chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 25.0
Sex: M
Vaccine: ANTH
Symptoms: Arrhythmia, Dizziness, Erythema, Immune system disorder, Injection site inflammation
Clinical narrative: Submitted to Docket No. 1980N-0208; 69 FR 78281, December 29, 2004 - Bacterial Vaccines & Toxoids Efficacy Review Proposal. I received my first three anthrax vaccinations from lots FAV030 in November and December of 1998 as mandated by the military vaccination program. FAV030 has tested positive for Squalene. I have also received several other anthrax shots from other lots. I was forced by the military to take some of these shots outside of the licensed schedule for them. I was in my mid-20's when I received the first shots an in extremely good physical condition. Within several months of receiving the injections, I developed seborrheic dermatitis. It has become progressively worse since then and now covers my entire face, head, groin, and underarms. My skin is red, inflamed, itchy, and covered with scales. I can only partially control it with a strong prescription steroid cream and shampoo. Seborrheic dermatitis is an immune disorder. My body's immune system has been triggered to attack it's own skin. The medication I use to control it has it's own set of side effects and risks. I also developed heart fibrillation's which have likewise become more frequent and severe in the years since 1998. Additionally, in the months following the anthrax injections, I suffered bouts of debilitating dizziness. Finally, I have developed chronic sleep problems. I have not been able to obtain a restful night of sleep in several years. I did not have any of these problems before receiving the Anthrax injection. There is very little doubt in my mind that the anthrax vaccine is the causal factor for my problems.
Age: 25.0
Sex: M
Vaccine: ANTH
Symptoms: Pruritus, Seborrhoeic dermatitis, Skin exfoliation, Sleep disorder
Clinical narrative: Submitted to Docket No. 1980N-0208; 69 FR 78281, December 29, 2004 - Bacterial Vaccines & Toxoids Efficacy Review Proposal. I received my first three anthrax vaccinations from lots FAV030 in November and December of 1998 as mandated by the military vaccination program. FAV030 has tested positive for Squalene. I have also received several other anthrax shots from other lots. I was forced by the military to take some of these shots outside of the licensed schedule for them. I was in my mid-20's when I received the first shots an in extremely good physical condition. Within several months of receiving the injections, I developed seborrheic dermatitis. It has become progressively worse since then and now covers my entire face, head, groin, and underarms. My skin is red, inflamed, itchy, and covered with scales. I can only partially control it with a strong prescription steroid cream and shampoo. Seborrheic dermatitis is an immune disorder. My body's immune system has been triggered to attack it's own skin. The medication I use to control it has it's own set of side effects and risks. I also developed heart fibrillation's which have likewise become more frequent and severe in the years since 1998. Additionally, in the months following the anthrax injections, I suffered bouts of debilitating dizziness. Finally, I have developed chronic sleep problems. I have not been able to obtain a restful night of sleep in several years. I did not have any of these problems before receiving the Anthrax injection. There is very little doubt in my mind that the anthrax vaccine is the causal factor for my problems.
Sex: F
Vaccine: ANTH
Symptoms: Chest pain, Hypoaesthesia, Injection site mass, Pruritus, Rash
Clinical narrative: Submitted to Docket No. 1980N-0208; 69 FR 78281, December 29, 2004 - Bacterial Vaccines & Toxoids Efficacy Review Proposal. On 9/17, I received my first Anthrax shot. The only side effects at the time was a lump on my arm where the shot was administered that lasted for over two weeks. The second shot was given on 10/04 with the same side effect. The third and final shot I received was on 10/18 with the same results as well. 11/29, I was awaken by a sharp pain in my chest that I had never felt before. My entire left arm was numb and I was scared to move it. I was debating on whether to go the emergency room, but decided to look up chest pain on the internet. In the mean time, I wrote a note to whom ever incase I did not wake up in the morning (b/c I had never felt anything like it; I was worried what might happen). When I woke up in the morning the pain was completely gone. 12/4, I was driving home from a party when a sharp pain in my chest that resembled the 11/29 pain but not as intense. Went to bed that night; woke up I was fine. 1/1/05, I was visiting family and driving home from dinner the same chest pain came back. It lasted the entire night but went away by the time I woke the next morning. 12/20, I was at my grandmother's house when my neck started itching really badly. I asked her what the back of my neck looked like because it felt like little bumps all over. She said it just looks like a rash. Not thinking anything about it, I went to bed. For the next week, my entire neck itched really bad and felt like little bumps in certain areas. On 1/8, I was in training when my neck festered to the point where it started oozing. I went to the emergency room worried /bc I had not ever seen anything like it. I have not started using any new products so I didn't think it was an allergic reaction to anything, besides it was only on my neck. I told the ER doctor my symptoms and he said it sort of looked like eczema, but then again it looked like an allergic reaction. He gave me a 4 day dose of Prednisone 20mg. I just took my last dose a few hours ago and still have red bumps and itching. Before taking the Anthrax shot, I have never had any type of chest pain, for that matter, any type of ache or pain which I have been feeling before my Anthrax shot. And for the rash, I have never seen or felt that type of rash before. It has been 20 days now and I still have this persistent rash. I have an appointment to see the doctor on Monday now that I'm back home. I have always been a very healthy person, so I find it strange that after taken the Anthrax shot, I am having all these strange symptoms I've never had before. Although I have no conclusive evidence these symptoms are from the Anthrax shot, I would like to bring it to government's attention.
Sex: M
Vaccine: ANTH
Symptoms: Arthralgia, Muscle twitching
Clinical narrative: Submitted to Docket No. 1980N-0208; 69 FR 78281, December 29, 2004 - Bacterial Vaccines & Toxoids Efficacy Review Proposal. I was ordered to take the anthrax vaccine and experienced life altering side effects from this vaccine. I took 3 of the 6 shots and after each shot I experienced joint pain which increased in severity and duration with each successive shot. I developed muscle twitching after the third shot and have been evaluated and document. I have since been separated from the guard and continue to have the muscle problems every few minutes. It is a constant reminder of this unnecessary vaccine which I was forced to take and the ongoing research that is being conducted on our troops.
Sex: M
Vaccine: ANTH
Symptoms: Erythema, Injection site inflammation, Injection site reaction, Memory impairment, Skin exfoliation
Clinical narrative: Submitted to Docket No. 1980N-0208; 69 FR 78281, December 29, 2004 - Bacterial Vaccines & Toxoids Efficacy Review Proposal. I was in the military for 8 years. In 2000, I was selected to deploy. This was my third deployment in my career. I was told that I would be given the Anthrax vaccine before and during my deployment. I began my injections and immediately we saw severe localized reactions around the injection site. My arm was inflamed, swollen and red as an apple. I received two injections state side and my third immediately after stepping off the plane. After my third injection, I began having problems. There were huge gaps in my memory. I couldn't remember anything from specific days that were only a couple days past. The skin on my fingers and hands began to separate like from a blister only there was no fluid involved. I could peel my fingers like a banana. This wasn't dry skin mind you; it was thick and moist and pliable. I developed lesions on my arms. I had heard stories of other solders when they went to the doctors office with concerns about the effects of the vaccine, so when I went I made no mention of the vaccine. I was given different diagnoses every time I went in. I was prescribed all sorts of creams, ointments, and antibiotics, none of which worked. My mom had started me on a strong regiment of herbs and vitamins to build and strengthen my immune system before I started the shots. I continued on these and it still took me over two years to recover. I still take these today over four years later. My wife says that I still have occasional memory losses.
Sex: M
Vaccine: ANTH
Symptoms: Skin ulcer, Swelling
Clinical narrative: Submitted to Docket No. 1980N-0208; 69 FR 78281, December 29, 2004 - Bacterial Vaccines & Toxoids Efficacy Review Proposal. I was in the military for 8 years. In 2000, I was selected to deploy. This was my third deployment in my career. I was told that I would be given the Anthrax vaccine before and during my deployment. I began my injections and immediately we saw severe localized reactions around the injection site. My arm was inflamed, swollen and red as an apple. I received two injections state side and my third immediately after stepping off the plane. After my third injection, I began having problems. There were huge gaps in my memory. I couldn't remember anything from specific days that were only a couple days past. The skin on my fingers and hands began to separate like from a blister only there was no fluid involved. I could peel my fingers like a banana. This wasn't dry skin mind you; it was thick and moist and pliable. I developed lesions on my arms. I had heard stories of other solders when they went to the doctors office with concerns about the effects of the vaccine, so when I went I made no mention of the vaccine. I was given different diagnoses every time I went in. I was prescribed all sorts of creams, ointments, and antibiotics, none of which worked. My mom had started me on a strong regiment of herbs and vitamins to build and strengthen my immune system before I started the shots. I continued on these and it still took me over two years to recover. I still take these today over four years later. My wife says that I still have occasional memory losses.
Age: 0.36
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Crying, Pyrexia, Screaming
Clinical narrative: From initial information received on 10Aug04 from another manufacturer, it was initially reported by a health care professional that a four month old female pt received a dose of Acthib, lot UE384AA; a dose of Pediarix, lot 21936A2 and a dose of Prevnar lot A57560A, administered on 19Jul04. The lot number provided for Acthib does not match the manf product. The sites and routes of admin were not provided for any of the products. The next day, on 20Jul04, the pt's mother called the physician's office and stated that the pt had been screaming for an hour and her temp was 100.3 degrees F. She was treated with Motrin 60mg every six hours. The pt's recovery status is unk and the pt's mother has not responded to messages left by the physicians office. From additional information received on 13Sep04 from the initial reporter, the pt was seen by a physician following the adverse events. She did not have any lab work or diagnostic testing done. No other medical information was provided and it was not reported whether the pt recovered from these events. No further information is anticipated, this case is considered closed.
Age: 0.52
Sex: M
Vaccine: DTAP, HIBV, PNC
Symptoms: Crying, Screaming
Clinical narrative: From initial information received on 20Aug04 from a physician regarding an adverse event occurring, it was reported that a six month old male pt received a second dose of ActHib, lot number UE119AA, administered in the right anterior lateral thigh; a third dose of Tripedia, lot U1272BA, route and site of admin not reported; and a dose of Prevnar, lot 495930, route and site of admin not reported, on 20Aug04. Immediately following the admin of ActHib, the pt began crying. The crying was persistent and got worse within the first ten minutes. Acthib was the second vaccine administered of three. The persistent crying improved after one hour. It was not reported whether the pt recovered from this event. From additional information received on 21/Mar/2005 from the responsible physician, it was reported that the patient has recovered from these events. No further information is anticipated. This case is considered closed.
Age: 0.16
Sex: M
Vaccine: DTAP, HIBV, IPV
Symptoms: Somnolence
Clinical narrative: From initial information received on 19Aug04 from another manf (ref HQWYE519218JUN04) regarding an adverse event occurring, it was reported by the pt's parent and a physician that a two month old male pt received an ACTHIB vaccination, an IPOL vaccination and a TRIPEDIA vaccination on 17Jun03. The lot numbers, routes and sites of admin were not reported. That same day the pt slept alot. The recovery status of the pt was unk at the time of this report. This pt had a second adverse event which is detailed in case 200402130.
Age: 0.15
Sex: F
Vaccine: HIBV, PNC, HEP, HIBV, PNC
Symptoms: Urticaria
Clinical narrative: From initial information received on 27Aug04 from manf (HQWYE739228JUN04) from information received from a physician regarding an adverse event occurring. It was reported that a two month old female pt received an Acthib vaccination, lot UE212AA, route and site of admin not reported on 09Jun04. The same day the pt developed a few hives on the face. The pt recovered from this event. From additional information received on 19Oct04 from the reporting physician, it was reported that Acthib vaccine was administered in the left leg. The pt also received a first dose of Prevnar, lot 495248, administered in the right leg on 09Jul04. The pt's mother called the physician's office later that same day after noticing three to four hives on the infants face at home. She was told to administer Benadryl. Approx a half hour later, the pt's mother called back and reported that the hives had faded without medication. No further problems were reported. The pt has since received additional Acthib and Prevnar vaccinations without any adverse reaction. No further information is anticipated, this case is considered closed.
Age: 0.34
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC, DTAP, HIBV, IPV, PNC
Symptoms: Injection site reaction, Urticaria
Clinical narrative: From initial information received on 27Aug04 from manf (HQWYE614423JUN04) from information received from a physician regarding an adverse event occurring. It was reported that a four month old female pt received an Acthib vaccination, lot number X0073, and Ipol vaccination, lot 40148, and a Tripedia vaccination, lot number 61258BA (lots provided for Ipol and Tripedia could not be confirmed as manf lot numbers and routes and sites of admin were not reported) on 22Jun04. The same day, the pt developed hives over upper body. The pt recovered from this event. From additional information received on 11Oct04 from the reporting physician, it was reported that the pt received the Acthib product IM in the left thigh; the Ipol product SC in the right thigh; and the Tripedia product IM in the right thigh. She also received a first dose of Prevnar, lot 495170, administered IM in the left thigh on 22Jun04. The pt developed hives on her left thigh within 15 minutes of receiving the vaccinations. The hives did not spread and slowly resolved over the next two to three hours. The pt did not experienced a reaction to a subsequent DPT injection given on 13Sep04. No treatment was needed for the hives and the pt recovered from these events. No further information is anticipated, this case is considered closed.
Age: 0.34
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC, DTAP, HIBV, IPV, PNC
Symptoms: Urticaria
Clinical narrative: From initial information received on 27Aug04 from manf (HQWYE614423JUN04) from information received from a physician regarding an adverse event occurring. It was reported that a four month old female pt received an Acthib vaccination, lot number X0073, and Ipol vaccination, lot 40148, and a Tripedia vaccination, lot number 61258BA (lots provided for Ipol and Tripedia could not be confirmed as manf lot numbers and routes and sites of admin were not reported) on 22Jun04. The same day, the pt developed hives over upper body. The pt recovered from this event. From additional information received on 11Oct04 from the reporting physician, it was reported that the pt received the Acthib product IM in the left thigh; the Ipol product SC in the right thigh; and the Tripedia product IM in the right thigh. She also received a first dose of Prevnar, lot 495170, administered IM in the left thigh on 22Jun04. The pt developed hives on her left thigh within 15 minutes of receiving the vaccinations. The hives did not spread and slowly resolved over the next two to three hours. The pt did not experienced a reaction to a subsequent DPT injection given on 13Sep04. No treatment was needed for the hives and the pt recovered from these events. No further information is anticipated, this case is considered closed.
Age: 3.0
Sex: F
Vaccine: DTAP, HIBV
Symptoms: Cellulitis, Erythema, Injection site erythema, Injection site oedema, Oedema peripheral
Clinical narrative: From initial information received on 09/09/2004 from a health care professional regarding an adverse event occurring in the U.S.A., it was reported that a 2 year old female patient received a dose of ACT-HIB, lot number UE390AA, administered in the left thigh, and a fourth dose of Tripedia, lot number U0848CA, administered in the left thigh on 01/31/2003. The routes of administration were not reported. The following day, on 01/31/03, the patients mother called the doctor's office to report her daughter's leg was swollen and red from the injection site at the upper thigh down to her toes. The patient was not seen for an office visit. It was reported that the patient recovered from these events. On 09/15/04, the reporter was contacted to confirm the lot number provided for ACTHIB. The lot number provided for ACTHIB was recorded as UE390AA, in the patient's chart. This number does not correspond to ACTHIB, but instead is the lot number for PRP-T diluent. A check in the internal database linked this diluent with ACTHIB lot number UA797AA (French lot number W-0795-2). It could not be confirmed whether the patient actually received the ACTHIB or the diluent. From additional information received on 11/22/04 from a health care professional, it was reported that the patient received her fourth dose of Tripedia, lot number U0848CA, administered intramuscularly in the left leg and her fourth dose of ACTHIB, lot number UE390AA, administered intramuscularly in the left leg on 01/30/03, not 01/31/03 as previously reported. The following day, on 01/31/03, the patient's grandmother complained of a possible site reaction, with swelling and redness of the left thigh. The patient was treated with alternating doses of Tylenol and ibuprofen for pain. No laboratory testing was obtained. No further information is anticipated, this case is considered closed.
Sex: F
Vaccine: DTAP, HIBV, IPV, MMR, PNC
Symptoms: Erythema, Injection site erythema, Injection site mass, Injection site warmth, Skin reaction
Clinical narrative: From initial information received on 09/27/2004 from a health care professional regarding an adverse event occurring in the U.S.A., it was reported that a female patient, age unknown, received her 5th dose of Daptacel vaccine, lot number C1700AA, as well as an IPV vaccination, an Act Hib vaccination, a Prevnar vaccination (manufacturer unknown) and a MMR vaccination (manufacturer unknown) on 09/22/04. Information regarding the lot numbers, site and route of administration for the administered products were not provided. Within 24 hours this patinet developed a large  red blotch and an area that was warm to the touch around the injection siet, exat site not specified. Reportedly, the patient recovered from this experience.  The reporter of this case is the same reportere of cases 200403223, 200403225, and 200403226.
Age: 0.33
Sex: F
Vaccine: DTAP, HIBV, IPV, MMR, PNC
Symptoms: Erythema, Injection site erythema, Injection site mass, Injection site warmth, Rash maculo-papular
Clinical narrative: From initial information received on 09/27/2004 from a health care professional regarding an adverse event occurring in the U.S.A., it was reported that a female patient, age unknown, received her 5th dose of Daptacel vaccine, lot number C1996AA, on 09/23/04. That same day she also received a dose of IPV vaccine, a dose of Act Hib vaccine, a dose of Prevnar vaccine and a dose of MMR (manufacturer unknown). Information regarding the lot numbers, dose and route of administration were not provided for these products. Reportedly, within 24 hours the patient experienced a large red blotch and an area that was warm to the touch around the injection site which lasted 4-5 days. Reportedly the patient recovered from the event. From additional information received on 11/02/04 from a health care professional, the patient's date of birth was  provided. The patient was 4 months old at the time of the event. Reportedly, the patient received her 2nd dose of Daptacel, lot number C1996AA, administered intramuscularly in the right thigh, her first dose of Act Hib, lot number UE250AC (Aventis Pasteur SA lot number X0703), administered intramuscularly in he left thigh, her 2nd dose of IPOL, lot number X1038, administered SQ in the left thigh, a 2nd dose of Prevnar, lot number A57559A, manufacturer Lederle, administered intra muscularly in the right thigh and a does of MMR/ Measles, Mumps, and Rubella Vaccine, manufacturer unknown (lot number, route and site of administration not reported) on 09/24/2004. Reportedly at 2:30 PM that same day, 09/24/04, the patient developed the adverse event. No further information is anticipated. This case is considered closed. The reporter of this case is the same reporter of cases 200403223, 200403224, and 200403226.
Age: 0.36
Sex: F
Vaccine: DTAP, HIBV, IPV, MMR, PNC
Symptoms: Injection site erythema, Injection site reaction, Injection site warmth, Rash macular
Clinical narrative: From initial information received on 09/27/2004 from a health care professional regarding an adverse event occurring in the U.S.A., it was reported  that a female patient received her 5 th dose of Daptacel vaccine, lot number C1996AA, administered on 09/23/2004. That same day the patient also received a dose of Act Hib vaccine, a dose of IPV vaccine, a dose of Prevnar vaccine and a dose of MMR/Measles, Mumps, and Rubella vaccine(manufacturer unknown). Information regarding the lot numbers, the dose, the route and site of administration were not reported for these vaccinations. Reportedly, within 24 hours of administration the patient developed a large red blotch and an area that was warm to the touch around the injection site, exact site not specified, that lasted 4-5 days. Reportedly the patient recovered from this event. From additional information received on 11/02/04 from a health care professional, the patient's date of birth was provided. The patient was four months old at the time of the event. Reportedly the patient received her second dose of Daptacel, lot number, C1996AA, administered IM in the left thigh, her first dose of Act Hib lot number UE250A (aventis pastuer lot number X0703) administered IM in the right thigh, a second dose of Prevnar, lot number A57559A, manufacturer Lederle, administered IM in the right thigh and a dose of MMR manufacturer unknown,  (lot number, route and site of administration not reported) on 09/23/2004. Reportedly the patient developed the adverse event at 3:30 pm that same day, 09/23/2004. No further information is anticipated. This case is considered closed. The reporter for this case is the same for cases;200403223, 200403224, and 200403225.
Sex: F
Vaccine: FLU3
Symptoms: Dermatitis acneiform
Clinical narrative: From initial information received on 10/22/2004 from a health care professional regarding and adverse event occurring in the U.S. A., it was reported that a six month old female patient received her 1st dose of Fluzone SV '2004-2005 USP, lot number U1454AA, administered IM in the RT on 10/16/2004. Two days later on 10/18/2004, the patient developed a pimple like rash on her upper chest, back and shoulders. RAST testing to egg white gelatin was not ordered. Reportedly the patient recovered from these events.
Age: 1.53
Sex: M
Vaccine: DTAP, HIBV, PNC
Symptoms: Injection site erythema, Injection site oedema, Injection site warmth
Clinical narrative: From initial information received on 11/19/2004 from a health care professional regarding an adverse event occurring in the USA, it was reported that an 18 month old male pt received a dose of Daptacel, lot number C1699AA, administered in the RL, a dose of Act Hib,  lot number UE2161AA, adminsitered in the RL and a dose of Prevnar (manufacturer Lederle) lot number A57562A, administered in the LL on 11/15/2004. The routes of administration were not reported and the lot number provided for the Act Hib product does not match an Aventis Pasteur product. The Following day, on 11/16/2004, the pt developed redness, and swelling at the injection site, which was also warm to the touch, the pt mother reported that the area was the size of a baby;s fist. Per the reporter, it is unknown whether the patient recovered from these events. The reporter for this case is the same reporter for cases: 200403770, 200403771, 200403772, 200403773, and 200403774.
Age: 1.51
Sex: M
Vaccine: DTAP, FLU3, IPV
Symptoms: Feeling hot, Injection site erythema, Injection site oedema
Clinical narrative: From initial information received on 19Nov04 from a health care professional regarding an adverse event occurring, it was reported that an 18 month old male pt received his third dose of Daptacel, lot number C1700AA, administered in the left thigh, a dose of Ipol, lot X1212, administered in the right thigh and a dose of Fluzone SV 2004-2005 Pediatric dose, lot number U1389AB, administered in the right thigh on 18Nov04. Routes of administration were not reported. That same day, the pt developed a diffuse, red, and warm reaction on his thigh. Reportedly, he was able to walk but the thigh was very swollen. The pt previously received a dose of Acthib,lot number UE443AA, administered in the left thigh, a dose of Fluzone SV 2004-2005 Pediatric dose, lot number U1389AB, administered in the left thigh and a dose of Varivax, lot number 0278P, manf Merck, administered in the right thigh on 18Oct04. Routes of admin of these vaccines were not reported. Concomitant medication at the time of vaccination included Pulmicort and Singulair. Pt's pre-existing medical conditions include Alpha Anti-Trypsin Deficit, Reactive Airways Disease and chronic otitis media. He has no known allergies. It is unk whether the pt recovered from these events. The reporter of this case is the same reporter as cases 200403769, 200403771, 200403772, 200403773 and 200403774.
Age: 0.36
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Injection site erythema
Clinical narrative: From initial information received on 19Nov04 from a health care professional regarding an adverse event occurring it was reported that a four month old male pt received a dose of Daptacel, lot number C1700AA, administered in the left thigh; a dose of Acthib, lot number UE395AA, administered in the left thigh; a dose of Ipol, lot number X1212 (site of administration not reported) and a dose of Prevnar, lot number A57562A, administered in the right thigh on 11Nov04. The routes of administration were not reported. An unspecified amount of time later, the pt developed redness at the site of the injection, but the exact site was not specified. It is unk whether he recovered from this event. The reporter of this case is the same reporter as cases 200403769, 200403770, 200403772, 200403773 and 200403774.
Age: 0.38
Sex: M
Vaccine: HIBV, IPV, DTAP, HIBV, IPV, PNC, DTAP
Symptoms: Pyrexia, Urticaria
Clinical narrative: From initial information received on 21Jan05 from another manf (HQWYE394611NOV04) regarding an adverse event occurring, it was initially reported by a physician that a four month old male pt received a dose of Acthib and a dose of Ipol on 20Dec01. The lot number, route and sites of administration were not reported. 24 hrs later, on 21Dec01, the pt developed hives and a low grade fever. Reportedly, he recovered from these events.
Age: 0.17
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Agitation, Crying
Clinical narrative: From initial information received on 24Jan05 from a RN registered an adverse event occurring, it was reported that a two month old female pt received her first dose of Daptacel, lot number C2104AA, administered in the left thigh, as well as her first doses of Acthib, Ipol, Prevnar, and Hep B vaccine, administered on 23Nov04. The lot number, routes and sites of administration for Acthib, Ipol, Prevnar and Hep B vaccine were not reported. Four to five hours later, the pt started to cry inconsolably for a duration of 45 minutes. She was given Tylenol by her mother, which gradually stopped the crying. Per the reporter, the pt recovered from this event.
Age: 0.54
Sex: F
Vaccine: DTAP, HIBV, PNC
Symptoms: Feeling hot, Injection site erythema
Clinical narrative: From initial information received on 06Aug04 from a health care professional regarding an adverse event occurring, it was reported that a six month old female pt received her third dose of Acthib, lot number UE203AA, administered in the right thigh; a third dose of Daptacel lot number C1697AA administered in the left thigh and a dose of Prevnar, lot A57559D, administered in the left thigh on 05Aug04. The routes of vaccination were not reported. That same day, the pt developed local redness measuring the size of a dime on her right thigh with heat at the site. The site was also described as warm to the touch. Tylenol and warm compresses were recommended. The pt's recovery status was reported as unk. From  additional information received on 10Sep04 from the initial reporter, additional pt, responsible physician, vaccine and adverse event information was provided. The adverse event onset date was corrected to 06Aug04 (previously reported as 05Aug04). None of the other information provided changes any of the previously reported medical information. From additional information received on 15Nov04 from the initial reporter, it was reported that the pt recovered from these events. No further information is anticipated. This case is considered closed.
Age: 1.97
Sex: F
Vaccine: DTAP, HIBV
Symptoms: Urticaria
Clinical narrative: From initial information received on 22Jun04 from a health care professional regarding an adverse event occurring it was reported that a two year old female pt received a dose of Diphtheria tetanus and acellular pertussis vaccine possibly administered on 13Apr01. Lot number, route and site of administration were not reported. Within 24 hrs of vaccination, the pt developed hives on her face and neck. The pt was seen in the ER on 16Apr04. Reportedly, the pt recovered from these events. From additional information received on 23Aug04 from a health care professional, it was reported, the immunization given to the pt on 13Apr01 was given at health dept. Reportedly the pt received TriHibit (Acthib, lot R1021) and Tripedia, lot U0299AA) administered IM in the deltoid. No further information reported. Further information will need to be obtained from the health dept. From additional information received on 03Sep04 from the health dept, the correct date of the ER visit was 14Apr01 and product and lot numbers confirmed. No other information is available. No additional information is anticipated this case is considered closed.
Age: 30.0
Sex: F
Vaccine: TYP
Symptoms: Hypersensitivity, Paralysis
Clinical narrative: It was reported that a woman, who was 38 years old at the time of reporting, was administered a dose of Typhoid vaccine in her left arm on 26-May-97. The day following vaccination, the pt presented with injected arm sensitive and motor paralysis, that lasted for one week. The pt could work, but she could not drive her car. She was treated with aspirin. Pt recovered. A previous Typhoid vaccination had been well tolerated. The reporter considered the case as serious (for seriousness criteria: disability). Further information is awaited. File to be completed.
Age: 57.0
Sex: M
Vaccine: PPV
Symptoms: Bacterial infection, Drug ineffective, Laboratory test abnormal, Pneumonia, Sepsis
Clinical narrative: Report regarding administration of protein-conjugate pneumococcal vaccine to patients who have invasive disease after splenectomy despite their having received received 23 valent pneumococcal polysaccharide vaccine. Information has been received from the authors of a published literature article, concerning a 57 year old male with a history of splenectomy in 1978 because of a complication of intestinal bypass surgery who in 1999 was vaccinated with his first does of pneumococcal 23v polysaccharide vaccine (manufacturer not reported). In 2001 the patient developed septic shock. S. pneumoniae serotype 4 was isolated from blood. Subsequently, the patient recovered. Subsequently, the patient was vaccinated with his second dose of pneumococcal 23v polysaccharide vaccine. Serum obtained after his recovery, and after he had received an additional dos of pneumococcal 23v polysaccharide vaccine, lacked detectable antibody to any of the 7 polysaccharides (PS) contained in heptavalent protein-conjugate pneumococcal vaccine (PCPV-7), including serotype 4 PS (see laboratory data table). Subsequently, the patient was vaccinated with pneumococcal 4 6B 9V 14 18C 19F 23F conj vaccine (CRM197) (PREVNAR), 0.5 ml of vaccine into each deltoid muscle for a total volume of 1.0 ml. Six weeks after his vaccination the pneumococcal 4 6B 9V 14 18C 19F 23F conj vaccine (CRM197) (PREVNAR), the patient had immunoglobulin (Ig) G to all of the PSs contained in PCPV-7, including serotype 4 PS. The reporter felt that the capacity to respond to 23 valent pneumococcal polysaccharide vaccine by producing IgG is genetically regulated, and that some portion of adults do not respond: "Recurrent pneumococcal bacteremia in patients in patients who have undergone splenectomy may indicate a genetically regulated failure to respond to 23 valent pneumococcal polysaccharide vaccine; heptavalent protein-conjugate pneumococcal vaccine may stimulated production of IgG to PSs in such patients". No further information is available. Upon internal review, septic shock was considered an other important medical event. Cross reference with WAES0503USA04856) (OMIC)
Age: 57.0
Sex: M
Vaccine: PPV
Symptoms: Shock
Clinical narrative: Report regarding administration of protein-conjugate pneumococcal vaccine to patients who have invasive disease after splenectomy despite their having received received 23 valent pneumococcal polysaccharide vaccine. Information has been received from the authors of a published literature article, concerning a 57 year old male with a history of splenectomy in 1978 because of a complication of intestinal bypass surgery who in 1999 was vaccinated with his first does of pneumococcal 23v polysaccharide vaccine (manufacturer not reported). In 2001 the patient developed septic shock. S. pneumoniae serotype 4 was isolated from blood. Subsequently, the patient recovered. Subsequently, the patient was vaccinated with his second dose of pneumococcal 23v polysaccharide vaccine. Serum obtained after his recovery, and after he had received an additional dos of pneumococcal 23v polysaccharide vaccine, lacked detectable antibody to any of the 7 polysaccharides (PS) contained in heptavalent protein-conjugate pneumococcal vaccine (PCPV-7), including serotype 4 PS (see laboratory data table). Subsequently, the patient was vaccinated with pneumococcal 4 6B 9V 14 18C 19F 23F conj vaccine (CRM197) (PREVNAR), 0.5 ml of vaccine into each deltoid muscle for a total volume of 1.0 ml. Six weeks after his vaccination the pneumococcal 4 6B 9V 14 18C 19F 23F conj vaccine (CRM197) (PREVNAR), the patient had immunoglobulin (Ig) G to all of the PSs contained in PCPV-7, including serotype 4 PS. The reporter felt that the capacity to respond to 23 valent pneumococcal polysaccharide vaccine by producing IgG is genetically regulated, and that some portion of adults do not respond: "Recurrent pneumococcal bacteremia in patients in patients who have undergone splenectomy may indicate a genetically regulated failure to respond to 23 valent pneumococcal polysaccharide vaccine; heptavalent protein-conjugate pneumococcal vaccine may stimulated production of IgG to PSs in such patients". No further information is available. Upon internal review, septic shock was considered an other important medical event. Cross reference with WAES0503USA04856) (OMIC)
Sex: U
Vaccine: PPV, PPV
Symptoms: Convulsion
Clinical narrative: Information has been received from a pharmacist concerning a hospitalized geriatric pt (age and sex not provided) with history of a possible cerebrovascular accident (CVA) and prior vaccination with a dose of PPV with either lot number 649978/0709P, 649981/0704P or 649977/0706P. The pharmacists was unaware of which lot number was administered to the pt. Following the vaccination, the pt developed seizures. It was reported unspecified medical attention was sought. The pharmacist reported that he believed the pt had been discharged. At the time of this report, the outcome of the event was unknown. The pharmacist reported that he did not think the PPV caused the seizures. Upon internal review, the seizures were considered to be other important medical events (OMIC). Additional information has been requested.
Sex: U
Vaccine: PPV, PPV
Symptoms: Convulsion
Clinical narrative: Information has been received from a pharmacist concerning a hospitalized geriatric patient (age and sex not provided) with a history of a possible cerebrovascular accident (CVA) and a prior vaccination with pneumococcal 23v polysaccharide in 2004. On an unspecified date in 2005, while in a neurology unit, the patient was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine with either lot # (649978/0709P, 649981/0706P or 64997/0706P). The pharmacist was unaware of which lot number was administered to the patient. Following the vaccination, the patient developed seizures. It was reported unspecified medical attention was sought. The pharmacist reported that he believed that the patient had been discharged. At the time of this report, the outcome of the event was unknown. The pharmacist reported that he did not think the pneumococcal 23v polysaccharide vaccine caused the seizures. Upon internal review, the seizures were considered to be other important medical events. Additional information has been requested. (OMIC)
Age: 28.0
Sex: M
Vaccine: PPV
Symptoms: Bacterial infection, Drug ineffective, Gangrene, Laboratory test abnormal, Meningitis
Clinical narrative: Information has been received from the authors of a published literature article, entitled as above, concerning a 28 year old male with HIV infection and idiopathic thrombocytopenic purpura (ITP) who in approximately November 2000 was vaccinated with his first dose of pneumococcal 23v polysaccharide vaccine (manufacturer not reported). In November 2000, after the administration of PPV, the pt underwent splenectomy for ITP. At the end of November 2000, the pt developed overwhelming pneumococcal bacteremia (serotypes were unknown) complicated by meningitis. In March 2001, the pt again developed overwhelming pneumococcal bacteremia (serotypes were unknown) complicated by peripheral gangrene. In March 2001, PPV was administered again. At that time, the pt's CD4 cell count was 441 cells/uL, and his viral load was 253 copies/mL. In January 2002, the pt developed septic shock.  S. pneumoniae serotype was 6b isolated from cerebrospinal fluid and blood. The pt's CD4 cell count was 475 cells/mL, and his viral load was 25,900 copies/mL. His convalescent serum had no detectable immunoglobulin to any of the polysaccharides, either before or after a third dose of PPV was administered. The pt subsequently received three doses of Prevnar at monthly intervals. Subsequently, he had IgG to all of the PSs contained in Prevnar including serotype 6B (see laboratory data table).  The reporter felt that the capacity to respond to 23-valent pneumococcal polysaccharide vaccine by producing IgG is genetically regulated, and that some proportion of adults do not respond: "Recurrent pneumococcal bacteremia in patients who have undergone splenectomy may indicate a genetically regulated failure to respond to 23-valent pneumococcal polysaccharide vaccine; heptavalent protein-conjugate pneumococcal vaccine may stimulate production of IgG to PSs in such patients". No further information is available. Upon internal review, meningitis was considered an other important medical event (OMIC). The article also discussed the experience of a 57 year old male while on therapy with pneumococcal 23v polysaccharide vaccine (WAES0503USA04442). A copy of the published literature article is attached as further documentation of the patient's experience.
Age: 28.0
Sex: M
Vaccine: PPV
Symptoms: Sepsis
Clinical narrative: Information has been received from the authors of a published literature article, entitled as above, concerning a 28 year old male with HIV infection and idiopathic thrombocytopenic purpura (ITP) who in approximately November 2000 was vaccinated with his first dose of pneumococcal 23v polysaccharide vaccine (manufacturer not reported). In November 2000, after the administration of PPV, the pt underwent splenectomy for ITP. At the end of November 2000, the pt developed overwhelming pneumococcal bacteremia (serotypes were unknown) complicated by meningitis. In March 2001, the pt again developed overwhelming pneumococcal bacteremia (serotypes were unknown) complicated by peripheral gangrene. In March 2001, PPV was administered again. At that time, the pt's CD4 cell count was 441 cells/uL, and his viral load was 253 copies/mL. In January 2002, the pt developed septic shock.  S. pneumoniae serotype was 6b isolated from cerebrospinal fluid and blood. The pt's CD4 cell count was 475 cells/mL, and his viral load was 25,900 copies/mL. His convalescent serum had no detectable immunoglobulin to any of the polysaccharides, either before or after a third dose of PPV was administered. The pt subsequently received three doses of Prevnar at monthly intervals. Subsequently, he had IgG to all of the PSs contained in Prevnar including serotype 6B (see laboratory data table).  The reporter felt that the capacity to respond to 23-valent pneumococcal polysaccharide vaccine by producing IgG is genetically regulated, and that some proportion of adults do not respond: "Recurrent pneumococcal bacteremia in patients who have undergone splenectomy may indicate a genetically regulated failure to respond to 23-valent pneumococcal polysaccharide vaccine; heptavalent protein-conjugate pneumococcal vaccine may stimulate production of IgG to PSs in such patients". No further information is available. Upon internal review, meningitis was considered an other important medical event (OMIC). The article also discussed the experience of a 57 year old male while on therapy with pneumococcal 23v polysaccharide vaccine (WAES0503USA04442). A copy of the published literature article is attached as further documentation of the patient's experience.
Age: 1.26
Sex: M
Vaccine: VARCEL
Symptoms: Cellulitis, Dyspnoea
Clinical narrative: Information has been received from a consumer concerning her 15 month old son with no allergies or drug reactions who on 23-FEB-2005 was vaccinated SC with a dose of Varivax. There was no concomitant medication. The reporter indicated that 18 days after vaccination, on approximately 13-MAR-2005, the pt was diagnosed with cellulitis. He also had some breathing difficulties (not further specified) and was administered a 10 day antibiotic. It was noted that the pt was in the ER for 12 hours. A white blood cell count was performed (results not reported). Therapy with Varivax was discontinued. At the time of the report, the pt had not recovered. A product quality complaint was not involved. Cellulitis and difficulties breathing were considered to be disabling by the reporter. Additional information has been requested. The reporter also indicated that the pt had a rash after vaccination with a dose of MMR (WAES0503USA05169)
Age: 2.0
Sex: M
Vaccine: VARCEL
Symptoms: Conjunctivitis, Dermatitis bullous, Drug ineffective, Pruritus, Skin ulcer
Clinical narrative: Information has been received from a LVN concerning a 4 year old male with no medical history and no allergies who on 18-JUN-2003 was vaccinated with the first dose of Varivax (lot number reported as "1378L"). There was no concomitant medication. On 20-MAR-2005 the pt developed classic varicella characterized by 80-100 very itchy lesions scattered on his body, including his scalp. The nurse also reported that the pt developed conjunctivitis. Unspecified medical attention was sought. The pt was treated with tobramycin (Tobrex) ophthalmic drops and Benadryl. No laboratory or diagnostic tests were performed. The pt's present status was reported as unknown. No product quality complaint was involved. The nurse considered the adverse experiences to be other important medical events (OMIC). Additional information has been requested.
Age: 2.0
Sex: M
Vaccine: VARCEL
Symptoms: Viral infection
Clinical narrative: Information has been received from a LVN concerning a 4 year old male with no medical history and no allergies who on 18-JUN-2003 was vaccinated with the first dose of Varivax (lot number reported as "1378L"). There was no concomitant medication. On 20-MAR-2005 the pt developed classic varicella characterized by 80-100 very itchy lesions scattered on his body, including his scalp. The nurse also reported that the pt developed conjunctivitis. Unspecified medical attention was sought. The pt was treated with tobramycin (Tobrex) ophthalmic drops and Benadryl. No laboratory or diagnostic tests were performed. The pt's present status was reported as unknown. No product quality complaint was involved. The nurse considered the adverse experiences to be other important medical events (OMIC). Additional information has been requested.
Age: 0.51
Sex: M
Vaccine: DTAP, HEP, HIBV, PNC
Symptoms: Coma, Hypoxia, Leukocytosis, Pyrexia, Status epilepticus
Clinical narrative: Pt developed fever within 3-4 hours after immunizations were given. Later in the evening child became unresponsive and presented to ER in status epilepticus.  Child was given Lorazepam, Valium, Phenobarbital, Rocephin and Vancomycin. Intubated and placed on ventilator. Was given oxygen. Child transferred to another hospital. Hospitalized x 1 day.
Age: 2.0
Sex: F
Vaccine: DTAP, MMR, VARCEL
Symptoms: Erythema, Injection site pain, Injection site warmth, Oedema
Clinical narrative: Left thigh, edema, and reddness hot to touch. Painful to touch x 2 days was seen in ER. On Cefzil for 10 days.
Age: 6.0
Sex: M
Vaccine: DTAP, HEPA, IPV, MMR
Symptoms: Erythema, Oedema, Pain
Clinical narrative: Immunized 03/29. Developed pain and swelling at site, same day with progressive redness
Age: 30.0
Sex: M
Vaccine: UNK
Symptoms: Lacrimation increased, Rhinorrhoea
Clinical narrative: Given Ciprofloxacin 500mg orally after Meningitis exposure- Pt took Cipro 500mg @ 10:00. At 10:45 he states, he started hving watery eyes and nasal draingage/running/