chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: PPV
Symptoms: Injection site discomfort, Injection site pain
Clinical narrative: This spontaneous report was received from a nurse via a company representative concerning two patients of unknown age and gender. On an unknown date, patients were vaccinated with a dose of PNEUMOVAX23 (lot number, expiry date, dose and route unspecified). No concomitant medications were reported. On an unknown date (several months ago), the patients experienced pain and discomfort at the injection site. The nurse informed the representative that the pain was similar but not to the same extent as the other patient (MARRS number 1304USA003687). It was unspecified if the patients sought any medical attention. It was unspecified if any treatment was given or any lab tests were performed. The outcome of pain and discomfort at the injection site was unknown. The relatedness for pain and discomfort at the injection site was unknown for PNEUMOVAX23. This is one of the two reports from the same source. Additional information has been requested.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMRV
Symptoms: Injection site erythema
Clinical narrative: 8 cm x 9 cm area of erythema (R) upper arm.
Age: 11.0
Sex: F
Vaccine: FLUN3, MNQ
Symptoms: Anxiety, Confusional state, Erythema, Feeling hot, Flushing
Clinical narrative: Initial report received from a Health care professional on 28 September 2012. An 11-year-old female patient, with no reported medical history and concomitant medication, received dose of MENACTRA (route, site and side not reported) (Lot unknown) on an unspecified date. It was reported that the patient experienced a "near" syncope episode. Instantly out of it. She also had developed huge patch of redness at the injection site and which extended to the arm on an unspecified date. She also experienced hives and severe headache on an unspecified date. Corrective medications and lab details were not reported. At the time of report the outcome of the event was unknown. Follow-up information was received on 22 February 2013 from a health care professional. The patient had a history of migraines and Asperger's syndrome with developmental delay. The patient who had no illness at the time of vaccination and adverse events following prior vaccines were reported as none, had received an intramuscular right arm injection of MENACTRA, lot number U4288AA and nasal FLUMIST, MedImmune lot number AH2108 on 25 September 2012 and immediately after vaccination, a near syncopal event in which the patient appeared to lose consciousness and was observed by a health care professional. The injection site redness with some swelling started on the same day 25 September 2012 within five minutes of vaccination. It was also noted that patient developed red patches down the same arm. Treatment included BENADRYL and observation for an additional hour. The redness was gone by the end of the hour. On 26 September 2012, the patient returned to physician office with complaint of severe headache. the patient had to "go home from school, flushed and very hot feeling." The patient was examined by a physician. No other treatments were reported. According to the reporter, the patient had no further complaint after the office visit on 26 September 2012. The patient's outcome was recovered. Follow-up received from a health care professional on 04 April 2013. This case was upgraded to serious due to the following event of confirmed loss of consciousness. Per the reporter, the patient did appear to lose consciousness for 30 seconds to 1 minute on 25 September 2012 following vaccinations. Upon becoming responsive the patient was confused and very anxious. It was clarified the onset date of the symptom of headache was 26 September 2012 which was the last date the patient was seen by the reporters office in relationship to these events. On that date, the parent was instructed to call back if the headache persisted, or if any other symptoms occurred. There have been no further contacts regarding this incident to the reporter. The date of full recovery was "probably 27 September 2012" as the patient or parent did not contact the physicians' office after that day with additional concerns. List of documents held by the sender: None.
Age: 11.0
Sex: F
Vaccine: FLUN3, MNQ
Symptoms: Headache, Immediate post-injection reaction, Injection site erythema, Injection site swelling, Laboratory test
Clinical narrative: Initial report received from a Health care professional on 28 September 2012. An 11-year-old female patient, with no reported medical history and concomitant medication, received dose of MENACTRA (route, site and side not reported) (Lot unknown) on an unspecified date. It was reported that the patient experienced a "near" syncope episode. Instantly out of it. She also had developed huge patch of redness at the injection site and which extended to the arm on an unspecified date. She also experienced hives and severe headache on an unspecified date. Corrective medications and lab details were not reported. At the time of report the outcome of the event was unknown. Follow-up information was received on 22 February 2013 from a health care professional. The patient had a history of migraines and Asperger's syndrome with developmental delay. The patient who had no illness at the time of vaccination and adverse events following prior vaccines were reported as none, had received an intramuscular right arm injection of MENACTRA, lot number U4288AA and nasal FLUMIST, MedImmune lot number AH2108 on 25 September 2012 and immediately after vaccination, a near syncopal event in which the patient appeared to lose consciousness and was observed by a health care professional. The injection site redness with some swelling started on the same day 25 September 2012 within five minutes of vaccination. It was also noted that patient developed red patches down the same arm. Treatment included BENADRYL and observation for an additional hour. The redness was gone by the end of the hour. On 26 September 2012, the patient returned to physician office with complaint of severe headache. the patient had to "go home from school, flushed and very hot feeling." The patient was examined by a physician. No other treatments were reported. According to the reporter, the patient had no further complaint after the office visit on 26 September 2012. The patient's outcome was recovered. Follow-up received from a health care professional on 04 April 2013. This case was upgraded to serious due to the following event of confirmed loss of consciousness. Per the reporter, the patient did appear to lose consciousness for 30 seconds to 1 minute on 25 September 2012 following vaccinations. Upon becoming responsive the patient was confused and very anxious. It was clarified the onset date of the symptom of headache was 26 September 2012 which was the last date the patient was seen by the reporters office in relationship to these events. On that date, the parent was instructed to call back if the headache persisted, or if any other symptoms occurred. There have been no further contacts regarding this incident to the reporter. The date of full recovery was "probably 27 September 2012" as the patient or parent did not contact the physicians' office after that day with additional concerns. List of documents held by the sender: None.
Age: 11.0
Sex: F
Vaccine: FLUN3, MNQ
Symptoms: Loss of consciousness, Presyncope, Urticaria
Clinical narrative: Initial report received from a Health care professional on 28 September 2012. An 11-year-old female patient, with no reported medical history and concomitant medication, received dose of MENACTRA (route, site and side not reported) (Lot unknown) on an unspecified date. It was reported that the patient experienced a "near" syncope episode. Instantly out of it. She also had developed huge patch of redness at the injection site and which extended to the arm on an unspecified date. She also experienced hives and severe headache on an unspecified date. Corrective medications and lab details were not reported. At the time of report the outcome of the event was unknown. Follow-up information was received on 22 February 2013 from a health care professional. The patient had a history of migraines and Asperger's syndrome with developmental delay. The patient who had no illness at the time of vaccination and adverse events following prior vaccines were reported as none, had received an intramuscular right arm injection of MENACTRA, lot number U4288AA and nasal FLUMIST, MedImmune lot number AH2108 on 25 September 2012 and immediately after vaccination, a near syncopal event in which the patient appeared to lose consciousness and was observed by a health care professional. The injection site redness with some swelling started on the same day 25 September 2012 within five minutes of vaccination. It was also noted that patient developed red patches down the same arm. Treatment included BENADRYL and observation for an additional hour. The redness was gone by the end of the hour. On 26 September 2012, the patient returned to physician office with complaint of severe headache. the patient had to "go home from school, flushed and very hot feeling." The patient was examined by a physician. No other treatments were reported. According to the reporter, the patient had no further complaint after the office visit on 26 September 2012. The patient's outcome was recovered. Follow-up received from a health care professional on 04 April 2013. This case was upgraded to serious due to the following event of confirmed loss of consciousness. Per the reporter, the patient did appear to lose consciousness for 30 seconds to 1 minute on 25 September 2012 following vaccinations. Upon becoming responsive the patient was confused and very anxious. It was clarified the onset date of the symptom of headache was 26 September 2012 which was the last date the patient was seen by the reporters office in relationship to these events. On that date, the parent was instructed to call back if the headache persisted, or if any other symptoms occurred. There have been no further contacts regarding this incident to the reporter. The date of full recovery was "probably 27 September 2012" as the patient or parent did not contact the physicians' office after that day with additional concerns. List of documents held by the sender: None.
Age: 20.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Myelitis transverse
Clinical narrative: Neck stiffness, muscle soreness, fever, confusion, urinary retention, and weakness developing over 8 days culminating in admission to hospital where presentation and MRI consistent with ADEM.
Age: 20.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Acute disseminated encephalomyelitis, Asthenia, Blood creatine phosphokinase increased, CSF test abnormal, Confusional state
Clinical narrative: Neck stiffness, muscle soreness, fever, confusion, urinary retention, and weakness developing over 8 days culminating in admission to hospital where presentation and MRI consistent with ADEM.
Age: 20.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Musculoskeletal stiffness, Myalgia, Nuclear magnetic resonance imaging brain abnormal, Nuclear magnetic resonance imaging spinal abnormal, Pyrexia
Clinical narrative: Neck stiffness, muscle soreness, fever, confusion, urinary retention, and weakness developing over 8 days culminating in admission to hospital where presentation and MRI consistent with ADEM.
Age: 20.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Urinary retention
Clinical narrative: Neck stiffness, muscle soreness, fever, confusion, urinary retention, and weakness developing over 8 days culminating in admission to hospital where presentation and MRI consistent with ADEM.
Age: 14.0
Sex: F
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Activities of daily living impaired, Asthenia, Back pain, Computerised tomogram, Laboratory test
Clinical narrative: Approximately 1 hour after vaccinations received daughter felt weak, lethargic, had low grade fever of 100, pain on lower back and tingling in legs. MD was contacted. MD advised to continue to monitor and if fever increased and/or pain worsened to call MD back. Fever resolved after Tylenol given. Pain in lower back and legs did not worsen but stayed constant. Daughter lethargic for approx 24 hours. MD followed up with call later that evening. Continued to monitor. Daughter felt better after 24 hours. Back pain subsided for a few days but continued to come and go. Since vaccinations my daughter has had constant lower back pain. Several follow ups with her primary MD were made. Several tests done such as CT, MRI, labs. Referral to specialist were made to rule out any other issues. Referrals to neurology, rheumatology, orthopedics, Physical therapy, spine specialist, pain specialist, acupuncture, stress relieving measures taken..to name a few. All steps were taken to rule out any other issues. At first MDs did not believe back pain could be related to immunizations. It wasn't until we had follow up appointments with specialists that it was now being discussed as the vaccinations being the cause of my daughters constant and on-going back pain. This pain has caused her to miss weeks of school, cause her stress and miss out on activities.
Age: 14.0
Sex: F
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Lethargy, Nuclear magnetic resonance imaging, Pain in extremity, Paraesthesia, Pyrexia
Clinical narrative: Approximately 1 hour after vaccinations received daughter felt weak, lethargic, had low grade fever of 100, pain on lower back and tingling in legs. MD was contacted. MD advised to continue to monitor and if fever increased and/or pain worsened to call MD back. Fever resolved after Tylenol given. Pain in lower back and legs did not worsen but stayed constant. Daughter lethargic for approx 24 hours. MD followed up with call later that evening. Continued to monitor. Daughter felt better after 24 hours. Back pain subsided for a few days but continued to come and go. Since vaccinations my daughter has had constant lower back pain. Several follow ups with her primary MD were made. Several tests done such as CT, MRI, labs. Referral to specialist were made to rule out any other issues. Referrals to neurology, rheumatology, orthopedics, Physical therapy, spine specialist, pain specialist, acupuncture, stress relieving measures taken..to name a few. All steps were taken to rule out any other issues. At first MDs did not believe back pain could be related to immunizations. It wasn't until we had follow up appointments with specialists that it was now being discussed as the vaccinations being the cause of my daughters constant and on-going back pain. This pain has caused her to miss weeks of school, cause her stress and miss out on activities.
Age: 14.0
Sex: F
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Stress
Clinical narrative: Approximately 1 hour after vaccinations received daughter felt weak, lethargic, had low grade fever of 100, pain on lower back and tingling in legs. MD was contacted. MD advised to continue to monitor and if fever increased and/or pain worsened to call MD back. Fever resolved after Tylenol given. Pain in lower back and legs did not worsen but stayed constant. Daughter lethargic for approx 24 hours. MD followed up with call later that evening. Continued to monitor. Daughter felt better after 24 hours. Back pain subsided for a few days but continued to come and go. Since vaccinations my daughter has had constant lower back pain. Several follow ups with her primary MD were made. Several tests done such as CT, MRI, labs. Referral to specialist were made to rule out any other issues. Referrals to neurology, rheumatology, orthopedics, Physical therapy, spine specialist, pain specialist, acupuncture, stress relieving measures taken..to name a few. All steps were taken to rule out any other issues. At first MDs did not believe back pain could be related to immunizations. It wasn't until we had follow up appointments with specialists that it was now being discussed as the vaccinations being the cause of my daughters constant and on-going back pain. This pain has caused her to miss weeks of school, cause her stress and miss out on activities.
Age: 50.0
Sex: M
Vaccine: JEV1, YF
Symptoms: Dizziness, Feeling hot, Headache, Injection site oedema, Injection site swelling
Clinical narrative: Pt experienced the following symptoms: light headedness, headache, severe edema on entire upper left arm, swelling of an area of 6" X 10" centering at the Sub Q injection site of Yellow Fever, and very hot skin.
Age: 50.0
Sex: M
Vaccine: JEV1, YF
Symptoms: Vaccination complication
Clinical narrative: Pt experienced the following symptoms: light headedness, headache, severe edema on entire upper left arm, swelling of an area of 6" X 10" centering at the Sub Q injection site of Yellow Fever, and very hot skin.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: 6 cm redness and warm day 2 surrounding injection site.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Influenza like illness, Oedema peripheral, Oropharyngeal pain, Pain
Clinical narrative: Swollen arm. "Flu like symptoms." Body aches, sore throat.
Age: 20.0
Sex: M
Vaccine: ANTH, SMALL
Symptoms: Pain, Rash erythematous, Rash pruritic, Skin lesion
Clinical narrative: Patient noted raised, red, mildly pruritic bumps on his hands. Some of the lesions are painful.
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Got a severe case of shingles less than 5 years after getting ZOSTAVAX.
Age: 4.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Cough, Eye swelling, Nausea, Pruritus, Scratch
Clinical narrative: Face swollen - esp around eyes - eyes almost completely closed - upper body scratching cough - nausea. Adrenaline - 2 mg/IM given.
Age: 4.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Swelling face
Clinical narrative: Face swollen - esp around eyes - eyes almost completely closed - upper body scratching cough - nausea. Adrenaline - 2 mg/IM given.
Age: 39.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site inflammation
Clinical narrative: Redness and inflammation on injection site developed a few hours post administration.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV
Symptoms: Injection site erythema, Injection site pain, Injection site papule, Injection site rash
Clinical narrative: (L) arm deltoid area where immunizations DTAP/IPV given - red approximately 2-3 cm area of redness/papules in center - rash comes/goes - last few hrs - pain - q 1-2 weeks.
Age: 17.0
Sex: F
Vaccine: MNQ
Symptoms: C-reactive protein increased, Erythema, Full blood count normal, Induration, Injection site erythema
Clinical narrative: 4-10-13 - Fever 104.6, 9x7 cm diameter erythema and induration on (R) deltoid. Rx'd Clindamycin 300mg cap, 2 cap TID x 10 days. Painful area. 4-11-13 - Fever 99.2, area 10.5 cm erythema and induration, itchy. BENADRYL added.
Age: 17.0
Sex: F
Vaccine: MNQ
Symptoms: Injection site induration, Metabolic function test normal, Pain, Pruritus, Pyrexia
Clinical narrative: 4-10-13 - Fever 104.6, 9x7 cm diameter erythema and induration on (R) deltoid. Rx'd Clindamycin 300mg cap, 2 cap TID x 10 days. Painful area. 4-11-13 - Fever 99.2, area 10.5 cm erythema and induration, itchy. BENADRYL added.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Erythema
Clinical narrative: Redness, one large (1/2 inch ball) blister surrounded by small blisters.
Age: 56.0
Sex: F
Vaccine: TDAP
Symptoms: Pain, Pyrexia
Clinical narrative: Hurt all over. Fever for 2 days, 100.2 degrees and 101.4 degrees F.
Age: 5.0
Sex: F
Vaccine: DTAP, HEPA, MMR, MNQ
Symptoms: Wrong drug administered
Clinical narrative: Patient was given DTAP, MMR, Hep A. Patient was given MCV4 and was suppose to receive varicella. I had wrote the order incorrect to MA. She did not check the chart and gave what I had ordered. We will contact parents.
Age: 62.0
Sex: F
Vaccine: PPV
Symptoms: Injection site swelling
Clinical narrative: This spontaneous report was received from a pharmacist refers to a approximately 62 year old female patient with sulfa allergy. The patient's medical history included lymph node removal about 20 years ago approximately in 1993. On an unknown date, the patient was vaccinated with a dose of pneumococcal vaccine, polyvalent (23-valent)(Manufacturer unknown)(lot#, route, dose not reported). No concomitant medications were reported. On an unknown date, the patient experienced severe injection site swelling after she received the vaccine. The outcome of injection site swelling was reported as recovered. The relatedness of the event with pneumococcal vaccine, polyvalent (23-valent)(Manufacturer unknown) was unknown. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to a patient of unknown age and gender. On 22-MAR-2013 at 10:40 am, the patient was vaccinated with VAQTA (lot # 0273AE and expiration date 06-DEC-2014) (dose, therapy route and anatomical location unspecified). The physician reported that VAQTA was exposed to multiple low temperature excursions. Excursion time at -1: 1556.50 hours (also reported 17 hours, 442 hours, 2 -5/4 hours, 59 hours, 2 admin). The patient was not experiencing any known symptoms. This is one of several reports from the same source. Additional information has been requested.
Sex: M
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a Registered Nurse refers to an unknown number of male patients (out of the 4 clients) of unknown age. The nurse reported that on an unknown date, the patients got their doses of GARDASIL a bit early. The patients received the second dose of GARDASIL (lot#, route, dose not reported) 4 weeks after the first dose and the third dose was received 12 weeks later. No adverse effects reported. This is 1 of 2 reports received from the same reporter. Additional information is not expected.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare student refers to a patient of unknown age. The reporter reported that the patient received the first dose of GARDASIL more than one year ago and received the second dose today. No adverse effect reported. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to a patient of unknown age and gender. On 13-MAR-2013 at 11:20 am, the patient was vaccinated with VAQTA (lot # 0273AE and expiration date 06-DEC-2014) (dose, therapy route and anatomical location unspecified). The physician reported that VAQTA was exposed to multiple low temperature excursions. Excursion time at-1: 126.50 hours (also reported 17 hours, 299 hours at 2 admin). The patient was not experiencing any known symptoms. This is one of several reports from the same source. Additional information has been requested.
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a physician refers to a 68 year old male patient. On 10-DEC-2010 the patient was vaccinated with ZOSTAVAX (lot# and dose unknown). No other co-suspects were reported. No concomitant medications were reported. On 18-MAY-2012, the patient experienced shingles. It was unknown if the patient had sought medical attention. Action taken was not provided. The outcome of shingles was unknown. The reporter did not provide assessment of the relationship of the adverse event to the suspect therapy. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a Registered Nurse refers to an unknown number of female patients (out of the 4 clients) of unknown age. The nurse reported that on an unknown date, the patients got their doses of GARDASIL a bit early. The patients received the second dose of GARDASIL(lot#, route, dose not reported) 4 weeks after the first dose and the third dose was received 12 weeks later. No adverse effects reported. This is 1 of 2 reports received from the same reporter. Additional information is not expected.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to a patient of unknown age and gender. On 11-MAR-2013 at 10:00 am, the patient was vaccinated with VAQTA (lot # 0273AE and expiration date 06-DEC-2014) (dose, therapy route and anatomical location unspecified. The physician reported that VAQTA was exposed to multiple low excursions. Excursion time at -1: 126.50 hours (also reported as 17 hours, 238 hours at 2 admin). The patient was not experiencing any known symptoms. This is one of several reports from the same source. Additional information has been requested.
Age: 55.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site swelling
Clinical narrative: Patient had a Tdap injection on 04/05/13. She now has a "bump" on her left deltoid. No other symptoms other then the "bump" she has now.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: VIIth nerve paralysis
Clinical narrative: Bells palsy.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV
Symptoms: Abasia, Musculoskeletal stiffness, Pain, Pyrexia, Weight bearing difficulty
Clinical narrative: Stiffness, soreness, unable to put pressure on leg and unable to walk.  Even unable to sit on toilet seat without experiencing pain.  Fever of 101.3-101.9, administered Advil for pain and fever, pain and fever relieved temporarily but returned within 4 hours.  Soreness and stiffness remain.
Age: 0.01
Sex: M
Vaccine: HEP
Symptoms: Bradycardia, Feeding disorder of infancy or early childhood, Hyporesponsive to stimuli, Laboratory test normal, Respiratory rate decreased
Clinical narrative: Patient was not eating and barely responsive. I called Dr. he told me to watch patient. I work in health care and ended up preforming CPR. He was brought to hospital placed on IVs. Several tests preformed which were all normal. He had gone into shock. He received a Heptavax that morning.
Age: 0.01
Sex: M
Vaccine: HEP
Symptoms: Resuscitation, Shock
Clinical narrative: Patient was not eating and barely responsive. I called Dr. he told me to watch patient. I work in health care and ended up preforming CPR. He was brought to hospital placed on IVs. Several tests preformed which were all normal. He had gone into shock. He received a Heptavax that morning.
Age: 41.0
Sex: M
Vaccine: TDAP
Symptoms: Blister
Clinical narrative: About 6 hours after receiving shot, patient broke out in blisters on his hands and feet.  Pt self-treated with diforasone diacetate, which resolved symptoms in two days.
Age: 5.0
Sex: F
Vaccine: MMR
Symptoms: Headache, Pyrexia
Clinical narrative: Headache began on March 6th.  Fever of 103 degrees started at 530pm and continued through 8am on March 7th.  Fever went up and down through out the day on March 7th and dissipated completed on March 8th.
Age: 57.0
Sex: F
Vaccine: TD
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Nodule, Pain
Clinical narrative: Swollen right arm at injection site. Site also red and sore.  Very painful and itching.  Took Advil, applied ice and heat. Swollen site approx 3" x 3". Temp the second day and night of 99.5, sore and achey all over. Large knot began shrinking approx. 5 days later.  Still have what feels like two small marbles under the skin 9 days later.
Age: 57.0
Sex: F
Vaccine: TD
Symptoms: Skin mass
Clinical narrative: Swollen right arm at injection site. Site also red and sore.  Very painful and itching.  Took Advil, applied ice and heat. Swollen site approx 3" x 3". Temp the second day and night of 99.5, sore and achey all over. Large knot began shrinking approx. 5 days later.  Still have what feels like two small marbles under the skin 9 days later.
Age: 58.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site scar, Injection site swelling
Clinical narrative: After receiving Fluzone intradermal, site swelling with red zone ~1.5 inches across.  Slowly went down over several days but I have a scar at injection site after six months.
Age: 5.0
Sex: F
Vaccine: HEPA
Symptoms: Abdominal pain, Asthenia, Diarrhoea, Headache, Nausea
Clinical narrative: Headache, 04/10/2013 4:00 AM started with abdominal pain and nausea which continued through 04/10/2013 5:00 PM which added diarrhea. At this time 04/11/2013 1:00 PM symptoms that continue are abdominal pain a nausea. And in addition is rectal pain and generalized weakness. Has eaten a handful of oyster crackers since 04/10/2013. Is drinking and urinating.
Age: 5.0
Sex: F
Vaccine: HEPA
Symptoms: Proctalgia
Clinical narrative: Headache, 04/10/2013 4:00 AM started with abdominal pain and nausea which continued through 04/10/2013 5:00 PM which added diarrhea. At this time 04/11/2013 1:00 PM symptoms that continue are abdominal pain a nausea. And in addition is rectal pain and generalized weakness. Has eaten a handful of oyster crackers since 04/10/2013. Is drinking and urinating.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Musculoskeletal pain, Sleep disorder
Clinical narrative: Pain in upper arm where shot was given and progressively got worse with time; went to DR. about 1 1/2 months later because pain was worse.  He gave me an RX for a compounded inflammation cream; did not help and pain is in upper arm and shoulder; getting dressed, putting my arm above my head and sleeping is disturbed when I stretch or sleep in certain positions.  I had my annual physical yesterday, 04/10/2013 and DR. has scheduled an MRI for shoulder/arm for 04/16/2013.
Age: 3.0
Sex: M
Vaccine: FLU3, HEP, MMRV, PNC13
Symptoms: Pruritus, Rash macular
Clinical narrative: Mother called at 1:10 PM & describe red blotches all over child's face.  The child told mother it was itchy.  Dr's office was notified.  Spoke with Dr. in same practice, who said mother should give 2 tsps of Children's Benadryl.  Mother was called & instructed.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Oedema peripheral, Rash, Rash erythematous, Skin warm
Clinical narrative: Rash on left arm. Erythematous, swollen, hot, measuring appx. 6cm in diameter. Within 24h reaction started.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Injection site rash, Oedema peripheral, Pain in extremity, Pruritus
Clinical narrative: Patient called pharmacy at 10:00 am and stated she had rash from inj. site down to elbow. Her arm was sore, swollen, red, and itchy. Pt. was advised to take BENADRYL and contact Dr. or pharmacy if no improvement after several hours. Patient called back around 12:35 pm stating that she did take 2 reg. strength BENADRYL and the swelling did go down slightly but an hour after taking them she said the itching and pain was starting to return. Advised her to take BENADRYL every 4-6 hours and if it does not continue to improve later in the day then call Dr.
Age: 52.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Oedema peripheral
Clinical narrative: Received shot Tuesday 9 April 13, that evening arm red from armpit to elbow and swollen. On Wednesday the red and swollen moved to bicep and forearm, and Thursday red and swollen in forearm area.
Age: 49.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Erythema, swelling and tenderness at injection site on (R) arm.
Age: 19.0
Sex: M
Vaccine: HEP
Symptoms: Face oedema, Loss of consciousness, Respiratory disorder, Seizure like phenomena
Clinical narrative: Hepatitis B #1 given.  Pt. lost consciousness, had facial edema, irregular respirations, seizure like activity for approximately 30 seconds.  Laid back in chair, pt. became alert.  Started oxygen with a rebreather mask and obtained vital signs.  Approximately 4 minutes later when I mentioned giving the other recommended vaccine, pt. again lost consciousness and had the same seizure like activity for about 20 seconds.  Pt. again laid back.  Oxygen continued, vital signs maintained every 15 minutes.  Discussed observation in ER if patient didn't improve or continued to worsen. Patient improved, no ER transport was necessary.  After patient feeling better, sat up and offered apple juice and graham crackers as patient hadn't eaten breakfast.  Pt. transported to car by wheelchair.  Pt. and father given written instructions on syncope after vaccination, and educated on syncope reactions.
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Cough, Pyrexia, Rales, Respiratory tract congestion, Wheezing
Clinical narrative: Cough, congestion, fever, wheezing, crackling sound in lungs. 5 weeks, ongoing. Sudogest 60 mg.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to a patient of unknown age and gender. On 22-MAR-2013 at 11:20 am, the patient was vaccinated with VAQTA (lot # 0273AE and expiration date 06-DEC-2014) (dose, therapy route and anatomical location unspecified). The physician reported that VAQTA was exposed to multiple low temperature excursions. Excursion time -1: 157.50 hours (also reported 17 hours, 443 hours, 2, -5.4 hours, 60 hours, 2 admin). The patient was not experiencing any known symptoms. This is one of several reports from the same source. Additional information has been requested.
Age: 9.0
Sex: F
Vaccine: HEPA, HPV4
Symptoms: Cold sweat, Pallor, Syncope
Clinical narrative: Child was told possibility of lightheaded/dizziness after vaccine HepA and HPV administered in each arm. I went to grap shot record, Mom calls me, states that she fainted.  Patient in chair, pale, clammy. She was responsive.  Reassurance given, waited 30 minutes. More patient education given verbally. Vitals checked.
Age: 82.0
Sex: M
Vaccine: VARZOS
Symptoms: Erythema
Clinical narrative: Patient experienced redness just above the band-aid that covered the vaccine injecton site. The redness appeared solid, and not streaky. His arm was not warm to the touch. I did not notice this redness prior to giving the vaccination. I discussed with the patient that his arm was a little red and he told me he is always red and bruised from his warfarin. He did not seem concerned. The patient stated that he felt fine and his arm felt fine.
Age: 58.0
Sex: F
Vaccine: HEP, TDAP
Symptoms: Dizziness, Feeling abnormal
Clinical narrative: Pt described "feeling funny, light headed, like she was going to faint". Pt had no difficulty breathing, swelling, redness, rash, or any physical sign/symptoms of reaction. All vitals WNL. Pt stated she only had a protein shake for lunch and had not been drinking a lot.
Age: 37.0
Sex: M
Vaccine: ANTH, YF
Symptoms: Dyspnoea, Feeling hot, Pruritus, Throat irritation
Clinical narrative: Shortness of breath, itchy throat and face, hot feeling body.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Patient came in 4/11/13 at 4pm to report redness at the injection site that spanned about 3 inches in diameter with soreness. No other symptoms.
Age: 1.02
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Febrile convulsion, Polymerase chain reaction, Pyrexia, Rash vesicular, Varicella virus test
Clinical narrative: Patient developed a fever of 103.9 on 4/10/2013 and had a febrile seizure in the morning of 4/11/13 and subsequently developed a vesicular rash.  Pt. went to emergency department and is currently admitted to the hospital.
Age: 1.02
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Viral test
Clinical narrative: Patient developed a fever of 103.9 on 4/10/2013 and had a febrile seizure in the morning of 4/11/13 and subsequently developed a vesicular rash.  Pt. went to emergency department and is currently admitted to the hospital.
Age: 12.0
Sex: M
Vaccine: HPV4, MNQ, TDAP, HPV4, MNQ, TDAP
Symptoms: Depressed level of consciousness, Dizziness
Clinical narrative: Child was seated in a chair for observation after vaccine administration.  Two minutes later child c/o dizziness. Child then had a change in LOC and paramedics were called.
Age: 12.0
Sex: M
Vaccine: HPV4, MNQ, TDAP, HPV4, MNQ, TDAP
Symptoms: Altered state of consciousness, Dizziness
Clinical narrative: Child was seated in a chair for observation after vaccine administration.  Two minutes later child c/o dizziness. Child then had a change in LOC and paramedics were called.
Age: 46.0
Sex: M
Vaccine: DTP, FLUX, PPV
Symptoms: Arthralgia, Bed rest, Fatigue, Injection site joint pain
Clinical narrative: JOINT PAIN AND FATIGUE 3 DAYS BED REST BUT RIGHT SHOULDER HAS HURT EVER SINCE AND RIGHT SHOULDER GETTING WORSE 4 MONTHS LATER.
Age: 48.0
Sex: F
Vaccine: DTAP
Symptoms: Chills, Headache, Injection site pain, Nausea
Clinical narrative: Headache, nausea, chills, pain at injection site.
Age: 0.77
Sex: F
Vaccine: HEP, PPV
Symptoms: Pyrexia, Vomiting
Clinical narrative: Fever greater than 102 for over 36 hours - still unresolved.  Vomiting.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a physician (reported as medical student) refers to a patient of unknown age and gender. On 0-APR-2013 the patient was vaccinated with dose 2, GARDASIL (lot#, expiration date and route not reported). On an unknown date in June 2012 the patient was vaccinated with dose 1, GARDASIL (lot#, expiration date and route not reported). No adverse effect reported. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Convulsion
Clinical narrative: This spontaneous report as received from a physician refers to a patient of unknown age and gender who on an unknown date, was vaccinated with GARDASIL (dose, lot # and route not provided). The Physician stated he spoke to his neighbor who is a pediatric neurologist. The physician stated the pediatric neurologist reported he saw one patient who one month post vaccination with GARDASIL developed uncontrolled, strange seizures. The patient sought medical attention and was seen on the physician's office. The outcome of uncontrolled, strange seizures was unknown. The relatedness adverse event was unknown for GARDASIL. Upon internal review uncontrolled, strange seizures was considered to be a medical important event. This is one of several reports from same source. Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Convulsion, Syncope
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to a 13 year old female patient with no medical history or drug reactions/allergies reported. On 17-JUN-2011 the patient was vaccinated with the first dose of GARDASIL (lot # 668819/0477AA, exp 29-JUN-2013), intramuscularly. After receiving the first dose of GARDASIL, on 17-JUN-2011, the patient fainted and developed a seizure. Oxygen was given to the patient. No lab diagnostics studies were performed. Patient's outcome was reported as recovered on 17-JUN-2011. The patient sought medical attention, the physician saw the patient. Upon internal review, seizure was considered as other medically important event. This is 2 of 4 cases reported. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to a patient of unknown age and gender. On 18-MAR-2013 at 2:20 pm, the patient was vaccinated with VAQTA (lot # 0273AE and expiration date 06-DEC-2014) (dose, therapy route and anatomical location unspecified). The physician reported that VAQTA was exposed to multiple low temperature excursions. Excursion time at -1: 132.50 (also reported 17 hours, 410 hours, 2 admin). The patient was not experiencing any known symptoms. This is one of several reports from the same source. Additional information has been requested.
Age: 33.0
Sex: M
Vaccine: HEPA, TYP, YF
Symptoms: Chorioretinal disorder, Choroiditis, Eye inflammation, Fundoscopy abnormal, Intraocular pressure test normal
Clinical narrative: Information has been received from a healthcare professional from a literature report. A previously healthy 33-year-old male was referred to reporters retina service for sudden onset of intermittent floaters and flashing lights in his right eye which developed. 3 weeks following inactivated hepatitis A (manufacturer unknown), yellow fever, and typhoid vaccinations. These vaccines were given prophylactically in preparation for a 2-week trip. The patient had previously received one dose of hepatitis A vaccine (manufacturer unknown) 12 years prior (he did not complete the series) and had never before been exposed to typhoid or yellow fever immunizations. On examination, visual acuity was 20/20 in both eyes. Pupil responses, visual fields to confrontation, and intraocular pressures (14 mmHg) were normal bilaterally. Slit lamp examination revealed 1 +anterior vitreous inflammation bilaterally. Fundus examination of the right eye revealed a few scattered peripheral nonpigmented chorioretinal lesions. The macula and optic nerve appeared normal, and the left fundus was unremarkable. Fluorescein angiography of the right eye demonstrated scattered peripheral hyperfluorescent lesions correlating with those seen in the fundus, and there was no evidence of disc leakage. A comprehensive review of systems was negative for fever, rash, oral ulcers, arthralgias, headache, or vertigo. There was no history of autoimmune disease or recent viral illness. There was no family history of autoimmune disease. The patient was diagnosed as having acute multifocal choroiditis and observed. After 2 weeks, the patient continued to describe occasional floaters. His ocular examination revealed continued low grade anterior vitreous inflammation and the peripheral retinal lesions began to demonstrate early hyperpigmentation. Because of the nonprogressive examination findings and given the excellent visual acuity, it was decided to continue close observation. At 8 weeks, the patient's symptoms had resolved, the vitreous was clear of cellular inflammation, and the fundus revealed punched out areas of retinal pigment epithelium atrophy. Although this case did not prove causation and the relationship remains presumptive, it did suggest that some vaccinations can act as a trigger for immunologic initiation that could subsequently lead to the development of noninfectious uveitis. Additional information has been requested.
Age: 33.0
Sex: M
Vaccine: HEPA, TYP, YF
Symptoms: Photopsia, Pupillary light reflex tests normal, Retinal depigmentation, Retinal pigmentation, Slit-lamp tests abnormal
Clinical narrative: Information has been received from a healthcare professional from a literature report. A previously healthy 33-year-old male was referred to reporters retina service for sudden onset of intermittent floaters and flashing lights in his right eye which developed. 3 weeks following inactivated hepatitis A (manufacturer unknown), yellow fever, and typhoid vaccinations. These vaccines were given prophylactically in preparation for a 2-week trip. The patient had previously received one dose of hepatitis A vaccine (manufacturer unknown) 12 years prior (he did not complete the series) and had never before been exposed to typhoid or yellow fever immunizations. On examination, visual acuity was 20/20 in both eyes. Pupil responses, visual fields to confrontation, and intraocular pressures (14 mmHg) were normal bilaterally. Slit lamp examination revealed 1 +anterior vitreous inflammation bilaterally. Fundus examination of the right eye revealed a few scattered peripheral nonpigmented chorioretinal lesions. The macula and optic nerve appeared normal, and the left fundus was unremarkable. Fluorescein angiography of the right eye demonstrated scattered peripheral hyperfluorescent lesions correlating with those seen in the fundus, and there was no evidence of disc leakage. A comprehensive review of systems was negative for fever, rash, oral ulcers, arthralgias, headache, or vertigo. There was no history of autoimmune disease or recent viral illness. There was no family history of autoimmune disease. The patient was diagnosed as having acute multifocal choroiditis and observed. After 2 weeks, the patient continued to describe occasional floaters. His ocular examination revealed continued low grade anterior vitreous inflammation and the peripheral retinal lesions began to demonstrate early hyperpigmentation. Because of the nonprogressive examination findings and given the excellent visual acuity, it was decided to continue close observation. At 8 weeks, the patient's symptoms had resolved, the vitreous was clear of cellular inflammation, and the fundus revealed punched out areas of retinal pigment epithelium atrophy. Although this case did not prove causation and the relationship remains presumptive, it did suggest that some vaccinations can act as a trigger for immunologic initiation that could subsequently lead to the development of noninfectious uveitis. Additional information has been requested.
Age: 33.0
Sex: M
Vaccine: HEPA, TYP, YF
Symptoms: Visual acuity tests normal, Visual field tests normal, Vitreous floaters
Clinical narrative: Information has been received from a healthcare professional from a literature report. A previously healthy 33-year-old male was referred to reporters retina service for sudden onset of intermittent floaters and flashing lights in his right eye which developed. 3 weeks following inactivated hepatitis A (manufacturer unknown), yellow fever, and typhoid vaccinations. These vaccines were given prophylactically in preparation for a 2-week trip. The patient had previously received one dose of hepatitis A vaccine (manufacturer unknown) 12 years prior (he did not complete the series) and had never before been exposed to typhoid or yellow fever immunizations. On examination, visual acuity was 20/20 in both eyes. Pupil responses, visual fields to confrontation, and intraocular pressures (14 mmHg) were normal bilaterally. Slit lamp examination revealed 1 +anterior vitreous inflammation bilaterally. Fundus examination of the right eye revealed a few scattered peripheral nonpigmented chorioretinal lesions. The macula and optic nerve appeared normal, and the left fundus was unremarkable. Fluorescein angiography of the right eye demonstrated scattered peripheral hyperfluorescent lesions correlating with those seen in the fundus, and there was no evidence of disc leakage. A comprehensive review of systems was negative for fever, rash, oral ulcers, arthralgias, headache, or vertigo. There was no history of autoimmune disease or recent viral illness. There was no family history of autoimmune disease. The patient was diagnosed as having acute multifocal choroiditis and observed. After 2 weeks, the patient continued to describe occasional floaters. His ocular examination revealed continued low grade anterior vitreous inflammation and the peripheral retinal lesions began to demonstrate early hyperpigmentation. Because of the nonprogressive examination findings and given the excellent visual acuity, it was decided to continue close observation. At 8 weeks, the patient's symptoms had resolved, the vitreous was clear of cellular inflammation, and the fundus revealed punched out areas of retinal pigment epithelium atrophy. Although this case did not prove causation and the relationship remains presumptive, it did suggest that some vaccinations can act as a trigger for immunologic initiation that could subsequently lead to the development of noninfectious uveitis. Additional information has been requested.
Age: 82.0
Sex: M
Vaccine: VARZOS
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report was received from a doctor of pharmacy refers to an 82-year-old male patient. On 09-APR-2013 (reported as today) the patient was vaccinated with an expired dose of 0.65 milliliter (ml) ZOSTAVAX (lot # 671451/1193AA, expiration date 25-OCT-2012) subcutaneously. No adverse effects reported. Additional information has been requested.
Age: 64.0
Sex: M
Vaccine: DTP, HEP, HEPA
Symptoms: Rash
Clinical narrative: Skin rash and rash.