chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR, DTAP, IPV, MMR
Symptoms: Injection site inflammation, Injection site pain, Injection site reaction, Injection site swelling, Irritability
Clinical narrative: From initial information received on 22JUL2003 from another company, regarding an adverse event occurring in the USA, it was reported that a five year old female pt received IPOL, administered SC in the left deltoid, Infanrix, administered IM in the left deltoid and MMR II Vaccine, administered SC in the right deltoid on 17APR2003. 24 hours later, the pat experienced injection site reaction characterized by pain, swelling and inflammation. The patient's left arm was stiff. The patient also experienced irritability and low grade fever. The events resolved on 20APR2003. This case was reported to the other manufacturer by a nurse, who considered the events to be related to vaccination with Infanrix. The reporter of this case is the same reporter of cases 2003-01441 through 2003-01445.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR, DTAP, IPV, MMR
Symptoms: Musculoskeletal stiffness, Pyrexia
Clinical narrative: From initial information received on 22JUL2003 from another company, regarding an adverse event occurring in the USA, it was reported that a five year old female pt received IPOL, administered SC in the left deltoid, Infanrix, administered IM in the left deltoid and MMR II Vaccine, administered SC in the right deltoid on 17APR2003. 24 hours later, the pat experienced injection site reaction characterized by pain, swelling and inflammation. The patient's left arm was stiff. The patient also experienced irritability and low grade fever. The events resolved on 20APR2003. This case was reported to the other manufacturer by a nurse, who considered the events to be related to vaccination with Infanrix. The reporter of this case is the same reporter of cases 2003-01441 through 2003-01445.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR, DTAP, IPV, MMR
Symptoms: Injection site inflammation, Injection site pain, Injection site swelling, Irritability, Musculoskeletal stiffness
Clinical narrative: From initial information received on 22JUL2003 from another company, regarding an adverse event occurring in the USA, it was reported that a five year old female pt received IPOL, administered SC in the left deltoid, Infanrix, administered IM in the left deltoid and MMR II Vaccine, administered SC in the right deltoid on 17APR2003. 24 hours later, the pat experienced injection site reaction characterized by pain, swelling and inflammation. The patient's left arm was stiff. The patient also experienced irritability and low grade fever. The events resolved on 20APR2003. This case was reported to the other manufacturer by a nurse, who considered the events to be related to vaccination with Infanrix. The reporter of this case is the same reporter of cases 2003-01441 through 2003-01445.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR, DTAP, IPV, MMR
Symptoms: Pyrexia
Clinical narrative: From initial information received on 22JUL2003 from another company, regarding an adverse event occurring in the USA, it was reported that a five year old female pt received IPOL, administered SC in the left deltoid, Infanrix, administered IM in the left deltoid and MMR II Vaccine, administered SC in the right deltoid on 17APR2003. 24 hours later, the pat experienced injection site reaction characterized by pain, swelling and inflammation. The patient's left arm was stiff. The patient also experienced irritability and low grade fever. The events resolved on 20APR2003. This case was reported to the other manufacturer by a nurse, who considered the events to be related to vaccination with Infanrix. The reporter of this case is the same reporter of cases 2003-01441 through 2003-01445.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, DTAP, IPV, MMR
Symptoms: Eyelid oedema, Hypersensitivity, Immediate post-injection reaction, Nasal oedema, Rhinorrhoea
Clinical narrative: From initial information received on 04/02/04 from another manufacturer (report reference # A0502210A) regarding an adverse event occurring in the USA, it was reported by the pt's parent that a 4 year old male received a dose of IPOL; a fifth dose of an INFANRIX, administered in the arm; and a dose of MMRII, on 12/03/03.  The lot #'s were not reported for any of the products. At an unspecified time following the administration of INFANRIX, on 12/03/03, the pt experienced swelling of the face and closing of his throat. The exact onset of the events was not reported. The pt was seen at a physician's office. It was reported that the pt recovered from these events on an unspecified date. This case is not medically confirmed. From additional information received on 06/15/04 from another manufacturer (reference # WAES0403USA00863), it was initially reported by both a consumer and a RN that the pt had a history of difficulty breathing, which was present prior to vaccination on 12/03/03.  The condition had not been diagnosed, but was noted to possibly be allergic asthma. He received a second dose of MMRII, Lot # 645626/0396N, administered SC in the right arm; a fourth dose of IPOL, Lot # W1619, administered IM in the left arm and the fifth dose of INFANRIX, Lot # DTPA616A2, administered IM in the left arm on 12/03/03 at 10:30am.  Immediately after receiving the vaccines, the pt developed a runny nose, nasal membrane edema and upper eyelid edema. He was treated with one and a half teaspoons of prednisolone (Prelone). On the way home from the office on 12/03/03, the pt had a severe allergic reaction. He had facial swelling and broke out into hives. The mother reported that she took her son back to the physician, where he received prednisone injection. The pt reportedly recovered from this event.  The adverse event coding was upgraded to severe allergic reaction. Based upon medical judgement, this case has been upgraded to serious/medically significant.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, DTAP, IPV, MMR
Symptoms: Swelling face, Urticaria
Clinical narrative: From initial information received on 04/02/04 from another manufacturer (report reference # A0502210A) regarding an adverse event occurring in the USA, it was reported by the pt's parent that a 4 year old male received a dose of IPOL; a fifth dose of an INFANRIX, administered in the arm; and a dose of MMRII, on 12/03/03.  The lot #'s were not reported for any of the products. At an unspecified time following the administration of INFANRIX, on 12/03/03, the pt experienced swelling of the face and closing of his throat. The exact onset of the events was not reported. The pt was seen at a physician's office. It was reported that the pt recovered from these events on an unspecified date. This case is not medically confirmed. From additional information received on 06/15/04 from another manufacturer (reference # WAES0403USA00863), it was initially reported by both a consumer and a RN that the pt had a history of difficulty breathing, which was present prior to vaccination on 12/03/03.  The condition had not been diagnosed, but was noted to possibly be allergic asthma. He received a second dose of MMRII, Lot # 645626/0396N, administered SC in the right arm; a fourth dose of IPOL, Lot # W1619, administered IM in the left arm and the fifth dose of INFANRIX, Lot # DTPA616A2, administered IM in the left arm on 12/03/03 at 10:30am.  Immediately after receiving the vaccines, the pt developed a runny nose, nasal membrane edema and upper eyelid edema. He was treated with one and a half teaspoons of prednisolone (Prelone). On the way home from the office on 12/03/03, the pt had a severe allergic reaction. He had facial swelling and broke out into hives. The mother reported that she took her son back to the physician, where he received prednisone injection. The pt reportedly recovered from this event.  The adverse event coding was upgraded to severe allergic reaction. Based upon medical judgement, this case has been upgraded to serious/medically significant.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, DTAP, IPV, MMR
Symptoms: Eyelid oedema, Face oedema, Rhinorrhoea, Tracheal oedema, Urticaria
Clinical narrative: From initial information received on 04/02/04 from another manufacturer (report reference # A0502210A) regarding an adverse event occurring in the USA, it was reported by the pt's parent that a 4 year old male received a dose of IPOL; a fifth dose of an INFANRIX, administered in the arm; and a dose of MMRII, on 12/03/03.  The lot #'s were not reported for any of the products. At an unspecified time following the administration of INFANRIX, on 12/03/03, the pt experienced swelling of the face and closing of his throat. The exact onset of the events was not reported. The pt was seen at a physician's office. It was reported that the pt recovered from these events on an unspecified date. This case is not medically confirmed. From additional information received on 06/15/04 from another manufacturer (reference # WAES0403USA00863), it was initially reported by both a consumer and a RN that the pt had a history of difficulty breathing, which was present prior to vaccination on 12/03/03.  The condition had not been diagnosed, but was noted to possibly be allergic asthma. He received a second dose of MMRII, Lot # 645626/0396N, administered SC in the right arm; a fourth dose of IPOL, Lot # W1619, administered IM in the left arm and the fifth dose of INFANRIX, Lot # DTPA616A2, administered IM in the left arm on 12/03/03 at 10:30am.  Immediately after receiving the vaccines, the pt developed a runny nose, nasal membrane edema and upper eyelid edema. He was treated with one and a half teaspoons of prednisolone (Prelone). On the way home from the office on 12/03/03, the pt had a severe allergic reaction. He had facial swelling and broke out into hives. The mother reported that she took her son back to the physician, where he received prednisone injection. The pt reportedly recovered from this event.  The adverse event coding was upgraded to severe allergic reaction. Based upon medical judgement, this case has been upgraded to serious/medically significant.
Age: 34.0
Sex: M
Vaccine: HEPAB, YF, HEPAB, YF
Symptoms: Arthralgia, Joint swelling
Clinical narrative: From initial information received on 16Sep04 from another manufacturer regarding an adverse event occurring, it was initially reported by a RN that a 33 year old male pt received a dose of YFVAX, lot number and site of administration unknown, as well as a second dose of Twinrix, lot number HAB015A8, administered in the right arm on 20Aug04. The routes of administration were not reported for either product. Fourteen days later, on 03Sep04, the pt developed swollen joints and joint pain in his hands and feet. The pt was hospitalized. The events were ongoing at the time of this report and the pt had not recovered. The nurse considered the events to possibly be related to vaccination with Twinrix.
Age: 34.0
Sex: M
Vaccine: HEPAB, YF, HEPAB, YF
Symptoms: Arthralgia, Oedema
Clinical narrative: From initial information received on 16Sep04 from another manufacturer regarding an adverse event occurring, it was initially reported by a RN that a 33 year old male pt received a dose of YFVAX, lot number and site of administration unknown, as well as a second dose of Twinrix, lot number HAB015A8, administered in the right arm on 20Aug04. The routes of administration were not reported for either product. Fourteen days later, on 03Sep04, the pt developed swollen joints and joint pain in his hands and feet. The pt was hospitalized. The events were ongoing at the time of this report and the pt had not recovered. The nurse considered the events to possibly be related to vaccination with Twinrix.
Age: 4.0
Sex: F
Vaccine: MMR
Symptoms: Laboratory test abnormal, Leukaemia, White blood cell disorder
Clinical narrative: Information has been received from an RN in a physician's office concerning a 4 year old female who on 9SEP2004 was vaccinated with MMR vaccine live. That same day the patient had blood work completed which revealed an elevated white blood cell count. The pt was diagnosed with leukemia and admitted to the hospital that same day. On 10 SEP2004 the patient began chemotherapy. Additional info has been requested. Follow up 03/03/05: Patient's recovery status is unknown.
Age: 31.0
Sex: M
Vaccine: SMALL
Symptoms: Blister, Erythema, Herpes zoster, Similar reaction on previous exposure to drug, Viral infection
Clinical narrative: Pt developed several vesicles and erythematous patches on left high about 1 week after vaccination. Distribution was L2 Dermatome, not crossing midline. General vaccinia vs herpes zoster. Diagnosis could not be confirmed with available resources. Treatment with acyclovir.
Age: 21.0
Sex: M
Vaccine: HEP
Symptoms: Unevaluable event
Clinical narrative: Antiphospholipid antibody syndrome after Hep B. (also states received several AVA but no documentation).
Age: 0.17
Sex: M
Vaccine: DTAP, HIBV, PPV, DTP, HIBV, PNC
Symptoms: Abnormal sleep-related event, Agitation, Coma, Crying, Hypotonia
Clinical narrative: Immunizations were given approx 11:30AM; mom now reports that about 2:30PM baby was sleeping on the floor (a folded blanket under him)- on his back and propped up a little on a pillow; as she passed by she noticed that he seemed unusually still; she is not sure about his color may have been pale but def not blue or ashy; also not sure about his respiration she did not wait or take specific note of whether he was breathing or not; she immediately picked him up and shook him gently and spoke his name several times; but he was totally unresponsive, his body habitus was a little on the limp side, def no rigidity; she then began to shake him a little more vigorously and slap his face lightly; after an unknown number of seconds he aroused and began to cry; after the baby quickly returned to his normal state of alertness tone and activity, and has been acting and looking quite normal since; has not felt febrile at anytime.
Age: 0.17
Sex: M
Vaccine: DTAP, HIBV, PPV, DTP, HIBV, PNC
Symptoms: Pallor
Clinical narrative: Immunizations were given approx 11:30AM; mom now reports that about 2:30PM baby was sleeping on the floor (a folded blanket under him)- on his back and propped up a little on a pillow; as she passed by she noticed that he seemed unusually still; she is not sure about his color may have been pale but def not blue or ashy; also not sure about his respiration she did not wait or take specific note of whether he was breathing or not; she immediately picked him up and shook him gently and spoke his name several times; but he was totally unresponsive, his body habitus was a little on the limp side, def no rigidity; she then began to shake him a little more vigorously and slap his face lightly; after an unknown number of seconds he aroused and began to cry; after the baby quickly returned to his normal state of alertness tone and activity, and has been acting and looking quite normal since; has not felt febrile at anytime.
Age: 0.17
Sex: M
Vaccine: DTAP, HIBV, PPV, DTP, HIBV, PNC
Symptoms: Coma, Hypotonia, Pallor, Respiratory arrest
Clinical narrative: Immunizations were given approx 11:30AM; mom now reports that about 2:30PM baby was sleeping on the floor (a folded blanket under him)- on his back and propped up a little on a pillow; as she passed by she noticed that he seemed unusually still; she is not sure about his color may have been pale but def not blue or ashy; also not sure about his respiration she did not wait or take specific note of whether he was breathing or not; she immediately picked him up and shook him gently and spoke his name several times; but he was totally unresponsive, his body habitus was a little on the limp side, def no rigidity; she then began to shake him a little more vigorously and slap his face lightly; after an unknown number of seconds he aroused and began to cry; after the baby quickly returned to his normal state of alertness tone and activity, and has been acting and looking quite normal since; has not felt febrile at anytime.
Age: 16.0
Sex: M
Vaccine: HEP, TD, VARCEL
Symptoms: Convulsion, Gaze palsy, Loss of consciousness
Clinical narrative: Pt had been given the HBV and Td and I just finished giving him the Varicella, his eyes rolled back and body went tonic. I eased him down to the floor protecting his head. He relaxed and became conscious about the time he was lay fully on the floor. Total of 10 sec unconscious tonic, he and family denied any seizure history or history of reaction to shots. They stated he had not eaten and was anxious about starting a new school.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Erythema, Pain, Tenderness
Clinical narrative: Left deltoid red and painful, tender Tx: Duricef 250mg twice/day x 7 days.
Age: 1.27
Sex: F
Vaccine: DTAP, HBHEPB
Symptoms: Erythema, Feeling hot, Injection site mass, Pyrexia
Clinical narrative: Day of vaccine left thigh with quarter size red area. On 9/16/04 area increased to 3-4 inch oval shape, red, warm and hard. Temp 9/15/04 was 102-102.6. Today 9/16/04 101 later afternoon, N in Am
Age: 4.0
Sex: F
Vaccine: DTAP, IPV
Symptoms: Cellulitis, Injection site erythema, Injection site mass
Clinical narrative: From initial information received on 08/20/03 from a health care professional regarding an adverse event occurring in the USA, it was reported that a 4 year old female pt received a fifth dose of DAPTACEL, Lot # C1387AA, administered in the left upper thigh (route not reported), and a fourth dose of IPOL, Lot # W1233, administered in the left lower thigh (route not reported) on 08/18/03.  Reportedly, the pt's mother called the physician's office on 08/19/03 stating that the pt had developed a mosquito bite sized knot with redness at the injection site. The pt's mother was instructed to apply cool compresses, administer Children's Tylenol and to call the physician if the symptoms worsened.  On 08/20/03 the pt's mother called to inform the physician that the reaction had worsened, increasing in size and redness to 11.5cm in diameter. The pt was seen by a physician and treated with Augmentin for cellulitis. The pt's recovery status was reported as unknown.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Pruritus, Urticaria, Wheezing
Clinical narrative: From initial information received on 09/09/03 from a healthcare professional regarding an adverse event occurring in the USA, it was reported that a 5 year old male pt received his fifth dose of TRIPEDIA, Lot # U1006AA, administered IM in the right thigh, a fourth dose of IPOL, Lot # W0704-2, administered SC in the right upper thigh, and a second dose of MMRII, Lot # U133N, administered SC in the left thigh on 09/03/03 at 16:00.  One hour later, at 17:00, the pt complained of onset of wheezing, generalized hives and itching. The pt was treated at and released from a local ER.  Reportedly, the pt recovered from this event.
Age: 5.0
Sex: M
Vaccine: IPV
Symptoms: Cellulitis, Injection site erythema, Injection site oedema
Clinical narrative: From initial information received on 10/02/03 from a physician regarding an adverse event occurring in the USA, it was reported that a 5 year old male pt received his fifth dose of IPOL (Lot # W1002 and expiration date 09/05/06) administered in the left deltoid on 09/30/03.  The route of administration was not reported. On 10/01/03, the pt developed an 8.5x7.5 area of redness with swelling. It was not reported whether the child was seen by a physician, however, the was prescribed Keflex for cellulitis. The pt's recovery status is unknown.
Age: 1.6
Sex: M
Vaccine: DTAP, IPV
Symptoms: Cellulitis, Injection site erythema, Injection site oedema
Clinical narrative: From initial information received on 01/06/04 from another manufacturer (report # A0438871A) regarding an adverse event occurring in the USA, it was initially reported by a RN that an 18 month old male pt received his fourth dose of INFANRIX, Lot # DTPA599A9 in his left thigh and a dose of IPOL, Lot # not reported, on 11/04/03. Two days post vaccination, on 11/06/03, the pt experienced cellulitis and an injection site reaction characterized by redness and swelling. The pt was seen in a physician's office and treated with an unspecified antibiotic. As of 11/06/03, the events were unresolved. The nurse considered the events to be probably related to vaccination with INFANRIX.  From additional information received on 04/12/04, it was reported, "Reviewed, no additional information at this time".  No further information is anticipated, this case is considered closed."
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site oedema, Injection site pain, Pyrexia
Clinical narrative: From initial information received on 02/12/04 from a physician regarding an adverse event occurring in the USA, it was reported that a 4 year old male pt received a DAPTACEL vaccination, Lot # C1680AA, administered in the right thigh on 02/11/04.  Later that same day the pt developed local redness and warmth at the site of injection on the right thigh measuring 13x12.5cm.  The pt's recovery status was not provided. From additional information received on 04/17/04 from the initial reporter, it was reported that the pt also received a dose of IPOL, Lot # X0316, administered in the left thigh, a TUBERSOL 5 TU skin test, Lot # C1422AA, administered in the right forearm and a dose of MMR vaccine, Lot # 0819N, administered in the left thigh on 02/11/04.  He did not have a fever and his temperature was reported as 97.4 degrees F.  Upon examination, the pt's thigh measurements were noted to be 18cm for the right thigh and 12.5cm for the left thigh. The right thigh was painful to palpation. Treatment included warm compresses and Motrin. The pt's recovery status was reported as unknown.
Age: 0.34
Sex: M
Vaccine: DTAP, HEP, IPV, PNC
Symptoms: Injection site mass
Clinical narrative: From initial information received on 05/28/04 from a RN regarding an adverse event occurring in the USA, it was reported that a 4 month old male pt received his second dose of IPOL, Lot # X0553-2, administered IM in the right thigh, his second dose of TRIPEDIA, Lot # U1007BA, administered IM in the left thigh, a second dose of RECOMBIVAX-HB/HEPATITIS B VACCINE, Lot # 0692M, administered IM in the left thigh and his second dose of PREVNAR, Lot # 491575, administered IM in the right thigh on 03/18/04.  An unspecified amount of time later that day, the pt developed a lump, callus and dimple like appearance at the site of injection. His pre-existing medical conditions include allergy to Omnicef and gastrointestinal irritation with bleeding. The child had a previous reaction of a lump at the site of injection when he was vaccinated on 01/16/04.  Specific vaccines administered were not provided. The pt's recovery status is currently unknown.
Age: 2.0
Sex: F
Vaccine: DTAP, IPV
Symptoms: Cellulitis, Injection site erythema, Injection site oedema, Injection site warmth
Clinical narrative: From initial information received on 06/09/04 from a RN regarding an adverse event occurring in the USA, it was reported that a 2 year old female pt received a dose of DAPTACEL, Lot # C1614AA, administered IM in the right thigh and a dose of IPOL, Lot # X0772, administered SC in the left thigh on 06/01/04.  Approximately 24 hours later, on 06/02/04 at 11:20pm, the pt developed cellulitis in her right leg. The area was red, warm and swollen and measured 3.5x6 inches in diameter. She was treated with oral Clindamycin for 2 days. Reportedly, the pt recovered from these events.
Age: 33.0
Sex: M
Vaccine: HEPAB, IPV, MEN
Symptoms: Influenza like illness, Oedema, Pyrexia, Rash
Clinical narrative: From initial information received on 06/16/04 from a health care professional regarding an adverse event occurring in the USA, it was reported that a 33 year old male pt with a history of asthma and eczema received an IPOL vaccination, Lot # X0772, administered SC in the upper right arm, a MENOMUNE A/C/Y/W-135 vaccination, Lot # UE111AA, administered SC in the lower left deltoid and a TWINRIX vaccination, Lot # AKE239A4, administered IM in the left deltoid on 01/09/04.  At the time of vaccination the pt was also taking albuterol, singulair and flovent.  Four days post-immunization, 06/13/04, the pt developed a fever, flu-like symptoms and a rash on his upper torso.  Three days later, 06/16/04, the pt developed swollen gums. He was evaluated that same day by a physician and Benadryl 25mg per oral every 4 hours was prescribed as treatment.  The pt is to be re-evaluated by the physician on 06/17/04.  It was not reported whether the pt recovered from these events. Previously the pt had received his first dose of YF-Vax vaccine, Lot # UE128AA, administered SC in the right upper arm, his first dose of Typhim VI vaccine, Lot # X0521, administered in the right deltoid and a booster dose of TD ADULT, Lot # U1024AA, admnistered IM in the left deltoid on 06/04/04.  There was not report of an adverse event occurring after the receipt of these vaccinations.
Age: 1.64
Sex: M
Vaccine: DTAP, IPV
Symptoms: Injection site erythema
Clinical narrative: From initial information received on 06/21/04 from a vaccine provider regarding an adverse event occurring in the USA, it was reported that a 19 month old male pt received a DAPTACEL vaccination, Lot # C1698AA administered IM in the right deltoid and an IPOL vaccination, Lot # X0828 administered SC in the left arm on 06/15/04.  Two days later, on 06/17/04, the pt developed localized redness of his right arm from shoulder to elbow. Cool compresses were prescribed. The pt has recovered from this event.
Age: 41.0
Sex: M
Vaccine: HEP, HEPA, TYP, YF
Symptoms: Cold sweat, Dizziness, Dyspnoea, Feeling cold, Hyperhidrosis
Clinical narrative: Pt c/o cold, clammy, profuse sweating- feels funny, felt it as soon as medicine went in, Pt s shortness of breath. BP 182/112 pulse 84 resp 28. On rev BP 176/120 pulse 88 resp 24, dizzy, lightheaded, but sweat decreased.
Age: 41.0
Sex: M
Vaccine: HEP, HEPA, TYP, YF
Symptoms: Hypertension
Clinical narrative: Pt c/o cold, clammy, profuse sweating- feels funny, felt it as soon as medicine went in, Pt s shortness of breath. BP 182/112 pulse 84 resp 28. On rev BP 176/120 pulse 88 resp 24, dizzy, lightheaded, but sweat decreased.
Age: 44.0
Sex: F
Vaccine: HEPA, TYP
Symptoms: Chest discomfort, Chills, Pyrexia, Urticaria
Clinical narrative: Hives began on 07-10-04 with chills and fever.  Took Benadryl po and began Vistarel po 7-11-04. Hives increased and continued fever and chills with tightness across chest.  Went to ER tx's with Vistarel steroids and tagament. Requested Drs report from client 9-15-04 no physicians report received. patient continues to recover.
Age: 30.0
Sex: F
Vaccine: ANTH
Symptoms: Cold sweat, Dizziness, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: 8/22/98- anthrax #1- < 5mins after the shot- felt clammy, lightheaded, dizzy- lasted 24 hours- denies urticaria, angioedema, pruritus- nl local rxn. 9/5/98- anthrax #2- moderate redness and edema around injection site- lasted 3-4ds- no systemic sxs. 9/19/98- anthrax #3- increased redness and edema around the site- involved most of her upper arm- worse than #2- tenderness around the site- EXTREME pruritus- given atarax- lasted 3-4 ds- no f/c, malaise, rashes, or sxs of anaphylaxis. 2/16/99- anthrax #4- mentioned about rxn to a practitioner- was given motrin/steroid cream/atarax days prior to vaccine- despite pretreatment, experienced same rxn as #3- except less pruritus d/t atarax- no systemic sxs 8/16/99- anthrax #5- pretreated- same rxn as #4- no systemic sxs 2/14/00- anthrax #6- pretreated- same rxn as #4- no systemic sxs
Age: 30.0
Sex: F
Vaccine: ANTH
Symptoms: Pruritus, Similar reaction on previous exposure to drug
Clinical narrative: 8/22/98- anthrax #1- < 5mins after the shot- felt clammy, lightheaded, dizzy- lasted 24 hours- denies urticaria, angioedema, pruritus- nl local rxn. 9/5/98- anthrax #2- moderate redness and edema around injection site- lasted 3-4ds- no systemic sxs. 9/19/98- anthrax #3- increased redness and edema around the site- involved most of her upper arm- worse than #2- tenderness around the site- EXTREME pruritus- given atarax- lasted 3-4 ds- no f/c, malaise, rashes, or sxs of anaphylaxis. 2/16/99- anthrax #4- mentioned about rxn to a practitioner- was given motrin/steroid cream/atarax days prior to vaccine- despite pretreatment, experienced same rxn as #3- except less pruritus d/t atarax- no systemic sxs 8/16/99- anthrax #5- pretreated- same rxn as #4- no systemic sxs 2/14/00- anthrax #6- pretreated- same rxn as #4- no systemic sxs
Age: 4.0
Sex: F
Vaccine: DTAPH, HEPA, MMR
Symptoms: Infection, Oedema peripheral
Clinical narrative: SWELLING FROM SHOULDER TO ELBOW, INFECTION HAD TO GO TO EMERGENCY ROOM WAS TREATED WITH A ANTIBIOTIC SHOT AS WELL AS WITH A STERIOD AND PRESCRIPTION.
Age: 4.0
Sex: F
Vaccine: DTAPHEPBIP, MMR
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Received report from PCP that client has redness, swelling, and heat to injection site.  Mother of client reported reaction started the day of injection and got progressively worst. First sought medical treatment on 09/22/2004.  Mother returned to MD's office today for worsening symptoms.  Child treated with Keflex 250mg/5cc po TIDx5days on first visit of 09/22/2004.
Age: 1.27
Sex: F
Vaccine: DTAP, PNC
Symptoms: Febrile convulsion
Clinical narrative: Patient experienced febrile seizure following DTaP and Prevnar.  Patient evaluated in ER and sent home.  Seizures less than 24 hours after vaccinations.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site rash
Clinical narrative: Rash on thighs of where MMR vaccine and DTaP vaccines were administered.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Feeling hot, Injection site erythema, Injection site induration, Injection site swelling, Oedema peripheral
Clinical narrative: 1 day after immunizations were given, parents noticed patient's left upper arm was red, swollen, and itchy.  On exam 2 days after immunization, she has erythema, induration, and swelling extending from her left shoulder to about 4 cm from her elbow.  The arm is warm to touch but not tender.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Pruritus
Clinical narrative: 1 day after immunizations were given, parents noticed patient's left upper arm was red, swollen, and itchy.  On exam 2 days after immunization, she has erythema, induration, and swelling extending from her left shoulder to about 4 cm from her elbow.  The arm is warm to touch but not tender.
Age: 0.2
Sex: M
Vaccine: DTAP, HBHEPB
Symptoms: Agitation, Crying, Irritability, Pyrexia
Clinical narrative: This case was reported by a physician and described the occurrence of fever in a 2 month old male patient who diphtheria and tetanus toxoids and acellular pertussis vaccine absorbed. This report was received from a physician who was also the patient's father. The patient's medical history reportedly included gastroesophageal reflux disease. On 1/17/03 the patient received the first dose of Infanrix in the left thigh (lot DTPA576A2). The physician reported that on 1/17/03 or 1/18/03, the patient experienced fever, irritability, crying, and was difficult to console. The patient was treated with ranitidine hydrochloride and ibuprofen. On 1/18/03 the patient died within hours of vaccination administration, according to the reporter. The physician stated he was unsure of the cause of death on the death certificate. An autopsy was performed: results were not provided to manufacturer.
Age: 0.2
Sex: M
Vaccine: DTAP, HBHEPB
Symptoms: Asphyxia, Cyanosis, Pyrexia
Clinical narrative: This case was reported by a physician and described the occurrence of fever in a 2 month old male patient who diphtheria and tetanus toxoids and acellular pertussis vaccine absorbed. This report was received from a physician who was also the patient's father. The patient's medical history reportedly included gastroesophageal reflux disease. On 1/17/03 the patient received the first dose of Infanrix in the left thigh (lot DTPA576A2). The physician reported that on 1/17/03 or 1/18/03, the patient experienced fever, irritability, crying, and was difficult to console. The patient was treated with ranitidine hydrochloride and ibuprofen. On 1/18/03 the patient died within hours of vaccination administration, according to the reporter. The physician stated he was unsure of the cause of death on the death certificate. An autopsy was performed: results were not provided to manufacturer.
Age: 21.0
Sex: M
Vaccine: ANTH
Symptoms: Erythema, Pruritus, Rash
Clinical narrative: Pt felt itchy 10 to 20 min after shot and noticed rash and redness 2 to 3 hours later rash on upper arms, chest, back and neck. Benadryl 50mg IM, Prednisone 10mg po 60/60-40/40-20/20-10/10, Hydroxyzine 25mg 1 tab every 6 hours.
Age: 20.0
Sex: M
Vaccine: SMALL
Symptoms: Asthenia, Erythema, Headache, Pyrexia, Rash
Clinical narrative: Headache, fever, extremely weak, red rashy spots here and there.
Age: 23.0
Sex: M
Vaccine: SMALL
Symptoms: Injection site reaction, Pain, Pyrexia, Skin ulcer
Clinical narrative: On Friday the 10th of September I noticed two extra lesions around the site. That weekend, I was experiencing fevers and body aches. On Suday the 12th of September, I took my bandage off to take a shower. I noticed lesions all over the site.
Age: 29.0
Sex: M
Vaccine: SMALL
Symptoms: Erythema, Injection site induration, Injection site ulcer
Clinical narrative: 10.5 erythema and induration , with 11 mm ulceration centrally. Robitussin Taken.
Sex: F
Vaccine: ANTH
Symptoms: Tongue ulceration
Clinical narrative: Ulcers on tongue x 1 month
Age: 0.75
Sex: F
Vaccine: FLU3, HEP, PNC
Symptoms: Abnormal behaviour, Eye movement disorder, Hypotonia
Clinical narrative: Around 24 hours after vaccine, pt went limp, eyes rolled back. Positive breathing. Event lasted a few seconds. Afterwards , patient was clingy and "out of it" for a few hours.
Age: 2.0
Sex: M
Vaccine: MMR
Symptoms: Irritability, Pyrexia, Rash maculo-papular
Clinical narrative: Approximately 10 days after date of MMR given. Pt developed temperature 103 (per mom), generalized maculopapular rash and irritability. Seen by pediatrician and given Prednisone for 3 days. I did not see child.
Age: 6.0
Sex: M
Vaccine: DTAP
Symptoms: Erythema, Feeling hot
Clinical narrative: 5" x 4" erythema, heat right deltoid.
Age: 15.0
Sex: M
Vaccine: TD
Symptoms: Arthralgia
Clinical narrative: Arthralgia of right deltoid, shoulder and neck.
Age: 54.0
Sex: M
Vaccine: HEP, PPV
Symptoms: Chills, Feeling hot, Injection site pain, Nausea, Pain
Clinical narrative: Initial symptom , nausea 6 hours later pain, itching and chills began (late afternoon). Woke up in night 2300, 0230 and 0600 with heat, swelling, itching and pain below injection site and radiation down arm.
Age: 54.0
Sex: M
Vaccine: HEP, PPV
Symptoms: Pruritus, Swelling
Clinical narrative: Initial symptom , nausea 6 hours later pain, itching and chills began (late afternoon). Woke up in night 2300, 0230 and 0600 with heat, swelling, itching and pain below injection site and radiation down arm.
Age: 3.0
Sex: F
Vaccine: HEPA
Symptoms: Erythema, Feeling hot, Injection site reaction, Swelling
Clinical narrative: Local reaction at site. Large 10x10 cm circular, erythematous reaction on right thigh, warm to touch, swelling.
Age: 15.0
Sex: M
Vaccine: HEP, TD
Symptoms: Chest discomfort, Cough, Pruritus, Pyrexia, Urticaria
Clinical narrative: 9/11/04 am awaken with whelps arms, back, shoulder, chest; itching, chest felt tight, sore throat, coughing. Temp 100.6-100.8. 9/14/04: complained of chest tightness, whelps were fading. No itching.
Age: 60.0
Sex: F
Vaccine: HEPA
Symptoms: Headache
Clinical narrative: Intense headache began within 2 days from vaccine. States headache was better when lying down and much more severe upright. Lasted several weeks. Went to doctor. Had MRI scan with negative results.
Age: 2.0
Sex: M
Vaccine: HEPA
Symptoms: Vomiting
Clinical narrative: Mother called and complained of patient vomiting in the morning after vaccine administration for three hours non stop. Mom made appointment, but then canceled when patient got better later in the afternoon per mom. Patient has had vomiting episodes in the past.
Age: 52.0
Sex: F
Vaccine: TD
Symptoms: Erythema, Swelling, Tenderness
Clinical narrative: Soreness of right arm 24 hours past adminitration followed by swelling and redness 4 days after administration.
Age: 53.0
Sex: F
Vaccine: TD
Symptoms: Dizziness, Injection site erythema, Injection site swelling, Injection site warmth, Malaise
Clinical narrative: 24 hours after immunization: right arm was sore. 48 hours after immunization, felt ill, nauseated and dizzy. Ached all over. 4 days after vaccine redness, heat and swelling below shot site.
Age: 53.0
Sex: F
Vaccine: TD
Symptoms: Nausea, Pain, Tenderness
Clinical narrative: 24 hours after immunization: right arm was sore. 48 hours after immunization, felt ill, nauseated and dizzy. Ached all over. 4 days after vaccine redness, heat and swelling below shot site.
Age: 6.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Erythema, Pyrexia, Swelling
Clinical narrative: Redness, swelling, fever. Tylenol q 4 hours. Cool pack to leg q 4 hours. RTC PRN if necessary.
Age: 7.0
Sex: F
Vaccine: IPV, MMR, TD
Symptoms: Swelling
Clinical narrative: Daughter woke up this morning an her face was swollen. There are no other symptoms.
Age: 27.0
Sex: M
Vaccine: ANTH
Symptoms: Fatigue, Injection site erythema, Injection site swelling, Nausea
Clinical narrative: Swelling, erythema of extremity at the location where the injection occurred within 48hrs.  Pt also has systemic symptoms-fatigue, nausea.  Treated with Motrin and Benadryl.
Age: 1.02
Sex: F
Vaccine: FLU3, PNC
Symptoms: Coma, Convulsion, Gait disturbance, Hypotonia, Hypoxia
Clinical narrative: Pt. received vaccine at 11:30 AM 9/23. Developed fever few hours later. Had "staring" episodes at 10:30 PM, became unresponsive 11 P, EMS activated taken to hospital. Intubated, transferred to another hospital. Anti-epileptic medications administered. Medical Record received on 1/3/2005 states abnormal gait, sleepy, limp, and vomit.
Age: 1.02
Sex: F
Vaccine: FLU3, PNC
Symptoms: Laboratory test abnormal, Pyrexia, Somnolence, Staring, Vomiting
Clinical narrative: Pt. received vaccine at 11:30 AM 9/23. Developed fever few hours later. Had "staring" episodes at 10:30 PM, became unresponsive 11 P, EMS activated taken to hospital. Intubated, transferred to another hospital. Anti-epileptic medications administered. Medical Record received on 1/3/2005 states abnormal gait, sleepy, limp, and vomit.
Age: 24.0
Sex: M
Vaccine: ANTH
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Anthrax vaccine was administered on 23Sep2004. No reaction was noted 30 minutes after immunization. On the morning of 24Sep, the patient noticed a red, hot, painful plaque around the site.
Age: 0.11
Sex: M
Vaccine: DTAP, HEP, HIBV, IPV
Symptoms: Apnoea, Cardiac arrest, Cyanosis, Epistaxis, Lung disorder
Clinical narrative: Death within 24-48 hours of vaccinations. Mother found infant not breathing and with bleeding from his nose. He was in his crib. Mother called 911. EMT's transported infant to ER. Infant probably died prior to EMT's arrival per reporter. Autopsy report received on 11/29/2004 cause of death is SIDS. Pt also experienced bilateral pulmonary congestion and edema perimortem.  Nurse follow up on 10/13/04 states: "Blue in color, cardiac arrest."
Age: 0.11
Sex: M
Vaccine: DTAP, HEP, HIBV, IPV
Symptoms: Pulmonary oedema, Sudden infant death syndrome
Clinical narrative: Death within 24-48 hours of vaccinations. Mother found infant not breathing and with bleeding from his nose. He was in his crib. Mother called 911. EMT's transported infant to ER. Infant probably died prior to EMT's arrival per reporter. Autopsy report received on 11/29/2004 cause of death is SIDS. Pt also experienced bilateral pulmonary congestion and edema perimortem.  Nurse follow up on 10/13/04 states: "Blue in color, cardiac arrest."
Age: 37.0
Sex: M
Vaccine: SMALL
Symptoms: Injection site abscess, Injection site erythema, Injection site induration, Injection site pain, Injection site warmth
Clinical narrative: Patient received the Smallpox vaccine in preparation for deployment overseas. Patient states was training and injured injection site about 4 days ago. Now has multiple satellite lesions forming around org site. Site is hot, erythemic, indurated, very tender, Fever is present, also there is weeping present. Pt was sent to the ER for further eval and tx.
Age: 37.0
Sex: M
Vaccine: SMALL
Symptoms: Pyrexia, Vaccination complication
Clinical narrative: Patient received the Smallpox vaccine in preparation for deployment overseas. Patient states was training and injured injection site about 4 days ago. Now has multiple satellite lesions forming around org site. Site is hot, erythemic, indurated, very tender, Fever is present, also there is weeping present. Pt was sent to the ER for further eval and tx.
Age: 30.0
Sex: F
Vaccine: SMALL
Symptoms: Erythema, Headache, Pruritus, Pyrexia, Skin striae
Clinical narrative: The first day site started itching by day three developed little pus filled bumps. Continued to cover those areas, started running fevers of about 101.4 to 102.3 along with several headaches. Day nine became sore in mid axillary area on day ten patient states she swelled enough that she couldn't wear a bra. On day 11 site turned red with several red streaks across chest.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site swelling
Clinical narrative: DTap and IPV administered into R deltoid. Approximately 24 hours after administration developed large area of erythema, swelling and induration involving approximately a 15 cm area of her upper arm. No fevers. Some tenderness. Getting Benadryl only.
Age: 0.33
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Agitation, Aphasia, Irritability, Pyrexia, Sleep disorder
Clinical narrative: Low fever most of afternoon Tuesday, Sept 21 2004 Wednesday, Sept 22, 2004 3:30 am.... high fever 102.3. Fever continued througout Wednesday am and Pm. Thursday, Sept 23, 2004 1:30 - 4:00.... continual inconsolable crying. Continued fussiness, fever, loss of vocal capabilities, abnormal sleep periods. change in temperment.
Age: 6.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Erythema, Hypersensitivity, Pruritus, Urticaria
Clinical narrative: Mother reported that on 9/11/04 child had reddened, raised "hive" and c/o "itching".  Saw FNP on 9/13/04. Was told possible allergic reaction to immunizations or could have had allergic reaction to something else he had came in contact with.  Child had three days of itching.  Hives diminished over ten day period.  Child followed up with primary care physician on 9/22/04.  He agreed it was allergic reaction to something and could have possibly been an immunization.
Age: 37.0
Sex: M
Vaccine: FLUX, MEN, MMR, TYP
Symptoms: Lymphadenopathy, Pain, Paraesthesia
Clinical narrative: Right sided pain and paresthesias to face, upper extremity, lower extremity starting 5-7 days after receiving multiple shots; painful right sided lymphadenopathy at temple, ear, anterior neck; symptoms have improved slowly but not resolved - tried NSAID's and Neurontin with limited success.
Age: 27.0
Sex: M
Vaccine: MMR, TD, VARCEL
Symptoms: Convulsion, Dizziness, Hyperhidrosis, Hypotonia, Syncope vasovagal
Clinical narrative: Approxiately 5 minutes after vaccination, pt reported feeling light headed and started "slumping" in the chair. Pt assisted to supine position, feet elevated. Pt stated that he could not move or feel his hands and arms, then subsequently began to arch his back in possible seizure activity. Pt's hand were contracted and generalized tremors noted. Pt diaphoretic and seizure activity intensified. Approximately 10 minutes after vaccines given EMSA called. Oxygen applied and emergency services established IV access. Generalized tremors continued, pt appeared dazed.Released to EMSA for transport to Hospital. Pt improved while being placed into ambulance and was released. It has now been 45 minutes after vaccination. Pt still shaky and dizzy and remained supine in the clinic until tranportation arrived to take him home. Was seen in the emergency department later in the day for follow-up and their determination was that pt had had a vasovagal resonse to the vaccines.When contacted the next day, pt reported that he still felt slightly dizzy, but otherwise improved.
Age: 27.0
Sex: M
Vaccine: MMR, TD, VARCEL
Symptoms: Tremor
Clinical narrative: Approxiately 5 minutes after vaccination, pt reported feeling light headed and started "slumping" in the chair. Pt assisted to supine position, feet elevated. Pt stated that he could not move or feel his hands and arms, then subsequently began to arch his back in possible seizure activity. Pt's hand were contracted and generalized tremors noted. Pt diaphoretic and seizure activity intensified. Approximately 10 minutes after vaccines given EMSA called. Oxygen applied and emergency services established IV access. Generalized tremors continued, pt appeared dazed.Released to EMSA for transport to Hospital. Pt improved while being placed into ambulance and was released. It has now been 45 minutes after vaccination. Pt still shaky and dizzy and remained supine in the clinic until tranportation arrived to take him home. Was seen in the emergency department later in the day for follow-up and their determination was that pt had had a vasovagal resonse to the vaccines.When contacted the next day, pt reported that he still felt slightly dizzy, but otherwise improved.
Age: 17.0
Sex: F
Vaccine: HEP, MEN, TD
Symptoms: Dysphonia, Pharyngolaryngeal pain, Tremor
Clinical narrative: Immunized at approx. 8am 7/30/04.  By 8pm c/o sore throat.  Lost voice by 12am & episodes of uncontrolled shaking w/out loss of consciousness x 15 min at approx. 2am.  Took two 200mg ibuprofen w/ relef in 5 min.  No fever or headache.  More tremors but improved w/ ibuprofen.  Did not seek medical care.
Age: 0.15
Sex: F
Vaccine: DTAP
Symptoms: Abdominal pain, Crying
Clinical narrative: Pt with uremitting crying greater than 3 hours. Pt also with hx of colic per mom's report received dtap thurs at primary pediatrician.
Age: 56.0
Sex: M
Vaccine: FLU3
Symptoms: Arthralgia, Chills, Dizziness, Hyperhidrosis, Lethargy
Clinical narrative: Shot was given on Monday 9/20/2004 at approximately 3:50pm. By the next afternoon around 2:30pm patient began to feel lethargic, fever increased, pain in all joints, sweats, chills, lightheadedness with fever peaking out at 102 on Thursday 9/23/04.  By Friday evening 9/24/04, the fever went down to 99 which was the lowest since Tuesday.  During the early morning hours of 9/25/04 at 4:30am, I awaked in a wet bed with my hair all wet and perspiration just running off my body, the fever was at 102 again and still is at 11:25am.  I have been taking Tylenol 500mg X 2 since Tuesday and using cold compresses as instructed by the clinic.  I am still feeling miserable and have received flu vaccines for 15 years without any reactions like this.  If it goes any higher than 102, I will go to the emergency room. Patient additionally developed UTI; improving with antibiotics.
Age: 56.0
Sex: M
Vaccine: FLU3
Symptoms: Pyrexia
Clinical narrative: Shot was given on Monday 9/20/2004 at approximately 3:50pm. By the next afternoon around 2:30pm patient began to feel lethargic, fever increased, pain in all joints, sweats, chills, lightheadedness with fever peaking out at 102 on Thursday 9/23/04.  By Friday evening 9/24/04, the fever went down to 99 which was the lowest since Tuesday.  During the early morning hours of 9/25/04 at 4:30am, I awaked in a wet bed with my hair all wet and perspiration just running off my body, the fever was at 102 again and still is at 11:25am.  I have been taking Tylenol 500mg X 2 since Tuesday and using cold compresses as instructed by the clinic.  I am still feeling miserable and have received flu vaccines for 15 years without any reactions like this.  If it goes any higher than 102, I will go to the emergency room. Patient additionally developed UTI; improving with antibiotics.