chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 12.0
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect route of drug administration
Clinical narrative: This spontaneous report as received from a registered nurse refers to two patients of unknown age and unknown gender. The patients were vaccinated intramuscularly with live ZOSTAVAX (lot number not reported) on 27-AUG-2012. No other co-suspects or concomitant medications were reported. No known adverse effects. It was unspecified if the patients had sought medical attention. Follow up information received with an aware date of 12-SEP-2012, telephone attempts to obtain follow up was unsuccessful. Follow up information was received from the registered nurse who reported that the 12 year old patients were vaccinated via a wrong route (intramuscularly) with the first dose of live ZOSTAVAX (lot number: 0468AE, dose not reported) on 22-AUG-2012 (previously reported as 27-AUG-2012) at 13:30. Additional information is not expected.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Immediate post-injection reaction, Injection site pain, Lip blister, Oral herpes
Clinical narrative: This spontaneous report as received from a 60 years old female patient with high blood pressure and drug reactions/allergies to amlodipine besylate and ace inhibitors referred to herself. The patient was vaccinated with a dose of live ZOSTAVAX (1 time vaccine, subcutaneous, lot#, dose were unspecified) on 25-JAN-2013. Concomitant medications included atenolol, TENORETIC, CRESTOR and PRILOSEC. The consumer stated 24 hours after receiving the vaccine(26-JAN-2013), she had a headache, runny nose,with no symptoms, cold sores on her lip on the right side, and 1 in the middle of her upper lip. She stated she also had pain at the injection site right after the injection. She would contact her physician. She also stated it was cold sores, with open blisters. Patient did not seek medical attention. No lab diagnostics studies performed and no treatment was given for events. At the time of reporting, the outcome of event were unknown. The relatedness for all events were unknown for live ZOSTAVAX. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Rhinorrhoea
Clinical narrative: This spontaneous report as received from a 60 years old female patient with high blood pressure and drug reactions/allergies to amlodipine besylate and ace inhibitors referred to herself. The patient was vaccinated with a dose of live ZOSTAVAX (1 time vaccine, subcutaneous, lot#, dose were unspecified) on 25-JAN-2013. Concomitant medications included atenolol, TENORETIC, CRESTOR and PRILOSEC. The consumer stated 24 hours after receiving the vaccine(26-JAN-2013), she had a headache, runny nose,with no symptoms, cold sores on her lip on the right side, and 1 in the middle of her upper lip. She stated she also had pain at the injection site right after the injection. She would contact her physician. She also stated it was cold sores, with open blisters. Patient did not seek medical attention. No lab diagnostics studies performed and no treatment was given for events. At the time of reporting, the outcome of event were unknown. The relatedness for all events were unknown for live ZOSTAVAX. Additional information has been requested.
Age: 0.77
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Apnoea, Chest X-ray normal, Cough, Laboratory test abnormal, Nasopharyngitis
Clinical narrative: Initial report received on 24 January 2013 from the Investigator participating in the post-marketing 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 Disease Surveillance (EDS) electronic database. The subject had received 3 doses of PENTACEL; Dose 1 received on 19 January 2012 (lot number not reported),  lot number C4131AA received on 17 May 2012, and lot number C4259AA received on 23 August 2012 (routes and sites of administration not reported). The subject developed a cough on 04 January 2013, approximately 134 days after the last dose, and a paroxysmal cough with a whoop on 12 January 2013. The subject also developed cold like symptoms on 14 December 2012 and apnea (start date not reported). Laboratory testing included positive PCR on 11 January 2013. Chest x-ray findings were negative for pneumonia. Corrective treatments consisted of azithromycin starting on 11 January 2013 for 5 days. The subject was not hospitalized. At the time of final contact on 18 January 2013, the subject's cough was still persisting. The duration of the cough was reported at that time as 14 days. Investigator causality assessment is not required as per protocol. Documents held by sender: None.
Age: 0.77
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Pertussis, Polymerase chain reaction
Clinical narrative: Initial report received on 24 January 2013 from the Investigator participating in the post-marketing 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 Disease Surveillance (EDS) electronic database. The subject had received 3 doses of PENTACEL; Dose 1 received on 19 January 2012 (lot number not reported),  lot number C4131AA received on 17 May 2012, and lot number C4259AA received on 23 August 2012 (routes and sites of administration not reported). The subject developed a cough on 04 January 2013, approximately 134 days after the last dose, and a paroxysmal cough with a whoop on 12 January 2013. The subject also developed cold like symptoms on 14 December 2012 and apnea (start date not reported). Laboratory testing included positive PCR on 11 January 2013. Chest x-ray findings were negative for pneumonia. Corrective treatments consisted of azithromycin starting on 11 January 2013 for 5 days. The subject was not hospitalized. At the time of final contact on 18 January 2013, the subject's cough was still persisting. The duration of the cough was reported at that time as 14 days. Investigator causality assessment is not required as per protocol. Documents held by sender: None.
Age: 0.5
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Chest X-ray normal, Cough, Laboratory test abnormal, Nasopharyngitis, Pertussis
Clinical narrative: Initial report received on 24 January 2013 from the Investigator participating in the post-marketing observational study under the reference number M5A16. A case of pertussis disease in a nine-month-old male subject (initials not collected) was identified by the investigator based on review of data from the Electronic Disease Surveillance (EDS) electronic database. The subject had received 3 doses of PENTACEL; lot number C4182AA received on 22 May 2012, lot number C4270AA received on 26 July 2012 and lot number C4275AA received on 26 September 2012 (routes and sites of administration not reported). The subject developed cold-like symptoms on 30 December 2012, approximately three months after the last dose. On 31 December 2012, the subject developed a cough and paroxysmal cough without a whoop. The subject also experienced sleep disturbance. Laboratory testing included positive PCR on 31 December 2012. Chest x-ray findings were negative for pneumonia. Corrective treatments consisted of azithromycin starting on 31 December 2012 for 5 days. The subject was not hospitalized. At the time of final contact on 14 January 2013, the subject's cough was still persisting. The duration of the cough was reported at that time as 14 days. Investigator causality assessment is not required as per protocol. Documents held by sender: None.
Age: 0.5
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Polymerase chain reaction, Sleep disorder
Clinical narrative: Initial report received on 24 January 2013 from the Investigator participating in the post-marketing observational study under the reference number M5A16. A case of pertussis disease in a nine-month-old male subject (initials not collected) was identified by the investigator based on review of data from the Electronic Disease Surveillance (EDS) electronic database. The subject had received 3 doses of PENTACEL; lot number C4182AA received on 22 May 2012, lot number C4270AA received on 26 July 2012 and lot number C4275AA received on 26 September 2012 (routes and sites of administration not reported). The subject developed cold-like symptoms on 30 December 2012, approximately three months after the last dose. On 31 December 2012, the subject developed a cough and paroxysmal cough without a whoop. The subject also experienced sleep disturbance. Laboratory testing included positive PCR on 31 December 2012. Chest x-ray findings were negative for pneumonia. Corrective treatments consisted of azithromycin starting on 31 December 2012 for 5 days. The subject was not hospitalized. At the time of final contact on 14 January 2013, the subject's cough was still persisting. The duration of the cough was reported at that time as 14 days. Investigator causality assessment is not required as per protocol. Documents held by sender: None.
Age: 0.53
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Chest X-ray normal, Cough, Laboratory test abnormal, Nasopharyngitis, Pertussis
Clinical narrative: Initial report received on 24 January 2013 from the Investigator participating in the post-marketing study under the reference number M5A16. A case of pertussis disease in a nine-month-old male subject (initial not collected) was identified by the investigator based on review of data from the Electronic Disease Surveillance (EDS) electronic database. The subject had received 3 doses of PENTACEL; lot number C3917AA received on 04 April 2012, lot number C3945BA received on 01 June 2012 and lot number C4049AA received on 16 August 2012 (routes and sites of administration not reported). The subject developed cold-like symptoms on 29 November 2012, approximately three months after the last dose. On 29 November 2012, the subject developed a cough and paroxysmal cough with a whoop. The subject also experienced sleep disturbance. Laboratory testing included positive PCR on 04 December 2012. Chest x-ray findings were negative for pneumonia. Corrective treatments consisted of azithromycin starting on 05 December 2012 for 5 days. The subject was not hospitalized. At the time of final contact on 13 December 2012, the subject's cough was still persisting. The duration of the cough was reported at that time as 14 days. Investigator causality assessment is not required as per protocol. Documents held by sender: None.
Age: 0.53
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Polymerase chain reaction, Sleep disorder
Clinical narrative: Initial report received on 24 January 2013 from the Investigator participating in the post-marketing study under the reference number M5A16. A case of pertussis disease in a nine-month-old male subject (initial not collected) was identified by the investigator based on review of data from the Electronic Disease Surveillance (EDS) electronic database. The subject had received 3 doses of PENTACEL; lot number C3917AA received on 04 April 2012, lot number C3945BA received on 01 June 2012 and lot number C4049AA received on 16 August 2012 (routes and sites of administration not reported). The subject developed cold-like symptoms on 29 November 2012, approximately three months after the last dose. On 29 November 2012, the subject developed a cough and paroxysmal cough with a whoop. The subject also experienced sleep disturbance. Laboratory testing included positive PCR on 04 December 2012. Chest x-ray findings were negative for pneumonia. Corrective treatments consisted of azithromycin starting on 05 December 2012 for 5 days. The subject was not hospitalized. At the time of final contact on 13 December 2012, the subject's cough was still persisting. The duration of the cough was reported at that time as 14 days. Investigator causality assessment is not required as per protocol. Documents held by sender: None.
Sex: F
Vaccine: FLUX
Symptoms: Depressed level of consciousness, Vaccination complication
Clinical narrative: This medically confirmed report (initial receipt 22-Jan-2013) concerns a female patient, age unspecified. Years ago the patient received a flu vaccine (manufacturer and batch number not specified) and developed a severe reaction. She was almost in a coma. She sought medical attention, details of which were not provided. The outcome was reported as recovered.
Age: 12.0
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Blindness, Ophthalmological examination abnormal, Visual impairment
Clinical narrative: This spontaneous report was received from a registered nurse concerning an approximately 12 year old female patient. On 13-JU-2012, the patient was vaccinated with dose 1 of 0.5 milliliter (ml) of GARDASIL (lot number, expiry date unspecified) intramuscularly. On 18-SEP-2012 (reported as 18-SEP-2013), she was vaccinated with dose 2 of 0.5 ml of GARDASIL (lot number, expiry date unspecified) intramuscularly. On 24-JAN-2013, she was vaccinated with dose 3 of 0.5 ml of GARDASIL (lot number, expiry date unspecified) intramuscularly. No concomitant medications were reported. Approximately on an unknown date in January 2013 (reported as over the weekend), the patient experienced peripheral visual changes. The patient sought medical attention (physician consultation). She was examined by an unspecified eye doctor who confirmed that the patient was experiencing a 10 percent loss of her vision. No treatment examined by an unspecified eye doctor who confirmed that the patient was experiencing a 10 percent loss of her vision. No treatment was provided. The outcome of a 10 percent loss of her vision was reported as not resolved. The relatedness for a 10 percent loss of her vision was unknown for GARDASIL. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Corrective lens user, Headache, Vision blurred, Visual acuity reduced
Clinical narrative: This spontaneous report was received from a registered nurse concerning an approximately 12 year old female patient. On 13-JU-2012, the patient was vaccinated with dose 1 of 0.5 milliliter (ml) of GARDASIL (lot number, expiry date unspecified) intramuscularly. On 18-SEP-2012 (reported as 18-SEP-2013), she was vaccinated with dose 2 of 0.5 ml of GARDASIL (lot number, expiry date unspecified) intramuscularly. On 24-JAN-2013, she was vaccinated with dose 3 of 0.5 ml of GARDASIL (lot number, expiry date unspecified) intramuscularly. No concomitant medications were reported. Approximately on an unknown date in January 2013 (reported as over the weekend), the patient experienced peripheral visual changes. The patient sought medical attention (physician consultation). She was examined by an unspecified eye doctor who confirmed that the patient was experiencing a 10 percent loss of her vision. No treatment examined by an unspecified eye doctor who confirmed that the patient was experiencing a 10 percent loss of her vision. No treatment was provided. The outcome of a 10 percent loss of her vision was reported as not resolved. The relatedness for a 10 percent loss of her vision was unknown for GARDASIL. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Dizziness, Fatigue, Headache, Photophobia, Sudden visual loss
Clinical narrative: This spontaneous report was received from a registered nurse concerning an approximately 12 year old female patient. On 13-JU-2012, the patient was vaccinated with dose 1 of 0.5 milliliter (ml) of GARDASIL (lot number, expiry date unspecified) intramuscularly. On 18-SEP-2012 (reported as 18-SEP-2013), she was vaccinated with dose 2 of 0.5 ml of GARDASIL (lot number, expiry date unspecified) intramuscularly. On 24-JAN-2013, she was vaccinated with dose 3 of 0.5 ml of GARDASIL (lot number, expiry date unspecified) intramuscularly. No concomitant medications were reported. Approximately on an unknown date in January 2013 (reported as over the weekend), the patient experienced peripheral visual changes. The patient sought medical attention (physician consultation). She was examined by an unspecified eye doctor who confirmed that the patient was experiencing a 10 percent loss of her vision. No treatment examined by an unspecified eye doctor who confirmed that the patient was experiencing a 10 percent loss of her vision. No treatment was provided. The outcome of a 10 percent loss of her vision was reported as not resolved. The relatedness for a 10 percent loss of her vision was unknown for GARDASIL. Additional information has been requested.
Age: 52.0
Sex: M
Vaccine: VARZOS
Symptoms: Accidental exposure to product, Pruritus
Clinical narrative: This spontaneous report was received from a 52 year old registered pharmacist (who is the patient) regarding himself. The patient has sulfur allergy. On an unknown date, the patient experienced itching in the thumb and wrist area of his hands and arms after preparation and administration of live ZOSTAVAX. The patient stated every time he prepares live ZOSTAVAX and administers the vaccine that he experiences itching about a half an hour later but eventually itching resolves after washing his hands with soap and water. The patient stated that he wears latex free gloves during preparation and administration of live ZOSTAVAX. Additional information has been requested.
Age: 14.0
Sex: M
Vaccine: MMRV
Symptoms: No adverse event
Clinical narrative: This spontaneous report was received from a certified medical assistant (CMA refers to a 14 years, 11-month-old male patient. On 25-OCT-2012 the patient was vaccinated with, 0.5 milliliter (ml) PROQUAD (merck) (lot # H015631 expiration date 23-FEB-2014) on the right thigh. No concomitant medications were reported. No adverse effects reported. No other information provided. Follow up information was received from a medical assistant who reported that the 14 year old male patient with an allergy to amoxicillin, was vaccinated subcutaneously into the right tight with the first dose of PROQUAD (merck) (lot # H015631) on 25-OCT-2012 at 2:04 pm. There was no illness at the time of vaccination. Additional information is not expected.
Age: 19.0
Sex: M
Vaccine: ANTH, TYP, ANTH, SMALL, TYP
Symptoms: Blood creatine phosphokinase MB, Blood creatine phosphokinase increased, Chest pain, Echocardiogram normal, Electrocardiogram normal
Clinical narrative: CHEST PAIN
Age: 19.0
Sex: M
Vaccine: ANTH, TYP, ANTH, SMALL, TYP
Symptoms: Fibrin D dimer normal, Troponin I
Clinical narrative: CHEST PAIN
Age: 19.0
Sex: M
Vaccine: ANTH, TYP, ANTH, SMALL, TYP
Symptoms: Echocardiogram normal, Electrocardiogram abnormal, Pericardial disease, Troponin I increased
Clinical narrative: CHEST PAIN
Age: 51.0
Sex: M
Vaccine: FLUX
Symptoms: Activities of daily living impaired, Grip strength decreased, Motor dysfunction, Muscular weakness, Paraesthesia
Clinical narrative: Arm felt weak, tingling in hand especially in small, ring, and middle fingers, loss of motor skills in hand, weak grasp/pincher grasp/inability to manipulate small objects, i.e. tying shoes, buckling pants etc.
Age: 40.0
Sex: F
Vaccine: UNK
Symptoms: Back injury, Disturbance in attention, Fall, Head injury, Headache
Clinical narrative: Soreness at the site of shot for the next couple of hours.  Early the next morning my daughter was sleep walking and I heard her scream and I got out of bed and the pain in my right arm and shoulder was so severe that I urinated on myself (which I have never done before due to pain from Fibromyalgia.)  I started walking toward the stairs where she was and was in such pain that I couldn't concentrate and focus and ended up falling down the stairs, hitting my head and back.  The next morning, I could barely move my right arm and was in excruciating pain in my right shoulder, which radiated down my right arm to the fingers of my right arm at times and into my neck.  My normal headaches would increase into migraines more often than they normally would.  The pain has continued to increase and now is in my bicep and tricep and down in my trapezoid and makes it very difficult for me to fall asleep at night and often wakes me up at night.  I am currently receiving treatment for Fibromyalgia which included physical therapy, which was slowly decreasing my pain level from about a 5 out of 10 (10 being worst pain) and the whole upper right side of my body is a constant 8 or 9 out of 10 (10 being worst pain) while continuing with physical therapy.)  I got an MRI after the injection on 1/18/12, which showed tendonitis, and the beginning of frozen shoulder syndrome.  I was used to having sore neck and shoulder muscles due to fibromyalgia, but this was/is different and continues to get worse.  I received a cortisone injection, which helped someone else move my arm a little, but I still cannot move my right arm more than the circumference of my elbow.  My dexterity of my right hand and fingers is better but that is about it.  I'm terrified that the pain is going to get worse and that my range of motion will never return to normal.
Age: 40.0
Sex: F
Vaccine: UNK
Symptoms: Injected limb mobility decreased, Injection site pain, Insomnia, Migraine, Motor dysfunction
Clinical narrative: Soreness at the site of shot for the next couple of hours.  Early the next morning my daughter was sleep walking and I heard her scream and I got out of bed and the pain in my right arm and shoulder was so severe that I urinated on myself (which I have never done before due to pain from Fibromyalgia.)  I started walking toward the stairs where she was and was in such pain that I couldn't concentrate and focus and ended up falling down the stairs, hitting my head and back.  The next morning, I could barely move my right arm and was in excruciating pain in my right shoulder, which radiated down my right arm to the fingers of my right arm at times and into my neck.  My normal headaches would increase into migraines more often than they normally would.  The pain has continued to increase and now is in my bicep and tricep and down in my trapezoid and makes it very difficult for me to fall asleep at night and often wakes me up at night.  I am currently receiving treatment for Fibromyalgia which included physical therapy, which was slowly decreasing my pain level from about a 5 out of 10 (10 being worst pain) and the whole upper right side of my body is a constant 8 or 9 out of 10 (10 being worst pain) while continuing with physical therapy.)  I got an MRI after the injection on 1/18/12, which showed tendonitis, and the beginning of frozen shoulder syndrome.  I was used to having sore neck and shoulder muscles due to fibromyalgia, but this was/is different and continues to get worse.  I received a cortisone injection, which helped someone else move my arm a little, but I still cannot move my right arm more than the circumference of my elbow.  My dexterity of my right hand and fingers is better but that is about it.  I'm terrified that the pain is going to get worse and that my range of motion will never return to normal.
Age: 40.0
Sex: F
Vaccine: UNK
Symptoms: Musculoskeletal pain, Neck pain, Nuclear magnetic resonance imaging abnormal, Pain in extremity, Periarthritis
Clinical narrative: Soreness at the site of shot for the next couple of hours.  Early the next morning my daughter was sleep walking and I heard her scream and I got out of bed and the pain in my right arm and shoulder was so severe that I urinated on myself (which I have never done before due to pain from Fibromyalgia.)  I started walking toward the stairs where she was and was in such pain that I couldn't concentrate and focus and ended up falling down the stairs, hitting my head and back.  The next morning, I could barely move my right arm and was in excruciating pain in my right shoulder, which radiated down my right arm to the fingers of my right arm at times and into my neck.  My normal headaches would increase into migraines more often than they normally would.  The pain has continued to increase and now is in my bicep and tricep and down in my trapezoid and makes it very difficult for me to fall asleep at night and often wakes me up at night.  I am currently receiving treatment for Fibromyalgia which included physical therapy, which was slowly decreasing my pain level from about a 5 out of 10 (10 being worst pain) and the whole upper right side of my body is a constant 8 or 9 out of 10 (10 being worst pain) while continuing with physical therapy.)  I got an MRI after the injection on 1/18/12, which showed tendonitis, and the beginning of frozen shoulder syndrome.  I was used to having sore neck and shoulder muscles due to fibromyalgia, but this was/is different and continues to get worse.  I received a cortisone injection, which helped someone else move my arm a little, but I still cannot move my right arm more than the circumference of my elbow.  My dexterity of my right hand and fingers is better but that is about it.  I'm terrified that the pain is going to get worse and that my range of motion will never return to normal.
Age: 40.0
Sex: F
Vaccine: UNK
Symptoms: Tendonitis, Urinary incontinence, Vision blurred
Clinical narrative: Soreness at the site of shot for the next couple of hours.  Early the next morning my daughter was sleep walking and I heard her scream and I got out of bed and the pain in my right arm and shoulder was so severe that I urinated on myself (which I have never done before due to pain from Fibromyalgia.)  I started walking toward the stairs where she was and was in such pain that I couldn't concentrate and focus and ended up falling down the stairs, hitting my head and back.  The next morning, I could barely move my right arm and was in excruciating pain in my right shoulder, which radiated down my right arm to the fingers of my right arm at times and into my neck.  My normal headaches would increase into migraines more often than they normally would.  The pain has continued to increase and now is in my bicep and tricep and down in my trapezoid and makes it very difficult for me to fall asleep at night and often wakes me up at night.  I am currently receiving treatment for Fibromyalgia which included physical therapy, which was slowly decreasing my pain level from about a 5 out of 10 (10 being worst pain) and the whole upper right side of my body is a constant 8 or 9 out of 10 (10 being worst pain) while continuing with physical therapy.)  I got an MRI after the injection on 1/18/12, which showed tendonitis, and the beginning of frozen shoulder syndrome.  I was used to having sore neck and shoulder muscles due to fibromyalgia, but this was/is different and continues to get worse.  I received a cortisone injection, which helped someone else move my arm a little, but I still cannot move my right arm more than the circumference of my elbow.  My dexterity of my right hand and fingers is better but that is about it.  I'm terrified that the pain is going to get worse and that my range of motion will never return to normal.
Age: 47.0
Sex: F
Vaccine: VARZOS
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist refers to a 49 year old female patient. The patient was vaccinated with ZOSTAVAX, (lot number, expiration date and route was not reported) on 17-JAN-2013. No concomitant medications were reported. No adverse event was reported. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Headache
Clinical narrative: This spontaneous report was received from a physician via company representative refers to a 19 year old female patient. Approximately on an unknown date in 2011, the patient was vaccinated with a dose of GARDASIL, (lot number, expiration date and route was not reported). No concomitant medications were reported. It was reported that the patient was getting headaches and discontinued GARDASIL series before completing the series. The outcome of headache was reported as not recovered. The patient sought medical attention (saw doctor and neurologist). Additional information is not expected.
Age: 11.0
Sex: M
Vaccine: FLU3, MNQ
Symptoms: Headache, Nausea, Pallor
Clinical narrative: Pale, nauseated, severe headache - 15 minutes.
Sex: M
Vaccine: MMR
Symptoms: Abnormal behaviour, Autism, Screaming
Clinical narrative: This spontaneous report was received from a consumer refers to a male patient of unknown age. The consumer stated her son received Merck vaccines in the early 1990's including MMR II (date, lot #, expiration date, doses and route were not reported) and varicella virus vaccine live (manufacturer unspecified) (date, lot #, expiration date, doses and route were not reported) and then developed autism. He exhibited erratic behavior and screaming. No concomitant medications were reported. At the time of the report the outcome for autism, erratic behavior and screaming events was unknown. Additional information is not expected.
Age: 58.0
Sex: F
Vaccine: FLU3
Symptoms: Activities of daily living impaired, Asthenia, Chills, Condition aggravated, Dizziness
Clinical narrative: Just thought I'd pass along this info to you about symptoms following getting the flu shot. I know it's been quite awhile, now, but I wasn't interested in paying to get a bunch of tests done, and hoped the symptoms would just clear up. About a half hour after receiving the vaccine, I was in the grocery store, thinking about what I was looking at, and suddenly experienced a very strange feeling in my head that I never felt before, and right after that felt like I was about to pass out. I never felt like that before, either. I grabbed onto something, and waited, and the symptoms mostly left up. Since then, at unexpected times, I have short periods of dizzy lightheadedness. Also, later the same day, I started with a lot of headache and neck stiffness, and in the following days, was tired, weak, and aching. My usual mild sinus symptoms got much worse. Most concerning was the recurrence of symptoms I had as a teenager, (after an mva, with head and neck injuries) mainly irritation and pressure at the base of the skull, and the right eye feeling strained and pulled upward. This was quite disturbing. I know that people who push for getting the flu shot say it's just a coincidence that people get sick following it. But I fully believe that my experience was a direct result of the vaccine. So now, even with the flu epidemic upon us, I see getting the flu shot to be a greater risk than not getting it. I'm told that the vaccine is only effective for a small percentage of the types of flu, anyway. Patient in office to fill out VAERS form re: flu shot. Alerted us to the fact that she missed work 1/16 and 1/17/13 due to sweats, headache, chills. She did not feel better until 1/23/13 and is not sure if it is related to all the other symptoms she has had since November.
Age: 58.0
Sex: F
Vaccine: FLU3
Symptoms: Fatigue, Headache, Hyperhidrosis, Musculoskeletal stiffness, Pain
Clinical narrative: Just thought I'd pass along this info to you about symptoms following getting the flu shot. I know it's been quite awhile, now, but I wasn't interested in paying to get a bunch of tests done, and hoped the symptoms would just clear up. About a half hour after receiving the vaccine, I was in the grocery store, thinking about what I was looking at, and suddenly experienced a very strange feeling in my head that I never felt before, and right after that felt like I was about to pass out. I never felt like that before, either. I grabbed onto something, and waited, and the symptoms mostly left up. Since then, at unexpected times, I have short periods of dizzy lightheadedness. Also, later the same day, I started with a lot of headache and neck stiffness, and in the following days, was tired, weak, and aching. My usual mild sinus symptoms got much worse. Most concerning was the recurrence of symptoms I had as a teenager, (after an mva, with head and neck injuries) mainly irritation and pressure at the base of the skull, and the right eye feeling strained and pulled upward. This was quite disturbing. I know that people who push for getting the flu shot say it's just a coincidence that people get sick following it. But I fully believe that my experience was a direct result of the vaccine. So now, even with the flu epidemic upon us, I see getting the flu shot to be a greater risk than not getting it. I'm told that the vaccine is only effective for a small percentage of the types of flu, anyway. Patient in office to fill out VAERS form re: flu shot. Alerted us to the fact that she missed work 1/16 and 1/17/13 due to sweats, headache, chills. She did not feel better until 1/23/13 and is not sure if it is related to all the other symptoms she has had since November.
Age: 58.0
Sex: F
Vaccine: FLU3
Symptoms: Sensory disturbance, Sinus disorder
Clinical narrative: Just thought I'd pass along this info to you about symptoms following getting the flu shot. I know it's been quite awhile, now, but I wasn't interested in paying to get a bunch of tests done, and hoped the symptoms would just clear up. About a half hour after receiving the vaccine, I was in the grocery store, thinking about what I was looking at, and suddenly experienced a very strange feeling in my head that I never felt before, and right after that felt like I was about to pass out. I never felt like that before, either. I grabbed onto something, and waited, and the symptoms mostly left up. Since then, at unexpected times, I have short periods of dizzy lightheadedness. Also, later the same day, I started with a lot of headache and neck stiffness, and in the following days, was tired, weak, and aching. My usual mild sinus symptoms got much worse. Most concerning was the recurrence of symptoms I had as a teenager, (after an mva, with head and neck injuries) mainly irritation and pressure at the base of the skull, and the right eye feeling strained and pulled upward. This was quite disturbing. I know that people who push for getting the flu shot say it's just a coincidence that people get sick following it. But I fully believe that my experience was a direct result of the vaccine. So now, even with the flu epidemic upon us, I see getting the flu shot to be a greater risk than not getting it. I'm told that the vaccine is only effective for a small percentage of the types of flu, anyway. Patient in office to fill out VAERS form re: flu shot. Alerted us to the fact that she missed work 1/16 and 1/17/13 due to sweats, headache, chills. She did not feel better until 1/23/13 and is not sure if it is related to all the other symptoms she has had since November.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant concerning a patient of unknown age and gender who was vaccinated in 2006 with dose 1 of GARDASIL (dose, route and lot # not provided) and in 2007 was vaccinated with a second dose of GARDASIL (dose, route and lot # not provided). No adverse events were reported. Additional information has been requested.
Sex: U
Vaccine: VARCEL, VARZOS
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report was received from a vendor refers to unknown patients of unknown age and gender. The vendor reported that one of her customers had a temperature excursion for VARIVAX (Merck) (lot # not reported and ZOSTAVAX (lot # not reported) at unspecified temperatures for an unspecified amount of time. The vendor was unable to specify if any of the doses were administered to patients. Additional information has been requested.
Age: 55.0
Sex: F
Vaccine: FLUX
Symptoms: Chest discomfort, Cough, Throat tightness
Clinical narrative: Severe tightness in throat & chest, coughing. Took 25 mg of BENADRYL got a little better, took another 25 mg and it went away within 45 min to 1 hr. After 2nd dose O2 sat had dropped to 86% then came back up to 98-100.
Age: 78.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Herpes zoster
Clinical narrative: Rec'd shingles vaccine 10/19/2012 came down with shingles 9 days later on 10/28/2012.
Age: 17.0
Sex: M
Vaccine: FLU3
Symptoms: Unevaluable event
Clinical narrative: None stated.
Sex: M
Vaccine: HEP
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a male patient of unknown age. The patient was vaccinated with RECOMBIVAX (lot number 660951/0398X; expiration date 18-NOV-2010) on 21-MAR-2009. Other suspect therapies included VAQTA (lot number not provided). No concomitant medications were reported. On 21-MAR-2009 the patient was suppose to get a second dos eof VAQTA but instead received an adult dose of RECOMBIVAX HB. The patient did not experience any adverse events. Additional information has been requested.
Age: 87.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Erythema, Injection site erythema
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 87 years old female patient with allergy to PNEUMOVAX (MARRS# 1302USA000541) and no pertinent medical history. On 19-JAN-2013 the patient was subcutaneously vaccinated with a 0.65 ml dose of ZOSTAVAX (lot # H018497, exp. date; 10-JAN-2014) for shingles prevention. There was no concomitant medication. It was reported that the following day on 20-JAN-2013 the patient had a "red line" going down her arm from the site of injection about 3.4 inches wide and approximately 3 to 4 inches long. According to the patient the line had not increased in length or width but was still visible. There was no treatment for the event. The patient did not seek medical attention other than call the Pharmacist today, 22-JAN-2013. None lab diagnostics studies were performed. The relatedness for the event was unknown for ZOSTAVAX. This is one of several reports received from the same patient. Additional information has been requested.
Age: 87.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site streaking, Injection site warmth
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 87 years old female patient with allergy to PNEUMOVAX (MARRS# 1302USA000541) and no pertinent medical history. On 19-JAN-2013 the patient was subcutaneously vaccinated with a 0.65 ml dose of ZOSTAVAX (lot # H018497, exp. date; 10-JAN-2014) for shingles prevention. There was no concomitant medication. It was reported that the following day on 20-JAN-2013 the patient had a "red line" going down her arm from the site of injection about 3.4 inches wide and approximately 3 to 4 inches long. According to the patient the line had not increased in length or width but was still visible. There was no treatment for the event. The patient did not seek medical attention other than call the Pharmacist today, 22-JAN-2013. None lab diagnostics studies were performed. The relatedness for the event was unknown for ZOSTAVAX. This is one of several reports received from the same patient. Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Allergy to vaccine
Clinical narrative: This spontaneous report as received from a pharmacist refers to a female patient with no pertinent medical history. On an unknown date the patient was vaccinated with a dose of PNEUMOVAX 23 (manufacture unknown) (lot # not reported). It was reported that on an unknown date the patient was allergic to PNEUMOVAX 23. The outcome of the event was unknown. The relatedness for the event was unknown for PNEUMOVAX 23 (manufacture unknown). This is one of several reports received from the same patient. Additional information has been requested.
Age: 0.33
Sex: M
Vaccine: PNC, RV5
Symptoms: Incorrect route of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist refers to a 4 months old patient. On 05-OCT-2012, the patient was inadvertently vaccinated with a dose of oral ROTATEQ intramuscularly (lot # not reported). No concomitant medications were reported. No adverse effect were reported. It was unspecified if the patient had sought medical attention. Follow up information has been received from a physician refers to the 4 months old male patient (weight 18lb 2.5oz, height: 25in) (birth weight; 8lb6oz). On 05-OCT-2012 at 18:17, the patient was vaccinated with the first dose of oral ROTATEQ orally (lot # 672509/0277AE, exp. date: unspecified date). There was no pre-existing allergies, birth defects, medical conditions. The patient had one sibling. On 05-OCT-2012 at 18:16, the patient was vaccinated intramuscularly with a dose of pneumococcal vaccine (unspecified) (manufactured by Wyeth) orally (lot # F45119, exp. date: unspecified date). There was none illness at time of vaccination. Additional information is not expected.
Age: 12.0
Sex: F
Vaccine: HEPA, MNQ, TDAP, VARCEL
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Local reaction
Clinical narrative: (L) upper arm swelling, red & warmth.
Age: 43.0
Sex: M
Vaccine: PPV
Symptoms: Chills, Injection site erythema, Injection site pain, Injection site swelling, Pyrexia
Clinical narrative: Redness, pain, swelling at injection site 12 hours after injection then developed fever, chills, T102.5 symptoms resolving on day 3 after vaccine.
Age: 4.0
Sex: F
Vaccine: DTAP, MMR
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Day after vaccine about 3 pm got acute lt upper arm redness, pain, swelling, warmth pt seen 1/24 2d after vaccine a recheck 1/25/13.
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Exposure during pregnancy, Pregnancy test urine positive
Clinical narrative: Patient received GARDASIL vaccine on 1/16/13. Pt. had pos. home pregnancy test on 1/17/13 and pos. urine preg. test at clinic on 1/18/13. Had IUD remove 12/11/12. Neg. pregnancy test on 1/9/13.
Age: 73.0
Sex: F
Vaccine: TDAP
Symptoms: Anti-cyclic citrullinated peptide antibody, Antibody test, Antinuclear antibody, Blood creatine phosphokinase, Blood thyroid stimulating hormone
Clinical narrative: Severe muscle pain all over body. Later settled in arms & legs. Right arm (injection site) very painful event after rx of steroids. Started and continues shortly after injection. Pain like a tooth ache. Difficulty getting out of bed and in & out of a car. Various lab work by two doctors-cannot determine cause of pain. Started in the neck & shoulders on left side a few days after injection.
Age: 73.0
Sex: F
Vaccine: TDAP
Symptoms: C-reactive protein, Full blood count, Injection site pain, Metabolic function test, Mobility decreased
Clinical narrative: Severe muscle pain all over body. Later settled in arms & legs. Right arm (injection site) very painful event after rx of steroids. Started and continues shortly after injection. Pain like a tooth ache. Difficulty getting out of bed and in & out of a car. Various lab work by two doctors-cannot determine cause of pain. Started in the neck & shoulders on left side a few days after injection.
Age: 73.0
Sex: F
Vaccine: TDAP
Symptoms: Musculoskeletal pain, Myalgia, Neck pain, Pain in extremity, Red blood cell sedimentation rate
Clinical narrative: Severe muscle pain all over body. Later settled in arms & legs. Right arm (injection site) very painful event after rx of steroids. Started and continues shortly after injection. Pain like a tooth ache. Difficulty getting out of bed and in & out of a car. Various lab work by two doctors-cannot determine cause of pain. Started in the neck & shoulders on left side a few days after injection.
Age: 73.0
Sex: F
Vaccine: TDAP
Symptoms: Rheumatoid factor
Clinical narrative: Severe muscle pain all over body. Later settled in arms & legs. Right arm (injection site) very painful event after rx of steroids. Started and continues shortly after injection. Pain like a tooth ache. Difficulty getting out of bed and in & out of a car. Various lab work by two doctors-cannot determine cause of pain. Started in the neck & shoulders on left side a few days after injection.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Injection site cellulitis
Clinical narrative: Cellulitis (L) deltoid. Treatment ibuprofen BACTRIM.
Age: 0.25
Sex: F
Vaccine: HIBV, PNC13
Symptoms: Dyskinesia, Screaming
Clinical narrative: 5 hours after HIB & PREVNAR had hours of inconsolable screaming, jerking that mom thought was seizure. Went to ER - thought to be screaming & upset no seizure.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Burning sensation, Oedema peripheral, Pain in extremity, Pruritus, Skin warm
Clinical narrative: Underside of (L) arm swelled, was fevered, itched, burned & was extremely painful for 7 days. On day 8 when reaction was reported, the arm still itched & burned.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Post herpetic neuralgia, Rash
Clinical narrative: Had ZOSTAVAX 12/10/2009-1-11-2013 to 2/11/2013 on going pain. Shingles with PHN & rash.
Age: 37.0
Sex: M
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site swelling, Pain, Pyrexia, Rash
Clinical narrative: At injection site swollen/red. Fever. Rash. Body aches.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Pt reported swelling, redness on 1/30/13 on the area ((R) SQ upper arm) where she received a shingles vaccine on 1/29/13. Pt was given per PA 500mg of ceftriaxone IM. Pt tolerated well and is scheduled for a f/up on 1/31/13 for an additional injection & re-evaluation.
Age: 55.0
Sex: F
Vaccine: FLU3
Symptoms: Headache, Herpes zoster, Pain, Rash erythematous
Clinical narrative: Developed shooting pains on left side of face, headache, and had red bumps on face starting on 12/3/12. Developed full blown shingles 12/4/12.
Age: 33.0
Sex: M
Vaccine: TDAP
Symptoms: Pain, Pain in extremity
Clinical narrative: Symptoms of shooting pain in left arm. Progressively worsening until doctor visit. Was prescribed VICODIN and Prednisone treatment by doctor.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist to a 58 years old female patient with no pertinent medical history and drug allergies reported, who on 25-JAN-2013 was vaccinated with 0.65 ml ZOSTAVAX lot # (671610/1164AA) (route not provided). No other co-suspects were reported. No concomitant medications were reported. The Pharmacist stated that there was any adverse effects reported at this time. Additional information has been requested. 04-Feb-2013: This is an amended report. Potential Lot box checked as no in Product Details.
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Pruritus, Rash, Urticaria
Clinical narrative: Rash & urticaria, pruritus.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Muscular weakness, Pain in extremity
Clinical narrative: Pain and weakness in arm down to hands reported to us on 1/31, started soon after vaccine, was already getting better. Upon rechecks on 2/1/13 and 2/3/13 patient was much better, (slight pain, full movement).
Age: 1.56
Sex: M
Vaccine: HEPA
Symptoms: Crying, Diarrhoea, Pyrexia, Respiratory tract congestion, Urticaria
Clinical narrative: 1-28-13 rec'd Hep A vaccine. 1-29-13 woke up with chest congestion. 1-30-13 diarrhea. 1-31-13 crying, fever 101.4 gave TYLENOL q 4 hours. 2-1-13 fever broke. 2-2-13 hives (gave BENADRYL). 2-4-13 hives gone.
Age: 0.1
Sex: F
Vaccine: HEP
Symptoms: Tonic convulsion
Clinical narrative: Patient 2 to 3 hour after receiving Hep B vaccine got tonic seizure at home per mother lasted for 30 to 60 seconds & happened again next day in the morning.
Age: 1.01
Sex: M
Vaccine: HEPA, MMR, PNC, VARCEL
Symptoms: Crying
Clinical narrative: 6 days after PREVNAR, MMR, VARIVAX, Hep A - uncontrollable crying, persistent.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: 24 hours after vaccine admin, pt experienced erythema, induration, warm to touch around admin site.
Age: 1.08
Sex: F
Vaccine: PNC13
Symptoms: Crying, Hypotonia, Pallor
Clinical narrative: After vaccination mother & MA reported that child had breath while crying and went limp/closed yes and became pale. Aroused immediately, cried more but remained pale. Re-examined w/ clear lung sounds & normal heart.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Oedema peripheral
Clinical narrative: Patient administered ZOSTAVAX 1/18/13. Stated at visit 1/21/13 that her arm had a large area of redness and swelling at the time of the 1/21 visit the redness/swelling markedly better.