chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 2.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Nasal congestion, Pruritus, Pyrexia, Rash papular, Scab
Clinical narrative: 21 days after primary Varicella vaccination, pt. (age 2) developed URI symptoms with nasal congestion and mild fever (99.5).  The next day he developed several papular lesions on his scalp and face. The following day these became papulo-vesicular in the classic "dew-drop on a rose" morphology with considerable pruritis.  New lesions continued to develop for two more days while the old resolved and crusted.  Total lesions were about thirty. All lesions were in a resolution state by the fifth day after the first arose and the URI symptoms were abating.  It seems likely there will be at least some temporary mild-moderate scarring.
Age: 2.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Upper respiratory tract infection
Clinical narrative: 21 days after primary Varicella vaccination, pt. (age 2) developed URI symptoms with nasal congestion and mild fever (99.5).  The next day he developed several papular lesions on his scalp and face. The following day these became papulo-vesicular in the classic "dew-drop on a rose" morphology with considerable pruritis.  New lesions continued to develop for two more days while the old resolved and crusted.  Total lesions were about thirty. All lesions were in a resolution state by the fifth day after the first arose and the URI symptoms were abating.  It seems likely there will be at least some temporary mild-moderate scarring.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Chills, Headache, Injection site erythema, Injection site swelling, Nausea
Clinical narrative: MENACTRA shot given in LD Wednesday afternoon - that night arm was red & swollen & also still Thursday morning.  Thursday night she felt nauseated.  Had chills, fever, & pain in arm - it was looking red/purple & felt hot to the touch - she also had a headache.  Didn't see a Dr. but felt better Friday morning.  Doing good now.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Pain in extremity, Pyrexia, Skin warm
Clinical narrative: MENACTRA shot given in LD Wednesday afternoon - that night arm was red & swollen & also still Thursday morning.  Thursday night she felt nauseated.  Had chills, fever, & pain in arm - it was looking red/purple & felt hot to the touch - she also had a headache.  Didn't see a Dr. but felt better Friday morning.  Doing good now.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Redness with swelling to R Deltoid.
Age: 44.0
Sex: F
Vaccine: HEP, MMR, TDAP, VARCEL
Symptoms: Erythema, Pruritus, Skin warm, Swelling
Clinical narrative: Itching, redness, warmth, swelling.
Age: 0.1
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC, RV5
Symptoms: Crying, Erythema, Injection site erythema, Injection site swelling, Pyrexia
Clinical narrative: Excessive prolonged crying, redness/swelling of left thigh, patient was brought back to doctors office later in the afternoon, given Tylenol, and symptoms resolved, then developed high fevers and staring spells for next two days, followed by decreased vocalization for two weeks.
Age: 0.1
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC, RV5
Symptoms: Speech disorder, Staring
Clinical narrative: Excessive prolonged crying, redness/swelling of left thigh, patient was brought back to doctors office later in the afternoon, given Tylenol, and symptoms resolved, then developed high fevers and staring spells for next two days, followed by decreased vocalization for two weeks.
Age: 37.0
Sex: M
Vaccine: TDAP
Symptoms: Unevaluable event
Clinical narrative: Pt feels fine- When I called to his home- per family member that speak a little english.
Age: 12.0
Sex: M
Vaccine: TDAP
Symptoms: Unevaluable event
Clinical narrative: Pt feels fine - when I called to his home - per family member that speak a little English.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Rash
Clinical narrative: Develop rash that resembles Rubella.
Age: 11.0
Sex: M
Vaccine: HEPA, MNQ, TDAP, VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site rash, Injection site swelling
Clinical narrative: Seen 2 days after vaccine with progressively enlarging red, blanching rash 5 x 6 cm mildly tender, 1 x 1 1/2 cm induration @ site of injection. No other SE's
Age: 0.63
Sex: M
Vaccine: DTAPHEPBIP, HPV4, PNC
Symptoms: Wrong drug administered
Clinical narrative: "none reported by parent".
Age: 4.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Lt leg (anterior thigh) 10 x 10 cm erythematous warm plaque with blanching.
Age: 5.0
Sex: M
Vaccine: DTAP, MMR, VARCEL
Symptoms: Eye swelling, Urticaria
Clinical narrative: Minor hives, swelling around eye. No respiratory distress.
Age: 31.0
Sex: M
Vaccine: RAB
Symptoms: Headache
Clinical narrative: Pt received shot 8pm on 8/24/09. Awoke at 6:30am on 8/25/09 with headache that lasted 3 hrs.
Age: 13.0
Sex: F
Vaccine: VARCEL
Symptoms: Erythema, Swelling
Clinical narrative: Red, swollen X 4 days.
Age: 16.0
Sex: F
Vaccine: TD
Symptoms: Dizziness, Headache, Hyperhidrosis, Loss of consciousness, Pallor
Clinical narrative: Headache. Momentarily passed out (opened her eyes and talked once laid down from slouching after covering shot with bandaid). Vomit, sweat said she was dizzy. Pale color after that. 911 came but all vital signs were OK.
Age: 16.0
Sex: F
Vaccine: TD
Symptoms: Vomiting
Clinical narrative: Headache. Momentarily passed out (opened her eyes and talked once laid down from slouching after covering shot with bandaid). Vomit, sweat said she was dizzy. Pale color after that. 911 came but all vital signs were OK.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Redness swollen to (L) deltoid.
Age: 4.0
Sex: M
Vaccine: DTAP, HEPA, IPV
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Erythema & mild pain at site of DTaP injection.
Age: 1.5
Sex: M
Vaccine: HIBV
Symptoms: Unevaluable event
Clinical narrative: None provided.
Age: 0.2
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Crying
Clinical narrative: Initial report received on 21 August 2008 from a health care professional. A 2 months old male patient received on 19 June 2008 at 11:30 hours the following vaccinations: DAPTACEL (lot #C2797AA), intramuscular first dose into the left thigh; IPOL (lot # C2797AA), into the left thigh; ACTHIB (sanofi pastiru ltd. lot # lot # UF370AA which corresponds to sanofi pastiru SA lot # A0824-2) intramuscular first dose into the right thigh and PREVNAR (lot # C63110), intramuscular first dose into the right thigh. Approximately 4.5 hours later the same day (at 16:50 hours) the patient began crying for approximately 4 hours. The patient was slightly consolidate when legs held in curtain way. Denied fever. TYLENOL was given as treatment at 19:30 hours. The patient fell asleep by 20:30 hours with no further crying. The patient recovered. The patient had no relevant medical history and no allergies.
Age: 28.0
Sex: M
Vaccine: IPV
Symptoms: No adverse event
Clinical narrative: This non-serious case was received from a health professional on 22 October 2008.  A 28-year-old male patient received a booster of IPOL (lot number A0169-2) on 02 June 2008.  A titer was subsequently drawn, and was negative for IPOL.  Per the reporter, the patient received two doses of IPOL as a booster, and had previously received three doses as a child.  At the time of the report, the patient had not experienced any adverse events.  Follow-up information was received from a health professional on 17 November 2008.  The patient received one intramuscular left deltoid dose of IPOL on 02 June 2008 and one intramuscular left deltoid dose of IPOL on 07 July 2008 (lot number for both doses was A0169-2).  Titers were drawn on 30 June 2008, 07 July 2008 and 28 August 2008.  Prior to 02 June 2008, the patient had received IPOL on 07 November 1979, 23 March 1980 and 03 June 1980.  In addition, the patient had previously received doses of OPV (oral polio vaccine) on 27 March 1981 and 15 October 1988.  Documents held by sender:  None
Age: 61.0
Sex: F
Vaccine: FLU3, HEPAB, MEN
Symptoms: Chills, Fatigue, Malaise, Oropharyngeal pain, Pyrexia
Clinical narrative: Initial report received from a health professional on 03 December 2008. A 61-year-old female patient received a dose of FLUZONE (lot number U2757AA); a dose of MENOMUNE (lot number UF282AA); and a dose of TWINRIX (manufacturer GlaxoSmithKline, lot number AHABB132AC) on 25 November 2008 at 4 PM. Routes and sites of administration were not reported. Fours hours later, the patient complained of congestion, sore throat and high fever (temperature was not taken). The patient took Nyquil, Benadryl and Motrin and went to bed. She awoke at 2 AM with chills, fever and malaise. The patient was very tired the next day. At the time of the report, patient outcome was unknown. The patient had previously received a dose of TWINRIX one month ago (date not specified). Follow up information was received on 05 January 2009 from a health professional. On 09 October 2008 the patient received a first dose of TWINRIX (manufacturer GlaxoSmithKline, lot number AHABB128AA) intramuscularly in the right upper arm, a first dose of TYPHIM VI ( lot number A0347) intramuscularly in the left upper arm and a first dose of IPOL (lot number AB0342) intramuscularly in the left upper arm. The patient recovered from the events on 26 November 2008. Follow up information was received on 28 January 2009 from a health professional. The patient received an initial dose of FLUZONE intramuscularly in the left upper arm, an initial dose of MENOMUNE subcutaneuosly in the right upper arm, TWINRIX intramuscularly in the upper right arm, IPOL and TYPHIM VI both in the left upper arm. The patient reported having a reaction in the 1980's to a possible flu vaccine. No other information was provided. Follow-up information received 12 February 2009 from a health care professional in response to our request for additional information pertaining to the specific flu vaccine manufacturer, lot number and type of reaction experienced by the patient during the 1980s. According to the reporter, this information was "Unknown. Patient relocated to a foreign country, and we did not give the vaccine in 1980." No further information was provided. Documents held by sender: None.
Age: 61.0
Sex: F
Vaccine: FLU3, HEPAB, MEN
Symptoms: Upper respiratory tract congestion
Clinical narrative: Initial report received from a health professional on 03 December 2008. A 61-year-old female patient received a dose of FLUZONE (lot number U2757AA); a dose of MENOMUNE (lot number UF282AA); and a dose of TWINRIX (manufacturer GlaxoSmithKline, lot number AHABB132AC) on 25 November 2008 at 4 PM. Routes and sites of administration were not reported. Fours hours later, the patient complained of congestion, sore throat and high fever (temperature was not taken). The patient took Nyquil, Benadryl and Motrin and went to bed. She awoke at 2 AM with chills, fever and malaise. The patient was very tired the next day. At the time of the report, patient outcome was unknown. The patient had previously received a dose of TWINRIX one month ago (date not specified). Follow up information was received on 05 January 2009 from a health professional. On 09 October 2008 the patient received a first dose of TWINRIX (manufacturer GlaxoSmithKline, lot number AHABB128AA) intramuscularly in the right upper arm, a first dose of TYPHIM VI ( lot number A0347) intramuscularly in the left upper arm and a first dose of IPOL (lot number AB0342) intramuscularly in the left upper arm. The patient recovered from the events on 26 November 2008. Follow up information was received on 28 January 2009 from a health professional. The patient received an initial dose of FLUZONE intramuscularly in the left upper arm, an initial dose of MENOMUNE subcutaneuosly in the right upper arm, TWINRIX intramuscularly in the upper right arm, IPOL and TYPHIM VI both in the left upper arm. The patient reported having a reaction in the 1980's to a possible flu vaccine. No other information was provided. Follow-up information received 12 February 2009 from a health care professional in response to our request for additional information pertaining to the specific flu vaccine manufacturer, lot number and type of reaction experienced by the patient during the 1980s. According to the reporter, this information was "Unknown. Patient relocated to a foreign country, and we did not give the vaccine in 1980." No further information was provided. Documents held by sender: None.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV
Symptoms: Decreased appetite, Diarrhoea, Dyskinesia, Injection site swelling, Lethargy
Clinical narrative: This non serious case was received on 06 February 2009 from a non health care professional.  A 5 year old female patient received DAPTACEL (lot number C3083AA) in the left arm and IPOL (lot number B0009) in the right arm on 04 February 2009.  On approximately 05 February 2009 the patient developed swelling at the injection site (right arm), arm swelling (arm not specified), vomiting, diarrhea, loss of appetite, jerkiness, shaking, swelling of face, and pallor.  The patient's mother called the doctor's office to report that the diarrhea and vomiting resolved.  The date the symptoms resolved and date of phone call was not provided.  Follow-up information received from a health care professional on 04 May 2009.  The patient's symptoms included swelling at IPV injection site, vomiting, diarrhea, lethargy, pallor, jerkiness, shaking, swelling of the face and hives.  The patient's mother was instructed to observe and call the office if symptoms increased or did not subside.  A follow-up call was made on 06 February 2009 and the mother reported no further vomiting or diarrhea but the patient had no appetite at that time and still showed swelling at the injection site.  At that time, the patient's mother expressed that she wanted no further vaccinations.  Information received on 04 May 2009 indicated that the patient had recovered.  Follow-up information received on 21 May 2009 from a health care professional who clarified that the patient experienced swelling at the injection site only and did not experience swelling throughout the entire arm.  Therefore, the event of arm swelling was removed from the adverse event screen.  The reporter did not have additional information to provide at the time of the report.  List of Documents held by Sender:  Vaccination History, Medical Records.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV
Symptoms: Oedema peripheral, Pallor, Swelling face, Tremor, Urticaria
Clinical narrative: This non serious case was received on 06 February 2009 from a non health care professional.  A 5 year old female patient received DAPTACEL (lot number C3083AA) in the left arm and IPOL (lot number B0009) in the right arm on 04 February 2009.  On approximately 05 February 2009 the patient developed swelling at the injection site (right arm), arm swelling (arm not specified), vomiting, diarrhea, loss of appetite, jerkiness, shaking, swelling of face, and pallor.  The patient's mother called the doctor's office to report that the diarrhea and vomiting resolved.  The date the symptoms resolved and date of phone call was not provided.  Follow-up information received from a health care professional on 04 May 2009.  The patient's symptoms included swelling at IPV injection site, vomiting, diarrhea, lethargy, pallor, jerkiness, shaking, swelling of the face and hives.  The patient's mother was instructed to observe and call the office if symptoms increased or did not subside.  A follow-up call was made on 06 February 2009 and the mother reported no further vomiting or diarrhea but the patient had no appetite at that time and still showed swelling at the injection site.  At that time, the patient's mother expressed that she wanted no further vaccinations.  Information received on 04 May 2009 indicated that the patient had recovered.  Follow-up information received on 21 May 2009 from a health care professional who clarified that the patient experienced swelling at the injection site only and did not experience swelling throughout the entire arm.  Therefore, the event of arm swelling was removed from the adverse event screen.  The reporter did not have additional information to provide at the time of the report.  List of Documents held by Sender:  Vaccination History, Medical Records.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV
Symptoms: Vomiting
Clinical narrative: This non serious case was received on 06 February 2009 from a non health care professional.  A 5 year old female patient received DAPTACEL (lot number C3083AA) in the left arm and IPOL (lot number B0009) in the right arm on 04 February 2009.  On approximately 05 February 2009 the patient developed swelling at the injection site (right arm), arm swelling (arm not specified), vomiting, diarrhea, loss of appetite, jerkiness, shaking, swelling of face, and pallor.  The patient's mother called the doctor's office to report that the diarrhea and vomiting resolved.  The date the symptoms resolved and date of phone call was not provided.  Follow-up information received from a health care professional on 04 May 2009.  The patient's symptoms included swelling at IPV injection site, vomiting, diarrhea, lethargy, pallor, jerkiness, shaking, swelling of the face and hives.  The patient's mother was instructed to observe and call the office if symptoms increased or did not subside.  A follow-up call was made on 06 February 2009 and the mother reported no further vomiting or diarrhea but the patient had no appetite at that time and still showed swelling at the injection site.  At that time, the patient's mother expressed that she wanted no further vaccinations.  Information received on 04 May 2009 indicated that the patient had recovered.  Follow-up information received on 21 May 2009 from a health care professional who clarified that the patient experienced swelling at the injection site only and did not experience swelling throughout the entire arm.  Therefore, the event of arm swelling was removed from the adverse event screen.  The reporter did not have additional information to provide at the time of the report.  List of Documents held by Sender:  Vaccination History, Medical Records.
Age: 1.6
Sex: M
Vaccine: DTAP, HIBV, IPV
Symptoms: Unevaluable event
Clinical narrative: Case is linked with case 2009-00558.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: This event was received from a health care professional on 19 February 2009. A four-year-old female, with a history of asthma and thrombocytopenia. received intramuscular injections of DAPTACEL (lot number C2798AA), MMR (Merck, lot number 066X), and Varicella (Merck, lot number 1017X) in the right thigh on 16 February 2009. She also received in intramuscular injection of IPOL (lot number A0298-2) in the left thigh. She subsequently developed an area of redness and swelling on the right thigh, spreading down the knee and around to the back of the leg. Outcome was unknown.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site swelling, Injection site vesicles
Clinical narrative: This non serious case was received on 06 April 2009 from a health care professional. A 4 and a half year old female patient received DAPTACEL (lot number C3082AA) in the right arm, IPOL (lot number A1229-2) in the right arm, PROQUAD (manufacturer Merck, lot number 0034Y) in the left arm, and VARIVAX (manufacturer Merck, lot number 0044Y) in the left arm on 02 April 2009. On 03 April 2009 the patient's right arm became swollen and red. On 04 April 2009 the patient's right arm developed blisters. The patient had one large blister at the injection site with smaller blisters around the arm from the shoulder to elbow. The patient stated that the blisters appeared on their own and the area is still reddened. Follow up information received on 21 April 2009 from a health care professional who reported that the patient was taking CLARITIN concomitantly. The patient received MMR II (manufacture Merck), which was previously captured as PROQUAD. The patient recovered from the events. Date of recovery was not reported. Follow-up information was received from the reporter on 08 May 2009. All vaccines were given intramuscularly. MMR II and VARIVAX had each been given once previously. The patient was fully recovered from all events on 15 April 2009. No additional information was available at the time of the report. List of Documents held by Sender: None.
Age: 0.18
Sex: U
Vaccine: DTAP, IPV
Symptoms: Injection site erythema, Injection site papule, Rash erythematous
Clinical narrative: Initial report was received 16 June 2009 from a health care professional. An 18-month old patient had received an injection of DAPTACEL and an injection of IPOL (lot numbers, routes, sites and dates of administration not reported) and an unspecified amount of time later, they developed a 5 cm erythematous area surrounding each injection site and erythematous papules on their arms and trunk. They were evaluated by their physician on 16 June 2009. The patient had not recovered from the event and no further information was provided at the time of the report. Documents held by sender: None.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site nodule, Injection site pain, Injection site swelling
Clinical narrative: This case was received from a health professional on 18 June 2009. A four-year-old male patient, with no reported medical history, received the following vaccinations on 05 June 2009: a fifth left leg injection of DAPTACEL (lot number C3082AA); a fourth left leg injection IPOL (lot number B1090-2); and a second left arm injection of MMR II (Merck, lot number 0423T). On 09 June 2009, four days post-vaccination, the patient developed swelling of the left upper leg from the front of his thigh to the back of the leg. The area was very reddened and painful. He was treated with an antibiotic and a three-day course of steroids. At the time of the report, there was a knot at the injection site. Patient outcome was reported as "unknown".
Age: 28.0
Sex: F
Vaccine: IPV
Symptoms: Erythema, Hyperaesthesia, Skin warm
Clinical narrative: Initial report was received 18 July 2008 from a health care professional. A 28-year-old female patient had received a subcutaneous left forearm injection of IPOL (lot number not reported), and one hour later she developed a 4 1/2 inch round, red, hot area was sensitive to touch. The nurse intended to administer TUBERSOL instead of IPOL. No other symptoms were experienced at the time of the report. According to the reporter, the patient's symptoms continued and the patient's recovery status was reported as unknown. Follow up information was received on 28 August 2008 for a health care professional. The patient received an injection of IPOL (lot number A0342) 0.5 mL. The patient was evaluated by a health care professional. No laboratory tests were performed. The patient's symptoms lasted approximately four days. The patient recovered.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth, No reaction on previous exposure to drug
Clinical narrative: Initial report received on 25 August 2008 from a health care professional. A 4 year old female patient, with no medical history, received on 21 August 2008 a right thigh intramuscular 0.5 ml injection of IPOL (lot number A0836-2), a right thigh intramuscular 0.5 ml injection of TRIPEDIA (lot number U2291BA), and left thigh injection of MMR (Merck lot number unknown). The patient had no illnesses at the time of vaccination. On 22 August 2008, one day post-vaccination, the patient's right thigh was red, swollen, hot to touch, and itching. The recommended treatment was cold compresses. At the time of the report 25 August 2008, the patient's recovery status had not been reported, but the patient was to follow-up with the physician on that day. Follow-up information was received 01 October 2008 from a health care professional. the reporter confirmed that the symptoms of redness and itching extended two inches from the injection site and corrective treatments consisted of TYLENOL and BENADRYL. The duration of the event was confirmed to have lasted one week and the patient recovered. The patient had received a total of three prior doses of IPOL (lot numbers not reported) on 13 November 2003, 26 January 2004, and 22 March 2004 respectively, with no adverse events experienced. No additional information was provided.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Body temperature increased
Clinical narrative: This case was received from a health professional on 03 September 2008. This case represents on in a cluster of two patients. A four-year-old male patient received the following vaccines on 29 August 2008: an intramuscular right thigh, fourth injection of IPOL (lot number A0491), intramuscular right thigh fifth injection of TRIPEDIA (lot number U2356CA), MMR (Merck, lot number not reported), and VARICELLA (Merck, lot number not reported). On 01 September 2008, he developed a temperature of 103.2 degrees Fahrenheit, lasting 48 hours. No other symptoms were reported, and the patient recovered. Follow-up information was received 29 September 2008 from a health care professional. The patient had no illness at the time of vaccination. The MMR and VARICELLA vaccines received by the patient had been a firs dose of MMR lot number 0425U, and a first dose of VARICELLA lot number 0514X (routes and sites not reported. The reporter in this case also reported a similar adverse reaction in another patient; that event is captured in case number 2008-02800.
Age: 0.17
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Body temperature increased, Injection site erythema
Clinical narrative: This case was received from a health professional on 03 September 2008. This case represents one in a cluster of two patients. A two-month-old female patient received the following vaccines on 26 August 2008: an intramuscularly right thigh, first injection of IPOL (lot number A0491), an intramuscular right thigh first injection of TRIPEDIA (lot number U2356CA), ACTHIB (lot number not reported), and PREVNAR (Wyeth, lot number not reported). On 27 August 2008, she developed a temperature of 102 degrees Fahrenheit, lasting 48 hours. She was seen by her physician on 31 August 2008, and at that time was noted to have local site redness. The symptoms subsequently resolved. Follow-up information received on 29 September 2008 from the original reporter wh0 is health care provider. Per the reporter, the lot number for the ACTHIB vaccine was UF493AA; and the lot number for the PREVNAR vaccine was C45721H. The patient had no concurrent illness or use of other medications at the time of the vaccinations on 26 August 2008. The birth weigh of the patient was provided as 7 pounds 7 ounces (4Kg). The patient has siblings. No relevant diagnostic tests/laboratory data were performed for the adverse events. No further information is expected. The reporter in this case also reported a similar adverse reaction in another patient; that event is captured in case number 2008-02799.
Age: 0.35
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC, RV5
Symptoms: Rash erythematous
Clinical narrative: Initial information was received from a health care professional on 16 September 2008. A four month old female patient with no reported past medical history developed a rash four days post vaccination after she received a second left thigh injection ACTHIB lot number UF492A (sanofi pasteur SA lot number B0067), DAPTACEL (lot number C2956BA), a second left arm injection of IPOL (lot number A0491-4), a second right thigh injection of PREVNAR (manufacturer Wyeth, lot number WC4527H), and an oral second dose of ROTATEG (lot number 0407Y) on 05 September 2008. On 09 September 2008 the patient developed a "red and raised" rash on her chest, arms, and legs. She did not have a fever or any other symptoms. The patient recovery status was unknown at the time of the report. This case is linked to case number 2008-02907.
Age: 0.17
Sex: F
Vaccine: HEP, HIBV, IPV, PNC, RV5
Symptoms: Rash erythematous
Clinical narrative: Initial information was received from a health professional on 16 September 2008. A two month old female patient with no reported past medical history developed a rash five days post vaccination after she received a first dose injection of ACTHIB lot number UF366A (sanofi pasteur SA lot number A0802-2), IPOL (lot number A0996-2), IPOL (lot number A0996-2) administered in the left deltoid, PREVNAR (manufacturer Wyeth, lot number C54766) administered in the right thigh, HEPATITIS B (manufacturer Merck, lot number 0574Y) administered in the right thigh, and ROTATEQ (manufacturer Merck, lot number 0281Y) administered orally. The vaccines were all administered on 03 July 2008. On 08 July 2008 the patient developed a "red and raised" rash on her chest, arms, and legs. The patient did not have a fever or any other symptoms. The patient's recovery status was unknown at the time of the event. This case is linked to case number 2008-02906.
Age: 4.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site urticaria, No reaction on previous exposure to drug, Pruritus, Urticaria
Clinical narrative: Initial non-serious report received from a health care professional on 06 November 2008. A four-year-old female patient received a left deltoid intramuscular injection of FLUZONE SV 2008-2009 on 30 September 2008 and since that time had been experiencing and "urticarial" appearance rash specifically known around the injection site only. In addition, the symptoms "itchy" was reported, however, it was not specified if this symptom was limited to the injection site. Specific onset date of symptoms was not reported. It was indicated that the rash had been coming and going since the patient was vaccinated. The patient had no further symptoms. The even required a visit to the doctors office. At the time of the report, the patient had not recovered. The patient had received the following vaccines on 29 August 2008: right deltoid injection of MMR (manufacturer no reported, lot number 0842X); right deltoid injection of VARICELLA (manufacturer not reported, lot number 0103X); left deltoid intramuscular injection of DAPTACEL (lot number C2957AA); left deltoid subcutaneous injection of IPOL (lot number A0491); and TB test to the left arm. Follow-up information was received 04 December 2008 from a health care professional. According to the reporter, the patient had no known illnesses at the time of vaccination and they had no prior reactions with the flu vaccine. Documents held by sender: None
Age: 0.51
Sex: M
Vaccine: DTAP, FLU3, HEP, HIBV, IPV, PNC
Symptoms: Urticaria
Clinical narrative: Initial report was received 19 November 2008 from a health care professional. A six-month old male patient had received a dose of FLUZONE SV and IPOL (manufactured by sanofi pasteur), PREVNAR (manufactured by Wyeth), and a dose of DTAP, HEP B, and HIB vaccines (manufactures not reported) on 06 February 2006 and an unspecified amount of time later, he developed hives. The lot numbers, routes and sites of vaccination were not reported. It was unknown of any corrective treatments were required for this event. Concurrent illness at the time of vaccination, concomitant medications, and pre-existing medical conditions were reported as unknown. According to the reporter, the patient had been seen by an allergist and had recovered from the event. Documents held by sender: None
Age: 5.0
Sex: M
Vaccine: IPV
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Reaction to previous exposure to any vaccine
Clinical narrative: Initial report was received 17 December 2008 from a health care professional. A five-year-old male patient had received an injection of IPOL, lot number A0273 (lot number invalid, route/site of administration not reported) on 25 August 2008 and an unspecified amount of time later, he developed erythema, pruritis and tenderness at the injection site. The patient had no known allergies. The patient experienced the same symptoms after receiving FLUZONE SV 2008-2009, (lot number, route and site of administration unknown) on 04 December 2008 (captured in case 2008-04031). According to the reporter, the patient recovered from the events. This patient experienced another event which has been captured in case 2008-04031. Documents held by sender: None.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: This case was received from a health care professional on 01 May 2009. It was reported as one of a cluster of three patients; the other two patients' events are captured in case numbers 2009-01932 and 2009-01933. A five-year-old female patient received the following vaccinations on 29 April 2009: a left arm fifth dose of DAPTACEL (lot number C3084AA), a left arm fourth dose of IPOL (lot number B0475-2), and a right arm second dose of MMRII (Merck, lot not reported). On 30 April 2009, the patient's parent reported a red, swollen area on the left arm to the shoulder. The area was treated with cool compresses. Outcome was not reported. Follow-up information was received from the health care professional on 22 May 2009. The MMRII lot number was reported as 0152Y. All events had recovered. No additional information was provided.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: This case was received from a health care professional on 01 May 2009. It was reported as one of a cluster of three patients; the other two patients' events are captured in case numbers 2009-01931 and 2009-01933. A five-year-old female patient received the following vaccinations on 28 April 2009: a left arm fifth dose of DAPTACEL (lot number C3084AA), and a left arm fourth dose of IPOL (lot number B0475-2). On either 29 or 30 April 2009, the patient's parent reported a red, swollen left arm. The area was treated with cool compresses. Outcome was not reported. Follow-up information was received from the health care professional on 22 May 2009. The patient recovered.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: This case was received from a health care professional on 01 May 2009. It was reported as one of a cluster of three patients, the other two patients' event are captured in case numbers 2009-01931 and 2009-01932. A five-year-old female patient received the following vaccinations on 28 April 2008: a left arm fifth dose of DAPTACEL (lot number C3084AA), a left arm fourth dose of IPOL (lot number B0475-2), and a right arm second dose of MMRII ( Merck, lot not reported). On 30 April 2009, the patient's parent reported a red, swollen left arm. The area was treated with cool compresses. Outcome was not reported. Follow-up information was received from the health care professional on 22 May 2009. The patient recovered.
Age: 1.42
Sex: M
Vaccine: HIBV, IPV
Symptoms: Crying, Decreased appetite, Dermatitis atopic, Irritability, Pyrexia
Clinical narrative: A 17 months old male patient received on 30 January 2009 at 15:00 the third dose of ACTHIB (lot# UF578AB, corresponding to lot# B0395-1) and the third dose of IPOL (Sanofi Pasteur lot# reported as B0075). The patient experienced within 24 to 48 hours "high fever" of 103. 4 Fahrenheit degrees (rectal), loss of appetite and crankiness with crying. Fever continued and he saw a physician on 02 February 2009 and was treated with MOTRIN and extra fluids. Outcome was unknown. The patient received on 06 January 2009 a dose of measles vaccine. The patient had slight runny nose at the time of vaccination. The patient had allergy to walnuts. The patient had no siblings. Follow up information received on 01 June 2009 from a consumer. The patient received ACTHIB and IPOL both in the upper arm intramuscularly (Specific arm not specified). ATTENUVAX (manufacturer Merck) in the right upper arm intramuscularly on 05 January 2009. The patient' parent stated that the patient had one time incident with walnuts at 7 months of age, which was previously reported as walnut allergy. A topical dermatitis was suspected when the skin was in contact with residue. The patient was treated with a single dose of BENADRYL and recovered. An allergy to walnuts was never confirmed. The patient was treated with TYLENOL for event of fever. The patient recovered 4-5 days after the event onset.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Blood pressure increased, Chest pain, Dizziness, Heart rate decreased, Hypoventilation
Clinical narrative: CNP present after incident.  1550- Became pale, lightheaded - became unresponsive immediately following injection .  Assisted with lowering head to knees (pt was sitting in chair).  Pulse present, resp shallow.  After approx 10 sec, opened eyes agreed to being ok.  1600 - B/P 104/68 P-72 - R 28 .  Didn't become clammy.  Denies nausea 0/0 dizziness.  "Chest hurts - 1605 - BP 118/70 - 1610 HRT R 24 - Recalls little.  1630 Attempted to leave clinic with mother - very vague - c/o tight - numb throat Resp 28 - Began breathing in paper sack - feels better.  1640 - feels better O2 sat 99%.  Left with mother.  Instructed to go to ER if doesn't improve.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Memory impairment, Oxygen saturation normal, Pallor, Pharyngeal hypoaesthesia, Throat tightness
Clinical narrative: CNP present after incident.  1550- Became pale, lightheaded - became unresponsive immediately following injection .  Assisted with lowering head to knees (pt was sitting in chair).  Pulse present, resp shallow.  After approx 10 sec, opened eyes agreed to being ok.  1600 - B/P 104/68 P-72 - R 28 .  Didn't become clammy.  Denies nausea 0/0 dizziness.  "Chest hurts - 1605 - BP 118/70 - 1610 HRT R 24 - Recalls little.  1630 Attempted to leave clinic with mother - very vague - c/o tight - numb throat Resp 28 - Began breathing in paper sack - feels better.  1640 - feels better O2 sat 99%.  Left with mother.  Instructed to go to ER if doesn't improve.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Unresponsive to stimuli
Clinical narrative: CNP present after incident.  1550- Became pale, lightheaded - became unresponsive immediately following injection .  Assisted with lowering head to knees (pt was sitting in chair).  Pulse present, resp shallow.  After approx 10 sec, opened eyes agreed to being ok.  1600 - B/P 104/68 P-72 - R 28 .  Didn't become clammy.  Denies nausea 0/0 dizziness.  "Chest hurts - 1605 - BP 118/70 - 1610 HRT R 24 - Recalls little.  1630 Attempted to leave clinic with mother - very vague - c/o tight - numb throat Resp 28 - Began breathing in paper sack - feels better.  1640 - feels better O2 sat 99%.  Left with mother.  Instructed to go to ER if doesn't improve.
Sex: F
Vaccine: MMR
Symptoms: Death
Clinical narrative: Information has been received from a consumer who reported a female child died after the second dose of MMR II (route and lot number not reported). Attempts to verify the existence of an identifiable patient and reporter have been unsuccessful.
Sex: F
Vaccine: HPV4
Symptoms: Headache, Hemiparesis, Neurological symptom
Clinical narrative: Information has been received from a cardiac surgeon concerning a female who was vaccinated with a dose of GARDASIL (lot #660618/0572X). Subsequently the patient developed hemiparesis, headaches and "other neurological symptoms". At the time of the report, the patient's outcome was unknown. The cardiac surgeon considered hemiparesis, headaches and "other neurological symptoms" to be were considered to be disabling since they have become longstanding and incapacitating. This is one of several reports received from the same source. A lot check has been requested. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Anogenital warts, Deafness, Deafness unilateral, Tinnitus
Clinical narrative: Information has been received from a pharmacist concerning a 17 year old female with unspecified drug reactions/allergies and medical history, who was vaccinated with a third dose of GARDASIL in July-2009 ("6 weeks" since vaccination) (route and lot number not reported). The pharmacist mentioned the patient experienced ringing in the ear, 50% hearing loss in the unspecified one ear and genital warts. At the time of the report the outcome of the patient was not recovered. The patient sought medical attention by visit physician's office. Ringing in the ear, 50% hearing loss in the unspecified one ear and genital warts were considered to be disabling. Additional information has been requested.
Sex: M
Vaccine: PPV
Symptoms: Cellulitis, Reiter's syndrome, Surgery
Clinical narrative: Information has been received from a healthcare worker concerning a male who in 2003 was vaccinated with PNEUMOVAX and developed what was thought to be cellulitis. The patient was suing the facility claiming he developed REITERS syndrome from the cellulitis that required back surgery and a long, painful recovery. His lawyers are making claims against the clinic including "dirty needles". The patient went to office and specialist for medical attention. At the time of the report, the patient's status was unknown. Upon internal review, REITER'S syndrome and cellulitis were determined to be other important medical events. This is one of several reports received from the same source. Additional information has been requested.
Age: 52.0
Sex: F
Vaccine: RAB
Symptoms: Allergy to metals, Chest pain, Dyspnoea, Swelling, Urticaria
Clinical narrative: Initial report received on 17 August 2009 from a consumer. A 54-year-old female patient, who has history of allergy to latex, thimerosal, PCN and sulfa, and who has history of increased blood pressure, had received a fourth dose of IMOVAX (lot number, route, and site not reported) on an unspecified day in October 2007. Within minutes of receiving the vaccine, the patient complained of severe swelling, shortness of breath, chest pain and generalized hives. The patient self medicated with BENADRYL and the symptoms resolved 2-3 days later. Documents held by sender: None.
Age: 13.0
Sex: F
Vaccine: MEN, MEN
Symptoms: Back pain, Decreased appetite, Headache, Human herpes virus 6 serology negative, Lumbar puncture
Clinical narrative: Initial report received on 21 August 2009 from a health care professional. A 13-year-old female patient, with unknown medical history, had received a dose of MENOMUNE (lot number, route and site not reported) on 11 August 2009 (date uncertain by reporter). One day post-vaccination, the patient started having a headache, backache, and fever of 105.0 degree Fahrenheit. The patient sought treatment at the emergency room on 14 August 2009 and again on 15 August 2009 and was admitted that day to the hospital. On day two of hospitalization, the patient developed severe nausea, decreased appetite and rash on her trunk and legs. Treatments received and diagnostic tests performed were not reported. The patient was discharged on day four of hospitalization. Subsequently, the patient returned to her health care provider for evaluation of continued "problems", and a "spinal tap" (lumbar puncture test) was performed on 20 August 2009; however the results were not reported. At the time of this report, the patient was in the hospital with a diagnosis of meningitis. No strain had been identified. Recovery status was not reported. Documents held by sender: None.  10/2/09 Hospital records received DOS 8/15/09 to 8/18/09. Assessment: Viral syndrome, gastroenteritis. Patient presents with a history of myalgias and fever. Back pain, headache. muscle aches involving back, legs, knees, ankles, feet and neck. Nothing po for 2 days. Nauseated. Cough, chills, eyes hurt and swollen. Erythema cheeks and shins. Abdominal pain.  10/2/09 Hospital records received DOS 8/21/98 to 8/25/09. Assessment: Viral meningitis. Prior admission for presumed viral illness. Patient c/o worsening headache and back pain. Vomited, fever, loose stools. Bothered by sounds, light and smell. Cough. Macular rash on chest, arms, and cheeks. 1/13/09 Medical records received. PMD notes for DOS 6/9-8/21. . Sports physical. Vaccines given. H/O sinusitis.  Approx 2 months later emesis, worst HA of life. Possible prolonged viral illness.ED visit.  CT head neg. To be admitted. LP planned.  Follow up information received on 18 September 2009 from a health care professional who reported that the patient was diagnosed with viral meningitis. Lot number was provided for MENOMUNE, UF389AA. The patient was reported as recovered. No further information was provided. Documents held by sender: None.
Age: 13.0
Sex: F
Vaccine: MEN, MEN
Symptoms: Nausea, Neutrophil count increased, Parosmia, Pyrexia, Rash
Clinical narrative: Initial report received on 21 August 2009 from a health care professional. A 13-year-old female patient, with unknown medical history, had received a dose of MENOMUNE (lot number, route and site not reported) on 11 August 2009 (date uncertain by reporter). One day post-vaccination, the patient started having a headache, backache, and fever of 105.0 degree Fahrenheit. The patient sought treatment at the emergency room on 14 August 2009 and again on 15 August 2009 and was admitted that day to the hospital. On day two of hospitalization, the patient developed severe nausea, decreased appetite and rash on her trunk and legs. Treatments received and diagnostic tests performed were not reported. The patient was discharged on day four of hospitalization. Subsequently, the patient returned to her health care provider for evaluation of continued "problems", and a "spinal tap" (lumbar puncture test) was performed on 20 August 2009; however the results were not reported. At the time of this report, the patient was in the hospital with a diagnosis of meningitis. No strain had been identified. Recovery status was not reported. Documents held by sender: None.  10/2/09 Hospital records received DOS 8/15/09 to 8/18/09. Assessment: Viral syndrome, gastroenteritis. Patient presents with a history of myalgias and fever. Back pain, headache. muscle aches involving back, legs, knees, ankles, feet and neck. Nothing po for 2 days. Nauseated. Cough, chills, eyes hurt and swollen. Erythema cheeks and shins. Abdominal pain.  10/2/09 Hospital records received DOS 8/21/98 to 8/25/09. Assessment: Viral meningitis. Prior admission for presumed viral illness. Patient c/o worsening headache and back pain. Vomited, fever, loose stools. Bothered by sounds, light and smell. Cough. Macular rash on chest, arms, and cheeks. 1/13/09 Medical records received. PMD notes for DOS 6/9-8/21. . Sports physical. Vaccines given. H/O sinusitis.  Approx 2 months later emesis, worst HA of life. Possible prolonged viral illness.ED visit.  CT head neg. To be admitted. LP planned.  Follow up information received on 18 September 2009 from a health care professional who reported that the patient was diagnosed with viral meningitis. Lot number was provided for MENOMUNE, UF389AA. The patient was reported as recovered. No further information was provided. Documents held by sender: None.