chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 4.0
Sex: M
Vaccine: DTAP, HEPA, IPV, MMRV
Symptoms: Abdominal pain, Urticaria
Clinical narrative: Patient received vaccines @ approx 4:45pm. Mom walked out side with patient @ 5pm and walked back in immediately requesting assistance stating something is wrong with her son. Symptoms included Itching, Generalized urticaria (rash,welts) and complaint of abdominal pain.
Age: 37.0
Sex: F
Vaccine: TDAP
Symptoms: Cold compress therapy, Hypokinesia, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Client received Tdap (Adacel) on April 24, 2007.  Her arm started to become sore that evening.  Next morning, April 25, 2007, states, she "could hardly move".  Client worked that day, and took Motrin 800 mg. TID. April 26, 2006, client states she felt the same way as she did on April 25.  Her arm had begun to swell, was hot to touch, and she was very uncomfortable.  States the swelling was "pretty large and had a lump" under the skin.  Worked this day.  Placed ice on the injection site that night.  April 27, 2007 client states arem was still hurting.  She took Motrin 800 mg. TID, applied ice to the are during the morning and evening, worked entire day.  April 28 & 29, 2007, arm remained swollen but was starting to cool.  She remained uncomfortable and was unable to sleep.  April 27, 28, & 29, 2007 the shot site began to itch.  April 30, 2007 client went to doctor.  Arm was warm to touch but not hot, remained slightly swollen.  Physician instructed client to apply ice to area QID.  Was also given Dexamethasome 1.5 mg. titrated dosage (6 pills Monday, 3 pills Tuesday, 1 pill Wednesday, 1 pill Thursday).  May 3, 2007 Client states she is feeling better, pain and swelling have resolved, she is applying ice to area PRN.
Age: 37.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site warmth, Insomnia
Clinical narrative: Client received Tdap (Adacel) on April 24, 2007.  Her arm started to become sore that evening.  Next morning, April 25, 2007, states, she "could hardly move".  Client worked that day, and took Motrin 800 mg. TID. April 26, 2006, client states she felt the same way as she did on April 25.  Her arm had begun to swell, was hot to touch, and she was very uncomfortable.  States the swelling was "pretty large and had a lump" under the skin.  Worked this day.  Placed ice on the injection site that night.  April 27, 2007 client states arem was still hurting.  She took Motrin 800 mg. TID, applied ice to the are during the morning and evening, worked entire day.  April 28 & 29, 2007, arm remained swollen but was starting to cool.  She remained uncomfortable and was unable to sleep.  April 27, 28, & 29, 2007 the shot site began to itch.  April 30, 2007 client went to doctor.  Arm was warm to touch but not hot, remained slightly swollen.  Physician instructed client to apply ice to area QID.  Was also given Dexamethasome 1.5 mg. titrated dosage (6 pills Monday, 3 pills Tuesday, 1 pill Wednesday, 1 pill Thursday).  May 3, 2007 Client states she is feeling better, pain and swelling have resolved, she is applying ice to area PRN.
Sex: U
Vaccine: HEPA
Symptoms: Pruritus, Rash generalised
Clinical narrative: rash/itching started approx 24 hours ago, initially involving abdomen, extending to genetalia & lower extremities. Currently resolving. Treatment: Benadryl
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMRV
Symptoms: Cold compress therapy, Full blood count, Heat therapy, Injection site erythema, Injection site swelling
Clinical narrative: Recieved Dtap and IPV vaccinations to Right arm. On 5/3/07 mother reported arm swollen at injection site without redness. On 5/4/07 presented at clinic with redness,warmth, and swelling from injection site to elbow area. Afebrile. Prescribed Keflex 250 mg/tsp one tsp p.o. b.i.d. for ten days and warm/ice pack prn. To go to E.R. if symptoms worsen or new ones develop.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMRV
Symptoms: Injection site warmth
Clinical narrative: Recieved Dtap and IPV vaccinations to Right arm. On 5/3/07 mother reported arm swollen at injection site without redness. On 5/4/07 presented at clinic with redness,warmth, and swelling from injection site to elbow area. Afebrile. Prescribed Keflex 250 mg/tsp one tsp p.o. b.i.d. for ten days and warm/ice pack prn. To go to E.R. if symptoms worsen or new ones develop.
Age: 5.0
Sex: F
Vaccine: DT, HEPA, IPV, VARCEL
Symptoms: Eye rolling, Hypotonia, Pallor, Skin warm, Tonic clonic movements
Clinical narrative: Dtap #5, IPV# 4, Hep A #2 were administered followed by Varicella #2. Immediately following Varicella administration, patient became limp, unreponsive, eyes rolled back, tonic/clonic movements lasting about 30 seconds. Patient recovered and was oriented X3, color was pale and was warm to touch. EMS notified, patient evaluated by first responders. Mother elected to not transport via ambulance. Mother took child to Emergency Room. Discharged with not significant findings. Appointment scheduled with pediatrician in one week.
Age: 5.0
Sex: F
Vaccine: DT, HEPA, IPV, VARCEL
Symptoms: Unresponsive to stimuli
Clinical narrative: Dtap #5, IPV# 4, Hep A #2 were administered followed by Varicella #2. Immediately following Varicella administration, patient became limp, unreponsive, eyes rolled back, tonic/clonic movements lasting about 30 seconds. Patient recovered and was oriented X3, color was pale and was warm to touch. EMS notified, patient evaluated by first responders. Mother elected to not transport via ambulance. Mother took child to Emergency Room. Discharged with not significant findings. Appointment scheduled with pediatrician in one week.
Age: 28.0
Sex: F
Vaccine: TDAP
Symptoms: C-reactive protein, Chills, Disturbance in attention, Hypokinesia, Influenza like illness
Clinical narrative: Received the Tdap vaccine in my left arm on Friday 4/6/07.  Had flu -like symptoms on Saturday and Sunday (Achy, fever, chills) and sore arm muscles around injection site.  On Monday 4/9/07, I woke up with severe left shoulder girdle pain and a marked decrease in range of motion of that shoulder.  The injection site was never red or inflammed.  I saw Dr. on Wednesday 4/11/07 who gave me a sling to wear for 10 days and prescribed Indomethicin and Darvocet for the pain and inflammation, as I was having trouble sleeping and concentrating during the day and could not use my arm without severe shoulder pain.  Started Physical Therapy on 4/24.  Got a second opinion from Dr. who is strongly suspicious of an autoimmune reaction to the vaccine that led caused marked stiffening of my left shoulder.
Age: 28.0
Sex: F
Vaccine: TDAP
Symptoms: Injected limb mobility decreased, Injection site pain, Insomnia, Joint range of motion decreased, Musculoskeletal pain
Clinical narrative: Received the Tdap vaccine in my left arm on Friday 4/6/07.  Had flu -like symptoms on Saturday and Sunday (Achy, fever, chills) and sore arm muscles around injection site.  On Monday 4/9/07, I woke up with severe left shoulder girdle pain and a marked decrease in range of motion of that shoulder.  The injection site was never red or inflammed.  I saw Dr. on Wednesday 4/11/07 who gave me a sling to wear for 10 days and prescribed Indomethicin and Darvocet for the pain and inflammation, as I was having trouble sleeping and concentrating during the day and could not use my arm without severe shoulder pain.  Started Physical Therapy on 4/24.  Got a second opinion from Dr. who is strongly suspicious of an autoimmune reaction to the vaccine that led caused marked stiffening of my left shoulder.
Age: 28.0
Sex: F
Vaccine: TDAP
Symptoms: Musculoskeletal stiffness, Pain, Pyrexia, Red blood cell sedimentation rate, Vaccination complication
Clinical narrative: Received the Tdap vaccine in my left arm on Friday 4/6/07.  Had flu -like symptoms on Saturday and Sunday (Achy, fever, chills) and sore arm muscles around injection site.  On Monday 4/9/07, I woke up with severe left shoulder girdle pain and a marked decrease in range of motion of that shoulder.  The injection site was never red or inflammed.  I saw Dr. on Wednesday 4/11/07 who gave me a sling to wear for 10 days and prescribed Indomethicin and Darvocet for the pain and inflammation, as I was having trouble sleeping and concentrating during the day and could not use my arm without severe shoulder pain.  Started Physical Therapy on 4/24.  Got a second opinion from Dr. who is strongly suspicious of an autoimmune reaction to the vaccine that led caused marked stiffening of my left shoulder.
Age: 0.2
Sex: F
Vaccine: RV5
Symptoms: Diarrhoea, Melaena, Occult blood positive, Vomiting
Clinical narrative: 2 Days of vomiting 0and diarrhea with some melena. This was 1st, and only, dose of Rotateq.
Age: 1.17
Sex: F
Vaccine: HEPA, MMRV, PNC
Symptoms: Injection site erythema, Injection site induration, Injection site nodule, Injection site pain
Clinical narrative: (+) 8.5X5cm indurated erythematous nodule left thigh slightly tender.
Age: 4.0
Sex: M
Vaccine: DTAP, HEPA, IPV, MMRV
Symptoms: Injection site swelling
Clinical narrative: Left thigh swollen at the sight where the injection was given.
Age: 1.1
Sex: F
Vaccine: HEPA, HIBV, MMRV
Symptoms: Body temperature increased, Lymphocyte count increased, Rash, White blood cell count abnormal
Clinical narrative: 5-01-07 Bumps on face, worst that evening, spread to neck, chest, back, buttocks, legs, behind ears. 5-02-07 Spread to scalp, palms of hands and feet. Saw physician - Blood test showed, increase lymphocytes. Augmentin administered April 25-May 01 for bilateral ear infection diagnosed April 25. Temp 101.8 (April 25).
Age: 18.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Lymphadenopathy, White blood cell count increased
Clinical narrative: Gardasil given 2/27/07 developed lymphadenopathy (L) neck w/in 2 wks of vaccine.
Age: 18.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Chest X-ray normal, Full blood count, Lymphadenopathy, White blood cell count increased
Clinical narrative: Gardasil given 2/27/07 developed lymphadenopathy (L) neck w/in 2 wks of vaccine.
Sex: U
Vaccine: FLU3
Symptoms: Injection site reaction, Nausea, Pain, Vomiting
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of injection site reaction in a subject of unspecified age and gender who was vaccinated with Flulaval for prophylaxis. On an unspecified date the subject received unspecified dose of Flulaval (unknown). At an unspecified time after vaccination with Flulaval, the subject experienced injection site reaction, nausea, vomiting and pain. At the time of reporting the outcome of the events was unspecified. The reporter is a wholesaler and a clinic reported to him that every staff member received Flulaval and each person experienced an event. The reporter had limited information. He thought that the Flulaval was all the same lot number.
Age: 42.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site pain, Nausea, Pain, Pharmaceutical product complaint, Pyrexia
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of injection site pain in a 42 year old male subject who was vaccinated with influenza virus vaccine (Flulaval) for prophylaxis. There was no concurrent medications or relevant medical history. The subject had received influenza vaccination previously and had not experienced any adverse events. On an unspecified date between December 2006 and early January 2007, the subject received an unspecified dose of Flulaval (0.5 ml, unknown, right arm). At an unspecified time after vaccination with Flulaval, the subject experienced severe pain at injection site, nausea, fever, aches and pain, and pharmaceutical product complaint. The subject consulted with his healthcare provider as a result of the events. The events lasted for three days. The reporter indicated that there were approximately six other patients who received the same lot of Flulaval who experienced the same adverse events. The reporter requested a credit for the remaining 86 Flulaval vials he had in stock, which were from the same lot. At the time of reporting the outcome of the events were was unspecified.
Sex: U
Vaccine: FLU3
Symptoms: Injection site pain, Pain, Pharmaceutical product complaint, Pyrexia
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of injection site pain in a subject of unspecified age and gender who was vaccinated with Flulaval for prophylaxis. On an unspecified date, on or prior to 05 February 2007, the subject received an unspecified dose of Flulaval. At an unspecified time after vaccination with Flulaval, the subject experienced severe pain at injections site, nausea, fever, aches and pain, and pharmaceutical product complaint. The events lasted for three days. The reporter indicated that there were approximately six other patients who
Sex: U
Vaccine: FLU3
Symptoms: Injection site pain, Nausea, Pain, Pharmaceutical product complaint, Pyrexia
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of injection site pain in a subject of unspecified age and gender who was vaccinated with Flulaval for prophylaxis. On an unspecified date on or prior to 05 February 2007, the subject received an unspecified dose of Flulaval. At an unspecified time after vaccination with Flulaval, the subject experienced severe pain at injection site, nausea, fever, aches and, and pharmaceutical product complaint. The reporter indicated that there were approximately six other patients who received the same lot of Flulaval who experienced the same adverse events. The reporter requested a credit for the remaining 86 Flulaval vials he had in stock, which were from the same lot. At the time of reporting the outcome of the events were was unspecified.
Sex: U
Vaccine: FLU3
Symptoms: Injection site pain, Nausea, Pain, Pharmaceutical product complaint, Pyrexia
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of injection site pain in a subject of unspecified age and gender who was vaccinated with Flulaval for prophylaxis. On an unspecified date on or prior to 05 February 2007, the subject received an unspecified dose of Flulaval. At an unspecified time after vaccination with Flulaval, the subject experienced severe pain at injection site, nausea, fever, aches and pain, and pharmaceutical product complaint. The reporter indicated that there were approximately six other patients who received the same lot of Flulaval who experienced the same adverse events. The reporter requested a credit for the remaining 86 Flulaval vials he had in stock, which were from the same lot. At the time of reporting the outcome of the events were as unspecified.
Sex: U
Vaccine: FLU3
Symptoms: Injection site pain, Nausea, Pain, Pharmaceutical product complaint, Pyrexia
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of injection site pain in a subject of unspecified age and gender who was vaccinated with Flulaval for prophylaxis. On an unspecified date on or prior to 05 February 2007, the subject received an unspecified dose of Flulaval. At an unspecified time after vaccination with Flulaval, the subject experienced severe pain at injection site, nausea, fever, aches and pain, and pharmaceutical product complaint. The reporter indicated that there were approximately six other patients who received the same lot of Flulaval who experienced the same adverse events. The reporter requested a credit for the remaining 86 Flulaval vials he had in stock, which were from the same lot. At the time of reporting the outcome of the events were was unspecified.
Sex: U
Vaccine: FLU3
Symptoms: Injection site pain, Nausea, Pain, Pharmaceutical product complaint, Pyrexia
Clinical narrative: This case was reported by a healthcare profession and described the occurrence of injection site pain in a subject of unknown age and gender who was vaccinated with Flulaval for prophylaxis. On an unspecified date on or prior to 05 February 2007, the subject received an unspecified dose of Flulaval. At an unspecified time after vaccination with Flulaval, the subject experienced severe pain at injection site, nausea, fever, aches and pain, and pharmaceutical product compliant. The reporter indicated that there were approximately six other patients who received the same lot of Flulaval who experienced the same adverse events. The reporter requested a credit for the remaining 86 Flulaval vials he had in stock, which were from the same lot. At the time of reporting the outcome of the events were was unspecified.
Sex: U
Vaccine: FLU3
Symptoms: Injection site pain, Nausea, Pain, Pyrexia
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of injection site pain in a subject of unknown age and gender who was vaccinated with Flulaval for prophylaxis. On an unspecified date on or prior to 05 February 2007, the subject received an unspecified dose of Flulaval. At an unspecified time after vaccination with Flulaval, the subject experienced severe pain at injection site, nausea, fever, aches and pain, and pharmaceutical product complaint. The reporter indicated that there were approximately six other patients who received the same lot of Flulaval who experienced the same adverse events. The reporter requested a credit for the remaining 86 Flulaval vials he had in stock, which were from the same lot. At the time of reporting the outcome of the events were was unspecified.
Age: 0.17
Sex: M
Vaccine: DTAP, HBHEPB, IPV, PNC, RV5
Symptoms: Diarrhoea, Faeces discoloured
Clinical narrative: Green foul-smelling diarrhea. Started 5/2/04, no treatment was necessary lasted through 5/4/07
Age: 38.0
Sex: F
Vaccine: ANTH
Symptoms: Erythema, Lymphadenopathy, Skin lesion
Clinical narrative: (L) triceps region 3x3cm erythema lesion noted (L) axillary lymphadenopathy. Previous Anthrax: 30Jan03/14Mar03
Age: 34.0
Sex: M
Vaccine: RAB
Symptoms: Influenza like illness, Nausea, Pain, Sluggishness, Vomiting
Clinical narrative: Vomiting and nauseated, sluggish, unable to go to work for 1 day. (3-27-07, 3-28-07), Body aches, Flu-type symptoms.
Age: 1.08
Sex: F
Vaccine: MMR, PNC, VARCEL
Symptoms: Pyrexia, Rash
Clinical narrative: Fever and Rash-(torso and back) approx 10 days after MMR vaccine given
Age: 4.0
Sex: M
Vaccine: DTAP, IPV
Symptoms: Injection site nodule, Injection site rash
Clinical narrative: mother called states child had dime-sized circumference and a little raised knot on (L) arm IM injection site with solid red rash down to elbow
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Asthenia, Nausea
Clinical narrative: 4-24-07 9:10 am PC from client, states she felt nauseated about 1 hr after receiving Gardasil. Today she states she continues to feel very weak-advised to see PMD or ER. 12:30pm PC from client states she cancelled DR appt because she felt better after lunch
Age: 5.0
Sex: F
Vaccine: DTAP, IPV
Symptoms: Injection site erythema, Injection site swelling, Lethargy, Vomiting
Clinical narrative: Red swollen arm w/i 24 hours. Seen 11 AM:      1" induration 3" redness at site of shot ,      lethargic, then vomited 1PM 5/5/07
Age: 21.0
Sex: M
Vaccine: ANTH, FLUX, HEP, SMALL, TYP
Symptoms: Arthralgia, Myalgia, Rash
Clinical narrative: Muscle pain, joint pain, unexplained rashes.
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Anorexia, Insomnia, Irritability, Middle ear effusion, Nasal congestion
Clinical narrative: Fever 2 days later of constant 102 degrees. Lasted for 5 days. Conjestion, runny nose, lost of appetite, vomiting, fussiness, insomnia. Used motrin to control fever.
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Pyrexia, Rhinorrhoea, Vomiting
Clinical narrative: Fever 2 days later of constant 102 degrees. Lasted for 5 days. Conjestion, runny nose, lost of appetite, vomiting, fussiness, insomnia. Used motrin to control fever.
Age: 30.0
Sex: F
Vaccine: TD
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Pyrexia
Clinical narrative: Initial report received on 14 October 2006 from a health care professional. A 30-year-old female patient, who has finger laceration, had received a right deltoid, intra-muscular injection of Decavac, lot number U1880CA, on 10 October 2006 at 17:28 pm. The afternoon of the next day, the patient experienced erythema, tenderness, and induration of the right deltoid and lateral upper arm. She also had a fever of 102.9 degrees Fahrenheit over four days. The patient required medical evaluation but diagnostic and treatments received were not reported. At the time of this report, the recovery status of the patient was unknown.
Age: 87.0
Sex: M
Vaccine: TDAP
Symptoms: Allergy to vaccine, Cellulitis, Erythema, Haematocrit decreased, Haemoglobin decreased
Clinical narrative: Initial report received from a health care professional, on 17 November 2006. An 87 year old male patient, received 03 November 2006, Adacel (lot number C2609AA), into the left deltoid (dose and route of administration not reported). On 04 November 2006, a day after vaccination, the patient experienced cellulitis (severe) and needed Emergency Room. Doctor (ER, DR) visit. The patient was given Leverquin and Elocom. The patient had recovered. On 18 October 2006, the patient had received influenza vaccine (lot number 71211) into the left deltoid. It was his yearly vaccination. The patient did not receive Adacel before. The patient medical history included: Peripheral Vascular Disease surgery (PND), Myocardial Infarction (MI), Hypertension (HTN), Arthritis, Gout, Non-Hodgkin's lymphoma, Hyperlipidemia, Spinal stenosis. The patient received multiple concomitant medications. Follow-up information received on 23 April 2007 from a healthcare professional. The patient, who had a history or Non-Hodgkin's lymphoma, had received a first dose, right deltoid injection of Adacel on 03 November 2006. The day following the vaccination, the family called the physician and reported that the patient was experiencing "arm swelling down to the wrist, red, itchy, hot." The patient experienced no lymphadenopathy. The patient was subsequently examined in an emergency room, on 06 November 2006, and given a clinical diagnosis of allergic reaction to injection and cellulitis. The emergency room record noted "right upper arm warm, red, and edematous." Right upper extremity venous doppler impression was a normal right arm venous ultrasound. WBC was 76.3 with a reported baseline of 68. The patient was treated with Levaquin and Benadryl. The exact duration of the event was from 04 November 2006 to 08 November 2006. Impression on the clinic note of 08 November 2006 was: "cellulitis resolved, swelling and pink may be secondary to edema going down due to gravity, inflammation better, history of non-Hodgkin's lymphoma, and pharyngitis." The patient was to have a follow-up CBC drawn and return for a recheck "next week." Per the reporter, the patient did not experience an adverse event to the influenza vaccination that was administered in the left deltoid, and the contents of the vial were not cultured. Past medical history included: carotid stenosis, azotemia, decreased albumin, musculoskeletal back pain, decreased visual acuity, GERD, arthritis, atrial fibrillation, pneumonia, pedal edema, depression, heart stent, decreased hearing acuity, leukemia, cholelithiasis, subdural hematoma, esophagitis, and pharyngitis.
Age: 87.0
Sex: M
Vaccine: TDAP
Symptoms: Medication error, Oedema peripheral, Platelet count normal, Pruritus, Skin warm
Clinical narrative: Initial report received from a health care professional, on 17 November 2006. An 87 year old male patient, received 03 November 2006, Adacel (lot number C2609AA), into the left deltoid (dose and route of administration not reported). On 04 November 2006, a day after vaccination, the patient experienced cellulitis (severe) and needed Emergency Room. Doctor (ER, DR) visit. The patient was given Leverquin and Elocom. The patient had recovered. On 18 October 2006, the patient had received influenza vaccine (lot number 71211) into the left deltoid. It was his yearly vaccination. The patient did not receive Adacel before. The patient medical history included: Peripheral Vascular Disease surgery (PND), Myocardial Infarction (MI), Hypertension (HTN), Arthritis, Gout, Non-Hodgkin's lymphoma, Hyperlipidemia, Spinal stenosis. The patient received multiple concomitant medications. Follow-up information received on 23 April 2007 from a healthcare professional. The patient, who had a history or Non-Hodgkin's lymphoma, had received a first dose, right deltoid injection of Adacel on 03 November 2006. The day following the vaccination, the family called the physician and reported that the patient was experiencing "arm swelling down to the wrist, red, itchy, hot." The patient experienced no lymphadenopathy. The patient was subsequently examined in an emergency room, on 06 November 2006, and given a clinical diagnosis of allergic reaction to injection and cellulitis. The emergency room record noted "right upper arm warm, red, and edematous." Right upper extremity venous doppler impression was a normal right arm venous ultrasound. WBC was 76.3 with a reported baseline of 68. The patient was treated with Levaquin and Benadryl. The exact duration of the event was from 04 November 2006 to 08 November 2006. Impression on the clinic note of 08 November 2006 was: "cellulitis resolved, swelling and pink may be secondary to edema going down due to gravity, inflammation better, history of non-Hodgkin's lymphoma, and pharyngitis." The patient was to have a follow-up CBC drawn and return for a recheck "next week." Per the reporter, the patient did not experience an adverse event to the influenza vaccination that was administered in the left deltoid, and the contents of the vial were not cultured. Past medical history included: carotid stenosis, azotemia, decreased albumin, musculoskeletal back pain, decreased visual acuity, GERD, arthritis, atrial fibrillation, pneumonia, pedal edema, depression, heart stent, decreased hearing acuity, leukemia, cholelithiasis, subdural hematoma, esophagitis, and pharyngitis.
Age: 87.0
Sex: M
Vaccine: TDAP
Symptoms: Ultrasound Doppler, White blood cell count increased
Clinical narrative: Initial report received from a health care professional, on 17 November 2006. An 87 year old male patient, received 03 November 2006, Adacel (lot number C2609AA), into the left deltoid (dose and route of administration not reported). On 04 November 2006, a day after vaccination, the patient experienced cellulitis (severe) and needed Emergency Room. Doctor (ER, DR) visit. The patient was given Leverquin and Elocom. The patient had recovered. On 18 October 2006, the patient had received influenza vaccine (lot number 71211) into the left deltoid. It was his yearly vaccination. The patient did not receive Adacel before. The patient medical history included: Peripheral Vascular Disease surgery (PND), Myocardial Infarction (MI), Hypertension (HTN), Arthritis, Gout, Non-Hodgkin's lymphoma, Hyperlipidemia, Spinal stenosis. The patient received multiple concomitant medications. Follow-up information received on 23 April 2007 from a healthcare professional. The patient, who had a history or Non-Hodgkin's lymphoma, had received a first dose, right deltoid injection of Adacel on 03 November 2006. The day following the vaccination, the family called the physician and reported that the patient was experiencing "arm swelling down to the wrist, red, itchy, hot." The patient experienced no lymphadenopathy. The patient was subsequently examined in an emergency room, on 06 November 2006, and given a clinical diagnosis of allergic reaction to injection and cellulitis. The emergency room record noted "right upper arm warm, red, and edematous." Right upper extremity venous doppler impression was a normal right arm venous ultrasound. WBC was 76.3 with a reported baseline of 68. The patient was treated with Levaquin and Benadryl. The exact duration of the event was from 04 November 2006 to 08 November 2006. Impression on the clinic note of 08 November 2006 was: "cellulitis resolved, swelling and pink may be secondary to edema going down due to gravity, inflammation better, history of non-Hodgkin's lymphoma, and pharyngitis." The patient was to have a follow-up CBC drawn and return for a recheck "next week." Per the reporter, the patient did not experience an adverse event to the influenza vaccination that was administered in the left deltoid, and the contents of the vial were not cultured. Past medical history included: carotid stenosis, azotemia, decreased albumin, musculoskeletal back pain, decreased visual acuity, GERD, arthritis, atrial fibrillation, pneumonia, pedal edema, depression, heart stent, decreased hearing acuity, leukemia, cholelithiasis, subdural hematoma, esophagitis, and pharyngitis.
Age: 39.0
Sex: F
Vaccine: TD
Symptoms: Injection site erythema, Pain in extremity
Clinical narrative: Initial report received from a health care professional in the USA on 18 December 2006. A 39 year old, female patient (with a history of allergy to PCN) developed minimal redness at the injection site and pain with movement of the right arm/shoulder after she received an injection of Decavac (lot numbers U1738AA) intramuscularly in the right deltoid on 12 December 2006. At the time of vaccination, she had cat scratches to her face. It was unknown if the patient recovered. Follow-up information received on 16 January 2007 from a health care professional. The reporter spoke with the patient, who stated that she is "70 percent" better, but she still cannot lift heavy objects. She is having trouble using her right arm and hand, mainly with "extension and lifting" . The redness has resolved. The reporter noted that the events were a "reaction to tetanus injection". The patient has not recovered.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMRV, DTAP, IPV, MMRV, DTAP, IPV, MMRV
Symptoms: Depressed level of consciousness, Eye swelling, Lethargy, Ocular hyperaemia
Clinical narrative: This case was received from another manufacturer (reference number WAES0701USA04388) on 26 April 2007. The following information is verbatim as it appears in the other manufacturer's report: "This is a follow-up report(s) previously submitted on 1/31/2007. Information has been received from a registered nurse concerning a 4 year old male with no allergies or medical history but was noted to be undergoing evaluation for autism and developmental delay who on 22-JAN-2007 at 11:30 AM was vaccinated SC in the right arm with a 0.5 mL second dose of Proquad (lot # 655752/1122F). Suspect vaccination at the same time included an IM sixth dose in the right arm of TRIPEDIA (lot # U1813AB) and an IM fifth dose in the left arm of IPOL (lot # Y0576). There was no other concomitant medication. There was no illness at the time of vaccination. On 22-JAN-2007, within one hour, the patient's eyes were pink and swollen. He was given BENADRYL 12.5 mg orally. Ten minutes later he was lethargic and unresponsive. He was given EPI-PEN and was observed for four hours in the emergency room. It was noted that previous vaccinations with PROQUAD, TRIPEDIA, and a dose of IPOL were well tolerated with no adverse symptoms. Subsequently, the patient recovered. He was scheduled to be at a clinic in a hospital on 24-JAN-2007. No diagnostic laboratory tests were performed. A product quality complaint was not involved. Additional information was received from the registered nurse who reported that the patient received the vaccinations as part of his four year annual physical exam. He was discharged and returned about one hour (walk in) with the mother stating that his eyes were red and puffy. He was seen immediately by a nurse practitioner. There was minimal redness and swelling of eyes and otherwise, was a negative exam. He was given BENADRYL 12.5 mg orally and observed. After 10 minutes he became lethargic and less responsive. Upon exam by a physical, he was administered epinephrine and taken to the emergency department. He was observed for four hours without further intervention and then discharged. He had no symptoms at discharged and was considered recovered. The patient's experience's were considered to be other important medical events by the reporter. No further information is expected."
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMRV, DTAP, IPV, MMRV, DTAP, IPV, MMRV
Symptoms: Eye swelling, Lethargy, Ocular hyperaemia, Unresponsive to stimuli
Clinical narrative: This case was received from another manufacturer (reference number WAES0701USA04388) on 26 April 2007. The following information is verbatim as it appears in the other manufacturer's report: "This is a follow-up report(s) previously submitted on 1/31/2007. Information has been received from a registered nurse concerning a 4 year old male with no allergies or medical history but was noted to be undergoing evaluation for autism and developmental delay who on 22-JAN-2007 at 11:30 AM was vaccinated SC in the right arm with a 0.5 mL second dose of Proquad (lot # 655752/1122F). Suspect vaccination at the same time included an IM sixth dose in the right arm of TRIPEDIA (lot # U1813AB) and an IM fifth dose in the left arm of IPOL (lot # Y0576). There was no other concomitant medication. There was no illness at the time of vaccination. On 22-JAN-2007, within one hour, the patient's eyes were pink and swollen. He was given BENADRYL 12.5 mg orally. Ten minutes later he was lethargic and unresponsive. He was given EPI-PEN and was observed for four hours in the emergency room. It was noted that previous vaccinations with PROQUAD, TRIPEDIA, and a dose of IPOL were well tolerated with no adverse symptoms. Subsequently, the patient recovered. He was scheduled to be at a clinic in a hospital on 24-JAN-2007. No diagnostic laboratory tests were performed. A product quality complaint was not involved. Additional information was received from the registered nurse who reported that the patient received the vaccinations as part of his four year annual physical exam. He was discharged and returned about one hour (walk in) with the mother stating that his eyes were red and puffy. He was seen immediately by a nurse practitioner. There was minimal redness and swelling of eyes and otherwise, was a negative exam. He was given BENADRYL 12.5 mg orally and observed. After 10 minutes he became lethargic and less responsive. Upon exam by a physical, he was administered epinephrine and taken to the emergency department. He was observed for four hours without further intervention and then discharged. He had no symptoms at discharged and was considered recovered. The patient's experience's were considered to be other important medical events by the reporter. No further information is expected."
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMRV, DTAP, IPV, MMRV, DTAP, IPV, MMRV
Symptoms: Autism, Developmental delay, Eye swelling, Lethargy, No reaction on previous exposure to drug
Clinical narrative: This case was received from another manufacturer (reference number WAES0701USA04388) on 26 April 2007. The following information is verbatim as it appears in the other manufacturer's report: "This is a follow-up report(s) previously submitted on 1/31/2007. Information has been received from a registered nurse concerning a 4 year old male with no allergies or medical history but was noted to be undergoing evaluation for autism and developmental delay who on 22-JAN-2007 at 11:30 AM was vaccinated SC in the right arm with a 0.5 mL second dose of Proquad (lot # 655752/1122F). Suspect vaccination at the same time included an IM sixth dose in the right arm of TRIPEDIA (lot # U1813AB) and an IM fifth dose in the left arm of IPOL (lot # Y0576). There was no other concomitant medication. There was no illness at the time of vaccination. On 22-JAN-2007, within one hour, the patient's eyes were pink and swollen. He was given BENADRYL 12.5 mg orally. Ten minutes later he was lethargic and unresponsive. He was given EPI-PEN and was observed for four hours in the emergency room. It was noted that previous vaccinations with PROQUAD, TRIPEDIA, and a dose of IPOL were well tolerated with no adverse symptoms. Subsequently, the patient recovered. He was scheduled to be at a clinic in a hospital on 24-JAN-2007. No diagnostic laboratory tests were performed. A product quality complaint was not involved. Additional information was received from the registered nurse who reported that the patient received the vaccinations as part of his four year annual physical exam. He was discharged and returned about one hour (walk in) with the mother stating that his eyes were red and puffy. He was seen immediately by a nurse practitioner. There was minimal redness and swelling of eyes and otherwise, was a negative exam. He was given BENADRYL 12.5 mg orally and observed. After 10 minutes he became lethargic and less responsive. Upon exam by a physical, he was administered epinephrine and taken to the emergency department. He was observed for four hours without further intervention and then discharged. He had no symptoms at discharged and was considered recovered. The patient's experience's were considered to be other important medical events by the reporter. No further information is expected."
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMRV, DTAP, IPV, MMRV, DTAP, IPV, MMRV
Symptoms: Ocular hyperaemia, Unresponsive to stimuli
Clinical narrative: This case was received from another manufacturer (reference number WAES0701USA04388) on 26 April 2007. The following information is verbatim as it appears in the other manufacturer's report: "This is a follow-up report(s) previously submitted on 1/31/2007. Information has been received from a registered nurse concerning a 4 year old male with no allergies or medical history but was noted to be undergoing evaluation for autism and developmental delay who on 22-JAN-2007 at 11:30 AM was vaccinated SC in the right arm with a 0.5 mL second dose of Proquad (lot # 655752/1122F). Suspect vaccination at the same time included an IM sixth dose in the right arm of TRIPEDIA (lot # U1813AB) and an IM fifth dose in the left arm of IPOL (lot # Y0576). There was no other concomitant medication. There was no illness at the time of vaccination. On 22-JAN-2007, within one hour, the patient's eyes were pink and swollen. He was given BENADRYL 12.5 mg orally. Ten minutes later he was lethargic and unresponsive. He was given EPI-PEN and was observed for four hours in the emergency room. It was noted that previous vaccinations with PROQUAD, TRIPEDIA, and a dose of IPOL were well tolerated with no adverse symptoms. Subsequently, the patient recovered. He was scheduled to be at a clinic in a hospital on 24-JAN-2007. No diagnostic laboratory tests were performed. A product quality complaint was not involved. Additional information was received from the registered nurse who reported that the patient received the vaccinations as part of his four year annual physical exam. He was discharged and returned about one hour (walk in) with the mother stating that his eyes were red and puffy. He was seen immediately by a nurse practitioner. There was minimal redness and swelling of eyes and otherwise, was a negative exam. He was given BENADRYL 12.5 mg orally and observed. After 10 minutes he became lethargic and less responsive. Upon exam by a physical, he was administered epinephrine and taken to the emergency department. He was observed for four hours without further intervention and then discharged. He had no symptoms at discharged and was considered recovered. The patient's experience's were considered to be other important medical events by the reporter. No further information is expected."
Age: 41.0
Sex: M
Vaccine: BCG, HEP, TTOX, HEP, TD
Symptoms: Erythema, Pain, Swelling
Clinical narrative: Cluster of 3 cases (individual identification provided) received from a nurse in the USA on 12 February 2007. This case represents patient 1 of 3. A 41 year old, male patient (with a history of hypertension) developed left arm swelling and redness after he received Decavac (lot number U1738AA) intramuscularly in the left arm and Tubersol (lot number C2258AA) intradermally (site not reported on 08 February 2007. The patient also received Hepatitis B vaccine (Merck, lot number 0186F) intramuscularly in the right arm. It was reported the needle length used was one inch needle. The pain scale was reported as a 5 out of 10 and the "area was hard" . The patient was instructed to take Advil and ice the area. At the time of the report, the patient had not recovered. Follow-up information received on 06 march 2007 from a health care professional. Tubersol was administered in the left forearm. The reaction occurred in the left deltoid at the Decavac site. The patient did not go to a physician, and no diagnosis was made. The duration of the event was 10 days, and the patient was recovered as of 02 March 2007. The case  has the same reporter as cases 2007-00424 and 2007-00425
Age: 41.0
Sex: M
Vaccine: BCG, HEP, TTOX, HEP, TD
Symptoms: Erythema, Injection site induration, Injection site pain, Oedema peripheral
Clinical narrative: Cluster of 3 cases (individual identification provided) received from a nurse in the USA on 12 February 2007. This case represents patient 1 of 3. A 41 year old, male patient (with a history of hypertension) developed left arm swelling and redness after he received Decavac (lot number U1738AA) intramuscularly in the left arm and Tubersol (lot number C2258AA) intradermally (site not reported on 08 February 2007. The patient also received Hepatitis B vaccine (Merck, lot number 0186F) intramuscularly in the right arm. It was reported the needle length used was one inch needle. The pain scale was reported as a 5 out of 10 and the "area was hard" . The patient was instructed to take Advil and ice the area. At the time of the report, the patient had not recovered. Follow-up information received on 06 march 2007 from a health care professional. Tubersol was administered in the left forearm. The reaction occurred in the left deltoid at the Decavac site. The patient did not go to a physician, and no diagnosis was made. The duration of the event was 10 days, and the patient was recovered as of 02 March 2007. The case  has the same reporter as cases 2007-00424 and 2007-00425
Age: 41.0
Sex: M
Vaccine: HEP, TTOX, HEP, TD
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Pyrexia, Tremor
Clinical narrative: Cluster of 3 cases (individual identification provided) received from a nurse in teh USA on 12 February 2007. This case represents patient 3 of 3. A 41 year old male patient complained of an injection site that was red, with slight swelling and painful after he received Decavac (lot number U1738AA) intramuscularly in the left arm and Tubersol (lot number C25008AA) intradermally in the left arm on 08 February 2007. It was reported the needle length used was a one inch needle. The pain scale was reported as a 4 out of 10 and the patient also complained of fever of 102 and shaking of the arm. The patient was instructed to take Advil and ice the area. He did not have any illness at the time of vaccination. At the time of the report, it was unknown if the patient recovered. Follow-up information received on 06 March 2007 from a health care professional. The patient had no previous medical history. Tubserol 5 TU was administered in the left forearm. The reaction occurred in the left deltoid at the Decavac administration site. NO final diagnosis was made and no laboratory testing was performed as the patient did not go to a physician. The duration of teh event was "ten days arm sore, redness seven days, swelling ten days." The patient had recovered as of 02 March 2007. The case has the same reporter as cases 2007-00423 and 2007-00425.
Age: 26.0
Sex: F
Vaccine: BCG, TD, TD
Symptoms: Injection site nodule
Clinical narrative: Cluster of 3 cases (individual identification provided)received from a nurse in the USA on 12 February 2007. This case represents patient 2 of 3. A 26 year old, female patient developed a nodule at the injection site, 7 days after she received Decavac (lot number U1738AA) intramuscularly in the left deltoid and Tubersol (lot number C2508AA) intradermally in the left arm on 19 January 2007. It was reported the needle length used was a one inch needle. At the time of vaccination, the patient had a UKT1. At the time of the report, the patient had not recovered. Follow-up information received on 06 March 2007 from a health care professional. Tubersol 5 TU was administered in the left forearm. The nodule occurred at the Decavac administration site, Left deltoid. The duration of the events has been one month. At present, the node is still present. The case has the same reporter as cases 2007-00423 and 2007-00425.
Age: 13.0
Sex: F
Vaccine: HPV4, HEPA, HPV4, MNQ, VARCEL
Symptoms: Menstruation irregular
Clinical narrative: Initial report received on 26 April 2007 from another manufacturer, report number WAES0702USA04012. The initial reporters to this manufacturer was a physician and a registered nurse. Verbatim from report: "Initial and follow-up information has been received from a physician and a registered nurse concerning a 13 year old Hispanic female student with allergic rhinitis, otitis media, asthma and history of cleft palate repair who on the morning of 06-NOV-2006 was vaccinated in the left arm with a dose of Gardasil (yeast) lot #653938/0954F. Concomitant therapy included MENACTRA, hepatitis A Virus vaccine and varicella virus vaccine live. After the patient's first dose of Gardasil (yeast) her menstrual cycle started and lasted about 2-3 weeks. On 09-JAN-2007, she was vaccinated in the right arm with the second dose of GARDASIL (yeast). In late February 2007, the patient's menstrual cycle lasted weeks and she experienced heavy bleeding. In follow-up information received on 22-FEB-2007 the physician reported that patient's mother alleges that since her daughter started GARDASIL (yeast) her periods became irregular and long. Her period in January was 15 days. The mother requested a gynecology consult. The reporter felt that irregular and long menstrual bleeding was an other important medical event. Additional information is not expected."
Age: 13.0
Sex: F
Vaccine: HPV4, HEPA, HPV4, MNQ, VARCEL
Symptoms: Menorrhagia, Menstruation irregular
Clinical narrative: Initial report received on 26 April 2007 from another manufacturer, report number WAES0702USA04012. The initial reporters to this manufacturer was a physician and a registered nurse. Verbatim from report: "Initial and follow-up information has been received from a physician and a registered nurse concerning a 13 year old Hispanic female student with allergic rhinitis, otitis media, asthma and history of cleft palate repair who on the morning of 06-NOV-2006 was vaccinated in the left arm with a dose of Gardasil (yeast) lot #653938/0954F. Concomitant therapy included MENACTRA, hepatitis A Virus vaccine and varicella virus vaccine live. After the patient's first dose of Gardasil (yeast) her menstrual cycle started and lasted about 2-3 weeks. On 09-JAN-2007, she was vaccinated in the right arm with the second dose of GARDASIL (yeast). In late February 2007, the patient's menstrual cycle lasted weeks and she experienced heavy bleeding. In follow-up information received on 22-FEB-2007 the physician reported that patient's mother alleges that since her daughter started GARDASIL (yeast) her periods became irregular and long. Her period in January was 15 days. The mother requested a gynecology consult. The reporter felt that irregular and long menstrual bleeding was an other important medical event. Additional information is not expected."