hrs her pruritis had become severe, with noticable hives and a sensation of her throat closing, at which time she proceeded to the ER. At ER she was evaluated, diagnosed and treated for anaphylaxis/allergic reaction and after stablization she was released from the ER at 0200hrs 6 Sept 2013 with rx's of Benadryl, Medrol dose pak, Atarax, Claritin, and Epi-pen.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Incorrect route of drug administration
Clinical narrative: Zostavax vaccine was given via intramuscular route instead of via subcutaneous route.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Hypersensitivity, Injection site swelling, Injection site warmth
Clinical narrative: Swelling of Left arm at site and down arm next day. Large swelling behind arm where Proquad given. Patient experienced heat coming from site and was taken to emergency room. Emergency Dr. advise to tell us.
Age: 40.0
Sex: F
Vaccine: YF
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Member noticed reaction approximately 1/2" diameter 3 days post injection. Site redness then grew to 3" diameter by 6 days post injection. While deployed reported to Dr who noted "oval shape, erythematuous, tender to palpation, warm".
Age: 3.0
Sex: F
Vaccine: DTAPH
Symptoms: Injection site bruising, Injection site swelling, PFAPA syndrome, Pyrexia, Rash erythematous
Clinical narrative: Large area of bruising and swelling on left arm. Bullseye about two inches in circumference. Fever started on 08/26/13 and lasted for one week (PFAPA) symptoms.
Age: 0.3
Sex: F
Vaccine: PNC13
Symptoms: Hypotonia, Unresponsive to stimuli
Clinical narrative: 15 minutes after receiving Prevnar vaccine mom noted the baby to be limp and unresponsive; no cyanosis or seizure noted. Baby recovered in one minute with tactile stimulation. Examination of baby in office was WNL.
Age: 28.0
Sex: M
Vaccine: ANTH
Symptoms: Arthralgia
Clinical narrative: Painful joints all over body that persisted for nearly a week.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Anger, Anxiety, Confusional state, Crying, Headache
Clinical narrative: Patient experienced headache, confusion, anger and anxiousness. By the end of the evening she was shaky and crying. The next morning 9/5/13 she felt better but still had a headache and confusion.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Tremor
Clinical narrative: Patient experienced headache, confusion, anger and anxiousness. By the end of the evening she was shaky and crying. The next morning 9/5/13 she felt better but still had a headache and confusion.
Age: 12.0
Sex: M
Vaccine: VARCEL
Symptoms: Pyrexia
Clinical narrative: This spontaneous report was received from a physician via company representative refers to a 12 year old male patient. On an uknown date (reported as several weeks ago), the patient was vaccinated with a dose of 2 VARIVAX (Merck) (lot number, expiry date and route was not reported). On an unknown date (reported as within 24 hours post vaccination), the patient spiked a 103 degree fever. The outcome of the event was reported as recovered. Additional information is not expected.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Hypersensitivity, Injection site erythema, Injection site swelling
Clinical narrative: Woke up Saturday 9-7-13 morning after shot's, arm red swollen was taken to ER where they gave her SEPTRA 200mg. The red spot on her arm was 6 inc by 4 inc. She came into our office 9-9-13. Red was gone but in a spot that was 1 inc by 1 1/2 inc. Dr expled it was not cellulitis but a allergic rxn to spot SEPTRA and start Amontolube TID.
Age: 24.0
Sex: M
Vaccine: ANTH
Symptoms: Convulsion, Encephalitis autoimmune, Laboratory test, Muscle twitching
Clinical narrative: Working diagnosis of Limbic encephalitis/NMDA-Ab encephalitis. 24 y/o male with no significant PMH. During p.m. of 22 JUL, while on the computer, patient had a sudden onset of twitching followed by generalized convulsions (witnessed). Patient remains hospitalized at clinic on 30 AUG 2013.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Eye disorder, Hypersensitivity, Injection site mass, Paraesthesia oral, Urticaria
Clinical narrative: This spontaneous report as received from a pharmacist who refers to herself a 50 year old female patient with depression and arthritis. Drug reactions or allergies were not reported. On 27-JUN-2013, the patient was vaccinated with ZOSTAVAX injection (0.65 ml once, lot # H021712, expiration date: 06-MAR-2014) subcutaneous. Concomitant therapies included CYMBALTA, Ibuprofen (manufacturer not provided) and SKELAXIN.  The patient stated my boss gave me the shot then the next day on 28-JUN-2013, patient noticed at bump at injection site within 2 days, a 12 inches diameter welt developed on arm with welts upon welt. The patient also stated my eyes felt funny and lips were tingling. On 28-JUN-2013, the patient went to an unspecified immediate clinic and received a dose of MEDROL and additionally a pack of MEDROL to take home, it was also ordered BENADRYL as needed. The patient stated that the reaction was diagnosed as allergic reaction. She also stated that it took a week (05-JUL-2013) to go down (welts on arm). At the time of the report the patient was doing fine. The causality between the adverse events and the vaccine was unknown.  Additional information has been requested.
Age: 91.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Rash
Clinical narrative: This spontaneous report as received from a consumer refers to herself, a 91 year old female patient with an unspecified lung condition. The patient had no history of drug reactions/allergies. In early July 2013 the patient was vaccinated with a dose of ZOSTAVAX in the upper arm. Lot number, strength, dose and exact vaccination date were not provided. Concomitantly the patient used unspecified blood pressure medication and unspecified medication for the lung condition. A few days after the vaccination the patient developed shingles. She developed a rash on the right side of her tummy and trunk and around to her back. The patient did not state how the diagnosis was made. The patient had not contacted her physician and did not seek medical attention. No lab diagnostic studies were performed. The patient stated the rash hurts. No treatment was provided for the event. The outcome of shingles was unknown. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a nurse refers to an unspecified number of patients of unknown age and gender. The nurse reported that the patient may have received improperly stored GARDASIL (lot #, expiry not reported) between 15-AUG-2013 to present 06-SEP-2013 (exact dates of administration unspecified). No adverse event reported. Additional information is not expected.
Age: 1.32
Sex: M
Vaccine: VARCEL
Symptoms: Antibody test negative, Blister, Rash, Varicella virus test negative
Clinical narrative: This spontaneous report was received from a physician refers to an approximately 15 month old male patient with downs syndrome. The patient had no drug allergies. On 15-FEB-2006, the patient was vaccinated with a first dose of VARIVAX (Merck) (lot number, expiry date and route was not reported). On 16-FEB-2005 (reported as within a day of receiving his first dose of VARIVAX), the patient developed horrendous rash with more than 20 vesicles. On an unknown date, the patients titer for varicella was negative. There was no treatment rendered for the events. The outcome of horrendous rash with more than 20 vesicles was reported as recovered. The outcome of titer for varicella was negative was unknown. The patient sought medical attention. Additional information has been requested.
Age: 3.0
Sex: F
Vaccine: FLUN4
Symptoms: Lip swelling, Urticaria
Clinical narrative: Swollen lips hives gave BENADRYL - helped, hives better, swelling down.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a Registered Nurse refers to 7 unspecified patients of unknown age and gender. The nurse reported that between 27-AUG-2013 and 06-SEP-2013, the patients received unspecified doses (in schedule) of GARDASIL (lot # H021861, expiry: 09-OCT-2015) 0.5 ml, intramuscularly. Nurse stated that the GARDASIL doses were exposed to 31F maximum for total of 1.5 hours cumulatively on 27-AUG-2013. No adverse effects reported. Additional information has been requested.
Age: 44.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Urticaria
Clinical narrative: Patient had Tdap administered on L deltoid no reactions at time of shot. Patient left to pharmacy, came back, had a big red welts behind L ear. No itching, hives, etc. Patient walked to see doctor. Given Benadryl discharged. Have no other allergies.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a nurse practitioner concerning an approximately 12 year old female patient. On an unknown date in November 2011, the patient was vaccinated with the first dose of GARDASIL (lot number, expiry date, dose and route unspecified) and was in clinic to complete the vaccination series with a second dose of GARDASIL on 06-SEP-2013. No concomitant therapy was reported. No adverse effect was reported. Additional information has been requested.
Age: 20.0
Sex: M
Vaccine: ANTH
Symptoms: Migraine
Clinical narrative: Developed new onset migraine headache syndrome after Anthrax #2 in Aug '11. Headaches were reproduced and worsened in frequency and intensity after Anthrax #3 in Feb '12. Headaches occur randomly and patient often has to go to ER to receive abortive treatment. Given permanent exemption to Anthrax vaccine unless exposed to the Anthrax Bacillus. The VHC has had multiple cases of new onset or worsening headache syndromes after Anthrax. The immunologic mechanism is unknown.
Age: 5.0
Sex: U
Vaccine: HPV4
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: This spontaneous report was received from a physician assistant via company representative who refers to a 5 year old patient of unknown gender. The physician assistant reported that on an unknown date the patient was vaccinated with a dose of GARDASIL (dose, route and lot # were not reported). The outcome and action taken were not reported. Additional information has been requested.
Age: 1.03
Sex: F
Vaccine: FLU3, VARCEL
Symptoms: Rash erythematous, Rash maculo-papular
Clinical narrative: Patient has CPX and flu in (L) thigh region. 14 days after vaccination started maculopap eryth. rash, started one spot patchy, now multiple, spreading red in an area of 2 x 2 inches. No syst. sympt.
Sex: U
Vaccine: MMR, VARCEL
Symptoms: Crying, Injection site pain
Clinical narrative: This spontaneous report as received from a nurse refers to an unspecified number of patients. On unknown dates, the patients were vaccinated with a dose of M-M-R II (lot number and expiration were not provided), 0.5 ml, subcutaneous. Other suspect therapies included VARIVAX (Merck) (lot number, expiration date unspecified) (both dose and route were not provided). It was reported that the patients cried after receiving M-M-R II and VARIVAX (Merck) because the vaccines caused burning at the injection site. The outcome of events was unknown. This is one of several reports received from the same source.  Additional information is not expected.
Sex: M
Vaccine: FLU3, VARZOS
Symptoms: VIIth nerve paralysis
Clinical narrative: This spontaneous report as received from a pharmacist refers to a male patient of unknown age. On an unknown date the patient was vaccinated with ZOSTAVAX, injection (route, dose, lot number and exp. date not provided). Other suspect vaccine administered in the same day included an unspecified flu vaccine (manufacturer unknown), injection (route, dose, lot number and exp. date not provided). On an unspecified date the patient had developed Bell's palsy. The outcome of event was unknown. Additional information has been requested.
Age: 1.01
Sex: F
Vaccine: DTAP, VARCEL
Symptoms: Full blood count, Pyrexia
Clinical narrative: Child developed fever 104.6 one day after vaccine (Dtap, Varivax). Went to urgent care, then hosptial. - Motrin given.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a physician via a field representative, refers to at least two or three unspecified patients of unknown age and genders. On an unknown dates, the patients were vaccinated with a dose of ZOSTAVAX (lot#, dose, routes and sites of administration were not reported). On an unspecified dates at least two or three unspecified patients experienced an outbreak of shingles after being administered ZOSTAVAX. According to the physician, the unspecified patients were treated with VALTREX on an unspecified dates for the shingles outbreak. The unspecified patients that experienced the outbreak of shingles had no symptoms of post-herpetic neuralgia. The outcome of shingles outbreak was not reported. The relatedness between vaccination with ZOSTAVAX and outbreak of shingles was not reported. Additional information is not expected.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Injection site erythema, Injection site pain
Clinical narrative: This spontaneous report was received from a registered pharmacist concerning an approximately 51 year old female patient with no pertinent medical history. Current condition of the patient included codeine allergy. On 04-SEP-2013, the patient was vaccinated with 0.65 milliliter (ml) of ZOSTAVAX (lot number and expiry date were reported as J003723 and 28-JUN-2014 respectively), subcutaneously. Concomitant therapies included TRIVORA, FLONASE and ASTELIN. On 06-SEP-2013, the patient developed redness and burning sensation at the ZOSTAVAX injection site. It was reported that the patient also complained of headaches on 06-SEP-2013 (reported as this morning). The patient sought medical attention (called the pharmacy). No treatment was given. No lab tests were performed. The patient was not recovered from the events. The relatedness for the events was unknown for ZOSTAVAX. Additional information has been received.
Age: 35.0
Sex: F
Vaccine: VARZOS
Symptoms: Borrelia test, Drug administered to patient of inappropriate age, Injection site erythema, Injection site induration, Injection site pain
Clinical narrative: Information has been received from a consumer's husband concerning a 35 year old, not pregnant, female patient with penicillin drug reaction/allergy and a history of Lyme disease and shingles 5 or 6 times in the past 6 years. On 03-APR-2012 the patient was vaccinated with ZOSTAVAX (lot# not reported) injection (dose, route, frequency not reported). Concomitant therapy included CRESTOR and XANAX. On 04-APR-2012 the patient experienced a hard, sore, burning sensation at the injection site. The patient was prescribed an unspecified high dose steroid. There was Lyme titer performed and with no result provided. About 2 weeks after receiving ZOSTAVAX, appropriately on 17-APR-2012, the patient recovered. The patient sought medical attention by visiting the doctor's office. Product Quality Complaint (PQC) was not involved. Follow up information has been received from a physician concerning the female patient (occupation reported as clerk) with anxiety and depression who was vaccinated with ZOSTAVAX. It was reported the patient's husband demanded vaccine because the patient felt she had zoster rash twice already and they felt it might help the patient attenuate any future event, even though they knew it wasn't indicated under age 50 due to no formal testing at this level. Since then the husband was upset that his insurance didn't cover the cost, and he was on a mission to find something wrong with it. There was a 2cm area of redness at the injection site. The AE onset date 05-APR-2012 and recovery date 06-APR-2012 was contradict to the former report (AE onset date 04-APR-2012). It was reported that the patient didn't sought medical attention. Follow up information has been received from physician, who stated the patient developed 2 cm size area of redness on her arm, at the injection site, after receiving ZOSTAVAX in April 2012. Additional information is not expected.
Age: 7.0
Sex: M
Vaccine: DTAP, HEPA, IPV, MMRV
Symptoms: Streptococcus test, Unevaluable event
Clinical narrative: None stated.
Age: 10.0
Sex: F
Vaccine: HEPA, PPV, TDAP
Symptoms: Injection site cellulitis, Pyrexia
Clinical narrative: This spontaneous report as received from a physician via a company representative refers to a 10 year old female patient. The patient's medical history included Henoch-Schonlein purpura (HSP). On 05-JUL-2013 the patient was vaccinated with PNEUMOVAX23 (lot # H021941, expiry date 11-JUL-2014, intramuscular, dose was unknown). The patient received BOOSTRIX and HAVRIX on the same day as receiving the PNEUMOVAX23 but in the "other" arm. "Two days later" approximately on 07-JUL-2013, the patient developed cellulitis "below the injection site just above the elbow" and a fever after receiving PNEUMOVAX23. The outcome of events was unknown. The patient went to an unspecified emergency room on an unspecified date to seek medical attention and was given an unspecified sulfur drug. This is one of two reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. On 28-AUG-2013 the patient was vaccinated with ZOSTAVAX (lot# J001005, expiration date 24-APR-2014) 0.65 ml, subcutaneously. The pharmacist reported that the patient received an improperly stored ZOSTAVAX. The last temperature that was recorded for the ZOSTAVAX was within the recommended storage range (0.1F) was on 21-AUG-2013. The highest temperature recorded since then was 22 F. The patient's outcome was unknown. This is one of two reports from the same source (related to MARRS 1309USA004207). Additional information is not expected.
Age: 54.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site reaction, Injection site swelling, Injection site warmth, Pyrexia, Rash erythematous
Clinical narrative: Site became warm to touch swollen and red hive like bumps - about the size of 4 fingers surrounding the sight.  Pt also ran a low fever.
Age: 54.0
Sex: F
Vaccine: FLU3
Symptoms: Urticaria
Clinical narrative: Site became warm to touch swollen and red hive like bumps - about the size of 4 fingers surrounding the sight.  Pt also ran a low fever.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Erythema, Macule, Rash
Clinical narrative: Rash on Face around mouth gradually spreading to cheeks consisting of pink-colored macules and patches.
Age: 30.0
Sex: F
Vaccine: TD
Symptoms: Blood pressure increased, Heart rate increased, Malaise, Paraesthesia
Clinical narrative: Pt stated she "did not feel well" after receiving TD vaccine. She felt tingling in arms, heart rate increased, BP increased, Benadryl administered and 911 called.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Hypoaesthesia, Pain, Peripheral coldness, Pyrexia
Clinical narrative: Pt states to have entire aches, even her skin, hands are cold, to the point where finger tips numb, fever like symptoms...taking Ibuprofen helps.
Age: 12.0
Sex: M
Vaccine: FLUN4, HPV4, MNQ, TDAP
Symptoms: Convulsion
Clinical narrative: Child began having seizures Friday PM.
Age: 6.0
Sex: M
Vaccine: FLU3
Symptoms: Cough, Dyspnoea, Ocular hyperaemia, Urticaria, Wheezing
Clinical narrative: Wheezing, Coughs, Hives, Eye redness, Dificulty breathing.
Age: 29.0
Sex: F
Vaccine: FLUX
Symptoms: Parotid gland enlargement, Salivary gland pain, Vaccination complication
Clinical narrative: At around 1:30 pm I noticed significant swelling and mild pain in my left parotid gland (the same side of my body where the vaccine had been administered).  The swelling was sudden developing over no more than thirty minutes.  The swelling is roughly marble sized.  After consulting with a colleague, we deemed it highly probable that it was vaccine related.  I am currently resting and if I see no improvement by tomorrow, I will see my primary care provider.
Age: 41.0
Sex: F
Vaccine: MMR, TD
Symptoms: Hypoaesthesia, Measles, Muscular weakness, Rash generalised
Clinical narrative: Starting with a rash which develops over the whole body. Very strong measles rash. Lasts over 10 days already. Numbness in fingers, tired legs.
Age: 1.15
Sex: M
Vaccine: MMR
Symptoms: Bronchiolitis, Convulsion, Dyspnoea, Pyrexia, Rash
Clinical narrative: Even though on 24hr rotation of Tylenol and Ibuprofen, my son had 2 mini seizures after the 3 shots he was given, one of those being the MMR vaccine.  One week later he was struggling to breathe and diagnosed with bronchiolitis and put on an inhaler.  Next, he had a 5 min seizure.  He ran a fever  99-102 for the next 4 days and then, 11 days after the shots, he broke out with a rash resembling the rash sometimes caused by the MMR vaccine.
Age: 27.0
Sex: M
Vaccine: ANTH
Symptoms: Abdominal discomfort, Asthenia, Dizziness, Nausea, Pallor
Clinical narrative: Service Member very pale, lightheadness, upset stomach, nausea, weakness.
Age: 0.64
Sex: F
Vaccine: HEP, RV5
Symptoms: Rash erythematous, Rash generalised, Rash macular
Clinical narrative: Blotchy red rash on face, body, arms and legs; if itchy to get Zyrtec liquid 1/2 to 3/4 tea sp once a day. Was to see allergist as had a "sunburn" like rash on neck after egg whites on 8/7/2013.
Age: 22.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Night sweats
Clinical narrative: Sunday night had night sweat.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. On 01-SEP-2013 the patient was vaccinated with ZOSTAVAX (lot # J001005, expiration date 24-APR-2014) 0.65 ml, subcutaneously. The pharmacist reported that the patient received an improperly stored ZOSTAVAX. The last temperature that was recorded for the ZOSTAVAX was within the recommended storage range (0.1F) was on 21-AUG-2013. The highest temperature recorded since then was 22 F. The patients outcome was unknown. This is one of two reports from the same source (related to MARRS 1309USA002695). Additional information is not expected.
Sex: U
Vaccine: VARZOS
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to a patient of unknown age and gender. On an unknown date the patient was vaccinated with ZOSTAVAX (lot #, expiration date, route and anatomical location unspecified). The physician reported that the patient received an expired dose of ZOSTAVAX at an unspecified time and location. No adverse effect was reported. The patient's outcome was reported as recovered. Additional information is not expected.