chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 24.0
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Lymphadenopathy, Lymphocyte percentage decreased, Metabolic function test normal, Mobility decreased, Musculoskeletal stiffness
Clinical narrative: Receipt of primary SPV on 1/6/2012 to left deltoid. No other vaccines given and no recent illness reported. Site checked 1/12/2012 with reported good take and bandage changed prior to drive home. Upon arrival home he complained of being tired. He awoke 1/13/2012 complaining of diffuse body stiffness and achiness stating it was hard to move (all joints/muscles ached). He noted bilateral axillary and cervical lymph node swelling which made it difficult to put arms down by his sides or lift overhead. He called medical and was advised reactions were normal to SPV but to report any onset of chest pain. He took "500 mg" Naproxen with partial relief of body aches. That evening his symptoms worsened and he reported "someone was standing on his chest". He complained of a sharp pulsing pain (4-5/10) to mid chest "as if bruised" and it "hurt to deep breathe". He took more Naproxen and got into his families whirlpool. His pain again eased (3-4/10) with heat, NSAIDs and position). His severe pain (7/10) lasted about 20 minutes. His symptoms continued with this on and off pattern over next 24-48 hours until returning to work on 1/16/12 when co-workers noticed him rubbing his chest (2-3/10) and he was directed to medical. 1/17/12 EKG normal-no ST-T changes, labs - hepatic panel nl with ALT 42, CBC low h/h 13.1/37.1, RBC 4.13 and platelets 126, differential nl w high neutrophils 79.9 and low lymph 13.4, CK panel normal (no troponin levels or LFT/chol levels documented), BNP high 274, and normal CMP, TSH and ESR. His echo was done 2/1/12 were normal with EF 65%. During interview with facility on 2/1/2012, this patient continued to complain of intermittent bouts of quick sharp midsternal chest aches that made him catch his breath. Duration of discomfort was about 2-10 minutes every other day. His last episode was during his 2/1/12 echocardiogram (resolved in 2 minutes). He advised position was a trigger (lying flat, on left side) otherwise bouts would occur at any time or day or position. Discomfort eased by changing position and slowing his breathing down. He was not taking any medication routinely. He denies any pain or restriction in ADL, and runs 1.5 miles every other day and does 100 pushups and sit-ups daily. He did admit to some chest pain when starting pushups but says this was a different pain and was more muscular in pectoris muscles by axilla. As of 2/8/2012 patient advised he has not had any recurrence of chest pain since taking Naproxen. He denied any other systemic symptoms (shortness of breath, n/v/d, joint pain, et al). Has f/u appt with PCP 2/24 for 6-8 wk check up...
Age: 24.0
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Myalgia, Neutrophil percentage increased, Pain, Painful respiration, Platelet count decreased
Clinical narrative: Receipt of primary SPV on 1/6/2012 to left deltoid. No other vaccines given and no recent illness reported. Site checked 1/12/2012 with reported good take and bandage changed prior to drive home. Upon arrival home he complained of being tired. He awoke 1/13/2012 complaining of diffuse body stiffness and achiness stating it was hard to move (all joints/muscles ached). He noted bilateral axillary and cervical lymph node swelling which made it difficult to put arms down by his sides or lift overhead. He called medical and was advised reactions were normal to SPV but to report any onset of chest pain. He took "500 mg" Naproxen with partial relief of body aches. That evening his symptoms worsened and he reported "someone was standing on his chest". He complained of a sharp pulsing pain (4-5/10) to mid chest "as if bruised" and it "hurt to deep breathe". He took more Naproxen and got into his families whirlpool. His pain again eased (3-4/10) with heat, NSAIDs and position). His severe pain (7/10) lasted about 20 minutes. His symptoms continued with this on and off pattern over next 24-48 hours until returning to work on 1/16/12 when co-workers noticed him rubbing his chest (2-3/10) and he was directed to medical. 1/17/12 EKG normal-no ST-T changes, labs - hepatic panel nl with ALT 42, CBC low h/h 13.1/37.1, RBC 4.13 and platelets 126, differential nl w high neutrophils 79.9 and low lymph 13.4, CK panel normal (no troponin levels or LFT/chol levels documented), BNP high 274, and normal CMP, TSH and ESR. His echo was done 2/1/12 were normal with EF 65%. During interview with facility on 2/1/2012, this patient continued to complain of intermittent bouts of quick sharp midsternal chest aches that made him catch his breath. Duration of discomfort was about 2-10 minutes every other day. His last episode was during his 2/1/12 echocardiogram (resolved in 2 minutes). He advised position was a trigger (lying flat, on left side) otherwise bouts would occur at any time or day or position. Discomfort eased by changing position and slowing his breathing down. He was not taking any medication routinely. He denies any pain or restriction in ADL, and runs 1.5 miles every other day and does 100 pushups and sit-ups daily. He did admit to some chest pain when starting pushups but says this was a different pain and was more muscular in pectoris muscles by axilla. As of 2/8/2012 patient advised he has not had any recurrence of chest pain since taking Naproxen. He denied any other systemic symptoms (shortness of breath, n/v/d, joint pain, et al). Has f/u appt with PCP 2/24 for 6-8 wk check up...
Age: 24.0
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Red blood cell count decreased, Red blood cell sedimentation rate normal
Clinical narrative: Receipt of primary SPV on 1/6/2012 to left deltoid. No other vaccines given and no recent illness reported. Site checked 1/12/2012 with reported good take and bandage changed prior to drive home. Upon arrival home he complained of being tired. He awoke 1/13/2012 complaining of diffuse body stiffness and achiness stating it was hard to move (all joints/muscles ached). He noted bilateral axillary and cervical lymph node swelling which made it difficult to put arms down by his sides or lift overhead. He called medical and was advised reactions were normal to SPV but to report any onset of chest pain. He took "500 mg" Naproxen with partial relief of body aches. That evening his symptoms worsened and he reported "someone was standing on his chest". He complained of a sharp pulsing pain (4-5/10) to mid chest "as if bruised" and it "hurt to deep breathe". He took more Naproxen and got into his families whirlpool. His pain again eased (3-4/10) with heat, NSAIDs and position). His severe pain (7/10) lasted about 20 minutes. His symptoms continued with this on and off pattern over next 24-48 hours until returning to work on 1/16/12 when co-workers noticed him rubbing his chest (2-3/10) and he was directed to medical. 1/17/12 EKG normal-no ST-T changes, labs - hepatic panel nl with ALT 42, CBC low h/h 13.1/37.1, RBC 4.13 and platelets 126, differential nl w high neutrophils 79.9 and low lymph 13.4, CK panel normal (no troponin levels or LFT/chol levels documented), BNP high 274, and normal CMP, TSH and ESR. His echo was done 2/1/12 were normal with EF 65%. During interview with facility on 2/1/2012, this patient continued to complain of intermittent bouts of quick sharp midsternal chest aches that made him catch his breath. Duration of discomfort was about 2-10 minutes every other day. His last episode was during his 2/1/12 echocardiogram (resolved in 2 minutes). He advised position was a trigger (lying flat, on left side) otherwise bouts would occur at any time or day or position. Discomfort eased by changing position and slowing his breathing down. He was not taking any medication routinely. He denies any pain or restriction in ADL, and runs 1.5 miles every other day and does 100 pushups and sit-ups daily. He did admit to some chest pain when starting pushups but says this was a different pain and was more muscular in pectoris muscles by axilla. As of 2/8/2012 patient advised he has not had any recurrence of chest pain since taking Naproxen. He denied any other systemic symptoms (shortness of breath, n/v/d, joint pain, et al). Has f/u appt with PCP 2/24 for 6-8 wk check up...
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Injection site erythema, Injection site pain, Injection site warmth, Local reaction
Clinical narrative: Large golf-ball sized local reaction on (R) deltoid pink, warm, tender.
Sex: F
Vaccine: FLU3
Symptoms: Diarrhoea, Dizziness, Dysgeusia, Dyspnoea, Pruritus
Clinical narrative: Had flu shot and had metallic taste in mouth. Then started feeling dizzy and had shortness of breath. Pharmacist said she might need to go to ER. Case worker took her home she had some diarrhea and skin began to itch. Fiance came home took her to ER. Gave BENADRYL and sent home with BENADRYL p.o. No further problems.
Age: 4.0
Sex: M
Vaccine: DTAPIPVHIB, MMR, VARCEL
Symptoms: Joint swelling, Oedema peripheral, Weight bearing difficulty
Clinical narrative: Pt was given MMR & PENTACEL on (R) leg on 2/20/2012. Pt developed leg/knee swelling & soreness to where he couldn't bear weight for 24h. Swelling has now decreased & pt is now bearing weight.
Age: 60.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Arthralgia, Hypoaesthesia, Injection site erythema, Injection site swelling
Clinical narrative: Feverish, chills, took Tylenol and went to bed. 11/24/2011 awakened to trouble walking with left leg. Felt numbness in left cheek, arm and leg. Injection site very swollen, red, hot painful to the touch.  Arm painful to move.  Left hip, knee and foot numb and difficult to walk. 11/25/2011  employee health closed, left armpit and left groin felt swollen, trouble walking, left side of face non responsive to movement. Manager sent me to ER. On 11/28/2011 itching everywhere. Emp Health sent to  me to ER again. Given Benadryl and Prednisone. Still having issues today 022512.
Age: 60.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Blood glucose increased, Chills, Full blood count abnormal, Gait disturbance, Hemiparesis
Clinical narrative: Feverish, chills, took Tylenol and went to bed. 11/24/2011 awakened to trouble walking with left leg. Felt numbness in left cheek, arm and leg. Injection site very swollen, red, hot painful to the touch.  Arm painful to move.  Left hip, knee and foot numb and difficult to walk. 11/25/2011  employee health closed, left armpit and left groin felt swollen, trouble walking, left side of face non responsive to movement. Manager sent me to ER. On 11/28/2011 itching everywhere. Emp Health sent to  me to ER again. Given Benadryl and Prednisone. Still having issues today 022512.
Age: 60.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Hypoaesthesia, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Feverish, chills, took Tylenol and went to bed. 11/24/2011 awakened to trouble walking with left leg. Felt numbness in left cheek, arm and leg. Injection site very swollen, red, hot painful to the touch.  Arm painful to move.  Left hip, knee and foot numb and difficult to walk. 11/25/2011  employee health closed, left armpit and left groin felt swollen, trouble walking, left side of face non responsive to movement. Manager sent me to ER. On 11/28/2011 itching everywhere. Emp Health sent to  me to ER again. Given Benadryl and Prednisone. Still having issues today 022512.
Age: 60.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Laboratory test abnormal, Local swelling, Pain, Pruritus generalised, Pyrexia
Clinical narrative: Feverish, chills, took Tylenol and went to bed. 11/24/2011 awakened to trouble walking with left leg. Felt numbness in left cheek, arm and leg. Injection site very swollen, red, hot painful to the touch.  Arm painful to move.  Left hip, knee and foot numb and difficult to walk. 11/25/2011  employee health closed, left armpit and left groin felt swollen, trouble walking, left side of face non responsive to movement. Manager sent me to ER. On 11/28/2011 itching everywhere. Emp Health sent to  me to ER again. Given Benadryl and Prednisone. Still having issues today 022512.
Age: 60.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Swelling, Vaccination complication, White blood cell count increased
Clinical narrative: Feverish, chills, took Tylenol and went to bed. 11/24/2011 awakened to trouble walking with left leg. Felt numbness in left cheek, arm and leg. Injection site very swollen, red, hot painful to the touch.  Arm painful to move.  Left hip, knee and foot numb and difficult to walk. 11/25/2011  employee health closed, left armpit and left groin felt swollen, trouble walking, left side of face non responsive to movement. Manager sent me to ER. On 11/28/2011 itching everywhere. Emp Health sent to  me to ER again. Given Benadryl and Prednisone. Still having issues today 022512.
Age: 0.55
Sex: M
Vaccine: DTAP, FLUX, HEP, OPV, PPV, RVX
Symptoms: Chills, Crying, Decreased appetite, Hypotonia, Vomiting
Clinical narrative: 3pm shots administered. 6pm dinner time - no appetite. 10:45pm crying, no appetite, vomited once, had shivers, limp in the knees, cried until nursed to sleep. It's currently 11:45pm so I hope this is the end of these reactions to the vaccines.
Age: 27.0
Sex: F
Vaccine: TD
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Pt seen 2/25/2012-pt stated after vaccine had some redness, pruritis, swelling, pain, and warmth at injection site, had low-grade temperature of 99 last 2 days.  Has been taking ibuprofen 800 mg every 8 hours. Today redness, swelling and pain improved slightly.  Examined patient-had 5 cm area of erythema, moderate swelling, sl warm to touch.  As redness/pain improving, will do watchful waiting-continue ibuprofen, ice pack to area.  Pt to f/u at this clinic in 24 hours to re-eval site for worsening erythema or symptoms.
Age: 27.0
Sex: F
Vaccine: TD
Symptoms: Pyrexia
Clinical narrative: Pt seen 2/25/2012-pt stated after vaccine had some redness, pruritis, swelling, pain, and warmth at injection site, had low-grade temperature of 99 last 2 days.  Has been taking ibuprofen 800 mg every 8 hours. Today redness, swelling and pain improved slightly.  Examined patient-had 5 cm area of erythema, moderate swelling, sl warm to touch.  As redness/pain improving, will do watchful waiting-continue ibuprofen, ice pack to area.  Pt to f/u at this clinic in 24 hours to re-eval site for worsening erythema or symptoms.
Age: 53.0
Sex: F
Vaccine: MMR
Symptoms: Dizziness, Loss of consciousness, Syncope
Clinical narrative: Was visiting a friend. Ate dinner, had 2 drinks. Was standing around talking. Felt dizzy, walked to bedroom, asked if I could lie down, passed out cold on floor. From dizziness to collapse, about 2 minutes.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, FLU3, MMR, VARCEL
Symptoms: Injection site reaction, Local reaction
Clinical narrative: Local reaction to left arm.
Age: 0.64
Sex: M
Vaccine: FLUX
Symptoms: Cough, Influenza B virus test positive, Nasal congestion, Rash generalised, Rash macular
Clinical narrative: Coughing, wheezing, stuffy nose, and splotchy rash from head to toe.
Age: 0.64
Sex: M
Vaccine: FLUX
Symptoms: Wheezing
Clinical narrative: Coughing, wheezing, stuffy nose, and splotchy rash from head to toe.
Age: 26.0
Sex: F
Vaccine: SMALL, SMALL
Symptoms: Injection site erythema, Nodule, Vaccination site nodule, Vaccination site pustule
Clinical narrative: Small red pustule like nodules appearing on outer aspect of Left arm near small pox vaccine site.  More nodules appeared over the past two weeks and have been noted to be on the Right arm as well.
Age: 26.0
Sex: F
Vaccine: SMALL, SMALL
Symptoms: Nodule, Vaccination site erythema, Vaccination site nodule, Vaccination site pustule
Clinical narrative: Small red pustule like nodules appearing on outer aspect of Left arm near small pox vaccine site.  More nodules appeared over the past two weeks and have been noted to be on the Right arm as well.
Age: 47.0
Sex: F
Vaccine: TD
Symptoms: Erythema, Local reaction
Clinical narrative: 6mm red/raised local reaction.
Age: 52.0
Sex: F
Vaccine: FLU3
Symptoms: Mobility decreased, Pain in extremity, Skin discolouration
Clinical narrative: Painful arm - cannot lift over head has discoloration remaining from band-aid.
Age: 51.0
Sex: U
Vaccine: FLU3
Symptoms: Anaphylactic reaction, Respiratory distress
Clinical narrative: Patient received INFLUENZA vaccine 10:45 am in right deltoid. At 10:55 am patient began demonstrating symptoms of anaphylaxis. At 10:55 am EMS was activated. At 11:00 am patient began showing signs/symptoms of respiratory distress. At 11:05 am 0.3 mg epinephrine was administered via auto-injector to lateral aspect of right thigh. 11:20 EMS arrives & care transferred.
Age: 3.0
Sex: M
Vaccine: PNC13
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: Pain & swelling to (L) deltoid measuring 45x55 cm within 1 day of vaccine administration to area.
Age: 66.0
Sex: F
Vaccine: FLUX, FLU3
Symptoms: Arthralgia, Back pain, Mobility decreased, Muscular weakness, Musculoskeletal pain
Clinical narrative: See letter. The pain and weakness in my left arm was really evident the following day after the shot. The shot hurt and was very sore the day of the shot. I was unable to lift my arm and the pain became severe. It was from my shoulder to my elbow and at its worst my left upper back and neck. It is still painful and more localized in my shoulder and upper arm. I can use it a bit more but if lying down at times I use my right hand to reposition my left arm which is just unable to move on its own. It is over four months since I received the shot and although I can move my arm better I am always in pain. The weakness in my arm is still terrible. Further Information: I went to the doctor on February 16 2012. I asked for the additional information you requested. I ask them to fill out the form but was told I should do so and if you want additional information you would contact them. I found out I had the wrong date for the flu shot. I got the shot on October 3, 2011 to the left deltoid arm. The manufacturer is Sanofi Pasteur and the lot UT440 AA. I have entered this on the form. The doctor called my reaction a form of paralysis. She said it will eventually go away and that I should have some physical therapy. She has given me a referral. I reported this to you because it is so devastating to lose the mobility of an arm and because of the severe pain. I did not go to the doctor before because I was depressed and some days I was unable to function at all. I happen to look up adverse reactions to flu shots, on the internet, one night when I could not sleep and found so many complaints I was shocked. That is how I heard of VAERS. I don't want anyone to suffer as I am so I reported what happened. If this was an allergic reaction after having flu shots for at least a decade I doubt that it is safe for me to have a flu shot again. I hope you have enough information now.
Age: 66.0
Sex: F
Vaccine: FLUX, FLU3
Symptoms: Pain in extremity
Clinical narrative: See letter. The pain and weakness in my left arm was really evident the following day after the shot. The shot hurt and was very sore the day of the shot. I was unable to lift my arm and the pain became severe. It was from my shoulder to my elbow and at its worst my left upper back and neck. It is still painful and more localized in my shoulder and upper arm. I can use it a bit more but if lying down at times I use my right hand to reposition my left arm which is just unable to move on its own. It is over four months since I received the shot and although I can move my arm better I am always in pain. The weakness in my arm is still terrible. Further Information: I went to the doctor on February 16 2012. I asked for the additional information you requested. I ask them to fill out the form but was told I should do so and if you want additional information you would contact them. I found out I had the wrong date for the flu shot. I got the shot on October 3, 2011 to the left deltoid arm. The manufacturer is Sanofi Pasteur and the lot UT440 AA. I have entered this on the form. The doctor called my reaction a form of paralysis. She said it will eventually go away and that I should have some physical therapy. She has given me a referral. I reported this to you because it is so devastating to lose the mobility of an arm and because of the severe pain. I did not go to the doctor before because I was depressed and some days I was unable to function at all. I happen to look up adverse reactions to flu shots, on the internet, one night when I could not sleep and found so many complaints I was shocked. That is how I heard of VAERS. I don't want anyone to suffer as I am so I reported what happened. If this was an allergic reaction after having flu shots for at least a decade I doubt that it is safe for me to have a flu shot again. I hope you have enough information now.
Age: 66.0
Sex: F
Vaccine: FLUX, FLU3
Symptoms: Activities of daily living impaired, Back pain, Depression, Injection site pain, Mobility decreased
Clinical narrative: See letter. The pain and weakness in my left arm was really evident the following day after the shot. The shot hurt and was very sore the day of the shot. I was unable to lift my arm and the pain became severe. It was from my shoulder to my elbow and at its worst my left upper back and neck. It is still painful and more localized in my shoulder and upper arm. I can use it a bit more but if lying down at times I use my right hand to reposition my left arm which is just unable to move on its own. It is over four months since I received the shot and although I can move my arm better I am always in pain. The weakness in my arm is still terrible. Further Information: I went to the doctor on February 16 2012. I asked for the additional information you requested. I ask them to fill out the form but was told I should do so and if you want additional information you would contact them. I found out I had the wrong date for the flu shot. I got the shot on October 3, 2011 to the left deltoid arm. The manufacturer is Sanofi Pasteur and the lot UT440 AA. I have entered this on the form. The doctor called my reaction a form of paralysis. She said it will eventually go away and that I should have some physical therapy. She has given me a referral. I reported this to you because it is so devastating to lose the mobility of an arm and because of the severe pain. I did not go to the doctor before because I was depressed and some days I was unable to function at all. I happen to look up adverse reactions to flu shots, on the internet, one night when I could not sleep and found so many complaints I was shocked. That is how I heard of VAERS. I don't want anyone to suffer as I am so I reported what happened. If this was an allergic reaction after having flu shots for at least a decade I doubt that it is safe for me to have a flu shot again. I hope you have enough information now.
Age: 66.0
Sex: F
Vaccine: FLUX, FLU3
Symptoms: Muscular weakness, Pain in extremity, Paralysis
Clinical narrative: See letter. The pain and weakness in my left arm was really evident the following day after the shot. The shot hurt and was very sore the day of the shot. I was unable to lift my arm and the pain became severe. It was from my shoulder to my elbow and at its worst my left upper back and neck. It is still painful and more localized in my shoulder and upper arm. I can use it a bit more but if lying down at times I use my right hand to reposition my left arm which is just unable to move on its own. It is over four months since I received the shot and although I can move my arm better I am always in pain. The weakness in my arm is still terrible. Further Information: I went to the doctor on February 16 2012. I asked for the additional information you requested. I ask them to fill out the form but was told I should do so and if you want additional information you would contact them. I found out I had the wrong date for the flu shot. I got the shot on October 3, 2011 to the left deltoid arm. The manufacturer is Sanofi Pasteur and the lot UT440 AA. I have entered this on the form. The doctor called my reaction a form of paralysis. She said it will eventually go away and that I should have some physical therapy. She has given me a referral. I reported this to you because it is so devastating to lose the mobility of an arm and because of the severe pain. I did not go to the doctor before because I was depressed and some days I was unable to function at all. I happen to look up adverse reactions to flu shots, on the internet, one night when I could not sleep and found so many complaints I was shocked. That is how I heard of VAERS. I don't want anyone to suffer as I am so I reported what happened. If this was an allergic reaction after having flu shots for at least a decade I doubt that it is safe for me to have a flu shot again. I hope you have enough information now.
Age: 16.0
Sex: F
Vaccine: HEPA, HPV4, VARCEL, HPV4, VARCEL, HEPA, HPV4, VARCEL
Symptoms: Maternal exposure during pregnancy
Clinical narrative: This report was received from GlaxoSmithKline and was assigned manufacturer report number A0965025A for HAVRIX, for GARDASIL and VARIVAX (Merck), Pregnancy Registry products, concerning a 16 year old female patient with postural orthostatic tachycardia syndrome who on 01-DEC-2011, was vaccinated with a second dose of GARDASIL (lot number 670048/0963AA; route not reported) and on the same date was also was vaccinated with the second dose of VARIVAX (Merck) (manufacturer unknown) (lot number 670178/0468AA; route not reported) and a second dose of HAVRIX, 720 elisa unit (lot number AHAVB481BB, expiration date: 10-MAY-2013; dose and route not reported). There was no concomitant medication reported. It was reported that the patient was one or two weeks pregnant at the time of vaccination but did not know she was pregnant. The patient experienced drug exposure in the first trimester of pregnancy, the date of last menstrual period and estimated delivery date were not provided. On 26-JAN-2012, 56 days after vaccination the patient experienced missed abortion, no heartbeat was detected on a routine OB/GYN (obstetrics and gynecology) exam performed on 26-JAN-2012 (fetal death in utero). On 27-JAN-2012, the patient underwent dilatation and curettage on an outpatient procedure basis. The registered nurse reported that it was unknown if the events were related to the administration of the vaccines. At the time of the report the patient's outcome was unknown. This was originally reported by a registered nurse. The registered nurse considered the events were clinically significant (or requiring intervention). Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HEPA, HPV4, VARCEL, HPV4, VARCEL, HEPA, HPV4, VARCEL
Symptoms: Foetal heart rate abnormal, Maternal exposure during pregnancy, Syncope
Clinical narrative: This report was received from GlaxoSmithKline and was assigned manufacturer report number A0965025A for HAVRIX, for GARDASIL and VARIVAX (Merck), Pregnancy Registry products, concerning a 16 year old female patient with postural orthostatic tachycardia syndrome who on 01-DEC-2011, was vaccinated with a second dose of GARDASIL (lot number 670048/0963AA; route not reported) and on the same date was also was vaccinated with the second dose of VARIVAX (Merck) (manufacturer unknown) (lot number 670178/0468AA; route not reported) and a second dose of HAVRIX, 720 elisa unit (lot number AHAVB481BB, expiration date: 10-MAY-2013; dose and route not reported). There was no concomitant medication reported. It was reported that the patient was one or two weeks pregnant at the time of vaccination but did not know she was pregnant. The patient experienced drug exposure in the first trimester of pregnancy, the date of last menstrual period and estimated delivery date were not provided. On 26-JAN-2012, 56 days after vaccination the patient experienced missed abortion, no heartbeat was detected on a routine OB/GYN (obstetrics and gynecology) exam performed on 26-JAN-2012 (fetal death in utero). On 27-JAN-2012, the patient underwent dilatation and curettage on an outpatient procedure basis. The registered nurse reported that it was unknown if the events were related to the administration of the vaccines. At the time of the report the patient's outcome was unknown. This was originally reported by a registered nurse. The registered nurse considered the events were clinically significant (or requiring intervention). Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HEPA, HPV4, VARCEL, HPV4, VARCEL, HEPA, HPV4, VARCEL
Symptoms: Abortion missed, Gynaecological examination abnormal, Intra-uterine death, Maternal exposure during pregnancy, Uterine dilation and curettage
Clinical narrative: This report was received from GlaxoSmithKline and was assigned manufacturer report number A0965025A for HAVRIX, for GARDASIL and VARIVAX (Merck), Pregnancy Registry products, concerning a 16 year old female patient with postural orthostatic tachycardia syndrome who on 01-DEC-2011, was vaccinated with a second dose of GARDASIL (lot number 670048/0963AA; route not reported) and on the same date was also was vaccinated with the second dose of VARIVAX (Merck) (manufacturer unknown) (lot number 670178/0468AA; route not reported) and a second dose of HAVRIX, 720 elisa unit (lot number AHAVB481BB, expiration date: 10-MAY-2013; dose and route not reported). There was no concomitant medication reported. It was reported that the patient was one or two weeks pregnant at the time of vaccination but did not know she was pregnant. The patient experienced drug exposure in the first trimester of pregnancy, the date of last menstrual period and estimated delivery date were not provided. On 26-JAN-2012, 56 days after vaccination the patient experienced missed abortion, no heartbeat was detected on a routine OB/GYN (obstetrics and gynecology) exam performed on 26-JAN-2012 (fetal death in utero). On 27-JAN-2012, the patient underwent dilatation and curettage on an outpatient procedure basis. The registered nurse reported that it was unknown if the events were related to the administration of the vaccines. At the time of the report the patient's outcome was unknown. This was originally reported by a registered nurse. The registered nurse considered the events were clinically significant (or requiring intervention). Additional information has been requested.
Age: 4.0
Sex: M
Vaccine: DTAP, FLU3, IPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site haematoma, Injection site swelling, Injection site warmth
Clinical narrative: Patient has a round 6.5cm diameter size bruise with red/pink outer limit outline, slightly raised warm to touch (WNL) on his right thigh.  Patient denies itching and pain.
Age: 49.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Oedema peripheral, Pain, Pain in extremity
Clinical narrative: On 2/24/12 at 10:00 am Pt was given vaccines on 2/22/12. Was given a call at the clinic that pt's arm was hurting to lift red, swollen, and painful. I had the pt come into be seen by another physician here at the clinic. Pt was evaluated and placed on clindamycin.
Age: 40.0
Sex: F
Vaccine: PPV
Symptoms: Band neutrophil percentage increased, C-reactive protein increased, Erythema, Feeling hot, Headache
Clinical narrative: Fever - headache - body aches - red - hot swollen arm. Administered 2/20/12 went to ER 2/22/12 seen in MD office 2/23/12. Reaction started 2/21 - swelling, pain, redness, then fever, myalgias, HA.
Age: 40.0
Sex: F
Vaccine: PPV
Symptoms: Myalgia, Neutrophil percentage increased, Oedema peripheral, Pain, Pyrexia
Clinical narrative: Fever - headache - body aches - red - hot swollen arm. Administered 2/20/12 went to ER 2/22/12 seen in MD office 2/23/12. Reaction started 2/21 - swelling, pain, redness, then fever, myalgias, HA.
Age: 40.0
Sex: F
Vaccine: PPV
Symptoms: Swelling, White blood cell count increased
Clinical narrative: Fever - headache - body aches - red - hot swollen arm. Administered 2/20/12 went to ER 2/22/12 seen in MD office 2/23/12. Reaction started 2/21 - swelling, pain, redness, then fever, myalgias, HA.
Age: 0.16
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC
Symptoms: Rash erythematous, Rash generalised
Clinical narrative: Diffuse, generalized erythematous rash (non-urticarial).
Age: 41.0
Sex: F
Vaccine: FLU3
Symptoms: Incorrect dose administered, Influenza, Vaccination failure
Clinical narrative: This case was reported by a healthcare professional (nurse practitioner) and described the occurrence of influenza in a currently 47-year-old female subject who was vaccinated with FLUARIX (GlaxoSmithKline). Concurrent medical conditions included BACTRIM allergy. On 10 October 2005 the subject, at the age of 41 years, received a dose of FLUARIX (1 ml, unknown route, unknown arm) and experienced overdose. The subject was administered a 1 ml dose of FLUARIX instead of the indicated 0.5 ml dose. At an unspecified time after vaccination with FLUARIX, the subject experienced influenza and vaccination failure. According to the healthcare provider, the subject said she got the flu after getting the vaccine. The healthcare professional noted that the subject received FLUARIX or FLULAVAL, but lot number provided was for FLUARIX. The healthcare professional answered no to the seriousness criteria. This case was assessed as medically serious by GSK. At the time of reporting the influenza was resolved.
Age: 53.0
Sex: M
Vaccine: HEPA
Symptoms: Arthralgia, Biopsy artery, Diplopia, Eye pain, Headache
Clinical narrative: This case was reported by a consumer (also the subject) and described the occurrence of possible temporal arteritis in a 53-year-old male subject who was vaccinated with HAVRIX (GlaxoSmithKline). A physician or other health care professional has not verified this report. On 1 November 2011 the subject received 2nd dose of HAVRIX (details unknown). On 25 November 2011, 24 days after vaccination with HAVRIX, the subject experienced headaches, which "felt like a severe stabbing on the inside". The headaches occurred every day for the next month and in January 2012, the headaches began to go away. However, in January 2012, the subject began to have muscle pain which moved from his legs to his shoulders and forearms. According to the subject, his "knees felt arthritic". Within months after vaccination with HAVRIX, "lately", he has wrist pain and pain in forearm and hand. He has experienced visual problems described as eye muscle pain, blurred vision and double vision. The subject physician thought that the subject had temporal arteritis and he had a biopsy of a 1 inch piece of artery from his left and right temple. The subject reported that the muscle pains are worse at night. This case was assessed as medically serious by GSK. At the time of reporting the outcome of the events was unspecified.
Age: 53.0
Sex: M
Vaccine: HEPA
Symptoms: Myalgia, Pain in extremity, Vision blurred
Clinical narrative: This case was reported by a consumer (also the subject) and described the occurrence of possible temporal arteritis in a 53-year-old male subject who was vaccinated with HAVRIX (GlaxoSmithKline). A physician or other health care professional has not verified this report. On 1 November 2011 the subject received 2nd dose of HAVRIX (details unknown). On 25 November 2011, 24 days after vaccination with HAVRIX, the subject experienced headaches, which "felt like a severe stabbing on the inside". The headaches occurred every day for the next month and in January 2012, the headaches began to go away. However, in January 2012, the subject began to have muscle pain which moved from his legs to his shoulders and forearms. According to the subject, his "knees felt arthritic". Within months after vaccination with HAVRIX, "lately", he has wrist pain and pain in forearm and hand. He has experienced visual problems described as eye muscle pain, blurred vision and double vision. The subject physician thought that the subject had temporal arteritis and he had a biopsy of a 1 inch piece of artery from his left and right temple. The subject reported that the muscle pains are worse at night. This case was assessed as medically serious by GSK. At the time of reporting the outcome of the events was unspecified.
Age: 2.0
Sex: M
Vaccine: DTAPIPVHIB, MMR, PNC13, VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site rash, Injection site swelling, Local reaction
Clinical narrative: (L) leg local large induration & rash, red, swollen leg after 24 hr of PENTACEL. (-) fever, (-) swg approx. 16cm x 12cm. (R) leg local rxn 4-5 cm x 4-5 cm at PREVNAR-13 site.
Age: 29.0
Sex: M
Vaccine: ANTH, SMALL, TYP, ANTH, SMALL, TYP, ANTH, SMALL, TYP
Symptoms: Blood creatine phosphokinase MB increased, Blood creatine phosphokinase normal, Chest discomfort, Troponin T
Clinical narrative: Infection Control notifies of hospitalization of a 29 y/o male with chest discomfort and elevated troponin after receipt of 7 Feb 12 vaccines, including SPV, AVA, and Typhoid. Patient develops chest discomfort on 19 Feb, has abnormal Troponin detected on 21 Feb and is admitted to the hospital later that same day.
Age: 29.0
Sex: M
Vaccine: ANTH, SMALL, TYP, ANTH, SMALL, TYP, ANTH, SMALL, TYP
Symptoms: Blood creatine phosphokinase MB increased, Blood creatine phosphokinase normal, Chest discomfort, Troponin T increased
Clinical narrative: Infection Control notifies of hospitalization of a 29 y/o male with chest discomfort and elevated troponin after receipt of 7 Feb 12 vaccines, including SPV, AVA, and Typhoid. Patient develops chest discomfort on 19 Feb, has abnormal Troponin detected on 21 Feb and is admitted to the hospital later that same day.
Age: 29.0
Sex: M
Vaccine: ANTH, SMALL, TYP, ANTH, SMALL, TYP, ANTH, SMALL, TYP
Symptoms: Chest pain, Echocardiogram, Electrocardiogram normal, Troponin I, Troponin normal
Clinical narrative: Infection Control notifies of hospitalization of a 29 y/o male with chest discomfort and elevated troponin after receipt of 7 Feb 12 vaccines, including SPV, AVA, and Typhoid. Patient develops chest discomfort on 19 Feb, has abnormal Troponin detected on 21 Feb and is admitted to the hospital later that same day.
Age: 21.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site haematoma
Clinical narrative: Patient returned to store 2/28/12 upset and complaining of redness and bruising at injection site.
Age: 35.0
Sex: F
Vaccine: HPV4
Symptoms: Abortion spontaneous, Maternal exposure during pregnancy, Pregnancy test positive
Clinical narrative: Information has been received from a patient and a certified nurse midwife, for GARDASIL, a Pregnancy Registry product, concerning a 36 year old female patient with a history of one miscarriage and D&C (dilation and curettage) procedure while on prior therapy with GARDASIL (MSD, WAES 1202USA02959) and drug reaction/allergy to "sulfa" who was vaccinated with the first dose of GARDASIL, 0.5ml, IM., (lot number 666931/0337Z) on 02-MAR-2011, the second dose of with GARDASIL, 0.5ml, IM., (lot number 667930/1561Z) on 02-MAY-2011 and the third dose of with GARDASIL, 0.5ml, IM., (lot number 668554/0306AA) on 12-SEP-2011. The patient did not receive any concomitant vaccinations when the GARDASIL vaccinations were administered. Concomitant therapy included CYMBALTA. Consumer reported that on 12-SEP-2011, she received the third dose of GARDASIL and on unknown date, also reported as "recently" became pregnant. Consumer stated that on 17-FEB-2012 she lost the baby again. Consumer reported that she contacted her physician. Pregnancy test, "blood work" and HCG (beta-human chorionic gonadotropin) levels studies were performed. The patient's outcome was unknown at the time of report. Upon internal review, "lost the baby again" was considered to be other important medical event. Additional information has been requested.
Sex: F
Vaccine: HEPA, HPV4
Symptoms: Pancreatitis
Clinical narrative: Information has been received from a physician concerning a female patient who on an unknown date, was vaccinated with the first dose of GARDASIL (dose, route and lot number not reported). Secondary suspect therapy included hepatitis A virus vaccination (manufacturer unknown) received at the same time. The physician reported that on an unknown date, a niece of a nurse in the physician's office developed pancreatitis after the first vaccination with GARDASIL. The niece of the nurse was not the patient of the reporting physician. The patient was being treated by another physician. On an unknown date, the patient recovered from pancreatitis. Upon internal review the pancreatitis was determined to be an other important medical event. Additional information is not expected.
Sex: U
Vaccine: VARZOS
Symptoms: Death
Clinical narrative: Information has been received from a pharmacist concerning an unspecified patient who on an unspecified date was vaccinated with a dose of ZOSTAVAX (Merck) (lot #, batch # and route not reported) for prevention of shingles. The pharmacist stated that she heard from an unspecified pharmacist who stated that he heard from another unspecified person that the patient died after receiving ZOSTAVAX (Merck). Attempts are being made to verify the existence of an identifiable patient. No further information is available.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Abortion spontaneous, Human chorionic gonadotropin positive, Maternal exposure during pregnancy
Clinical narrative: Information has been received from an 18 year old female consumer reporting herself for a pregnancy registry product for GARDASIL with no pertinent medical history and no known drug reactions or allergies, who on 14-MAR-2011 was vaccinated with the second dose of GARDASIL (dose, route and lot number not reported). There was no concomitant medication. On 15-MAR-2011, a urine test for pregnancy was done and the patient found out that she was six weeks pregnant. The patient sought unspecified medical attention. The last menstrual period was on approximately 01-FEB-2011 and the estimated delivery date was: November 2011. Follow-up information has been received from a physician via initial pregnancy questionnaire who reported that on 14-MAR-2011, the patient was vaccinated with a second dose of GARDASIL (Lot # 666948/0886Z) (Dose and route not reported). Follow up information has been received via telephone from a registered nurse who reported that the patient had a spontaneous abortion at 6/4 weeks gestation. The nurse could not verify the exact date of fetal loss. When was asked, she said there was no mention of fetal content examination. At the time of the report outcome of spontaneous abortion was unknown. There was no there information reported regarding miscarriage or pregnancy. Upon internal review, spontaneous abortion was determined to be an other important medical event. Additional information has been requested.
Age: 71.0
Sex: F
Vaccine: TDAP
Symptoms: Contusion, Dry mouth, Erythema, Fatigue, Formication
Clinical narrative: Patient reports initially some soreness at injection site. Injection done 02/07/12. After about 1.5d, she developed redness & bruising, had sweat 2nd night. Then developed aches; fatigue; dry mouth; cramping on fingers & toes; sensation of skin crawling on back, and increased redness around upper arm - more small dilated vessels - not general erythema; not urticaria.
Age: 71.0
Sex: F
Vaccine: TDAP
Symptoms: Hyperhidrosis, Injection site pain, Muscle spasms, Pain
Clinical narrative: Patient reports initially some soreness at injection site. Injection done 02/07/12. After about 1.5d, she developed redness & bruising, had sweat 2nd night. Then developed aches; fatigue; dry mouth; cramping on fingers & toes; sensation of skin crawling on back, and increased redness around upper arm - more small dilated vessels - not general erythema; not urticaria.
Age: 51.0
Sex: M
Vaccine: FLU3
Symptoms: Balance disorder, Fall, Gait disturbance, Hypoaesthesia, Pain in extremity
Clinical narrative: Lost of feelings in hands & feet. Balance, couldn't look up without falling. Stumbled a lot, numbness in legs and arms. Pain in to toes.
Age: 51.0
Sex: M
Vaccine: FLU3
Symptoms: Sensory loss
Clinical narrative: Lost of feelings in hands & feet. Balance, couldn't look up without falling. Stumbled a lot, numbness in legs and arms. Pain in to toes.
Age: 70.0
Sex: M
Vaccine: FLU3
Symptoms: Tenderness
Clinical narrative: Patient complains that his arm is still tender after administration. Administration was 4 months ago.
Age: 4.0
Sex: M
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Swelling, redness, warm to touch at and around injection site.
Age: 0.08
Sex: F
Vaccine: DTAPIPVHIB, HPV4, PNC13, RV5
Symptoms: Drug administered to patient of inappropriate age, No adverse event, Wrong drug administered
Clinical narrative: Pt accidentally received HPV (GARDASIL) instead of Hep B vaccine. Dr. notified, counseled pt father, answered all questions. Spoke with CDC instructed to watch for s/s of local reaction. None noted. Manufacturer notified.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Confusional state, Dizziness, Headache, Muscular weakness
Clinical narrative: 10 minutes after the vaccine was administered, she felt dizzy with headache & weakness of leg. The next day in school, she was confused and had to think hard about classroom location.
Age: 43.0
Sex: M
Vaccine: FLU3
Symptoms: Cerebrovascular accident, Laboratory test, Miller Fisher syndrome
Clinical narrative: Patient got Miller Fisher a variant of Guillain Barre 1-1-11. He has been healing since. It is very slow going.
Age: 1.07
Sex: M
Vaccine: DTAP, FLU3, MMR, PNC13
Symptoms: Death, Unresponsive to stimuli
Clinical narrative: Patient found unresponsive by babysitter. EMS called to scene. Patient transported to ER at Medical Center. Time of death noted to be 20:48 on 2/8/12 by ER.
Age: 6.0
Sex: M
Vaccine: FLU3, IPV, MMR, VARCEL
Symptoms: Full blood count abnormal, Idiopathic thrombocytopenic purpura, Inappropriate schedule of drug administration, Increased tendency to bruise, Petechiae
Clinical narrative: My son had an acute ITP reaction after receiving negligent 2nd dose of MMR, varicella, and IPV vaccines. Due to his history of severe aplastic anemia, he now suffers with chronic ITP.
Age: 6.0
Sex: M
Vaccine: FLU3, IPV, MMR, VARCEL
Symptoms: Platelet count decreased
Clinical narrative: My son had an acute ITP reaction after receiving negligent 2nd dose of MMR, varicella, and IPV vaccines. Due to his history of severe aplastic anemia, he now suffers with chronic ITP.
Age: 3.0
Sex: F
Vaccine: FLUN3
Symptoms: Influenza, Lethargy, Vomiting
Clinical narrative: A non-serious spontaneous report of influenza, vomiting and lethargy has been received from a consumer concerning a 36-month-old female, subsequent to FLUMIST. This case will be submitted in accordance with MedImmune's FLUMIST post-marketing commitment for the indicated population of 2 years to 59 months of age. Neither relevant medical history nor concomitant medications have been reported for this patient. In Sep-2011, the patient received FLUMIST. The patient was diagnosed with influenza in the first week of Nov-2011. The patient was getting better but had symptoms of lethargy and vomiting. The events of influenza, vomiting and lethargy were recovering.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Cellulitis, Rash erythematous, Skin warm
Clinical narrative: 2/5 pt complained of red raised rash. Warm to touch. Treated with antihistamine. 2/7 called pt - pt said MD diagnosed as cellulitis. Treated with cephalexin and MEDROL.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Erythema, Swelling
Clinical narrative: Got ADACEL vaccine on 2-20-12. The following day had size of apple red area on upper arm. Slightly raised non tender. Mom gave BENADRYL.
Age: 34.0
Sex: F
Vaccine: HEPAB
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 4.0
Sex: F
Vaccine: DTAPIPVHIB, HEP, HEPA
Symptoms: Cellulitis
Clinical narrative: Cellulitis.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Erythema, Headache, Injection site erythema, Injection site swelling
Clinical narrative: Friday about 2 p.m. had some dizziness. Had redness and swelling at sight of injection. Also, itching. Had redness for about 1 week. Also, sharp pain on left side of head that continue and went.