chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 4.0
Sex: F
Vaccine: DTAPIPV, FLU3, MMR, VARCEL
Symptoms: Febrile convulsion
Clinical narrative: Pt had seizure in pm - after having vaccines listed below - per ER - febrile seizure child treated and went home.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, FLU3, MMRV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Redness and swelling at injection site (R) UA.
Age: 60.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site swelling
Clinical narrative: Pt noticed large bump 4-5 inches south of injection site that hasn't gone away in 2 weeks.
Age: 72.0
Sex: F
Vaccine: FLU3
Symptoms: Headache, Pyrexia, Rash
Clinical narrative: Rash across chest. Low grade temp. HA. Was given BENADRYL and TYLENOL.
Age: 80.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Influenza like illness, Nausea, Oropharyngeal pain, Vomiting
Clinical narrative: Chills N/V x 1, Sore throat, "flu like symptoms". Was given Benadryl and Tylenol.
Age: 11.0
Sex: M
Vaccine: TDAP, VARCEL
Symptoms: Erythema, Nodule, Skin warm
Clinical narrative: Red, hot knot.
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Abdominal pain upper, Chills, Diarrhoea, Pyrexia, Vomiting
Clinical narrative: Patient experienced fever, chills, stomach cramps, vomiting, diarrhea.
Age: 24.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Body temperature increased, Erythema, Pain in extremity, Skin warm
Clinical narrative: 15cm x 9.5cm red, sore, warm (L) arm. Temp 100.9. Cool compresses. ADVIL 400 BID.
Age: 18.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Erythema, Skin warm, Swelling, Upper extremity mass
Clinical narrative: Red, round, raised, hot, lumps on both arms.
Age: 79.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site streaking, Injection site swelling, Injection site warmth
Clinical narrative: Site of injection warm to touch, swelling and redness streaking down arm, was given Benadryl and Tylenol.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Hypersensitivity, Urticaria
Clinical narrative: Generalized urticaria (scalp, trunk, extremities) with no visible rash. Began approximately 24 hours post-injection. Advised Benadryl every 4-6 hours as needed to control itching and to seek medical attention if worsens or develop  SOB/cough. Sx's allergic rxn. Under treatment.
Age: 77.0
Sex: M
Vaccine: YF
Symptoms: Pruritus, Urticaria
Clinical narrative: Hives, itching, starting night of vaccine and persisting to time of presentation. No systemic symptoms otherwise.
Age: 36.0
Sex: F
Vaccine: FLU3
Symptoms: Confusional state, Dizziness, Dyspnoea, Hyperhidrosis, Nausea
Clinical narrative: Dizziness, sweating, nausea, throat tightness, labored breathing, pale complexion, confusion. Patient given EPIPEN before paramedics arrived.
Age: 36.0
Sex: F
Vaccine: FLU3
Symptoms: Pallor, Throat tightness
Clinical narrative: Dizziness, sweating, nausea, throat tightness, labored breathing, pale complexion, confusion. Patient given EPIPEN before paramedics arrived.
Age: 5.0
Sex: M
Vaccine: DTAP, HEPA, IPV, MMR
Symptoms: Erythema, Injection site erythema, Injection site swelling, Pyrexia, Swelling
Clinical narrative: Swelling and redness of (R) thigh with fever since yesterday. It is located on the lower body and on the (R) thigh. It is described as acute. The color is described as erythematous. Pertinent findings include fever and denies itching. TYLENOL and BENADRYL ok. Warm or cold compresses.
Age: 47.0
Sex: F
Vaccine: TDAP
Symptoms: Arthralgia, Injection site pain, Pyrexia
Clinical narrative: Pain at injection site, generalized arthralgias, fever. Symptoms began hrs after. At day 4 after symptoms improving.
Age: 62.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Pain, Pruritus, Rash
Clinical narrative: Patient reported a rash around hairline just days after receiving the shingles vaccine. Reports occasional sting and occasional itch.
Sex: M
Vaccine: UNK
Symptoms: Headache, Myalgia, Urticaria
Clinical narrative: 4x6 cm welt on right shoulder, severe headache, s/ muscle pains. Sxs began within 12 hours of the injection and abated 12 18 hours after they began. Welt persisted at 48 hours.
Age: 47.0
Sex: M
Vaccine: HEP
Symptoms: Rash, Swollen tongue
Clinical narrative: Rash. Swollen tongue.
Age: 76.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Bacterial infection, Rash erythematous
Clinical narrative: -Large, red, painful rash that spread over right arm (most of the upper arm). Occurred within 24 hours per patient. Follow up reported a bacterial infection. Pt was given antibiotics.  - Right area only affected - Spread to lower arm - Went back to MD - Stayed on Keflex 500mg TID. - Patient said second MD thought it may have been allergy and not an infection.
Age: 3.0
Sex: M
Vaccine: UNK
Symptoms: Local reaction
Clinical narrative: Moderate to severe localized reaction at least 12 cm.
Age: 55.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site rash
Clinical narrative: Rash that developed about 2 inches around injection site and persisted for 3 days, is now resolving. No other adverse effects/complications.
Age: 2.0
Sex: M
Vaccine: FLU4
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: Pt received 36 mo and up vaccine instead of under 36 mos. MOC informed per office protocol.
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Malaise, Neuralgia
Clinical narrative: Patient said she experienced extreme malaise and "nerve pain" through her chest and nose.
Age: 34.0
Sex: F
Vaccine: FLU3
Symptoms: Pruritus, Rash
Clinical narrative: Vaccine administered at 9am, later noticed itch and fine rash (not hives) on both forearms, more on left than right. At 12 noon took diphenhydramine 25mg tablet and now at 2:30p itch resolved. 10/3 rash persists but no antihistamine needed.
Age: 80.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Local swelling, Pain in extremity, Pyrexia
Clinical narrative: Entire arm became swollen and painful day after vaccine. Developed fever as well. Resolved on its own.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Red circle formation around injection site. Slightly warm and somewhat painful per patient. Formation began around 1 to 2 days after administration. Patient to f/u with PCP noted above.
Age: 91.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Pain in extremity
Clinical narrative: Pt's daughter called saying pt's arm was approx. 3" "down" from site. Very red, very sore. Gave her daughter BENADRYL 25mg once q 4-6 hours prn redness and to call Dr. if further prob.
Age: 0.19
Sex: M
Vaccine: HIBV, PNC13
Symptoms: Rash erythematous, Rash generalised
Clinical narrative: 10-3-13, the next morning after receiving HIB and PREVNAR, child had red, bumpy rash on face, neck, arms torso and legs. No difficulty breathing. Had ran low grade temp of 99 degrees during night. Lungs auscultated by this nurse, they were clear with no wheezes, no rales, no rhonchi. Advised to see MD, pt, MOC declined at this time. Recommended hydrocortisone cream on rash and if not less red by end of day to notify MD and this nurse. MOC conveyed understanding.
Age: 42.0
Sex: M
Vaccine: FLU3
Symptoms: Blister, Pain in extremity
Clinical narrative: Pt returned to pharmacy with "excessive" soreness. RPh examined area of injection (no redness, no swelling). Pt did have 4 small blisters on hand (of same injection arm). Gave pt BENADRYL 25mg.
Age: 50.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Patient has a large area of erythema, warmth and tenderness on her left upper arm. No discrete fluctuance. This was the site of her flu vaccine injection.
Age: 38.0
Sex: M
Vaccine: DTAP
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: None.
Age: 43.0
Sex: F
Vaccine: DTAP
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: None!!
Age: 75.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site swelling, Injection site warmth, Muscular weakness, Pharyngeal oedema
Clinical narrative: Throat swelling, weak in the knees within a few hours of administration. Site of injection warm and swollen.
Age: 1.75
Sex: F
Vaccine: DTAP, FLU3, HIBV
Symptoms: Injection site erythema, Injection site induration, Injection site oedema
Clinical narrative: Erythema (L) thigh 5 x 7 cm. Slightly edematous and firm on palpation. No d/c, no fever. Plan cephalexin TID for 7 days topic cortisone cream and ice prn redness/swelling.
Age: 61.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Large red, palm-sized swelling and pain on injection site.
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Chest X-ray normal, Cough, Dyspnoea, Eye discharge, Influenza virus test negative
Clinical narrative: Vaccine adverse reaction. Pt's husband called 911 on 10/02/2013 at 8:43pm. Pt had difficulty from breathing, no fluid in lungs from x-ray, cough and discharge from eyes. Pt sent home using nebulizer, prednisone and TAMIFLU. Tested (-) for flu.
Age: 72.0
Sex: F
Vaccine: FLU3
Symptoms: Rash
Clinical narrative: Patient had rash above injection site on shoulder and on back around scapula.
Age: 10.0
Sex: F
Vaccine: FLU3
Symptoms: Abdominal pain, Diarrhoea, Vomiting
Clinical narrative: Pt. had vomiting, abdominal pain and diarrhea.
Age: 13.0
Sex: M
Vaccine: HPV4
Symptoms: Asthenia, Fatigue, Laboratory test normal, Lymphadenopathy, Metabolic function test
Clinical narrative: This spontaneous report as received from a nurse who is also the mother of the patient, refers to a 13 year old male patient with dust, grass, cat and CEFTIN allergy. Medical history was not reported. On approximately 16-AUG-2013 reported as "about 6 weeks ago", the patient was vaccinated with GARDASIL (dose, route and lot were not reported). Concomitant therapies included ALLERTEC, BENADRYL and an unspecified allergy shot (manufacturer unknown). On approximately 18-AUG-2013, about 48 hours after GARDASIL was administered, the patient developed huge, swollen lymph nodes on his left neck and clavicular area. The reporter stated that since the patient was administered GARDASIL in approximately August 2013, the patient had been very tired, weak and had developed a cold. The reporter stated that as of 27-SEP-2013, the swelling had reduced significantly; however, the patient still had 8 lymph nodes that were still swollen and palpable on his left side. The patient sought for medical attention. He went to the physician's office twice. On an unknown date, results of a complete metabolic panel that was performed were "fine". No treatment given for the events. The reporter stated that the patient has been getting unspecified allergy shots (manufacturer unknown) for four years and received an unspecified allergy shot about a week before GARDASIL was administered. Also reported that beginning on an unspecified date within 2 months prior GARDASIL administration, the frequency of the patient's allergy shots were increased to every two weeks. The patient's unspecified allergist had postponed all allergy shots at this time. At the time of the report, the outcome of the events was reported as recovering. Additional information has been requested.
Age: 13.0
Sex: M
Vaccine: HPV4
Symptoms: Nasopharyngitis
Clinical narrative: This spontaneous report as received from a nurse who is also the mother of the patient, refers to a 13 year old male patient with dust, grass, cat and CEFTIN allergy. Medical history was not reported. On approximately 16-AUG-2013 reported as "about 6 weeks ago", the patient was vaccinated with GARDASIL (dose, route and lot were not reported). Concomitant therapies included ALLERTEC, BENADRYL and an unspecified allergy shot (manufacturer unknown). On approximately 18-AUG-2013, about 48 hours after GARDASIL was administered, the patient developed huge, swollen lymph nodes on his left neck and clavicular area. The reporter stated that since the patient was administered GARDASIL in approximately August 2013, the patient had been very tired, weak and had developed a cold. The reporter stated that as of 27-SEP-2013, the swelling had reduced significantly; however, the patient still had 8 lymph nodes that were still swollen and palpable on his left side. The patient sought for medical attention. He went to the physician's office twice. On an unknown date, results of a complete metabolic panel that was performed were "fine". No treatment given for the events. The reporter stated that the patient has been getting unspecified allergy shots (manufacturer unknown) for four years and received an unspecified allergy shot about a week before GARDASIL was administered. Also reported that beginning on an unspecified date within 2 months prior GARDASIL administration, the frequency of the patient's allergy shots were increased to every two weeks. The patient's unspecified allergist had postponed all allergy shots at this time. At the time of the report, the outcome of the events was reported as recovering. Additional information has been requested.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Arthralgia, Injected limb mobility decreased, Muscle twitching, Muscular weakness, Myalgia
Clinical narrative: This spontaneous report was received from a 67 year old female patient concerning herself. The patient's medical history included back issues. The patient had allergy to unspecified anti-inflammatory medications and Selective Serotonin Reuptake Inhibiting Drugs (SSRI's). On 20-SEP-2013 the patient was vaccinated with PNEUMOVAX23 one shot dose in her upper right arm (route not provided). There was no concomitant medication. The patient reported that after she had received the PNEUMOVAX23 she experienced several adverse experiences. She stated that on 2-SEP-2013 she had excruciating pain in her right arm, her right arm was immobilized, she could not raise her right arm, and the muscle in the arm was experiencing extreme pain. On Friday night and Saturday on 20-SEP-2013 and 21-SEP-2013, the patient experienced soreness and tenderness in her shoulder joint. At the time of the report, the patient still had a twitch in her arm, weakness and momentary pain. The patient was using warm/wet compresses on her arm as treatment for the adverse events. There were no laboratory tests or diagnostic studies performed. The patient's outcome from she could not raise her right arm/her right arm was immobilized, soreness and tenderness in her shoulder joint and the muscle in the arm was experiencing extreme pain was unknown. The outcome of excruciating pain in her right arm/momentary pain, weakness and twitch in her arm was reported as not recovered/not resolved. The patient sought medical attention by speaking with a pharmacist. Additional information has been requested.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Pain in extremity, Tenderness
Clinical narrative: This spontaneous report was received from a 67 year old female patient concerning herself. The patient's medical history included back issues. The patient had allergy to unspecified anti-inflammatory medications and Selective Serotonin Reuptake Inhibiting Drugs (SSRI's). On 20-SEP-2013 the patient was vaccinated with PNEUMOVAX23 one shot dose in her upper right arm (route not provided). There was no concomitant medication. The patient reported that after she had received the PNEUMOVAX23 she experienced several adverse experiences. She stated that on 2-SEP-2013 she had excruciating pain in her right arm, her right arm was immobilized, she could not raise her right arm, and the muscle in the arm was experiencing extreme pain. On Friday night and Saturday on 20-SEP-2013 and 21-SEP-2013, the patient experienced soreness and tenderness in her shoulder joint. At the time of the report, the patient still had a twitch in her arm, weakness and momentary pain. The patient was using warm/wet compresses on her arm as treatment for the adverse events. There were no laboratory tests or diagnostic studies performed. The patient's outcome from she could not raise her right arm/her right arm was immobilized, soreness and tenderness in her shoulder joint and the muscle in the arm was experiencing extreme pain was unknown. The outcome of excruciating pain in her right arm/momentary pain, weakness and twitch in her arm was reported as not recovered/not resolved. The patient sought medical attention by speaking with a pharmacist. Additional information has been requested.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site induration, Injection site urticaria
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 76 year old female patient with hypothyroid, anxiety and arthritis. On 24-SEP-2013 the patient was vaccinated with ZOSTAVAX (lot # J001005; expiry date: 24-APR-2014) in the arm. The patient also received FLUZONE in the other arm on 24-SEP-2013. Pharmacist reported that on 24-SEP-2013, after receiving both vaccinations, the patient experienced a "wheal" like injection site reaction on the arm in which she received the ZOSTAVAX, which was "hardish" and about 3.5 inches in diameter. Pharmacist reported that today, on 27-SEP-2013, the "wheal" at the injection site reaction had gotten smaller and was currently about 2 inches in diameter. Pharmacist further reported that patient was allergic to Ampicillin, which caused a swollen tongue in the past. The outcome of the events was reported as recovering. No treatment was given. No lab tests were performed. Additional information has been requested.
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Urticaria
Clinical narrative: This spontaneous report as received from a treating physician via a company representative refers to a 24 year old female patient. On an unknown date (in the past, while under the care of another, unspecified Medical Practice) the patient was vaccinated with at least one dose of GARDASIL, injection, (lot #, expiration date, dose, route unspecified). It was unclear if the patient had received only one, or multiple doses of GARDASIL. On an unknown date the patient experienced hives afterwards. Therapy with GARDASIL was reported as discontinued. The patient had not sought medical attention. The event was improved after stopping therapy. On an unknown date, the patient went to her new treating physician for an initial appointment, for an unspecified reason. Additional information has been requested.
Age: 68.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Case number PHHY2013US069542 is an initial spontaneous report from the Vaccine Adverse Event Reporting System (VAERS reference number: 478096) website on 03 Jul 2013, with the follow-up received from a Quality Assurance Department (reference number: 239356) on 26 Sep 2013. This report refers to a 68-year-old female patient. Her medical history included allergy to KEFLEX and current condition included depression. She was vaccinated with FLUVIRIN (batch number: 1206401 via intramuscular route and ZOSTAVAX (other manufacturer, batch number: H013945) via subcutaneous route on 18 Nov 2012, both vaccines given in right arm. On 21 Nov 2012, 72 hours after ZOSTAVAX vaccination, she presented with swelling, erythema and redness at the injection site. She was referred to primary care MD (ER), diagnosed with possible cellulitis like reaction and given treatment with antibiotic. The outcome of the events was reported as not recovered. The seriousness and causality of the events were not reported. Based on the investigation performed, the QA department stated that the concerned FLUVIRIN batch number: 1206401 was manufactured in accordance with the approved internal procedures and was in compliance with the cGMP requirements. Follow-up received from a Quality Assurance Department (reference number: 239356) on 26 Sep 2013: Updated batch review report.
Age: 55.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Cellulitis, Erythema, Pain, Pyrexia
Clinical narrative: Case number PHHY2013US097205 is an initial report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 494468) website on 05 Sep 2013, with the follow up received Quality Assurance Department (reference number: 250925) on 02 Oct 2013. This report refers to a 55-year-old female patient. Her medical history and concomitant medications were not reported. She was vaccinated with FLUVIRIN (batch number: 1204201) intramuscularly in the left arm and PNEUMOVAX (batch number: H010515; other manufacturer) intramuscularly in the left arm on 06 Sep 2012. On an unspecified date after vaccination she developed pain, redness and fever. She visited emergency room and Doctor diagnosed her with cellulitis. She was treated with KEFLEX for 10 days. She recovered from the events on unknown date. Causality and seriousness were not reported. Based on the batch review performed, the QA department stated that, the concerned FLUVIRIN (batch number: 1204201) was manufactured in accordance with the approved internal procedures and was in compliance with the cGMP requirements. Follow up received Quality Assurance Department (reference number: 250925) on 02 Oct 2013: Updated batch review report.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL, DTAPIPV, MMR, VARCEL
Symptoms: Rash generalised, Rash macular, Urticaria
Clinical narrative: This case was reported by a healthcare professional (nurse) and described the occurrence of hive in a 4-year-old male subject who was vaccinated with KINRIX (GlaxoSmithKline), MMR (non-GSK), and VARIVAX. On 29 July 2013 at 14:30 the subject received a dose of KINRIX (.5 ml, unknown route, right arm) as the 5th DTaP and the 4th IPV dose. On 29 July 2013 the subject received 2nd dose of MMR vaccine (unknown details. 2nd dose of VARIVAX (unknown details). On 2 August 2013, 4 days after vaccination with KINRIX, MMR vaccine and VARIVAX, the subject experienced hive. Per the nurse, KINRIX is not suspected cause of hives. The series has been discontinued. Birth weight of the subject was not known but the 3 day old weight was 8 pounds 10 ounces. At the time of reporting the event was unresolved. Follow up was received from nurse on 3 September 2013. The nurse documented that the adverse event had improved. The nurse documented that KINRIX, MMR, and VARIVAX were the suspect products. The nurse did not consider this case to be serious. The nurse documented that an "unknown food or environmental allergy" could be associated with the event. There were no relevant medical conditions. The nurse documented that the 2nd dose of MMR vaccine (0.5ml, subcutaneous) was administered in the left upper arm and the 2nd dose of VARIVAX (0.5ml, subcutaneous) was administered in the right upper arm. The nurse documented that the subject had not received the suspect drugs before. The nurse documented that the immunization series for KINRIX, MMR, and VARIVAX were completed.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL, DTAPIPV, MMR, VARCEL
Symptoms: Urticaria
Clinical narrative: This case was reported by a healthcare professional (nurse) and described the occurrence of hive in a 4-year-old male subject who was vaccinated with KINRIX (GlaxoSmithKline), MMR (non-GSK), and VARIVAX. On 29 July 2013 at 14:30 the subject received a dose of KINRIX (.5 ml, unknown route, right arm) as the 5th DTaP and the 4th IPV dose. On 29 July 2013 the subject received 2nd dose of MMR vaccine (unknown details. 2nd dose of VARIVAX (unknown details). On 2 August 2013, 4 days after vaccination with KINRIX, MMR vaccine and VARIVAX, the subject experienced hive. Per the nurse, KINRIX is not suspected cause of hives. The series has been discontinued. Birth weight of the subject was not known but the 3 day old weight was 8 pounds 10 ounces. At the time of reporting the event was unresolved. Follow up was received from nurse on 3 September 2013. The nurse documented that the adverse event had improved. The nurse documented that KINRIX, MMR, and VARIVAX were the suspect products. The nurse did not consider this case to be serious. The nurse documented that an "unknown food or environmental allergy" could be associated with the event. There were no relevant medical conditions. The nurse documented that the 2nd dose of MMR vaccine (0.5ml, subcutaneous) was administered in the left upper arm and the 2nd dose of VARIVAX (0.5ml, subcutaneous) was administered in the right upper arm. The nurse documented that the subject had not received the suspect drugs before. The nurse documented that the immunization series for KINRIX, MMR, and VARIVAX were completed.
Age: 66.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Chills, Headache, Vomiting
Clinical narrative: Unable to move arm for 6 hours after she recieved injection. At 2:00 AM on 9/12/2013 she had chills vomiting headache and fever. She reported symptoms lasted 36 hours.
Age: 66.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Chills, Headache, Injected limb mobility decreased, Pyrexia, Vomiting
Clinical narrative: Unable to move arm for 6 hours after she recieved injection. At 2:00 AM on 9/12/2013 she had chills vomiting headache and fever. She reported symptoms lasted 36 hours.
Age: 1.3
Sex: F
Vaccine: HEPA, HIBV, MMR, PNC13, VARCEL, MMR, VARCEL
Symptoms: Adenovirus infection, Alpha 1 foetoprotein normal, Amino acid level, Ammonia decreased, Anaemia
Clinical narrative: This spontaneous report as received from a physician refers to a 15 month old female patient, who on 10-JUL-2013, was vaccinated with VARIVAX (Merck) (dose, route and lot number were not reported). Other suspect therapies included M-M-R II (dose, route and lot number were not reported) and HepA (manufacturer unknown) (date, dose, route and lot number were not reported). The physician reported about a month after vaccinations were given in August 2013, the patient developed disseminated varicella disease, hemolytic anemia, rubella, mumps, and developmental regression of the brain. The patient sought medical attention, the patient's parents brought infant to the hospital. The patient was hospitalized at an unspecified hospital A in early September and was transferred to Hospital B on 05-SEP-2013 and had been there ever since that date. The patient has had her spinal fluid looked at, her varicella like rash biopsied and it tested positive for varicella, and has received daily blood transfusions. Patient also has received oxygen, CPAP, and has been intubated. Patient was also on IGB, steroids, acyclovir, and foscarnet. The physician was sending out VZVIP packet since this AE involved developmental regression of the brain affecting areas of the Pons in the patient's brain detected by a MRI. At the time of the report, the patient had not recovered from the adverse events. The relatedness for the adverse events were unknown for VARIVAX (Merck), HepA (manufacturer unknown) and M-M-R II. The events of regression of the brain affecting areas of the pons, mumps, hemolytic anemia, rubella and disseminated varicella disease and tracheal intubation were considered disability and life threatening by the physician. The events were considered to be an other important medical events by the physician. Additional information has been requested.
Age: 1.3
Sex: F
Vaccine: HEPA, HIBV, MMR, PNC13, VARCEL, MMR, VARCEL
Symptoms: Anti-NMDA antibody negative, Antibody test, Antibody test negative, Antinuclear antibody negative, Aspergillus test
Clinical narrative: This spontaneous report as received from a physician refers to a 15 month old female patient, who on 10-JUL-2013, was vaccinated with VARIVAX (Merck) (dose, route and lot number were not reported). Other suspect therapies included M-M-R II (dose, route and lot number were not reported) and HepA (manufacturer unknown) (date, dose, route and lot number were not reported). The physician reported about a month after vaccinations were given in August 2013, the patient developed disseminated varicella disease, hemolytic anemia, rubella, mumps, and developmental regression of the brain. The patient sought medical attention, the patient's parents brought infant to the hospital. The patient was hospitalized at an unspecified hospital A in early September and was transferred to Hospital B on 05-SEP-2013 and had been there ever since that date. The patient has had her spinal fluid looked at, her varicella like rash biopsied and it tested positive for varicella, and has received daily blood transfusions. Patient also has received oxygen, CPAP, and has been intubated. Patient was also on IGB, steroids, acyclovir, and foscarnet. The physician was sending out VZVIP packet since this AE involved developmental regression of the brain affecting areas of the Pons in the patient's brain detected by a MRI. At the time of the report, the patient had not recovered from the adverse events. The relatedness for the adverse events were unknown for VARIVAX (Merck), HepA (manufacturer unknown) and M-M-R II. The events of regression of the brain affecting areas of the pons, mumps, hemolytic anemia, rubella and disseminated varicella disease and tracheal intubation were considered disability and life threatening by the physician. The events were considered to be an other important medical events by the physician. Additional information has been requested.
Age: 1.3
Sex: F
Vaccine: HEPA, HIBV, MMR, PNC13, VARCEL, MMR, VARCEL
Symptoms: Asthenia, B-lymphocyte count, B-lymphocyte count decreased, Bacterial infection, Biopsy skin abnormal
Clinical narrative: This spontaneous report as received from a physician refers to a 15 month old female patient, who on 10-JUL-2013, was vaccinated with VARIVAX (Merck) (dose, route and lot number were not reported). Other suspect therapies included M-M-R II (dose, route and lot number were not reported) and HepA (manufacturer unknown) (date, dose, route and lot number were not reported). The physician reported about a month after vaccinations were given in August 2013, the patient developed disseminated varicella disease, hemolytic anemia, rubella, mumps, and developmental regression of the brain. The patient sought medical attention, the patient's parents brought infant to the hospital. The patient was hospitalized at an unspecified hospital A in early September and was transferred to Hospital B on 05-SEP-2013 and had been there ever since that date. The patient has had her spinal fluid looked at, her varicella like rash biopsied and it tested positive for varicella, and has received daily blood transfusions. Patient also has received oxygen, CPAP, and has been intubated. Patient was also on IGB, steroids, acyclovir, and foscarnet. The physician was sending out VZVIP packet since this AE involved developmental regression of the brain affecting areas of the Pons in the patient's brain detected by a MRI. At the time of the report, the patient had not recovered from the adverse events. The relatedness for the adverse events were unknown for VARIVAX (Merck), HepA (manufacturer unknown) and M-M-R II. The events of regression of the brain affecting areas of the pons, mumps, hemolytic anemia, rubella and disseminated varicella disease and tracheal intubation were considered disability and life threatening by the physician. The events were considered to be an other important medical events by the physician. Additional information has been requested.
Age: 1.3
Sex: F
Vaccine: HEPA, HIBV, MMR, PNC13, VARCEL, MMR, VARCEL
Symptoms: Blood creatine phosphokinase decreased, Blood culture negative, Blood fibrinogen increased, Blood fibrinogen normal, Blood homocysteine normal
Clinical narrative: This spontaneous report as received from a physician refers to a 15 month old female patient, who on 10-JUL-2013, was vaccinated with VARIVAX (Merck) (dose, route and lot number were not reported). Other suspect therapies included M-M-R II (dose, route and lot number were not reported) and HepA (manufacturer unknown) (date, dose, route and lot number were not reported). The physician reported about a month after vaccinations were given in August 2013, the patient developed disseminated varicella disease, hemolytic anemia, rubella, mumps, and developmental regression of the brain. The patient sought medical attention, the patient's parents brought infant to the hospital. The patient was hospitalized at an unspecified hospital A in early September and was transferred to Hospital B on 05-SEP-2013 and had been there ever since that date. The patient has had her spinal fluid looked at, her varicella like rash biopsied and it tested positive for varicella, and has received daily blood transfusions. Patient also has received oxygen, CPAP, and has been intubated. Patient was also on IGB, steroids, acyclovir, and foscarnet. The physician was sending out VZVIP packet since this AE involved developmental regression of the brain affecting areas of the Pons in the patient's brain detected by a MRI. At the time of the report, the patient had not recovered from the adverse events. The relatedness for the adverse events were unknown for VARIVAX (Merck), HepA (manufacturer unknown) and M-M-R II. The events of regression of the brain affecting areas of the pons, mumps, hemolytic anemia, rubella and disseminated varicella disease and tracheal intubation were considered disability and life threatening by the physician. The events were considered to be an other important medical events by the physician. Additional information has been requested.
Age: 1.3
Sex: F
Vaccine: HEPA, HIBV, MMR, PNC13, VARCEL, MMR, VARCEL
Symptoms: Blood immunoglobulin A normal, Blood immunoglobulin E, Blood immunoglobulin G normal, Blood immunoglobulin M increased, Blood lactate dehydrogenase increased
Clinical narrative: This spontaneous report as received from a physician refers to a 15 month old female patient, who on 10-JUL-2013, was vaccinated with VARIVAX (Merck) (dose, route and lot number were not reported). Other suspect therapies included M-M-R II (dose, route and lot number were not reported) and HepA (manufacturer unknown) (date, dose, route and lot number were not reported). The physician reported about a month after vaccinations were given in August 2013, the patient developed disseminated varicella disease, hemolytic anemia, rubella, mumps, and developmental regression of the brain. The patient sought medical attention, the patient's parents brought infant to the hospital. The patient was hospitalized at an unspecified hospital A in early September and was transferred to Hospital B on 05-SEP-2013 and had been there ever since that date. The patient has had her spinal fluid looked at, her varicella like rash biopsied and it tested positive for varicella, and has received daily blood transfusions. Patient also has received oxygen, CPAP, and has been intubated. Patient was also on IGB, steroids, acyclovir, and foscarnet. The physician was sending out VZVIP packet since this AE involved developmental regression of the brain affecting areas of the Pons in the patient's brain detected by a MRI. At the time of the report, the patient had not recovered from the adverse events. The relatedness for the adverse events were unknown for VARIVAX (Merck), HepA (manufacturer unknown) and M-M-R II. The events of regression of the brain affecting areas of the pons, mumps, hemolytic anemia, rubella and disseminated varicella disease and tracheal intubation were considered disability and life threatening by the physician. The events were considered to be an other important medical events by the physician. Additional information has been requested.
Age: 1.3
Sex: F
Vaccine: HEPA, HIBV, MMR, PNC13, VARCEL, MMR, VARCEL
Symptoms: Blood lactic acid decreased, Blood lactic acid normal, Blood pyruvic acid, Blood pyruvic acid increased, Blood triglycerides increased
Clinical narrative: This spontaneous report as received from a physician refers to a 15 month old female patient, who on 10-JUL-2013, was vaccinated with VARIVAX (Merck) (dose, route and lot number were not reported). Other suspect therapies included M-M-R II (dose, route and lot number were not reported) and HepA (manufacturer unknown) (date, dose, route and lot number were not reported). The physician reported about a month after vaccinations were given in August 2013, the patient developed disseminated varicella disease, hemolytic anemia, rubella, mumps, and developmental regression of the brain. The patient sought medical attention, the patient's parents brought infant to the hospital. The patient was hospitalized at an unspecified hospital A in early September and was transferred to Hospital B on 05-SEP-2013 and had been there ever since that date. The patient has had her spinal fluid looked at, her varicella like rash biopsied and it tested positive for varicella, and has received daily blood transfusions. Patient also has received oxygen, CPAP, and has been intubated. Patient was also on IGB, steroids, acyclovir, and foscarnet. The physician was sending out VZVIP packet since this AE involved developmental regression of the brain affecting areas of the Pons in the patient's brain detected by a MRI. At the time of the report, the patient had not recovered from the adverse events. The relatedness for the adverse events were unknown for VARIVAX (Merck), HepA (manufacturer unknown) and M-M-R II. The events of regression of the brain affecting areas of the pons, mumps, hemolytic anemia, rubella and disseminated varicella disease and tracheal intubation were considered disability and life threatening by the physician. The events were considered to be an other important medical events by the physician. Additional information has been requested.
Age: 1.3
Sex: F
Vaccine: HEPA, HIBV, MMR, PNC13, VARCEL, MMR, VARCEL
Symptoms: Blood urea, Bordetella test negative, Bronchial secretion retention, CD4 lymphocytes decreased, CD4/CD8 ratio
Clinical narrative: This spontaneous report as received from a physician refers to a 15 month old female patient, who on 10-JUL-2013, was vaccinated with VARIVAX (Merck) (dose, route and lot number were not reported). Other suspect therapies included M-M-R II (dose, route and lot number were not reported) and HepA (manufacturer unknown) (date, dose, route and lot number were not reported). The physician reported about a month after vaccinations were given in August 2013, the patient developed disseminated varicella disease, hemolytic anemia, rubella, mumps, and developmental regression of the brain. The patient sought medical attention, the patient's parents brought infant to the hospital. The patient was hospitalized at an unspecified hospital A in early September and was transferred to Hospital B on 05-SEP-2013 and had been there ever since that date. The patient has had her spinal fluid looked at, her varicella like rash biopsied and it tested positive for varicella, and has received daily blood transfusions. Patient also has received oxygen, CPAP, and has been intubated. Patient was also on IGB, steroids, acyclovir, and foscarnet. The physician was sending out VZVIP packet since this AE involved developmental regression of the brain affecting areas of the Pons in the patient's brain detected by a MRI. At the time of the report, the patient had not recovered from the adverse events. The relatedness for the adverse events were unknown for VARIVAX (Merck), HepA (manufacturer unknown) and M-M-R II. The events of regression of the brain affecting areas of the pons, mumps, hemolytic anemia, rubella and disseminated varicella disease and tracheal intubation were considered disability and life threatening by the physician. The events were considered to be an other important medical events by the physician. Additional information has been requested.
Age: 1.3
Sex: F
Vaccine: HEPA, HIBV, MMR, PNC13, VARCEL, MMR, VARCEL
Symptoms: CD8 lymphocytes decreased, CSF culture negative, CSF oligoclonal band absent, CSF test abnormal, CSF test normal
Clinical narrative: This spontaneous report as received from a physician refers to a 15 month old female patient, who on 10-JUL-2013, was vaccinated with VARIVAX (Merck) (dose, route and lot number were not reported). Other suspect therapies included M-M-R II (dose, route and lot number were not reported) and HepA (manufacturer unknown) (date, dose, route and lot number were not reported). The physician reported about a month after vaccinations were given in August 2013, the patient developed disseminated varicella disease, hemolytic anemia, rubella, mumps, and developmental regression of the brain. The patient sought medical attention, the patient's parents brought infant to the hospital. The patient was hospitalized at an unspecified hospital A in early September and was transferred to Hospital B on 05-SEP-2013 and had been there ever since that date. The patient has had her spinal fluid looked at, her varicella like rash biopsied and it tested positive for varicella, and has received daily blood transfusions. Patient also has received oxygen, CPAP, and has been intubated. Patient was also on IGB, steroids, acyclovir, and foscarnet. The physician was sending out VZVIP packet since this AE involved developmental regression of the brain affecting areas of the Pons in the patient's brain detected by a MRI. At the time of the report, the patient had not recovered from the adverse events. The relatedness for the adverse events were unknown for VARIVAX (Merck), HepA (manufacturer unknown) and M-M-R II. The events of regression of the brain affecting areas of the pons, mumps, hemolytic anemia, rubella and disseminated varicella disease and tracheal intubation were considered disability and life threatening by the physician. The events were considered to be an other important medical events by the physician. Additional information has been requested.
Age: 1.3
Sex: F
Vaccine: HEPA, HIBV, MMR, PNC13, VARCEL, MMR, VARCEL
Symptoms: Carnitine decreased, Cell marker, Cerebral atrophy, Ceruloplasmin, Chlamydia test negative
Clinical narrative: This spontaneous report as received from a physician refers to a 15 month old female patient, who on 10-JUL-2013, was vaccinated with VARIVAX (Merck) (dose, route and lot number were not reported). Other suspect therapies included M-M-R II (dose, route and lot number were not reported) and HepA (manufacturer unknown) (date, dose, route and lot number were not reported). The physician reported about a month after vaccinations were given in August 2013, the patient developed disseminated varicella disease, hemolytic anemia, rubella, mumps, and developmental regression of the brain. The patient sought medical attention, the patient's parents brought infant to the hospital. The patient was hospitalized at an unspecified hospital A in early September and was transferred to Hospital B on 05-SEP-2013 and had been there ever since that date. The patient has had her spinal fluid looked at, her varicella like rash biopsied and it tested positive for varicella, and has received daily blood transfusions. Patient also has received oxygen, CPAP, and has been intubated. Patient was also on IGB, steroids, acyclovir, and foscarnet. The physician was sending out VZVIP packet since this AE involved developmental regression of the brain affecting areas of the Pons in the patient's brain detected by a MRI. At the time of the report, the patient had not recovered from the adverse events. The relatedness for the adverse events were unknown for VARIVAX (Merck), HepA (manufacturer unknown) and M-M-R II. The events of regression of the brain affecting areas of the pons, mumps, hemolytic anemia, rubella and disseminated varicella disease and tracheal intubation were considered disability and life threatening by the physician. The events were considered to be an other important medical events by the physician. Additional information has been requested.
Age: 1.3
Sex: F
Vaccine: HEPA, HIBV, MMR, PNC13, VARCEL, MMR, VARCEL
Symptoms: Clostridium test, Clostridium test negative, Complement factor, Corynebacterium test, Culture negative
Clinical narrative: This spontaneous report as received from a physician refers to a 15 month old female patient, who on 10-JUL-2013, was vaccinated with VARIVAX (Merck) (dose, route and lot number were not reported). Other suspect therapies included M-M-R II (dose, route and lot number were not reported) and HepA (manufacturer unknown) (date, dose, route and lot number were not reported). The physician reported about a month after vaccinations were given in August 2013, the patient developed disseminated varicella disease, hemolytic anemia, rubella, mumps, and developmental regression of the brain. The patient sought medical attention, the patient's parents brought infant to the hospital. The patient was hospitalized at an unspecified hospital A in early September and was transferred to Hospital B on 05-SEP-2013 and had been there ever since that date. The patient has had her spinal fluid looked at, her varicella like rash biopsied and it tested positive for varicella, and has received daily blood transfusions. Patient also has received oxygen, CPAP, and has been intubated. Patient was also on IGB, steroids, acyclovir, and foscarnet. The physician was sending out VZVIP packet since this AE involved developmental regression of the brain affecting areas of the Pons in the patient's brain detected by a MRI. At the time of the report, the patient had not recovered from the adverse events. The relatedness for the adverse events were unknown for VARIVAX (Merck), HepA (manufacturer unknown) and M-M-R II. The events of regression of the brain affecting areas of the pons, mumps, hemolytic anemia, rubella and disseminated varicella disease and tracheal intubation were considered disability and life threatening by the physician. The events were considered to be an other important medical events by the physician. Additional information has been requested.
Age: 1.3
Sex: F
Vaccine: HEPA, HIBV, MMR, PNC13, VARCEL, MMR, VARCEL
Symptoms: Culture urine negative, Culture wound negative, Culture wound positive, Cytomegalovirus test, Cytomegalovirus test negative
Clinical narrative: This spontaneous report as received from a physician refers to a 15 month old female patient, who on 10-JUL-2013, was vaccinated with VARIVAX (Merck) (dose, route and lot number were not reported). Other suspect therapies included M-M-R II (dose, route and lot number were not reported) and HepA (manufacturer unknown) (date, dose, route and lot number were not reported). The physician reported about a month after vaccinations were given in August 2013, the patient developed disseminated varicella disease, hemolytic anemia, rubella, mumps, and developmental regression of the brain. The patient sought medical attention, the patient's parents brought infant to the hospital. The patient was hospitalized at an unspecified hospital A in early September and was transferred to Hospital B on 05-SEP-2013 and had been there ever since that date. The patient has had her spinal fluid looked at, her varicella like rash biopsied and it tested positive for varicella, and has received daily blood transfusions. Patient also has received oxygen, CPAP, and has been intubated. Patient was also on IGB, steroids, acyclovir, and foscarnet. The physician was sending out VZVIP packet since this AE involved developmental regression of the brain affecting areas of the Pons in the patient's brain detected by a MRI. At the time of the report, the patient had not recovered from the adverse events. The relatedness for the adverse events were unknown for VARIVAX (Merck), HepA (manufacturer unknown) and M-M-R II. The events of regression of the brain affecting areas of the pons, mumps, hemolytic anemia, rubella and disseminated varicella disease and tracheal intubation were considered disability and life threatening by the physician. The events were considered to be an other important medical events by the physician. Additional information has been requested.