chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 17.0
Sex: M
Vaccine: HPV4
Symptoms: Headache, Nausea, Vomiting
Clinical narrative: Had Liq-Nitrogen rx to wart - gave HPV #2 IM - told pt to wait 15 minutes before they could leave - Adult person with child came to inform us - he had headache & nausea - Pt checked vitals normal - asked to laid down - gave clear fluids po - emesis - discharged after 1 hr 10 minutes to home - continued with headache until 7pm resolved without problems (pain noted 10 on pain scale).
Age: 1.26
Sex: F
Vaccine: DTAP, HEP, HEPA, HIBV, PNC
Symptoms: Injection site erythema, Injection site induration, Injection site oedema, Local reaction
Clinical narrative: Localized reaction on left deltoid redness, edema (+) induration treated with TYLENOL.
Age: 59.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Fatigue, Oedema peripheral, Pain in extremity, Pyrexia
Clinical narrative: Arm swelled with severe pain 4-6 hours after injection size of silver dollar. Then swelling spread with redness and pain to rear bicep to elbow. Ice did not reduce swelling. Low grade fever and tired no reaction to any other immunizations.
Age: 4.0
Sex: M
Vaccine: MMR, PNC13, VARCEL
Symptoms: Abdominal pain, Asthenia, Crying, Screaming, Unresponsive to stimuli
Clinical narrative: 10/18/10 Given shot & then cried, calmed down, got dressed & began to leave office & then c/o severe abdominal pain. By the time got outside office doubled over in pain (<5 min). Went car, buckled in refused snack & kept screaming. Came back in & vomited in office. During vomiting episode got very weak & unresponsive. Afterwards he improved & was back to baseline. Total (<10-15 min) observed in office. Pt alert oriented no more abd pain & says he feels ok, but looks tired now playful with toys. (A) Shot rxn - prob secondary to being upset, but unclear if directly to shots.
Age: 4.0
Sex: M
Vaccine: MMR, PNC13, VARCEL
Symptoms: Vomiting
Clinical narrative: 10/18/10 Given shot & then cried, calmed down, got dressed & began to leave office & then c/o severe abdominal pain. By the time got outside office doubled over in pain (<5 min). Went car, buckled in refused snack & kept screaming. Came back in & vomited in office. During vomiting episode got very weak & unresponsive. Afterwards he improved & was back to baseline. Total (<10-15 min) observed in office. Pt alert oriented no more abd pain & says he feels ok, but looks tired now playful with toys. (A) Shot rxn - prob secondary to being upset, but unclear if directly to shots.
Age: 8.0
Sex: F
Vaccine: DTAP
Symptoms: Erythema, Oedema peripheral, Skin warm
Clinical narrative: Arm was swollen & red to 15cm diam. warm to touch.
Age: 48.0
Sex: F
Vaccine: FLUN3
Symptoms: Biopsy skin abnormal, Drug eruption, Exfoliative rash, Rash papular, Skin plaque
Clinical narrative: A serious spontaneous report of drug eruption manifested by rash that had small papules and scaly plaques has been received from a physician concerning a 48-year-old female, subsequent to FLUMIST. The patient's past medical history includes hereditary angioedema. Concomitant medications included cinryze. The patient received FLUMIST on 14-Sep-2009. On 21-Sep-2009, the patient experienced a rash that had "small papules". The patient stated that she had no rash during C1 esterase inhibitor infusion. However, on approximately one and half day after the C1 esterase inhibitor infusion, the rash worsened. On an unspecified date, the papules developed into scaly plaques that spread from her back to her trunk, then to her chest and finally to her upper arms and legs. On 05-Oct-2009, she underwent a biopsy and the results identified a drug eruption. The patient reported the rash was thought to be due to either the FLUMIST or a "lot of" C1 esterase inhibitor infusion. The reporter stated that the rash resolved and had not reoccurred.
Sex: F
Vaccine: FLUN3
Symptoms: Abasia, Cerebellar ataxia, Fall, Immunoglobulin therapy, Viral infection
Clinical narrative: A serious spontaneous report of post viral cerebellum ataxia with symptoms of falling down and unable to walk has been received from a physician concerning a female, subsequent to FLUMIST. Neither the patient's past medical history nor any concomitant medications were reported. The patient received FLUMIST on 21-Oct-2009. The patient received FLUMIST and then started falling down a lot on 23-Oct-2009 and then was admitted to the hospital on 24-Oct-2009 because she couldn't walk. The patient was diagnosed with post viral cerebellum ataxia and treated with intravenous immunoglobulin and steroids. The outcome of post viral cerebellum ataxia with symptoms of falling down and unable to walk was unknown.
Age: 39.0
Sex: M
Vaccine: FLU3, PPV, TDAP
Symptoms: Cellulitis, Injection site pain, Injection site swelling
Clinical narrative: Pt given TDAP/ADACEL (R) deltoid IM. PNEUMOVAX R upper arm SQ on 12-2-10. Presented to urgent care 12-5 with R arm swelling, tenderness over TDAP site. Treated for cellulitis.
Age: 7.0
Sex: M
Vaccine: FLUN3, VARCEL
Symptoms: Erythema, Skin warm, Swelling
Clinical narrative: (L) upper arm 6 cm x 5 cm area of swelling redness & warmth after varicella vaccine. Reaction started after vaccine on 11/24/10 now 2 days 11/26/10.
Age: 1.51
Sex: M
Vaccine: DTAP, FLU3, HIBV
Symptoms: Pallor, Pyrexia, Rash macular
Clinical narrative: Fever started approximately 24hrs after vaccines increased to 103.5 lasting approximately 48 hours, blanching macular rash on trunk started 5 days after vaccines.
Age: 13.0
Sex: F
Vaccine: FLU3, HPV4, MNQ, TDAP
Symptoms: Blood pressure decreased, Chest discomfort, Cold sweat, Dizziness, Heart rate increased
Clinical narrative: Ten minutes after vaccination pt reports feeling dizzy, lightheaded, and chest tightness. Nurse observed increased HR, decreased BP, thready pulse, pt looks pale, feels cool and clammy. Pt recovered 1 hour after onset of symptoms mentioned above.
Age: 13.0
Sex: F
Vaccine: FLU3, HPV4, MNQ, TDAP
Symptoms: Pallor, Pulse abnormal
Clinical narrative: Ten minutes after vaccination pt reports feeling dizzy, lightheaded, and chest tightness. Nurse observed increased HR, decreased BP, thready pulse, pt looks pale, feels cool and clammy. Pt recovered 1 hour after onset of symptoms mentioned above.
Age: 19.0
Sex: F
Vaccine: FLU3
Symptoms: Urticaria
Clinical narrative: Hives upper abd & ant. thighs bilat.
Age: 16.0
Sex: F
Vaccine: FLU3
Symptoms: Expired drug administered
Clinical narrative: Patient was administered expired Flu vaccine on 12/01/10.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Pt received ZOSTAVAX & still got shingles.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR, PNC13, VARCEL
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: (L) upper arm red, warm, swollen shoulder to elbow - non tender Nl ROM of arm.
Age: 57.0
Sex: F
Vaccine: MMR
Symptoms: Joint swelling, Oedema peripheral, Pyrexia
Clinical narrative: MMR administered 11-22-10 on 12-6-10 pt called clinic. C/o "can't walk due to feet swollen & joints of both big toes, hands swollen esp index & middle fingers of both hands, (R) knee swollen & had fever 101 degrees on 12-5-10 no fever today. Pt to call Dr - PCP.
Age: 0.51
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Abnormal faeces, Culture stool positive, Diarrhoea, Rotavirus test positive, Vomiting
Clinical narrative: Vaccine given on 11/1. By at least 10 days later explosive smelly stool started up to 4x day. Diarrhea continued when vomiting of solids started & now vomiting of formula.
Age: 8.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Patient received influenza vaccine 12/1/10 and called 12/2/10 to report arm red and swollen where received vaccine. On 12/3/10 came into office to have checked left upper arm from injection site (deltoid) to antecubital red, swollen, tense, itchy per patient.
Age: 36.0
Sex: F
Vaccine: MMR, TDAP
Symptoms: Headache, Nausea, Pain in extremity, Pyrexia, Swelling
Clinical narrative: Patient presented with pain and swelling on left arm, fever, headache and nausea. Treated with MOTRIN and cold compress at home.
Sex: U
Vaccine: RV1
Symptoms: Abdominal pain, Haematochezia
Clinical narrative: This case was reported by a physician via a sales representative and described the occurrence of cramping in a subject of unspecified age (sales representative thought that the subject was a 2 month old because this was the subject's 1st dose of ROTARIX) and gender who was vaccinated with ROTARIX (GlaxoSmithKline). On an unspecified date the subject received 1st dose of ROTARIX at 1 ml orally. At an unspecified time after vaccination with ROTARIX, the subject experienced cramping and blood in stools. At the time of reporting the outcome of the events was unspecified.
Age: 16.0
Sex: F
Vaccine: MNQ
Symptoms: Headache, Nasopharyngitis, Visual impairment
Clinical narrative: The initial case was received on 04 November 2010 from a healthcare professional. A 16 year old female patient received on 23 August 2010 an injection of MENACTRA (lot number not reported). On 29 October 2010, she experienced "seeing spots" and a headache. Her physician contributed it to having a "cold". She had a physical on 26 October 2010 and "all systems checked out" okay and her vision was 20/20 in both eyes. The patient had no illness at the time of the vaccination. She had no concomitant medications. Her pre-existing medical conditions included chronic back pain and headaches (she had fallen from a horse years ago). She was evaluated by an ophthalmologist on 29 October 2010 and was referred to a neurologist. No further information was provided. The patient's recovery status was unknown. Documents held by sender: None.
Age: 15.0
Sex: F
Vaccine: MNQ
Symptoms: Headache, Musculoskeletal stiffness, Overdose, Pyrexia
Clinical narrative: Initial report received from a health care professional on 12 November 2010. A 15-year-old female patient, with a history of a "cold" with upper respiratory symptoms at the time of vaccination, received the first dose of MENACTRA on 04 June 2010 and then again on 29 October 2010 an injection (route and site not provided) of MENACTRA, lot numbers not reported. On an unknown date in October 2010 and after the second MENACTRA, the patient developed a stiff neck, severe headache and a fever of 102.6. No further information was provided. The outcome was not reported. Documents held by sender: None.
Age: 12.0
Sex: F
Vaccine: HPV4, HPV4, MNQ, TDAP
Symptoms: Autoimmune hepatitis, Liver transplant, Myelitis transverse, Renal failure
Clinical narrative: 8/11/07 - First injection. 9/07 - Amenorrhea, hair loss, wart (scalp). 10/3/07 - Second injection. 2/08 - Third injection - See attachment.
Age: 12.0
Sex: F
Vaccine: HPV4, HPV4, MNQ, TDAP
Symptoms: Alopecia, Amenorrhoea, Hepatic enzyme increased, Skin papilloma
Clinical narrative: 8/11/07 - First injection. 9/07 - Amenorrhea, hair loss, wart (scalp). 10/3/07 - Second injection. 2/08 - Third injection - See attachment.
Age: 63.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Guillain-Barre syndrome
Clinical narrative: Guillain Barre syndrome, ascending paralysis and sensory loss, autonomic dysfunction
Age: 63.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Autonomic nervous system imbalance, Demyelination, Electromyogram abnormal, Guillain-Barre syndrome, Hypertension
Clinical narrative: Guillain Barre syndrome, ascending paralysis and sensory loss, autonomic dysfunction
Age: 63.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Nerve conduction studies abnormal, Nuclear magnetic resonance imaging abnormal, Reversible posterior leukoencephalopathy syndrome, Sensory loss
Clinical narrative: Guillain Barre syndrome, ascending paralysis and sensory loss, autonomic dysfunction
Age: 13.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Concussion, Head injury, Syncope
Clinical narrative: Initial report received on 23 Nov 2010 from a health care professional: This patient was vaccinated with FLUVIRIN (batch 111815P1), at an unknown dose intramuscularly on 06 Nov 2010. It was reported that approximately 4 minutes after the vaccination the patient got up to drink water and fainted. The patient bent over to take a drink and when he stood upright again, his blood pressure dropped so low that he fell to the floor backward, severely hitting the head on the floor. The patient regained consciousness almost immediately but exhibited signs of mild seizures. The paramedics were called and the patient was transferred to the hospital. Due to severe concussion the patient was kept in the ICU until 07 Nov 2010. The patient was discharged on 07 Nov 2010. It was reported that the patient had received flu vaccines for many years and had never had a reaction before. Final outcome of the patient was reported to be improving.
Age: 13.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Blood pressure decreased, Concussion, Convulsion, Fall, Head injury
Clinical narrative: Initial report received on 23 Nov 2010 from a health care professional: This patient was vaccinated with FLUVIRIN (batch 111815P1), at an unknown dose intramuscularly on 06 Nov 2010. It was reported that approximately 4 minutes after the vaccination the patient got up to drink water and fainted. The patient bent over to take a drink and when he stood upright again, his blood pressure dropped so low that he fell to the floor backward, severely hitting the head on the floor. The patient regained consciousness almost immediately but exhibited signs of mild seizures. The paramedics were called and the patient was transferred to the hospital. Due to severe concussion the patient was kept in the ICU until 07 Nov 2010. The patient was discharged on 07 Nov 2010. It was reported that the patient had received flu vaccines for many years and had never had a reaction before. Final outcome of the patient was reported to be improving.
Age: 13.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Intensive care, Loss of consciousness, Syncope
Clinical narrative: Initial report received on 23 Nov 2010 from a health care professional: This patient was vaccinated with FLUVIRIN (batch 111815P1), at an unknown dose intramuscularly on 06 Nov 2010. It was reported that approximately 4 minutes after the vaccination the patient got up to drink water and fainted. The patient bent over to take a drink and when he stood upright again, his blood pressure dropped so low that he fell to the floor backward, severely hitting the head on the floor. The patient regained consciousness almost immediately but exhibited signs of mild seizures. The paramedics were called and the patient was transferred to the hospital. Due to severe concussion the patient was kept in the ICU until 07 Nov 2010. The patient was discharged on 07 Nov 2010. It was reported that the patient had received flu vaccines for many years and had never had a reaction before. Final outcome of the patient was reported to be improving.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Amenorrhoea
Clinical narrative: Amennorhea - missed two menstrual periods following first Gardasil injection.  Patient was taking hormonal contraceptives at the time and never missed a menstrual period before.  Patient was not pregnant.  Menstrual periods resumed after two missed months.
Age: 60.0
Sex: F
Vaccine: FLUX, FLUX(H1N1)
Symptoms: Musculoskeletal pain, Pain in extremity
Clinical narrative: Severe pain in left shoulder.  At the time of filling out this document, pain goes from shoulder to elbow.  I have taken pain relievers and Mobid.  I have used ice and heat.
Age: 54.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Rotator cuff syndrome
Clinical narrative: Morning after flu vaccine (R) upper arm sore and noted significant soreness in (R) upper arm when removing clothing over my head. These symptoms gradually worsened over 3 wks. At 3 weeks visit to my F.P. MD et he diagnosed supraspinatus tendonitis (R) shoulder. Followed with home P.T. at 5 weeks symptoms persist, but at times are improved. No previous injury or pain history to (R) shoulder.
Age: 62.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity
Clinical narrative: Pt came in today (12-6-10) and complained about their arm still hurting from a shot given on 10-9-10, she said she had been taking ALEVE and APAP but her arm still hurts. I told her I would make a report and to see her own doctor.
Age: 7.0
Sex: F
Vaccine: FLU3
Symptoms: Expired drug administered
Clinical narrative: Patient was administered expired FLUZONE on 12/01/10.
Age: 10.0
Sex: F
Vaccine: FLU3
Symptoms: Expired drug administered
Clinical narrative: Patient was administered expired FLUZONE on 12/01/10.
Age: 7.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Rash macular
Clinical narrative: Receive Flu vacc .5cc inj. on 12/3/10; injection site red, itchy, swollen x 3d, non-tender, local splotchy, non-raised, (L) upper arm; physician prescribed DIPROLENE AF to apply locally BID and p.o BENADRYL 3 tsps q. 6 hours when she saw the pt. today.
Age: 39.0
Sex: F
Vaccine: FLU3
Symptoms: Injected limb mobility decreased, Injection site pain, Pain in extremity
Clinical narrative: Left arm pain from shoulder to hand. Hand pain has since gone away, arm pain remains. Movement of arm is minimal.
Age: 64.0
Sex: F
Vaccine: FLU3
Symptoms: Inappropriate schedule of drug administration, Nausea, Vomiting
Clinical narrative: Given high dose Flu shot in error - 4 hours after shot became nauseated - vomited repeatedly 12-6-10 until nothing left - recovered - back to work this AM - was fine prior to getting Flu shot.
Age: 80.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Nausea, Vomiting
Clinical narrative: In for Flu shot received high dose Flu shot around 11AM - nauseated 3p - vomited repeatedly all pm 12-6-10 - weak - nauseated 23 hours later - recovering.
Age: 0.77
Sex: F
Vaccine: HEP
Symptoms: Chapped lips, Hypersensitivity, Lip haemorrhage, Lip swelling, Skin discolouration
Clinical narrative: Swollen Lips, Cracked/Bleeding, Top lip touching nose. Treated with Benadryl, ER visit followed by steroids for allergic reaction. Onset approximately 1-2 hrs. after administration. Next day blue/purplish discoloration of face & forehead again for approximately 2 weeks.  Discoloration first began with child one day after first set of immunizations and continued until after 6 month immunizations.  During the break between her 6 and 9 month vaccines, the discoloration had ceased.  It was not until after her 9 month Hep B vaccine did I realize the discoloration was from vaccines.
Age: 1.3
Sex: M
Vaccine: DTAP, FLU3, HEPA, HIBV
Symptoms: Injection site discolouration, Injection site erythema, Injection site mass
Clinical narrative: Bump 2cm x 2cm with reddish blue discoloration on thigh - was decreased significantly by office visit time per mom.
Age: 9.0
Sex: M
Vaccine: FLU3, PNC13
Symptoms: Injection site erythema, Injection site pruritus, Injection site rash, Injection site swelling
Clinical narrative: Approx. 16 hrs after injection ptn. began with itchy red swollen warm rash over injection site. Approx 6"x8".
Age: 66.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injected limb mobility decreased, Injection site induration, Injection site pain
Clinical narrative: Firmness Lt arm - T-97.2. Pt received Pneumo vaccine LT deltoid IM on 11-30-10 10:35. At bedtime unable to lie on left arm due to pain. Called nurse 12-2-10. Advised to come in. No redness no fever. Area tender. Advised ice packs and Ibuprofen, move arm. Doctor PAC notified.
Age: 58.0
Sex: F
Vaccine: FLU3
Symptoms: Lymphadenitis, Rotator cuff syndrome
Clinical narrative: Tendonitis in shoulder rotator cuff tendonitis.
Age: 70.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Aspiration joint, Inflammation, Injection site pain, Injection site swelling, Joint range of motion decreased
Clinical narrative: Patient developed pain and swelling over the right upper arm and right shoulder area within few hours of vaccine (pneumonia vaccine) administration. Continues to have limitation ROM on day # 15. Inflammation & rotator cuff tear on MRI.
Age: 70.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Musculoskeletal pain, Nuclear magnetic resonance imaging abnormal, Rotator cuff syndrome, X-ray
Clinical narrative: Patient developed pain and swelling over the right upper arm and right shoulder area within few hours of vaccine (pneumonia vaccine) administration. Continues to have limitation ROM on day # 15. Inflammation & rotator cuff tear on MRI.
Age: 81.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site mass, Injection site pruritus, Mass, Scratch
Clinical narrative: Large bump in shot injection area, itched for 4 days & I scratched it in my sleep & also when I wakened (as well) one night. When I arose for the day, I noticed the entire bump which had a white center had moved down my arm to a new site. This event was foreign to our culture. I believe it was a parasite. I persistently used alcohol, peroxide, and CALADRYL. The bump is gone.
Age: 56.0
Sex: M
Vaccine: FLU3
Symptoms: Respiratory distress, Urticaria
Clinical narrative: Pt broke out in severe hives all over his body and pt had respiratory distress. It started on the following day at 10:30 PM and lasted until the morning when pt finally went to the E.R. around noon. Physician at E.R. gave pt Prednisone and ATARAX.
Age: 7.0
Sex: F
Vaccine: DT
Symptoms: Erythema, Oedema peripheral, Tenderness
Clinical narrative: Redness and swollen on Right arm. Tender to touch and was given AUGMENTIN 250/125 mg #30 tab only.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Immediate post-injection reaction, Injection site erythema, Injection site pruritus
Clinical narrative: Redness and itching at injection site immediately following injection. BENADRYL 50 mg PO given. Prednisone 60 mg PO given for persistent upper body itching.
Age: 67.0
Sex: M
Vaccine: VARCEL
Symptoms: Biopsy bone marrow abnormal, Biopsy skin abnormal, Bone marrow granuloma, CD4 lymphocytes decreased, Granuloma
Clinical narrative: Information has been received from a physician concerning a male patient with a history of lymphoma who received a BMT in 2006, had a relapse in 2009 and responded completely to chemotherapy.  In May 2010 his primary care physician administered him a dose of VARIVAX (Oka/Merck) (lot # not reported).  In July 2010 the patient developed shingles on the T4 dermatome and was given a short course of acyclovir.  In September 2010 another episode on his face in VI distribution was reported.  Then October 2010 was the same distribution.  The patient was transferred to a hospital with pancytopenia, a bone marrow biopsy with granuloma, and skin biopsy showed Herpes viral inclusions with granulomas on his back lesions.  His CD4 on approximately 26-NOV-2010, just came back this morning at 53.  On 29-NOV-2010, the patient still had large lesions on his nose and forehead and back.  The facial lesions were present since mid October.  It was also reported that the skin biopsy was growing varicella ("and the reporter also noted that this was suspected varivax dissemination").  The patient had a hepatitis that they had biopsied and necrotizing granulomas on bone marrow.  The Infectious Disease faculty had started that patient on IV acyclovir and noted that the lesions were presumed to be crusted and resolving, but they were clearly active.  The patient was enrolled in the Varicella Zoster Virus Identification Program to identify if VZV is present and if it is present, to identify if it is associated with the wild-type VZV strain or with the OKA/Merck vaccine strain.  Upon internal review pancytopenia was considered an other important medical event.  Additional information has been requested.
Age: 67.0
Sex: M
Vaccine: VARCEL
Symptoms: Hepatitis, Herpes zoster, Pancytopenia, Skin lesion, Varicella
Clinical narrative: Information has been received from a physician concerning a male patient with a history of lymphoma who received a BMT in 2006, had a relapse in 2009 and responded completely to chemotherapy.  In May 2010 his primary care physician administered him a dose of VARIVAX (Oka/Merck) (lot # not reported).  In July 2010 the patient developed shingles on the T4 dermatome and was given a short course of acyclovir.  In September 2010 another episode on his face in VI distribution was reported.  Then October 2010 was the same distribution.  The patient was transferred to a hospital with pancytopenia, a bone marrow biopsy with granuloma, and skin biopsy showed Herpes viral inclusions with granulomas on his back lesions.  His CD4 on approximately 26-NOV-2010, just came back this morning at 53.  On 29-NOV-2010, the patient still had large lesions on his nose and forehead and back.  The facial lesions were present since mid October.  It was also reported that the skin biopsy was growing varicella ("and the reporter also noted that this was suspected varivax dissemination").  The patient had a hepatitis that they had biopsied and necrotizing granulomas on bone marrow.  The Infectious Disease faculty had started that patient on IV acyclovir and noted that the lesions were presumed to be crusted and resolving, but they were clearly active.  The patient was enrolled in the Varicella Zoster Virus Identification Program to identify if VZV is present and if it is present, to identify if it is associated with the wild-type VZV strain or with the OKA/Merck vaccine strain.  Upon internal review pancytopenia was considered an other important medical event.  Additional information has been requested.
Age: 67.0
Sex: M
Vaccine: VARCEL
Symptoms: Varicella virus test
Clinical narrative: Information has been received from a physician concerning a male patient with a history of lymphoma who received a BMT in 2006, had a relapse in 2009 and responded completely to chemotherapy.  In May 2010 his primary care physician administered him a dose of VARIVAX (Oka/Merck) (lot # not reported).  In July 2010 the patient developed shingles on the T4 dermatome and was given a short course of acyclovir.  In September 2010 another episode on his face in VI distribution was reported.  Then October 2010 was the same distribution.  The patient was transferred to a hospital with pancytopenia, a bone marrow biopsy with granuloma, and skin biopsy showed Herpes viral inclusions with granulomas on his back lesions.  His CD4 on approximately 26-NOV-2010, just came back this morning at 53.  On 29-NOV-2010, the patient still had large lesions on his nose and forehead and back.  The facial lesions were present since mid October.  It was also reported that the skin biopsy was growing varicella ("and the reporter also noted that this was suspected varivax dissemination").  The patient had a hepatitis that they had biopsied and necrotizing granulomas on bone marrow.  The Infectious Disease faculty had started that patient on IV acyclovir and noted that the lesions were presumed to be crusted and resolving, but they were clearly active.  The patient was enrolled in the Varicella Zoster Virus Identification Program to identify if VZV is present and if it is present, to identify if it is associated with the wild-type VZV strain or with the OKA/Merck vaccine strain.  Upon internal review pancytopenia was considered an other important medical event.  Additional information has been requested.
Age: 15.0
Sex: U
Vaccine: PPV
Symptoms: Acute disseminated encephalomyelitis
Clinical narrative: Information has been received from a physician concerning a 15 year old patient who on an unknown date was vaccinated with a dose of PNEUMOVAX 23 (lot # not reported). The reporter stated that after receiving PNEUMOVAX 23 the patient developed an acute disseminated encephalomyelitis. At the time of reporting, the outcome of the patient was unknown. It was unknown if the patient sought medical attention. The reporter was not the patient's physician. Upon internal review, acute disseminated encephalomyelitis was determined to be an other important medical event. Additional information has been requested.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Amnesia, Brain oedema, Brain scan abnormal, Coma, Dizziness
Clinical narrative: Information has been received from a pharmacist concerning an approximately 65 year-old female with a history of muscular weakness while taking LIPITOR who on 16-MAR-2010 was vaccinated subcutaneously with 0.65ml ZOSTAVAX (Oka/Merck) (lot # 664350/0957Y) in the right arm.  The pharmacist recently found out the patient felt faint and dizzy sometime post vaccination.  The pharmacist did not know when symptoms began.  The patient fell down the stairs on 23-MAY-2010.  She felt lightheaded when she stood up and then fell down steps.  She was taken to the hospital with a hematoma and broken ribs.  After a brain scan (no result reported) in the Emergency Room she was medically transferred by helicopter to another hospital.  She was admitted for 3-4 days.  She was discharged to home and then became lethargic, ill and not functioning.  She was taken to hospital and diagnosed with brain swelling and went into a coma.  She was transferred to the neurologic intensive care unit.  She was hospitalized for 3 weeks and was comatose most of time.  Since returning home she has experienced short term memory loss.  At the time of report, the outcome was unknown.  The patient took about 16 different unknown medications and was not taking LIPITOR at the time of the fall.  Additional information has been requested.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Fall, Haematoma, Intensive care, Lethargy, Malaise
Clinical narrative: Information has been received from a pharmacist concerning an approximately 65 year-old female with a history of muscular weakness while taking LIPITOR who on 16-MAR-2010 was vaccinated subcutaneously with 0.65ml ZOSTAVAX (Oka/Merck) (lot # 664350/0957Y) in the right arm.  The pharmacist recently found out the patient felt faint and dizzy sometime post vaccination.  The pharmacist did not know when symptoms began.  The patient fell down the stairs on 23-MAY-2010.  She felt lightheaded when she stood up and then fell down steps.  She was taken to the hospital with a hematoma and broken ribs.  After a brain scan (no result reported) in the Emergency Room she was medically transferred by helicopter to another hospital.  She was admitted for 3-4 days.  She was discharged to home and then became lethargic, ill and not functioning.  She was taken to hospital and diagnosed with brain swelling and went into a coma.  She was transferred to the neurologic intensive care unit.  She was hospitalized for 3 weeks and was comatose most of time.  Since returning home she has experienced short term memory loss.  At the time of report, the outcome was unknown.  The patient took about 16 different unknown medications and was not taking LIPITOR at the time of the fall.  Additional information has been requested.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Rib fracture
Clinical narrative: Information has been received from a pharmacist concerning an approximately 65 year-old female with a history of muscular weakness while taking LIPITOR who on 16-MAR-2010 was vaccinated subcutaneously with 0.65ml ZOSTAVAX (Oka/Merck) (lot # 664350/0957Y) in the right arm.  The pharmacist recently found out the patient felt faint and dizzy sometime post vaccination.  The pharmacist did not know when symptoms began.  The patient fell down the stairs on 23-MAY-2010.  She felt lightheaded when she stood up and then fell down steps.  She was taken to the hospital with a hematoma and broken ribs.  After a brain scan (no result reported) in the Emergency Room she was medically transferred by helicopter to another hospital.  She was admitted for 3-4 days.  She was discharged to home and then became lethargic, ill and not functioning.  She was taken to hospital and diagnosed with brain swelling and went into a coma.  She was transferred to the neurologic intensive care unit.  She was hospitalized for 3 weeks and was comatose most of time.  Since returning home she has experienced short term memory loss.  At the time of report, the outcome was unknown.  The patient took about 16 different unknown medications and was not taking LIPITOR at the time of the fall.  Additional information has been requested.
Age: 44.0
Sex: F
Vaccine: DTAP
Symptoms: Oedema peripheral, Pain, Pruritus, Pyrexia
Clinical narrative: Swelling of area, itching, fever of 100.1 orally, body aches
Age: 36.0
Sex: F
Vaccine: FLU(H1N1), PPV
Symptoms: Dyspnoea, Erythema, Myalgia, Pain, Pruritus
Clinical narrative: Swelling, pain, redness, shortness of breath, myalgia, itching. Seen by provider in office 12-2 initially.
Age: 36.0
Sex: F
Vaccine: FLU(H1N1), PPV
Symptoms: Swelling, White blood cell count increased
Clinical narrative: Swelling, pain, redness, shortness of breath, myalgia, itching. Seen by provider in office 12-2 initially.
Age: 7.0
Sex: F
Vaccine: FLU3
Symptoms: Hypersensitivity, Injection site urticaria, Urticaria
Clinical narrative: Hives broke out on arm from injection site to wrist on the arm where seasonal influenza vaccine was given.  Child has recieved both seasonal flu vaccine and H1N1 flu vaccine in the past.  No history of prior egg allergy or chicken allergy or other known allergies. Mother recognized allergic reaction and administered appropriate dose of Benadryl.  She contacted her child's PCP and informed; not seen but they suggested it was due to seasonal flu vaccine.
Age: 67.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Contusion, Oedema peripheral
Clinical narrative: Bruising and swelling down the length of the Left arm
Age: 33.0
Sex: F
Vaccine: FLU3
Symptoms: Impaired work ability, Pain, Tenderness
Clinical narrative: My entire arm from the middle of my neck (C3) to the tips of my fingers and into my chest and back sternum to spine down to about T7 felt extremely tender like I had shut it in a door, and I couldn't put pressure on my hand without shooting pains up into my neck, and movement also caused pain it lasted until about 4pm and then it is still a little sore now and it is 12-07-10 but the real pain is gone. I couldn't work on Sunday and had to call out.
Age: 62.0
Sex: F
Vaccine: FLU3
Symptoms: Condition aggravated, Erosive oesophagitis, Gastritis erosive, Gastrooesophageal reflux disease, Histamine level increased
Clinical narrative: Immediately after receiving flu vaccine, I had an immune response reaction. The histamines rose in my body and my acid reflux went into severe mode. I now have erosive esophagitis & terrible stomach lining erosion. I'm on 3 meds: ACIPHEX, ZANTAC, MAALOX.
Age: 62.0
Sex: F
Vaccine: FLU3
Symptoms: Immediate post-injection reaction, Vaccination complication
Clinical narrative: Immediately after receiving flu vaccine, I had an immune response reaction. The histamines rose in my body and my acid reflux went into severe mode. I now have erosive esophagitis & terrible stomach lining erosion. I'm on 3 meds: ACIPHEX, ZANTAC, MAALOX.
Age: 60.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain
Clinical narrative: The pt has had pain at the injection site since the vaccination. It has improved a little but it isn't gone.
Age: 14.0
Sex: M
Vaccine: FLU3, HPV4
Symptoms: Hypotonia, Pallor
Clinical narrative: Child in exam room with mom. Injections given. Timer set 10 minutes. After 5 minutes, mom yells out, entered exam room to find child pale, slumped in chair. Put head between knees, applied cool cloth to neck and forehead. Talking to child entire time. Recovered approx 1 minute. Given H2O. Waited approx 7 minutes. Left office alert.
Age: 17.0
Sex: F
Vaccine: FLU3, HPV4
Symptoms: Amnesia, Convulsion
Clinical narrative: Nurse giving injection, patient and mom were present when apparent seizure took place. I was called stat to room where pt was sitting in a chair. Apparently patient was sitting on exam table when the HPV (2nd inj) was given and she began her seizure activity. She is amnestic of event.
Age: 0.35
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Abdominal distension, C-reactive protein increased, Diarrhoea, Full blood count normal, Pyrexia
Clinical narrative: Fever & abdominal distention with explosive stools, abd ultrasound = some bowel distension with minimal amounts of extra fluid scattered throughout bowel, no intussusception, nl UA, nl CBC, CRP = 1.4 (high).
Age: 0.35
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Ultrasound abdomen abnormal, Urine analysis normal
Clinical narrative: Fever & abdominal distention with explosive stools, abd ultrasound = some bowel distension with minimal amounts of extra fluid scattered throughout bowel, no intussusception, nl UA, nl CBC, CRP = 1.4 (high).
Age: 51.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Erythema, Mobility decreased, Oedema peripheral, Skin warm
Clinical narrative: On 11-15 the nurse on the I.M.U. floor administered a flu and pneumonia shots to my left upper arm. That night I awoke to a very swollen, hot, red arm. Unable to use the arm for 4 days and it stayed red, swollen for 4 days.
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Injection site cellulitis, Injection site erythema, Injection site streaking, Injection site swelling
Clinical narrative: Patient seen day after vaccine with redness, swelling, streaking near injection site. Will be seen again to reevaluate. Started on antibiotics for cellulitis.
Age: 50.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Full blood count, Injection site abscess, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Redness extending from elbow to shoulder, swelling, pain developing within a few hours of vaccine. Treated with IM ROCEPHIN, and then admitted to hospital for IV antibiotics.
Age: 50.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Pain, Swelling
Clinical narrative: Redness extending from elbow to shoulder, swelling, pain developing within a few hours of vaccine. Treated with IM ROCEPHIN, and then admitted to hospital for IV antibiotics.
Age: 28.0
Sex: F
Vaccine: FLU3, HEP, MMR, TDAP
Symptoms: Dysaesthesia, Hypoaesthesia, Paraesthesia
Clinical narrative: 6 wk hx of numbness, paresthesia, dysesthesia in LE's. Had flu vaccine 10/19/10.
Age: 25.0
Sex: F
Vaccine: FLU3
Symptoms: Mobility decreased, Musculoskeletal pain, Sleep disorder
Clinical narrative: 7-10 days after vaccine, left shoulder pain, posterior to injection site, along tendon began hurting. Limited ROM, unable to sleep on Lt side. Lasted around 1 week, gone after using heating pad x 2 days. Pain returned around 3 weeks later 11/29/10, limited ROM & unable to sleep on Lt side. Worse in am. No nodule or swelling. Pain better 4 days later, still present, though after heating pad.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Rash pruritic
Clinical narrative: Pruritic morbilliform skin rash. Treated with oral corticosteroid & topical corticosteroids.
Age: 17.0
Sex: M
Vaccine: FLU3
Symptoms: Dyspnoea, Malaise, Pyrexia, Urticaria
Clinical narrative: 5 hrs after vaccination started "feeling sick" next am he woke up with hives on face then fever & dyspnea - hives progressed to chest - then back, arms, butt & legs approx 40hrs after vaccination hives increased in intensity 100%.
Age: 47.0
Sex: F
Vaccine: IPV
Symptoms: Back pain, Hypoaesthesia, Muscle spasms, Vaccine positive rechallenge
Clinical narrative: 11/29/10 Pt called and c/o back pain stabbing through to front and right arm numbness starting with fingers and moving up arm, and muscle spasms started to next day after receiving second Inj Polio vaccine; woke up that AM with symptoms really bad at first. Heat pad to back all weekend helped some. C/O exact same symptoms after first Inj. Polio vaccine but thought it was stress from school. 11/29/10 11:30AM refer to emerg room. Pt also received 11/22/10 HBV Adult dose Health Dept and #2 dose MMR II subQ Rt Arm Lot 0254Z Health Dept.
Age: 1.13
Sex: U
Vaccine: FLU3, MMR, VARCEL
Symptoms: Injection site papule, Papule
Clinical narrative: Papules legs & arms.
Age: 74.0
Sex: F
Vaccine: FLUX
Symptoms: Urticaria
Clinical narrative: Had flu shot on late afternoon Oct 7 - a few hives began appearing on Sat & were full blown from head to toe Sat. Sun Mon - went to Dr on 10/11/10 steroids & BENADRYL 2 more days of hives then went away.
Age: 28.0
Sex: F
Vaccine: FLU3
Symptoms: Cold sweat, Dizziness, Feeling hot, Immediate post-injection reaction, Injection site haemorrhage
Clinical narrative: Immediately after inj, there was slight bleeding. A cotton ball was applied. Local site began to swell. Pt was asked how she was feeling. Soon after she felt lightheaded "like fainting". 911 was called. Pt got hot & clammy & "felt like passing out", but remained conscious. EMTs arrived, checked pt - was stabilizing - bp ok- pt signed waiver of release. Dx: 'syncope episode'. Bump at site went down.
Age: 28.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site mass, Injection site swelling, Presyncope, Syncope
Clinical narrative: Immediately after inj, there was slight bleeding. A cotton ball was applied. Local site began to swell. Pt was asked how she was feeling. Soon after she felt lightheaded "like fainting". 911 was called. Pt got hot & clammy & "felt like passing out", but remained conscious. EMTs arrived, checked pt - was stabilizing - bp ok- pt signed waiver of release. Dx: 'syncope episode'. Bump at site went down.
Age: 42.0
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Bacterial infection, Chest X-ray abnormal, Gastrostomy, Hypoxia, Ill-defined disorder
Clinical narrative: Initial report was retrieved from the scientific literature on 30 November 2010. A 42-year-old male patient received an injection of H1N1 (lot number UP005A) on 22 October 2009. The patient was bedridden and resided in a long-term care facility; medical history included tonic-clonic epilepsy and spastic quadriplegia, for which he was treated with an anticonvulsant and tranquilizer. He had a feeding gastrostomy. He experienced no vaccine-related adverse events following vaccination, and had previously received inactivated trivalent seasonal influenza vaccine (2000 through 2009) and pneumococcal vaccine. On Day 41 following vaccination, he suddenly became seriously ill with a fever and hypoxemia. He had no cough, rhinorrhea, jaundice, rash or diarrhea; pharynx was not injected or edematous. A nasopharyngeal swab, using rapid-enzyme immunoassay, was positive for influenza A, and subsequent reverse transcriptase-polymerase chain reaction was positive for influenza A subtype H1 swine-like virus (wild type pH1N1). The patient was treated with OSELTAMIVIR and supplemental oxygen, and kept in a single-patient room with droplet and standard infection-control precautions. On Day 2 of his illness, the patient experienced greater respiratory distress. Leukocyte count was 15,5000 uL (normal 4000-10, 5000 uL), and a chest radiograph at that time revealed right middle and upper lobe pneumonia. He was treated with intravenous antibiotics, and subsequent radiographs showed improvement by Day 9; the patient was considered to be fully recovered on Day 22.
Age: 42.0
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Immunology test, Influenza, Influenza A virus test positive, Pneumonia, Polymerase chain reaction
Clinical narrative: Initial report was retrieved from the scientific literature on 30 November 2010. A 42-year-old male patient received an injection of H1N1 (lot number UP005A) on 22 October 2009. The patient was bedridden and resided in a long-term care facility; medical history included tonic-clonic epilepsy and spastic quadriplegia, for which he was treated with an anticonvulsant and tranquilizer. He had a feeding gastrostomy. He experienced no vaccine-related adverse events following vaccination, and had previously received inactivated trivalent seasonal influenza vaccine (2000 through 2009) and pneumococcal vaccine. On Day 41 following vaccination, he suddenly became seriously ill with a fever and hypoxemia. He had no cough, rhinorrhea, jaundice, rash or diarrhea; pharynx was not injected or edematous. A nasopharyngeal swab, using rapid-enzyme immunoassay, was positive for influenza A, and subsequent reverse transcriptase-polymerase chain reaction was positive for influenza A subtype H1 swine-like virus (wild type pH1N1). The patient was treated with OSELTAMIVIR and supplemental oxygen, and kept in a single-patient room with droplet and standard infection-control precautions. On Day 2 of his illness, the patient experienced greater respiratory distress. Leukocyte count was 15,5000 uL (normal 4000-10, 5000 uL), and a chest radiograph at that time revealed right middle and upper lobe pneumonia. He was treated with intravenous antibiotics, and subsequent radiographs showed improvement by Day 9; the patient was considered to be fully recovered on Day 22.
Age: 42.0
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Pyrexia, Respiratory distress, White blood cell count increased
Clinical narrative: Initial report was retrieved from the scientific literature on 30 November 2010. A 42-year-old male patient received an injection of H1N1 (lot number UP005A) on 22 October 2009. The patient was bedridden and resided in a long-term care facility; medical history included tonic-clonic epilepsy and spastic quadriplegia, for which he was treated with an anticonvulsant and tranquilizer. He had a feeding gastrostomy. He experienced no vaccine-related adverse events following vaccination, and had previously received inactivated trivalent seasonal influenza vaccine (2000 through 2009) and pneumococcal vaccine. On Day 41 following vaccination, he suddenly became seriously ill with a fever and hypoxemia. He had no cough, rhinorrhea, jaundice, rash or diarrhea; pharynx was not injected or edematous. A nasopharyngeal swab, using rapid-enzyme immunoassay, was positive for influenza A, and subsequent reverse transcriptase-polymerase chain reaction was positive for influenza A subtype H1 swine-like virus (wild type pH1N1). The patient was treated with OSELTAMIVIR and supplemental oxygen, and kept in a single-patient room with droplet and standard infection-control precautions. On Day 2 of his illness, the patient experienced greater respiratory distress. Leukocyte count was 15,5000 uL (normal 4000-10, 5000 uL), and a chest radiograph at that time revealed right middle and upper lobe pneumonia. He was treated with intravenous antibiotics, and subsequent radiographs showed improvement by Day 9; the patient was considered to be fully recovered on Day 22.
Age: 28.0
Sex: F
Vaccine: FLU3
Symptoms: Lymphadenopathy, Pain
Clinical narrative: Lymph node in shoulder area same side vaccine administered (Left deltoid) became swollen accompanied with pain when moving left arm, several hours after injection, no other symptoms presented.  Client had Tdap administered three weeks prior by private provider that also became swollen but with much less pain.  Current symptom was decreasing at time notified provider.
Age: 67.0
Sex: M
Vaccine: FLU3
Symptoms: Chills, Injection site pain, Pain
Clinical narrative: Patient reported having chills and aches and also local soreness in his arm the day after receiving the FluzoneHD vaccine lasting 2 days
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Skin warm
Clinical narrative: Redness, warm to touch next AM.  Area initially approximately 3"x3", increased to 6"x7".  No treatment except cool compress to area.
Age: 52.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Myalgia, Myositis, Pain, Tenderness
Clinical narrative: Seen 11/19/10 - 3 weeks of severe tenderness in (L) arm & shoulder/trapezius muscles. Unable to lie on (L) side. No redness, no fever or sxs of infection. Rx- MEDROL Dose pak for myositis -> Resolved but achy after Rx. dose -> Ibuprofen now.
Age: 27.0
Sex: F
Vaccine: TDAP
Symptoms: Dyspnoea
Clinical narrative: 1 1/4 hrs. after immunization - pt. became dyspneic, went to nearby clinic - was given epinephrine and O2. Returned to home in satisfactory condition.
Age: 29.0
Sex: F
Vaccine: FLUN3
Symptoms: Blood test, Erythema, Injection site pain, Nasal congestion, Skin warm
Clinical narrative: Vertigo local - redness, hot/warm to the touch, pain at injection site, swollen.
Age: 29.0
Sex: F
Vaccine: FLUN3
Symptoms: Urine analysis, Vertigo
Clinical narrative: Vertigo local - redness, hot/warm to the touch, pain at injection site, swollen.
Age: 8.0
Sex: M
Vaccine: HEPA
Symptoms: Arthralgia, Pain, Pain in extremity
Clinical narrative: C/o arm being sore for 3hrs after injection and then c/o pain and aching all over with arthralgia for several hrs in the evening of the same day.
Age: 55.0
Sex: F
Vaccine: FLU3
Symptoms: Pruritus generalised, Urticaria
Clinical narrative: Started feeling itchy everywhere...progressively worse by 8:30 PM.  Noticed welts forming.  Applied hydro cortisone cream.
Age: 52.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Skin warm
Clinical narrative: Local erythema and warmth.