chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: VARCEL
Symptoms: Varicella post vaccine, Varicella virus test positive
Clinical narrative: This spontaneous report was received from a male physician of unknown age referring himself via company representative. The patient's drug allergies and medical history was unspecified. On an unknown date the patient was vaccinated with chickenpox vaccine (manufacturer unknown) (brand name and manufacturer of the vaccine unspecified). Concomitant medications were unspecified. On an unknown date the patient developed chickenpox a few years after receiving chickenpox vaccine (manufacturer unknown). The patient sought medical attention. The patient had a blood test that determined that the strain of varicella he was infected with, was not covered by the vaccine. The outcome of developed chicken pox after receiving chickenpox vaccine (manufacturer unknown) was reported as recovered. The causality was not provided. No product complaint was reported for chickenpox vaccine (manufacturer unknown). Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unknown number of patients of unknown age and gender. The registered nurse reported that on an unspecified dates an unknown number of patients had been administered GARDASIL (route, dose, frequency and lot # not reported) which had been improperly stored. No adverse effects reported. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from the registered nurse refers to a patient of unknown gender and age. On 20-OCT-2014, the patient was vaccinated with a dose of (Merck) VARIVAX, 0.5 ml, subcutaneous injection (dose number, lot/batch number, expiration date were not reported) that underwent temperature excursion (date of excursion and temperature values were unspecified). No adverse effect were reported. No product quality complaint (PQC) involved. Additional information is not expected as no consent for contact was given.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse on 15-OCT-2014 concerning an unspecified number of patients. On an unknown date the patients were vaccinated with GARDASIL (route, dose was unknown) which was improperly stored. No adverse effects were reported. No product quality complaint was involved. It was reported that this case was opened on 26-AUG-2014 for temperature inquiry only. The outcome of the events was unknown. This case is linked to the cases MARRS# 1410USA008635, 1410USA013360, 1410USA013358 and 1410USA013359 with the same reporter link. Additional information is not expected.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker and a certified medical assistant refers to a patient of unknown age and gender. On 26-AUG-2014, the patient was vaccinated with a dose of (Merck) VARIVAX (dose, units, route of administration, anatomical location were not reported) which was exposed to a supported temperature excursion on 15-AUG-2014. No adverse events had been observed or reported. No product quality complaint (PQC) involved. This is one of several reports from the same source. Additional information has been requested.
Age: 15.0
Sex: M
Vaccine: HEPA
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a 15 year old male patient. The patient's medical history was not reported. On 30-JUL-2014 the patient was vaccinated with first dose of VAQTA (dose, frequency, route and lot # were not reported). Concomitant medications were not reported. On 17-OCT-2014 the patient was vaccinated with second dose of VAQTA. No adverse effect was reported. No product complaint was reported for VAQTA. This case is linked to case # 1410USA013423 (same patient link). Additional information has been requested.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site discomfort, Injection site erythema
Clinical narrative: Red and uncomfortable at injection site. No fever, drainage or rash.
Age: 21.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site rash, Injection site swelling
Clinical narrative: My arm was swollen and red with rash and it started around the site and then spread to my elbow. I took BENADRYL, and never got second vaccination.
Sex: U
Vaccine: PPV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacy technician (reported also as: healthcare worker) refers to an unspecified patient of unknown age and demographics. Information regarding medical history and drug reactions or allergies was not reported. On 20-OCT-2014 an unspecified patient was vaccinated with a dose of PNEUMOVAX 23 (lot#, expiration date, anatomical location, route of administration not reported) after being exposed to a supported temperature excursion. No adverse effect had been observed or reported. Concomitant medications were not reported. Product quality complaint (PQC) was not involved. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and office manager and refers to patient of unknown age and gender. On 09-SEP-2014 the patient was vaccinated with PEDVAXHIB, (lot # K000331, expiry 23-OCT-2016, dose, dose # and route unspecified), that was exposed to temperatures outside of the proper storage range on unspecified dates. No adverse effect reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: M
Vaccine: VARCEL
Symptoms: Rash vesicular
Clinical narrative: This spontaneous report as received from a registered nurse refers to a male patient of unknown age. The patient's current conditions or medical history were not reported. On an unknown date, the patient was vaccinated with 1 injection of VARIVAX (Merck) (dose, route, lot number and expiration date not reported). On an unknown date, reported as is being a long time, the reporter stated that the patient developed varicella like rash after being vaccinated with VARIVAX (Merck). Outcome of varicella like rash was unknown at the time of the report. Additional information has been requested.
Age: 41.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Pain
Clinical narrative: ADACEL administered 10/21/14 IM into (L) deltoid. Pt reported feeling achy. (L) deltoid became red, warm, swollen. Reported to facility on 10/24/14.
Age: 83.0
Sex: F
Vaccine: VARZOS
Symptoms: Ophthalmic herpes zoster
Clinical narrative: This spontaneous report as received from a physician via a Company representative refers to an 83 year old female patient. The patient had a history of breast cancer, current conditions were not reported. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX vial (dose, route, lot number and expiration date not reported). On an unknown date, the physician reported that the patient was diagnosed with shingles in the eye area after receiving ZOSTAVAX. The patient sought for medical attention on an unspecified date. Outcome of shingles in the eye area was unknown at the time of the report. Additional information is not expected since no consent was given to perform follow up.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and office manager and refers to patient of unknown age and gender. On 02-SEP-2014 the patient was vaccinated with PEDVAXHIB, (lot # K000331, expiry 23-OCT-2016, dose, dose # and route unspecified), that was exposed to temperatures outside of the proper storage range on unspecified dates. No adverse effect reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to a patient of unknown gender and age. On 22-OCT-2014, the patient was vaccinated with an expired dose of VARIVAX (Merck) lot # H013181, expiration date: 05-JUL-2014 (dose, dose number and route were not reported). No symptoms were reported. No product quality complaint (PQC) involved. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse refers to a patient of unknown demographics. No relevant medical history of the patient was reported. On 15-OCT-2014, the patient was inadvertently administered with an expired VARIVAX (Merck) (lot # H016577, expiration date: 05-SEP-2014) (strength, route of administration and site of administration were not reported) dose 3. There were no concomitant medications reported. There were no adverse effects reported. There was no product quality complaint (PQC) involved. The outcome was unknown. Additional information is not expected because it was reported that there were no additional information to report.
Age: 45.0
Sex: F
Vaccine: TDAP
Symptoms: Chills, Culture urine negative, Injection site erythema, Injection site pain, Pyrexia
Clinical narrative: Left shoulder approximately 5 cm redness and tenderness around immunization site. In addition fever/chills 24-36 hours after vaccination - but may be due to possible UTI (mild sx).
Age: 25.0
Sex: F
Vaccine: MMRV
Symptoms: Crying, Depression, Emotional distress, Exposure during breast feeding
Clinical narrative: This spontaneous report as received from a physician via a company representative refers to a currently 25 year old female patient who was a mother in nursing. On an unknown date the patient was vaccinated with PROQUAD, (lot#, expiry date, dose and route not reported), while she was nursing. Patient was informed by the physician to stop nursing for 2 weeks. The patient had seek medical attention by seeing the doctor. Follow-up information has been received from a consumer who refers to his 25 year old female wife who was a lactating and nursing mother. On 14-OCT-2014, the consumer reported that his wife was vaccinated with M-M-R II (conflicting information, previously reported by the physician that the patient was vaccinated with PROQUAD, (lot#, expiry date, dose and route not reported), while she was lactating and nursing her infant 9see MARRS # 1410USA011961). On the evening of 14-OCT-2014, the consumer and his wife were notified by the health care professional's staff, that his wife should discontinue breast-feeding their infant immediately. On 14-OCT-2014, the patient started to become depressed upon being instructed by the health care professional's staff to discontinued breast-feeding. The consumer stated that after his wife received PROQUAD, on 14-OCT-2014, she breast-fed their infant "4 or  times" during that day, on 14-OCT-2014, before being instructed to discontinue breast-feeding. The consumer stated his wife followed the instructions of the health care provider's office to immediately stop breast-feeding their infant and he purchased a breast-pump and formula so that the mother and infant could make the transition to formula-feeding. The consumer stated that this disruption in his family's process has caused great distress for his wife. He reported that his wife has been crying more frequently, and he thinks that he may need to take her to see a psychologist. The consumer was concerned about his wife's well being. The patient did seek medical attention (not otherwise specified). Additional information has been requested.
Age: 0.11
Sex: U
Vaccine: MMRV
Symptoms: Exposure during breast feeding, Infantile spitting up, Somnolence
Clinical narrative: Information has been received from a consumer who refers to his 25 year old wife (see MARRS # 1410USA008581) and his 5 week old infant. On 14-OCT-2014, the consumer reported that his wife received M-M-R II vaccination (conflicting information, also reported by the physician as PROQUAD (Merck), (lot#, expiry date, dose and route not reported), while she was lactating and nursing their infant. On the evening of 14-OCT-2014, the consumer and his wife were notified by the health care professional's staff, that his wife should discontinue breast-feeding their infant immediately. The consumer stated that after his wife received PROQUAD (Merck), on 14-OCT-2014, she breast-fed their infant "4 or 5 times" during that day, on 14-OCT-2014, before being instructed to discontinue breast-feeding. The consumer reported that he purchased a breast-pump and formula so that the mother and infant could make the transition to formula-feeding. The consumer stated that his infant "has been sleeping more and has been spitting-up more." The consumer was concerned about his infant's well-being. Additional information has been requested.
Age: 0.2
Sex: F
Vaccine: DTAP, PNC13, RV5
Symptoms: Diarrhoea, Infantile spitting up, Irritability
Clinical narrative: Received ROTATEQ vaccine on 8/25/14 and on 10/24/14 mother reported that after vaccine on 8/25 child had diarrhea and spitting up along with fussiness x 12-18 hours.
Sex: U
Vaccine: VARZOS
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. On 21-OCT-2014 the patient was vaccinated with a dose of ZOSTAVAX (lot # J006831, expiration date: 14-SEP-2014) (dose and route were not reported). The reporter stated that ZOSTAVAX did not have any previous temperature excursions. No adverse symptoms were reported. Additional information has been requested.
Age: 54.0
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Erythema, Pruritus, Urticaria
Clinical narrative: Itchy/red welts and blisters all over body on arms, leg, and stomach.
Age: 29.0
Sex: F
Vaccine: TDAP
Symptoms: Exposure during pregnancy, Musculoskeletal pain, Pain
Clinical narrative: Received Tdap 9.29.14, called on 10-6 to say that she had slight pain for a day. Then on 10-2-14 woke with severe shoulder pain. Better but still present. Has tried heat/cold/TYLENOL. Was 30+ wk preg.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia
Clinical narrative: Joint pain in the arm vaccine was given. Patient has taken ibuprofen 400mg with little to no relief. This has occurred starting 1 week after vaccine, and has not resolved (now longer than 1 month after vaccine).
Age: 1.15
Sex: F
Vaccine: MMR
Symptoms: Blister, Rash generalised
Clinical narrative: Mother reports pt. experienced blistering rash on face and body 10 days after MMR vaccine. Lasted 4 days, pt. afebrile. Pediatrician gave abx. ointment.
Age: 12.0
Sex: M
Vaccine: HPV4
Symptoms: Eyelid oedema, Pruritus, Swelling face
Clinical narrative: Received GARDASIL dose #1 on 10/22/14 at 10 am; facial swelling noted on the evening of 10/22/14. By morning of 10/23/14, eyes were swollen shut and face was swollen itchy. Pt with multiple environmental allergies (shellfish, tree nuts) treated with BENADRYL.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Back pain, Grip strength decreased, Injected limb mobility decreased, Nasopharyngitis, Neck pain
Clinical narrative: Four hours after vaccine, pt could not move arm (L) or grasp with hand (L). Had lower back pn that moved up neck. Also developed symptoms of a cold. Saw PCP who prescribed Ibuprofen. Symptoms resolved two weeks later.
Age: 15.0
Sex: M
Vaccine: HPV4
Symptoms: Activities of daily living impaired, Dizziness, Pyrexia, Syncope
Clinical narrative: Mom called the following day to report that pt had a GARDASIL shot at his PE and was fine afterwards. He had eaten a snack before the shot as well. About 45 minutes later he felt dizzy and fainted in the car. When he got home he had a fever and stayed home the next day. He didn't seem sick at all per mom.
Age: 12.0
Sex: M
Vaccine: MNQ
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Pt. received 1st MCV4 on 10/18/14 - left upper arm. Became tender and red by 24 hours.
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Lipids, Mobility decreased, Muscular weakness, Myalgia
Clinical narrative: This spontaneous report as received from a 72 year old male patient with type 2 diabetes and no drug reactions or allergies consumer reporting on himself. On 24-SEP-2014, the patient was vaccinated with a dose of ZOSTAVAX (dose, route and lot # not reported). Concomitant therapies included unspecified medications. The consumer reported that on 02-OCT-2014, about a week after he received the vaccination, he experienced muscle pains and joint aches. The consumer reported that he could barely move his arms and legs. The consumer also mentioned he developed a sore throat around the middle of October 2014 that only lasted a couple of days. The patient was suggested to take two ALEVE a day as treatment. The patient underwent a lipid panel and a kidney function test (results not provided). The consumer stated that was still currently experiencing the pain and muscle weakness. Additional information has been requested.
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Oropharyngeal pain, Renal function test
Clinical narrative: This spontaneous report as received from a 72 year old male patient with type 2 diabetes and no drug reactions or allergies consumer reporting on himself. On 24-SEP-2014, the patient was vaccinated with a dose of ZOSTAVAX (dose, route and lot # not reported). Concomitant therapies included unspecified medications. The consumer reported that on 02-OCT-2014, about a week after he received the vaccination, he experienced muscle pains and joint aches. The consumer reported that he could barely move his arms and legs. The consumer also mentioned he developed a sore throat around the middle of October 2014 that only lasted a couple of days. The patient was suggested to take two ALEVE a day as treatment. The patient underwent a lipid panel and a kidney function test (results not provided). The consumer stated that was still currently experiencing the pain and muscle weakness. Additional information has been requested.
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Dizziness, Injection site pain, Injection site swelling, Local swelling, Pyrexia
Clinical narrative: Patient stated that pain developed around injection site within 30 minutes of administration. After an hour, the skin around the site began to swell. For the rest of the day, patient complained of one-sided "swelling" feeling on her nerve on the same side as the site. Patient felt "lightheaded and dizzy" during the rest of that day. Also reported mild fever.
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site reaction, Injection site swelling, Injection site warmth, Muscle atrophy
Clinical narrative: This spontaneous report as received from a pharmacist via company representative refers to a female patient of unknown age. Current conditions and medical history was not reported. On an unknown date approximately in 2013 (reported as last year) the patient was vaccinated with PNEUMOVAX 23 1 shot of injection. Concomitant medications were not reported. On an unknown date, after PNEUMOVAX 23 administration patient complained of swelling, redness and feeling hot at the injection site, and the pharmacist saw that there was a muscle indentation at the injection site. The patient was treated with BENADRYL and compresses. The outcome of the events was reported as recovered on an unknown date. Causality assessment was not reported. Patient sought unspecified medical attention. Product quality complaint was not reported. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to 10 patients of unknown age and gender. On an unknown date those patients were inadvertently vaccinated with MMR II (albumin status, dose, units, route of administration, anatomical location, lot number were not reported) that had been improperly stored. No adverse effects reported. Additional information is not expected because the reporter refused to be contacted.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and office manager and refers to patient of unknown age and gender. On 09-SEP-2014 the patient was vaccinated with PEDVAXHIB (lot # K000331, expiry 23-OCT-2016, dose, dose # and route unspecified), that was exposed to temperatures outside the proper storage range on unspecified dates. No adverse effect reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age and gender. Information about concurrent conditions and medical history was not provided. On 15-OCT-2014 the patient was vaccinated with an expired M-M-R II lot # H018181, dose 0.5 ml, expiration date 05-OCT-2014, route subcutaneous. Co-suspect and concomitant therapies were not reported. No adverse effects were reported. Additional information is not expected because the reporter did not want to be contacted.
Age: 0.66
Sex: F
Vaccine: HEP
Symptoms: Hepatitis B surface antibody negative
Clinical narrative: This spontaneous report as received from a healthcare professional refers to a 1 day old non-pregnant female patient with no pertinent medical history, current conditions or drug reactions or allergies. On 19-APR-1995, the patient was vaccinated with the first dose of RECOMBIVAX HB (40 microgram/mL, intramuscular injection, dose 1, route, anatomical location, batch/lot # and expiration date not reported). On 12-JUN-1995 the patient was vaccinated with the second dose of RECOMBIVAX HB (40 microgram/mL, intramuscular injection, dose 2, route, anatomical location, batch/lot # and expiration date not reported). On 15-DEC-1995 the patient was vaccinated with the third dose of RECOMBIVAX HB (40 microgram/mL, intramuscular injection, dose 3, route, anatomical location, batch/lot # and expiration date not reported). There were no concomitant medications. On 16-JUN-2014, titers were ran for the patient and the results came back "nonreactive" (exact values and units not provided). No treatment was given for the adverse event. Outcome of the event was reported as not recovered. Causality assessment was not provided by the reporter. Additional information has been requested.
Age: 51.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Erythema of eyelid, Eyelids pruritus, Injection site erythema, Injection site haematoma
Clinical narrative: Injection given - 10/22/14. Developed erythema/hematoma around injection site -10/24/14. Developed erythema and pruritus around left eye 10/25/14.
Age: 51.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Erythema of eyelid, Injection site erythema, Injection site haematoma
Clinical narrative: Injection given - 10/22/14. Developed erythema/hematoma around injection site -10/24/14. Developed erythema and pruritus around left eye 10/25/14.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and office manager and refers to patient of unknown age and gender. On 09-SEP-2014 the patient was vaccinated with PEDVAXHIB (lot # K000331, expiry 23-OCT-2016, dose, dose # and route unspecified), that was exposed to temperatures outside of the proper storage range on unspecified dates. No adverse effect reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 12.0
Sex: M
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site macule
Clinical narrative: 2 in diameter erythematous macules, one on each upper arm with induration.
Age: 65.0
Sex: F
Vaccine: PPV, FLU3, PPV
Symptoms: Injection site cellulitis
Clinical narrative: 10-17-14 patient's (R) upper arm swelling and had redness since 3pm. Warm to the touch since 2pm. Swelling increased to the patient's axilla area. No redness, tenderness, or warmth on the deltoid area where the vaccine was administered. Patient sent to ER for further evaluation.
Age: 65.0
Sex: F
Vaccine: PPV, FLU3, PPV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Oedema peripheral
Clinical narrative: 10-17-14 patient's (R) upper arm swelling and had redness since 3pm. Warm to the touch since 2pm. Swelling increased to the patient's axilla area. No redness, tenderness, or warmth on the deltoid area where the vaccine was administered. Patient sent to ER for further evaluation.
Age: 64.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Injection site mass, Injection site pain, Insomnia, Mobility decreased, Pain in extremity
Clinical narrative: This spontaneous report was received from a consumer and refers to herself as an approximately 64 year old female patient. The patient's medical history included open heart surgery on an unknown date in 2004. On an unknown date approximately in 2009 (reported as 5 years ago), the patient was vaccinated with PNEUMOVAX 23 without any side effects. On 09-SEP-2014 the patient was re-vaccinated with PNEUMOVAX 23 (dose and route unknown). Concomitant therapies included metoprolol, ZOCOR, furosemide and lisinopril (manufacturer unknown). On 09-SEP-2014, the patient couldn't move her hand and that she experienced paralysis that evening (disability, hospitalisation and medically significant) and her arm started to hurt (disability and hospitalization) right after the vaccination. The patient stated that she could barely move her hand for 3 days. On 09-SEP-2014, the patient went to the emergency room for her pain and stayed till 10-SEP-2014. On 09-SEP-2014, the patient also reported that her blood pressure was high because of the pain. The outcome of the events was reported as recovering. The causality was unknown. Upon internal review the event paralysis was determined to be medically significant. Additional information has been requested.
Age: 64.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Hypertension, Immediate post-injection reaction, Mobility decreased, Pain in extremity, Paralysis
Clinical narrative: This spontaneous report was received from a consumer and refers to herself as an approximately 64 year old female patient. The patient's medical history included open heart surgery on an unknown date in 2004. On an unknown date approximately in 2009 (reported as 5 years ago), the patient was vaccinated with PNEUMOVAX 23 without any side effects. On 09-SEP-2014 the patient was re-vaccinated with PNEUMOVAX 23 (dose and route unknown). Concomitant therapies included metoprolol, ZOCOR, furosemide and lisinopril (manufacturer unknown). On 09-SEP-2014, the patient couldn't move her hand and that she experienced paralysis that evening (disability, hospitalisation and medically significant) and her arm started to hurt (disability and hospitalization) right after the vaccination. The patient stated that she could barely move her hand for 3 days. On 09-SEP-2014, the patient went to the emergency room for her pain and stayed till 10-SEP-2014. On 09-SEP-2014, the patient also reported that her blood pressure was high because of the pain. The outcome of the events was reported as recovering. The causality was unknown. Upon internal review the event paralysis was determined to be medically significant. Additional information has been requested.
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Influenza
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of influenza like symptoms in a adult female patient who received Influenza vaccine. On an unknown date, the patient received Influenza vaccine (unknown). On an unknown date, an unknown time after receiving Influenza vaccine, the patient experienced influenza like symptoms. On an unknown date, the outcome of influenza like symptoms was unknown. It was unknown if the reporter considered the influenza like symptoms to be related to Influenza vaccine. Additional details: Patient's mother reported that at least once, maybe twice, her daughter had influenza after receiving the influenza vaccination. She does not know what brand her daughter received that/those year(s), or what year(s) this occurred. The influenza symptoms were less severe that the case she has last year, when she had influenza before receiving the vaccination. This case was linked to case US2014GSK010135 as it refers to the same patient.
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Influenza like illness
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of influenza like symptoms in a adult female patient who received Influenza vaccine. On an unknown date, the patient received Influenza vaccine (unknown). On an unknown date, an unknown time after receiving Influenza vaccine, the patient experienced influenza like symptoms. On an unknown date, the outcome of influenza like symptoms was unknown. It was unknown if the reporter considered the influenza like symptoms to be related to Influenza vaccine. Additional details: Patient's mother reported that at least once, maybe twice, her daughter had influenza after receiving the influenza vaccination. She does not know what brand her daughter received that/those year(s), or what year(s) this occurred. The influenza symptoms were less severe that the case she has last year, when she had influenza before receiving the vaccination. This case was linked to case US2014GSK010135 as it refers to the same patient.
Age: 37.0
Sex: F
Vaccine: FLUX
Symptoms: Autoimmune thyroiditis, Urticaria
Clinical narrative: Urticaria, onset of Hashimoto's thyroiditis.
Age: 41.0
Sex: F
Vaccine: FLUC3
Symptoms: Dyspnoea, Injection site erythema, Injection site inflammation, Injection site pruritus, Injection site urticaria
Clinical narrative: Injection site was red, inflamed, approximately 5 mm wheel and patient reported itching at site.   Patient also had shortness of breath and wheezing. Used albuterol inhaler for wheezing/shortness of breath and given diphenhydramine/Zyrtec.  Patient given prescription for Advair 100/50 to resume therapy and prednisone dose pack.  Wheezing resolved 12 hours post injection.
Age: 41.0
Sex: F
Vaccine: FLUC3
Symptoms: Wheezing
Clinical narrative: Injection site was red, inflamed, approximately 5 mm wheel and patient reported itching at site.   Patient also had shortness of breath and wheezing. Used albuterol inhaler for wheezing/shortness of breath and given diphenhydramine/Zyrtec.  Patient given prescription for Advair 100/50 to resume therapy and prednisone dose pack.  Wheezing resolved 12 hours post injection.
Age: 65.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Abasia, Body temperature increased, Chills, Headache, Moaning
Clinical narrative: Took to ER.  Temp 103 vomiting, chills, headache to the point he was moaning, shaking to the point he could not walk.  ER gave him shots of morphine for headache.  Hands and feet ice cold.
Age: 65.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Peripheral coldness, Tremor, Vomiting
Clinical narrative: Took to ER.  Temp 103 vomiting, chills, headache to the point he was moaning, shaking to the point he could not walk.  ER gave him shots of morphine for headache.  Hands and feet ice cold.
Age: 37.0
Sex: F
Vaccine: FLU3
Symptoms: Activities of daily living impaired, Exposure during pregnancy, Hypoaesthesia, Laboratory test, Musculoskeletal disorder
Clinical narrative: Flu vaccine given in right am and 5 days later woke up with pain in left bicep, muscle soreness, dificulty using both hands, numbness and tingling.
Age: 37.0
Sex: F
Vaccine: FLU3
Symptoms: Myalgia, Pain in extremity, Paraesthesia
Clinical narrative: Flu vaccine given in right am and 5 days later woke up with pain in left bicep, muscle soreness, dificulty using both hands, numbness and tingling.
Age: 83.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Headache, Hyperhidrosis
Clinical narrative: RN called to pt's bedside d/t pt's c/o dizziness/headache and diaphoresis. Pt's vital signs stable on assessment. No rash noted. Pt declined nausea/vomiting. Frequent vitals assessed. Drs notified. Order received to medicate pt. Benadryl 25 mg po given and Tylenol 650 mg po given. Pt remained on constant observation. Pt voiced relief after an hour and half of monitoring.
Age: 46.0
Sex: F
Vaccine: FLU3
Symptoms: Rash, Urticaria
Clinical narrative: Pt broke out with hives/rash a day later after eating egg products. Had no history of egg allergy before vaccination.
Age: 31.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site pain, Urticaria
Clinical narrative: Shoulder and arm where shot was administered was extremely sore. Began breaking out in hives on arms, legs, and back.  Took Zyrtec (cetirizine) - 10mg as a histamine blocker to treat hives overnight.  They only got worse and within 24hrs covered my entire body.  Began taking Benadryl (Diphenhydramine) - 25mg, which reduced the swelling of the hives significantly.
Age: 34.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Injection site erythema, Injection site pruritus, Injection site swelling, Pruritus
Clinical narrative: I am a nurse at the clinic and administered my own flu shot in my left VL.  Within 10-15 minutes I developed itching and a red, raised area at the injection site.  Within two hours of the injection, the area became significantly raised, red and aprox 6 inches in diameter.  The skin of my neck and torso also became uniformly red and slightly itchy.  I also developed very mild wheezing.  I took loratidine 10mg and Benadryl 50mg orally.  The wheezing and torso symptoms resolved with this treatment.  The injection site symptoms are slowly resolving.
Age: 34.0
Sex: F
Vaccine: FLU4
Symptoms: Wheezing
Clinical narrative: I am a nurse at the clinic and administered my own flu shot in my left VL.  Within 10-15 minutes I developed itching and a red, raised area at the injection site.  Within two hours of the injection, the area became significantly raised, red and aprox 6 inches in diameter.  The skin of my neck and torso also became uniformly red and slightly itchy.  I also developed very mild wheezing.  I took loratidine 10mg and Benadryl 50mg orally.  The wheezing and torso symptoms resolved with this treatment.  The injection site symptoms are slowly resolving.
Age: 53.0
Sex: F
Vaccine: TDAP
Symptoms: Aphagia, Arthritis, Borrelia test negative, General physical health deterioration, Laboratory test normal
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of couldn't eat in a 53-year-old female patient who received BOOSTRIX (batch number AC52B054BA, expiry date March 2012). Concomitant products included Herbs and Vitamins. On 19th August 2010, the patient received BOOSTRIX (injection). On an unknown date, an unknown time after receiving BOOSTRIX, the patient experienced couldn't eat (serious criteria GSK medically significant), decline in health and joints inflamed. BOOSTRIX was continued with no change. On an unknown date, the outcome of the couldn't eat, decline in health and joints inflamed were recovering/resolving. It was unknown if the reporter considered the couldn't eat, decline in health and joints inflamed to be related to BOOSTRIX. Additional details: Caller reports that she received a Tdap vaccine that was manufactured by GSK in August of 2010, after that vaccination she began to experience a decline in her health. She states she couldn't eat and her joints were inflamed. She didn't go to the hospital but states most people probably would have. She did notify her physician who ran lab tests, Lyme disease test and a pH study but reports all were negative. She wouldn't elaborate but states that she made some lifestyle changes but didn't take medications. The issues have improved but not resolved completely. Caller was not able to provide exact onset of symptoms date. She denied any medical history noting she was healthy. She states she may have been taking a vitamin or herb supplement but not sure. Caller didn't know the amount of vaccine or where it was given on her body.
Age: 53.0
Sex: F
Vaccine: TDAP
Symptoms: pH body fluid normal
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of couldn't eat in a 53-year-old female patient who received BOOSTRIX (batch number AC52B054BA, expiry date March 2012). Concomitant products included Herbs and Vitamins. On 19th August 2010, the patient received BOOSTRIX (injection). On an unknown date, an unknown time after receiving BOOSTRIX, the patient experienced couldn't eat (serious criteria GSK medically significant), decline in health and joints inflamed. BOOSTRIX was continued with no change. On an unknown date, the outcome of the couldn't eat, decline in health and joints inflamed were recovering/resolving. It was unknown if the reporter considered the couldn't eat, decline in health and joints inflamed to be related to BOOSTRIX. Additional details: Caller reports that she received a Tdap vaccine that was manufactured by GSK in August of 2010, after that vaccination she began to experience a decline in her health. She states she couldn't eat and her joints were inflamed. She didn't go to the hospital but states most people probably would have. She did notify her physician who ran lab tests, Lyme disease test and a pH study but reports all were negative. She wouldn't elaborate but states that she made some lifestyle changes but didn't take medications. The issues have improved but not resolved completely. Caller was not able to provide exact onset of symptoms date. She denied any medical history noting she was healthy. She states she may have been taking a vitamin or herb supplement but not sure. Caller didn't know the amount of vaccine or where it was given on her body.
Age: 10.0
Sex: F
Vaccine: FLU3
Symptoms: Abasia, Myalgia, Pyrexia
Clinical narrative: This case was reported by a pharmacist and described the occurrence of can't walk in a 10-year-old female patient who received FLUARIX TETRA (batch number 7S75Y, expiry date 30th June 2015). Previously administered products included influenza vaccine. On 15th October 2014, the patient received FLUARIX TETRA. On 16th October 2014, 1 days after receiving FLUARIX TETRA, the patient experienced can't walk (serious criteria disability and GSK medically significant), fever (serious criteria disability) and loss of muscle soreness (serious criteria disability). On an unknown date, the outcome of the can't walk, fever and loss of muscle soreness were not recovered/not resolved. It was unknown if the reporter considered the can't walk, fever and loss of muscle soreness to be related to FLUARIX TETRA. Additional information: The patient had no relevant medical history. The patient didn't experience any event after the previous influenza vaccination. There was no concomitant medication. The vaccine was administered between 7 and 10 PM. On 16 October 2014, the patient called her mother from school and stated her body temperature was 99 Deg. F. The patient consulted a health care professional.
Age: 11.0
Sex: F
Vaccine: FLUX
Symptoms: Activities of daily living impaired, Headache, Pyrexia
Clinical narrative: HIGH FEVER 104.7F ACCOMPANIED BY HEADACHE FIRST DAY, ADMINISTERED MOTRIN EVERY 6 HOURS AND FEVER HOVERED BETWEEN 101F & 102F, GAVE CHILD ICE-WATER & JUICE TO DRINK, FED COLD FOODS AND KEPT HOME FROM SCHOOL FOR 2 DAYS UNTIL FEVER BROKE.
Age: 32.0
Sex: F
Vaccine: FLU3
Symptoms: Injected limb mobility decreased, Pain in extremity
Clinical narrative: 32 year old female presents ambulatory to clinic with complaints of a sore left arm. Patient states that it became sore after she got the flu shot on 10/03/2014. She states it has slowly gotten worse to where she has a hard time moving arm. Patient has been taking Tylenol.
Age: 57.0
Sex: F
Vaccine: FLUX
Symptoms: Hypersensitivity
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of allergic reaction in a 57-year-old female patient who received Influenza vaccine. Concurrent medical conditions included latex allergy. In 2013, the patient received Influenza vaccine. On an unknown date, an unknown time after receiving Influenza vaccine, the patient experienced allergic reaction (serious criteria life threatening). On an unknown date, the outcome of the allergic reaction was recovered/resolved. It was unknown if the reporter considered the allergic reaction to be related to Influenza vaccine. Additional details: The name of the flu vaccine (Lot/expiry date) and the manufacturer's name were unknown. The dosage given was unknown. Date vaccine was given was unknown. The reporter was unaware if other vaccines were given. The date of adverse event was unknown. The time frame after receiving vaccine and start of allergic reaction was unknown. Per the reporter, the patient was told the allergic reaction was to latex being on the syringe. It was unknown if the patient was hospitalization.
Age: 73.0
Sex: M
Vaccine: FLU3
Symptoms: Ecchymosis, Injection site haemorrhage
Clinical narrative: Diffuse ecchymosis - left arm from deltoid to mid forearm.
Age: 32.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Rec'd vaccine approx 11:15 AM today. At 7:45 PM reports swelling (starts arm double size), redness, pain and heat at site. No previous rxn to vaccines, only allergic to PCN, denied rash, breathing problems, dizziness or any other symptoms. Recommenced IBU, ice, BENADRYL and see a Dr.
Age: 2.0
Sex: M
Vaccine: FLU4
Symptoms: Incorrect dose administered
Clinical narrative: On 10-14-14 pt was given 0.5 ml of the quadrivalent influenza vaccine in the left deltoid. Patient was supposed to be given 0.25 ml of the influenza vaccine due to his age.
Age: 38.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain
Clinical narrative: Continued pain at injection site for 3 weeks. Ice, heat, TYLENOL.
Age: 25.0
Sex: M
Vaccine: FLU3
Symptoms: Loss of consciousness
Clinical narrative: Patient passed out for 30 seconds about 30 minutes after receiving his vaccination.
Age: 48.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Feeling abnormal, Muscular weakness, Myalgia, Pain in extremity
Clinical narrative: 1st had strange sensation in head (2 days) - everything was amplified and overall weakness and muscle weakness. Pins and needles - started on legs - spread to whole body. Arms got very sore - muscle ache.
Age: 48.0
Sex: F
Vaccine: FLU3
Symptoms: Paraesthesia
Clinical narrative: 1st had strange sensation in head (2 days) - everything was amplified and overall weakness and muscle weakness. Pins and needles - started on legs - spread to whole body. Arms got very sore - muscle ache.
Age: 2.0
Sex: F
Vaccine: FLU3
Symptoms: Aggression, Fall, Psychomotor hyperactivity
Clinical narrative: Ever since received xxxx vaccine 10/22/14. Since then  xxx, xxx, falling a lot and xxxx or throwing things, hyperactive but agreeable.
Age: 73.0
Sex: M
Vaccine: FLU3
Symptoms: Chest X-ray abnormal, Death, Fungal test positive, Gun shot wound, Influenza A virus test negative
Clinical narrative: Patient ended up hospitalized 3 days later with severe pneumonia he was hospitalized on 9/25/14 and placed in ICU. He signed out AMA on 9/26/14 and died of self inflicted gun shot.
Age: 73.0
Sex: M
Vaccine: FLU3
Symptoms: Influenza B virus test, Influenza virus test negative, Intensive care, Intentional self-injury, Pneumonia
Clinical narrative: Patient ended up hospitalized 3 days later with severe pneumonia he was hospitalized on 9/25/14 and placed in ICU. He signed out AMA on 9/26/14 and died of self inflicted gun shot.
Age: 73.0
Sex: M
Vaccine: FLU3
Symptoms: Sputum abnormal, White blood cell count increased
Clinical narrative: Patient ended up hospitalized 3 days later with severe pneumonia he was hospitalized on 9/25/14 and placed in ICU. He signed out AMA on 9/26/14 and died of self inflicted gun shot.
Age: 51.0
Sex: F
Vaccine: FLU3
Symptoms: Pruritus generalised, Rash, Urticaria
Clinical narrative: Approximately 1 hr. after receiving vaccine developed generalized itching and hives rash to face, neck, and cheeks.
Age: 1.01
Sex: M
Vaccine: FLU3, VARCEL
Symptoms: Expired drug administered, No adverse event
Clinical narrative: No adverse events other than the FLUZONE that was given expired 6/22/14.
Age: 0.37
Sex: F
Vaccine: DTAP, HIBV, RV1
Symptoms: Eosinophil percentage increased, Erythema multiforme, Haematocrit normal, Haemoglobin normal, Metabolic function test normal
Clinical narrative: ERYTHEMA MULTIFORME MINOR.
Age: 0.37
Sex: F
Vaccine: DTAP, HIBV, RV1
Symptoms: Platelet count normal, Red blood cell sedimentation rate increased, White blood cell count normal
Clinical narrative: ERYTHEMA MULTIFORME MINOR.
Age: 34.0
Sex: M
Vaccine: FLU3
Symptoms: Blood culture, CSF test, Culture urine, Electromyogram, Full blood count
Clinical narrative: Fever 101.8, myalgias, headache, vomiting. Ascending weakness and numbness of upper and lower extremeties following influenza vaccine 2 days prior.
Age: 34.0
Sex: M
Vaccine: FLU3
Symptoms: Headache, Hypoaesthesia, Laboratory test, Muscular weakness, Myalgia
Clinical narrative: Fever 101.8, myalgias, headache, vomiting. Ascending weakness and numbness of upper and lower extremeties following influenza vaccine 2 days prior.
Age: 34.0
Sex: M
Vaccine: FLU3
Symptoms: Nerve conduction studies, Pyrexia, Sputum culture, Vomiting
Clinical narrative: Fever 101.8, myalgias, headache, vomiting. Ascending weakness and numbness of upper and lower extremeties following influenza vaccine 2 days prior.
Age: 34.0
Sex: F
Vaccine: FLU3
Symptoms: Axillary pain, Carpal tunnel syndrome, Injection site erythema, Injection site oedema, Injection site warmth
Clinical narrative: Pain in left axilla and paresthesia down left FA into 2nd, 3rd and 4th digit. Reports a carpel tunnel like feeling. Fingers feel colder to patient. Symptoms began upon waking in the morning. Denies icing or taking ibuprofen. Doesn't recall sleeping awkwardly on left arm. Patient counseled to take Iburofen and ice injection site and to call if symptoms do not resolve. Exam did not reveal any abnormalities or enlarged nodes in axilla or comparable difference in temperature of fingers to other side. Exam noted erythema, mild edema and warmth at injection site.
Age: 34.0
Sex: F
Vaccine: FLU3
Symptoms: Paraesthesia, Peripheral coldness
Clinical narrative: Pain in left axilla and paresthesia down left FA into 2nd, 3rd and 4th digit. Reports a carpel tunnel like feeling. Fingers feel colder to patient. Symptoms began upon waking in the morning. Denies icing or taking ibuprofen. Doesn't recall sleeping awkwardly on left arm. Patient counseled to take Iburofen and ice injection site and to call if symptoms do not resolve. Exam did not reveal any abnormalities or enlarged nodes in axilla or comparable difference in temperature of fingers to other side. Exam noted erythema, mild edema and warmth at injection site.
Age: 47.0
Sex: M
Vaccine: FLU3
Symptoms: Breast pain, Breast swelling, Erythema, Lymph node pain, Lymphadenopathy
Clinical narrative: 1) Swollen and painful breasts (under each nipple) with slight redness. 2) Swollen and painful nodes under both arms (3-5 swollen nodes in each armpit).