chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 13.0
Sex: F
Vaccine: HPV2, MNQ, TDAP, VARCEL, HPV2, MNQ, TDAP, VARCEL
Symptoms: Nuclear magnetic resonance imaging, Pain, Pain in extremity, Tremor, X-ray
Clinical narrative: Case number PHHY2014US051453 is an initial spontaneous report received via vaccine adverse event reporting system (VAERS reference number: 522136) on 24 Apr 2014 with a follow up report received from VAERS on 28 May 2014 with a follow up report received from the Quality Assurance department (QA reference number: 303056) on 02 Jun 2014 and a follow up report from the QA department received on 19 Jun 2014. This report refers to a 13-years-old female patient. Her medical history included asthma, tonsillectomy, Helicobacter pylori infection, allergic rhinitis and lactose intolerance. Her concomitant medications were not reported. She was vaccinated with MENVEO, (batch number: A11072), BOOSTRIX (other manufacturer, batch number: AC52B099CA), CERVARIX (other manufacturer, batch number: AHPVA169AB) and VARIVAX (other manufacturer, batch number: H016920) on 10 Jun 2013. On 11 Jun 2013, she had left arm pain from elbow all the way down to middle finger. It was reported that her arm was numb. She held it close to her body and used pain killers, ice and heat till 13 Jun 2013. She went to the physician and her hand and arm was swollen. It was reported that her hand was shaking and it hurt to move the fingers. She went to emergency room and had her blood work, magnetic resonance imaging (MRI) and X-ray done. She claimed that she had Reflex Sympathetic Dystrophy (RSD) and bad fibromyalgia. The event outcome was reported as condition unchanged. The event was reported non-serious, but was internally upgraded as medically significant by the agency. The causality was not reported. Based on the document review, it was stated that the MENVEO, batch number A11072 was manufactured in accordance with approved internal procedures and it was in compliance with the current good manufacturing practices (cGMP) requirements. Follow up report received from VAERS on 28 May 2014: Updated suspect vaccine trade names (MENVEO, BOOSTRIX, CERVARIX and VARIVAX) and vaccine batch numbers. Non significant follow up report was received from the Quality Assurance department on 02 Jun 2014: The QA reference number was updated. Follow up report from the QA department received on 19 Jun 2014: Updated batch review report.
Age: 65.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Injected limb mobility decreased, Vaccination site pain
Clinical narrative: Case number PHHY2014US049805 is an initial spontaneous report received from vaccine adverse event reporting system (VAERS reference number: 523369) on 24 Apr 2014 with a follow up information received from vaccine adverse event reporting system on 25 Jun 2014. This report refers to a 65 years old female patient. Her medical history and concomitant medications were not reported. She was vaccinated with Seasonal influenza vaccine (unknown manufacturer, batch number: not reported) in arm on 17 Oct 2013. It was reported that on 17 Oct 2013, her vaccinated arm began to hurt and caused immobility. The outcome of the event was reported as condition unchanged. The events were reported as medically significant and caused permanent disability. The causality of the events was not reported. Upon follow up information received on 25 Jun 2014, it was reported that the patient was administered FLUARIX which was a non Novartis vaccine and hence the case was deactivated. Follow up information received from vaccine adverse event reporting system on 25 Jun 2014: Updated suspect vaccine as FLUARIX (Non-Novartis vaccine) and case was deactivated.
Age: 65.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Injected limb mobility decreased, Pain in extremity
Clinical narrative: Case number PHHY2014US049805 is an initial spontaneous report received from vaccine adverse event reporting system (VAERS reference number: 523369) on 24 Apr 2014 with a follow up information received from vaccine adverse event reporting system on 25 Jun 2014. This report refers to a 65 years old female patient. Her medical history and concomitant medications were not reported. She was vaccinated with Seasonal influenza vaccine (unknown manufacturer, batch number: not reported) in arm on 17 Oct 2013. It was reported that on 17 Oct 2013, her vaccinated arm began to hurt and caused immobility. The outcome of the event was reported as condition unchanged. The events were reported as medically significant and caused permanent disability. The causality of the events was not reported. Upon follow up information received on 25 Jun 2014, it was reported that the patient was administered FLUARIX which was a non Novartis vaccine and hence the case was deactivated. Follow up information received from vaccine adverse event reporting system on 25 Jun 2014: Updated suspect vaccine as FLUARIX (Non-Novartis vaccine) and case was deactivated.
Age: 52.0
Sex: F
Vaccine: FLUC3, PPV, TDAP, FLUC3, PPV, TDAP
Symptoms: Deafness, Feeling abnormal, Hypoaesthesia, Pain in extremity
Clinical narrative: Case number PHHY2014US054773 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS, reference number: 524482) website on 06 May 2014, with a follow-up received from Quality Assurance Department (QA, reference number: 298149) on 23 Jun 2014. This report refers to a 52-year-old female patient. Her medical history included COPD (chronic obstructive pulmonary disease), macrocytosis and elevated LFTs (liver function test). She was vaccinated with FLUCELVAX (batch number: 005011A) intramuscularly into right arm on 31 Jan 2014. On the same day, she was also vaccinated with PNEUMOVAX (other manufacturer, batch number: J010332) intramuscularly into left arm and Tdap (other manufacturer, batch number: 3D425) intramuscularly into right arm. On 02 Feb 2014, two days after vaccination, she experienced loss of hearing, head numb, left arm pain and felt awful. These events were reported as non-serious; however the event of loss of hearing case was internally upgraded as medically significant by the agency. Outcome of the events was reported as recovered. Causality of the events was not reported. Based on the investigation performed, the QA department stated that, the FLUCELVAX (batch number: 005011A) was manufactured in accordance with the approved internal procedures and it was in compliance with the cGMP requirements. Follow-up received from Quality Assurance Department (QA, reference number: 298149) on 23 Jun 2014: Updated batch review report.
Age: 76.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Biopsy kidney abnormal, Blood creatinine increased, Cryoglobulinaemia, Glomerulonephritis membranoproliferative, Hypersensitivity
Clinical narrative: Case number PHHY2014US065749 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 527862) website on 28 May 2014 and a follow up report received on 25 Jun 2014. This report refers to a 76-year-old male patient. He had a past medical history of hypertension, gastro-esophageal reflux disease and increased cholesterol. His concomitant medications included Prednisone for immunosuppression and CYTOXAN for acute glomerulonephritis. On 01 Oct 2013, he was vaccinated with seasonal influenza vaccine (unknown manufacturer, batch number: not reported). It was reported that shortly after vaccination on 01 Oct 2013, he got sick, developed rash and persistent leg swelling. He was hospitalized from 15 Nov 2013 to 23 Nov 2013 for "delay sensitivity reaction to flu shot with transient angiitis" and acute renal failure. On an unspecified date, in Nov 2013, he had a creatinine level of 2.5. His urine protein level tested in 24 hours was 6677 mg. He showed limited response to prednisone trial. He was readmitted in the hospital on 03 Jan 2014. He had pulmonary/renal symptom and positive rheumatoid factor. On 06 Jan 2014, he underwent kidney biopsy which showed membranoproliferative glomerulonephritis (MPGN) with cryoglobulinemic glomerulonephritis. He was released from the hospital on 10 Jan 2014. The causality of the events was not reported. The event outcome was unknown. The reporter assessed the event as serious. Upon follow up, it confirmed that the influenza vaccine taken by the patient was a non-Novartis vaccine and hence the case will be deactivated. Follow up report received on 25 Jun 2014: Upon follow up, it confirmed that the influenza vaccine taken by the patient was a non-Novartis vaccine and hence the case will be deactivated.
Age: 76.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Local swelling, Lung disorder, Malaise, Protein urine present, Rash
Clinical narrative: Case number PHHY2014US065749 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 527862) website on 28 May 2014 and a follow up report received on 25 Jun 2014. This report refers to a 76-year-old male patient. He had a past medical history of hypertension, gastro-esophageal reflux disease and increased cholesterol. His concomitant medications included Prednisone for immunosuppression and CYTOXAN for acute glomerulonephritis. On 01 Oct 2013, he was vaccinated with seasonal influenza vaccine (unknown manufacturer, batch number: not reported). It was reported that shortly after vaccination on 01 Oct 2013, he got sick, developed rash and persistent leg swelling. He was hospitalized from 15 Nov 2013 to 23 Nov 2013 for "delay sensitivity reaction to flu shot with transient angiitis" and acute renal failure. On an unspecified date, in Nov 2013, he had a creatinine level of 2.5. His urine protein level tested in 24 hours was 6677 mg. He showed limited response to prednisone trial. He was readmitted in the hospital on 03 Jan 2014. He had pulmonary/renal symptom and positive rheumatoid factor. On 06 Jan 2014, he underwent kidney biopsy which showed membranoproliferative glomerulonephritis (MPGN) with cryoglobulinemic glomerulonephritis. He was released from the hospital on 10 Jan 2014. The causality of the events was not reported. The event outcome was unknown. The reporter assessed the event as serious. Upon follow up, it confirmed that the influenza vaccine taken by the patient was a non-Novartis vaccine and hence the case will be deactivated. Follow up report received on 25 Jun 2014: Upon follow up, it confirmed that the influenza vaccine taken by the patient was a non-Novartis vaccine and hence the case will be deactivated.
Age: 76.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Renal disorder, Renal failure acute, Rheumatoid factor positive, Vasculitis
Clinical narrative: Case number PHHY2014US065749 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 527862) website on 28 May 2014 and a follow up report received on 25 Jun 2014. This report refers to a 76-year-old male patient. He had a past medical history of hypertension, gastro-esophageal reflux disease and increased cholesterol. His concomitant medications included Prednisone for immunosuppression and CYTOXAN for acute glomerulonephritis. On 01 Oct 2013, he was vaccinated with seasonal influenza vaccine (unknown manufacturer, batch number: not reported). It was reported that shortly after vaccination on 01 Oct 2013, he got sick, developed rash and persistent leg swelling. He was hospitalized from 15 Nov 2013 to 23 Nov 2013 for "delay sensitivity reaction to flu shot with transient angiitis" and acute renal failure. On an unspecified date, in Nov 2013, he had a creatinine level of 2.5. His urine protein level tested in 24 hours was 6677 mg. He showed limited response to prednisone trial. He was readmitted in the hospital on 03 Jan 2014. He had pulmonary/renal symptom and positive rheumatoid factor. On 06 Jan 2014, he underwent kidney biopsy which showed membranoproliferative glomerulonephritis (MPGN) with cryoglobulinemic glomerulonephritis. He was released from the hospital on 10 Jan 2014. The causality of the events was not reported. The event outcome was unknown. The reporter assessed the event as serious. Upon follow up, it confirmed that the influenza vaccine taken by the patient was a non-Novartis vaccine and hence the case will be deactivated. Follow up report received on 25 Jun 2014: Upon follow up, it confirmed that the influenza vaccine taken by the patient was a non-Novartis vaccine and hence the case will be deactivated.
Age: 76.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Biopsy kidney abnormal, Blood creatinine increased, Cryoglobulinaemia, Glomerulonephritis membranoproliferative, Local swelling
Clinical narrative: Case number PHHY2014US065749 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 527862) website on 28 May 2014 and a follow up report received on 25 Jun 2014. This report refers to a 76-year-old male patient. He had a past medical history of hypertension, gastro-esophageal reflux disease and increased cholesterol. His concomitant medications included Prednisone for immunosuppression and CYTOXAN for acute glomerulonephritis. On 01 Oct 2013, he was vaccinated with seasonal influenza vaccine (unknown manufacturer, batch number: not reported). It was reported that shortly after vaccination on 01 Oct 2013, he got sick, developed rash and persistent leg swelling. He was hospitalized from 15 Nov 2013 to 23 Nov 2013 for "delay sensitivity reaction to flu shot with transient angiitis" and acute renal failure. On an unspecified date, in Nov 2013, he had a creatinine level of 2.5. His urine protein level tested in 24 hours was 6677 mg. He showed limited response to prednisone trial. He was readmitted in the hospital on 03 Jan 2014. He had pulmonary/renal symptom and positive rheumatoid factor. On 06 Jan 2014, he underwent kidney biopsy which showed membranoproliferative glomerulonephritis (MPGN) with cryoglobulinemic glomerulonephritis. He was released from the hospital on 10 Jan 2014. The causality of the events was not reported. The event outcome was unknown. The reporter assessed the event as serious. Upon follow up, it confirmed that the influenza vaccine taken by the patient was a non-Novartis vaccine and hence the case will be deactivated. Follow up report received on 25 Jun 2014: Upon follow up, it confirmed that the influenza vaccine taken by the patient was a non-Novartis vaccine and hence the case will be deactivated.
Age: 76.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Malaise, Protein urine present, Rash, Renal failure acute, Rheumatoid factor positive
Clinical narrative: Case number PHHY2014US065749 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 527862) website on 28 May 2014 and a follow up report received on 25 Jun 2014. This report refers to a 76-year-old male patient. He had a past medical history of hypertension, gastro-esophageal reflux disease and increased cholesterol. His concomitant medications included Prednisone for immunosuppression and CYTOXAN for acute glomerulonephritis. On 01 Oct 2013, he was vaccinated with seasonal influenza vaccine (unknown manufacturer, batch number: not reported). It was reported that shortly after vaccination on 01 Oct 2013, he got sick, developed rash and persistent leg swelling. He was hospitalized from 15 Nov 2013 to 23 Nov 2013 for "delay sensitivity reaction to flu shot with transient angiitis" and acute renal failure. On an unspecified date, in Nov 2013, he had a creatinine level of 2.5. His urine protein level tested in 24 hours was 6677 mg. He showed limited response to prednisone trial. He was readmitted in the hospital on 03 Jan 2014. He had pulmonary/renal symptom and positive rheumatoid factor. On 06 Jan 2014, he underwent kidney biopsy which showed membranoproliferative glomerulonephritis (MPGN) with cryoglobulinemic glomerulonephritis. He was released from the hospital on 10 Jan 2014. The causality of the events was not reported. The event outcome was unknown. The reporter assessed the event as serious. Upon follow up, it confirmed that the influenza vaccine taken by the patient was a non-Novartis vaccine and hence the case will be deactivated. Follow up report received on 25 Jun 2014: Upon follow up, it confirmed that the influenza vaccine taken by the patient was a non-Novartis vaccine and hence the case will be deactivated.
Age: 76.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Type IV hypersensitivity reaction, Vasculitis
Clinical narrative: Case number PHHY2014US065749 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 527862) website on 28 May 2014 and a follow up report received on 25 Jun 2014. This report refers to a 76-year-old male patient. He had a past medical history of hypertension, gastro-esophageal reflux disease and increased cholesterol. His concomitant medications included Prednisone for immunosuppression and CYTOXAN for acute glomerulonephritis. On 01 Oct 2013, he was vaccinated with seasonal influenza vaccine (unknown manufacturer, batch number: not reported). It was reported that shortly after vaccination on 01 Oct 2013, he got sick, developed rash and persistent leg swelling. He was hospitalized from 15 Nov 2013 to 23 Nov 2013 for "delay sensitivity reaction to flu shot with transient angiitis" and acute renal failure. On an unspecified date, in Nov 2013, he had a creatinine level of 2.5. His urine protein level tested in 24 hours was 6677 mg. He showed limited response to prednisone trial. He was readmitted in the hospital on 03 Jan 2014. He had pulmonary/renal symptom and positive rheumatoid factor. On 06 Jan 2014, he underwent kidney biopsy which showed membranoproliferative glomerulonephritis (MPGN) with cryoglobulinemic glomerulonephritis. He was released from the hospital on 10 Jan 2014. The causality of the events was not reported. The event outcome was unknown. The reporter assessed the event as serious. Upon follow up, it confirmed that the influenza vaccine taken by the patient was a non-Novartis vaccine and hence the case will be deactivated. Follow up report received on 25 Jun 2014: Upon follow up, it confirmed that the influenza vaccine taken by the patient was a non-Novartis vaccine and hence the case will be deactivated.
Age: 1.0
Sex: F
Vaccine: MMR, VARCEL, PNC13, VARCEL, PNC13, VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a physician refers to a patient of unknown age and gender. On 14-APR-2014, the patient was vaccinated with her first dose of (Oka/Merck) VARIVAX (lot# J009729; exp. date: 07-AUG-2015), subcutaneously in her right leg which was exposed to 13C for 68 hours. No adverse effects were reported. The patient was also vaccinated with MMR II, HSA, which were exposed to 13C for 68 hours (captured in MARRS 1404USA010752). This is one of several reports received from the same source. Follow up information has been received from the physician who reported that the patient was a 12 months old female patient who on 14-APR-2014 13:30pm, was vaccinated with her first dose of (Oka/Merck) VARIVAX, subcutaneously in her right leg. The patient was also vaccinated on 14-APR-2014 13:30pm with the fourth dose of PREVENAR 13 (lot # H01428), intramuscular in her right leg. there were not illnesses at time of vaccination. No adverse event reported. Additional information is not expected.
Age: 14.0
Sex: M
Vaccine: MNQ, MNQ
Symptoms: Petechiae, Urticaria
Clinical narrative: Case number PHEH2014US012655, is an initial spontaneous report from a nurse received on 20 Jun 2014. This report refers to a 14-year-old male patient. Historical conditions were not reported. No concomitant medication was reported. He was vaccinated with MENVEO (batch number: M13064) intramuscularly on 13 Jun 2014. 12 to 24 hours after the vaccination, he experienced hives all over the body. He had seen a physician on 14 Jun 2014 and was sent to emergency room. Treatment for the events was rendered with prednisone and antihistamines. The outcome of the event was recovered. Seriousness and causality was not reported.
Age: 14.0
Sex: M
Vaccine: MNQ, MNQ
Symptoms: Urticaria
Clinical narrative: Case number PHEH2014US012655, is an initial spontaneous report from a nurse received on 20 Jun 2014. This report refers to a 14-year-old male patient. Historical conditions were not reported. No concomitant medication was reported. He was vaccinated with MENVEO (batch number: M13064) intramuscularly on 13 Jun 2014. 12 to 24 hours after the vaccination, he experienced hives all over the body. He had seen a physician on 14 Jun 2014 and was sent to emergency room. Treatment for the events was rendered with prednisone and antihistamines. The outcome of the event was recovered. Seriousness and causality was not reported.
Age: 60.0
Sex: M
Vaccine: HEP
Symptoms: Anxiety, Asthenia, Vision blurred, Visual impairment
Clinical narrative: Patient reported visual changes, vison cloudy "like a curtain film", c/o feeling weak. Reported feeling very anxious.  Referred to urgent care facility for evaluation.  Normal exam. Vision returned to 'normal' at 1200:PM. Seen by a opthalmologist the following day.  Normal eye exam.  No further complaints.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Bacterial test negative, Herpes zoster, Pain
Clinical narrative: I received the Shingles Vaccination (Zoster) On Feb 25, 2014 and by March 2, 2014 my right leg developed a severe case of shingles with significant pain. The shingles is currently (July 1, 2014) finally resolving and pain is diminishing. Standard treatments were used by my primary care physician (Prednisone, anti-viral meds, and pain management meds).
Age: 12.0
Sex: M
Vaccine: HPV4
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: No adverse effects reported from additional Gardasil vacc. given.
Sex: F
Vaccine: VARZOS
Symptoms: Cellulitis
Clinical narrative: This spontaneous report as received from a physician, via a company representative, refers to a female patient of unknown age. No information on medical history, concurrent conditions or concomitant drugs was provided. On an unknown date the patient was vaccinated with a dose of ZOSTAVAX, 1 injection, route and site of injection, lot# and expiration date not reported. On an unknown date the patient experienced cellulitis and had to be admitted to a hospital (dates of hospitalization not provided). The outcome of cellulitis and relatedness between use of ZOSTAVAX and the adverse event were unknown. Additional information has been requested.
Age: 0.16
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Body temperature increased, Crying, Injection site erythema, Injection site swelling
Clinical narrative: At pt's 4mo check-up, mom reported that after pt's 2mo shots (at another pediatrician) she had a period of crying that lasted for 5 hours. She calmed down for a short moment but "would kick her legs and then begin crying again". Mom also reports the pt's injection site was slightly red and swollen??, but that it only lasted until the next day. Pt's temp was ~99.1F during this crying episode, per parents. No medical attention was sought by the parents and the symptoms resolved by the next day.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Irritability, Pyrexia
Clinical narrative: Mother called clinic. Reported fussiness and fever of 101 rectally.
Age: 58.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site bruising, Injection site pain, Injection site reaction, Injection site warmth, Myalgia
Clinical narrative: Significant pain at injection site; bruise and warm area approx three inches around injection site; muscular pain in upper arm. Note no pain whatsoever at time of injection.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Erythema, Injection site reaction, Local reaction, Pruritus
Clinical narrative: Several vesicular lesions with surrounding erythema, associated pruritis.  Local injection site reaction as well.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Skin lesion
Clinical narrative: Several vesicular lesions with surrounding erythema, associated pruritis.  Local injection site reaction as well.
Age: 34.0
Sex: F
Vaccine: MMR, TDAP
Symptoms: Injection site pruritus, Vaccination site rash, Vaccination site swelling
Clinical narrative: 20 minutes after receiving MMR vaccine, Pt. called, reporting that she developed rash, swelling and itching at site of vaccine. She has these symptoms radiating from injection site, moving around her arm.
Age: 2.0
Sex: M
Vaccine: DTAP, MMR
Symptoms: Injection site rash, Irritability, Pyrexia, Rash
Clinical narrative: Rash starting on his back.  On 7/1/14 it has spread all over his trunk, arms, legs.  He is running a fever and fussy.
Age: 0.36
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Injection site erythema, Injection site induration, Injection site oedema, Injection site warmth
Clinical narrative: Seen for check-up in office on (F) 6/27/14. Rec'd 4 mo immunizations. Mom reports s/s reaction began 6/28/14 and include: Edema, erythema, warmth and induration at site on (RT) thigh. Seen for s/s on 6/30/14 and tx'd with KEFLEX (250/5) - SIG: 1/2 tsp po BID x 10 days.
Age: 11.0
Sex: M
Vaccine: VARCEL
Symptoms: Erythema, Local reaction, Skin warm, Swelling
Clinical narrative: Local reaction to varicella shot. Hot, red, swollen about 7.5 cm round with a 3 cm square in middle.
Age: 39.0
Sex: M
Vaccine: TDAP
Symptoms: Injected limb mobility decreased, Injection site pain, Injection site swelling, Pain in extremity, Tendonitis
Clinical narrative: Painful swelling at injection site followed by limited mobility. Can't sleep on left side. Naproxen, heat/cold application, topical pain relievers all ineffective. Two weeks since TDAP injection and arm is still as sore as the first day. Saw a GP about it and she dismissed it as tendinitis, which I did NOT have prior to this vaccination. Normal tendinitis treatments have been ineffective. Anticipating physical therapy or cortisone next.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Patient reports pain and redness at site. Redness is raised, hot to touch and measures 3in by 3in.
Age: 77.0
Sex: F
Vaccine: HEP
Symptoms: Abdominal pain, Abdominal pain lower, Arthralgia, Asthenia, Diarrhoea
Clinical narrative: First symptom: pain in muscle and joints from the waist down still present. Took ibuprofen with some relief.   Lower mid abdominal pain off and on.  Tired and weak.  Some days worse than others. Diarrhea 2-4 bowel movements per day since 6/18/14.
Age: 77.0
Sex: F
Vaccine: HEP
Symptoms: Fatigue, Myalgia
Clinical narrative: First symptom: pain in muscle and joints from the waist down still present. Took ibuprofen with some relief.   Lower mid abdominal pain off and on.  Tired and weak.  Some days worse than others. Diarrhea 2-4 bowel movements per day since 6/18/14.
Age: 83.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Arthritis, Myalgia, Pain in extremity
Clinical narrative: This spontaneous report was received from a 83 year old male consumer, reporting on himself. The patient's medical history included shingles. On 02-JUN-2014, the patient was vaccinated with a dose of ZOSTAVAX (dose number, strength and route were not reported). Co-suspect and concomitant therapies were not reported. The patient stated about a week, on 16-JUN-2014, after receiving the ZOSTAVAX he started experiencing muscle ache in his shoulders. He also experiences hip joint and muscle pain in his legs. Patient did not distinguish which/shoulder, hip or legs. Patient indicated his primary physician was on vacation and he saw another physician (name and location unspecified) who indicated it may be arthritis. At the time of the report the outcome was reported as not recovered. Patient seek medical attention at the office visit. Additional information has been requested.
Age: 0.6
Sex: U
Vaccine: HIBV
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report was received from a nurse referring to a 6 month old patient (gender unspecified). No pertinent medical history and concurrent conditions reported. On 26-JUN-2014 the patient was vaccinated with PEDVAXHIB does 3, intramuscular (dose not reported). The patient received the first dose of PEDVAXHIB in February 2014 (reported as at 2 months of age) and second dose in April 2014 (reported as 4 months of age). No other concomitant therapies reported. No adverse effect reported. The outcome of the events was unknown. No PQC reported.
Age: 16.0
Sex: M
Vaccine: HPV4
Symptoms: Incorrect dose administered, Pain in extremity
Clinical narrative: This spontaneous report was received from a physician and refers to a 16 year old male patient. The patient has no pertinent medical history and no drug allergies. On 20-JUN-2014 the patient was vaccinated with two doses of GARDASIL due to staff error. This should have been dose three in series. Concomitant therapies reported included: typhoid vaccine (unspecified) for travel. On 20-JUN-2014 the patient was vaccinated with two doses of GARDASIL (indication reported: vaccination; lot number not reported): first dose (0.5ml) was injected intramuscularly in patient's left arm and second dose (0.5ml) was injected intramuscularly into patient's right arm. The physician stated that the patient complained of his arm hurting post vaccination. There was no treatment given for the event. Patient sought medical attention 'in the office'. There was no intervention to prevent serious criteria. There was no PQC involved. The outcome of the event (his arm hurting post vaccination) was reported as not recovered/not resolved. The relationship between the GARDASIL and the event (his arm hurting post vaccination) was unknown. Additional information has been requested.
Age: 43.0
Sex: M
Vaccine: TDAP
Symptoms: Feeling hot, Injection site erythema, Injection site swelling, Pyrexia
Clinical narrative: Redness and swelling on site of shot. Felt warm and had a fever 2 days ago.
Age: 1.01
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: This spontaneous report was received from a nurse concerning to a 1 year old female patient. Medical history and concurrent conditions were not reported. On 18-JUN-2014, the patient was vaccinated with the first dose of VARIVAX lot # J011125, expiration date 05-SEP-2015, 0.5 ml, subcutaneous in the right arm. Other suspect therapies included MMR II, lot number 1720AA, expiration date 17-APR-2015, rHA status, 0.5ml subcutaneous route. Concomitant therapies included VAQTA, lot number J005010, expiration date 23-OCT-2015, 0.5 ml, intramuscular in left arm. On 18-JUN-2014, patient "instantaneously" experienced redness and swelling at the injection sites for MMR II and (Oka/Merck) VARIVAX. The areas that were swollen were further described as 3.5 to 4 inches in diameter, golf ball size, raised and looked like they were going to blister, injection sites were still painful, swollen, red and with erythema when patient left the healthcare providers office. Patient did not experience an adverse site reaction at the VAQTA injection site. Patient received medical attention treatment in the healthcare providers office included BENADRYL and ice. No lab diagnostics studies were performed.  Additional information has been requested.
Age: 62.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site induration, Injection site pruritus
Clinical narrative: Erythema, induration, itching (L) deltoid area at site of injection, left upper arm.
Age: 54.0
Sex: F
Vaccine: TDAP
Symptoms: Fatigue, Headache, Pain, Pyrexia, Rash macular
Clinical narrative: Severe soreness 3 days. tired 2-3 days. Swollen 1.5 wks. Fever 2-3 days. Red/blotchy 1.5 wks. Sore approx. 1.5 wks. Headache 2-3 days.
Age: 54.0
Sex: F
Vaccine: TDAP
Symptoms: Swelling
Clinical narrative: Severe soreness 3 days. tired 2-3 days. Swollen 1.5 wks. Fever 2-3 days. Red/blotchy 1.5 wks. Sore approx. 1.5 wks. Headache 2-3 days.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a nurse referring to a patient of unknown age and gender. No pertinent medical history and concurrent conditions reported. On an unknown date doses of VARVIAX (vial 1350U, were exposed to temperatures of -14.9c to -13c, 5 different times in the past 6 months, (duration of each excursion unknown), have been administered, subcutaneously . No other concomitant therapies reported. No adverse effect reported. The outcome of the events was unknown. The causality was not reported. No PQC reported. Additional information has been requested.
Age: 58.0
Sex: M
Vaccine: TYP, YF, TYP, YF
Symptoms: Nausea, Oral herpes
Clinical narrative: Patient was vaccinated with Typhoid inj. and Yellow Fever vaccine on 6-19-14 and developed a cold sore on his tongue on 6-20-14. C/O minimal nausea, no vomiting, afebrile and sore was gone in 1 week. Sanofi Pasteur R.N. aware and says possible immune response to 'live vaccine.'
Age: 58.0
Sex: M
Vaccine: TYP, YF, TYP, YF
Symptoms: Oral herpes
Clinical narrative: Patient was vaccinated with Typhoid inj. and Yellow Fever vaccine on 6-19-14 and developed a cold sore on his tongue on 6-20-14. C/O minimal nausea, no vomiting, afebrile and sore was gone in 1 week. Sanofi Pasteur R.N. aware and says possible immune response to 'live vaccine.'
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from nurse via company representative refers to a patient of unknown age and gender. Patient's medical history and other drug allergic reactions were not reported. On unspecified dates in 2008, a patient received 2 doses of GARDASIL (strength, dose unit, route, lot# and expiry date unknown). Then, on an unspecified date in 2014, that patient received the 3rd dose of GARDASIL (strength, dose unit, route, lot# and expiry date unknown). No known adverse effects were reported. The outcome of in 2008, patient received 2 doses of GARDASIL, in 2014 received the 3rd dose of GARDASIL and no adverse effect was unknown. No further information provided. Additional information has been requested.
Age: 2.0
Sex: M
Vaccine: DTAPHEPBIP, HEPA, HIBV
Symptoms: Injection site discolouration, Injection site discomfort, Injection site erythema, Injection site mass, Pain
Clinical narrative: Pt aunt described large lump on right upper leg with purple and red in color, with minor discomfort, pt was sensitive. Tx: BACTRIM 200mg, KEFLEX 250mg.
Age: 1.8
Sex: M
Vaccine: VARZOS
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a Registered Nurse refers to a 22 month old male patient. On 27-JUN-2014 the patient was vaccinated with a dose of ZOSTAVAX (lot # J006158, expiration date 30-AUG-2013, dose, indication, route not reported) instead of PROQUAD. No adverse effects reported. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender> The reporter stated that on 25-JUN-2014 the patient was vaccinated with expired PROQUAD (Merck) (lot # H021358, expiration date: 29-MAY-2041, dose, units, anatomical location, route of administration were not reported). No adverse effect has been observed. This is one of several reports from the same reporter. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: MNQ, MNQ
Symptoms: Cellulitis, Injection site swelling, Local swelling, Pain, Swelling face
Clinical narrative: 6-3-15-Client here for Meningitis vaccine. NKDA. No reaction while here. What appeared to be adverse reaction started (L) arm that p.m. 3-4 inches wide. 6-4-15 Swelling was up whole arm into neck-face and tongue. To see PVT M.D. reported cellulitis. Clients parent was not satisfied with Drs. diagnosis. Parent took client to Hospital ER. Hospital diagnosed cellulitis, and informed that meds given by PVT M.D. were sufficient. Prednisone dosepack. 6-5-14 Patient doing better swelling going down. 6-6-14. Swelling is much better, some pain noted. Back to see Dr. today.
Age: 14.0
Sex: F
Vaccine: MNQ, MNQ
Symptoms: Swollen tongue
Clinical narrative: 6-3-15-Client here for Meningitis vaccine. NKDA. No reaction while here. What appeared to be adverse reaction started (L) arm that p.m. 3-4 inches wide. 6-4-15 Swelling was up whole arm into neck-face and tongue. To see PVT M.D. reported cellulitis. Clients parent was not satisfied with Drs. diagnosis. Parent took client to Hospital ER. Hospital diagnosed cellulitis, and informed that meds given by PVT M.D. were sufficient. Prednisone dosepack. 6-5-14 Patient doing better swelling going down. 6-6-14. Swelling is much better, some pain noted. Back to see Dr. today.
Sex: U
Vaccine: MMRV
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. The reporter stated that on 25-JUN-2014 the patient was vaccinated with PROQUAD (Merck) (lot # H021358, expiration date: 29-MAY-2014, dose, units, anatomical location, route of administration were not reported). No adverse effect has been observed. This is one of several reports from the same reporter. Additional information has been requested,
Sex: U
Vaccine: HEPA
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a patient of unspecified age and gender. The healthcare worker reported that, on unknown date, VAQTA (dose, frequency, route, lot number and exp. date were not reported) that underwent a temperature excursion has been administered to an unspecified amount of patients. No adverse effect was reported. Additional information has been requested.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, HIBV, MMR, VARCEL
Symptoms: Injection site cellulitis
Clinical narrative: Child developed cellulitis of (L) thigh around injection site (KINRIX) (baseball size) and smaller area on (R) side (Hib given).
Sex: U
Vaccine: HEPA
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age. The patient's medical history was not reported. On an unknown date the patient was vaccinated with VAQTA (dose, frequent and route were unknown) which was improperly stored. Concomitant medications were not reported. Medical assistant confirmed that VAQTA was administered according to the dose and route recommended in the prescribing information. No adverse effects were reported. No product quality complaint (PQC) was reported. This case is linked to case # 1407USA000032 (same reporter link). Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a physician assistant referring to a patient of unknown age and gender. No pertinent medical history and concurrent condition reported. On 25-JUN-2013, 12-MAY-2013 and 07-JUN-2014 the patient was vaccinated with GARDASIL dose 1, dose 2 and dose 3  (dose not reported). No other concomitant therapies reported. No known adverse effects reported. The outcome of the events was unknown. The causality of the events was unspecified. No PQC reported. Additional information has been requested.
Age: 1.26
Sex: F
Vaccine: DTAPIPVHIB, PNC13
Symptoms: Febrile convulsion, Pneumonia, Pyrexia, Vomiting
Clinical narrative: Vomiting, fever, complex febrile convulsions, pneumonia.
Sex: U
Vaccine: MMRV
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. The reporter stated that on 26-JUN-2014 the patient was vaccinated with expired PROQUAD (Merck) (lot # H021358, expiration date: 29-MAY-2014, dose, units, anatomical location, route of administration were not reported). No adverse effect has been observed. Additional information has been requested. This is one of several reports from the same reporter.
Sex: U
Vaccine: MMRV
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. The reporter stated that on 19-JUN-2014 the patient was vaccinated with PROQUAD (Merck) (lot # H021358, expiration date: 29-MAY-2014, dose, units, anatomical location, route of administration were not reported). No adverse effect has been observed. This is one of several reports from the same reporter. Additional information has been requested.
Age: 36.0
Sex: F
Vaccine: MMR, TDAP
Symptoms: Dyspnoea, Urticaria
Clinical narrative: Pt developed hives two weeks after receiving MMR on May 2014. Also SOB. Pt reported hives on her (L) leg.
Sex: U
Vaccine: MMRV
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. The reporter stated that on 25-JUN-2014 the patient was vaccinated with expired PROQUAD (merck) (lot # H021358, expiration date: 29-MAY-2014, dose, units, anatomical location, route of administration were not reported). No adverse effect has been observed. This is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX (dose, route, lot# and expiration date were not reported and inadvertently the patient was administered a second dose of ZOSTAVAX) (dose, route, lot # and expiration date were not reported). 2 years later (exact date unspecified). No adverse effects were reported. No PQC  (product quality complaint) was involved. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker via company representative refers to a patient of unknown age and gender. On an unknown date the patient was vaccinated with RECOMBIVAX HIB (lot #, expiration date, dose not reported). No concomitant medications were reported. The reporter stated that the patient had only received the first two doses in the RECOMBIBVAX HB series, and those two doses were given abut a year apart at an unspecified facility. No adverse effects reported. Additional information has ben requested.
Sex: U
Vaccine: MMRV
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. The reporter stated that on 25-JUN-2014 the patient was vaccinated with expired PROQUAD (Merck) (lot # H021358, expiration date: 29-MAY-2014, dose, units, anatomical location, route of administration were not reported). No adverse effect has been observed. This is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. The reporter stated that on 19-JUN-2014 the patient was vaccinated with expired PROQUAD (lot # H021358, expiration date: 29-MAY-2014, dose, units, anatomical location, route of administration were not reported). No adverse effect has been observed. This is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age. The patient's medical history was not reported. On 23-JUN-2014 the patient was vaccinated with GARDASIL (Dose, frequent and route were unknown) which was improperly stored. Concomitant medications were not reported. Medical assistant confirmed that GARDASIL was administered according to the dose and route recommended in the prescribing information. No adverse effects were reported. No product quality complaint (PQC) was reported. This case is linked to case # 1407USA000289 (same reporter link). Additional information has been requested.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, HEPA, MMRV
Symptoms: Blister, Body temperature increased, Erythema, Local reaction, Oropharyngeal pain
Clinical narrative: 4yo boy who developed large local reaction/Arthus reaction consisting of >10cm patch of erythema with some associated vesicles within 24 hours of receiving MMRV vaccine to right thigh. Systemic symptoms included low grade temp and sore throat. No associated hives, angioedema, arthralgias or myalgias. No problems with ambulation. The following day temperature back to normal and sore throat resolved. Vesicles burst and erythema somewhat darker but resolving. Treated symptomatically with topical steroids.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, HEPA, MMRV
Symptoms: Type III immune complex mediated reaction
Clinical narrative: 4yo boy who developed large local reaction/Arthus reaction consisting of >10cm patch of erythema with some associated vesicles within 24 hours of receiving MMRV vaccine to right thigh. Systemic symptoms included low grade temp and sore throat. No associated hives, angioedema, arthralgias or myalgias. No problems with ambulation. The following day temperature back to normal and sore throat resolved. Vesicles burst and erythema somewhat darker but resolving. Treated symptomatically with topical steroids.
Age: 5.0
Sex: M
Vaccine: DTAP, HEP
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Erythema approximately 10 inches diameter with swelling and warmth at injection site on (R) arm.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Immediate post-injection reaction, Rash, Rash macular
Clinical narrative: Vaccine was given in left leg and pt. instantly became red and blotchy on legs, arms, stomach and back. Pt reported no itching or difficulty in breathing. Pt. was given 1 tsp. BENADRYL and observed for 20 mins.
Age: 37.0
Sex: M
Vaccine: ANTH
Symptoms: Muscle twitching, Muscular weakness, Wrong drug administered
Clinical narrative: Weakness in right arm began approximately one hour post-injection.  Sporadic twitching in right arm began approximately 4 hours post injection. I previously had an adverse reaction to the anthrax vaccine, and a VAERS report was submitted.  I was instructed not to have the anthrax vaccine again; however, the immunization technician mistakenly injected me with the wrong vaccine: she was supposed to administer a Typhoid vaccine, but she gave me anthrax instead.
Age: 59.0
Sex: F
Vaccine: HEP
Symptoms: Blood glucose decreased, Fatigue, Feeling abnormal
Clinical narrative: Patient alert and orinted reporting "out of body experience, something strange going on inside body". Reporting increase of fatigue after second Hepatitis B vaccination.
Age: 10.0
Sex: M
Vaccine: HEP
Symptoms: Unevaluable event
Clinical narrative: No harmful outcomes for the patient.
Age: 66.0
Sex: M
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Malaise
Clinical narrative: Red, swollen, tender injection site several hours following the injection.  Symptoms persisted for several hours.  Mild generalized malaise.
Age: 0.18
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Enema administration, Intussusception, Ultrasound abdomen abnormal
Clinical narrative: Pt was admitted to Hospital with intussusception.
Age: 10.0
Sex: M
Vaccine: HEPA, HIBV, MMR, HEPA, HIBV, MMR
Symptoms: Erythema, Local swelling, Wrong drug administered
Clinical narrative: Swelling and redness (L) arm. No fevers or body rashes. Pt was given Hib instead of HepB.
Age: 10.0
Sex: M
Vaccine: HEPA, HIBV, MMR, HEPA, HIBV, MMR
Symptoms: Injection site erythema, Injection site mass, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Swelling and redness (L) arm. No fevers or body rashes. Pt was given Hib instead of HepB.