chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 62.0
Sex: F
Vaccine: DTAP
Symptoms: Glossodynia, Hemicephalalgia, Hypoaesthesia oral, Musculoskeletal pain, Musculoskeletal stiffness
Clinical narrative: Severe headache on left side of head, sore left arm and left shoulder, stiff neck, numb and burning tongue and lips, lasting 3-4 days.  For the last 3 weeks and currently, tongue burns constantly, and stiff neck and headache on left side come and go.
Age: 62.0
Sex: F
Vaccine: DTAP
Symptoms: Pain in extremity
Clinical narrative: Severe headache on left side of head, sore left arm and left shoulder, stiff neck, numb and burning tongue and lips, lasting 3-4 days.  For the last 3 weeks and currently, tongue burns constantly, and stiff neck and headache on left side come and go.
Age: 45.0
Sex: F
Vaccine: DTAP, MMR
Symptoms: Dizziness, Neck pain, Pyrexia, Somnolence
Clinical narrative: Extreme dizziness, sleepiness, neck pain, fever of 101.
Age: 0.3
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13
Symptoms: Pyrexia
Clinical narrative: Febrile episode poss 2/2 vaccination. R/O PNA.
Age: 18.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Erythema, Skin warm, Swelling, Tenderness
Clinical narrative: C/O redness, swelling, skin hot with possible fever, 98.8 at visit, tenderness streaking after SQ inj MENACTRA.
Age: 1.02
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Pyrexia, Rash macular, Rash papular
Clinical narrative: Pt. dev. fever low grade approximately 100 degrees F on the 6th day after vaccines and lasted for 2 days then rash (eryth. maculopapular) dev. on face then spread to body/ext. on 10th day after vaccines given. No conjunctivitis.
Age: 17.0
Sex: F
Vaccine: MEN
Symptoms: Chills, Dizziness, Injection site pain, Injection site swelling, Malaise
Clinical narrative: Pt reports with dizziness, generalized body aches, chills, and malaise. She also had significant swelling and tenderness to the area when the vaccine was administered.
Age: 17.0
Sex: F
Vaccine: MEN
Symptoms: Pain
Clinical narrative: Pt reports with dizziness, generalized body aches, chills, and malaise. She also had significant swelling and tenderness to the area when the vaccine was administered.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site cellulitis, Injection site discolouration, Injection site erythema, Injection site induration, Injection site pain
Clinical narrative: 6-13-11 15x25 red, slightly tender, slightly firm patch (L) upper ant. thigh with central dark purple area - injection site of DTAP. Given DURICEF 250/5 1 tsp BID for leg cellulitis.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Drug administered at inappropriate site, Nerve injury, Pain
Clinical narrative: Had flu shot she states high in arm & doctor says it hit nerve. Has been in pain since Sept 2010. Has been on DARVOCET and PERCOCET for pain. Does seem to be getting better.
Age: 10.0
Sex: M
Vaccine: HEPA, MNQ, VARCEL
Symptoms: Presyncope
Clinical narrative: Patient was given Hepatitis A, VZV, MENACTRA. Upon administration of VZV (3rd shot as Hep A & MENACTRA given 1st) patient had vasovagal episode < 10 seconds and recovered in prone position. No further complications.
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Nausea, Vomiting
Clinical narrative: Felt nauseated and vomited once. No treatment.
Age: 54.0
Sex: F
Vaccine: TDAP
Symptoms: Feeling abnormal, Headache, Injection site erythema, Pain, Vaccination site pain
Clinical narrative: Day after vaccine given. 5 inch swollen area to vacc. admin. site (Lt thigh), reddened, sore, h/a, achy - just felt bad x 5 days - in bed, took BENADRYL, ice pk, & TYLENOL.
Age: 54.0
Sex: F
Vaccine: TDAP
Symptoms: Vaccination site swelling
Clinical narrative: Day after vaccine given. 5 inch swollen area to vacc. admin. site (Lt thigh), reddened, sore, h/a, achy - just felt bad x 5 days - in bed, took BENADRYL, ice pk, & TYLENOL.
Age: 11.0
Sex: M
Vaccine: TDAP, TDAP
Symptoms: Anaphylactic reaction, Blood immunoglobulin E increased, Respiratory tract congestion, Sneezing, Urticaria
Clinical narrative: Initial report was received via a search of the scientific literature on 03 June 2011. The patient captured in this case was one of eight patients noted in the article who experienced anaphylaxis after receiving a diphtheria, tetanus and acellular pertussis containing vaccine (manufacturer unknown). These patients tolerated their initial vaccinations but reacted to booster doses. A 11-year-old male patient had received an injection of TDAP vaccine (manufacturer unknown, lot number, route, site and date of administration not reported) and within 10 minutes after vaccination, he developed anaphylaxis with symptoms of generalized urticaria, sneezing, congestion and wheezing. Corrective treatments consisted of Levalbuterol, diphenhydramine, and an oral steroid. The patient had a history of asthma and milk allergy demonstrated by urticaria and vomiting at 11 months of age after eating yogurt, and facial swelling and diffuse rash at eight years of age after eating turkey with milk. Laboratory testing showed the patient had increased IgE levels (58.9) within two years of vaccination. Outcome was not reported. This patient had previously been referenced in case number 2011-01614. The other seven patients have been captured in case numbers 2011-03272, -03275, -03276, -03277, -03279, -03280 and -03281. Documents held by sender: None.
Age: 11.0
Sex: M
Vaccine: TDAP, TDAP
Symptoms: Wheezing
Clinical narrative: Initial report was received via a search of the scientific literature on 03 June 2011. The patient captured in this case was one of eight patients noted in the article who experienced anaphylaxis after receiving a diphtheria, tetanus and acellular pertussis containing vaccine (manufacturer unknown). These patients tolerated their initial vaccinations but reacted to booster doses. A 11-year-old male patient had received an injection of TDAP vaccine (manufacturer unknown, lot number, route, site and date of administration not reported) and within 10 minutes after vaccination, he developed anaphylaxis with symptoms of generalized urticaria, sneezing, congestion and wheezing. Corrective treatments consisted of Levalbuterol, diphenhydramine, and an oral steroid. The patient had a history of asthma and milk allergy demonstrated by urticaria and vomiting at 11 months of age after eating yogurt, and facial swelling and diffuse rash at eight years of age after eating turkey with milk. Laboratory testing showed the patient had increased IgE levels (58.9) within two years of vaccination. Outcome was not reported. This patient had previously been referenced in case number 2011-01614. The other seven patients have been captured in case numbers 2011-03272, -03275, -03276, -03277, -03279, -03280 and -03281. Documents held by sender: None.
Age: 11.0
Sex: M
Vaccine: TDAP, TDAP
Symptoms: Anaphylactic reaction, Blood immunoglobulin E increased, Condition aggravated, Respiratory tract congestion, Sneezing
Clinical narrative: Initial report was received via a search of the scientific literature on 03 June 2011. The patient captured in this case was one of eight patients noted in the article who experienced anaphylaxis after receiving a diphtheria, tetanus and acellular pertussis containing vaccine (manufacturer unknown). These patients tolerated their initial vaccinations but reacted to booster doses. A 11-year-old male patient had received an injection of TDAP vaccine (manufacturer unknown, lot number, route, site and date of administration not reported) and within 10 minutes after vaccination, he developed anaphylaxis with symptoms of generalized urticaria, sneezing, congestion and wheezing. Corrective treatments consisted of Levalbuterol, diphenhydramine, and an oral steroid. The patient had a history of asthma and milk allergy demonstrated by urticaria and vomiting at 11 months of age after eating yogurt, and facial swelling and diffuse rash at eight years of age after eating turkey with milk. Laboratory testing showed the patient had increased IgE levels (58.9) within two years of vaccination. Outcome was not reported. This patient had previously been referenced in case number 2011-01614. The other seven patients have been captured in case numbers 2011-03272, -03275, -03276, -03277, -03279, -03280 and -03281. Documents held by sender: None.
Age: 11.0
Sex: M
Vaccine: TDAP, TDAP
Symptoms: Urticaria, Wheezing
Clinical narrative: Initial report was received via a search of the scientific literature on 03 June 2011. The patient captured in this case was one of eight patients noted in the article who experienced anaphylaxis after receiving a diphtheria, tetanus and acellular pertussis containing vaccine (manufacturer unknown). These patients tolerated their initial vaccinations but reacted to booster doses. A 11-year-old male patient had received an injection of TDAP vaccine (manufacturer unknown, lot number, route, site and date of administration not reported) and within 10 minutes after vaccination, he developed anaphylaxis with symptoms of generalized urticaria, sneezing, congestion and wheezing. Corrective treatments consisted of Levalbuterol, diphenhydramine, and an oral steroid. The patient had a history of asthma and milk allergy demonstrated by urticaria and vomiting at 11 months of age after eating yogurt, and facial swelling and diffuse rash at eight years of age after eating turkey with milk. Laboratory testing showed the patient had increased IgE levels (58.9) within two years of vaccination. Outcome was not reported. This patient had previously been referenced in case number 2011-01614. The other seven patients have been captured in case numbers 2011-03272, -03275, -03276, -03277, -03279, -03280 and -03281. Documents held by sender: None.
Sex: F
Vaccine: HPV4
Symptoms: Movement disorder, Posture abnormal, Syncope
Clinical narrative: Initial and follow up information has been received from a registered nurse (RN) concerning a female patient who on 12-AUG-2010 was vaccinated with a dose of GARDASIL (dose, route and lot number not provided). The RN stated that following the vaccination, on approximately 12-AUG-2010, the patient experienced syncope and seizure-like posturing. The RN stated that the patient was taken by Ambulance to the Emergency Room. The patient was not admitted to the hospital. It was reported that the patient recovered (date unspecified). The RN stated that the patient also had a sibling that received GARDASIL prior to the patient receiving it, but the patient's sibling did not have an adverse event following the vaccination. Upon internal review, seizure-like posturing was considered to be an other important medical event. This is one of two reports from the same source. Additional information has been requested.
Age: 17.0
Sex: M
Vaccine: HEPA, TDAP, TDAP, TDAP
Symptoms: Anaphylactic reaction
Clinical narrative: Initial report was received via a search of the scientific literature on 03 June 2011. The patient captured in this case was one of eight patients noted in the article who experienced anaphylaxis after receiving a diphtheria, tetanus and acellular pertussis containing vaccine (manufacturer unknown). These patients tolerated their initial vaccinations but reacted to booster doses. A 17-year-old male patient had received an injection of Tdap vaccine (manufacturer unknown, lot number, route, site and date of administration not reported) and within 20 minutes after vaccination, he developed anaphylaxis with symptoms of wheezing, respiratory distress, and flushing of the face and neck. Corrective treatments consisted of epinephrine. The patient had a history of asthma, and milk allergy demonstrated by hives, lip and tongue swelling, diarrhea and abdominal pain at four years of age. Laboratory testing showed the patient had increased IgE levels (>100) within two years of vaccination. Outcome was not reported. This patient had previously been referenced in case number 2011-01614. The other seven patients have been captured in case numbers 2011-03272, -03275, -03276, -03277, -03278, -03279 and -03280. Documents held by sender: None.
Age: 17.0
Sex: M
Vaccine: HEPA, TDAP, TDAP, TDAP
Symptoms: Anaphylactic reaction, Blood immunoglobulin E increased, Flushing, Respiratory distress, Wheezing
Clinical narrative: Initial report was received via a search of the scientific literature on 03 June 2011. The patient captured in this case was one of eight patients noted in the article who experienced anaphylaxis after receiving a diphtheria, tetanus and acellular pertussis containing vaccine (manufacturer unknown). These patients tolerated their initial vaccinations but reacted to booster doses. A 17-year-old male patient had received an injection of Tdap vaccine (manufacturer unknown, lot number, route, site and date of administration not reported) and within 20 minutes after vaccination, he developed anaphylaxis with symptoms of wheezing, respiratory distress, and flushing of the face and neck. Corrective treatments consisted of epinephrine. The patient had a history of asthma, and milk allergy demonstrated by hives, lip and tongue swelling, diarrhea and abdominal pain at four years of age. Laboratory testing showed the patient had increased IgE levels (>100) within two years of vaccination. Outcome was not reported. This patient had previously been referenced in case number 2011-01614. The other seven patients have been captured in case numbers 2011-03272, -03275, -03276, -03277, -03278, -03279 and -03280. Documents held by sender: None.
Age: 1.28
Sex: M
Vaccine: MMR, MNQ, VARCEL, MMR, PNC13, VARCEL, MMR, MNQ, PNC, VARCEL
Symptoms: Cough, Dyspnoea, Pyrexia, Vaccine positive rechallenge
Clinical narrative: fever of 101; difficulty with breathing
Age: 1.28
Sex: M
Vaccine: MMR, MNQ, VARCEL, MMR, PNC13, VARCEL, MMR, MNQ, PNC, VARCEL
Symptoms: Dyspnoea, Pyrexia
Clinical narrative: fever of 101; difficulty with breathing
Age: 1.28
Sex: M
Vaccine: MMR, MNQ, VARCEL, MMR, PNC13, VARCEL, MMR, MNQ, PNC, VARCEL
Symptoms: Cough, Dyspnoea, Pyrexia
Clinical narrative: fever of 101; difficulty with breathing
Age: 35.0
Sex: M
Vaccine: MMR, VARCEL, MMR, VARCEL
Symptoms: Rash
Clinical narrative: Information has been received from a physician concerning a 35 year old male nurse with atrial fibrillation and no drug reactions or allergies who on 12-MAY-2011 came to the employee health and was vaccinated with a dose of MMR (dose, route and expiration date not reported) (lot number 668074/0798Z). Second suspect therapy included VARIVAX (Merck) (route, dose and expiration date not reported) (Lot number 668598/1472Z). Concomitant therapy included CLARITIN. The physician reported that about three days after the vaccination, on approximately 15-MAY-2011 the patient started to develop a diffuse rash on the upper extremities. The rash was reported as red, diffuse, covering the neck, back and arms. At the site of the VARIVAX (Merck) the patient had an induration (specifics not provided). About 6 days after vaccination, on approximately 18-MAY-2011 the patient reported to employee health where exam revealed 15 papules (no vesicles initially) on the neck, trunk and upper extremities. The patient reported mild body aches. The rash continued to worsen over the next two weeks, as well as the arthralgia had gotten worse. On 02-JUN-2011 the patient was seen again at employee health. The patient reported the pain in his joints to be 6 out of 10 on the pain scale. The pain was equal on both sides in hips, ankles and feet. The pain was worse with movement. The rash continued to be reported as maculopapular rash, and now there were vesicles present on neck, trunk and arms. The patient had taken MOTRIN for the pain, which did not help. He had been unable to work because he was a nurse in the ICU. No treatment for the adverse events was given. Laboratory diagnostics studies were not performed. The physician considered the adverse events to be disabling. At the time of the report, the patient had not recovered. Additional information has been requested.
Age: 35.0
Sex: M
Vaccine: MMR, VARCEL, MMR, VARCEL
Symptoms: Arthralgia, Blister, Impaired work ability, Injection site induration, Pain
Clinical narrative: Information has been received from a physician concerning a 35 year old male nurse with atrial fibrillation and no drug reactions or allergies who on 12-MAY-2011 came to the employee health and was vaccinated with a dose of MMR (dose, route and expiration date not reported) (lot number 668074/0798Z). Second suspect therapy included VARIVAX (Merck) (route, dose and expiration date not reported) (Lot number 668598/1472Z). Concomitant therapy included CLARITIN. The physician reported that about three days after the vaccination, on approximately 15-MAY-2011 the patient started to develop a diffuse rash on the upper extremities. The rash was reported as red, diffuse, covering the neck, back and arms. At the site of the VARIVAX (Merck) the patient had an induration (specifics not provided). About 6 days after vaccination, on approximately 18-MAY-2011 the patient reported to employee health where exam revealed 15 papules (no vesicles initially) on the neck, trunk and upper extremities. The patient reported mild body aches. The rash continued to worsen over the next two weeks, as well as the arthralgia had gotten worse. On 02-JUN-2011 the patient was seen again at employee health. The patient reported the pain in his joints to be 6 out of 10 on the pain scale. The pain was equal on both sides in hips, ankles and feet. The pain was worse with movement. The rash continued to be reported as maculopapular rash, and now there were vesicles present on neck, trunk and arms. The patient had taken MOTRIN for the pain, which did not help. He had been unable to work because he was a nurse in the ICU. No treatment for the adverse events was given. Laboratory diagnostics studies were not performed. The physician considered the adverse events to be disabling. At the time of the report, the patient had not recovered. Additional information has been requested.
Age: 35.0
Sex: M
Vaccine: MMR, VARCEL, MMR, VARCEL
Symptoms: Papule, Rash erythematous, Rash maculo-papular
Clinical narrative: Information has been received from a physician concerning a 35 year old male nurse with atrial fibrillation and no drug reactions or allergies who on 12-MAY-2011 came to the employee health and was vaccinated with a dose of MMR (dose, route and expiration date not reported) (lot number 668074/0798Z). Second suspect therapy included VARIVAX (Merck) (route, dose and expiration date not reported) (Lot number 668598/1472Z). Concomitant therapy included CLARITIN. The physician reported that about three days after the vaccination, on approximately 15-MAY-2011 the patient started to develop a diffuse rash on the upper extremities. The rash was reported as red, diffuse, covering the neck, back and arms. At the site of the VARIVAX (Merck) the patient had an induration (specifics not provided). About 6 days after vaccination, on approximately 18-MAY-2011 the patient reported to employee health where exam revealed 15 papules (no vesicles initially) on the neck, trunk and upper extremities. The patient reported mild body aches. The rash continued to worsen over the next two weeks, as well as the arthralgia had gotten worse. On 02-JUN-2011 the patient was seen again at employee health. The patient reported the pain in his joints to be 6 out of 10 on the pain scale. The pain was equal on both sides in hips, ankles and feet. The pain was worse with movement. The rash continued to be reported as maculopapular rash, and now there were vesicles present on neck, trunk and arms. The patient had taken MOTRIN for the pain, which did not help. He had been unable to work because he was a nurse in the ICU. No treatment for the adverse events was given. Laboratory diagnostics studies were not performed. The physician considered the adverse events to be disabling. At the time of the report, the patient had not recovered. Additional information has been requested.
Age: 41.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Hyperhidrosis, Swollen tongue
Clinical narrative: This medical assistant (MA) reports that this 42 year old female consumer received 0.5mL of Pneumovax (pneumococcal vaccine) IM in her right deltoid at a local health center on 27Jan2011. The patient's relevant medical history includes no history of a previous allergy or reaction to Pneumovax. She had not received this vaccine before. The patient's relevant concomitant medications include: The patient was taking unspecified antihistamine medications per the patient's report. On 27Jan2011, this MA reports that per a physician's request she ran the LCR immunization rules and verified that the patient was recommended to have the Pneumovax vaccine. The MA asked the patient routine adult screening questions for immunizations. Patient denied any contraindications, and possible side effects of the Pneumovax vaccine were discussed. On 27Jan2011, a dose of the Pneumovax vaccine was administered to the patient. The patient and MA walked to the MA's office to set a future appointment and patient stated she felt "something was wrong, her tongue felt like it was swelling. Then her face began to turn red and she became very sweaty. The MA told her to breathe slow and called for a nurse on the voicera. An RN arrived and MA went to notify the physician. Pulse oximetry was checked and it was normal. The patient began to return to her normal color and stated she was feeling better. The physician ordered two of Benadryl 25mg to be given now. MA took the prescription to the pharmacy while the RN stood with the patient. The patient took Benadryl and we had her return to room where she wanted to lay down and we told her we would keep an eye on her for at least 30 minutes. After 30 minutes with the RN observing the patient, the patient stated she felt better and went to the bathroom. When she returned she was cleared to leave after her vitals signs were checked and they were stable. Allergy to Pneumovax was added to the patient's medical record for future use.
Age: 47.0
Sex: M
Vaccine: FLUX, PPV, TDAP
Symptoms: Axillary pain, Injection site swelling, Pain in extremity
Clinical narrative: On 10Mar2011, this 48 year old male patient received Pneumovax, Combined Tetanus, Diptheria and Pertussis (Tdap) and an unknown influenza vaccine in the ID Clinic. He was offered to receive the vaccines 2 in one arm and 1 in the other arm. The patient requested to receive all three vaccines in the right deltoid. On 11Mar2011 he reported that he was having pain in his right arm, radiating to his armpit and had slight swelling at the injection site. He denied noting any redness. It was recommended that he return to the clinic immediately for treatment but he declined. On 11Mar2011, he will take ibuprofen and use a hot pad to treat his symptoms and go to the emergency room if his symptoms worsen. It is unknown if he continues to experience pain in his right arm and arm pit or swelling at the injection site.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Erythema of eyelid, Eyelid oedema, Pain in extremity
Clinical narrative: Under eyes red and swollen, sore arm.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, VARCEL, DTAP
Symptoms: Anaphylactic reaction, Blood immunoglobulin E increased, Cough, Rhinorrhoea, Sneezing
Clinical narrative: Initial report was received via a search of the scientific literature on 03 June 2011. The patient captured in this case was one of eight patients noted in the article who experienced anaphylaxis after receiving DTaP vaccine (manufacturer unknown). These patients tolerated their initial vaccinations but reacted to booster doses. A 5-year-old male patient had received an injection of DTaP vaccine (manufacturer unknown, lot number, route, site and date of administration not reported) and 10 minutes later, he developed anaphylaxis with symptoms of repetitive cough, sneezing and rhinorrhea. Corrective treatments consisted of Albuterol and diphenhydramine. The patient had a history of asthma, and milk allergy demonstrated by hives, lip angioedema, wheezing at three years of age after eating turkey with milk contamination. Laboratory testing showed the patient had increased IgE levels (>100) within two years of vaccination. Outcome was not reported. This patient had previously been referenced in case number 2011-01614. The other seven patients have been captured in case numbers 2011-03272, -03276, -03277, -03278, -03279, -03280 and -03281. Documents held by sender: None.
Age: 5.0
Sex: M
Vaccine: DTAP, DTAP
Symptoms: Anaphylactic reaction, Blood immunoglobulin E increased, Condition aggravated, Dyspnoea, Immediate post-injection reaction
Clinical narrative: Initial report was received via a search of the scientific literature on 03 June 2011. The patient captured in this case was one of eight patients noted in the article who experienced anaphylaxis after receiving a diphtheria, tetanus and acellular pertussis containing vaccine (manufacturer unknown). These patients tolerated their initial vaccinations but reacted to booster doses. A 5-year-old male patient had received an injection of DTaP vaccine (manufacturer unknown, lot number, route, site and date of administration not reported) and immediately after vaccination, he developed anaphylaxis with symptoms of generalized urticaria, facial swelling, wheezing, retractions and difficulty breathing. Corrective treatments consisted of diphenhydramine and epinephrine. The patient had a history of asthma and milk allergy demonstrated by urticaria, edema of the face, and wheezing after contact with milk-based formula at two years of age. Laboratory testing showed the patient had increased IgE levels (>100) within two years of vaccination. Outcome was not reported. This patient had previously been referenced in case number 2011-01614. The other seven patients have been captured in case numbers 2011-03272, -03275, -03277, -03278, -03279, -03280 and -03281. Documents held by sender: None.
Age: 5.0
Sex: M
Vaccine: DTAP, DTAP
Symptoms: Swelling face, Urticaria, Use of accessory respiratory muscles, Wheezing
Clinical narrative: Initial report was received via a search of the scientific literature on 03 June 2011. The patient captured in this case was one of eight patients noted in the article who experienced anaphylaxis after receiving a diphtheria, tetanus and acellular pertussis containing vaccine (manufacturer unknown). These patients tolerated their initial vaccinations but reacted to booster doses. A 5-year-old male patient had received an injection of DTaP vaccine (manufacturer unknown, lot number, route, site and date of administration not reported) and immediately after vaccination, he developed anaphylaxis with symptoms of generalized urticaria, facial swelling, wheezing, retractions and difficulty breathing. Corrective treatments consisted of diphenhydramine and epinephrine. The patient had a history of asthma and milk allergy demonstrated by urticaria, edema of the face, and wheezing after contact with milk-based formula at two years of age. Laboratory testing showed the patient had increased IgE levels (>100) within two years of vaccination. Outcome was not reported. This patient had previously been referenced in case number 2011-01614. The other seven patients have been captured in case numbers 2011-03272, -03275, -03277, -03278, -03279, -03280 and -03281. Documents held by sender: None.
Age: 6.0
Sex: M
Vaccine: DTAP, IPV, DTAP
Symptoms: Anaphylactic reaction, Blood immunoglobulin E increased, Cough, Swelling face, Urticaria
Clinical narrative: Initial report was received via a search of the scientific literature on 03 June 2011. The patient captured in this case was one of eight patients noted in the article who experienced anaphylaxis after receiving a diphtheria, tetanus and acellular pertussis containing vaccine (manufacturer unknown). These patients tolerated their initial vaccinations but reacted to booster doses. A 6-year-old male patient had received an injection of DTaP vaccine (manufacturer unknown, lot number, route, site and date of administration not reported) and within 15 minutes after vaccination, he developed anaphylaxis with symptoms of cough, hives and facial swelling. Corrective treatments consisted of Levalbuterol and diphenhydramine. The patient had a history of asthma and milk allergy (milk was eliminated based on serologic allergy testing as an infant after presenting with atopic dermatitis). Laboratory testing showed the patient had increased IgE levels (>100) within two years of vaccination. Outcome was not reported. This patient had previously been referenced in case number 2011-01614. The other seven patients have been captured in case numbers 2011-03272, -03275, -03276, -03278, -03279, -03280 and -03281. Documents held by sender: None.
Age: 6.0
Sex: M
Vaccine: DTAP, IPV, DTAP
Symptoms: Anaphylactic reaction, Blood immunoglobulin E, Cough, Swelling face, Urticaria
Clinical narrative: Initial report was received via a search of the scientific literature on 03 June 2011. The patient captured in this case was one of eight patients noted in the article who experienced anaphylaxis after receiving a diphtheria, tetanus and acellular pertussis containing vaccine (manufacturer unknown). These patients tolerated their initial vaccinations but reacted to booster doses. A 6-year-old male patient had received an injection of DTaP vaccine (manufacturer unknown, lot number, route, site and date of administration not reported) and within 15 minutes after vaccination, he developed anaphylaxis with symptoms of cough, hives and facial swelling. Corrective treatments consisted of Levalbuterol and diphenhydramine. The patient had a history of asthma and milk allergy (milk was eliminated based on serologic allergy testing as an infant after presenting with atopic dermatitis). Laboratory testing showed the patient had increased IgE levels (>100) within two years of vaccination. Outcome was not reported. This patient had previously been referenced in case number 2011-01614. The other seven patients have been captured in case numbers 2011-03272, -03275, -03276, -03278, -03279, -03280 and -03281. Documents held by sender: None.
Age: 11.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Anaphylactic reaction, Respiratory distress, Throat tightness, Wheezing
Clinical narrative: Initial report was received via a search of the scientific literature on 03 June 2011. The patient captured in this case was one of eight patients noted in the reference who experienced anaphylaxis after receiving a diphtheria, tetanus and acellular pertussis containing vaccine (manufacturer unknown). These patients tolerated their initial vaccinations but reacted to booster doses. A 11-year-old female patient had received an injection of Tdap vaccine (manufacturer unknown, lot number, route, site and date of administration not reported) and while driving home from the pediatricians, she developed anaphylaxis with symptoms of throat tightness, wheezing and respiratory distress. Corrective treatments consisted of epinephrine. The patient had a history of asthma, and milk allergy demonstrated by vomiting after milk-based formula as an infant and angioedema of hands after contact with spilled milk at one year of age. Laboratory testing showed the patient had increased IgE levels (96.1) within two years of vaccination. Outcome was not reported. This patient had previously been referenced in case number 2011-01614. The other seven patients have been captured in case numbers 2011-03272, -03275, -03276, -03277, -03278, -03280 and -03281. Documents held by sender: None.
Age: 11.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Anaphylactic reaction, Blood immunoglobulin E increased, Respiratory distress, Throat tightness, Wheezing
Clinical narrative: Initial report was received via a search of the scientific literature on 03 June 2011. The patient captured in this case was one of eight patients noted in the reference who experienced anaphylaxis after receiving a diphtheria, tetanus and acellular pertussis containing vaccine (manufacturer unknown). These patients tolerated their initial vaccinations but reacted to booster doses. A 11-year-old female patient had received an injection of Tdap vaccine (manufacturer unknown, lot number, route, site and date of administration not reported) and while driving home from the pediatricians, she developed anaphylaxis with symptoms of throat tightness, wheezing and respiratory distress. Corrective treatments consisted of epinephrine. The patient had a history of asthma, and milk allergy demonstrated by vomiting after milk-based formula as an infant and angioedema of hands after contact with spilled milk at one year of age. Laboratory testing showed the patient had increased IgE levels (96.1) within two years of vaccination. Outcome was not reported. This patient had previously been referenced in case number 2011-01614. The other seven patients have been captured in case numbers 2011-03272, -03275, -03276, -03277, -03278, -03280 and -03281. Documents held by sender: None.
Age: 16.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Anaphylactic reaction, Blood immunoglobulin E increased, Chest discomfort, Lacrimation increased, Nasal congestion
Clinical narrative: Initial report was received via a search of the scientific literature on 03 June 2011. The patient captured in this case was one of eight patients noted in a reference who experienced anaphylaxis after receiving a diphtheria, tetanus and acellular pertussis containing vaccine (manufacturer unknown). These patients tolerated their initial vaccinations but reacted to booster doses. A 16-year-old female patient had received an injection of Tdap vaccine (manufacturer unknown, lot number, route, site and date of administration not reported) and within one hour after vaccination, she developed anaphylaxis with symptoms of nasal congestion, watery eyes, hives, wheezing and chest tightness. Corrective treatments consisted of diphenhydramine and an oral steroid. The patient had a history of milk allergy demonstrated by cough, wheezing and vomiting after milk at one year of age and a subsequent event of respiratory distress, vomiting, hypotension and cardiac arrest after eating pasta sprinkled with cheese at eight years of age. Laboratory testing showed the patient had increased IgE levels (>100) within two years of vaccination. Outcome was not reported. This patient had previously been referenced in case number 2011-01614. The other seven patients have been captured in case numbers 2011-03272, -03275, -03276, -03277, -03278, -03279, and -03281. Documents held by sender: None.
Age: 16.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Urticaria, Wheezing
Clinical narrative: Initial report was received via a search of the scientific literature on 03 June 2011. The patient captured in this case was one of eight patients noted in a reference who experienced anaphylaxis after receiving a diphtheria, tetanus and acellular pertussis containing vaccine (manufacturer unknown). These patients tolerated their initial vaccinations but reacted to booster doses. A 16-year-old female patient had received an injection of Tdap vaccine (manufacturer unknown, lot number, route, site and date of administration not reported) and within one hour after vaccination, she developed anaphylaxis with symptoms of nasal congestion, watery eyes, hives, wheezing and chest tightness. Corrective treatments consisted of diphenhydramine and an oral steroid. The patient had a history of milk allergy demonstrated by cough, wheezing and vomiting after milk at one year of age and a subsequent event of respiratory distress, vomiting, hypotension and cardiac arrest after eating pasta sprinkled with cheese at eight years of age. Laboratory testing showed the patient had increased IgE levels (>100) within two years of vaccination. Outcome was not reported. This patient had previously been referenced in case number 2011-01614. The other seven patients have been captured in case numbers 2011-03272, -03275, -03276, -03277, -03278, -03279, and -03281. Documents held by sender: None.
Age: 16.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Anaphylactic reaction, Blood immunoglobulin E increased, Chest discomfort, Condition aggravated, Lacrimation increased
Clinical narrative: Initial report was received via a search of the scientific literature on 03 June 2011. The patient captured in this case was one of eight patients noted in a reference who experienced anaphylaxis after receiving a diphtheria, tetanus and acellular pertussis containing vaccine (manufacturer unknown). These patients tolerated their initial vaccinations but reacted to booster doses. A 16-year-old female patient had received an injection of Tdap vaccine (manufacturer unknown, lot number, route, site and date of administration not reported) and within one hour after vaccination, she developed anaphylaxis with symptoms of nasal congestion, watery eyes, hives, wheezing and chest tightness. Corrective treatments consisted of diphenhydramine and an oral steroid. The patient had a history of milk allergy demonstrated by cough, wheezing and vomiting after milk at one year of age and a subsequent event of respiratory distress, vomiting, hypotension and cardiac arrest after eating pasta sprinkled with cheese at eight years of age. Laboratory testing showed the patient had increased IgE levels (>100) within two years of vaccination. Outcome was not reported. This patient had previously been referenced in case number 2011-01614. The other seven patients have been captured in case numbers 2011-03272, -03275, -03276, -03277, -03278, -03279, and -03281. Documents held by sender: None.
Age: 16.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Nasal congestion, Urticaria, Wheezing
Clinical narrative: Initial report was received via a search of the scientific literature on 03 June 2011. The patient captured in this case was one of eight patients noted in a reference who experienced anaphylaxis after receiving a diphtheria, tetanus and acellular pertussis containing vaccine (manufacturer unknown). These patients tolerated their initial vaccinations but reacted to booster doses. A 16-year-old female patient had received an injection of Tdap vaccine (manufacturer unknown, lot number, route, site and date of administration not reported) and within one hour after vaccination, she developed anaphylaxis with symptoms of nasal congestion, watery eyes, hives, wheezing and chest tightness. Corrective treatments consisted of diphenhydramine and an oral steroid. The patient had a history of milk allergy demonstrated by cough, wheezing and vomiting after milk at one year of age and a subsequent event of respiratory distress, vomiting, hypotension and cardiac arrest after eating pasta sprinkled with cheese at eight years of age. Laboratory testing showed the patient had increased IgE levels (>100) within two years of vaccination. Outcome was not reported. This patient had previously been referenced in case number 2011-01614. The other seven patients have been captured in case numbers 2011-03272, -03275, -03276, -03277, -03278, -03279, and -03281. Documents held by sender: None.
Age: 63.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Inflammation, White blood cell count
Clinical narrative: (R) arm erythema, inflammation.
Age: 12.0
Sex: F
Vaccine: HEPA, MNQ, TDAP
Symptoms: Immediate post-injection reaction, Syncope
Clinical narrative: Pt is 12 yrs old given DTAP left arm tolerated well, then given Hepatitis A right arm tolerated fine then gave MENACTRA meningitis right arm as so as vaccine went in patient fainted. Pt recovered within second. Doctor evaluated her normal findings.
Age: 12.0
Sex: F
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Body temperature increased, Chills
Clinical narrative: Onset of temp 4am after of vaccines. T 100-101 x 24 hrs. No sxs except temp/chills. No sxs noted after 24 hrs.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Urticaria
Clinical narrative: Urticaria & hives.
Age: 11.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Acute lymphocytic leukaemia
Clinical narrative: Diagnosed with Acute Lymphoblastic Leukemia (ALL) on 12/31/2009.
Age: 11.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Acute lymphocytic leukaemia, Anisocytosis, Asthenia, B-cell type acute leukaemia, Blood glucose increased
Clinical narrative: Diagnosed with Acute Lymphoblastic Leukemia (ALL) on 12/31/2009.
Age: 11.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Blood lactate dehydrogenase increased, Blood phosphorus normal, Blood potassium decreased, Blood smear test abnormal, Blood uric acid increased
Clinical narrative: Diagnosed with Acute Lymphoblastic Leukemia (ALL) on 12/31/2009.
Age: 11.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Chemotherapy, Constipation, Decreased appetite, Emotional distress, Glossodynia
Clinical narrative: Diagnosed with Acute Lymphoblastic Leukemia (ALL) on 12/31/2009.
Age: 11.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Haematocrit decreased, Haemoglobin decreased, Hyperglycaemia, Hypochromasia, Intensive care
Clinical narrative: Diagnosed with Acute Lymphoblastic Leukemia (ALL) on 12/31/2009.
Age: 11.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Laboratory test abnormal, Lymphocyte percentage increased, Monocyte percentage decreased, Myelocyte percentage increased, Nasal congestion
Clinical narrative: Diagnosed with Acute Lymphoblastic Leukemia (ALL) on 12/31/2009.
Age: 11.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Neutrophil percentage decreased, Packed red blood cell transfusion, Pallor, Petechiae, Platelet count decreased
Clinical narrative: Diagnosed with Acute Lymphoblastic Leukemia (ALL) on 12/31/2009.
Age: 11.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Poikilocytosis, Proctalgia, Pyrexia, Red blood cell anisocytes present, Red blood cell count decreased
Clinical narrative: Diagnosed with Acute Lymphoblastic Leukemia (ALL) on 12/31/2009.
Age: 11.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Red blood cell hypochromic morphology present, Red blood cell macrocytes present, Red blood cell nucleated morphology present, Red blood cell poikilocytes present, Red cell distribution width increased
Clinical narrative: Diagnosed with Acute Lymphoblastic Leukemia (ALL) on 12/31/2009.
Age: 11.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Tearfulness, White blood cell count increased, White blood cell disorder
Clinical narrative: Diagnosed with Acute Lymphoblastic Leukemia (ALL) on 12/31/2009.
Age: 18.0
Sex: M
Vaccine: MNQ
Symptoms: Meningitis meningococcal
Clinical narrative: Initial report received from a health care professional on 08 June 2011. A 23-year-old male patient, with medical history not reported, received an injection (route and site not reported) of MENACTRA, sanofi pasteur lot number not reported, in July 2005. On 27 May 2011, the patient was admitted to the hospital and subsequently diagnosed with meningitis. The strain or the serogroup has not yet been identified. The strain was a strain of N. meningitidis. The patient did survive and has not suffered any amputations nor loss of limb due to this event. The patient was currently being rehabilitated. The outcome was reported as not recovered. Documents held by sender: None.
Age: 33.0
Sex: M
Vaccine: TDAP
Symptoms: Injection site swelling, Injection site warmth
Clinical narrative: Local swelling at site of injection with TTP since 4 days. No report of fever injection site warm to touch,
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site warmth
Clinical narrative: Baseball sized, warm, itchy, red spot at injection site.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Contusion, Hyperaesthesia
Clinical narrative: Light bruising appeared right away after vaccine given. Later in the evening very dark bruising occurred on right side of large bruise. Area is sensitive to touch. No raised areas, no rash. No SOB.
Age: 65.0
Sex: F
Vaccine: DT, PPV
Symptoms: Full blood count normal, Rash macular
Clinical narrative: Macular erythematous rash that covers both legs, arms, torso, and neck that began after pneumococcal vaccine. Tx: CLARITIN 10mg QD; Ranitidine 150 BID; MEDROL Dose pak.
Age: 1.32
Sex: F
Vaccine: MMR
Symptoms: Abnormal behaviour, Asthenia, Blood test, Body temperature fluctuation, Chest X-ray
Clinical narrative: Information has been received from a consumer concerning his 16 month old daughter with no medical history and no drug allergies/reactions who on 26-MAY-2011 or 27-MAY-2011 was vaccinated with a dose of MMR II (lot # not reported). The reporter stated that his daughter received MMR II and later experienced high fevers to 105F. It was unknown if the child received additional vaccines when MMR II was administered. On 02-JUN-2011 she did not respond to APAP or ibuprofen with temperature fluctuating to 100F and then back up to 104F-105F. The next day, on 03-JUN-2011 the patient was in a weird state of mind, not cheerful like she usually was but lethargic. She had purple toned skin that looked black and blue. Later that day she was taken to hospital emergency room. She then had shivering which the doctor said was a probable febrile seizure with dehydration. She had one episode of vomiting during an exam of her mouth and throat. Her temperature was 104.5. She was admitted to the hospital. She was treated with intravenous fluids and intravenous ROCEPHIN. Fever decreased. No seizure activity. On 04-JUN-2011 the patient was discharged from the hospital. On 05-JUN-2011 the patient experienced a blotchy rash in chest, neck, cheeks for 24 hours and tired, lethargic, very weak, fever again to 101F. The patient was seen by pediatrician on 05-JUN-2011 with possible roseola. Today, on 07-JUN-2011 she was starting to eat and doing a little better. Also her sister had a history of epilepsy and her cousin had Guillain-Barre at age 2. Chest x ray, blood and urine tests were performed with no results provided. At the time of reporting, the patient was recovering. Additional information has been requested.
Age: 1.32
Sex: F
Vaccine: MMR
Symptoms: Chills, Dehydration, Fatigue, Febrile convulsion, Lethargy
Clinical narrative: Information has been received from a consumer concerning his 16 month old daughter with no medical history and no drug allergies/reactions who on 26-MAY-2011 or 27-MAY-2011 was vaccinated with a dose of MMR II (lot # not reported). The reporter stated that his daughter received MMR II and later experienced high fevers to 105F. It was unknown if the child received additional vaccines when MMR II was administered. On 02-JUN-2011 she did not respond to APAP or ibuprofen with temperature fluctuating to 100F and then back up to 104F-105F. The next day, on 03-JUN-2011 the patient was in a weird state of mind, not cheerful like she usually was but lethargic. She had purple toned skin that looked black and blue. Later that day she was taken to hospital emergency room. She then had shivering which the doctor said was a probable febrile seizure with dehydration. She had one episode of vomiting during an exam of her mouth and throat. Her temperature was 104.5. She was admitted to the hospital. She was treated with intravenous fluids and intravenous ROCEPHIN. Fever decreased. No seizure activity. On 04-JUN-2011 the patient was discharged from the hospital. On 05-JUN-2011 the patient experienced a blotchy rash in chest, neck, cheeks for 24 hours and tired, lethargic, very weak, fever again to 101F. The patient was seen by pediatrician on 05-JUN-2011 with possible roseola. Today, on 07-JUN-2011 she was starting to eat and doing a little better. Also her sister had a history of epilepsy and her cousin had Guillain-Barre at age 2. Chest x ray, blood and urine tests were performed with no results provided. At the time of reporting, the patient was recovering. Additional information has been requested.