chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 1.05
Sex: F
Vaccine: DTAP, HIBV
Symptoms: Rhinorrhoea, Sneezing, Vomiting
Clinical narrative: Fever between 100.0 - 102.0 degrees F that lasted until 06/11/2014 AM; redness and severe swelling at injection site, vomited once on 06/10/2014 AM, lethargic on 06/10/2014 - 06/11/2014, became sick with a cough, runny nose, sneezing on 06/13/2014.
Age: 0.51
Sex: M
Vaccine: DTAPHEPBIP, PNC13
Symptoms: Irritability, Opisthotonus, Pyrexia, White blood cell count increased
Clinical narrative: Child began fever in evening. The following morning increased to Tmax 104.1 degrees Fahrenheit. Irritable and arching back.
Age: 71.0
Sex: F
Vaccine: TDAP
Symptoms: Abdominal pain, Injection site erythema, Injection site swelling, Pyrexia
Clinical narrative: Pt had TDAP vaccines at Dr's office and developed fever, redness and swelling to left arm at injection site for 2 days.  Pt then developed abdominal pain for 1 day. Pt came to the urgent care in to seek medical care.
Age: 17.0
Sex: M
Vaccine: TD
Symptoms: Rash, Rash erythematous
Clinical narrative: Flat, pink rash all over lower extremities, and lighter rash on torso.
Age: 62.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema
Clinical narrative: Patient's injection site even after 4 months is still dark reddish to blackish, the size of a dime.
Age: 35.0
Sex: F
Vaccine: MMR
Symptoms: Erythema, Pain, Pruritus
Clinical narrative: Painful, itching, redness.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 69 year old female patient with high blood pressure, high cholesterol, thyroid condition, allergy to penicillin. On 03-JUN-2014 the patient was vaccinated with ZOSTAVAX (lot #J013449, Expiration date: 24-JAN-2015, strength and dosage unknown, route unknown). Concomitant therapy included blood pressure medication, thyroid medication, cholesterol medication, medication for heartburn. On 04-JUN-2014, the patient experienced redness, warmth and swelling around injection site. The outcome of the events was reported as not recovered. The causality of the events and therapy with ZOSTAVAX was unknown. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse reported that different facilities might have administered vaccines after vaccines were exposed to temperatures outside of recommended storage range. She stated that she does not have any patient specific information. At the first facility they might have administered VAQTA, RECOMBIVAX HB, and GARDASIL which had been exposed to 33F for 129 hours. No adverse effects reported. The nurse reported that at a second facility they have two sets of vaccines which have both been exposed to temperatures outside of range, and may have been administered to patients. The first set of vaccines were RECOMBIVAX HB, COMVAX, GARDASIL, ROTATEQ which were exposed to 30F for 466 hours, and 47F for 39 hours and may have been administered to an unspecified number of patients. No adverse effects reported. The second set of vaccines for this facility were COMVAX and GARDASIL which were exposed to 30F for 221 hours and 47F for 15 hours and may have been administered to an unspecified number of patients. No adverse effects reported. This is one of the several reports received from the same source (same reporter link: 1406USA000768, 1406USA007003, 1406USA007004, 1406USA007005). Additional information has been requested.
Sex: U
Vaccine: HBHEPB
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse reported that different facilities might have administered vaccines after vaccines were exposed to temperatures outside of recommended storage range. She stated that she does not have any patient specified information. At the first facility they might have administered VAQTA, RECOMBIVAX HP, and GARDASIL which had been exposed to 33F for 129 hours. No adverse effects reported. The nurse reported that at a second facility they have two sets of vaccines which have both been exposed to temperatures outside of range, and may have been administered to patients. The first set of vaccines were RECOMBIVAX HB, COMVAX, GARDASIL, ROTATEQ which were exposed to 30F for 466 hours, and 47F for 39 hours and may have been administered to an unspecified number of patients. No adverse effects reported.  The second set of vaccines for this facility were COMVAX and GARDASIL which were exposed to 30F for 221 hours and 47F for 15 hours and may have been administered to an unspecified number of patients. No adverse effects reported. This is one of the several reports received from the same source (same reporter link: 1406USA000768, 1406USA007003, 1406USA007004, 1406USA007006). Additional information has been requested.
Age: 1.0
Sex: F
Vaccine: MMR
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to a 1 year old female patient. On 10-JUN-2014 the patient was vaccinated with an expired dose of MMR II (lot # H010135, expiration date 17-MAY-2014, dose and route were unknown), dose 1. No adverse effect reported. No product quality complaint (PQC). Additional information is not expected.
Age: 21.0
Sex: F
Vaccine: RAB
Symptoms: Blood glucose decreased, Dizziness, Loss of consciousness
Clinical narrative: Case number PHHY2013US083984 is an initial spontaneous report received from a consumer (mother of the patient) via Vaccine Adverse Event Reporting System (VAERS reference number: 490623) website on 06 Aug 2013, with a follow up received from Quality Assurance Department (reference number: 245999) on 04 Jun 2014. This report refers to a 21-year-old female patient. Her medical history and concomitant medication were not reported. She was vaccinated with RABAVERT (batch number: 507011A) intramuscularly into left arm on 01 May 2013. On the same day, after vaccination, she felt some dizziness and passed out later in the evening. Her mother did not witness this incident but said it could be due to low blood sugar as patient experienced this event once in past. She consulted the physician, but said that physician was not too concerned. The outcome of the event was reported as recovered as of unspecified date. Seriousness and causality of the events were not reported. Based on the investigation performed, the QA department stated that, RABAVERT (batch number: 507011A) was manufactured in accordance with the approved internal procedures and it was in compliance with the cGMP requirements. Follow up information received from the Quality Assurance Department (reference number: 245999) on 04 Jun 2014: Updated batch review report.
Age: 43.0
Sex: M
Vaccine: RAB
Symptoms: Headache, Muscle spasms, Myalgia, Overdose, Pyrexia
Clinical narrative: Case number PHHY2013US110846 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 495033) website on 04 Oct 2013, with a follow up received from Quality Assurance Department (reference number: 257027) on 04 Jun 2014. This report refers to a 43-year-old male patient. He was bitten by a raccoon at work on 02 Apr 2013 and therefore went emergency room (ER) on 05 Apr 2013. He started series of rabies vaccination and was vaccinated with first dose of RABAVART (batch number: 517011A) intramuscularly into arm on 08 Apr 2013, he had very bad side effects of headaches, severe muscle pain, muscle spasms and fever and had an emergency visit. On 15 Apr 2013, he went back to ER, to receive second dose. At that time he was informed that he was given overdose of rabies vaccine. Outcome of the events was reported as not recovered as of 03 Jun 2013. Reporter assessed the case as serious (life threatening and disability). Causality was not reported. based on the investigation performed, the QA department stated that, RABAVERT vaccine (batch number: 517011A) was manufactured in accordance with the approved internal procedures and it was in compliance with the cGMP requirements. Follow up information received from the Quality Assurance Department (reference number: 257027) on 04 Jun 2014: Updated batch review report.
Age: 32.0
Sex: F
Vaccine: HEPA, RAB
Symptoms: Abdominal pain, Anaemia, Full blood count abnormal, Hypotension, Metabolic function test abnormal
Clinical narrative: Case number PHHY2013US127782 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 498587) website on 11 Nov 2013, with a follow-up information received from Quality Assurance Department (reference number: 264960) on 10 Jun 2014. This report refers to a 32-year-old female patient. Her medical history and concomitant medication were not reported. She was vaccinated with RABAVERT (batch number: 507011A) intramuscularly into left arm and HAVRIX (other manufacturer, batch number: AHAVB532AA) intramuscularly into right arm on 18 Jul 2013. On 20 Jul 2013, she experienced nausea, vomiting, abdominal pain and hypotension. She underwent complete blood count and comprehensive metabolic panel (CMP) test which revealed anemia. Outcome of the events was reported as recovered. No seriousness and causality was reported for the events. Based on the investigation performed, the QA department stated that, RABAVERT (batch number: 507011A) was manufactured in accordance with the approved internal procedures and it was in compliance with the cGMP requirements. Follow up information received from the Quality Assurance Department (reference number: 264960) on 10 Jun 2014: Updated batch review report.
Age: 32.0
Sex: F
Vaccine: HEPA, RAB
Symptoms: Nausea, Vomiting
Clinical narrative: Case number PHHY2013US127782 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 498587) website on 11 Nov 2013, with a follow-up information received from Quality Assurance Department (reference number: 264960) on 10 Jun 2014. This report refers to a 32-year-old female patient. Her medical history and concomitant medication were not reported. She was vaccinated with RABAVERT (batch number: 507011A) intramuscularly into left arm and HAVRIX (other manufacturer, batch number: AHAVB532AA) intramuscularly into right arm on 18 Jul 2013. On 20 Jul 2013, she experienced nausea, vomiting, abdominal pain and hypotension. She underwent complete blood count and comprehensive metabolic panel (CMP) test which revealed anemia. Outcome of the events was reported as recovered. No seriousness and causality was reported for the events. Based on the investigation performed, the QA department stated that, RABAVERT (batch number: 507011A) was manufactured in accordance with the approved internal procedures and it was in compliance with the cGMP requirements. Follow up information received from the Quality Assurance Department (reference number: 264960) on 10 Jun 2014: Updated batch review report.
Age: 76.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site warmth, Local swelling
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 76 year old male patient. Pertinent medical history and drug reactions or allergies were unspecified. On 21-MAY-2014 the patient was vaccinated with ZOSTAVAX, subcutaneous for prevention of shingles (dose, frequency, strength, dose number, lot number and anatomical location were not reported). Concomitant therapies were unspecified. On 21-MAY-2014, same day of the onset of therapy, the patient experienced swelling from elbow to the fingers, hot sensation and redness at the injection site. The patient was treated with prednisone. Laboratory diagnostics studies were not reported. The outcome of swelling and hot sensation and redness was reported as recovering. Additional information has been requested.
Age: 76.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Arthralgia, Injection site swelling, Local swelling
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 76 year old male patient. Pertinent medical history and drug reactions or allergies were unspecified. On 21-MAY-2014 the patient was vaccinated with ZOSTAVAX, subcutaneous for prevention of shingles (dose, frequency, strength, dose number, lot number and anatomical location were not reported). Concomitant therapies were unspecified. On 21-MAY-2014, same day of the onset of therapy, the patient experienced swelling from elbow to the fingers, hot sensation and redness at the injection site. The patient was treated with prednisone. Laboratory diagnostics studies were not reported. The outcome of swelling and hot sensation and redness was reported as recovering. Additional information has been requested.
Age: 57.0
Sex: F
Vaccine: FLUX
Symptoms: Acoustic stimulation tests, Blood test, Nausea, Neurological examination, Nuclear magnetic resonance imaging
Clinical narrative: Sudden onset vertigo with spinning and nausea.
Age: 57.0
Sex: F
Vaccine: FLUX
Symptoms: Vertigo
Clinical narrative: Sudden onset vertigo with spinning and nausea.
Age: 54.0
Sex: F
Vaccine: FLU3
Symptoms: Guillain-Barre syndrome, Hypoaesthesia, Immunoglobulin therapy, Lumbar puncture
Clinical narrative: Guillain-Barre Syndrome. 3 doses of IVIG - Jan 2014. Still numb in hands, arms, legs, feet.
Age: 24.0
Sex: F
Vaccine: HEP
Symptoms: Abdominal pain upper, Asthenia, Crohn's disease, Diarrhoea, Fatigue
Clinical narrative: "The day I received the shot I had a general feeling of un-wellness. About 45 min after being given the shot the left side of my face began to go numb but subsided after about an hour." "My Crohn's symptoms started 5 days after receiving the shot. My Crohn's symptoms have not subsided yet but are not as severe as they were last week. I have been having severe stomach pain and diarrhea. I have also began having rectal pain, swelling and bleeding. These symptoms are common with my Crohns as it is mostly in what is left of my colon. I have also been experiencing severe fatigue. Exactly 5 days after I received the shot, I had to leave work due to weakness and fatigue. This is still affecting me some." I am having her contact our Nurse Triage line and get a referral to the clinic to be seen by an MD.
Age: 24.0
Sex: F
Vaccine: HEP
Symptoms: Hypoaesthesia, Impaired work ability, Malaise, Proctalgia, Rectal haemorrhage
Clinical narrative: "The day I received the shot I had a general feeling of un-wellness. About 45 min after being given the shot the left side of my face began to go numb but subsided after about an hour." "My Crohn's symptoms started 5 days after receiving the shot. My Crohn's symptoms have not subsided yet but are not as severe as they were last week. I have been having severe stomach pain and diarrhea. I have also began having rectal pain, swelling and bleeding. These symptoms are common with my Crohns as it is mostly in what is left of my colon. I have also been experiencing severe fatigue. Exactly 5 days after I received the shot, I had to leave work due to weakness and fatigue. This is still affecting me some." I am having her contact our Nurse Triage line and get a referral to the clinic to be seen by an MD.
Age: 24.0
Sex: F
Vaccine: HEP
Symptoms: Swelling
Clinical narrative: "The day I received the shot I had a general feeling of un-wellness. About 45 min after being given the shot the left side of my face began to go numb but subsided after about an hour." "My Crohn's symptoms started 5 days after receiving the shot. My Crohn's symptoms have not subsided yet but are not as severe as they were last week. I have been having severe stomach pain and diarrhea. I have also began having rectal pain, swelling and bleeding. These symptoms are common with my Crohns as it is mostly in what is left of my colon. I have also been experiencing severe fatigue. Exactly 5 days after I received the shot, I had to leave work due to weakness and fatigue. This is still affecting me some." I am having her contact our Nurse Triage line and get a referral to the clinic to be seen by an MD.
Age: 1.28
Sex: F
Vaccine: HIBV
Symptoms: Immediate post-injection reaction, Injection site erythema, Injection site induration, Injection site pain, Injection site swelling
Clinical narrative: Immediately there was redness at the injection site and warmth.  The tenderness/pain and elevation with firmness began on 6/10/14.  The redness also expanded to the size of a quarter in diameter, at the injection site.  The firmness is hard like a marble, and elevated about 1-2cm above the skin. The firmness is still present as of today, 6/16/2014 and hasn't resolved. The redness is also still present, but has diminished in size by 70%.
Age: 1.28
Sex: F
Vaccine: HIBV
Symptoms: Injection site warmth
Clinical narrative: Immediately there was redness at the injection site and warmth.  The tenderness/pain and elevation with firmness began on 6/10/14.  The redness also expanded to the size of a quarter in diameter, at the injection site.  The firmness is hard like a marble, and elevated about 1-2cm above the skin. The firmness is still present as of today, 6/16/2014 and hasn't resolved. The redness is also still present, but has diminished in size by 70%.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Dyspnoea, Heart rate increased, Heart rate irregular, Hypertension
Clinical narrative: Case number PHEH2014US011502 is an initial spontaneous report received from a consumer on 05 Jun 2014. This report refers to a 69-year-old female patient. Her medical history and concomitant medications were not reported. On 13 Oct 2013, she was vaccinated with FLUVIRIN (batch number: 13082C1, expiry date: May 2014) intramuscularly at a dose of 0.5 ml at around 12:45 pm. It was reported that within an hour of the vaccination, she started experiencing shortness of breath. Around two hours after receiving the flu shot, she measured her blood pressure, and her blood pressure was very high with a diastolic pressure above 200. Her pulse rate was also very high, around in the 160s and was also irregular. It was reported that the symptoms subsided around 3-3.5 hours after receiving the flu shot. The final outcome was reported as complete recovery. The events were reported as non-serious and causality of the events was not reported.
Age: 12.0
Sex: M
Vaccine: MNQ
Symptoms: Abscess limb, Cellulitis, Skin warm
Clinical narrative: Case number PHEH2014US011474 is an initial spontaneous report received from a medical assistant on 05 Jun 2014. This report refers to a 12 year old male patient. His medical history and concomitant medication were not reported. He was vaccinated with MENVEO, (batch number: M13017, expiry date: Sep 2014) intramuscularly at a dose of 0.5 ml on 13 May 2014. On the same day evening or the next day early in the morning, he developed cellulitis. On 15 May 2014, he was evaluated by the reporter and was found to have a non-tender non-pruritic warm to touch enlarged abscess in his left arm. The events were reported as non serious. The outcome and causality were not reported.
Age: 16.0
Sex: F
Vaccine: MNQ
Symptoms: Cellulitis
Clinical narrative: Case number PHEH2014US011475 is an initial spontaneous report received Medical assistant via company (reference number: NA14-002351) on 05 Jun 2014. This report refers to female adolescent patient. Her medical history and concomitant medications were not reported. She was vaccinated with MENVEO (batch number: M13017, expiry date: Sep 2014) intramuscularly at a dose of 0.5 ml on 02 Jan 2014. It was reported that she developed cellulitis starting either same day evening or next day morning. The outcome of cellulitis was not reported. The event was assessed as non serious by the reporter and causality of the event was not reported.
Age: 20.0
Sex: M
Vaccine: SMALL
Symptoms: Papule
Clinical narrative: Approximately 06/06/14 pt developed asymptomatic papules on the dorsal side of hands, elbows and knees.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Headache, Pyrexia
Clinical narrative: Patient woke up from sleeping with a severe headache and a fever of 100.4.
Age: 50.0
Sex: F
Vaccine: FLU3
Symptoms: Injected limb mobility decreased, Injection site inflammation, Injection site pain, Periarthritis
Clinical narrative: After receiving mandatory flu vaccine in right deltoid, worsening  stiffness and pain beginning about 2 weeks after administration progressing into adhesive capsulitis / chronic inflammation of entire shoulder girdle causing severe pain lasting many months post injection.  This reaction is identical to that of the Left shoulder adhesive capsulitis which occurred after influenza vaccination 2012!!
Age: 89.0
Sex: M
Vaccine: PPV
Symptoms: Back pain, Chest discomfort, Flushing, Pain in extremity
Clinical narrative: He had a flushed face and bilateral arm pain/chest discomfort within minutes of injection. These symptoms resolved over a few minutes.  Patient then used left foot to push onto bed and then experienced severe lower back pain (10/10) which lasted >10 minutes so EMS was called and patient was brougt to emergency room. Pain completed resolved after 2 hours and patient was discharged home.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Aortic bruit, Aortic valve incompetence, Aphagia, Echocardiogram abnormal, Endocarditis bacterial
Clinical narrative: On June 21, 2013, I received a shingles shot by a technician in the medical office of Dr. There was no screening and no physical exam to discern if I was well enough to get the shot. Within forty-eight hours, I became very ill and could not eat or drink. I was rushed to the emergency room. There, it was diagnosed that I had Bacterial Endocarditis ("B.E."), with resultant aortic murmur, severe aortic insufficiency by echocardiogram, and a splenic infarct 9 x 4 cm. I was shocked because this condition was until then, unknown to me. I was monitored in the cardiac intensive care unit for nine days, not sure if I would live. It has been the formal opinion of the attending infectious disease doctor and cardiologist that my body was trying to fight the B.E. They opined that the shingles shot overloaded my immune system and pushed me over the edge and exacerbated the B.E. to harm my heart. I have now asked the opinion of ten top internists regarding this issue. They all stated if they knew a patient had a fever, a heart murmur or B.E., that patient would be precluded from getting the vaccine. The problem is that presently, there is no protocol of a medical doctor screening required before the shot is administered. For instance, in my case, the doctor, if they had performed a physical exam, would have been likely to detect a fever, a heart murmur, etc. Therefore, I am extremely concerned, why Merck, as well as state and national regulatory agencies, allow the shot to be given without any medical work up including but not limited to a thorough physical exam. For instance, every time I see a drug store that offers the vaccine, I am very concerned about the dangers and resultant public safety issues regarding the non-existent physician screening for this vaccine, I am now aware of articles medical director of Merck personally wrote in that he helped promote having pharmacies give the shot, which doubled the amount of Merck vaccines sent out. Such a stance puts profits before the safety the public. Prior to this episode I had been in excellent health due to in large part, to an exceptionally healthy, non-processed fuel-centric diet, and regular exercise. Dr. had previously done an annual exam, on Nov. 26, 2012, with a written report stating due to my health practices, "the chance of a cardiac event is less than one percent in next ten years." He detected no murmur on exam and said did I not need an echo. Now due to the strep infection and the shingles vaccine, which significantly exacerbated overload of my immune system, I have subsequently been told by several cardiac surgeons that I need cardiac surgeon for aortic valve replacement else it will cause my death. I am currently being followed by a cardiac surgeon. Also, I must now see a cardiology and have frequent serial echoes and cardiology exam and told will need the cardiac surgery soon.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Fluid intake reduced, Immune system disorder, Intensive care, Malaise, Splenic infarction
Clinical narrative: On June 21, 2013, I received a shingles shot by a technician in the medical office of Dr. There was no screening and no physical exam to discern if I was well enough to get the shot. Within forty-eight hours, I became very ill and could not eat or drink. I was rushed to the emergency room. There, it was diagnosed that I had Bacterial Endocarditis ("B.E."), with resultant aortic murmur, severe aortic insufficiency by echocardiogram, and a splenic infarct 9 x 4 cm. I was shocked because this condition was until then, unknown to me. I was monitored in the cardiac intensive care unit for nine days, not sure if I would live. It has been the formal opinion of the attending infectious disease doctor and cardiologist that my body was trying to fight the B.E. They opined that the shingles shot overloaded my immune system and pushed me over the edge and exacerbated the B.E. to harm my heart. I have now asked the opinion of ten top internists regarding this issue. They all stated if they knew a patient had a fever, a heart murmur or B.E., that patient would be precluded from getting the vaccine. The problem is that presently, there is no protocol of a medical doctor screening required before the shot is administered. For instance, in my case, the doctor, if they had performed a physical exam, would have been likely to detect a fever, a heart murmur, etc. Therefore, I am extremely concerned, why Merck, as well as state and national regulatory agencies, allow the shot to be given without any medical work up including but not limited to a thorough physical exam. For instance, every time I see a drug store that offers the vaccine, I am very concerned about the dangers and resultant public safety issues regarding the non-existent physician screening for this vaccine, I am now aware of articles medical director of Merck personally wrote in that he helped promote having pharmacies give the shot, which doubled the amount of Merck vaccines sent out. Such a stance puts profits before the safety the public. Prior to this episode I had been in excellent health due to in large part, to an exceptionally healthy, non-processed fuel-centric diet, and regular exercise. Dr. had previously done an annual exam, on Nov. 26, 2012, with a written report stating due to my health practices, "the chance of a cardiac event is less than one percent in next ten years." He detected no murmur on exam and said did I not need an echo. Now due to the strep infection and the shingles vaccine, which significantly exacerbated overload of my immune system, I have subsequently been told by several cardiac surgeons that I need cardiac surgeon for aortic valve replacement else it will cause my death. I am currently being followed by a cardiac surgeon. Also, I must now see a cardiology and have frequent serial echoes and cardiology exam and told will need the cardiac surgery soon.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Streptococcal infection
Clinical narrative: On June 21, 2013, I received a shingles shot by a technician in the medical office of Dr. There was no screening and no physical exam to discern if I was well enough to get the shot. Within forty-eight hours, I became very ill and could not eat or drink. I was rushed to the emergency room. There, it was diagnosed that I had Bacterial Endocarditis ("B.E."), with resultant aortic murmur, severe aortic insufficiency by echocardiogram, and a splenic infarct 9 x 4 cm. I was shocked because this condition was until then, unknown to me. I was monitored in the cardiac intensive care unit for nine days, not sure if I would live. It has been the formal opinion of the attending infectious disease doctor and cardiologist that my body was trying to fight the B.E. They opined that the shingles shot overloaded my immune system and pushed me over the edge and exacerbated the B.E. to harm my heart. I have now asked the opinion of ten top internists regarding this issue. They all stated if they knew a patient had a fever, a heart murmur or B.E., that patient would be precluded from getting the vaccine. The problem is that presently, there is no protocol of a medical doctor screening required before the shot is administered. For instance, in my case, the doctor, if they had performed a physical exam, would have been likely to detect a fever, a heart murmur, etc. Therefore, I am extremely concerned, why Merck, as well as state and national regulatory agencies, allow the shot to be given without any medical work up including but not limited to a thorough physical exam. For instance, every time I see a drug store that offers the vaccine, I am very concerned about the dangers and resultant public safety issues regarding the non-existent physician screening for this vaccine, I am now aware of articles medical director of Merck personally wrote in that he helped promote having pharmacies give the shot, which doubled the amount of Merck vaccines sent out. Such a stance puts profits before the safety the public. Prior to this episode I had been in excellent health due to in large part, to an exceptionally healthy, non-processed fuel-centric diet, and regular exercise. Dr. had previously done an annual exam, on Nov. 26, 2012, with a written report stating due to my health practices, "the chance of a cardiac event is less than one percent in next ten years." He detected no murmur on exam and said did I not need an echo. Now due to the strep infection and the shingles vaccine, which significantly exacerbated overload of my immune system, I have subsequently been told by several cardiac surgeons that I need cardiac surgeon for aortic valve replacement else it will cause my death. I am currently being followed by a cardiac surgeon. Also, I must now see a cardiology and have frequent serial echoes and cardiology exam and told will need the cardiac surgery soon.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Fluid intake reduced, Intensive care, Malaise, Shock, Splenic infarction
Clinical narrative: On June 21, 2013, I received a shingles shot by a technician in the medical office of Dr. There was no screening and no physical exam to discern if I was well enough to get the shot. Within forty-eight hours, I became very ill and could not eat or drink. I was rushed to the emergency room. There, it was diagnosed that I had Bacterial Endocarditis ("B.E."), with resultant aortic murmur, severe aortic insufficiency by echocardiogram, and a splenic infarct 9 x 4 cm. I was shocked because this condition was until then, unknown to me. I was monitored in the cardiac intensive care unit for nine days, not sure if I would live. It has been the formal opinion of the attending infectious disease doctor and cardiologist that my body was trying to fight the B.E. They opined that the shingles shot overloaded my immune system and pushed me over the edge and exacerbated the B.E. to harm my heart. I have now asked the opinion of ten top internists regarding this issue. They all stated if they knew a patient had a fever, a heart murmur or B.E., that patient would be precluded from getting the vaccine. The problem is that presently, there is no protocol of a medical doctor screening required before the shot is administered. For instance, in my case, the doctor, if they had performed a physical exam, would have been likely to detect a fever, a heart murmur, etc. Therefore, I am extremely concerned, why Merck, as well as state and national regulatory agencies, allow the shot to be given without any medical work up including but not limited to a thorough physical exam. For instance, every time I see a drug store that offers the vaccine, I am very concerned about the dangers and resultant public safety issues regarding the non-existent physician screening for this vaccine, I am now aware of articles medical director of Merck personally wrote in that he helped promote having pharmacies give the shot, which doubled the amount of Merck vaccines sent out. Such a stance puts profits before the safety the public. Prior to this episode I had been in excellent health due to in large part, to an exceptionally healthy, non-processed fuel-centric diet, and regular exercise. Dr. had previously done an annual exam, on Nov. 26, 2012, with a written report stating due to my health practices, "the chance of a cardiac event is less than one percent in next ten years." He detected no murmur on exam and said did I not need an echo. Now due to the strep infection and the shingles vaccine, which significantly exacerbated overload of my immune system, I have subsequently been told by several cardiac surgeons that I need cardiac surgeon for aortic valve replacement else it will cause my death. I am currently being followed by a cardiac surgeon. Also, I must now see a cardiology and have frequent serial echoes and cardiology exam and told will need the cardiac surgery soon.
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Aortic bruit, Aortic valve incompetence, Aphagia, Echocardiogram abnormal, Endocarditis bacterial
Clinical narrative: A spontaneous report was received from a male patient who on 21-JUN-2013 (conflicting information as the patient reported a future start date of 21-JUN-2014), the patient received a ZOSTAVAX by a technician in his physician's medical office. The patient reported there was no screening and no physical exam to discern if he was well enough to get the shot. Within forty-eight hours (start date 23-JUN-2013), the patient became very ill and could not eat or drink. The patient reported he was rushed to the emergency room hospital. There, it was diagnosed that the patient had bacterial endocarditis, with resultant aortic murmur, severe aortic insufficiency by echocardiogram, and a splenic infarction that measured 9 x 4 cm. The patient stated he was shocked because this condition was until then, unknown to him. The patient reported he was monitored in the cardiac intensive care unit for nine days, not sure if he would live. The patient reported it was the formal opinion of the attending infectious disease doctor and cardiologist that the patient's body was trying to fight the bacterial endocarditis. The patient stated, "they opined that the shingles shot overloaded my immune system and pushed me over the edge and exacerbated the bacterial endocarditis to harm my heart." The patient reported he had asked the opinion of ten top internists regarding this issue and "they all stated if they knew a patient had a fever, a  heart murmur or bacterial endocarditis, that the patient would be precluded from getting the vaccine. "The patient stated, if they had performed a physical exam, it would have been likely to detect a fever, a heart murmur, etc." Prior to this episode, the patient reported he had been in excellent health due in large part, to an exceptionally healthy, non-processed fuel-centric diet, and regular exercise. The patient's physician had previously done an annual exam, on 26-NOV-2012, with a written report stating due to my health practices, "the chance of a cardiac event is less than one percent in next ten years." The patient reported that now due to streptococcal infection and the ZOSTAVAX, which exacerbated overload of my immune system, I have subsequently been told by several cardiac surgeons that I need a cardiac surgeon for aortic valve replacement else it will cause death." The patient is currently being followed by a cardiac surgeon. The patient stated, I must now see cardiology and have frequent serial echoes and cardiology exam and told will need the cardiac surgery soon." The patient reported the sequelae from the ZOSTAVAX was serious and life threatening. No further information was provided. Additional information has been requested.
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Fluid intake reduced, Immune system disorder, Intensive care, Malaise, Splenic infarction
Clinical narrative: A spontaneous report was received from a male patient who on 21-JUN-2013 (conflicting information as the patient reported a future start date of 21-JUN-2014), the patient received a ZOSTAVAX by a technician in his physician's medical office. The patient reported there was no screening and no physical exam to discern if he was well enough to get the shot. Within forty-eight hours (start date 23-JUN-2013), the patient became very ill and could not eat or drink. The patient reported he was rushed to the emergency room hospital. There, it was diagnosed that the patient had bacterial endocarditis, with resultant aortic murmur, severe aortic insufficiency by echocardiogram, and a splenic infarction that measured 9 x 4 cm. The patient stated he was shocked because this condition was until then, unknown to him. The patient reported he was monitored in the cardiac intensive care unit for nine days, not sure if he would live. The patient reported it was the formal opinion of the attending infectious disease doctor and cardiologist that the patient's body was trying to fight the bacterial endocarditis. The patient stated, "they opined that the shingles shot overloaded my immune system and pushed me over the edge and exacerbated the bacterial endocarditis to harm my heart." The patient reported he had asked the opinion of ten top internists regarding this issue and "they all stated if they knew a patient had a fever, a  heart murmur or bacterial endocarditis, that the patient would be precluded from getting the vaccine. "The patient stated, if they had performed a physical exam, it would have been likely to detect a fever, a heart murmur, etc." Prior to this episode, the patient reported he had been in excellent health due in large part, to an exceptionally healthy, non-processed fuel-centric diet, and regular exercise. The patient's physician had previously done an annual exam, on 26-NOV-2012, with a written report stating due to my health practices, "the chance of a cardiac event is less than one percent in next ten years." The patient reported that now due to streptococcal infection and the ZOSTAVAX, which exacerbated overload of my immune system, I have subsequently been told by several cardiac surgeons that I need a cardiac surgeon for aortic valve replacement else it will cause death." The patient is currently being followed by a cardiac surgeon. The patient stated, I must now see cardiology and have frequent serial echoes and cardiology exam and told will need the cardiac surgery soon." The patient reported the sequelae from the ZOSTAVAX was serious and life threatening. No further information was provided. Additional information has been requested.
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Streptococcal infection
Clinical narrative: A spontaneous report was received from a male patient who on 21-JUN-2013 (conflicting information as the patient reported a future start date of 21-JUN-2014), the patient received a ZOSTAVAX by a technician in his physician's medical office. The patient reported there was no screening and no physical exam to discern if he was well enough to get the shot. Within forty-eight hours (start date 23-JUN-2013), the patient became very ill and could not eat or drink. The patient reported he was rushed to the emergency room hospital. There, it was diagnosed that the patient had bacterial endocarditis, with resultant aortic murmur, severe aortic insufficiency by echocardiogram, and a splenic infarction that measured 9 x 4 cm. The patient stated he was shocked because this condition was until then, unknown to him. The patient reported he was monitored in the cardiac intensive care unit for nine days, not sure if he would live. The patient reported it was the formal opinion of the attending infectious disease doctor and cardiologist that the patient's body was trying to fight the bacterial endocarditis. The patient stated, "they opined that the shingles shot overloaded my immune system and pushed me over the edge and exacerbated the bacterial endocarditis to harm my heart." The patient reported he had asked the opinion of ten top internists regarding this issue and "they all stated if they knew a patient had a fever, a  heart murmur or bacterial endocarditis, that the patient would be precluded from getting the vaccine. "The patient stated, if they had performed a physical exam, it would have been likely to detect a fever, a heart murmur, etc." Prior to this episode, the patient reported he had been in excellent health due in large part, to an exceptionally healthy, non-processed fuel-centric diet, and regular exercise. The patient's physician had previously done an annual exam, on 26-NOV-2012, with a written report stating due to my health practices, "the chance of a cardiac event is less than one percent in next ten years." The patient reported that now due to streptococcal infection and the ZOSTAVAX, which exacerbated overload of my immune system, I have subsequently been told by several cardiac surgeons that I need a cardiac surgeon for aortic valve replacement else it will cause death." The patient is currently being followed by a cardiac surgeon. The patient stated, I must now see cardiology and have frequent serial echoes and cardiology exam and told will need the cardiac surgery soon." The patient reported the sequelae from the ZOSTAVAX was serious and life threatening. No further information was provided. Additional information has been requested.
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Fluid intake reduced, Intensive care, Malaise, Shock, Splenic infarction
Clinical narrative: A spontaneous report was received from a male patient who on 21-JUN-2013 (conflicting information as the patient reported a future start date of 21-JUN-2014), the patient received a ZOSTAVAX by a technician in his physician's medical office. The patient reported there was no screening and no physical exam to discern if he was well enough to get the shot. Within forty-eight hours (start date 23-JUN-2013), the patient became very ill and could not eat or drink. The patient reported he was rushed to the emergency room hospital. There, it was diagnosed that the patient had bacterial endocarditis, with resultant aortic murmur, severe aortic insufficiency by echocardiogram, and a splenic infarction that measured 9 x 4 cm. The patient stated he was shocked because this condition was until then, unknown to him. The patient reported he was monitored in the cardiac intensive care unit for nine days, not sure if he would live. The patient reported it was the formal opinion of the attending infectious disease doctor and cardiologist that the patient's body was trying to fight the bacterial endocarditis. The patient stated, "they opined that the shingles shot overloaded my immune system and pushed me over the edge and exacerbated the bacterial endocarditis to harm my heart." The patient reported he had asked the opinion of ten top internists regarding this issue and "they all stated if they knew a patient had a fever, a  heart murmur or bacterial endocarditis, that the patient would be precluded from getting the vaccine. "The patient stated, if they had performed a physical exam, it would have been likely to detect a fever, a heart murmur, etc." Prior to this episode, the patient reported he had been in excellent health due in large part, to an exceptionally healthy, non-processed fuel-centric diet, and regular exercise. The patient's physician had previously done an annual exam, on 26-NOV-2012, with a written report stating due to my health practices, "the chance of a cardiac event is less than one percent in next ten years." The patient reported that now due to streptococcal infection and the ZOSTAVAX, which exacerbated overload of my immune system, I have subsequently been told by several cardiac surgeons that I need a cardiac surgeon for aortic valve replacement else it will cause death." The patient is currently being followed by a cardiac surgeon. The patient stated, I must now see cardiology and have frequent serial echoes and cardiology exam and told will need the cardiac surgery soon." The patient reported the sequelae from the ZOSTAVAX was serious and life threatening. No further information was provided. Additional information has been requested.
Age: 22.0
Sex: F
Vaccine: MMR
Symptoms: Injection site reaction, Rash papular
Clinical narrative: Employee alleges she developed linear papular rash distal to injection site (left deltoid) and proximally up to the shoulder region.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Immediate post-injection reaction, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Pain at injection site. Red raised area around injection site. Pain up and down left arm, some tingling in lower left arm. Felt faint immediately after injection.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Pain in extremity, Paraesthesia
Clinical narrative: Pain at injection site. Red raised area around injection site. Pain up and down left arm, some tingling in lower left arm. Felt faint immediately after injection.
Age: 31.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site pain
Clinical narrative: Pain in (L) deltoid.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Convulsion, Syncope
Clinical narrative: Possible syncope or seizure.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Paraesthesia, Rash, Rash erythematous
Clinical narrative: Redness at injection site that started as a small red dot, which progressed to a spot the size of a hand. Tingling on & off in hands and body. Red dots on front of legs.
Age: 41.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Dyspnoea, Headache, Influenza like illness, Throat tightness
Clinical narrative: Tightness in throat. Trouble taking deep breaths. Flu like symptoms. Headache.
Age: 42.0
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report as received from a pharmacy technician concerning a currently 42 year old patient. Gender was not reported. Medical history and concurrent conditions were not reported. On 24-APR-2014, the patient was vaccinated with VARIVAX lot#J003700; expiration date: 27-MAR2015, (dose, strength and route were not reported). Secondary and concomitant therapies were not reported. Patient was vaccinated with VARIVAX that was exposed to 43.1 degrees F  for 29 hours on 03-MAR-2014. This is one of several reports from the same reporter. Additional information has been requested.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Adverse event
Clinical narrative: This spontaneous report as received from a 64 year old female patient concerning herself. Pregnancy was reported as no. No drug reaction/allergy was reported. Pertinent medical history included multiple sclerosis (M.S.). On an unknown date in January 2013, the patient was vaccinated with ZOSTAVAX, injection, (lot # and expiry date were unknown) one vaccine. Concomitant therapies included valacyclovir hydrochloride for multiple sclerosis (M.S.) and other medications were taken a the time of vaccination, patient stated that she had taken a ton of medications, but none of them were listed in the article. Patient had been taking valacyclovir for years. She read an article in magazine stating that Antiviral medications may interfere with the replication of the live virus so anyone taking valacyclovir, regularly should discontinue use 24 hours before administration and up to two weeks after. Patient spoke with her Neurologist concerning the fact that she was unaware and thus did not temporarily discontinue use of valacyclovir when she had ZOSTAVAX administered to her in January of 2013. Event onset date was also reported as March 2014. Patient sought medical attention. Treatment given for adverse event was reported as no. No lab diagnostics studies were performed. No (Product Quality Complain) PQC was involved. The outcome of event was unknown. Additional information has been requested.