chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Vomiting, Wheezing
Clinical narrative: After receiving the Pentacel Vaccination, the patient began experiencing stomach upsets, constipation and vomiting, mucous and blood in stool, and extreme crying. The patient could no longer sleep on his back or lying down, and would wake up frequently crying in pain. The patient started nursing more frequently, sleeping sporadically and wheezing frequently.  The patient also appeared to have a case of whooping cough, and was brought in at around 3 months of age but the doctor refused to believe it, and instead gave patient a test for rsv which came out negative.  The patient was breastfed and an elimination diet was started by the patient's mother, after the symptoms did not go away.  Some relief was experienced after several potential allergens were eliminated but the patient at 15 months is still suffering from gastrointestinal distress, and having difficulty sleeping.
Age: 74.0
Sex: M
Vaccine: PNC13
Symptoms: Cellulitis
Clinical narrative: Pt developed cellulitis day after shot and was referred to the ER for treatment on 12/24/14. Received cephalexin to treat infection.
Age: 25.0
Sex: F
Vaccine: FLU3, FLU4
Symptoms: Local swelling, Throat tightness
Clinical narrative: Initial report received from a health care professional on 12 December 2014. This case is a part of cluster of 3 cases and is linked to case 2014SA156617, 2014SA173241 and 2014SA130000. A 25-year-old female patient, had received an intramuscular dose of FLUZONE (lot number: U158AA, dose number and site was not reported) on 17 September 2014 ("PM"). The patient had no illness at the time of vaccination. The patient pre-existing physician diagnosed allergies, birth defects, medical conditions was not reported. On 17 September 2014 ("AM") i.e. same day after vaccination patient had experienced throat tightness and severe arm swelling. Corrective treatment and laboratory details were not reported. On an unspecified date patient was recovered from the event. Upon medical review, the case was considered as serious due to important medical event: throat tightness and severe arm swelling. Documents held by sender: None.
Age: 12.0
Sex: F
Vaccine: FLUN4, HPVX
Symptoms: Decreased appetite, Headache, Injection site pain, Injection site warmth, Pyrexia
Clinical narrative: She was sluggish this morning, barely interested in Christmas presents.  Also, she was complaining of pain and "heat" in her left upper arm where she was given her first HPV vaccination (same date/time as Flumist).  Her appetite has been miniscule- not even Holiday dinner. She slept from 1pm to 7pm then developed a fever of 101.2 at last check at 11pm on 12/25/14.  She is also extremely congested and she says her brain hurts.  I've been treating her with Motrin for discomfort during the day so we are continuing that for fever control along with Sudafed for congestion.
Age: 12.0
Sex: F
Vaccine: FLUN4, HPVX
Symptoms: Respiratory tract congestion, Sluggishness
Clinical narrative: She was sluggish this morning, barely interested in Christmas presents.  Also, she was complaining of pain and "heat" in her left upper arm where she was given her first HPV vaccination (same date/time as Flumist).  Her appetite has been miniscule- not even Holiday dinner. She slept from 1pm to 7pm then developed a fever of 101.2 at last check at 11pm on 12/25/14.  She is also extremely congested and she says her brain hurts.  I've been treating her with Motrin for discomfort during the day so we are continuing that for fever control along with Sudafed for congestion.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Developed swelling and redness to vaccine injection site on patient's left thigh (site where Var#1 and PCV#4 were given).
Age: 0.22
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Dehydration, Diarrhoea, Rotavirus infection, Rotavirus test positive, Vomiting
Clinical narrative: Developed watery diarrhea and vomiting. Hospitalized for dehydration 12/14/14-12/16/14. Per mother's history, child was confirmed to have Rotavirus.
Age: 33.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Pt noted pain and redness at injection site hours after getting Pneumovax vaccine.
Age: 25.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Redness, swelling and pain at the injection site.
Age: 1.33
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Chest X-ray normal, Cough, Laboratory test abnormal, Pertussis, Polymerase chain reaction
Clinical narrative: This is one case out of a cumulative total of 245 cases solicited from the EDSS database during the surveillance period from 01 January 2010 to 16 December 2014. These 235 cases represent children who received 3 or more doses of Sanofi Pasteur vaccine; cases of pertussis disease in children who received DTaP combination vaccines from other manufacturers are not reported as per study protocol. Initial report was received on 16 December 2014 from the Investigator participating in a post-marketing study under the reference number M5A16. A case of pertussis disease in a 27 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 02 October 2012 (lot number C4230AA), dose two on 06 December 2012 (lot number C4355AA), dose three on 31 January 2013 (lot number C4358AA) and dose four on 27 November 2013 (lot number C4487AA) (routes and sites of administration for all doses not reported). Approximately 11 months after the last dose, on 19 November 2014, the subject developed cough. Eleven days later, on 30 November 2014, the subject developed a paroxysmal cough. The subject also experienced post-tussive vomiting and sleep disturbance on an unspecified date. Laboratory testing included a positive PCR on 02 December 2014. Chest x-ray findings were negative for pneumonia. Corrective treatments consisted of Azithromycin starting on 02 December 2014 for three days. The subject was not hospitalized. At the time of final contact on 04 December 2014, the subject's cough was still persisting. The duration of the cough was reported at that time as 15 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: 1.33
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Post-tussive vomiting, Sleep disorder
Clinical narrative: This is one case out of a cumulative total of 245 cases solicited from the EDSS database during the surveillance period from 01 January 2010 to 16 December 2014. These 235 cases represent children who received 3 or more doses of Sanofi Pasteur vaccine; cases of pertussis disease in children who received DTaP combination vaccines from other manufacturers are not reported as per study protocol. Initial report was received on 16 December 2014 from the Investigator participating in a post-marketing study under the reference number M5A16. A case of pertussis disease in a 27 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 02 October 2012 (lot number C4230AA), dose two on 06 December 2012 (lot number C4355AA), dose three on 31 January 2013 (lot number C4358AA) and dose four on 27 November 2013 (lot number C4487AA) (routes and sites of administration for all doses not reported). Approximately 11 months after the last dose, on 19 November 2014, the subject developed cough. Eleven days later, on 30 November 2014, the subject developed a paroxysmal cough. The subject also experienced post-tussive vomiting and sleep disturbance on an unspecified date. Laboratory testing included a positive PCR on 02 December 2014. Chest x-ray findings were negative for pneumonia. Corrective treatments consisted of Azithromycin starting on 02 December 2014 for three days. The subject was not hospitalized. At the time of final contact on 04 December 2014, the subject's cough was still persisting. The duration of the cough was reported at that time as 15 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: 1.51
Sex: F
Vaccine: DTAP
Symptoms: Chest X-ray normal, Cough, Nasopharyngitis, Pertussis, Polymerase chain reaction
Clinical narrative: This is one case out of a cumulative total of 244 cases solicited from the EDSS database during the surveillance period from 01 January 2010 to 17 December 2014. These 244 cases represent children who received 3 or more doses of sanofi pasteur vaccine; cases of pertussis disease in children who received DTaP combination vaccines from other manufacturers are not reported as per study protocol. Initial report received on 16 December 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 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 4 doses of DAPTACEL, on 25 October 2011, 20 December 2011, 14 February 2012 (lot numbers not reported), and 11 February 2013 (lot number C4310AA) (routes and sites of administration not reported). On 23 October 2014, the subject developed a cough and catarrhal illness. Paroxysmal cough was noted on 25 October 2014 with a whoop. The subject also experienced sleep disturbance. PCR result was not reported; chest x-ray findings were negative. Corrective treatments consisted of Azithromycin starting on 01 November 2014 for 5 days. The subject was not hospitalized. At the time of final contact on 21 November 2014 the subject's cough was still persisting. The duration of the cough was reported at that time as 29 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: 1.51
Sex: F
Vaccine: DTAP
Symptoms: Sleep disorder
Clinical narrative: This is one case out of a cumulative total of 244 cases solicited from the EDSS database during the surveillance period from 01 January 2010 to 17 December 2014. These 244 cases represent children who received 3 or more doses of sanofi pasteur vaccine; cases of pertussis disease in children who received DTaP combination vaccines from other manufacturers are not reported as per study protocol. Initial report received on 16 December 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 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 4 doses of DAPTACEL, on 25 October 2011, 20 December 2011, 14 February 2012 (lot numbers not reported), and 11 February 2013 (lot number C4310AA) (routes and sites of administration not reported). On 23 October 2014, the subject developed a cough and catarrhal illness. Paroxysmal cough was noted on 25 October 2014 with a whoop. The subject also experienced sleep disturbance. PCR result was not reported; chest x-ray findings were negative. Corrective treatments consisted of Azithromycin starting on 01 November 2014 for 5 days. The subject was not hospitalized. At the time of final contact on 21 November 2014 the subject's cough was still persisting. The duration of the cough was reported at that time as 29 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: 0.52
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Apnoea, Chest X-ray normal, Cough, Laboratory test abnormal, Nasopharyngitis
Clinical narrative: This is one case out of a cumulative total of 243 cases solicited from the EDSS database during the surveillance period from 01 January 2010 to 16 December 2014. These 243 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 17 December 2014 from the Investigator participating in a post-marketing study under the reference number M5A16. A case of pertussis disease in a 6 month 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, lot number C4669AA received on 10 June 2014, lot number C4538AA received on 12 August 2014, and lot number C4724AA received on 09 October 2014 (routes and sites of administration not reported). On 17 October 2014, the subject developed a cough and catarrhal illness. Paroxysmal cough was noted on 19 October 2014 without a whoop. The subject also experienced sleep disturbance and apnea. Laboratory testing included positive PCR on 20 October 2014. Chest x-ray findings were negative. Corrective treatments consisted of Azithromycin starting on 20 October 2014 for 5 days. The subject was not hospitalized. At the time of final contact on 11 November 2014 the subject's cough was still persisting. The duration of the cough was reported at that time as 25 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: 0.52
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Pertussis, Polymerase chain reaction, Sleep disorder
Clinical narrative: This is one case out of a cumulative total of 243 cases solicited from the EDSS database during the surveillance period from 01 January 2010 to 16 December 2014. These 243 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 17 December 2014 from the Investigator participating in a post-marketing study under the reference number M5A16. A case of pertussis disease in a 6 month 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, lot number C4669AA received on 10 June 2014, lot number C4538AA received on 12 August 2014, and lot number C4724AA received on 09 October 2014 (routes and sites of administration not reported). On 17 October 2014, the subject developed a cough and catarrhal illness. Paroxysmal cough was noted on 19 October 2014 without a whoop. The subject also experienced sleep disturbance and apnea. Laboratory testing included positive PCR on 20 October 2014. Chest x-ray findings were negative. Corrective treatments consisted of Azithromycin starting on 20 October 2014 for 5 days. The subject was not hospitalized. At the time of final contact on 11 November 2014 the subject's cough was still persisting. The duration of the cough was reported at that time as 25 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: 0.5
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 242 cases solicited from the database during the surveillance period from 01 January 2010 to 16 December 2014. These 242 cases represent children who received 3 or more doses of Sanofi Pasteur vaccine; cases of pertussis disease in children who received DTaP combination vaccines from other manufacturers are not reported as per study protocol. Initial report received on 16 December 2014 from the Investigator participating in a post-marketing observational surveillance study under the reference number M5A16. A case of pertussis disease in a 13-month-old female subject (initials not collected) was identified by the investigator based on review of data from the electronic database. The subject had received 3 doses of PENTACEL; lot number C4478AB received on 31 October 2013, lot number C4577AA received on 31 December 2013 and lot number C4538AA received on 24 February 2014 (routes and sites of administration not reported). The subject developed cold-like symptoms on 11 October 2014, approximately seven months after the last dose. On 11 October 2014, the subject developed a cough and paroxysmal cough on 13 October 2014 without a whoop. The subject also experienced sleep disturbance. The subject did not experience post-tussive vomiting or apnea. Laboratory testing included positive PCR on 18 October 2014. Chest x-ray findings were negative for pneumonia. Corrective treatments consisted of azithromycin starting on 20 October 2014 for 5 days. The subject was not hospitalized. At the time of final contact on 27 October 2014, the subject's cough was still persisting. The duration of the cough was reported at that time as 16 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: 0.5
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Polymerase chain reaction, Sleep disorder
Clinical narrative: This is one case out of a cumulative total of 242 cases solicited from the database during the surveillance period from 01 January 2010 to 16 December 2014. These 242 cases represent children who received 3 or more doses of Sanofi Pasteur vaccine; cases of pertussis disease in children who received DTaP combination vaccines from other manufacturers are not reported as per study protocol. Initial report received on 16 December 2014 from the Investigator participating in a post-marketing observational surveillance study under the reference number M5A16. A case of pertussis disease in a 13-month-old female subject (initials not collected) was identified by the investigator based on review of data from the electronic database. The subject had received 3 doses of PENTACEL; lot number C4478AB received on 31 October 2013, lot number C4577AA received on 31 December 2013 and lot number C4538AA received on 24 February 2014 (routes and sites of administration not reported). The subject developed cold-like symptoms on 11 October 2014, approximately seven months after the last dose. On 11 October 2014, the subject developed a cough and paroxysmal cough on 13 October 2014 without a whoop. The subject also experienced sleep disturbance. The subject did not experience post-tussive vomiting or apnea. Laboratory testing included positive PCR on 18 October 2014. Chest x-ray findings were negative for pneumonia. Corrective treatments consisted of azithromycin starting on 20 October 2014 for 5 days. The subject was not hospitalized. At the time of final contact on 27 October 2014, the subject's cough was still persisting. The duration of the cough was reported at that time as 16 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: 45.0
Sex: M
Vaccine: TDAP
Symptoms: Asthenia, Body temperature increased, Feeling of body temperature change, Influenza virus test negative, Nausea
Clinical narrative: On 12/09/2014 patient experienced weakness and nausea.  He described his body as going from cold to hot. Temperature was 99.9.  He visited his physician the next day and placed on Tamiflu and flu cultures were performed.  Cultures were negative for flu.
Age: 73.0
Sex: M
Vaccine: PPV
Symptoms: Body temperature increased, Pain in extremity
Clinical narrative: EXTREME SORENESS, graduating to excruciating pain in arm, 101.7 degrees temp. intense pain 4 days, moderating to lesser degree for 6 more days...used ice, Tylenol, Voltaren gel.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from another healthcare professional refers to an unspecified number of patients of unknown age and gender. On an unknown date the patients were vaccinated with an improperly stored dose of VAQTA (strength, dose, route of administration and lot # were not reported). No adverse effects were reported. On 17-DEC-2014 a telephone call was placed to the medical assistant who stated that she was unfamiliar with the reported incident of incorrect product storage. The reporter transferred the call to another person who was also unfamiliar with the event. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: M
Vaccine: VARCEL
Symptoms: Extra dose administered, No therapeutic response
Clinical narrative: This spontaneous report as received from a physician refers to a male patient of unknown age. The patient was allergic to sulfur and had no pertinent medical history reported. In the past, the patient was vaccinated with 3 doses of VARIVAX (Merck) injection (dates, strength, frequency, dose, route and lot # not reported). Concomitant therapies included lisinopril (manufacturer unknown). On an unknown date, it was determined that the patient was a "non-responder". No Lab Diagnostics Studies were performed. Causality between VARIVAX (Merck) and non-responder was unknown. The outcome of the "non-responder" was reported as not recovered/not resolved. Additional information has been requested.
Age: 26.0
Sex: F
Vaccine: FLUX
Symptoms: Anxiety, Dysphagia, Dyspnoea, Rash, Throat tightness
Clinical narrative: This 27 year old female reported receipt of an annual influenza vaccine (unknown manufacturer or lot number) on 9/24/2013 to her left arm approximately 3 hours after eating 2 boiled eggs, a fruit cup (cantaloupe, melon, grapes) and a sausage patty. Approximately 5 minutes later she began to rub her throat complaining it felt weird as if being squeezed (after returning to work area and was speaking with another employee). She returned to medical complaining "her throat was closing as if someone was grabbing it", had difficulty breathing and swallowing and feeling anxious. A medical record review 9/24/2013 documented possible allergic reaction with c/o  throat closing. Exam was negative with patient and with no difficulty speaking or swallowing. Provider wrote she had no difficulty speaking. Lung sounds and vitals were normal with pulse 60, rr 16, BP 117/71. There was no documentation of angioedema, hives, redness or any other systemic symptom (see 9/24/2013 progress note). There were no records of treatment or plan of care listed in hard copy of medical records or electronic records identified. She denied any new foods, detergents, deodorants, fume exposure, and no hives, headaches, rash, palpitations, n/v, visual disturbances, angioedema, or any other symptoms. She advised she was given IM BENARYL for this, slept and was sent home when awoke with resolution of all symptoms. She has had no reoccurrence of above symptoms. She presented to medical 11/2014 for follow up to flu reaction and referred to hc on 11/19/2014. She advised she is agreeable to the flu vaccine once cleared.
Age: 61.0
Sex: F
Vaccine: PNC13
Symptoms: Arthralgia, Induration, Upper extremity mass
Clinical narrative: Hard lump on arm. Joint pain (knees).
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Blood test, Burning sensation, Chest X-ray, Food allergy
Clinical narrative: This spontaneous report was received from a 64 year old male patient regarding himself. Patient never had chickenpox and had no allergies nor drug reactions. On an unknown date in September 2014 (reported as 1st or 2nd week of September), the patient was vaccinated with ZOSTAVAX, 1 single shot, subcutaneous for prevention of shingles (lot number and expiration date were not reported). Concomitant therapies included CELEBREX and unspecified blood pressure and thyroid medications. On an unknown date in September 2014 (reported as within 2 weeks), the patient felt as though as he was on fire (the feeling of being on fire started on the back of the patient's legs), patient became allergic to many foods like milk, developed nerve damage, rash, hives and blisters. Multiple blood test and lung rays were performed (result not provided). The outcome of nerve damage, became allergic to many foods like milk, felt as though I was on fire, rash, hives and blisters was reported as not recovered. Additional information has been requested.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Milk allergy, Nerve injury, Rash, Urticaria
Clinical narrative: This spontaneous report was received from a 64 year old male patient regarding himself. Patient never had chickenpox and had no allergies nor drug reactions. On an unknown date in September 2014 (reported as 1st or 2nd week of September), the patient was vaccinated with ZOSTAVAX, 1 single shot, subcutaneous for prevention of shingles (lot number and expiration date were not reported). Concomitant therapies included CELEBREX and unspecified blood pressure and thyroid medications. On an unknown date in September 2014 (reported as within 2 weeks), the patient felt as though as he was on fire (the feeling of being on fire started on the back of the patient's legs), patient became allergic to many foods like milk, developed nerve damage, rash, hives and blisters. Multiple blood test and lung rays were performed (result not provided). The outcome of nerve damage, became allergic to many foods like milk, felt as though I was on fire, rash, hives and blisters was reported as not recovered. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from another healthcare professional refers to an unspecified number of patients of unknown age and gender. On an unknown date the patients were vaccinated with an improperly stored dose of ROTATEQ oral, (strength, dose and lot # were not reported). No adverse effects were reported. On 17-DEC-2014 a telephone call was placed to the medical assistant who stated that she was unfamiliar with the reported incident of incorrect product storage. The reporter transferred the call to another person who was also unfamiliar with the event. This is one of several reports received form the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from another health professional refers to an unspecified number of patients of unknown age and gender. On an unknown date the patients were vaccinated with an improperly stored dose of RECOMBIVAX HB (strength, dose, route of administration and lot # were not reported). No adverse effects were reported. On 17-DEC-2014 a telephone call was placed to the medical assistant who stated that she was unfamiliar with the reported incident of incorrect product storage. The reporter transferred the call to another person who was also unfamiliar with the event. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 63.0
Sex: M
Vaccine: FLU3
Symptoms: Mobility decreased, Musculoskeletal pain, Pain
Clinical narrative: Pt complains of shoulder pain, unable to lift arm up (soreness).
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a other health professional (registered nurse) refers to a patient of unknown age. Current conditions and medical history was not reported. On 22-DEC-2014, the patient was vaccinated with PROQUAD injection, subcutaneously. Concomitant medications were not reported. On an unknown date, PROQUAD was improperly stored and was administered to the patient and no adverse effect reported. Outcome of the event was not reported. No additional information provided. Product quality complaint was not reported. Additional information has been requested.
Sex: F
Vaccine: HPV4, VARCEL
Symptoms: Exposure during pregnancy, Neonatal disorder
Clinical narrative: Information has been received from the authors in a published article. This retrospective pregnancy report refers to a female pregnant patient of unknown age. On an unknown date, the patient was vaccinated with a dose of GARDASIL (dose, route, anatomical location, lot number and expiration date were not reported) and to Varicella Vaccine (manufacturer unknown) (dose, route, anatomical location, lot number and expiration date were not reported). A baby was born with total anomalous pulmonary venous return, the infant had surgery at 4 weeks of age to repair this defect. This review of VAERS reports comprising more than 6 years of monitoring found no safety concern among pregnant women or their infants who received this vaccine during pregnancy. This is one of several cases from the same literature (1412USA009575 and 1412USA011730). Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: Information has been received from the authors in a published literature article title as stated above and refers a retrospective pregnancy report and concerns to 145 female pregnant patients of unknown ages. The patient's current conditions or medical history were not reported. On unknown date, between 01-JUN-2006 and 31-DEC-2013, the patients were vaccinated with a dose of GARDASIL (dose numbers, route, anatomical location, lot numbers and expiration dates were not reported). All patients were pregnant at the time of vaccination, Last menstrual period, (LMP), estimated conception date and estimated due date were not reported. This review of VAERS reports comprising more than 6 years of monitoring found no safely concern among pregnant women or their infants who received this vaccine during pregnancy. This is one of several cases from the same literature (1412USA011729 and 1412USA011730). A copy of the published article is attached as further documentation of the patient's experience. Additional information has been requested.
Age: 33.0
Sex: F
Vaccine: FLUX
Symptoms: Injection site inflammation, Injection site swelling, Musculoskeletal pain, Myalgia, Pain in extremity
Clinical narrative: Pain in arm, shoulder, and connective tendons. Inflammation and swelling at injection site and muscle pain grew progressively worse over four weeks. Eventually patient could not lie on her side or move arm or use it to bear weight, at which point she contacted a doctor. Patient recovered after a course of physical therapy.
Age: 33.0
Sex: F
Vaccine: FLUX
Symptoms: Tendon pain, Weight bearing difficulty
Clinical narrative: Pain in arm, shoulder, and connective tendons. Inflammation and swelling at injection site and muscle pain grew progressively worse over four weeks. Eventually patient could not lie on her side or move arm or use it to bear weight, at which point she contacted a doctor. Patient recovered after a course of physical therapy.
Age: 60.0
Sex: M
Vaccine: FLU3
Symptoms: Pain, Pain in extremity
Clinical narrative: Patient's arm hurts upon raising. He said it began hurting about 2 days after receiving the shot.
Age: 56.0
Sex: M
Vaccine: RAB, TDAP
Symptoms: Blood test normal, Chills, Computerised tomogram normal, Electroencephalogram normal, Fatigue
Clinical narrative: Flu-like symptoms chills, tired, headache.
Age: 56.0
Sex: M
Vaccine: RAB, TDAP
Symptoms: Headache, Influenza like illness, Lumbar puncture normal, Nuclear magnetic resonance imaging normal
Clinical narrative: Flu-like symptoms chills, tired, headache.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Nausea, Paraesthesia
Clinical narrative: Patient had just received Zostavax vaccine and walked away from pharmacy when she started to feel queasy and light headed and tingly all over. EMS was called to evaluate patient.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Blood glucose normal, Blood sodium normal, Computerised tomogram, Convulsion, Electrocardiogram normal
Clinical narrative: Seizure, generalized (lasted approx 10 minutes).
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Electroencephalogram normal, Laboratory test normal, Troponin normal
Clinical narrative: Seizure, generalized (lasted approx 10 minutes).
Age: 43.0
Sex: M
Vaccine: FLUC3
Symptoms: Injection site rash, Rash
Clinical narrative: Patient stated that had rash on the right arm where he had the shot a couple of hours later on 12/9/2014.  It has spread to the right arm and to his armpits today (12/26/2014).  He has not taken anything or has gone to a doctor.  He said he was going to.
Age: 87.0
Sex: F
Vaccine: FLUX
Symptoms: Abnormal behaviour, Asthenia, Dizziness, Dysphonia, Headache
Clinical narrative: Soreness/redness of injection site. Fainting, Headache, Runny Nose, Stiff neck, Muscle aches intense, Hoarseness, Paleness, Weakness, Dizziness, Behavior changes, extreme shoulder and leg pains.
Age: 87.0
Sex: F
Vaccine: FLUX
Symptoms: Injection site erythema, Injection site pain, Musculoskeletal pain, Musculoskeletal stiffness, Myalgia
Clinical narrative: Soreness/redness of injection site. Fainting, Headache, Runny Nose, Stiff neck, Muscle aches intense, Hoarseness, Paleness, Weakness, Dizziness, Behavior changes, extreme shoulder and leg pains.
Age: 87.0
Sex: F
Vaccine: FLUX
Symptoms: Pain in extremity, Pallor, Rhinorrhoea, Syncope
Clinical narrative: Soreness/redness of injection site. Fainting, Headache, Runny Nose, Stiff neck, Muscle aches intense, Hoarseness, Paleness, Weakness, Dizziness, Behavior changes, extreme shoulder and leg pains.
Age: 33.0
Sex: F
Vaccine: HPV4
Symptoms: Abortion spontaneous, Blood test, Exposure during pregnancy, Ultrasound scan
Clinical narrative: This spontaneous retrospective pregnancy report was received from a 33 year old female patient with allergy to RONDEC. Without concurrent conditions and medical history. On 25-NOV-2014 the patient was vaccinated with a dose of GARDASIL, (strength, dose, frequency, route, anatomical location, lot number and expiration date were not reported). Concomitant therapies included cyanocobalamin (reported as B12). On an unknown date the patient became pregnant (also reported as pregnant "no"). The last menstrual period (LMP) and estimated date of delivery (EDD) were not reported. On 14-DEC-2014, the patient had a miscarriage after receiving GARDASIL. The patient stated that she was not aware that she was pregnant until she had the miscarriage, also she stated that she did not know that they could not be pregnant while getting the vaccine. She mentioned that no one at the office asked her to check and see if she was pregnant. The patient reported that the physician said the baby stopped growing at 6 weeks. He also said that the patient was further along with the pregnancy than 6 weeks but he was unsure of an actual gestation period. The physician took an estimated guess saying the patient may had been between 8-12 weeks. The patient went to the urgent care and was directed to the emergency room. Ultrasound and blood drawn (test unspecified) were performed, the results were not provided. The outcome of miscarriage was unknown. The relatedness between the miscarriage and therapy with GARDASIL was not reported. Additional information has been requested.
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Borrelia test negative, Drug dependence, Uveitis, Varicella virus test negative
Clinical narrative: Bilateral panuveitis, steroid dependent requiring initiation of methotrexate.
Age: 4.0
Sex: M
Vaccine: DTAPHEPBIP, FLU3
Symptoms: Injection site erythema
Clinical narrative: Patient received an PROQUAD that contains MMR and Varicella. After injection mom states redness start within 24 hours and she Vicks and alcohol to injection site. Patient had redness measuring 6mmX9mm. Patient instructed to take BENADRYL, apply ice, and take Ibuprofen or TYLENOL as needed.
Age: 1.3
Sex: M
Vaccine: DTAP, HIBV, PNC13
Symptoms: Blood culture, C-reactive protein, Full blood count, Metabolic function test, Pyrexia
Clinical narrative: Fever and vomiting.
Age: 1.3
Sex: M
Vaccine: DTAP, HIBV, PNC13
Symptoms: Vomiting
Clinical narrative: Fever and vomiting.
Age: 4.0
Sex: F
Vaccine: MMRV
Symptoms: Pyrexia, Vomiting
Clinical narrative: Vomiting multiple times over few hours (3 x 12 hours). Fever (100.6).
Age: 11.0
Sex: M
Vaccine: FLU4, HPV4, MNQ, TDAP
Symptoms: Erythema, Local swelling
Clinical narrative: Father phoned Public Health on 12/18/14 - 10 AM. Reported school nurse had applied ice to patient's left upper arm - half dollar size redden raised area. Informed father of vaccinations given that day and which ones in left arm. Father to contact doctor.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MNQ, VARCEL
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Meningococcal was given instead of MMR. No adverse events known at this time.
Age: 62.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Myalgia, Peripheral swelling, Pyrexia, Rash, Urticaria
Clinical narrative: Pt reports fever 99.8, extreme muscle soreness, arm swelling, rash/hives.
Sex: U
Vaccine: MMR
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified patient of unknown age and gender. No medical history and concomitant therapy were reported. On 02-DEC-2014 the patient was vaccinated with M-M-R II (Lot #, Dose, route were not provided) first dose and received the second dose on 24-DEC-2014. This was less than one month indicated minimal interval between doses. No adverse effects were reported. No product quality complaint was involved. Additional information has been requested.
Sex: M
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to two unspecified patients of unknown age and gender. On an unknown date the patients were vaccinated with a dose of 0.5 ml improperly GARDASIL that exposed to 32F for 39 hours, intramuscular. No adverse effects were reported. Follow up information received on 17-DEC-2014 regarding 2 patients who received improperly stored GARDASIL, via a phone call that was placed to the CMA. The CMA did not have any additional information available at this time. The CMA stated she would look for the patient's information and if available the CMA would call back at a later date. The CMA called back and reported on the names of the two patients (refer to MARRS # 1411USA01208) who received the improperly stored GARDASIL. Also the CMA reported on the GARDASIL information for both was Lot # J006236 and Exp. date: 25-FEB-2016. This is one of two reports from the same reporter. Additional information has been requested.
Age: 3.0
Sex: F
Vaccine: MMRV
Symptoms: Erythema, Induration
Clinical narrative: 3 inch, circular, erythematous induration, bullseye appearance.
Age: 45.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: 12/23 administered (L) upper arm (TRICEPS). 12/24 developed  redness; swelling pain that increased on 12/25; persists 12.26. No fever. Exam : 11 cm x 7 cm area redness, warmth, swelling, tenderness (L) triceps area plan US to r/o abscess.
Age: 45.0
Sex: F
Vaccine: TDAP
Symptoms: Pain, Swelling, Ultrasound scan
Clinical narrative: 12/23 administered (L) upper arm (TRICEPS). 12/24 developed  redness; swelling pain that increased on 12/25; persists 12.26. No fever. Exam : 11 cm x 7 cm area redness, warmth, swelling, tenderness (L) triceps area plan US to r/o abscess.
Age: 16.0
Sex: M
Vaccine: HPV4
Symptoms: Generalised tonic-clonic seizure
Clinical narrative: Patient arrived for nurse visit for HPV #3, after receiving first two doses without any problems. Today, about 2-3 minutes after receiving vaccine - patient had a tonic-clonic seizure lasting about 15 seconds. Last, and only seizure was 4 years ago. Patient not on any medications. Patient monitored and 911 called - to ER.
Age: 46.0
Sex: F
Vaccine: MMR
Symptoms: Mumps antibody test negative
Clinical narrative: This spontaneous report as received from a registered pharmacist refers to a 46 year old female patient with no drug reactions or allergies. On an unknown date "years ago", the patient was vaccinated with a dose of MMR II (dose, route and lot # not reported). The pharmacist reported that in December 2014 "within the last two weeks", the patient underwent a blood titer was negative for mumps antibodies. The patient's present status was unchanged since that blood titer was performed. The patient did not receive treatment for the adverse event. Additional information has been requested.
Sex: F
Vaccine: HEPA, HPV4
Symptoms: Exposure during pregnancy, Neonatal disorder
Clinical narrative: Information has been received from the authors in a published literature article and refers to a retrospective pregnancy report and concerns a female patient of unknown age. On an unknown date, the patient was vaccinated with GARDASIL (dose, route, anatomical location, lot number and expiration date were not reported) and hepatitis A vaccine (manufacturer unknown) (dose, route, anatomical location, lot number and expiration date were not reported) while being pregnant. The patient's last menstrual period, (LMP), estimated conception date and estimated due date were not reported. The patient gave birth to a baby, the infant was born without both lower limbs. This review of VAERS reports comprising more than 6 years of monitoring found no safety concern among pregnant women or their infants who received this vaccine during pregnancy, causality between reported AEs and GARDASIL vaccine was not specifically assessed. This is one of several cases from the same literature (1412USA009575 and 1412USA011729). Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report was received from a register nurse concerning an unspecified number of patients of an unknown age and gender that were vaccinated with a dose of ZOSTAVAX dose, dose number, lot number, expiration date and route were not reported), that were improperly stored. Medical history and concurrent conditions of the patients were not reported. Co-suspect and concomitant therapies were not reported. This is one (1) of three (3) reports from the same source. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to a patient of unknown age and gender. On 23-DEC-2014, the patient was vaccinated with an expired dose of GARDASIL (lot # J005661 exp 26-SEP-2014) (dose and route not reported). No adverse effects were reported. Additional information has been requested.
Age: 1.0
Sex: M
Vaccine: MMR, PNC13, VARCEL
Symptoms: Lymphadenopathy, Pyrexia, Rash
Clinical narrative: Lymphadenopathy, fever, facial rash.
Age: 65.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Peripheral swelling, Pyrexia
Clinical narrative: Patient had FLUZONE HD, PNEUMOVAX 23 on 12/23. Came home and had fever on 12/23 - and her arm was swollen/redness by 12/24 - no more fever, and redness/swolleness was subsided. She was much better on 12/26.
Age: 26.0
Sex: M
Vaccine: PPV
Symptoms: Bursitis, Impaired work ability, Joint range of motion decreased, Pain
Clinical narrative: Pt was seen by Dr. on 11/25/14 and given injection. He had pain later that day and was seen in ER. Pt had pain and decreased ROM, diagnosed with bursitis due to placement of injection. Pt. followed-up with PA and pt states slight pain but better ROM. Pt lose time from work from 11/26/14-12/3/14.
Age: 66.0
Sex: F
Vaccine: FLU3, PPV, TDAP
Symptoms: Asthenia, Mobility decreased, Pain
Clinical narrative: Pt was seen by Dr. on 11/24/14 and given injection. Flu and PNEUMOVAX were given (Rt) arm and Tdap given (Lt) arm. Pt had severe pain 2 days after injections and has slowly improved with NAPROSYN, heat. Pt stated having trouble lifting arm due to pain and "feels weak". Pt referred to physical therapy, TYLENOL, ADVIL, heat, ROM exercises, walking wall. Pt was seen 11/26/14, 12/1/14 and 12/8/14.
Age: 80.0
Sex: U
Vaccine: FLU3, PNC13
Symptoms: Injection site pain, Injection site pruritus, Injection site warmth
Clinical narrative: Pt came in for an appointment with PA on 12/2/14. Pt complained of reaction of injection site and warm, pruritic and sore to touch. Pt took BENADRYL and iced it that night. Clinicial confirmed reaction to "pneumococcal immunization." Advised to recheck if worsening.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Rash
Clinical narrative: Rash on both arms. May be shingles?
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Erythema, Herpes zoster, Pain, Pruritus
Clinical narrative: Rash on both arms. May be shingles?
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Pruritus generalised, Urticaria
Clinical narrative: This spontaneous report refers to a 67 year old male patient. Concurrent conditions included high blood pressure, diabetes, high cholesterol, phlegm in throat and a cough for about a year (approximately since 2013) and recently place stent. On 11-DEC-2014 the patient was vaccinated with a dose of ZOSTAVAX single shot in the back of the right arm for shingles prevention, (route, dose, lot, batch # and expiration date not reported). Concomitant therapies included lisinopril (manufacturer unknown), carvedilol, amlodipine, NOVOLOG, atorvastatin, aspirin and omega-3 fish oil and PLAVIX for recently placed stent. On 19-DEC-2014 the patient began to itch all over, both legs were itchy, and there were welts on the backs of both legs. He tried to call his Primary Care Physician (PCP), but there was no answer on the phone. He would try again to reach his PCP. There was no relevant laboratory data. As of 20-DEC-2014, he no longer took ZOSTAVAX and experienced worsening of itching all over, both legs itching, and having welts on the backs of both legs (outcome not recovered). Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to multiple unspecified patients of unknown age and gender. On an unknown date, the patients were vaccinated with doses of VARIVAX (Merck) (dose, route and lot # not reported) post supported excursion. No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to multiple unspecified patients of unknown age and gender. On an unknown date, the patients were vaccinated with doses of PROQUAD (dose, route and lot # not reported) post supported excursion. No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a health care professional refers to unspecified number or patients of unknown age and gender. On unknown dates, between October 2014 and December 2014, the patients were vaccinated with improperly stored doses of ZOSTAVAX, (dose, route, lot number and expiration date not reported). No symptoms reported. This is one of several reports received from the same reporter. Additional information has been requested.