chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 29.0
Sex: M
Vaccine: RAB
Symptoms: Dyspnoea, Headache, Pyrexia
Clinical narrative: A 29-year-old male patient experienced fever, headache and shortness of breath after receiving RabAvert. The patient received the 4th dose of RabAvert at 14:00 on 10 Sep 03. The patient was bitten by a dog and had been treated with the first three doses of RabAvert without any reported adverse effects.  On 11 Sep 03 he presented to the emergency department with complaints of fever of 101.3 F, headache and shortness of breath. He had been noted to be completely well by the health department staff on the prior day. No further case details are currently available.   Follow-up received 10 Oct 03: The patient (LL) received his 1st RabAvert vaccine on 24 Aug 03 and his 4th RabAvert vaccine on 10 Sep 03. He had no past medical history and no allergies to medications.   On 11 Sep 03 the patient was seen in the emergency room for fever that improved with Tylenol. The patient was stated as having a complete recovery.
Age: 74.0
Sex: M
Vaccine: HEPA, TD, YF
Symptoms: Back pain, Fatigue, Pyrexia
Clinical narrative: C/O fatigue/ back pain/ low grade fever x 5 days.
Age: 7.0
Sex: M
Vaccine: MMR
Symptoms: Autism
Clinical narrative: Information has been received from a consumer concerning her currently 7 year old son who was vaccinated on an unspecified date with a dose of MMRII (Lot # not reported) (manufacturer unknown).  The pt's mother reported that subsequently the pt developed mercury induced autism and this was reported to be disabling.  The pt was seeing a physician and it was reported that treatment (unspecified) was required.  No further information is available.
Age: 4.0
Sex: M
Vaccine: DTAP, HEP, IPV, MMR
Symptoms: Abnormal behaviour, Alopecia, Amnesia
Clinical narrative: Information has been received from a registered dietician concerning a male pt who at the age of 4 years old was vaccinated with a dose of MMRII (Lot # 644415/1008M).  Concomitant therapy included a dose of hepatitis B vaccine, recomb (manufacter unknown), IPV (unspecified) (manufacturer unknown) DTAP, Tetanus toxoid (manufacturer unknown).  In Feb 2003, the pt lost all hair.  The pt's mother noticed "a patch on the back of the boy's head the day after vaccination," and "within 2 weeks all hair was gone."  On 01/14/04, the pt's hair had not returned.  Unspecified medical attention was sought.  Upon internal review, alopecia was considered to be an other important medical event (OMIC).  Additional information has been requested. Follow up on 04/29/04 states: "In follow up information from the pt's mother, it was reported that the pt had allergies to soy and peanut products. She also reported that on 02/10/03 the pt received his second dose of hepatitis A virus vaccine inactivated (Lot # 643816/1061M) into the right thigh. A first dose of hepatitis A virus vaccine inactivated was given on 12/11/03.  It was reported that the pt was not ill at the time of vaccination. The reporter indicated that the pt received 4 shots in one day and about 2 weeks later, on 02/25/03, the pt had bad stomachaches and had to go to the MD for diarrhea.  Reportedly the pt woke up with a bald spot the size of a quarter and within 3 months he had no hair, eyebrows or eyelashes. The pt's mother noticed that a "different behavior", almost like she had a "different child".  She reported that the pt had memory loss on and off. The change in the pt's behavior was noticed by the mother, after vaccination with hepatitis A virus vaccine inactivated on 12/11/03 and the hair loss after vaccination with hepatitis A virus vaccine inactivated on 02/10/03.  According to the reporter, the physician diagnosed the pt with alopecia. Upon internal review, alopecia, memory impairment and abnormal behavior were considered to be an other important medical events.  The pt's experience were considered to be disabling by the pt's mother. Additional information has been requested."
Age: 14.0
Sex: M
Vaccine: FLUN3
Symptoms: Nasopharyngitis, Wheezing
Clinical narrative: This report of a special interest event is being submitted in an expedited time frame as requested by the FDA.  Information regarding Flumist (2003-2004 Formula) (influenza virus vaccine, live intranasal (2003-2004 formula) nasal solution (frozen)) was received from a mother regarding her 14 year old son who experienced head cold and wheezing.  At 14 years of age, the pt received a dose on 12/09/03.  Seven to 9 days post-immunization, the child developed a head cold (nasopharyngitis).  The head cold resolved after 9 to 10 days without treatment.  On 01/03/04, he developed another head cold with wheezing.  The mother reported that the child's physician was contacted.  The physician prescribed an increased in the frequency of albuterol and Azmacort.  As of 01/12/04, the symptoms persisted.  No additional information was available at the time of this report.
Age: 19.0
Sex: F
Vaccine: RAB, RAB
Symptoms: Neurological symptom, Swelling
Clinical narrative: Swelling all over body [Swelling NOS]. Neurological Changes [Neurological Symptoms NOS].
Age: 40.0
Sex: F
Vaccine: RAB
Symptoms: Asthma, Chest pain
Clinical narrative: A 40 year old female with past medical history of complex unspecified pulmonary problems and thyroid cancer, received RabAvert for pre-exposure. After the second dose of RabAvert, the pt experienced chest pressure and asthma-like symptoms. When the pt received her first dose of RabAvert, she was also on a steroid inhaler. Her treating physician had approved the administration of RabAvert knowing there was a drug interaction. When the second dose of RabAvert was given, the pt was NOT on the steroid inhaler. The event occurred within one hour after the second dose, and resolved within 8 hrs.
Age: 37.0
Sex: F
Vaccine: RAB
Symptoms: Disorientation, Fatigue, Headache, Myalgia, Pain
Clinical narrative: A patient was treated with RabAvert for post-exposure prophylaxis, experienced severe body ache, headache, soreness in arm, echo in the ear, tiredness, and disorientation. The patient had received 4 dosed and reportedly felt sicker with each dose.
Age: 37.0
Sex: F
Vaccine: RAB
Symptoms: Tinnitus
Clinical narrative: A patient was treated with RabAvert for post-exposure prophylaxis, experienced severe body ache, headache, soreness in arm, echo in the ear, tiredness, and disorientation. The patient had received 4 dosed and reportedly felt sicker with each dose.
Age: 37.0
Sex: F
Vaccine: RAB, TD
Symptoms: Anxiety, Arthralgia, Musculoskeletal stiffness, Myalgia, Pain
Clinical narrative: A 37 year old female completed the series of RabAvert treatment for post-exposure and experienced increasing joint pain, muscle soreness, stiffness, throbbing throughout her body, anxiety, and tension. She received RabAvert 1ml IM on 4, 7, 11, 18 July and 1 Aug 2002 after being attacked by a wild cat. The attack resulted in multiple severe puncture wounds on both of her legs, right hand and forearm. After the first dose the pt complained of increasing joint pain, muscle soreness, stiffness, throbbing throughout her body, and a sensation of anxiety and tension. She reported that the symptoms lasted for approximately two weeks and that subsequent dosing resulted in increased throbbing at all of the bite wound sites was worse in her right hand and sometimes radiated to her neck. The nurse reporter assessed the events as possibly related to treatment drug. Follow up received on 12/19/02: On 7/4/02, the pt received tetanus/ diphtheria three hrs prior to receiving BayRab and first RabAvert dose IM. The pt was mildly sedated and went home to sleep. At that time, she noted increased joint pain, stiffness, throbbing joints, and muscle soreness in the morning, along with anxiety and tension. With each succeeding dose she had throbbing pain at all sites but most concentrated on right hand and occasionally felt up to her neck. The symptoms persisted for two weeks after initial RabAvert dose. She received subsequent doses on 7 Jul , 11 Jul, 18 Jul, and 1 Aug. The pt completely recovered without medical intervention. Follow up received on 5/1/03: lot numbers and expiration dates for administered RabAvert were received for injections 1 and 5.
Age: 37.0
Sex: F
Vaccine: RAB, TD
Symptoms: Tension
Clinical narrative: A 37 year old female completed the series of RabAvert treatment for post-exposure and experienced increasing joint pain, muscle soreness, stiffness, throbbing throughout her body, anxiety, and tension. She received RabAvert 1ml IM on 4, 7, 11, 18 July and 1 Aug 2002 after being attacked by a wild cat. The attack resulted in multiple severe puncture wounds on both of her legs, right hand and forearm. After the first dose the pt complained of increasing joint pain, muscle soreness, stiffness, throbbing throughout her body, and a sensation of anxiety and tension. She reported that the symptoms lasted for approximately two weeks and that subsequent dosing resulted in increased throbbing at all of the bite wound sites was worse in her right hand and sometimes radiated to her neck. The nurse reporter assessed the events as possibly related to treatment drug. Follow up received on 12/19/02: On 7/4/02, the pt received tetanus/ diphtheria three hrs prior to receiving BayRab and first RabAvert dose IM. The pt was mildly sedated and went home to sleep. At that time, she noted increased joint pain, stiffness, throbbing joints, and muscle soreness in the morning, along with anxiety and tension. With each succeeding dose she had throbbing pain at all sites but most concentrated on right hand and occasionally felt up to her neck. The symptoms persisted for two weeks after initial RabAvert dose. She received subsequent doses on 7 Jul , 11 Jul, 18 Jul, and 1 Aug. The pt completely recovered without medical intervention. Follow up received on 5/1/03: lot numbers and expiration dates for administered RabAvert were received for injections 1 and 5.
Age: 28.0
Sex: F
Vaccine: RAB
Symptoms: Hypoaesthesia, Pain, Sensation of heaviness, Skin burning sensation
Clinical narrative: A 28 year-old female developed an injection site reaction with arm numbness after receiving two doses of RabAvert. The patient's past medical history included post-traumatic stress disorder. Concomitant medications included Valium and Ambien on an as needed basis.  The patient was bitten by a wild raccoon on 29 Oct 02. She received a tetanus shot on 30 Oct 02. Two doses of RabAvert were subsequently administered on 05 Nov 02 and 08 Nov 02. After receiving both RabAvert doses the patient complained of stinging and burning at the injection site immediately and at 2 hours after each injection. She also complained of a heaving feeling in the arms and numbness for one week, stating that her arms felt like they were asleep. The first dose of RabAvert was given in her left arm (the patient is left-handed), which the second dose was given in her right arm. With each dose she experienced these injection site reactions. By the time the patient received here second dose of RabAvert, her left arm was still hurting. The patient considered these events unacceptable, stating that she could not pick up her children because her arm hurt so much. She subsequently failed to return for the remaining doses.   The events resolved approximately one week after each RabAvert injection.
Age: 55.0
Sex: M
Vaccine: RAB
Symptoms: Headache, Hypoaesthesia, Influenza like illness, Pain
Clinical narrative: A 55 year old male pt was bitten by a rabid raccoon (confirmed) and received post-exposure prophylaxis treatment of RabAvert and human rabies immune globulin (HRIG) Feb 02 to March 02. He received all 5 doses of RabAvert. The pt developed severe flu-like symptoms and bad headaches. The symptoms got worse with each dose. The pt is still experiencing severe headaches, body aches, and numbness in finger 10 months after completion of treatment.
Age: 15.0
Sex: M
Vaccine: RAB
Symptoms: Bone pain, Chest pain, Myalgia
Clinical narrative: A 15 year old male pt experienced mid-sternal chest pain, musculoskeletal pain and myalgia while rreceiving RabAvet. The pt received 1ml of RabAvert IM on 3/10/03 for a stray cat bite, on a post-exposure basis. The pt had received 2 doses at the time of the report and was still on treatment. He developed mid-sternal chest pain, musculoskeletal pain and myalgia following the first dose, and was evaluated in the ER for these complaints. No interruption of the drug therapy occurred. The physician determined that the events were possibly related to the RabAvert.
Sex: F
Vaccine: RAB
Symptoms: Arthralgia, Back pain, Chest pain, Shoulder pain
Clinical narrative: An adolescent female patient with exposure to rabies experienced back, shoulder, hip and chest pain after receiving RabAvert. The patient received rabies vaccine approximately 3-4 years ago. No past medical history or concomitant medication were know.   The patient complained of back, shoulder, hip and chest pain after receiving rabies vaccine. The same symptoms continue to persist for the patient. No further details were available at this time.  The events are considered possibly related to the RabAvert.
Sex: F
Vaccine: RAB
Symptoms: Unintended pregnancy
Clinical narrative: A female patient was exposed to a rabies bat when she picked up an apparently dead bat on her street and brought it into her home. Her physician treated her with 3/5 doses of RabAvert for post-exposure protocol.  Sometime prior to the 4th dose, the patient missed her menstrual period and did a pregnancy test which was positive. The physician was trying to contact the patient to return for the the two remaining immunizations in the series.   Outcome is unknown.
Age: 16.0
Sex: M
Vaccine: RAB
Symptoms: Urticaria
Clinical narrative: A 16 year-old male exposed to a rabid kitten developed hives while being treated with RabAvert. This individual developed hives on his abdomen and upper legs after receiving the 2nd dose of series. The evaluating physician discontinued the series. There was no known history of allergies.   The patient was treated with Prednisone 30 mg, two hours prior to vaccination and 12 hours after vaccination. The patient was also given Benadryl, dose unknown. The event resolved.   The physician assessed the event to be related to treatment drug.
Sex: F
Vaccine: RAB
Symptoms: Dizziness, Erythema, Face oedema, Hypoacusis, Rash
Clinical narrative: A female patient with rabies exposure experienced a rash, facial swelling, dizziness and temporary hearing loss while receiving RabAvert. The patient had received RabAvert 1ml, scheduled to be administered on days 0,3,7,14 and 28. Past medical history indicated no known hypersensitivity to eggs.   The patient was bitten by a raccoon and the status of the rabies in the raccoon was unknown as the animal was not retrieved. The patient received her 4th vaccination approximately 1 month prior to the report, and 12 hours later developed a generalized rash that was described as strawberry colored, with facial swelling, dizziness and temporary hearing loss in one ear. There was no associated fever. A recent rabies antibody titer was 2.01 IU. The patient was stated as having a complete recovery.
Sex: M
Vaccine: RAB
Symptoms: Asthenia, Dizziness, Fatigue, Insomnia, Nasal congestion
Clinical narrative: A 38 year old male pt developed benign positional vertigo, decreased peripheral vision, nuchal rigidity and signs of anaphylactic reactions after receiving RabAvert.  RabAvert was given on 07/16/03 and 07/19/03.  The pt has a history of possible glaucoma.  The pt came to the ER on 07/16/03 with three marks on his left arm and two marks on his right leg, possibly due to bat bites.  The wound was cleansed and he was administered human rabies immune globulin (HRIG) and the first dose of RabAvert.  On 07/19/03, he received the second dose of RabAvert.  On approximately 07/20/03, the pt developed vertigo, dizziness, insomnia, weakness, fatigue, neck pain, sinus congestion, red eyes and light sensitivity.  On 07/30/03, the treating physician noted findings of benign positional vertigo, gaze deviation, decreased peripheral vision, without acute focal weakness.  No fever, nuchal rigidity, change in blood pressure or anaphylactic signs were present.  A neurologist confirmed the physical findings on 07/31/03.  MRI results were negative, specifically for demyelinating findings.
Sex: M
Vaccine: RAB
Symptoms: Neck pain, Ocular hyperaemia, Photosensitivity reaction, Vertigo, Visual field defect
Clinical narrative: A 38 year old male pt developed benign positional vertigo, decreased peripheral vision, nuchal rigidity and signs of anaphylactic reactions after receiving RabAvert.  RabAvert was given on 07/16/03 and 07/19/03.  The pt has a history of possible glaucoma.  The pt came to the ER on 07/16/03 with three marks on his left arm and two marks on his right leg, possibly due to bat bites.  The wound was cleansed and he was administered human rabies immune globulin (HRIG) and the first dose of RabAvert.  On 07/19/03, he received the second dose of RabAvert.  On approximately 07/20/03, the pt developed vertigo, dizziness, insomnia, weakness, fatigue, neck pain, sinus congestion, red eyes and light sensitivity.  On 07/30/03, the treating physician noted findings of benign positional vertigo, gaze deviation, decreased peripheral vision, without acute focal weakness.  No fever, nuchal rigidity, change in blood pressure or anaphylactic signs were present.  A neurologist confirmed the physical findings on 07/31/03.  MRI results were negative, specifically for demyelinating findings.
Age: 34.0
Sex: F
Vaccine: RAB
Symptoms: Abdominal pain, Headache, Malaise, Vaccine positive rechallenge
Clinical narrative: A 34 year old female pt exposed to a bat developed severe abdominal pain, headache, and generalized sickness after each injection of RabAvert.  The pt received three doses of RabAvert 1mL IM.  The pt was exposed to a bat that was in the stroller of her child.  The animal escaped and the pt was started on the post-exposure RabAvert series.  With each of the three injections she experienced increasing abdominal pain, headache, and generalized sickness. She refused additional treatment with RabAvert.  Her rabies virus antibody titer after the third injection was 2.5IU.  No other information was provided.
Age: 40.0
Sex: M
Vaccine: RAB
Symptoms: Chest discomfort, Laboratory test abnormal, Urticaria
Clinical narrative: A 40 year old male pt exposed to rabies from a dog bite developed urticaria after receiving RabAvert.  The pt received his first two doses of RabAvert on days recommended for the post-exposure series.  After his second dose, he developed urticaria and was referred to an allergist.  The allergist gave the pt a dose of Prednisone for generalized urticaria reaction.  Prednisone was subsequently tapered off.  The third dose was given on day nine instead of day seven with pretreatment of Zyrtec and Zantac. RabAvert was given in small fractions until the entire 1mL was administered.  The pt was observed for a period of time and had no further reaction to RabAvert.  Follow up information received on 09/23/03: The pt's allergist provided the following information.  The pt received RabAvert from 08/12/03 to 09/09/03.  On day four of his RabAvert series he developed generalized urticaria and chest tightness. His symptoms were treated with a Medrol dose pak, Zyrtec and Zantac and resolved in five days.  On 09/09/03, after his final dose of RabAvert, his tital IgA was 225mg/dl and rabies antibody screen was greater than 4.5.  Allergy skin testing to PCN, cephalosporins, RabAvert, beef and egg was negative; rabies immune globulin was positive.  The physican assessed these events as non serious and not related to RabAvert.
Age: 9.0
Sex: F
Vaccine: RAB
Symptoms: Injection site pain, Nausea, Pyrexia
Clinical narrative: A 9-year-old female developed fever, injection site pain and nausea during RabAvert dosing. On 25 August 03, the subject received her fourth 1 mL dose of RabAvert, intramuscularly. While traveling on vacation, the family packed the fourth dose of RabAvert without maintaining the medication in the proper temperature range. It was reported the vaccine felt "cool". She developed a fever of 102 degrees F, pain at the injection site and nausea the evening after the fourth dose was administered. No rash, hives or sore throat were noted.  Follow up received 09 Sep 03: The patient received the third dose of RabAvert on 25 Aug 03, not the fourth as previously stated. RabAvert was given due potential exposure to a bat. She developed the fever of 102 F the afternoon of 25 Aug 03. The next morning, the patient awoke with a fever of 101.5 F. Soreness at the injection site was noted. The patient's parents stated the vaccine had remained unrefrigerated for six hours. She has made a complete recovery from the events.   Follow-up received 09 Sep 03: The patient received the third dose of RabAvert on 25 Aug 03, not the fourth as previously stated. RabAvert was given due potential exposure to a bat. She developed a fever of 102 F the afternoon of 25 Aug 03. The next morning, the patient awoke with a fever of 101.5 F. Soreness at the injection site was noted. The patient's parents stated the vaccine had remained unrefrigerated for six hours. She has made a complete recovery from the events.
Age: 18.0
Sex: M
Vaccine: RAB
Symptoms: Asthenia, Fatigue, Gastroenteritis, Influenza like illness, Lethargy
Clinical narrative: An 18-year-old male patient (WA) experienced lethargy after receiving RabAvert therapy. The patient received the first three doses of RabAvert, 1 ml intramuscularly on days zero, three and seven with the third dose given on 22 Jul 03.   The patient received the first three doses of RabAvert and became lethargic after the injections. He skipped the fourth and fifth doses due to the lethargy. The patient had returned to the hospital in Sep 03 complaining of a sore throat and vomiting, treated with amoxicillin. The reported stated these events were unrelated to RabAvert. No further details are available at this time.  Follow-up received 08 Dec 03: The patient sustained a coyote bite on 06 Jul 03 and experienced lethargy, weakness, tiredness and flu-like symptoms while receiving RabAvert. He received 5 injections of RabAvert from 08 Jul 03 to 07 Oct 03 (first dose 08 Jul 03, second dose 11 Jul 03 and third dose 15 Jul 03). He also experienced and episode of pharyngitis, gastroenteritis and vomiting on 17 Sep 03 during the RabAvert series, treated with Amoxicillin. Other concomitant medications included a diphtheria tetanus (DT) vaccination on 07 Jul 03 and a 10 day course of Augmentin beginning 07 Jul 03.  On 11 Jul 03 the patient complained of tiredness and flu-like symptoms (described as severe after the first injection on 08 Jul 03). On 15 Jul 03 he still had flu symptoms, tiredness and lack of energy that lasted for three days. On 22 Jul 03 the patient did not present to the clinic to take the RabAvert injection #4 because he was feeling so lethargic, so it was administered on 22 Sep 03. He received the 5th injection on 07 Oct 03. After the fourth and fifth doses the patient experienced weaknesss, lethargy and flu-like symptoms, lasting three to four days post injection. The symptoms were more noticeable after the fifth dose. He had a complete recovery by 04 Dec 03.
Age: 18.0
Sex: M
Vaccine: RAB
Symptoms: Malaise, Pharyngitis, Pharyngolaryngeal pain, Vomiting
Clinical narrative: An 18-year-old male patient (WA) experienced lethargy after receiving RabAvert therapy. The patient received the first three doses of RabAvert, 1 ml intramuscularly on days zero, three and seven with the third dose given on 22 Jul 03.   The patient received the first three doses of RabAvert and became lethargic after the injections. He skipped the fourth and fifth doses due to the lethargy. The patient had returned to the hospital in Sep 03 complaining of a sore throat and vomiting, treated with amoxicillin. The reported stated these events were unrelated to RabAvert. No further details are available at this time.  Follow-up received 08 Dec 03: The patient sustained a coyote bite on 06 Jul 03 and experienced lethargy, weakness, tiredness and flu-like symptoms while receiving RabAvert. He received 5 injections of RabAvert from 08 Jul 03 to 07 Oct 03 (first dose 08 Jul 03, second dose 11 Jul 03 and third dose 15 Jul 03). He also experienced and episode of pharyngitis, gastroenteritis and vomiting on 17 Sep 03 during the RabAvert series, treated with Amoxicillin. Other concomitant medications included a diphtheria tetanus (DT) vaccination on 07 Jul 03 and a 10 day course of Augmentin beginning 07 Jul 03.  On 11 Jul 03 the patient complained of tiredness and flu-like symptoms (described as severe after the first injection on 08 Jul 03). On 15 Jul 03 he still had flu symptoms, tiredness and lack of energy that lasted for three days. On 22 Jul 03 the patient did not present to the clinic to take the RabAvert injection #4 because he was feeling so lethargic, so it was administered on 22 Sep 03. He received the 5th injection on 07 Oct 03. After the fourth and fifth doses the patient experienced weaknesss, lethargy and flu-like symptoms, lasting three to four days post injection. The symptoms were more noticeable after the fifth dose. He had a complete recovery by 04 Dec 03.
Age: 35.0
Sex: F
Vaccine: RAB
Symptoms: Vision blurred
Clinical narrative: A 35-year-old female patient experienced an alteration of vision after receiving her first pre-exposure dose of RabAvert on 17 Sep 03. The patient's medical history included anxiety with injection and allergies to sulfa and codeine. Concomitant medication included Lexapro.   After receiving her first injection the patient experienced blurry vision in her left eye, lasting about 30 minutes. The event resolved. Later that day she experienced blurry vision in her right eye also lasting approximately 30 minutes. The patient has since recovered and has not had a repeat of these events. The patient reported these symptoms the nurse just prior to receiving a second dose of RabAvert. The second dose had not been given at the time of this report.   The nurse assessed the event as possibly related to RabAvert.
Age: 1.75
Sex: M
Vaccine: RAB, RAB
Symptoms: Feeling hot, Injection site erythema, Injection site rash, Pyrexia
Clinical narrative: A 21-month old male toddler (NP) experienced an injection site rash and fever after receiving RabAvert. The patient was administered 1 dose of RabAvert 1 ml injection and 1 dose of human recombinant immune globulin (HRIG) by injection on 25 Sep 03. The toddler has a history of rashes that have occurred post vaccination and also without medication administered.   On 25 Sep 03 the toddler was discovered by his mother standing over a bat but was not bitten. He was taken to the pediatric emergency department (ER) on that day and an injection of RabAvert and HRIG were administered by injection in his thighs. The child developed a rash consisting of red dots surrounding the injection site of both thighs in a circular pattern. The rash on one thigh was worse than the other one and it was not known by the ER staff which medication went into which thigh. The toddler also felt warm for 24 hours and the fever was treated with Tylenol. The fever resolved and the rash has improved spontaneously without treatment. The bat was tested and was negative for rabies  The events are considered possibly related to the RabAvert and the HRIG.
Age: 1.75
Sex: M
Vaccine: RAB, RAB
Symptoms: Feeling hot, Malaise, Pyrexia, Rash
Clinical narrative: A 21-month old male toddler (NP) experienced an injection site rash and fever after receiving RabAvert. The patient was administered 1 dose of RabAvert 1 ml injection and 1 dose of human recombinant immune globulin (HRIG) by injection on 25 Sep 03. The toddler has a history of rashes that have occurred post vaccination and also without medication administered.   On 25 Sep 03 the toddler was discovered by his mother standing over a bat but was not bitten. He was taken to the pediatric emergency department (ER) on that day and an injection of RabAvert and HRIG were administered by injection in his thighs. The child developed a rash consisting of red dots surrounding the injection site of both thighs in a circular pattern. The rash on one thigh was worse than the other one and it was not known by the ER staff which medication went into which thigh. The toddler also felt warm for 24 hours and the fever was treated with Tylenol. The fever resolved and the rash has improved spontaneously without treatment. The bat was tested and was negative for rabies  The events are considered possibly related to the RabAvert and the HRIG.
Age: 40.0
Sex: F
Vaccine: RAB
Symptoms: Agitation, Back pain, Fatigue, Headache, Muscular weakness
Clinical narrative: A 40-year-old female patient experienced leg weakness, achiness, increased tiredness, fever, pain in her back, neck and head after receiving RabAvert. The patient received one dose of RabAvert, 1 ml intramuscularly, on 25 Sep 03. She had previously received one dose of human rabies immunoglobin (HRIG) and Imovax for her first post-exposure dose on 12 Sep 03. Concomitant medications included Diovan HCT, Allegra, Rhinocort, Flovent, and Xanax. The patient's medical history included eczema, severe allergies to unspecified agents and current sinus infection for which she was receiving amoxicillin.  On 12 Sep 03 the patient received her first dose of HRIG and Imovax for post exposure treatment. Due to symptoms of headache and tiredness after HRIG and Imovax administration, the patient was switched to RabAvert per her physician. She received her first dose of RabAvert on 25 Sep 03, after which she complained of leg weakness, achiness, and neck, lumbar, and head pain described as shooting, intermittent pains and twinges in the back of her head. She also complained that she was feeling feverish and was more tired that usual. She reported that she experienced similar side effects after her first injection of Imovax.  Follow-up information received on 06 Oct 03: The reporter (patient) was contacted via telephone and provided the following information. She was receiving the post-exposure series because of a "possible" secondary exposure to rabies. She had gotten saliva from and unknown animal in her eye while she was chasing her cat, and subsequently informed her physician who thought she should start the rabies series. During this time she called the Center for Disease Control (CDC) to ask about her symptoms. The CDC physician told her that she did not consider the patient to be "exposed" per the case details and should not probably be receiving rabies treatment. The patient communicated this to her physician who decided to stop the post-exposure series based her discussion with the CDC. The patient's physician was going to contact the physician at the CDC to follow-up. She had not received any additional doses of RabAvert other than the one dose.   The patient's worse remaining symptom was the intermittent shooting pain/twinges in the back of her head and neck. She also described "awful headaches." She was no longer taking antibiotics for the sinus infection, though her physician said she was still "swollen" and put her on Allegra D. The patient has had swollen eyes in the past from animal exposures. Her physician did blood work on her after the symptoms started and the blood work came back "ok". She may follow-up with a neurologist if her physician feels that she should.
Age: 40.0
Sex: F
Vaccine: RAB
Symptoms: Neck pain, Pain, Pyrexia
Clinical narrative: A 40-year-old female patient experienced leg weakness, achiness, increased tiredness, fever, pain in her back, neck and head after receiving RabAvert. The patient received one dose of RabAvert, 1 ml intramuscularly, on 25 Sep 03. She had previously received one dose of human rabies immunoglobin (HRIG) and Imovax for her first post-exposure dose on 12 Sep 03. Concomitant medications included Diovan HCT, Allegra, Rhinocort, Flovent, and Xanax. The patient's medical history included eczema, severe allergies to unspecified agents and current sinus infection for which she was receiving amoxicillin.  On 12 Sep 03 the patient received her first dose of HRIG and Imovax for post exposure treatment. Due to symptoms of headache and tiredness after HRIG and Imovax administration, the patient was switched to RabAvert per her physician. She received her first dose of RabAvert on 25 Sep 03, after which she complained of leg weakness, achiness, and neck, lumbar, and head pain described as shooting, intermittent pains and twinges in the back of her head. She also complained that she was feeling feverish and was more tired that usual. She reported that she experienced similar side effects after her first injection of Imovax.  Follow-up information received on 06 Oct 03: The reporter (patient) was contacted via telephone and provided the following information. She was receiving the post-exposure series because of a "possible" secondary exposure to rabies. She had gotten saliva from and unknown animal in her eye while she was chasing her cat, and subsequently informed her physician who thought she should start the rabies series. During this time she called the Center for Disease Control (CDC) to ask about her symptoms. The CDC physician told her that she did not consider the patient to be "exposed" per the case details and should not probably be receiving rabies treatment. The patient communicated this to her physician who decided to stop the post-exposure series based her discussion with the CDC. The patient's physician was going to contact the physician at the CDC to follow-up. She had not received any additional doses of RabAvert other than the one dose.   The patient's worse remaining symptom was the intermittent shooting pain/twinges in the back of her head and neck. She also described "awful headaches." She was no longer taking antibiotics for the sinus infection, though her physician said she was still "swollen" and put her on Allegra D. The patient has had swollen eyes in the past from animal exposures. Her physician did blood work on her after the symptoms started and the blood work came back "ok". She may follow-up with a neurologist if her physician feels that she should.
Sex: F
Vaccine: RAB
Symptoms: Chills, Headache, Pain, Pyrexia
Clinical narrative: A female vet student received pre-exposure rabies series, and developed body aches and fever. She received her first dose of RabAvert vaccine on 9/24/03. Afterwa0rds she complained of body aches, headache and chills, which worsened over next 2 days. The pt then developed a fever of 103 F, and a backache and went to urgent care. She was examined and had normal CBC. No further testing was done. Her symptoms, especially fever, subsided. She was due for #2 vaccinations on 10/1/03. The pt had not been medicating until seen in the urgent care center. Since then she had been taking Tylenol or NSAIDs with relief. The physician reported that the pt had improved, and insisted on continuing with treatment. She had the second injection on 10/2/03. The pt was sent home with instructions to take Tylenol for three days and also Benadryl if necessary for the next three days.
Age: 58.0
Sex: F
Vaccine: HEPA
Symptoms: Disorientation, Dizziness, Headache, Hypertension, Hypoaesthesia
Clinical narrative: Within a few hours after the shot, I became dizzy.  The next day my symptoms were nausea, headache, dizziness, fever, vomiting, disoriented, trembling.  By the third day my legs and arms were numb.  On or about Dec 15, I first saw a MD and found out my blood pressure was dangerously high.  My symptoms continued so I returned to the MD.  I had additional blood work done and a CT Brain Scan.  Since I became ill I am unable to work and enjoy my normal activities.  My symptoms continue to be headaches and numbness in my hands and feet, and elevated blood pressure.  Some trembling in my hands.  My physician has prescribed medication and I am currently under her care. Per medical record, pt experienced lethargy and tinnitus. Nurse follow up on 05/14/04 states report is complete.
Age: 58.0
Sex: F
Vaccine: HEPA
Symptoms: Lethargy, Nausea, Pyrexia, Tinnitus, Tremor
Clinical narrative: Within a few hours after the shot, I became dizzy.  The next day my symptoms were nausea, headache, dizziness, fever, vomiting, disoriented, trembling.  By the third day my legs and arms were numb.  On or about Dec 15, I first saw a MD and found out my blood pressure was dangerously high.  My symptoms continued so I returned to the MD.  I had additional blood work done and a CT Brain Scan.  Since I became ill I am unable to work and enjoy my normal activities.  My symptoms continue to be headaches and numbness in my hands and feet, and elevated blood pressure.  Some trembling in my hands.  My physician has prescribed medication and I am currently under her care. Per medical record, pt experienced lethargy and tinnitus. Nurse follow up on 05/14/04 states report is complete.
Age: 58.0
Sex: F
Vaccine: HEPA
Symptoms: Vomiting
Clinical narrative: Within a few hours after the shot, I became dizzy.  The next day my symptoms were nausea, headache, dizziness, fever, vomiting, disoriented, trembling.  By the third day my legs and arms were numb.  On or about Dec 15, I first saw a MD and found out my blood pressure was dangerously high.  My symptoms continued so I returned to the MD.  I had additional blood work done and a CT Brain Scan.  Since I became ill I am unable to work and enjoy my normal activities.  My symptoms continue to be headaches and numbness in my hands and feet, and elevated blood pressure.  Some trembling in my hands.  My physician has prescribed medication and I am currently under her care. Per medical record, pt experienced lethargy and tinnitus. Nurse follow up on 05/14/04 states report is complete.
Age: 60.0
Sex: F
Vaccine: FLUX
Symptoms: Myocardial infarction
Clinical narrative: Heart attack at home, called 911, taken to hospital, couldn't revive.  County coroner called because sudden death.  Family thinks death is a result of flu shot received about 2 weeks ago.
Age: 18.0
Sex: M
Vaccine: FLUX, HEPA, SMALL, TYP
Symptoms: Anorexia, Bronchitis, Chills, Cough, Headache
Clinical narrative: Dry cough, high temperature 103 F, unable to break high fever.  IV MD x2 liters given transfer to another hospital. The medical record received on 3/16/04 states headache, chills, sore throat, decreased appetite, nausea, bronchitis, volume depleted, lethargic, and bacterial pneumonia. (no site problem). Most likely did Ar: deployed overseas.
Age: 18.0
Sex: M
Vaccine: FLUX, HEPA, SMALL, TYP
Symptoms: Lethargy, Lung disorder, Nausea, Pharyngolaryngeal pain, Pneumonia
Clinical narrative: Dry cough, high temperature 103 F, unable to break high fever.  IV MD x2 liters given transfer to another hospital. The medical record received on 3/16/04 states headache, chills, sore throat, decreased appetite, nausea, bronchitis, volume depleted, lethargic, and bacterial pneumonia. (no site problem). Most likely did Ar: deployed overseas.
Age: 18.0
Sex: M
Vaccine: FLUX, HEPA, SMALL, TYP
Symptoms: Pyrexia
Clinical narrative: Dry cough, high temperature 103 F, unable to break high fever.  IV MD x2 liters given transfer to another hospital. The medical record received on 3/16/04 states headache, chills, sore throat, decreased appetite, nausea, bronchitis, volume depleted, lethargic, and bacterial pneumonia. (no site problem). Most likely did Ar: deployed overseas.
Age: 20.0
Sex: M
Vaccine: ANTH
Symptoms: Convulsion, Influenza like illness, Meningitis, Thinking abnormal
Clinical narrative: Flu like symptoms followed by mental status changes, then seizures.
Age: 40.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Chest pain, Dyspnoea, Laboratory test abnormal, Neck pain
Clinical narrative: Patient states the day after she received the flu vaccine she developed joint pain of her extremities, shoulder and neck area. She then noticed approximately 10-14 days later becoming short of breath which seemed to gradually become worse and had left sided chest pain which made her have a hard time taking a deep breath. She was seen by her PCP approximately mid November and subsequently was referred to a Cardiologist and Pulmonogist due to continued shortness of breath. Patient states multiple tests were done that were normal. Referred to a Rheumatologist 1/6/4. Labs showed ANA positve, ANA titer 1:320. Patient continues to be short of breath and presently being treated with prednisone. Patient states MD feels she will need to continue steroids for one year. Employee has been out of work since the beginning of December.
Age: 40.0
Sex: F
Vaccine: FLU3
Symptoms: Shoulder pain
Clinical narrative: Patient states the day after she received the flu vaccine she developed joint pain of her extremities, shoulder and neck area. She then noticed approximately 10-14 days later becoming short of breath which seemed to gradually become worse and had left sided chest pain which made her have a hard time taking a deep breath. She was seen by her PCP approximately mid November and subsequently was referred to a Cardiologist and Pulmonogist due to continued shortness of breath. Patient states multiple tests were done that were normal. Referred to a Rheumatologist 1/6/4. Labs showed ANA positve, ANA titer 1:320. Patient continues to be short of breath and presently being treated with prednisone. Patient states MD feels she will need to continue steroids for one year. Employee has been out of work since the beginning of December.
Age: 4.0
Sex: M
Vaccine: DTAP, FLU3, IPV, MMR
Symptoms: Injection site erythema, Injection site oedema, Injection site warmth
Clinical narrative: 5.1x3.8cm area of edema, erythema and heat around injection site 1 day after immunizations.  Given pt advised to use Benadryl and ice packs.
Age: 41.0
Sex: M
Vaccine: SMALL, ANTH, SMALL
Symptoms: Cardiomegaly, Chest pain, Dyspnoea
Clinical narrative: SOB with chest wall pain. Oxygen sat 93% with clear lungs. Chest x-ray clear upper airway with significant cardio meglia. Lasix 20mg IV, ASA, NTG SL. Transported to ER. This report is considered to be an other important medical event (OMIC). Deployed overseas.
Age: 41.0
Sex: M
Vaccine: SMALL, ANTH, SMALL
Symptoms: Asthenia, Chest pain, Dyspnoea, Headache, Malaise
Clinical narrative: SOB with chest wall pain. Oxygen sat 93% with clear lungs. Chest x-ray clear upper airway with significant cardio meglia. Lasix 20mg IV, ASA, NTG SL. Transported to ER. This report is considered to be an other important medical event (OMIC). Deployed overseas.
Age: 41.0
Sex: M
Vaccine: SMALL, ANTH, SMALL
Symptoms: Vaccine positive rechallenge
Clinical narrative: SOB with chest wall pain. Oxygen sat 93% with clear lungs. Chest x-ray clear upper airway with significant cardio meglia. Lasix 20mg IV, ASA, NTG SL. Transported to ER. This report is considered to be an other important medical event (OMIC). Deployed overseas.
Age: 1.0
Sex: F
Vaccine: FLU3, IPV, MMR, VARCEL
Symptoms: Blister, Erythema, Rash, Skin ulcer
Clinical narrative: Mother phoned 01/13/04 had 3 day history of rash, 20 lesions some blistered, some red, 1 scab.  Afebrile, developed rash 01/10/04.
Age: 4.0
Sex: F
Vaccine: DTAP, FLU3, HBHEPB, IPV, MMR
Symptoms: Injection site erythema, Injection site oedema
Clinical narrative: Redness and swelling of left thigh given Benadryl in office reaction a few minutes after vaccine given.
Age: 33.0
Sex: F
Vaccine: FLU3
Symptoms: Chest pain, Dyspepsia, Hypoaesthesia
Clinical narrative: The very next day (10/28) I experienced severe heartburn which turned into chest pain. Soon, my arm (left) became numb. Next the left side of my face became numb and some of my left toes.
Age: 1.0
Sex: M
Vaccine: FLU3
Symptoms: Pyrexia
Clinical narrative: Family reported patient developed a high fever (104.0 F) exactly one week following the injection of the flu vaccine.
Age: 43.0
Sex: F
Vaccine: FLUX
Symptoms: Asthenia, Dizziness, Heart rate increased, Injection site hypersensitivity, Pruritus
Clinical narrative: Onset was itching on left arm in proximity to shot. Then bumps, dizziness, weakness, fast heart rate. Please note this is the 1st flu shot ever received.
Age: 43.0
Sex: F
Vaccine: FLUX
Symptoms: Rash
Clinical narrative: Onset was itching on left arm in proximity to shot. Then bumps, dizziness, weakness, fast heart rate. Please note this is the 1st flu shot ever received.
Age: 42.0
Sex: F
Vaccine: TD, TD
Symptoms: Hypoaesthesia, Injection site pain, Musculoskeletal stiffness, Night sweats, Paraesthesia
Clinical narrative: DT on 12/24/03, MD visit on 01/04/04, complained of painful site spreading to the back of the arm and into forearm, numbness, tingling, stiff neck, fever on 12/28 to 12/30/03.  Night sweats.  Given steroid injection into muscle spasm of back.  MD visit on 01/05/04, complained of same symptoms-referred to Ortho MD 01/07/04, ortho MD visit Pt ordered is getting treatment.
Age: 42.0
Sex: F
Vaccine: TD, TD
Symptoms: Pyrexia
Clinical narrative: DT on 12/24/03, MD visit on 01/04/04, complained of painful site spreading to the back of the arm and into forearm, numbness, tingling, stiff neck, fever on 12/28 to 12/30/03.  Night sweats.  Given steroid injection into muscle spasm of back.  MD visit on 01/05/04, complained of same symptoms-referred to Ortho MD 01/07/04, ortho MD visit Pt ordered is getting treatment.
Age: 42.0
Sex: F
Vaccine: TD, TD
Symptoms: Hypoaesthesia, Injection site pain, Muscle spasms, Musculoskeletal stiffness, Night sweats
Clinical narrative: DT on 12/24/03, MD visit on 01/04/04, complained of painful site spreading to the back of the arm and into forearm, numbness, tingling, stiff neck, fever on 12/28 to 12/30/03.  Night sweats.  Given steroid injection into muscle spasm of back.  MD visit on 01/05/04, complained of same symptoms-referred to Ortho MD 01/07/04, ortho MD visit Pt ordered is getting treatment.
Age: 42.0
Sex: F
Vaccine: TD, TD
Symptoms: Paraesthesia, Pyrexia
Clinical narrative: DT on 12/24/03, MD visit on 01/04/04, complained of painful site spreading to the back of the arm and into forearm, numbness, tingling, stiff neck, fever on 12/28 to 12/30/03.  Night sweats.  Given steroid injection into muscle spasm of back.  MD visit on 01/05/04, complained of same symptoms-referred to Ortho MD 01/07/04, ortho MD visit Pt ordered is getting treatment.
Age: 6.0
Sex: F
Vaccine: VARCEL
Symptoms: Drug ineffective, Infection
Clinical narrative: Varicella vaccine failure-twin sisters.  Developed a light case of chickenpox on Monday 01/13/04.  Approximately 50 lesions, going away 01/15/04.  Exposed to 8 year old brother, who did not have vaccine. Brother developed illness 12/31/03.
Age: 6.0
Sex: F
Vaccine: VARCEL
Symptoms: Dermatitis bullous, Drug ineffective, Fatigue, Infection, Skin ulcer
Clinical narrative: 01/15/04, twin sisters with varicella vaccine failure.  Tired Sunday evening 01/12/04.  Father noticed a couple of spots on her upper back that night.  More on Monday, on back and abdomen.  Today blistery, none crusted as yet.  Has approximately 100 lesions.  More ill than sister.  Exposed to unvaccinated 8 year old brother who developed chickenpox on 12/31/03.
Age: 0.7
Sex: M
Vaccine: DTAP, HBHEPB, IPV, PNC
Symptoms: Injection site erythema, Injection site mass, Pyrexia
Clinical narrative: According to pt's mother, had "high fever of 104.9" for 4 days.  Unable to "break the fever", took child to ER for evaluation; also "red bumps" on "sites of injection"; fever "broke" after 5 days.
Age: 8.0
Sex: F
Vaccine: VARCEL
Symptoms: Chest pain, Dermatitis bullous, Dizziness, Fatigue, Headache
Clinical narrative: Dizziness, paleness, increased heart rate, complained of chest hurting/burning like sensation, headache, fatigue, myalgias, temperature (per mothers report) started with symptoms on 01/05/04.  Breaking out.  Mother gave Benadryl and Motrin and Fluids. Broke out with chicken pox.
Age: 8.0
Sex: F
Vaccine: VARCEL
Symptoms: Heart rate increased, Myalgia, Pallor, Pyrexia
Clinical narrative: Dizziness, paleness, increased heart rate, complained of chest hurting/burning like sensation, headache, fatigue, myalgias, temperature (per mothers report) started with symptoms on 01/05/04.  Breaking out.  Mother gave Benadryl and Motrin and Fluids. Broke out with chicken pox.
Age: 5.0
Sex: F
Vaccine: DTAP
Symptoms: Injection site induration, Injection site oedema, Injection site warmth
Clinical narrative: DTAP at right deltoid area real swollen and warm to touch.  Area hard with measurments as below.  22.5cm width over 3/4 of arm length.
Age: 18.0
Sex: F
Vaccine: HEP
Symptoms: Arthralgia, Urticaria
Clinical narrative: Urticaria on arms, back, upper chest; with joint discomfort.