chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 62.0
Sex: F
Vaccine: TD
Symptoms: Feeling abnormal, Nausea, Stomatitis
Clinical narrative: 1145am B/P 150/80 P 60 - states feels like "fluid coming in head". and sensation in month like fluid in mouth c/o nausea 1150am 140/80 no nausea. States feels like much better.
Age: 1.24
Sex: F
Vaccine: DTAP, HBHEPB, VARCEL
Symptoms: Infection
Clinical narrative: Infection with Varicella
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Blister, Erythema, Rash, Rash papular, Scab
Clinical narrative: Mom noted rash started 11/4/07. Patient now has red papules, vesicles and scabbed lesions primarily to head spreading to trunk. No temp at present.
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Skin lesion
Clinical narrative: Mom noted rash started 11/4/07. Patient now has red papules, vesicles and scabbed lesions primarily to head spreading to trunk. No temp at present.
Age: 10.0
Sex: M
Vaccine: VARCEL
Symptoms: Rash
Clinical narrative: Rash on abdomen and thighs.
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Swelling
Clinical narrative: Patient received flu shot in left arm and right arm rec'd Pneumovax, red swollen slightly raised, afebrile unable to left arm, redness went all around cold compress.
Sex: U
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Erythema, Local reaction, Oedema peripheral
Clinical narrative: - Same day of vaccinations, leg swelling and red. Went to ER after Tylenol and cold pack did  not improve. "Local Reaction" per ER doctor. CRNP spoke with mother 11-5-07, redness and swelling, much better.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Erythema, Reaction to preservatives
Clinical narrative: Redness no swollen right arm to elbow tense ----> reaction to DTaP
Age: 14.0
Sex: F
Vaccine: FLU3, HPV4
Symptoms: Syncope
Clinical narrative: Syncope 24 hours after administration of Gardasil and Flu vaccine.
Age: 45.0
Sex: F
Vaccine: FLU3
Symptoms: Anaphylactic reaction, Cardiac enzymes normal, Electrocardiogram normal, Full blood count normal, Metabolic function test normal
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of anaphylaxis in a 45-year-old female subject who was vaccinated with Flulaval (GlaxoSmithKline).  Concurrent medical conditions included hypertension.  Concurrent medications included Benicar.  On 3 October 2007 at 09:30 the subject received unspecified dose of Flulaval at 0.5 ml, intramuscularly in the left arm.  On 3 October 2007, five minutes after vaccination with Flulaval, the subject experienced anaphylaxis.  The healthcare professional considered the event was clinically significant (or requiring intervention).  At the time of reporting the outcome of the event was unspecified.  Follow-up received on 22 October 2007 via the healthcare professional.  She reported that the events resolved on 13 October 2007.  The healthcare professional considered that the events were serious and life-threatening.  The subject was hospitalized.  Diagnostic testing revealed normal results for cardiac enzymes, complete blood count, metabolic profile and electrocardiogram. The healthcare professional considered that the events were not related to medical history of concurrent illness, lack of efficacy, erroneous administration or suspected transmission of an infectious agent via a medicinal product.  The healthcare professional considered that the events were related to the use of Flulaval.
Age: 52.0
Sex: F
Vaccine: FLU3
Symptoms: Expired drug administered, Injection site erythema, Injection site swelling
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of a medication error in a 52-year-old female subject who was vaccinated with Flulaval (GlaxoSmithKline).  On 28 August 2007 at 15:00 the subject received 1st dose of Flulaval at 0.5 ml in the right arm.  On 28 August 2007, immediately following vaccination with Flulaval, it was noted that the vaccine given was from the past flu season (2006-2007).  This was considered to be a medication error.  The subject also developed injection site redness and swelling on 28 August 2007.  At the time of reporting the medication error was unresolved.  In the reporter's opinion, the events were probably related to treatment with Flulaval.
Sex: U
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pruritus, Injection site warmth
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of injection site redness in a subject of unspecified age and gender who was vaccinated with Flulaval (GlaxoSmithKline).  In September 2007 the subject received unspecified dose of Flulaval at 0.5 ml.  Subjects received doses of Flulaval from 25 September 2007 to 27 September 2007 in either the right or left arm.  This subject developed redness, itching and warmth to the touch at the injection site on a date 25 September 2007 to 27 September 2007.  At the time of reporting the events were resolved.  Six subjects experienced these events.  The physician recommended that the subjects take Tylenol and use cold compresses.
Sex: U
Vaccine: FLU3
Symptoms: Injection site irritation, Injection site rash, Wrong technique in drug usage process
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of injection site rash in a "few" elderly subjects of unspecified gender, all greater than 65-years-old, who were vaccinated with Flulaval (GlaxoSmithKline).  In September 2007, the subjects received the first doses of Flulaval (.5 ml, unknown, administered in either the right or left arm).  The reporter indicated that the vaccines were administered with 5/8 inch needles (it was noted that the Center for Disease Control recommends 1 to 1.5 inch needles to prevent seepage into tissues).  At an unspecified time after vaccination with Flulaval, the subjects experienced rashes around the injection sites and/or injection site burning.  Those subject who contacted the medical office were instructed to apply cold compresses to the affected areas; the three or four subjects had not re-contacted the medical office at the time of this report.  At the time of reporting the events were resolved.
Age: 86.0
Sex: F
Vaccine: FLU3
Symptoms: Cough, Influenza like illness
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of influenza-like symptoms in an 86-year-old female subject who was vaccinated with Flulaval (GlaxoSmithKline).  In September 2007 the subject received the first dose of Flulaval (.5 ml, unknown, unknown arm).  At an unspecified time after vaccination with Flulaval, the subject experienced influenza-like symptoms and cough.  At the time of reporting the events were unresolved.
Sex: U
Vaccine: FLU3
Symptoms: Injection site reaction, Urticaria
Clinical narrative: This case was reported by a healthcare resourced management company and described the occurrence of welts at injection sites in an unspecified number of subjects of unspecified ages and genders who was vaccinated with Flulaval (GlaxoSmithKline).  On unspecified dates the subjects received unspecified dose(s) of Flulaval (unknown).  At an unspecified time after vaccination with Flulaval, all of the subjects vaccinated at an unspecified healthcare provider's location experienced welts at the injection sites.  Each subject's welt was "about two inches across and looks very similar to a bug bite".  At the time of reporting the outcome of the events was unspecified.
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of injection site redness in a female subject of unspecified age who was vaccinated with Flulaval (GlaxoSmithKline).  On an unspecified date in 2007 (between 18 September 2007 and 02 October 20007), the subject received unspecified dose of Flulaval (0.5 ml, unknown, left arm).  On the same date as vaccination with Flulaval, the subject experienced injection site redness, injection site pruritus, and swelling injection site.  Medical attention was required at the doctor's office.  The events were resolved on the same of vaccination/ onset of the adverse events.  The healthcare professional considered the events were probably related to vaccination with Flulaval.  The nurse reported a total of four subjects who experienced similar reactions following administrations of Flulaval between 18 September 2007 and the time of reporting on 02 October 2007 (please see GSK reference numbers A0686378A, A0686379A, and A0686380A).  "Some" of the subjects experienced "swelling at the site of injection to about softball size".  The subjects had previously received influenza vaccinations and had not experienced adverse reactions "other than one patient who may have experienced redness at injection site".
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of injection site redness in a female subject of unspecified age who was vaccinated with Flulaval (GlaxoSmithKline).  On an unspecified date in 2007 (between 18 September 2007 and 02 October 20007), the subject received unspecified dose of Flulaval (0.5 ml, unknown, left arm).  On the same date as vaccination with Flulaval, the subject experienced injection site redness, injection site pruritus, and swelling injection site.  Medical attention was required at the doctor's office.  The events were resolved on the same day of vaccination/ onset of the adverse events.  The healthcare professional considered the events were probably related to vaccination with Flulaval.  The nurse reported a total of four subjects who experienced similar reactions following administrations of Flulaval between 18 September 2007 and the time of reporting on 02 October 2007 (please see GSK reference numbers A0686373A, A0686379A, and A0686380A).  "Some" of the subjects experienced "swelling at the site of injection to about softball size".  The subjects had previously received influenza vaccinations and had not experienced adverse reactions "other than one patient who may have experienced redness at injection site".
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of injection site redness in a female subject of unspecified age who was vaccinated with Flulaval (GlaxoSmithKline).  On an unspecified date in 2007 (between 18 September 2007 and 02 October 20007), the subject received unspecified dose of Flulaval (0.5 ml, unknown, left arm).  On the same date as vaccination with Flulaval, the subject experienced injection site redness, injection site pruritus, and swelling injection site.  Medical attention was required at the doctor's office.  The events were resolved on the same day of vaccination/ onset of the adverse events.  The healthcare professional considered the events were probably related to vaccination with Flulaval.  The nurse reported a total of four subjects who experienced similar reactions following administrations of Flulaval between 18 September 2007 and the time of reporting on 02 October 2007 (please see GSK reference numbers A0686373A, A0686378A, and A0686380A).  "Some" of the subjects experienced "swelling at the site of injection to about softball size".  The subjects had previously received influenza vaccinations and had not experienced adverse reactions "other than one patient who may have experienced redness at injection site".
Sex: U
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of injection site redness in a subject of unspecified age and gender who was vaccinated with Flulaval (GlaxoSmithKline).  On an unspecified date in 2007 (between 18 September 2007 and 02 October 20007), the subject received unspecified dose of Flulaval (0.5 ml, unknown, left arm).  On the same date as vaccination with Flulaval, the subject experienced injection site redness, injection site pruritus, and swelling injection site.  Medical attention was required at the doctor's office.  The events were resolved on the same day of vaccination/ onset of the adverse events.  The healthcare professional considered the events were probably related to vaccination with Flulaval.  The nurse reported a total of four subjects who experienced similar reactions following administrations of Flulaval between 18 September 2007 and the time of reporting on 02 October 2007 (please see GSK reference numbers A0686373A, A0686378A, and A0686379A).  "Some" of the subjects experienced "swelling at the site of injection to about softball size".  The subjects had previously received influenza vaccinations and had not experienced adverse reactions "other than one patient who may have experienced redness at injection site".
Sex: F
Vaccine: FLU3
Symptoms: Accidental overdose, Immediate post-injection reaction, Incorrect dose administered, Injection site pain, Vaccine positive rechallenge
Clinical narrative: This case was reported by a healthcare professional (also the subject) and described the occurrence of sore arm (injection site) in an adult female subject who was vaccinated with Flulaval (GlaxoSmithKline).  Concurrent medical conditions included back pain and high blood pressure.  Concurrent medications included Diovan, Ultram and naproxen.  In 2006 the subject inadvertently received a dose of Flulaval at 1.0 ml.  This was considered to be an accidental asymptomatic overdose.  Flulaval is indicated for use at a dose of 0.5 ml.  No adverse events were reported.  On 3 October 2007, the subject again inadvertently received a dose of Flulaval at 1.0 ml (dose given with one-half inch needle).  This was considered a medication error.  Immediately after vaccination with Flulaval, the subject developed a sore arm at the injection site.  This too was considered to be an accidental asymptomatic overdose.  The subject should have received a 0.5 ml dose of Flulaval.  At the time of reporting the outcome of the sore arm at injection site was unresolved and in the reporter's opinion, the event was possibly related to treatment with Flulaval.
Sex: U
Vaccine: FLU3, PPV
Symptoms: Immediate post-injection reaction, Injection site erythema, Injection site induration, Injection site pain, Injection site pruritus
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of injection site pruritus in eight to ten adult subjects of unspecified gender who were vaccinated with Flulaval (GlaxoSmithKline).  Concurrent vaccination included pneumonia vaccine, (manufacturer unspecified) given between 28 September 2007 and 04 October 2007.  Between 28 September 207 and 04 October 2007 the subjects received unspecified doses of Flulaval (0.5 mL, unknown).  "Right away" following vaccination with Flulaval, the subjects developed itching at the injection sites.  At an unspecified time after receiving Flulaval, the subjects also experienced events including hard "knots" at the injection sites, injection site redness and injection site pain.  At the time of reporting the events were unresolved.  The healthcare professional considered the events were probably related to vaccination with Flulaval.  The healthcare professional stated that eight to ten subjects of the approximately fifty who were administered Flulaval between 28 September 2007 and 04 October 2007 reported side effects.  The healthcare professional also indicated that "most symptoms have resolved but unsure exactly how many"; however, an outcome of unresolved was also reported.
Sex: U
Vaccine: FLU3
Symptoms: Injection site irritation, Injection site reaction
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of injection site reaction in a subject of unspecified age and gender who was vaccinated with Flulaval (GlaxoSmithKline).  On an unspecified date the subject received unspecified dose of Flulaval (unknown).  After vaccination with Flulaval, the subject experienced injection site reaction and burning sensation injection site.  At the time of reporting the outcome of the events was unspecified.  The healthcare professional considered the injection site reaction possibly related to vaccination with Flulaval.  The reporter believed that there may have been a problem with the particular lot of vaccine used.
Age: 17.0
Sex: M
Vaccine: HEPAB, MNQ, TDAP, HEPAB, MNQ, TDAP, UNK, HEPAB, MNQ, TD, HEPAB, MNQ, TDAP
Symptoms: Asthenia, Dysphagia, Dyspnoea, Hypoaesthesia, Intestinal functional disorder
Clinical narrative: Pt developed weakness to lower legs bilaterally after 5 days. He avoided sick call but during a febrile respiratory illness (FRI) screen in a squad bay, noted he was not doing well and took him to the IDC. Dx: Peripheral neuropathy and GBS. CDC and VAERS completed previously.
Age: 17.0
Sex: M
Vaccine: HEPAB, MNQ, TDAP, HEPAB, MNQ, TDAP, UNK, HEPAB, MNQ, TD, HEPAB, MNQ, TDAP
Symptoms: Regurgitation, Speech disorder, Vision blurred
Clinical narrative: Pt developed weakness to lower legs bilaterally after 5 days. He avoided sick call but during a febrile respiratory illness (FRI) screen in a squad bay, noted he was not doing well and took him to the IDC. Dx: Peripheral neuropathy and GBS. CDC and VAERS completed previously.
Age: 17.0
Sex: M
Vaccine: HEPAB, MNQ, TDAP, HEPAB, MNQ, TDAP, UNK, HEPAB, MNQ, TD, HEPAB, MNQ, TDAP
Symptoms: Guillain-Barre syndrome, Muscular weakness, Neuropathy peripheral
Clinical narrative: Pt developed weakness to lower legs bilaterally after 5 days. He avoided sick call but during a febrile respiratory illness (FRI) screen in a squad bay, noted he was not doing well and took him to the IDC. Dx: Peripheral neuropathy and GBS. CDC and VAERS completed previously.
Age: 17.0
Sex: M
Vaccine: HEPAB, MNQ, TDAP, HEPAB, MNQ, TDAP, UNK, HEPAB, MNQ, TD, HEPAB, MNQ, TDAP
Symptoms: Asthenia, Dysphagia, Dyspnoea, Gait disturbance, Guillain-Barre syndrome
Clinical narrative: Pt developed weakness to lower legs bilaterally after 5 days. He avoided sick call but during a febrile respiratory illness (FRI) screen in a squad bay, noted he was not doing well and took him to the IDC. Dx: Peripheral neuropathy and GBS. CDC and VAERS completed previously.
Age: 17.0
Sex: M
Vaccine: HEPAB, MNQ, TDAP, HEPAB, MNQ, TDAP, UNK, HEPAB, MNQ, TD, HEPAB, MNQ, TDAP
Symptoms: Hypoaesthesia, Intestinal functional disorder, Regurgitation, Speech disorder, Swelling
Clinical narrative: Pt developed weakness to lower legs bilaterally after 5 days. He avoided sick call but during a febrile respiratory illness (FRI) screen in a squad bay, noted he was not doing well and took him to the IDC. Dx: Peripheral neuropathy and GBS. CDC and VAERS completed previously.
Age: 17.0
Sex: M
Vaccine: HEPAB, MNQ, TDAP, HEPAB, MNQ, TDAP, UNK, HEPAB, MNQ, TD, HEPAB, MNQ, TDAP
Symptoms: Vision blurred
Clinical narrative: Pt developed weakness to lower legs bilaterally after 5 days. He avoided sick call but during a febrile respiratory illness (FRI) screen in a squad bay, noted he was not doing well and took him to the IDC. Dx: Peripheral neuropathy and GBS. CDC and VAERS completed previously.
Age: 17.0
Sex: M
Vaccine: HEPAB, MNQ, TDAP, HEPAB, MNQ, TDAP, UNK, HEPAB, MNQ, TD, HEPAB, MNQ, TDAP
Symptoms: Hypoaesthesia, Intestinal functional disorder, Regurgitation, Speech disorder, Vision blurred
Clinical narrative: Pt developed weakness to lower legs bilaterally after 5 days. He avoided sick call but during a febrile respiratory illness (FRI) screen in a squad bay, noted he was not doing well and took him to the IDC. Dx: Peripheral neuropathy and GBS. CDC and VAERS completed previously.
Age: 0.4
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Crying, Diarrhoea, Diet refusal, Haematochezia
Clinical narrative: Inconsolable crying 6 hrs total, 4 loose stools - one with small amount of blood. Suspect Rotateq.
Age: 0.4
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Crying, Diarrhoea, Haematochezia
Clinical narrative: Inconsolable crying 6 hrs total, 4 loose stools - one with small amount of blood. Suspect Rotateq.
Age: 9.0
Sex: M
Vaccine: VARCEL, VARCEL
Symptoms: Erythema multiforme, Injection site pain, Rash
Clinical narrative: Patient developed erythema multiforme. Onset on 10/27/07, twelve days after the injection.  The diagnosis was made on 10/29/07.  Symptoms resolved without treatment by 11/6/07.
Age: 9.0
Sex: M
Vaccine: VARCEL, VARCEL
Symptoms: Erythema multiforme
Clinical narrative: Patient developed erythema multiforme. Onset on 10/27/07, twelve days after the injection.  The diagnosis was made on 10/29/07.  Symptoms resolved without treatment by 11/6/07.
Age: 66.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Cellulitis, Injection site erythema, Injection site pruritus, Injection site vesicles
Clinical narrative: Pt presented with localized redness, swelling, and warmth at injection site. The area grew overnight. Physician prescribed Cephalexin 500mg TID for 7 days.
Age: 66.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Pt presented with localized redness, swelling, and warmth at injection site. The area grew overnight. Physician prescribed Cephalexin 500mg TID for 7 days.
Age: 60.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Computerised tomogram normal, Inflammation, Injection site pruritus, Pyrexia
Clinical narrative: itchyness at  the site of the injection Fever or 103 and higher Cellulitis inflamation of the muscle continued muscle damage since event - treated symptomatically  for 2 days - doctor called on both occasions- saw doctor on day 3 -she suggested trying an anitbiotic for 1 day - if no imporvement then go to the ER the next day - went to the ER the next day - IV antibiotic and pregnisone
Age: 60.0
Sex: F
Vaccine: PPV
Symptoms: Ultrasound scan normal
Clinical narrative: itchyness at  the site of the injection Fever or 103 and higher Cellulitis inflamation of the muscle continued muscle damage since event - treated symptomatically  for 2 days - doctor called on both occasions- saw doctor on day 3 -she suggested trying an anitbiotic for 1 day - if no imporvement then go to the ER the next day - went to the ER the next day - IV antibiotic and pregnisone
Age: 1.25
Sex: F
Vaccine: DTAP, FLU3, HIBV, MMRV
Symptoms: Contusion, Erythema, Oedema peripheral, Skin warm
Clinical narrative: Lt thigh swollen and bruise looking warm to touch  and very red
Age: 21.0
Sex: F
Vaccine: TYP
Symptoms: Abnormal behaviour, Disturbance in attention, Pyrexia
Clinical narrative: Each of dose days, became "loopy".  Having a hard time concentrating. Example- turned off lights, shut door and was getting ready to go home from work in the middle of the day until coworker stopped her.  Also had fever- exact degrees unknown.  Stayed home last two dose days.
Age: 65.0
Sex: M
Vaccine: FLU3
Symptoms: Asthenia, Diarrhoea, Dizziness, Dysphonia, Dyspnoea
Clinical narrative: Pt called on 11/6/07 to report reaction, he says he got sob and wheezy right after the vaccine. He used albuterol inhaler. He continues to have sore throat ,hoarseness, dizziness and weakness, and diarrhea one week later.
Age: 65.0
Sex: M
Vaccine: FLU3
Symptoms: Pharyngolaryngeal pain, Wheezing
Clinical narrative: Pt called on 11/6/07 to report reaction, he says he got sob and wheezy right after the vaccine. He used albuterol inhaler. He continues to have sore throat ,hoarseness, dizziness and weakness, and diarrhea one week later.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Wrong drug administered
Clinical narrative: DTaP given instead of Tdap. No adverse effects - per step-mother 11/06/07.
Age: 1.42
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Pyrexia, Rash morbilliform, Upper respiratory tract infection
Clinical narrative: Patient received vaccinations on 10/25/2007 and developed a morbilliform rash over neck, legs and abdomen on 10/26/2007.  She also had fever to a maximum of 102F, that defervesced within 2 days, and upper respiratory symptoms.
Age: 51.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site swelling, Injection site urticaria, Injection site warmth
Clinical narrative: got flu vaccine with thimersol had 3 inch hive develop below injection site heat redness swelling of deltoid worse evening of 11/05/2007
Age: 0.58
Sex: F
Vaccine: FLU3, PNC
Symptoms: Convulsion
Clinical narrative: Seizure - Brief 6 days after administration of vaccines
Age: 10.0
Sex: F
Vaccine: VARCEL
Symptoms: Pruritus, Pyrexia, Rash, Swelling face, Tenderness
Clinical narrative: puffy face; tender/itchy skin and rash to face, anterior arms; low grade fever;  Treated with benedryl
Age: 48.0
Sex: F
Vaccine: FLU3
Symptoms: Headache, Hypoaesthesia, Neck pain, Pain in extremity, Respiratory tract congestion
Clinical narrative: ON 10/16/07 DEVELOPED PAIN GOING DOWN NECK HEADACHE-- NOT RELEASED BY TYLENOL OR MOTRIN-PROGRESS TO SINUS AND CHEST CONGESTION- STARTED LEVQUIN ON 10/18/07-FOR 6 DAYS DIDN'T IMPROVE- FOLLOW UP WITH NP STARTED ON FACTIVE- DEVELOPED ON 10/22/07 LT ARM AND L LEG PAIN/NUMBNESS-REPORTED 11/2/07
Age: 48.0
Sex: F
Vaccine: FLU3
Symptoms: Sinus congestion
Clinical narrative: ON 10/16/07 DEVELOPED PAIN GOING DOWN NECK HEADACHE-- NOT RELEASED BY TYLENOL OR MOTRIN-PROGRESS TO SINUS AND CHEST CONGESTION- STARTED LEVQUIN ON 10/18/07-FOR 6 DAYS DIDN'T IMPROVE- FOLLOW UP WITH NP STARTED ON FACTIVE- DEVELOPED ON 10/22/07 LT ARM AND L LEG PAIN/NUMBNESS-REPORTED 11/2/07
Age: 80.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Skin warm
Clinical narrative: Diffuse erythemia and tactile warmth to Left upper arm
Age: 4.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site erythema, Rash macular
Clinical narrative: Splotchy rash on legs and arms,erythema to vaccination site 15 min after vaccination was administerd. Benedryl 18.75 mg po, Orapred ODT 15mg was given stat.  Reaction had improve after 45min. Will repeate Orapred ODT 15mg for 4 days
Sex: U
Vaccine: PPV
Symptoms: Swelling
Clinical narrative: Information has been received from an employee of a distributor and a health care provider concerning a patient who on an unspecified date was vaccinated with Pneumovax 23. Subsequently the patients was hospitalized with swelling. No further details were provided. No further information is expected.
Age: 25.0
Sex: M
Vaccine: DTAP, FLUX, PPV
Symptoms: Chills, Headache, Inappropriate schedule of drug administration, Influenza like illness, Pain
Clinical narrative: Information has been received from a PharmD concerning a 25-26 year old male whose vaccination history was unknown was vaccinated (route and site not reported) on 23-OCT-2007 with Pneumovax 23. On the same day the patient was concomitantly vaccinated with DTAP (manufacturer unknown) and influenza virus vaccine (unspecified - manufacturer unknown). On 24-OCT-2007, the patient developed influenza-like symptoms: headache, chills, fever and body aches which resulted in the patient missing two days of work. The patient sought unspecified medical attention and no further information is available. At the time of this report the patient had not recovered. The pharmacist felt that the patient's headache, chills, fever and body aches were disabling. This is one of several reports from the same source. Additional information has been requested.
Age: 25.0
Sex: M
Vaccine: DTAP, FLUX, PPV
Symptoms: Pyrexia
Clinical narrative: Information has been received from a PharmD concerning a 25-26 year old male whose vaccination history was unknown was vaccinated (route and site not reported) on 23-OCT-2007 with Pneumovax 23. On the same day the patient was concomitantly vaccinated with DTAP (manufacturer unknown) and influenza virus vaccine (unspecified - manufacturer unknown). On 24-OCT-2007, the patient developed influenza-like symptoms: headache, chills, fever and body aches which resulted in the patient missing two days of work. The patient sought unspecified medical attention and no further information is available. At the time of this report the patient had not recovered. The pharmacist felt that the patient's headache, chills, fever and body aches were disabling. This is one of several reports from the same source. Additional information has been requested.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Abortion induced, Blood human chorionic gonadotropin positive, Chlamydia serology, Drug exposure during pregnancy, Laboratory test
Clinical narrative: Information has been received through the Merck pregnancy registry from a registered nurse concerning a 22 year old female with no drug reactions/allergies, hypothyroidism, depression and a history of 3 pregnancies and 3 live birth who on 30-JAN-2007 was vaccinated with the first dose of Gardasil IM in right deltoid (Lot # 65519/1427F). Concomitant therapy included levothyroxine Na (SYNTHROID) and bupropion HCl (WELLBUTRIN). The patient was found to be pregnant (LMP 08-JAN-2007). The estimated delivery date was reported as 16-OCT-2007.  A pregnancy test, chlamydia culture, thyroid level and wellness screening panel were done (results not reported). An ultrasound done on 19-FEB-2007 for prenatal care and was noted to be normal. Additional information indicated that in April, 2007, week from LMP 12, the patient had an elective termination of pregnancy. It was unknown whether the fetus was normal and the products of conception examined. Additional information has been requested.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Thyroid function test, Ultrasound scan normal
Clinical narrative: Information has been received through the Merck pregnancy registry from a registered nurse concerning a 22 year old female with no drug reactions/allergies, hypothyroidism, depression and a history of 3 pregnancies and 3 live birth who on 30-JAN-2007 was vaccinated with the first dose of Gardasil IM in right deltoid (Lot # 65519/1427F). Concomitant therapy included levothyroxine Na (SYNTHROID) and bupropion HCl (WELLBUTRIN). The patient was found to be pregnant (LMP 08-JAN-2007). The estimated delivery date was reported as 16-OCT-2007.  A pregnancy test, chlamydia culture, thyroid level and wellness screening panel were done (results not reported). An ultrasound done on 19-FEB-2007 for prenatal care and was noted to be normal. Additional information indicated that in April, 2007, week from LMP 12, the patient had an elective termination of pregnancy. It was unknown whether the fetus was normal and the products of conception examined. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Cervix carcinoma, Smear cervix abnormal
Clinical narrative: Information has been received from a consumer concerning her friend's 19 to 20 year old daughter who was vaccinated with the first and second dose of Gardasil. She indicated that her daughter developed "cancer cell" after the second dose. The patient had pap smear before the first dose and had normal results. However, after the second dose about  a month ago the patient had abnormal pap smear results, "cancer cells," which had to be removed. It was indicated that cancer cells were removed and the patient was fine. Unknown medical attention was sought. The patient was recovered. No product quality complaint was involved. On 30-OCT-2007 the followup information indicated that the patient never received the third dose of vaccination. This is one of two cases from the same source. Additional information has been requested.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Computerised tomogram, Laboratory test, Oedema peripheral, Splenomegaly
Clinical narrative: Information has been received from a physician concerning a 25 year old female who in May 2007, was vaccinated with the first dose of Gardasil. There was no concomitant medication. about 10 days after the vaccination her foot swelled up. Then the swelling spread to her knee and shoulder. The patient had a CAT-scan done and it revealed that she had an enlarged spleen. Unknown medical attention was sought. The patient was put on high dose of Ibuprofen (manufacturer unspecified) and the condition resolved by July. The enlarged spleen and swollen foot considered to be disabling. No product quality complaint was involved. No further information is available.
Sex: F
Vaccine: HPV4
Symptoms: Colitis
Clinical narrative: Information has been received from a Nurse Practitioner concerning a female with no pertinent medical history and no prior drug reactions who, in February 2007, was vaccinated with the first dose of Gardasil. There was no concomitant medication. The patient's second dose of Gardasil was administered in March 2007. The nurse practitioner reported that the patient developed colitis after she received her second dose of Gardasil. The lot numbers were not known. As of 30-OCT-2007, the patient had not recovered from the colitis. The reporter considered the colitis to be disabling. Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Arthralgia, Injected limb mobility decreased, Pain in extremity
Clinical narrative: Information has been received from a health care worker concerning a 20 year old female with seasonal allergies to mold, grass, and dust who on 20-OCT-2007 was vaccinated with the second dose of Gardasil (lot# 654540/1209U) intramuscularly (IM) in the left arm. There was no concomitant medication. The evening of the second dose of Gardasil, the patient experienced injection site pain, causing immobility and inability to raise the left arm to get dressed. The patient's left arm pain/immobility had not improved and had worsened since the second Gardasil. No lab testing was performed. The patient was seen in the office on 31-OCT-2007. Injection site arm pain and immobility were considered disabling by the reporter. Additional information has been requested. Additional information was received 04/16/08. The patient came into the office for severe worsening arthralgia pain. At the time of the report the patient had not recovered. Follow-up information revealed that the patient needed help with dressing due to pain and immobility, but was able to attend classes and perform her other activities. The reporter decided the events were not disabling. The patient was still having arthralgia. The patient was to see a rheumatologist in January 2008. The office suggested that the patient not receive the 3rd does of HPV rL1 16 18 VLP vaccine (yeast). The reporting health care professional felt that pain in the arm and difficulty raising the arm, pain in arm and severe arthralgia were related to therapy with HPV rL1 6 11 16 18 VLP vaccine (yeast). Additional information is not expected.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Convulsion
Clinical narrative: Information has been received from a physician concerning a 14 year old female who on an unspecified date was vaccinated with a first dose of Gardasil IM. Subsequently, the patient experienced a latent seizure after receiving the first dose of the vaccine. The outcome of the seizure was not reported. Upon internal review, seizure was considered to be an Other Important Medical Event. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Polyarteritis nodosa
Clinical narrative: Information has been received from a medical student concerning a female who was vaccinated with a dose of Gardasil. It was reported that "within a few weeks or a few months" after vaccination the patient was diagnosed with cutaneous polyarteritis nodosa. The patient's outcome was unknown. Upon internal review, polyarteritis nodosa was considered to be an other important medical event. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Cervix carcinoma, Smear cervix abnormal
Clinical narrative: Information has been received from a consumer concerning her friend's mid 20 year old daughter who was vaccinated with the first and second dose of Gardasil. She indicated that her daughter developed "cancer cell" after the second dose. The patient had pap smear before the first dose and had normal results. However, after the second dose about a month ago the patient had abnormal pap smear results, "cancer cells," which had to be removed. It was indicated that cancer cells were removed and the patient was fine. Unknown medical attention was sought. The patient was recovered. No product quality complaint was involved. On 30-Oct-2007 the followup information indicated that the patient never received the third dose of vaccination. This is one of two cases from the same source. Additional information has been requested.
Age: 35.0
Sex: F
Vaccine: FLUX
Symptoms: Blood count abnormal, Blood pressure decreased, Cough, Loss of consciousness, Vomiting
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of decreased blood pressure in a 35-year-old female subject who was vaccinated with influenza virus vaccine (manufacturer unspecified) for prophylaxis. The subject's medical history included celiac sprue and gluten intolerance. The reporter was not aware of any reactions experienced by previous influenza vaccinations other than this reported event. On an unspecified date in 2005 the subject received unspecified dose of Influenza virus vaccine (unknown). In 2005, less than one year after vaccination with Influenza virus vaccine, the subject experienced decreased blood pressure, vomiting, cough, passed out and blood count "changes." The healthcare professional reported on 30 October 2007, that the events occurred 2 years ago. The subject reported to the healthcare professional that the reaction was similar to those reactions she developed following exposure to Gluten. The subject was seen in an emergency room. At the time of reporting the events were resolved. Comment: Passed out was assessed as medically serious by GSK.
Age: 30.0
Sex: M
Vaccine: FLUN3
Symptoms: Blood creatine phosphokinase increased, Chromaturia
Clinical narrative: 24 hours after receiving FluMist patient noticed dark brown urine. Next day CK level found elevated. Did have afebrile URI symptoms starting 2 days prior to receiving FluMist. Received IV fluid therapy for 48 hours after 24 hrs of oral therapy until CK < 5000. No other complications.  11/27/2007 MR received DOS 10/13-16/2007.  Pt reported dark brown urine 1 day following Flumist vax.  Pt had 5 day hx of afebrile URI prior to receiving vaccine.  PE (+) for pharyngeal erythema and nasal discharge. Diffuse aches noted in arms and back.  DX:  Rhabdomyolysis (likely due to viral illness, possibly Flumist). TXd with IVF.  Normal urine color noted 10/16/2007. Resolution of Lab abnormalities noted on 10/16 as well.
Age: 15.0
Sex: F
Vaccine: HEPA
Symptoms: Abdominal pain, Abdominal pain upper, Anorexia, Back pain, Body temperature increased
Clinical narrative: 2 days after shot child had temp of 102 or more with back and stomach ache, loss of appetite, weight, soreness in the eyes, and ulcer in the mouth. Child was very fatigue with major back aches and sore throat. Upper abdomen was very painful. Hemoglobin went a 13.0 to a 8.6 count. Also child had chills and sweat. Child was given Tylenol for fever and pain. The illness course was 23 days. 11/14/07-records received-office visit 8/17/07-C/O prolonged fever since 7/26/07-back pain, abdominal pain eye pain, productive cough and runny nose. Last fever 8/16/07.Impression, viral infection unrelated to receiving the hepaitis A vaccine, she has antibody to HAV and does not need a second dose of HAV. Mild leucopenia.
Age: 15.0
Sex: F
Vaccine: HEPA
Symptoms: Chills, Eye pain, Fatigue, Haemoglobin decreased, Hyperhidrosis
Clinical narrative: 2 days after shot child had temp of 102 or more with back and stomach ache, loss of appetite, weight, soreness in the eyes, and ulcer in the mouth. Child was very fatigue with major back aches and sore throat. Upper abdomen was very painful. Hemoglobin went a 13.0 to a 8.6 count. Also child had chills and sweat. Child was given Tylenol for fever and pain. The illness course was 23 days. 11/14/07-records received-office visit 8/17/07-C/O prolonged fever since 7/26/07-back pain, abdominal pain eye pain, productive cough and runny nose. Last fever 8/16/07.Impression, viral infection unrelated to receiving the hepaitis A vaccine, she has antibody to HAV and does not need a second dose of HAV. Mild leucopenia.
Age: 15.0
Sex: F
Vaccine: HEPA
Symptoms: Mouth ulceration, Pain, Pharyngolaryngeal pain, Pyrexia, Weight decreased
Clinical narrative: 2 days after shot child had temp of 102 or more with back and stomach ache, loss of appetite, weight, soreness in the eyes, and ulcer in the mouth. Child was very fatigue with major back aches and sore throat. Upper abdomen was very painful. Hemoglobin went a 13.0 to a 8.6 count. Also child had chills and sweat. Child was given Tylenol for fever and pain. The illness course was 23 days. 11/14/07-records received-office visit 8/17/07-C/O prolonged fever since 7/26/07-back pain, abdominal pain eye pain, productive cough and runny nose. Last fever 8/16/07.Impression, viral infection unrelated to receiving the hepaitis A vaccine, she has antibody to HAV and does not need a second dose of HAV. Mild leucopenia.
Age: 34.0
Sex: F
Vaccine: ANTH
Symptoms: Erythema, Heat therapy, Skin warm, Swelling, Tenderness
Clinical narrative: One day after the vaccination with Anthrax #4 pt developed a red, swollen, raised, flat, tender and warm area 2 x 6 cm. Pt advised to treat with Motrin and warm compressions per Dr of the Healthcare Center. He also requested future Anthrax vaccinations be give IM as opposed to SC.
Age: 74.0
Sex: M
Vaccine: FLU3
Symptoms: Chest discomfort, Cough, Headache, Rhinorrhoea
Clinical narrative: Patient reported complaints of chest "irritation", cough, runny nose and headache within few hours of receipt of flu shot.
Age: 26.0
Sex: F
Vaccine: FLUN3
Symptoms: C-reactive protein, Full blood count, Metabolic function test, Pain in extremity, Red blood cell sedimentation rate
Clinical narrative: Received flumist on 3 Oct 07, on 5 Oct developed soreness in pad of right thumb (thenar surface). This became much more sore by 2 wks after flumist.  Was seen by provider and given Motrin (didn't help), was seen again one wk later and was given tramadol (didn't help either). Today 6 Nov, hand is still sore.  Is being worked up now by different provider.
Age: 39.0
Sex: F
Vaccine: FLU3
Symptoms: Back pain, Immediate post-injection reaction, Injected limb mobility decreased, Muscle spasms, Pain
Clinical narrative: PATIENT STATES INJECTION DID NOT FEEL RIGHT FROM THE TIME IT WAS GIVEN. ACUTE ONSET OF PAIN @ 1PM BY EVENING WAS HAVING BACK SPASMS & BACK PAIN. COULD NOT LIFT LEFT ARM, PATIENT CALLED NFP NEXT DAY & INSTRUCTED TO CALL PRIMARY CARE PHYSICIAN. SEEN BY PCP 11/2/07 DX WITH INFLAMED ROTATOR CUFF, GIVEN IBUPROPHEN 800MG TID, ICE BID,& REFERRED TO PT. UNABLE TO GO @ PRESENT DOING HOME EXERCISES PER PCP'S INSTRUCTIONS.
Age: 39.0
Sex: F
Vaccine: FLU3
Symptoms: Rotator cuff syndrome
Clinical narrative: PATIENT STATES INJECTION DID NOT FEEL RIGHT FROM THE TIME IT WAS GIVEN. ACUTE ONSET OF PAIN @ 1PM BY EVENING WAS HAVING BACK SPASMS & BACK PAIN. COULD NOT LIFT LEFT ARM, PATIENT CALLED NFP NEXT DAY & INSTRUCTED TO CALL PRIMARY CARE PHYSICIAN. SEEN BY PCP 11/2/07 DX WITH INFLAMED ROTATOR CUFF, GIVEN IBUPROPHEN 800MG TID, ICE BID,& REFERRED TO PT. UNABLE TO GO @ PRESENT DOING HOME EXERCISES PER PCP'S INSTRUCTIONS.
Sex: U
Vaccine: PPV
Symptoms: Dyspnoea, Heart rate increased
Clinical narrative: Patient experienced elevated heart rate and shortness of breath.
Age: 23.0
Sex: F
Vaccine: PPV
Symptoms: Dyspnoea, Heart rate increased
Clinical narrative: Patient experienced elevated heart rate and shortness of breath.
Age: 43.0
Sex: F
Vaccine: PPV
Symptoms: Headache, Injection site pain, Injection site swelling, Injection site warmth, Nausea
Clinical narrative: Administered vaccine on 10/29/07 at 1129 to right deltoid area. Employee states she was unable to sleep due to pain/swelling at site and she also had a fever. Site was tender and warm to touch. Employee returned to work the following day but was naseated and had a headache. She was taken to the E.R. for evaluation due to several cardiac surgeries she had had during this year.
Age: 43.0
Sex: F
Vaccine: PPV
Symptoms: Pyrexia, Sleep disorder
Clinical narrative: Administered vaccine on 10/29/07 at 1129 to right deltoid area. Employee states she was unable to sleep due to pain/swelling at site and she also had a fever. Site was tender and warm to touch. Employee returned to work the following day but was naseated and had a headache. She was taken to the E.R. for evaluation due to several cardiac surgeries she had had during this year.
Age: 44.0
Sex: F
Vaccine: FLU3
Symptoms: Dyspnoea, Pruritus
Clinical narrative: she recieved flu shot in left deltoid at 3:30 pm. about 1 1/2 hours later, she developed itching upper left arm, shoulder, left lateral neck to her hairline. No rash or swelling. This subsided about two hours later. In the morning, the itch returned and spread to her lateral hips. She applied caladryl with some relief. comlained of having trouble taking a deep breath, but no shortness of breath. Given atarax 25 mg po q6-8 hours prn. Advised not to recieve flu vaccine
Age: 38.0
Sex: F
Vaccine: FLU3
Symptoms: Burning sensation, Rash, Urticaria
Clinical narrative: burning hives on back of neck...was not sure if resulted from vaccination but did not notice the rash before.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Acne, Anxiety, Asthenia, Contusion, Depressed mood
Clinical narrative: Patient went from being a very healthy, active, goal oriented student to feeling tired and sick all the time. Two weeks after the first dose she had a severe sore throat which lasted for weeks and she was in extreme pain and had to take Tylenol with Codeine and felt tired and weak all the time.   After the second dose she also started to experience anxiety because she was concerned that something was wrong with her.  After the third dose she has had several things happen.  She began breaking out with a small pimple like lesion on her face which turned into a dime size open wound which looked like a burn.  To this day she still gets one a month and they are all leaving scars on her face.  She has been to a dermatologist and to her pediatrician and no one has an answer as to what they are or where she is getting them from.  The end of August she began feeling depressed because she never feels well and she lost 18 pounds in 4 weeks time.  She went down to 88 pounds.  Her legs are bruising terribly and she has been to the doctor's twice and no answers.  Her CBC's were all WNL. I was afraid she was suffering from Anorexia, however, since then she has gained the 20 pounds back in a four week period of time which seems very unusual in such a short period of time.  She states that ever since she has had the second dose of the vaccine she always feels scattered whereas in the past she was always so focused.