chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 31.0
Sex: F
Vaccine: FLU3
Symptoms: Cough, Pharyngeal oedema
Clinical narrative: Only after I inquired several days later, the patient reported she felt like her throat was swelling inside and developed a cough around 6pm- she did not call anyone but states she took some Benadryl and went to bed- resolved in morning when awoke.  No localized reaction reported. I explained the seriousness of anaphylaxis and advised her to consider this an allergy from here on.
Age: 78.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness
Clinical narrative: called and reported dizziness; called primary provider and told to take Meclazine; stated not any better; advised to seek care at PCP/urgent care or ER and not to drive
Age: 68.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus
Clinical narrative: Patient presented localized redness on her right bicep area. She described soreness and itching in the area but also stated that the itching had resolved.
Age: 76.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Injected limb mobility decreased, Injection site erythema, Injection site streaking
Clinical narrative: ERYTHEMA, LOSS OF LIMB USE, RED LINE FROM INJECTION SITE TOWARDS ELBOW
Age: 51.0
Sex: F
Vaccine: FLUX
Symptoms: Chills, Cough, Dry throat, Headache, Heart rate increased
Clinical narrative: Dry throat, cough, chills, body aches, headache, rapid heartbeat
Age: 51.0
Sex: F
Vaccine: FLUX
Symptoms: Pain
Clinical narrative: Dry throat, cough, chills, body aches, headache, rapid heartbeat
Age: 69.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Cough, Pyrexia, Sinus congestion
Clinical narrative: fever, cough, head congestion
Age: 25.0
Sex: F
Vaccine: FLU3
Symptoms: Eyelid oedema, Flushing, Hyperhidrosis, Hypersensitivity, Ocular hyperaemia
Clinical narrative: Swelling/ redness of eye flushing/hives/itching/sweating treated at ER for allergic Rx.
Age: 25.0
Sex: F
Vaccine: FLU3
Symptoms: Pruritus, Urticaria
Clinical narrative: Swelling/ redness of eye flushing/hives/itching/sweating treated at ER for allergic Rx.
Age: 84.0
Sex: M
Vaccine: FLU3
Symptoms: Cough, Pyrexia
Clinical narrative: fever, cough
Age: 0.63
Sex: F
Vaccine: FLUX
Symptoms: Decreased appetite, Diarrhoea, Dysphonia, Irritability, Laryngitis
Clinical narrative: A few hours after receiving a flu shot, my child's voice started to become hoarse. The hoarseness worsened over the next day, and into the following morning. She also had a lack of appetite, looser stools, and irritability. This all prompted me to take her to the doctor.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Diarrhoea, Dizziness, Feeling abnormal, Nausea
Clinical narrative: About 4 hours after flu shot I started having body aches. Shortly after that I felt weak and then very nauseous and dizzy. Then I began throwing up and had uncontrollable diarrhea. Shortly after it was over but I was still weak even the next day. It's been about 36 hours and I feel I am getting better. I was so  miserable I will never have another flu shot.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Pain
Clinical narrative: About 4 hours after flu shot I started having body aches. Shortly after that I felt weak and then very nauseous and dizzy. Then I began throwing up and had uncontrollable diarrhea. Shortly after it was over but I was still weak even the next day. It's been about 36 hours and I feel I am getting better. I was so  miserable I will never have another flu shot.
Age: 32.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Syncope
Clinical narrative: Patient fainted.  She felt like she was going to faint so she went to her knees.  She stated that she had fainted in the past so she know what it felt like.
Age: 11.0
Sex: M
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site induration, Injection site warmth, Oedema peripheral, Pain
Clinical narrative: When I came home from work patient stated his arm was hurting, which is normal for a shot.  He came up a few minutes saying his arm was swollen.  I looked and he has a hard, red, hot area starting at the vaccine site almost 5 inches long and 2 inches wide.  It is hurting to lift his arm.  I had 2 children receive this shot yesterday, and of 3 children I have never seen a reaction like this.  It looks like cellulitis.
Age: 11.0
Sex: M
Vaccine: DTAP
Symptoms: Pain in extremity
Clinical narrative: When I came home from work patient stated his arm was hurting, which is normal for a shot.  He came up a few minutes saying his arm was swollen.  I looked and he has a hard, red, hot area starting at the vaccine site almost 5 inches long and 2 inches wide.  It is hurting to lift his arm.  I had 2 children receive this shot yesterday, and of 3 children I have never seen a reaction like this.  It looks like cellulitis.
Age: 52.0
Sex: M
Vaccine: FLU3
Symptoms: Arthralgia, Fatigue, Headache, Malaise, Muscle spasms
Clinical narrative: Left shoulder pain, weakness in legs severe aches and pain in joints in left side of arms chest and down to both legs. Feeling very cramped and severly aching with headache, lasting several days. Fatigued and tired for up to week. Still waiting for symptoms to alleviate no fever. General feeling of malaise lastng over a week about 5 days after vaccination.
Age: 52.0
Sex: M
Vaccine: FLU3
Symptoms: Muscular weakness, Musculoskeletal pain
Clinical narrative: Left shoulder pain, weakness in legs severe aches and pain in joints in left side of arms chest and down to both legs. Feeling very cramped and severly aching with headache, lasting several days. Fatigued and tired for up to week. Still waiting for symptoms to alleviate no fever. General feeling of malaise lastng over a week about 5 days after vaccination.
Age: 63.0
Sex: U
Vaccine: FLU3
Symptoms: Muscle spasms
Clinical narrative: Patient was given a Flu shot on 8/21/2010 and to pharmacy complaining of leg spasm. Dr received pt's profile and verified the pt has no neurologic deficit that related to the reaction from the Flu shot on 8/21/2010.
Age: 52.0
Sex: F
Vaccine: TDAP
Symptoms: Asthenia, Dyspnoea, Fatigue, Painful respiration, Pallor
Clinical narrative: sudden difficulty breathing & pain upon inhaling, weakness, pale, followed by wheezing and tiredness for 1-2 days
Age: 52.0
Sex: F
Vaccine: TDAP
Symptoms: Wheezing
Clinical narrative: sudden difficulty breathing & pain upon inhaling, weakness, pale, followed by wheezing and tiredness for 1-2 days
Age: 24.0
Sex: F
Vaccine: FLU3
Symptoms: Breath sounds, Urticaria
Clinical narrative: Received influenza vaccine 0130AM 9/30/10 within 4-6 hrs. developed hives on neck and trunk denies SOB or difficulty breathing. VS WNL once assessed following day.
Age: 77.0
Sex: F
Vaccine: FLUX
Symptoms: Erythema, Malaise, Pruritus generalised, Rash, Rash pruritic
Clinical narrative: Itchy, burning rash beginning on hands, arms spreading to torso on Tues Sept 21st disappeared by noon the next day. On eve of 22nd, rash began again - very ill- whole body itch, face, legs red. Dr prescribed ALLEGRA - some relief found.
Age: 77.0
Sex: F
Vaccine: FLUX
Symptoms: Skin burning sensation, Urticaria
Clinical narrative: Itchy, burning rash beginning on hands, arms spreading to torso on Tues Sept 21st disappeared by noon the next day. On eve of 22nd, rash began again - very ill- whole body itch, face, legs red. Dr prescribed ALLEGRA - some relief found.
Age: 60.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Rash, Swollen tongue, Urticaria
Clinical narrative: Received phone call from Pt. Co-workers that the pt. is in the SCU at the hospital due to hives, rash and swollen tongue. Pt. returned to work after injections and coworkers stated she was fine when she left but later in the P.M. symptoms started. Pt. received both VIS sheets prior to injections. State Immunization Program notified of pt. reaction.
Age: 17.0
Sex: M
Vaccine: FLU3
Symptoms: Urticaria
Clinical narrative: large Hives w/in 24 degrees - treated w/BENADRYL - hives have continued to appear for 3 days - always treated with BENADRY
Age: 1.27
Sex: M
Vaccine: FLU3, HIBV, VARCEL
Symptoms: Body temperature increased, Decreased appetite, Diarrhoea, Papule, Pyrexia
Clinical narrative: 8-10 red papule on trunk - few vesicle mild chickenpox 2 vaccine. Treat sx: TYLENOL, BENADRYL. Fever x 48 hrs - T max 102 degrees. Decreased appetite, diarrhea x3 Sat. No cough, congestion, noticed spots on back. VARIVAX x 3 days ago 9/27/10.
Age: 1.27
Sex: M
Vaccine: FLU3, HIBV, VARCEL
Symptoms: Rash vesicular, Varicella
Clinical narrative: 8-10 red papule on trunk - few vesicle mild chickenpox 2 vaccine. Treat sx: TYLENOL, BENADRYL. Fever x 48 hrs - T max 102 degrees. Decreased appetite, diarrhea x3 Sat. No cough, congestion, noticed spots on back. VARIVAX x 3 days ago 9/27/10.
Age: 80.0
Sex: F
Vaccine: FLU3
Symptoms: Herpes zoster
Clinical narrative: Pt was seen 3 days after vaccine and claimed to be diagnosed with shingles.
Age: 82.0
Sex: F
Vaccine: FLU3
Symptoms: Burning sensation, Fatigue, Gingival pain, Increased upper airway secretion, Injection site pain
Clinical narrative: Injection site so sore couldn't sleep on arm first two nights following vaccination. Same first two nights such a severe burning sensation in cheeks and especially gums. Awakened from sleep. So fatigued two days after vaccination had to take several rests in bed during day. Mild feeling of nausea, diarrhea but no actual episodes. Some nose drippings, need to keep clearing throat from phlegm. On third day slight sore throat by fifth day, with injection site back to normal. All symptoms pretty much gone.
Age: 82.0
Sex: F
Vaccine: FLU3
Symptoms: Nausea, Oropharyngeal pain, Rhinorrhoea, Sleep disorder, Throat irritation
Clinical narrative: Injection site so sore couldn't sleep on arm first two nights following vaccination. Same first two nights such a severe burning sensation in cheeks and especially gums. Awakened from sleep. So fatigued two days after vaccination had to take several rests in bed during day. Mild feeling of nausea, diarrhea but no actual episodes. Some nose drippings, need to keep clearing throat from phlegm. On third day slight sore throat by fifth day, with injection site back to normal. All symptoms pretty much gone.
Age: 12.0
Sex: F
Vaccine: FLU3, MNQ
Symptoms: Oedema peripheral
Clinical narrative: Swelling at (L) arm 1 day after MENACTRA and FLUZONE vaccine 4 x 4 in.
Age: 40.0
Sex: F
Vaccine: FLU3
Symptoms: Diarrhoea, Dyspnoea, Palpitations, Vomiting
Clinical narrative: Symptoms - vomiting, racing heart, SOB, diarrhea.
Age: 1.7
Sex: F
Vaccine: FLU3
Symptoms: Febrile convulsion
Clinical narrative: Patient had febrile seizure 16 hours after receiving flu shot - went to ER- Given antipyretic.
Age: 84.0
Sex: F
Vaccine: FLU3
Symptoms: Haematoma, Skin discolouration
Clinical narrative: Pt presented with large, raised hematoma on right arm (approximately equal to 3" diameter), deep purple in color.
Age: 81.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Cellulitis, Dizziness, Erythema, Lymphadenopathy, Nausea
Clinical narrative: When got home from clinic complained of dizziness/nausea. Laid down for 3-4 hours when got up arm was red and swollen. Took to Urgent care next day. Swelling in the morning - from shoulder past elbow, very red and in armpit. Mass on side of elbow - "moves down arm" went to wrist.
Age: 81.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Oedema peripheral, Upper extremity mass
Clinical narrative: When got home from clinic complained of dizziness/nausea. Laid down for 3-4 hours when got up arm was red and swollen. Took to Urgent care next day. Swelling in the morning - from shoulder past elbow, very red and in armpit. Mass on side of elbow - "moves down arm" went to wrist.
Age: 90.0
Sex: F
Vaccine: FLU3
Symptoms: Blister, Injection site pain, Musculoskeletal pain, Rash
Clinical narrative: Left shoulder blade pain that spread to injection site. A rash appeared, + blisters came on the arm. Called doctor, they may send something later for patient.
Age: 37.0
Sex: F
Vaccine: FLU3
Symptoms: Pruritus
Clinical narrative: Received vaccine IM in (L) deltoid at 230pm. Itching of (L) arm started at 4pm and spread to both arms, head, chest and legs. BENADRYL po taken at onset of itching and repeated 4 hours later.
Age: 11.0
Sex: M
Vaccine: FLUN3, MNQ, TDAP, VARCEL
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 23.0
Sex: F
Vaccine: FLU3
Symptoms: Fall, Syncope
Clinical narrative: Patient fainted and fell shortly after receiving immunization.
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Hyperhidrosis, Hypotension, Hypoventilation
Clinical narrative: Around 2AM the following day, pt reports waking up w/ drenching sweat, shallow breathing, low blood pressure (self test approximately 90/60), and states "fought passing out for one hour."
Age: 67.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Dizziness, Neck pain, Pain in extremity, Parosmia
Clinical narrative: Weird smell, feeling faint leg and neck pain - severe.
Age: 12.0
Sex: M
Vaccine: FLUN3, MNQ
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Health preadolescent given MENVEO in (L) arm on 9/28/10. On 9/29/10, developed erythema and swelling in surrounding area. When area was 8 1/2 x 10cm in size started diphenhydramine 25mg q 6 hours. Eighteen hour later (9/30) area more swollen and red (13 x 17 cm). Pt continued BENADRYL and started on Prednisone.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Feeling hot, Hyperhidrosis, Nausea, Pallor, Tremor
Clinical narrative: 30 min after vaccine pt returned - Hot, nauseated, pale, sweating, shaky. Pt was seated given cool cloth for head, and BTL of water. After 30 min pt's color returned, sweating stopped, shakiness stopped, nausea subsided. Pt requested to go home.
Age: 37.0
Sex: F
Vaccine: FLU3
Symptoms: Muscle spasms, Pain, Peripheral coldness, Skin discolouration
Clinical narrative: 4 days after 9-18-10 injection - cramping (L) increase arm, lifting arm causes pain + hurts to lower arm - pain increasing, (L) forearm darker + cooler. No redness or inflammation at injection site.
Age: 56.0
Sex: F
Vaccine: FLU3
Symptoms: Immediate post-injection reaction, Injection site haemorrhage, Injection site induration, Injection site swelling
Clinical narrative: Gave Flu shot. When needle retracted site started to bleed. Put cotton ball and slight pressure to site to help stop bleeding. Site began to swell and started to get slightly hard. Put bandaid on. About 15 min. Later site stopped bleeding and swelling went down.
Age: 65.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Chills, Injection site pain, Myalgia, Pyrexia, Tremor
Clinical narrative: 101.4 degrees fever, chills, muscle aches out of ordinary, shaking (from chills). Duration: 9.22-9.24.10 very sore arm at site of shots. Duration - 9.22-9.26.10
Age: 62.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: Swelling and tenderness with pain around the injection site.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Herpes zoster, Injection site nerve damage, Pain in extremity
Clinical narrative: Got shot, fine for 2 days, then left arm started to ache. Kept increasing in pain. No pain killer touched pain. Put on NEURONTIN after building up of 2 wks or so finally dealt with pain. Was on NEURONTIN for 6 mos. According to Dr shot hit nerve developed shingles without rash on arm. I also developed sores across my shoulders which happened before number of years ago.
Age: 82.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Diarrhoea, Nausea, Vaccination complication
Clinical narrative: Beginning day after influenza vaccine, pt queasy, nauseous, diarrhea, weak. Continued for 10 days. She saw her Primary Physician. He said probably reaction to flu vaccine. No fever, no local redness or swelling. Pt still under treatment.
Age: 84.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Arthralgia, Injection site pain, Pain in extremity
Clinical narrative: 9-29-10 TC from client she reports - she had a flu shot in her left arm on 9-27-10, and when she got the vaccine she felt a sharp pain at injection site on 9-28-10 AM. She had left wrist pain. Denies swelling, redness at injection site. She told RN the pain radiates to her fingers. The pain occurs with use of left hand and still has achyness with hand at rest. She told RN she is taking TYLENOL 500mg PO PRN for discomfort declined to call her MD to report symptoms. 9-30-10 TC from client - she reports her wrist is better - she continues to take 500mg TYLENOL 500mg PRN - she said her fingers are also better but still aches - advised to call MD - but said she is having less pain and will not call MD.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Abdominal discomfort, Chills, Condition aggravated, Diarrhoea, Fatigue
Clinical narrative: sore arm, tired, achy, slightly nauseous, some chills, sweats, supra ventricular tachycardia, diarrhea, upset stomach, general aches & pains, low grade fever
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Hyperhidrosis, Nausea, Pain, Pain in extremity, Pyrexia
Clinical narrative: sore arm, tired, achy, slightly nauseous, some chills, sweats, supra ventricular tachycardia, diarrhea, upset stomach, general aches & pains, low grade fever
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Supraventricular tachycardia
Clinical narrative: sore arm, tired, achy, slightly nauseous, some chills, sweats, supra ventricular tachycardia, diarrhea, upset stomach, general aches & pains, low grade fever
Age: 66.0
Sex: M
Vaccine: FLU3
Symptoms: Pyrexia, Tremor
Clinical narrative: 4 PM 9/16/2010 flu vaccine given. Middle of night same day patient had fever chills shaking - gone by the morning.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Eye swelling, Rash generalised, Rhinorrhoea
Clinical narrative: Swelling of left eye, runny nose and rash all over within 30 min. of vaccination.
Age: 60.0
Sex: M
Vaccine: PPV, TDAP, VARZOS
Symptoms: Erythema, Injection site pain, Injection site swelling, Malaise, Myalgia
Clinical narrative: Fever - 101, pain to entire arm, malaise, myalgias, radiculoneuropathy, erythema, sore and puffy (R) upper arm.
Age: 60.0
Sex: M
Vaccine: PPV, TDAP, VARZOS
Symptoms: Neuropathy peripheral, Pain in extremity, Pyrexia
Clinical narrative: Fever - 101, pain to entire arm, malaise, myalgias, radiculoneuropathy, erythema, sore and puffy (R) upper arm.
Age: 76.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site inflammation, Injection site oedema, Injection site pain, Injection site pruritus, Injection site reaction
Clinical narrative: 24 cm of red, inflamed, edema, itchy, painful, local reaction (R) upper arm at injection site.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site anaesthesia
Clinical narrative: Pt. C/o numbness at the site for 1-2 days after the shot and recovered completely.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Hypoaesthesia, Vaccine positive rechallenge
Clinical narrative: Pt. arm went numb after dose #1 and when received dose #2, arm went numb as well - Lasted 1-2d. Vaccines given in opposite arm and fully recovered.
Age: 3.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema
Clinical narrative: Redness at injection site.
Age: 1.54
Sex: M
Vaccine: HEPA
Symptoms: Coxsackie viral infection, Febrile convulsion, Laboratory test, Pyrexia
Clinical narrative: Fever w/in 24 hrs of vax -> febrile seizure. F/u exam c/w Coxsackie infection.
Age: 17.0
Sex: M
Vaccine: HEPA, MNQ, TDAP, VARCEL
Symptoms: Headache, Pyrexia
Clinical narrative: 8/13/10 Pt had vaccines 8/13 1 PM. This AM had temp 100.3. Given ibuprofen - States temp did no go down. Four hours later temp 101.3. C/o headache - Denies sore throat, cough, runny nose, body aches, rash, ear pain. Advised to try TYLENOL for temp. - Monitor condition if fever persists, headache becomes intense or develops other symptoms - Consult with PMD.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Abdominal pain upper, Facial pain, Fatigue, Feeling hot, Headache
Clinical narrative: Right-sided cheek pain and swelling (no abnormal discoloration), headache, fatigue 8/27/10. "Felt warm", per mother, but temp not taken. On 8/29/10 "everything hurting" and stomach hurting" 8/28/10. Recommended mom seek medical evaluation for patient.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Pain, Swelling face
Clinical narrative: Right-sided cheek pain and swelling (no abnormal discoloration), headache, fatigue 8/27/10. "Felt warm", per mother, but temp not taken. On 8/29/10 "everything hurting" and stomach hurting" 8/28/10. Recommended mom seek medical evaluation for patient.
Age: 1.05
Sex: M
Vaccine: PNC13, VARCEL
Symptoms: Injection site erythema, Injection site nodule
Clinical narrative: 2 small red knots where injection given in right arm. *ROI sent on 9/21/10 - 0 response.
Age: 68.0
Sex: F
Vaccine: UNK
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 80.0
Sex: F
Vaccine: UNK
Symptoms: Activities of daily living impaired, Immobile
Clinical narrative: One day, day of shot was immobilized in bed for several hours.
Age: 27.0
Sex: F
Vaccine: RAB
Symptoms: Urticaria
Clinical narrative: Received #3 Rabies vaccine 9/22/10. 28 hours after vaccine she developed a urticarial rash. She was seen 9/30/10 and was given RX for BENADRYL 25 mg PO. The following day hives doubled in size and spread down torso. Pt taken to emergency room for ER 10/1/10.
Age: 9.0
Sex: M
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site swelling, Injection site warmth
Clinical narrative: Pt presented to clinic with redness, swelling and heat to injection area. Also there was a hard area in the center of the injection site. Pt was given prednisone 10mg & advised to return to clinic or ER if worsens.
Age: 71.0
Sex: F
Vaccine: HEP
Symptoms: Pyrexia
Clinical narrative: Developed very high fever after receiving vaccine. She also states developed fever again a few days later after eating eggs. No temp taken by patient. Reported on 9/20/10 to PA.
Age: 11.0
Sex: M
Vaccine: IPV, TDAP
Symptoms: Back pain, Dizziness, Erythema, Localised oedema, Myalgia
Clinical narrative: 10 x 7 cm local redness, edema - Pt states dizziness, muscle aches and back pain.
Age: 1.59
Sex: F
Vaccine: DTAPIPVHIB, HEPA, PNC13
Symptoms: Injection site erythema, Injection site induration, Injection site swelling, Injection site warmth, Pyrexia
Clinical narrative: On the day following vaccination, patient developed redness and swelling at injection site on (R) leg; refused to walk on leg. Exam 9/25 showed 3-4cm erythema, slight induration and warmth, no fluctuance or streaking. Positive fever 9/24 - 9/27, responsive to TYLENOL/MOTRIN. BENADRYL PO, cool compresses 9/25 - 9/27. Resolved spontaneously.
Age: 1.59
Sex: F
Vaccine: DTAPIPVHIB, HEPA, PNC13
Symptoms: Weight bearing difficulty
Clinical narrative: On the day following vaccination, patient developed redness and swelling at injection site on (R) leg; refused to walk on leg. Exam 9/25 showed 3-4cm erythema, slight induration and warmth, no fluctuance or streaking. Positive fever 9/24 - 9/27, responsive to TYLENOL/MOTRIN. BENADRYL PO, cool compresses 9/25 - 9/27. Resolved spontaneously.
Age: 12.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Erythema, Injection site erythema, Pain, Pain in extremity
Clinical narrative: TDAP and MENACTRA admin in right deltoid 9/27 in AM. Evening 9/27 some pain in arm took TYLENOL x 2 pills. 9/28 AM redness size of quarter with some pain - took TYLENOL x 2 pills. 9/29 2:15pm 3 inch red area rt upper arm. Mother taking her to med express for evaluation.
Sex: F
Vaccine: HIBV, MMR, PNC13, VARCEL
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: Erythema and induration of the (L) thigh (Approx 3in. in diameter)
Age: 0.18
Sex: M
Vaccine: RV1
Symptoms: Incorrect route of drug administration, Injection site erythema, Injection site swelling
Clinical narrative: Administration of ROTARIX vaccination as intramuscular injection (oral immunization route). Facility made immediate phone call to pharmaceutical manufacturer regarding incident. Upon the advice of the pharmaceutical representative, the patient was brought back into our facility the following day for administration of the oral vaccine ROTARIX. Based on the recommendations from the American Academy of Pediatrics "... previous immunization with a dose that was .... Administered by a non-standard route should not be counted, and the person should be immunized as recommended for age". No signs of adverse reaction was noted. IM injection site 'erythema and swelling of shot sites has resolved' documentation noted upon return visit by pediatric physician. If you have any further questions, please do not hesitate to contact me.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Local reaction
Clinical narrative: Pt. had a localized reaction about 3 inches around the sight of injection. Appeared red and slightly swollen. Presented me with symptom 2 days after vaccination.
Age: 81.0
Sex: M
Vaccine: VARZOS
Symptoms: Ear discomfort, Eye irritation, Pruritus generalised
Clinical narrative: On 9/22/10 at 10:35 AM, patient received ZOSTAVAX. On 9/23/10, patient started to experience itching all over his body from head to toe. He reports no sign of rash, took BENADRYL which helped a little. The itching would start up again about 4 hrs. His eyes and ears itch and burn. Will see an MD on 9/27/10.
Age: 0.39
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Crying, Irritability, Pyrexia
Clinical narrative: Patient came in on 9-7-10 got 4 mo shots. PENTACEL, PCV13, Rota. Later that day Dr. received call mom stating kid had fever 101 degrees. None stop crying very fussy. That lasted until the next day Saturday evening. Is doing better now. Dr. did recommend ER if not better, but they didn't feel they had to take her.
Age: 11.0
Sex: F
Vaccine: TDAP
Symptoms: Blood electrolytes, Cough, Full blood count, Thyroid function test
Clinical narrative: Coughing two days after vaccine administered parent states child has been coughing since patient being eval for other cough sources parent wanted report.
Age: 0.52
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Injection site erythema, Pyrexia
Clinical narrative: - Fever to 104 degrees F ~ 12 hours after vaccine; redness @ injection site.
Age: 51.0
Sex: M
Vaccine: TDAP
Symptoms: Arthralgia, Chest pain, Chills, Diarrhoea, Fatigue
Clinical narrative: 19 Sep 10 Extremely fatigued at 1630; aching leg joints and muscles plus chills at 2000; nausea at 2100; vomiting/diarrhea from 2200 until 0600 20 Sep 10. 20 Sep 10 nausea and headaches most of the day; minimal po intake; 21 Sep 10 "chest on fire" at 2200 --> relieved by sitting upright.
Age: 51.0
Sex: M
Vaccine: TDAP
Symptoms: Headache, Hypophagia, Myalgia, Nausea, Vomiting
Clinical narrative: 19 Sep 10 Extremely fatigued at 1630; aching leg joints and muscles plus chills at 2000; nausea at 2100; vomiting/diarrhea from 2200 until 0600 20 Sep 10. 20 Sep 10 nausea and headaches most of the day; minimal po intake; 21 Sep 10 "chest on fire" at 2200 --> relieved by sitting upright.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site erythema
Clinical narrative: 3 1/2" x 3 1/2" redness of (R) upper thigh.
Age: 0.34
Sex: M
Vaccine: DTAPIPVHIB, PNC, RV5
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Irritability, Rash erythematous
Clinical narrative: Swelling, redness, warmth on thighs L > R also generalized rough red papular rash on trunk arms and legs. Pt also fussy. Temp 100.5 swelling, redness subsiding today, less fussy.
Age: 0.34
Sex: M
Vaccine: DTAPIPVHIB, PNC, RV5
Symptoms: Rash generalised, Rash papular
Clinical narrative: Swelling, redness, warmth on thighs L > R also generalized rough red papular rash on trunk arms and legs. Pt also fussy. Temp 100.5 swelling, redness subsiding today, less fussy.
Age: 26.0
Sex: M
Vaccine: SMALL
Symptoms: Vaccinia virus infection
Clinical narrative: Generalized vaccinia g/l arms.
Age: 10.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Erythema, Injection site pustule, Oedema peripheral, Pain in extremity, Rash
Clinical narrative: Patient developed a rash/area of warmth in a streaky red pattern down his arm. Rash was warm to the touch. Painful and swollen. Patient had no fever, no nausea or vomiting. At injection site there was a raised pustule left arm.
Age: 10.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Skin warm
Clinical narrative: Patient developed a rash/area of warmth in a streaky red pattern down his arm. Rash was warm to the touch. Painful and swollen. Patient had no fever, no nausea or vomiting. At injection site there was a raised pustule left arm.
Age: 63.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Fatigue, Feeling of body temperature change, Injection site pain, Joint range of motion decreased, Malaise
Clinical narrative: 10/5/10 midnight - increased pain over (R) deltoid pain (injection site) - limited ROM. 10/6/10 9AM - fatigue, malaise. 10/6/10 12 noon - vertigo, near syncope. 10/6/10 1-3pm felt ? and cold, "aching, tenderness with palpating over area.
Age: 63.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Presyncope, Vertigo
Clinical narrative: 10/5/10 midnight - increased pain over (R) deltoid pain (injection site) - limited ROM. 10/6/10 9AM - fatigue, malaise. 10/6/10 12 noon - vertigo, near syncope. 10/6/10 1-3pm felt ? and cold, "aching, tenderness with palpating over area.
Age: 2.0
Sex: M
Vaccine: DTP, HEPA, HIBV, IPV, PPV
Symptoms: Injected limb mobility decreased
Clinical narrative: Left arm he will not use at all. Pt can move arm but is limited to how far he will move it. Both vertically and horizontally.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Contusion, Erythema, Tenderness
Clinical narrative: Arm tenderness, redness and bruising. Warm to touch 1 wk post vaccine. No treatment just observation.
Age: 0.36
Sex: F
Vaccine: DTAPIPVHIB, PNC, RV5
Symptoms: Abdominal pain, Acne infantile, Crying, Dermatitis diaper, Eczema
Clinical narrative: Initial report received from a consumer's mother on 20 May 2010.  A 4-month-old female infant, with a history of acid reflux and dairy allergy, had received dose 2 injection of PENTACEL (lot number, route and site unknown), PREVNAR (Wyeth) and ROTATEQ (Merck) on the day of 10 May 2010 and that evening of 10 May 2010 became colicky, crying for no apparent reason, and developed baby acne/eczema rash on face and a diaper rash.  The patient was fussy prior to the vaccine.  The patient was to be evaluated by an allergist next week.  The outcome was reported as recovered.  Follow-up information was received on 12 July 2010 from a healthcare professional.  The lot number for PENTACEL was C3591AA and was a right thigh intramuscular injection.  The previously reported PREVNAR was PREVNAR 13 with a lot number of E44526 and was a left thigh intramuscular injection.  The lot number for ROTATEQ was 0066Y and 2 mL was given by mouth (PO).  Documents held by sender: None.
Age: 0.36
Sex: F
Vaccine: DTAPIPVHIB, PNC, RV5
Symptoms: Irritability
Clinical narrative: Initial report received from a consumer's mother on 20 May 2010.  A 4-month-old female infant, with a history of acid reflux and dairy allergy, had received dose 2 injection of PENTACEL (lot number, route and site unknown), PREVNAR (Wyeth) and ROTATEQ (Merck) on the day of 10 May 2010 and that evening of 10 May 2010 became colicky, crying for no apparent reason, and developed baby acne/eczema rash on face and a diaper rash.  The patient was fussy prior to the vaccine.  The patient was to be evaluated by an allergist next week.  The outcome was reported as recovered.  Follow-up information was received on 12 July 2010 from a healthcare professional.  The lot number for PENTACEL was C3591AA and was a right thigh intramuscular injection.  The previously reported PREVNAR was PREVNAR 13 with a lot number of E44526 and was a left thigh intramuscular injection.  The lot number for ROTATEQ was 0066Y and 2 mL was given by mouth (PO).  Documents held by sender: None.
Age: 0.67
Sex: F
Vaccine: DTAPIPVHIB, PNC13
Symptoms: Body temperature increased
Clinical narrative: Vaccination site reaction. Initial case was received on 13 July 2010 from a healthcare professional. It contains information for a cluster of 9 unidentified patients. Nine unidentified patients ("children" age and gender not reported) received PENTACEL (lot number C3602AB) on unspecified dates. Seven of the patients had uncontrollable crying. Two patients had cellulitis with greater than 3 inch diameter of swelling and redness and had pain and fever. "Several" of the nine patients had local reaction and fever. There were no diagnostic tests or laboratory tests done. The reporter provided no further information. All the patients recovered from the events. Follow-up information was received 14 July 2010 from a health care professional who reported that the events consisted of multiple high grade fevers, local reactions, cellulitis in two cases, and inconsolable crying (previously reported as uncontrollable crying). Patient information was reported as "female". No additional information was reported. Follow-up information was received on 02 August 2010 from a healthcare professional who identified one of the previously nine unidentified patients as an eight month old female. The patient had received on 23 June 2010 a third dose, left leg injection of PENTACEL, lot number C3602AB and a third dose, right leg injection of PCV13 (lot number #52353, manufacturer Wyeth). The next day she developed a temperature >103 which was treated with TYLENOL and MOTRIN. The patient had no concurrent illness at the time of the vaccination. No additional information was reported. Documents held by sender: None.
Age: 0.3
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC, RV5, DTAP, DTAPH, DTAPHEPBIP, PNC, RV5
Symptoms: Abdominal pain, Haematochezia, Intussusception, Irritability, Laparoscopic surgery
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. A 3 month old male patient with no pertinent medical history, no allergies and no preexisting conditions on 01-JUN-2010 was vaccinated by mouth with the first dose of ROTATEQ (Lot # 664946/0148Z). Concomitant therapies included intramuscular vaccination with the first dose of TRIHIBIT (UF819AC), intramuscular vaccination with the first dose of PREVNAR (Lot # E49135), intramuscular vaccination with the first dose of PEDIARIX (Lot # D0042) and intramuscular vaccination with the first dose of DAPTACEL (Lot # C3139AA). No other medications. Child developed severe abdominal pain on "22-JUL-2010". He was very irritable, screaming from the pain, vomited once, seen in ER, had bloody stool there. Intussusception was diagnosed, laparoscopy surgery was done at hospital on 23-JUL-2010. The following information was obtained through follow-up and/or provided by the government. 04-AUG-2010. DC (discharge summary) for DOS (date of service) 21-JUL-2010 - 22-JUL-2010. Diagnosis: intussusception. Patient presented with abdominal pain, crying, vomiting, lethargic, pale, jelly like bloody stool. Air contrast barium enema performed/repeated and unsuccessful. Patient had laparascopic reduction of intussusception. Patient tolerated milk well. Treated with IV hydration, TYLENOL. Patient was discharged home 09-AUG-2010. Primary care physician notes for 22-JUL-2010 to 03-AUG-2010. Patient admitted to ER after vomiting, not eating, jelly like stool. On 03-AUG-2010, patient was doing better and had no problems. The patient required an emergency room/doctor visit, the events required hospitalization, were considered to be immediately life-threatening and were considered to be serious by the reporter. A standard lot check has been finalized. All in-process quality checks for the lot number in question were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. The original reporting source was not provided. The VAERS ID # is 394209. No further information is available.
Age: 0.3
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC, RV5, DTAP, DTAPH, DTAPHEPBIP, PNC, RV5
Symptoms: Screaming, Vomiting
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. A 3 month old male patient with no pertinent medical history, no allergies and no preexisting conditions on 01-JUN-2010 was vaccinated by mouth with the first dose of ROTATEQ (Lot # 664946/0148Z). Concomitant therapies included intramuscular vaccination with the first dose of TRIHIBIT (UF819AC), intramuscular vaccination with the first dose of PREVNAR (Lot # E49135), intramuscular vaccination with the first dose of PEDIARIX (Lot # D0042) and intramuscular vaccination with the first dose of DAPTACEL (Lot # C3139AA). No other medications. Child developed severe abdominal pain on "22-JUL-2010". He was very irritable, screaming from the pain, vomited once, seen in ER, had bloody stool there. Intussusception was diagnosed, laparoscopy surgery was done at hospital on 23-JUL-2010. The following information was obtained through follow-up and/or provided by the government. 04-AUG-2010. DC (discharge summary) for DOS (date of service) 21-JUL-2010 - 22-JUL-2010. Diagnosis: intussusception. Patient presented with abdominal pain, crying, vomiting, lethargic, pale, jelly like bloody stool. Air contrast barium enema performed/repeated and unsuccessful. Patient had laparascopic reduction of intussusception. Patient tolerated milk well. Treated with IV hydration, TYLENOL. Patient was discharged home 09-AUG-2010. Primary care physician notes for 22-JUL-2010 to 03-AUG-2010. Patient admitted to ER after vomiting, not eating, jelly like stool. On 03-AUG-2010, patient was doing better and had no problems. The patient required an emergency room/doctor visit, the events required hospitalization, were considered to be immediately life-threatening and were considered to be serious by the reporter. A standard lot check has been finalized. All in-process quality checks for the lot number in question were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. The original reporting source was not provided. The VAERS ID # is 394209. No further information is available.
Age: 0.3
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC, RV5, DTAP, DTAPH, DTAPHEPBIP, PNC, RV5
Symptoms: Abdominal pain, Barium double contrast, Crying, Haematochezia, Intussusception
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. A 3 month old male patient with no pertinent medical history, no allergies and no preexisting conditions on 01-JUN-2010 was vaccinated by mouth with the first dose of ROTATEQ (Lot # 664946/0148Z). Concomitant therapies included intramuscular vaccination with the first dose of TRIHIBIT (UF819AC), intramuscular vaccination with the first dose of PREVNAR (Lot # E49135), intramuscular vaccination with the first dose of PEDIARIX (Lot # D0042) and intramuscular vaccination with the first dose of DAPTACEL (Lot # C3139AA). No other medications. Child developed severe abdominal pain on "22-JUL-2010". He was very irritable, screaming from the pain, vomited once, seen in ER, had bloody stool there. Intussusception was diagnosed, laparoscopy surgery was done at hospital on 23-JUL-2010. The following information was obtained through follow-up and/or provided by the government. 04-AUG-2010. DC (discharge summary) for DOS (date of service) 21-JUL-2010 - 22-JUL-2010. Diagnosis: intussusception. Patient presented with abdominal pain, crying, vomiting, lethargic, pale, jelly like bloody stool. Air contrast barium enema performed/repeated and unsuccessful. Patient had laparascopic reduction of intussusception. Patient tolerated milk well. Treated with IV hydration, TYLENOL. Patient was discharged home 09-AUG-2010. Primary care physician notes for 22-JUL-2010 to 03-AUG-2010. Patient admitted to ER after vomiting, not eating, jelly like stool. On 03-AUG-2010, patient was doing better and had no problems. The patient required an emergency room/doctor visit, the events required hospitalization, were considered to be immediately life-threatening and were considered to be serious by the reporter. A standard lot check has been finalized. All in-process quality checks for the lot number in question were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. The original reporting source was not provided. The VAERS ID # is 394209. No further information is available.
Age: 0.3
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC, RV5, DTAP, DTAPH, DTAPHEPBIP, PNC, RV5
Symptoms: Irritability, Laparoscopic surgery, Lethargy, Pain, Pallor
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. A 3 month old male patient with no pertinent medical history, no allergies and no preexisting conditions on 01-JUN-2010 was vaccinated by mouth with the first dose of ROTATEQ (Lot # 664946/0148Z). Concomitant therapies included intramuscular vaccination with the first dose of TRIHIBIT (UF819AC), intramuscular vaccination with the first dose of PREVNAR (Lot # E49135), intramuscular vaccination with the first dose of PEDIARIX (Lot # D0042) and intramuscular vaccination with the first dose of DAPTACEL (Lot # C3139AA). No other medications. Child developed severe abdominal pain on "22-JUL-2010". He was very irritable, screaming from the pain, vomited once, seen in ER, had bloody stool there. Intussusception was diagnosed, laparoscopy surgery was done at hospital on 23-JUL-2010. The following information was obtained through follow-up and/or provided by the government. 04-AUG-2010. DC (discharge summary) for DOS (date of service) 21-JUL-2010 - 22-JUL-2010. Diagnosis: intussusception. Patient presented with abdominal pain, crying, vomiting, lethargic, pale, jelly like bloody stool. Air contrast barium enema performed/repeated and unsuccessful. Patient had laparascopic reduction of intussusception. Patient tolerated milk well. Treated with IV hydration, TYLENOL. Patient was discharged home 09-AUG-2010. Primary care physician notes for 22-JUL-2010 to 03-AUG-2010. Patient admitted to ER after vomiting, not eating, jelly like stool. On 03-AUG-2010, patient was doing better and had no problems. The patient required an emergency room/doctor visit, the events required hospitalization, were considered to be immediately life-threatening and were considered to be serious by the reporter. A standard lot check has been finalized. All in-process quality checks for the lot number in question were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. The original reporting source was not provided. The VAERS ID # is 394209. No further information is available.
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5, DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Blood culture negative, C-reactive protein increased, CSF culture negative, Coronary artery dilatation, Culture urine negative
Clinical narrative: This report was identified from a line listing obtained on request by the company from the FDA under the Freedom of Information Act. A 0.5 year old patient with no pertinent medical history who on 26-JUL-2010 was vaccinated orally with ROTATEQ (lot#668041/0510Z). Concomitant therapy included a third dose of PEDIARIX (IM at right leg) (Lot # AC21B248CA), a second dose of PREVNAR 13 (IM at right leg) (Lot # E57642) and a third dose of ACTHIB (IM at left leg) (Lot # UH045AB). On 04-AUG-2010 the patient diagnosed with Kawasaki's disease (KD) and treated with two rounds of IV Ig and was hospitalized. The laboratory tests revealed that leukocytosis with platelet count increasing to 922,000, serum C-reactive protein greater than 300, erythrocyte sedimentation rate maximum at 130 mm/hr, urinalysis test with leukocytosis, culture of blood, urine and cerebrospinal fluid (CSF) were negative, Echocardiography (ECHO) demonstrated coronary artery ectasia, clinical picture of KD. The adverse events were considered to be immediately life-threatening. The original reporting source was not provided. The VAERS ID # is 395496. A standard lot check investigation has been finalized. All in-process quality checks for the lot number (lot # 668041/0510Z) in question were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. No further information is available.
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5, DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Echocardiogram abnormal, Immunoglobulin therapy, Kawasaki's disease, Leukocytosis, Platelet count increased
Clinical narrative: This report was identified from a line listing obtained on request by the company from the FDA under the Freedom of Information Act. A 0.5 year old patient with no pertinent medical history who on 26-JUL-2010 was vaccinated orally with ROTATEQ (lot#668041/0510Z). Concomitant therapy included a third dose of PEDIARIX (IM at right leg) (Lot # AC21B248CA), a second dose of PREVNAR 13 (IM at right leg) (Lot # E57642) and a third dose of ACTHIB (IM at left leg) (Lot # UH045AB). On 04-AUG-2010 the patient diagnosed with Kawasaki's disease (KD) and treated with two rounds of IV Ig and was hospitalized. The laboratory tests revealed that leukocytosis with platelet count increasing to 922,000, serum C-reactive protein greater than 300, erythrocyte sedimentation rate maximum at 130 mm/hr, urinalysis test with leukocytosis, culture of blood, urine and cerebrospinal fluid (CSF) were negative, Echocardiography (ECHO) demonstrated coronary artery ectasia, clinical picture of KD. The adverse events were considered to be immediately life-threatening. The original reporting source was not provided. The VAERS ID # is 395496. A standard lot check investigation has been finalized. All in-process quality checks for the lot number (lot # 668041/0510Z) in question were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. No further information is available.