chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 12.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Pyrexia, Streptococcus test negative
Clinical narrative: Initial report received from a nurse on 21 June 2011. A 12-year-old male patient had received a dose of VARIVAX (Merck, lot number not reported), and a dose of Hep A vaccine (manufacturer unknown, lot number not reported) on 09 June 2011. The patient subsequently received a dose of ADACEL (lot number U3956AA, Sanofi Pasteur lot number C3902), and MENACTRA (lot number U3051AA) in the right thigh on 20 June 2011. On 21 June 2011, one day following the ADACEL and MENACTRA vaccinations, which was also 12 days following varicella and Hep A vaccinations, the patient experienced temporal temperature of 105.0 degrees Fahrenheit with no other symptoms. The event required a physician visit, however it was not reported whether the patient required treatment. At the time of ADACEL and MENACTRA vaccinations, it was noted the patient had no known allergies, no concurrent illnesses, but was thought to be taking other medication of anastrozol ("ARIMIDEX" (indication not reported)). Outcome was reported as not recovered. Follow-up information was received on 02 August 2011 from a health care professional. The patient had a history of precocious puberty, an allergy to LUPRON and at the time of vaccination had nasal congestion. The patient had received the varicella vaccine, lot number 1697Z in the right thigh and HAVRIX, GSK lot number AHAVB498BB in the left thigh. According to the reporter, the patient's mother called to report the patient developed nasal congestion and a sore throat the day after the vaccines were administered (nasal congestion was also reported to be present at the time of vaccination). The patient was evaluated by the physician on 24 June 2011 and was diagnosed with otitis media. Treatments included TYLENOL, MOTRIN, OMNICEF and popsicles. Laboratory investigations included a CBC, Mono and strep test which were all negative. No further information was available at the time of the report. The patient's outcome was not reported. Follow-up information was received from a health care professional on 06 September 2011. On 24 June 2011, the patient's fever resolved. The patient has had no adverse reactions reported since that time. The outcome was reported as recovered on 24 June 2011. Documents held by sender: None.
Age: 12.0
Sex: M
Vaccine: FLU3, MNQ
Symptoms: Injection site erythema, Injection site vesicles, Vaccination site swelling
Clinical narrative: Initial report was received 26 October 2011 from a health care professional. A 12-year-old male patient who had a history of gluten allergy, had received an intramuscular left deltoid injection of FLUZONE, lot number UH455AD and an intramuscular right deltoid injection of MENACTRA, lot number U3840AA on 20 October 2011 and two days later on 22 October 2011, the site of MENACTRA vaccination on the right arm became reddened and swollen with blisters. The patient had no reported concurrent illnesses or concomitant medications, and he had not received any other vaccines during the four week prior. When the reporter contacted the patient on 24 October 2011, symptoms had resolved. Outcome was recovered. Documents held by sender: None.
Age: 39.0
Sex: F
Vaccine: TDAP
Symptoms: Arthralgia, Muscle spasms, Myalgia, Pain in extremity
Clinical narrative: Initial report was received on 16 November 2011 from a consumer, who was also the patient, at which time this case was assessed as non-serious listed. Based upon follow-up information received on 02 March 2012 from a health care professional, it was determined this case now meets seriousness criteria (OTHER- MEDICALLY SIGNIFICANT) and this case has been upgraded from non-serious to serious. This narrative includes information reported on both dates. A 39-year-old female patient had received an intramuscular injection in the right deltoid of ADACEL, sanofi pasteur Ltd. (lot number unknown) on 07 November 2011. On 07 November 2011, the patient's left arm was sore, aching and painful with some radiation and joint pain. The patient still experienced deltoid pain four months later, although much less severe and was very achy. The symptoms were not relieved by non-steroidal anti-inflammatory drugs (NSAIDs) and the pain led to arm spasms. The patient had no illness at the time of vaccination, received no other vaccinations within four weeks of ADACEL, had no allergies and took no concomitant medications. No further information was available at the time of the report. The patient's outcome was not recovered. Documents held by sender: None.
Age: 1.7
Sex: M
Vaccine: DTAP, HEP, HIBV, IPV, PNC, HEP, MMR, VARCEL
Symptoms: Diarrhoea, Emotional distress, Fatigue, Gait disturbance, Irritability
Clinical narrative: Information has been received from a mother (consumer) concerning her 19 month (current 22 year) (conflicting information with the DOB) old boy who in approximately January 2001, was vaccinated with RECOMBIVAX HB, (dose, route and lot # not reported). Secondary suspect vaccines included VARIVAX (duration, dose and lot # not reported) and MMR II (duration, dose and Lot # not reported), (albumin status HSA). In approximately January 2001, the patient experienced fever and irritability. At the time of the report the patient's status was unknown. No further information is available.
Age: 1.7
Sex: M
Vaccine: DTAP, HEP, HIBV, IPV, PNC, HEP, MMR, VARCEL
Symptoms: Pyrexia
Clinical narrative: Information has been received from a mother (consumer) concerning her 19 month (current 22 year) (conflicting information with the DOB) old boy who in approximately January 2001, was vaccinated with RECOMBIVAX HB, (dose, route and lot # not reported). Secondary suspect vaccines included VARIVAX (duration, dose and lot # not reported) and MMR II (duration, dose and Lot # not reported), (albumin status HSA). In approximately January 2001, the patient experienced fever and irritability. At the time of the report the patient's status was unknown. No further information is available.
Age: 1.7
Sex: M
Vaccine: DTAP, HEP, HIBV, IPV, PNC, HEP, MMR, VARCEL
Symptoms: Irritability, Pyrexia
Clinical narrative: Information has been received from a mother (consumer) concerning her 19 month (current 22 year) (conflicting information with the DOB) old boy who in approximately January 2001, was vaccinated with RECOMBIVAX HB, (dose, route and lot # not reported). Secondary suspect vaccines included VARIVAX (duration, dose and lot # not reported) and MMR II (duration, dose and Lot # not reported), (albumin status HSA). In approximately January 2001, the patient experienced fever and irritability. At the time of the report the patient's status was unknown. No further information is available.
Age: 51.0
Sex: M
Vaccine: ANTH, HEP, ANTH, HEP
Symptoms: Arthralgia, Hypoaesthesia
Clinical narrative: 51 y/o male who received anthrax vaccine (1) in his right arm and hepatitis B vaccine (1) in his left upper arm on 24 Jan 2012. He denies significant redness, pain, and swelling surrounding either vaccination site and denies anything unusual about vaccine administration. He experienced mild "achiness" x 2 days after receipt. Patient denies angioedema, hives/rashes, swelling of mouth and throat, cardiovascular, respiratory, and GI symptoms. He denies significant or prolonged fever/chills, headaches, and fatigue following vaccine receipt. Patient experienced sharp pains in both of his shoulders and numbness in both of hands, with onset about 2-3 days post-vaccination. The numbness did not feel like the sensation after receiving a shot at the dentist or like when your foot is asleep. Difficult for patient to described sensation, but sensation seemed worse in the morning and was intermittent (every other day) for 3-4 days before resolving. He denies changes in color or changes in temperature of hands. He denies edema of hands or redness and warmth over joints, but describes sensation of his hands feeling swollen or "tight", making it difficult to make a fist and movement of fingers and hands were painful. No weakness or decreased grasps. No history of carpal tunnel syndrome or previous altered sensation in hands. Patient describes his shoulder pain as a sharp pain that felt like "grinding glass" in both shoulders. He rates pain intensity as ranging from 2-5/10 using pain scale of 0 (=no pain) to 10 (=worst pain ever experienced). Pain worse upon arising, limiting range of motion of shoulders. Unable to lift arms above his head without increased pain. Pain usually decreased as day progressed but did not completely resolve for about 2 weeks. No radiation of pain. Patient self treated pain with ibuprofen for the first 24 hours after onset without significant decreased in pain. Sought evaluation after shoulder pain persisted for almost 2 weeks. No treatment prescribed; anthrax vaccine exemption issued and VAERS filed. Patient reported feeling well on the day of and prior to vaccinations. No other known exposures on day of vaccine receipt. No upper extremity trauma or injuries. Medication taken on day of vaccine receipt included daily aspirin. No medication allergies. He denies reactions to foods and latex. Reports bad reaction to yellow jacket sting as child. Denies previous vaccine adverse events. PMH noncontributory. Currently patient traveling and returning home within 4 weeks. Since resolution of symptoms, patient received his second hepatitis B vaccine on 29 FEB without recurrence of symptoms or adverse event.
Age: 51.0
Sex: M
Vaccine: ANTH, HEP, ANTH, HEP
Symptoms: Hypoaesthesia, Injection site joint pain, Joint range of motion decreased, Pain, Sensory disturbance
Clinical narrative: 51 y/o male who received anthrax vaccine (1) in his right arm and hepatitis B vaccine (1) in his left upper arm on 24 Jan 2012. He denies significant redness, pain, and swelling surrounding either vaccination site and denies anything unusual about vaccine administration. He experienced mild "achiness" x 2 days after receipt. Patient denies angioedema, hives/rashes, swelling of mouth and throat, cardiovascular, respiratory, and GI symptoms. He denies significant or prolonged fever/chills, headaches, and fatigue following vaccine receipt. Patient experienced sharp pains in both of his shoulders and numbness in both of hands, with onset about 2-3 days post-vaccination. The numbness did not feel like the sensation after receiving a shot at the dentist or like when your foot is asleep. Difficult for patient to described sensation, but sensation seemed worse in the morning and was intermittent (every other day) for 3-4 days before resolving. He denies changes in color or changes in temperature of hands. He denies edema of hands or redness and warmth over joints, but describes sensation of his hands feeling swollen or "tight", making it difficult to make a fist and movement of fingers and hands were painful. No weakness or decreased grasps. No history of carpal tunnel syndrome or previous altered sensation in hands. Patient describes his shoulder pain as a sharp pain that felt like "grinding glass" in both shoulders. He rates pain intensity as ranging from 2-5/10 using pain scale of 0 (=no pain) to 10 (=worst pain ever experienced). Pain worse upon arising, limiting range of motion of shoulders. Unable to lift arms above his head without increased pain. Pain usually decreased as day progressed but did not completely resolve for about 2 weeks. No radiation of pain. Patient self treated pain with ibuprofen for the first 24 hours after onset without significant decreased in pain. Sought evaluation after shoulder pain persisted for almost 2 weeks. No treatment prescribed; anthrax vaccine exemption issued and VAERS filed. Patient reported feeling well on the day of and prior to vaccinations. No other known exposures on day of vaccine receipt. No upper extremity trauma or injuries. Medication taken on day of vaccine receipt included daily aspirin. No medication allergies. He denies reactions to foods and latex. Reports bad reaction to yellow jacket sting as child. Denies previous vaccine adverse events. PMH noncontributory. Currently patient traveling and returning home within 4 weeks. Since resolution of symptoms, patient received his second hepatitis B vaccine on 29 FEB without recurrence of symptoms or adverse event.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Erythema, Pain, Pain in extremity, Pyrexia
Clinical narrative: Fever, chills, sore and very red upper arm, aches.
Age: 3.0
Sex: M
Vaccine: IPV
Symptoms: Abnormal behaviour, Aggression, Crying, Fatigue, Psychomotor hyperactivity
Clinical narrative: Severe behavior change. Extremely hyper, argumentative, uncharacteristically aggressive, using lots of gibberish, excessive crying, excessive tiredness.
Age: 3.0
Sex: M
Vaccine: IPV
Symptoms: Speech disorder
Clinical narrative: Severe behavior change. Extremely hyper, argumentative, uncharacteristically aggressive, using lots of gibberish, excessive crying, excessive tiredness.
Age: 28.0
Sex: F
Vaccine: VARCEL
Symptoms: Rash macular
Clinical narrative: Employee reported to us on 3-6-12 that she had a "red blotched area > 4 inches" on arm after 2-1-12 vaccine administration.
Age: 27.0
Sex: M
Vaccine: UNK
Symptoms: Unevaluable event
Clinical narrative: None.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: 3/8 Pt noticed redness at site c/o itching no pain (+) fever. Circumferential erythema at injection site.
Age: 30.0
Sex: F
Vaccine: TDAP
Symptoms: Chills, Mobility decreased, Musculoskeletal pain, Oedema peripheral, Pain in extremity
Clinical narrative: Arm became swollen and unable to move.   Had taken 2 Motrin right after Tdap was given.  Took 2 more Tdap @ 10 PM.  @ approx 2 AM the next Morning, chills started and pain in left arm, shoulder and side started.
Age: 60.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling, Malaise, Pyrexia
Clinical narrative: Swelling of injection site with raised red places, low grade fever (100 degrees), general unwell feeling.
Age: 42.0
Sex: F
Vaccine: HEP
Symptoms: Pruritus, Urticaria
Clinical narrative: Itching and hives on chest and arms.
Age: 11.0
Sex: F
Vaccine: TDAP, VARCEL
Symptoms: Rash, Rash erythematous, Rhinorrhoea, Varicella post vaccine
Clinical narrative: Second varicella vaccine given 2/27, mild rash broke out 3/4. Pt has mild runny nose, but otherwise feels fine. No fever. Rash is scattered on trunk and extremities - pink bumps, smaller than normal. Chickenpox lesions, and pt reports they do not itch.
Age: 4.0
Sex: F
Vaccine: DTAPIPVHIB, MMR, VARCEL
Symptoms: Injection site swelling
Clinical narrative: Two days after visit presented with local swelling at site of vaccine. No loss of function. (L) deltoid.
Age: 60.0
Sex: M
Vaccine: TDAP, TDAP
Symptoms: Electrocardiogram ambulatory, Ventricular extrasystoles
Clinical narrative: About 30 hrs after vaccine -> occasional PVC's.
Age: 27.0
Sex: F
Vaccine: FLU3, PPV, TDAP
Symptoms: Blood culture, Body temperature increased, Chills, Culture urine, Erythema
Clinical narrative: Had vaccines on 3/5/12. Started with elevated temp & chills later that evening. Elevated to 101 degrees on 3/6/12 at 1310. Labs & blood cx care. Developed redness & warmth to left arm on 3/7/12. IV antibiotics given. On 3/8/12 arm not as reddened. Patient discharged.
Age: 27.0
Sex: F
Vaccine: FLU3, PPV, TDAP
Symptoms: Full blood count, Skin warm
Clinical narrative: Had vaccines on 3/5/12. Started with elevated temp & chills later that evening. Elevated to 101 degrees on 3/6/12 at 1310. Labs & blood cx care. Developed redness & warmth to left arm on 3/7/12. IV antibiotics given. On 3/8/12 arm not as reddened. Patient discharged.
Age: 36.0
Sex: F
Vaccine: HEP, MMR, TDAP
Symptoms: Blood pressure increased, Burning sensation, Eye pruritus, Hypotension, Injection site reaction
Clinical narrative: 10:55 AM patient reported 10-15 minutes - post vaccination c/o itching tingling over right eye. Itching/welt feeling over lip area and itching/burning sensation in right upper arm area. V/S noted stabled - B/P increased d/t hypotensive -  not taken med in several days. B/P 14/100 25 mg BENADRYL given - po, at 11:10 patient noted s/s had stopped no problems noted via s/s.
Age: 36.0
Sex: F
Vaccine: HEP, MMR, TDAP
Symptoms: Paraesthesia, Pruritus, Urticaria
Clinical narrative: 10:55 AM patient reported 10-15 minutes - post vaccination c/o itching tingling over right eye. Itching/welt feeling over lip area and itching/burning sensation in right upper arm area. V/S noted stabled - B/P increased d/t hypotensive -  not taken med in several days. B/P 14/100 25 mg BENADRYL given - po, at 11:10 patient noted s/s had stopped no problems noted via s/s.
Age: 0.18
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC, RV5
Symptoms: Diarrhoea, Faeces discoloured, Haematochezia, Mucous stools, Occult blood positive
Clinical narrative: Vaccines 3/5/12. Diarrhea began that pm with loose, mucus, bloody stools. Today 3/9/12 green, mucus, stools, Heme (+).
Age: 48.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Arthralgia, Blood test normal, Gait disturbance, Joint swelling
Clinical narrative: Ankle & knee swelling and persistent joint pain in ankles & knee. Difficulty walking.
Age: 48.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Antinuclear antibody positive, Arthralgia, Blood uric acid increased, Bone erosion, Borrelia test negative
Clinical narrative: Ankle & knee swelling and persistent joint pain in ankles & knee. Difficulty walking.
Age: 48.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: C-reactive protein increased, Immediate post-injection reaction, Joint swelling, Red blood cell sedimentation rate increased, Rheumatoid factor negative
Clinical narrative: Ankle & knee swelling and persistent joint pain in ankles & knee. Difficulty walking.
Age: 48.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Tendon disorder, Ultrasound scan abnormal, X-ray limb abnormal
Clinical narrative: Ankle & knee swelling and persistent joint pain in ankles & knee. Difficulty walking.
Age: 12.0
Sex: F
Vaccine: FLU3, HPV4
Symptoms: Syncope
Clinical narrative: 24 hours after receiving GARDASIL fainted on the subway.
Age: 16.0
Sex: F
Vaccine: FLU3, HEPA, MNQ, VARCEL
Symptoms: Dizziness, Hyperventilation, Muscle spasms, Pallor
Clinical narrative: Muscle spasm upper extremities. Hyperventilation. Dizziness, paleness.
Age: 11.0
Sex: M
Vaccine: HPV4, MNQ, HPV4, MNQ
Symptoms: Oedema peripheral, Rash, Skin warm
Clinical narrative: (L) arm rash, swollen. Felt warm. Pt was given BENADRYL and KENALOG.
Age: 11.0
Sex: M
Vaccine: HPV4, MNQ, HPV4, MNQ
Symptoms: Feeling hot, Oedema peripheral, Rash
Clinical narrative: (L) arm rash, swollen. Felt warm. Pt was given BENADRYL and KENALOG.
Age: 4.0
Sex: F
Vaccine: DTAP, FLU3, IPV
Symptoms: Injection site erythema, Injection site induration, Injection site warmth, Local reaction
Clinical narrative: Local reaction (L) lower thigh. Pink red spot 5 x 8 in - mild induration at center slight warm to touch.
Age: 4.0
Sex: M
Vaccine: DTAP, FLU3, IPV, MMR, PNC13, VARCEL
Symptoms: Injection site reaction, Rash, Rash erythematous, Rash pruritic
Clinical narrative: Bright red rash at injection site that spread to trunk - itchy.
Age: 52.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Headache, Injection site swelling, Malaise, Pyrexia
Clinical narrative: Fever, redness, swelling at injection site((R) deltoid), also malaise, HA. F/u visit 3/9/12 - improved. No fever.
Age: 38.0
Sex: M
Vaccine: MMR
Symptoms: Arthralgia, Back pain, Neck pain
Clinical narrative: One week after MMR, developed joint pains; back, neck, hips & elbows.
Age: 13.0
Sex: M
Vaccine: VARCEL
Symptoms: Blood glucose, Lethargy, Loss of consciousness, Presyncope
Clinical narrative: Nurse at school said patient was lethargic, passed out & had to get a wheelchair. Patient did go to ER. Discharged diagnosis vasovagal episode.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Injection site pain
Clinical narrative: Round red painful area at injection site (1.5 inches in diameter). Headache today.
Age: 1.04
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Pruritus, Pyrexia, Rash vesicular, Varicella post vaccine
Clinical narrative: Spots started - last evening 3/4/12. New spots every hour, vesicular rash, low grade fever, felt itchy 1-2 days before breaking out. 10-20 vesicular lesions - trunk, face, foot, legs, mild chicken pox. Calamine, BENADRYL. No school.
Age: 16.0
Sex: M
Vaccine: VARCEL
Symptoms: Incorrect dose administered
Clinical narrative: Patient presented for follow up. Provided records for immunization indicating 2nd varicella needed. Varicella administered today. After vaccine was given to patient I noticed that a separate vaccine record for our chart had that he had already had his second varicella vaccine 8/15/11.
Age: 48.0
Sex: M
Vaccine: TDAP
Symptoms: Back pain, Headache, Pain
Clinical narrative: Vaccine given 2.28.12. Pt states on 2-28-12 he had body aches, back pain , & HA. 3-2-12 Pt calls clinic with above info but states symptoms are getting better each day.
Age: 3.0
Sex: M
Vaccine: PNC13
Symptoms: Urticaria
Clinical narrative: A little over 24hrs after receiving dose of PREVNAR 13 patient developed hives on lower extremities. This responded to diphenhydramine but recurred again 24hrs later.
Age: 1.0
Sex: M
Vaccine: HIBV, MMR, PNC, VARCEL
Symptoms: Injection site erythema
Clinical narrative: Vaccines were given on 3/8/12. On the morning of 3/9/12 mom noticed redness around injection site (left). Patient has brought to office & prescribed AUGMENTIN (600/5) 5 ml PO BID x 10 days.
Age: 1.12
Sex: M
Vaccine: MMR, PNC13, VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site pruritus, Injection site pustule, Injection site reaction
Clinical narrative: Raised red rash on right thigh/itching. Received VZV vaccine on 2/24/12. No fever - pustule surrounded by 2.5cm dia. area of erythema, blanchable, area hard, warm & non-tender.
Age: 1.12
Sex: M
Vaccine: MMR, PNC13, VARCEL
Symptoms: Injection site warmth, Pallor, Rash erythematous
Clinical narrative: Raised red rash on right thigh/itching. Received VZV vaccine on 2/24/12. No fever - pustule surrounded by 2.5cm dia. area of erythema, blanchable, area hard, warm & non-tender.
Age: 33.0
Sex: M
Vaccine: VARCEL
Symptoms: Cellulitis, Erythema, Feeling hot, Hypersensitivity, Induration
Clinical narrative: 2 weeks following injection noted generalized itching for one hour followed by redness. Soreness to injection site - increased in soreness & redness over next 2 days. 3 cm firm induration erythema  & heat noted. Without adenopathy. T-98. Advised BENADRYL at bedtime & corticosteroid cream. Cellulitis vs delayed allergic reaction.
Age: 33.0
Sex: M
Vaccine: VARCEL
Symptoms: Injection site pain, Pruritus generalised
Clinical narrative: 2 weeks following injection noted generalized itching for one hour followed by redness. Soreness to injection site - increased in soreness & redness over next 2 days. 3 cm firm induration erythema  & heat noted. Without adenopathy. T-98. Advised BENADRYL at bedtime & corticosteroid cream. Cellulitis vs delayed allergic reaction.
Age: 18.0
Sex: F
Vaccine: HEPA, MNQ, MNQ
Symptoms: Fatigue, Myalgia
Clinical narrative: Muscle pain (legs, arms, & back). Constant pain (scale of 6-8) (achy muscle feeling). - Severe fatigue.
Age: 18.0
Sex: F
Vaccine: HEPA, MNQ, MNQ
Symptoms: Fatigue, Hyperaesthesia, Laboratory test normal, Menorrhagia, Migraine
Clinical narrative: Muscle pain (legs, arms, & back). Constant pain (scale of 6-8) (achy muscle feeling). - Severe fatigue.
Age: 18.0
Sex: F
Vaccine: HEPA, MNQ, MNQ
Symptoms: Mononucleosis heterophile test negative, Pain in extremity
Clinical narrative: Muscle pain (legs, arms, & back). Constant pain (scale of 6-8) (achy muscle feeling). - Severe fatigue.
Age: 1.3
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Autopsy, Death, Sudden infant death syndrome
Clinical narrative: Unexplained crib death 7d after MMR + VARIVAX.
Age: 0.32
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13
Symptoms: Erythema, Swelling, Vaccination site inflammation
Clinical narrative: Baseball size inflammation at vaccination site (L) thigh. Reaction occurred 3-4 hours post vaccination. Relief from swelling and redness 30 minutes after BENADRYL was administered.
Age: 76.0
Sex: F
Vaccine: FLU3
Symptoms: Cough, Feeling abnormal, Malaise, Pneumonia
Clinical narrative: Initial report was received from a consumer, who was also the patient, on 29 February 2012. A 76-year-old female patient had received an injection of FLUZONE HIGH-DOSE, sanofi pasteur Inc. (lot number, route and site not reported) on 25 September 2011. Ever since the shot, the patient had been sick, had pneumonia and had been coughing. The patient felt like she was incapacitated. Medical history and concomitant medications were not reported. No further information was available at the time of the report. The patient's outcome was not reported. Documents held by sender: None.
Age: 5.0
Sex: M
Vaccine: DTAP, FLUX, IPV, MMR, VARCEL
Symptoms: Bordetella test positive, Cough, Dyspnoea, Nasal congestion, Oropharyngeal pain
Clinical narrative: This case is a cluster of 6 patients who tested positive for pertussis following administration of DTAP vaccines. The 5 other patient s are captured in case numbers 2012-01240, 2012-02345, 2012-02347, 2012-02350 and 2012-02351. Initial report was received from a health care professional on 24 February 2012. A 6-year-old male patient had received 4 previous injections of DTaP: Dose 1 of DTAP (manufacturer, lot number, route and site not reported) on 17 November 2005, dose 2 of PENTACEL, sanofi pasteur Ltd. lot number C2243AA (route and site not reported) on 14 December 2005 and doses 3 and 4 of DTAP (manufacturer, lot number, route and site not reported) on 20 February 2006 and 07 December 2006. The patient had received a 0.5ml dose 5 injection of DAPTACEL, sanofi pasteur Ltd. lot number C358AA (route and site not reported) on 01 November 2010. On the same date, the patient also received a 0.5ml dose 4 injection of POLIOMYELITIS vaccine inactivated, a 0.5 ml dose 2 injection of MMR, a 0.5ml dose 2 injection of VARIVAX, Merck and a 0.5ml dose 4 injection of INFLUENZA vaccine (manufacturer, lot numbers, routes and sites not reported). The patient was seen on 26 January 2012 with complaints of a barky cough, post-tussive vomiting five time over the past 3 days, fever on and off, shortness of breath (SOB), sore throat and cannot catch breath during coughing spasms. Upon examination, the patient had nasal congestion, mild erythema on right tonsil, no cervical lymphadenopathy and lungs were clear to auscultation. The physician's assessment was cough. A nasopharyngeal swab was performed. The patient's nasopharyngeal swab PCR results on 29 January 2012 were "Bordetella pertussis DNA detected. (Does not distinguish between B. pertussis and B. holmesii)." The patient was treated with azithromycin, fluids, increased humidity, honey and DELSYM. The patient had no known drug allergies and took DELSYM concomitantly. The patient had a past medical history of cryptorchidism repaired at 9 months, pharyngitis and strep. The patient was up-to-date on Hep B, hib, IPV/OPV, PREVNAR, MMR, varicella, hep A and flu vaccinations. No further information was available at the time of the report. The patient's outcome was not reported. Documents held by sender: Medical records.
Age: 5.0
Sex: M
Vaccine: DTAP, FLUX, IPV, MMR, VARCEL
Symptoms: Pertussis, Pharyngeal erythema, Polymerase chain reaction, Post-tussive vomiting, Pyrexia
Clinical narrative: This case is a cluster of 6 patients who tested positive for pertussis following administration of DTAP vaccines. The 5 other patient s are captured in case numbers 2012-01240, 2012-02345, 2012-02347, 2012-02350 and 2012-02351. Initial report was received from a health care professional on 24 February 2012. A 6-year-old male patient had received 4 previous injections of DTaP: Dose 1 of DTAP (manufacturer, lot number, route and site not reported) on 17 November 2005, dose 2 of PENTACEL, sanofi pasteur Ltd. lot number C2243AA (route and site not reported) on 14 December 2005 and doses 3 and 4 of DTAP (manufacturer, lot number, route and site not reported) on 20 February 2006 and 07 December 2006. The patient had received a 0.5ml dose 5 injection of DAPTACEL, sanofi pasteur Ltd. lot number C358AA (route and site not reported) on 01 November 2010. On the same date, the patient also received a 0.5ml dose 4 injection of POLIOMYELITIS vaccine inactivated, a 0.5 ml dose 2 injection of MMR, a 0.5ml dose 2 injection of VARIVAX, Merck and a 0.5ml dose 4 injection of INFLUENZA vaccine (manufacturer, lot numbers, routes and sites not reported). The patient was seen on 26 January 2012 with complaints of a barky cough, post-tussive vomiting five time over the past 3 days, fever on and off, shortness of breath (SOB), sore throat and cannot catch breath during coughing spasms. Upon examination, the patient had nasal congestion, mild erythema on right tonsil, no cervical lymphadenopathy and lungs were clear to auscultation. The physician's assessment was cough. A nasopharyngeal swab was performed. The patient's nasopharyngeal swab PCR results on 29 January 2012 were "Bordetella pertussis DNA detected. (Does not distinguish between B. pertussis and B. holmesii)." The patient was treated with azithromycin, fluids, increased humidity, honey and DELSYM. The patient had no known drug allergies and took DELSYM concomitantly. The patient had a past medical history of cryptorchidism repaired at 9 months, pharyngitis and strep. The patient was up-to-date on Hep B, hib, IPV/OPV, PREVNAR, MMR, varicella, hep A and flu vaccinations. No further information was available at the time of the report. The patient's outcome was not reported. Documents held by sender: Medical records.
Age: 17.0
Sex: M
Vaccine: HEPA, HPV4, MNQ, HEPA, HPV4, MNQ
Symptoms: Communication disorder, Confusional state, Dizziness, Electrolyte imbalance, Erythema
Clinical narrative: Redness of lower arms, itching sensation in throat then seemed very confused, unable to complete sentences. Felt dizzy - taken to ER via 911. Given IVF's/ketorolac and BENADRYL and recovered, sent home.
Age: 17.0
Sex: M
Vaccine: HEPA, HPV4, MNQ, HEPA, HPV4, MNQ
Symptoms: Full blood count normal, Throat irritation
Clinical narrative: Redness of lower arms, itching sensation in throat then seemed very confused, unable to complete sentences. Felt dizzy - taken to ER via 911. Given IVF's/ketorolac and BENADRYL and recovered, sent home.
Age: 17.0
Sex: M
Vaccine: HEPA, HPV4, MNQ, HEPA, HPV4, MNQ
Symptoms: Blood electrolytes normal, Confusional state, Dizziness, Erythema, Full blood count normal
Clinical narrative: Redness of lower arms, itching sensation in throat then seemed very confused, unable to complete sentences. Felt dizzy - taken to ER via 911. Given IVF's/ketorolac and BENADRYL and recovered, sent home.
Age: 17.0
Sex: M
Vaccine: HEPA, HPV4, MNQ, HEPA, HPV4, MNQ
Symptoms: Speech disorder, Throat irritation
Clinical narrative: Redness of lower arms, itching sensation in throat then seemed very confused, unable to complete sentences. Felt dizzy - taken to ER via 911. Given IVF's/ketorolac and BENADRYL and recovered, sent home.
Age: 31.0
Sex: M
Vaccine: ANTH, FLUN3, SMALL
Symptoms: Chest pain, Echocardiogram normal, Electrocardiogram abnormal, Troponin I
Clinical narrative: This study case was received from the investigator in a trial on 22 February 2012 with additional information received on 28 February 2012. A 31-year-old male subject had received the following vaccinations: On 01 September 2011, an injection of ACAM2000 (lot number not reported), an injection of ANTHRAX (manufacturer and lot number not reported) and INFLUENZA (manufacturer and lot number not reported). On 13 September 2011, the subject had an abnormal ECG. On 18 September 2011, the subject had a normal echocardiogram. The subject had a normal troponin I on 16 September 2011. The subject was diagnosed with unspecified chest pain on 13 September 2011. The subject had a medical history of palpitations/pounding heart without exercise, chest pain, chest pressure, abnormal ECG and shortness of breath. No further information was available at the time of the report. The subject's outcome was not reported. Note: There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study. Documents held by sender: None.
Age: 19.0
Sex: M
Vaccine: ANTH, HEPAB, SMALL
Symptoms: Echocardiogram normal, Electrocardiogram, Painful respiration, Troponin I increased
Clinical narrative: This study case was received from the investigator on 22 February 2012 with additional information received on 28 February 2012. A 19-year-old male subject had received the following vaccinations: On 21 June 2011, an injection of ACAM2000 (lot number not reported), an injection of ANTHRAX (manufacturer and lot number not reported) and injection of HEPATITIS A-HEPATITIS B (manufacturer and lot number not reported). On 02 July 2011, the subject had an abnormal troponin I of 00.15. On 19 July 2011, the subject had a normal echocardiogram. The subject's ECG results were not available. The subject was diagnosed with painful respirations on 02 July 2011. The subject had no significant medical history. No further information was available at the time of the report. The subject's outcome was not reported. Note: There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study. Documents held by sender: None.
Age: 23.0
Sex: M
Vaccine: ANTH, SMALL
Symptoms: Chest pain, Condition aggravated, Electrocardiogram normal, Troponin I increased
Clinical narrative: This study case was received from the investigator on 22 February 2012 with additional information received on 28 February 2012. A 23-year-old male subject had received the following vaccinations: On 29 April 2011, an injection of ACAM2000 (lot number not reported) and ANTHRAX (manufacturer and lot number not reported). On 01 May 2011, the subject's ECG was normal. On 17 May 2011, the subject had an abnormal troponin I of 00.12. The subject was diagnosed with other, chest pain on 17 May 2011. The subject had a medical history of chest pain and chest pressure. No further information was available at the time of the report. The subject's outcome was not reported. Note: There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study. Documents held by sender: None.
Sex: U
Vaccine: SMALL
Symptoms: Acute myocardial infarction
Clinical narrative: This study case was received from the investigator on 22 February 2012. An unidentified subject whose medical history was not available was found to have on 29 April 2011 an acute myocardial infarction, subendocardial infarction after the subject had received an injection of ACAM2000 (lot number, route, site and date of administration not reported). Relevant laboratory tests and treatments were not reported. Additional information will be requested from the investigator. The subject's outcome was not reported. Note: There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study. Documents held by sender: none.
Sex: U
Vaccine: SMALL
Symptoms: Pericardial disease
Clinical narrative: This study case was received from the investigator on 22 February 2012. A subject (age, date of birth and gender not reported) had received an injection of ACAM2000 and an injection of ANTHRAX VACCINE (lot numbers, routes and sites not reported) on 16 March 2011. The subject was diagnosed with unspecified disease of pericardium on 04 April 2011. Medical history was not reported. No further information was available at the time of the report. The subject's outcome was not reported. Note: There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study. Documents held by sender: None.
Age: 5.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Cough, Soft tissue disorder, Urticaria
Clinical narrative: Hives began on back on evening of 03/08/2012.  Worsened throughout the evening with urticaria with soft tissue involvement on 03/09/2012.
Age: 5.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Incorrect dose administered
Clinical narrative: MMR and VARIVAX given.  The went into impact and found out child had received these vaccines on 3/8/12.
Age: 29.0
Sex: F
Vaccine: TDAP
Symptoms: Decreased appetite, Dizziness, Erythema, Muscle spasms, Nausea
Clinical narrative: PAIN, ITCHING, REDNESS, SWELLING, MUSCLE SPASMS, NAUSEA, LIGHTHEADED w/WALKING, LOSS OF APPETITE.
Age: 29.0
Sex: F
Vaccine: TDAP
Symptoms: Pain, Pruritus, Swelling
Clinical narrative: PAIN, ITCHING, REDNESS, SWELLING, MUSCLE SPASMS, NAUSEA, LIGHTHEADED w/WALKING, LOSS OF APPETITE.
Age: 9.0
Sex: M
Vaccine: VARCEL
Symptoms: Dyspnoea, Epistaxis, Wheezing
Clinical narrative: Difficulty breathing, wheezing, bloody nose; gave albuterol back to back.
Age: 0.16
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5, DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Abdominal X-ray, Abdominal distension, Blood culture negative, CSF culture negative, Culture urine negative
Clinical narrative: Patient experienced acute onset of inconsolability, abdominal distension, emesis, unusual green stool, and pale/gray color change.  Patient treated emergently with antibiotics and IV fluids for possible sepsis and admitted to intensive care unit for observation. There was high clincial suspicion for self-resolved intussusception.
Age: 0.16
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5, DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Emotional distress, Faeces discoloured, Intensive care, Intussusception, Pallor
Clinical narrative: Patient experienced acute onset of inconsolability, abdominal distension, emesis, unusual green stool, and pale/gray color change.  Patient treated emergently with antibiotics and IV fluids for possible sepsis and admitted to intensive care unit for observation. There was high clincial suspicion for self-resolved intussusception.
Age: 0.16
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5, DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Skin discolouration, Ultrasound abdomen normal, Vomiting, X-ray gastrointestinal tract normal, X-ray normal
Clinical narrative: Patient experienced acute onset of inconsolability, abdominal distension, emesis, unusual green stool, and pale/gray color change.  Patient treated emergently with antibiotics and IV fluids for possible sepsis and admitted to intensive care unit for observation. There was high clincial suspicion for self-resolved intussusception.
Age: 0.16
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5, DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Abdominal X-ray, Abdominal distension, Abdominal tenderness, Blood culture negative, Blood potassium normal
Clinical narrative: Patient experienced acute onset of inconsolability, abdominal distension, emesis, unusual green stool, and pale/gray color change.  Patient treated emergently with antibiotics and IV fluids for possible sepsis and admitted to intensive care unit for observation. There was high clincial suspicion for self-resolved intussusception.
Age: 0.16
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5, DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Blood sodium decreased, CSF culture negative, CSF neutrophil count increased, CSF test normal, CSF white blood cell count increased
Clinical narrative: Patient experienced acute onset of inconsolability, abdominal distension, emesis, unusual green stool, and pale/gray color change.  Patient treated emergently with antibiotics and IV fluids for possible sepsis and admitted to intensive care unit for observation. There was high clincial suspicion for self-resolved intussusception.
Age: 0.16
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5, DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Capillary nail refill test abnormal, Chest X-ray normal, Cold sweat, Cough, Crying
Clinical narrative: Patient experienced acute onset of inconsolability, abdominal distension, emesis, unusual green stool, and pale/gray color change.  Patient treated emergently with antibiotics and IV fluids for possible sepsis and admitted to intensive care unit for observation. There was high clincial suspicion for self-resolved intussusception.
Age: 0.16
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5, DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Culture urine negative, Dehydration, Emotional distress, Erythema, Faeces discoloured
Clinical narrative: Patient experienced acute onset of inconsolability, abdominal distension, emesis, unusual green stool, and pale/gray color change.  Patient treated emergently with antibiotics and IV fluids for possible sepsis and admitted to intensive care unit for observation. There was high clincial suspicion for self-resolved intussusception.
Age: 0.16
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5, DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Gaze palsy, Intensive care, Intussusception, Irritability, Livedo reticularis
Clinical narrative: Patient experienced acute onset of inconsolability, abdominal distension, emesis, unusual green stool, and pale/gray color change.  Patient treated emergently with antibiotics and IV fluids for possible sepsis and admitted to intensive care unit for observation. There was high clincial suspicion for self-resolved intussusception.
Age: 0.16
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5, DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Lymphocyte percentage decreased, Lymphocyte percentage increased, Mucous stools, Nasal congestion, Neutrophil percentage decreased
Clinical narrative: Patient experienced acute onset of inconsolability, abdominal distension, emesis, unusual green stool, and pale/gray color change.  Patient treated emergently with antibiotics and IV fluids for possible sepsis and admitted to intensive care unit for observation. There was high clincial suspicion for self-resolved intussusception.
Age: 0.16
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5, DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Pallor, Platelet count increased, Poor peripheral circulation, Red blood cells CSF positive, Rhinorrhoea
Clinical narrative: Patient experienced acute onset of inconsolability, abdominal distension, emesis, unusual green stool, and pale/gray color change.  Patient treated emergently with antibiotics and IV fluids for possible sepsis and admitted to intensive care unit for observation. There was high clincial suspicion for self-resolved intussusception.
Age: 0.16
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5, DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Sinus tachycardia, Skin discolouration, Tachycardia, Ultrasound abdomen normal, Ultrasound scan normal
Clinical narrative: Patient experienced acute onset of inconsolability, abdominal distension, emesis, unusual green stool, and pale/gray color change.  Patient treated emergently with antibiotics and IV fluids for possible sepsis and admitted to intensive care unit for observation. There was high clincial suspicion for self-resolved intussusception.
Age: 0.16
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5, DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Urinary system X-ray, Urinary system x-ray normal, Vomiting, White blood cell count normal, X-ray normal
Clinical narrative: Patient experienced acute onset of inconsolability, abdominal distension, emesis, unusual green stool, and pale/gray color change.  Patient treated emergently with antibiotics and IV fluids for possible sepsis and admitted to intensive care unit for observation. There was high clincial suspicion for self-resolved intussusception.
Age: 0.36
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5, DTAPIPVHIB, PNC13, RV5
Symptoms: Blood culture negative, Culture urine negative, Diarrhoea, Faeces discoloured, Gastrointestinal disorder
Clinical narrative: Patient presented with sudden onset of copious emesis, unusual watery green stool, lethargy. In emergency department, was tachycardic and hypotensive with concern for sepsis or acute abdominal process.  Received IV fluids and IV antibiotics and was admitted to the hospital for observation.  Cultures remained negative and there was high clinical suspicion for intussusception.
Age: 0.36
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5, DTAPIPVHIB, PNC13, RV5
Symptoms: Hypotension, Intussusception, Lethargy, Sepsis, Tachycardia
Clinical narrative: Patient presented with sudden onset of copious emesis, unusual watery green stool, lethargy. In emergency department, was tachycardic and hypotensive with concern for sepsis or acute abdominal process.  Received IV fluids and IV antibiotics and was admitted to the hospital for observation.  Cultures remained negative and there was high clinical suspicion for intussusception.
Age: 0.36
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5, DTAPIPVHIB, PNC13, RV5
Symptoms: Ultrasound abdomen normal, Vomiting, X-ray gastrointestinal tract normal
Clinical narrative: Patient presented with sudden onset of copious emesis, unusual watery green stool, lethargy. In emergency department, was tachycardic and hypotensive with concern for sepsis or acute abdominal process.  Received IV fluids and IV antibiotics and was admitted to the hospital for observation.  Cultures remained negative and there was high clinical suspicion for intussusception.
Age: 0.36
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5, DTAPIPVHIB, PNC13, RV5
Symptoms: Abnormal behaviour, Alanine aminotransferase increased, Aspartate aminotransferase increased, Blood albumin decreased, Blood culture negative
Clinical narrative: Patient presented with sudden onset of copious emesis, unusual watery green stool, lethargy. In emergency department, was tachycardic and hypotensive with concern for sepsis or acute abdominal process.  Received IV fluids and IV antibiotics and was admitted to the hospital for observation.  Cultures remained negative and there was high clinical suspicion for intussusception.
Age: 0.36
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5, DTAPIPVHIB, PNC13, RV5
Symptoms: Chest X-ray normal, Culture urine negative, Diarrhoea, Faeces discoloured, Hypotension
Clinical narrative: Patient presented with sudden onset of copious emesis, unusual watery green stool, lethargy. In emergency department, was tachycardic and hypotensive with concern for sepsis or acute abdominal process.  Received IV fluids and IV antibiotics and was admitted to the hospital for observation.  Cultures remained negative and there was high clinical suspicion for intussusception.
Age: 0.36
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5, DTAPIPVHIB, PNC13, RV5
Symptoms: Intussusception, Lethargy, Liver palpable subcostal, Lymphocyte count increased, Lymphocyte percentage increased
Clinical narrative: Patient presented with sudden onset of copious emesis, unusual watery green stool, lethargy. In emergency department, was tachycardic and hypotensive with concern for sepsis or acute abdominal process.  Received IV fluids and IV antibiotics and was admitted to the hospital for observation.  Cultures remained negative and there was high clinical suspicion for intussusception.
Age: 0.36
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5, DTAPIPVHIB, PNC13, RV5
Symptoms: Neutrophil count increased, Neutrophil percentage decreased, Occult blood negative, Pallor, Platelet count increased
Clinical narrative: Patient presented with sudden onset of copious emesis, unusual watery green stool, lethargy. In emergency department, was tachycardic and hypotensive with concern for sepsis or acute abdominal process.  Received IV fluids and IV antibiotics and was admitted to the hospital for observation.  Cultures remained negative and there was high clinical suspicion for intussusception.
Age: 0.36
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5, DTAPIPVHIB, PNC13, RV5
Symptoms: Protein total decreased, Tachycardia, Ultrasound abdomen normal, Urinary system X-ray, Vomiting
Clinical narrative: Patient presented with sudden onset of copious emesis, unusual watery green stool, lethargy. In emergency department, was tachycardic and hypotensive with concern for sepsis or acute abdominal process.  Received IV fluids and IV antibiotics and was admitted to the hospital for observation.  Cultures remained negative and there was high clinical suspicion for intussusception.
Age: 0.36
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5, DTAPIPVHIB, PNC13, RV5
Symptoms: White blood cell count increased, X-ray normal
Clinical narrative: Patient presented with sudden onset of copious emesis, unusual watery green stool, lethargy. In emergency department, was tachycardic and hypotensive with concern for sepsis or acute abdominal process.  Received IV fluids and IV antibiotics and was admitted to the hospital for observation.  Cultures remained negative and there was high clinical suspicion for intussusception.