chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.17
Sex: F
Vaccine: DTAP, HEP, HIBV, IPV, DTAP, HEP, HIBV, IPV, DTAP, HEP, HIBV, IPV
Symptoms: Sudden infant death syndrome
Clinical narrative: From initial information received on 8/30/04 from another manufacturer regarding an adverse event occurring in the USA, it was reported by the patient's parent that a two month old female received her first dose of IPOL, her first dose of DTAP vaccine, her first dose of HIB vaccine, and her second dose of Hepatitis B vaccine on 8/28/02. The lot numbers, route and site of administration of the vaccines administered were not reported. Approximately 72 hours post-immunization, on 8/31/02, the patient died at her residence. The reporter stated that the autopsy indicated that the patient had died due to SIDS. The patient's medical history, concurrent conditions and concurrent medications were not reported, however, the reporter stated that a younger sibling had severe sleep apnea. It is unknown if the patient had an specific illness at the time of vaccination. The reporter did state that the patient received her first dose of Hepatitis B vaccine, at the time of birth without incident.  An obituary forwarded by the siblings former pediatrician indicated that the infant died on the morning of 01Sep2002 at a hospital. The autopsy reportedly indicated that the pt had died due to SIDS. THe manufacturere is attempting to gain authorization from the mother to contact the vaccine provider.
Age: 3.5
Sex: M
Vaccine: DTAP, HIBV, PNC, VARCEL, DTAP, IPV, VARCEL
Symptoms: Antisocial behaviour, Autism, Deafness, Speech disorder
Clinical narrative: From initial information received on 08/27/04 from manufacturer regarding an adverse event occurring in the USA, it was reported that a 3.5 year old male pt received his third dose of IPOL vaccine (Lot # route and site of administration were not reported) sometime in 01/01 (exact date not reported). Previous IPOL vaccines were given 10/00/2000 and 08/00/2000. Sometime in 12/03 (exact date not reported) the pt was diagnosed with autism. The recovery status of the pt was not reported.  Follow up on 11/12/04 states: "From additional information received on 11/03/04 it was reported from a physician at a pediatric group that the autism was not thought to be a side effect of the vaccine. It was also requested that the manufacturer's stop sending notifications to their facility. No further information is anticipated, this case is considered closed."
Age: 3.5
Sex: M
Vaccine: DTAP, HIBV, PNC, VARCEL, DTAP, IPV, VARCEL
Symptoms: Autism
Clinical narrative: From initial information received on 08/27/04 from manufacturer regarding an adverse event occurring in the USA, it was reported that a 3.5 year old male pt received his third dose of IPOL vaccine (Lot # route and site of administration were not reported) sometime in 01/01 (exact date not reported). Previous IPOL vaccines were given 10/00/2000 and 08/00/2000. Sometime in 12/03 (exact date not reported) the pt was diagnosed with autism. The recovery status of the pt was not reported.  Follow up on 11/12/04 states: "From additional information received on 11/03/04 it was reported from a physician at a pediatric group that the autism was not thought to be a side effect of the vaccine. It was also requested that the manufacturer's stop sending notifications to their facility. No further information is anticipated, this case is considered closed."
Age: 3.0
Sex: M
Vaccine: DTAP, HIBV, PNC, VARCEL, DTAP, IPV, VARCEL
Symptoms: Antisocial behaviour, Autism, Deafness, Speech disorder
Clinical narrative: Information has been received from a manufacturer and was assigned manufacturer control number HQWYE274513AUG04.  It was reported that a 41 month old male in September 2001 was vaccinated with a dose of varicella virus vaccine live. Other vaccinations included a dose of Hepatitis B virus vaccine rHBsAg (yeast)(+) Hib conj vaccine (OMPC) in August 2000, a first dose of hepatitis B virus vaccine rHBsAg (yeast) in October 2000, a dose of Hib conj vaccine (OMPC) in January 2001, a dose of MMRII in August 2001, and a second dose of Hepatitis B vaccine rHBsAg (yeast) in August 2001. It was reported that in December 2003, the pt developed autism. At the time of the report, the outcome was unknown. Autism was determined to be an other important medical event (OMIC).  This was originally reported by a physician's office. Additional information has been requested.
Age: 3.0
Sex: M
Vaccine: DTAP, HIBV, PNC, VARCEL, DTAP, IPV, VARCEL
Symptoms: Autism
Clinical narrative: Information has been received from a manufacturer and was assigned manufacturer control number HQWYE274513AUG04.  It was reported that a 41 month old male in September 2001 was vaccinated with a dose of varicella virus vaccine live. Other vaccinations included a dose of Hepatitis B virus vaccine rHBsAg (yeast)(+) Hib conj vaccine (OMPC) in August 2000, a first dose of hepatitis B virus vaccine rHBsAg (yeast) in October 2000, a dose of Hib conj vaccine (OMPC) in January 2001, a dose of MMRII in August 2001, and a second dose of Hepatitis B vaccine rHBsAg (yeast) in August 2001. It was reported that in December 2003, the pt developed autism. At the time of the report, the outcome was unknown. Autism was determined to be an other important medical event (OMIC).  This was originally reported by a physician's office. Additional information has been requested.
Age: 26.0
Sex: M
Vaccine: ANTH, ANTH
Symptoms: Pruritus, Rash
Clinical narrative: Generalized rash which lasted 2-3 weeks. A 26 year old active duty Navy Corpsman received his first three anthrax shots about 2 years ago. He does not recall any significant local or systemic reactions. He was given his fourth in the series of 6 anthrax vaccinations. He received his shot in his upper left arm on July 26. The next morning he noted redness, swelling, mild pruritus, and small papules surrounding the vaccinations site. By the next morning this reaction spread to involve the entire lateral aspect of his upper arm. In addition the same area of his right arm was now involved. He denied muscle aches, joint aches, headache, malaise, chills, low grade fever or nausea. While Benadryl lessened the pruritus, it had no effect on the rash . Over the next 48-72 hours, the rash progressed to symmetrically involve his calves, then medial thighs, then upper shoulders. He is unsure of the duration of each individual lesion. He has also noted mild fatigue and decreased endurance when working out. His past medical history is significant for rhinoconjunctivitis with both seasonal and environmental triggers for which he briefly received allergen immunotherapy while in NC. The AIT ceased when he transferred to CA. His nasal symptoms have remained minimal since moving to MD. He has no known drug, food or hymenoptera sensitivities. He denies any similar cutaneous sxs with previous vaccinations, medications, or exposures. He denies preceding illness prior to receiving this anthrax vaccination. He takes no OTC medications or supplements. He received a PPD at the same time as the anthrax vaccination and this was read as positive at 18 mm. I don't have access to prior PPD results.
Age: 26.0
Sex: M
Vaccine: ANTH, ANTH
Symptoms: Erythema, Fatigue, Injection site reaction, Pruritus, Rash
Clinical narrative: Generalized rash which lasted 2-3 weeks. A 26 year old active duty Navy Corpsman received his first three anthrax shots about 2 years ago. He does not recall any significant local or systemic reactions. He was given his fourth in the series of 6 anthrax vaccinations. He received his shot in his upper left arm on July 26. The next morning he noted redness, swelling, mild pruritus, and small papules surrounding the vaccinations site. By the next morning this reaction spread to involve the entire lateral aspect of his upper arm. In addition the same area of his right arm was now involved. He denied muscle aches, joint aches, headache, malaise, chills, low grade fever or nausea. While Benadryl lessened the pruritus, it had no effect on the rash . Over the next 48-72 hours, the rash progressed to symmetrically involve his calves, then medial thighs, then upper shoulders. He is unsure of the duration of each individual lesion. He has also noted mild fatigue and decreased endurance when working out. His past medical history is significant for rhinoconjunctivitis with both seasonal and environmental triggers for which he briefly received allergen immunotherapy while in NC. The AIT ceased when he transferred to CA. His nasal symptoms have remained minimal since moving to MD. He has no known drug, food or hymenoptera sensitivities. He denies any similar cutaneous sxs with previous vaccinations, medications, or exposures. He denies preceding illness prior to receiving this anthrax vaccination. He takes no OTC medications or supplements. He received a PPD at the same time as the anthrax vaccination and this was read as positive at 18 mm. I don't have access to prior PPD results.
Age: 26.0
Sex: M
Vaccine: ANTH, ANTH
Symptoms: Rash papular, Skin ulcer, Swelling
Clinical narrative: Generalized rash which lasted 2-3 weeks. A 26 year old active duty Navy Corpsman received his first three anthrax shots about 2 years ago. He does not recall any significant local or systemic reactions. He was given his fourth in the series of 6 anthrax vaccinations. He received his shot in his upper left arm on July 26. The next morning he noted redness, swelling, mild pruritus, and small papules surrounding the vaccinations site. By the next morning this reaction spread to involve the entire lateral aspect of his upper arm. In addition the same area of his right arm was now involved. He denied muscle aches, joint aches, headache, malaise, chills, low grade fever or nausea. While Benadryl lessened the pruritus, it had no effect on the rash . Over the next 48-72 hours, the rash progressed to symmetrically involve his calves, then medial thighs, then upper shoulders. He is unsure of the duration of each individual lesion. He has also noted mild fatigue and decreased endurance when working out. His past medical history is significant for rhinoconjunctivitis with both seasonal and environmental triggers for which he briefly received allergen immunotherapy while in NC. The AIT ceased when he transferred to CA. His nasal symptoms have remained minimal since moving to MD. He has no known drug, food or hymenoptera sensitivities. He denies any similar cutaneous sxs with previous vaccinations, medications, or exposures. He denies preceding illness prior to receiving this anthrax vaccination. He takes no OTC medications or supplements. He received a PPD at the same time as the anthrax vaccination and this was read as positive at 18 mm. I don't have access to prior PPD results.
Age: 4.0
Sex: M
Vaccine: DTP, IPV, MMR, DTAP, IPV, MMR
Symptoms: Chest pain, Cough, Eye swelling, Pharyngolaryngeal pain, Urticaria
Clinical narrative: From initial information received on 08/31/04 from another manufacturer (reference # WAES0408USA01316), initially reported by a physician, regarding an adverse event occurring in the USA, it was reported that a 4 year old male pt received a dose of IPOL, Lot # not reported, route and site of administration not reported, a dose of Diphtheria, tetanus and pertussis vaccine, lot # not reported, manufacturer lot # 646343/0960N, administered IM in an unspecified site on 07/20/04.  That same day approximately 30 minutes post-immunization, the pt developed a dry cough, rubbing throat, rubbing chest, generalized hives and both of his eyes swelled shut. He did not experienced wheezing, shortness of breath or difficulty swallowing. The pt was taken to the ER and treated with Oral Benadryl 12.5mg and subsequently recovered within 30 minutes. The physician stated that she did not see the pt for this event, therefore, could not determine if the events would have progressed to a life-threatening situation if the pt had not received treatment.  The reporter indicated that the chest discomfort, cough, eye oedema, throat irritation and generalized hives were determined to be other important medical events (OMIC). Follow up 03/23/05: From additional information received on 12/03/04 from the initial reporter, it was reported that this was the patient's fourth dose of the IPOL, lot number X0711, fifth dose of DAPTACEL, lot number C1696AA, and the patient's 3rd does of MEASLES, MUMPS AND RUBELLA VACCINE/MMR. He did not have any relevant tests or labs performed. This patient has recovered. No further information is anticipated, this case is considered closed. Company remarks: (Medical assessment: The clinical feature, the time to onset after the vaccination, the quick and complete recovery after treatment could evoke an anaphylactic reaction. All the symptoms described for this case (hives, eye swelling, chest discomfort, throat irritation) are consistent with anaphylatic reaction. It would have been useful to perform allergic tests to confirm the dianosis and to identify one or several components of the three vaccines. To be noted that this child has pre-existing medical conditions such as immunological diseases and food and animal allergies, particularly egg allergy.
Age: 4.0
Sex: M
Vaccine: DTP, IPV, MMR, DTAP, IPV, MMR
Symptoms: Chest pain, Cough, Dry throat, Eyelid oedema, Urticaria
Clinical narrative: From initial information received on 08/31/04 from another manufacturer (reference # WAES0408USA01316), initially reported by a physician, regarding an adverse event occurring in the USA, it was reported that a 4 year old male pt received a dose of IPOL, Lot # not reported, route and site of administration not reported, a dose of Diphtheria, tetanus and pertussis vaccine, lot # not reported, manufacturer lot # 646343/0960N, administered IM in an unspecified site on 07/20/04.  That same day approximately 30 minutes post-immunization, the pt developed a dry cough, rubbing throat, rubbing chest, generalized hives and both of his eyes swelled shut. He did not experienced wheezing, shortness of breath or difficulty swallowing. The pt was taken to the ER and treated with Oral Benadryl 12.5mg and subsequently recovered within 30 minutes. The physician stated that she did not see the pt for this event, therefore, could not determine if the events would have progressed to a life-threatening situation if the pt had not received treatment.  The reporter indicated that the chest discomfort, cough, eye oedema, throat irritation and generalized hives were determined to be other important medical events (OMIC). Follow up 03/23/05: From additional information received on 12/03/04 from the initial reporter, it was reported that this was the patient's fourth dose of the IPOL, lot number X0711, fifth dose of DAPTACEL, lot number C1696AA, and the patient's 3rd does of MEASLES, MUMPS AND RUBELLA VACCINE/MMR. He did not have any relevant tests or labs performed. This patient has recovered. No further information is anticipated, this case is considered closed. Company remarks: (Medical assessment: The clinical feature, the time to onset after the vaccination, the quick and complete recovery after treatment could evoke an anaphylactic reaction. All the symptoms described for this case (hives, eye swelling, chest discomfort, throat irritation) are consistent with anaphylatic reaction. It would have been useful to perform allergic tests to confirm the dianosis and to identify one or several components of the three vaccines. To be noted that this child has pre-existing medical conditions such as immunological diseases and food and animal allergies, particularly egg allergy.
Age: 0.51
Sex: F
Vaccine: PNC
Symptoms: Bacterial infection, Cough, Drug ineffective, Pyrexia, Rhinorrhoea
Clinical narrative: Follow up information from the attending physician provided the patient's date of birth, dates of Prevnar immunization, event onset date and date of death. Information regarding Prevnar was received from a physician regarding a 13 month old female patient who received the third dose at 6 months of age, and died of invasive S. pneumo on 5/2/04. The patient's concurrent illness included a viral upper respiratory tract infection with a past history of jaundice (at 4 days old) and upper respiratory tract infection (at 1 year and 3 weeks of age). Family history included antitrypsin deficiency. Indication for Prevnar was immunization. Product was administered on 9/8/03. Dose regimen was 1 dose 1 time per day. Patient was not taking concomitant therapy. On 4/27/04, the patient presented with a fever of 102-104 degrees F, cough with post-tussive vomiting, and sinus drainage. A white blood cell count was 13K. The child was diagnosed with a viral upper respiratory tract infection. No antibiotics were received. On 5/2/04, the child was found dead by the parents. A culture of brain tissue revealed Streptococcus pneumoniae serotype 19-F. A pneumococcal antibody test revealed: Streptococcus pneumoniae antibody titers are similar to those found in similarly aged children who have not received a full series for age of pneumo. conjugate vaccine. Titers are lower than expected for a fully immunized child. The reported cause of death was Streptococcus pneumoniae meningitis. The child had received Prevnar vaccine at 2, 4, and 6 months of age. The fourth dose was not given.  Nurse follow up on 09/07/04 states: "Complete."  Follow up on 09/10/04 states: "The cause of the death of pt, was an infection around the brain with Streptococcus pneumoniae, a bacteria commonly found in the nose and air passages and a frequent cause of meningitis in this age group. There is no evidence of significant trauma.  Toxicology showed nothing abnormal."
Age: 0.51
Sex: F
Vaccine: PNC
Symptoms: Upper respiratory tract infection, Vomiting, White blood cell count increased
Clinical narrative: Follow up information from the attending physician provided the patient's date of birth, dates of Prevnar immunization, event onset date and date of death. Information regarding Prevnar was received from a physician regarding a 13 month old female patient who received the third dose at 6 months of age, and died of invasive S. pneumo on 5/2/04. The patient's concurrent illness included a viral upper respiratory tract infection with a past history of jaundice (at 4 days old) and upper respiratory tract infection (at 1 year and 3 weeks of age). Family history included antitrypsin deficiency. Indication for Prevnar was immunization. Product was administered on 9/8/03. Dose regimen was 1 dose 1 time per day. Patient was not taking concomitant therapy. On 4/27/04, the patient presented with a fever of 102-104 degrees F, cough with post-tussive vomiting, and sinus drainage. A white blood cell count was 13K. The child was diagnosed with a viral upper respiratory tract infection. No antibiotics were received. On 5/2/04, the child was found dead by the parents. A culture of brain tissue revealed Streptococcus pneumoniae serotype 19-F. A pneumococcal antibody test revealed: Streptococcus pneumoniae antibody titers are similar to those found in similarly aged children who have not received a full series for age of pneumo. conjugate vaccine. Titers are lower than expected for a fully immunized child. The reported cause of death was Streptococcus pneumoniae meningitis. The child had received Prevnar vaccine at 2, 4, and 6 months of age. The fourth dose was not given.  Nurse follow up on 09/07/04 states: "Complete."  Follow up on 09/10/04 states: "The cause of the death of pt, was an infection around the brain with Streptococcus pneumoniae, a bacteria commonly found in the nose and air passages and a frequent cause of meningitis in this age group. There is no evidence of significant trauma.  Toxicology showed nothing abnormal."
Sex: M
Vaccine: PPV
Symptoms: Guillain-Barre syndrome
Clinical narrative: Information has been received from a registered nurse concerning a male patient who on an unspecified date was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (lot # not available). Subsequently, the patient experienced Guillain-Barre syndrome. It was unknown if medical attention was sought. On 8/26/04 it was reported that the event did not improve and the patient's present status was reported as unknown. Upon internal review, Guillain-Barre syndrome was determined to be an other important medical event (OMIC). No further information is available. Follow up 03/03/05: Patient has not recovered from the event(s).
Age: 12.0
Sex: F
Vaccine: MMR, TD
Symptoms: Brain oedema, Confusional state, Depressed level of consciousness, Hyperreflexia, Laboratory test abnormal
Clinical narrative: It was reported through a published article that a 12 year old female was vaccinated with a dose of MMR. Concomitant therapy included diphtheria toxoid/tetanus toxoid. It was noted that after 8 days she developed a sore throat for which she was prescribed aspirin, 500mg twice a day for two days. After 3 days she had 30-40 episodes of vomiting with decreased consciousness, mental confusion, hyperreflexia and was sent to the intensive care unit. The patient was positioned for invasive monitoring of intracranial pressure. Laboratory tests included a toxic screen which was negative; blood PH: normal; AST 887 U/I; ALT 1194 U/I; INR 1.4; bilirubin 13 umol/l; lactate 2.9 mmol/l; ammonia 230 umol/l; CSF was normal and urea cycle defects and fatty acid oxidation defects were ruled out. An EEG was slowed and of reduced amplitude. A head CT scan showed generalized cerebral edema and monitoring of intracranial pressure revealed 30 mmHg with spikes at 50 mmHg, responsive to deep sedation and boluses of thiopentone. The management of raised ICP was then commenced, including mannitol and inotropic support to maintain a cerebral perfusion greater than 60 mmHg. After a week from the onset a CT scan showed marked reduction of cerebral edema and after three weeks the child was discharged with normal liver function and normal neurological exam apart from mild residual ataxia. No further information was provided. Follow up 03/03/05: Patient has not recovered from adverse event(s).
Age: 12.0
Sex: F
Vaccine: MMR, TD
Symptoms: Liver function test abnormal, Pharyngolaryngeal pain, Vomiting
Clinical narrative: It was reported through a published article that a 12 year old female was vaccinated with a dose of MMR. Concomitant therapy included diphtheria toxoid/tetanus toxoid. It was noted that after 8 days she developed a sore throat for which she was prescribed aspirin, 500mg twice a day for two days. After 3 days she had 30-40 episodes of vomiting with decreased consciousness, mental confusion, hyperreflexia and was sent to the intensive care unit. The patient was positioned for invasive monitoring of intracranial pressure. Laboratory tests included a toxic screen which was negative; blood PH: normal; AST 887 U/I; ALT 1194 U/I; INR 1.4; bilirubin 13 umol/l; lactate 2.9 mmol/l; ammonia 230 umol/l; CSF was normal and urea cycle defects and fatty acid oxidation defects were ruled out. An EEG was slowed and of reduced amplitude. A head CT scan showed generalized cerebral edema and monitoring of intracranial pressure revealed 30 mmHg with spikes at 50 mmHg, responsive to deep sedation and boluses of thiopentone. The management of raised ICP was then commenced, including mannitol and inotropic support to maintain a cerebral perfusion greater than 60 mmHg. After a week from the onset a CT scan showed marked reduction of cerebral edema and after three weeks the child was discharged with normal liver function and normal neurological exam apart from mild residual ataxia. No further information was provided. Follow up 03/03/05: Patient has not recovered from adverse event(s).
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Cellulitis, Hypersensitivity, Injection site erythema, Injection site oedema, Similar reaction on previous exposure to drug
Clinical narrative: Right thigh with large circumferential erythema, edema.  Nurse follow up on 09/08/04 states: "Allergic reaction vs. Cellulitis."
Age: 1.4
Sex: F
Vaccine: HBHEPB, MMR, VARCEL
Symptoms: Convulsion, Haematuria, Pyrexia
Clinical narrative: Pt had fever x2 days and at approximately 18:30 on 08/19/04 started having a 'seizure' per mom. Mom says it lasted 30 minutes and fever was almost 104 F. Child in hospital when mom called. Follow up 01/21/05: Patient recovery status unknown. She as an appointment with a neurologist on 02/23/05. No more seizure activity, but has times when just stares. Family history of seizures- grandfather and cousins.
Age: 28.0
Sex: M
Vaccine: ANTH, SMALL, ANTH, SMALL
Symptoms: Chest pain, Dyspnoea, Laboratory test abnormal, Pericarditis
Clinical narrative: Pericarditis (suspected) 9 days past smallpox vaccine + AVA.  This is a 28 year old Active Duty male who received anthrax 3 and his first smallpox vaccine on 15July04. Nine days later he awakened with chest pain which was sharp and stabbing, then burning, rated at a 9/10. He had no radiation of pain, no nausea and vomiting, no sweating. He had some associated shortness of breath with deep inspiration only. He wen to sick call 2 days later and had a normal ekg and lab work. Arrived at medical center on 27 July 2004 for cardiac evaluation. Continued with chest pain intermittently and shortness of breath on even minimal exertion. EKG, echo and cardiac enzymes WNL. One month later service member has developed a new type of chest pain that is along the superior left substernal border, is present in all positions, and worsens with deep inspiration, movement and palpation. On a subsequent visit to WRAMC a repeat echo and cardiac enzymes remained normal. Cardiology has evaluated the pain as non-cardiac and has diagnosed it as a variant of regional pain syndrome. DoD Cardiology working group has classified this case as "suspected pericarditis" according to the pericarditis case definition.
Age: 28.0
Sex: M
Vaccine: ANTH, SMALL, ANTH, SMALL
Symptoms: Chest pain, Pericarditis, Radiculitis brachial
Clinical narrative: Pericarditis (suspected) 9 days past smallpox vaccine + AVA.  This is a 28 year old Active Duty male who received anthrax 3 and his first smallpox vaccine on 15July04. Nine days later he awakened with chest pain which was sharp and stabbing, then burning, rated at a 9/10. He had no radiation of pain, no nausea and vomiting, no sweating. He had some associated shortness of breath with deep inspiration only. He wen to sick call 2 days later and had a normal ekg and lab work. Arrived at medical center on 27 July 2004 for cardiac evaluation. Continued with chest pain intermittently and shortness of breath on even minimal exertion. EKG, echo and cardiac enzymes WNL. One month later service member has developed a new type of chest pain that is along the superior left substernal border, is present in all positions, and worsens with deep inspiration, movement and palpation. On a subsequent visit to WRAMC a repeat echo and cardiac enzymes remained normal. Cardiology has evaluated the pain as non-cardiac and has diagnosed it as a variant of regional pain syndrome. DoD Cardiology working group has classified this case as "suspected pericarditis" according to the pericarditis case definition.
Age: 21.0
Sex: F
Vaccine: ANTH
Symptoms: Foetal growth retardation, Medication error, Unintended pregnancy
Clinical narrative: Had AVA #2 about the time of conception. Term infant born with fetal Sacral Teratoma and multiple Vertebral and rib abnormalities.
Age: 0.2
Sex: M
Vaccine: DTAPHEPBIP
Symptoms: Medication error
Clinical narrative: Child given outdated Pediarix vaccine on July 16th 2004; wanted to repeat vaccination 3 weeks after it was discovered. 3 weeks early by state regulation.
Age: 5.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Cough, Pharyngolaryngeal pain, Pyrexia, Rash
Clinical narrative: Cough, increased temperature, sore throat, rash
Age: 1.0
Sex: M
Vaccine: DTAP, VARCEL
Symptoms: Pyrexia, Tremor
Clinical narrative: Mom came into office and reported that they were at the park and the babysitter saw the baby have shaking movements of the body for approximately 1 minute. Temperature was 100.5 rectal. Mother and brother both with history of seizures.
Age: 5.0
Sex: F
Vaccine: IPV, MMR
Symptoms: Feeling hot, Pyrexia, Vomiting
Clinical narrative: Mom reports that approximately 2-3 hours after vaccines child complained of feeling hot and had a temperature of 103 degrees. She is also complaining of vomiting. I spoke with her on 8/31/04.
Age: 4.0
Sex: M
Vaccine: HBHEPB, VARCEL
Symptoms: Herpes zoster, Infection, Rash, Swelling
Clinical narrative: 8/27/04: child developed rash and swollen fingers. 8/31/04: came to office. Diagnosis : Shingles
Age: 72.0
Sex: F
Vaccine: TD
Symptoms: Erythema, Feeling hot, Injection site erythema, Injection site induration, Injection site pain
Clinical narrative: Site of injection red and painful, warm outside of arm by deltoid and around inside of arm. Erythema with induration at point of injection. Erythema encompasses more than 75% circumference to upper arm.
Age: 36.0
Sex: F
Vaccine: TD
Symptoms: Pain, Swelling
Clinical narrative: Developed swelling with pain left deltoid around 1-2 days after receiving Td booster. Last Td reportedly 1990 and no reaction then.
Age: 12.0
Sex: M
Vaccine: HEP, HEPA, TD
Symptoms: Aphasia, Dyskinesia, Eye movement disorder, Nausea, Somnolence
Clinical narrative: Mother states approximately 10 min after vaccines given, while she was driving home with pt he stopped talking to her. She observed his eyes rolled back, mouth open. He involuntarily kicked his legs up once and hands jerked at the same time. This happened within 5 seconds as patient "woke up" he stated he felt nauseated and felt as if he had been asleep for a long time. 8/30/04: spoke with RN regarding medical follow up. The mother reported the incident the day after it occurred. There was no medical follow because the family is now away and didn't know where to do.
Age: 8.0
Sex: M
Vaccine: HEP, PNC, VARCEL
Symptoms: Drug ineffective, Infection
Clinical narrative: Pt received varicella vaccine 10/04/2001. Was diagnosed with chicken pox in office today 8/30/04.
Age: 3.0
Sex: F
Vaccine: PNC, VARCEL
Symptoms: Injection site erythema, Injection site induration, Pyrexia, Tenderness
Clinical narrative: Vaccine administered to left deltoid area 8/27/04 in the right thigh around 4:30 PM. Next day, red, tender, indurated area around injection site. Fever 102.7F 8/29/04.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Erythema, Pain
Clinical narrative: Left deltoid not to touch 98 mm x 78 mm erythema , painful to touch.
Age: 0.2
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Irritability, Laboratory test abnormal, Muscle rigidity, Pyrexia, Tension
Clinical narrative: Extreme fussiness initially, then periodic episodes of tensing entire body for 10 second intervals multiple times over around 1 hour on evening after shots given. Seen in ER, temp there 99.6. Lab work normal. No further episodes. Sent home.
Age: 4.0
Sex: F
Vaccine: DTAP, HEP, IPV, MMR, VARCEL
Symptoms: Arthralgia, Purpura
Clinical narrative: Henoch Schonlein Purpura. Joint pains in lower extremities developed 8-10 days after immunizations, purpura buttocks and lower extremities developed 5-6 days after onset of joint pains.
Sex: F
Vaccine: DTAP, HIBV
Symptoms: Erythema, Pruritus, Swelling
Clinical narrative: 11 cm x 7 cm area of redness, swelling and itching right thigh.
Age: 41.0
Sex: F
Vaccine: TD
Symptoms: Fatigue, Feeling hot, Injection site pain, Pain
Clinical narrative: Patient reported feeling feverish, fatigued and pain in left axilla with node inflammation as well as pain at injection site left deltoid within 3-4 hours of injection.
Age: 5.0
Sex: M
Vaccine: DTAP, HIBV, IPV, MMR
Symptoms: Swelling
Clinical narrative: Mom called 8/25/04. Said grandmother had brought child with her permission to get shots and "his left arm was twice the size of other arm."
Age: 2.0
Sex: M
Vaccine: DTAP, IPV
Symptoms: Diarrhoea, Pyrexia, Vomiting
Clinical narrative: Fever T101 degrees and vomiting developed approximately 12 hours after DTaP and IPV were given. Also associated with diarrhea. Sxs have continued for 6 days.
Age: 5.0
Sex: M
Vaccine: DTAP, HEPA, IPV, MMR
Symptoms: Erythema, Eyelid oedema, Face oedema, Rash, Rash macular
Clinical narrative: Pt appt 11:15. Pt arrival at clinic after vaccinations at 1300 with complaints of red, blotchy rash on cheeks and trunk of his body with itching. Cheeks swollen, eyes slightly swollen. Gave 25mg Benadryl 1300. Monitored vital signs for 45 minutes, sent to hospital for continual monitoring.
Age: 17.0
Sex: F
Vaccine: HEP, TTOX
Symptoms: Fatigue, Headache, Somnolence
Clinical narrative: Severe headache, history of seizures-headache before and after seizure according to mom. Became very sleepy and tired. Observed and vital signs checked. 10:40. home with mom. To call PCP or ER if further problems.
Age: 5.0
Sex: M
Vaccine: DTAP, MMR
Symptoms: Injection site erythema, Injection site oedema, Injection site warmth
Clinical narrative: Right deltoid with erythema and edema with increased warmth to area of 85mmx90mm often. DTaP administered on 08/11/04 to right deltoid. Pt returned on 08/12/04 with above signs/symptoms.
Age: 12.0
Sex: M
Vaccine: TD
Symptoms: Injection site erythema, Injection site pain, Pyrexia
Clinical narrative: Temperature up to 101, local reaction: erythema, pain, 25x35mm on exam today- 2 days after dT given.
Age: 5.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema
Clinical narrative: Pt in office 08/24/04 with 6x6cm reddened area on left upper arm, no induration noted at injection site, no warmth.
Age: 5.0
Sex: M
Vaccine: DTAP, MMR, VARCEL
Symptoms: Cellulitis, Injection site reaction
Clinical narrative: Cellulitis at site of immunization on left arm. No fever. Pt acting well otherwise.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Chest pain
Clinical narrative: Father stated child was outside at school playing in PE. Started to have mild chest pain. Continue from 'noon until supper'. Did not seek medical attention. States the family moved here from another state and they are not used to the humidity. No further problems.
Age: 11.0
Sex: M
Vaccine: VARCEL
Symptoms: Injection site erythema, Urticaria
Clinical narrative: 7-10 minutes after vaccine administered, 1 inch hive developed at injection site with 3 inch of redness. No other hives or signs and symptoms of respiratory distress. Sent to physician for follow up, was given oral antihistamine. 09/02/04, called mother, fine today.
Age: 42.0
Sex: M
Vaccine: HEP
Symptoms: Musculoskeletal stiffness, Neck pain
Clinical narrative: Pt complained of pain/stiffness left side neck 1-2 days after immunization.
Age: 47.0
Sex: M
Vaccine: HEP
Symptoms: Musculoskeletal stiffness, Neck pain
Clinical narrative: Pt complained of pain-stiffness left side neck 1-2 days after immunization.
Age: 1.3
Sex: M
Vaccine: MMR
Symptoms: Dizziness, Gait disturbance, Irritability
Clinical narrative: Within 3-4 hours of MMR vaccine administration pt seemed dizzy, increased fussy and refused to walk. He began crawling instead of walking. By the next morning he seemed better. Had normal physical exam 07/13/04 AM before vaccine. Later in afternoon pt refused to walk on exam, but non tender with from passively.
Sex: F
Vaccine: MMR
Symptoms: Conjunctivitis, Pyrexia, Rash macular, Rash papular
Clinical narrative: Fever. Maculopapular rash, conjunctivitis suspected.
Age: 6.0
Sex: F
Vaccine: HEPA, HEPA
Symptoms: Lethargy, Pyrexia, Rash, Vomiting
Clinical narrative: Rash, fever, vomiting and lethargy occurred within 24 hours of shot. Symptoms subsided in 2 days.
Age: 5.0
Sex: M
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site oedema
Clinical narrative: Mother states redness and swelling began 24 hours post vaccination. States noticed today the swelling in the left pectoral area. Today 08/26/04 about 6cm circumferential band of erythema around arm, mild, nontender soft tissue swelling into deltoid and left pectoris.
Age: 7.0
Sex: F
Vaccine: DTAP, HIBV, VARCEL
Symptoms: Viral infection
Clinical narrative: Received Varicella injection on 09/15/99. Diagnosed with Varicella 09/02/04.
Age: 4.0
Sex: F
Vaccine: DTAP, HIBV
Symptoms: Injection site erythema, Injection site vesicles
Clinical narrative: 10x7cm erythema with small water filled vesicles on the left arm.
Age: 4.0
Sex: M
Vaccine: DTAP, HEPA, IPV, MMR
Symptoms: Injection site oedema
Clinical narrative: Swelling at immunization site. RA. Given Diphenhydramine 12.5mg/mL, 3.5mL per mouth every 8 hours.
Age: 43.0
Sex: F
Vaccine: HEP
Symptoms: Asthenia, Back pain, Confusional state, Fatigue, Lethargy
Clinical narrative: Next day after vaccine. Weakness and fatigue and confusion, back pain and low grade fever, malaise, lethargy. After vaccine, slight wheeze within 10 minutes of Hep B injection.
Age: 43.0
Sex: F
Vaccine: HEP
Symptoms: Malaise, Pyrexia, Wheezing
Clinical narrative: Next day after vaccine. Weakness and fatigue and confusion, back pain and low grade fever, malaise, lethargy. After vaccine, slight wheeze within 10 minutes of Hep B injection.
Age: 1.6
Sex: F
Vaccine: VARCEL
Symptoms: Rash vesicular
Clinical narrative: Rash on abdomen and behind ear (vesicular rash), 2 weeks after Varicella shot.
Age: 5.0
Sex: M
Vaccine: DTAP
Symptoms: Fatigue, Feeling hot, Injection site erythema, Injection site pain, Urticaria
Clinical narrative: 08/24/04 evening: red, sore right arm, 08/25/04 Ice and Motrin; tired, 8/26/04 stayed at Dad's; unknown symptoms, 8/27/04 3"x4" red site, very warm, looks like "bulls eye" looks "hivey".
Age: 17.0
Sex: F
Vaccine: HEP, IPV, MMR, TD
Symptoms: Acne
Clinical narrative: 5 to 7 days after receiving vaccines, began breaking out, worse than normal and continued to get worse. (Face) Typically only 1 to 2 pimples. Breakout continued to worsen and at 1 mouth is grouped in individuals pimples with pustules that ooze at times. Appears to be grouped to left side of face near hairline above ear to face, head and between brows.
Age: 5.0
Sex: M
Vaccine: DTAP, HEPA, IPV
Symptoms: Injection site erythema, Injection site oedema, Injection site pain
Clinical narrative: Left deltoid swollen, red, painful.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Erythema, Oedema
Clinical narrative: LD with swelling and redness.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Erythema, Oedema
Clinical narrative: Within 24 hours of immunization, erythema noted. Within 48 hours swelling of upper arm past elbow with erythema from upper arm to elbow. Full ROM at elbow (Reaction to right arm).
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site oedema, Injection site pain, Pruritus, Pyrexia
Clinical narrative: Swelling and erythema on left arm was noted 15 hours after vaccination (DTaP and IPV). Pt complained of slight pain and itchiness on injection area. Mother claimed she had a low grade fever but temperature was not taken. Motrin was given every 8 hrs. Swelling subsided after 4 days.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site oedema, Pruritus
Clinical narrative: Swelling and erythema on left arm was noted after 7 hrs after vaccination (Dtap and IPV). Two days after pt complained of itchiness on injection site and was seen at the office. Tylenol and Motrin every 4 hours alternately were given. Swelling subsided after 3 days.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site oedema, Pruritus, Pyrexia
Clinical narrative: Swelling and erythema on right arm was noted 18 hrs after vaccination (DTaP and IPV). Pt complained of pain but more itchiness on area. Mother claimed she might have had low grade fever but temperature was not taken. Motrin and Tylenol alternatively every 4 hrs were given as well as warm compress. Swelling subsided after 4 days.
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Gaze palsy, Pyrexia, Tremor
Clinical narrative: 4 hrs after shots, temp high, 102-eyes rolling back, arms quivering, not consolable to breast feeding, called ER, advised to give .8ml Tylenol- had given .4ml after his shot. Cooled him down, fell asleep about 6 hrs later physician advised to use DT next time.
Age: 1.42
Sex: M
Vaccine: MMR, PNC
Symptoms: Agitation, Convulsion, Crying, Febrile convulsion, Gaze palsy
Clinical narrative: 3d after imm. on 1/11/04 about 11PM had seizure lasting 3 min, eyes rolled back, intense shaking, temp 104, limp and crying when seizure stopped. Advised by Pediatrician to go to ER. Was told it was a febrile seizure. Saw pediatrician in 1 week, ok.
Age: 1.42
Sex: M
Vaccine: MMR, PNC
Symptoms: Hypotonia, Pyrexia, Tremor
Clinical narrative: 3d after imm. on 1/11/04 about 11PM had seizure lasting 3 min, eyes rolled back, intense shaking, temp 104, limp and crying when seizure stopped. Advised by Pediatrician to go to ER. Was told it was a febrile seizure. Saw pediatrician in 1 week, ok.
Age: 15.0
Sex: M
Vaccine: HEP, IPV, MMR, TD
Symptoms: Erythema, Infection, Lymphadenopathy, Oedema, Tenderness
Clinical narrative: On 05/01/2004, Dr. reported: some erythema, swelling, mild tenderness. Could be localizing infection from the immunization, though a high probability of simple immunization reaction to the immunization. Augmentin and Clarinex prescribed 5/6/04. Left deltoid slightly swollen. ? Lymph node left side. 5/14/04 spoke with dad-completely resolved.
Age: 14.0
Sex: F
Vaccine: VARCEL
Symptoms: Pain
Clinical narrative: Received vaccine 5/20/04 and developed pain on 6/2/04. Described as mild by mother: (20 spots, sibling with chicken pox reported 5/19/04 as onset date. To defer second dose of Varivax.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Back pain, Erythema, Feeling hot, Rash
Clinical narrative: We were informed by PCP; after leaving the health dept pt told her aunt her back hurt and felt funny; aunt found red rash that was warm to touch on pt's back. Went to see PCP and was given Benadryl on 8/31/04 I called the home and was told the rash was gone and pt is fine.
Age: 13.0
Sex: M
Vaccine: HEP, IPV, MMR, TD, VARCEL
Symptoms: Eyelid oedema
Clinical narrative: Client developed swelling of eyes (lower lid Bid) and c/o eyes itching. No visible rash or wheals. No edema at injection site.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Wheezing
Clinical narrative: Wheezing noted at 30min afterward immunization in well known asthmatic pt. Px- Alisol, albuterol and PO Preloxe. Resolve excellent. Pulse ox 97
Age: 1.33
Sex: F
Vaccine: DTAP, HIBV, MMR, VARCEL
Symptoms: Pyrexia, Rash
Clinical narrative: 07/07/2004 Grandmom states temp 99-101; 7/10/04 rash appeared on neck and shoulders; 7/12/04 temp 99 and diarrhea; 7/13/04 rash on entire body (face,arms, legs and back per grandmom; grandmom took child to Dr. Dx. given was reaction to MMR he ordered Tylenol, fluids and Aveeno baths during exam here child noted raised rash over entire body (face, arms, legs, back, abdomen) with rough texture, no itching noted by grandmom-if no improvement by Friday child is to be re-evaluated by Dr.
Age: 11.0
Sex: F
Vaccine: TD, VARCEL
Symptoms: Viral infection
Clinical narrative: Mother called 7/9/04. Stated child had VZV 6/25/04 and now has chickenpox. Seen at Urgent Care. 7/8/04 They advised parent to call for report to be sent in.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Erythema, Feeling hot, Oedema, Tenderness
Clinical narrative: Slightly red, swollen, warm hot to touch, tenderness, Tylenol every 6 hours.
Age: 5.0
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Erythema, Feeling hot, Oedema, Pyrexia
Clinical narrative: Temp 102.1 for 24 hours, swelling of both thighs, hot to the touch, slight redness. 7/27/04-Client recovered- Mom states fever and swelling gone after 7/21/04.
Age: 5.0
Sex: F
Vaccine: DTAP
Symptoms: Feeling hot, Injection site erythema, Injection site oedema, Injection site reaction, Pruritus
Clinical narrative: Clients left deltoid has localized reaction, measured at 108mmx95mm. Arm was edematous, red, hot to touch, and client complained of itching. Per father vaccine given at 4PM notice reaction around 9PM 7/29/04. Pt given Tylenol per father. Nurse advise to use cold compress ever 20 min x 24 hours. Also advise to give Tylenol or Motrin to help with the swelling. Father advised if symptoms worsen to call private Dr or to go to ER.
Age: 2.0
Sex: M
Vaccine: DTAP
Symptoms: Crying, Pyrexia, Vomiting
Clinical narrative: Mother stated fever of 104 degrees F, crying, whining and throwing up began about 12 hours after receiving DTaP and lasted about 6 hours.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Pruritus
Clinical narrative: Complaints of itching prior to leaving clinic; band aid removed. Arm swelling 3.5 by 3 around/above injection site, pink, warm to touch.
Age: 18.0
Sex: F
Vaccine: MEN, TD
Symptoms: Pharyngeal oedema, Urticaria
Clinical narrative: Patient's mother called to say her daughter's throat swelled and she broke out in hives 3 hours after administration of meningitis vaccine and Td vaccine.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Blister, Injection site erythema, Injection site swelling, Injection site warmth, Tenderness
Clinical narrative: Left deltoid 3"x2" area with redness and slight edema, warm to touch with numerous fluid filled small blister like areas; 3 larger fluid filled blister like areas noted. Tender to touch; denies fever or other symptoms. Referred to PCP for evaluation. 6/30/04 Mother contacted clinic to report reaction.
Age: 1.0
Sex: F
Vaccine: HBHEPB, MMR, VARCEL
Symptoms: Erythema, Rash papular
Clinical narrative: Cheeks and chin turned red followed papular rash on upper arm and upper chest.
Age: 5.0
Sex: M
Vaccine: DTAP, HEPA, IPV, MMR
Symptoms: Swelling
Clinical narrative: Patient was given 5 year WCC and immunization was fine until about 10:00 that night and then leg started to swell.
Age: 1.0
Sex: F
Vaccine: DTAP, HIBV, MMR
Symptoms: Convulsion
Clinical narrative: Seizure; generalized tonic clonic.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Received injections for school Monday 8/2/02. Mother states initial slight edema, redness over DTaP site on left arm (deltoid). By Tuesday, afternoon/evening, mother states left arm medial to DTaP injection site very warm/hot to touch and red, tender to touch. Telephone call to local physician Wednesday morning and instructed to use warm wet packs over site. Mother also called health department after speaking with physician. Telephone call to mother same afternoon for follow up. Swelling (fist size) and remains hot, red. Encouraged to notify doctor. Started on Cephalexin. Telephone call 8/5/04 with less swelling and redness.
Age: 1.04
Sex: M
Vaccine: HBHEPB, MMR
Symptoms: Convulsion, Pyrexia
Clinical narrative: Patient developed low grade fevers approximately 5 days after immunization given. On day 7 and day 10, patient had two short self limited generalized tonic clonic seizures. Evaluation by CT and EEG was NL. Temperature with seizures 100.9 and 100.6.
Age: 4.0
Sex: M
Vaccine: DTAPHEPBIP, HIBV, MMR
Symptoms: Injection site rash, Urticaria
Clinical narrative: Hives type rash around the injection site.
Age: 2.0
Sex: M
Vaccine: DTAP, HEPA, MMR, VARCEL
Symptoms: Erythema, Swelling, Vomiting
Clinical narrative: Swelling and redness left thigh. Throwing up this morning.
Age: 17.0
Sex: F
Vaccine: HEPA, MEN
Symptoms: Dizziness, Dysarthria, Gait disturbance, Headache, Neck pain
Clinical narrative: On evening of vaccination at approximately 9:00 PM, patient had slurred speech. By late Thursday 8/12/04, patient acted drunk, was staggering and had slurred speech. On Friday, 8/13/04, patient complained of headaches, dizziness, and had mild fever, vomiting and neck pain on palpation. Was taken to ER; blood and urine tests normal. Was treated with Toredal and Naprosyn. Reaction attributed by ER MD to vaccines. Symptoms gone by Saturday 8/14/04 but returned in mild form 8/15/04. 8/17/04 no further symptoms.
Age: 17.0
Sex: F
Vaccine: HEPA, MEN
Symptoms: Pyrexia, Vomiting
Clinical narrative: On evening of vaccination at approximately 9:00 PM, patient had slurred speech. By late Thursday 8/12/04, patient acted drunk, was staggering and had slurred speech. On Friday, 8/13/04, patient complained of headaches, dizziness, and had mild fever, vomiting and neck pain on palpation. Was taken to ER; blood and urine tests normal. Was treated with Toredal and Naprosyn. Reaction attributed by ER MD to vaccines. Symptoms gone by Saturday 8/14/04 but returned in mild form 8/15/04. 8/17/04 no further symptoms.