chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 1.0
Sex: M
Vaccine: VARCEL, VARCEL
Symptoms: CSF lymphocyte count increased, Headache, Herpes zoster, Lumbar puncture, Lymphocyte count decreased
Clinical narrative: Patient was transfered to our facility after developing severe headache, meningitis in setting of zoster of left upper arm (site of previous vaccination 7 years prior).   CSF had pleocytosis and was PCR + for VZV at outside facility, negative at our facility after 3 days of acyclovir intervenously.   Isolate subsequently identified as vaccine-strain from both arm lesions and CSF. 6/26/08-recoreds received for DOS 6/14-6/20/07-DC DX: VZV meningitis. Presented with headache and photophobia. 9 days PTA itchy lesion on left shoulder which spread into vesicular rash over next 2 days. 6 days PTA diagnosed with shingles. 5 day PTA developed severe headache, neck stiffness, photophobia vomiting, sleepy.
Age: 1.0
Sex: M
Vaccine: VARCEL, VARCEL
Symptoms: Meningism, Meningitis, Photophobia, Pruritus, Pyrexia
Clinical narrative: Patient was transfered to our facility after developing severe headache, meningitis in setting of zoster of left upper arm (site of previous vaccination 7 years prior).   CSF had pleocytosis and was PCR + for VZV at outside facility, negative at our facility after 3 days of acyclovir intervenously.   Isolate subsequently identified as vaccine-strain from both arm lesions and CSF. 6/26/08-recoreds received for DOS 6/14-6/20/07-DC DX: VZV meningitis. Presented with headache and photophobia. 9 days PTA itchy lesion on left shoulder which spread into vesicular rash over next 2 days. 6 days PTA diagnosed with shingles. 5 day PTA developed severe headache, neck stiffness, photophobia vomiting, sleepy.
Age: 1.0
Sex: M
Vaccine: VARCEL, VARCEL
Symptoms: Rash papular, Scab, Somnolence, Varicella zoster virus serology positive, Vomiting
Clinical narrative: Patient was transfered to our facility after developing severe headache, meningitis in setting of zoster of left upper arm (site of previous vaccination 7 years prior).   CSF had pleocytosis and was PCR + for VZV at outside facility, negative at our facility after 3 days of acyclovir intervenously.   Isolate subsequently identified as vaccine-strain from both arm lesions and CSF. 6/26/08-recoreds received for DOS 6/14-6/20/07-DC DX: VZV meningitis. Presented with headache and photophobia. 9 days PTA itchy lesion on left shoulder which spread into vesicular rash over next 2 days. 6 days PTA diagnosed with shingles. 5 day PTA developed severe headache, neck stiffness, photophobia vomiting, sleepy.
Age: 82.0
Sex: F
Vaccine: VARZOS
Symptoms: Decreased appetite, Pain, Rash pruritic
Clinical narrative: Extreme body pain (ached all over) late in day and next two days.  By the third day an itchy rash came on my back and eventually spread all over my back.  It gradually went away after about a week.  The first couple of days my tummy did not feel like eating, but managed to get a little food down.  I had had shingles some years ago and my primary care doctor felt I should get the shingles vaccine to prevent getting them again.
Age: 1.0
Sex: M
Vaccine: HEP, HEPA, MMR, RV5
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: NO ADVERSE EFFECTS AT PRESENT IMMUNIZATION GIVEN OUT OF RECOMENDED GUIDELINES (ROTAVIRUS)
Age: 1.5
Sex: M
Vaccine: DTAP, FLU3
Symptoms: Blood test normal, Erythema multiforme, Laboratory test normal, Streptococcal identification test negative, Urine analysis normal
Clinical narrative: Erythema multiforme recurring for 6 weeks. 2 er visits and 4 pediatrician visits. 2 visits to dermatologist. child was treated with repeated doses of prednisolone 3 times. I have asked pediatricians office twicw to report and document this and have gotten no response from them. the dermatologist has noted in his report that there is correlation between the Em dx and the vaccinations.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Crying, Irritability
Clinical narrative: Very fussy.  Cried for several hours after vaccine
Age: 75.0
Sex: M
Vaccine: VARZOS
Symptoms: Pruritus, Rash, Rash erythematous, Rash pustular
Clinical narrative: Pt recieved Zostavax on 4/14/08. Pt states rash developed on face approx 4/28/08. Per wife pt has a red rash with about a dozen pustules on right side of face (temple to chin)with itching. Also has rash under left side of chin. No fever
Age: 18.0
Sex: F
Vaccine: HEP, HEPA, TDAP
Symptoms: Body temperature increased, Headache, Hypersomnia, Injected limb mobility decreased, Injection site erythema
Clinical narrative: Client rec'd immunization on Tuesday morning, 04-29-08 and felt fine until later that evening when she developed a "severe" headache, temp 101.5, left arm soreness beyond the normal--hard to lift her left arm, small amount of redness at left arm injection site and she is sleeping more than normal.  Mom is "pushing fluids" and giving Advil as directed.  Symptoms are alleviated with the Advil, but return as Advil wears off.  Symptoms were worse today than yesterday, but, again, are alleviated with Advil.  Client is able to keep appointments today and was talking on the phone to me without difficulty.
Age: 18.0
Sex: F
Vaccine: HEP, HEPA, TDAP
Symptoms: Pain in extremity
Clinical narrative: Client rec'd immunization on Tuesday morning, 04-29-08 and felt fine until later that evening when she developed a "severe" headache, temp 101.5, left arm soreness beyond the normal--hard to lift her left arm, small amount of redness at left arm injection site and she is sleeping more than normal.  Mom is "pushing fluids" and giving Advil as directed.  Symptoms are alleviated with the Advil, but return as Advil wears off.  Symptoms were worse today than yesterday, but, again, are alleviated with Advil.  Client is able to keep appointments today and was talking on the phone to me without difficulty.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Blister, Crying, Flushing, Rash erythematous, Rash generalised
Clinical narrative: Mother reports childs face become flushed approx 20-30 minutes after vaccines, was uncertain if was due to crying or reaction.  Flushed face continued.  Mother reports that next morning child developed red rash over entire body.  Denies trouble breathing.  Then reports that child's face is like one big blister.  Mother informed to follow-up with pediatrican ASAP.  If s/s worsen or become emergent take child to ER immediatley.  No treatment thus far.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Asked to see 4 y/o female at WIC clinic.  Received IPV on 4/28/08 in RDT.  Mom noticed swelling, redness and itching the day after immunizations given.  Treated with warm washcloth but swelling and redness has increased around immunization site.  Site warm to the touch, non tender.
Age: 55.0
Sex: F
Vaccine: HEPA
Symptoms: Arthralgia, Dizziness, Malaise, Myalgia, Pain
Clinical narrative: about 12 days after injection I had episodic dizzy spells,  then on 4/29 I just wasn't feeling well. on 4/30 I had severe migrating muscle pain w/ occ. pain in knee and hip joints.  nex day I ache all aver w/ most severe pain in lt lateral thigh, ? fever, malaise.
Age: 55.0
Sex: F
Vaccine: HEPA
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: about 12 days after injection I had episodic dizzy spells,  then on 4/29 I just wasn't feeling well. on 4/30 I had severe migrating muscle pain w/ occ. pain in knee and hip joints.  nex day I ache all aver w/ most severe pain in lt lateral thigh, ? fever, malaise.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Returned to clinic two days after receiving vaccines.  Right upper arm to elbow red and warm to touch.  No pain noted. No fever.  Keflex 250mg, TID x 5 days ordered.
Age: 2.0
Sex: M
Vaccine: DTAP, HEPA
Symptoms: Erythema, Oedema peripheral, Pyrexia, Skin warm
Clinical narrative: low grade fever on 4/30/08 no fevers today leg swollen 8cm x 9cm, red and hot to touch.  observed in office for monitoring advised tylenol and warm packs.  patient will be in office tomorrow with sibling and will observe swelling at that time again otherwise mother to call if swelling or redness goes outside drawn line.
Age: 1.0
Sex: F
Vaccine: HEPA, MMRV, PNC
Symptoms: Irritability, Rash
Clinical narrative: onset of rash 2 days ago, other than being a little more irritable, she has been eating and sleeping well, does not seem pruritic.
Age: 45.0
Sex: M
Vaccine: HEP
Symptoms: Stevens-Johnson syndrome
Clinical narrative: Patient admitted to hospital after developed rash suspicious for Steven Johnson syndrome, this rash began 4 days after he received the Hepatitis B shot, his second dose of the series. 06/27/08 Reviewed hospital medical records of 4/16-4/18/2008 FINAL DX: no d/c summary available.  H&P states Stevens-JOhnson syndrome secondary to hepatitis B vaccine. records reveal patient experienced a worsening urticarial rash since day after vaccination.  Had been seen in ER on 4/13 & dx w/allergic reaction to hepatitis vaccine, cellulitis & tinea pedis.  Sent home on antibiotics & antifungal meds.   Bilateral LE & hands swollen. Seen by dermatologist, dx w/erythema multiforme & received steroid injection.  Condition worsened.  Developed oral lesions 2 days prior to admission & had decreased oral intake.  Seen by PCP, sent to ER & admitted.  Skin lesions were now clear blisters & more violaceous involving entire body w/ulcers on feet that had ruptured.  Tx w/IV steroids & IVF.
Age: 1.42
Sex: M
Vaccine: DTAP, MMR, VARCEL
Symptoms: Rash vesicular
Clinical narrative: rash with vesicles, 2 weeks post vaccine
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Alopecia
Clinical narrative: Started losing patches of hair after 2nd injection.
Age: 1.33
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Blister, Rash maculo-papular
Clinical narrative: diffuse macular papular rash with a few vesicles, no fever or other symptoms
Age: 1.9
Sex: F
Vaccine: VARCEL
Symptoms: Varicella
Clinical narrative: Sibling had break-through dx of varicella (VAERS submitted 4/24/08).  Patient given Varivax #2 4/23/08, had onset of pox...5 days later - only 5 pox.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Injection site erythema, Injection site rash, Injection site swelling
Clinical narrative: Pt c/o swelling, redding, rash around all three injection site x 2 days. Benadryl given
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Asthenia, Body temperature increased
Clinical narrative: Temperature per patient 99.2 - patient took Tylenol. Weakness - no treatment done.
Age: 16.0
Sex: F
Vaccine: HPV4, TTOX
Symptoms: Rash pruritic
Clinical narrative: 4 hours after vaccines administered developed pruritic rash on thighs and upper (L) chest. Treated next day with Benadryl. Depo Medrol 40mg and Decadron 4mg.
Age: 50.0
Sex: F
Vaccine: TDAP
Symptoms: Pain in extremity, Paraesthesia, Tenderness
Clinical narrative: (R) deltoid pain, pain down (R) arm, tingling in (R) hand, tender area (R) arm just below acromion. Shot given 4/21/08. Pt called 4/30/08. Pt seen back in clinic 5-1-08. Pat given a Medrol dose pak.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Arthralgia, Asthenia, Blood test normal, Dizziness, Headache
Clinical narrative: 1 hrs after receiving Gardasil pt felt weak, dizzy, hyperventilated.  Pt felt dizzy & weak with a headache for 5 days post injection.  Pt went to pediatrician had blood tests-all were WNL.  Pt has fully recovered.  Pt. also complained of joints aching.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Hyperventilation
Clinical narrative: 1 hrs after receiving Gardasil pt felt weak, dizzy, hyperventilated.  Pt felt dizzy & weak with a headache for 5 days post injection.  Pt went to pediatrician had blood tests-all were WNL.  Pt has fully recovered.  Pt. also complained of joints aching.
Sex: U
Vaccine: HEPA, VARCEL
Symptoms: Injection site pain, Injection site pruritus, Injection site rash
Clinical narrative: Rash at injection site x3 days.  Painful, itchy.  Given Benadryl ice packs.
Age: 11.0
Sex: F
Vaccine: TD
Symptoms: Chills, Nausea, Pyrexia, Vomiting
Clinical narrative: Pt experienced fever 100.4, chills, nausea, vomiting x 2. Recovered enoug to go back to school 5/1/08 (Pt's father and grandmother are allergic to Tetanus)
Age: 2.0
Sex: F
Vaccine: DTAP, MMR, PNC, VARCEL
Symptoms: Feeling hot, Full blood count, Grand mal convulsion, Pyrexia
Clinical narrative: One week after immunizations, patient developed a low-grade fever (100.3 deg) - then patient felt warm and suddenly had a one-minute generalized tonic-clonic seizure. Paramedics arrived - patient had fever >101 deg and was post-ictal. seen in local ED, discharged home.
Age: 46.0
Sex: F
Vaccine: DTAP
Symptoms: Wrong drug administered
Clinical narrative: Patient was given DTaP (Daptacel) instead of Tdap.
Age: 7.0
Sex: U
Vaccine: HEPA
Symptoms: Lip swelling, Swelling face
Clinical narrative: Upper lip swelling and right cheek swelling, duration 1-2 hours, upon awaking 5/1/08. Hep A vaccine given at 130pm 4/30/08. No airway compose.
Age: 1.3
Sex: U
Vaccine: IPV, MMR, VARCEL
Symptoms: Arthropod bite, Body temperature increased, Rash erythematous, Rash papular
Clinical narrative: MMR, varicella, IPV on 4/15 - on 4/26 rash on face, neck.  4/27 spread to trunk ext.  Papular, erythematous, no confluent, low grade temp.  Note pt bitten on feet by large amt fire ants 4/25.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, PPV
Symptoms: Erythema, Local reaction, Urticaria
Clinical narrative: Local reaction redness at the site 7 cm x 5 cm Rt thigh, and had urticaria face and extremities
Age: 45.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Erythema, Injection site coldness, Oedema, Pain
Clinical narrative: Patient presented to clinic with complaints of coldness at posterior aspect of right upper arm, shaking, chills and body aches (2 days after receiving Pneumovax vaccine). Patient  noted to have mild visible edema, erythema 18 cm x 18.5cm, warm to touch. Pt treated with Keflex 500 mg 4 day for 10 days
Age: 45.0
Sex: F
Vaccine: PPV
Symptoms: Skin warm, Tremor
Clinical narrative: Patient presented to clinic with complaints of coldness at posterior aspect of right upper arm, shaking, chills and body aches (2 days after receiving Pneumovax vaccine). Patient  noted to have mild visible edema, erythema 18 cm x 18.5cm, warm to touch. Pt treated with Keflex 500 mg 4 day for 10 days
Age: 10.0
Sex: M
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site rash, Pain, Pharyngeal oedema, Rash macular
Clinical narrative: Pt given vaccine (Varivax) approx 5 min later c/o throat swelling, lip stinging, red blotchy rash noted on R arm where vaccine given.  Administered Benadryl, epi.  Sent pt to local ER via ambulance.
Age: 5.0
Sex: F
Vaccine: RAB
Symptoms: Injection site pain, Nausea, Pyrexia, Vomiting
Clinical narrative: Initial report received from a nurse on 14 March 2007. A 5 year old, female patient (with a medical history of no known allergies; asthma and eczema) who was bitten by a dog, developed a fever of 102F and complained of nausea vomiting and soreness at the injection site after she received IMOVAX (lot number Z0905-1) intramuscularly in the right deltoid and IMOGAM (lot number, route and site of administration not reported) on 13 March 2007. There was no local reaction noted. She denied any illness at the time of vaccinations and not on any medications. The patient was treated with Motrin and at the time of the report, she had not recovered. Follow-up information received on 06 June 2007 from a health care professional. The patient had fully recovered and had received "all vaccines of the series without complication." Follow-up information received on 06 September 2007 from a health care professional. The patient made a full recovery and experienced no further adverse events.
Age: 23.0
Sex: F
Vaccine: RAB
Symptoms: Abdominal pain, Colitis ulcerative, Computerised tomogram abnormal, Diarrhoea haemorrhagic, Granulocyte count increased
Clinical narrative: Initial report received from the patient's parent on 31 July 2007. A 23-year-old female with no known allergies and no reported medical history had received a right deltoid injection of IMOVAX Rabies vaccine for pre-exposure prophylaxis on 26 July 2007, lot number unknown, and within 24 hours developed muscle aches at the site of injection and on 29 July 2007, three days post vaccination, developed abdominal pain and bloody diarrhea. It was reported that the patient had not been ill at the time of vaccination. The patient had been evaluated on 30 July 2007 by a physician. CT scan results were positive for ulcerative colitis and stool culture results are pending. A diagnosis of ulcerative colitis had not been confirmed. The patient had been scheduled for a follow-up evaluation on 31 July 2007. The patient had not recovered at the time of this report. Follow-up information received from a health care provider on 10 September 2007. Information confirming vaccine lot numbers and their sites of administration were provided by the patient's physician. The patient received a left deltoid injection of IMOVAX Rabies Vaccine, lot number Z0877-2 on 25 July 2007 and a second dose of IMOVAX Rabies Vaccine (same lot number and same site) on 27 August 2007. No adverse event had been reported after receipt of the second dose: rechallenge: negative. Lab culture specimens were obtained on 30/Jul/2007. Stool culture results: all Negative for C. Difficile Toxin A/B, salmonella, shigella, campylobacter, and E. coli. Ova/parasite Smear-Exam - Negative for helminth eggs/larvae, protozoa (Giardia and Amoebae), and Coccidia (Ctyptosporidium, Cyclospora), findings: moderate granulocytes observed. Additional information confirming the diagnosis of ulcerative colitis was not provided. The reporter stated that the, "Patient was cleared by the doctor and given a second vaccine, third vaccine due 9/10 or 9/17". No additional information was provided at this time. Follow-up information received from a health care provider on 23 October 2007. The patient continued the rabies pre-exposure series and received a third right deltoid intramuscular injection of IMOVAX Rabies Vaccine, lot number Z0877-2 on 10 September 2007. The reporter did not indicate the occurrence of any adverse events after receipt of the third dose. The reporter confirmed the patient had not received any other vaccines during the four weeks prior to receipt of the first dose of IMOVAX Rabies Vaccine. The patient was recovered at the time of the report. Follow-up information received from a health care provider on 02 January 2008. It was confirmed by the reporter that the patient had not experienced any adverse events after receiving their second and third dose of the pre-exposure IMOVAX Rabies Vaccine series. No additional information was provided at the time. Documents held by sender: Lab reports, Dr. notes.
Age: 23.0
Sex: F
Vaccine: RAB
Symptoms: Injection site pain, Myalgia, Parasite stool test negative
Clinical narrative: Initial report received from the patient's parent on 31 July 2007. A 23-year-old female with no known allergies and no reported medical history had received a right deltoid injection of IMOVAX Rabies vaccine for pre-exposure prophylaxis on 26 July 2007, lot number unknown, and within 24 hours developed muscle aches at the site of injection and on 29 July 2007, three days post vaccination, developed abdominal pain and bloody diarrhea. It was reported that the patient had not been ill at the time of vaccination. The patient had been evaluated on 30 July 2007 by a physician. CT scan results were positive for ulcerative colitis and stool culture results are pending. A diagnosis of ulcerative colitis had not been confirmed. The patient had been scheduled for a follow-up evaluation on 31 July 2007. The patient had not recovered at the time of this report. Follow-up information received from a health care provider on 10 September 2007. Information confirming vaccine lot numbers and their sites of administration were provided by the patient's physician. The patient received a left deltoid injection of IMOVAX Rabies Vaccine, lot number Z0877-2 on 25 July 2007 and a second dose of IMOVAX Rabies Vaccine (same lot number and same site) on 27 August 2007. No adverse event had been reported after receipt of the second dose: rechallenge: negative. Lab culture specimens were obtained on 30/Jul/2007. Stool culture results: all Negative for C. Difficile Toxin A/B, salmonella, shigella, campylobacter, and E. coli. Ova/parasite Smear-Exam - Negative for helminth eggs/larvae, protozoa (Giardia and Amoebae), and Coccidia (Ctyptosporidium, Cyclospora), findings: moderate granulocytes observed. Additional information confirming the diagnosis of ulcerative colitis was not provided. The reporter stated that the, "Patient was cleared by the doctor and given a second vaccine, third vaccine due 9/10 or 9/17". No additional information was provided at this time. Follow-up information received from a health care provider on 23 October 2007. The patient continued the rabies pre-exposure series and received a third right deltoid intramuscular injection of IMOVAX Rabies Vaccine, lot number Z0877-2 on 10 September 2007. The reporter did not indicate the occurrence of any adverse events after receipt of the third dose. The reporter confirmed the patient had not received any other vaccines during the four weeks prior to receipt of the first dose of IMOVAX Rabies Vaccine. The patient was recovered at the time of the report. Follow-up information received from a health care provider on 02 January 2008. It was confirmed by the reporter that the patient had not experienced any adverse events after receiving their second and third dose of the pre-exposure IMOVAX Rabies Vaccine series. No additional information was provided at the time. Documents held by sender: Lab reports, Dr. notes.
Age: 46.0
Sex: F
Vaccine: RAB
Symptoms: Chills, Hyperhidrosis
Clinical narrative: Initial report received from a patient on 17 August 2007. A 46 year old, female (with a history of allergies to trees, grass, shellfish, mycins, sulfa, PCN) complained of sweating, chills, the night after she received her first dose of IMOVAX (lot number A0208-2, route of administration not reported) in the left deltoid and IMOGAN (lot number, route and site of administration not reported) on 08 August 2007. She did not have any illness at the vaccinations and was not any medications. She had not recovered. The patient also experienced adverse events after receiving the second and third dose of IMOVAX - these are detailed in cases 2007-02827 (second dose) and 2007-02828 (third dose). Follow-up information was received from a health professional on 24 September 2007, which included details and dates of administration for the patient's other IMOVAX vaccination. It was unknown if the patient had recovered from the events.
Age: 46.0
Sex: F
Vaccine: RAB
Symptoms: Lethargy, Nausea, Pain
Clinical narrative: Initial report received from a patient on 17 August 2007. A 46 year old, female (with a history of allergies to trees, grass, shellfish, mycins, sulfa, PCN) felt lethargic, mildly achy and slightly nauseated, the day after she received her second dose of IMOVAX (lot number A0208-2, route of administration not reported) in the right deltoid on 11 August 2007. The symptoms subsided after a day except for the aches. She did not have any illness at the time of vaccinations and was not any medications. She had not recovered. Follow-up information was received from the health professional on 24 September 2007, which noted that IMOVAX dose one had been given on 08 August 2007, dose three on 15 August 2007, dose four on 20 August 2007, and dose five on 05 September 2007. Route of administration was confirmed as intramuscular. Outcome was unknown. The patient also complained of sweating chills, the night after she received her first dose of IMOVAX and IMOGAN - detailed in case 2007-02826. She also experienced adverse events after receiving the third dose of IMOVAX - detailed in case 2007-02828.
Age: 46.0
Sex: F
Vaccine: RAB
Symptoms: Lethargy, Nausea, Pain
Clinical narrative: Initial report received from a patient on 17 August 2007. A 46 year old, female (with a history of allergies to trees, grass, shellfish, mycins, sulfa, PCN) developed aches and joint pain, 2 days after she received her third dose of IMOVAX (lot number A0208-2, route of administration not reported) in the left deltoid on 15 August 2007. The symptoms are much worse. She did not have any illness at the time of the vaccinations and was not any medications. She was not recovered. The patient also complained of sweating, chills, the night after she received her first dose of IMOVAX and IMOGAN - case detailed in case 2007-02826. She also felt lethargic, mildly achy and slightly nauseated, the day after she received her second dose of IMOVAX - case details in case 2007-02827. Follow-up information was received from a health professional on 24 September 2007. The patient had received IMOVAX (lot number A0208) injections intramuscularly on the following dates: dose one (08 August 2007, left deltoid), dose two (11 August 2007, right deltoid), dose three (15 August 2007, left deltoid), dose four (20 August 2007, right deltoid), and dose five (05 September 2007, left deltoid). Events occurred following dose three. According to the reporter, the outcome was "unknown".
Age: 29.0
Sex: M
Vaccine: RAB
Symptoms: Lymphadenopathy, Nasal congestion, Pharyngolaryngeal pain
Clinical narrative: Initial report received from a patient on 29 August 2007. A 29 year old, male patient (with no medical history) developed a stuffy nose, sore throat and swollen glands in the neck, a few hours after receiving his fourth dose of IMOVAX (lot number A0208-2) intramuscularly in the right arm on 28 August 2007. He had a bat bit in April. He received the following previous vaccines: IMOVAX - dose 1 and IMOGAN - dose 1 on 14 August 2007; IMOVAX - dose 2 - intramuscularly on 17 August 2007; IMOVAX - dose 3 - intramuscularly on 21 August 2007. There were no adverse reactions reported after the vaccinations. At the time of the report, the symptoms were resolving. Follow-up information received on 12 October 2007 from a health care professional. The case was reviewed, and there was no additional information.
Age: 59.0
Sex: F
Vaccine: RAB
Symptoms: Dysgeusia, Ear discomfort, Headache
Clinical narrative: Initial report received from a physician on 31 August 2007. A 59 year old, female patient (with a history of chemical sensitivities), felt as if her "ears were plugged up" and had a "bad taste in her mouth", immediately after she received 2 shots of IMOVAX (lot number not reported) in the right and left deltoids on 21 August 2007. She had rabies post exposure series in the past. A second exposure occurred and she was seen in the hospital. A few days later, she began having a severe headache in the frontal/temporal area. She experienced the same symptoms as when she is exposed to substances such as pesticides. At the time of the report, she had not recovered.
Age: 24.0
Sex: F
Vaccine: RAB
Symptoms: Diarrhoea, Flushing, Nausea, Pregnancy test negative, Vomiting
Clinical narrative: Initial non-serious report received from a health care professional on 18 September 2007. A 24-year-old female with history of diabetes and allergy to codeine received a left deltoid intramuscular injection of IMOVAX (second dose of a post-exposure series; lot number Z0877-2) on 15 September 2007 and two days later complained of facial flushing (lasting 48 hours), nausea, vomiting and diarrhea. She was afebrile and had no complaints of symptoms at the injection site. Needle length for IM injection was reported as one inch, 25 gauge. The patient had no illness at the time of vaccination other than a reported "bite". The event was treated with PHENERGAN. Recovery status was reported as "not recovered". On 12 September 2007, the patient had received the first dose of IMOVAX (right deltoid intramuscular injection; lot number not reported) in addition to a left gluteal intramuscular injection of IMOGAM (lot number not reported). No additional information was provided at the time of this report.
Sex: F
Vaccine: RAB
Symptoms: Epstein-Barr virus infection, Migraine
Clinical narrative: Initial report received on 17 October 2007, and follow-up information was received on 23 October 2007, and 24 October 2007 from a physician.  A female patient (demographics not provided), who had no previous history of migraines, no concurrent illnesses, no pre-existing medical history, or use of other medications, had received a second intramuscular dose of IMOVAX (lot number A0208-2) in the deltoid muscle on 27 September 2007.  The patient had received the first dose of IMOVAX on 20 September 2007.  The indication for IMOVAX was preparation for the patient to be a donor for Rabies Immune Globulin.  Twenty-four hours post-vaccination of the second dose of IMOVAX on 27 September 2007, the patient developed migraine type headaches.  She was treated with over the counter analgesics and was to follow-up with her own health care provider.  On 23 October 2007 and on 24 October 2007 additional information was received from the physician stating the patient had been diagnosed with Epstein-Barr and the headaches were considered to be secondary to the Epstein-Barr diagnosis.  The patient recovered from the headaches on 23 October 2007 (approximately 25 days after onset).  Additional information has been requested.  The reporter for this case is the same as for case 2007-03512.  28 January 2008:  A corrective version was created with the same latest received date as the last version (17 October 2007) for the sole purpose of adding the term "cluster" to the narrative as per internal guidelines.  This case is part of a cluster of two cases that came from the same reporter, case 2007-03512 involves a patient who received IMOVAX, lot number A0208-2, and developed migraine type headaches.  No other relevant medically significant information was added to the case.
Sex: F
Vaccine: RAB
Symptoms: Migraine
Clinical narrative: Initial report received on 17 October 2007 and 23 October 2007 from a physician.  A female patient (demographics not provided), with no previous history of migraines, no concurrent illnesses and no pre-existing medical history, had received a first intramuscular deltoid dose of IMOVAX (lot number A0208-2) on 03 October 2007.  The patient had received the vaccination in order to be a blood donor for rabies immunoglobulin.  Twenty-four hours post-vaccination, the patient developed migraine type headaches.  The patient was provided over the counter analgesics and advised to follow-up with her primary health care provider.  At the time of this report, the patient was being evaluated by a neurologist for the migraines; however no information was provided for the neurologist.  At the time of this report, it was unknown if the patient had recovered.  The reporter for this case is the same as for case 2007-03511.  28 January 2008:  A corrective version was created with the same latest received date as the last version (17 October 2007) for the sole purpose of adding the term "cluster" to the narrative as per internal guidelines.  This case is part of a cluster of two cases that came from the same reporter, case 2007-03511 involves a patient who received IMOVAX, lot number A0208-2, and developed Epstein-Barr.  No other relevant medically significant information was added to the case.
Age: 37.0
Sex: F
Vaccine: RAB
Symptoms: Hypoaesthesia, Injection site anaesthesia, Musculoskeletal stiffness, Paraesthesia
Clinical narrative: Initial report received from a health care professional on 12 December 2007. Four or five patients (identifiers not provided) had received an intramuscular deltoid (site not reported) injection of IMOVAX RABIES Vaccine for pre-exposure prophylaxis and a few hours after vaccination (date not reported), experienced numbness, tingling, and difficulty bending their fingers. Their fingers felt swollen, but did not appear swollen. Symptoms were felt from the injection site, down the arm, to the fingers and resolved within 24 hours. The patients have not been ill at the time of vaccination. All of the patients had recovered from the event. No further information was provided at the time of the report. 28 January 2008: A corrective version was created with the same latest received date as the last version (12 December 2007) for the sole purpose of adding the term "cluster" to the top of the narrative as per internal guidelines. Follow-up information received on 01 February 2008 from a health care professional. Information was provided for one patient. The patient had been a 27-year-old female with a history of allergic dermatitis and nausea and pre-existing allergies to pollen, cats, rabbits and grass. Concomitant medications at the time of vaccination included birth control pills. The patient had been immunized on 04 December 2007 at 10:00 and had not received any prior doses of IMOVAX RABIES Vaccine in the past. No further information was provided at the time of the report.
Age: 49.0
Sex: M
Vaccine: RAB
Symptoms: Herpes zoster, Rash
Clinical narrative: Initial report received on 13 February 2008 from a health care provider.  A 49-year-old male patient with a medical history of hypertension, bipolar, and thyroid hormone replacement had received a first dose intramuscular left deltoid injection of IMOVAX RABIES vaccine, lot number A0257-2 on 31 January 2008 and four days later developed a rash on the left side of his thorax.  It was described as a "classic shingles outbreak of vesicles along dermatomal distribution over left ribs (9th or 10th rib) in a narrow band".  The patient had been taking SYNTHROID, lisinopril and PROZAC concomitantly at the time of vaccination and had a history of allergy to DEMEROL.  No other vaccines were received during the four week period prior to receipt of IMOVAX RABIES vaccination.  The patient's recovery status was unknown at the time of the report.
Age: 40.0
Sex: M
Vaccine: RAB
Symptoms: Hypoaesthesia, Mobility decreased, Musculoskeletal stiffness, Pain in extremity
Clinical narrative: Initial report received from a relative of patient on 02 July 2007. A 40 year old, male patient (with a history of allergy to ASA, doxicillin; herniated discs and Lyme's disease) experienced arm stiffness, numbness, limited mobility and pain to the entire limb within hours after he received IMOVAX (lot number Z0877-2) intramuscularly in the left deltoid on 07 June 2007. He had exposure to a bat bate and received IMOGAM (lot number Z0373-4, gluteal) and a first dose of IMOVAX in the left, lower deltoid (date of administration not reported) without incident. At the time of the third vaccination with IMOVAX, he did not have any illness. At the time of the report, the patient had not recovered.
Age: 56.0
Sex: F
Vaccine: RAB
Symptoms: Capillary disorder, Chills, Haemorrhage, Influenza like illness, Myalgia
Clinical narrative: Case received from a patient on 30 July 2007.  A 56-year-old female patient with a medical history of asthma, had received an intramuscular right deltoid injection of IMOVAX RABIES vaccine on 25 July 2007, lot number not provided.  The patient reported that within 24 hours after vaccination, she experienced flu-like symptoms, chills, fever, muscle aches and breakage of small blood vessels and bleeding in her extremities.  The patient reported that she had received BENADRYL before vaccination.  This had been the third dose of the rabies post exposure prophylactic series.  The first and second dose of IMOVAX RABIES had been administered on 19 July 2007 and 22 July 2007.  Her medical history included allergies to eggs, dyes and NOVOCAIN.  At the time of this report the patient had not been evaluated by a health care professional and she had not recovered.
Age: 56.0
Sex: F
Vaccine: RAB
Symptoms: Pyrexia
Clinical narrative: Case received from a patient on 30 July 2007.  A 56-year-old female patient with a medical history of asthma, had received an intramuscular right deltoid injection of IMOVAX RABIES vaccine on 25 July 2007, lot number not provided.  The patient reported that within 24 hours after vaccination, she experienced flu-like symptoms, chills, fever, muscle aches and breakage of small blood vessels and bleeding in her extremities.  The patient reported that she had received BENADRYL before vaccination.  This had been the third dose of the rabies post exposure prophylactic series.  The first and second dose of IMOVAX RABIES had been administered on 19 July 2007 and 22 July 2007.  Her medical history included allergies to eggs, dyes and NOVOCAIN.  At the time of this report the patient had not been evaluated by a health care professional and she had not recovered.
Age: 10.0
Sex: M
Vaccine: RAB
Symptoms: Chest pain, Headache, Nausea, Wrong drug administered
Clinical narrative: This case was reported by a consumer (the patient's mother) on 02 August 2007. A 10-year-old male patient with no reported medical history received IMOVAX (lot number A0017-2) after being exposed to a bat in his house. According to the reporter, after the second dose of IMOVAX the patient began experiencing mild headaches and nausea. After the fourth dose of IMOVAX, the patient experienced left sided chest pain, described as "sharp" and lasting 10 to 15 minutes. All events were reported as persisting "occasionally". The patient's mother reported that he "may have received at least one dose of RABAVERT" but was unsure as to which dose it may have been. Additionally, upon presenting for his second dose of IMOVAX, the patient was inadvertently given INTERFERON. Per the patient's mother, the patient was "late getting a few of those doses" and "still needs one additional dose"; he had received a total of four doses (dates not provided). No additional information was provided. Follow-up information received on 19 September 2007 from a health care professional. Although the patient was a patient in the reporter's practice, his vaccination and follow-up care for the adverse event were provided by another facility. Per the reporter, "I had nothing to do with this incident."
Sex: U
Vaccine: RV5, RV5
Symptoms: Enema administration, Intussusception
Clinical narrative: Information has been received from a physician concerning a patient who was vaccinated with a dose (number of dose unspecified) of ROTATEQ (no lot# given).  Subsequently the patient experienced intussusception.  The patient sought unspecified medical attention.  The outcome was unknown.  No further information was provided.  There was no product quality complaint.  Upon internal review, intussusception was determined to be an other important medical event.  Additional information has been requested.
Sex: U
Vaccine: RV5, RV5
Symptoms: Intussusception
Clinical narrative: Information has been received from a physician concerning a patient who was vaccinated with a dose (number of dose unspecified) of ROTATEQ (no lot# given).  Subsequently the patient experienced intussusception.  The patient sought unspecified medical attention.  The outcome was unknown.  No further information was provided.  There was no product quality complaint.  Upon internal review, intussusception was determined to be an other important medical event.  Additional information has been requested.
Age: 10.0
Sex: F
Vaccine: VARCEL, VARCEL
Symptoms: Cellulitis, Erythema, Hyperaesthesia, Oedema, Skin warm
Clinical narrative: Information has been received from a health professional concerning a 10 year old female with no pertinent medical history or drug allergies who on 25-MAR-2008, was vaccinated with a second 0.5 ml. subcutaneous dose of VARIVAX (lot # "1796U). There was no concomitant medication. On 27-MAR-2008, the patient developed erythema, edema, tenderness, soreness, swelling, and warmth at the site of the injection. It was indicated by the reporter that the erythema and edema at the injection site spread to the size of a softball. Therapy with AUGMENTIN was implemented. There was no laboratory or diagnostic studies performed. It was indicated that the patient's symptoms had improved by the next day (28-MAR-2008). It was noted that the patients vaccination history included on 05-MAR-1999, a first 0.5 ml subcutaneous dose of VARIVAX (lot "628527/1834H). At the time of this report, the patient was recovering. A product quality complaint was not reported. Additional information has been requested. Follow up information has been received on 15-APR-2008 from a health professional concerning a 10 year old female patient with no pertinent medical history or drug allergies who on 25-MAR-2008, was vaccinated with a second dose of VARIVAX (lot # 659944/1796U), 0.5ml, subcutaneously in left arm. The night of 26-MAR-2008, the patient developed "10.5 to 7 cm erythema with increased warmth circle, edema and tenderness to the touch. " The patient recovered (reported as "improved") on 28-MAR-2008. The reporter considered that "10.5 to 7 cm erythema with increased warmth circle, edema and tenderness to the touch" was serious as other important medical event. No further information is available.
Age: 10.0
Sex: F
Vaccine: VARCEL, VARCEL
Symptoms: Injection site erythema, Injection site oedema, Injection site pain, Injection site warmth
Clinical narrative: Information has been received from a health professional concerning a 10 year old female with no pertinent medical history or drug allergies who on 25-MAR-2008, was vaccinated with a second 0.5 ml. subcutaneous dose of VARIVAX (lot # "1796U). There was no concomitant medication. On 27-MAR-2008, the patient developed erythema, edema, tenderness, soreness, swelling, and warmth at the site of the injection. It was indicated by the reporter that the erythema and edema at the injection site spread to the size of a softball. Therapy with AUGMENTIN was implemented. There was no laboratory or diagnostic studies performed. It was indicated that the patient's symptoms had improved by the next day (28-MAR-2008). It was noted that the patients vaccination history included on 05-MAR-1999, a first 0.5 ml subcutaneous dose of VARIVAX (lot "628527/1834H). At the time of this report, the patient was recovering. A product quality complaint was not reported. Additional information has been requested. Follow up information has been received on 15-APR-2008 from a health professional concerning a 10 year old female patient with no pertinent medical history or drug allergies who on 25-MAR-2008, was vaccinated with a second dose of VARIVAX (lot # 659944/1796U), 0.5ml, subcutaneously in left arm. The night of 26-MAR-2008, the patient developed "10.5 to 7 cm erythema with increased warmth circle, edema and tenderness to the touch. " The patient recovered (reported as "improved") on 28-MAR-2008. The reporter considered that "10.5 to 7 cm erythema with increased warmth circle, edema and tenderness to the touch" was serious as other important medical event. No further information is available.
Age: 23.0
Sex: M
Vaccine: ANTH, SMALL
Symptoms: Erythema multiforme
Clinical narrative: Two weeks after receiving Smallpox vaccination at pre-deployment event (AM 17 April 08), patient developed Erythema Multiforme as diagnosed by Dermatologist.  Erythema developed initially in the early morning of 01 May 08 down his left arm per patient.  Pt reported to clinic at 1600 on 01 May 08 to see provider. Provider examined patient given rx for Hydroxyzine HCL 25 mg 1 tablet three times per day and referred immediately to Dermatology where he was seen at 0800 on 02 May 08 and given dx of Erythema Multiforme. The actual Smallpox vaccination site is progressing as normal. NOT disseminated vaccinia.
Age: 1.0
Sex: F
Vaccine: PNC
Symptoms: Autopsy, Bacterial culture positive, Death, Meningitis pneumococcal
Clinical narrative: Information regarding Prevnar was received from a healthcare professional regarding a female patient who received the fourth dose on 22-Jan-2007 at 12 months of age and died from Streptococcus pneumoniae meningitis at the age of 26 months. The patient's concurrent illnesses included nasopharyngitis or viral infection. Concomitant medications were not reported. On an unspecified date in 2008, the patient developed Streptococcus pneumoniae meningitis. On 17-Apr-2008, the patient died. The autopsy cause of death was meningitis pneumococcal. A serotype was not provided. The reporter noted that the patient had "something going on in her system, such as possibly a cold or another type of viral infection, that weakened her immune system." Bacterial culture (results: negative for Haemophilus infection, Group B strep, Neisseria meningitides, and Escherichia coli) and bacterial culture (results: Streptococcus pneumoniae) were done in 2008. No additional information was available at the time of this report.   6/27/08 Autopsy report states COD as bacterial meningitis & streptococcus pneumoniae. States acute bacterial meningitis: purulent exudate of subarachnoid space & meninges; c/s (+) for alpha hemolytic streptococcus; PCR for herpes simplex & enterovirus (-).    7/8/08 Reviewed hospital medical records of 4/16/2008. FINAL DX: Admitted for viral gastroenteritis.  Final Dx: bacteremia. Records reveal patient seen by PCP w/fever, nausea & vomiting x 3 days; diarrhea x 1 day; no oral intake; no further BMs; decreased UO; tired; irritable; excessive sleepiness; minimal nasal congestion.  Tx w/IVF.  Began to become more alert then found unresponsive, cyanotic & no pulse/respirations later in evening.  Resuscitation unsuccessful.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Abortion spontaneous, Drug exposure during pregnancy
Clinical narrative: Information has been received from a 23 year old female who on 15-OCT-2007 was vaccinated with her first dose of Gardasil.  On 18-OCT-2007 the patient found out she was pregnant.  On 22-APR-2008, it was reported by the patient, that on approximately 01-NOV-2007, reported as "about two weeks after calling," that she had lost the baby.  She reported that the miscarriage was early in her pregnancy and she was doing fine.  Upon internal review, spontaneous abortion was considered to be an other important medical event.  No further information is available.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Lip swelling, Rash maculo-papular
Clinical narrative: Initial and follow-up information has been received from a physician concerning an 18 year old female with a urinary tract infection at the time of vaccination and no allergies or drug reactions who on 28-MAR-2008 was vaccinated with a first dose of GARDASIL (lot# 659182/1757U) injection in the left arm at 10:00 AM. Concomitant therapy included BACTRIM for the urinary tract infection. After receiving the vaccine in the office and on the way home the patient developed diffuse rash. On 29-MAR-2008 the patient was seen by the physician and saw the patient at that time had markedly swollen lips and she had a diffuse maculopapular rash all over. Subsequently, on an unspecified date the patient recovered from the rash and swollen lips. No further information was provided. The reporter felt that maculopapular rash and swollen lips were considered to be an other medical event. Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Abortion spontaneous, Blood human chorionic gonadotropin negative, Drug exposure during pregnancy
Clinical narrative: Information has been received from a medical assistant concerning a 19 year old female, who on 09-APR-2008 was vaccinated with a 0.5mL first dose of Gardasil.  Subsequently, the patient was pregnant.  It was reported that the office did not conduct a pregnancy test prior to the vaccination.  The patient called the office to report that she experienced a miscarriage on 21-APR-2008.  The patient went to see the physician.  A total serum human chorionic gonadotropin test was performed and did not show that the patient was pregnant.  On 09-APR-2008 the patient experienced received first dose while pregnant.  At the time of the report, the outcome of the patient was unknown.  Upon internal review miscarriage was considered to be an other important medical event.  Additional information has been requested.