chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: TDAP
Symptoms: Dysarthria, Dyspnoea, Reflexes abnormal
Clinical narrative: Initial unsolicited report received from non-healthcare professional (office staff) on 17 April 2015. A female patient, whose age, medical history and concomitant medication were not reported, had received a dose of ADACEL (batch number: U5081AA, expiration date: 25 June 2017, dose, dose cycle, route and site of administration were not reported) on an unspecified date. On unspecified date, 2 hours after vaccination patient had experienced slurred speech, jerky reflexes, and shortness of breath. It was reported that, patient's parents took the patient to the emergency room (ER) for follow up. Laboratory investigation and corrective treatment were not reported. At the time of this report, outcome of the event were unknown. List of the document held by sender: None. Follow up report received from non-healthcare professional (office staff) on 27 July 2015. No new information reported. Documents held by sender: none.
Age: 62.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site bruising, Injection site erythema
Clinical narrative: Initial unsolicited report received from a healthcare professional (PharmD) on 04 May 2015. A 62-year-old female patient, whose concomitant medications were not reported, had received an intramuscular dose of ADACEL (batch number C4774AA) into left deltoid on 30 April 2015. The patient did not have any known allergy. On 30 April 2015, same day after vaccination, the patient experienced approximately 4 inch diameter at injection site of redness, bruising and erythema. The patient did not experience pain at site or other symptoms. Laboratory investigations and corrective treatments were not reported. At the time of this report outcome of events were unknown. Documents held by sender: none.
Age: 46.0
Sex: F
Vaccine: TDAP
Symptoms: Diarrhoea, Headache, Injection site bruising, Injection site induration, Injection site pain
Clinical narrative: Initial unsolicited report received consumer on 4 May 2015. A female patient, who had medical history of Formaldehyde allergy and concomitant medications were not reported, received a dose of ADACEL (batch number -C4714AA, route of administration was not reported) on 23 April 2015. The patient has no illness at the time of vaccination. On 23 April 2015, few hours after vaccination, the patient experienced right upper arm bruising, soreness, hard area at injection site and hot to touch area at injection site. Patient also stated that for next several days she continued with right upper arm bruising, arm soreness, arm stiffness and also had headache, diarrhea, vomiting and all over body soreness. Laboratory investigations and corrective treatments were not reported. On an unspecified date, the patient recovered from the events body soreness, headache, diarrhea, and vomiting resolved but was still persisting with upper arm bruising, soreness, stiffness. As of 5 April 2015, the patient had not recovered from all the events. Documents held by sender: none. Follow-up report received from a physician on 22 June 2015. A 46 year old female patient had received 0.5 ml second intramuscular dose of ADACEL. On an unspecified date the patient had received first dose of ADACEL. List of documents held by sender: none.
Age: 46.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site warmth, Musculoskeletal stiffness, Pain, Vomiting
Clinical narrative: Initial unsolicited report received consumer on 4 May 2015. A female patient, who had medical history of Formaldehyde allergy and concomitant medications were not reported, received a dose of ADACEL (batch number -C4714AA, route of administration was not reported) on 23 April 2015. The patient has no illness at the time of vaccination. On 23 April 2015, few hours after vaccination, the patient experienced right upper arm bruising, soreness, hard area at injection site and hot to touch area at injection site. Patient also stated that for next several days she continued with right upper arm bruising, arm soreness, arm stiffness and also had headache, diarrhea, vomiting and all over body soreness. Laboratory investigations and corrective treatments were not reported. On an unspecified date, the patient recovered from the events body soreness, headache, diarrhea, and vomiting resolved but was still persisting with upper arm bruising, soreness, stiffness. As of 5 April 2015, the patient had not recovered from all the events. Documents held by sender: none. Follow-up report received from a physician on 22 June 2015. A 46 year old female patient had received 0.5 ml second intramuscular dose of ADACEL. On an unspecified date the patient had received first dose of ADACEL. List of documents held by sender: none.
Age: 67.0
Sex: M
Vaccine: TDAP
Symptoms: Inappropriate schedule of drug administration, Pain in extremity
Clinical narrative: Initial unsolicited report received from a physician on 29 May 2015. A 67-year-old male patient, whose concomitant medications were not reported, had received an second injection of ADACEL (batch number and site of administration were not reported) via intramuscular route on 20 May 2015. Patient's illness at the time of vaccination involved lacerations and injuries due to car accident. Pre-existing physician diagnosed allergies, birth defects, medical condition was reported as "none chronic back". Patient had received ADACEL vaccine only previously 2 months prior on unspecified date. On 20 May 2015, same day after vaccination, the patient experienced arm pain. It was vaccine administration interval too short. Laboratory investigations were reported as none. Corrective treatments were not reported. Patient required ER/doctor visit. And the patient was advised to see a neurologist. At the time of this report, the patient was not recovered from the event. Documents held by sender: none.
Age: 37.0
Sex: M
Vaccine: TDAP
Symptoms: Muscle twitching
Clinical narrative: Initial unsolicited report received from a non-healthcare professional on 12 June 2015. A 37-year -old male patient, whose medical history was none and concomitant medications was not reported, had received a dose of ADACEL (batch number U5213BA and expiry:02-DEC-2017) via unspecified route and site of administration on 11 June 2015. No information about prior exposure to vaccine was provided. It was reported that, on 12 June 2015 (one day after vaccination), the patient experienced twitching of arm and reported twitching in arm occurs three times in a row in an hour and is happening once an hour. Laboratory investigations and corrective treatments were not reported. At the time of this report, the patient outcome from the event was not recovered. Documents held by sender: none.
Age: 43.0
Sex: M
Vaccine: TDAP
Symptoms: Chills, Hyperaesthesia, Inappropriate schedule of drug administration, Myalgia, Pain
Clinical narrative: Initial unsolicited report received from a pharmacist on 12 June 2015. A 43-year-old male patient, whose medical history and concomitant medications were not reported, had received a second dose of ADACEL (batch number- C4774AA, expiry date-15 July 2017, route and site of administration was not reported) on 07 May 2015. As patient received ADACEL vaccine within a few months of a previous dose of Tdap vaccine, it was an inappropriate schedule in drug administration. Patient had previously received a dose of Tdap vaccine. Illness at time of vaccination was not reported. On 08 May 2015, one day post vaccination, the patient was seen in emergency room for chills, myalgia, pain and hyperthesia. Laboratory investigations and corrective treatments were not reported. Patient required ER/doctor visit. At the time of this report, outcome of the events was unknown. Documents held by sender: none.
Age: 64.0
Sex: U
Vaccine: TDAP
Symptoms: Skin abrasion
Clinical narrative: Initial unsolicited report received from a physician on 03 September 2015. This case is linked to 2014SA030217. (same reporter). This case involves a [age and gender unknown] patient who was vaccinated with a [dose unknown] intramuscularly [dose in series unknown] dose of ADACEL (batch number U4825AA, expiry date was not reported) in the right deltoid on 03 March 2015. The patient medical history and concomitant medications were not reported. On an unspecified date, following the vaccination, the patient experienced abrasion of forearm. Lab data and corrective treatment was not reported. The outcome of event was not reported. List of documents held by sender: none.
Age: 48.0
Sex: M
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site reaction, Injection site swelling, Injection site warmth
Clinical narrative: Initial unsolicited report received from a physician on 23 September 2015. This case involves a 48 years old male patient who was vaccinated with a dose of ADACEL (batch number:U5209AA), (dose, dose number were unknown) via intramuscular route in the left deltoid on 21 September 2015. The patient's medical history and concomitant medications were unknown. It was reported that, on 23 September 2015 (2 days after vaccination) the patient had the following events: large, red, swollen, warm to touch, painful area of upper left arm to shoulder with a fine, macular and light red rash at same area of left arm. Lab data was unknown. It was reported that patient was treated with NSAIDS as corrective treatment. The outcome of the events fine, macular, light red rash at same area of left arm and large, red, swollen, warm to touch, painful area of upper left arm to shoulder were not recovered. The patient was advised for ER/doctor visit and the physician had ruled out cellulitis. List of documents held by sender: none.
Age: 48.0
Sex: M
Vaccine: TDAP
Symptoms: Rash macular
Clinical narrative: Initial unsolicited report received from a physician on 23 September 2015. This case involves a 48 years old male patient who was vaccinated with a dose of ADACEL (batch number:U5209AA), (dose, dose number were unknown) via intramuscular route in the left deltoid on 21 September 2015. The patient's medical history and concomitant medications were unknown. It was reported that, on 23 September 2015 (2 days after vaccination) the patient had the following events: large, red, swollen, warm to touch, painful area of upper left arm to shoulder with a fine, macular and light red rash at same area of left arm. Lab data was unknown. It was reported that patient was treated with NSAIDS as corrective treatment. The outcome of the events fine, macular, light red rash at same area of left arm and large, red, swollen, warm to touch, painful area of upper left arm to shoulder were not recovered. The patient was advised for ER/doctor visit and the physician had ruled out cellulitis. List of documents held by sender: none.
Sex: F
Vaccine: TDAP
Symptoms: Vaccination complication
Clinical narrative: Initial unsolicited report received from a Consumer on 10-Nov-2015. This case involves a patient (age and gender was not reported) who was vaccinated with a dose of ADACEL (batch number, expiry date and site of administration was not reported) on an unspecified date. Medical history and concomitant medications were not reported. On an unspecified date, after vaccination, patient experienced reaction to ADACEL. Laboratory investigations and corrective treatments were not reported. On unspecified date, outcome of the event was not reported. Documents held by sender: none.
Age: 30.0
Sex: F
Vaccine: TDAP
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: Initial unsolicited pregnancy report received from a non-healthcare professional on 22 December 2015. This case involves a 30-years old female patient who was vaccinated with first dose of ADACEL (batch number: U5263AA, Expiry Date: 21 January 2018; dose and site of administration were not reported) via intramuscular route on 22 December 2015. The patient's last menstrual period was unknown, estimated delivery date reported as 02 March 2016 and treatment for infertility was reported as none. The patient's medical history and concomitant medications were not reported. She did not undergo any specific risk factors (e.g.: alcohol, tobacco or recreational drugs). It was a vaccine exposure during pregnancy. Laboratory data was not reported and corrective treatment was not reported. The patient did not experience any adverse event. Documents held by sender: none. Follow up information received from consumer on 15 March 2016. No additional information reported.
Sex: F
Vaccine: TDAP
Symptoms: Injection site nodule, Injection site reaction, Pain, Pain in extremity
Clinical narrative: Initial unsolicited report received from a non-healthcare professional on 23 December 2015. This case involves a female patient (age was not reported) who was vaccinated with a dose of ADACEL (lot number was reported as unknown, expiration date, dose, dose in series, route and site of administration was not reported) on 09 December 2015. Illness at time of vaccination and Pre-existing physician diagnosed allergies, birth defects, medical conditions were reported as unknown. Any other vaccination within four weeks of vaccinations was reported as unknown. On 18 December 2015, nine days after the vaccination, (reported as approximately 10 days after vaccination) the patient experienced sharp, shooting pain from injection site to wrist which had not subsided and deep knot at injection site, pharmacist was unable to palpate knot. No redness, erythema or numbness to arm. Lab data and corrective treatments were not reported. The patient was not recovered from sharp, shooting pain from injection site to wrist. Outcome of deep knot at injection site was reported as unknown. List of documents held by sender: none.
Age: 32.0
Sex: F
Vaccine: TDAP
Symptoms: Feeling abnormal, Headache, Malaise, Pain in extremity, Pyrexia
Clinical narrative: Initial unsolicited report received from a pharmacist on 28 December 2015. This case involves a 32-year-old female patient who was vaccinated with a dose of ADACEL (batch number: UI288AA, dose, dose in series, site of administration were not reported) intramuscularly on 08 November 2015. The patient's medical history and concomitant medications were not reported. On 08 November 2015, same day following the vaccination, the patient had developed sore arm, low grade fever, malaise/felt poorly and had headache (2 times). It was unaware whether the patient had medical care. Laboratory data and corrective treatment was not reported. The outcomes of the events were unknown. List of documents held by sender: none. Follow up information received from a pharmacist on 19 February 2016. No additional information provided.
Age: 14.0
Sex: M
Vaccine: HEP, HEPA, MNQ, TDAP
Symptoms: Diabetes mellitus, Herpes zoster, Malaise, Pain in extremity
Clinical narrative: SERIOUSNESS CRITERIA: IMPORTANT MEDICAL EVENT Initial unsolicited report received from a consumer (patient) on 06 April 2016. This case involves 14-year-old male patient who was vaccinated with a dose of MENACTRA (batch number and site of administration not reported) intramuscularly, dose of TDAP (batch number, route and site of administration not reported), a dose of HEPATITIS A VACCINE (batch number, route and site of administration not reported) and dose of HEPATITIS B VACCINE (batch number, route and site of administration not reported) on an unspecified date in 2006. Illness at time of vaccination and pre-existing physician diagnosed allergies, birth defects, medical conditions was reported as unknown. The patient's medical history and concomitant medications were not reported. On an unspecified date in 2006, same day following the vaccination, the patient's arm was sore. seven days later, the patient was diagnosed with shingles. The patient felt sick and diagnosed with diabetes on an unspecified date. The patient required ER/doctor visit. Laboratory data and corrective treatment were not reported. The patient was not recovered from events. Upon internal review the case was considered as serious because of important medical event diabetes. List of documents held by sender: none.; Sender's Comments: Diabetes mellitus, Pain in extremity and Herpes zoster are unlisted for MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE. Time to onset is not compatible with the role of the vaccine. This case is not sufficiently documented. Additional information including time to onset after vaccination, previous medical history particularly chicken pox, concomitant medications, and immune status at the time of vaccination is needed to further assess this case. Based on the available information, the role of vaccine cannot be assessed.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Abnormal behaviour, Decreased appetite, Electroencephalogram normal, Vomiting, Weight decreased
Clinical narrative: Started vomiting and not eating well. ER 4/5 to r/o intussusception > sent home. Worsened over the next day > sent back to the ER > admitted 4/6/2006 until 4/9/2016.  Discharged home > f/u in the office 4/11 significant wgt loss and still not eating well and not smiling.  Follow up on 4/13 > still not eating well but more alert but not smiling > sent for EEG on Friday 4/15/2016 which was normal and was pretty much back to baseline in terms of eating and smiling.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Redness and swelling at injection site and warm to touch.
Age: 52.0
Sex: F
Vaccine: MENB
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 52-year-old female patient who received BEXSERO (batch number 146101D, expiry date 30th April 2016). On 7th April 2016, the patient received BEXSERO .5 ml. On 7th April 2016, less than a day after receiving BEXSERO, the patient experienced injection site pain, injection site warmth and injection site erythema. On an unknown date, the outcome of the injection site pain, injection site warmth and injection site erythema were not recovered/not resolved. It was unknown if the reporter considered the injection site pain, injection site warmth and injection site erythema to be related to BEXSERO. Additional details were received as follows: The reporter called to report that a female adult patient received her second dose of BEXSERO on 7th April 2016 and experienced a painful, hot-to-the-touch two inch in diameter raised red mark below the injection site in the subcutaneous area. The patient called the clinic this morning, and had an appointment with the physician at the clinic on the day of reporting, and the painful event has not yet resolved.
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse regarding 3 patients of unknown demographics. There was no information about concurrent condition and historical medication. On approximately 10-MAR-2016, 5 weeks ago, the patient was vaccinated with GARDASIL 9 dose 1. Since the patients were in the office she stated that they would like to administer the second dose today that was on 14-APR-2016. No adverse event was reported. The outcome of the event was unknown. Additional information is not expected because patient does not wants to get contacted.
Sex: F
Vaccine: HEP
Symptoms: Anaphylactic reaction, Angioedema, Urticaria
Clinical narrative: Information has been received from a pharmacist referring to a currently 44 year old female patient who was allergic to oxycodone. On an unknown date the patient was vaccinated with an unspecified Hepatitis B vaccine (manufacturer unknown) (dose and route were not reported). On an unknown date, an unspecified time after receiving the Hepatitis B vaccine (manufacturer unknown), the patient experienced an anaphylactic reaction that she described as angioedema and hives. The patient sought medical attention by seeing an unspecified physician. The patient recovered from the event on an unknown date. Additional information has been requested.
Age: 36.0
Sex: M
Vaccine: HEPAB
Symptoms: Erythema, Mouth swelling, Pharyngeal oedema, Pruritus, Urticaria
Clinical narrative: Hives, itching, redness, swelling of mouth and throat.
Age: 9.0
Sex: F
Vaccine: HPV9
Symptoms: Head injury, Seizure, Syncope
Clinical narrative: After pt. received shot, she stood up started moving around and proceeded to collapse mother caught her and laid her on the ground and pt bumped her head and went into a seizure lasting aprox 20-30 seconds, signs of breathing and pulse pt was turned to her side. Ambulance was called and pt was taken to Hosp.
Age: 23.0
Sex: F
Vaccine: IPV, TYP, YF
Symptoms: Headache, Pain, Photophobia, Tenderness
Clinical narrative: T 98.1. From student health center from 4/4/2016: Headache/tenderness at base of skull began within a few hours of receiving immunizations on 3/25/2016. Intensity of headaches waxes and wanes, but never resolves (baseline pain 6 on 0-10 scale). Headache increases when she flexes her neck. Also has sensitivity to light when headache is at its worst. Tried ADVIL and TYLENOL with very minimal effect. Evaluated by this provider on 4/4/2016 - no signs of meningeal irritation. Headaches continue but not worse. On 4/7/2016 pt reported by phone that pain is sl improved (baseline is 3 on 0-10 scale); getting some relief w/ EXEDRIN (APAP w/ caffeine). Pt seen for another reason on 4/11/2016; reported headache improving slowly (2.5 on 0-10 scale).
Age: 0.37
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5, DTAPIPVHIB, PNC13, RV5
Symptoms: Abdominal X-ray, Diarrhoea, Intussusception, X-ray abnormal
Clinical narrative: Pt got vaccines on 4/7. Developed intussusception on 4/9. VIS says that diarrhea is supposed to start 7 days after vaccine. Her diarrhea started 2 days later.
Age: 0.37
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5, DTAPIPVHIB, PNC13, RV5
Symptoms: Diarrhoea, Nausea, Vomiting
Clinical narrative: Pt got vaccines on 4/7. Developed intussusception on 4/9. VIS says that diarrhea is supposed to start 7 days after vaccine. Her diarrhea started 2 days later.
Age: 2.0
Sex: M
Vaccine: PNC13, VARCEL
Symptoms: Discomfort, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: 4-7-16 mom called and spoke with interpreter. She reports (R) thigh swollen, red and tender to the touch. This began 4-6-16 in the am - unsure what time she noticed it. No fever. Advised TYLENOL or ADVIL per age/wt for discomfort. Cool cloth today to site follow with warm cloth tomorrow to site.
Age: 54.0
Sex: F
Vaccine: FLU3
Symptoms: Balance disorder, Eye pain, Facial pain, Fall, Fatigue
Clinical narrative: On 3-29-14 it started with tingling and numbness in my hands and feet.  Over the next week, I had pain in my face and when I moved my eyes. Was unsteady on my feet and beginning to fall. I went to the doctors a few different times and finally after another trip to the Drs. they decided I had GBS. 4-9-14 they sent me to the hospital. I was there for 3 days and sent me home and said it was not GBS. Once I saw an Orthopedic Dr. on 4-14-14 they sent me to a Neurologist who diagnosed me with GBS, and sent me back to the hospital on 4-15-14. I remained there until May 1-2014. It's now 4-5-16 and still have weakness in my legs and still have extreme fatigue.
Age: 54.0
Sex: F
Vaccine: FLU3
Symptoms: Guillain-Barre syndrome, Hypoaesthesia, Muscular weakness, Paraesthesia
Clinical narrative: On 3-29-14 it started with tingling and numbness in my hands and feet.  Over the next week, I had pain in my face and when I moved my eyes. Was unsteady on my feet and beginning to fall. I went to the doctors a few different times and finally after another trip to the Drs. they decided I had GBS. 4-9-14 they sent me to the hospital. I was there for 3 days and sent me home and said it was not GBS. Once I saw an Orthopedic Dr. on 4-14-14 they sent me to a Neurologist who diagnosed me with GBS, and sent me back to the hospital on 4-15-14. I remained there until May 1-2014. It's now 4-5-16 and still have weakness in my legs and still have extreme fatigue.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Abdominal pain upper, Decreased appetite, Dizziness, Electrocardiogram normal, Fatigue
Clinical narrative: This case was reported by a consumer and described the occurrence of passed out in a 17-year-old female patient who received BEXSERO. On 30th March 2016, the patient received BEXSERO. On 8th April 2016, 9 days after receiving BEXSERO, the patient experienced passed out (serious criteria GSK medically significant), nausea, dizziness and fainting. On 9th April 2016, the patient experienced appetite absent, stomach pain and tiredness. On an unknown date, the outcome of the passed out, nausea, dizziness, fainting, appetite absent, stomach pain and tiredness were unknown. It was unknown if the reporter considered the passed out, nausea, dizziness, fainting, appetite absent, stomach pain and tiredness to be related to BEXSERO. Additional details were received as follows: This case was reported by the patient's mother. On 08 April 2016, 9 days after the vaccination, the patient experienced nausea, dizziness and passed out or fainted for two minutes. The mother took the patient to the emergency room. In emergency room, they did Electrocardiogram and urine test. No findings were observed. On 09 April 2016, the patient was still experiencing nausea, did not want to eat, stomach ache and very tired. In the emergency room, the mother did not remember to tell the physicians that, the patient had received a dose of BEXSERO. When she remembered the vaccine administration, she called the nurse's line and they advised the events were from BEXSERO. The mother of the patient wanted to know how long the side effects would continue.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Loss of consciousness, Nausea, Syncope, Urine analysis normal
Clinical narrative: This case was reported by a consumer and described the occurrence of passed out in a 17-year-old female patient who received BEXSERO. On 30th March 2016, the patient received BEXSERO. On 8th April 2016, 9 days after receiving BEXSERO, the patient experienced passed out (serious criteria GSK medically significant), nausea, dizziness and fainting. On 9th April 2016, the patient experienced appetite absent, stomach pain and tiredness. On an unknown date, the outcome of the passed out, nausea, dizziness, fainting, appetite absent, stomach pain and tiredness were unknown. It was unknown if the reporter considered the passed out, nausea, dizziness, fainting, appetite absent, stomach pain and tiredness to be related to BEXSERO. Additional details were received as follows: This case was reported by the patient's mother. On 08 April 2016, 9 days after the vaccination, the patient experienced nausea, dizziness and passed out or fainted for two minutes. The mother took the patient to the emergency room. In emergency room, they did Electrocardiogram and urine test. No findings were observed. On 09 April 2016, the patient was still experiencing nausea, did not want to eat, stomach ache and very tired. In the emergency room, the mother did not remember to tell the physicians that, the patient had received a dose of BEXSERO. When she remembered the vaccine administration, she called the nurse's line and they advised the events were from BEXSERO. The mother of the patient wanted to know how long the side effects would continue.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to two unspecified patients of unknown age and gender. There was no information about the patients' pertinent medical histories, concomitant medications and drug reactions or allergies reported. On an unknown dates, two patients were vaccinated with an improperly stored doses of ROTATEQ (lot# L010844, expiration date 16-NOV-2016, dose was not reported; orally). No adverse effects were reported. Temperature 34.9 Fahrenheit with time frame 3 hours, data logger was involved and there was no previous temperature excursion reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to two unspecified patients of unknown age and gender. There was no information about the patients' pertinent medical histories, concomitant medications and drug reactions or allergies reported. On an unknown dates, the two patients were vaccinated with an improperly stored doses of VAQTA (lot# L018499, expiration date 25-FEB-2017, dose, anatomical location and route of administration were not reported). No adverse effects were reported. Temperature was 34.9 Fahrenheit with time frame 3 hours data logger was involved and there was no previous temperature excursion reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a pharmacist via company representative refers to a male patient in his seventies. There was no information about the patient's pertinent medical history, concomitant medications and drug reactions or allergies reported. On an unknown date, reported as "a while ago - over a year ago, but less than two years ago", the patient was vaccinated with ZOSTAVAX injection (lot#, expiration date, dose and anatomical location were not reported) subcutaneously to prevent shingles. On an unknown date, an unspecified time after vaccination, the patient experienced a case of the shingles. The treatment was given and included an unspecified pain medication. The reporter also stated that the therapy was continued. The outcome of the event was reported as recovered (on an unknown date). The patient sought medical attention and went to an unspecified physician. The relatedness between the event and the ZOSTAVAX was not reported. Additional information has been requested.
Age: 22.0
Sex: F
Vaccine: HEP, MMR, TDAP
Symptoms: Dizziness, Hyperhidrosis, Hyperreflexia, Loss of consciousness, Nausea
Clinical narrative: Pt had vaso-vagal reaction, after being given 3 vaccines. Tdap L Deltoid, MMR (neg preg test) LUA, Hep B R Deltoid. Became diaphoretic, blacked out for few seconds. When face patted she opened her eyes with startled reflex and followed commands appropriately. Patient had a vaso-vagal reaction to vaccine administration. She was given 3 vaccines on Friday 4/15/2016 at 16:45. Administered Tdap vaccine to left deltoid, then given MMR vaccine in left upper arm after performing pregnancy test, which was negative. During administration of Hepatitis B vaccine in right deltoid patient became diaphoretic and blacked out a second. She would breath deep when advised and would open eyes on command, but would close them again. When nurse patted pts face she opened eyes with startled reflex and became responsive. She was assisted to a exam room and was assisted to lying down position with cool wet cloth to face and neck. Pt was talking coherently during this time. Pt c/o feeling nausea and dizziness. She was assisted to a reclining chair where we could raiser her feet up. She asked to see the VIS papers again. She asked if her face was swelling and then began to complain of feeling as if her throat was closing. At this time her vitals were taken and WNL, P. 68, 02 sat was 100% and patient continued to talk. She was given water and GATORADE and appeared to be swallowing liquids without difficulty. After about 45 minutes, patient was advised she would need to call someone to pick her up as she would not be able to drive or return to work after having this event. She caller her father and he came to driver her home. He was instructed to monitor her and is she was not better within a few hours to take her to the emergency room and explain she was given 3 vaccines and show them the VIS sheets so they would know what she was given. He verbalized understanding a compliance. Pt was escorted to car via wheelchair. VAERS was completed and sent to CDC.
Age: 22.0
Sex: F
Vaccine: HEP, MMR, TDAP
Symptoms: Presyncope, Swelling face, Throat tightness
Clinical narrative: Pt had vaso-vagal reaction, after being given 3 vaccines. Tdap L Deltoid, MMR (neg preg test) LUA, Hep B R Deltoid. Became diaphoretic, blacked out for few seconds. When face patted she opened her eyes with startled reflex and followed commands appropriately. Patient had a vaso-vagal reaction to vaccine administration. She was given 3 vaccines on Friday 4/15/2016 at 16:45. Administered Tdap vaccine to left deltoid, then given MMR vaccine in left upper arm after performing pregnancy test, which was negative. During administration of Hepatitis B vaccine in right deltoid patient became diaphoretic and blacked out a second. She would breath deep when advised and would open eyes on command, but would close them again. When nurse patted pts face she opened eyes with startled reflex and became responsive. She was assisted to a exam room and was assisted to lying down position with cool wet cloth to face and neck. Pt was talking coherently during this time. Pt c/o feeling nausea and dizziness. She was assisted to a reclining chair where we could raiser her feet up. She asked to see the VIS papers again. She asked if her face was swelling and then began to complain of feeling as if her throat was closing. At this time her vitals were taken and WNL, P. 68, 02 sat was 100% and patient continued to talk. She was given water and GATORADE and appeared to be swallowing liquids without difficulty. After about 45 minutes, patient was advised she would need to call someone to pick her up as she would not be able to drive or return to work after having this event. She caller her father and he came to driver her home. He was instructed to monitor her and is she was not better within a few hours to take her to the emergency room and explain she was given 3 vaccines and show them the VIS sheets so they would know what she was given. He verbalized understanding a compliance. Pt was escorted to car via wheelchair. VAERS was completed and sent to CDC.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report was received from a healthcare worker who was referring to an unspecified number of patients of unknown ages and genders. The patients' concurrent conditions and medical histories were not reported. On unknown dates, the patients were vaccinated with unspecified number of inappropriate stored doses of GARDASIL 9 which had a lot # of L019297 and an expiration date of 18-AUG-2017 (routes, concentrations, doses and anatomical places of vaccination were not reported). The doses of GARDASIL 9 were stored at 32.5 degrees F for 68 hours without previous excursion. No product quality complaint was involved. Additional information has been requested.
Age: 51.0
Sex: F
Vaccine: HEPAB, MMR
Symptoms: Injection site erythema, Injection site mass, Injection site pain, Injection site pruritus, Injection site warmth
Clinical narrative: Patient walked into health dept to report she was seen at urgent care by A.P.N. and was treated with antibiotics x 7 days and steroid dose pack for her left arm where she received vaccine, area is still hot, red, itchy and lumpy area over vaccination area. Pt. was seen at urgent care for this red painful arm.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Pruritus, Rash, Skin burning sensation
Clinical narrative: Rash on left arm. Burns and itches. Vaccine administered in left arm.
Age: 22.0
Sex: F
Vaccine: TDAP, TYP
Symptoms: Seizure
Clinical narrative: I received a phone call at approximately 1:20 pm from the patient's mother stating that she had woken from a nap having a seizure. Patient was taken to ER and had another seizure there.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse, referring to unspecified patients of unknown ages and genders. Medical history or concurrent conditions were not reported. On unspecified dates, the patients were vaccinated with improperly stored doses of PROQUAD (Merck) (which had the lot number L042818, expiration date 26-APR-2017) (strength, dose and route were not reported). Concomitant medication was not provided. Additionally no adverse effects were reported. It was also reported that the temperature was -8.9 degrees C, in a time frame of 33 hours and 19 minutes, there was not previous temperature excursion and there was not product quality complaint involved. This is one of several cases from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse, referring to unspecified patients of unknown ages and genders. Medical history or concurrent conditions were not reported. On unspecified dates, the patients were vaccinated with improperly stored doses of VARIVAX (which had the lot number L028277, expiration date 28-JUL-2017) (strength, dose and route were not reported). Concomitant medication was not provided. Additionally no adverse effects were reported. It was also reported that the temperature was -8.9 degrees C, in a time frame of 33 hours and 19 minutes, there was not a previous temperature excursion and there was not product quality complaint involved. This is one of several cases from the same reporter. Additional information has been requested.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus, Rash, Varicella
Clinical narrative: Mild dose of chickenpox - rash on belly - chest - back - top of arms and butt. Some have pus in the center and itch. It's still there and some new ones. "BENADRYL" for itch.
Age: 72.0
Sex: F
Vaccine: PNC13
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient receive 2 dosed of PREVNAR 13 3 months apart. No physical reaction to this immunization.
Age: 75.0
Sex: F
Vaccine: PNC13
Symptoms: Contusion, Erythema, Malaise, Skin warm, Urticaria
Clinical narrative: Red, bruising, warm, hives, malaise. Pt. tried taking BENADRYL, but no improvement. Pt. was started on cephalexin 500 mg, 1 cap qid x 7 days.
Age: 1.25
Sex: F
Vaccine: DTAP, HEPA, HIBV
Symptoms: Vomiting
Clinical narrative: Vomiting after vaccine given.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Swelling face, Throat irritation
Clinical narrative: Family reports acute onset facial swelling and scratchy throat within hours of HPV vaccine, required ED visit. Also c/o lightheadedness.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Injection site erythema, Injection site pruritus, Injection site swelling, Nodule
Clinical narrative: Arm red, swollen, itching from injection site to shoulder (elbow to shoulder). Pt has headache. Knot in arm.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site vesicles
Clinical narrative: Redness, swelling, itching, blistering around injection site.
Age: 23.0
Sex: F
Vaccine: HPV9
Symptoms: Chills, Headache, Pain in extremity, Pyrexia
Clinical narrative: Day after receiving third GARDASIL 9 had (L) arm soreness, fever, chills, headache.
Age: 20.0
Sex: F
Vaccine: MENB
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Hypoaesthesia, Vaccination failure
Clinical narrative: This spontaneous report as received from a pharmacist via field employee refers to a 72 year old female patient, who was a family member of the reporting pharmacist. No concurrent conditions, medical history or allergy/drug reactions were reported. On an unknown date, the patient was vaccinated with ZOSTAVAX (dosing details, lot #, expiry and route of administration were not reported). No concomitant medication was reported. About 3 months later the patient developed shingles on an unspecified date in the "March to April time frame", and then on an unknown date the patient developed "numbness" at an unspecified location. The outcome of numbness was not recovered (reported as patient was still experiencing numbness) and the outcome of shingles was unknown. The reporter did not provide the causality between the event and the suspect therapy. There were no product quality complaints (PQC) involved. Additional information has been requested.
Age: 94.0
Sex: F
Vaccine: PNC13
Symptoms: Contusion, Erythema, Joint range of motion decreased, Musculoskeletal pain, Oedema
Clinical narrative: Resident had developed a small bruises (approx. 2 cm diameter) after receiving PREVNAR injection around 3-15-16. This brownish colored bruise remains on arm. Resident also has c/o right upper arm and shoulder pain on and off since injection, which is severe at time and affects her range of motion to the arm and shoulder. At this time there is yellowish discoloration to the area with a 24.8 x 22.0 cm light reddish/purple area just below yellow area. There is also some edema.
Age: 94.0
Sex: F
Vaccine: PNC13
Symptoms: Pain in extremity, Skin discolouration, Yellow skin
Clinical narrative: Resident had developed a small bruises (approx. 2 cm diameter) after receiving PREVNAR injection around 3-15-16. This brownish colored bruise remains on arm. Resident also has c/o right upper arm and shoulder pain on and off since injection, which is severe at time and affects her range of motion to the arm and shoulder. At this time there is yellowish discoloration to the area with a 24.8 x 22.0 cm light reddish/purple area just below yellow area. There is also some edema.
Sex: U
Vaccine: VARZOS
Symptoms: Local reaction
Clinical narrative: This spontaneous report was received from a pharmacist via company representative regarding multiple unspecified patients of unknown age. There was no information about concurrent condition and historical medication. On an unknown date the patients was vaccinated with ZOSTAVAX. No concomitant medication was reported. On an unknown date the patients experienced local reactions. The outcome of local reactions was unknown. Causality was unknown. Additional information has been requested.
Sex: F
Vaccine: FLU3
Symptoms: Influenza, Vaccination failure
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of vaccination failure in a adult female patient who received Influenza vaccine. On an unknown date, the patient received Influenza vaccine at an unknown dose. On an unknown date, less than a year after receiving Influenza vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and influenza. On an unknown date, the outcome of the vaccination failure and influenza were unknown. It was unknown if the reporter considered the vaccination failure and influenza to be related to influenza vaccine. Additional details were received as follows: The GSK field sales representative was speaking with a nurse practitioner (patient) and during the conversation, the patient told that she received the flu shot for this flu season and just recently experienced the flu. The representative asked the patient if she tested positive for the flu and the nurse said she did not get tested, but she just knew she had the flu. The representative did not have any information on what flu vaccine she was given or any other details. No other information was provided and not all questions asked. The adverse event was determined after call. This case was considered as suspected vaccination failure because the time to onset and confirmatory lab test results for flu was not provided.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: This spontaneous prospective pregnancy report was received from a certified medical assistant concerning a 19 year old female patient with no drug reactions/allergies. The patient's concurrent conditions and medical history were not reported. The patient went to see her gynecologist (name unspecified) on 23-FEB-2016 (the day before the vaccination), where she received an ultrasound, which revealed the pregnancy. It was reported that on 24-FEB-2016, the patient was vaccinated with a dose of GARDASIL 9, lot # L043213, expiration date: 28-AUG-2017, intramuscularly (dose not reported). Concomitant vaccine included MENACTRA. The physician was unaware that the patient was actually pregnant at the time of vaccination. The ultrasound was not sent to the primary care physician until 25-FEB-2016. No known adverse events. The last menstrual period (LMP) was on 06-NOV-2015 and estimated delivery date (EDD) was 12-AUG-2016. Follow up information has been received from a physician on 11-APR-2016. Her concurrent conditions included gravidity 2 and parity 2. She received a dose of GARDASIL on 30-JUL-2012. On 24-FEB-2016, she received a 0.5 ml dose of GARDASIL (not GARDASIL 9 as previously reported) lot# L018286, expiration date: 13-APR-2017. The patient did not tell that she was pregnant. It was found out several days later when a laboratory result came to the office. No treatment was required. Additional information is not expected as follow up information has been received. Patient's demographics, suspect therapy details and narrative were updated.
Age: 77.0
Sex: M
Vaccine: PNC13
Symptoms: Musculoskeletal pain, Myalgia
Clinical narrative: Patient is experiencing ongoing muscle and shoulder pain.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Blood glucose increased, Blood potassium decreased, C-reactive protein increased, Haemoglobin decreased, Injection site pain
Clinical narrative: Pain, Swelling and itching of left arm around injection site. Hives covering body.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pruritus, Injection site swelling, Troponin normal, Urine ketone body present, Urine leukocyte esterase positive
Clinical narrative: Pain, Swelling and itching of left arm around injection site. Hives covering body.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Urticaria
Clinical narrative: Pain, Swelling and itching of left arm around injection site. Hives covering body.
Age: 0.18
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Abdominal pain, Abdominal rigidity, Abnormal faeces, Crying, Haematochezia
Clinical narrative: Acute onset of crying and screaming change in stools with development of sprasmodic abdominal pain and bloody stools that resolved over 3-4 days.
Age: 0.18
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Occult blood, Screaming, Ultrasound abdomen
Clinical narrative: Acute onset of crying and screaming change in stools with development of sprasmodic abdominal pain and bloody stools that resolved over 3-4 days.
Age: 1.02
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Injection site erythema, Injection site reaction, Irritability, Somnolence, Urticaria
Clinical narrative: Mom noticed small red line on Lt thigh, looked like he had been scratched.  That evening around 2000 noticed welt on lt thigh and in groin area on left.  Mom states child was fussy on Saturday.  Beginning Friday night child began sleeping more then usual.  Mom would have to wake him in mornings and from naps the whole week-end.  States temperature was 99 degrees on Sunday morning at 1100.  Started putting Resinol cream on areas on Friday night, uses on diaper rash.  States Sunday night 'welts' were decreased and are improved today.  Child still fussy at times today.  Mom states she thinks the welts were hives.
Sex: U
Vaccine: HPV4
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to a patient of unknown demography. The patient's medical history and concurrent conditions were not reported.. On unspecified dates, the patient was vaccinated with dose 1, dose 2 and dose 3 of GARDASIL by different healthcare provider. On an unspecified date, the patient inadvertently received a fourth dose of GARDASIL (extra dose administered). No symptoms were reported. The outcome of the events was unknown. Additional information has been requested.