chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 49.0
Sex: M
Vaccine: BCG
Symptoms: Chills, Haematuria, Night sweats, Pyrexia
Clinical narrative: A 49 year old male patient was being treated with Oncotice for carcinoma in situ of the bladder since 22 August 2005.  After the second instillation on 29 August 2005 the patient experienced low-grade fever, night sweats with chills and hematuria on the same day as the instillation.  The complaints resolved the next day. The patient did not measure his temperature, therefore it is uncertain if he actually had an elevated body temperature. He experienced the same events after the third instillation on 6 September 2005.  The events resolved the next day.  He treated the fever with a non-steroidal anti-inflammatory (unspecified) drug and that improved his fever.  Corrective treatment: Non-steroidal anti-inflammatory (unspecified) drug
Age: 64.0
Sex: M
Vaccine: BCG
Symptoms: Blood cholesterol decreased
Clinical narrative: A 64 year old male pt was treated with Oncotice for bladder cancer since late 2003, since being diagnosed with bladder cancer, over a 1.5 year period of time, he had received Oncotice as two series of 6 instillations each, followed by a third series of three instillations, last administered 5-6 months prior to report of 9/19/05. Approx 1/2 year after receiving his initial Tice BCG treatments, he reported he was found to have an abnormal blood cholesterol (lot natural not elevated). Treatment with Oncotice was continued. Corrective treatment Rosuvastatin.
Age: 73.0
Sex: M
Vaccine: BCG
Symptoms: Chills, Condition aggravated, Haematuria, Hiatus hernia, Hypertension
Clinical narrative: A 72 year old male pt was treated with Oncotice since 5/27/05 for bladder cancer. After his first instillation, he experienced a 4 deg C fever, chills and hematuria on 5/30/05. The fever, chills and hematuria lasted for only 24 hours and resolved after taking acetaminophen. After his second instillation on 6/3/05, he experienced a high blood pressure and nausea on 6/4/05. The high blood pressure was regulated by changing the consumers blood pressure medication from Quinapril to Enalapril. The nausea continued to recur after every instillation of Oncotice and lasted for two to three hours. A gastroenterological examination revealed a tiny hiatal hernia and a tiny colonic polyp, all other investigations were normal. Zofran was described for the nausea, but reportedly the pt was non complaint. Acetaminophen.
Age: 73.0
Sex: M
Vaccine: BCG
Symptoms: Nausea, Polyp, Pyrexia
Clinical narrative: A 72 year old male pt was treated with Oncotice since 5/27/05 for bladder cancer. After his first instillation, he experienced a 4 deg C fever, chills and hematuria on 5/30/05. The fever, chills and hematuria lasted for only 24 hours and resolved after taking acetaminophen. After his second instillation on 6/3/05, he experienced a high blood pressure and nausea on 6/4/05. The high blood pressure was regulated by changing the consumers blood pressure medication from Quinapril to Enalapril. The nausea continued to recur after every instillation of Oncotice and lasted for two to three hours. A gastroenterological examination revealed a tiny hiatal hernia and a tiny colonic polyp, all other investigations were normal. Zofran was described for the nausea, but reportedly the pt was non complaint. Acetaminophen.
Age: 45.0
Sex: M
Vaccine: BCG
Symptoms: Arthralgia, Arthropathy, Blood cholesterol increased, Pyrexia, Thermal burn
Clinical narrative: A 44 year old male pt received preventative maintenance treatment with Oncotice for carcinoma in situ of the bladder since Sept 2003. He presented with fever three times since 9/3/04 and recurring burning, right hip pain since 9/13/04. He also presented with a high cholesterol and high thyroid levels since approx two years ago. The fever resolved without treatment, high cholesterol and high thyroid levels resolved with current medication, the right hip pain was considered unresolved.
Age: 45.0
Sex: M
Vaccine: BCG
Symptoms: Thyroid disorder
Clinical narrative: A 44 year old male pt received preventative maintenance treatment with Oncotice for carcinoma in situ of the bladder since Sept 2003. He presented with fever three times since 9/3/04 and recurring burning, right hip pain since 9/13/04. He also presented with a high cholesterol and high thyroid levels since approx two years ago. The fever resolved without treatment, high cholesterol and high thyroid levels resolved with current medication, the right hip pain was considered unresolved.
Age: 41.0
Sex: F
Vaccine: BCG
Symptoms: Blister, Erythema, Medication error, Skin burning sensation, Skin exfoliation
Clinical narrative: A 41 year old female medical assistant reportedly was not taught how to properly administer Oncotice and as a result, during an administration to a patient, accidentally and amount sprayed in her throat. Results of tuberculosis test were neg, but less than two weeks later she developed a bump on her left forearm, which blistered and peeled. Her initial physician felt it was only a reaction to Oncotice exposure. Reportedly the bump and the surrounding area now looks like a burn and the woman was referred to another physician for further treatment and evaluation. Follow up received on 11/10/2005 female stated the bump on her forearm continues to grow and is now the size of a dime. It is still red, raised and blistering. She consulted with her primary care physician who conducted a lung X ray approx three weeks ago. Results were neg for any findings.
Age: 41.0
Sex: F
Vaccine: BCG
Symptoms: Skin nodule
Clinical narrative: A 41 year old female medical assistant reportedly was not taught how to properly administer Oncotice and as a result, during an administration to a patient, accidentally and amount sprayed in her throat. Results of tuberculosis test were neg, but less than two weeks later she developed a bump on her left forearm, which blistered and peeled. Her initial physician felt it was only a reaction to Oncotice exposure. Reportedly the bump and the surrounding area now looks like a burn and the woman was referred to another physician for further treatment and evaluation. Follow up received on 11/10/2005 female stated the bump on her forearm continues to grow and is now the size of a dime. It is still red, raised and blistering. She consulted with her primary care physician who conducted a lung X ray approx three weeks ago. Results were neg for any findings.
Age: 70.0
Sex: M
Vaccine: BCG
Symptoms: Chills, Dysuria, Pollakiuria, Pyrexia
Clinical narrative: An 80 year old male pt was being treated with Oncotice since 10/10/2005. In Nov 2005, he experienced urinary frequency with burning, slow urine flow, fever and chills. The events were ongoing.
Age: 52.0
Sex: F
Vaccine: BCG
Symptoms: Dysuria, Urinary tract disorder
Clinical narrative: A 52 year old female pt was started on Oncotice treatment for bladder cancer since July 2005. After an initial induction course, in Nov 2005 monthly instillations were started. After the first and second monthly instillation she experienced burning of the urinary tract, for which Urised was prescribed. On the evening of the second instillation the pt was inadvertently exposed to voided urine. Dysuria, accidental exposure.
Age: 62.0
Sex: F
Vaccine: BCG
Symptoms: Alopecia, Blood urine, Chills, Dysuria, Fatigue
Clinical narrative: A 62 year old female pt was treated with 6 weekly Oncotice instillations for bladder cancer from the end of Oct 2005. A few days after the first instillation she presented with blood in her urine, burning during urination, flu like symptoms (chills, tiredness, muscle ache), nausea after eating, skin irritation and hair loss which have currently not yet resolved. Dysuria.
Age: 62.0
Sex: F
Vaccine: BCG
Symptoms: Influenza like illness, Myalgia, Nausea, Skin irritation
Clinical narrative: A 62 year old female pt was treated with 6 weekly Oncotice instillations for bladder cancer from the end of Oct 2005. A few days after the first instillation she presented with blood in her urine, burning during urination, flu like symptoms (chills, tiredness, muscle ache), nausea after eating, skin irritation and hair loss which have currently not yet resolved. Dysuria.
Age: 71.0
Sex: M
Vaccine: BCG
Symptoms: Dysuria, Micturition urgency, Pollakiuria
Clinical narrative: A 70 year old male pt was treated with three Oncotice instillations for bladder cancer in July 2004. Almost since the beginning of his treatment with Oncotice, he began experiencing pain with voiding, urinary frequency and urgency and some difficulty initiating flow of urine. Dysuria, Pollakiuria, micturition urgency.
Age: 75.0
Sex: M
Vaccine: BCG
Symptoms: Dermatitis contact, Pollakiuria
Clinical narrative: A 75 year old male pt was started on combined Oncotice/Interferon treatment (unapproved combination) on 12/1/05 for T1 bladder cancer with CIS. Since 2/23 he presented with an increased urinary frequency, mostly at night. On 2/24 the pt developed contact dermatitis, which was mostly located at the bilateral upper posterior thigh area behind the knees, which resolved after treatment. Corrective treatment Celestone injection and local cream.
Sex: M
Vaccine: BCG
Symptoms: Dysuria, Skin burning sensation
Clinical narrative: A male pt (age not reported) has been treated with Oncotice for an unspecified period. After an unspecified delay he experienced a burning sensation.
Age: 64.0
Sex: F
Vaccine: BCG
Symptoms: Pollakiuria
Clinical narrative: A 64 year old female pt was diagnosed with bladder cancer in Aug 2005 for which bladder surgery (unspecified) was performed. BCG treatment (brand unk) every 3 months was started in 2005. Reportedly after the first dose she experienced increased urinary frequency.
Age: 56.0
Sex: M
Vaccine: BCG
Symptoms: Blood urine, Cystitis, Dysuria, Increased appetite, Pain
Clinical narrative: A 56 year old male was treated with an initial series of 6 Oncotice instillations for recurrent bladder cancer in 2005, after a TURBT on 7/22/05. Reportedly, following each instillation, he experienced bloody urine (lasting approx 2 days), penile irritation and pain, and also burning with urination. He has also experienced bladder infections, for which he was treated with Levaquin, with subsequent resolution. The same events were also reported during a second series of 3 instillations in early 2006. Additionally, the pt reported 13kg weight gain and increased appetite since approx 6-8 months. Cystitis, Haematuria, Dysuria.
Age: 56.0
Sex: M
Vaccine: BCG
Symptoms: Penis disorder, Weight increased
Clinical narrative: A 56 year old male was treated with an initial series of 6 Oncotice instillations for recurrent bladder cancer in 2005, after a TURBT on 7/22/05. Reportedly, following each instillation, he experienced bloody urine (lasting approx 2 days), penile irritation and pain, and also burning with urination. He has also experienced bladder infections, for which he was treated with Levaquin, with subsequent resolution. The same events were also reported during a second series of 3 instillations in early 2006. Additionally, the pt reported 13kg weight gain and increased appetite since approx 6-8 months. Cystitis, Haematuria, Dysuria.
Sex: M
Vaccine: BCG
Symptoms: Bladder pain, Dysuria
Clinical narrative: A male pt 9age unk) was treated with Oncotice for an unk indication and for an unreported time period. reportedly he experienced bladder pain and had trouble retaining Oncotice. Dysuria.
Age: 91.0
Sex: M
Vaccine: BCG
Symptoms: Urinary tract infection
Clinical narrative: A 91 year old male pt was treated with Oncotice for an unk indication. Reportedly, after one instillation he developed a urinary tract infection. For treatment sulfamethoxazole trimethoprim was prescribed.
Sex: M
Vaccine: BCG
Symptoms: Hepatitis C virus
Clinical narrative: Case report 2006-141999-NL is a spontaneous case report sent by a consumer which refers to a male pt of an unk age who was treated with an unk brand of BCG for an unk indication during a specified period of time. Reportedly, he was tested positive for Hepatitis C.
Age: 65.0
Sex: M
Vaccine: BCG
Symptoms: Asthenia, Chills, Influenza like illness, Pyrexia
Clinical narrative: A 65 year old male pt received Oncotice for bladder cancer on 6/8/06. After a few hours after the administration of Oncotice, the pt experienced flu-like symptoms of chills, weakness and fever.
Age: 52.0
Sex: M
Vaccine: BCG
Symptoms: Arthralgia, Polymyalgia rheumatica, Urticaria, Vaccine positive rechallenge
Clinical narrative: A currently 60 year old male pt was diagnosed with bladder cancer, for which he was treated in 1998 with two cycles of six weekly instillation of Oncotice. At the end of his first cycle in 1998 he presented with joint pain and was diagnosed with polymyalgia rheumatica. Oncotice treatment was continued. The pt received prednisone for about a year and his symptoms subsided. In Feb 2006 he was diagnosed with a bladder cancer recurrence and Oncotice treatment (10% dose) was initiated in April 2006. After the third instillation he presented with symptoms of polymyalgia rheumatica and hives. Oncotice treatment was continued.
Age: 58.0
Sex: U
Vaccine: BCG
Symptoms: Medication error
Clinical narrative: A 58 year old female nurse was inadvertently exposed to Oncotice, while reconstituting a vial for administration to a pt, with fluid being spilled on her face, neck, and her upper chest. Reportedly no fluid entered her eyes or mouth.
Age: 71.0
Sex: M
Vaccine: BCG
Symptoms: Abdominal pain, Back pain, Blood urine, Hot flush, Hyperhidrosis
Clinical narrative: A 71 year old male pt was treated for bladder cancer with Oncotice since 7/3/06. Before his second instillation, blood wad found in the urine after catherterisation (not due to the caterisation procedure). Reportedly he experienced flu like symptoms (achy lower abdomen, thigh and lower back pain, low grade fever, intermittent brief episodes of hot flashes with diaphoresis) and therefore the second treatment with Oncotice was withheld. As of 7/17/06, his temp had gone down and visually his urine had cleared.
Age: 71.0
Sex: M
Vaccine: BCG
Symptoms: Influenza like illness, Pain, Pyrexia
Clinical narrative: A 71 year old male pt was treated for bladder cancer with Oncotice since 7/3/06. Before his second instillation, blood wad found in the urine after catherterisation (not due to the caterisation procedure). Reportedly he experienced flu like symptoms (achy lower abdomen, thigh and lower back pain, low grade fever, intermittent brief episodes of hot flashes with diaphoresis) and therefore the second treatment with Oncotice was withheld. As of 7/17/06, his temp had gone down and visually his urine had cleared.
Sex: M
Vaccine: BCG
Symptoms: Urinary tract disorder
Clinical narrative: A male pt, age unk, was treated with Oncotice (indication and treatment period not reported). Reportedly, he experienced urinary discomfort six hours after Oncotice instillation.
Age: 0.35
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Convulsion
Clinical narrative: Repeatative seizures started approx 12 hours after vaccines. Multiple seizures during the next several hours, baby then given Phenobarbital to stop seizures.  12/1/06 Received medical records which reveal:  On 10/21/06 seen in ER for fever & seizure/s/p vax (presumed DTaP).  LP done.  Received IVF.  Developed diarrhea.
Age: 51.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Ear pain, Headache, Injection site erythema, Injection site pain, Neck pain
Clinical narrative: Had influenza vaccine 4 pneumovax or 10/17/2006 at 11:30am, soreness to arms started 10/17/06. Redness to both arms, 1 3/4 redness to left deltoid arm and 2 3/4" redness to right deltoid area. SX started 10/18/06. Severe headache, hurting down into left ear and jaws bilateral and down into neck. Started today. No relief of symptoms with Tylenol.
Age: 51.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Pain in jaw
Clinical narrative: Had influenza vaccine 4 pneumovax or 10/17/2006 at 11:30am, soreness to arms started 10/17/06. Redness to both arms, 1 3/4 redness to left deltoid arm and 2 3/4" redness to right deltoid area. SX started 10/18/06. Severe headache, hurting down into left ear and jaws bilateral and down into neck. Started today. No relief of symptoms with Tylenol.
Age: 72.0
Sex: F
Vaccine: FLU3
Symptoms: Fluid retention, Injection site abscess, Injection site erythema, Injection site pain, Urticaria
Clinical narrative: Received vaccine 10/18/06 area became reddened et sore, by 10/18/06 area was like an abscess with fluid in it approx walnut sized. Pt expressed pus et blood from injection site on 10/22/2006 estimated about 4 oz, consulted her Dr and was prescribed an antibiotic to start 10/23/06. (Wheal was bout 10mm+).
Age: 4.0
Sex: F
Vaccine: IPV, MMRV
Symptoms: Injection site erythema, Injection site nodule, Injection site swelling, Lymphadenopathy, Pruritus
Clinical narrative: Right thigh began with itching with shot sight Saturday night, Sunday had red, raised bump size of baseball. Has 3cm x 2cm red, raised area in close proximity to shot sight. Swollen lymph node in right groin.
Age: 53.0
Sex: F
Vaccine: FLU3
Symptoms: Condition aggravated, Supraventricular tachycardia
Clinical narrative: Pt has had an SUT her entire life. She has had 2 episodes in the last 3 weeks that sent her to the ER. On of those episodes occurred after her vaccination. (SVT = Ventricle tachycardia).
Age: 53.0
Sex: F
Vaccine: FLU3
Symptoms: Chest discomfort, Chest pain, Cough, Eye inflammation, Headache
Clinical narrative: Tightness and burning in chest. Suddenly. 7 hours after injection coughing with small production phlem. 16 hours after burning sinus and eyes and headaches. Benadryl. For 2 hrs hard to breath.
Age: 53.0
Sex: F
Vaccine: FLU3
Symptoms: Sinusitis
Clinical narrative: Tightness and burning in chest. Suddenly. 7 hours after injection coughing with small production phlem. 16 hours after burning sinus and eyes and headaches. Benadryl. For 2 hrs hard to breath.
Age: 34.0
Sex: F
Vaccine: MMR, TD
Symptoms: Arthralgia, Diarrhoea, Infection, Musculoskeletal stiffness, Neck pain
Clinical narrative: Welts to left thigh, pain to both knees and neck. Symptoms began 10/17/2006, aches, pain, stiffness on 10/18/06 fever 102 the diarrhea, visit Dr Dr thinks she has an intestinal infection.
Age: 34.0
Sex: F
Vaccine: MMR, TD
Symptoms: Pain, Pyrexia, Urticaria
Clinical narrative: Welts to left thigh, pain to both knees and neck. Symptoms began 10/17/2006, aches, pain, stiffness on 10/18/06 fever 102 the diarrhea, visit Dr Dr thinks she has an intestinal infection.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site oedema
Clinical narrative: Localized reaction redness, and swelling.
Age: 0.76
Sex: M
Vaccine: IPV
Symptoms: Erythema, Urticaria
Clinical narrative: Flu vaccine administered 10/19/06 approx 10am mother phones at 1:30pm described red face and hives. Tylenol elixir and Benadryl prescribed. Call MD if worse, appt made for 10/20/2006 am.
Age: 22.0
Sex: M
Vaccine: SMALL
Clinical narrative: Myopericarditis 2/13/07 Received medical records from hospital which reveal patient experienced SOB worse on exertion & progressively worsening with sharp left pleuritic chest pain which improved w/lying down & worsened w/sitting up, diaphoresis, chills & fever, lightheadedness & productive cough of thick brown sputum.  Exam revealed  a focal pericardial rub & tenderness to palpation of left chest. Continued to experience intermittent chest pain while hospitalized FINAL DX: myopericarditis.
Age: 64.0
Sex: M
Vaccine: FLU3
Symptoms: Blood pressure increased, Condition aggravated, Heart rate increased
Clinical narrative: Patient reported that about 2-3 hours after receiving fluzone injection his blood pressure was elevated.  He checked it at home and reported it to be 155/98.  He had been doing yardwork (planting flowers).  He reported that his pulse was elevated at about 105.  He reports that after about 2 hours of elevated blood pressure he stopped the yard work and just rested.  He monitored both blood pressure and pulse for about the next 8 hours, it decreased after about 7 hours and patient reports he went to bed as usual.  The next morning patient states his blood pressure was only a little elevated.  He does suffer from high blood pressure which is normally controlled by medication, and he reports that he did take his medication as usual the evening before the vaccination, and the evening after the vaccination.  He did not seek any medical attention and reported this back to the pharmacy 2 days following the vaccination.  He reports he has received a flu shot every year for about the last 10 years without any problem.
Age: 48.0
Sex: M
Vaccine: TD
Symptoms: Injection site mass, Injection site pain, Injection site swelling
Clinical narrative: Patient gave history of pain and swelling at injection site noticed 5 days after injection was given; did not return to me for evaluation, but reported reaction on next scheduled visit. Pain and swelling resolved without treatment but a 3 x 3 cm mass remains at the left deltoid injection site.
Age: 50.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Fatigue, Hypoaesthesia, Injection site mass, Pain
Clinical narrative: Patient reported local irritation, swelling and redness and slight fever. Patient reports exceptional tiredness and runny nose. Local reaction continued to worsen with increased soreness and development of knot at site and weakness in the arm.  Reported slight numbness around mouth and lips that increased and was spreading to face.  Reported that she routinely take NSAID.
Age: 50.0
Sex: F
Vaccine: FLU3
Symptoms: Pyrexia, Rhinorrhoea, Skin irritation, Swelling
Clinical narrative: Patient reported local irritation, swelling and redness and slight fever. Patient reports exceptional tiredness and runny nose. Local reaction continued to worsen with increased soreness and development of knot at site and weakness in the arm.  Reported slight numbness around mouth and lips that increased and was spreading to face.  Reported that she routinely take NSAID.
Age: 29.0
Sex: F
Vaccine: FLU3
Symptoms: Urticaria
Clinical narrative: Developed severe urticaria starting the evening after administration.
Age: 56.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Feeling hot, Joint effusion, Joint swelling, Tenderness
Clinical narrative: SWELLING AT ELBOW, MILD ELBOW EFFUSION, WARMTH, ERYTHEMA AND TENDERNESS TO ELBOW AND FOREARM. NO FEVER OR OTHER SYMPTOMS. PATIENT SEEN AND TREATED AT URGENT CARE CENTER.
Age: 61.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Blood pressure increased, Heart rate increased, Hypersensitivity, Injection site erythema, Injection site swelling
Clinical narrative: Patient had symptoms of racing heart and increased blood pressure approx 1 hour after the pneumovax vaccine. Patient went to emergency room and was treated for BP 155/100 to 160/112 and HR 100-110. Vaccine injection site was warm, swollen and red on back of left arm at SQ injection site. Patient had EKG that was normal and told to watch back of left arm. Patient returned to ER next day for continuing elevated BP. Patient diagnosed with an inflammatory hypersensitivity reaction over SQ site that covered the span of the back of the left arm and told to watch area, no antibiotic prescribed. No medication needed for elevated BP, told to see primary physician regarding BP levels.
Age: 61.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site warmth
Clinical narrative: Patient had symptoms of racing heart and increased blood pressure approx 1 hour after the pneumovax vaccine. Patient went to emergency room and was treated for BP 155/100 to 160/112 and HR 100-110. Vaccine injection site was warm, swollen and red on back of left arm at SQ injection site. Patient had EKG that was normal and told to watch back of left arm. Patient returned to ER next day for continuing elevated BP. Patient diagnosed with an inflammatory hypersensitivity reaction over SQ site that covered the span of the back of the left arm and told to watch area, no antibiotic prescribed. No medication needed for elevated BP, told to see primary physician regarding BP levels.
Age: 45.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Cellulitis, Injection site erythema, Injection site reaction, Injection site warmth, Pain
Clinical narrative: Per ER diagnosis:  Cellulitis in right deltoid area two days post vaccination.  Injection site was purple; red wheal, 2-inches in diameter formed around the purple area.  Warm to touch.  Increased pain (touch and movement).  Elevated temperature=101 degrees Farenheit.  Treatment:  Erythromycin 333 mg. t.i.d. X 10 days; Vicodin PRN.
Age: 45.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Pyrexia, Urticaria
Clinical narrative: Per ER diagnosis:  Cellulitis in right deltoid area two days post vaccination.  Injection site was purple; red wheal, 2-inches in diameter formed around the purple area.  Warm to touch.  Increased pain (touch and movement).  Elevated temperature=101 degrees Farenheit.  Treatment:  Erythromycin 333 mg. t.i.d. X 10 days; Vicodin PRN.
Age: 12.0
Sex: F
Vaccine: TDAP
Symptoms: Pyrexia
Clinical narrative: Elevated temperature over 101F with chills. Seen by school nurse in family home on 10/13/2006 with temperature less than 100F. Nurse recommended that child be seen by physician if no improvement by 10/14/2006.
Age: 76.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site pain
Clinical narrative: Pain and burning in muscle in shoulder area after receiving a shingles vaccine on Oct 3, 2006 and still hurting on Oct 23, 2006.   Pt. reports that a vaccine for shingles was given NOT GARDASIL as reported.  Pain and burning in shoulder began the next day and continued 3 weeks post vax.  Still reporting that arm is sore but improving. Pt. also reports that beginning 10/19/2006 she began to experience swelling and itching around her Right eye with development of a blister, then scab near the right eye.  She saw an eye doctor (OD) 10/23/06 who commented that it might be shingles.  She then reported to him that she had the shingles vaccine 3 weeks prior. No other medical treatment sought.  Office visit report received from eye OD which describes an ulcerated eyelid lesion above the right eye. Tx'd with Elestat PRN.   Received Vax. record.  Confirmed Zostavax (0981F) given on October 3,2006-not Gardasil as reported on VAERS form.
Age: 76.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Eye irritation, Eye swelling, Myalgia, Pain, Skin burning sensation
Clinical narrative: Pain and burning in muscle in shoulder area after receiving a shingles vaccine on Oct 3, 2006 and still hurting on Oct 23, 2006.   Pt. reports that a vaccine for shingles was given NOT GARDASIL as reported.  Pain and burning in shoulder began the next day and continued 3 weeks post vax.  Still reporting that arm is sore but improving. Pt. also reports that beginning 10/19/2006 she began to experience swelling and itching around her Right eye with development of a blister, then scab near the right eye.  She saw an eye doctor (OD) 10/23/06 who commented that it might be shingles.  She then reported to him that she had the shingles vaccine 3 weeks prior. No other medical treatment sought.  Office visit report received from eye OD which describes an ulcerated eyelid lesion above the right eye. Tx'd with Elestat PRN.   Received Vax. record.  Confirmed Zostavax (0981F) given on October 3,2006-not Gardasil as reported on VAERS form.
Age: 1.26
Sex: F
Vaccine: DTAP, PNC
Symptoms: Bacterial infection, Drug ineffective, Nasal congestion, Pyrexia, Retching
Clinical narrative: Seen in ED on 10/2/2006 with fever (102F), vomiting, gagging, stuffy nose, wheezy. Has past hx of elevated blood lead level of 11 on 6/20/2006
Age: 1.26
Sex: F
Vaccine: DTAP, PNC
Symptoms: Vomiting, Wheezing
Clinical narrative: Seen in ED on 10/2/2006 with fever (102F), vomiting, gagging, stuffy nose, wheezy. Has past hx of elevated blood lead level of 11 on 6/20/2006
Age: 2.0
Sex: F
Vaccine: DTAP, MMR, VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site mass, Urticaria
Clinical narrative: Mother  stated the Right bottom thigh  were  the  mmr immunization  was  given,  developed a red  hard  nodule the  size of a  half dollar.  Then  on 10/22/2006 broke  out   in  hives under her arms  and  over  the rest  of her  body.  The  areas  that  were  scratched  did scabe  over.  No complaints  of a fever or  lethargy. 24  hours  after  the development of  hives  the  intensity has deminished.
Age: 23.0
Sex: F
Vaccine: FLU3
Symptoms: Dyspnoea, Hypoxia, Respiratory distress, Wheezing
Clinical narrative: PT IS NURSE AT OUR HOSPITAL, CAME TO INF. CONTROL FOR INFLUENZA VACCINE AT 1300.  REC'D VACCINE WHICH SHE HAS TAKEN EVERY YEAR FOR THE LAST 4-5 YEARS AND NEVER HAD A PROBLEM. APPROX. 5-10 MINUTES AFTER GETTING THE SHOT SHE REPORTED TO A COWORKER THAT SHE "WAS HAVING TROUBLE GETTING HER BREATH.  tHE COWORKER BROUGHT HER TO THE ER IMMEDIATELY WHERE SHE WAS FOUND TO BE IN EXTREME RESP. DISTRESS WITH AUDIBLE WHEEZING AND AN INITIAL OXYGEN SAT OF 85%.  SHE WAS TREATED WITH CONTINUOUS NEBULIZERS, XOPENEX (SHE TOOK 4 PUFFS FROM HER MDI ENROUTE TO ER), ALBUTEROL AND RACEMIC EPINEPHRINE.  SHE REC'D 0.4 EPINEPHRINE SUB Q AND SOLUMEDROL 250MG IV.  SHE IMPROVED SOMEWHAT BUT HAD TO TRANSFERRED TO A PULMONOLOGIST AND AN ALLERGIST.  THEY BOTH TOLD HER THEY BELIEVED THE REACTION WAS FROM THE FLU SHOT--NOT HER ASTHMA.  SHE IS A NEWLY DIAGNOSED ASTHMATIC AND WAS HOSP. ABOUT 2 MOS PRIOR TO VACCINATION WITH ASTHMA. INCIDENTLY, SHE HAD STOPPED TAKING HER SINGULAIR ABOUT ONE WEEK PRIOR TO VACCINATION AS ORDERED.
Age: 52.0
Sex: F
Vaccine: FLU3
Symptoms: Headache, Heart rate increased, Pyrexia, Tremor
Clinical narrative: Individual called today to report a reaction to her flu shot 2 days ago. She noticed her heart pounding approx. 5 hours after her flu vaccine. She then began brief periods of shaking over the next 2 hours. Sometimes the shaking began in her thighs and moved upward to her shoulders. Other times the shaking began at the top of her body and moved to lower extremities. She describes it as being intense enough to shake her bed and "almost" seizure-like. The episodes lasted approx 1 min each. Her temperature was 98.1 F. Her husband was with her and they did not seek emergency help. The following day her temperature was 99.6 F and she had a headache, but had no further episodes of shaking. No sore throat or other respiratory symptoms were experienced. 2 days following the flu shot she felt her health was back to normal. She has had many flu shots in the past. She was advised to report these symptoms to her physician and to consult him regarding next year's flu shot.
Age: 37.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Chills, Eye swelling, Face oedema, Injection site pain
Clinical narrative: Fluzone administered on 10/20/2006 - L deltoid.  Developed L arm pain.  In the evening had muscle aches in cheat and arms. 10/21/2006 had R sided upper lip swelling, aches and chills, the L sided upper lip swelling in pm. Severe difficulty moving L arm and generalized weakness. 10/22/06 Decreased lip swelling, R eye swollen, Decrease in body aches. 10/23/06 lower lip swollen, but is feeling better.
Age: 37.0
Sex: F
Vaccine: FLU3
Symptoms: Myalgia, Pain
Clinical narrative: Fluzone administered on 10/20/2006 - L deltoid.  Developed L arm pain.  In the evening had muscle aches in cheat and arms. 10/21/2006 had R sided upper lip swelling, aches and chills, the L sided upper lip swelling in pm. Severe difficulty moving L arm and generalized weakness. 10/22/06 Decreased lip swelling, R eye swollen, Decrease in body aches. 10/23/06 lower lip swollen, but is feeling better.
Age: 86.0
Sex: F
Vaccine: FLU3
Symptoms: Contusion
Clinical narrative: Patient received the flu vaccine without complications on 10/20/06 at an offsite clinic.  Nothing stood out in my mind.  Patient presented with bruising on Monday 10/23/06.  The pharmacist who viewed the site called me.  Said that there was significant bruising below the site of injection.  The pharmacist said she could view where I injected her, it was in the deltoid muscle, and the bruising was lower then the site and down to her elbow.  Patient also brought it to our attention then that she was on plavix.  We called her doctor, no answer.  We instructed her to go to the emergency room.  I did a follow up call with her latter on 10/23/06 and she said she did see her doctor, that there was no infection and that it would take time to clear up.  There is minimumal discomfort and she is able to move her arm freely.  I told her I would follow up with her on Tuesday 10/24/06.  When I talked with her in the morning trying to assess what was going on she seem conherent and able to answer all of my questions without problems.  When I called to check on her she seemed out of it and had no idea who I was.  I will continue to follow up.
Age: 4.0
Sex: M
Vaccine: DTAPHEPBIP, FLU3, HEPA, IPV, MMR, PNC
Symptoms: Pain, Pyrexia, Vomiting
Clinical narrative: L arm sore, fever 104 0ne day, emesis.
Age: 0.17
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC, RV5
Symptoms: Crying, Erythema, Oral intake reduced, Swelling
Clinical narrative: Large amount of redness and edema lt leg crying non stop refusal to nurse.
Age: 40.0
Sex: F
Vaccine: FLU3
Symptoms: Back pain, Cough, Dysphonia, Eye discharge, Hypersensitivity
Clinical narrative: 2 hours post vaccination, she developed lower back pain, followed shortly with a persistant cough, within the next hour both eyes swelled shut with matter developing in the eyes. The back pain grew more intense with hives following and a fever of 99.1 degrees. Several hours after the vaccination, she complained of constricted breathing both in the lungs and tightness around the throat. Also noted was hoarseness in the voice. She went to a local medical clinic where a Physician's Assistant declared that she developed an allergic reaction to the (protein)in the flu vaccination and he prescribed Zyrtec for the symptoms. Complete resolutions of the symptoms with treatment occured after 48 hours.
Age: 40.0
Sex: F
Vaccine: FLU3
Symptoms: Pyrexia, Throat tightness
Clinical narrative: 2 hours post vaccination, she developed lower back pain, followed shortly with a persistant cough, within the next hour both eyes swelled shut with matter developing in the eyes. The back pain grew more intense with hives following and a fever of 99.1 degrees. Several hours after the vaccination, she complained of constricted breathing both in the lungs and tightness around the throat. Also noted was hoarseness in the voice. She went to a local medical clinic where a Physician's Assistant declared that she developed an allergic reaction to the (protein)in the flu vaccination and he prescribed Zyrtec for the symptoms. Complete resolutions of the symptoms with treatment occured after 48 hours.
Age: 17.0
Sex: M
Vaccine: HEPA
Symptoms: Fatigue, Malaise, Nausea, Sensation of heaviness, Swelling
Clinical narrative: Was feeling ill within 10 minutes of the immunization. (Nausea, Malaise, felt heavy and tired)  He had an area on his left cheek after the shot that was described as an "inflamed zit" that swelled to the size of a golf ball and was tender to touch all around the area.  He felt ill for three days but was able to play football the evening of 10-20-2006.  The vaccine was given 10-19-2006
Age: 1.49
Sex: F
Vaccine: DTAPHEPBIP, HIBV, MMRV, PNC
Symptoms: Dyspnoea, Pyrexia, Rash, Vomiting
Clinical narrative: Grandmother reported to me that after receiving immunizations on 10/20/06, sometime that evening, patient began to vomit and have fever, and developed a rash on her left thigh. On Saturday the 21st she developed dyspnea and was taken to the ER where she was treated for croup with an injection, name of medication unknown to grandmother. By today, she is much better, rash is going away, had no further vomiting or dyspnea and will return to Day Care tomorrow, per grandmother.
Age: 33.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Contusion, Erythema, Injection site warmth, Muscle spasms, Pain
Clinical narrative: RIGHT ARM IS EXTREMELY SORE AND CRAMPING ALL THE WAY DOWN (MAINLY IN THE UPPER ARM).  FEELS AS THOUGH IT IS BRUISED AND HAS FEVER IN A 4 TO 6 INCH DIAMETER AROUND SHOT AREA, AS WELL AS HIVES (RAISED WITH WHELPS, ITCHING AND REDNESS).  WHOLE UPPER ARM IS SORE TO TOUCH.  FIRST NOTICED REDNESS & CRAMPING 10-23-06 8:00 AM.  FIRST NOTICED SORENESS 10-20-06 6:00 PM.  EXTREME SORENESS NOTED 10-21-06 2:00 PM. EXTREME SORENESS IS GETTING BETTER NOW (10-23-06 10:15 PM), BUT IS STILL VERY SORE.
Age: 33.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Pruritus, Urticaria
Clinical narrative: RIGHT ARM IS EXTREMELY SORE AND CRAMPING ALL THE WAY DOWN (MAINLY IN THE UPPER ARM).  FEELS AS THOUGH IT IS BRUISED AND HAS FEVER IN A 4 TO 6 INCH DIAMETER AROUND SHOT AREA, AS WELL AS HIVES (RAISED WITH WHELPS, ITCHING AND REDNESS).  WHOLE UPPER ARM IS SORE TO TOUCH.  FIRST NOTICED REDNESS & CRAMPING 10-23-06 8:00 AM.  FIRST NOTICED SORENESS 10-20-06 6:00 PM.  EXTREME SORENESS NOTED 10-21-06 2:00 PM. EXTREME SORENESS IS GETTING BETTER NOW (10-23-06 10:15 PM), BUT IS STILL VERY SORE.
Age: 57.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Injection site oedema, Lymphadenopathy, Pruritus, Tenderness
Clinical narrative: Noted tender, enlarges supra clavicular lymph node on right side, day after flu shot in right arm. Itching and redness also noted. Enlarged lymph node on right side, day after flu shot in right arm. Itching and redness also noted. Enlarged lymph node last year also. No itching or redness. On this date, condition is the same with swelling in are of affected node.
Age: 57.0
Sex: F
Vaccine: FLU3
Symptoms: Vaccine positive rechallenge
Clinical narrative: Noted tender, enlarges supra clavicular lymph node on right side, day after flu shot in right arm. Itching and redness also noted. Enlarged lymph node on right side, day after flu shot in right arm. Itching and redness also noted. Enlarged lymph node last year also. No itching or redness. On this date, condition is the same with swelling in are of affected node.
Age: 1.62
Sex: M
Vaccine: DTP, MMR, DTPHIB, HIBV
Symptoms: Abdominal pain, Abnormal behaviour, Antisocial behaviour, Autism, Bacterial infection
Clinical narrative: This case was considered medically important (OMIC). Information regarding Hib Titer vaccine was received from a attorney regarding a male pt who developed autism and autism spectrum disorder. The pt received the fourth dose on 10/20/95. The pt also received the fourth dose of DPT/Hit on 10/20/1995. The pts concurrent illness includes pervasive developmental delays. Indication for Hib Titer vaccine was immunisation. Product was administered on 10/20/95. Dose regimen was 1 dose 1 time per day. Additional suspect medication included Prohibit, Varivax, DTP/Hib, Polio oral, Hep B and MMR. Concomitant medications were not reported. Medical records have been received from an attorney indication that on an unk date a male pt was diagnosed with autism and autism spectrum disorder. Results of DNA testing performed on 4/22/97 detected no Fragile X. The outcome is unk. No additional information was available at the time of this report.
Age: 1.62
Sex: M
Vaccine: DTP, MMR, DTPHIB, HIBV
Symptoms: Cellulitis, Cognitive disorder, Constipation, Croup infectious, Dehydration
Clinical narrative: This case was considered medically important (OMIC). Information regarding Hib Titer vaccine was received from a attorney regarding a male pt who developed autism and autism spectrum disorder. The pt received the fourth dose on 10/20/95. The pt also received the fourth dose of DPT/Hit on 10/20/1995. The pts concurrent illness includes pervasive developmental delays. Indication for Hib Titer vaccine was immunisation. Product was administered on 10/20/95. Dose regimen was 1 dose 1 time per day. Additional suspect medication included Prohibit, Varivax, DTP/Hib, Polio oral, Hep B and MMR. Concomitant medications were not reported. Medical records have been received from an attorney indication that on an unk date a male pt was diagnosed with autism and autism spectrum disorder. Results of DNA testing performed on 4/22/97 detected no Fragile X. The outcome is unk. No additional information was available at the time of this report.
Age: 1.62
Sex: M
Vaccine: DTP, MMR, DTPHIB, HIBV
Symptoms: Dermatitis atopic, Drug toxicity, Encephalopathy, Epistaxis, Eructation
Clinical narrative: This case was considered medically important (OMIC). Information regarding Hib Titer vaccine was received from a attorney regarding a male pt who developed autism and autism spectrum disorder. The pt received the fourth dose on 10/20/95. The pt also received the fourth dose of DPT/Hit on 10/20/1995. The pts concurrent illness includes pervasive developmental delays. Indication for Hib Titer vaccine was immunisation. Product was administered on 10/20/95. Dose regimen was 1 dose 1 time per day. Additional suspect medication included Prohibit, Varivax, DTP/Hib, Polio oral, Hep B and MMR. Concomitant medications were not reported. Medical records have been received from an attorney indication that on an unk date a male pt was diagnosed with autism and autism spectrum disorder. Results of DNA testing performed on 4/22/97 detected no Fragile X. The outcome is unk. No additional information was available at the time of this report.
Age: 1.62
Sex: M
Vaccine: DTP, MMR, DTPHIB, HIBV
Symptoms: Eye discharge, Gaze palsy, Hypersensitivity, Hypertrophy, Insomnia
Clinical narrative: This case was considered medically important (OMIC). Information regarding Hib Titer vaccine was received from a attorney regarding a male pt who developed autism and autism spectrum disorder. The pt received the fourth dose on 10/20/95. The pt also received the fourth dose of DPT/Hit on 10/20/1995. The pts concurrent illness includes pervasive developmental delays. Indication for Hib Titer vaccine was immunisation. Product was administered on 10/20/95. Dose regimen was 1 dose 1 time per day. Additional suspect medication included Prohibit, Varivax, DTP/Hib, Polio oral, Hep B and MMR. Concomitant medications were not reported. Medical records have been received from an attorney indication that on an unk date a male pt was diagnosed with autism and autism spectrum disorder. Results of DNA testing performed on 4/22/97 detected no Fragile X. The outcome is unk. No additional information was available at the time of this report.
Age: 1.62
Sex: M
Vaccine: DTP, MMR, DTPHIB, HIBV
Symptoms: Mental impairment, Mental retardation severity unspecified, Nasal congestion, Nervous system disorder, Pharyngitis
Clinical narrative: This case was considered medically important (OMIC). Information regarding Hib Titer vaccine was received from a attorney regarding a male pt who developed autism and autism spectrum disorder. The pt received the fourth dose on 10/20/95. The pt also received the fourth dose of DPT/Hit on 10/20/1995. The pts concurrent illness includes pervasive developmental delays. Indication for Hib Titer vaccine was immunisation. Product was administered on 10/20/95. Dose regimen was 1 dose 1 time per day. Additional suspect medication included Prohibit, Varivax, DTP/Hib, Polio oral, Hep B and MMR. Concomitant medications were not reported. Medical records have been received from an attorney indication that on an unk date a male pt was diagnosed with autism and autism spectrum disorder. Results of DNA testing performed on 4/22/97 detected no Fragile X. The outcome is unk. No additional information was available at the time of this report.
Age: 1.62
Sex: M
Vaccine: DTP, MMR, DTPHIB, HIBV
Symptoms: Psychomotor hyperactivity, Pyrexia, Rash, Restlessness, Rhinitis
Clinical narrative: This case was considered medically important (OMIC). Information regarding Hib Titer vaccine was received from a attorney regarding a male pt who developed autism and autism spectrum disorder. The pt received the fourth dose on 10/20/95. The pt also received the fourth dose of DPT/Hit on 10/20/1995. The pts concurrent illness includes pervasive developmental delays. Indication for Hib Titer vaccine was immunisation. Product was administered on 10/20/95. Dose regimen was 1 dose 1 time per day. Additional suspect medication included Prohibit, Varivax, DTP/Hib, Polio oral, Hep B and MMR. Concomitant medications were not reported. Medical records have been received from an attorney indication that on an unk date a male pt was diagnosed with autism and autism spectrum disorder. Results of DNA testing performed on 4/22/97 detected no Fragile X. The outcome is unk. No additional information was available at the time of this report.
Age: 1.62
Sex: M
Vaccine: DTP, MMR, DTPHIB, HIBV
Symptoms: Rhinitis allergic, Rhinorrhoea, Sinusitis, Skin papilloma, Speech disorder
Clinical narrative: This case was considered medically important (OMIC). Information regarding Hib Titer vaccine was received from a attorney regarding a male pt who developed autism and autism spectrum disorder. The pt received the fourth dose on 10/20/95. The pt also received the fourth dose of DPT/Hit on 10/20/1995. The pts concurrent illness includes pervasive developmental delays. Indication for Hib Titer vaccine was immunisation. Product was administered on 10/20/95. Dose regimen was 1 dose 1 time per day. Additional suspect medication included Prohibit, Varivax, DTP/Hib, Polio oral, Hep B and MMR. Concomitant medications were not reported. Medical records have been received from an attorney indication that on an unk date a male pt was diagnosed with autism and autism spectrum disorder. Results of DNA testing performed on 4/22/97 detected no Fragile X. The outcome is unk. No additional information was available at the time of this report.
Age: 1.62
Sex: M
Vaccine: DTP, MMR, DTPHIB, HIBV
Symptoms: Tonsillitis, Upper respiratory tract infection, Vomiting
Clinical narrative: This case was considered medically important (OMIC). Information regarding Hib Titer vaccine was received from a attorney regarding a male pt who developed autism and autism spectrum disorder. The pt received the fourth dose on 10/20/95. The pt also received the fourth dose of DPT/Hit on 10/20/1995. The pts concurrent illness includes pervasive developmental delays. Indication for Hib Titer vaccine was immunisation. Product was administered on 10/20/95. Dose regimen was 1 dose 1 time per day. Additional suspect medication included Prohibit, Varivax, DTP/Hib, Polio oral, Hep B and MMR. Concomitant medications were not reported. Medical records have been received from an attorney indication that on an unk date a male pt was diagnosed with autism and autism spectrum disorder. Results of DNA testing performed on 4/22/97 detected no Fragile X. The outcome is unk. No additional information was available at the time of this report.
Age: 1.62
Sex: M
Vaccine: DTP, MMR, DTPHIB, HIBV
Symptoms: Autism
Clinical narrative: This case was considered medically important (OMIC). Information regarding Hib Titer vaccine was received from a attorney regarding a male pt who developed autism and autism spectrum disorder. The pt received the fourth dose on 10/20/95. The pt also received the fourth dose of DPT/Hit on 10/20/1995. The pts concurrent illness includes pervasive developmental delays. Indication for Hib Titer vaccine was immunisation. Product was administered on 10/20/95. Dose regimen was 1 dose 1 time per day. Additional suspect medication included Prohibit, Varivax, DTP/Hib, Polio oral, Hep B and MMR. Concomitant medications were not reported. Medical records have been received from an attorney indication that on an unk date a male pt was diagnosed with autism and autism spectrum disorder. Results of DNA testing performed on 4/22/97 detected no Fragile X. The outcome is unk. No additional information was available at the time of this report.
Age: 72.0
Sex: F
Vaccine: TYP
Symptoms: Rash
Clinical narrative: Rash to arms and legs, torso.  Pt came to Emergency Dept and received IV solumedrol, Benadryl, and famotidine.