chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 29.0
Sex: M
Vaccine: FLUX, PPV
Symptoms: Injection site warmth, Malaise, Nausea, Pyrexia, Somnolence
Clinical narrative: On 11/21/2012 woke up with 101.5 temperature. I was able take Tylenol to bring it down, but the fever kept fluctuating between normal and fever. Had nausea, uncontrollable chills, was cold and hot, very sleepy, vomiting, weakness also had loss of appetite. I had had knee surgery on 11/19/2012 for knee realignment. PNEUMOVAX was given to me on 11/20/2012 in my left shoulder. Also Influenza Split injection was given in my right shoulder.  I had a rash on my left shoulder that grew from the injection site to the elbow and shoulder that was very sore, red and hot. Started as small and grew. I kept getting worse and  On 11/23/2012 woke up with 102.5 temperature and was really sick I was able to get the temperature down with Tylenol but my Dr advised me to go to the to the emergency room. The ER did test for the flu and came back negative. The Dr also checked my leg for infection and did not see any sign on the incision of infection and said looked really good.  Also did blood tests found that came back as had infection somewhere. The ER Dr said she thought I had a infection in my left arm near the injection site and put me on antibiotic. My temperature and side effects went away on 11/25/2012 but the rash remained for another week or so.
Age: 29.0
Sex: M
Vaccine: FLUX, PPV
Symptoms: Vomiting
Clinical narrative: On 11/21/2012 woke up with 101.5 temperature. I was able take Tylenol to bring it down, but the fever kept fluctuating between normal and fever. Had nausea, uncontrollable chills, was cold and hot, very sleepy, vomiting, weakness also had loss of appetite. I had had knee surgery on 11/19/2012 for knee realignment. PNEUMOVAX was given to me on 11/20/2012 in my left shoulder. Also Influenza Split injection was given in my right shoulder.  I had a rash on my left shoulder that grew from the injection site to the elbow and shoulder that was very sore, red and hot. Started as small and grew. I kept getting worse and  On 11/23/2012 woke up with 102.5 temperature and was really sick I was able to get the temperature down with Tylenol but my Dr advised me to go to the to the emergency room. The ER did test for the flu and came back negative. The Dr also checked my leg for infection and did not see any sign on the incision of infection and said looked really good.  Also did blood tests found that came back as had infection somewhere. The ER Dr said she thought I had a infection in my left arm near the injection site and put me on antibiotic. My temperature and side effects went away on 11/25/2012 but the rash remained for another week or so.
Age: 5.0
Sex: F
Vaccine: FLU3
Symptoms: Convulsion
Clinical narrative: Last year several days after vaccine had a seizure was sent to ER and evaluated and released. No further seizures in the last year. Received flu vaccine and 1 days post vaccine had another seizure. To ER for evaluation and treatment released and was to follow up at PCP office 12/10/12.
Age: 9.0
Sex: M
Vaccine: RAB, RAB
Symptoms: Arthralgia, Gait disturbance, Henoch-Schonlein purpura, Joint swelling, Oedema peripheral
Clinical narrative: 24 hours after the 4th Rabies vaccine was administered, the patient developed pain in his feet and knees. This then developed into swelling of feet, knees, and elbows within 24hrs.  Large red "dots" developed on lower extremities. Difficulty walking.  Family brought patient to ED. Pedi MD diagnoses patient with HSP (Henoch-Schonlein Purpura).
Age: 9.0
Sex: M
Vaccine: RAB, RAB
Symptoms: Pain in extremity, Rash, Rash erythematous
Clinical narrative: 24 hours after the 4th Rabies vaccine was administered, the patient developed pain in his feet and knees. This then developed into swelling of feet, knees, and elbows within 24hrs.  Large red "dots" developed on lower extremities. Difficulty walking.  Family brought patient to ED. Pedi MD diagnoses patient with HSP (Henoch-Schonlein Purpura).
Age: 9.0
Sex: M
Vaccine: RAB, RAB
Symptoms: Abasia, Arthralgia, Henoch-Schonlein purpura, Joint swelling, Oedema peripheral
Clinical narrative: 24 hours after the 4th Rabies vaccine was administered, the patient developed pain in his feet and knees. This then developed into swelling of feet, knees, and elbows within 24hrs.  Large red "dots" developed on lower extremities. Difficulty walking.  Family brought patient to ED. Pedi MD diagnoses patient with HSP (Henoch-Schonlein Purpura).
Age: 9.0
Sex: M
Vaccine: RAB, RAB
Symptoms: Pyrexia, Rash
Clinical narrative: 24 hours after the 4th Rabies vaccine was administered, the patient developed pain in his feet and knees. This then developed into swelling of feet, knees, and elbows within 24hrs.  Large red "dots" developed on lower extremities. Difficulty walking.  Family brought patient to ED. Pedi MD diagnoses patient with HSP (Henoch-Schonlein Purpura).
Age: 9.0
Sex: F
Vaccine: FLUN3, VARCEL
Symptoms: Injection site swelling, Injection site warmth, Pain in extremity, Pyrexia
Clinical narrative: FOC reports pt having fever Saturday evening, sore arm, swelling on her upper L arm and as well the site to be hot to touch. No medication was given, no intervention treatment such as ICE was given as well.
Age: 55.0
Sex: F
Vaccine: FLU3
Symptoms: Altered visual depth perception, Arrhythmia, Chest pain, Computerised tomogram, Coordination abnormal
Clinical narrative: Severe chest pain within 10 minutes. 24 hrs later had reduced sensation on entire (L) side (arm, leg & head). 36 hrs later, lost fine motor coordination, disoriented, short of breath cardiac arrhythmias. Hand tremors, still unresolved. Sensitivity to sound & lights. Visual perception reduced.
Age: 55.0
Sex: F
Vaccine: FLU3
Symptoms: Disorientation, Dyspnoea, Hyperacusis, Laboratory test, Motor dysfunction
Clinical narrative: Severe chest pain within 10 minutes. 24 hrs later had reduced sensation on entire (L) side (arm, leg & head). 36 hrs later, lost fine motor coordination, disoriented, short of breath cardiac arrhythmias. Hand tremors, still unresolved. Sensitivity to sound & lights. Visual perception reduced.
Age: 55.0
Sex: F
Vaccine: FLU3
Symptoms: Photophobia, Sensory disturbance, Tremor
Clinical narrative: Severe chest pain within 10 minutes. 24 hrs later had reduced sensation on entire (L) side (arm, leg & head). 36 hrs later, lost fine motor coordination, disoriented, short of breath cardiac arrhythmias. Hand tremors, still unresolved. Sensitivity to sound & lights. Visual perception reduced.
Age: 68.0
Sex: M
Vaccine: TD
Symptoms: CSF culture negative, CSF glucose normal, CSF protein increased, CSF white blood cell count increased, Confusional state
Clinical narrative: Fever & confusion starting "1 week after vaccine given. CSF WBC 79, prot 71, glucose normal. CSF HSV PCR (-) CSF Gram & culture (-). Resolved quickly (1-2d).
Age: 68.0
Sex: M
Vaccine: TD
Symptoms: Gram stain negative, Herpes simplex serology negative, Polymerase chain reaction, Pyrexia
Clinical narrative: Fever & confusion starting "1 week after vaccine given. CSF WBC 79, prot 71, glucose normal. CSF HSV PCR (-) CSF Gram & culture (-). Resolved quickly (1-2d).
Age: 47.0
Sex: F
Vaccine: MMR
Symptoms: Chills, Pain, Rash
Clinical narrative: Soreness all over this past week (today 12/10). Over weekend, developed a rash to face, neck, shoulders, and chest - FRI - rash noted to face. C/O chills this weekend.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Flushing, Headache, Injection site erythema, Myalgia
Clinical narrative: Pt had headache, muscle aches, fatigue, flushed face, large red circle at injection site.
Age: 0.46
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Crying, Similar reaction on previous exposure to drug
Clinical narrative: Mom states child cried for 3 hours after vaccinations. Reports same thing with first round of shots at 2 mths.
Age: 11.0
Sex: F
Vaccine: HPV4, TDAP
Symptoms: Dizziness, Musculoskeletal stiffness, Nausea, Syncope, Vomiting
Clinical narrative: Rec'd GARDASIL #1 on 11-30-12. Mother states c/o nausea Friday night. Child awakened Saturday am & went to shower. Mom heard her collapse, patient came out of shower, vomited, became dizzy again. C/o of feeling "stiff" symptoms lasted about 1 hr & then were gone. Mom states she doesn't want her to have any more GARDASIL.
Age: 65.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Blister, Herpes zoster, Rash pruritic
Clinical narrative: Patient received shingles vaccine in (L) arm. Within 24 hours started breaking out in itchy patches of blisters. Started under neck, then down underside of (R) arm & one spot on (R) inner thigh. Came back to clinic & diagnosed with shingles. Treated with ZOVIRAX Cream & triamcinolone 0.1% cream. Instructed patient to return to clinic tomorrow if symptoms worsen.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Patient was in office for visit on 12-3-12. Concerns of vaccine reaction. Symptoms include swelling, redness and itching left upper arm.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Local reaction
Clinical narrative: Local redness, swelling and pain at the site of vaccine. Given BENADRYL PRN. Reaction at site of DTaP.
Age: 44.0
Sex: F
Vaccine: HEPAB, IPV
Symptoms: Injected limb mobility decreased, Injection site pain
Clinical narrative: C/O sore (R) deltoid weeks after injection followed by loss of (R) shoulder motion, saw PCP, then 8 wk of physical therapy to regain shoulder ROM.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Cyanosis, Erythema, Skin discolouration, Swelling
Clinical narrative: Redness, swelling, black & blue.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pruritus, Skin warm, Swelling
Clinical narrative: Pt received ZOSTAVAX in left tricep on 12/7/12. Within 12 hours swelling and redness occurred progressing steadily to 8 in long / 5 in wide. It is warm to the touch & itchy.
Age: 49.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site reaction, Local reaction, Urticaria
Clinical narrative: Severe local reaction at site of injection. PNEUMOVAX 23 0.5 mL given IM RA deltoid. Large welt reaction approx. hand-size observed appearing within hrs of injection. Resolved within 48 hours as per patient.
Age: 58.0
Sex: F
Vaccine: DTAP
Symptoms: Insomnia, Mobility decreased, Neuralgia, Pain, Swelling
Clinical narrative: Shoulder swelled to the size of a grapefruit. Severe pain with movement. Unable to raise affected arm over my head without assistance from other arm. Unable to sleep because of pain.  Soaks, heating pad, cold applied. Massage and exercise to add absorption of vaccine. Pain medication, Advil 800mg every 4 hours. Progressed to hydroco/apap 7.5-500 tab at night only to be able to sleep. 12/10/12 Pain continues to a lesser degree, neuralgia down my arm to my wrist and up my clavicle through my neck.
Age: 64.0
Sex: F
Vaccine: TDAP
Symptoms: Extensive swelling of vaccinated limb, Injected limb mobility decreased, Injection site pain, Injection site swelling, Joint range of motion decreased
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of decreased range of motion arm in a 64-year-old female subject who was vaccinated with BOOSTRIX (GlaxoSmithKline). Historic vaccination included tetanus vaccine (non-gsk);non-GSK manufacturer;unknown;unknown given in 2008. Concurrent medications included PROTONIX. On 10 October 2012 at 11:00 the subject received unspecified dose of BOOSTRIX (.5 ml. intramuscular, left deltoid). On 11 October 2012, within 24 hours after vaccination with BOOSTRIX, the subject experienced injection site pain and extensive swelling of vaccinated limb. On an unspecified date the subject experienced decreased range of motion arm. The healthcare professional, who is also a nurse practitioner, reported that within 24 hours of BOOSTRIX administration the subject experienced swelling at the injection site that extended under the arm nearly to the elbow and also to the axilla and down to the "galline". The swelling resolved after three to four days. Since the swelling resolved, the subject has had decreased mobility/range of motion in her left arm and shoulder. The subject also experienced severe pain/aching at the injection site within 24 hours of BOOSTRIX administration which was still evident to the subject but had since improved. The subject had presented to the clinic to follow-up with the healthcare professional. At the time of reporting, the healthcare professional was considering a physical therapy referral for the subject. The healthcare professional considered the events were disabling. At the time of reporting the extensive swelling of vaccinated limb was resolved, injection site pain had improved and decreased range of motion arm was unresolved. The healthcare professional considered the events were probably related to vaccination with BOOSTRIX.
Age: 0.5
Sex: M
Vaccine: RV5
Symptoms: Dermatitis diaper, Diarrhoea, Faeces discoloured, Flatulence, Frequent bowel movements
Clinical narrative: Continuous loose green stools, approximately increased as day went on.  Normally happy infant now fussy and irritable, stools with gas, infant panting seems crampy, low groan whine, wanting to breastfeed constantly. Stool increased to every 20 minutes, diaper rash ensued from frequent stools. increased in fussy demenor with frequent diaper changes.
Age: 0.5
Sex: M
Vaccine: RV5
Symptoms: Increased appetite, Irritability, Moaning, Muscle spasms, Respiratory rate increased
Clinical narrative: Continuous loose green stools, approximately increased as day went on.  Normally happy infant now fussy and irritable, stools with gas, infant panting seems crampy, low groan whine, wanting to breastfeed constantly. Stool increased to every 20 minutes, diaper rash ensued from frequent stools. increased in fussy demenor with frequent diaper changes.
Age: 11.0
Sex: M
Vaccine: TDAP
Symptoms: Asthenia, Chills, Dizziness, Fatigue, Gait disturbance
Clinical narrative: Vaccine injury report December 10, 2012. Patient received the TDap vaccine at 10am on Friday, December 7, 2012. He immediately felt pain (left arm) at the injection site like a "charley horse" and felt the vaccine run through his arm. He seemed to be ok the rest of the day with just soreness in his arm. The following day he felt tired, his throat was slightly sore. On Sunday, December 9, 2012 he reported symptoms of headache, chills, lack of energy, mucus in his throat. As of early evening he had a fever of 100F and the headache pain increased. Overnight he did not sleep well. He had chills and fever all night with nausea. At 6am Monday, December 10, 2012, he presented symptoms of 103F fever, nausea, headache, chills, body aches and total lack of energy, uncontrollable body shaking and dizzy enough that I had to walk him to the bathroom. As of 6:50pm this evening he still has the same symptoms.
Age: 11.0
Sex: M
Vaccine: TDAP
Symptoms: Headache, Immediate post-injection reaction, Increased upper airway secretion, Injection site pain, Nausea
Clinical narrative: Vaccine injury report December 10, 2012. Patient received the TDap vaccine at 10am on Friday, December 7, 2012. He immediately felt pain (left arm) at the injection site like a "charley horse" and felt the vaccine run through his arm. He seemed to be ok the rest of the day with just soreness in his arm. The following day he felt tired, his throat was slightly sore. On Sunday, December 9, 2012 he reported symptoms of headache, chills, lack of energy, mucus in his throat. As of early evening he had a fever of 100F and the headache pain increased. Overnight he did not sleep well. He had chills and fever all night with nausea. At 6am Monday, December 10, 2012, he presented symptoms of 103F fever, nausea, headache, chills, body aches and total lack of energy, uncontrollable body shaking and dizzy enough that I had to walk him to the bathroom. As of 6:50pm this evening he still has the same symptoms.
Age: 11.0
Sex: M
Vaccine: TDAP
Symptoms: Oropharyngeal pain, Pain, Pain in extremity, Poor quality sleep, Pyrexia
Clinical narrative: Vaccine injury report December 10, 2012. Patient received the TDap vaccine at 10am on Friday, December 7, 2012. He immediately felt pain (left arm) at the injection site like a "charley horse" and felt the vaccine run through his arm. He seemed to be ok the rest of the day with just soreness in his arm. The following day he felt tired, his throat was slightly sore. On Sunday, December 9, 2012 he reported symptoms of headache, chills, lack of energy, mucus in his throat. As of early evening he had a fever of 100F and the headache pain increased. Overnight he did not sleep well. He had chills and fever all night with nausea. At 6am Monday, December 10, 2012, he presented symptoms of 103F fever, nausea, headache, chills, body aches and total lack of energy, uncontrollable body shaking and dizzy enough that I had to walk him to the bathroom. As of 6:50pm this evening he still has the same symptoms.
Age: 11.0
Sex: M
Vaccine: TDAP
Symptoms: Tremor
Clinical narrative: Vaccine injury report December 10, 2012. Patient received the TDap vaccine at 10am on Friday, December 7, 2012. He immediately felt pain (left arm) at the injection site like a "charley horse" and felt the vaccine run through his arm. He seemed to be ok the rest of the day with just soreness in his arm. The following day he felt tired, his throat was slightly sore. On Sunday, December 9, 2012 he reported symptoms of headache, chills, lack of energy, mucus in his throat. As of early evening he had a fever of 100F and the headache pain increased. Overnight he did not sleep well. He had chills and fever all night with nausea. At 6am Monday, December 10, 2012, he presented symptoms of 103F fever, nausea, headache, chills, body aches and total lack of energy, uncontrollable body shaking and dizzy enough that I had to walk him to the bathroom. As of 6:50pm this evening he still has the same symptoms.
Age: 65.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Cellulitis, Malaise, Pain, Swelling
Clinical narrative: Pneumonia vaccine given in rt arm.  Pt started getting cellulits on his rt arm the next evening of 12/6/12.  Pt reported, pain, swelling and generalized ill feeling.
Age: 24.0
Sex: F
Vaccine: TD
Symptoms: Electroencephalogram abnormal, Injected limb mobility decreased, Injury, Monoplegia, Nerve conduction studies abnormal
Clinical narrative: I was given the vaccine before being released from hospital within few hours I start having pain in my arm and it gradually turned severe within hours of receiving vaccine, couldn't use my arm for about two weeks, it caused paralysis, I have been put on many medications and I am currently on gabapentin to control my nerve pain.
Age: 24.0
Sex: F
Vaccine: TD
Symptoms: Neuralgia, Nuclear magnetic resonance imaging abnormal, Pain in extremity
Clinical narrative: I was given the vaccine before being released from hospital within few hours I start having pain in my arm and it gradually turned severe within hours of receiving vaccine, couldn't use my arm for about two weeks, it caused paralysis, I have been put on many medications and I am currently on gabapentin to control my nerve pain.
Age: 2.0
Sex: M
Vaccine: DTAP, HIBV, MMR, PNC13, DTAP, HIBV, MMR, PNC13
Symptoms: Abnormal behaviour, Aggression, Balance disorder, Coordination abnormal, Crying
Clinical narrative: Within about 6 hours of being given the shots, my 2 yr. old son showed signs of being unusually unbalanced - his coordination and motor skills were affected, he was staggering, hitting furniture and "woozy" and he was not responsive at times staring off. He has also exhibited behavior changes with increased aggressiveness and irritability, interrupted sleep patterns at night waking often and crying during the last several nights.
Age: 2.0
Sex: M
Vaccine: DTAP, HIBV, MMR, PNC13, DTAP, HIBV, MMR, PNC13
Symptoms: Dizziness, Gait disturbance, Irritability, Middle insomnia, Psychomotor skills impaired
Clinical narrative: Within about 6 hours of being given the shots, my 2 yr. old son showed signs of being unusually unbalanced - his coordination and motor skills were affected, he was staggering, hitting furniture and "woozy" and he was not responsive at times staring off. He has also exhibited behavior changes with increased aggressiveness and irritability, interrupted sleep patterns at night waking often and crying during the last several nights.
Age: 2.0
Sex: M
Vaccine: DTAP, HIBV, MMR, PNC13, DTAP, HIBV, MMR, PNC13
Symptoms: Sleep disorder, Staring, Unresponsive to stimuli
Clinical narrative: Within about 6 hours of being given the shots, my 2 yr. old son showed signs of being unusually unbalanced - his coordination and motor skills were affected, he was staggering, hitting furniture and "woozy" and he was not responsive at times staring off. He has also exhibited behavior changes with increased aggressiveness and irritability, interrupted sleep patterns at night waking often and crying during the last several nights.
Age: 2.0
Sex: M
Vaccine: DTAP, HIBV, MMR, PNC13, DTAP, HIBV, MMR, PNC13
Symptoms: Aggression, Crying, Fall, Gait disturbance, Insomnia
Clinical narrative: Within about 6 hours of being given the shots, my 2 yr. old son showed signs of being unusually unbalanced - his coordination and motor skills were affected, he was staggering, hitting furniture and "woozy" and he was not responsive at times staring off. He has also exhibited behavior changes with increased aggressiveness and irritability, interrupted sleep patterns at night waking often and crying during the last several nights.
Age: 2.0
Sex: M
Vaccine: DTAP, HIBV, MMR, PNC13, DTAP, HIBV, MMR, PNC13
Symptoms: Irritability, Psychomotor hyperactivity, Skin warm, Staring, Unresponsive to stimuli
Clinical narrative: Within about 6 hours of being given the shots, my 2 yr. old son showed signs of being unusually unbalanced - his coordination and motor skills were affected, he was staggering, hitting furniture and "woozy" and he was not responsive at times staring off. He has also exhibited behavior changes with increased aggressiveness and irritability, interrupted sleep patterns at night waking often and crying during the last several nights.
Age: 40.0
Sex: F
Vaccine: TYP
Symptoms: Abdominal pain upper, Diarrhoea, Fatigue, Headache, Nausea
Clinical narrative: Very mild sore throat and sinus drainage initially on day 1. Day 2 - Sinus and sore throat, fatigue. Day 3 - Body aches, headache, severe nausea, stomach pains. Day 4: mild body aches, nausea, severe stomach pains, mild diarrhea.
Age: 40.0
Sex: F
Vaccine: TYP
Symptoms: Oropharyngeal pain, Pain, Paranasal sinus hypersecretion
Clinical narrative: Very mild sore throat and sinus drainage initially on day 1. Day 2 - Sinus and sore throat, fatigue. Day 3 - Body aches, headache, severe nausea, stomach pains. Day 4: mild body aches, nausea, severe stomach pains, mild diarrhea.
Age: 81.0
Sex: M
Vaccine: FLUX, VARZOS
Symptoms: Muscle spasms
Clinical narrative: This spontaneous report was received from a patient's daughter concerning to an 81 years old male patient. On 04-DEC-2012, the patient was vaccinated with a subcutaneous dose of 0.65 ml ZOSTAVAX (lot not reported). No other co-suspects were reported. Since 05-DEC-2012, he had been having intermittent muscle spasms in the ZOSTAVAX injection arm. The patient's daughter stated that her father received the shot subcutaneously in the deltoid, but spasms were from his wrist to elbow. The patient also received an unspecified flu shot the same day in the opposite arm. The outcome of the event was unknown. The relatedness the event was unknown for ZOSTAVAX. Additional information has been requested.
Age: 66.0
Sex: F
Vaccine: TDAP
Symptoms: Arthralgia, Injection site pain
Clinical narrative: Patient experienced tenderness at injection site in the first 24hrs after. Then 48hrs later experienced arthralgia in left shoulder joint which continues to worsen.
Age: 1.28
Sex: M
Vaccine: DTAP, FLU3, HIBV, PNC13
Symptoms: Pharyngitis, Pyrexia
Clinical narrative: 12/4/12 Immunizations given 15 mo check up. 12/6/12 Office visit / mom stated fever 101-104 degrees since immunizations given. 12/7/12 Follow up visit Dx: Acute Pharyngitis / post vaccination.
Age: 24.0
Sex: F
Vaccine: FLU3
Symptoms: Burning sensation, Headache
Clinical narrative: Headache, burning in axilla and across chest.
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site induration, Injection site pain
Clinical narrative: 18x25 cm tender, indurated, erythematous area (L) deltoid - (Pt. unaware he was previously vaccinated with PPV 6/5/12).
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Pruritus, Rash
Clinical narrative: Having rash on chest and legs. Itching. Scratching.
Age: 26.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site rash
Clinical narrative: Patient called on 12/10/12 after receiving the immunization on 12/8/12 asking what she could take for a rash that had developed at site of injection. Patient advised to take BENADRYL and or hydrocortisone if discomfort continues.
Age: 1.1
Sex: M
Vaccine: FLU3, MMR, VARCEL
Symptoms: Erythema, Local swelling
Clinical narrative: Localized swelling and redness.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site discolouration, Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Within 10 minutes of receiving the vaccine, I had severe itching and burning at the site of injection. The site became swollen and hot to the touch. The area was dark reddish purple (1 x 2 inches) with induration. Reaction lasted approximately 4 weeks.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site warmth
Clinical narrative: Within 10 minutes of receiving the vaccine, I had severe itching and burning at the site of injection. The site became swollen and hot to the touch. The area was dark reddish purple (1 x 2 inches) with induration. Reaction lasted approximately 4 weeks.
Age: 29.0
Sex: F
Vaccine: FLU3, VARZOS, FLU3, PPV, VARZOS
Symptoms: Herpes zoster
Clinical narrative: Patient received ZOSTAVAX on 11/13/2012. Approximately 2 weeks later the patient had shingles. Patient has Crohn's disease and had resumed her ENTOCORT a week prior to acquiring her third case of shingles.
Age: 29.0
Sex: F
Vaccine: FLU3, VARZOS, FLU3, PPV, VARZOS
Symptoms: Bronchospasm
Clinical narrative: Patient received ZOSTAVAX on 11/13/2012. Approximately 2 weeks later the patient had shingles. Patient has Crohn's disease and had resumed her ENTOCORT a week prior to acquiring her third case of shingles.
Age: 29.0
Sex: F
Vaccine: FLU3, VARZOS, FLU3, PPV, VARZOS
Symptoms: Herpes zoster
Clinical narrative: Patient was immunized in the early evening. Later that night she experienced 4 episodes of severe bronchospasm. Patient has a history of asthma and her physician has subsequently prescribed SINGULAIR.
Age: 29.0
Sex: F
Vaccine: FLU3, VARZOS, FLU3, PPV, VARZOS
Symptoms: Bronchospasm
Clinical narrative: Patient was immunized in the early evening. Later that night she experienced 4 episodes of severe bronchospasm. Patient has a history of asthma and her physician has subsequently prescribed SINGULAIR.
Age: 1.48
Sex: F
Vaccine: DTAP, HEPA
Symptoms: Skin test positive, Urticaria
Clinical narrative: Mild hives 1 day after receiving immunizations. Treated with ZYRTEC and hydrocortisone cream.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pain, Pruritus, Swelling
Clinical narrative: Pt received shingles vaccine at pharmacy next day itching, swelling, redness, pain.
Age: 57.0
Sex: F
Vaccine: FLU3
Symptoms: Eye irritation, Eye swelling, Lacrimation increased
Clinical narrative: Pt. stated she had sandy, watery eyes about 4 hrs following vaccine followed by her eyes being swollen shut the morning after. Did clear up later the following day approximately 24 hours after vaccine.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Syncope
Clinical narrative: Syncopal episode after immunizations.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Eye swelling, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Injection site red, warm, raised. Patient has swollen neck, red neck and upper chest, eyes swollen red and irritated, tickly throat. Advised BENADRYL & call P.C.P. MD advised BENADRYL 4 tablespoons every 4-6 hours.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Local swelling, Ocular hyperaemia, Throat irritation
Clinical narrative: Injection site red, warm, raised. Patient has swollen neck, red neck and upper chest, eyes swollen red and irritated, tickly throat. Advised BENADRYL & call P.C.P. MD advised BENADRYL 4 tablespoons every 4-6 hours.
Age: 78.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injected limb mobility decreased, Injection site pain
Clinical narrative: Patient had severe pain at site of injection, could not lift arm.
Sex: F
Vaccine: HPV4
Symptoms: Pharyngeal oedema
Clinical narrative: This spontaneous report as received from a registered pharmacist refers to a female patient of unknown age. The patient was vaccinated with a dose of GARDASIL (Lot # not reported) on an unspecified date. No other co-suspects were reported. No concomitant medications were reported. The pharmacist reported that on an unknown date the patient experienced her throat swelled up after receiving GARDASIL. The patient was prescribed an unspecified medication and she fully recovered. The relatedness for throat swelled up was unknown for GARDASIL. Additional information is not expected.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered pharmacist refers to an unknown number of patients who were vaccinated with doses of GARDASIL (Lot # not reported) on an unspecified date, that were exposed to 29 F for 15 minutes. No adverse effect was reported. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse refers to multiple unspecified patients of unknown age. The nurse reported that during the last 2 weeks the patient may have received doses of with GARDASIL,(lot number, expiration date and route was not reported ) that had been exposed to unsupportable cold temperatures. No concomitant medications were reported. It was unknown if or not any individual patient might have received more that one of the affected vaccines. No adverse effect was reported. It was unspecified if the patients had sought medical attention. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age. The patient was vaccinated with the first dose of GARDASIL (Lot # not reported) in October 2011 and received her second dose of GARDASIL (Lot # not reported) in October 2012. No adverse effect was reported. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age. The patient was vaccinated with the second dose of GARDASIL (Lot # not reported) in 2009 and received her third dose of GARDASIL (Lot # not reported) on 05-DEC-2012. No adverse effect was reported. Additional information has been requested.
Age: 16.0
Sex: U
Vaccine: HPV4
Symptoms: Expired drug administered
Clinical narrative: This spontaneous report as received from a other health professional. The primary reporter is a nurse who states the same expired GARDASIL lot # (666595/0096Z) expiration date 14Oct2012, was administered to 3 clients. This was the second dose in the GARDASIL series for all three clients, and they were vaccinated on 30Nov2012. Client one, vaccinated in left deltoid. No other co-suspects were reported. No treatment information was reported. All drop down boxes apply to all three clients. No concomitant medications were reported. No other information was provided.
Age: 0.22
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Choking, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse refers to a 7 month old female patient. The patient's current condition included eczema. On 29-JUN-2012, the patient was vaccinated with live, oral ROTATEQ,(lot number (672075/1711AA), expiration date 13-JUL-2013, route not reported). No concomitant medications were reported. The reporter stated that the patient might have aspirated a dose of oral ROTATEQ during administration. No adverse effect was reported. The patient did not receive any treatment. The patient sought medical attention. (reported as happened in office). Follow up information received the patient. The patient had no pre existing allergies. On 29-JUN-2012 at 10:00 a.m. the patient was vaccinated with a dose of live, ROTATEQ orally. On 29-JUN-2012, the patient was also vaccinated with PENTACEL, (lot number C7193AA, route intramuscular administered on the left thigh) and PREVNAR 13, (lot number FLA178, route intramuscular, administered on right thigh). The reporter stated that the patient choked on live, oral ROTATEQ vaccine. No adverse reactions occurred. The patient completely recovered. The patient had no relevant diagnostic tests done. The patient had no illness at the time of vaccination. Additional information is not expected.
Age: 11.0
Sex: M
Vaccine: HPV4
Symptoms: Expired drug administered
Clinical narrative: This spontaneous report as received from a other health professional. The primary reporter is a nurse who states the same expired GARDASIL lot # (666595/0096Z) expiration date 14Oct2012, was administered to 3 clients. This was the second dose in the GARDASIL series for all three clients, and they were vaccinated on 30Nov2012. Client one, vaccinated in right deltoid. No other co-suspects were reported. No treatment information was reported. All drop down boxes apply to all three clients. No concomitant medications were reported. No other information was provided.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a nurse practitioner refers to a patient of unknown age (gender unspecified). On an unknown date, the patient was vaccinated with first dose (reported as dose 1 was given many years ago by a different unspecified provider) of GARDASIL, (lot number, expiration date and route not reported). No concomitant medications were reported. On approximately 29-NOV-2012, the reporter stated that the patient was in the office now to receive dose 2 of GARDASIL which would be late. No symptoms were reported. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age. The patient was vaccinated with GARDASIL. No other co-suspects were reported. No concomitant medications were reported. On an unknown date the patient experienced first dose unspecified 1 year ago, to received the second dose 12/04/2012. No treatment information was reported. The outcome of first dose unspecified 1 year ago, to received the second dose 12/04/2012 is unknown. The relatedness for first dose unspecified 1 year ago, to received the second dose 12/04/2012 is unknown for GARDASIL. Patient is in the office today, 12/04/2012, to receive the second dose of GARDASIL. No AE reported. Additional information has been requested.
Age: 12.0
Sex: M
Vaccine: HPV4
Symptoms: Expired drug administered
Clinical narrative: This spontaneous report as received from a other health professional. The primary reporter is a nurse who states the same expired GARDASIL lot #666595/0096Z) expiration date 14Oct2012, was administered to 3 clients. This was the second dose in the GARDASIL series for all three clients, and they were vaccinated on 30Nov2012. Client, vaccinated in right deltoid. No other co-suspects were reported. No treatment information was reported. All drop down boxes apply to all three clients. No concomitant medications were reported. No other information was provided.
Age: 36.0
Sex: F
Vaccine: MMR
Symptoms: Rubella antibody negative
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 36 years old female patient. On an unknown date the patient was vaccinated with an unspecified number of doses of M-M-R II, dose and route of administration were not reported. No other co-suspects were reported. No concomitant medications were reported. On an unknown date the patient had titers for rubella that were "equivocal". The nurse reported that because of this "equivocal" titer result the patient will need to receive another dose of M-M-R II. It was reported that the patient sought medical attention by an office visit. The nurse also mentioned that she has been seen in the past an unspecified number of female patient who are postpartum and have low rubella titers even though they have received an unspecified number of doses of MMR in the past (MARRS case # 1212USA003240, same reporter link). The outcome of has titers for rubella that are "equivocal" is unknown. The relatedness for has titers for rubella that are "equivocal" was no reported for M-M-R II. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age. On an unknown date, the patient was vaccinated with,1 DF ZOSTAVAX (dose and route not reported). No other co-suspects were reported. No concomitant medications were reported. On an unknown date the patient experienced shingles. No treatment information was reported. The outcome of shingles was unknown. The relatedness for shingles was unknown for ZOSTAVAX. Follow up information was received from a pharmacist refers to a 60 year old female patient with a history of chickenpox long time ago. On 11-OCT-2012 the patient was subcutaneously vaccinated with a 0.6 ml dose of ZOSTAVAX in the left triceps (lot number reported as H011333). It was reported that there was no rash at the site of injection post vaccination. On approximately 11-OCT-2012, the patient experienced rash on the one side on hip and herpes zoster. At the time of the report the outcome of the event was unknown. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Expired drug administered, No adverse event
Clinical narrative: Information has been received from a registered nurse refers to a patient (age and gender unknown). On 04-DEC-2012, the patient was vaccinated with 0.65 ml ZOSTAVAX (lot #670986/0730AA, exp: 17-AUG-2012) subcutaneously. No other co-suspects were reported. No concomitant medications were reported. On 04-DEC-2012, the patient received expired ZOSTAVAX. No adverse effects reported. Additional information has been requested.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: This spontaneous report was received from a registered pharmacist concerning to a 61 years old male patient. On 24-OCT-2012, the patient was vaccinated with the first dose of ZOSTAVAX Lot No. reported as H014366 (dose and route not reported). No other co-suspects were reported. No concomitant medications were reported. Pharmacist reported that on 25-OCT-2012, the patient experienced rash post vaccination 2 x 2 inches in the arm. The patient was treated with cortisone cream. On 29-OCT-2012, rash was reported as recovered/resolved. The relatedness for the event was unknown for ZOSTAVAX. Additional information has been requested.
Age: 56.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Injection site swelling, Musculoskeletal stiffness, Pain in extremity
Clinical narrative: This spontaneous report as received from a physician's assistant refers to a 56 years old female patient with Amyotrophic lateral sclerosis (ALS) and allergy to sulfa drug. It was reported that on February 2012, the patient was vaccinated subcutaneously with a dose of PNEUMOVAX23 lot # (0225AE) (exp 03-JUN-2013), with no problems. There was no other co-suspects were reported. No concomitant medications. The physician's assistant noted that then, the patient was administered another dose of PNEUMOVAX23 on 12-NOV-2012 and that on 13-NOV-2012 the arm circumference of the arm where the PNEUMOVAX23 was inject doubled, and that the arm was also red, painful, and stiff. The physician's assistant notice this adverse event was resolved by 14-NOV-2012). The patient sought medical attention (the patient called the office). The relatedness for circumference of the arm where PNEUMOVAX23 was injected was red, painful and stiff is unknown for PNEUMOVAX23. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 79.0
Sex: M
Vaccine: HIBV
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 79 years old male patient. The patient was vaccinated with a dose of PEDVAXHIB (lot #, dose and route not reported) on 21-NOV-2012. No other co-suspects were reported. No concomitant medications were reported. The registered nurse also mentioned that the patient was scheduled to have a splenectomy in the future on an unspecified date. Additional information has been requested.
Sex: F
Vaccine: MMR
Symptoms: Rubella antibody negative
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified number of postpartum female patients. On an unknown date the patients were vaccinated with an unspecified number of doses of MMR II, dose and route of administration were not reported. No other co-suspects were reported. No concomitant medications were reported. On an unknown date the patient had titers for rubella that were low. The nurse also reported on an single patient with "equivocal" titer results who needed another vaccine dose (MARRS case # 1212USA002764, same reporter link). The outcome of low rubella titers is unknown. The relatedness for low rubella titers was not reported for MMR II. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to multiple unspecified patient's of unknown age and gender. Approximately on an unspecified date in November 2012 (reported as during the last two weeks) the patient's might have received RECOMBIVAX HB (Lot number, expiry date, dose and route were unspecified) exposed to unsupportable cold temperatures. No concomitant medications were reported. No adverse effect reported. No information was available as to whether any individual patient might have received more that one of the effected vaccines. This is one of the several reports from the same reporter (MARRS# 1212USA000871, 1212USA000867 and 1212USA000873) Additional information has been requested.
Age: 48.0
Sex: F
Vaccine: PPV
Symptoms: Fatigue, Headache, Myalgia, Nausea
Clinical narrative: This spontaneous report as received from a physician refers to a 48 years old female patient. The patient was vaccinated with PNEUMOVAX 23 on 20-NOV-2012. Dose and route of administration were not reported. The physician reported that an unspecified physician who administered the vaccine reports that he was unsure if the patient was immunocompromised. No other co-suspects were reported. No concomitant medications were reported. The patient experienced headache, nausea, muscle aches and fatigue ever since (from 20-NOV-2012). No treatment information was reported. The outcome of headache, nausea, muscle aches and fatigue was reported as not recovered/not resolved. The relatedness for headache, nausea, muscle aches and fatigue was not reported for PNEUMOVAX 23. Additional information is not expected.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect route of drug administration, Injection site haematoma, Injection site pruritus
Clinical narrative: This spontaneous report as received from a 71 years old female patient with no drug reactions/allergies and heart murmur who on in July or August 2012, was vaccinated at the local pharmacy with a dose of ZOSTAVAX (dose and lot # not reported). No other co-suspects were reported. Concomitant medications included: CRESTOR, LUMIGAN and CLARINEX. The caller stated she was given the shot in the muscle, not in the fatty tissue of her upper left arm. A couple of days after receiving the ZOSTAVAX shot, the caller developed bruising and itching at the injection site which lasted about two weeks and then went away. The caller was concerned that she was given the shot in the wrong way and wanted to know if she should get another shot. The caller had not talked to her doctor about this but planned to do so. No treatment was given for the events. The patient did not seek medical attention. The relatedness for bruising and itchiness at the injection site was unknown for ZOSTAVAX. Additional information has been requested.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema
Clinical narrative: Information has been received from a nurse concerning a 64 year old male patient with no pertinent medical history, drug reaction or allergies. On 12-NOV-2012, the patient was vaccinated with single dose of 0.65 ml ZOSTAVAX subcutaneously injection. No other co-suspects were reported. No concomitant medications were reported. On 12-NOV-2012, the patient complains of a 2.5 inch barely noticeable area of redness at the injection site that appeared shortly after the vaccination and persists through the time of informed the event. No treatment information was reported. Labs diagnostic or studies were not performed. The patient seeks medical attention. At the time of the report, the outcome of 2.5 inch barely noticeable area of redness at the injection site was not recovered. The relatedness for 2.5 inch barely noticeable area of redness at the injection site was unknown for ZOSTAVAX. Additional information is not expected.
Sex: F
Vaccine: VARZOS
Symptoms: Local reaction
Clinical narrative: This spontaneous report as received from a physician assistant (P.A.) via a company representative refers to her mother, a female patient of unknown age. On an unknown date, the patient was vaccinated with ZOSTAVAX (lot # not reported). On an unknown date the patient developed a "localized reaction". It was unspecified whether the patient sought for medical attention. The outcome of localized reaction was unknown. The relatedness for localized reaction was unknown for ZOSTAVAX. This is one of several reports received from the same source. Additional information has been requested.
Age: 50.0
Sex: M
Vaccine: VARZOS
Symptoms: Cellulitis, Erythema, Local reaction
Clinical narrative: This spontaneous report as received from a physician assistant (P.A.) via a company representative refers to himself, who was a male patient around 50 years old. On an unknown date, the physician assistant was vaccinated subcutaneously with one dose of ZOSTAVAX (lot # not reported). After receiving the ZOSTAVAX injection, the physician assistant developed "a lot of localized reaction that radiated down to his arm." The physician assistant thought it was "cellulitis" because of the "red streaking down the arm". It was unspecified whether the physician assistant sought for medical attention. The adverse event improved and it took about a week before physician assistant recovered. This is one of several reports received from the same source. Additional information has been requested.