chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV, DTAPIPV, MMRV
Symptoms: Abnormal behaviour, Decreased appetite, Feeling abnormal, Pain in extremity, Pyrexia
Clinical narrative: KINRIX given Rt leg 6/28/13. 6/29/13 had pain, redness, swelling; contacted CPNP and treated with amoxicillin and prednisolone 6/30/13. Came into office 7/1/13 redness measured 5.5" wide x 3.5" long.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV, DTAPIPV, MMRV
Symptoms: Skin warm, Swelling
Clinical narrative: KINRIX given Rt leg 6/28/13. 6/29/13 had pain, redness, swelling; contacted CPNP and treated with amoxicillin and prednisolone 6/30/13. Came into office 7/1/13 redness measured 5.5" wide x 3.5" long.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV, DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: KINRIX given Rt leg 6/28/13. 6/29/13 had pain, redness, swelling; contacted CPNP and treated with amoxicillin and prednisolone 6/30/13. Came into office 7/1/13 redness measured 5.5" wide x 3.5" long.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Blood test, Dizziness postural, Fatigue, Feeling abnormal, Headache
Clinical narrative: Symptoms: Tingling in hands and feet while standing; Dizziness while standing; Fatigue; Frequent headaches; Panic attack feelings without the panic.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Nuclear magnetic resonance imaging, Paraesthesia, Tilt table test
Clinical narrative: Symptoms: Tingling in hands and feet while standing; Dizziness while standing; Fatigue; Frequent headaches; Panic attack feelings without the panic.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Nausea, Pyrexia, Vomiting
Clinical narrative: This spontaneous report was received from a pharmacist refers to a 67 year old male patient with hypertension. On 06-MAY-2013, the patient was vaccinated with first dose of ZOSTAVAX (lot #:H013023, expiry:09-OCT-2013), 0.65 ml, subcutaneously. On 18-JUN-2013, the patient was vaccinated with second dose of ZOSTAVAX (lot #, expiry not reported), 0.65 ml, subcutaneously. On 21-JUN-2013, the patient experienced fever, vomiting and nausea. Patient sought medical attention. The patient went to an unspecified hospital on 21-JUN-2013. It was unknown if the patient was admitted or if there was a hospital stay. The outcome of vomiting, fever and nausea 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 physician via office manager refers to a patient of unknown age. On 22-MAY-2013, the patient was vaccinated with a dose of GARDASIL, (lot # H021608, expiry date 13-AUG-2015), which was exposed to 31 Fahrenheit for 1 hour. Concomitant medications were not reported. No adverse effects were reported. This is one of the several reports received from the same reporter. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Convulsion, Fall, Head injury, Syncope
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 17 year old female patient. On 21-JUN-2013 the patient was vaccinated with GARDASIL dose 1 (route, site and lot number not provided). Concomitant therapies included PPD tine test and MENACTRA. On 21-JUN-2013, the patient had a seizure, fell and hit her head, also fainted and fell and subsequently hit her head. The patient sought unspecified medical attention. It was unknown if this patient had received any further doses of GARDASIL. The outcome of the events was unknown. The causal relationship was not reported. Upon internal review, seizure was considered medically significant. Additional information has been requested.
Sex: M
Vaccine: HEP
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a physician via office manager refers to a patient of unknown age. On 15-APR-2013, the patient was vaccinated with a dose of RECOMBIVAX HB (lot # H015537, expiry date JUL-2015), with the same lot of improperly stored RECOMBIVAX HB. Concomitant medications were not reported. No adverse effects were reported. This is one of the several reports received from the same reporter. Additional information has been requested.
Age: 0.34
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV1
Symptoms: Abdominal X-ray, Barium enema, Condition aggravated, Dehydration, Intussusception
Clinical narrative: 6.27.13 started with vomiting; 6.28.13 vomiting and very fussy, dehydrated. Sent to hospital for evaluation and IV rehydration. Intussusception diagnosed and treated by barium enema.
Age: 0.34
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV1
Symptoms: Irritability, Vomiting
Clinical narrative: 6.27.13 started with vomiting; 6.28.13 vomiting and very fussy, dehydrated. Sent to hospital for evaluation and IV rehydration. Intussusception diagnosed and treated by barium enema.
Age: 0.61
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC, DTAPIPVHIB, HEP, PNC13
Symptoms: Apnoea, Cyanosis
Clinical narrative: On changing table, held breath for 30 sec with lips turning blue. Recovered and was fine thereafter.
Age: 0.61
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC, DTAPIPVHIB, HEP, PNC13
Symptoms: Breath holding, Cyanosis
Clinical narrative: On changing table, held breath for 30 sec with lips turning blue. Recovered and was fine thereafter.
Age: 0.25
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Autopsy, Death
Clinical narrative: Possible SIDS (SUID).
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a physician via office manager refers to a patient of unknown age. On 03-JUN-2013, the patient was vaccinated with a dose of GARDASIL, (lot # H021608, expiry date 13-AUG-2015), which was exposed to 31 Fahrenheit for 1 hour. Concomitant medications were not reported. No adverse effects were reported. This is one of the several reports received from the same reporter. Additional information has been requested.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Approx 4 inch diameter area of redness to the right posterior upper arm. Area was warm and soft to touch. No treatment documented.
Age: 53.0
Sex: F
Vaccine: FLU3
Symptoms: Carpal tunnel decompression, Hypoaesthesia, Paraesthesia, Vaccination complication
Clinical narrative: Numbness and tingling both hands.  She had left carpal tunnel release on 6/7/13.  States surgeon and neurologist attributed the symptoms to the flu vaccine.
Age: 46.0
Sex: F
Vaccine: PPV
Symptoms: Injection site induration, Injection site pain
Clinical narrative: 3.5 inch firm, round and tender area with injection site at center.
Age: 45.0
Sex: M
Vaccine: ANTH, MNQ
Symptoms: Blood immunoglobulin G, Blood immunoglobulin M, Chest pain, Disorientation, Dizziness
Clinical narrative: On morning of 31 March 2013 I woke up feeling tired with mild flu like symptoms and some dull pain radiating from left shoulder area. On night of 31 March I slept 15 hours and woke up on 1 April with same symptoms. Night of 2 April I slept 12 more hours and woke up on 2 April with same symptoms but getting worse in severity. Reported to work and started feeling dizziness, SOB, and pain radiating from left shoulder cap area. An ambulance was called and I was transported to Medical Center. BP on ambulance was 166/126 with disorientation, and dizziness. Was kept in ER for about 3 hours and released with normal vitals. ER doctor said he thought I was experiencing an Auto-Immune reaction to vaccines received on 29 Mar 2013. Referred to flight medicine. On 3 April 2013 saw flight medicine at. I told flight doc I still had mild pain radiating from left shoulder and chest area but thought I was getting better and he said it was probably a reaction of some kind to vaccines and I should be OK. Returned on 4 April 2013. Started feeling same symptoms in post mission crew rest and reported the following week to squadron that I should see a doctor again about symptoms. I was referred to another facility and saw my PCM on 12 April. Symptoms at that time were; pain radiating from left side chest, shoulder and breast area (7/10 in severity). EKG was normal blood work showed an acute zoster infection and was put on Gabapentin, Valtrex, Prednisone, Hydrocodone, Amitriptyline, Naproxin, Docusate, and Lidocaine Patches. Condition continues...
Age: 45.0
Sex: M
Vaccine: ANTH, MNQ
Symptoms: Dyspnoea, Electrocardiogram normal, Fatigue, Full blood count, Herpes zoster
Clinical narrative: On morning of 31 March 2013 I woke up feeling tired with mild flu like symptoms and some dull pain radiating from left shoulder area. On night of 31 March I slept 15 hours and woke up on 1 April with same symptoms. Night of 2 April I slept 12 more hours and woke up on 2 April with same symptoms but getting worse in severity. Reported to work and started feeling dizziness, SOB, and pain radiating from left shoulder cap area. An ambulance was called and I was transported to Medical Center. BP on ambulance was 166/126 with disorientation, and dizziness. Was kept in ER for about 3 hours and released with normal vitals. ER doctor said he thought I was experiencing an Auto-Immune reaction to vaccines received on 29 Mar 2013. Referred to flight medicine. On 3 April 2013 saw flight medicine at. I told flight doc I still had mild pain radiating from left shoulder and chest area but thought I was getting better and he said it was probably a reaction of some kind to vaccines and I should be OK. Returned on 4 April 2013. Started feeling same symptoms in post mission crew rest and reported the following week to squadron that I should see a doctor again about symptoms. I was referred to another facility and saw my PCM on 12 April. Symptoms at that time were; pain radiating from left side chest, shoulder and breast area (7/10 in severity). EKG was normal blood work showed an acute zoster infection and was put on Gabapentin, Valtrex, Prednisone, Hydrocodone, Amitriptyline, Naproxin, Docusate, and Lidocaine Patches. Condition continues...
Age: 45.0
Sex: M
Vaccine: ANTH, MNQ
Symptoms: Influenza like illness, Musculoskeletal pain, Pain, Varicella virus test positive
Clinical narrative: On morning of 31 March 2013 I woke up feeling tired with mild flu like symptoms and some dull pain radiating from left shoulder area. On night of 31 March I slept 15 hours and woke up on 1 April with same symptoms. Night of 2 April I slept 12 more hours and woke up on 2 April with same symptoms but getting worse in severity. Reported to work and started feeling dizziness, SOB, and pain radiating from left shoulder cap area. An ambulance was called and I was transported to Medical Center. BP on ambulance was 166/126 with disorientation, and dizziness. Was kept in ER for about 3 hours and released with normal vitals. ER doctor said he thought I was experiencing an Auto-Immune reaction to vaccines received on 29 Mar 2013. Referred to flight medicine. On 3 April 2013 saw flight medicine at. I told flight doc I still had mild pain radiating from left shoulder and chest area but thought I was getting better and he said it was probably a reaction of some kind to vaccines and I should be OK. Returned on 4 April 2013. Started feeling same symptoms in post mission crew rest and reported the following week to squadron that I should see a doctor again about symptoms. I was referred to another facility and saw my PCM on 12 April. Symptoms at that time were; pain radiating from left side chest, shoulder and breast area (7/10 in severity). EKG was normal blood work showed an acute zoster infection and was put on Gabapentin, Valtrex, Prednisone, Hydrocodone, Amitriptyline, Naproxin, Docusate, and Lidocaine Patches. Condition continues...
Age: 77.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site reaction, Rash erythematous
Clinical narrative: Red, painful rash over left deltoid at site of Zoster vaccination.
Age: 0.28
Sex: M
Vaccine: 6VAX-F, RVX
Symptoms: Screaming, Vomiting
Clinical narrative: Vomiting and screaming continually for about an hour. She is not keeping any formula down.
Age: 33.0
Sex: F
Vaccine: PPV
Symptoms: Asthenia, Dyspnoea, Injection site pain, Motor dysfunction, Speech disorder
Clinical narrative: WEAKNESS, SHORTNESS OF BREATH, EXCESSIVE PAIN AT INJECTION SITE, DIFFICULTY SPEAKING - MOTOR SKILLS IMPAIRED, BACK OF THROAT FELT HOT.
Age: 33.0
Sex: F
Vaccine: PPV
Symptoms: Throat irritation
Clinical narrative: WEAKNESS, SHORTNESS OF BREATH, EXCESSIVE PAIN AT INJECTION SITE, DIFFICULTY SPEAKING - MOTOR SKILLS IMPAIRED, BACK OF THROAT FELT HOT.
Age: 57.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Blister, Pruritus, Rash, Secretion discharge, Viral test negative
Clinical narrative: Pt in office 6/21/13 stating she had "weeping & itching" blisters on abdomen. Pt in office 6/24/2013 after developed same type rash on top of lt wrist.
Age: 57.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Culture, Erythema, Herpes zoster
Clinical narrative: Pt in office 6/21/13 stating she had "weeping & itching" blisters on abdomen. Pt in office 6/24/2013 after developed same type rash on top of lt wrist.
Age: 17.0
Sex: F
Vaccine: MNQ
Symptoms: Body temperature increased, Headache, Oedema peripheral, Pain, Vaccination site pain
Clinical narrative: Arm swollen and sore at vaccine site, headache, low grade temp., and body aches.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a physician via office manager refers to a patient of unknown age. On 21-MAY-2013, the patient was vaccinated with a dose of GARDASIL, (lot # H020002, expiry date 08-AUG-2015), with the same lot of improperly stored GARDASIL. Concomitant medications were not reported. No adverse effects were reported. This is one of the 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 was received from a Licensed Practical Nurse refers to an unknown number of patients of unknown age and gender. On an unknown date, the patients were vaccinated with improperly stored GARDASIL (lot#, expiry not reported). No adverse effects reported. The nurse stated that the vaccine was exposed to warmer temperatures. However, she had to research to determine if the vaccines were administered. This is 1 of several reports received 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 was received from a physician via office manager refers to a patient of unknown age. On 31-MAY-2013, the patient was vaccinated with a dose of GARDASIL, (lot # H021608, expiry date 13-AUG-2015), which was exposed to 31 Fahrenheit for 1 hour. Concomitant medications were not reported. No adverse effects were reported. This is one of the several reports received from the same reporter. Additional information has been requested.
Age: 1.03
Sex: F
Vaccine: PPV
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from Certified Medical Assistant (CMA) refers to a 12 month old infant patient. On 18-JUN-2013 the patient received PNEUMOVAX 23, 0.5 ml, intramuscular (lot # was not reported) instead of PREVNAR. No adverse effect reported. Additional information has been requested.
Age: 18.0
Sex: M
Vaccine: HEPA
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a 18 year old male patient. The patient was vaccinated with an adult dose of VAQTA (route, dose and lot # were unknown) on 20-JUN-2013. No adverse effects. Additional information has been requested.
Age: 22.0
Sex: M
Vaccine: VARCEL
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a 22 year old male adult patient. on 21-JUN-2013 ("today") the patient was vaccinated subcutaneously with a 0.5 ml dose of VARIVAX (Merck) (lot # 670709/0820AA, expire date 02-JUN-2013), Injection that has been expired. No adverse effects reported at this time. Additional information is not expected.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a physician via office manager refers to a patient of unknown age. On 30-MAY-2013, the patient was vaccinated with a dose of GARDASIL, (lot # H021608, expiry date 13-AUG-2015), which was exposed to 31 Fahrenheit for 1 hour. Concomitant medications were not reported. No adverse effects were reported. This is one of the several reports received 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 was received from a physician via office manager refers to a patient of unknown age. On 23-MAY-2013, the patient was vaccinated with a dose of GARDASIL, (lot # H021608, expiry date 13-AUG-2015), which was exposed to 31 Fahrenheit for 1 hour. Concomitant medications were not reported. No adverse effects were reported. This is one of the several reports received 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 was received from a physician via office manager refers to a patient of unknown age. On 22-MAY-2013, the patient was vaccinated with a dose of GARDASIL, (lot # H020002, expiry date 08-AUG-2015), with the same lot of improperly stored GARDASIL. Concomitant medications were not reported. No adverse effects were reported. This is one of the several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a Licensed Practical Nurse refers to an unknown number of patients of unknown age and gender. On an unknown date, the patients were vaccinated with improperly stored RECOMBIVAX HB (lot #, expiry not reported). No adverse effects reported. The nurse stated that the vaccine was exposed to warmer temperatures. However, she had to research to determine if the vaccines were administered. This is 1 of several reports received from the same reporter. Additional information has been requested.
Sex: F
Vaccine: HEPA
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a physician via office manager refers to a patient of unknown age. On 23-APR-2013, the patient was vaccinated with a dose of VAQTA (lot # 0100AE, expiry date OCT-2014), with the same lot of improperly stored VAQTA. Concomitant medications were not reported. No adverse effects were reported. This is one of the several reports received from the same reporter. Additional information has been requested.
Sex: F
Vaccine: HEPA
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a physician via office manager refers to a patient of unknown age. On 05-JUN-2013, the patient was vaccinated with a dose of VAQTA (lot # 0100AE, expiry date OCT-2014), with the same lot of improperly stored VAQTA. Concomitant medications were not reported. No adverse effects were reported. This is one of the several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a physician via office manager refers to a patient of unknown age. On 13-MAY-2013, the patient was vaccinated with a dose of VAQTA, (lot # 0100AE, expiry date OCT-2014), with the same lot of improperly stored VAQTA. Concomitant medications were not reported. No adverse effects were reported. This is one of the several reports received 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 was received from a physician via office manager refers to a patient of unknown age. On 07-JUN-2013, the patient was vaccinated with a dose of GARDASIL, (lot # H021608, expiry date 13-AUG-2015), which was exposed to 31 Fahrenheit for 1 hour. Concomitant medications were not reported. No adverse effects were reported. This is one of the several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a physician via office manager refers to a patient of unknown age. On 29-MAY-2013, the patient was vaccinated with a dose of VAQTA, (lot # 0100AE, expiry date OCT-2014), with the same lot of improperly stored VAQTA. Concomitant medications were not reported. No adverse effects were reported. This is one of the several reports received 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 was received from a physician via office manager refers to a patient of unknown age. On 04-JUN-2013, the patient was vaccinated with a dose of GARDASIL, (lot # H021608, expiry date 13-AUG-2015), which was exposed to 31 Fahrenheit for 1 hour. Concomitant medications were not reported. No adverse effects were reported. This is one of the several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a physician via office manager refers to a patient of unknown age. On 07-MAY-2013, the patient was vaccinated with a dose of VAQTA, (lot # 0100AE, expiry date OCT-2014), with the same lot of improperly stored VAQTA. Concomitant medications were not reported. No adverse effects were reported. This is one of the several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a physician via office manager refers to a patient of unknown age. On 26-APR-2013, the patient was vaccinated with a dose of VAQTA, (lot # 0100AE, expiry date OCT-2014), with the same lot of improperly stored VAQTA. Concomitant medications were not reported. No adverse effects were reported. This is one of the several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a physician via office manager refers to a patient of unknown age. On 20-MAY-2013, the patient was vaccinated with a dose of VAQTA, (lot # 0100AE, expiry date OCT-2014), with the same lot of improperly stored VAQTA. Concomitant medications were not reported. No adverse effects were reported. This is one of the several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a physician via office manager refers to a patient of unknown age. On 13-APR-2013, the patient was vaccinated with a dose of RECOMBIVAX HB, (lot # H015537, expiry date JUL-2015), with the same lot of improperly stored RECOMBIVAX HB. Concomitant medications were not reported. No adverse effects were reported. This is one of the several reports received 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 was received from a registered nurse refers to a patient of unknown age and gender. Nurse had previously called on 21-JUN-2013 to discuss vaccine temperature stability data at that time reported no patients had received improperly stored vaccine. On 27-JUN-2013, nurse reported that she discovered 3 patients received improperly stored vaccine. On 20-JUN-2013, one of the patient received an improperly stored dose of GARDASIL (lot#, expiry not reported). No symptoms reported. This is 1 of 3 reports received from the same reporter. Additional information is not expected.
Sex: M
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse refers to a patient of unknown age and gender. Nurse had previously called on 21-JUN-2013 to discuss vaccine temperature stability data but at that time reported no patients had received improperly stored vaccine. On 27-JUN-2013, nurse reported that she discovered 3 patients received improperly stored vaccine. On 20-JUN-2013, one of the patient received an improperly stored dose of GARDASIL (lot #, expiry not reported). No symptoms reported. This is 1 of 3 reports received from the same reporter. Additional information is not expected.
Sex: U
Vaccine: HEP
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a physician via office manager refers to a patient of unknown age. On 15-APR-2013, the patient was vaccinated with a dose of RECOMBIVAX HB, (lot # H015537, expiry date JUL-2015), with the same lot of improperly stored RECOMBIVAX HB. Concomitant medications were not reported. No adverse effects were reported. This is one of the several reports received from the same reporter. Additional information has been requested.
Age: 39.0
Sex: F
Vaccine: HEP
Symptoms: Headache, Nausea, Somnolence
Clinical narrative: Nausea, headache, drowsy employee was sent home.
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 a patient of unknown age and gender. Nurse had previously called on 21-JUN-2013 to discuss vaccine temperature stability data but at that time reported no patients had received improperly stored vaccine. On 27-JUN-2013, nurse reported that she discovered 3 patients received improperly stored vaccine. On 20-JUN-2013, one of the patient received an improperly stored dose of GARDASIL (lot #, expiry not reported). No symptoms reported. This is 1 of 3 reports received from the same reporter. Additional information is not expected.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a physician via office manager refers to a patient of unknown age. On 06-JUN-2013, the patient was vaccinated with a dose of GARDASIL (lot # H021608, expiry date 13-AUG-2015), which was exposed to 31 Fahrenheit for 1 hour. Concomitant medications were not reported. No adverse effects were reported. This is one of the several reports received from the same reporter. Additional information has been requested.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Cellulitis, Herpes zoster, Hypersensitivity
Clinical narrative: Allergic reaction - cellulitis and shingles.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report was received from a Registered Nurse refers to an unspecified number of patients of unknown age and gender. The nurse reported that on an unknown date, an unspecified number of patients were administered GARDASIL (lot #, expiry not reported) that were exposed to 31 F (Fahrenheit) for up to 6 months. The Nurse will gather information for processing the need for revaccination and call back. This is 1 of 2 reports from the same reporter. Additional information has been requested.
Age: 1.2
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Rash generalised
Clinical narrative: Was given varicella and MMR vaccines on 06/12/13. Pt's mother brought child in on 06/28/13 stating child developed rash on 06/25/13 - seems better now. Rash is all over body - head to toe. BENADRYL given and help.
Sex: U
Vaccine: HEP
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a physician via office manager refers to a patient of unknown age. On 30-MAY-2013, the patient was vaccinated with a dose of RECOMBIVAX HB, (lot # H015537, expiry date JUL-2015), with the same lot of improperly stored RECOMBIVAX HB. Concomitant medications were not reported. No adverse effects were reported. This is one of the several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a physician via office manager refers to a patient of unknown age. On 28-MAY-2013, the patient was vaccinated with a dose of VAQTA, (lot # H019104, expiry date 19-JUL-2015), which was exposed to 31 degree Fahrenheit. Concomitant medications were not reported. No adverse effects were reported. This is one of the several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report was received from a Registered Nurse refers to an unspecified number of patients of unknown age and gender. The nurse reported that on an unknown date, an unspecified number of patients were administered with RECOMBIVAX HB (lot#, expiry not reported) that were exposed to 31 F(Fahrenheit) for up to 6 months. The Nurse will gather information for processing the need for revaccination and call back. This is 1 of 2 reports from the same reporter. Additional information has been requested.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site pruritus, Injection site rash, Injection site warmth
Clinical narrative: Pt has a medium size rash at the injection site left arm. It's sore and hot. It is also lightly itchy. It seemed to get worse a day after the vaccine give. No treatment taken so far.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a physician via office manager refers to a patient of unknown age. On 31-MAY-2013, the patient was vaccinated with a dose of VAQTA, (lot # H019104, expiry date 19-JUL-2015), which was exposed to 31 degree Fahrenheit. Concomitant medications were not reported. No adverse effects were reported. This is one of the several reports received from the same reporter. Additional information has been requested.
Age: 63.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Red, itchy, swelling at site of Tdap injection. Began within 3 hrs of getting injection. Minimal erythema. Treated with KEFLEX 500mg TID x 10 days.
Age: 43.0
Sex: F
Vaccine: RAB
Symptoms: Arthralgia, Asthenia, Differential white blood cell count normal, Full blood count normal, Headache
Clinical narrative: Weakness, nausea, vomiting, headache, hot flashes, joint pain and swelling.
Age: 43.0
Sex: F
Vaccine: RAB
Symptoms: Hot flush, Joint swelling, Nausea, Vomiting
Clinical narrative: Weakness, nausea, vomiting, headache, hot flashes, joint pain and swelling.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Headache, Injection site rash, Pain in extremity, Rash, Vision blurred
Clinical narrative: Patient reports she got a rash on the right and left upper arm. Complaints of headache and blurred vision. Complained of sore right and left arms.
Age: 0.18
Sex: M
Vaccine: DTAPHEPBIP, HIBV, RV1
Symptoms: Body temperature increased, Dehydration, Diet refusal, Irritability
Clinical narrative: Mom reported on 6/26/13 that within 5 hrs from administration of PEDIARIX (DTaP, IPV, HBV) #1, Hib PEDVAX #1 and ROTARIX #1 pt had temp of 103 degrees and could not take bottle. Mom took to ER and was told it may be from immunizations. Given IV fluid for dehydration. Stayed in hosp x 2 days for IVF and fussing.
Age: 0.45
Sex: M
Vaccine: DTAP, HIBV, PNC13, RV1
Symptoms: Convulsion, Endotracheal intubation, Investigation, Mechanical ventilation, Pyrexia
Clinical narrative: 10:50pm mother heard gurgling noises from son in crib. Found son having a seizure in crib. Patient received 2nd series of vaccinations earlier that day. Mother immed. called 911 to ER. ER gave patient ATIVAN. Patient spiked 101 degrees. Fever after ATIVAN (no fever reported prior) and stopped breathing. Patient was intubated and placed on ventilator and flown to another hospital. Stayed at hospital until 6/8/13. Saw neurology, infectious disease, etc.
Age: 0.45
Sex: M
Vaccine: DTAP, HIBV, PNC13, RV1
Symptoms: Respiratory arrest
Clinical narrative: 10:50pm mother heard gurgling noises from son in crib. Found son having a seizure in crib. Patient received 2nd series of vaccinations earlier that day. Mother immed. called 911 to ER. ER gave patient ATIVAN. Patient spiked 101 degrees. Fever after ATIVAN (no fever reported prior) and stopped breathing. Patient was intubated and placed on ventilator and flown to another hospital. Stayed at hospital until 6/8/13. Saw neurology, infectious disease, etc.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Hyperhidrosis, Paraesthesia
Clinical narrative: Pt complained of sweating, tingliness in fingertips and dizzy. Pt denied shortness of breath, rash, swelling. Wet towel given to pt. Blood pressure reading was taken. Blood pressure resumed from 99/64 - 115/76.
Age: 2.0
Sex: F
Vaccine: FLU3, HEPA, PNC
Symptoms: Activities of daily living impaired, Gait disturbance, Loss of control of legs
Clinical narrative: Grandmother (guardian) noticed child limping (R) leg 6/25/13 about 5 p.m. When child ran, her leg buckled under her. She asked for help to climb stairs. No complaint of pain. 6/27/13 (TC) to grandmother -  symptom is gone now.
Age: 2.0
Sex: F
Vaccine: HEPA
Symptoms: Fatigue, Gait disturbance, Loss of consciousness, Pyrexia, Vomiting
Clinical narrative: Pt developed tactile fever and vomiting 15 minutes after vaccine was administered. She was tired for the rest of the day, briefly stumbled to one side when carried out of the shower and placed on the floor, woke up and vomited and was febrile about 12 hours after vaccine given. Seen in office the next day with normal exam.
Age: 0.34
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Pyrexia
Clinical narrative: Fever 103 degrees F for few hours on the night of vaccine administration at 4 months.
Age: 5.0
Sex: M
Vaccine: DTAP
Symptoms: Erythema, Skin warm, Swelling
Clinical narrative: As per pt's father red swollen warm to touch. Pt was taken to hospital.
Age: 31.0
Sex: F
Vaccine: MMR
Symptoms: Arthralgia, Aspiration joint normal, Blood uric acid normal, C-reactive protein increased, Full blood count normal
Clinical narrative: Started with joint aching, progressed to right knee pain and swelling over the next few days.  Responded to Ibuprofen.  Seen at ER 6/30 and had labs that were normal except increased sed rate and CRP.  Xray normal.  Knee tapped and no crystals or infection.
Age: 31.0
Sex: F
Vaccine: MMR
Symptoms: Human chorionic gonadotropin normal, Joint swelling, Metabolic function test normal, Red blood cell sedimentation rate increased, X-ray limb normal
Clinical narrative: Started with joint aching, progressed to right knee pain and swelling over the next few days.  Responded to Ibuprofen.  Seen at ER 6/30 and had labs that were normal except increased sed rate and CRP.  Xray normal.  Knee tapped and no crystals or infection.
Age: 11.0
Sex: F
Vaccine: HEPA, HPV4, MEN, TDAP
Symptoms: Dizziness, Pallor, Syncope
Clinical narrative: Dizziness, fainting, paleness.
Age: 27.0
Sex: M
Vaccine: ANTH
Symptoms: Erythema, Rash, Swelling
Clinical narrative: PATIENT REPORTS REDNESS, SWELLING AND RASH. REPORT FOUND IN CHART IN MAY, VACCINE GIVEN IN PRIOR OCTOBER. UNSURE OF EXACT ONSET OF SYMPTOMS.
Age: 46.0
Sex: F
Vaccine: FLU3, FLUX
Symptoms: Asthenia, Back pain, Dysphagia, Dyspnoea, Guillain-Barre syndrome
Clinical narrative: Do not know date and time of event--pt reported symptoms started approximately 4 days prior to admission to hospital on 12/20/2012  symptoms: back and neck pain, generalized weakness, numbness, shortness of breath, difficulty swallowing--> diagnosed with Guillain Barre syndrome with respiratory failure requiring mechanical ventilation/tracheostomy, prolonged rehabilitation.
Age: 46.0
Sex: F
Vaccine: FLU3, FLUX
Symptoms: Hypoaesthesia, Mechanical ventilation, Neck pain, Respiratory failure, Tracheostomy
Clinical narrative: Do not know date and time of event--pt reported symptoms started approximately 4 days prior to admission to hospital on 12/20/2012  symptoms: back and neck pain, generalized weakness, numbness, shortness of breath, difficulty swallowing--> diagnosed with Guillain Barre syndrome with respiratory failure requiring mechanical ventilation/tracheostomy, prolonged rehabilitation.
Age: 46.0
Sex: F
Vaccine: FLU3, FLUX
Symptoms: Asthenia, Back pain, Delirium, Dysphagia, Dyspnoea
Clinical narrative: Do not know date and time of event--pt reported symptoms started approximately 4 days prior to admission to hospital on 12/20/2012  symptoms: back and neck pain, generalized weakness, numbness, shortness of breath, difficulty swallowing--> diagnosed with Guillain Barre syndrome with respiratory failure requiring mechanical ventilation/tracheostomy, prolonged rehabilitation.
Age: 46.0
Sex: F
Vaccine: FLU3, FLUX
Symptoms: Guillain-Barre syndrome, Hallucination, Hypoaesthesia, Immunoglobulin therapy, Mechanical ventilation
Clinical narrative: Do not know date and time of event--pt reported symptoms started approximately 4 days prior to admission to hospital on 12/20/2012  symptoms: back and neck pain, generalized weakness, numbness, shortness of breath, difficulty swallowing--> diagnosed with Guillain Barre syndrome with respiratory failure requiring mechanical ventilation/tracheostomy, prolonged rehabilitation.
Age: 46.0
Sex: F
Vaccine: FLU3, FLUX
Symptoms: Metabolic encephalopathy, Muscular weakness, Neck pain, Pneumonia, Respiratory failure
Clinical narrative: Do not know date and time of event--pt reported symptoms started approximately 4 days prior to admission to hospital on 12/20/2012  symptoms: back and neck pain, generalized weakness, numbness, shortness of breath, difficulty swallowing--> diagnosed with Guillain Barre syndrome with respiratory failure requiring mechanical ventilation/tracheostomy, prolonged rehabilitation.
Age: 46.0
Sex: F
Vaccine: FLU3, FLUX
Symptoms: Tracheostomy
Clinical narrative: Do not know date and time of event--pt reported symptoms started approximately 4 days prior to admission to hospital on 12/20/2012  symptoms: back and neck pain, generalized weakness, numbness, shortness of breath, difficulty swallowing--> diagnosed with Guillain Barre syndrome with respiratory failure requiring mechanical ventilation/tracheostomy, prolonged rehabilitation.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Localized swelling and redness to administration site (left anterior thigh).
Age: 0.94
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13
Symptoms: Rash, Skin warm
Clinical narrative: Mother phoned on 6/11 to report that approximately 10 minutes after leaving immunization clinic child developed a bump like rash on his stomach, face, and legs. Mother did not seek medical attention at time of out break. Stated that she continued the use of Tylenol, mother said he seemed warm she did not take his temperature. PHN advised mother to contact pediatrician, or return to local hospital emergency room. Mother expressed understanding. Agreed that she would contact PHN to disclose condition and treatment of child. Mother did not contact me and I have been unsuccessful at contacting family, two non-function phone numbers.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Injection site reaction, Local reaction, Nausea
Clinical narrative: The current episode started in the past 7 days. Localized site reaction, mild nausea, fatigue, no other sx, patient advised she is ok, increase fluids, rest, ice to injection area, recheck prn.
Age: 27.0
Sex: F
Vaccine: HPV4
Symptoms: Dry skin, Pruritus, Rash, Scab
Clinical narrative: Started getting itchy, as I started scratching it started spreading little bumps and I have a rash by my armpit on the same arm that the vaccine got injected into (the left arm) also my right elbow is really dry and scabbing.
Age: 5.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: Redness, hard area, warm to touch at injection site. Pt was seen at UC, and treated with abx on 06/30/2013.
Age: 18.0
Sex: M
Vaccine: HPV4
Symptoms: Gaze palsy, Immediate post-injection reaction, Pallor, Syncope
Clinical narrative: Has fainted immediately during the HPV vaccination. Legs kept high, didn't fall on the floor. Kept him on the table, he became pale, eyes rolling backward. NO seizure activity last for 10-15 seconds, recovered fully.
Age: 1.05
Sex: M
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Injection site erythema, Pruritus, Rash, Rash erythematous
Clinical narrative: Redness at injection sites and erythematous rash to torso.  Some itching.  Given 12.5mg of diphenhydramine and observed for 30 minutes.  Rash mostly resolved and pt continued on diphenhydramine at home for 24 hrs.
Age: 57.0
Sex: F
Vaccine: YF
Symptoms: Injection site erythema, Injection site pain, Oedema peripheral
Clinical narrative: Vaccinated Arm; Swollen; Injection Site Red; Painful.
Age: 0.18
Sex: M
Vaccine: DTAPHEPBIP
Symptoms: Body temperature increased
Clinical narrative: Temp up to 104.0.
Age: 0.5
Sex: M
Vaccine: DTAPIPV, HIBV, RVX
Symptoms: Injection site urticaria, Lacrimation increased, Pyrexia, Respiratory tract congestion, Rhinorrhoea
Clinical narrative: Fever; hives on b/l legs; non-stop screaming; congestion, runny nose; left eye watery.
Age: 0.5
Sex: M
Vaccine: DTAPIPV, HIBV, RVX
Symptoms: Screaming, Urticaria
Clinical narrative: Fever; hives on b/l legs; non-stop screaming; congestion, runny nose; left eye watery.
Age: 12.0
Sex: M
Vaccine: HPVX
Symptoms: Syncope
Clinical narrative: Was fainted.
Age: 4.0
Sex: M
Vaccine: DTAP, MMRV
Symptoms: Aggression, Condition aggravated, Nervous system disorder, Sensory disturbance
Clinical narrative: Hour long tantrum from time of vaccine until long after arriving home, neurological issues including sensory issues and evolving sensory and possible Sensory Processing Disorder or ADHD became increasingly worse within days of vaccine.
Age: 4.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Injection site rash, Rash macular
Clinical narrative: (L) thigh rash. Mild and faint erythematous macular area w/faint borders located on anterior thigh from proximal to midline. No pain or edema. Onset x 3 days. Monitor sxs (conservative mngmt).
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Abnormal behaviour, Discomfort, Pyrexia, Vomiting
Clinical narrative: On June 4th, 2013, my son after receiving (4) 12 month immunization shots vomited approximately 7 times in a 6 hour period. On June 11th, 2013, he began running high temperatures ranging from 100 to 103 degrees for approx. 3 days total with exhibited discomfort and behavior change.
Sex: U
Vaccine: HEP
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a physician via office manager refers to a patient of unknown age. On 03-JUN-2013, the patient was vaccinated with a dose of RECOMBIVAX HB, (lot # H015537, expiry date JUL-2015), with the same lot of improperly stored RECOMBIVAX HB. Concomitant medications were not reported. No adverse effects were reported. This is one of the several reports received from the same reporter. Additional information has been requested.
Age: 27.0
Sex: M
Vaccine: MMR
Symptoms: Mumps antibody test negative
Clinical narrative: This spontaneous report was received from a registered nurse refers to a currently 27 years old male patient with no pertinent medical history reported. On an unknown date (also reported as "as a child") the patient was vaccinated with MMRII (lot number and expiration date not reported) (dose and route not reported). No other suspect therapies or concomitant medications were reported. The reporter stated that on an unknown date (also reported as "recently") the patient had a negative titer for Mumps. The patient had no records of his vaccinations as a child, but stated that he received all of his childhood vaccinations. The patient recently (date unspecified) had titers for Measles, Mumps and Rubella. The titers for Measles and Rubella were acceptable but the titer for Mumps was negative. No adverse event reported other than the negative titer for Mumps. The reporting nurse did not assess the relatedness between negative titer for Mumps and MMRII. Additional information is not expected.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Exposure during pregnancy, No adverse event, Pregnancy test positive
Clinical narrative: This spontaneous prospective pregnancy report as received from a registered nurse refers to a 25 year old female patient with asthma and unspecified reaction to latex. On 09-APR-2013 the patient was vaccinated with the first dose of GARDASIL (INJ 0.5 ML) (lot # H019088, expiration date 26-JUN-2015), intramuscular for prevention of HPV. There was no concomitant medication reported. On 22-MAY-2013 the patient had a positive pregnancy test. It was reported that patient's last menstrual period of 21-MAR-2013 and Estimated delivery date of 26-DEC-2013. Initial exposure to GARDASIL was at 2 weeks. The pregnancy outcome was unknown. On an unspecified date the patient was contacted in the office. The nurse stated that the patient had not had any adverse reactions. Additional information has been requested.
Age: 30.0
Sex: F
Vaccine: HEPAB, MMR, VARCEL
Symptoms: Blister, Varicella post vaccine
Clinical narrative: Chickenpox outbreak following vaccination. Outbreak noticed on 6/30/13 with vesicles on feet, legs, thighs.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report was received from a physician via office manager refers to a patient of unknown age. On 04-JUN-2013, the patient was vaccinated with a dose of VAQTA, (lot # H019104, expiry date 19-JUL-2015), which was exposed to 31 degree Fahrenheit. Concomitant medications were not reported. This is one of the several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a physician via office manager refers to a patient of unknown age. On 01-JUN-2013, the patient was vaccinated with a dose of VAQTA, (lot # H019104, expiry date 19-JUL-2015), which was exposed to 31 degree Fahrenheit. Concomitant medications were not reported. No adverse effects were reported. This is one of the several reports received from the same reporter. Additional information has been requested.