chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 49.0
Sex: F
Vaccine: HEPA
Symptoms: Hepatic enzyme abnormal
Clinical narrative: Report A0367904A describes elevated liver enzyme concentrations in a 49 year old female who received hep A vaccine. Medical history, concurrent conditions, and concurrent medications were not provided. On 4/4/02, the vaccinee received an injection of Havrix. On 4/26/02, the vaccinee gave blood. At that time, lab tests revealed elevated concentrations of unspecified liver enzymes.
Age: 55.0
Sex: M
Vaccine: HEPA
Symptoms: Laboratory test abnormal
Clinical narrative: This report describes an increased ferritin level in a 55 y.o. male who received Hap A vax inactivated. The PT had no relevant medical history and had no concomitant medications. He received his first injection of Hep A vax w/no problems noted. On 3/12/02, the vaccinee received his 2nd dose of Hep A vax inactivated. On 3/26/02, his ferritin level was found to be increased. The reporter stated that the increased ferritin level was possibly due to Havrix. As of 5/7/02, the event was ongoing.
Age: 22.0
Sex: F
Vaccine: HEPA
Symptoms: Abdominal pain, Asthenia, Injection site induration, Injection site oedema, Injection site pain
Clinical narrative: Report A0370603A describes the occurrence of arm pain and paresthesias in a 22 year old female who received hep A vaccine inactivated. The subject had no relevant history, concurrent medical conditions, or concurrent medications. The vaccinee had no history of relevant allergies. The subject indicated the use of alcohol. On 6/3/02 at 11:00, the vaccinee received her first injection of Havrix into her left deltoid. Within one hour, she experienced "severe" left arm pain accompanied by paresthesia; the pain radiated to the jaw. Her pain worsened with movement and increased progressively during the day of the injection, prompting her to seek medical attention at an urgent care facility that evening. Upon evaluation at the urgent care facility, the vaccinee also reported abdominal pain and nausea. On physical examination, the physician noted, "questionable swelling on the upper arm near the injection site" with one centimeter of induration. In addition, the physician noted decreased two-point discrimination in the left arm and decreased left handgrip strength. The physician also noted right lower quadrant tenderness. The vaccinee was referred to a neurologist.
Age: 22.0
Sex: F
Vaccine: HEPA
Symptoms: Nausea, Paraesthesia
Clinical narrative: Report A0370603A describes the occurrence of arm pain and paresthesias in a 22 year old female who received hep A vaccine inactivated. The subject had no relevant history, concurrent medical conditions, or concurrent medications. The vaccinee had no history of relevant allergies. The subject indicated the use of alcohol. On 6/3/02 at 11:00, the vaccinee received her first injection of Havrix into her left deltoid. Within one hour, she experienced "severe" left arm pain accompanied by paresthesia; the pain radiated to the jaw. Her pain worsened with movement and increased progressively during the day of the injection, prompting her to seek medical attention at an urgent care facility that evening. Upon evaluation at the urgent care facility, the vaccinee also reported abdominal pain and nausea. On physical examination, the physician noted, "questionable swelling on the upper arm near the injection site" with one centimeter of induration. In addition, the physician noted decreased two-point discrimination in the left arm and decreased left handgrip strength. The physician also noted right lower quadrant tenderness. The vaccinee was referred to a neurologist.
Age: 39.0
Sex: M
Vaccine: HEPA
Symptoms: Convulsion, Hypoaesthesia, Laboratory test abnormal
Clinical narrative: Report A0370902A describes the occurrence of a seizure in a 39 year old male who received hep A vaccine inactivated. The reporter submitted this report directly to VAERS. Medical history included a seizure disorder for twenty years, and concurrent medications included unspecified anti-seizure medications. It was also noted that the vaccinee received unspecified medication (dates unk) which are known to reduce the seizure threshold. On 5/29/02, the vaccinee received his first injection of Havrix. On that same day, he experienced a seizure witnessed by a friend. The seizure was preceded by the aura of arm numbness. The seizure was characterized by clonic movements limited to the arms, face and head. He was not incontinent. The vaccinee did not lose consciousness and was able to recall the event. There was no evidence that the seizure may have resulted from withdrawal of alcohol or other psychotropic substances, nor was there any evidence of a new neurological lesion or infection that might have been the cause of the seizure. Concentrations of unspecified serum electrolytes were found to be abnormal. Blood concentrations of his seizure medications were found to be in the "normal to high range." The seizure resolved that day. The reporter considered the seizure to be possibly related to Havrix administration. The Havrix immunization series was discontinued. Seizure is considered medically serious (OMIC).
Age: 45.0
Sex: M
Vaccine: HEPA
Symptoms: Abdominal pain upper, Arthralgia, Diarrhoea haemorrhagic, Pyrexia
Clinical narrative: Report A0371830A describes bloody diarrhea in a 45 year old male who received hep A vaccine inactivated. There was no relevant medical history, concurrent conditions, or concurrent medications specified. The subject reported alcohol use of two drinks per week and denied tobacco use. The subject had no adverse experiences following receipt of prior immunizations. On 6/14/02, the subject received his first injection of Havrix. One hour post immunization, the subject experienced "bloody" diarrhea, stomach pain, joint pain, and fever of 101 deg F. The vaccinee was sent to the ER for further evaluation. Follow up info received on 7/16/02 from the reporting nurse indicated that the events of bloody diarrhea, stomach pain and fever resolved on 6/21/02, while the event of joint pain subsequently resolved on 6/28/02. It was noted that the immunization series was discontinued. The reporting nurse considered the events to be possibly related to Havrix immunization.
Age: 35.0
Sex: M
Vaccine: HEPA
Symptoms: Rash
Clinical narrative: This report was received from a physician which described a rash in a thirty five year old male who received hep A vaccine inactivated for prophylaxis. No pertinent medical history or concurrent conditions were reported. Concomitant medications were not specified. The subject did not use alcohol or tobacco. The reporting physician was unsure of adverse event history following receipt of prior immunizations. On 6/14/02, the vaccine received his first injection of Havrix. On 6/23/02, the vaccinee experienced a rash. The rash started in the axilla area and spread to the trunk, arms and legs. The physician reported that the vaccinee developed no other problems. Treatment included Benadryl. The rash resolved on 6/24/02. The reporting physician considered the event to be possibly related to Havrix administration.
Age: 4.0
Sex: F
Vaccine: DTAP, HEPA, MMR
Symptoms: Urticaria
Clinical narrative: Report A0373064A describes hives in a 4 year old female who was vaccinated with hep A vaccine inactivated. The subject had no known allergies. Medical history and concurrent conditions were not provided. The subject had experienced no adverse events following previous immunizations. On 6/25/02, the subject received her first injection of Havrix (721A2). On the same date, she received injections of MMR II and diphtheria and tetanus toxoids and acellular pertussis vaccine (manuf unk). Post-immunization, on 6/27/02, the subject "broke out in hives from the waist down." The subject was seen by a physician, who prescribed Benadryl. The reporter stated that the event was probably related to Havrix administration. The hives resolved on 6/27/02.
Age: 27.0
Sex: F
Vaccine: HEPA
Symptoms: Dermatitis, Pruritus
Clinical narrative: Report A0373114A describes the occurrence of dermatitis in a 27 year old female who received hep A vaccine. This report was received from a medical assistant. Medical history was not specified. The vaccinee has a history of allergy to sulfa. Concurrent medications include Zovia, multivitamins and Differin gel. On 6/25/02, the vaccinee received the first injections of Havrix. On 6/27/02, the vaccinee experienced dermatitis on her legs and arms described as "discrete papules with surrounding clear zones" and mild itching. The reporter stated that the events were probably related to Havrix. As of 6/28/02, the adverse events were unresolved.
Age: 10.0
Sex: F
Vaccine: HEPA
Symptoms: Rash
Clinical narrative: A nurse reported the occurrence of rash in a ten year old female who received hep A vaccine inactivated. There were no concomitant medical conditions, concurrent conditions, or concomitant medications reported. On 8/2/02, the subject received the first injection of hep A vaccine. On 8/3/02, the subject experienced a rash on her back, chest, and buttocks without fever or itching. The subject was treated with Benadryl. The outcome of the event was unknown. The reporter considered the event to be possibly related to Havrix. However, upon follow-up info received on 9/17/02, the reporter indicated during  on office visit on 9/6/02, the father reported he felt the event was due to an allergic reaction to a strawberry pop.
Age: 59.0
Sex: M
Vaccine: HEPA
Symptoms: Malaise, Pyrexia
Clinical narrative: Report A0377268A describes the occurrence of "feeling crummy" in a 59 year old male who received hep A vaccine. This report was received from a nurse. The vaccinee's relevant concurrent condition included hypertension. The vaccinee's concomitant medications include Avapro. On 8/7/02, the vaccinee received the second injection of Havrix. Later that same day, the vaccinee developed a fever of 101.5 deg. and he reportedly "feels crummy." Reporter stated that the vaccinee apparently was already starting to feel bad before his Havrix injection, but didn't tell anyone. Therefore, the reporter is not sure if the vaccinee had a reaction to the vaccine or was just getting sick. No adverse event was reported following the first Havrix injection, therefore, she noted the events could possibly be related to Havrix. The most recent info received on 8/8/02 reports the events to be unresolved; it is unknown if the Havrix immunization series will continue.
Age: 23.0
Sex: F
Vaccine: HEPA
Symptoms: Oedema, Urticaria
Clinical narrative: A nurse reported the occurrence of hives and edema in a 23 year old female who was vaccinated with hep A vaccine inactivated for prophylaxis. The subject's medical history, concurrent conditions, and concurrent medications were unknown. On an unspecified date "several years ago," the subject received her third injection of Havrix. Subsequently, she experienced hives and edema. The events resolved after an unspecified period of time.
Sex: F
Vaccine: HEPA
Symptoms: Therapeutic response decreased
Clinical narrative: An MD reported the occurrence of reduced antibody levels in a female of unspec'd age who was vax'd w/Hep A vax inactivated for prophylaxis. The subject's medical history included HIV infection. Concurrent medications were unknown. On unspecified dates, the subject received 2 injections of Havrix. Initially, it was reported that the subject was found to be a nonresponder to the Havrix immunization series because her antibody titers (NOS) were negative. The most recent info. was received on 12/27/02. The reporter stated that she had discussed the subject w/the CDC and prevention. She stated, "We later decided the PT probably had responded, w/lower than detectable antibody levels in serum."
Age: 17.0
Sex: F
Vaccine: HEPA
Symptoms: Vertigo
Clinical narrative: A nurse reported the occurrence of vertigo in a 17 y.o. female who inadvertently received adult dose of Hep A vax inactivated for prophylaxis. The subject's medical history, concurrent conditions, and concurrent medications were unknown. She had no adverse experiences following receipt of her first injection of Havrix. On 8/27/02, the subject received her 2nd injection of Havrix. Later that afternoon, she experienced vertigo. As of 8/30/02, she was "doing ok" and her condition was reported to be "improved."
Age: 66.0
Sex: F
Vaccine: HEPA
Symptoms: Anorexia, Back pain, Chills, Eye pain, Hypertonia
Clinical narrative: This report describes the occurrence of vomiting in a 66 y.o. female who was vax'd w/Hep A vax for prophylaxis. This report was received from a subject and has not been verified by an MD or health care prof'l. Reportedly, the subject was in "good health" and received no concomitant medications. She stated that she experienced no adverse events following previous immunizations. She reported that on 8/19/02, she received her 2nd injection of Hep A vax. 5 days later, on 8/24/02, her skin felt "different", she had an "odd feeling in head", and she felt cold, but her skin was warm to the touch (her oral temp was reportedly 97 deg F; her rectal temp was reportedly 98.2 deg F). She reported that additionally she experienced tingling, "no appetite", stiffness, backache, increased pulse (reportedly 89 beats / min), eye pain, nausea, and vomiting. She stated that she was seen in the ER and was sent home "because nothing was wrong w/her." As of 9/6/02, the events reportedly persisted.
Age: 66.0
Sex: F
Vaccine: HEPA
Symptoms: Nausea, Nonspecific reaction, Paraesthesia, Tachycardia, Vasodilation procedure
Clinical narrative: This report describes the occurrence of vomiting in a 66 y.o. female who was vax'd w/Hep A vax for prophylaxis. This report was received from a subject and has not been verified by an MD or health care prof'l. Reportedly, the subject was in "good health" and received no concomitant medications. She stated that she experienced no adverse events following previous immunizations. She reported that on 8/19/02, she received her 2nd injection of Hep A vax. 5 days later, on 8/24/02, her skin felt "different", she had an "odd feeling in head", and she felt cold, but her skin was warm to the touch (her oral temp was reportedly 97 deg F; her rectal temp was reportedly 98.2 deg F). She reported that additionally she experienced tingling, "no appetite", stiffness, backache, increased pulse (reportedly 89 beats / min), eye pain, nausea, and vomiting. She stated that she was seen in the ER and was sent home "because nothing was wrong w/her." As of 9/6/02, the events reportedly persisted.
Age: 66.0
Sex: F
Vaccine: HEPA
Symptoms: Vomiting
Clinical narrative: This report describes the occurrence of vomiting in a 66 y.o. female who was vax'd w/Hep A vax for prophylaxis. This report was received from a subject and has not been verified by an MD or health care prof'l. Reportedly, the subject was in "good health" and received no concomitant medications. She stated that she experienced no adverse events following previous immunizations. She reported that on 8/19/02, she received her 2nd injection of Hep A vax. 5 days later, on 8/24/02, her skin felt "different", she had an "odd feeling in head", and she felt cold, but her skin was warm to the touch (her oral temp was reportedly 97 deg F; her rectal temp was reportedly 98.2 deg F). She reported that additionally she experienced tingling, "no appetite", stiffness, backache, increased pulse (reportedly 89 beats / min), eye pain, nausea, and vomiting. She stated that she was seen in the ER and was sent home "because nothing was wrong w/her." As of 9/6/02, the events reportedly persisted.
Sex: M
Vaccine: HEPA
Symptoms: Rash, Urticaria
Clinical narrative: A nurse reported the occurrence of urticaria in an adult male of unspec'd age who was vax'd with Hep A vax inactivated for prophylaxis. Medical history, concurrent conditions, and concurrent medications were not provided. The subject had no adverse experiences following receipt of prior immunizations. On an unspecified date, the subject (a firefighter) received his 2nd injection of Havrix. "A few" mins later, he responded to a call, during which he was exposed to an "abundance" of animal hair and dander. While still responding at the scene of the emergency, approx 1 hr post-vax, he developed rash and urticaria on his elbow and torso. There was no reaction localized to the inject site. When the subject returned to the fire station, he was treated w/an intravenous injection of diphenhydramine (Benadryl). The events resolved an an "unspecified time" after the diphenhydramine admin. The reporter stated that "the rash was more likely due to the exposure to the animal dander." The events in this report are considered GSK medically serious due to the nature of the medical intervention.
Age: 62.0
Sex: M
Vaccine: HEPA
Symptoms: Drug ineffective
Clinical narrative: An MD reported the occurrence of a 62 y.o. male who did not respond to 2 series of Hep A vax inactivated for prophylaxis. The subject's medical history included gastroesophageal reflex disease and an unspecified collagen vascular disease. Concurrent medications include omeprazole (Prilosec), finasteride (Proscar), fluvoxamine maleate (Luvox) and alendronate sodium (Fosamax). The subject consumes one glass of wine per day and denies tobacco use. Approx 4 yrs ago, in 98, the subject completed one dose of Hep A vax inactivated and his titer (NOS) revealed he had "not developed an antibody response." Beginning in Jan 02, the subject initiated a 2nd series of Hep A vax inactivated. A titer (NOS) was drawn on 3/4/03 and revealed that he had not developed an antibody response.
Sex: U
Vaccine: HEPA
Symptoms: Cellulitis
Clinical narrative: A nurse reported the occurrence of cellulitis in a child of unspec'd age who was vax'd w/Hep A vax inactivated for prophylaxis. The reporter stated that local health dept would submit another report directly. The subject's medical history, concurrent conditions, and concurrent medications were not specified. On an unspecified date, "a child was administered an injection of Havrix w/a 5/8 inch needle and subsequently developed cellulitis."
Sex: F
Vaccine: HEPA
Symptoms: Drug ineffective
Clinical narrative: An MD reported the occurrence of non-response in a adult female who was vax'd w/Hep A vax inactivated. The subject's medical history, concurrent medical conditions, and concurrent medications were not provided. On an unspec'd date, the subject received 2 injections of Hep A vax inactivated. The first injection (primary) was administered in the MD's office and the 2nd injection (booster) outside of USA. After the 2nd injection, the MD obtained a titer test NOS and the results were negative.
Age: 19.0
Sex: M
Vaccine: HEPA
Symptoms: Jaundice
Clinical narrative: An MD reported the occurrence of jaundice in a 19 y.o. male who was vax'd w/Hep A vax inactivated for prophylaxis. The subject's medical history, concurrent conditions, and concurrent medications were unknown. In approx Jan 02, the subject received his 2nd Havrix injection. In approx Oct. 02, the subject was seen by an MD for a cold, and the MD reportedly said, "You look a little yellow, you have Hep A." Subsequently, all tests (NOS) for Hep A were negative and his liver function tests (NOS) were "fine". The subject was still being tested to determine the cause of the jaundice. As of 10/31/02, the jaundice persisted. The outcome of the cold was not spec'd. The most recent info was received on 1/8/03. The reporting MD stated, "The case was a false alarm. It turned out not to be hepatitis. No significant disease." As of 1/8/03, the outcomes of the events were unknown. The jaundice in this report is considered GSK medically serious.
Sex: M
Vaccine: HEPA
Symptoms: Hepatitis A
Clinical narrative: A nurse described the occurrence of Hep A in an adult male of unspec'd age who was vax'd w/Hep A vax inactivated for prophylaxis. The subject's medical history, concurrent conditions, and concurrent medications were not reported. On 11/5/02, the subject received his first injection of Havrix. The subject reported to the nurse that 19 days later, on 11/24/02, his MD made a Dx of Hep A. As of 12/18/02, the event persisted. Hep A is considered GSK medically serious.
Sex: M
Vaccine: HEPA
Symptoms: Pain
Clinical narrative: A nurse reported the occurrence of a burning sensation in an adult male of unspec'd age who was vax'd w/Hep A vax inactivated for prophylaxis. The subject's relevant medical history, concurrent conditions, and concurrent medications were not reported. In Dec. 02, the subject received an injection of Havrix. It was not known if he had received previous injections of Havrix. 18 hrs later, he started to experience burning sensation in the thigh, back, and shoulders. As of 12/23/02, the burning sensation persisted.
Age: 17.0
Sex: M
Vaccine: HEPA
Symptoms: Eye disorder, Eye movement disorder, Muscle twitching, Tic, Tourette's disorder
Clinical narrative: It was reported that a pt rec'd and injection of hepatitis A (brand name unknown). This report was rec'd from the pt's mother and has been confirmed by a physician. Later on the day of vaccination he reportedly began twitching, his shoulders started shrugging, his eyes started to blinking, he was unable to control the twitching, shrugging, or blinking. These events persisted and reportedly became worse. His mother reported that he began to have tics in his arm in 1998. He has reportedly been seen numerous times  by physicians. A neurologist performed and unspecified MRI study (results of this study were not provided) The mother reported that the neurologist made a diagnosis of Tourette's syndrome. The subject now has severe tics all over his body, his eyes rolled back into his head. Tx of Tourette's syndrome was not specified. On 9/10/02 info was rec'd from the neurologist indicating that the onset of the symptoms proceeded Havrix administration. It was reported that the onset of symptoms to have started in 1996 however the subject was 1st examined by the physician on 12/31/98. On the date of the exam, test were preformed. As of 8/28/02, the  neurologist reported the symptoms persisted. The reporting physician indicated that it was unknown if the events were related to hepatitis A vaccine. According to the neurologist, the pt's mother stated that her son incurred his 1st closed head injury with loss of consciousness when he was 1 1/2 yrs old. The reporting physician attributed the events to the closed head injuries.
Age: 21.0
Sex: M
Vaccine: SMALL
Symptoms: Rash papular
Clinical narrative: GENERALIZED PAPULAR RASH ON TORSO UPPER ARMS NECK AND FACE.
Age: 23.0
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Chest pain, Myocarditis
Clinical narrative: 23 YOM 9 days s/p primary SPV pt started to feel substernal CP. He presented to a local ER 36 hrs later and was d/w myopericarditis. He was admitted to CCU for observation and was treated with prednisone. The sxs quickly resolved. 60-day follow up on 02/11/04: "It is unknown if the pt recovered from adverse events.  We cannot state whether he has recovered until after his 2 year follow up."
Age: 23.0
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Unevaluable event
Clinical narrative: 23 YOM 9 days s/p primary SPV pt started to feel substernal CP. He presented to a local ER 36 hrs later and was d/w myopericarditis. He was admitted to CCU for observation and was treated with prednisone. The sxs quickly resolved. 60-day follow up on 02/11/04: "It is unknown if the pt recovered from adverse events.  We cannot state whether he has recovered until after his 2 year follow up."
Age: 39.0
Sex: M
Vaccine: HEP, TYP
Symptoms: Arthralgia, Oedema, Pruritus
Clinical narrative: Swelling in both hands and feet with generalized itching and joint aches. No Shortness of Breath or Cardiac Problems
Age: 45.0
Sex: M
Vaccine: ANTH
Symptoms: Headache, Influenza like illness, Injection site hypersensitivity, Lacrimation increased, Nasal congestion
Clinical narrative: burning in arm after injection greatly surpassed 2 previous shots...lasted approx 1 hour. ringing in ears started approx 3 hours after injection (1030 am) headache followed severe at first for approx 8 to 10 hours then tapered off to dull throb lasting approx 3 days. Flu like symptoms kicked in approx 4 to 5 hours following shot. tearing of eyes, runny nose, head congestion, ear stuffiness/ slight ringing... all these symptoms still persisted for 3 days after shot received. Self treat with Motrin, various over counter cold / flu treatments. Here on 4 day just starting to subside.  no reactions like this to first 2 shots 15 dec and 29 dec 2002.
Age: 45.0
Sex: M
Vaccine: ANTH
Symptoms: Rhinorrhoea, Tinnitus
Clinical narrative: burning in arm after injection greatly surpassed 2 previous shots...lasted approx 1 hour. ringing in ears started approx 3 hours after injection (1030 am) headache followed severe at first for approx 8 to 10 hours then tapered off to dull throb lasting approx 3 days. Flu like symptoms kicked in approx 4 to 5 hours following shot. tearing of eyes, runny nose, head congestion, ear stuffiness/ slight ringing... all these symptoms still persisted for 3 days after shot received. Self treat with Motrin, various over counter cold / flu treatments. Here on 4 day just starting to subside.  no reactions like this to first 2 shots 15 dec and 29 dec 2002.
Age: 28.0
Sex: F
Vaccine: SMALL
Symptoms: Diarrhoea, Lymphadenopathy, Malaise, Nausea, Pyrexia
Clinical narrative: PT c/o NVD fever malaise, URI. lymphadenopathy of afillary in cervical area left groin vaccine site f/u and wnl. PTS primary physician examined 3-11-03 continued adenopathy wound is scabbed approx. 2 cm rx's cipro.
Age: 28.0
Sex: F
Vaccine: SMALL
Symptoms: Upper respiratory tract infection, Vomiting
Clinical narrative: PT c/o NVD fever malaise, URI. lymphadenopathy of afillary in cervical area left groin vaccine site f/u and wnl. PTS primary physician examined 3-11-03 continued adenopathy wound is scabbed approx. 2 cm rx's cipro.
Age: 25.0
Sex: M
Vaccine: ANTH, HEP, HEPA, SMALL, TYP
Symptoms: Injection site hypersensitivity, Pruritus, Vaccination complication
Clinical narrative: Secondary reaction ("take") at 1100 position to primary smallpox innoculation.  Pt c/o excessive itching - but denies scratching site.  Site covered w/ occlusive dressing since 5 March 03 - no drainage on outside of bandage.
Age: 22.0
Sex: M
Vaccine: SMALL
Symptoms: Erythema multiforme
Clinical narrative: Erythema multiforme rash on hands, arms, right knee, feet and gluteal cleft. PT taken off the military ship and seen by Dermatology at a medical center. Punch biopsy done. Atarax prescribed.
Age: 34.0
Sex: F
Vaccine: HEP, MMR
Symptoms: Anxiety, Feeling abnormal, Panic reaction
Clinical narrative: Pt. c/o anxiety, "feeling funny, not herself" this morning, about 17 hours after receiving first Hepatitis B vaccine and MMR.  Pt. seen by P.A. who elicited a prior hx of "panic attacks". Pt. referred to EAP.
Age: 38.0
Sex: M
Vaccine: ANTH
Symptoms: Dry throat, Dyspnoea, Injection site erythema, Injection site oedema, Insomnia
Clinical narrative: Patient received his first Anthrax vaccination on 29 Jan 2003. He did not experience any immediate reactions. That evening he had some mild shortness of breath, particularly with lying down therefore making sleep difficult. He thought he must be getting a chest cold. These symptoms resolved within 5 days. He received his second anthrax vaccination on 20 February 2003. No other shots were given in between the 1st and 2nd dose of the anthrax vaccine. He experienced local swelling and redness at the injection site (left upper arm over triceps). He awoke the morning of 21 February with tightness and dryness in his throat causing him to have difficulty breathing. That morning he began wheezing on expiration and the labored breathing continued. He did not have any symptoms of fever, rhinorrea, cough, myalgias. The difficulty sleeping did lend to him being tired throughout the day. He sought treatment. THe PA he saw found patient to have clear lungs and a local vaccination reaction. He gave patient Naproxen for the local reaction swelling, Albuterol inhaler and Prednisone 20mg BID for the breathing. After several days on the medication the breathing had improved slightly yet he was still having some throat tightness and some slight wheezing. He returned to primary care and he was told to continue the prednisone. By 10 Mar 2003 his symptoms of throat tightness and labored breathing had resolved (total of 18 days of symptoms). The VHC referred patient to an allergist for immediate evaluation due to a pending 14 March deployment and issued a temporary medical exemption from the anthrax vaccine. VHC recommended rhinoscopy be performed to rule out vocal cord dysfunction and spirometry to rule out any obstruction to breathing. Dr. evaluated patient on 11 March and diagnosed him with a delayed hypersensitivity to the anthrax vaccine. The VHC is awaiting the dictated notes from Dr. to determine if a permanent exemption is needed for this patient. The patient is currently temporarily medically exempt for a six month period. VHC will review records and issue revised exemptions as needed. VHC discussed with the patient the potential of receiving an additional dose only in the case of exposure to the bacillus anthracis bacteria.
Age: 38.0
Sex: M
Vaccine: ANTH
Symptoms: Throat tightness, Wheezing
Clinical narrative: Patient received his first Anthrax vaccination on 29 Jan 2003. He did not experience any immediate reactions. That evening he had some mild shortness of breath, particularly with lying down therefore making sleep difficult. He thought he must be getting a chest cold. These symptoms resolved within 5 days. He received his second anthrax vaccination on 20 February 2003. No other shots were given in between the 1st and 2nd dose of the anthrax vaccine. He experienced local swelling and redness at the injection site (left upper arm over triceps). He awoke the morning of 21 February with tightness and dryness in his throat causing him to have difficulty breathing. That morning he began wheezing on expiration and the labored breathing continued. He did not have any symptoms of fever, rhinorrea, cough, myalgias. The difficulty sleeping did lend to him being tired throughout the day. He sought treatment. THe PA he saw found patient to have clear lungs and a local vaccination reaction. He gave patient Naproxen for the local reaction swelling, Albuterol inhaler and Prednisone 20mg BID for the breathing. After several days on the medication the breathing had improved slightly yet he was still having some throat tightness and some slight wheezing. He returned to primary care and he was told to continue the prednisone. By 10 Mar 2003 his symptoms of throat tightness and labored breathing had resolved (total of 18 days of symptoms). The VHC referred patient to an allergist for immediate evaluation due to a pending 14 March deployment and issued a temporary medical exemption from the anthrax vaccine. VHC recommended rhinoscopy be performed to rule out vocal cord dysfunction and spirometry to rule out any obstruction to breathing. Dr. evaluated patient on 11 March and diagnosed him with a delayed hypersensitivity to the anthrax vaccine. The VHC is awaiting the dictated notes from Dr. to determine if a permanent exemption is needed for this patient. The patient is currently temporarily medically exempt for a six month period. VHC will review records and issue revised exemptions as needed. VHC discussed with the patient the potential of receiving an additional dose only in the case of exposure to the bacillus anthracis bacteria.
Age: 21.0
Sex: F
Vaccine: MMR, SMALL
Symptoms: Arthralgia, Myalgia, Pain, Pyrexia
Clinical narrative: Generalized body aches with joint aches. Temp 100 left armpit pain and pain to joints. Tx consisted of increased fluids. Bed rest x 24 hrs. Tylenol 325 mg and GA T (?) tabs PO QY (?) PRN pain.
Age: 34.0
Sex: F
Vaccine: SMALL
Symptoms: Abortion, Unintended pregnancy
Clinical narrative: Condom broke during sex, not sure what day. Took ovral she had on hand. Positive pregnancy test 3/1. Confirmed blood test 3/3/03. Spontaneous and complete abortion 3/11/03 1 p.m. Confirmed by blood test 3/3/03.
Age: 26.0
Sex: M
Vaccine: SMALL
Symptoms: Psoriasis
Clinical narrative: Patient received vaccinia vaccine after being screened medically and answering "yes" to questions about eczema and psoriasis.Patient had over 50% of body surface psoriasis at time of vaccination. Patient deployed after receiving vaccine and has since been sent back one month after receiving the vaccine. Patient devolped Guttate psoriasis. He is currently being treated with narrow band UVB, 3 times a week and is doing fine. Meds include Aristocort A 60 gm Topical 0.1%;desonide topical 0.05%; Coal tar topical 2.5%.
Age: 37.0
Sex: F
Vaccine: SMALL
Symptoms: Amblyopia, Conjunctivitis, Lacrimal disorder
Clinical narrative: Throbbing inner corner left eye burning and tearing, redness, ?? blurred 2-3 days.
Age: 56.0
Sex: M
Vaccine: ANTH
Symptoms: Blood pressure decreased, Dizziness, Hyperhidrosis, Injection site inflammation, Syncope vasovagal
Clinical narrative: Immediately after immunization, a burning sensation was felt from shoulder to elbow, followed by copious sweating, faint feeling and dropping blood pressure (70/50 nadir).  Taken by ambulance to nearest ER where bp had risen to 120/86 upon arrival.  ER physician diagnosed a vagal reaction.  Patient reports no other fainting episodes related to blood draws or other immunizations and this "felt different".
Age: 44.0
Sex: M
Vaccine: SMALL
Symptoms: Erythema multiforme
Clinical narrative: Erythema multiforme, mild to extensive (direct quote from physician who completed paper form.  Resolving on 3-11-03
Age: 48.0
Sex: F
Vaccine: SMALL
Symptoms: Pruritus
Clinical narrative: Smallpox vaccine was given at approx. 8:15 p.m. I was giving site care instructions and noticed she was scratching herself all over her body. She stated it was like when she had penicillin. No rash was noted and she did not have any respiratory distress. She cont. to itch this a.m. Treated with Zyrtec.
Age: 59.0
Sex: F
Vaccine: SMALL
Symptoms: Erythema
Clinical narrative: Erythema multiforme - appeared 3 days post smallpox vax on forearm of vax'd arm. Prescribed steroid creme.
Age: 23.0
Sex: F
Vaccine: ANTH
Symptoms: Injection site erythema, Injection site mass
Clinical narrative: are of redness up to 15 cm extending down right arm, small nodule at shot site. was seen in urgent care and treated with benadryl and keflex 2 days ago. redness has decrease by about 1/2
Age: 25.0
Sex: M
Vaccine: ANTH
Symptoms: Arthralgia, Asthenia, Blister, Dizziness, Fatigue
Clinical narrative: On Feb 23 03 became weak, fatigued, dizzy , had myalgias and had fever of 102-103. This continued 6 days. On Mar 2 developed large blister on right nare which burst causing excoriation and subsequent blistering of area under exudate. On Mar 3 awakened with sore throat and blisters on tongue and inside of mouth. Currently continues to have generalized joint pain, intermittent fevers , sore throat, and fatigue.
Age: 25.0
Sex: M
Vaccine: ANTH
Symptoms: Myalgia, Oral mucosal blistering, Pharyngolaryngeal pain, Pyrexia
Clinical narrative: On Feb 23 03 became weak, fatigued, dizzy , had myalgias and had fever of 102-103. This continued 6 days. On Mar 2 developed large blister on right nare which burst causing excoriation and subsequent blistering of area under exudate. On Mar 3 awakened with sore throat and blisters on tongue and inside of mouth. Currently continues to have generalized joint pain, intermittent fevers , sore throat, and fatigue.
Age: 49.0
Sex: F
Vaccine: ANTH
Symptoms: Discomfort, Injection site erythema, Injection site induration, Injection site oedema, Injection site warmth
Clinical narrative: Received Anthrax vaccine on left upper arm on 8 Mar 03.  Developed increasing redness, warmth and discomfort at injection site.  Redness spread up to 6"x3" below injection site.  Some induration and swelling at erythematous site.  Itching & fever-like symptoms relieved by Benadryl.
Age: 49.0
Sex: F
Vaccine: ANTH
Symptoms: Pruritus, Pyrexia
Clinical narrative: Received Anthrax vaccine on left upper arm on 8 Mar 03.  Developed increasing redness, warmth and discomfort at injection site.  Redness spread up to 6"x3" below injection site.  Some induration and swelling at erythematous site.  Itching & fever-like symptoms relieved by Benadryl.
Age: 30.0
Sex: F
Vaccine: SMALL
Symptoms: Chills, Laryngitis, Pharyngolaryngeal pain, Pyrexia, Vaccination complication
Clinical narrative: Patient's husband received smallpox vaccine 1/17/03, as part of a research-based program. Approx. 3 weeks after his vaccination, she noted a "red pimple" on her Right breast. Later that week, she felt feverish (did not take temp), chills, fatigued, sore throat, laryngitis x 2 days. She stayed home from work for 1 day. "Pimple" progressed to pustule, "looked exactly like my vaccination site", according to husband. They took precautions with covering and handwashing. Called to Employee Health physician. He advised visit but they were unable to come in due to plan visit out of town. Seen in Employee Health Clnic (EHC) on 3/7/03. Small (1cm) light colored scab on medial aspect lower quadrant. No erythema surrounding scab. Wife reports no menstrual period x 2mos. Did home pregnancy test 3-4 days ago-negative. Serum pregnancy test through EHC negative. Feels well now. Previous smallpox immunizations: 10/24/72 and 9/21/78.
Age: 50.0
Sex: F
Vaccine: SMALL
Symptoms: Hepatitis, Jaundice
Clinical narrative: Patient with prior history of Hepatitis (I do not know type). Recieved smallpox vaccination and noted to be progressively jaundiced. Currently diagnosed as possibly having autoimmune hepatitis and/or chronic hepatitis. Patient has been an inpatient at hosptial since 03/03/03.
Age: 22.0
Sex: M
Vaccine: ANTH
Symptoms: Encephalitis, Encephalopathy, Headache, Herpes simplex, Laboratory test abnormal
Clinical narrative: Patient was given 3rd dose of Anthrax Vaccine on 03Feb03.  Was subsequently admitted for HSV encephalitis on 17Feb03. Received treatment and initial rehab.  Currently with encephalopathy (permanence as yet undetermined). Discharge summary states Herpes encephalopathy, renal insufficency, headache.
Age: 22.0
Sex: M
Vaccine: ANTH
Symptoms: Renal failure
Clinical narrative: Patient was given 3rd dose of Anthrax Vaccine on 03Feb03.  Was subsequently admitted for HSV encephalitis on 17Feb03. Received treatment and initial rehab.  Currently with encephalopathy (permanence as yet undetermined). Discharge summary states Herpes encephalopathy, renal insufficency, headache.
Age: 0.3
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Irritability, Pyrexia
Clinical narrative: Pt received vaccinations on 3/7/03 in am. At 7:22pm pt's mother called the urgent care dept to report pt had 102.2 fever and was fussy-no rash or redness was present. Pt was seen that evening. On 3/8/03 pt was reported to look better. On 3/9/03 pt was found deceased in crib.
Age: 0.2
Sex: M
Vaccine: DTAP, HBHEPB, IPV, PNC
Symptoms: Encephalopathy
Clinical narrative: A pharmacist reported that a 2 month old male received Prevnar, Comvax, diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (manuf unk), and Polio vaccines in November, 2002. Two days post immunization, the infant developed encephalopathy and was admitted to the hospital. He was hospitalized for "about a week," Encephalopathic and sepsis tests (not specified) were performed at the hospital and the results were negative. The encephalopathy resulted in "no sequela." No additional info was available as of the date of this report. A copy of this report has been forwarded to manufacturers of concomitantly administered vaccines.
Age: 1.2
Sex: M
Vaccine: DTAP, HEP
Symptoms: Antisocial behaviour, Cognitive disorder, Speech disorder
Clinical narrative: A physician reported the occurrence of "symptoms of speech, language, and social delay" in a male child of unspecified age who was vaccinated with Infanrix and hep B vaccine for prophylaxis. This report was received from manufacturer (HQ6283021JAN2003). The subject's medical history, concurrent conditions, and concurrent medications were not included in the report from manufacturer. The subject received injections of Infanrix on 2/28/01, 4/28/01, 7/23/01 and 8/19/02. He received injections of Engerix B on 2/28/01 and 7/23/01. At an unspecified time post-immunization, he began to experience "symptoms of speech, language, and social delay." The outcomes of these events were unknown. The language and social delays in this report are considered medically serious (OMIC).   A 15-day follow up report received 6/18/2003 adds: The most recent info, received from the physician on 06/03/2003, indicated that the "symptoms of speech, language and social delay" had "improved" by 05/30/2003. The physician considered these events to be possibly related to immunization and to be serious because they "may" become disabling. The language and social delays in this report are considered GSK medically serious.
Age: 0.4
Sex: M
Vaccine: DTAP, HIBV, IPV
Symptoms: Convulsion, Postictal state, Strabismus, Tremor
Clinical narrative: Hospitalized by 1st seizure < 24 hrs, shaky body, ?, MD seizure < 48 hrs. Brought to EMT-longer duration-admitted to hospital w/U (-) culture (-) CT scan. Seen by neurologist started on phenobarbital.  Information received from discharge summary states tremor, eyes rolled back, post ictal. msv
Age: 0.7
Sex: M
Vaccine: PNC
Symptoms: Drug ineffective, Pyrexia, Sepsis
Clinical narrative: PT went to ED for fever 103. Blood culture drawn - positive for strep pneumo. Culture to state lab for grouping. Vax failure.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Erythema, Injection site inflammation, Pain, Rash papular
Clinical narrative: L FA - 3 cm x cm erythematous papular tender area with increased local temp. Rx: Tylenol, Benadryl, local heat and three days of periopred (?)
Age: 5.0
Sex: F
Vaccine: DTAP, IPV
Symptoms: Erythema, Oedema
Clinical narrative: Started swelling 24 hrs on arm very red size of baseball. Right arm.
Age: 29.0
Sex: F
Vaccine: HEP, HEP
Symptoms: Asthenia, Dysphagia, Dyspnoea, Paraesthesia
Clinical narrative: 1st 15-30 mins - dyspnea, dysphagia, numbness and tingling of hands and feet. Tx: 50 mg Benadryl, 0.5 mg epinephius - Sx's improved, but persistent paresthesias and weakness 72 hrs later.
Age: 29.0
Sex: F
Vaccine: HEP, HEP
Symptoms: Dysphagia, Hyperventilation, Paraesthesia
Clinical narrative: 1st 15-30 mins - dyspnea, dysphagia, numbness and tingling of hands and feet. Tx: 50 mg Benadryl, 0.5 mg epinephius - Sx's improved, but persistent paresthesias and weakness 72 hrs later.
Age: 1.9
Sex: M
Vaccine: DTAP, FLU3, IPV, VARCEL
Symptoms: Ecchymosis, Erythema, Oedema
Clinical narrative: Left leg edema, erythema, ecchymosis 48 hrs post vax.
Age: 36.0
Sex: M
Vaccine: ANTH
Symptoms: Arthralgia, Influenza, Myalgia
Clinical narrative: Received shot approx 10/5/02. One wk later flu Sx's. Body ache, pain in joints. Hip flexor shoulders.
Age: 40.0
Sex: F
Vaccine: JEV
Symptoms: Dizziness, Erythema, Oedema, Pain, Pallor
Clinical narrative: PT c/o'd of severe burning at time of injection. Burning cont'd over 1 hr with severe pain to upper arm. PT became diaphoretic, dizzy and pale. PT's physical status was improved with severe pain, redness, swelling to left arm.
Age: 40.0
Sex: F
Vaccine: JEV
Symptoms: Skin burning sensation
Clinical narrative: PT c/o'd of severe burning at time of injection. Burning cont'd over 1 hr with severe pain to upper arm. PT became diaphoretic, dizzy and pale. PT's physical status was improved with severe pain, redness, swelling to left arm.
Age: 1.6
Sex: M
Vaccine: DTAP, HBHEPB, IPV, MMR, VARCEL
Symptoms: Erythema, Oedema, Pain
Clinical narrative: Left thigh swollen, red, painful starting approx 12 on 3/5/03.
Age: 14.0
Sex: F
Vaccine: HEP
Symptoms: Bradycardia, Oral intake reduced, Pallor, Syncope
Clinical narrative: PT fainted and pale and bradycardia around 15 mins post vax. PT was stimulated and came out of it.  Given cookie ? she said she was hungry. She hasn't eaten for at least 19 hrs before.
Age: 0.3
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Agitation, Crying
Clinical narrative: Irritable, crying inconsolable 10 p.m. to 1 a.m.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Erythema, Injection site induration, Injection site inflammation, Oedema
Clinical narrative: Red, swollen, hard, hot upper red arm. Arm began to swell - mom noticed on 3/6 at 8 p.m. PT started on Amoxicillin 2.5 tsp bid x 10 days.
Age: 0.2
Sex: M
Vaccine: DTAP, HBHEPB, IPV
Symptoms: Injection site oedema, Skin ulcer
Clinical narrative: W/in 10 mins PT had red swollen area right thigh. lindenated (?) lesions (DTaP) as well as on right upper arm (TR) Gave Benadryl 6.25 mg po x 1.
Age: 1.6
Sex: M
Vaccine: DTAPH, HEP, MMR, PNC, VARCEL
Symptoms: Rash, Rash erythematous
Clinical narrative: Patient's mother states rash on face Sunday morning. Then it spread all over entire body. Patient presents in clinic Tuesday with red, raised, fine rash covering entire body.
Age: 31.0
Sex: M
Vaccine: ANTH
Symptoms: Blister, Herpes zoster
Clinical narrative: Herpes zoster-like reaction with serous vesicles and pain to Right side of chest and Right upper arm and wrist.  Received third Anthrax immunization on 1/8/03 and reported to the medical clinic on 2/17/03 with the complaint of possible Anthrax reaction.  Did not have any reaction to previous two Anthrax immunizations on 10/5/02 and 10/23/02.  Did have varicella zoster as a child without complications.  Has not received vaccinia vaccine.
Age: 40.0
Sex: M
Vaccine: SMALL
Symptoms: Cow pox, Headache, Malaise, Nausea, Periodontal disease
Clinical narrative: Generalized Vaccinia Day 4 developed severe malaise Day 6 develped vessicular rash throughout skin including gingiva and R ear Day 8 developed HA, Temp to 101.5, nausea Was treated with Percocet and 23 hr obs Day 9 marked improvement
Age: 40.0
Sex: M
Vaccine: SMALL
Symptoms: Pyrexia, Rash vesicular
Clinical narrative: Generalized Vaccinia Day 4 developed severe malaise Day 6 develped vessicular rash throughout skin including gingiva and R ear Day 8 developed HA, Temp to 101.5, nausea Was treated with Percocet and 23 hr obs Day 9 marked improvement
Age: 57.0
Sex: F
Vaccine: SMALL
Symptoms: Chills, Erythema, Injection site rash, Pain, Rash papular
Clinical narrative: Received smallpox vaccine 2/25 on LD. On 3/6 developed a rash on Right upper arm, at injection site and on her back. Rash is several clusters of erythema  papule, pustule lesions. Had some muscle aches and cills at that time also. No temp. taken. On 3/12 went to Dr. new lesions were still coming. The follow up states virology reports were negative. Pt's condition is still under investigation by a dermatologist.
Age: 57.0
Sex: F
Vaccine: SMALL
Symptoms: Rash pustular, Skin ulcer
Clinical narrative: Received smallpox vaccine 2/25 on LD. On 3/6 developed a rash on Right upper arm, at injection site and on her back. Rash is several clusters of erythema  papule, pustule lesions. Had some muscle aches and cills at that time also. No temp. taken. On 3/12 went to Dr. new lesions were still coming. The follow up states virology reports were negative. Pt's condition is still under investigation by a dermatologist.
Age: 1.3
Sex: M
Vaccine: DTAP
Symptoms: Erythema, Irritability, Oedema, Pruritus
Clinical narrative: marked swelling of thigh one day after administration, mild reddness, no pain, no heat, some itching, some fussiness.
Age: 25.0
Sex: M
Vaccine: SMALL
Symptoms: Myalgia, Pyrexia
Clinical narrative: Fever 102 deg F, myalgia, 3 days post fax. treated with Naprosyn and Tylenol
Sex: F
Vaccine: SMALL
Symptoms: Pruritus, Rash, Rash pruritic, Vasodilation procedure
Clinical narrative: PT 35 y.o. female who began having reaction to tegadum about 3 days post vax. Continued to use tegadum ? at work; arm very irritated. On approx day 10 began with "heat rash" under breasts, behind ? on neck and down - very pruritic. No pustules developed. PT tried Benadryl w/out much relief. PT seen day 13; minimal remains ? but still c/o of itching. PT under significant stress due to family situation - feel this is definitely contribution to the rash. PT started on Atarax 50 - 100 mg prn itching.