chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.52
Sex: U
Vaccine: RV5
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report as received from a nurse. She states that doses of MMR II and ROTATEQ that were exposed to 50F for 48 hours were administered to patients. The patients were vaccinated with MMR II. Other suspect therapies included ROTATEQ. No concomitant medications were reported. On an unknown date the patient experienced doses of MMR II and ROTATEQ that were exposed to 50F for 48 hours were administered to patients. No treatment information was reported. Doses of MMR II and ROTATEQ that were exposed to 50F for 48 hours were administered to patients is not related to MMR II nd ROTATEQ. At the time of the call, she does not know who received the doses of improperly stored vaccine, but she would like to know if they should be revaccinated. She will call to provide details when she is able to retrieve the information. SR # provided. It is not known at this time if there have been any adverse effects. Rotavirus vaccine Date given 11/02/2012. Lot # 0210AE. Additional information has been requested.
Age: 1.01
Sex: M
Vaccine: MMR
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report as received from a nurse. She states that doses of MMR II and ROTATEQ that were exposed to 50F for 48 hours were administered to patients. The patients were vaccinated with MMR II. Other suspect therapies included ROTATEQ. No concomitant medications were reported. On an unknown date the patient experienced doses of MMR II and ROTATEQ that were exposed to 50F for 48 hours were administered to patients. No treatment information was reported. Doses of MMR II and ROTATEQ that were exposed to 50F for 48 hours were administered to patients is not related to MMR II nd ROTATEQ. At the time of the call, she does not know who received the doses of improperly stored vaccine, but she would like to know if they should be revaccinated. She will call to provide details when she is able to retrieve the information. SR # provided. It is not known at this time if there have been any adverse effects. 13Nov2012 Additional information received: MMR vaccine Date given 11/01/2012. Lot # 1571AA. Additional information has been requested.
Age: 0.32
Sex: F
Vaccine: RV5
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report as received from a nurse. She states that doses of MMR II and ROTATEQ that were exposed to 50F for 48 hours were administered to patients. The patients were vaccinated with MMR II. Other suspect therapies included ROTATEQ. No concomitant medications were reported. On an unknown date the patient experienced doses of MMR II and ROTATEQ that were exposed to 50F for 48 hours were administered to patients. No treatment information was reported. Doses of MMR II and ROTATEQ that were exposed to 50F for 48 hours were administered to patients is not related to MMR II nd ROTATEQ. At the time of the call, she does not know who received the doses of improperly stored vaccine, but she would like to know if they should be revaccinated. She will call to provide details when she is able to retrieve the information. SR # provided. It is not known at this time if there have been any adverse effects. Rotavirus vaccine Date given 11/01/0212. Lot # 0057AE. Additional information has been requested.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash pruritic, Rash vesicular
Clinical narrative: This spontaneous report was received from a 67-year-old female patient regarding herself. Current conditions included multiple sclerosis (MS). The patient was allergic to penicillin and sulfa drugs. The patient was vaccinated with ZOSTAVAX on 07-NOV-2012. Concomitant medications included COPAXONE. The patient reported that she developed a 2 inch by 1 inch varicella rash on the right side of her chest on 11-NOV-2012. The patient stated that the rash was slightly itchy. No treatment was given for the events. No lab studies were performed. The patient did not recover from the events. The patient sought medical attention the patient called her physician and was waiting for call back. Additional information has been requested.
Age: 0.19
Sex: U
Vaccine: RV5
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report as received from a nurse, She states that doses of MMR II and ROTATEQ that were exposed to 50F for 48 hours were administered to patients. The patients were vaccinated with M-M-R II. Other suspect therapies included ROTATEQ, oral. No concomitant medications were reported. On an unknown date the patient experienced doses of MMR II and ROTATEQ that were exposed to 50f for 48 hours were administered to patients. No treatment information was reported. Doses of MMR II and ROTATEQ that were exposed to 50f for 48 hours were administered to patients is not related to M-M-R II and ROTATEQ, Oral. At the time of the call, she does not know who received the doses of improperly stored vaccine, but she would like to know if they should be revaccinated. She will call to provide the details where she is able to retrieve the information. SR # provided. It is not know at this time if there have been any adverse effects. Rotavirus vaccine Date given 11/02/2012. Lot # 0210AE. Additional has been requested.
Age: 80.0
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Paraesthesia, Piloerection, Skin discolouration
Clinical narrative: This spontaneous report as received from a 80 years old male patient regarding himself. The patient was allergic to penicillin. There was no pertinent medical history. On 07-Nov-2012, the patient was vaccinated with a dose of ZOSTAVAX (lot number, expiration date and route not reported) 1 time injection on the left arm. Dose number was unspecified. Route, dose and lot number were unspecified. Concomitant medications included losartan potassium 50 milligrams (mg), LIPITOR 40 mg and aspirin 81 mg (reported as baby Aspirin). On 16-NOV-2012, the patient experienced tingling sensation on his fingers (in between his fingers) and on his palm, had blisters in the inside of both hands, also had small goosebumps or discolouration of the skin where his elbow bends. The patient sought no medical attention and no treatment was provided. The outcome of all the reported events were unknown. Additional information has been requested.
Age: 0.32
Sex: U
Vaccine: RV5
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report as received from a nurse. She states that doses of ROTATEQ that were exposed to 50F for 48 hours were administered to patients. The patients were vaccinated with MMR II. Other suspect therapies included live, oral ROTATEQ. No concomitant medications were reported. On an unknown date the patient experienced doses of MMR II and ROTATEQ that were exposed to 50F for 48 hours were administered to patients. No treatment information was reported. Doses of MMR II and ROTATEQ that were exposed to 50F for 48 hours were administered to patients is not related to MMR II and live, oral ROTATEQ. At the time of the call, she does not know who received the doses of improperly stored vaccine, but she would like to know if they should be revaccinated. She will call to provide the details when she is able to retrieve the information. SR # provided. It is not know at this time if there have been any adverse effects. Rotavirus vaccine date given 10/31/2012, Medical record # 147602, Lot # 0210AE. Additional information has been requested.
Sex: F
Vaccine: VARCEL
Symptoms: Accidental exposure, Eye pain, Headache, Needle issue, Syringe issue
Clinical narrative: This spontaneous report as received from a Nurse Practitioner refers to a female of unknown age, also a nurse (L.N.P) and also the reporter, who had VARIVAX (Merck) sprayed on her face and in her eyes while administering VARIVAX (Merck) (dose and lot # not reported) on 20-NOV-2012. No other co-suspects were reported. No concomitant medications were reported. The Licensed Practical Nurse stated that she was administering VARIVAX (Merck) when the needle and syringe separated. She experienced stinging of her eyes for 30 minutes to 1 hour after flushing them with water. She also developed a slight headache. The outcome of slight headache and stinging of her eyes for 30 minutes to 1 hour was reported as not recovered/not resolved. The relatedness for slight headache, VARIVAX (Merck) sprayed on her face and in her eyes and stinging of her eyes for 30 minutes to 1 hour was unknown for VARVIAX (Merck). Licensed Practical Nurse sought medical attention via speaking to Nurse Practitioner. Additional information has been requested.
Age: 59.0
Sex: F
Vaccine: FLUX, PPV, FLU3, PPV
Symptoms: Chills, Injection site erythema, Injection site induration, Injection site pain, Pain
Clinical narrative: Patient developed severe swelling, pain, & redness right deltoid. Fever to 101 - swelling & redness persisted for 2 weeks.
Age: 59.0
Sex: F
Vaccine: FLUX, PPV, FLU3, PPV
Symptoms: Pyrexia
Clinical narrative: Patient developed severe swelling, pain, & redness right deltoid. Fever to 101 - swelling & redness persisted for 2 weeks.
Age: 59.0
Sex: F
Vaccine: FLUX, PPV, FLU3, PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Pyrexia
Clinical narrative: Patient developed severe swelling, pain, & redness right deltoid. Fever to 101 - swelling & redness persisted for 2 weeks.
Age: 0.11
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5, DTAPIPVHIB, PNC13, RV5
Symptoms: Bone disorder, Culture, Culture positive, Injection site abscess, Injection site movement impairment
Clinical narrative: 10/12/12 - (L) thigh tenderness & swelling. 10/25/12 - (L) femur xray "periosteal rxn along (L) femur femur diaphysis with soft tissue swelling". 10/27/12 - (L) leg incision & drainage (L) femur, bone biopsy (L) femur. 10/28/12 - Fluid + V Vancomycin: MRI "multiloculated quadriceps abscess & myositis". 10/28/12 - Fluid cx: MSSA, switch to IV ANCEF.
Age: 0.11
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5, DTAPIPVHIB, PNC13, RV5
Symptoms: Injection site swelling, Muscle abscess, Nuclear magnetic resonance imaging abnormal, Osteomyelitis, Staphylococcal abscess
Clinical narrative: 10/12/12 - (L) thigh tenderness & swelling. 10/25/12 - (L) femur xray "periosteal rxn along (L) femur femur diaphysis with soft tissue swelling". 10/27/12 - (L) leg incision & drainage (L) femur, bone biopsy (L) femur. 10/28/12 - Fluid + V Vancomycin: MRI "multiloculated quadriceps abscess & myositis". 10/28/12 - Fluid cx: MSSA, switch to IV ANCEF.
Age: 0.11
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5, DTAPIPVHIB, PNC13, RV5
Symptoms: X-ray abnormal
Clinical narrative: 10/12/12 - (L) thigh tenderness & swelling. 10/25/12 - (L) femur xray "periosteal rxn along (L) femur femur diaphysis with soft tissue swelling". 10/27/12 - (L) leg incision & drainage (L) femur, bone biopsy (L) femur. 10/28/12 - Fluid + V Vancomycin: MRI "multiloculated quadriceps abscess & myositis". 10/28/12 - Fluid cx: MSSA, switch to IV ANCEF.
Age: 0.11
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5, DTAPIPVHIB, PNC13, RV5
Symptoms: Bacterial test positive, Biopsy bone, Incisional drainage, Injection site abscess, Injection site pain
Clinical narrative: 10/12/12 - (L) thigh tenderness & swelling. 10/25/12 - (L) femur xray "periosteal rxn along (L) femur femur diaphysis with soft tissue swelling". 10/27/12 - (L) leg incision & drainage (L) femur, bone biopsy (L) femur. 10/28/12 - Fluid + V Vancomycin: MRI "multiloculated quadriceps abscess & myositis". 10/28/12 - Fluid cx: MSSA, switch to IV ANCEF.
Age: 0.11
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5, DTAPIPVHIB, PNC13, RV5
Symptoms: Injection site swelling, Myositis, Nuclear magnetic resonance imaging abnormal, Oedema peripheral, Staphylococcus test positive
Clinical narrative: 10/12/12 - (L) thigh tenderness & swelling. 10/25/12 - (L) femur xray "periosteal rxn along (L) femur femur diaphysis with soft tissue swelling". 10/27/12 - (L) leg incision & drainage (L) femur, bone biopsy (L) femur. 10/28/12 - Fluid + V Vancomycin: MRI "multiloculated quadriceps abscess & myositis". 10/28/12 - Fluid cx: MSSA, switch to IV ANCEF.
Age: 0.11
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5, DTAPIPVHIB, PNC13, RV5
Symptoms: X-ray limb abnormal
Clinical narrative: 10/12/12 - (L) thigh tenderness & swelling. 10/25/12 - (L) femur xray "periosteal rxn along (L) femur femur diaphysis with soft tissue swelling". 10/27/12 - (L) leg incision & drainage (L) femur, bone biopsy (L) femur. 10/28/12 - Fluid + V Vancomycin: MRI "multiloculated quadriceps abscess & myositis". 10/28/12 - Fluid cx: MSSA, switch to IV ANCEF.
Age: 72.0
Sex: M
Vaccine: FLUX, PPV, FLU3, PPV
Symptoms: Chills, Muscle spasms
Clinical narrative: Extreme chills & leg cramps caused by having to urinate 5 times during night.
Age: 72.0
Sex: M
Vaccine: FLUX, PPV, FLU3, PPV
Symptoms: Chills, Muscle spasms, Nocturia
Clinical narrative: Extreme chills & leg cramps caused by having to urinate 5 times during night.
Age: 58.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Angiogram, C-reactive protein, Colour blindness, Colour blindness acquired, Eye swelling
Clinical narrative: The day after flu vaccine, patient developed decreased vision in left eye. After evaluation with 2 eye specialists, dx of optic neuritis made. Evaluation including MRI & labs, brain without etiology for symptoms.
Age: 58.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Nuclear magnetic resonance imaging brain, Red blood cell sedimentation rate, Rheumatoid factor, Treponema test, Tuberculin test
Clinical narrative: The day after flu vaccine, patient developed decreased vision in left eye. After evaluation with 2 eye specialists, dx of optic neuritis made. Evaluation including MRI & labs, brain without etiology for symptoms.
Age: 58.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Ultrasound Doppler, Vision blurred, Visual field tests, Visual impairment
Clinical narrative: The day after flu vaccine, patient developed decreased vision in left eye. After evaluation with 2 eye specialists, dx of optic neuritis made. Evaluation including MRI & labs, brain without etiology for symptoms.
Age: 58.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: C-reactive protein normal, Nuclear magnetic resonance imaging brain normal, Optic neuritis, Red blood cell sedimentation rate normal, Rheumatoid factor negative
Clinical narrative: The day after flu vaccine, patient developed decreased vision in left eye. After evaluation with 2 eye specialists, dx of optic neuritis made. Evaluation including MRI & labs, brain without etiology for symptoms.
Age: 58.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Treponema test negative, Visual acuity reduced
Clinical narrative: The day after flu vaccine, patient developed decreased vision in left eye. After evaluation with 2 eye specialists, dx of optic neuritis made. Evaluation including MRI & labs, brain without etiology for symptoms.
Age: 65.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Erythema, Pruritus
Clinical narrative: Rash, at injection site, surrounding area. Warm to touch, painful. Varicella-like rash.
Age: 65.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site rash, Pain in extremity, Rash, Rash vesicular, Skin warm
Clinical narrative: Rash, at injection site, surrounding area. Warm to touch, painful. Varicella-like rash.
Age: 61.0
Sex: M
Vaccine: FLU3, PPV, VARZOS, FLU3, PPV, VARZOS
Symptoms: Cellulitis, Injection site erythema
Clinical narrative: Information has been received from a pharmacist concerning a 61 year old male patient with no pertinent medical history and no drug reactions or allergies, who on 16-NOV-2012 was vaccinated with a dose of PNEUMOVAX23, subcutaneously, lot # (672781/1706AA), expiry date 03-OCT-2013 (dose not reported). Other suspect therapies included ZOSTAVAX given on 16-NOV-2012 ("at the same time"; dose, route and lot # not reported). Concomitant medications included: FLUVIRIN. The pharmacist noted that, on 18-NOV-2012, the patient developed cellulitis around the injection site of the PNEUMOVAX23. The patient was seen in a walk-in clinic and prescribed an antibiotic. No laboratory tests were performed. At the time of the report, the patent did not recover from cellulitis. The relatedness for cellulitis around the injection site is unknown for PNEUMOVAX23 and ZOSTAVAX. This is one of two reports from the same source. The other report is 1211USA009556. Additional information has been requested.
Age: 61.0
Sex: M
Vaccine: FLU3, PPV, VARZOS, FLU3, PPV, VARZOS
Symptoms: Injection site cellulitis
Clinical narrative: Information has been received from a pharmacist concerning a 61 year old male patient with no pertinent medical history and no drug reactions or allergies, who on 16-NOV-2012 was vaccinated with a dose of PNEUMOVAX23, subcutaneously, lot # (672781/1706AA), expiry date 03-OCT-2013 (dose not reported). Other suspect therapies included ZOSTAVAX given on 16-NOV-2012 ("at the same time"; dose, route and lot # not reported). Concomitant medications included: FLUVIRIN. The pharmacist noted that, on 18-NOV-2012, the patient developed cellulitis around the injection site of the PNEUMOVAX23. The patient was seen in a walk-in clinic and prescribed an antibiotic. No laboratory tests were performed. At the time of the report, the patent did not recover from cellulitis. The relatedness for cellulitis around the injection site is unknown for PNEUMOVAX23 and ZOSTAVAX. This is one of two reports from the same source. The other report is 1211USA009556. Additional information has been requested.
Age: 34.0
Sex: M
Vaccine: TDAP, TDAP
Symptoms: Activities of daily living impaired, Mobility decreased, Musculoskeletal pain, Pain in extremity
Clinical narrative: Client received vaccine on 10-26-12. Starting having shoulder & arm pain that night. Saw MD on 11-11-12, given steroid injection. Has not been able to work-out or use arm in normal capacity. There was no redness or rash associated at site. Pain improved with steroid but now returning as steroid is wearing off.
Age: 34.0
Sex: M
Vaccine: TDAP, TDAP
Symptoms: Musculoskeletal pain, Pain in extremity
Clinical narrative: Client received vaccine on 10-26-12. Starting having shoulder & arm pain that night. Saw MD on 11-11-12, given steroid injection. Has not been able to work-out or use arm in normal capacity. There was no redness or rash associated at site. Pain improved with steroid but now returning as steroid is wearing off.
Age: 14.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Burning sensation, Gait disturbance, Joint swelling, Skin warm
Clinical narrative: Complained of "swollen wrists & ankles and burning & pain in all joints/entire body."
Age: 14.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Arthralgia, Joint swelling, Pain
Clinical narrative: Complained of "swollen wrists & ankles and burning & pain in all joints/entire body."
Age: 72.0
Sex: F
Vaccine: FLU3, PER
Symptoms: Herpes zoster
Clinical narrative: After receiving a higher dose of flu vaccine plus whooping cough vaccine I broke out with Shingles within a week. Dr. prescribed antiviral med. As of Nov 26, 2012 I still have symptoms.
Age: 0.12
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RVX
Symptoms: Blood culture, Blood test, CSF test, Chest X-ray, Culture urine
Clinical narrative: Fever, blood in stool.
Age: 0.12
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RVX
Symptoms: Haematochezia, Lumbar puncture, Pyrexia, Urine analysis
Clinical narrative: Fever, blood in stool.
Age: 61.0
Sex: M
Vaccine: FLU3
Symptoms: Rash erythematous, Rash pruritic
Clinical narrative: Generalize raised, red, itching rash on bilateral arms, bilateral hands, trunk, upper back.
Age: 37.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Oedema peripheral, Pain in extremity
Clinical narrative: This spontaneous report as received from a physician refers to a 37 years old female patient. The patient current conditions included with type 1 diabetes and asthma. The patient experienced anaphylaxis with TEQUIN. On 20-NOV-2012, the patient was vaccinated with a dose 0.5 milliliter (ml) PNEUMOVAX23 (lot # (672368/1849AA) and Expiry date was 28-JUL-2013)intramuscularly on the left deltoid. Concomitant medications included LANTUS, NOVOLOG, VENTOLIN HFA and PREDNISONE. On 21-NOV-2012, the patient had called the physician and reported that the arm in which she received her dose of PNEUMOVAX23 was swollen, red and painful (disability)which began on 21-NOV-2012 (reported as yesterday). The patient also reported that the event seemed to be worst at the time of this report. The patient sought medical attention (consulted the physician) and the physician advised to use ice, elevation, also to take ibuprofen as needed in addition to cetirizine. The outcome of the reported events was not recovered. Additional information has been requested.
Age: 30.0
Sex: M
Vaccine: ANTH, SMALL
Symptoms: Chest pain, Electrocardiogram normal, Epistaxis, Productive cough, Rhinorrhoea
Clinical narrative: This study case was received from the investigator on 15 November 2012. A 30-year-old male subject, with no past medical history, had received the following vaccinations on 20 March 2012: ACAM2000 (lot number, route and site not reported) and anthrax vaccine (manufacturer, lot number, route and site not reported). Nine days post-vaccination on 29 March 2012, the subject experienced three episodes of moderate chest pain on three sequential days. The first two episodes noted on waking and resolved once he arose. The last episode on 31 March 2012 occurred while sitting wearing tactical gear and resolved when gear was removed. Troponin I and ECG were normal on 03 April 2012. The subject also experienced runny nose and productive cough from 23 March 2012 to 25 March 2012 and a nose bleed on 25 March 2012. All symptoms recovered. No further information was available at the time of the report. The subject's outcome was recovered. Per the investigator, this represents a case of potential myopericarditis and was referred to the study's adjudication committee for assessment. Documents held by sender: None.
Age: 30.0
Sex: M
Vaccine: ANTH, SMALL
Symptoms: Troponin I, Troponin normal
Clinical narrative: This study case was received from the investigator on 15 November 2012. A 30-year-old male subject, with no past medical history, had received the following vaccinations on 20 March 2012: ACAM2000 (lot number, route and site not reported) and anthrax vaccine (manufacturer, lot number, route and site not reported). Nine days post-vaccination on 29 March 2012, the subject experienced three episodes of moderate chest pain on three sequential days. The first two episodes noted on waking and resolved once he arose. The last episode on 31 March 2012 occurred while sitting wearing tactical gear and resolved when gear was removed. Troponin I and ECG were normal on 03 April 2012. The subject also experienced runny nose and productive cough from 23 March 2012 to 25 March 2012 and a nose bleed on 25 March 2012. All symptoms recovered. No further information was available at the time of the report. The subject's outcome was recovered. Per the investigator, this represents a case of potential myopericarditis and was referred to the study's adjudication committee for assessment. Documents held by sender: None.
Age: 0.51
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Chest X-ray normal, Cough, Laboratory test abnormal, Nasopharyngitis, Pertussis
Clinical narrative: This is one case out of a cumulative total of 173 cases solicited from the database during the surveillance period from 01 January 2010 to 15 November 2012. These 173 cases represent children who received 3 or more doses of sanofi pasteur vaccine; cases of pertussis disease in children who received DTaP combination vaccines from other manufacturers are not reported as per study protocol. Initial report received on 15 November 2012 from the Investigator participating in the post-marketing observational surveillance study under the reference number M5A16. A case of pertussis disease in a 15-month-old male subject (initials not collected) was identified by the investigator based on review of data from the Electronic Disease Surveillance electronic database. The subject had received 3 doses of PENTACEL; lot number C3834AA received on 17 August 2011, lot number C4058AA received on 11 October 2011 and lot number C4083AA received on 13 December 2011 (route and sites of administration not reported). The subject developed cold-like symptoms on 01 October 2012, approximately 10 months after the last dose. On 08 October 2012, the subject developed a cough and paroxysmal cough without a whoop. The subject also experienced posttussive vomiting and sleep disturbance. Laboratory testing included positive PCR on 25 October 2012. Chest x-ray findings were negative for pneumonia. Corrective treatments consisted of azithromycin starting on 26 October 2012 for 5 days. The subject was not hospitalized. At the time of final contact on 06 November 2012, the subject's cough was still persisting. The duration of the cough was reported at that time as 29 days. Investigator causality assessment is not required as per protocol. Documents held by sender: None.
Age: 0.51
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Polymerase chain reaction, Post-tussive vomiting, Sleep disorder
Clinical narrative: This is one case out of a cumulative total of 173 cases solicited from the database during the surveillance period from 01 January 2010 to 15 November 2012. These 173 cases represent children who received 3 or more doses of sanofi pasteur vaccine; cases of pertussis disease in children who received DTaP combination vaccines from other manufacturers are not reported as per study protocol. Initial report received on 15 November 2012 from the Investigator participating in the post-marketing observational surveillance study under the reference number M5A16. A case of pertussis disease in a 15-month-old male subject (initials not collected) was identified by the investigator based on review of data from the Electronic Disease Surveillance electronic database. The subject had received 3 doses of PENTACEL; lot number C3834AA received on 17 August 2011, lot number C4058AA received on 11 October 2011 and lot number C4083AA received on 13 December 2011 (route and sites of administration not reported). The subject developed cold-like symptoms on 01 October 2012, approximately 10 months after the last dose. On 08 October 2012, the subject developed a cough and paroxysmal cough without a whoop. The subject also experienced posttussive vomiting and sleep disturbance. Laboratory testing included positive PCR on 25 October 2012. Chest x-ray findings were negative for pneumonia. Corrective treatments consisted of azithromycin starting on 26 October 2012 for 5 days. The subject was not hospitalized. At the time of final contact on 06 November 2012, the subject's cough was still persisting. The duration of the cough was reported at that time as 29 days. Investigator causality assessment is not required as per protocol. Documents held by sender: None.
Age: 23.0
Sex: F
Vaccine: PPV
Symptoms: Dyspnoea, Headache, Injected limb mobility decreased, Injection site erythema, Injection site swelling
Clinical narrative: - Redness/swelling at injection site, fever up to 103 degrees, vomiting and headache. - see attached sheet. Patient is 23-year-old female comes emergency department with complaint of fever for the last 3 days and she got the PNEUMOVAX shot. She states that she has redness, swelling of the left upper arm since she had the shot. She had fever to 103 maximum temperature at home. She complains of pain at the site of the vaccination. She is taking TYLENOL for her symptoms which does help with fever however when TYLENOL wears off fever comes back. She vomited 3 times but this was nonbloody and nonbilious. No diarrhea. No angioedema or shortness of breath. She complains of headache and congestion without rhinorrhea. She denies any ear pain or sore throat. No cough. Patient states she has difficulty raising her left arm overhead secondary to pain. Minimal shortness of breath.
Age: 23.0
Sex: F
Vaccine: PPV
Symptoms: Pain, Pyrexia, Respiratory tract congestion, Vaccination site pain, Vomiting
Clinical narrative: - Redness/swelling at injection site, fever up to 103 degrees, vomiting and headache. - see attached sheet. Patient is 23-year-old female comes emergency department with complaint of fever for the last 3 days and she got the PNEUMOVAX shot. She states that she has redness, swelling of the left upper arm since she had the shot. She had fever to 103 maximum temperature at home. She complains of pain at the site of the vaccination. She is taking TYLENOL for her symptoms which does help with fever however when TYLENOL wears off fever comes back. She vomited 3 times but this was nonbloody and nonbilious. No diarrhea. No angioedema or shortness of breath. She complains of headache and congestion without rhinorrhea. She denies any ear pain or sore throat. No cough. Patient states she has difficulty raising her left arm overhead secondary to pain. Minimal shortness of breath.
Age: 27.0
Sex: F
Vaccine: ANTH, FLUX, HEPAB, SMALL, TYP
Symptoms: Dyspnoea, Electrocardiogram normal, Lymphadenopathy, Palpitations, Troponin I
Clinical narrative: This study case was received from the investigator in the trial on 15 November 2012. A 27-year-old female subject had received the following vaccinations on 09 January 2012: ACAM2000 (lot number, route and site not reported), anthrax vaccine (manufacturer, lot number, route and site not reported), typhoid vaccine (manufacturer, lot number, route and site not reported), TWINRIX (lot number, route and site not reported) and influenza vaccine (manufacturer, lot number, route and site not reported). Five days post-vaccination on 14 January 2012, the subject noted "strong heartbeat" and shortness of breath while lying in bed supine for 15-20 minutes. The episode lasted for 15-20 minutes and cleared up on its own. The subject also experienced swollen glands under the left arm from 15 January 2012 to 20 January 2012. The subject treated with ibuprofen for symptoms around 3 times daily as needed. The subject denied any anxiety or cardiac history. Troponin I and ECG were normal on 25 January 2012. The subject was a prior smoker and had no past medical history. The subject had Lasik surgery on both eyes in September of 2011. Prior to the vaccination, the subject started to cough and had a sore throat and runny nose that started "a few days ago". Concomitant medication included birth control. The subject was cleared for duty with no restrictions. No further information was available at the time of the report. The subject's outcome was recovered. Per the investigator, this represents a case of potential myopericarditis and was referred to the study's adjudication committee for assessment. Documents held by sender: none.
Age: 27.0
Sex: F
Vaccine: ANTH, FLUX, HEPAB, SMALL, TYP
Symptoms: Troponin normal
Clinical narrative: This study case was received from the investigator in the trial on 15 November 2012. A 27-year-old female subject had received the following vaccinations on 09 January 2012: ACAM2000 (lot number, route and site not reported), anthrax vaccine (manufacturer, lot number, route and site not reported), typhoid vaccine (manufacturer, lot number, route and site not reported), TWINRIX (lot number, route and site not reported) and influenza vaccine (manufacturer, lot number, route and site not reported). Five days post-vaccination on 14 January 2012, the subject noted "strong heartbeat" and shortness of breath while lying in bed supine for 15-20 minutes. The episode lasted for 15-20 minutes and cleared up on its own. The subject also experienced swollen glands under the left arm from 15 January 2012 to 20 January 2012. The subject treated with ibuprofen for symptoms around 3 times daily as needed. The subject denied any anxiety or cardiac history. Troponin I and ECG were normal on 25 January 2012. The subject was a prior smoker and had no past medical history. The subject had Lasik surgery on both eyes in September of 2011. Prior to the vaccination, the subject started to cough and had a sore throat and runny nose that started "a few days ago". Concomitant medication included birth control. The subject was cleared for duty with no restrictions. No further information was available at the time of the report. The subject's outcome was recovered. Per the investigator, this represents a case of potential myopericarditis and was referred to the study's adjudication committee for assessment. Documents held by sender: none.
Age: 56.0
Sex: M
Vaccine: FLU3
Symptoms: Blood creatine phosphokinase increased, Guillain-Barre syndrome, Hypoaesthesia, Immunoglobulin therapy, Muscular weakness
Clinical narrative: Weakness, numbness (motor & sensory) all 4 extremities. Elevated CPK & muscle pain. Guillain Barre --> IVIG.
Age: 56.0
Sex: M
Vaccine: FLU3
Symptoms: Myalgia
Clinical narrative: Weakness, numbness (motor & sensory) all 4 extremities. Elevated CPK & muscle pain. Guillain Barre --> IVIG.
Age: 24.0
Sex: M
Vaccine: ANTH, SMALL
Symptoms: Chest discomfort, Conduction disorder, Cough, Electrocardiogram T wave amplitude decreased, Electrocardiogram abnormal
Clinical narrative: Initial report received on 15 November 2012 from an investigator. A 24-year-old male subject, with no relevant past medical history received the following vaccines on 09 January 2012: smallpox (vaccinia) vaccine, (lot number, not reported) and concomitant anthrax vaccine (other manufacturer, lot number not reported); (route, site and dose number not reported); (route, site and dose number not reported for either vaccine). Seven days later on 16 January 2012, the subject developed possible myopericarditis of mild severity (also reported as six days post inoculation). The subject reported intermittent chest pressure, mild, with onset seven days post vaccination, occurring over three days (also reported as four days), which he noted when lying supine, but resolved when lying on right side. He also reported symptoms consistent with a mild upper respiratory illness, including cough, runny nose and sinus congestion which started on 14 January 2012 and resolved on 17 January 2012 without treatment. The subject also reported mild swollen glands under left underarm and chest pressure on 16 January 2012, which resolved on 19 January 2012 without treatment or medication. Vaccination site (unspecified vaccine) was left arm. On 25 January 2012, a rapid Troponin 1 level was reported as normal, less than (<) 0.10ng/mL. specimens for Immunogenicity Aliquot 2 and Immunogenicity Blood Clot were collected on 25 January 2012, with no results reported; and an electrocardiogram (ECG) was reported as abnormal with Intraventricular Conduction Defect and flat T waves. The subject took no concomitant medications and treatments were reported as none. The subject was given a Cardiology referral, which the patient did not wish to follow-up as he stated he felt the episode was due to high elevation with intense training and carrying a heavy backpack. On 08 February 2012, the patient was advised to follow-up with cardiology if symptoms reoccur. On 18 July 2012, the investigator documented on Medical Record that given report of Intraventricular Conduction Defect, she recommended contacting the subject to give him results and encourage him to see a cardiologist "although not related to vaccine." The subject's outcome was reported as resolved four days later on 19 January 2012. According to the investigator the event possible myopericarditis was possibly related to the trial product or the trial procedures. Documents held by sender: Medical Records.
Age: 24.0
Sex: M
Vaccine: ANTH, SMALL
Symptoms: Immunology test, Lymphadenopathy, Rhinorrhoea, Sinus congestion, Troponin I
Clinical narrative: Initial report received on 15 November 2012 from an investigator. A 24-year-old male subject, with no relevant past medical history received the following vaccines on 09 January 2012: smallpox (vaccinia) vaccine, (lot number, not reported) and concomitant anthrax vaccine (other manufacturer, lot number not reported); (route, site and dose number not reported); (route, site and dose number not reported for either vaccine). Seven days later on 16 January 2012, the subject developed possible myopericarditis of mild severity (also reported as six days post inoculation). The subject reported intermittent chest pressure, mild, with onset seven days post vaccination, occurring over three days (also reported as four days), which he noted when lying supine, but resolved when lying on right side. He also reported symptoms consistent with a mild upper respiratory illness, including cough, runny nose and sinus congestion which started on 14 January 2012 and resolved on 17 January 2012 without treatment. The subject also reported mild swollen glands under left underarm and chest pressure on 16 January 2012, which resolved on 19 January 2012 without treatment or medication. Vaccination site (unspecified vaccine) was left arm. On 25 January 2012, a rapid Troponin 1 level was reported as normal, less than (<) 0.10ng/mL. specimens for Immunogenicity Aliquot 2 and Immunogenicity Blood Clot were collected on 25 January 2012, with no results reported; and an electrocardiogram (ECG) was reported as abnormal with Intraventricular Conduction Defect and flat T waves. The subject took no concomitant medications and treatments were reported as none. The subject was given a Cardiology referral, which the patient did not wish to follow-up as he stated he felt the episode was due to high elevation with intense training and carrying a heavy backpack. On 08 February 2012, the patient was advised to follow-up with cardiology if symptoms reoccur. On 18 July 2012, the investigator documented on Medical Record that given report of Intraventricular Conduction Defect, she recommended contacting the subject to give him results and encourage him to see a cardiologist "although not related to vaccine." The subject's outcome was reported as resolved four days later on 19 January 2012. According to the investigator the event possible myopericarditis was possibly related to the trial product or the trial procedures. Documents held by sender: Medical Records.
Age: 24.0
Sex: M
Vaccine: ANTH, SMALL
Symptoms: Troponin normal, Upper respiratory tract infection
Clinical narrative: Initial report received on 15 November 2012 from an investigator. A 24-year-old male subject, with no relevant past medical history received the following vaccines on 09 January 2012: smallpox (vaccinia) vaccine, (lot number, not reported) and concomitant anthrax vaccine (other manufacturer, lot number not reported); (route, site and dose number not reported); (route, site and dose number not reported for either vaccine). Seven days later on 16 January 2012, the subject developed possible myopericarditis of mild severity (also reported as six days post inoculation). The subject reported intermittent chest pressure, mild, with onset seven days post vaccination, occurring over three days (also reported as four days), which he noted when lying supine, but resolved when lying on right side. He also reported symptoms consistent with a mild upper respiratory illness, including cough, runny nose and sinus congestion which started on 14 January 2012 and resolved on 17 January 2012 without treatment. The subject also reported mild swollen glands under left underarm and chest pressure on 16 January 2012, which resolved on 19 January 2012 without treatment or medication. Vaccination site (unspecified vaccine) was left arm. On 25 January 2012, a rapid Troponin 1 level was reported as normal, less than (<) 0.10ng/mL. specimens for Immunogenicity Aliquot 2 and Immunogenicity Blood Clot were collected on 25 January 2012, with no results reported; and an electrocardiogram (ECG) was reported as abnormal with Intraventricular Conduction Defect and flat T waves. The subject took no concomitant medications and treatments were reported as none. The subject was given a Cardiology referral, which the patient did not wish to follow-up as he stated he felt the episode was due to high elevation with intense training and carrying a heavy backpack. On 08 February 2012, the patient was advised to follow-up with cardiology if symptoms reoccur. On 18 July 2012, the investigator documented on Medical Record that given report of Intraventricular Conduction Defect, she recommended contacting the subject to give him results and encourage him to see a cardiologist "although not related to vaccine." The subject's outcome was reported as resolved four days later on 19 January 2012. According to the investigator the event possible myopericarditis was possibly related to the trial product or the trial procedures. Documents held by sender: Medical Records.
Sex: F
Vaccine: VARZOS, PPV, VARZOS
Symptoms: Malaise, Wrong drug administered
Clinical narrative: This spontaneous report as received from a consumer refers to a female patient of unknown age. 4 weeks prior to the vaccination the patient was administered the flu shot, AFLURIA. On an unknown date the patient was vaccinated with ZOSTAVAX subcutaneously. No concomitant medications were reported. On an unknown date ZOSTAVAX was mistakenly given instead of PNEUMOVAX 23. As a result the patient has not been feeling to well. No treatment information was reported. The outcome of has not been feeling well is unknown. The relatedness for has not been feeling to well is unknown for ZOSTAVAX and AFLURIA. Additional information is not expected.
Sex: F
Vaccine: VARZOS, PPV, VARZOS
Symptoms: Chills, Fatigue, Pain, Pyrexia, Rash
Clinical narrative: This spontaneous report as received from a consumer refers to a female patient of unknown age. 4 weeks prior to the vaccination the patient was administered the flu shot, AFLURIA. On an unknown date the patient was vaccinated with ZOSTAVAX subcutaneously. No concomitant medications were reported. On an unknown date ZOSTAVAX was mistakenly given instead of PNEUMOVAX 23. As a result the patient has not been feeling to well. No treatment information was reported. The outcome of has not been feeling well is unknown. The relatedness for has not been feeling to well is unknown for ZOSTAVAX and AFLURIA. Additional information is not expected.
Sex: F
Vaccine: VARZOS, PPV, VARZOS
Symptoms: Rash vesicular
Clinical narrative: This spontaneous report as received from a consumer refers to a female patient of unknown age. 4 weeks prior to the vaccination the patient was administered the flu shot, AFLURIA. On an unknown date the patient was vaccinated with ZOSTAVAX subcutaneously. No concomitant medications were reported. On an unknown date ZOSTAVAX was mistakenly given instead of PNEUMOVAX 23. As a result the patient has not been feeling to well. No treatment information was reported. The outcome of has not been feeling well is unknown. The relatedness for has not been feeling to well is unknown for ZOSTAVAX and AFLURIA. Additional information is not expected.
Age: 72.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Immediate post-injection reaction, Pain in extremity
Clinical narrative: Arm hurt immediately after receiving injection. Pt. went to ER & sent home. Pt saw Dr. Monday, and admitted her to hospital.
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Blood culture negative, CSF culture negative, Immunoglobulin therapy, Muscular weakness
Clinical narrative: The child complained of bilateral leg weakness the day after vaccines and progressively worsen. He was admitted to hospital 11/10 - 11/15/12 and received 2 doses of IVIG. Symptoms improved.
Age: 44.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Autoimmune thrombocytopenia, Full blood count abnormal
Clinical narrative: I developed an acute case of immune thrombocytopenia, discovered in a routine physical exam confirmed by CBC bloodwork.
Age: 44.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Activities of daily living impaired, Blood test abnormal, Contusion, Petechiae, Stress
Clinical narrative: I developed an acute case of immune thrombocytopenia, discovered in a routine physical exam confirmed by CBC bloodwork.
Age: 44.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Thrombocytopenia
Clinical narrative: I developed an acute case of immune thrombocytopenia, discovered in a routine physical exam confirmed by CBC bloodwork.
Age: 24.0
Sex: M
Vaccine: MMR
Symptoms: Eye pruritus, Hyperhidrosis, Lacrimation increased, Nausea, Oedema peripheral
Clinical narrative: Nausea, sweating, vomiting, eyes itching and watering and opposite hand from injections site with finger swelling and itching. On 11/28/2012 reported fever of 99 to 101.
Age: 24.0
Sex: M
Vaccine: MMR
Symptoms: Pruritus, Pyrexia, Vomiting
Clinical narrative: Nausea, sweating, vomiting, eyes itching and watering and opposite hand from injections site with finger swelling and itching. On 11/28/2012 reported fever of 99 to 101.
Age: 27.0
Sex: M
Vaccine: FLU3
Symptoms: Chest pain, Dizziness, Fatigue, Headache, Hypoaesthesia
Clinical narrative: Friday: profound fatigue and dizziness. Saturday: rt arm numb, headache, fatigue, dizziness with nausea. Sunday: headache with pulsation, vision impacted, chest pain. Monday: headache with pulsation persisted, nausea with emesis.
Age: 27.0
Sex: M
Vaccine: FLU3
Symptoms: Nausea, Visual impairment, Vomiting
Clinical narrative: Friday: profound fatigue and dizziness. Saturday: rt arm numb, headache, fatigue, dizziness with nausea. Sunday: headache with pulsation, vision impacted, chest pain. Monday: headache with pulsation persisted, nausea with emesis.
Age: 56.0
Sex: M
Vaccine: FLU3
Symptoms: Bacterial test negative, Blood creatine phosphokinase increased, Inflammation, Injection site erythema, Injection site induration
Clinical narrative: 11/17/2012: Initial symptom was more pain at injection site (right upper arm) following day.  Pain, swelling increased.  11/19/2012: fever of 101.5 F.  Due to underlying leukemia, patient went to hospital.  Dx rhinovirus, sent home w oral antibiotic levofloxacin.  11/20/2012 2PM fever increased to 102.5, so patient returned to hospital, admitted for IV anti-biotics; swelling in right upper arm very pronounced, skin hot & red, deltoid muscle very swollen & firm to the touch.   11/28/2012: patient remains admitted to hospital, receiving IV vancomycin, Zosyn, Unasyn, but swelling not resolved, still experiencing intermittent fevers; now receiving IV steroids to treat inflammation.  MRI imagining (11/21 and 11/25) showed myositis but no abscess or collection.  Blood work identified no bacterial infection, but elevated CPK was found.  Best to request records from the hospital.  The patient will grant access upon request.  Patient has had flu shot many times in past year without problem, no other allergies
Age: 56.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site pain, Injection site swelling, Injection site warmth, Myositis, Nuclear magnetic resonance imaging abnormal
Clinical narrative: 11/17/2012: Initial symptom was more pain at injection site (right upper arm) following day.  Pain, swelling increased.  11/19/2012: fever of 101.5 F.  Due to underlying leukemia, patient went to hospital.  Dx rhinovirus, sent home w oral antibiotic levofloxacin.  11/20/2012 2PM fever increased to 102.5, so patient returned to hospital, admitted for IV anti-biotics; swelling in right upper arm very pronounced, skin hot & red, deltoid muscle very swollen & firm to the touch.   11/28/2012: patient remains admitted to hospital, receiving IV vancomycin, Zosyn, Unasyn, but swelling not resolved, still experiencing intermittent fevers; now receiving IV steroids to treat inflammation.  MRI imagining (11/21 and 11/25) showed myositis but no abscess or collection.  Blood work identified no bacterial infection, but elevated CPK was found.  Best to request records from the hospital.  The patient will grant access upon request.  Patient has had flu shot many times in past year without problem, no other allergies