chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 12.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Anxiety, Confusional state, Crying, Dizziness, Fall
Clinical narrative: Patient said he started to feel really nauseous and really tired then he doesn't remember anything until we were picking him up. The dr and I were talking and patient slowly awkwardly fell to the ground by my feet and laid his head down and his eyes closed.  He started to shake and twitch for a couple seconds then started to come to when we were asking if he was okay and helping him up. At first he looked similar to sleep walking, vacant, and confused, then he started to make eye contact and get scared.  He was dazed and crying and said that he felt dizzy.  We walked him from the exam room where he just had his well check up to a station where another nurse took his blood pressure and gave him juice.  He was very tired and just wanted to come home and sleep.  The doctor said it couldn't have been a reaction to the vaccine because it happened so quickly, within 5 mins after injection.  She said he probably just passed out from pain and/or anxiety, but to watch him and call if anything changes.
Age: 12.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Fatigue, Loss of consciousness, Muscle twitching, Nausea, Pain
Clinical narrative: Patient said he started to feel really nauseous and really tired then he doesn't remember anything until we were picking him up. The dr and I were talking and patient slowly awkwardly fell to the ground by my feet and laid his head down and his eyes closed.  He started to shake and twitch for a couple seconds then started to come to when we were asking if he was okay and helping him up. At first he looked similar to sleep walking, vacant, and confused, then he started to make eye contact and get scared.  He was dazed and crying and said that he felt dizzy.  We walked him from the exam room where he just had his well check up to a station where another nurse took his blood pressure and gave him juice.  He was very tired and just wanted to come home and sleep.  The doctor said it couldn't have been a reaction to the vaccine because it happened so quickly, within 5 mins after injection.  She said he probably just passed out from pain and/or anxiety, but to watch him and call if anything changes.
Age: 12.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Tremor
Clinical narrative: Patient said he started to feel really nauseous and really tired then he doesn't remember anything until we were picking him up. The dr and I were talking and patient slowly awkwardly fell to the ground by my feet and laid his head down and his eyes closed.  He started to shake and twitch for a couple seconds then started to come to when we were asking if he was okay and helping him up. At first he looked similar to sleep walking, vacant, and confused, then he started to make eye contact and get scared.  He was dazed and crying and said that he felt dizzy.  We walked him from the exam room where he just had his well check up to a station where another nurse took his blood pressure and gave him juice.  He was very tired and just wanted to come home and sleep.  The doctor said it couldn't have been a reaction to the vaccine because it happened so quickly, within 5 mins after injection.  She said he probably just passed out from pain and/or anxiety, but to watch him and call if anything changes.
Age: 0.54
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC
Symptoms: Body temperature increased, Crying, Irritability, Pyrexia
Clinical narrative: Pt got PENTACEL, Hep B, and PREVNAR at health dept. on 06/07/10. Within 12 hours, pt had temp 104-105 and cried for more than 4 hours, was irritable. Mom that PM 6-7-10 took child to medical center ER. Told there pt. had no cold, no ear infection and fever was due to "shot".
Age: 74.0
Sex: F
Vaccine: PPV
Symptoms: Diarrhoea, Injected limb mobility decreased, Nausea, Pain in extremity, Vomiting
Clinical narrative: Severe left arm pain with inability to move left arm, nausea, vomiting, diarrhea.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site urticaria, Injection site warmth
Clinical narrative: Dime size red welp on left upper thigh on injection site.  Warm to the touch, painful and itchy to patient.  Following morning, 06/10/2010, injection site had grown significantly was very warm to the touch, painful and itchy.  Returned to the clinic vaccine was received.  Was told to take Benadryl every 6 hrs. and prescription medication Cephalexin.  Told to give Dr. a call in the a.m. to let her know how the whelp was looking.  The following day, 6/11/2010 whelp had grown overnight.  Called Dr. at her clinic.  She had the patient come in and get a steroid shot in the arm and start on prescription steroids the following day along with current prescription of Cephalexin.
Age: 1.03
Sex: M
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Muscle twitching, Pyrexia, Rash, Roseola
Clinical narrative: Fever to 103.8 the evening and day following the vaccine.  Twitching during sleep.  Fever resolved on 06/11/10.  (Vaccine given 6/7). Update.  Patient developed a rash on 6/12/10.  Suspect Roseola.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Hyperaesthesia, Pruritus, Rash macular, Urticaria
Clinical narrative: Vaccine adm. at 1045 AM. Pt observed for 15 min with no s/sx adverse reaction. TC received from pt. at 230 pm stating 4-5 large pink hives on neck - itchy. (I) to take BENADRYL. Pt. reports will take it and that she has "sensitive skin". Will follow-up (I) if any s/sx, resp. difficulty to go to ER. 6/10/10 830PM. TC to patient. States BENADRYL worked earlier but still has areas that are "slightly pink". She is going to take 2 BENADRYL now and go to bed. Big blotches are completely gone. 6/11/10 2 PM. TC to patient. She said all areas have gone away completely. No pink areas or blotches remain. Denies ever having any respiratory difficulty or other complaints.
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash papular
Clinical narrative: Pt noticed pumps on face when she sitting outside.  Dermatologist diagnosed it as Herpes Zoster.  Dr. gave RX for VALTREX 1 GM.
Age: 3.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: (L) thigh reddened & mild swelling & warm to the touch.
Age: 3.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Received in L upper arm PREVNAR 13 -> developed erythema and warmth at area 7cm x 7cm, approximately 24 hours afterwards - KEFLEX, BENADRYL.
Sex: U
Vaccine: VARCEL
Symptoms: Herpes zoster
Clinical narrative: Pt had VARIVAX at 1 year (unknown lot #) and now has herpes zoster. Never had clinical varicella.
Sex: F
Vaccine: HPV4
Symptoms: Atrial septal defect, Cardiac murmur, Cough, Drug exposure during pregnancy, Nasal congestion
Clinical narrative: Information has been received from a nurse practitioner and a consumer with no drug allergies and no pertinent medical history for GARDASIL, a Pregnancy Registry product. The baby's 24 year old mother did not have any previous pregnancies, pre-term deliveries, spontaneous abortions, elective terminations or fetal deaths. On 06-NOV-2008 the baby's mother was vaccinated with the first dose of GARDASIL (lot number unknown). On 23-JAN-2009 the baby's mother was vaccinated with the second dose of GARDASIL (lot number 661703/0651X). On 12-JUN-2009 the baby's mother was vaccinated with the third dose of GARDASIL (lot number 661703/0651X). On 16-FEB-2010, the baby's mother delivered the normal female baby with no congenital anomalies weighing 8 pounds, 7 ounces, length 20 inches. It was reported that the baby was stuck, so the patient had to have a C-section. The baby's mother had no concurrent medical conditions. On an unspecified date, the baby experienced heart murmur. At the time of the report, the patient's outcome was unknown. Follow-up information has been received via a medical record concerning the female baby with no known drug allergies who on 20-APR-2010 was vaccinated with the first dose of RECOMBIVAX HB (lot# 665622/1023Y) in her right thigh. Other concomitant vaccines administered on the same day included the first dose of DAPTACEL (manufacturer: Sanofi Pasteur) (lot# C3191AA) in the left thigh, the first dose of ACTHIB (manufacturer: Sanofi Pasteur) (lot# UF596AB) in the right thigh, the first dose of IPOL (manufacturer: Sanofi Pasteur) (lot#D0123) in the left thigh and the first dose of pneumococcal conj vaccine (unspecified) (manufacturer: Lederle) (lot#D93212) in the right thigh. On 24-FEB-2010, the 8 day old patient visited the office. her vital signs were within normal limits. She eats 2 to 4 ounces every four hours. She has bowel movements 1 to 2 times a day. At this visit the patient's patent ductus arteriosus was not audible. The patient was to follow up with cardiology as scheduled. On 05-MAR-2010, the 18 day old patient visited the office. She was fed with bottle. The PDA was again inaudible. She was instructed to follow up with cardiology as scheduled. On 20-APR-2010, the 9 week old patient had a development check appointment in the office. The patient had frequent nasal congestion and occasional cough. She had no fever. She had been experiencing eval scattered rash on chest, shoulders and back for 1 month. It was reported that she had saw pediatric cardiologist on 19-APR-2010 and the patient's murmur was reported to be "gone". The patient was instructed to follow up with cardiology as scheduled. At the time of the report, the patient's outcome was unknown. Upon internal review, patent ductus arteriosus and patent foramen ovale were considered congenital anomalies. The mother's experience was captured in WAES # 0907USA01322. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Patent ductus arteriosus, Rash
Clinical narrative: Information has been received from a nurse practitioner and a consumer with no drug allergies and no pertinent medical history for GARDASIL, a Pregnancy Registry product. The baby's 24 year old mother did not have any previous pregnancies, pre-term deliveries, spontaneous abortions, elective terminations or fetal deaths. On 06-NOV-2008 the baby's mother was vaccinated with the first dose of GARDASIL (lot number unknown). On 23-JAN-2009 the baby's mother was vaccinated with the second dose of GARDASIL (lot number 661703/0651X). On 12-JUN-2009 the baby's mother was vaccinated with the third dose of GARDASIL (lot number 661703/0651X). On 16-FEB-2010, the baby's mother delivered the normal female baby with no congenital anomalies weighing 8 pounds, 7 ounces, length 20 inches. It was reported that the baby was stuck, so the patient had to have a C-section. The baby's mother had no concurrent medical conditions. On an unspecified date, the baby experienced heart murmur. At the time of the report, the patient's outcome was unknown. Follow-up information has been received via a medical record concerning the female baby with no known drug allergies who on 20-APR-2010 was vaccinated with the first dose of RECOMBIVAX HB (lot# 665622/1023Y) in her right thigh. Other concomitant vaccines administered on the same day included the first dose of DAPTACEL (manufacturer: Sanofi Pasteur) (lot# C3191AA) in the left thigh, the first dose of ACTHIB (manufacturer: Sanofi Pasteur) (lot# UF596AB) in the right thigh, the first dose of IPOL (manufacturer: Sanofi Pasteur) (lot#D0123) in the left thigh and the first dose of pneumococcal conj vaccine (unspecified) (manufacturer: Lederle) (lot#D93212) in the right thigh. On 24-FEB-2010, the 8 day old patient visited the office. her vital signs were within normal limits. She eats 2 to 4 ounces every four hours. She has bowel movements 1 to 2 times a day. At this visit the patient's patent ductus arteriosus was not audible. The patient was to follow up with cardiology as scheduled. On 05-MAR-2010, the 18 day old patient visited the office. She was fed with bottle. The PDA was again inaudible. She was instructed to follow up with cardiology as scheduled. On 20-APR-2010, the 9 week old patient had a development check appointment in the office. The patient had frequent nasal congestion and occasional cough. She had no fever. She had been experiencing eval scattered rash on chest, shoulders and back for 1 month. It was reported that she had saw pediatric cardiologist on 19-APR-2010 and the patient's murmur was reported to be "gone". The patient was instructed to follow up with cardiology as scheduled. At the time of the report, the patient's outcome was unknown. Upon internal review, patent ductus arteriosus and patent foramen ovale were considered congenital anomalies. The mother's experience was captured in WAES # 0907USA01322. Additional information has been requested.
Age: 47.0
Sex: M
Vaccine: TDAP
Symptoms: Headache, Mobility decreased
Clinical narrative: Extreme headackes, Loss of mobility and Functions. Returned to Doctors office immediately as allowed.
Age: 66.0
Sex: M
Vaccine: PPV
Symptoms: Injection site swelling, Oedema peripheral, Pain in extremity, Skin warm
Clinical narrative: Severe swelling of arm around vaccination site.  Most of arm became very swollen, warm, painful.  Effects going on four days.
Age: 65.0
Sex: F
Vaccine: HEP
Symptoms: Cough, Dizziness, Headache, Nausea, Palpitations
Clinical narrative: Woke up this morning with headache, dizziness, coughing, palpitation, slight nausea, low grade temperature.
Age: 65.0
Sex: F
Vaccine: HEP
Symptoms: Pyrexia
Clinical narrative: Woke up this morning with headache, dizziness, coughing, palpitation, slight nausea, low grade temperature.
Age: 21.0
Sex: F
Vaccine: ANTH
Symptoms: Disturbance in attention, Feeling drunk, Migraine, Nightmare, Thinking abnormal
Clinical narrative: I was given three doses of the anthrax vaccination while in the Army and deployed to Kirkuk, Iraq in 2007: 14JUL07, 03AUG07, and 19NOV07. I was told these were mandatory vaccinations and that if I refused to receive one, I would be punished under the UCMJ. Each time it was given to me, I experienced horrible nightmares that following night. I woke up each time with a throbbing migraine that was almost unbearable. It also horribly effected my vision for the folling 24 hours. I was unable to focus my eyes, and felt like I was in a haze the whole time, like things weren't real. My eyes would focus in and out and I was unable to control it. The second biggest thing was my inability to concentrate or see things clearly. I was made to go on missions where I felt my brain wasn't exactly functioning right. I was a driver at the time and I told my superiors that I felt I shouldn't be driving but I was made to go, anyhow. While driving, I felt like I was in a really exagerated, drunken state. That's the only thing I compare it to. Today I am still amazed at how I was able to drive when I couldn't even focus or control my eyes. After the third vaccination, I refused to receive another. I would rather have been reprimanded and punished than receive another anthrax vaccination.
Age: 21.0
Sex: F
Vaccine: ANTH
Symptoms: Vision blurred, Visual acuity reduced, Visual impairment
Clinical narrative: I was given three doses of the anthrax vaccination while in the Army and deployed to Kirkuk, Iraq in 2007: 14JUL07, 03AUG07, and 19NOV07. I was told these were mandatory vaccinations and that if I refused to receive one, I would be punished under the UCMJ. Each time it was given to me, I experienced horrible nightmares that following night. I woke up each time with a throbbing migraine that was almost unbearable. It also horribly effected my vision for the folling 24 hours. I was unable to focus my eyes, and felt like I was in a haze the whole time, like things weren't real. My eyes would focus in and out and I was unable to control it. The second biggest thing was my inability to concentrate or see things clearly. I was made to go on missions where I felt my brain wasn't exactly functioning right. I was a driver at the time and I told my superiors that I felt I shouldn't be driving but I was made to go, anyhow. While driving, I felt like I was in a really exagerated, drunken state. That's the only thing I compare it to. Today I am still amazed at how I was able to drive when I couldn't even focus or control my eyes. After the third vaccination, I refused to receive another. I would rather have been reprimanded and punished than receive another anthrax vaccination.
Age: 44.0
Sex: M
Vaccine: TDAP, TDAP
Symptoms: Hypoaesthesia facial
Clinical narrative: Pt left the pharmacy 20 minutes, after vaccination. He called one hr later regarding numbness on his face. His wife was with him. I told him call 911. On 6/9, We called him, and his MD. He called back on 6/10. He received the Benadryl. I asked him to fax the details to me. He has not done it yet.
Age: 44.0
Sex: M
Vaccine: TDAP, TDAP
Symptoms: Chest discomfort, Dizziness, Dyspnoea, Hypersensitivity, Hypoaesthesia
Clinical narrative: Pt left the pharmacy 20 minutes, after vaccination. He called one hr later regarding numbness on his face. His wife was with him. I told him call 911. On 6/9, We called him, and his MD. He called back on 6/10. He received the Benadryl. I asked him to fax the details to me. He has not done it yet.
Age: 44.0
Sex: M
Vaccine: TDAP, TDAP
Symptoms: Hypoaesthesia facial, Paraesthesia, Pharyngeal hypoaesthesia
Clinical narrative: Pt left the pharmacy 20 minutes, after vaccination. He called one hr later regarding numbness on his face. His wife was with him. I told him call 911. On 6/9, We called him, and his MD. He called back on 6/10. He received the Benadryl. I asked him to fax the details to me. He has not done it yet.
Age: 54.0
Sex: F
Vaccine: TDAP
Symptoms: Chills, Differential white blood cell count normal, Full blood count normal, Haematocrit normal, Haemoglobin normal
Clinical narrative: Awakened by fever at 2:00 AM, took Tylenol, returned to bed.  Temp at 07:30AM was 101.5, c/o sore injection site and chills/achiness.  Took a nap, returned to urgent care at 4:34 PM, temp was 102.4. given Tylenol 650mg. Lab work done, WBC 6.7.  (She is on Augmentin for the dog scratch.)
Age: 54.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site pain, Lymphocyte count normal, Pain, Pyrexia
Clinical narrative: Awakened by fever at 2:00 AM, took Tylenol, returned to bed.  Temp at 07:30AM was 101.5, c/o sore injection site and chills/achiness.  Took a nap, returned to urgent care at 4:34 PM, temp was 102.4. given Tylenol 650mg. Lab work done, WBC 6.7.  (She is on Augmentin for the dog scratch.)
Age: 1.07
Sex: F
Vaccine: VARCEL
Symptoms: Blood test, Body temperature increased, Injection site rash, Neutropenia, Neutrophil count decreased
Clinical narrative: Patient developed rash on arm surrounding varicella vaccine injection site within a couple days of the vaccine being administered. Within a week, the rash spread from the injection site onto the back. About 6 or 7 red bumps appeared on rash on back that resembled mosquito bites. Two of the bumps became infected and one of them became an abscess the size of a quarter. Doctor was unable to culture the abscess as the fluid was too deep and would have caused patient too much pain. Patient started antibiotics (Keflex) and applied Bactroban cream on spots. Infected spots showed no improvement after 24 hours of antibiotics and patient developed a temperature of 103. New spots also appeared on rash. Patient stopped Keflex and began a different type of antibiotics (Bactrim) and continued using Bactroban cream on spots. The infected spots started improving after about 2 weeks time. The one spot that turned into an abscess took months to fully heal. Ever since then, patient chronically gets red bumps (that resemble the ones which were on the vaccine rash) on various parts of her body which usually clear up with no treatment. A few months later, another bump that turned into an abscess on the back of the patient's thigh became infected and was cultured. The results of the culture came back as Psuedomonas aeruginosa but since very little fluid was obtained, the results were considered inconclusive (although it did come back as a single organism bacterium). About a month later, the same abscess was drained and a considerable amount of fluid was cultured. The results of the culture again came back as Pseudomonas and a single organism bacterium (this abscess again took months to clear up and patient was left with an odd pigmentation where it was that seems permanent). At this point a full workup blood test was given which revealed that patient was neutropenic. Blood tests were repeated at later dates indicating patient is still neutropenic. Patient saw hematologist who diganosed patient with Chronic Benign Neutropenia. Prior to varicella vaccine, patient did not get skin spots recurrently like this and skin spots look exactly like the spots that first showed up on the rash from the vaccine. Patient has not recovered from the neutropenia or the recurrent skin spots as of now (1 year after vaccine), however, the skin spots seem less frequent and patient has not developed any infected skin spots requiring treatment since about 8 months after vaccine was given.
Age: 1.07
Sex: F
Vaccine: VARCEL
Symptoms: Pseudomonas infection, Pseudomonas test positive, Skin infection
Clinical narrative: Patient developed rash on arm surrounding varicella vaccine injection site within a couple days of the vaccine being administered. Within a week, the rash spread from the injection site onto the back. About 6 or 7 red bumps appeared on rash on back that resembled mosquito bites. Two of the bumps became infected and one of them became an abscess the size of a quarter. Doctor was unable to culture the abscess as the fluid was too deep and would have caused patient too much pain. Patient started antibiotics (Keflex) and applied Bactroban cream on spots. Infected spots showed no improvement after 24 hours of antibiotics and patient developed a temperature of 103. New spots also appeared on rash. Patient stopped Keflex and began a different type of antibiotics (Bactrim) and continued using Bactroban cream on spots. The infected spots started improving after about 2 weeks time. The one spot that turned into an abscess took months to fully heal. Ever since then, patient chronically gets red bumps (that resemble the ones which were on the vaccine rash) on various parts of her body which usually clear up with no treatment. A few months later, another bump that turned into an abscess on the back of the patient's thigh became infected and was cultured. The results of the culture came back as Psuedomonas aeruginosa but since very little fluid was obtained, the results were considered inconclusive (although it did come back as a single organism bacterium). About a month later, the same abscess was drained and a considerable amount of fluid was cultured. The results of the culture again came back as Pseudomonas and a single organism bacterium (this abscess again took months to clear up and patient was left with an odd pigmentation where it was that seems permanent). At this point a full workup blood test was given which revealed that patient was neutropenic. Blood tests were repeated at later dates indicating patient is still neutropenic. Patient saw hematologist who diganosed patient with Chronic Benign Neutropenia. Prior to varicella vaccine, patient did not get skin spots recurrently like this and skin spots look exactly like the spots that first showed up on the rash from the vaccine. Patient has not recovered from the neutropenia or the recurrent skin spots as of now (1 year after vaccine), however, the skin spots seem less frequent and patient has not developed any infected skin spots requiring treatment since about 8 months after vaccine was given.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Bacterial infection, Injection site erythema, Injection site inflammation, Injection site pain, Injection site warmth
Clinical narrative: Site of injection inflamed, warm, red, mild pain. Patient was sent to ER and started on cephalexin for bacterial skin infection. Patient has follow-up with primary physician and same diagnosis with second round of cephalexin given.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Skin infection
Clinical narrative: Site of injection inflamed, warm, red, mild pain. Patient was sent to ER and started on cephalexin for bacterial skin infection. Patient has follow-up with primary physician and same diagnosis with second round of cephalexin given.
Age: 0.36
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Blood test, Blood test normal, Diarrhoea, Gastroenteritis, Pyrexia
Clinical narrative: Son had a fever running about 99.9 beginning on Monday night (June 7) and Wednesday he woke up, had his formula bottle of approx. 4 ounces and vomited it up entirely...he repeated this behavior at 6:15 am following a bottle and after every feeding thereafter. He also had diarrhea several times throughout the day. Father called doctor office and was told to give child pedialyte and 1/2 pedialyte; 1/2 formula bottles after that if he could tolerate it. Child refused to drink pedialyte and kept vomiting up his formula.
Age: 0.36
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Urine analysis, Vomiting
Clinical narrative: Son had a fever running about 99.9 beginning on Monday night (June 7) and Wednesday he woke up, had his formula bottle of approx. 4 ounces and vomited it up entirely...he repeated this behavior at 6:15 am following a bottle and after every feeding thereafter. He also had diarrhea several times throughout the day. Father called doctor office and was told to give child pedialyte and 1/2 pedialyte; 1/2 formula bottles after that if he could tolerate it. Child refused to drink pedialyte and kept vomiting up his formula.
Age: 23.0
Sex: F
Vaccine: RAB, RAB
Symptoms: Fatigue, Headache, Hypoaesthesia, Lymphadenopathy, Pain
Clinical narrative: Initial report received from a physician on 17 May 2010: This patient was vaccinated with first dose of RABAVERT (batch number unknown) on 04 May 2010 and second dose (batch number: 456011A, intramuscular) into left deltoid on 11 May 2010 as part of pre-exposure series. The patient experienced body felt numb after the 45 minutes of second dose of RABAVERT vaccination on 11 May 2010 and on next day the patient woke up with pain in left side of body, severe headache, and felt hangover and later that, the patient left side neck swelled up. Another physician confirmed that, the patients neck swelled due to swollen lymph nodes. It was reported that, the patients lips did not swelled. It was also reported that, the patient did not experience any adverse reactions after the first dose of RABAVERT vaccination. The outcome of events was reported as completely recovered. Follow-up report received from a physician on 01 Jun 2010: The reporter stated that about half an hour to 45 min after vaccination, the patient felt very numb and dizzy on 11 may 2010. A few hours later her left side of the body started to ache and got worse throughout the next day. The patient felt dizzy, extremely tired and felt as if had a bad hangover (date unspecified). The patient also experienced body ache as if she had flu and her left side of the neck started to swell following which her treating physician diagnosed her with swollen lymph nodes on 12 May 2010. The events "numb and dizzy" recovered on 11 May 2010 and cervical lymphadenopathy recovered on 14 May 2010. The reporter assessed the events as serious (medically significant) and related to the drug.
Age: 23.0
Sex: F
Vaccine: RAB, RAB
Symptoms: Dizziness, Fatigue, Hangover, Headache, Hypoaesthesia
Clinical narrative: Initial report received from a physician on 17 May 2010: This patient was vaccinated with first dose of RABAVERT (batch number unknown) on 04 May 2010 and second dose (batch number: 456011A, intramuscular) into left deltoid on 11 May 2010 as part of pre-exposure series. The patient experienced body felt numb after the 45 minutes of second dose of RABAVERT vaccination on 11 May 2010 and on next day the patient woke up with pain in left side of body, severe headache, and felt hangover and later that, the patient left side neck swelled up. Another physician confirmed that, the patients neck swelled due to swollen lymph nodes. It was reported that, the patients lips did not swelled. It was also reported that, the patient did not experience any adverse reactions after the first dose of RABAVERT vaccination. The outcome of events was reported as completely recovered. Follow-up report received from a physician on 01 Jun 2010: The reporter stated that about half an hour to 45 min after vaccination, the patient felt very numb and dizzy on 11 may 2010. A few hours later her left side of the body started to ache and got worse throughout the next day. The patient felt dizzy, extremely tired and felt as if had a bad hangover (date unspecified). The patient also experienced body ache as if she had flu and her left side of the neck started to swell following which her treating physician diagnosed her with swollen lymph nodes on 12 May 2010. The events "numb and dizzy" recovered on 11 May 2010 and cervical lymphadenopathy recovered on 14 May 2010. The reporter assessed the events as serious (medically significant) and related to the drug.
Age: 23.0
Sex: F
Vaccine: RAB, RAB
Symptoms: Local swelling, Lymphadenopathy, Pain
Clinical narrative: Initial report received from a physician on 17 May 2010: This patient was vaccinated with first dose of RABAVERT (batch number unknown) on 04 May 2010 and second dose (batch number: 456011A, intramuscular) into left deltoid on 11 May 2010 as part of pre-exposure series. The patient experienced body felt numb after the 45 minutes of second dose of RABAVERT vaccination on 11 May 2010 and on next day the patient woke up with pain in left side of body, severe headache, and felt hangover and later that, the patient left side neck swelled up. Another physician confirmed that, the patients neck swelled due to swollen lymph nodes. It was reported that, the patients lips did not swelled. It was also reported that, the patient did not experience any adverse reactions after the first dose of RABAVERT vaccination. The outcome of events was reported as completely recovered. Follow-up report received from a physician on 01 Jun 2010: The reporter stated that about half an hour to 45 min after vaccination, the patient felt very numb and dizzy on 11 may 2010. A few hours later her left side of the body started to ache and got worse throughout the next day. The patient felt dizzy, extremely tired and felt as if had a bad hangover (date unspecified). The patient also experienced body ache as if she had flu and her left side of the neck started to swell following which her treating physician diagnosed her with swollen lymph nodes on 12 May 2010. The events "numb and dizzy" recovered on 11 May 2010 and cervical lymphadenopathy recovered on 14 May 2010. The reporter assessed the events as serious (medically significant) and related to the drug.
Age: 60.0
Sex: F
Vaccine: FLU(H1N1), VARZOS
Symptoms: Erythema, Oedema peripheral
Clinical narrative: Less than 24 hours after administration. Pt w/rt arm redness, swelling which eventually got to be size of "small cucumber". No rash, (+) myalgias, nausea.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site oedema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Usual mild sting w/ administration, then increased deltoid swelling and beginning edema upper arm below deltoid. At 48 hrs deltoid almost 2x normal size.  Marked redness/heat of entire upper arm. Edema traveled down to wrist stopping @ hand. Marked pain in entire arm--have NEVER had that type of reaction to vaccine before.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Oedema peripheral, Pain in extremity
Clinical narrative: Usual mild sting w/ administration, then increased deltoid swelling and beginning edema upper arm below deltoid. At 48 hrs deltoid almost 2x normal size.  Marked redness/heat of entire upper arm. Edema traveled down to wrist stopping @ hand. Marked pain in entire arm--have NEVER had that type of reaction to vaccine before.
Age: 37.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Rash erythematous, Rash pruritic
Clinical narrative: Pt received H1N1 vaccination.  Next day awoke with red, itchy rash to diffuse body.  Never before.  No uri.  No sob/cp/abd pain.  No n/v/d.  No ha/dizzy. No blisters/pus. No new meds.  No new foods.
Age: 42.0
Sex: M
Vaccine: FLU(H1N1), FLUX
Symptoms: Eye pruritus, Lacrimation increased, Ocular hyperaemia, Pharyngeal oedema
Clinical narrative: Eye watering, itching and redness. Mild throat swelling
Age: 47.0
Sex: M
Vaccine: JEV1, RAB, TYP
Symptoms: Abdominal pain upper, Feeling cold, Flushing, Headache, Hyperhidrosis
Clinical narrative: Pt received Ixiaro, Rabies, and Typhoid on 6/03/2010.  The first night pt experienced facial diaphoresis and flushing while body was cold from the neck down. Pt did not take temp but felt feverish, had a HA, all symptoms relieved with Aleve. HAs continued for 5 days, always resolved with Aleve. Pt also reports stomach cramping that has continued until 6/10/2010 though with less frequency, no diarrhea or vomiting. Pt states he is in excellent health and has never had these symptoms before. Pt reports no local inflammation or soreness at sites of injection.  SEs reported to physician asst and medical director.  Both think this relates to the Ixiaro, recommend giving it alone at 28 days.  Pt given rabies #2 6/10/2010, reported no SEs on 6/11/2010.
Age: 47.0
Sex: M
Vaccine: JEV1, RAB, TYP
Symptoms: Pyrexia, Skin warm, Vaccination complication
Clinical narrative: Pt received Ixiaro, Rabies, and Typhoid on 6/03/2010.  The first night pt experienced facial diaphoresis and flushing while body was cold from the neck down. Pt did not take temp but felt feverish, had a HA, all symptoms relieved with Aleve. HAs continued for 5 days, always resolved with Aleve. Pt also reports stomach cramping that has continued until 6/10/2010 though with less frequency, no diarrhea or vomiting. Pt states he is in excellent health and has never had these symptoms before. Pt reports no local inflammation or soreness at sites of injection.  SEs reported to physician asst and medical director.  Both think this relates to the Ixiaro, recommend giving it alone at 28 days.  Pt given rabies #2 6/10/2010, reported no SEs on 6/11/2010.
Age: 14.0
Sex: F
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Dizziness, Fall, Head injury, Hypotension, Laboratory test normal
Clinical narrative: 30 seconds after receiving vaccine pt. felt faint was laid down and monitored for 10 min. pt was able to stand & walk without problems, then while standing at the check-out desk with her mother, she passed out-falling backward and striking her head on the wall. Was sent to ER by ambulance due to head injury and low blood pressure.
Age: 14.0
Sex: F
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Loss of consciousness
Clinical narrative: 30 seconds after receiving vaccine pt. felt faint was laid down and monitored for 10 min. pt was able to stand & walk without problems, then while standing at the check-out desk with her mother, she passed out-falling backward and striking her head on the wall. Was sent to ER by ambulance due to head injury and low blood pressure.
Age: 0.36
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Death, Unresponsive to stimuli
Clinical narrative: Infant found unresponsive by parents on the afternoon of 6/10/10.
Age: 43.0
Sex: M
Vaccine: PPV
Symptoms: Dizziness, Feeling hot, Flushing
Clinical narrative: Felt "hot & dizzy", looked flushed, BP: 133/90, HR: 67. Cool cloth to forehead, 16 oz ice water consumed. Symptoms resolved by 2:35pm.
Age: 24.0
Sex: F
Vaccine: MEN, TDAP
Symptoms: Diarrhoea, Headache, Musculoskeletal stiffness
Clinical narrative: Onset of diarrhea @ 48 hrs, followed by headache, stiff neck.  Doesn't think she had fever.  Was taking Tylenol. Symptoms still present on day 5.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Rash erythematous, Rash vesicular
Clinical narrative: 3 cm erythema area (L) upper arm 20-25 red spots over trunk with a few vesicular.
Age: 41.0
Sex: M
Vaccine: SMALL
Symptoms: Blood creatine phosphokinase MB, Blood creatine phosphokinase increased, C-reactive protein increased, Cardiac stress test, Chest X-ray
Clinical narrative: PCM consulted HC for assessment of the patient's chest pain after the SPV. Per pt on 3/3/10 during a PT run which lasted 1 hour and 15 minutes the pt experienced left sided chest pressure (3/10) and a sensation that his "heart was beating out of sync". For the first hour after the run the pain continued but was a 1/10. The pt stated that he felt like he had run 30 miles instead of just 4 miles. The pt had no N, V or SOB or diaphoresis (other than from exercise). The pain subsided after one hour of rest. On 3/5/10 during a 45 min. run the pt experienced chest pressure/discomfort, 1/10, no palpitations, no N, V, SOB. The pain lasted for 20 minutes after he stopped running. During a PT test on 3/8/20 the pt did not experience chest pain/pressure or palpitations. The pt was evaluated by cardiology on 4/19/10 and had a normal physical exam. The pt had been asymptomatic since 3/5/10. It was determined that the patient's chest pain was non-cardiac in nature (does not meet the case definition for myocarditis or pericarditis) and patient was returned to full duty without restriction. Pain, chest NEC(786.59), Palpitations(785.1).
Age: 41.0
Sex: M
Vaccine: SMALL
Symptoms: Chest discomfort, Chest pain, Echocardiogram, Electrocardiogram, Heart rate irregular
Clinical narrative: PCM consulted HC for assessment of the patient's chest pain after the SPV. Per pt on 3/3/10 during a PT run which lasted 1 hour and 15 minutes the pt experienced left sided chest pressure (3/10) and a sensation that his "heart was beating out of sync". For the first hour after the run the pain continued but was a 1/10. The pt stated that he felt like he had run 30 miles instead of just 4 miles. The pt had no N, V or SOB or diaphoresis (other than from exercise). The pain subsided after one hour of rest. On 3/5/10 during a 45 min. run the pt experienced chest pressure/discomfort, 1/10, no palpitations, no N, V, SOB. The pain lasted for 20 minutes after he stopped running. During a PT test on 3/8/20 the pt did not experience chest pain/pressure or palpitations. The pt was evaluated by cardiology on 4/19/10 and had a normal physical exam. The pt had been asymptomatic since 3/5/10. It was determined that the patient's chest pain was non-cardiac in nature (does not meet the case definition for myocarditis or pericarditis) and patient was returned to full duty without restriction. Pain, chest NEC(786.59), Palpitations(785.1).
Age: 41.0
Sex: M
Vaccine: SMALL
Symptoms: Red blood cell sedimentation rate normal, Troponin
Clinical narrative: PCM consulted HC for assessment of the patient's chest pain after the SPV. Per pt on 3/3/10 during a PT run which lasted 1 hour and 15 minutes the pt experienced left sided chest pressure (3/10) and a sensation that his "heart was beating out of sync". For the first hour after the run the pain continued but was a 1/10. The pt stated that he felt like he had run 30 miles instead of just 4 miles. The pt had no N, V or SOB or diaphoresis (other than from exercise). The pain subsided after one hour of rest. On 3/5/10 during a 45 min. run the pt experienced chest pressure/discomfort, 1/10, no palpitations, no N, V, SOB. The pain lasted for 20 minutes after he stopped running. During a PT test on 3/8/20 the pt did not experience chest pain/pressure or palpitations. The pt was evaluated by cardiology on 4/19/10 and had a normal physical exam. The pt had been asymptomatic since 3/5/10. It was determined that the patient's chest pain was non-cardiac in nature (does not meet the case definition for myocarditis or pericarditis) and patient was returned to full duty without restriction. Pain, chest NEC(786.59), Palpitations(785.1).
Age: 0.34
Sex: M
Vaccine: DTAPHEPBIP, HEP, PNC13, RV5
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: no adverse events
Age: 1.63
Sex: M
Vaccine: MMR
Symptoms: Body temperature increased, Decreased appetite, Ear pruritus, Eye irritation, Irritability
Clinical narrative: 103 TEMERATURE - 24 HOURS. 101 TEMERATURE - 2ND 24 HOURS. 99-100 TEMPERATURE - 3RD 24 HOURS. RUNNY NOSE. VISIBLE SWOLLEN NODES ON NECK. RASH ON FACE. RUBBING EARS DURING 3RD 24 HOUR PERIOD. RUBBING FOREHEAD DURING 3RD 24 HOUR PERIOD AND CONTINUES. RUBBING EYES DURING 3RD 24 HOUR PERIOD ON CONTINUES. SLEEPS ONLY 2 HOURS AT A TIME WAKES UP SCREAMING SINCE ONSET OF REACTION. LACK OF INTEREST FOR EATING FIRST 96 HOURS. VERY FUSSY FOR FIRST 96 HOURS
Age: 1.63
Sex: M
Vaccine: MMR
Symptoms: Lymphadenopathy, Rash, Rhinorrhoea, Screaming, Skin irritation
Clinical narrative: 103 TEMERATURE - 24 HOURS. 101 TEMERATURE - 2ND 24 HOURS. 99-100 TEMPERATURE - 3RD 24 HOURS. RUNNY NOSE. VISIBLE SWOLLEN NODES ON NECK. RASH ON FACE. RUBBING EARS DURING 3RD 24 HOUR PERIOD. RUBBING FOREHEAD DURING 3RD 24 HOUR PERIOD AND CONTINUES. RUBBING EYES DURING 3RD 24 HOUR PERIOD ON CONTINUES. SLEEPS ONLY 2 HOURS AT A TIME WAKES UP SCREAMING SINCE ONSET OF REACTION. LACK OF INTEREST FOR EATING FIRST 96 HOURS. VERY FUSSY FOR FIRST 96 HOURS
Age: 1.63
Sex: M
Vaccine: MMR
Symptoms: Somnolence
Clinical narrative: 103 TEMERATURE - 24 HOURS. 101 TEMERATURE - 2ND 24 HOURS. 99-100 TEMPERATURE - 3RD 24 HOURS. RUNNY NOSE. VISIBLE SWOLLEN NODES ON NECK. RASH ON FACE. RUBBING EARS DURING 3RD 24 HOUR PERIOD. RUBBING FOREHEAD DURING 3RD 24 HOUR PERIOD AND CONTINUES. RUBBING EYES DURING 3RD 24 HOUR PERIOD ON CONTINUES. SLEEPS ONLY 2 HOURS AT A TIME WAKES UP SCREAMING SINCE ONSET OF REACTION. LACK OF INTEREST FOR EATING FIRST 96 HOURS. VERY FUSSY FOR FIRST 96 HOURS
Age: 3.0
Sex: M
Vaccine: PNC13
Symptoms: Culture throat negative, Peritonsillar abscess, Pharyngitis, Pyrexia, Streptococcus test positive
Clinical narrative: fever 102, mild pharyngitis Neg TC
Age: 1.01
Sex: M
Vaccine: MMR, PNC13, VARCEL
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Within a few minutes after receiving injections pt's legs started to get red and warm to touch at injection site. Pt didn't experience any difficulty breathing or any other problems. Pt did receive 1st MMR and Varicella and PREVNAR 13. Pt has had previous doses of PREVNAR 7. Mom stated No Known Allergies. Pt stayed in office and was treated in office same day. Diphenhydramine 9 ml given R IM thigh Lot 019077 exp 1/12 given ORALPRED ODT 15mg mom was instructed by Dr. to f/u in 24 hours with Dr. which she did pt was doing well and legs looked normal.
Age: 1.01
Sex: M
Vaccine: MMR, PNC13, VARCEL
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Within a few minutes after receiving injections pts both legs started to turn red and warm at injection site. Pt didn't experience any difficulty breathing or any other problems. Pt did receive 1st MMR and varicella and Prevnar 13. Pt has had previous doses of Prevnar 7. Mom stated no known allergies. Pt stayed in office and was treated in office same day. BENADRYL 9mg given (R) IM thigh lot D19077 exp 1/11-given ORAPRED O DT 15 mg. Mom was instructed by Dr to make f/u in 24 hours.
Sex: F
Vaccine: HPV4
Symptoms: Drug exposure during pregnancy, Neonatal disorder
Clinical narrative: Information has been received from a Pediatrician via medical records concerning a male baby who was born to a 23 year old mother with allergy to anything in the "cillin family", PPD skin test positive and a history of caesarean section and tuberculosis exposure. It was reported that the mother had one previous pregnancy and one full term delivery. On 05-SEP-2008, 05-NOV-2008 and 16-MAR-2009 the mother was vaccinated with the first, second and third dose of GARDASIL, respectively (Lot # for the third dose: 661953/1130X). Her LMP was 16-FEB-2009. On approximately 17-MAR-2009, the mother experienced sharp pains located "4 inches below her belly button and 4 inches to the left of her belly button". She stated the pain might due to a previous caesarian section (see WAES #0903USA02927). On 16-NOV-2009, the mother delivered a normal, healthy male baby weighing 8 pounds, 6 ounces, length 21 inches. The mother had no complication and no infections or illnesses during pregnancy. The mother had no complication during labor/delivery. On an unspecified date the baby had a circumcision. On 12-APR-2010 the baby had a 4 month follow-up visit. It was reported that the baby was breast feeding 6 ounces every 2-3 hours and he was up 2 times at night. His height was 26 1/4 inches; weight was 18 pounds 6.5 ounces. Physical examination showed birth mark on his forehead and small Mongolian spot on his buttocks. The assessment was normal 4 month exam. On the same day the baby was vaccinated with the first dose of PREVNAR (lot #E38312) in the left, hepatitis B vaccine (Lot #AHBVB79CKA) in the left and PENTACEL (Lot# C355S7AA) in the right. Birth mark on his forehead and small Mongolian spot on his buttocks were considered to be congenital anomalies. Additional information has been requested. All available medical records will be provided upon request.
Age: 18.0
Sex: F
Vaccine: VARCEL
Symptoms: Headache, Injection site induration, Injection site urticaria
Clinical narrative: Urticaria large indurated at site of injection 8 x 10cm. Not infected. Headache.
Age: 27.0
Sex: F
Vaccine: TTOX
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Area Lt deltoid, erythematous macular, red, painful, isolated/localized 2 inches in diameter, no fever, no drainage, no treatment.
Sex: U
Vaccine: HPV4
Symptoms: Drug exposure during pregnancy, Talipes, Ultrasound scan abnormal
Clinical narrative: Information has been received from a certified nurse midwife concerning a prenatal baby whose mother, a 17 year old female, on 01-APR-2008, 17-OCT-2008 and 03-JAN-2009 was vaccinated with the first, second and third 0.5 ml IM dose of GARDASIL (lot # 658554/0928U, 660391/0063X, 661530/0575X) respectively. Concomitant therapy included prenatal vitamins (unspecified). Subsequently the patient's mother was pregnant. LMP was on 04-JAN-2009, estimated delivery date was 11-OCT-2009 (see WAES #0904USA03151). On 20-JUN-2009, the patient's mother had an anatomy survey sonogram which identified a left club foot. At the time of reporting, the outcome was unknown. Left club foot was considered to be congenital anomaly. The mother's experience has been captured in WAES 0904USA03151. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Cerebral ventricle dilatation, Drug exposure during pregnancy, Gastric disorder, Pericardial effusion, Thalassaemia alpha
Clinical narrative: Information has been received from a medical assistant concerning a newborn female who's mother was vaccinated on 21-MAY-2009 and 29-JUL-2009 with a 0.5 ml first and a second dose (lot # 662300/0100Y) of GARDASIL. During pregnancy the patient was also exposed to YASMIN, CONCEPT and iron (unspecified) ("INTERJCA"). The patient experienced pericardial effusion, intracranial ventriculomegaly, stomach duodenum, possibly aneuploidy and alpha thalassemia trait (after baby born no abnormalities). The patient's outcome was unknown. The mother's experience has been captured in WAES # 0909USA01458. Pericardial effusion, intracranial ventriculomegaly, possibly aneuploidy and alpha thalassemia trait were considered to be congenital anomalies. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Drug exposure during pregnancy, Intensive care, Jaundice, Sepsis, Weight gain poor
Clinical narrative: Information has been received from a physician assistant, for GARDASIL, a Pregnancy Registry product, concerning a female 0 day old infant who on 01-SEP-2009 was vaccinated with a first dose of GARDASIL via transplacental administration. Concomitant therapy included vitamins (unspecified). On 03-MAY-2010 the infant experienced jaundice at birth and slow weight gain. On unspecified date, the infant was sent to NICU for r/o sepsis. At the time of the report, the infant recovered from jaundice at birth and slow weight gain. The outcome of sent to NICU for r/o sepsis was unknown. Additional information has been requested. The mother's experience has been captured in WAES0910USA02157.