chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 45.0
Sex: F
Vaccine: FLU3
Symptoms: Activities of daily living impaired, Arthralgia, Gait disturbance, Headache, Myalgia
Clinical narrative: Headache, neck pain, shooting pains throughout my body, joint pain in shoulders, arms, knees, and toes. Pain became chronic for six months and still linger. Also had muscle weakness in fingers, arms and legs with difficulty walking and performing daily activities. I went to my physician and a rheumatologist.
Age: 45.0
Sex: F
Vaccine: FLU3
Symptoms: Neck pain, Pain
Clinical narrative: Headache, neck pain, shooting pains throughout my body, joint pain in shoulders, arms, knees, and toes. Pain became chronic for six months and still linger. Also had muscle weakness in fingers, arms and legs with difficulty walking and performing daily activities. I went to my physician and a rheumatologist.
Age: 1.58
Sex: F
Vaccine: DTAP, HEPA
Symptoms: Crying, Injection site erythema, Injection site swelling, Irritability, Lethargy
Clinical narrative: Raised temperature (fever) lethargy, red swollen injection site, cranky (crying). 4 days later onset of high fever (over 103) and lethargy, crying, still red injection site. Fever continues (as does lethargy)
Age: 1.58
Sex: F
Vaccine: DTAP, HEPA
Symptoms: Pyrexia
Clinical narrative: Raised temperature (fever) lethargy, red swollen injection site, cranky (crying). 4 days later onset of high fever (over 103) and lethargy, crying, still red injection site. Fever continues (as does lethargy)
Age: 5.0
Sex: M
Vaccine: PNC13
Symptoms: Vaccination site cellulitis
Clinical narrative: Cellulitis at vaccine site.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Headache, Injection site erythema, Injection site pain, Pruritus
Clinical narrative: Area around inj site sore to touch & red day following injection. Area on (L) lower leg appeared red and itchy at 6 am. Persistent headache.
Age: 42.0
Sex: F
Vaccine: FLU3
Symptoms: Hypoaesthesia, Muscular weakness
Clinical narrative: Patient is suffering from weakness and numbness on her arm (left) to index finger which she had vaccine being administered on 8-28-11. Pt stopped on 9-16-11 evening time.
Age: 59.0
Sex: M
Vaccine: FLU3
Symptoms: Musculoskeletal stiffness, Pain
Clinical narrative: Pt reported having stiffness in neck after few hours after receiving flu shot. He said he is taking bed rest & using wet towel helps relieve pain to some extent. Pt said will see a physician if pain continued.
Age: 62.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pruritus, Injection site reaction, Injection site warmth, Joint range of motion decreased
Clinical narrative: Flu shot given (R) deltoid approximately equal to 4:45 pm 9/12/11. Arm felt heavy afterward. Became increasingly painful by 8 pm. Pt. took TYLENOL without relief. Following day used ice & heat - no relief. 9/14 developed redness, warmth & itchy red papular/vesicular rash over (R) deltoid. Responded to MOMETASONE cream today. Rash less itchy. Still with pain (R) deltoid to (R) elbow & (R) scapula. Decreased ROM D/T pain. Now will try ADVIL & continue MOMETASONE for rash. T 98.5 B/P 112/74.
Age: 62.0
Sex: F
Vaccine: FLU3
Symptoms: Musculoskeletal pain, Pain, Pain in extremity, Rash papular, Sensation of heaviness
Clinical narrative: Flu shot given (R) deltoid approximately equal to 4:45 pm 9/12/11. Arm felt heavy afterward. Became increasingly painful by 8 pm. Pt. took TYLENOL without relief. Following day used ice & heat - no relief. 9/14 developed redness, warmth & itchy red papular/vesicular rash over (R) deltoid. Responded to MOMETASONE cream today. Rash less itchy. Still with pain (R) deltoid to (R) elbow & (R) scapula. Decreased ROM D/T pain. Now will try ADVIL & continue MOMETASONE for rash. T 98.5 B/P 112/74.
Age: 67.0
Sex: F
Vaccine: TD
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Redness and swelling of right upper arm at injection site with slight itching. Patient said it started the same day of injection on 9/13/11 and was enlarging still when she reported to me at clinic on 9/15/11. Treated with cold compresses, OTC Hydrocortisone cream and oral BENADRYL 25-50 mg. She reported improvement on 9/16/11.
Age: 43.0
Sex: F
Vaccine: PPV
Symptoms: Asthenia, Blood test, Chest X-ray, Dizziness, Injection site erythema
Clinical narrative: weakness dizziness stiff neck fever racing heartbeat redness/swelling at injection site
Age: 43.0
Sex: F
Vaccine: PPV
Symptoms: Injection site swelling, Lumbar puncture, Musculoskeletal stiffness, Palpitations, Pyrexia
Clinical narrative: weakness dizziness stiff neck fever racing heartbeat redness/swelling at injection site
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Blood pressure abnormal, Chills, Pruritus generalised, Pyrexia
Clinical narrative: Fever, chills and blood pressure - 210/114. Took 2 Lorazepam .5MG for BP. BP took 3 hours to return to normal. Itching over entire body started at same time and lasted 2 1/2 days
Age: 68.0
Sex: F
Vaccine: FLUX
Symptoms: Ear pain
Clinical narrative: For the first time in my life, since childhood, I am having intermittent stabbing ear ache. Painful.
Age: 1.33
Sex: F
Vaccine: FLUX, MMR, VARCEL
Symptoms: Pyrexia
Clinical narrative: Patient suddenly had a fever of 103.3 degrees, rectally, when she woke up from nap time. I gave her 1 tsp. of Advil. Fever lowered after medicine was given.
Age: 30.0
Sex: F
Vaccine: PPV
Symptoms: Convulsion, Dizziness, Headache, Nausea, Pyrexia
Clinical narrative: rash fever convulsions, dizziness, nausea vomiting head ache
Age: 30.0
Sex: F
Vaccine: PPV
Symptoms: Rash, Vomiting
Clinical narrative: rash fever convulsions, dizziness, nausea vomiting head ache
Age: 2.0
Sex: F
Vaccine: DTAP, MMR
Symptoms: Pyrexia, Rash erythematous, Rash maculo-papular
Clinical narrative: 101-104.5 Degree fever for 3 days followed by erythemic maculopapular rash indicative of measles infection. Medicated with children's Advil every 6 hours and cool bath to decrease temperature. Treatment was effective at fever reduction.
Age: 51.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Injection site warmth, Malaise, Oedema peripheral, Pain in extremity
Clinical narrative: Dizzy, arm swelling and soreness, general malaise, warm touch administration area. Negative for fever, or redness to administration area. Patient taking fluids, ibuprofen, Benadryl.
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Influenza like illness, Malaise, Pain, Pharyngeal oedema, Swelling
Clinical narrative: With in 3 hours of shot pt reported throat swelling and uvula swelling with one side thicker than the other. She also reported flu-like symptoms w/ malaise, achyness. She took Benadryl and that relieved her throat symptoms.
Age: 27.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site induration, Injection site rash, Injection site swelling, Injection site warmth, Pain
Clinical narrative: Began to experience substantial swelling at the injection site and the skin was very hot to the touch.  The arm became very painful to move and I could hardly raise it.  On 9/17/11 it continued to swell and It seemed like the area that was swollen was hardened.  At some point during the afternoon, a circular rash began to develop around the injection site and extending down the arm a bit.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Anogenital warts, Laboratory test abnormal
Clinical narrative: After having only received the first of the three dose vaccination, Now have genital warts.  Was diagnosed approx 3.5yrs after first injection. Never received the 2nd or 3rd doses.
Age: 24.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Dyspnoea, Pain, Pyrexia, Syncope
Clinical narrative: fever, chills, aches, short of breath, syncope,
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Antinuclear antibody, Arthralgia, Borrelia test positive, Diplopia, Hypoaesthesia
Clinical narrative: Pain in calves in days following vaccination along with numbness in legs, temporarily lost feeling in half of face, tingling in mouth and tongue, double vision, vibration sensations in legs. Patient still experiences joint pain, especially in left elbow, left hand left wrist, left shoulder and at injection site, vibration sensations in legs, double vision, muscle pain, was treated for Lyme diagnosis on 02/08/11, am now on Plaquenil (400mg daily) and course of Prednisone for possible rheumatoid arthritis.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site joint pain, Lumbar puncture, Lyme disease, Myalgia, Nuclear magnetic resonance imaging
Clinical narrative: Pain in calves in days following vaccination along with numbness in legs, temporarily lost feeling in half of face, tingling in mouth and tongue, double vision, vibration sensations in legs. Patient still experiences joint pain, especially in left elbow, left hand left wrist, left shoulder and at injection site, vibration sensations in legs, double vision, muscle pain, was treated for Lyme diagnosis on 02/08/11, am now on Plaquenil (400mg daily) and course of Prednisone for possible rheumatoid arthritis.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Pain in extremity, Paraesthesia oral, Rheumatoid factor, Sensory disturbance
Clinical narrative: Pain in calves in days following vaccination along with numbness in legs, temporarily lost feeling in half of face, tingling in mouth and tongue, double vision, vibration sensations in legs. Patient still experiences joint pain, especially in left elbow, left hand left wrist, left shoulder and at injection site, vibration sensations in legs, double vision, muscle pain, was treated for Lyme diagnosis on 02/08/11, am now on Plaquenil (400mg daily) and course of Prednisone for possible rheumatoid arthritis.
Age: 0.99
Sex: M
Vaccine: HEPA, MMR
Symptoms: Depressed mood, Muscle twitching, Pyrexia, Rash
Clinical narrative: Fever for 3 days, peaked at 103.2 on day 2. Rash started on day 3 (8/17/2011). Twitches and despondence started 08/15/2011.
Age: 48.0
Sex: M
Vaccine: FLU3
Symptoms: Hypersensitivity, Pruritus
Clinical narrative: About 1 & 1/2 hours after patient received FLUVIRIN Injection he returned to pharmacy with symptoms of allergic reaction. Rash & itching on arms, chest & head. Dr. said for patient to take 1-2 BENADRYL 25mg every 4-6h & if not better to go to ER.
Age: 81.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Injection site red and swollen, hot. One dose of ADVIL did not help. Seems to be getting worse. Advised patient to call doctor.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Petechiae, Pruritus
Clinical narrative: Dispersed petechiae and pruritis, treating with diphenhydramine started 09/17/2011.
Age: 65.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Cellulitis, Erythema
Clinical narrative: Redness starting at the shoulder continuing down to the forearm. Diagnosed as cellulitis and treated with an antibiotic.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Headache, Injection site rash, Pain in extremity
Clinical narrative: Patient experienced headache, arm soreness, rash beneath injection site (not at actual injection site).
Age: 79.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Fatigue, Nausea, Pyrexia, Vomiting
Clinical narrative: Received vaccine about 10:00am. Reported vomiting, nausea, and fatigue by 1:00pm. Checked in at about 8:00pm and reported continuing symptoms and fever and chills. Checked in next day; feeling better no more nausea, vomiting, fever, or chills. Still fatigued.
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Oedema peripheral, Skin induration, Skin warm
Clinical narrative: Arm got red & hot, swelling occurred around whole arm. Firmness felt around whole upper arm. 9/18/11 swelling has subsided somewhat but arm still warm. Taking BENADRYL will contact MD.
Age: 31.0
Sex: F
Vaccine: FLU3
Symptoms: Contusion, Fall, Haemorrhage, Head injury, Loss of consciousness
Clinical narrative: Patient passed out within 5-10 mins after receiving a flu vaccine. She fell forward while sitting and hit her head on a table in the waiting area. Forehead was bruised and bleeding.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Burning sensation, Rash, Rash erythematous, Rash pruritic
Clinical narrative: Red rash appeared in two different spots; upper left leg and right hip. The spots were itchy and burning. Now there are small raised bumps like blisters. Has slightly improved as of 9/18/11.
Age: 0.3
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5, RV5, DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Lethargy, Vomiting
Clinical narrative: Initial report received on 07 September 2011 from another manufacturer, report #WAES 1107USA03816. The initial reporter to his manufacturer had been a health care professional. Verbatim from the report: "Information has been received from a physician concerning an approximately 22 weeks old male patient who approximately on 14 July 2011, was orally vaccinated with 2 mL of the second dose of ROTATEQ (Lot# and expiration date not reported). Physician reported that 11 days (approximately on 25 July 2011) after being given his second dose of ROTATEQ, within the last week, the patient developed intussusception. The patient was admitted to an unspecified hospital on an unspecified date and had surgery done as an emergency intervention on 25 July 2011. The patient was currently in the hospital. The adverse event was not diagnosed as intussusception when the patient was first admitted to the hospital. Physician reported that the adverse event improved after stopping therapy and the adverse event first occurred after reintroduction. At the time of reporting, the patient was still hospitalized but the intussusception had improved. Intussusception was determined to be an other important medical event by the physician. Follow-up information was received from another health professional who stated that the 13 week old male patient, with gastrooesophageal reflux disease and no illnesses at time of vaccination, on 13 July 2011, was vaccinated PO with the second dose of ROTATEQ (lot# 668963/1199Z) in the afternoon. Secondary suspect vaccine given IM on the same day, included the second dose of RECOMBIVAX HB thimerosal free (lot# 668308/0491AA) given in the afternoon. Concomitant vaccines included the second dose of pneumococcal conj vaccine (unspecified) (lot# E55587) and the second dose of PENTACEL (lot#C3852AA), all vaccines given IM in the afternoon. On 24 July 2011, the patient had persistent vomiting and lethargy. The patient was admitted to hospital with a diagnosis of intussusception with surgical reduction. Minor criteria included non-bilious vomiting and lethargy. On 25 July 2011, the patient had radiography and an abdominal ultrasound performed which showed mass/intussusceptum and visible intussusceptum of soft tissue mass, respectively. On the same day, the patient had a surgery of cecum and terminal ileum resected. The patient was hospitalized for 7 days. On 31 July 2011, the patient recovered. Intussusception and cecum and terminal ileum resected were determined to be life threatening illness by the other health professional." "Additional information is not expected." Documents held by sender: None.
Age: 0.3
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5, RV5, DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Intussusception, Surgery
Clinical narrative: Initial report received on 07 September 2011 from another manufacturer, report #WAES 1107USA03816. The initial reporter to his manufacturer had been a health care professional. Verbatim from the report: "Information has been received from a physician concerning an approximately 22 weeks old male patient who approximately on 14 July 2011, was orally vaccinated with 2 mL of the second dose of ROTATEQ (Lot# and expiration date not reported). Physician reported that 11 days (approximately on 25 July 2011) after being given his second dose of ROTATEQ, within the last week, the patient developed intussusception. The patient was admitted to an unspecified hospital on an unspecified date and had surgery done as an emergency intervention on 25 July 2011. The patient was currently in the hospital. The adverse event was not diagnosed as intussusception when the patient was first admitted to the hospital. Physician reported that the adverse event improved after stopping therapy and the adverse event first occurred after reintroduction. At the time of reporting, the patient was still hospitalized but the intussusception had improved. Intussusception was determined to be an other important medical event by the physician. Follow-up information was received from another health professional who stated that the 13 week old male patient, with gastrooesophageal reflux disease and no illnesses at time of vaccination, on 13 July 2011, was vaccinated PO with the second dose of ROTATEQ (lot# 668963/1199Z) in the afternoon. Secondary suspect vaccine given IM on the same day, included the second dose of RECOMBIVAX HB thimerosal free (lot# 668308/0491AA) given in the afternoon. Concomitant vaccines included the second dose of pneumococcal conj vaccine (unspecified) (lot# E55587) and the second dose of PENTACEL (lot#C3852AA), all vaccines given IM in the afternoon. On 24 July 2011, the patient had persistent vomiting and lethargy. The patient was admitted to hospital with a diagnosis of intussusception with surgical reduction. Minor criteria included non-bilious vomiting and lethargy. On 25 July 2011, the patient had radiography and an abdominal ultrasound performed which showed mass/intussusceptum and visible intussusceptum of soft tissue mass, respectively. On the same day, the patient had a surgery of cecum and terminal ileum resected. The patient was hospitalized for 7 days. On 31 July 2011, the patient recovered. Intussusception and cecum and terminal ileum resected were determined to be life threatening illness by the other health professional." "Additional information is not expected." Documents held by sender: None.
Age: 0.3
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5, RV5, DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Abdominal X-ray, Abdominal mass, Caecum operation, Ileectomy, Intussusception
Clinical narrative: Initial report received on 07 September 2011 from another manufacturer, report #WAES 1107USA03816. The initial reporter to his manufacturer had been a health care professional. Verbatim from the report: "Information has been received from a physician concerning an approximately 22 weeks old male patient who approximately on 14 July 2011, was orally vaccinated with 2 mL of the second dose of ROTATEQ (Lot# and expiration date not reported). Physician reported that 11 days (approximately on 25 July 2011) after being given his second dose of ROTATEQ, within the last week, the patient developed intussusception. The patient was admitted to an unspecified hospital on an unspecified date and had surgery done as an emergency intervention on 25 July 2011. The patient was currently in the hospital. The adverse event was not diagnosed as intussusception when the patient was first admitted to the hospital. Physician reported that the adverse event improved after stopping therapy and the adverse event first occurred after reintroduction. At the time of reporting, the patient was still hospitalized but the intussusception had improved. Intussusception was determined to be an other important medical event by the physician. Follow-up information was received from another health professional who stated that the 13 week old male patient, with gastrooesophageal reflux disease and no illnesses at time of vaccination, on 13 July 2011, was vaccinated PO with the second dose of ROTATEQ (lot# 668963/1199Z) in the afternoon. Secondary suspect vaccine given IM on the same day, included the second dose of RECOMBIVAX HB thimerosal free (lot# 668308/0491AA) given in the afternoon. Concomitant vaccines included the second dose of pneumococcal conj vaccine (unspecified) (lot# E55587) and the second dose of PENTACEL (lot#C3852AA), all vaccines given IM in the afternoon. On 24 July 2011, the patient had persistent vomiting and lethargy. The patient was admitted to hospital with a diagnosis of intussusception with surgical reduction. Minor criteria included non-bilious vomiting and lethargy. On 25 July 2011, the patient had radiography and an abdominal ultrasound performed which showed mass/intussusceptum and visible intussusceptum of soft tissue mass, respectively. On the same day, the patient had a surgery of cecum and terminal ileum resected. The patient was hospitalized for 7 days. On 31 July 2011, the patient recovered. Intussusception and cecum and terminal ileum resected were determined to be life threatening illness by the other health professional." "Additional information is not expected." Documents held by sender: None.
Age: 0.3
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5, RV5, DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Lethargy, Surgery, Ultrasound abdomen abnormal, Vomiting, X-ray abnormal
Clinical narrative: Initial report received on 07 September 2011 from another manufacturer, report #WAES 1107USA03816. The initial reporter to his manufacturer had been a health care professional. Verbatim from the report: "Information has been received from a physician concerning an approximately 22 weeks old male patient who approximately on 14 July 2011, was orally vaccinated with 2 mL of the second dose of ROTATEQ (Lot# and expiration date not reported). Physician reported that 11 days (approximately on 25 July 2011) after being given his second dose of ROTATEQ, within the last week, the patient developed intussusception. The patient was admitted to an unspecified hospital on an unspecified date and had surgery done as an emergency intervention on 25 July 2011. The patient was currently in the hospital. The adverse event was not diagnosed as intussusception when the patient was first admitted to the hospital. Physician reported that the adverse event improved after stopping therapy and the adverse event first occurred after reintroduction. At the time of reporting, the patient was still hospitalized but the intussusception had improved. Intussusception was determined to be an other important medical event by the physician. Follow-up information was received from another health professional who stated that the 13 week old male patient, with gastrooesophageal reflux disease and no illnesses at time of vaccination, on 13 July 2011, was vaccinated PO with the second dose of ROTATEQ (lot# 668963/1199Z) in the afternoon. Secondary suspect vaccine given IM on the same day, included the second dose of RECOMBIVAX HB thimerosal free (lot# 668308/0491AA) given in the afternoon. Concomitant vaccines included the second dose of pneumococcal conj vaccine (unspecified) (lot# E55587) and the second dose of PENTACEL (lot#C3852AA), all vaccines given IM in the afternoon. On 24 July 2011, the patient had persistent vomiting and lethargy. The patient was admitted to hospital with a diagnosis of intussusception with surgical reduction. Minor criteria included non-bilious vomiting and lethargy. On 25 July 2011, the patient had radiography and an abdominal ultrasound performed which showed mass/intussusceptum and visible intussusceptum of soft tissue mass, respectively. On the same day, the patient had a surgery of cecum and terminal ileum resected. The patient was hospitalized for 7 days. On 31 July 2011, the patient recovered. Intussusception and cecum and terminal ileum resected were determined to be life threatening illness by the other health professional." "Additional information is not expected." Documents held by sender: None.
Age: 10.0
Sex: M
Vaccine: DTAP, HEPA, HEPA, TDAP
Symptoms: Depressed level of consciousness, Fatigue, Injection site pain, Vaccination complication
Clinical narrative: C/O extreme fatigue, suddenly layed down on floor. Mother unable to keep pt awake. When briefly awake they were able to determine that pt was oriented to time, place and person. Was evaluated by EMT at location where they were visiting during the occurrence. Released in normal condition after an hour of the s/s.
Age: 10.0
Sex: M
Vaccine: DTAP, HEPA, HEPA, TDAP
Symptoms: Fatigue, Somnolence
Clinical narrative: C/O extreme fatigue, suddenly layed down on floor. Mother unable to keep pt awake. When briefly awake they were able to determine that pt was oriented to time, place and person. Was evaluated by EMT at location where they were visiting during the occurrence. Released in normal condition after an hour of the s/s.
Age: 68.0
Sex: M
Vaccine: FLU3, VARZOS, FLU3, VARZOS, FLU3, VARZOS
Symptoms: Dizziness, Hyperhidrosis, Nausea, Slow response to stimuli
Clinical narrative: Initial report received on 07 September 2011 from another manufacturer, report #WAES 1109USA00204. The initial reporter to his manufacturer had been a health care professional. Verbatim from the report: "Information has been received from a registered pharmacist concerning a 68 year old male patient with no medical history and no drug reactions/allergies who on 31 August 2011 was vaccinated with ZOSTAVAX (Merck) (lot # 670820/0660AA, EXP 04-Aug-2012), 0.65 ml, one time dose, subcutaneously administered by the pharmacist. Pharmacist also mentioned that the patient was administered FLUZONE a few seconds after being vaccinated with ZOSTAVAX (Merck). On 31 August 2011, post administration, the patient became lightheaded, nauseous, unresponsive to questioning for a short period of time, and sweating profusely. The pharmacist called emergency medical services who evaluated the patient. Patient refused to go to the hospital as recommended. Lab diagnostics studies were not performed. The patient recovered from adverse events on 31 August 2011. Lightheaded, nauseous, unresponsive to questioning for a short period of time and sweating profusely were considered to be immediately life-threatening and significant disabling/incapacity by the reporter. A lot check has been initiated. Additional information has been requested." Documents held by sender: None.
Age: 68.0
Sex: M
Vaccine: FLU3, VARZOS, FLU3, VARZOS, FLU3, VARZOS
Symptoms: Dizziness, Hyperhidrosis, Nausea, Unresponsive to stimuli
Clinical narrative: Initial report received on 07 September 2011 from another manufacturer, report #WAES 1109USA00204. The initial reporter to his manufacturer had been a health care professional. Verbatim from the report: "Information has been received from a registered pharmacist concerning a 68 year old male patient with no medical history and no drug reactions/allergies who on 31 August 2011 was vaccinated with ZOSTAVAX (Merck) (lot # 670820/0660AA, EXP 04-Aug-2012), 0.65 ml, one time dose, subcutaneously administered by the pharmacist. Pharmacist also mentioned that the patient was administered FLUZONE a few seconds after being vaccinated with ZOSTAVAX (Merck). On 31 August 2011, post administration, the patient became lightheaded, nauseous, unresponsive to questioning for a short period of time, and sweating profusely. The pharmacist called emergency medical services who evaluated the patient. Patient refused to go to the hospital as recommended. Lab diagnostics studies were not performed. The patient recovered from adverse events on 31 August 2011. Lightheaded, nauseous, unresponsive to questioning for a short period of time and sweating profusely were considered to be immediately life-threatening and significant disabling/incapacity by the reporter. A lot check has been initiated. Additional information has been requested." Documents held by sender: None.
Age: 1.69
Sex: M
Vaccine: VARCEL, MMR, VARCEL, MMR
Symptoms: Eyelid oedema, Lip swelling, Oedema peripheral, Rash generalised, Swelling face
Clinical narrative: Hives started evening on 9/9/11.
Age: 1.69
Sex: M
Vaccine: VARCEL, MMR, VARCEL, MMR
Symptoms: Swollen tongue, Vomiting
Clinical narrative: Hives started evening on 9/9/11.
Age: 1.69
Sex: M
Vaccine: VARCEL, MMR, VARCEL, MMR
Symptoms: Culture throat, Urticaria
Clinical narrative: Hives started evening on 9/9/11.
Age: 1.69
Sex: M
Vaccine: VARCEL, MMR, VARCEL, MMR
Symptoms: Dyspnoea, Eye swelling, Injection site urticaria, Swollen tongue, Urticaria
Clinical narrative: Hives started evening on 9/9/11.
Age: 42.0
Sex: M
Vaccine: FLU3
Symptoms: Arthralgia, Chills, Dyspepsia, Headache, Hyperhidrosis
Clinical narrative: Severe rigors, chills with inability to get and feel warm, fever up to 101, sweats, severe headache and all over joint pain and achiness which lasted 48hours. Some nausea and dyspepsia in the later 24hours as well. Almost took him to the ER.
Age: 42.0
Sex: M
Vaccine: FLU3
Symptoms: Nausea, Pain, Pyrexia
Clinical narrative: Severe rigors, chills with inability to get and feel warm, fever up to 101, sweats, severe headache and all over joint pain and achiness which lasted 48hours. Some nausea and dyspepsia in the later 24hours as well. Almost took him to the ER.
Age: 59.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Injection site erythema, Injection site induration, Injection site mass, Injection site pain, Injection site warmth
Clinical narrative: Pt received 2 vaccines on 09/13/11, Tdap (L) arm & influenza shot (L) arm. She presented to clinic 09/15/11 at 1340 with golf ball sized lump that's hard, red & painful & warm. Notified provider of this on (L) arm from Tdap & advised to do this form.
Age: 12.0
Sex: M
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site pain, Swelling
Clinical narrative: Pt was given varicella SQ in his (R) arm. Pt had pain & redness at site within first 30 mins of injection. Since then redness & swelling & pain have worsened.
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Dysphonia, Heart rate increased, Palpitations
Clinical narrative: Reported to emergency room with dizziness, heart palpitations, rapid heart rate, hoarseness and blood pressure 204/197.
Age: 24.0
Sex: M
Vaccine: FLU3
Symptoms: Fatigue, Lymphadenopathy, Rash
Clinical narrative: Swollen lymph node, fatigue, rash.
Age: 11.0
Sex: M
Vaccine: VARCEL
Symptoms: Pyrexia, Rash
Clinical narrative: Fever, rash.
Age: 41.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Vaccination site oedema, Wheezing
Clinical narrative: Significant arm redness, edema above and below vaccine site. Increased wheezing (Hx asthma).
Age: 68.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Rash erythematous, Swelling
Clinical narrative: 2x4 in. swelling and dark red uniform rash.
Age: 86.0
Sex: F
Vaccine: FLU3
Symptoms: Feeling abnormal, Injection site swelling, Nausea, Pain in extremity, Reflexes abnormal
Clinical narrative: Throw up reflex/nausea, sore arm, mental fog. Swelling at site of injection lasted 2-3 days.
Age: 86.0
Sex: F
Vaccine: FLU3
Symptoms: Vomiting
Clinical narrative: Throw up reflex/nausea, sore arm, mental fog. Swelling at site of injection lasted 2-3 days.
Age: 0.18
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Blood culture, Colitis, Colonoscopy, Computerised tomogram abdomen, Culture stool
Clinical narrative: Colitis, bloody diarrhea, duodenitis, gastritis, fever within 48 hours of receiving vaccine (ROTATEQ).
Age: 0.18
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Diarrhoea haemorrhagic, Duodenitis, Endoscopy, Full blood count, Gastritis
Clinical narrative: Colitis, bloody diarrhea, duodenitis, gastritis, fever within 48 hours of receiving vaccine (ROTATEQ).
Age: 0.18
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Immunoglobulins, Metabolic function test, Pyrexia, Ultrasound abdomen
Clinical narrative: Colitis, bloody diarrhea, duodenitis, gastritis, fever within 48 hours of receiving vaccine (ROTATEQ).
Age: 4.0
Sex: F
Vaccine: DTAP, MMR, VARCEL
Symptoms: Erythema, Swelling
Clinical narrative: 2"x1" red raised area. Pt. was given BENADRYL & MOTRIN.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, VARCEL
Symptoms: Injection site urticaria
Clinical narrative: Per mom child had a hive like reaction on Rt upper arm; no fever.
Age: 4.0
Sex: M
Vaccine: PPV
Symptoms: Productive cough, Urticaria
Clinical narrative: Hives, on extremities. Benadryl. Wet sounding cough.
Age: 34.0
Sex: M
Vaccine: FLUN3, VARCEL
Symptoms: Erythema, Oedema, Pruritus
Clinical narrative: PT COMPLAINS OF ITCHING WITH EDEMA AND ERYTHEMA. HE WAS TREATED WITH BENADRYL, CALADRYL AND ALLEGRA.
Age: 12.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Amnesia, Chills, Dizziness, Headache, Tremor
Clinical narrative: Headache Chills Dizziness Shakiness Memory loss Until 09/17/2011 the patient felt better
Age: 12.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Amnesia, Chills, Dizziness, Headache, Nervousness
Clinical narrative: Headache Chills Dizziness Shakiness Memory loss Until 09/17/2011 the patient felt better
Age: 44.0
Sex: F
Vaccine: RAB
Symptoms: Dizziness, Palpitations, Vaccine positive rechallenge
Clinical narrative: After I gave third Rabies shot and walked out the door, client husband came outside and told me his wife was alittle light headed and heart was racing, and had to sit down.  She also told me she just took her inhaler prior to me coming to the house. After a few minutes she felt better, and proceeded to go shopping with family.  I explained to her when she gets her last shot, if she wanted to she could take some Benadryl before her next shot.  She also told me this happened after her first 2 shots, but just never told me. When client got her last shot, she never stated anything to the nurse.  No reactions noticed.
Age: 67.0
Sex: M
Vaccine: FLU3
Symptoms: Chills, Hot flush
Clinical narrative: Alternating feelings of chills and hot flashes for 8-9 hours.  Patient did not report temperature readings. Resolved without treatment.
Age: 24.0
Sex: F
Vaccine: FLU3
Symptoms: Rash, Urticaria
Clinical narrative: Rash on arms, face, small hives on face.
Age: 56.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site reaction, Injection site swelling
Clinical narrative: Patient had an injection site reaction that turned red and swelled up to the size of a softball.  The patient was seen by her primary care physician and treated with antihistamines until the reaction resolved.
Age: 29.0
Sex: M
Vaccine: TDAP
Symptoms: Abdominal pain, Blood electrolytes, Chills, Dehydration, Full blood count
Clinical narrative: Pt's wife called for husband c/o sore arm and fever; advised to go to ER if serious sx per RN; 09/09/2011; ER RN called for other ER requesting records of vaccine given becasue pt there; records sent by CPH; records from ER indicate pt came there approx 9:00AM c/o abdominal pain (pain 8 on scale 10), fever, chills, frontal h/a; per ER notes, dehydrated and given IVs; DX :"Medication reaction." Discharged "improved" at approx 5:00PM
Age: 29.0
Sex: M
Vaccine: TDAP
Symptoms: Headache, Hypersensitivity, Laboratory test, Pain in extremity, Pyrexia
Clinical narrative: Pt's wife called for husband c/o sore arm and fever; advised to go to ER if serious sx per RN; 09/09/2011; ER RN called for other ER requesting records of vaccine given becasue pt there; records sent by CPH; records from ER indicate pt came there approx 9:00AM c/o abdominal pain (pain 8 on scale 10), fever, chills, frontal h/a; per ER notes, dehydrated and given IVs; DX :"Medication reaction." Discharged "improved" at approx 5:00PM
Age: 29.0
Sex: M
Vaccine: TDAP
Symptoms: Urine analysis
Clinical narrative: Pt's wife called for husband c/o sore arm and fever; advised to go to ER if serious sx per RN; 09/09/2011; ER RN called for other ER requesting records of vaccine given becasue pt there; records sent by CPH; records from ER indicate pt came there approx 9:00AM c/o abdominal pain (pain 8 on scale 10), fever, chills, frontal h/a; per ER notes, dehydrated and given IVs; DX :"Medication reaction." Discharged "improved" at approx 5:00PM
Age: 8.0
Sex: M
Vaccine: HIBV, PNC13
Symptoms: Injection site erythema
Clinical narrative: Left upper arm redness which spread to involve entire upper arm from shoulder to elbow
Age: 58.0
Sex: F
Vaccine: FLU3
Symptoms: Burning sensation, Headache, Injection site pain, Injection site swelling, Local swelling
Clinical narrative: Pt. reports raccoon mask on face that was on fire, neck, shoulders, and bilat. arms to the elbows swollen, tender, painful. Severe headaches and vomiting.
Age: 58.0
Sex: F
Vaccine: FLU3
Symptoms: Musculoskeletal pain, Neck pain, Oedema peripheral, Pain in extremity, Tenderness
Clinical narrative: Pt. reports raccoon mask on face that was on fire, neck, shoulders, and bilat. arms to the elbows swollen, tender, painful. Severe headaches and vomiting.
Age: 58.0
Sex: F
Vaccine: FLU3
Symptoms: Vomiting
Clinical narrative: Pt. reports raccoon mask on face that was on fire, neck, shoulders, and bilat. arms to the elbows swollen, tender, painful. Severe headaches and vomiting.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Oedema peripheral, Pruritus
Clinical narrative: Noticed on 9/17/11 (R) arm itchy, red, swollen. No c/o pain.
Age: 30.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Cellulitis, Injection site discomfort, Injection site erythema
Clinical narrative: 9-10-11 Developed redness, discomfort at injection site (L) deltoid. Clindamycin 150 1 PO TID x 7 days. Dx cellulitis.
Age: 26.0
Sex: F
Vaccine: TDAP, FLU3, PPV
Symptoms: Headache, Injection site pain, Injection site rash, Injection site swelling, Pain
Clinical narrative: Onset of severe HA with body ache; approx 24 hours post vaccination followed by soreness, swelling, red bumps at injection site. Itchy rash spread down (R) arm and across chest over next few hours. One or two itchy spots on face, mainly arms & trunk. Rash consists of small "prickly pimples", not hives. Rash is improving, worse at night. Patient reports her mother told her, after, Tdap administered that she had a high fever (105) and a rash following dose #1 of DTaP at age 2 months. This history was unknown to patient at time of Tdap receipt.
Age: 26.0
Sex: F
Vaccine: TDAP, FLU3, PPV
Symptoms: Rash, Rash pruritic
Clinical narrative: Onset of severe HA with body ache; approx 24 hours post vaccination followed by soreness, swelling, red bumps at injection site. Itchy rash spread down (R) arm and across chest over next few hours. One or two itchy spots on face, mainly arms & trunk. Rash consists of small "prickly pimples", not hives. Rash is improving, worse at night. Patient reports her mother told her, after, Tdap administered that she had a high fever (105) and a rash following dose #1 of DTaP at age 2 months. This history was unknown to patient at time of Tdap receipt.
Age: 26.0
Sex: F
Vaccine: TDAP, FLU3, PPV
Symptoms: Discomfort, Erythema, Injection site urticaria, Malaise, Pain
Clinical narrative: Onset of severe HA with body ache; approx 24 hours post vaccination followed by soreness, swelling, red bumps at injection site. Itchy rash spread down (R) arm and across chest over next few hours. One or two itchy spots on face, mainly arms & trunk. Rash consists of small "prickly pimples", not hives. Rash is improving, worse at night. Patient reports her mother told her, after, Tdap administered that she had a high fever (105) and a rash following dose #1 of DTaP at age 2 months. This history was unknown to patient at time of Tdap receipt.
Age: 26.0
Sex: F
Vaccine: TDAP, FLU3, PPV
Symptoms: Urticaria
Clinical narrative: Onset of severe HA with body ache; approx 24 hours post vaccination followed by soreness, swelling, red bumps at injection site. Itchy rash spread down (R) arm and across chest over next few hours. One or two itchy spots on face, mainly arms & trunk. Rash consists of small "prickly pimples", not hives. Rash is improving, worse at night. Patient reports her mother told her, after, Tdap administered that she had a high fever (105) and a rash following dose #1 of DTaP at age 2 months. This history was unknown to patient at time of Tdap receipt.
Age: 45.0
Sex: F
Vaccine: HEP
Symptoms: Injection site pain, Injection site swelling, Joint range of motion decreased, X-ray limb normal
Clinical narrative: Swelling and pain in (L) upper arm x 2 weeks, then swelling resolved but pain never went away. It is unchanged. PT attempted - 7 sessions, ROM of LUE improved but the pain is unchanged.
Age: 0.53
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Insomnia, Irritability
Clinical narrative: Fussy, irritable, not sleeping since vaccines. Tx: symptomatic tx.
Age: 32.0
Sex: F
Vaccine: FLU3
Symptoms: Needle issue, Thrombosis
Clinical narrative: Patient said needle got stuck in her arm, and RPH had a hard time getting it out. Now patient says she has blood clot in her arm 2 week later.
Age: 14.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Blood test, Computerised tomogram, Convulsion
Clinical narrative: Information has been received from a consumer concerning her 14 year old daughter with no pertinent medical history and drug reactions/allergies who on 01-AUG-2011 was vaccinated with the first dose of GARDASIL subcutaneously. Concomitant therapy included SOLODYN. On 30-AUG-2011 (reported as 29 days after receiving the first shot) the patient had a seizure. The patient was taken to the hospital and released. Cat scan and blood work was performed (results not reported). The caller was following up with the patient's primary physician to decide if they would continue the therapy. It was also reported that the therapy with GARDASIL was not reintroduced. At the time of report, the patient was recovering. Follow up information has been received from a physician's office assistant who read from the patient's chart and stated that GARDASIL lot # was 669265/0181AA. The patient did not receive any concomitant vaccinations. Follow up information was also received from a medical assistant from the physician's office who stated that the patient did not have a family history of seizures. The medical assistant did not know if the patient was referred to a Neurologist. The medical assistant stated that the physician had documented that she had spoken to the patient's mother and explained that the patient would not receive anymore doses of GARDASIL. The patient would resume her other scheduled vaccinations excluding GARDASIL. Upon internal review, seizure was determined to be an other important medical event. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Grand mal convulsion
Clinical narrative: Information has been received from a consumer concerning her 14 year old daughter with no pertinent medical history and drug reactions/allergies who on 01-AUG-2011 was vaccinated with the first dose of GARDASIL subcutaneously. Concomitant therapy included SOLODYN. On 30-AUG-2011 (reported as 29 days after receiving the first shot) the patient had a seizure. The patient was taken to the hospital and released. Cat scan and blood work was performed (results not reported). The caller was following up with the patient's primary physician to decide if they would continue the therapy. It was also reported that the therapy with GARDASIL was not reintroduced. At the time of report, the patient was recovering. Follow up information has been received from a physician's office assistant who read from the patient's chart and stated that GARDASIL lot # was 669265/0181AA. The patient did not receive any concomitant vaccinations. Follow up information was also received from a medical assistant from the physician's office who stated that the patient did not have a family history of seizures. The medical assistant did not know if the patient was referred to a Neurologist. The medical assistant stated that the physician had documented that she had spoken to the patient's mother and explained that the patient would not receive anymore doses of GARDASIL. The patient would resume her other scheduled vaccinations excluding GARDASIL. Upon internal review, seizure was determined to be an other important medical event. Additional information has been requested.
Sex: M
Vaccine: HPV4
Symptoms: Deafness unilateral
Clinical narrative: Information has been received from a physician's assistant concerning a male patient who on 05-SEP-2011 was intramuscularly vaccinated with the 0.5 mL first dose of GARDASIL (Lot # and expiration not reported). It was reported that on 07-SEP-2011 the patient experienced loss of hearing in left ear. The patient sought medical attention by an office visit to ear, nose and throat physician. Therapy with GARDASIL was discontinued. At the time of reporting the patient had not recovered. Upon internal review, loss of hearing in left ear was determined to be an other medical important event. Additional information has been requested.
Age: 72.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Breast cancer female, Injection site warmth
Clinical narrative: Information has been received from a pharmacist concerning a 72 year old female patient who on 09-SEP-2011, was vaccinated with a dose of ZOSTAVAX (Merck) (Lot # not provided) in her right upper deltoid. Secondary suspect vaccinations received at the same time included AFLURIA (manufacturer unspecified). On an unreported date, the patient experienced warmth at the injection site. It was reported that the patient was recently diagnosed with breast cancer and had not started any form of treatment at the time of this report. Upon internal review, breast cancer was determined to be an other important medical event. The patient's outcome was not reported. Additional information has been requested.
Age: 89.0
Sex: F
Vaccine: FLU3
Symptoms: Blood pressure increased, Dizziness
Clinical narrative: Increased elevated blood pressure and light headedness.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Laboratory test, Pain, Pruritus, Renal failure
Clinical narrative: Information has been received from a registered nurse concerning herself a 73 year old female with no allergies, Zollinger-Ellison syndrome, osteoarthritis, gout, high blood pressure and a history of knee operation (date unspecified) who "sometime in the last month to 6 weeks" (in approximately July 2011), was vaccinated with a dose of ZOSTAVAX (Merck) (dose, route and lot number were not reported). Concomitant therapy included hydrocodone, atenolol, allopurinol and COUMADIN. "About a week ago" (on approximately 02-SEP-2011), the patient developed blisters on the back side of her right arm above her elbow in a circular pattern. It itches, burns and she felt it all the time painful. On an unknown date, the nurse was taking CELEBREX a while back there and went into third stage kidney failure, the nurse stated that she had not been taking CELEBREX any more and was not taking it when she received ZOSTAVAX (Merck). The patient did not seek medical attention. The patient did not receive any treatment for the events. "A whole battery of every thing" laboratories were performed no results were provided. At the time of the report the patient had not recovered. Upon internal review, went into third stage kidney failure was determined to be an other important medical event. Additional information has been requested.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Skin burning sensation
Clinical narrative: Information has been received from a registered nurse concerning herself a 73 year old female with no allergies, Zollinger-Ellison syndrome, osteoarthritis, gout, high blood pressure and a history of knee operation (date unspecified) who "sometime in the last month to 6 weeks" (in approximately July 2011), was vaccinated with a dose of ZOSTAVAX (Merck) (dose, route and lot number were not reported). Concomitant therapy included hydrocodone, atenolol, allopurinol and COUMADIN. "About a week ago" (on approximately 02-SEP-2011), the patient developed blisters on the back side of her right arm above her elbow in a circular pattern. It itches, burns and she felt it all the time painful. On an unknown date, the nurse was taking CELEBREX a while back there and went into third stage kidney failure, the nurse stated that she had not been taking CELEBREX any more and was not taking it when she received ZOSTAVAX (Merck). The patient did not seek medical attention. The patient did not receive any treatment for the events. "A whole battery of every thing" laboratories were performed no results were provided. At the time of the report the patient had not recovered. Upon internal review, went into third stage kidney failure was determined to be an other important medical event. Additional information has been requested.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity, Paraesthesia
Clinical narrative: Pain down arm to elbow, tingling in 3 fingers on Lt hand. (Pain started 2 days after injection) (tingling started on 9/15/11 - 8 days after injection).
Age: 75.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Neck pain, Pain, Vision blurred
Clinical narrative: Shooting pain in neck. Light headedness. Blurry vision.