chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 78.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Injection site erythema, Injection site swelling, Oedema peripheral
Clinical narrative: Began to have redness and swelling at injection site.  By Sunday Morning stated that arm was red and swollen from elbow to shoulder. Pt stated it took until Tuesday until the swelling went away.
Age: 59.0
Sex: F
Vaccine: FLUX
Symptoms: Asthenia, Dizziness, Heart rate irregular, Paraesthesia, Photopsia
Clinical narrative: My heart beat fast before my shot because I was afraid. After my shot I felt weak, and sat in the chair about 10 minutes. I thought I was better and headed for my car. I got dizzy and leaned against the wall after about 30 steps. Several times I walked some steps to Starbucks, (way closer than my car) and leaned against the wall, in-between. I was starting to feel better and sat in Starbucks about 30 minutes. I felt better still after that and walked to my car.  I waited until 1:55 PM, when I felt completely back to normal and drove home. That night at work I felt dizzy for about 5 minutes and leaned against the wall. Then felt better. Probably completely coincidental, but never before or since are the following: A few funny heart beats the next day, and some bright light flashes in my eye a few days later. Tingly leg too. Well, better now, 100%. I am going to check life threatening only because, what if I had fallen? Next time I will sit down longer.
Age: 39.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Dizziness, Tremor, Vomiting
Clinical narrative: Feeling faint, shaky, vomited a small amount. 911 called. Patient recovered and requested to go home.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, PNC13, VARCEL
Symptoms: Injection site swelling, Injection site warmth
Clinical narrative: Grandparent states left and right arm became swollen and hot 10/31/12 around 7 PM. Instructed grandparent to apply cool packs to area and if it gets worse take patient to the family doctor or ER.
Age: 0.75
Sex: M
Vaccine: FLUX
Symptoms: Wheezing
Clinical narrative: Wheezing.
Age: 44.0
Sex: F
Vaccine: FLU3
Symptoms: Hypoaesthesia, Musculoskeletal pain, Pain
Clinical narrative: Severe pain in shoulder when moved. Pain while sleeping, numbness lasting to present. Saw Dr yesterday, will have physical therapy.
Age: 56.0
Sex: F
Vaccine: FLUX
Symptoms: Headache, Hypoaesthesia, Hypoaesthesia oral, Paraesthesia
Clinical narrative: I was in shower and right arm began to tingle. Right side of face went numb including tongue but only on right side. The tingling in my arm became less. Numbness of tongue and lips on right side remain numb (6pm CST). Slight headache.
Age: 28.0
Sex: M
Vaccine: FLU3
Symptoms: Chills, Dizziness, Fatigue, Headache, Hyperhidrosis
Clinical narrative: Vision and hearing faded rapidly and suddenly became very dizzy.  Started sweating over entire body and had sweat dripping off arms and face in a room at 68 degrees.  Lasted for approx. 20 minutes and then was very cold and getting chills.  No fever, slight fatigue and headache.  Took 2 OTC Aspirin.
Age: 28.0
Sex: M
Vaccine: FLU3
Symptoms: Hypoacusis, Visual impairment
Clinical narrative: Vision and hearing faded rapidly and suddenly became very dizzy.  Started sweating over entire body and had sweat dripping off arms and face in a room at 68 degrees.  Lasted for approx. 20 minutes and then was very cold and getting chills.  No fever, slight fatigue and headache.  Took 2 OTC Aspirin.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Blepharospasm, Computerised tomogram normal, Drooling, Dry eye, Dysphagia
Clinical narrative: 36 hours after flu shot started with HA, stiff neck, tired and achy. Next day trouble swallowing. On 9/20 noticed mouth drooping, went to ER and dx wtih Bell's Palsy. Left eye twitches and dry because she can't shut eye, mouth drools left side. CT ruled out stroke. Given Deltasone 20mg x3/day for 7 days and valacylovir 1gm x 3/day fir 7 days. Told to follow up with PCP.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Eyelid function disorder, Fatigue, Headache, Musculoskeletal stiffness, Oral disorder
Clinical narrative: 36 hours after flu shot started with HA, stiff neck, tired and achy. Next day trouble swallowing. On 9/20 noticed mouth drooping, went to ER and dx wtih Bell's Palsy. Left eye twitches and dry because she can't shut eye, mouth drools left side. CT ruled out stroke. Given Deltasone 20mg x3/day for 7 days and valacylovir 1gm x 3/day fir 7 days. Told to follow up with PCP.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Pain, VIIth nerve paralysis
Clinical narrative: 36 hours after flu shot started with HA, stiff neck, tired and achy. Next day trouble swallowing. On 9/20 noticed mouth drooping, went to ER and dx wtih Bell's Palsy. Left eye twitches and dry because she can't shut eye, mouth drools left side. CT ruled out stroke. Given Deltasone 20mg x3/day for 7 days and valacylovir 1gm x 3/day fir 7 days. Told to follow up with PCP.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Pt has redness and swelling at the injection site, warm to touch and painful and seems to be increasing in size.
Age: 35.0
Sex: F
Vaccine: HPVX
Symptoms: Chills, Cough, Dyspnoea, Headache, Heart rate increased
Clinical narrative: Fever/chills, muscle aches, headache, itching, cough, difficulty breathing, fast heart beat.
Age: 35.0
Sex: F
Vaccine: HPVX
Symptoms: Myalgia, Pruritus, Pyrexia
Clinical narrative: Fever/chills, muscle aches, headache, itching, cough, difficulty breathing, fast heart beat.
Age: 38.0
Sex: M
Vaccine: FLU3
Symptoms: Flushing, Malaise, Pain, Pyrexia
Clinical narrative: Sore for a day or two but has been really sick with fever, achy and flushed for 5-7 days, started a week after vaccination. Going to PCP.
Age: 53.0
Sex: M
Vaccine: FLUX
Symptoms: Cold sweat, Feeling hot, Pain, Paraesthesia, Paraesthesia oral
Clinical narrative: Tingling hands, arms, lips, face in waves.  Hot and clammy back and forth for two days. Rash started 2-3 days after vaccine and still has it. Also, 10/18/2012 sharp stabbing pain, different parts of body, comes and goes, still having (11/1/2012).  Mentioned to Dr. and was ignored.
Age: 53.0
Sex: M
Vaccine: FLUX
Symptoms: Rash
Clinical narrative: Tingling hands, arms, lips, face in waves.  Hot and clammy back and forth for two days. Rash started 2-3 days after vaccine and still has it. Also, 10/18/2012 sharp stabbing pain, different parts of body, comes and goes, still having (11/1/2012).  Mentioned to Dr. and was ignored.
Age: 48.0
Sex: M
Vaccine: FLUX
Symptoms: Borrelia test negative, Fatigue, Full blood count normal, HIV test negative, Influenza like illness
Clinical narrative: Achy muscles and exhaustion off & on for 4 weeks and continuing to  this day. Peaked Oct 23-29 with severe flu-like symptoms but no fever.
Age: 48.0
Sex: M
Vaccine: FLUX
Symptoms: Myalgia
Clinical narrative: Achy muscles and exhaustion off & on for 4 weeks and continuing to  this day. Peaked Oct 23-29 with severe flu-like symptoms but no fever.
Age: 75.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Injection site swelling, Injection site warmth
Clinical narrative: Husband came in to report both wife and he had (R) arm swollen & red from injection that traveled down to inner elbow. Patient referred to PCP for treatment. 9/27 given TAGAMET 800 & Cephalexin 500.
Age: 75.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Husband came in to report both wife and he had (R) arm swollen & red from injection that traveled down to inner elbow. Patient referred to PCP for treatment. 9/27 given TAGAMET 800 & Cephalexin 500.
Age: 59.0
Sex: F
Vaccine: FLU3
Symptoms: Urticaria
Clinical narrative: Sporadic whelps erupting and receding on various parts of body. No SOB. Pt takes chlortabs routinely at night. Last dose was 10/31/12 at approx. 1800 hrs. Receives annual Flu vaccines. 1st time pt has reactions.
Age: 59.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Flushing
Clinical narrative: Patient complained of feeling flushed approx. 1/2 hr after receiving vaccine - her chest was reddened. This subsided after approx 15-20 min. Her BP was 124/80 left arm - she placed a cool pack on her chest - redness subsided. At 1:50 pm she stated she was fine.
Age: 44.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Burning sensation, Hypersensitivity, Nasal congestion, Pruritus, Pruritus generalised
Clinical narrative: Head started feeling real stuffy, took a DAYQUIL about 15 mins after the palms of hands started itching and burning. Within mins it had spread to all my body. Took a cold shower but still kept itching. Went to firehall, they called hospital, went to hospital and they gave BENADRYL.
Age: 36.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Induration, Pain in extremity, Upper extremity mass
Clinical narrative: Pt developed a hard red lump on her arm. She stated it began the day of the flu shot and has gotten progressively worse. It is painful all the way down to her fingertips. Advised pt to MD.
Age: 24.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Skin warm
Clinical narrative: Became red and hot to touch. Started on KEFLEX 500 mg BID x 7 days.
Age: 52.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Eye swelling, Fatigue, Pain, Swelling face
Clinical narrative: Approximately 1:30 PM received vaccine. 6:30 PM could not stay awake - exhausted. 10:00 PM woke up by husband, LUE "like an egg" applied ice, went to bed, husband felt something wrong. 12:00 AM - aches/pain/chills/swollen eyes & face. 5:00 AM - ice pack to swollen face.
Age: 18.0
Sex: M
Vaccine: MNQ
Symptoms: Cold sweat, Headache, Myalgia, Pyrexia, Syncope
Clinical narrative: Fainted, low grade fever, muscle aches - neck, HA, clammy, lasted for 24 hours. Went to ER.
Age: 67.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Swelling of the injection site, redness & itching.
Age: 35.0
Sex: F
Vaccine: FLU3
Symptoms: Exposure during breast feeding, Lactation disorder
Clinical narrative: She is nursing her baby states her breast milk dried up after she received her flu vaccine baby is 2 months old.
Age: 12.0
Sex: F
Vaccine: FLU3, HPV4
Symptoms: Immediate post-injection reaction, Pain in extremity
Clinical narrative: Immediately following the admin of GARDASIL, pt experienced intense pain in her left arm that radiated down into her hand. Pain lasted approx 15 min.
Age: 65.0
Sex: M
Vaccine: FLU3, PPV, PPV
Symptoms: Dizziness, Musculoskeletal pain, Nausea, Swelling
Clinical narrative: Patient received Pneumonia vaccine 10/31/12. Came back to see MD today 11-01-12 complaining of (R) shoulder pain, swelling - nausea & dizziness. Tx: warm compress, steroid taper, OTC antihistamine. KEFLEX 500mg 3x day for 10 days.
Age: 65.0
Sex: M
Vaccine: FLU3, PPV, PPV
Symptoms: Dizziness, Injection site erythema, Injection site pain, Injection site swelling, Nausea
Clinical narrative: Patient received Pneumonia vaccine 10/31/12. Came back to see MD today 11-01-12 complaining of (R) shoulder pain, swelling - nausea & dizziness. Tx: warm compress, steroid taper, OTC antihistamine. KEFLEX 500mg 3x day for 10 days.
Age: 59.0
Sex: F
Vaccine: FLU3
Symptoms: Activities of daily living impaired, Hypoaesthesia, Injection site pain, Mobility decreased, Pain
Clinical narrative: FLUZONE Influenza vaccine administered 10/25/12. Today client reports to PH agency pain at site, numbness, tingling at fingers. Difficult to pick up arm and raise arm to dress. Pain with moving arm. Site (L) deltoid. Pain started 10/26/12. No treatment sought. Patient will contact clinic today.
Age: 59.0
Sex: F
Vaccine: FLU3
Symptoms: Paraesthesia
Clinical narrative: FLUZONE Influenza vaccine administered 10/25/12. Today client reports to PH agency pain at site, numbness, tingling at fingers. Difficult to pick up arm and raise arm to dress. Pain with moving arm. Site (L) deltoid. Pain started 10/26/12. No treatment sought. Patient will contact clinic today.
Age: 22.0
Sex: M
Vaccine: SMALL
Symptoms: Electrocardiogram change, Myopericarditis, Troponin increased
Clinical narrative: Myopericarditis following smallpox vaccine.
Age: 64.0
Sex: F
Vaccine: FLU3
Symptoms: Blood test, Chills, Diarrhoea, Influenza like illness, Pain
Clinical narrative: 4 H after inj. flu like sx chills, diarrhea. 6-7 H after inj severe body aches. Took hot bath, ibuprofen PM. Awoke 7AM felt fine & has since.
Age: 45.0
Sex: F
Vaccine: TDAP
Symptoms: Activities of daily living impaired, Dizziness, Influenza like illness, Limb discomfort
Clinical narrative: Within 24 H of inj sudden onset of flu like sx & dizziness. Could not go to work. Typical arm discomfort present. Feeling better over next 24 H.
Age: 49.0
Sex: F
Vaccine: FLU3
Symptoms: Pruritus, Rash, Rash erythematous
Clinical narrative: Received Flu shot 10-8-12. On 10-11-12 developed fine red rash on neck & arms with pruritis. Sts had similar reaction 2 years ago & Tx with antibiotics & BENADRYL. VAERS form completed 2 yrs ago. Sts. her personal MD would not sign exemption form.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Fall, Feeling abnormal, Syncope
Clinical narrative: Pt rec tdap & MENACTRA in (rt) arm at 3:15 pm, walked out of rm immed. after, was standing at counter, stated she didn't feel good, and then fainted fell backwards about 3 mins after vaccines. Woke within 30 seconds & discharged to home.
Age: 28.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Injection site rash, Malaise, Rash, Rash pruritic
Clinical narrative: Flu shot 10-1-12 AM and that evening developed pruritic rash upper arms & wrists along with malaise & chills. No fever. No previous reaction to flu shot. Tx: ZYRTEC 10 mg. daily per Dr.
Age: 31.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Flushing, Pain, Pruritus
Clinical narrative: Flu vaccine 10-5-12. Within 1 hr of receiving shot got achy feeling - itchy scalp. Flushed face. Erythema on extremities. Tx: Cold compresses - OTC antihistamines.
Age: 51.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Pruritus, Rash
Clinical narrative: Flu vaccine 10-1-12. Four days later had rash on both thighs a& itchy scalp. Along with facial pruritus/erythema. Tx: OTC antihistamines.
Age: 68.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Malaise
Clinical narrative: Patient received 2 vaccinations early in the day. Later at night while getting ready for bed she became ill & went to ER. Prescribed meclizine.
Age: 35.0
Sex: M
Vaccine: FLU3
Symptoms: Headache, Lacrimation increased, Rash erythematous, Swelling face
Clinical narrative: Red spots on face, puffy face (L) eye, watery, headache. Pt's 1st flu vaccine.
Age: 62.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Injection site pain, Pain
Clinical narrative: Received shot of FLUVIRIN 0.5 mL on 9/17/12 at 5:30 P.M. On 9/20/12 had appt. w/primary care physician. My arm at the site was tender but by Sat. up to present I have been in severe pain.
Age: 62.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Muscle disorder, Pain in extremity
Clinical narrative: Received shot of FLUVIRIN 0.5 mL on 9/17/12 at 5:30 P.M. On 9/20/12 had appt. w/primary care physician. My arm at the site was tender but by Sat. up to present I have been in severe pain.
Age: 19.0
Sex: F
Vaccine: FLU3
Symptoms: Urticaria
Clinical narrative: One day after the flu vaccine given patient states she broke out with hives on her abdomen. Patient took BENADRYL and hives resolved.
Age: 54.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site swelling, Pruritus
Clinical narrative: 30 minutes after pt. was itchy, continued 72 hrs, swelling, redness at injection site. Pt. took diphenhydramine & daily OTC antihistamine.
Age: 33.0
Sex: F
Vaccine: FLU3
Symptoms: Nasal congestion, Rash pruritic
Clinical narrative: Morning after flu shot awoke with itchy rash anterior neck, chin, lower face. Nasal congestion. Evaluated in E.R. Tx: Prednisone - PEPCID - VISTARIL.
Age: 43.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site swelling, Injection site warmth, Neuralgia
Clinical narrative: Left arm swelled & was hot around injection site that lasted for about a day. Then 2 days later patient developed nerve pain up & down her arm which she has had for 2 weeks now & is still experiencing. Dr told her she will have pain until nerve heals, could be 6 weeks. Her PCP told her to take 2 ALEVE twice a day and on 10/31 he told her to go down to 1 twice a day for 2 weeks & to call him back.
Age: 48.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Diarrhoea, Headache, Injection site pain, Pyrexia
Clinical narrative: Diarrhea, vomiting, headaches, severe pain on injection site (from shoulder to elbow), fever, chills.
Age: 48.0
Sex: F
Vaccine: FLU3
Symptoms: Vomiting
Clinical narrative: Diarrhea, vomiting, headaches, severe pain on injection site (from shoulder to elbow), fever, chills.
Age: 8.0
Sex: M
Vaccine: FLU3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Gave child an adult influenza immunization child did not have any type of reaction.
Age: 6.0
Sex: F
Vaccine: FLU3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Gave child an adult influenza immunization, child did not have any reaction.
Age: 68.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Back pain, Erythema, Pain in extremity, Swelling
Clinical narrative: Redness, swelling, pain that went up arm and around to back. Still extremely red and swollen 4 days later.
Age: 82.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Local reaction
Clinical narrative: Increased pain, redness and induration 10 cm diameter in localized area around injection site Rt deltoid.
Age: 33.0
Sex: M
Vaccine: FLU3
Symptoms: Feeling abnormal, Loss of consciousness
Clinical narrative: Received flu shot, began to feel "funny". Started to sit down & passed out. Called 911 & by the time they arrived (approximately 3-5 minutes) he had come to.
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Biopsy, Varicella post vaccine
Clinical narrative: Pt developed varicella b/c he was on ENBREL but his PCP was aware & authorized vaccine.
Age: 43.0
Sex: F
Vaccine: FLU3
Symptoms: Headache, Injection site pain, Insomnia
Clinical narrative: Patient described unusual injection pain that lead to no sleep and then headache later, which patient states uncommon for her.
Age: 4.0
Sex: F
Vaccine: DTAP, FLU3, IPV, PNC
Symptoms: Erythema multiforme, Rhinorrhoea
Clinical narrative: Erythema multiforme 24 hours after 4 vaccines. Also had MOTRIN dose post vaccines, prior to E.M. I have seen 2 cases of E.M. this week in clinic. Questionable viral syndrome. The child has slight rhinorrhea - mom thought allergies, dad thought URI.
Age: 65.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Erythema, Injection site induration, Injection site nodule, Skin warm
Clinical narrative: Patient had hard knot at injection site and an extended erythema along the inside of the left arm. Erythema area was hot to touch. Dr. was contacted and given antibiotic.
Age: 66.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Cellulitis, Injection site erythema, Injection site induration, Injection site pain, Pyrexia
Clinical narrative: Patient reported - feeling feverish, hardness, pain and redness, at site of injection on right arm where patient had received pneumonia vaccination on 10/11/12. Patient's PCP confirmed that it was cellulitis. Patient was prescribed antibiotic Clindamycin on 10/12/12. On 10/12/12 patient reported no improvement.
Age: 57.0
Sex: F
Vaccine: FLU3
Symptoms: Contusion, Diarrhoea, Nausea, Pharyngeal oedema, Pyrexia
Clinical narrative: Arm black & blue, fever, N/V/D, throat swelling. Pt given Valacyclovir 500 mg QID.
Age: 57.0
Sex: F
Vaccine: FLU3
Symptoms: Skin discolouration, Vomiting
Clinical narrative: Arm black & blue, fever, N/V/D, throat swelling. Pt given Valacyclovir 500 mg QID.
Age: 75.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site pain, Myalgia
Clinical narrative: Patient reports pain at injection site and continued pain and soreness of muscle. Arm muscle is still hurting 6 weeks after injection. Has seen primary physician but has not received any treatment.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, FLU3, VARCEL
Symptoms: Anion gap decreased, Aspartate aminotransferase increased, Blood albumin normal, Blood alkaline phosphatase increased, Blood bilirubin normal
Clinical narrative: 5-10 minutes after vaccine & PPD placed had brief generalized convulsion. Seemed "out of it" afterward. Returned to our clinic (was in the car). Transported by ambulance to hospital.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, FLU3, VARCEL
Symptoms: Blood calcium increased, Blood chloride normal, Blood creatinine normal, Blood glucose normal, Blood magnesium normal
Clinical narrative: 5-10 minutes after vaccine & PPD placed had brief generalized convulsion. Seemed "out of it" afterward. Returned to our clinic (was in the car). Transported by ambulance to hospital.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, FLU3, VARCEL
Symptoms: Blood phosphorus normal, Blood potassium normal, Blood sodium decreased, Blood urea normal, Carbon dioxide decreased
Clinical narrative: 5-10 minutes after vaccine & PPD placed had brief generalized convulsion. Seemed "out of it" afterward. Returned to our clinic (was in the car). Transported by ambulance to hospital.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, FLU3, VARCEL
Symptoms: Convulsion, Electroencephalogram, Feeling abnormal, Protein total normal
Clinical narrative: 5-10 minutes after vaccine & PPD placed had brief generalized convulsion. Seemed "out of it" afterward. Returned to our clinic (was in the car). Transported by ambulance to hospital.
Age: 72.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain
Clinical narrative: Pt stated upper arm sore since admin of shot.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Redness, itching, burning swelling *where injection site (given at inner bicep).
Age: 16.0
Sex: F
Vaccine: HEPA, HPV4, VARCEL
Symptoms: Injection site erythema, Injection site pruritus, Injection site rash
Clinical narrative: Red rash, with itching at site.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Back pain, Blister, Chest pain, Paraesthesia, Pruritus
Clinical narrative: Tingling, soreness, blisters and itching on (R) side of chest and back. Some blisters have broke open and have scabbed over and some have not. Feels better than it did last week per patient. Recvd shingles shot on 10/16/12 at 2:37pm. Stated he felt these symptoms the following Saturday. No MD visit at time of my conversation with patient.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Scab
Clinical narrative: Tingling, soreness, blisters and itching on (R) side of chest and back. Some blisters have broke open and have scabbed over and some have not. Feels better than it did last week per patient. Recvd shingles shot on 10/16/12 at 2:37pm. Stated he felt these symptoms the following Saturday. No MD visit at time of my conversation with patient.
Age: 60.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Erythema, Local swelling, Mass, Pain
Clinical narrative: Left arm localized swelling, soreness, redness & lump.
Age: 72.0
Sex: U
Vaccine: FLU3
Symptoms: Fatigue, Hypersomnia, Pyrexia
Clinical narrative: 4 hours after, high temperature. 6 weeks of catastrophic fatigue. Sleep 12-18 hours a day.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, Paraesthesia, Rash erythematous, Rash vesicular
Clinical narrative: Painful skin rash, started in May continues thru October 2012. Some look like shingles (backside) some look like red spots, all below waist, on legs and toes - most don't look like shingles. Has severe pain in legs and feet - also tingling. Each last about 10 days then they start again about every 10-20 days.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Asthma, Chest pain, Dyspnoea, Local reaction, Urticaria
Clinical narrative: Systemic reaction urticaria, hives, asthma attack, severe local reaction, chest pain, SOB.
Age: 66.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Erythema, Oedema peripheral, Pruritus
Clinical narrative: Right arm was swollen, itchy, red day following ZOSTAVAX vaccination.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Cellulitis, Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Pt. called same day stating the area was itchy at the time of admin. and her arm at the site is swollen and red. Advised pt. to ice the arm and that a little inflammation is common. A few days later, she called and said she went to her MD b/c of the swelling and was given antibiotic for cellulitis. Spoke with pt. a couple of days later and arm seems to be doing better.
Age: 9.0
Sex: M
Vaccine: PPV
Symptoms: Injection site rash, Rash macular
Clinical narrative: Red macular rash expanding from injection site.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Activities of daily living impaired, Antinuclear antibody negative, Borrelia test negative, Full blood count normal, Mobility decreased
Clinical narrative: Started with pain in neck. Could not turn head. Polymyalgia. X-rays taken. Stated was muscle spasm. Put on prednisolone 5 wks. Muscle pain progressed to shoulders & hips. Could not raise legs or arms to comb hair. Placed on prednisone 20 mg/day. Will see rheumatologist.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Monocyte count increased, Muscle spasms, Myalgia, Neck pain, Red blood cell sedimentation rate increased
Clinical narrative: Started with pain in neck. Could not turn head. Polymyalgia. X-rays taken. Stated was muscle spasm. Put on prednisolone 5 wks. Muscle pain progressed to shoulders & hips. Could not raise legs or arms to comb hair. Placed on prednisone 20 mg/day. Will see rheumatologist.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Rheumatoid factor negative
Clinical narrative: Started with pain in neck. Could not turn head. Polymyalgia. X-rays taken. Stated was muscle spasm. Put on prednisolone 5 wks. Muscle pain progressed to shoulders & hips. Could not raise legs or arms to comb hair. Placed on prednisone 20 mg/day. Will see rheumatologist.
Age: 73.0
Sex: M
Vaccine: PPV
Symptoms: Pain in extremity, Rash papular, Tenderness
Clinical narrative: Pt. reported skin reaction pt. presented with red raised rash on anterior portion of upper (R) arm c/o pain and tenderness.
Age: 28.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site swelling, Local reaction
Clinical narrative: Pt had large local reaction where vaccine was administered. Three days after administration, the redness and swelling was continuing to spread. Reaction was 13.5 cm erythematous area x 5.5 cm.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site pain
Clinical narrative: Pt had pain at the left deltoid at site of HPV vaccine. Mother is nervous about such a new vaccine MSM didn't really want this due to it not out in the community long enough. But we sent this anyway due to the pain at same muscle group.
Age: 32.0
Sex: M
Vaccine: ANTH
Symptoms: Arthralgia, Erythema, Fatigue, Headache, Influenza like illness
Clinical narrative: The patient received anthrax immunization dose #6 on 5/14/2012 and the next day developed a LLR to the left arm from shoulder to elbow---redness all the way around, aching, hot and felt like leather. He had flu like symptoms of aching joints, fatigue, nausea, headache and itching all over his body. A couple of days later he had burning of the skin over right thigh, buttock and right side of abdomen. Symptoms are resolving over the subsequent 1-2 weeks. Treated with Ibuprofen and ATARAX. Recovering, but not nearly complete. He had a large, local reaction with a rash following anthrax immunization dose #4, no reaction following dose #5.
Age: 32.0
Sex: M
Vaccine: ANTH
Symptoms: Local reaction, Nausea, Pain, Pruritus generalised, Skin burning sensation
Clinical narrative: The patient received anthrax immunization dose #6 on 5/14/2012 and the next day developed a LLR to the left arm from shoulder to elbow---redness all the way around, aching, hot and felt like leather. He had flu like symptoms of aching joints, fatigue, nausea, headache and itching all over his body. A couple of days later he had burning of the skin over right thigh, buttock and right side of abdomen. Symptoms are resolving over the subsequent 1-2 weeks. Treated with Ibuprofen and ATARAX. Recovering, but not nearly complete. He had a large, local reaction with a rash following anthrax immunization dose #4, no reaction following dose #5.
Age: 32.0
Sex: M
Vaccine: ANTH
Symptoms: Skin warm
Clinical narrative: The patient received anthrax immunization dose #6 on 5/14/2012 and the next day developed a LLR to the left arm from shoulder to elbow---redness all the way around, aching, hot and felt like leather. He had flu like symptoms of aching joints, fatigue, nausea, headache and itching all over his body. A couple of days later he had burning of the skin over right thigh, buttock and right side of abdomen. Symptoms are resolving over the subsequent 1-2 weeks. Treated with Ibuprofen and ATARAX. Recovering, but not nearly complete. He had a large, local reaction with a rash following anthrax immunization dose #4, no reaction following dose #5.
Age: 12.0
Sex: F
Vaccine: HEPA, MNQ, TDAP, VARCEL
Symptoms: Syncope
Clinical narrative: Patient had a syncopal episode. No fall. She was caught by MA and mother. Patient recovered within 15 seconds, her legs were elevated and the patient was monitored. She was released after 40 minutes of monitoring without symptoms.
Age: 47.0
Sex: F
Vaccine: FLU3
Symptoms: Lymphadenopathy, Swelling face
Clinical narrative: Face and lymph nodes swelled in neck and under arms. Has had flu shots in past with no adverse effect. Was given steroid treatment by Dr.
Age: 2.0
Sex: F
Vaccine: DTAP, HEPA
Symptoms: Injection site rash, Pyrexia
Clinical narrative: (R) arm at site of injection Hep A noticed after Band Aid removed round circle of raised bumps. Appx size of a quarter. Has become bigger since vaccination. Had slight fever x 1 day 10/26/12. No respiratory problem.
Age: 44.0
Sex: F
Vaccine: MMR, TDAP
Symptoms: Headache, Injection site induration, Injection site pain, Nausea
Clinical narrative: Patient became nauseated with HA after vaccine and continue to have nausea also site is sore with a 10 mm induration noted.
Age: 11.0
Sex: M
Vaccine: HPV4
Symptoms: Injection site erythema, Injection site swelling, Pain
Clinical narrative: Mild redness & swelling at site of injection - pain with movement no treatment (just rest).
Age: 0.34
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Rash, Rash papular
Clinical narrative: Rash to bilateral thighs noticed 10/27/12. Small red bumps to entire upper legs treatment - TYLENOL, cool compresses.
Age: 68.0
Sex: F
Vaccine: VARCEL
Symptoms: Wrong drug administered
Clinical narrative: VARIVAX was given instead of ZOSTAVAX. 10/29/12 Vaccinated with ZOSTAVAX on this date.
Age: 28.0
Sex: M
Vaccine: VARCEL
Symptoms: Injection site pain
Clinical narrative: - (L) AC/deltoid pain x 2 months no warmth no erythema no crepitus. Possible bursitis to (L) shoulder. Recommend OTC MOTRIN f/u with PCP.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema
Clinical narrative: Pt reported redness around injection site after 2 wks of vaccination. Pt will take BENADRYL & follow up w/ MD.
Age: 48.0
Sex: F
Vaccine: PPV, TDAP, VARZOS
Symptoms: Injection site rash
Clinical narrative: Rash on entire upper left arm 2 days post vaccination.
Age: 3.0
Sex: F
Vaccine: PNC
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site swelling
Clinical narrative: Swelling, redness, induration, pain at injection site.
Sex: U
Vaccine: HPV4
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to 2 patients of unknown age. The 2 patients were inadvertently administered 0.5 ml GARDASIL (lot # 666595/0096Z) intramuscularly on 15-OCT-2012 that had expired on 14-OCT-2012. No other co-suspects were reported. No concomitant medications were reported. No adverse effects reported. It was unspecified if the patients had sought medical attention. Additional information is not expected. This is one of several reports received from the same source.
Sex: F
Vaccine: HPV4
Symptoms: Injection site pain
Clinical narrative: This spontaneous report as received from a registered nurse refers to a female patient of unknown age with no pertinent medical history and no drug reaction/allergy. The patient was vaccinated with the first dose of GARDASIL on 09-FEB-2012, and the second dose on an unspecified date in 2012. There was no concomitant medication. It was reported that the patient experienced soreness around injection site after receiving first two doses of GARDASIL. The patient stated that soreness lasted about an hour after injection. No treatment information was given. The patient sought medical attention via office visit. Additional information is not expected.
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a consumer refers to a her daughter, a female patient of unknown age. The patient was vaccinated (route not reported) with dose 1 GARDASIL in December 2011 and she received her second dose in February 2012, but she has not received her third dose yet. No other co-suspects were reported. No concomitant medications were reported. No adverse event involved. Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: FLUX, HPV4
Symptoms: Urticaria
Clinical narrative: The primary reporter is the field representative. The representative reported this AE as he heard it from an HCP. The HCP had a patient who developed hives "all over her body" after receiving her second dose of GARDASIL. She also received a flu shot concomitantly; however, it was not AFLURIA. This AE refers only to the GARDASIL AE. No further AE information was provided. Treatment given: oral prednisone and referred to allergist.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Menstrual disorder
Clinical narrative: Information has been received from a physician concerning a 15 years old female patient, who on an unknown date was vaccinated with the second dose of GARDASIL 0.5 ml (route and lot # not reported). No other co-suspects were reported. No concomitant medications were reported. On an unknown date while on GARDASIL, the product affected the color of her (the patient's) menstruation. No treatment was given for the event. The outcome of the event was reported as not recovered/not resolved. Therapy with GARDASIL was reported as discontinued as not reintroduced. The patient did not seek medical attention. The relatedness for the event was unknown for GARDASIL. Additional information is not expected.
Age: 54.0
Sex: M
Vaccine: HPV4
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a biller for a physician practice refers to a 54 years old male (also reported as female) patient who on an unknown date was vaccinated with a dose of GARDASIL (dose, route and lot # not reported) "because the patient requested it". No symptoms reported. Additional information is not expected.
Age: 1.31
Sex: M
Vaccine: VARCEL
Symptoms: Varicella
Clinical narrative: Information has been received from a registered nurse concerning a 16 months old male patient. On 11-OCT-2012, the patient was vaccinated with a dose of VARIVAX (Merck) (dose and route were not reported) (Lot #: H009639; Expiration date not reported). Concomitant medications included PEDIARIX, Hib conj vaccine (unspecified carrier) MMR II, hepatitis A virus vaccine (unspecified) and PREVNAR. On 22-OCT-2012 the patient developed a chickenpox rash, on the thigh where the shot was given after receiving VARIVAX (Merck). The patient sought unspecified medical attention. No treatment was given for the event. At the time of the report, the patient's outcome for chickenpox rash was reported as recovered/resolved. The relatedness for chickenpox rash was unknown for VARIVAX (Merck). Additional information has been requested.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site haematoma, Injection site haemorrhage, Injection site pain, Injection site reaction
Clinical narrative: This spontaneous report was received from a 63 years old female consumer regarding herself. No concomitant medications were reported. The patient reported that on 04-OCT-2012, after she was vaccinated with a dose of ZOSTAVAX (lot# and route not reported, product circular # 9989115) she had a large bruise and bleeding at the injection site and muscle soreness. She was worried that the needle hit her muscle since she was experiencing so much soreness and bleeding. At the time of this report the patient still has soreness and bruising at the injection site was worried that she did not get the protective dose of ZOSTAVAX. She thinks it was delivered into the muscle. She asked about titers and was told her that the prescribing information did not contain that data. She also gave the name of her healthcare professional (HCP) but did not want him to be contacted. No medical attention was sought. No treatment information was reported. Additional information has been requested.
Age: 84.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Diarrhoea, Feeling cold, Myalgia, Nausea
Clinical narrative: This spontaneous report was received from a 84 year old female patient regarding herself. Patient's current condition included sulfa drug allergy. On 05-OCT-2012 (Friday), the patient was vaccinated with a dose of ZOSTAVAX (dose, route and lot number unspecified). No concomitant medications were reported. On 07-OCT-2012 (Sunday night), the patient experienced cold feeling in her back accompanied by muscle and joint pain. She also stated that she was having diarrhea and nausea. The patient did not seek medical attention. She inquired how long she would be feeling the symptoms and inquired if she could take any treatment for the joint pain. The outcome of cold feeling in her back, muscle and joint pain, nausea and diarrhea was unknown. The relatedness for cold feeling in her back, nausea, diarrhea, muscle and joint pain was unknown for ZOSTAVAX. Additional information has been requested.
Age: 1.31
Sex: U
Vaccine: HEPA
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a nurse refers to an approximately 1 years old patient. The patient was vaccinated with dose 1, 0.5 ml VAQTA intramuscularly (lot # reported as H010437, expiry: 28-FEB-2015) on 18-JUN-2012. No concomitant medications were reported. On 04-OCT-2012, the patient was administered second dose of VAQTA intramuscularly (lot # not reported) four months after the first dose of VAQTA was administered. No adverse experience had been observed or reported. No medical attention was sought by the patient. Additional information has been requested.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Condition aggravated, Contraindication to vaccination, Heart rate irregular, Immediate post-injection reaction, Injection site erythema
Clinical narrative: This spontaneous report was received from a 74 years old female patient regarding herself. The patient reported that last year she received sulfamethoxazole/trimethoprim and had a toxic reaction from this. She had spots with the similar appearance of age spots all over her body. The patient was in bed for three days and had lost 8 pounds in 3 days. The patient's current condition included leukemia. The patient's medical history included atrial fibrillation and prolapse irregular heartbeat. Concomitant medications included PIRAM/HCPZ, metoprolol, simvastatin (manufacturer unknown) and TOPALA TARTOR. On 01-OCT-2012, the patient was vaccinated with ZOSTAVAX (lot # and route not reported) and immediately started to have some adverse experiences. The patient experienced red welt at the injection site and was not feeling well. On 02-OCT-2012, the red welt was as big as a "50 cent coin" and was raised in a few spots, but it was better than yesterday. The patient now had a fever of 99.7 and was having some heart irregularity. The patient has leukemia and this was contraindicated for this medication ZOSTAVAX. Patient also provided the pharmacist's information who had administered the ZOSTAVAX shot to the patient. No treatment was given. Patient had not sought medical attention. No laboratory tests were performed. The outcome of the events was reported as recovering. Additional information has been requested.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site urticaria, Malaise, Pyrexia
Clinical narrative: This spontaneous report was received from a 74 years old female patient regarding herself. The patient reported that last year she received sulfamethoxazole/trimethoprim and had a toxic reaction from this. She had spots with the similar appearance of age spots all over her body. The patient was in bed for three days and had lost 8 pounds in 3 days. The patient's current condition included leukemia. The patient's medical history included atrial fibrillation and prolapse irregular heartbeat. Concomitant medications included PIRAM/HCPZ, metoprolol, simvastatin (manufacturer unknown) and TOPALA TARTOR. On 01-OCT-2012, the patient was vaccinated with ZOSTAVAX (lot # and route not reported) and immediately started to have some adverse experiences. The patient experienced red welt at the injection site and was not feeling well. On 02-OCT-2012, the red welt was as big as a "50 cent coin" and was raised in a few spots, but it was better than yesterday. The patient now had a fever of 99.7 and was having some heart irregularity. The patient has leukemia and this was contraindicated for this medication ZOSTAVAX. Patient also provided the pharmacist's information who had administered the ZOSTAVAX shot to the patient. No treatment was given. Patient had not sought medical attention. No laboratory tests were performed. The outcome of the events was reported as recovering. Additional information has been requested.
Sex: F
Vaccine: HEP
Symptoms: Pyrexia
Clinical narrative: This spontaneous report as received from a female consumer of unknown age reporting on herself. The patient was vaccinated with a dose of hepatitis B vaccine (recombinant) (manufacturer unknown) (dose, route and lot # not reported). No other co-suspects were reported. No concomitant medications were reported. On an unknown date, many years ago the patient developed 103 degrees fever after receiving Hepatitis B vaccines. No treatment information was reported. It was unknown if the patient sought medical attention. The outcome of the event was unknown. The relationship between the event and Hepatitis B vaccine (manufacturer unknown) was not reported. Additional information has been requested.
Sex: F
Vaccine: MMR
Symptoms: Maternal exposure before pregnancy, Rubella antibody negative
Clinical narrative: This spontaneous prospective pregnancy report was received from a physician assistant refers to a female patient of unknown age. The patient's history of previous pregnancies and live births was not known. The patient was vaccinated with MMR II (dose, route and lot # not reported) on an unspecified date. It was reported that the patient became pregnant after receiving MMR II in the past. The patient was pregnant for 25 weeks at the time of reporting. The patient's LMP is 09-APR-2012 and EDD date is 14-JAN-2013. The patient's rubella titer came back low in a recent blood test. At the time of reporting, the patient had not recovered. The patient sought medical attention by seeing the physician assistant. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Vertigo
Clinical narrative: This spontaneous report as received from a medical assistant that inquired on behalf of the physician, if ZOSTAVAX could cause vertigo. The medical assistant did not know if there was a patient involved but due to the nature of the question asked, there might have been a patient who experienced vertigo after receiving ZOSTAVAX. The outcome of possible vertigo was unknown. The relatedness possible vertigo was unknown for ZOSTAVAX. Additional information is not expected.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Varicella, Viral titre decreased
Clinical narrative: This spontaneous report as received from a physician refers to an over 65 years old male patient with a history of coronary artery disease (CAD) and exposed to chicken pox, who on an unspecified date was vaccinated with a dose of ZOSTAVAX 0.65 ml subcutaneously (lot number not reported). No other co-suspects were reported. No concomitant medications were reported. The physician reported that on 26-OCT-2012 the patient developed a case of full blown chickenpox as of today. The physician had checked the patient for varicella titers prior to vaccination and the titers were low. The patient was treated with VALTREX for the adverse event. At the time of the report, the patient had not recovered from adverse events. The patient sought medical attention: office visit. The relatedness for the adverse events was unknown for ZOSTAVAX. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Back pain
Clinical narrative: This spontaneous report was received from a female patient of unknown age with no drug reactions or allergies. The patient's medical history included pneumonia. In the end of November 2009, the patient was vaccinated with a dose of ZOSTAVAX (dose, route and lot not reported). No other co-suspects were reported. Concomitant medications included H1N1 and influenza virus vaccine (unspecified). "90" later from the date of vaccination the patient developed searing pain in her back. The patient explained that she never developed a rash or skin lesion, however she was told by her neurologist that the pain was caused as a reaction to ZOSTAVAX. The patient was treated with a dermal patch. At the time of the report, the patient had not recovered from the event; her back pain was spreading. There were no laboratories performed. The relationship between the event and ZOSTAVAX was reported as related by the reporter. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Injection site erythema, Injection site mass, Injection site pain, Injection site pruritus
Clinical narrative: This spontaneous report as received from a consumer refers to herself a female patient of unknown age with no pertinent drug reactions. On 22-OCT-2012, the patient was vaccinated with ZOSTAVAX (dose, route and lot provided). No concomitant medications were reported. The consumer stated that on 22-OCT-2012 she received ZOSTAVAX at a local pharmacy and a few hours after receiving the vaccine the injection site became hot, red, and developed a little lump in a circle about 3 inches in diameter, the lump was itchy, and painful. The patient also developed a headache. The patient was put on treatment with ibuprofen for headache. The patient did not sought medical attention and did not performed any laboratory tests. On 25-OCT-2012, the patient explained that she was feeling better. At the time of the report, the patient's outcome was reported as recovering/resolving. The relatedness for adverse events was unknown for ZOSTAVAX. Additional information is not expected.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site rash, Injection site warmth
Clinical narrative: This spontaneous report as received from a consumer refers to herself a female patient of unknown age with no pertinent drug reactions. On 22-OCT-2012, the patient was vaccinated with ZOSTAVAX (dose, route and lot provided). No concomitant medications were reported. The consumer stated that on 22-OCT-2012 she received ZOSTAVAX at a local pharmacy and a few hours after receiving the vaccine the injection site became hot, red, and developed a little lump in a circle about 3 inches in diameter, the lump was itchy, and painful. The patient also developed a headache. The patient was put on treatment with ibuprofen for headache. The patient did not sought medical attention and did not performed any laboratory tests. On 25-OCT-2012, the patient explained that she was feeling better. At the time of the report, the patient's outcome was reported as recovering/resolving. The relatedness for adverse events was unknown for ZOSTAVAX. Additional information is not expected.