chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.2
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Lethargy, Lung infection, Pain, Pallor, Tachycardia
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Act. On 25-JUN-2008, a 2 month old female who two weeks prior developed upper respiratory infection with runny nose and slight cough, was vaccinated with the first dose of ROTATEQ (Lot # 657510/0970U) on an unknown site by mouth. Concomitant therapy included the first dose of PREVENAR (Lot # C57538), given intramuscularly into the right leg, the first dose of OMNIHIB (Lot # UF345AC) given intramuscularly into the left leg and the first dose of PEDIARIX (Lot # AC21B142AA), given intramuscularly into the left leg. On 29-SEP-2008, the patient experienced intussusception reduced with air contrast enema. On 08-OCT-2008, records received for DOS 20-SEP-2008 presented with vomiting, lethargy and cough. On day of admission, the patient began vomiting 1 to 15 times and greenish in color with dark material in it. Diapers not wet, decreased urine output. Not interested in drinking. The patient weight loss, pale with decreased capillary refill and decreased responsiveness to stimulation and pain. The patient was tachycardic, with abdomen distended infrequent bowel sounds. The patient was transferred to another facility. On 08-OCT-2008 ED report for DOS 08-OCT-2008 C/O lethargy, pale and bilious forming again. Probably recurrent intussusception. The patient was previously hospitalized for intussusception and lung infection on 29-SEP-2008. On 28-OCT-2008, records received from receiving facility for DOS 30-SEP-2008 and 08-OCT-2008 and 09-OCT-2008, DC DX: Reduced Intussusception. Laboratory tests were performed which reported that on 20-SEP-2008 records for an air contrast enema for diagnostic and therapeutic were received. CXR showed increased density in right middle lobe. An abdominal x-ray was normal. On 28-OCT-2008 records received reported a Barium enema reduction with air enema. WBC was 21. The listing indicated that one or more of the events required ER visit, hospitalization, and were considered to be immediately life-threatening. The original reporting source was not provided. The VAERS ID # is 327133. No further information is available. A standard lot check investigation was performed. All in-process quality checks for the lot number in question were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements of the research center and was released.
Age: 0.2
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Unresponsive to stimuli, Urine output decreased, Vomiting, Weight decreased, White blood cell count increased
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Act. On 25-JUN-2008, a 2 month old female who two weeks prior developed upper respiratory infection with runny nose and slight cough, was vaccinated with the first dose of ROTATEQ (Lot # 657510/0970U) on an unknown site by mouth. Concomitant therapy included the first dose of PREVENAR (Lot # C57538), given intramuscularly into the right leg, the first dose of OMNIHIB (Lot # UF345AC) given intramuscularly into the left leg and the first dose of PEDIARIX (Lot # AC21B142AA), given intramuscularly into the left leg. On 29-SEP-2008, the patient experienced intussusception reduced with air contrast enema. On 08-OCT-2008, records received for DOS 20-SEP-2008 presented with vomiting, lethargy and cough. On day of admission, the patient began vomiting 1 to 15 times and greenish in color with dark material in it. Diapers not wet, decreased urine output. Not interested in drinking. The patient weight loss, pale with decreased capillary refill and decreased responsiveness to stimulation and pain. The patient was tachycardic, with abdomen distended infrequent bowel sounds. The patient was transferred to another facility. On 08-OCT-2008 ED report for DOS 08-OCT-2008 C/O lethargy, pale and bilious forming again. Probably recurrent intussusception. The patient was previously hospitalized for intussusception and lung infection on 29-SEP-2008. On 28-OCT-2008, records received from receiving facility for DOS 30-SEP-2008 and 08-OCT-2008 and 09-OCT-2008, DC DX: Reduced Intussusception. Laboratory tests were performed which reported that on 20-SEP-2008 records for an air contrast enema for diagnostic and therapeutic were received. CXR showed increased density in right middle lobe. An abdominal x-ray was normal. On 28-OCT-2008 records received reported a Barium enema reduction with air enema. WBC was 21. The listing indicated that one or more of the events required ER visit, hospitalization, and were considered to be immediately life-threatening. The original reporting source was not provided. The VAERS ID # is 327133. No further information is available. A standard lot check investigation was performed. All in-process quality checks for the lot number in question were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements of the research center and was released.
Age: 30.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Asthenia, Dizziness, Nausea, Vomiting
Clinical narrative: Lightheaded, dizzy, nausea, vomiting 3x, feeling weak. Report received from EMT on 20-Oct-2008. A 30 year-old male patient (F.W.D., DOB 31-Jan-1978) received AFLURIA lot 03549111A on 20-Oct-2008 at 10:00am at his work facility. AFLURIA was administered at the left deltoid. Patient began feeling lightheaded, dizzy and nauseous 30 minutes after administration. He then vomited three times over the next 30 minutes. Patient denied ever having headache, chest pain, difficulty breathing, abdominal pain, dizzy and nauseous. He then left work for the day and was contacted at home 2 hours later and at that time he was still feeling weak and dizzy. At the time of vaccination, patient had no illnesses; however, patient was uneasy as he does not like receiving needles. Patient has no pre-existing physician-diagnosed allergies, birth defects, or medical conditions. The reporter considered events as non-serious. No further information is expected.
Age: 30.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Activities of daily living impaired, Asthenia, Dizziness, Nausea, Vomiting
Clinical narrative: Lightheaded, dizzy, nausea, vomiting 3x, feeling weak. Report received from EMT on 20-Oct-2008. A 30 year-old male patient (F.W.D., DOB 31-Jan-1978) received AFLURIA lot 03549111A on 20-Oct-2008 at 10:00am at his work facility. AFLURIA was administered at the left deltoid. Patient began feeling lightheaded, dizzy and nauseous 30 minutes after administration. He then vomited three times over the next 30 minutes. Patient denied ever having headache, chest pain, difficulty breathing, abdominal pain, dizzy and nauseous. He then left work for the day and was contacted at home 2 hours later and at that time he was still feeling weak and dizzy. At the time of vaccination, patient had no illnesses; however, patient was uneasy as he does not like receiving needles. Patient has no pre-existing physician-diagnosed allergies, birth defects, or medical conditions. The reporter considered events as non-serious. No further information is expected.
Age: 29.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Oral pruritus, Pruritus generalised
Clinical narrative: Report received from a nurse on 22-Oct-2008.  A 29 year-old female received AFLURIA (lot 03549111A, IM right deltoid) for influenza immunization on 20-Oct-2008 at approximately 14:00 hours.  The patient had a medical history of BACTRIM allergy.  She is on no other medications.  Patient had no illness at time of vaccination.  On 20-Oct-2008 at approximately 18:00 hours (four hours post vaccination with AFLURIA), the patient developed serve itching in her mouth and over her entire body.  There were no visible rash, hives, or skin disorders noted.  The patient returned to work on 21-Oct-2008 and informed the medical staff.  The patient was offered referral to emergency room but she refused treatment.  Investigation by the nurse revealed no rash, hives and skin disorders.  The nurse educated the patient regarding signs/symptoms of anaphylactic shock, and she instructed the patient to go to the ER if the symptoms persist or worsen.  The nurse indicates the patient has not yet recovered.  Additional information has been requested.  No serious criteria mentioned.  Follow-up information was received on 28-Oct-2008 from the Physician.  The patient's reaction has subsided (no date provided).  She is not pregnant and has not contacted her primary care physician (PCP) about this reaction.  No additional information is expected.  No change in assessment.  Information derived from this AE report does not change the current safety profile of the product.
Age: 35.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Dyspnoea, Muscle contracture
Clinical narrative: Report received from a medical staff associate on 24-Oct-20008.  A 35-year-old female received AFLURIA (CSL influenza vaccine) by IM injection to the right deltoid (lot number 03549111A, exp date 30-Jul-2009) on 23-Oct-2008 at 6:00 pm.  At 8:30 pm on 23-Oct-2008, the patient had shortness of breath and suffered abdominal muscle contractions.  The patient stated that this incident was similar to previous allergic reactions, leading her to believe that the reaction was an allergic reaction.  Reactions resolved after self-administering BENADRYL PO.  The patient was not ill at the time of vaccination.  The patient has a medical history of allergic reactions; allergy to sulfa and to cough syrup with codeine.  No additional information is expected. No serious criteria mentioned.  Causality: Possible.  Follow-up report received via telephone from the consumer on 27-Oct-2008.  Patient confirms she is not pregnant and she recovered within 24 hours of the vaccination.  No change is assessment.  No further information is expected.  Information derived from this AE report does not change the current safety profile of the product.
Age: 35.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Abdominal rigidity, Dyspnoea, Similar reaction on previous exposure to drug
Clinical narrative: Report received from a medical staff associate on 24-Oct-20008.  A 35-year-old female received AFLURIA (CSL influenza vaccine) by IM injection to the right deltoid (lot number 03549111A, exp date 30-Jul-2009) on 23-Oct-2008 at 6:00 pm.  At 8:30 pm on 23-Oct-2008, the patient had shortness of breath and suffered abdominal muscle contractions.  The patient stated that this incident was similar to previous allergic reactions, leading her to believe that the reaction was an allergic reaction.  Reactions resolved after self-administering BENADRYL PO.  The patient was not ill at the time of vaccination.  The patient has a medical history of allergic reactions; allergy to sulfa and to cough syrup with codeine.  No additional information is expected. No serious criteria mentioned.  Causality: Possible.  Follow-up report received via telephone from the consumer on 27-Oct-2008.  Patient confirms she is not pregnant and she recovered within 24 hours of the vaccination.  No change is assessment.  No further information is expected.  Information derived from this AE report does not change the current safety profile of the product.
Age: 0.3
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Intussusception, Lethargy, Vomiting
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. A 4 month old male with no medical history was vaccinated with ROTATEQ (lot # 660882/0642X) by mouth on 22-OCT-2008. Concomitant therapy included ACTHIB (lot # UF514AA) IM into the left leg, PREVNAR (lot # C80901) IM into the right leg and PEDIARIX (lot # AC21B192BA) IM into the left leg. On 27-OCT-2008 the patient experienced intussusception, lethargy, nasal congestion and vomiting and was hospitalized. On 27-OCT-2008 therapeutic enema without surgery reduced intussusception. Abdomen X-ray suggested of obstruction. On 04-NOV-2008 records received from DOS on 27-OCT-2008 presented with C/O lethargy and emesis, yellow tinged emesis, congestion last stool 2 days ago. On 04-NOV-2008, the patient received X-ray RLQ paucity of gas. UGI indicated normal D-J junction. Hydrostatic BE reduction of intussusception with reflux into distal small bowel. WBC was 17.1. The patient sought medical attention by ER visit. The listing indicated that one or more of the events required hospitalization, was considered to be immediately life-threatening. No further information is available. The original reporting source was not provided. The VAERS ID # is 330559. A standard lot check investigation was performed. All in-process quality checks for the lot number in question were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements of the government and was released.
Age: 0.3
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Abdominal X-ray, Enema administration, Intussusception, Lethargy, Nasal congestion
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. A 4 month old male with no medical history was vaccinated with ROTATEQ (lot # 660882/0642X) by mouth on 22-OCT-2008. Concomitant therapy included ACTHIB (lot # UF514AA) IM into the left leg, PREVNAR (lot # C80901) IM into the right leg and PEDIARIX (lot # AC21B192BA) IM into the left leg. On 27-OCT-2008 the patient experienced intussusception, lethargy, nasal congestion and vomiting and was hospitalized. On 27-OCT-2008 therapeutic enema without surgery reduced intussusception. Abdomen X-ray suggested of obstruction. On 04-NOV-2008 records received from DOS on 27-OCT-2008 presented with C/O lethargy and emesis, yellow tinged emesis, congestion last stool 2 days ago. On 04-NOV-2008, the patient received X-ray RLQ paucity of gas. UGI indicated normal D-J junction. Hydrostatic BE reduction of intussusception with reflux into distal small bowel. WBC was 17.1. The patient sought medical attention by ER visit. The listing indicated that one or more of the events required hospitalization, was considered to be immediately life-threatening. No further information is available. The original reporting source was not provided. The VAERS ID # is 330559. A standard lot check investigation was performed. All in-process quality checks for the lot number in question were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements of the government and was released.
Age: 0.3
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Vomiting, White blood cell count increased, X-ray abnormal, X-ray gastrointestinal tract normal
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. A 4 month old male with no medical history was vaccinated with ROTATEQ (lot # 660882/0642X) by mouth on 22-OCT-2008. Concomitant therapy included ACTHIB (lot # UF514AA) IM into the left leg, PREVNAR (lot # C80901) IM into the right leg and PEDIARIX (lot # AC21B192BA) IM into the left leg. On 27-OCT-2008 the patient experienced intussusception, lethargy, nasal congestion and vomiting and was hospitalized. On 27-OCT-2008 therapeutic enema without surgery reduced intussusception. Abdomen X-ray suggested of obstruction. On 04-NOV-2008 records received from DOS on 27-OCT-2008 presented with C/O lethargy and emesis, yellow tinged emesis, congestion last stool 2 days ago. On 04-NOV-2008, the patient received X-ray RLQ paucity of gas. UGI indicated normal D-J junction. Hydrostatic BE reduction of intussusception with reflux into distal small bowel. WBC was 17.1. The patient sought medical attention by ER visit. The listing indicated that one or more of the events required hospitalization, was considered to be immediately life-threatening. No further information is available. The original reporting source was not provided. The VAERS ID # is 330559. A standard lot check investigation was performed. All in-process quality checks for the lot number in question were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements of the government and was released.
Age: 45.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Chills, Erythema, Fatigue, Headache, Hypersensitivity
Clinical narrative: Report received from a Registered Nurse (RN) on 29-Oct-2008.  A female patient (E.W./ age not yet known) received AFLURIA (CSL Influenza vaccine, lot 02649111A) on 27-Oct-2008.  The patient developed bruising at the site (less than a pencil head), soreness of deltoid muscles, pain down forearm, across neck and down back, patchy rash on upper arm (pinker than flesh tone), and flushing on upper back.  The injection site was also sore and swollen.  Patient will be following-up with either her family physician or a personal medical center.  Additional information has been requested.  Assessment: No serious criteria mentioned.  Causality:  Possible.  Follow-up information received on 31-Oct-2008 from RN.  A 45 year-old female received AFLURIA IM on the left deltoid on 27-Oct-2008 at 12:00 pm with no problem.  At the time of vaccination, patient was not ill.  Patient has a history of cervical cellular dysphasia.  Patient does has a history of allergy to seafood (oysters and crabs) which caused a rash and itchiness to her palm and soles of feet.  Sore arm started on 28-Oct-2008.  On 29-Oct-2008 at 7:30am, her reaction was more painful; patient's left upper arm was swollen, reddened with a patchy non-raised rash.  It was painful down her left forearm and her left side of neck was stiff.  Patient also had a headache.  On 30-Oct-2008, she had general malaise, chills, and fatigue; her left deltoid and trapeziums were sore, and she had a headache.  As of 31-Oct-2008, patient still had neck and trapeziums muscular stiffness/pain and her headache persisted.  For treatment, patient took prednisone dose pack and BENADRYL.  Her physician diagnosed her with a localized allergic reaction.  Concomitant medication includes ZOLOFT 200 mg daily and PEPCID 20 mg daily.  Patient is not pregnant.  Mfr./imm. Proj. report no. 200814240.  No further information is expected.  No change in assessment.  Information derived from this AE report does not affect the current safety profile of AFLURIA (Fluvax).
Age: 45.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Malaise, Musculoskeletal stiffness, Oedema peripheral, Pain in extremity, Rash
Clinical narrative: Report received from a Registered Nurse (RN) on 29-Oct-2008.  A female patient (E.W./ age not yet known) received AFLURIA (CSL Influenza vaccine, lot 02649111A) on 27-Oct-2008.  The patient developed bruising at the site (less than a pencil head), soreness of deltoid muscles, pain down forearm, across neck and down back, patchy rash on upper arm (pinker than flesh tone), and flushing on upper back.  The injection site was also sore and swollen.  Patient will be following-up with either her family physician or a personal medical center.  Additional information has been requested.  Assessment: No serious criteria mentioned.  Causality:  Possible.  Follow-up information received on 31-Oct-2008 from RN.  A 45 year-old female received AFLURIA IM on the left deltoid on 27-Oct-2008 at 12:00 pm with no problem.  At the time of vaccination, patient was not ill.  Patient has a history of cervical cellular dysphasia.  Patient does has a history of allergy to seafood (oysters and crabs) which caused a rash and itchiness to her palm and soles of feet.  Sore arm started on 28-Oct-2008.  On 29-Oct-2008 at 7:30am, her reaction was more painful; patient's left upper arm was swollen, reddened with a patchy non-raised rash.  It was painful down her left forearm and her left side of neck was stiff.  Patient also had a headache.  On 30-Oct-2008, she had general malaise, chills, and fatigue; her left deltoid and trapeziums were sore, and she had a headache.  As of 31-Oct-2008, patient still had neck and trapeziums muscular stiffness/pain and her headache persisted.  For treatment, patient took prednisone dose pack and BENADRYL.  Her physician diagnosed her with a localized allergic reaction.  Concomitant medication includes ZOLOFT 200 mg daily and PEPCID 20 mg daily.  Patient is not pregnant.  Mfr./imm. Proj. report no. 200814240.  No further information is expected.  No change in assessment.  Information derived from this AE report does not affect the current safety profile of AFLURIA (Fluvax).
Age: 45.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Back pain, Chills, Erythema, Fatigue, Flushing
Clinical narrative: Report received from a Registered Nurse (RN) on 29-Oct-2008.  A female patient (E.W./ age not yet known) received AFLURIA (CSL Influenza vaccine, lot 02649111A) on 27-Oct-2008.  The patient developed bruising at the site (less than a pencil head), soreness of deltoid muscles, pain down forearm, across neck and down back, patchy rash on upper arm (pinker than flesh tone), and flushing on upper back.  The injection site was also sore and swollen.  Patient will be following-up with either her family physician or a personal medical center.  Additional information has been requested.  Assessment: No serious criteria mentioned.  Causality:  Possible.  Follow-up information received on 31-Oct-2008 from RN.  A 45 year-old female received AFLURIA IM on the left deltoid on 27-Oct-2008 at 12:00 pm with no problem.  At the time of vaccination, patient was not ill.  Patient has a history of cervical cellular dysphasia.  Patient does has a history of allergy to seafood (oysters and crabs) which caused a rash and itchiness to her palm and soles of feet.  Sore arm started on 28-Oct-2008.  On 29-Oct-2008 at 7:30am, her reaction was more painful; patient's left upper arm was swollen, reddened with a patchy non-raised rash.  It was painful down her left forearm and her left side of neck was stiff.  Patient also had a headache.  On 30-Oct-2008, she had general malaise, chills, and fatigue; her left deltoid and trapeziums were sore, and she had a headache.  As of 31-Oct-2008, patient still had neck and trapeziums muscular stiffness/pain and her headache persisted.  For treatment, patient took prednisone dose pack and BENADRYL.  Her physician diagnosed her with a localized allergic reaction.  Concomitant medication includes ZOLOFT 200 mg daily and PEPCID 20 mg daily.  Patient is not pregnant.  Mfr./imm. Proj. report no. 200814240.  No further information is expected.  No change in assessment.  Information derived from this AE report does not affect the current safety profile of AFLURIA (Fluvax).
Age: 45.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Headache, Hypersensitivity, Injection site haematoma, Injection site pain, Injection site swelling
Clinical narrative: Report received from a Registered Nurse (RN) on 29-Oct-2008.  A female patient (E.W./ age not yet known) received AFLURIA (CSL Influenza vaccine, lot 02649111A) on 27-Oct-2008.  The patient developed bruising at the site (less than a pencil head), soreness of deltoid muscles, pain down forearm, across neck and down back, patchy rash on upper arm (pinker than flesh tone), and flushing on upper back.  The injection site was also sore and swollen.  Patient will be following-up with either her family physician or a personal medical center.  Additional information has been requested.  Assessment: No serious criteria mentioned.  Causality:  Possible.  Follow-up information received on 31-Oct-2008 from RN.  A 45 year-old female received AFLURIA IM on the left deltoid on 27-Oct-2008 at 12:00 pm with no problem.  At the time of vaccination, patient was not ill.  Patient has a history of cervical cellular dysphasia.  Patient does has a history of allergy to seafood (oysters and crabs) which caused a rash and itchiness to her palm and soles of feet.  Sore arm started on 28-Oct-2008.  On 29-Oct-2008 at 7:30am, her reaction was more painful; patient's left upper arm was swollen, reddened with a patchy non-raised rash.  It was painful down her left forearm and her left side of neck was stiff.  Patient also had a headache.  On 30-Oct-2008, she had general malaise, chills, and fatigue; her left deltoid and trapeziums were sore, and she had a headache.  As of 31-Oct-2008, patient still had neck and trapeziums muscular stiffness/pain and her headache persisted.  For treatment, patient took prednisone dose pack and BENADRYL.  Her physician diagnosed her with a localized allergic reaction.  Concomitant medication includes ZOLOFT 200 mg daily and PEPCID 20 mg daily.  Patient is not pregnant.  Mfr./imm. Proj. report no. 200814240.  No further information is expected.  No change in assessment.  Information derived from this AE report does not affect the current safety profile of AFLURIA (Fluvax).
Age: 45.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Malaise, Musculoskeletal stiffness, Myalgia, Neck pain, Pain in extremity
Clinical narrative: Report received from a Registered Nurse (RN) on 29-Oct-2008.  A female patient (E.W./ age not yet known) received AFLURIA (CSL Influenza vaccine, lot 02649111A) on 27-Oct-2008.  The patient developed bruising at the site (less than a pencil head), soreness of deltoid muscles, pain down forearm, across neck and down back, patchy rash on upper arm (pinker than flesh tone), and flushing on upper back.  The injection site was also sore and swollen.  Patient will be following-up with either her family physician or a personal medical center.  Additional information has been requested.  Assessment: No serious criteria mentioned.  Causality:  Possible.  Follow-up information received on 31-Oct-2008 from RN.  A 45 year-old female received AFLURIA IM on the left deltoid on 27-Oct-2008 at 12:00 pm with no problem.  At the time of vaccination, patient was not ill.  Patient has a history of cervical cellular dysphasia.  Patient does has a history of allergy to seafood (oysters and crabs) which caused a rash and itchiness to her palm and soles of feet.  Sore arm started on 28-Oct-2008.  On 29-Oct-2008 at 7:30am, her reaction was more painful; patient's left upper arm was swollen, reddened with a patchy non-raised rash.  It was painful down her left forearm and her left side of neck was stiff.  Patient also had a headache.  On 30-Oct-2008, she had general malaise, chills, and fatigue; her left deltoid and trapeziums were sore, and she had a headache.  As of 31-Oct-2008, patient still had neck and trapeziums muscular stiffness/pain and her headache persisted.  For treatment, patient took prednisone dose pack and BENADRYL.  Her physician diagnosed her with a localized allergic reaction.  Concomitant medication includes ZOLOFT 200 mg daily and PEPCID 20 mg daily.  Patient is not pregnant.  Mfr./imm. Proj. report no. 200814240.  No further information is expected.  No change in assessment.  Information derived from this AE report does not affect the current safety profile of AFLURIA (Fluvax).
Age: 45.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Rash
Clinical narrative: Report received from a Registered Nurse (RN) on 29-Oct-2008.  A female patient (E.W./ age not yet known) received AFLURIA (CSL Influenza vaccine, lot 02649111A) on 27-Oct-2008.  The patient developed bruising at the site (less than a pencil head), soreness of deltoid muscles, pain down forearm, across neck and down back, patchy rash on upper arm (pinker than flesh tone), and flushing on upper back.  The injection site was also sore and swollen.  Patient will be following-up with either her family physician or a personal medical center.  Additional information has been requested.  Assessment: No serious criteria mentioned.  Causality:  Possible.  Follow-up information received on 31-Oct-2008 from RN.  A 45 year-old female received AFLURIA IM on the left deltoid on 27-Oct-2008 at 12:00 pm with no problem.  At the time of vaccination, patient was not ill.  Patient has a history of cervical cellular dysphasia.  Patient does has a history of allergy to seafood (oysters and crabs) which caused a rash and itchiness to her palm and soles of feet.  Sore arm started on 28-Oct-2008.  On 29-Oct-2008 at 7:30am, her reaction was more painful; patient's left upper arm was swollen, reddened with a patchy non-raised rash.  It was painful down her left forearm and her left side of neck was stiff.  Patient also had a headache.  On 30-Oct-2008, she had general malaise, chills, and fatigue; her left deltoid and trapeziums were sore, and she had a headache.  As of 31-Oct-2008, patient still had neck and trapeziums muscular stiffness/pain and her headache persisted.  For treatment, patient took prednisone dose pack and BENADRYL.  Her physician diagnosed her with a localized allergic reaction.  Concomitant medication includes ZOLOFT 200 mg daily and PEPCID 20 mg daily.  Patient is not pregnant.  Mfr./imm. Proj. report no. 200814240.  No further information is expected.  No change in assessment.  Information derived from this AE report does not affect the current safety profile of AFLURIA (Fluvax).
Age: 25.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Chest discomfort, Dyspnoea, Heart rate, Hyperhidrosis, Pallor
Clinical narrative: Allergic reaction, chest tightness, difficulty breathing, pale, diaphoretic, pulse 118. Report received on 27-Oct-2008. A 25 year-old female patient(AEH, DOB 20-Mar-1983) received AFLURLA (Influenza vaccine, lot 03549111A) by IM injection in right deltoid for immunization on 24-Oct-2008 at 10:40 Am. The patient had no illness at the time of vaccination and had no pre-existing medical conditions. On 24-Oct-2008 at 11:15 Am after AFLURLA was injected, patient developed chest tightness, had difficulty breathing, became pale, and experienced diaphoresis and rapid pulse(118). Investigation by representative at emergency room (ER) treated patient for allergic reaction (ICD 995.3, allergy unspecified) and the patient returned to work on 27-Oct-@008. The reporter indicates the patient recovered
Age: 25.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Chest discomfort, Dyspnoea, Heart rate increased, Hyperhidrosis, Hypersensitivity
Clinical narrative: Allergic reaction, chest tightness, difficulty breathing, pale, diaphoretic, pulse 118. Report received on 27-Oct-2008. A 25 year-old female patient(AEH, DOB 20-Mar-1983) received AFLURLA (Influenza vaccine, lot 03549111A) by IM injection in right deltoid for immunization on 24-Oct-2008 at 10:40 Am. The patient had no illness at the time of vaccination and had no pre-existing medical conditions. On 24-Oct-2008 at 11:15 Am after AFLURLA was injected, patient developed chest tightness, had difficulty breathing, became pale, and experienced diaphoresis and rapid pulse(118). Investigation by representative at emergency room (ER) treated patient for allergic reaction (ICD 995.3, allergy unspecified) and the patient returned to work on 27-Oct-@008. The reporter indicates the patient recovered
Age: 25.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Pallor
Clinical narrative: Allergic reaction, chest tightness, difficulty breathing, pale, diaphoretic, pulse 118. Report received on 27-Oct-2008. A 25 year-old female patient(AEH, DOB 20-Mar-1983) received AFLURLA (Influenza vaccine, lot 03549111A) by IM injection in right deltoid for immunization on 24-Oct-2008 at 10:40 Am. The patient had no illness at the time of vaccination and had no pre-existing medical conditions. On 24-Oct-2008 at 11:15 Am after AFLURLA was injected, patient developed chest tightness, had difficulty breathing, became pale, and experienced diaphoresis and rapid pulse(118). Investigation by representative at emergency room (ER) treated patient for allergic reaction (ICD 995.3, allergy unspecified) and the patient returned to work on 27-Oct-@008. The reporter indicates the patient recovered
Sex: U
Vaccine: HPV4, HPV4
Symptoms: Arthralgia, Blindness, Blindness transient, Chest pain, Computerised tomogram
Clinical narrative: Information has been received from a physician, concerning a patient who was vaccinated with GARDASIL vaccine 0.5ml, intramuscularly.  The physician reported that after receiving the GARDASIL vaccine, about 2 months ago, the patient experienced cerebral vasculitis and seizures.  The doctor was unsure if it was the first or second 0.5ml dose.  The doctor was not sure if the patient would be seeing a specialist about this AE.  The outcome is unknown.  The patient sought unspecified medical attention.  Upon internal review, seizures were determined to be an other important medical event.  Additional information has been requested.
Sex: U
Vaccine: HPV4, HPV4
Symptoms: Convulsion, Dizziness, Dyspnoea, Fatigue, Full blood count
Clinical narrative: Information has been received from a physician, concerning a patient who was vaccinated with GARDASIL vaccine 0.5ml, intramuscularly.  The physician reported that after receiving the GARDASIL vaccine, about 2 months ago, the patient experienced cerebral vasculitis and seizures.  The doctor was unsure if it was the first or second 0.5ml dose.  The doctor was not sure if the patient would be seeing a specialist about this AE.  The outcome is unknown.  The patient sought unspecified medical attention.  Upon internal review, seizures were determined to be an other important medical event.  Additional information has been requested.
Sex: U
Vaccine: HPV4, HPV4
Symptoms: Headache, Hypoaesthesia, Muscular weakness, Myalgia, Nausea
Clinical narrative: Information has been received from a physician, concerning a patient who was vaccinated with GARDASIL vaccine 0.5ml, intramuscularly.  The physician reported that after receiving the GARDASIL vaccine, about 2 months ago, the patient experienced cerebral vasculitis and seizures.  The doctor was unsure if it was the first or second 0.5ml dose.  The doctor was not sure if the patient would be seeing a specialist about this AE.  The outcome is unknown.  The patient sought unspecified medical attention.  Upon internal review, seizures were determined to be an other important medical event.  Additional information has been requested.
Sex: U
Vaccine: HPV4, HPV4
Symptoms: Ophthalmological examination, Paraesthesia, Paralysis, Rash, Transient ischaemic attack
Clinical narrative: Information has been received from a physician, concerning a patient who was vaccinated with GARDASIL vaccine 0.5ml, intramuscularly.  The physician reported that after receiving the GARDASIL vaccine, about 2 months ago, the patient experienced cerebral vasculitis and seizures.  The doctor was unsure if it was the first or second 0.5ml dose.  The doctor was not sure if the patient would be seeing a specialist about this AE.  The outcome is unknown.  The patient sought unspecified medical attention.  Upon internal review, seizures were determined to be an other important medical event.  Additional information has been requested.
Sex: U
Vaccine: HPV4, HPV4
Symptoms: Ultrasound scan
Clinical narrative: Information has been received from a physician, concerning a patient who was vaccinated with GARDASIL vaccine 0.5ml, intramuscularly.  The physician reported that after receiving the GARDASIL vaccine, about 2 months ago, the patient experienced cerebral vasculitis and seizures.  The doctor was unsure if it was the first or second 0.5ml dose.  The doctor was not sure if the patient would be seeing a specialist about this AE.  The outcome is unknown.  The patient sought unspecified medical attention.  Upon internal review, seizures were determined to be an other important medical event.  Additional information has been requested.
Sex: U
Vaccine: HPV4, HPV4
Symptoms: Convulsion, Vasculitis cerebral
Clinical narrative: Information has been received from a physician, concerning a patient who was vaccinated with GARDASIL vaccine 0.5ml, intramuscularly.  The physician reported that after receiving the GARDASIL vaccine, about 2 months ago, the patient experienced cerebral vasculitis and seizures.  The doctor was unsure if it was the first or second 0.5ml dose.  The doctor was not sure if the patient would be seeing a specialist about this AE.  The outcome is unknown.  The patient sought unspecified medical attention.  Upon internal review, seizures were determined to be an other important medical event.  Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: PPV
Symptoms: Hypersensitivity, Injection site abscess, Oedema peripheral
Clinical narrative: Information has been received from a physician concerning a 12 year old female patient with asthma who about two weeks ago was vaccinated with PNEUMOVAX 23, lot # not reported. Concomitant therapy included FLUMIST, manufacturer unspecified. It was reported that the patient had an allergic reaction to the pneumonia vaccine, the patient's arm swelled up and had the appearance of an abscess at the injection site. The physician stated that the patient was treated with antibiotics. The patient was hospitalized for two days and was discharged, dates were not specified. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Convulsion
Clinical narrative: Information has been received from a physician concerning a 16 year old female patient with a history of seizure disorders who in approximately 15-NOV-2008 "about a month ago", was vaccinated with a second 0.5ml dose of GARDASIL.  The physician reported that the patient experienced a seizure after receiving the vaccine.  The patient sought unspecific medical attention.  The patient recovered within a few minutes.  Upon internal review seizure disorders were considered as an other important medical event.  Additional information has been requested.
Age: 1.01
Sex: M
Vaccine: DTAP, FLU3, HEP, HIBV, IPV, PNC
Symptoms: Injection site erythema, Injection site pain, Pyrexia, Weight bearing difficulty, White blood cell count increased
Clinical narrative: Child was seen in our office 2 days after shots given - continued to run high fever and (L) thigh area red and painful - would not bear weight. 1/27/09-records received for DOS 12/11-12/14/08-DC DX:Cellulitis versus reaction to DTaP in left thigh. Presented with C/O pain, redness and swelling left thigh and temperature 104. Unable to contact hasn't been seen since.
Age: 60.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Injection site reaction, Pain
Clinical narrative: C/o pain and redness. Reaction to inj. - to use BENADRYL, MOTRIN.
Age: 1.3
Sex: M
Vaccine: FLU3, MMR, VARCEL
Symptoms: Computerised tomogram, Febrile convulsion, Lumbar puncture
Clinical narrative: Pt. had 2 febrile seizures on 12/10/08, 1 day after receiving vaccines.
Age: 0.3
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Full blood count normal, Irritability, Pyrexia
Clinical narrative: Fever (102) - evening after. Increased irritability (-) PE - resolved over 2 days.
Age: 66.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Injected limb mobility decreased, Pain, Pain in extremity
Clinical narrative: Shingles shot (right arm) when I awoke the next morning, the arm was extremely sore.  Unable to move it (including combing hair, brushing teeth).  It was worse when I walked, as I could feel the skin on my arm move with each step.  This  lasted only 1 day.  Took TYLENOL for pain.  Mild ache the evening of vaccination.
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Erythema, Swelling
Clinical narrative: 5 in X 5in swelling and redness over (L) Deltoid.
Age: 35.0
Sex: F
Vaccine: TDAP
Symptoms: Dizziness, Erythema, Induration, Tenderness
Clinical narrative: Reports dizziness, and  local redness within 2-3 hours of immunization 12/4/08 no syncope. No fever -  dizziness was objective - lasting over nite (12 hours) now resolved. 3.5 x 2.5 cm Lt arm tender red hardened area centered remious.
Age: 10.0
Sex: M
Vaccine: DTAP, FLU3, VARCEL
Symptoms: Wrong drug administered
Clinical narrative: Based on lot # recording- appears that DTap was administered instead of Hep A.  Unable to confirm if DTap was actually given instead of Hep. A.  Recommended re start Hep A series.  Mother stated there were no adverse side effects following vaccines, told  to wait minimum 6 mos after any Td/Tdap dose.
Age: 1.5
Sex: F
Vaccine: DTAP, FLU3, HEPA
Symptoms: Nasopharyngitis, Rhinorrhoea, Urticaria
Clinical narrative: Urticaria. Developed clear rhinorrhea "cold symptoms 1 day after immunizations.
Age: 53.0
Sex: F
Vaccine: YF
Symptoms: Cough, Fatigue, Feeling hot, Nasal congestion, Nausea
Clinical narrative: Pt called on 12-15-08 to report adverse event from yellow fever vaccine given 12-10-08. Symptoms started on 12-11-08 when she woke up. At that time she had hot feeling (she didn't take her temperature), nausea, cough and nasal congestion.  On 12-12-08 nasal congestion , hot feeling, cough and fatigue continued. Pt states she vomited X 1. on 12-13-08 and 12-14-08 she started to improve. Today 12-15-08 she is improving but still has nasal congestion, cough and fatigue. She has not sought care.  She reported the symptoms to our office today because it was suggested on the Vis.
Age: 53.0
Sex: F
Vaccine: YF
Symptoms: Vomiting
Clinical narrative: Pt called on 12-15-08 to report adverse event from yellow fever vaccine given 12-10-08. Symptoms started on 12-11-08 when she woke up. At that time she had hot feeling (she didn't take her temperature), nausea, cough and nasal congestion.  On 12-12-08 nasal congestion , hot feeling, cough and fatigue continued. Pt states she vomited X 1. on 12-13-08 and 12-14-08 she started to improve. Today 12-15-08 she is improving but still has nasal congestion, cough and fatigue. She has not sought care.  She reported the symptoms to our office today because it was suggested on the Vis.
Age: 18.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Dizziness, Gait disturbance, Gaze palsy, Malaise
Clinical narrative: Dizziness approx 5pm.  Stumbling & trouble walking approx 5:30pm- felt eyes rolling back, eyes were fluttering for approx 5min, extreme malaise, fell asleep- next am felt  fine
Age: 18.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Convulsion, Dizziness, Gait disturbance, Gaze palsy, Malaise
Clinical narrative: Dizziness approx 5pm.  Stumbling & trouble walking approx 5:30pm- felt eyes rolling back, eyes were fluttering for approx 5min, extreme malaise, fell asleep- next am felt  fine
Age: 13.0
Sex: M
Vaccine: MNQ
Symptoms: Nausea, Pain, Pyrexia
Clinical narrative: Received MENACTRA vaccine 11/21/08. On same evening fever 104, general aching all over and nausea. Last approximately 24-48 hours.
Age: 39.0
Sex: F
Vaccine: FLU3
Symptoms: Inflammation, Injection site pain, Pain in extremity
Clinical narrative: On October 8, 2008 my family (husband, 2 sons, and myself) met at the middle school where our sons attend school, to receive our yearly flu shots. This is where the Department of Health was set up. The Flu shot that was given was administered very high in my left arm, in shoulder area. This shot hurt more than any other shot that I have received. I told the nurse that gave me the shot that it hurt extremely bad. She told me that the new syringes that they use now require them to put a little pressure on them to make the needle retract. After I was given the shot my arm started getting sore. In the next few weeks the pain increased, hurting when I tried to lift my arm, when I was laying down and rolled over on my left shoulder or when I was dressing or undressing. On October 21, 2008 I went to se my family doctor. He examined me and told me that the shot had either punctured the bursa sack in my left shoulder or had come extremely close to it, causing there to be some inflammation in that area. He prescribed me an anti- inflammatory medication, but that did not help the pain. On October 30, 2008 I went back to Dr, he then prescribed PREDNISONE. After taking this medication for 10 days, there was still no relief from the pain. On November 12, 2008 I went to see Dr, an orthopedic doctor. After his exam, he agreed with family Dr. diagnosis that the bursa area was inflamed due to shot. He gave me cortisone shot in my left shoulder to target the affected area, but still did not relieve pain. On December 2, 2008 I went back to Dr for 3 week follow- up. Since the cortisone shot did not help, Dr ordered an MRI. He said , depending on the results from the MRI, he may recommend physical therapy. On December 4, 2008 I went for MRI and currently have an appointment with Dr on December 9, 2008 to get results.
Age: 49.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site rash, Rash papular, Rash pruritic, Scar
Clinical narrative: The evening of the flu shot, noticed raised lesions that resemble hives, vesicle fluid filled, itched-broke out on arms, chest- injection site- no lesions noted- no fever noted - lesion scarred in two days.
Age: 38.0
Sex: F
Vaccine: FLU3
Symptoms: Pruritus, Rash
Clinical narrative: 4 days after FLUVIRIN vaccine notice bump ? chickenpox on lower leg (2), trunk (cluster of 3), and arm, very itchy, no temperature - lesion went away in a day.
Age: 0.18
Sex: M
Vaccine: DTAPIPVHIB, PNC, RV5
Symptoms: Crying, Screaming, Sleep disorder
Clinical narrative: No fever per mother. Mother called public health nurse stating 2 month old son is waking from deep sleep screeching with high pitched crying. Called private MD told to give Tylenol. By 10:00pm patient feeling better. Patient given immunization approximately 930am.
Age: 53.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site haematoma, Injection site pain
Clinical narrative: 11/7/08 day of vaccine - note routine soreness and bruising at injection site. 11/13/08c/o left arm pain at injection site. 11/19/08 check arm no swelling,  no induration, no bruising - pain at site. 12-2-08 went to doctor on ER for arm pain - R/O pinch nerve vs muscle infection.
Age: 1.0
Sex: F
Vaccine: PNC
Symptoms: Decreased appetite, Injection site induration, Irritability, Pyrexia
Clinical narrative: Induration at injection site (RL): 3pm 12/18. No treatment. Irritability, Decreased appetite, Fever noted at 8am 12/18. Treatment provided 80ml Tylenol every 4 hours.
Age: 18.0
Sex: M
Vaccine: MNQ
Symptoms: Blood culture positive, Meningococcal infection, Serology positive
Clinical narrative: Patient vaccinated on 6/14/05 with Menactra (lot U1639AA).  Culture confirmed meningococcal disease on 9/17/06.  Blood culture was positive for Neisseria meningitidis serogroup C.  2/6/09 ER record for 9/17/06 received with DX:  R shoulder strain, elevated WBCs, vomiting and L hand contusion. Pt presented with c/o R shoulder and hand pain with bruising with no recall of trauma.  Pt reports fever, chills and vomiting the night prior. Had sore throat approx 2 weeks ago,  now resolved. PE (+) for R deltoid pain and bruising of the R hand with tenderness. Tx with abx and D/C. Called back for further tx once (+) blood cx result in. Unable to locate treating MD/facility despite multiple attempts. Case closed.
Age: 1.83
Sex: M
Vaccine: DTAP, DTAPH, HEPA, PNC
Symptoms: Diarrhoea, Wrong drug administered
Clinical narrative: Child who is 22 months old came in needing 4th DtaP, 3rd HIB, 4 Prevnar, 1st  Hep A and a flu which mom declined. When the clerk did data entry she discovered an error on HIB lot number. Investigation determined I had administered DTaP-HIB rather than just plain HIB. I didn't realize there was still any of this in the house. I called and spoke with father who said both of his kids did well after the shots except this one had a little diarrhea but that's all. Explained the error I made resulting in him getting 2 doses of DTaP. Reassured him that his son is very well protected but the concern was it could cause a very swollen left leg. He reports he is fine. I apologized for my mistake.
Age: 37.0
Sex: F
Vaccine: FLUX
Symptoms: Asthenia, Disorientation, Dizziness, Dysphonia, Pallor
Clinical narrative: Had a fever of 103.5, disorientation, paleness, weakness, tachycardia of 120-130's, hoarseness and dizziness.
Age: 37.0
Sex: F
Vaccine: FLUX
Symptoms: Pyrexia, Tachycardia
Clinical narrative: Had a fever of 103.5, disorientation, paleness, weakness, tachycardia of 120-130's, hoarseness and dizziness.