chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 1.31
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, DTAPHEPBIP, HIBV, PNC13, DTAPHEPBIP, HIBV, PNC13, DTAPHEPBIP, HIBV, PNC13
Symptoms: Autopsy, Death, Inappropriate schedule of drug administration
Clinical narrative: This spontaneous report as received from a nurse refers to a female patient of unknown age. On 18-NOV-2014 the patient was vaccinated with second dose of PEDVAXHIB, 1 single shot, intramuscular. No adverse effects were reported with the first dose. The nurse reported that on 18-NOV-2014 the patient also received PREVNAR (manufacturer unknown) and PEDIARIX (manufacturer unknown). On 19-NOV-2014, 2 days after onset of therapy the patient passed away (death, disability and life threatening). The patient had sought medical attention which was reported as office visit. The outcome of the event was reported as fatal. Additional information has been requested.
Age: 1.31
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, DTAPHEPBIP, HIBV, PNC13, DTAPHEPBIP, HIBV, PNC13, DTAPHEPBIP, HIBV, PNC13
Symptoms: Autopsy, Death
Clinical narrative: This spontaneous report as received from a nurse refers to a female patient of unknown age. On 18-NOV-2014 the patient was vaccinated with second dose of PEDVAXHIB, 1 single shot, intramuscular. No adverse effects were reported with the first dose. The nurse reported that on 18-NOV-2014 the patient also received PREVNAR (manufacturer unknown) and PEDIARIX (manufacturer unknown). On 19-NOV-2014, 2 days after onset of therapy the patient passed away (death, disability and life threatening). The patient had sought medical attention which was reported as office visit. The outcome of the event was reported as fatal. Additional information has been requested.
Age: 1.31
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, DTAPHEPBIP, HIBV, PNC13, DTAPHEPBIP, HIBV, PNC13, DTAPHEPBIP, HIBV, PNC13
Symptoms: Death
Clinical narrative: This spontaneous report as received from a nurse refers to a female patient of unknown age. On 18-NOV-2014 the patient was vaccinated with second dose of PEDVAXHIB, 1 single shot, intramuscular. No adverse effects were reported with the first dose. The nurse reported that on 18-NOV-2014 the patient also received PREVNAR (manufacturer unknown) and PEDIARIX (manufacturer unknown). On 19-NOV-2014, 2 days after onset of therapy the patient passed away (death, disability and life threatening). The patient had sought medical attention which was reported as office visit. The outcome of the event was reported as fatal. Additional information has been requested.
Age: 3.0
Sex: F
Vaccine: FLUN4
Symptoms: Dehydration, Vomiting
Clinical narrative: Acute onset of emesis that could not be relieved.  Child had mild dehydration during the office visit and needed Zofran in order to stop vomiting.
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Wrong drug administered
Clinical narrative: Inadvertently given flu vaccine - client requested pneumonia.
Age: 48.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Muscle disorder, Pain
Clinical narrative: Pain after flu shot that is debilitating and muscle freeze.
Age: 56.0
Sex: M
Vaccine: FLUX
Symptoms: Electromyogram abnormal, Guillain-Barre syndrome, Immunoglobulin therapy, Muscular weakness, Pain
Clinical narrative: Guillain Barre Syndrome. Pain, tingling and paraesthesias in a stocking-glove distribution. Also proximal muscle weakness. EMG consistent with Guillian-Barre Syndrome. Responding to treatment with IVIG.
Age: 56.0
Sex: M
Vaccine: FLUX
Symptoms: Paraesthesia
Clinical narrative: Guillain Barre Syndrome. Pain, tingling and paraesthesias in a stocking-glove distribution. Also proximal muscle weakness. EMG consistent with Guillian-Barre Syndrome. Responding to treatment with IVIG.
Age: 27.0
Sex: F
Vaccine: FLUX
Symptoms: Injection site injury, Injection site pain, Musculoskeletal stiffness, Pain, X-ray limb
Clinical narrative: Shoulder Injury Related to Vaccine Administration. Continuous pain in left shoulder upon movement. Achiness when still. Throbbing and stiffness upon waking.
Age: 22.0
Sex: M
Vaccine: TYP
Symptoms: Abdominal pain upper
Clinical narrative: Severe stomach cramping.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to unknown number patients of unknown age and gender. The nurse reported that an unknown number of doses of ROTATEQ (dose and lot# not reported) that were improperly stored (outside of the range specified in the prescribing information) might have been administered oral. ROTATEQ was exposed to 30F then 48F for 72 hours. No adverse effect was reported. This is one of several reports received from the same source. Additional information has been requested.
Age: 58.0
Sex: M
Vaccine: FLU4
Symptoms: Chills, Fatigue, Feeling cold, Malaise, Tremor
Clinical narrative: Shivers, chills, shaking spells, episodes of feeling cold, fatigue, washed out, malaise for 2 days.
Age: 0.34
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5, DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Intussusception
Clinical narrative: Intussusception
Age: 0.34
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5, DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Blood bicarbonate normal, Enema administration, Haematocrit decreased, Intestinal resection, Intussusception
Clinical narrative: Intussusception
Age: 0.34
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5, DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Irritability, Ultrasound abdomen abnormal, Vomiting, Weight decreased, White blood cell count increased
Clinical narrative: Intussusception
Age: 13.0
Sex: M
Vaccine: FLUN4, HEPA, HPV4, MNQ, TDAP
Symptoms: Syncope, Vomiting
Clinical narrative: Pt experienced extreme syncope after receiving immunizations. Pt vomited once after immunization. Pt was put in Trendelenburg and given juice and crackers. Pt was unable to recover and was sent to the emergency room by ambulance. The EMTs gave him a fluid bolus and transported him to the ER. The ER monitored him and gave him two sandwiches. Pt was discharged.
Age: 46.0
Sex: F
Vaccine: FLUN4
Symptoms: Sinus congestion
Clinical narrative: Small amount of daily, intermittent sinus drainiage since receiving the Flu Mist.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Cellulitis, Erythema, Herpes zoster, Pain
Clinical narrative: Lots of pain and notice redness was spreading.
Age: 41.0
Sex: F
Vaccine: FLU3
Symptoms: Blood pressure increased, Dyspnoea
Clinical narrative: Patient called and reported having trouble breathing while she was at work.  PharmD recommended patient come to the pharmacy.  Patient arrived and pharmacists administered epinephrine (1 shot 0.3mg) and called 911.  Paramedics arrived quickly, and patient reported improvement in breathing.  BP was elevated.  Patient and paramedics stayed until breathing was much improved and BP had lowered.
Age: 83.0
Sex: M
Vaccine: FLU3
Symptoms: Chills, Headache, Nausea, Pyrexia, Vomiting
Clinical narrative: Severe, uncontrollable chills, extreme nausea, vomited twice, headache, fever that reached 101.9 at 2:00 am.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: Severe arm soreness x 5 days following shot. Went away for 3-4 days. Area effected was from elbow to shoulder. After that 3-4 days it came back and never went away. Still severely limited mobility in shoulder.
Age: 52.0
Sex: F
Vaccine: FLU3
Symptoms: Immediate post-injection reaction, Injection site swelling
Clinical narrative: Swelling at injection site immediately. Gave her a BENADRYL 25g - she said that she usually takes that for allergies. She left after swelling was getting better.
Age: 0.54
Sex: M
Vaccine: DTAP, DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Extra dose administered
Clinical narrative: Patient in for 6 month well child. NP ordered Dtap and Pediarix. The nurse did not catch the error resulting in the child receiving 2 doses of Dtap at once.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Arthritis, Aspiration joint normal, Joint effusion
Clinical narrative: Arthritis of left ankle with effusion.  Admitted to hospital.  Tap of joint negative for infection.  Started on anti-inflammatory medication.  Arthritis thought to be post-viral and not related to vaccines.
Age: 38.0
Sex: F
Vaccine: FLUN4
Symptoms: Cough, Dry throat, Ear pain, Immediate post-injection reaction, Myalgia
Clinical narrative: Immediate sneezing, then sore throat, ear ache, cough, sore muscles, dry throat, blurred vision, still continuing.
Age: 38.0
Sex: F
Vaccine: FLUN4
Symptoms: Oropharyngeal pain, Sneezing, Vision blurred
Clinical narrative: Immediate sneezing, then sore throat, ear ache, cough, sore muscles, dry throat, blurred vision, still continuing.
Age: 63.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Peripheral swelling, Pruritus, Skin warm
Clinical narrative: Arm red, swollen, itch, hot to touch.
Age: 55.0
Sex: F
Vaccine: FLU3
Symptoms: Fatigue, Flushing, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Reaction at injection site, itching, swelling & heat.  Patient became flush just before site reaction occurred.  Left arm (arm injection received in)itched as well as areas of head and scalp.  Morning prior to reaction patient experienced localized area pain at injection site.  Type of discomfort first experienced after most people have an injection.
Age: 55.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site warmth, Malaise, Pruritus
Clinical narrative: Reaction at injection site, itching, swelling & heat.  Patient became flush just before site reaction occurred.  Left arm (arm injection received in)itched as well as areas of head and scalp.  Morning prior to reaction patient experienced localized area pain at injection site.  Type of discomfort first experienced after most people have an injection.
Age: 75.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity
Clinical narrative: Patient developed soreness in arm where vaccine was administered, which has not subsided for over one month.
Age: 48.0
Sex: F
Vaccine: FLU4
Symptoms: Rash, Urticaria
Clinical narrative: Rash/hives across chest at back (upper), back of neck, no itching, gone by next am.
Age: 70.0
Sex: M
Vaccine: FLU3, PNC13
Symptoms: Erythema, Local swelling, Pruritus, Skin warm
Clinical narrative: Right upper extremity swelling, itching, redness and warm/hot to touch after injection. Patient was seen at acute care and treated with antibiotic.
Age: 6.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site erythema
Clinical narrative: Patient's mother reports that patient has a small red spot at site of which flu vaccine was administered on the rt arm. Area is not hot or tender. Area 1 inch in diameter.
Age: 52.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Chest discomfort, Dizziness, Feeling hot, Hypoaesthesia, Immediate post-injection reaction
Clinical narrative: Patient felt hot, light headed-immediately chest felt tight. Legs numb and tingly. Took blood pressure it was 105/77. Pulse 77.
Age: 52.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Paraesthesia
Clinical narrative: Patient felt hot, light headed-immediately chest felt tight. Legs numb and tingly. Took blood pressure it was 105/77. Pulse 77.
Age: 10.0
Sex: F
Vaccine: HPV4, TDAP
Symptoms: Injection site erythema, Injection site pruritus, Injection site rash
Clinical narrative: Day after received TDAP booster (1st in 2008) she developed a 9 1/2 x 13 1/2 cm red rash with itching at the site of the injection.
Age: 0.35
Sex: F
Vaccine: RV5, RV5
Symptoms: Expired product administered, No adverse event
Clinical narrative: None. Patient given vaccine of ROTATEQ and had expired date of 11/20/14 no reactions. Spoke with Merck no further action needed.
Age: 34.0
Sex: F
Vaccine: FLU3
Symptoms: Throat irritation, Urticaria
Clinical narrative: Few hours after flu shot developed hives, scratchy throat. Given BENADRYL, PEPCID, SOLU-MEDROL - sx resolved.
Age: 63.0
Sex: F
Vaccine: FLU3
Symptoms: Dyspnoea, Throat tightness
Clinical narrative: Received flu vaccine about 15 min. after developed throat tightness, difficulty breathing. Declined meds, resolved. Seen in ED.
Age: 1.25
Sex: M
Vaccine: DTAP
Symptoms: Chest X-ray normal, Cough, Laboratory test normal, Nasopharyngitis, Pertussis
Clinical narrative: This is one case out of a cumulative total of 240 cases solicited from the EDSS database during the surveillance period from 01 January 2010 to 25 November 2014. These 240 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 solicited report received on 25 November 2014 from the Investigator participating in a post-marketing study under the reference number M5A16. A case of pertussis disease in a 3-year-old male subject (initials not collected) was identified by the investigator based on review of data from the Electronic Disease Surveillance (EDSS) electronic database. The subject had received 3 doses of PENTACEL on 11 March 2011, 29 April 2011 and 05 July 2011, (routes and lot numbers not reported) and a dose of DAPTACEL on 27 March 2012, lot number C4183AA, (route and site not reported). The subject developed cold-like symptoms on 21 October 2014, approximately 30 months after the last dose. On 21 October 2014, the subject developed a cough and paroxysmal cough without a whoop. The subject experienced posttussive vomiting on an unreported date. The subject experienced sleep disturbance but did not experience apnea. Laboratory testing included negative PCR on 01 November 2014. Chest x-ray findings were negative for pneumonia. Corrective treatments consisted of azithromycin starting on 01 November 2014 for an unknown duration. The subject was not hospitalized. At the time of final contact on 04 November 2014, the subject's cough was still persisting. The duration of the cough was reported at that time as 14 days. According to the investigator, this case was epidemiologically linked to a laboratory confirmed case. Investigator causality assessment is not required as per protocol. Documents held by sender: None.
Age: 1.25
Sex: M
Vaccine: DTAP
Symptoms: Polymerase chain reaction, Post-tussive vomiting, Sleep disorder
Clinical narrative: This is one case out of a cumulative total of 240 cases solicited from the EDSS database during the surveillance period from 01 January 2010 to 25 November 2014. These 240 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 solicited report received on 25 November 2014 from the Investigator participating in a post-marketing study under the reference number M5A16. A case of pertussis disease in a 3-year-old male subject (initials not collected) was identified by the investigator based on review of data from the Electronic Disease Surveillance (EDSS) electronic database. The subject had received 3 doses of PENTACEL on 11 March 2011, 29 April 2011 and 05 July 2011, (routes and lot numbers not reported) and a dose of DAPTACEL on 27 March 2012, lot number C4183AA, (route and site not reported). The subject developed cold-like symptoms on 21 October 2014, approximately 30 months after the last dose. On 21 October 2014, the subject developed a cough and paroxysmal cough without a whoop. The subject experienced posttussive vomiting on an unreported date. The subject experienced sleep disturbance but did not experience apnea. Laboratory testing included negative PCR on 01 November 2014. Chest x-ray findings were negative for pneumonia. Corrective treatments consisted of azithromycin starting on 01 November 2014 for an unknown duration. The subject was not hospitalized. At the time of final contact on 04 November 2014, the subject's cough was still persisting. The duration of the cough was reported at that time as 14 days. According to the investigator, this case was epidemiologically linked to a laboratory confirmed case. Investigator causality assessment is not required as per protocol. Documents held by sender: None.
Age: 1.29
Sex: F
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 239 cases solicited from the EDSS database during the surveillance period from 01 January 2010 to 25 November 2014. These 239 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 solicited report was received on 25 November 2014 from the Investigator participating in a post-marketing study under the reference number M5A16. A case of pertussis disease in a 15 month-old female subject (initials not collected) was identified by the investigator based on review of data from the Electronic Disease Surveillance (EDSS) electronic database. The subject had received four doses of PENTACEL: dose one on 19 August 2013 (lot number C4482AA), dose two on 25 October 2013 (lot number C4478AB), dose three on 26 December 2013 and dose four on 03 October 2014 (lot number C4625AA). Routes and sites of administration for all doses were not reported. The subject developed cough, paroxysmal cough and cold-like symptoms on 08 October 2014, approximately 5 days after the last dose of PENTACEL. The subject also experienced post-tussive vomiting and sleep disturbance on an unspecified date. Laboratory testing included a positive PCR on 17 October 2014. Chest x-ray findings were negative. Corrective treatments consisted of azithromycin starting on 17 October 2014 for 5 days. The subject was not hospitalized. At the time of final contact on 12 November 2014, the subject's cough was still persisting. The duration of the cough was reported at that time as 35 days. Investigator causality assessment is not required as per protocol. Documents held by sender: None.
Age: 1.29
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Polymerase chain reaction, Post-tussive vomiting, Sleep disorder
Clinical narrative: This is one case out of a cumulative total of 239 cases solicited from the EDSS database during the surveillance period from 01 January 2010 to 25 November 2014. These 239 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 solicited report was received on 25 November 2014 from the Investigator participating in a post-marketing study under the reference number M5A16. A case of pertussis disease in a 15 month-old female subject (initials not collected) was identified by the investigator based on review of data from the Electronic Disease Surveillance (EDSS) electronic database. The subject had received four doses of PENTACEL: dose one on 19 August 2013 (lot number C4482AA), dose two on 25 October 2013 (lot number C4478AB), dose three on 26 December 2013 and dose four on 03 October 2014 (lot number C4625AA). Routes and sites of administration for all doses were not reported. The subject developed cough, paroxysmal cough and cold-like symptoms on 08 October 2014, approximately 5 days after the last dose of PENTACEL. The subject also experienced post-tussive vomiting and sleep disturbance on an unspecified date. Laboratory testing included a positive PCR on 17 October 2014. Chest x-ray findings were negative. Corrective treatments consisted of azithromycin starting on 17 October 2014 for 5 days. The subject was not hospitalized. At the time of final contact on 12 November 2014, the subject's cough was still persisting. The duration of the cough was reported at that time as 35 days. Investigator causality assessment is not required as per protocol. Documents held by sender: None.
Age: 59.0
Sex: M
Vaccine: FLUX
Symptoms: Cough, Headache, Influenza B virus test positive, Pyrexia
Clinical narrative: Initial unsolicited case received from a healthcare professional on 25 November 2014. A 60-year-old male patient with no reported medical history had received a dose of Flu vaccine on 03 November 2014 (manufacturer, lot number, route and site of administration not reported). On 23 November 2014, i.e. 3 weeks post vaccination, he experienced pyrexia, headache and cough. A quick view nasal swab test indicated "Flu B". The events required ER/doctor visit. No further details were provided. Patient's outcome was unknown. Documents held by sender: None.
Age: 0.56
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Chest X-ray normal, Cough, Laboratory test abnormal, Nasopharyngitis, Pertussis
Clinical narrative: Initial report was received on 26 November 2014 from the Investigator participating in a post-marketing study under the reference number M5A16. This is one case in a series of 241 pertussis cases received during the surveillance period from 01 January 2010 to 26 November 2014. A case of pertussis disease in a 10 month-old, female subject (initials not collected) was identified by the investigator based on review of data from the Electronic Disease Surveillance System (EDSS). The subject's vaccine history included three doses of PENTACEL; dose one lot number C4577AA received on 17 February 2014, dose two lot number C4662AA received on 21 April 2014 and dose three lot number C4680AA received on 08 July 2014 (routes and sites of administration not reported). Nearly 4 months after the last dose, on 04 November 2014, the subject developed a cough. Six days later on 10 November 2014, the subject developed a paroxysmal cough. The subject also experienced cold-like symptoms, posttussive vomiting and sleep disturbance (onset dates not reported). Laboratory testing included positive PCR on 13 November 2014. Chest x-ray findings were negative for pneumonia. Corrective treatment included Azithromycin on 13 November 2014 for five days. The subject was not hospitalized. At the time of final contact on 21 November 2014, the subject's cough was still persisting after 17 days. According to the investigator, this case was not epidemiologically linked to a laboratory confirmed case. Investigator causality assessment is not required as per protocol. Documents held by sender: none.
Age: 0.56
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Polymerase chain reaction, Post-tussive vomiting, Sleep disorder
Clinical narrative: Initial report was received on 26 November 2014 from the Investigator participating in a post-marketing study under the reference number M5A16. This is one case in a series of 241 pertussis cases received during the surveillance period from 01 January 2010 to 26 November 2014. A case of pertussis disease in a 10 month-old, female subject (initials not collected) was identified by the investigator based on review of data from the Electronic Disease Surveillance System (EDSS). The subject's vaccine history included three doses of PENTACEL; dose one lot number C4577AA received on 17 February 2014, dose two lot number C4662AA received on 21 April 2014 and dose three lot number C4680AA received on 08 July 2014 (routes and sites of administration not reported). Nearly 4 months after the last dose, on 04 November 2014, the subject developed a cough. Six days later on 10 November 2014, the subject developed a paroxysmal cough. The subject also experienced cold-like symptoms, posttussive vomiting and sleep disturbance (onset dates not reported). Laboratory testing included positive PCR on 13 November 2014. Chest x-ray findings were negative for pneumonia. Corrective treatment included Azithromycin on 13 November 2014 for five days. The subject was not hospitalized. At the time of final contact on 21 November 2014, the subject's cough was still persisting after 17 days. According to the investigator, this case was not epidemiologically linked to a laboratory confirmed case. Investigator causality assessment is not required as per protocol. Documents held by sender: none.
Age: 49.0
Sex: M
Vaccine: ANTH, SMALL, TYP
Symptoms: Chest pain, Electrocardiogram abnormal, Troponin I normal
Clinical narrative: Note: Any requests for follow-up information on this case should be sent directly to the sponsor of this study, Sanofi Pasteur. This solicited case was received from the investigator participating in a trial on 26 November 2014. A 49 year-old male subject with past medical history of high blood pressure, elevated cholesterol, chest pain, abnormal ECG and numbness or paralysis had received the following vaccines on 28 July 2014: an injection of ACAM2000 (lot number, route and site of administration not reported), TYPHIM VI (lot number, route and site of administration not reported) and Anthrax vaccine (manufacturer, lot number, route and site of administration not reported). On 19 August 2014, the subject was diagnosed with precordial pain. Results of ECG performed on 19 August 2014 were abnormal. Echocardiogram, MRI (heart, spinal cord and brain) were not performed. Troponin I level measured on 19 August 2014 was normal. The subject's outcome was not reported. Note: There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study. Documents held by sender: None.
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash vesicular
Clinical narrative: Shingles like rash in left armpit area.
Age: 87.0
Sex: F
Vaccine: PPV
Symptoms: Body temperature increased
Clinical narrative: Elevated temperature @ 100.0.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Chest discomfort, Diarrhoea, Dyspnoea, Injection site pain, Pain
Clinical narrative: Shortness of breath, tightness in chest, severe aches all over body, vomiting, diarrhea, very sore at site of injection, fever. Too much pain for older person.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Pyrexia, Vomiting
Clinical narrative: Shortness of breath, tightness in chest, severe aches all over body, vomiting, diarrhea, very sore at site of injection, fever. Too much pain for older person.
Age: 68.0
Sex: F
Vaccine: PNC13
Symptoms: Condition aggravated, Dizziness, Immediate post-injection reaction, Palpitations
Clinical narrative: Immediately following the PCV 13 injection client c/o feeling dizzy.  After sitting for approx. 10 minutes she reported feeling better and left the clinic.  She returned at 11:50 AM with her spouse and reported having heart palpitations.  Denied dizziness, chest pain, shortness of breath, hives, itching, or any other symptoms.  Her BP was taken and was 192/82 and heart rate was 77.  She was advised to go to ER to have complaint of heart palpitations assessed.
Age: 0.11
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Body temperature increased
Clinical narrative: Had a temp up to 102 after 2 month vaccinations.
Age: 0.19
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV1
Symptoms: Choking, Crying, Head banging, Infantile spitting up, Productive cough
Clinical narrative: Uncontrollable crying for about 4 hours.  Vomiting & spitting up phlegm and choking on it, pounding on his head with his hands.
Age: 0.19
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV1
Symptoms: Vomiting
Clinical narrative: Uncontrollable crying for about 4 hours.  Vomiting & spitting up phlegm and choking on it, pounding on his head with his hands.
Age: 41.0
Sex: M
Vaccine: FLU3
Symptoms: Dizziness, Headache, Loss of consciousness
Clinical narrative: ABOUT 13 MINUTES AFTER RECEIVING FLU VACCINE, PT REPORTED FEELING LIGHT HEADED; RPH WITNESSED PT ACTUALLY LOSE CONSCIOUSNESS BRIEFLY, BUT RECOVERED CONSCIOUSNESS ALMOST IMMEDIATELY. RPH HAD PT LIE DOWN AND HAD CUSTOMER SERVICE DIAL 911. RPH CHECKED PT'S BP AT 2 FIVE MINUTE INTERVALS (110/80 MMHG, 112/86 MMHG). PT REPORTED FEELING MUCH BETTER AFTER A FEW MINUTES LYING DOWN. WHEN EMS ARRIVED ABOUT 5 MIN LATER, PT SAID HE FELT MUCH BETTER, JUST OCCASIONAL LIGHT-HEADEDNESS. EMS TOLD RPH NOT TO ADMINISTER ANY EPINEPHRINE. EMS MONITORED PT ANOTHER 10 MIN OR SO; PT'S BP CONTINUED TO BE NORMAL, HR AND BG ALSO NORMAL. PT DECLINED BEING TAKEN TO ER AND EMS LEFT. RPH CONTACTED PT'S MD; NURSE SAID FOR PT TO GO TO ER IF HE FELT HE NEEDED TO, BUT IF FELT OKAY, THEN JUST TO F/U WITH OFFICE IF HE HAD QUESTIONS. PT STAYED IN STORE ANOTHER 1.5 HRS AS HE CONTINUED TO HAVE OCCASIONAL LIGHT-HEADEDNESS AND HEADACHE. HE HAD A GLASS OF WATER AND ATE A TURKEY SANDWICH TO SEE IF THAT IMPROVED HIS SYMPTOMS; SYMPTOMS REMAINED THE SAME. HIS OCCASIONAL LIGHT-HEADEDNESS CONTINUED AND PT OPTED TO HAVE A FRIEND DRIVE HIM TO THE ER TO MAKE SURE HE WAS OKAY. PT LEFT STORE ABOUT 12:15PM.
Age: 0.34
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV1
Symptoms: Choking, Crying, Dyspnoea, Head banging, Productive cough
Clinical narrative: Uncontrollable crying for about 3 hours.  Vomiting of milk and phlegm, choking and hard time breathing, pounding on his head with his hands.
Age: 0.34
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV1
Symptoms: Vomiting
Clinical narrative: Uncontrollable crying for about 3 hours.  Vomiting of milk and phlegm, choking and hard time breathing, pounding on his head with his hands.
Age: 1.03
Sex: F
Vaccine: HEPA, HIBV, PNC13
Symptoms: Pyrexia, Rash
Clinical narrative: Patient received Hep A (Havrix), PedvaxHib, and PCV 13 vaccine on 11/6/2014 and mother states patient started getting fever the next day of 101-102 on average, lasting 4-5 days; at one point peaking to 103. Patient also got a rash on abdomen and back that lasted about 4-5 days as well. Mom admits patient does have sensitive skin and has a history of eczema. Mom says this rash looked different then her eczema. Patient went ot the ER and was monitored.
Age: 68.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Back pain, Chest pain, Chills, Dizziness, Dyspnoea
Clinical narrative: Chills, very cold, shivers, severe shaking with tight, prolonged body clenching, head ache, dizziness, sharp pains stabbing in back and chest, shortness of breath due to long body spasms.  Pain to hamstrings, location of shots in both arms provided unusually deep ache and soreness....far above normal.  Lasted till' about 4 AM the following morning.  Would have gone to ER but could not drive with nature of symptoms.  I went to Med. Center and they advised they did not have the flu shot strong enough for my age group....advised I go to pharmacy.  Pharmacy said that I should also have the children's level pneumonia shot in conjunction with the flu shot, which I did....one in each arm.  This was a miserable experience; not a light annoying one.  I am not getting answers from the Clinic regarding how I should proceed next year.  I will be hard pressed to get another shot without some direction.  I occasionally experience lower back tightness but today it is quite tight and aching....more than usual...not certain if it is related to last night but the level of cramping and spasms could very well have strained my muscles....hope to get a call or some direction.
Age: 68.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Feeling cold, Headache, Muscle contractions involuntary, Muscle spasms, Muscle tightness
Clinical narrative: Chills, very cold, shivers, severe shaking with tight, prolonged body clenching, head ache, dizziness, sharp pains stabbing in back and chest, shortness of breath due to long body spasms.  Pain to hamstrings, location of shots in both arms provided unusually deep ache and soreness....far above normal.  Lasted till' about 4 AM the following morning.  Would have gone to ER but could not drive with nature of symptoms.  I went to Med. Center and they advised they did not have the flu shot strong enough for my age group....advised I go to pharmacy.  Pharmacy said that I should also have the children's level pneumonia shot in conjunction with the flu shot, which I did....one in each arm.  This was a miserable experience; not a light annoying one.  I am not getting answers from the Clinic regarding how I should proceed next year.  I will be hard pressed to get another shot without some direction.  I occasionally experience lower back tightness but today it is quite tight and aching....more than usual...not certain if it is related to last night but the level of cramping and spasms could very well have strained my muscles....hope to get a call or some direction.
Age: 68.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Tremor
Clinical narrative: Chills, very cold, shivers, severe shaking with tight, prolonged body clenching, head ache, dizziness, sharp pains stabbing in back and chest, shortness of breath due to long body spasms.  Pain to hamstrings, location of shots in both arms provided unusually deep ache and soreness....far above normal.  Lasted till' about 4 AM the following morning.  Would have gone to ER but could not drive with nature of symptoms.  I went to Med. Center and they advised they did not have the flu shot strong enough for my age group....advised I go to pharmacy.  Pharmacy said that I should also have the children's level pneumonia shot in conjunction with the flu shot, which I did....one in each arm.  This was a miserable experience; not a light annoying one.  I am not getting answers from the Clinic regarding how I should proceed next year.  I will be hard pressed to get another shot without some direction.  I occasionally experience lower back tightness but today it is quite tight and aching....more than usual...not certain if it is related to last night but the level of cramping and spasms could very well have strained my muscles....hope to get a call or some direction.
Age: 1.0
Sex: F
Vaccine: FLU3, HEPA, MMR, VARCEL
Symptoms: Febrile convulsion, Pyrexia
Clinical narrative: Patient had febrile seizure 9 days post vaccination, went to ER and fever of 102.2 was discovered. Patient monitored and released.
Age: 1.48
Sex: F
Vaccine: MMRV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Has raised red bump on top of the skin that is painful to the touch (left leg). Growing in size.
Age: 84.0
Sex: F
Vaccine: PNC13
Symptoms: Cellulitis, Erythema, Malaise, Pain in extremity, Skin warm
Clinical narrative: Rapid onset of right arm redness, swelling, warmth, pain, and malaise. Elevated WBC count, treating for cellulitis.
Age: 84.0
Sex: F
Vaccine: PNC13
Symptoms: Swelling, White blood cell count increased
Clinical narrative: Rapid onset of right arm redness, swelling, warmth, pain, and malaise. Elevated WBC count, treating for cellulitis.
Age: 36.0
Sex: M
Vaccine: FLU4
Symptoms: Convulsion, Fall, Malaise, Nervousness, Tremor
Clinical narrative: C/o not feeling well after flu vaccine. Feeling shaky. Visibly shaky. Blood pressure 138/92 Pulse 80 Respirations 20. Began to feel better after 5 minutes of rest. Stood up and took a few steps. Turned around and took another step. Then fell forward and began seizing.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pain, Swelling
Clinical narrative: Swelling, redness, and mild pain.
Age: 63.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site rash, Pruritus, Rash generalised
Clinical narrative: 2 days after received vaccine had localized rash at injection site, which progressivley spread to most of her entire body, had itching.
Age: 60.0
Sex: M
Vaccine: FLU3
Symptoms: Ocular hyperaemia, Rash generalised, Rash pruritic
Clinical narrative: About one and a half days after taking flu shot, employee experienced a generalized rash over entire body and his eyes became bloodshot.  The rash was accompanied by non-severe itching.  On 12/3/14 the rash is fading and itching has subsided.  Eyes remain somewhat reddened.  Employee did not seek medical help.
Age: 28.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Cough, Fatigue, Pain in extremity, Pyrexia
Clinical narrative: Tiredness followed by chills and fever of up to 102.3 for 5 days.   After 5 days developed cough but no longer had fever. Started antibiotics prescribed by oncologist after 4 days of fever.    Arm is still sore after 7 days.
Age: 2.0
Sex: F
Vaccine: FLUN4
Symptoms: Abdominal pain upper, Pyrexia
Clinical narrative: Stomach ache, high fevers to 104.
Age: 59.0
Sex: F
Vaccine: FLU3
Symptoms: Muscle disorder, Myalgia
Clinical narrative: The patient came in after 2 months of receiving the vaccination (12/03/2014) to complain of the muscle pain she says got after receiving the flu shot. She says she does not have any pain during the day unless she tries to reach for something. At night she says the muscle is painful and freezes up. She also states that the pain is improving and going away. At the time of getting the flu shot the pharmacist went over all the signs and symptoms of common adverse effects (muscle weakness and pain included) and how to treat them if they should develop.
Age: 79.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site irritation, Injection site pruritus
Clinical narrative: Patient says the injection site has been itching/irritated since day of immunization.  The itching and redness has continued to increase and spread down the arm towards the elbow.  I, the pharmacist, referred patient to her PCP.  She stated that she had already had contacted them and that they asked her to come in.  I encouraged her to follow through with that.  She did not want me to contact the doctor.
Age: 28.0
Sex: M
Vaccine: PPV
Symptoms: Injection site pain, Injection site pruritus, Injection site rash, Injection site swelling
Clinical narrative: Pruritus, rash, swelling, and tender around the injection site.
Age: 55.0
Sex: M
Vaccine: VARZOS
Symptoms: Vaccination site erythema, Vaccination site induration, Vaccination site warmth
Clinical narrative: A golf ball sized induration developed two days post Zostavax vaccine in the general area the vaccine was administered on the left arm. The induration was warm, hard, and had surrounding erythema twice the size. There was a concern of cellulitis, so a 7 day course of cephalexin 500mg four times daily was started. The redness, warmth, and size of the induration was significantly reduced within one day of treatment with cephalexin. It resolved within two to three days of antibiotic treatment.
Age: 49.0
Sex: M
Vaccine: FLU4
Symptoms: Musculoskeletal pain
Clinical narrative: Pt stated some pain in shoulder after vaccination administration. Pt declined evaluation.
Age: 54.0
Sex: F
Vaccine: FLUX
Symptoms: Oedema peripheral
Clinical narrative: I had swelling in the armpit of the vaccination arm. The swelling was so severe it was visible from the outside. When I hold up both arms, it looks like I have a little pillow in my left armpit. There is no redness. I have treated it with ibuprofen and warm compresses.
Age: 37.0
Sex: M
Vaccine: FLU3
Symptoms: Chills, Feeling hot, Hyperaesthesia, Injection site pain, Pain
Clinical narrative: SORENESS AT SITE OF INJECTION, SENSITIVE SKIN, BODY ACHES, HOT/COLD CHILLS, AND FEVERISH.
Age: 37.0
Sex: M
Vaccine: FLU3
Symptoms: Pyrexia, Vaccine positive rechallenge
Clinical narrative: SORENESS AT SITE OF INJECTION, SENSITIVE SKIN, BODY ACHES, HOT/COLD CHILLS, AND FEVERISH.
Age: 60.0
Sex: F
Vaccine: FLU3
Symptoms: Angioedema, Eye pruritus, Swelling face
Clinical narrative: Patient reported itchy eyes within 30 mins of administration. She was advised to try Benadryl and follow up with Dr. if symptoms worsened. This was a flu shot clinic held at her place of employment.  I was not notified of the more serious adverse event until 12/2/14, more that 30 days after.  She went to Urgent Care about 4-5 days after vaccine because of swelling in face (angioedema) and received a steroid pak. After completing that and not seeing improvement, she went to her primary care Dr. He prescribed a longer dosed steroid as well as Ranitidine, Loratadine. Her PCP has referred her to an allergist for further testing.  She states she is not 100% better and is still dealing with the aftermath.
Age: 33.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Pain in extremity, Tremor
Clinical narrative: Husband called 12/3/14 and spoke with pharmacist on duty. He stated that patient started having extreme pain in both arms (had Fluzone in left and Pneumovax in right) about 7pm. Husband said she had to take Percocet to help with pain as she equated it to the pain from child birth. Patient also had the shakes quite badly and husband almost took her to the ER.
Age: 16.0
Sex: M
Vaccine: HPV4
Symptoms: Rash, Urticaria
Clinical narrative: Rash (hives) on back, spreading to chest, neck, face. Continued to worsen, persists today and required doctor visit.
Sex: U
Vaccine: FLUX
Symptoms: Intensive care, Skin exfoliation
Clinical narrative: Initial unsolicited case received from a consumer on 21 November 2014. A patient was admitted to the intensive care unit of the hospital two days after receiving an Influenza vaccine (manufacturer and lot number not reported) for "loss of skin". The reporter declined to provide any additional information; date of vaccination, patient identifiers, medical history, diagnosis, administration details, and outcome were not reported. Documents held by sender: None.
Sex: F
Vaccine: FLU3
Symptoms: Local reaction
Clinical narrative: Initial report received from healthcare professional on 21 November 2014. This case is linked to case 2014SA163375 (same reporter, same patient). A female patient, whose age at the time of event, medical history and concomitant medications were not reported, had received a dose of FLUZONE (batch number, route and anatomical site of administration were not reported) on an unspecified date of 2013. It was reported that on an unspecified date, after receiving FLUZONE, the patient had a very severe local reaction for which she required hospitalization. The patient's corrective treatments and laboratory investigations were not reported. At the time of this report, the outcome was unknown. Documents held by sender: none.
Sex: U
Vaccine: FLUX
Symptoms: Death, Immediate post-injection reaction, Pyrexia
Clinical narrative: Initial unsolicited case received from a consumer on 24 November 2014, during routine media monitoring. Five patients, whose ages and genders were not reported, received Influenza vaccine (manufacturer and lot numbers not reported) on 07 November 2014. It was reported that the patients immediately developed a fever, and all died within one week of vaccination. No additional information pertaining to the patients was reported. Documents held by sender: None.
Age: 24.0
Sex: M
Vaccine: ANTH, SMALL, TYP
Symptoms: Chest pain, Echocardiogram abnormal, Electrocardiogram abnormal, Troponin I
Clinical narrative: Initial solicited case was received from the investigator participating in a trial on 25 November 2014. A 24-year-old male subject, with no reported past medical history, had received the following vaccines on 15 July 2014: an injection of ACAM2000 (lot number, route and site of administration not reported), TYPHIM VI (lot number, route and site of administration not reported), and Anthrax vaccine (manufacturer, lot number, route and site of administration not reported). On 25 July 2014, the subject was diagnosed with unspecified chest pain. Abnormal results were found with ECG and echocardiogram performed on 25 July 2014. MRA (brain, spinal cord, heart) and lumbar puncture were not performed and Troponin I levels were not available. The subject's outcome was not reported. Note: There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study. Documents held by senders: none.
Age: 19.0
Sex: M
Vaccine: ANTH, SMALL, TYP
Symptoms: Electrocardiogram abnormal, Pericarditis
Clinical narrative: Note: Any requests for follow-up information on this case should be sent directly to the sponsor of this study, Sanofi Pasteur. Initial solicited case was received from the investigator participating in a trial on 25 November 2014. A 19 year-old male subject with a past medical history of chest pain and numbness or paralysis was found to have acute pericarditis on 02 September 2014, 7 days after the subject had received the following vaccines on 26 August 2014: an injection of ACAM2000 (lot number and site of administration not reported), Typhoid VI vaccine (batch number, route and sites of administration were not reported) and Anthrax vaccine (batch number, route and sites of administration were not reported). Troponin I was not performed. On 02 September 2014 an ECG was abnormal. An echocardiogram, lumbar puncture (spinal tap) and MRI of the brain, spinal cord and heart were not performed. Treatments were not reported. The subject's outcome was not reported. Note: There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study. Documents held by sender: None.
Age: 19.0
Sex: F
Vaccine: SMALL
Symptoms: Electrocardiogram abnormal, Pericardial disease
Clinical narrative: This solicited case was received from the investigator participating in a trial on 21 November 2014. A 19-year-old female subject, with no reported medical history, had received an injection of ACAM2000 (lot number, route and site of administration not reported) on 06 May 2014. ECG performed on 15 May 2014 showed abnormal results (no details provided). On 02 June 2014, i.e. 27 days post vaccination, she was diagnosed with unspecified disease of pericardium. Electrocardiogram performed on 13 June 2014 showed normal results. MRI (brain, heart, spinal cord), lumbar puncture and troponin I level were not performed. Patient's outcome was not provided. Note: There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study. Documents held by sender: none.
Age: 25.0
Sex: M
Vaccine: SMALL
Symptoms: Echocardiogram, Electrocardiogram abnormal, Pericarditis, Troponin I normal
Clinical narrative: Note: Any requests for follow-up information on this case should be send directly to the sponsor of this study, Sanofi Pasteur. This study case was received from the investigator in a trial on 19 November 2014. A 25 year-old male subject whose past medical was reported as no was found to have acute pericarditis unspecified 23 days after the subject had received on 08 July 2014 an injection of ACAM2000 (lot number, route and site of administration not reported) and on 26 June 2014 he received Anthrax (manufacturer, lot number, route and site of administration not reported). Relevant laboratory data included: a normal Troponin I on 19 July 2014 and an abnormal Echocardiogram on 19 July 2014. Results of an ECG were not available. Lumbar puncture and MRI of the brain, spinal cord and heart were not performed. Treatments were not reported. Additional information will be requested from the investigator. The subject's outcome was not reported. Note: There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study. Documents held by sender: none.
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Hypersensitivity, Skin test positive
Clinical narrative: The reporter of this case also reported another event for this patient which is captured in 2014SA145945. Initial spontaneous information received on 17 November 2014 from a health care professional (physician). A male child, age of event not reported with a history of an allergic reaction to FLUZONE in 2013 at the age of 3 years, was vaccinated on an unknown date with IPV, DTAP and MMR, manufacturers, batch, route and site of administration were not reported. On an unreported date since 2013, the patient experienced an allergic reaction. The patient had an allergy skin prick test on an unreported date which was positive to MMRV, gelatin and +/- to neomycin. Laboratory tests and treatment details were not reported. No further details were available at the time of this report. The patient outcome is unknown. Documents held by sender: None.
Age: 78.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Blood pressure fluctuation, Headache
Clinical narrative: Initial unsolicited report received from a pharmacist on 18 November 2014. A 78-year-old female patient, whose medical history and concomitant medications were unknown, received FLUZONE HD (lot number U5042CA) on 03 November 2014. One day post-vaccination, on 04 November 2014, she experienced a headache and her blood pressure "went up and then down". The patient informed the reporter that she had been hospitalized for three days but that no cause had been found for her symptoms. The symptoms recovered on an unspecified date. According to the patient, she "was having follow-up done for possible cardiac issues". Documents held by sender: None.