chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity, Paraesthesia
Clinical narrative: Initial unsolicited report received from a consumer on 12 October 2015. This case involves a 65-years-old female patient who was vaccinated with a dose of FLUZONE HD (batch number, dose, dose in series, expiry date were not reported) intramuscularly in left deltoid on 23 September 2015. The patient's illness at time of vaccination reported as no and pre-existing physician diagnosed allergies, birth defects, medical conditions reported as no known allergies, fibromyalgia, peripheral neuropathy feet. Previous medication included TRAMADOL HYDROCHLORIDE (Tramadol) and HYDROCODONE BITARTRATE/PARACETAMOL (Vicodin) for pain management. Concomitant medications were not reported. Laboratory data and corrective treatment was not reported. On 23 September 2015, the patient's injection site became red, warm and swollen two days after the vaccination. The patient's symptoms abated two days after vaccination and began having tingling of left hand, shooting pains from elbow to fingers in left arm, aching, increased with movements. The patient required ER/doctor visit. Laboratory data and corrective treatment was not reported. The outcome was reported as not recovered. Patient's pain persisted since 48 hours after vaccination. List of documents held by sender: none.
Age: 67.0
Sex: M
Vaccine: FLU3
Symptoms: Epistaxis, International normalised ratio
Clinical narrative: Initial unsolicited report received from consumer (patient's wife) on 12-Oct-2015. This case involves a 67-year-old male patient who was vaccinated with an intramuscular dose of FLUZONE HD (batch number was not on immunization record, expiry date and site of administration were not reported) on 09-Oct-15. It was reported that patient has received yearly flu shots. Patient's illness at the time of vaccination was not reported and patient's Pre-existing physician diagnosed allergies, birth defects, medical conditions included Cardiac on warfarin and baby aspirin (ASA). Other medical history and concomitant medications were not reported. On 10-Oct-15, one day after vaccination, patient developed nose bleed when he bent over from the waist on the deck and is still actively bleeding. Patient had an international normalized ratio (INR) drawn and results pending. Patient has not been evaluated or treated by a physician after which it will be determined if he will be seen by his cardiologist. At the time of report, outcome of the event was reported as unknown. It was reported that reporter was concerned because the information on flu vaccine provided by the pharmacist addressed a possible warfarin/vaccine interaction. Documents held by sender: none.
Sex: M
Vaccine: FLUX
Symptoms: Cough, Nasopharyngitis
Clinical narrative: Initial unsolicited report received from a consumer (non-healthcare professional) on 7 October 2015. This case involve a male patient (age not reported) who was vaccinated with a dose of INFLUENZA VACCINE (Flu shot) (batch number, expiration date, dose, dose number, route and site of administration were not reported) on an unspecified date on Friday. The patient's medical history and concomitant medication were not reported. Next Day on Saturday, the patient experienced cough and cold. Laboratory investigation was not reported. Same day (on Saturday), as a corrective treatment the patient received PARACETAMOL (Tylenol) and rested. On an unspecified date on Monday, the patient was recovered from events. List of documents held by sender: none.
Sex: U
Vaccine: FLUX
Symptoms: Burning sensation
Clinical narrative: Initial solicited report received during market research on 05 October 2015 from a consumer in the study. The subject (gender and age were not reported) received a dose of INFLUENZA VACCINE (date of vaccination, site and route of administration and batch number were not reported). Medical history and concomitant therapies details were not reported. The subejct had burn for couple of days. The lab data and corrective treatment details were not reported. Relationship to investigational product according to company: not associated. Relationship to investigational product according to reporter: not reported.  List of documents held by sender: none.
Sex: U
Vaccine: FLU4
Symptoms: Pain in extremity
Clinical narrative: Initial unsolicited report received from a healthcare professional on 20 October 2015. This case involves 2 patients (age and gender was not reported) who were vaccinated with a dose of FLUZONE QIV (batch number, dose, dose in series, route and site of administration were not reported) on an unspecified date. The patient's medical history and concomitant medications were not reported. On an unknown date, one day following the vaccination (the day after vaccination), the patients had experienced severe arm pain which continued for more than one week. Laboratory data and corrective treatments were not reported. The patients had not recovered from the event. List of documents held by sender: none.
Sex: U
Vaccine: FLUX
Symptoms: Oral herpes
Clinical narrative: Initial unsolicited report received from a consumer via other company (Merck) on 22 October 2015. Manufacturing report number: 1-14141918733. This case involves patient (age and gender was not reported) who was vaccinated with a dose of INFLUENZA VACCINE (batch number, expiration date, dose,dose in series, route and site of administration was not reported) on an unspecified date. Medical history and concomitant medications were not reported. On an unspecified date, following the vaccination, the patient experienced cold sores. Lab data and corrective treatments were not reported. Outcome of event was not reported. List of documents held by sender: none.
Age: 11.0
Sex: M
Vaccine: FLU4
Symptoms: Erythema, Oedema peripheral
Clinical narrative: Initial unsolicited report received from nurseon 16-Oct-2015. This case involves an 11-year-old male patient who was vaccinated with an intramuscular dose of FLUZONE QIV (batch number: U5309BA, expiry date: 30-Jun-2016) in left deltoid on 14-Oct-2015. Illness at time of vaccination and pre-existing physician diagnosed allergies, birth defects, medical conditions were reported as none. Concomitant medications were not reported. On 15-Oct-2015, one day after vaccination, the patient experienced red and puffy left arm pit. Laboratory investigations and corrective treatments were not reported. The outcome of the event was reported as unknown. Documents held by sender: none. Follow-up information received from nurse on 20 January 2016. No additional information provided. Reporter states that trail with parent was done and no complaints were voiced.
Age: 65.0
Sex: M
Vaccine: FLU3
Symptoms: Feeling hot, Hyperhidrosis, Influenza like illness
Clinical narrative: Initial unsolicited report received from a consumer on 23 October 2015. This case involves a 65-year-old-male patient who was vaccinated with a dose of FLUZONE HD (batch number, route, dose and site of administration was not reported) on an unspecified date in 2014. The patient did not have illness at time of vaccination and pre-existing physician diagnosed allergies, birth defects, medical conditions were reported as none. Concomitant medications were not reported. On an unspecified date in 2014, immediately after the vaccination, the patient developed "flu-like" symptoms, was hot, and sweaty. Lab data and corrective treatments were not reported. The patient was recovered from the events (reported as symptoms lasted 24 hours). Follow up information received from consumer on 14 March 2016. Patient had no adverse events following prior vaccination and patient's concomitant medication was reported as none. It was reported that on an unspecified date, the first night post vaccination, the patient experienced the events. No additional information was provided. List of documents held by sender: none.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to multiple unspecified patients of unknown age and gender. Patients pertinent medical history, concurrent condition and concomitant medication were not reported. No previous drug reactions/allergies were reported. On unknown dates these unspecified patients were vaccinated with improperly stored ZOSTAVAX (strength, dosing details, anatomical location, lot# and expiration date were unknown). There were previous temperature excursions but, no information was provided on previous excursion. The temperature excursions were detected by a data logger. No product quality complaint was involved. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to multiple unspecified patients of unknown age and gender. Patients pertinent medical history, concurrent condition and concomitant medication were not reported. No previous drug reactions/allergies were reported. On unknown dates these unspecified patients were vaccinated with improperly stored (Oka-Merck) PROQUAD (strength, dosing details, anatomical location, lot# and expiration date were unknown). There were previous temperature excursion but, no information was provided on previous excursions. The temperature excursions were detected by a data logger. No product quality complaint was involved. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to multiple unspecified patients of unknown age and gender. Patient pertinent medical history, concurrent condition and concomitant medication were not reported. No previous drug reactions/allergies were reported. On unknown dated these unspecified patients were vaccinated with improperly stored GARDASIL 9 (strength, dosing details, anatomical location, lot# and expiration date were unknown). There were previous temperature excursions but, no information was provided on previous excursions. The temperature excursions were detected by a data logger. No product quality complaint was involved. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to multiple unspecified patients of unknown age and gender. Patients pertinent medical history, concurrent conditions and concomitant medication were not reported. No previous drug reactions/allergies were reported. On unknown dates these unspecified patients were vaccinated with improperly stored PNEUMOVAX 23 (strength, dosing details, anatomical location, lot# and expiration date were unknown). There were previous temperature excursions but, no information was provided on previous excursions. The temperature excursions were detected by a data logger. No product quality complaint was involved. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On 13-JUL-2016 the patient was inadvertently vaccinated with ROTATEQ (lot # L000433, expiry date: 09-JUL-2016) orally (expired vaccine used). This was supported as per memo. No adverse effects reported. The outcome of the events was unknown. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to multiple unspecified patients of unknown age and gender. Patients pertinent medical history, concurrent condition and concomitant medication were not reported. No previous drug reactions/allergies were reported. On unknown dates these unspecified patients were vaccinated with improperly stored RECOMBIVAX HB (strength, dosing details, anatomical location, lot# and expiration date were unknown). There were previous temperature excursions but, no information was provided on previous excursions. The temperature excursions were detected by a data logger. No product quality complaint was involved. Additional information has been requested.
Sex: M
Vaccine: HEP
Symptoms: Laboratory test, No adverse event, Serology test, Therapy non-responder
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of therapy non-responder in a 19-year-old male patient who received ENGERIX B pediatric. Co-suspect products included ENGERIX B pediatric and ENGERIX B pediatric. On an unknown date, the patient received 1st dose of ENGERIX B pediatric .5 ml, the 2nd dose of ENGERIX B pediatric .5 ml and the 3rd dose of ENGERIX B pediatric .5 ml. On an unknown date, an unknown time after receiving ENGERIX B pediatric, ENGERIX B pediatric and ENGERIX B pediatric, the patient experienced therapy non-responder. On an unknown date, the outcome of the therapy non-responder was unknown. It was unknown if the reporter considered the therapy non-responder to be related to ENGERIX B pediatric, ENGERIX B pediatric and ENGERIX B pediatric. Additional detail were provided as follows: The age at vaccination was not reported. The healthcare professional reported that the patient was studying in college and had previously received all 3 pediatric doses of ENGERIX B. The patient underwent laboratory tests and found that he did not have any antibodies against hepatitis B antigen. Thus, leading the patient to be a therapy non-responder. No side effects were reported.
Age: 76.0
Sex: F
Vaccine: PPV
Symptoms: Pain in extremity
Clinical narrative: SORENESS IN RIGHT ARM.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to multiple unspecified patients of unknown age and gender. Patient pertinent medical history, concurrent condition and concomitant medication were not reported. No previous drug reactions/allergies were reported. On unknown dates these unspecified patients were vaccinated with improperly stored VARIVAX (strength, dosing details, anatomical location, lot# and expiration date were unknown. There were previous temperature excursions but, no information was provided on previous excursions. The temperature excursions were detected by a data logger. No product quality complaint was involved. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Information has been received from a pharmacist referring to a female patient of unknown age. The patient's medical history, concurrent condition and concomitant medication were not reported. On 14-AUG-2015, the patient was vaccinated with the first dose of GARDASIL (lot #, expiration date and route were not reported). On 28-JUL-2016, the patient received the second dose of GARDASIL (lot # M014929, expiration date 27-MAY-2017, route unknown), later than the recommended dosing schedule in the prescribing information. No adverse effects were reported. 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 medical assistant and refers to a multiple unspecified patients of unknown age and gender. No information about the patients' pertinent medical history, concomitant medications, drug reactions or allergies was provided. On an unknown dates, the patient received improperly stored doses of VARIVAX lot # L020002 with expiration date 02-JUN-2017 and lot # M000757 with expiration date 06-JAN-2018 (dose and route of administration were not reported). The vaccines underwent a temperature excursion of 14.4 degrees Celsius for 30 minutes and 13.3 degrees Celsius for 1 hour. Data logger was used. It was provided that vaccines underwent previous excursion at 9.0 degrees Fahrenheit for 7 hours on an unspecified date. No adverse effect reported. This is one of two reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a Nurse refers to 21 patients of unknown demography. On an unknown date, the 21 patients were vaccinated with one dose of improperly stored VARIVAX (lot # L034372, lot # M006722 and lot # M006731) subcutaneous (incorrect product storage). The Nurse reported that the VARIVAX underwent a temperature excursion prior being administration to the patients. The maximum temperature was 18.4F for 1 hour 47 minutes and time frame and date of excursion was unknown by the reporter. No known adverse effects were reported. No further information was provided. No PQC involved. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a multiple unspecified patients of unknown age and gender. No information about the patients' pertinent medical history, concomitant medications, drug reactions or allergies was provided. On unknown dates, the patients received improperly stored doses of (Oka-Merck) PROQUAD lot # M006104 with expiration date 01-AUG-2017 and lot # L031600 with expiration date 18-FEB-2017 (dose and route of administration were not reported). The vaccines underwent a temperature excursion of 14.4 degrees Celsius for 30 minutes and 13.3 degrees Celsius for 1 hour. Data logger was used. It was provided that vaccines underwent previous excursion at 9.0 degrees Fahrenheit for 7 hours on an unspecified date. No adverse effects reported. This is one of two reports received from the same source. Additional information has been requested.
Age: 4.0
Sex: F
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information was received from a office manager referring to a patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant therapy were not reported. On 14-JUL-2016 the patient was administered a dose of improperly stored (Oka-Merck) PROQUAD injection (lot # L040415, expired on 13-APR-2017) (dose and route unknown). The vaccine was exposure under 32.9 Fahrenheit degree (F). There was no previous temperature excursion. No adverse event was reported. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an unspecified number patients of unknown age and gender. No information regarding the patients' pertinent medical history, concomitant medication and drug reactions or allergies was reported. On an unknown dates, the patients were vaccinated with improperly stored VARIVAX injection, lot # L023594 with expiry date 26-JUN-2017 and lot # L026405 with expiry date 15-JUL-2017 (dose, route of administration and anatomical location were not specified). It was unknown which lot # each patient was administered. No adverse effects were reported. Product quality complaint (PQC) was not involved. Additional information is not expected as there was no consent for further contact.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse referring to unspecified patients of unknown age and gender. On unknown dates the patients were vaccinated with 3 doses of improperly stored GARDASIL 9 (lot# reported as L011117 with expiration date 07-DEC-2017, lot# L024993 with expiration date 17-OCT-2017, route unknown). The vaccine had been stored under 50.9 Fahrenheit for 34 minutes. There was no previous exposures. Digital data logger had been involved. No adverse effects were reported. This is one of several reports received 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 as received from an immunization coordinator refers to multiple patients of an unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On unknown dates, the patients were vaccinated with an unspecified number of doses of improperly stored VARIVAX lot # M002063 with expiration date: 12-JAN-2018 (dose and route of administration were not reported). Administered doses of VARIVAX underwent temperature excursions at -11.6 degrees Celsius for 1 hour and 30 minutes. There was no previous temperature excursion. Data logger was involved. No adverse effects were reported. Product quality complaint (PQC) was not involved. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Morbillivirus test positive, Polymerase chain reaction positive, Pyrexia, Rash
Clinical narrative: This spontaneous report as received from a physician refers to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On an unknown date, the patient was vaccinated with M-M-R II, (route of administration: subcutaneous). On an unknown date (reported as an unspecified time after receiving M-M-R), the patient developed fever and rash. The outcome of the events fever and rash was unknown. The causality of the events was not reported. This is one of the two reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified number of 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 patients were vaccinated with an improperly stored doses of RECOMBIVAX HB (lot# M001578, expiration date 21-NOV-2018, dose, anatomical location and route of administration were not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 2.0
Sex: M
Vaccine: HEPA
Symptoms: Pyrexia, Rash generalised, Streptococcus test negative
Clinical narrative: Fever started 7/29/16 in the evening, started with rash 7/31/16 on cheek, increased to body 8/1/16.
Age: 15.0
Sex: M
Vaccine: HPV9
Symptoms: Loss of consciousness
Clinical narrative: 10 seconds after receiving the injection, patient lost consciousness for about 6 seconds. Regained consciousness with no interventions.  Had no further symptoms for 30 minutes. Given juice and crackers, patient said he had not eaten this morning, and felt much better.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Amnesia, Delirium, Dizziness, Dysarthria, Electrocardiogram
Clinical narrative: Patient passed out, was completely delerious for over 30 minutes, slurring words, could not see, was dizzy, did not remember anything except getting the injection and wakling up in the hospital.  Pt hit her head when she fainted, no concussion.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Head injury, Loss of consciousness, Neurological examination, Syncope, Visual impairment
Clinical narrative: Patient passed out, was completely delerious for over 30 minutes, slurring words, could not see, was dizzy, did not remember anything except getting the injection and wakling up in the hospital.  Pt hit her head when she fainted, no concussion.
Age: 19.0
Sex: M
Vaccine: HEP, HEPA
Symptoms: Cardiac stress test, Computerised tomogram, Echocardiogram, Electrocardiogram abnormal, Electroencephalogram
Clinical narrative: Patient had syncope event when Immunzation Hep A + B given during PHA.  Went home fatigued then had second event of fatigue and question of normal headache.  Went to ED 8 march and had abnormal EKG 3/8/16.
Age: 19.0
Sex: M
Vaccine: HEP, HEPA
Symptoms: Fatigue, Syncope
Clinical narrative: Patient had syncope event when Immunzation Hep A + B given during PHA.  Went home fatigued then had second event of fatigue and question of normal headache.  Went to ED 8 march and had abnormal EKG 3/8/16.
Age: 3.0
Sex: F
Vaccine: DTAP
Symptoms: Erythema, Induration, Local swelling
Clinical narrative: Hardened, red, swollen area approximately 1.5" in diameter.
Sex: U
Vaccine: FLUX
Symptoms: Discomfort
Clinical narrative: Initial solicited report received from market research on 05 October 2015 from a consumer in study. The subject (gender and age were not reported) received a dose of INFLUENZA VACCINE (date of vaccination, site and route of administration and batch number were not reported, manufacturer unknown). Medical history and concomitant therapies details were not reported. The subject felt uncomfortable on an unspecified date. The lab data and corrective treatment details were not reported. Relationship to investigational product according to company: not associated. Relationship to investigational product according to reporter: not reported. List of documents held by sender: none.
Sex: M
Vaccine: FLU4
Symptoms: Malaise, Muscle enzyme increased, Muscle spasms
Clinical narrative: Initial unsolicited report received from a physician on 21 October 2015. This case involves a male patient (age not reported) who was vaccinated with a dose of FLUZONE QIV (batch number,route, dose, cycle in series and site of administration were not reported) on an unspecified date in 2014. Patient medical history and concomitant medications were not reported. On an unspecified date in 2014, following the vaccination, the patient experienced malaise, leg cramps, and elevated muscle enzymes. Lab data and corrective treatments were not reported. The patient recovered from the events. List of documents held by sender: none.
Sex: U
Vaccine: FLUX
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: Initial unsolicited report received from a consumer on 22 October 2015. This case involves a patient (age and gender was not reported) who was vaccinated with a dermal dose of INFLUENZA VACCINE (Flu shot) (Batch number, dose, dose in series and site of administration were not reported) on an unspecified date. The patient's medical history and concomitant medications were not reported. On an unspecified date, following the vaccination, the patient had a prominent red patch around the injection site and was very itchy. Laboratory data and corrective treatments were not reported. On an unspecified date, patient was recovered from the event (duartion :3 days). List of documents held by sender: none.
Age: 67.0
Sex: M
Vaccine: FLU3
Symptoms: Abdominal pain upper, Chills, Headache, Hyperhidrosis, Pyrexia
Clinical narrative: Initial unsolicited report received from consumeron 27 October 2015. This case involves a 67-years-old male patient who was vaccinated with first dose of FLUZONE HD (batch number was unknown, dose, expiry date were not reported) intramuscularly in left deltoid on 26 October 2015 at 2 PM. Illness at time of vaccination and pre-existing physician diagnosed allergies, birth defects, medical conditions were unknown. Concomitant medications were not reported. On 26 October 2015, 07 hours (at 9 PM) following the vaccination, the patient had developed pain in stomach, sweating thru pajamas, chills, fever and headache. At the time of reporting all symptoms were subsided. Laboratory data and corrective treatment was not reported. The patient was not recovered from the events. List of documents held by sender: none.
Age: 22.0
Sex: M
Vaccine: FLU4
Symptoms: Nonspecific reaction
Clinical narrative: Initial solicited report received on 08 June 2016 from a consumer participating in the below-mentioned study. This case involves a 22-year-old male, who received a dose of FLUZONE Intradermal (site of administration and batch number not reported). On an unknown date after receiving a dose of FLUZONE Intradermal (site of administration and batch number not reported), idk didn't really help. The outcome of event idk didn't really help was not reported. Relationship to investigational product according to company: not associated. Relationship to investigational product according to reporter: not reported. List of documents held by sender: none.
Age: 30.0
Sex: M
Vaccine: FLU4
Symptoms: Adverse drug reaction
Clinical narrative: Initial solicited report received on 08 June 2016 from a consumer participating in the study. This case involves a 30 year old male, who received a dose of FLUZONE Intradermal (site of administration and batch number not reported). On an unknown date after receiving a dose of FLUZONE Intradermal (site of administration and batch number not reported), the subject reacts to prescriptions. The outcome of event reacts to prescriptions was not reported. Relationship to investigational product according to company: not associated. Relationship to investigational product according to reporter: not reported. List of documents held by sender: none.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Dizziness, Headache, Muscular weakness, Nausea, Pallor
Clinical narrative: Nausea, leg weakness, paleness, dizziness, headache, dry heaving, low grade temp.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Pyrexia, Retching
Clinical narrative: Nausea, leg weakness, paleness, dizziness, headache, dry heaving, low grade temp.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Local swelling, Skin warm
Clinical narrative: (L) deltoid swollen and warm to touch.
Age: 36.0
Sex: M
Vaccine: TDAP
Symptoms: Pain, Pain in extremity
Clinical narrative: Upper arm pain since receiving the vaccine(x6 weeks ago). Pain is worse with movement.
Age: 12.0
Sex: M
Vaccine: FLU3, HEP, HEPA, HPV9, IPV, MMR, MNQ, TDAP, VARCEL
Symptoms: Injection site pruritus, Injection site urticaria
Clinical narrative: Child C/O itching at site of vaccine. There were 50-100 pin point raised welts at SQ site. Client was given 50mg of Diphenhydramine.
Age: 0.18
Sex: M
Vaccine: DTAPHEPBIP
Symptoms: Injection site erythema
Clinical narrative: Crossed linear redness to vastus lateralis. Area does not appear to bother patient. No fevers.
Age: 3.0
Sex: M
Vaccine: HEPA
Symptoms: Body temperature increased, Diet refusal, Fluid intake reduced, Influenza virus test, Laboratory test
Clinical narrative: Temp. 104.0 very lethargic, wouldn't eat barley taking fluids. Slept through the full exam. Wasn't talking, asked us to carry him to the bathroom to urinate.
Age: 3.0
Sex: M
Vaccine: HEPA
Symptoms: Lethargy, X-ray
Clinical narrative: Temp. 104.0 very lethargic, wouldn't eat barley taking fluids. Slept through the full exam. Wasn't talking, asked us to carry him to the bathroom to urinate.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Body temperature increased, Erythema, Irritability, Urticaria
Clinical narrative: Developed red round circles noted 1 on chest and back, 2 on each arm 3-4 on each leg, and several on "web" of toes, yesterday after vaccine, mother took temp this am 99, and daughter told mother she was crabby. Has appt with CNP - seen - hives - on BENADRYL and ZYRTEC.
Age: 17.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of injection site warmth in a 17-year-old female patient who received BEXSERO. Concomitant products included MENACTRA. On 18th July 2016, the patient received BEXSERO. In July 2016, less than a week after receiving BEXSERO, the patient experienced injection site warmth, injection site pain and injection site redness. On an unknown date, the outcome of the injection site warmth, injection site pain and injection site redness were unknown. The reporter considered the injection site warmth, injection site pain and injection site redness to be probably related to BEXSERO. Additional details were provided as follows: On 22nd July 2016, the patient's mother called the physician's office to report that the patient was experiencing warmth, redness, and soreness around the injection site, where the BEXSERO vaccine was administered. The patient had received a dose of MENACTRA in right deltoid. The field representative was unable to provide any further details. It was unknown if the reactions were considered life-threatening or if the patient had to be hospitalized.
Age: 19.0
Sex: F
Vaccine: MENB
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site warmth, Pyrexia
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of injection site pain in a 19-year-old female patient who received BEXSERO. On an unknown date, the patient received the 1st dose of BEXSERO. On an unknown date, 2 hrs after receiving BEXSERO, the patient experienced injection site pain, injection site erythema, injection site warmth, injection site induration and fever. The patient was treated with MOTRIN. On an unknown date, the outcome of the injection site pain, injection site erythema, injection site warmth, injection site induration and fever were recovered/resolved. The reporter considered the injection site pain, injection site erythema, injection site warmth, injection site induration and fever to be related to BEXSERO. Additional details were provided as follows: This case was reported by a sales representative on behalf of physician. The patient was daughter of reporter, who experienced significant soreness at injection site (unknown arm). The injection site was also described as hot, hard and red. The patient also felt as though she had a fever. The body temperature was not officially measured. The patient was treated with MOTRIN (800mg).
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Back pain, Chills, Headache, Hyperhidrosis, Muscle spasms
Clinical narrative: Chills, sweats, headache, body aches, back pain, muscle spasms in legs.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Pain
Clinical narrative: Chills, sweats, headache, body aches, back pain, muscle spasms in legs.
Age: 1.27
Sex: F
Vaccine: DTAP, HIBV, MMR
Symptoms: Neutrophil count decreased, Platelet count normal, Rash
Clinical narrative: 7/22/16 vaccines administered at 12 mo WCC. 7/31/16 developed rash, started on neck seen in office 8/22/16 rash covering all surfaces.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to multiple patients of unknown age and gender. The patients' concurrent conditions, medical history and concomitant medications were not reported. On unknown dates, the patients were vaccinated with improperly stored VARIVAX, subcutaneously, lot # L021216, expiry date 21-JAN-2017 and lot # L025208, expiry date 07-JUL-2017 (strength, dose and site of administration were not reported). The temperature excursion was to 41.2 degrees Fahrenheit for 5 hours 21 minutes in February 2016. There were no reports of any adverse effects. Additional information has been requested.
Age: 55.0
Sex: F
Vaccine: HEPAB
Symptoms: Disturbance in attention, Dizziness, Heart rate increased, Hepatitis A antibody positive, Hepatitis B antibody positive
Clinical narrative: My arm starting swelling. It was swollen 3x its size. The shot site was red. I developed these red streaks underneath the shot about 3 of them appx 2 inches in length and inch thick. I developed hives all over the upper arm. It hurt to lift my arm the next day. I put alcohol on the site and it was stinging and burning. I had some lumps on my upper arm that were raised and resembled mosquitoe bites, fast heart rate. I was dizzy and passed out 7/15/2016. The next day I had a hard time concentrating on what the teaching was saying in my CPR class. For the next 3 days I put alcohol on the site in the morning and at night. It would sting and I developed a scab over the shot site. Showed arm to co-workers and family members.
Age: 55.0
Sex: F
Vaccine: HEPAB
Symptoms: Injection site erythema, Injection site pain, Injection site scab, Injection site streaking, Loss of consciousness
Clinical narrative: My arm starting swelling. It was swollen 3x its size. The shot site was red. I developed these red streaks underneath the shot about 3 of them appx 2 inches in length and inch thick. I developed hives all over the upper arm. It hurt to lift my arm the next day. I put alcohol on the site and it was stinging and burning. I had some lumps on my upper arm that were raised and resembled mosquitoe bites, fast heart rate. I was dizzy and passed out 7/15/2016. The next day I had a hard time concentrating on what the teaching was saying in my CPR class. For the next 3 days I put alcohol on the site in the morning and at night. It would sting and I developed a scab over the shot site. Showed arm to co-workers and family members.
Age: 55.0
Sex: F
Vaccine: HEPAB
Symptoms: Pain, Peripheral swelling, Upper extremity mass, Urticaria
Clinical narrative: My arm starting swelling. It was swollen 3x its size. The shot site was red. I developed these red streaks underneath the shot about 3 of them appx 2 inches in length and inch thick. I developed hives all over the upper arm. It hurt to lift my arm the next day. I put alcohol on the site and it was stinging and burning. I had some lumps on my upper arm that were raised and resembled mosquitoe bites, fast heart rate. I was dizzy and passed out 7/15/2016. The next day I had a hard time concentrating on what the teaching was saying in my CPR class. For the next 3 days I put alcohol on the site in the morning and at night. It would sting and I developed a scab over the shot site. Showed arm to co-workers and family members.
Age: 3.0
Sex: F
Vaccine: PNC13
Symptoms: Dyskinesia, Lethargy, Loss of consciousness, Muscle spasms, Pallor
Clinical narrative: Approximately 3 minutes after walking to lobby with parents after receiving PCV 13 Vaccination Child had seizure like event with loss of consciousness, spasms and jerking of body and extremities. No loss of bowel or bladder. Father witnessed and picked child up before she fell and told the desk clerk "help, she is having a seizure" and the clerk called a code.  Two RN's responded, oxygen was placed on child via mask and child carried to exam table and placed on left side in rescue position with parents at child's side.  Brachial pulse obtained at 110 with 14 respirations.  Child is pale and lethargic, but is responding and "seizure" activity lasted less than one minute.  Parents refuse ambulance to be called.  Child was alert and whimpering and talking with mother within 15 minutes of event occurring.  Medical Director for PHD notified.  Parents advised to seek immediate emergency treatment if "seizure" occurs again before seeing PCP in the morning.  Referral faxed to PCP.
Age: 3.0
Sex: F
Vaccine: PNC13
Symptoms: Seizure like phenomena
Clinical narrative: Approximately 3 minutes after walking to lobby with parents after receiving PCV 13 Vaccination Child had seizure like event with loss of consciousness, spasms and jerking of body and extremities. No loss of bowel or bladder. Father witnessed and picked child up before she fell and told the desk clerk "help, she is having a seizure" and the clerk called a code.  Two RN's responded, oxygen was placed on child via mask and child carried to exam table and placed on left side in rescue position with parents at child's side.  Brachial pulse obtained at 110 with 14 respirations.  Child is pale and lethargic, but is responding and "seizure" activity lasted less than one minute.  Parents refuse ambulance to be called.  Child was alert and whimpering and talking with mother within 15 minutes of event occurring.  Medical Director for PHD notified.  Parents advised to seek immediate emergency treatment if "seizure" occurs again before seeing PCP in the morning.  Referral faxed to PCP.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to 3 patients of unknown demography. The reporter stated that on an unknown date, the 3 unspecified patients were vaccinated with improperly stored VARIVAX lot # L048465, subcutaneous. No adverse effects were reported. No further information was informed. No PQC involved. Additional information has been requested.
Age: 19.0
Sex: M
Vaccine: HEP, MNQ, TDAP, VARCEL
Symptoms: Immediate post-injection reaction, Pallor, Syncope
Clinical narrative: 8/3/16--9:30 a.m.Patient fainted briefly (less than 1 minute) immediately after vaccinations given while still seated in chair.  Mom & nurses assisted with cold packs & wet paper towels on neck, face, and arms.  At no time did patient fall to the floor.  Patient was offered cold water and took a few sips & also began to lick on the lollipop offered.  After 10 minutes, patient was offered cold Sprite and began to sip it, holding the can himself.  After approximately 15 minutes patient regained color in his face and neck, mom and nurses assisted him to waiting room where he laid down on table.  Nurse  offered to call 911 to have paramedics come and evaluate patient, but mother adamantly refused.  Patient and family was advised to not let patient drive until he returned to normal and to take all the time needed to rest.  Nurse, patient's mom & sisters assisted patient with cold packs while patient continued to lick lollipop while lying on table. At 10:10 mother determined that patient was well enough to sit up, so patient sat on table for 5 minutes, then walked slowly around waiting room.  At 10:17 family members and patient told Nurse that patient was felling normal again, and all family members including patient ambulated normally out of building.  Family and patient thanked Nurse for assistance given.
Age: 76.0
Sex: F
Vaccine: PPV
Symptoms: Diarrhoea, Dizziness, Vomiting
Clinical narrative: Dizziness, vomiting, diarrhea.
Age: 66.0
Sex: M
Vaccine: PPV
Symptoms: Dizziness, Emotional disorder, Injected limb mobility decreased, Injection site erythema, Injection site pain
Clinical narrative: Horrible reaction to PPSV: Wanted to document my week of agony from PPSV. As stated previously, pain started to get bad about 4 hours after receiving the shot on Wednesday morning. Pain was way above Ibuprofen's pay grade, so I tried Aleve with no effect whatsoever. Also cold compresses had no effect. That night, I woke and was able to make it to the bathroom, but then had red dots dancing in front of my eyes and became very dizzy. Was able to make it back to bedroom by holding onto doors and walls then blindly pushed off from wall and hoped I hit the bed before I fainted completely and hit the floor. Dizziness was gone in AM, but pain was so bad all day Thursday I could do nothing with right arm. Was just like when it was broken. By Friday the pain was slightly better but still could not use arm very much. Pain started to migrate from bicep area to underneath, I guess that is the tricep. By Saturday I could use my arm slightly but the pain was still in the tricep area and my skin turned pink in that area. By Monday the pain in the muscle area had mostly gone away but the skin was extremely sensitive where it was pink and I couldn't even put clothing there or rest my arm on a table as it hurt a lot. By Tuesday the skin pain went mostly away but then the itching started. I had low level itching all over my underarm from the elbow to the armpit where the skin was pink although the pink had gone away. It itched constantly and no itch cream helped it. That continued all through Wednesday and Wednesday night. This morning I tried hydrocortisone and either it worked or the itching has finally stopped except for a bit on my elbow and on the underside of my forearm. I very much regret getting this shot. Friend will now never get one after seeing my reaction to it. I would like you to report this to VAERS on my behalf. Thank you.  I'm still experiencing itching from the side effects from the pneumonia shot. About 3-4 times during the day or night the itching will start. Even at a low level it is very annoying and upsetting as I did not have this problem before. Nothing I used relieved the symptoms of the pain and it seems nothing is helping relieve the itching as I thought it was - when I applied the cream it must have just been between itching sessions. What can I use to stop this?  I forgot to mention when my skin turned pink, it was the color of pepto bismal - not a color I'd ever seen before on my skin. Did you forward my problems about this? Will I get an apology from the mfg? Do they have any idea when this itching will go away? Have there been lawsuits from others about similar problems? Do I now have shingles??? I am very upset.
Age: 66.0
Sex: M
Vaccine: PPV
Symptoms: Middle insomnia, Pain, Pruritus, Vaccination complication, Visual impairment
Clinical narrative: Horrible reaction to PPSV: Wanted to document my week of agony from PPSV. As stated previously, pain started to get bad about 4 hours after receiving the shot on Wednesday morning. Pain was way above Ibuprofen's pay grade, so I tried Aleve with no effect whatsoever. Also cold compresses had no effect. That night, I woke and was able to make it to the bathroom, but then had red dots dancing in front of my eyes and became very dizzy. Was able to make it back to bedroom by holding onto doors and walls then blindly pushed off from wall and hoped I hit the bed before I fainted completely and hit the floor. Dizziness was gone in AM, but pain was so bad all day Thursday I could do nothing with right arm. Was just like when it was broken. By Friday the pain was slightly better but still could not use arm very much. Pain started to migrate from bicep area to underneath, I guess that is the tricep. By Saturday I could use my arm slightly but the pain was still in the tricep area and my skin turned pink in that area. By Monday the pain in the muscle area had mostly gone away but the skin was extremely sensitive where it was pink and I couldn't even put clothing there or rest my arm on a table as it hurt a lot. By Tuesday the skin pain went mostly away but then the itching started. I had low level itching all over my underarm from the elbow to the armpit where the skin was pink although the pink had gone away. It itched constantly and no itch cream helped it. That continued all through Wednesday and Wednesday night. This morning I tried hydrocortisone and either it worked or the itching has finally stopped except for a bit on my elbow and on the underside of my forearm. I very much regret getting this shot. Friend will now never get one after seeing my reaction to it. I would like you to report this to VAERS on my behalf. Thank you.  I'm still experiencing itching from the side effects from the pneumonia shot. About 3-4 times during the day or night the itching will start. Even at a low level it is very annoying and upsetting as I did not have this problem before. Nothing I used relieved the symptoms of the pain and it seems nothing is helping relieve the itching as I thought it was - when I applied the cream it must have just been between itching sessions. What can I use to stop this?  I forgot to mention when my skin turned pink, it was the color of pepto bismal - not a color I'd ever seen before on my skin. Did you forward my problems about this? Will I get an apology from the mfg? Do they have any idea when this itching will go away? Have there been lawsuits from others about similar problems? Do I now have shingles??? I am very upset.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Eating disorder, Immune system disorder, Nausea, Pain, Pyrexia
Clinical narrative: Mom reports that child became nauseated and would not eat. Started throwing up that night and continued to the next day. Child complained of body aches and also ran a fever of 102. Went to doctor on 7/27/16 and was told that he probably got a virus and the immunizations weakened his immune system. Gave anti nausea meds.