chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 35.0
Sex: F
Vaccine: ANTH, HEP
Symptoms: Malaise, Mean cell haemoglobin concentration normal, Mean cell haemoglobin normal, Mean cell volume normal, Mean platelet volume normal
Clinical narrative: Patient is a 41-year-old female who presents to the Vaccine Healthcare Center for further evaluation and recommendations regarding possible adverse reaction to anthrax vaccine. Patient describes being in her normal state of health until August 2007. Patient describes receiving anthrax #4 on 21 August 2007 (reports no problems with anthrax #1-3). That evening, the patient developed a large local reaction as well as flu like symptoms of fatigue, low-grade fever, myalgias, and arthralgias as well as a bad headache. The following morning she went to the local Medical Clinic and was instructed that her symptoms were a normal reaction. However, she notes a distinct change in quality of headaches that began within one day of the vaccine. She describes the headaches as "an electric current in my head constantly". She further describes this as an ice pick constantly in her brain. She denies the pain being a throbbing quality. She localizes the headaches to the top of the bilateral parietal bone area of her head. She endorses associated photophobia, phonophobia, nausea, and vomiting associated with headache. The headache may also be exacerbated by strong smells and exertion. She states she has not been headache free since March 2008. However, the headache does wax and wane. At its worst, the headache is 10 out of 10 in intensity and at its best it is 2/10 in intensity. Before August 2007 the headaches were in a different location, more throbbing in nature, near the temple area (but bilateral) and not associated with any emesis, nausea, photophobia or phonophobia. Additionally, prior to August 2007 the medications responded to MOTRIN. Currently, the headaches are well controlled with prophylactic medicines to include LYRICA and CYMBALTA and abortive therapy with IMITREX. Additionally, the patient describes deploying in December 2007 with the headaches continuing. However, when she redeployed in March 2008 she noted the headaches became increasingly more severe and "never went away". She describes being hospitalized in May 2008 for these headaches. She has been followed by a neurologist at the headache clinic for several years now and has been diagnosed with "new daily persistent headaches". The patient went on to have anthrax #5 on 9 June 2011 and anthrax #6 on 30 May 2012 with no significant change in her headache syndrome. However, she does endorse developing generalized fatigue, malaise, as well as generalized arthralgias and myalgias that began within one week after anthrax #5. The symptoms have persisted and an intermittent nature she ever since. She states "I have good days and bad days". She was recently diagnosed with fibromyalgia by her internist in February 2014.
Age: 35.0
Sex: F
Vaccine: ANTH, HEP
Symptoms: Monocyte count increased, Monocyte percentage increased, Myalgia, Nausea, Neutrophil count normal
Clinical narrative: Patient is a 41-year-old female who presents to the Vaccine Healthcare Center for further evaluation and recommendations regarding possible adverse reaction to anthrax vaccine. Patient describes being in her normal state of health until August 2007. Patient describes receiving anthrax #4 on 21 August 2007 (reports no problems with anthrax #1-3). That evening, the patient developed a large local reaction as well as flu like symptoms of fatigue, low-grade fever, myalgias, and arthralgias as well as a bad headache. The following morning she went to the local Medical Clinic and was instructed that her symptoms were a normal reaction. However, she notes a distinct change in quality of headaches that began within one day of the vaccine. She describes the headaches as "an electric current in my head constantly". She further describes this as an ice pick constantly in her brain. She denies the pain being a throbbing quality. She localizes the headaches to the top of the bilateral parietal bone area of her head. She endorses associated photophobia, phonophobia, nausea, and vomiting associated with headache. The headache may also be exacerbated by strong smells and exertion. She states she has not been headache free since March 2008. However, the headache does wax and wane. At its worst, the headache is 10 out of 10 in intensity and at its best it is 2/10 in intensity. Before August 2007 the headaches were in a different location, more throbbing in nature, near the temple area (but bilateral) and not associated with any emesis, nausea, photophobia or phonophobia. Additionally, prior to August 2007 the medications responded to MOTRIN. Currently, the headaches are well controlled with prophylactic medicines to include LYRICA and CYMBALTA and abortive therapy with IMITREX. Additionally, the patient describes deploying in December 2007 with the headaches continuing. However, when she redeployed in March 2008 she noted the headaches became increasingly more severe and "never went away". She describes being hospitalized in May 2008 for these headaches. She has been followed by a neurologist at the headache clinic for several years now and has been diagnosed with "new daily persistent headaches". The patient went on to have anthrax #5 on 9 June 2011 and anthrax #6 on 30 May 2012 with no significant change in her headache syndrome. However, she does endorse developing generalized fatigue, malaise, as well as generalized arthralgias and myalgias that began within one week after anthrax #5. The symptoms have persisted and an intermittent nature she ever since. She states "I have good days and bad days". She was recently diagnosed with fibromyalgia by her internist in February 2014.
Age: 35.0
Sex: F
Vaccine: ANTH, HEP
Symptoms: Neutrophil percentage, Nitrite urine absent, Nuclear magnetic resonance imaging brain normal, Paraesthesia, Phonophobia
Clinical narrative: Patient is a 41-year-old female who presents to the Vaccine Healthcare Center for further evaluation and recommendations regarding possible adverse reaction to anthrax vaccine. Patient describes being in her normal state of health until August 2007. Patient describes receiving anthrax #4 on 21 August 2007 (reports no problems with anthrax #1-3). That evening, the patient developed a large local reaction as well as flu like symptoms of fatigue, low-grade fever, myalgias, and arthralgias as well as a bad headache. The following morning she went to the local Medical Clinic and was instructed that her symptoms were a normal reaction. However, she notes a distinct change in quality of headaches that began within one day of the vaccine. She describes the headaches as "an electric current in my head constantly". She further describes this as an ice pick constantly in her brain. She denies the pain being a throbbing quality. She localizes the headaches to the top of the bilateral parietal bone area of her head. She endorses associated photophobia, phonophobia, nausea, and vomiting associated with headache. The headache may also be exacerbated by strong smells and exertion. She states she has not been headache free since March 2008. However, the headache does wax and wane. At its worst, the headache is 10 out of 10 in intensity and at its best it is 2/10 in intensity. Before August 2007 the headaches were in a different location, more throbbing in nature, near the temple area (but bilateral) and not associated with any emesis, nausea, photophobia or phonophobia. Additionally, prior to August 2007 the medications responded to MOTRIN. Currently, the headaches are well controlled with prophylactic medicines to include LYRICA and CYMBALTA and abortive therapy with IMITREX. Additionally, the patient describes deploying in December 2007 with the headaches continuing. However, when she redeployed in March 2008 she noted the headaches became increasingly more severe and "never went away". She describes being hospitalized in May 2008 for these headaches. She has been followed by a neurologist at the headache clinic for several years now and has been diagnosed with "new daily persistent headaches". The patient went on to have anthrax #5 on 9 June 2011 and anthrax #6 on 30 May 2012 with no significant change in her headache syndrome. However, she does endorse developing generalized fatigue, malaise, as well as generalized arthralgias and myalgias that began within one week after anthrax #5. The symptoms have persisted and an intermittent nature she ever since. She states "I have good days and bad days". She was recently diagnosed with fibromyalgia by her internist in February 2014.
Age: 35.0
Sex: F
Vaccine: ANTH, HEP
Symptoms: Photophobia, Platelet count normal, Protein total normal, Protein urine absent, Pyrexia
Clinical narrative: Patient is a 41-year-old female who presents to the Vaccine Healthcare Center for further evaluation and recommendations regarding possible adverse reaction to anthrax vaccine. Patient describes being in her normal state of health until August 2007. Patient describes receiving anthrax #4 on 21 August 2007 (reports no problems with anthrax #1-3). That evening, the patient developed a large local reaction as well as flu like symptoms of fatigue, low-grade fever, myalgias, and arthralgias as well as a bad headache. The following morning she went to the local Medical Clinic and was instructed that her symptoms were a normal reaction. However, she notes a distinct change in quality of headaches that began within one day of the vaccine. She describes the headaches as "an electric current in my head constantly". She further describes this as an ice pick constantly in her brain. She denies the pain being a throbbing quality. She localizes the headaches to the top of the bilateral parietal bone area of her head. She endorses associated photophobia, phonophobia, nausea, and vomiting associated with headache. The headache may also be exacerbated by strong smells and exertion. She states she has not been headache free since March 2008. However, the headache does wax and wane. At its worst, the headache is 10 out of 10 in intensity and at its best it is 2/10 in intensity. Before August 2007 the headaches were in a different location, more throbbing in nature, near the temple area (but bilateral) and not associated with any emesis, nausea, photophobia or phonophobia. Additionally, prior to August 2007 the medications responded to MOTRIN. Currently, the headaches are well controlled with prophylactic medicines to include LYRICA and CYMBALTA and abortive therapy with IMITREX. Additionally, the patient describes deploying in December 2007 with the headaches continuing. However, when she redeployed in March 2008 she noted the headaches became increasingly more severe and "never went away". She describes being hospitalized in May 2008 for these headaches. She has been followed by a neurologist at the headache clinic for several years now and has been diagnosed with "new daily persistent headaches". The patient went on to have anthrax #5 on 9 June 2011 and anthrax #6 on 30 May 2012 with no significant change in her headache syndrome. However, she does endorse developing generalized fatigue, malaise, as well as generalized arthralgias and myalgias that began within one week after anthrax #5. The symptoms have persisted and an intermittent nature she ever since. She states "I have good days and bad days". She was recently diagnosed with fibromyalgia by her internist in February 2014.
Age: 35.0
Sex: F
Vaccine: ANTH, HEP
Symptoms: Red blood cell count normal, Red cell distribution width normal, Specific gravity urine normal, Urine ketone body absent, Urine leukocyte esterase
Clinical narrative: Patient is a 41-year-old female who presents to the Vaccine Healthcare Center for further evaluation and recommendations regarding possible adverse reaction to anthrax vaccine. Patient describes being in her normal state of health until August 2007. Patient describes receiving anthrax #4 on 21 August 2007 (reports no problems with anthrax #1-3). That evening, the patient developed a large local reaction as well as flu like symptoms of fatigue, low-grade fever, myalgias, and arthralgias as well as a bad headache. The following morning she went to the local Medical Clinic and was instructed that her symptoms were a normal reaction. However, she notes a distinct change in quality of headaches that began within one day of the vaccine. She describes the headaches as "an electric current in my head constantly". She further describes this as an ice pick constantly in her brain. She denies the pain being a throbbing quality. She localizes the headaches to the top of the bilateral parietal bone area of her head. She endorses associated photophobia, phonophobia, nausea, and vomiting associated with headache. The headache may also be exacerbated by strong smells and exertion. She states she has not been headache free since March 2008. However, the headache does wax and wane. At its worst, the headache is 10 out of 10 in intensity and at its best it is 2/10 in intensity. Before August 2007 the headaches were in a different location, more throbbing in nature, near the temple area (but bilateral) and not associated with any emesis, nausea, photophobia or phonophobia. Additionally, prior to August 2007 the medications responded to MOTRIN. Currently, the headaches are well controlled with prophylactic medicines to include LYRICA and CYMBALTA and abortive therapy with IMITREX. Additionally, the patient describes deploying in December 2007 with the headaches continuing. However, when she redeployed in March 2008 she noted the headaches became increasingly more severe and "never went away". She describes being hospitalized in May 2008 for these headaches. She has been followed by a neurologist at the headache clinic for several years now and has been diagnosed with "new daily persistent headaches". The patient went on to have anthrax #5 on 9 June 2011 and anthrax #6 on 30 May 2012 with no significant change in her headache syndrome. However, she does endorse developing generalized fatigue, malaise, as well as generalized arthralgias and myalgias that began within one week after anthrax #5. The symptoms have persisted and an intermittent nature she ever since. She states "I have good days and bad days". She was recently diagnosed with fibromyalgia by her internist in February 2014.
Age: 35.0
Sex: F
Vaccine: ANTH, HEP
Symptoms: Urobilinogen urine decreased, Vomiting, White blood cell count normal, pH urine normal
Clinical narrative: Patient is a 41-year-old female who presents to the Vaccine Healthcare Center for further evaluation and recommendations regarding possible adverse reaction to anthrax vaccine. Patient describes being in her normal state of health until August 2007. Patient describes receiving anthrax #4 on 21 August 2007 (reports no problems with anthrax #1-3). That evening, the patient developed a large local reaction as well as flu like symptoms of fatigue, low-grade fever, myalgias, and arthralgias as well as a bad headache. The following morning she went to the local Medical Clinic and was instructed that her symptoms were a normal reaction. However, she notes a distinct change in quality of headaches that began within one day of the vaccine. She describes the headaches as "an electric current in my head constantly". She further describes this as an ice pick constantly in her brain. She denies the pain being a throbbing quality. She localizes the headaches to the top of the bilateral parietal bone area of her head. She endorses associated photophobia, phonophobia, nausea, and vomiting associated with headache. The headache may also be exacerbated by strong smells and exertion. She states she has not been headache free since March 2008. However, the headache does wax and wane. At its worst, the headache is 10 out of 10 in intensity and at its best it is 2/10 in intensity. Before August 2007 the headaches were in a different location, more throbbing in nature, near the temple area (but bilateral) and not associated with any emesis, nausea, photophobia or phonophobia. Additionally, prior to August 2007 the medications responded to MOTRIN. Currently, the headaches are well controlled with prophylactic medicines to include LYRICA and CYMBALTA and abortive therapy with IMITREX. Additionally, the patient describes deploying in December 2007 with the headaches continuing. However, when she redeployed in March 2008 she noted the headaches became increasingly more severe and "never went away". She describes being hospitalized in May 2008 for these headaches. She has been followed by a neurologist at the headache clinic for several years now and has been diagnosed with "new daily persistent headaches". The patient went on to have anthrax #5 on 9 June 2011 and anthrax #6 on 30 May 2012 with no significant change in her headache syndrome. However, she does endorse developing generalized fatigue, malaise, as well as generalized arthralgias and myalgias that began within one week after anthrax #5. The symptoms have persisted and an intermittent nature she ever since. She states "I have good days and bad days". She was recently diagnosed with fibromyalgia by her internist in February 2014.
Age: 11.0
Sex: M
Vaccine: HEPA, MNQ, TDAP
Symptoms: Axillary pain, Erythema, Local swelling, Pyrexia, Swelling
Clinical narrative: Had Hep A, MENACTRA and Tdap on 7-15-14. Per ED note, had pain in right axilla and swelling anterior chest on 7-16-14. Pain progressed thru the day. Fever developed in the evening of 7-16-14. Increased swelling in arm early 7-17-14; fever spiked to 102. Mom took him to local ED. Venous/doppler was negative. Dx with vaccine reaction. Discharged from ED with KEFLEX Rx to fill if redness spreads/fever persists. Mom states symptoms are improving.
Age: 11.0
Sex: M
Vaccine: HEPA, MNQ, TDAP
Symptoms: Ultrasound Doppler normal, Vaccination complication
Clinical narrative: Had Hep A, MENACTRA and Tdap on 7-15-14. Per ED note, had pain in right axilla and swelling anterior chest on 7-16-14. Pain progressed thru the day. Fever developed in the evening of 7-16-14. Increased swelling in arm early 7-17-14; fever spiked to 102. Mom took him to local ED. Venous/doppler was negative. Dx with vaccine reaction. Discharged from ED with KEFLEX Rx to fill if redness spreads/fever persists. Mom states symptoms are improving.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Redness, swelling and itching near injection site on left upper arm.
Age: 1.91
Sex: F
Vaccine: DTAP, IPV
Symptoms: Injection site induration, Injection site swelling
Clinical narrative: Pt. w/ swelling to (L) leg at injection site. 1 inch firm hard area w/ treatment: KEFLEX (250/5) 3.6 mL PO TID x 10 days. F/U at dr office 7/21/14 to recheck.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Discomfort, Injection site inflammation, Injection site rash, Pain
Clinical narrative: Pt had injection site reaction. Injection site was inflamed and a rash that continued to grow out. Pt was experiencing pain and discomfort. Pt notified pharmacy of condition on 7/17/14 at 0800.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Discomfort, Injection site inflammation, Pain, Rash
Clinical narrative: Pt had injection site reaction. Injection site was inflamed and a rash that continued to grow out. Pt was experiencing pain and discomfort. Pt notified pharmacy of condition on 7/17/14 at 0800.
Age: 25.0
Sex: M
Vaccine: YF
Symptoms: Dizziness, Loss of consciousness, Pallor
Clinical narrative: After injected yellow fever vaccine to patient, patient felt fainting and looked very pale. Patient then became unconscious for seconds. Called 911. While waiting for paramedic, pt slowly regained consciousness. Paramedic arrived and measure his blood pressure. The result was normal. Patient denied to go to hospital.
Age: 51.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Joint range of motion decreased, Pain, Pyrexia, Swelling
Clinical narrative: Woke up 7/11/14 achy and fever. Decreased ROM (L) arm. Erythema, swelling and tenderness 7/12/14.
Age: 51.0
Sex: F
Vaccine: TDAP
Symptoms: Tenderness
Clinical narrative: Woke up 7/11/14 achy and fever. Decreased ROM (L) arm. Erythema, swelling and tenderness 7/12/14.
Age: 25.0
Sex: F
Vaccine: FLUX, FLU3
Symptoms: Musculoskeletal pain, Nuclear magnetic resonance imaging abnormal
Clinical narrative: Less than a week after receiving the influenza vaccine in LT deltoid, the patient developed LT shoulder pain that has not resolved.
Age: 25.0
Sex: F
Vaccine: FLUX, FLU3
Symptoms: Injection site pain, Nuclear magnetic resonance imaging abnormal
Clinical narrative: Less than a week after receiving the influenza vaccine in LT deltoid, the patient developed LT shoulder pain that has not resolved.
Age: 33.0
Sex: M
Vaccine: TDAP, TDAP
Symptoms: Chills, Headache, Malaise, Nausea, Photophobia
Clinical narrative: H/A, f/c, malaise, nausea, photophobia.
Age: 33.0
Sex: M
Vaccine: TDAP, TDAP
Symptoms: Pyrexia
Clinical narrative: H/A, f/c, malaise, nausea, photophobia.
Age: 33.0
Sex: M
Vaccine: TDAP, TDAP
Symptoms: Headache, Malaise, Nausea, Photophobia
Clinical narrative: H/A, f/c, malaise, nausea, photophobia.
Age: 1.11
Sex: F
Vaccine: PNC13, VARCEL, PNC13, VARCEL
Symptoms: Injection site erythema, Injection site reaction, Urticaria
Clinical narrative: Child has redness at site of injection, with increased swelling and hardness described by mother as 2" long.  Next formed two pustules.  Pediatrician stated child was allergic to Varivax, but did not do any treatment or medical exemption.
Age: 1.11
Sex: F
Vaccine: PNC13, VARCEL, PNC13, VARCEL
Symptoms: Allergy to vaccine, Injection site erythema, Injection site induration, Injection site pustule, Injection site swelling
Clinical narrative: Child has redness at site of injection, with increased swelling and hardness described by mother as 2" long.  Next formed two pustules.  Pediatrician stated child was allergic to Varivax, but did not do any treatment or medical exemption.
Age: 1.42
Sex: F
Vaccine: DTAP, HIBV, MMR
Symptoms: Blepharospasm, Blood bicarbonate decreased, Blood glucose, Convulsion, Crying
Clinical narrative: had ibuprofen at 715pm prior to bedtime for teething.  cried out in sleep and began having tonic/clonic arm/leg movements and eye twitching.  lasted several minutes.  vomited afterwards.  had had slight diarrhea the day prior.  no fever.  after vomiting appeard drowsy.  mom drove patient to ER.  en route had another seizure, tonic/clonic with twitching/stiffening, lasted several minutes, vomited afterwards.  in ER vomited twice more.  afebrile on arrival to ER.  no fever noted at home, but had had ibuprofen as noted above prior to bedtime.  appeared post-ictal drowsy afterwards in ER, within 1 hour returned to baseline mental status by 230am in ER.  Admitted to pediatric floor at hospital for further monitoring.  received IV zofran x1 in ER for vomiting.
Age: 1.42
Sex: F
Vaccine: DTAP, HIBV, MMR
Symptoms: Diarrhoea, Grand mal convulsion, Muscle twitching, Musculoskeletal stiffness, Postictal state
Clinical narrative: had ibuprofen at 715pm prior to bedtime for teething.  cried out in sleep and began having tonic/clonic arm/leg movements and eye twitching.  lasted several minutes.  vomited afterwards.  had had slight diarrhea the day prior.  no fever.  after vomiting appeard drowsy.  mom drove patient to ER.  en route had another seizure, tonic/clonic with twitching/stiffening, lasted several minutes, vomited afterwards.  in ER vomited twice more.  afebrile on arrival to ER.  no fever noted at home, but had had ibuprofen as noted above prior to bedtime.  appeared post-ictal drowsy afterwards in ER, within 1 hour returned to baseline mental status by 230am in ER.  Admitted to pediatric floor at hospital for further monitoring.  received IV zofran x1 in ER for vomiting.
Age: 1.42
Sex: F
Vaccine: DTAP, HIBV, MMR
Symptoms: Somnolence, Tonic clonic movements, Vomiting
Clinical narrative: had ibuprofen at 715pm prior to bedtime for teething.  cried out in sleep and began having tonic/clonic arm/leg movements and eye twitching.  lasted several minutes.  vomited afterwards.  had had slight diarrhea the day prior.  no fever.  after vomiting appeard drowsy.  mom drove patient to ER.  en route had another seizure, tonic/clonic with twitching/stiffening, lasted several minutes, vomited afterwards.  in ER vomited twice more.  afebrile on arrival to ER.  no fever noted at home, but had had ibuprofen as noted above prior to bedtime.  appeared post-ictal drowsy afterwards in ER, within 1 hour returned to baseline mental status by 230am in ER.  Admitted to pediatric floor at hospital for further monitoring.  received IV zofran x1 in ER for vomiting.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Body temperature increased, Injection site erythema, Injection site warmth
Clinical narrative: red hot area at injection site measuring approximately 4 x 4 inches. Tempurature of 99.8 orally.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and unknown gender. The patient's pertinent medical history was not reported. On 14-MAY-2013 the patient was vaccinated with second dose of GARDASIL (dose: 0.5 (units not reported), route: intramuscular) for prophylaxis. Concurrent medications were not reported. The patient received her second dose of GARDASIL one year after receiving her first dose and has not received her third dose yet. No adverse effects were reported. No product quality complaint was filed for GARDASIL. Additional information has been requested.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: This spontaneous report as received from a pharmacist regarding his wife refers to a 52 year old female patient. The patient's medical history included high cholesterol. Concomitant therapies included aspirin (manufacturer unknown) and LIPITOR. On 07-JUL-2014 the patient was vaccinated with ZOSTAVAX lot # J011548, expiration date 19-DEC-2014, dose 0.65 ml, route subcutaneous. The reporter stated that on 08-JUL-2014, the patient developed redness at injection site after receiving ZOSTAVAX and injection site was tender to touch. The reporter also mentioned that the patient was with friend of hers on 08-JUL-2014, and then the friend of the patient informed the patient on 10-JUL-2014 that she developed shinlges due to coming in contact with the redness on patient's arm and now has to take an unspecified medication for developed the shingles. The outcome of events reported was reported as not recovered/not resolved. The patient had not sought medical attention. No product quality complaint was involved. This case is linked to the case 1407USA006479 via same reporter link. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Secondary transmission
Clinical narrative: This spontaneous report as received from a pharmacist refers to a female patient of unknown age. No information about medical history, concurrent conditions and concomitant medications were reported. On 08-JUL-2014 the patient was with her friend (also reported as wife of the reporter) who was vaccinated with ZOSTAVAX on 07-JUL-2014. The reporter stated that the patient developed shingles on an unknown date in July 2014 due to coming in contact with the redness on the patient friend's arm. The patient had taken an unspecified medication for shingles. The outcome of events reported is unknown. This case is linked to the case 1407USA005754 via same reporter link. Additional information has been requested.
Sex: U
Vaccine: HEP, HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unknown number of patients of an unknown age. The nurse reported that an unknown number of doses of GARDASIL (0.5ml, intramuscularly) and RECOMBIVAX HB (Pediatric/Adolescent formulation) that were exposed to temperature blow 32F have been administered. No adverse effect was reported. It was unknown if the patients sought medical attention. At the time of report the status of patients was unknown. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash vesicular, Vaccination site reaction
Clinical narrative: This spontaneous report as received from a pharmacist refers to a female patient, age reported as "60". She had none pertinent medical history and no drug reactions or allergies on file. On 03-JUL-2014 the patient was vaccinated with a dose of ZOSTAVAX, 0.65 ml in the left deltoid; route not specified, expiration date 06-MAR-2015, lot# reported as K000995M. On 05-JUL-2014, the patient developed a rash that looked like shingles surrounding the vaccination site. The patient reported no other symptoms to the reporting pharmacist. There was no treatment provided and no lab diagnostic studies were performed. The patient sought medical attention and had an appointment with her primary physician scheduled, however, expressed concerns about seeing the physician because of physician's pregnancy. The outcome of the adverse event was unknown. Relatedness between use of ZOSTAVAX and the adverse event was not reported. Lot number K000995M is an invalid lot number for ZOSTAVAX. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified number of patients (no demographics provided). On an unspecified dates an unspecified number of patients were administered (oka/MERCK) VARIVAX that was improperly stored at temperatures outside the product insert. No adverse effects were reported. This is one of two reports from the same reporter. Additional information is not expected, as there was no consent for contact.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified number of patients (no demographics provided). ON an unspecified dates an unspecified number of patients were administered (Oka/Merck) PROQUAD that was improperly stored at temperatures outside the product insert. No adverse effects were reported. This is one of two reports from the same reporter. Additional information is not expected, as there was no consent for contact.
Age: 53.0
Sex: M
Vaccine: PNC13
Symptoms: Eyelid ptosis, Lethargy, Pain in extremity, White blood cell count increased
Clinical narrative: After administration of PREVNAR 13, a pneumococcal immunization, patient became extremely lethargic, left eyelid was drooping, severe pain in legs and white count increased to 19,000. The immunization PREVNAR 13, was administered June 11, 2014 and as of July 16, 2014, the patient is starting to recover. This event was reported to Immunologist, whose practice administered the vaccine. A message was left for the manufacturer of PREVNAR 13, Wyeth Pharmaceuticals. Please note the lot number of the PREVNAR 13 was H45391, expiration, May 31, 2015.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Influenza like illness, Pain, Pruritus, Rash
Clinical narrative: Large swollen dark purple rash, smaller pink rash, itching.  Flu like symptoms, aches and a headache.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash erythematous, Skin discolouration, Swelling
Clinical narrative: Large swollen dark purple rash, smaller pink rash, itching.  Flu like symptoms, aches and a headache.
Age: 26.0
Sex: F
Vaccine: VARCEL
Symptoms: Urticaria
Clinical narrative: Develope hives on neck and torso, went to MD tx hives with antihistamine.  This clear the hives.  16 hrs later got some pox lasted only 3 days and went away.
Age: 16.0
Sex: F
Vaccine: HEPA, HPV4
Symptoms: Dysstasia, Syncope, Vomiting
Clinical narrative: I administered vaccinations Hep A(1) in Left Deltoid and HPV(3) in Right Deltoid as per MD orders at 0851.  Afterwards patient was given paperwork and education related to vaccinations received and went to check out.  At 0900 I was paged by the front office PC for a stat triage in the lobby.  Upon arrival I told by the PC and family member that patient had fainted and when we tried to assist patient to the back she was unable to stand and patient began to vomit(vomit was clear no food or blood noted at this time).  I asked PC to call 911 and get the LPN and PCP from the clinical area to assist me with the patient.  We put the patient in the W/C and brought her back to the clinical area, I checked patient's Spox which was 100% on RA at that time, while LPN checked B/P, and provider asked mom had this happened before, Mom stated, "No".  Mom informed provider that patient had not eaten anything today.  Provider ordered O2 @ 2L via nasal cannula.  Small sips of water as well as saltine crackers were offered.  EMT's arrived and took over from there.
Age: 25.0
Sex: F
Vaccine: TDAP
Symptoms: Arthralgia, Chills, Headache, Injection site pain, Myalgia
Clinical narrative: Pt. described fever (103.3), joint, muscle aches, site pain, chills, nausea, H/A.
Age: 25.0
Sex: F
Vaccine: TDAP
Symptoms: Nausea, Pyrexia
Clinical narrative: Pt. described fever (103.3), joint, muscle aches, site pain, chills, nausea, H/A.
Sex: U
Vaccine: VARZOS
Symptoms: Underdose, Urticaria
Clinical narrative: This spontaneous report was received from a pharmacist referring to unspecified patient of unknown age and unspecified gender. No pertinent medical history and concurrent conditions reported. On an unknown date the patient was vaccinated with ZOSTAVAX vial (dose not reported). No other concomitant therapies reported. On an unknown date it was reported that ZOSTAVAX leaked from the injection site of the patient's arm therefore the patient only received half of a dose. The pharmacist reported that this patient ended up experiencing hives after receipt of the dose of ZOSTAVAX. The action taken was reported as not applicable. The outcome of the events was unknown. The causality of the event was unspecified. No PQC reported. Additional information has been requested.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
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 ZOSTAVAX (dose, route, lot # not reported). On an unknown date in 2014 (reported as a month or so ago) the patient experienced red, swollen, itching at the injection site. The outcome of the events of red, swollen, itching at the injection site was unknown. Relatedness between the events and ZOSTAVAX was not specified. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site warmth
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 ZOSTAVAX (dose, route, lot # not reported). On an unknown date in 2014 (reported as a month or so ago) the patient experienced red, swollen, itching at the injection site. The outcome of the events of red, swollen, itching at the injection site was unknown. Relatedness between the events and ZOSTAVAX was not specified. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 73.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 73 year old female patient with allergy to BENICAR and BENICAR HCT. The patient had no pertinent medical history. On 28-JUN-2014 the patient was vaccinated with ZOSTAVAX 0.65 ml, subcutaneous (anatomical location, lot # not reported). There was no concomitant medication. On unspecified date in June 2014 the patient experienced redness and warm to touch at the injection site. The patient sought medical attention by contacting the pharmacist. BENADRYL cream and ice was given as a treatment. The outcome of redness and warm to touch at the injection site was unknown. The relatedness between the events and ZOSTAVAX was not specified. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 73.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 73 year old female patient with allergy to BENICAR and BENICAR HCT. The patient had no pertinent medical history. On 28-JUN-2014 the patient was vaccinated with ZOSTAVAX 0.65 ml, subcutaneous (anatomical location, lot # not reported). There was no concomitant medication. On unspecified date in June 2014 the patient experienced redness and warm to touch at the injection site. The patient sought medical attention by contacting the pharmacist. BENADRYL cream and ice was given as a treatment. The outcome of redness and warm to touch at the injection site was unknown. The relatedness between the events and ZOSTAVAX was not specified. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site rash, Injection site warmth
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 54 year old female patient with multiple sclerosis and no drug reactions or allergies. On 07-JUL-2014 the patient was vaccinated subcutaneously with a dose of ZOSTAVAX (0.65ml, once, lot# J014811, expiration date 21-FEB-2015). Concomitant therapies included oxycodone, LYRICA, morphine, and REBIF. On 08-JUL-2014 reported as "the day after", the patient experienced a raised red rash that was warm to the touch at the injection site and "surround area". The reporter stated that the reaction got "progressively worse" on 08-JUL-2014 (reported as "yesterday"). On 09-JUL-2014 (reported as "today"), the patient came in to the pharmacy to seek guidance with the pharmacist. The pharmacist stated that he recommended the patient take BENADRYL and topical hydrocortisone for treatment. There was no lab diagnostic test performed. The outcome of the events was not recovered. The relatedness between the events and ZOSTAVAX was not reported. Additional information has been requested.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site pruritus
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 71 years old female patient. On 18-JUN-2014 the patient was vaccinated with ZOSTAVAX (vial, 19400 PFU, LOT#: J013135, expiry date: 17-JAN-2016, dose, frequency were not reported). On unknown date in June 2014 the patient experienced injection site pain and pruritus. It was reported that the patient contacted the pharmacist. No treatment was given for adverse event. The outcome of the injection site pain and pruritus was reported as not recovered/not resolved. The causality between ZOSTAVAX and injection site pain and pruritus was not reported. Additional information has been requested.
Age: 9.0
Sex: M
Vaccine: TDAP
Symptoms: Dizziness, Immediate post-injection reaction, Pallor
Clinical narrative: Pale, dizzy and lightheaded immediatiately after shot. Walked out after 25 minutes to car.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Vaccine did not prevent shingles. I have a very severe case. It involves the right side of my head. I am seeing 2 doctors. My PCP and eye doctor. I'm hoping more research is done and I am willing to answer any questions to help in this way.
Age: 27.0
Sex: F
Vaccine: TDAP
Symptoms: Chills, Headache, Nausea, Pyrexia
Clinical narrative: Fever of 101, chills, nausea, headache.
Age: 62.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Headache, Muscle rigidity, Pain, Pyrexia
Clinical narrative: Pain, swelling, fever and shivers, ridigity, headache.
Age: 62.0
Sex: F
Vaccine: PPV
Symptoms: Swelling
Clinical narrative: Pain, swelling, fever and shivers, ridigity, headache.
Sex: U
Vaccine: VARZOS
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report was received from a register nurse concerning a patient of unknown age and gender. Medical history and concurrent conditions were not reported. On 14-JUL-2014, the patient was vaccinated with ZOSTAVAX (strength reported as 19400 PFU), lot # J004267, expiration date 12-JUL-2014, 0.65 ml, subcutaneous. Co-suspect and concomitant therapies were not reported. The register nurse reported that on 14-JUL-2014, a patient received an expired dose of ZOSTAVAX. No adverse effects reported. Additional information has been requested.
Age: 0.2
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Pyrexia
Clinical narrative: Pt had a fever of 103.7, when pt came in for a follow up on 7/10/14 his temp ws 94.9 tympanic problem had resolved.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Molluscum contagiosum
Clinical narrative: This spontaneous report was received from a physician, reporting on her daughter, a 13 year old female patient. Medical history and concurrent conditions were not reported. In 2013 (reported as on an unspecified date last year) the patient was vaccinated with the second dose of GARDASIL (dose, strength, lot number, expiration date and route were not reported) for vaccination. Co-suspect and concomitant therapies were not reported. The physician reported that on an unspecified date, since dose two of GARDASIL was administered her daughter was diagnosed with molluscum contagiosum. Diagnosed by a dermatologist. At the time of the report the outcome was unknown. Patient seek medical attention with a dermatologist. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to 6 patients of unknown demographics. Pertinent medical history, drug reactions or allergies were not reported. Since February 2014, the patients may have been vaccinated with improperly stored doses of ZOSTAVAX 19,400 unit, 1 standard package vial of 1, (dose and lot numbers were not reported). No adverse effects reported. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant who reported that ZOSTAVAX reached temperatures that were outside the prescribing information. No adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist concerning to a patient of unknown age and gender. Medical history and concurrent conditions were not reported. On 16-JUL-2014, the patient was vaccinated with the second dose of ZOSTAVAX (dose, strength, lot number, expiration date and route were not reported), subcutaneous. Co-suspect and concomitant therapies were not reported. The pharmacist reported that a patient received ZOSTAVAX on an unspecified date in September 2013. The pharmacist reported that the patient inadvertently received a second dose of ZOSTAVAX today, on 16-JUL-2014. No adverse effects reported. Additional information has been requested.
Sex: U
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site joint pain, Injection site swelling, Injection site warmth
Clinical narrative: This spontaneous report was received from a pharmacist concerning to a patient of unknown age and gender. Medical history and concurrent conditions were not reported. On 16-JUL-2014, the patient was vaccinated with the second dose of ZOSTAVAX (dose, strength, lot number, expiration date and route were not reported), subcutaneous. Co-suspect and concomitant therapies were not reported. The pharmacist reported that a patient received ZOSTAVAX on an unspecified date in September 2013. The pharmacist reported that the patient inadvertently received a second dose of ZOSTAVAX today, on 16-JUL-2014. No adverse effects reported. Additional information has been requested.
Sex: U
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: This spontaneous report was received from a pharmacist concerning to a patient of unknown age and gender. Medical history and concurrent conditions were not reported. On 16-JUL-2014, the patient was vaccinated with the second dose of ZOSTAVAX (dose, strength, lot number, expiration date and route were not reported), subcutaneous. Co-suspect and concomitant therapies were not reported. The pharmacist reported that a patient received ZOSTAVAX on an unspecified date in September 2013. The pharmacist reported that the patient inadvertently received a second dose of ZOSTAVAX today, on 16-JUL-2014. No adverse effects reported. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant who reported that M-M-R II, HSA, reached temperatures that were outside the prescribing information. No adverse effects reported. This is one several reports received from the same reporter. Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: HEPA, TYP, YF
Symptoms: Feeling abnormal, Loss of consciousness, Muscle tightness, Musculoskeletal stiffness
Clinical narrative: Pt reported feeling "funny" 1-2 min post vaccines. Upon reclining pt developed stiffness of arm, legs, fist - jaw clenched, and loss of consciousness. Pt responded quickly to ammonia inhalant. Pt was alert and examined by physician following episode. Pt kept in office 1 1/2 hrs post episode without further reaction.
Age: 45.0
Sex: F
Vaccine: PPV, TDAP, PPV, TDAP
Symptoms: Blood test, Local swelling, Pyrexia, White blood cell count increased
Clinical narrative: Swollen left arm and fever. Husband took patient to hospital and was treated there.
Age: 45.0
Sex: F
Vaccine: PPV, TDAP, PPV, TDAP
Symptoms: Blood test, Eye swelling, Local swelling, Pyrexia
Clinical narrative: Swollen left arm and fever. Husband took patient to hospital and was treated there.
Age: 45.0
Sex: F
Vaccine: PPV, TDAP, PPV, TDAP
Symptoms: Blood test, Local swelling, Pyrexia, White blood cell count increased
Clinical narrative: Vaccine at 10:40 AM on 7/11/14. Symptoms started at 7:00 PM on 7/11/14 high fever 104 at 4:00 AM on 7/12/14 taken to the E.R. at 11:00 AM. Fever, swollen arm and eyes and admitted to hospital same day.
Age: 45.0
Sex: F
Vaccine: PPV, TDAP, PPV, TDAP
Symptoms: Blood test, Eye swelling, Local swelling, Pyrexia
Clinical narrative: Vaccine at 10:40 AM on 7/11/14. Symptoms started at 7:00 PM on 7/11/14 high fever 104 at 4:00 AM on 7/12/14 taken to the E.R. at 11:00 AM. Fever, swollen arm and eyes and admitted to hospital same day.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect dose administered, No adverse event, Product reconstitution issue
Clinical narrative: This spontaneous report as received from a healthcare worker refers to unspecified number of patients of unknown demographics. On unspecified dates, the patients were vaccinated with (Oka/Merck) VARIVAX (dose, frequency unknown). No concomitant medication was reported. The healthcare worker reported patients received less than recommended dose of (Oka/Merck) VARIVAX due to incorrect reconstitution methods. Healthcare worker reported that the full amount of diluent was being drawn up to reconstitute the product but then only 0.5 millilitre of reconstituted product was being administered to the patients. No adverse effects were reported. No product quality complaint was reported. The outcome of events was unknown. This case is related with 1407USA008555, 1407USA008556, 1407USA008557, 1407USA008558, 1407USA008559 and 1407USA007501. Additional information has been requested.