chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Information has been received regarding a case in litigation, from a lawyer, concerning a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On an unspecified date in 2014, the patient was vaccinated with ZOSTAVAX, due to health care professional recommendation, for permanent prevention and protection against shingles and zoster-related injuries (prophylaxis) (strength, anatomical location, dose, route of administration, lot # and expiration date were not provided). On an unknown date, on or about 2016, the patient was treated by a physician for shingles, as the patient was diagnosed with shingles or other related injuries after and despite being inoculated with the ZOSTAVAX vaccine, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. As a direct and proximate result of the ZOSTAVAX vaccine, the patient had and would continue suffer ongoing injuries, included but not limited to: mental and physical pain and suffering, extensive medical care and treatment for these injuries; significant medical an related expenses as a result of these injuries, included but not limited to medical losses and cost include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions. At the time of report, the patient was not recovered from emotional distress, injury and pain. The outcome of vaccination failure, quality of life decreased, herpes zoster and the pre-existing unspecified conditions aggravated was unknown. The reporter considered the events to be disabling, life-threatening and medically significant.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Peripheral swelling, Skin warm
Clinical narrative: Customer called on Wed 12/5 to report that her arm his red, swollen and warm to the touch. It has been that way since Tuesday, she only received the vaccine 2 days ago and sometimes these symptoms subside after a few days. She has been taking ibuprofen for the swelling.
Age: 20.0
Sex: F
Vaccine: HEP
Symptoms: Cold sweat, Headache, Hot flush, Vomiting
Clinical narrative: Patient began vomiting 30 minutes after injection. Stated was clammy and having hot flashes. Then complained of having a headache. At 1400 Patient stated felt no side effects.
Age: 1.08
Sex: M
Vaccine: DTAPIPVHIB, HEPA, MMRV, PNC13
Symptoms: Ear discomfort, Pyrexia, Rash
Clinical narrative: Parent called on 12/5/18 to report child had developed fever on 11/30/18 in the evening. Child continued to run fever until 12/4/18, on morning of 12/5/18, child woke with rash on shoulder that traveled up neck to head. Child rubbing at ears on morning of 12/5/18 but no complaints of fever.
Age: 34.0
Sex: F
Vaccine: FLU3, HEP, PPV
Symptoms: Chills, Mobility decreased, Pain in extremity, Rash, Swelling
Clinical narrative: Severe pain, rash, swelling, teeth chattering, shivering. Patient states the pain and rash started about an hour after she received the vaccine. She was unable to dress undress or dress her self because the pain in her arm was so bad. This morning the patient rated her pain at 10/10. Patient did use TYLENOL to try to resolve symptoms. Denies fever.
Age: 23.0
Sex: F
Vaccine: VARCEL
Symptoms: Erythema, Induration, Pruritus, Tenderness
Clinical narrative: Red itchy area that had a firm center and was tender to the touch.
Age: 55.0
Sex: M
Vaccine: VARZOS
Symptoms: Discomfort, Malaise, Oropharyngeal pain, Pain in jaw
Clinical narrative: I took shingle vaccine first dose on 08/2018 and second dose on 11/2018. I am developing a very strong throat pain, discomfort on my body, jaw pain. It bothers me because I am feeling so sick.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Bed rest, Chills, Pain, Pyrexia
Clinical narrative: Severe body aches, chills, fever lasting two days, required bed rest.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Peripheral swelling, Skin warm
Clinical narrative: Swelling, red and warm to touch on whole upper arm.
Age: 72.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site rash, Injection site streaking, Malaise
Clinical narrative: PATIENT RECEIVED 2 VACCINATIONS IN SAME ARM AS LISTED ABOVE ON 12/1/2018. REPORTED ON PHARMACY ON 12/4/2018 OF NOT FEELING WELL AFTER GETTING VACCINATION AND DEEP RED STREAKING RASH FROM ARM FROM INJECTION SITE. PATIENT WAS ADVISED TO FOLLOW UP WITH MEDICAL OFFICE TO GET SITE LOOKED AT AND SAID MAY DO SO ON THE MORNING OF 12/5/2018. PATIENT REPORTED WOULD LET PHARMACY KNOW OF OUTCOME, BUT HAVE NOT HEARD BACK AFTER PHONE CALL WITH MESSAGE LEFT 12/5/2018 AM. PATIENT REPORTED THAT HE THOUGHT HE WAS FEELING BETTER AT TIME OF REPORTING EVENT.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Pain, Pain in extremity
Clinical narrative: Patient states that she experienced pain immediately upon administration and has had a throbbing/shooting pain ever since that radiates down her left arm and up to her shoulder. Patient was referred to her MD for diagnosis.
Age: 82.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Tremor
Clinical narrative: Day of (at midnight) patient had began to experience chills and shaking, next day extreme fatigue, next day symptoms resolved.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Pain in extremity
Clinical narrative: Lost of strength in left arm. Symptoms improve after a few days, however when working out the arm becomes extremely sore as if the vaccine was given again.
Age: 3.0
Sex: F
Vaccine: FLU4
Symptoms: Oxygen saturation normal, Urticaria
Clinical narrative: Pt was here for RN visit for flu vaccine; rec'd it without event and then, on way down in elevator, parents noted hives and brought her right back to clinic. Went in to see pt - she was in NAD, 100% O2 sat, sitting on mom's lap; OP clear, lungs CTA without wheezing and heart with RRR and no murmurs; no lip swelling; hives appreciated on neck and face but nowhere else. Per mom, pt doing well other than a recent URI which has resolved. No other concerns prior to flu vaccine. On review of record, pt did receive BENADRYL once before in clinic at last visit on 2/28/18 for pruritis and hives (no vaccines at that visit); per mom, no add'l doses given at home after that visit. BENADRYL 12.5 mg x 1 given in clinic. VS remained WNL (O2 sat always >98%) throughout 30+ minute observation and hives almost completely resolved and no additional sx occurred. Never any mucosal involvement or breathing difficulties - OP remained clear and nml lung exam. She remained in triage room coloring and interacting with parents. As hives had all but resolved, decision to discharge home with Rx for BENADRYL to be given Q6hrs as needed at home. Parents advised that if she develops any e/o anaphylaxis (lip swelling, difficulty breathing), that they are to call 911 and head to ED. Additionally, due to proximity to flu vaccine, referral placed to allergy for input and recs.
Age: 8.0
Sex: M
Vaccine: FLU3
Symptoms: Asthenia, Syncope
Clinical narrative: PATIENT FAINTED MINUTES AFTER VACCINE AND WAS WEEK AFTERWARDS.
Age: 74.0
Sex: M
Vaccine: FLU4
Symptoms: Cardiac stress test normal, Extrasystoles, Heart rate increased, Hyperhidrosis, Laboratory test normal
Clinical narrative: Starting on 10/14/2018 my heart started skipping beats every 4-20 beats with episodes lasting up to 90 minutes daily. On 10/21/2018 episodes were ongoing throughout the day. At 4 AM on 10/22/18 I woke with a very fast heart rate and sweating profusely. At 4:30 AM my blood pressure was 155/80 with a 95 heart rate (my normal is 55 to 60). At 5 AM I called 911 and asked for medical help. I was transported to the emergency room where tests were run confirming that I did not have a heart attack. A subsequent stress test by Doctor showed no issues of concern. Since the emergency room visit I have not had any heart irregularities as of today 12/5/2018. I have not had severe reactions to flu shots previously other than very sore arm.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Injection site pain, Nausea
Clinical narrative: Woke up feeling fine other than a sore arm at the injection site. Around 9 am began feeling very tired, whole body seemed to ache. Headache and nausea. Slept for 2 1/2 hours. Less tired. Body aches continued. Chills. Took ibuprophen through the day.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: Woke up feeling fine other than a sore arm at the injection site. Around 9 am began feeling very tired, whole body seemed to ache. Headache and nausea. Slept for 2 1/2 hours. Less tired. Body aches continued. Chills. Took ibuprophen through the day.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Swelling
Clinical narrative: Large area of erythema, swelling 17x10 in.
Age: 54.0
Sex: M
Vaccine: FLU4
Symptoms: Generalised tonic-clonic seizure, Myoclonus, Syncope, Unresponsive to stimuli
Clinical narrative: Known history of vasovagal syncope following prior phlebotomy and vaccinations. Following administration of his seasonal influenza vaccine today at 1012 patient experienced an episode of vasovagal syncope and was unresponsive for 10 minutes; during this time he exhibited varying episodes of myoclonic jerks and tonic-clonic activity which resolved spontaneously. No loss of bowel or bladder control. No signs/symptoms consistent with an immediate hypersensitivity/IgE-mediated systemic reaction and his vital signs remained unremarkable and stable during this time. He regained consciousness and was alert and conversant following this episode. He was observed for 60 minutes and was stable and asymptomatic at discharge from the clinic at 1025 today.
Age: 79.0
Sex: M
Vaccine: VARZOS
Symptoms: Hypoaesthesia, Muscle spasms
Clinical narrative: WAVES OF NUMBNESS AND CRAMP EVERY FEW MINUTES.
Age: 2.0
Sex: M
Vaccine: DTAP, FLU4, HEPA, HIBV, MMR, PNC13, VARCEL
Symptoms: Nasal congestion, Pyrexia, Swelling face, Urticaria
Clinical narrative: Hives on bilateral legs about 48 hours after vaccination. Fever and "puffy face" 4 days after vaccination. Seen in office the next day. Fever 100.7 unmedicated. Hives upper thighs, anterior trunk, left side of face, and bilateral arms, possible targetoid rash right arm. Possible erythema multiforme vs urticaria. Also some mild viral symptoms including nasal congestion. Rash possibly vaccine related, more likely viral.
Age: 12.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Patient has a red warm area at injection site. Area measures 2 inch wide  and 1.5 inches long on 12/5/18. Mom was advised to monitor area closely. Use ice and Motrin for pain and discomfort. Return to office or call if this worsens.
Age: 33.0
Sex: F
Vaccine: FLU4
Symptoms: Inflammation, Injection site pain, Joint range of motion decreased, Loss of personal independence in daily activities, Muscular weakness
Clinical narrative: Approximately 2 hours after receiving the flu shot I began to have severe pain in my left arm at the injection site. This pain still hasn't gone away. It is affecting my daily life, it wakes me up at night, it limits my activities of daily living and my performance at my job.
Age: 33.0
Sex: F
Vaccine: FLU4
Symptoms: Sleep disorder, X-ray normal
Clinical narrative: Approximately 2 hours after receiving the flu shot I began to have severe pain in my left arm at the injection site. This pain still hasn't gone away. It is affecting my daily life, it wakes me up at night, it limits my activities of daily living and my performance at my job.
Age: 46.0
Sex: F
Vaccine: TDAP
Symptoms: Contusion, Pain, Pain in extremity, Swelling, Urticaria
Clinical narrative: Large bruise developed along with a hive like patch that was raised below the bruise. Extreme pain when trying to lift arm above head or behind back. Began about 1 week after vaccination. Returned about 2 weeks after vaccine to show pharmacist. Swelling went down after about a month, bruising lasted 2 weeks.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Arthralgia, Headache, Myalgia
Clinical narrative: Extreme muscle and joint pain, headache, stomach cramps.
Age: 71.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Myalgia, Urine analysis normal
Clinical narrative: Patient woke morning after injection with muscular aches that worsened throughout the day to become localized in the lower back region of the spine. Patient tried to rest and recover a few days before finally going to primary care doctor for treatment.
Age: 71.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Back pain, Dysstasia, Influenza like illness, Pain, Urine analysis normal
Clinical narrative: Patient woke morning after injection with muscular aches that worsened throughout the day to become localized in the lower back region of the spine. Patient tried to rest and recover a few days before finally going to primary care doctor for treatment.
Age: 71.0
Sex: F
Vaccine: FLUA3, FLUA3
Symptoms: Oral pruritus, Throat irritation
Clinical narrative: The patient received FLUAD IM vaccine on 12/5/18 at approximately 11:40 AM. At 12:00 PM, the patient stated that she had an itchy throat/tongue but no trouble breathing or injection site reaction. I gave patient a 12.5 mg dose of diphenhydramine oral solution at 12:05 PM as patient stated she is extremely sensitive to BENADRYL and I would monitor her in case we needed to administer more. At 12:10 PM, the patient stated that she was not feeling any worse and was having no issues breathing or talking. She still had some itchiness/tickling in the back of her throat but airway was ok. At 12:15 PM, patient continued to improve and still had no issues breathing or swelling of throat or tongue. Throat was slightly itchy, but no worsening of symptoms reported. I sat with patient and husband from approximately 12:20 PM to 12:35 PM to continue to monitor situation and patient continued to improve with no worsening, but improvement in symptoms. At 12:35 PM, patient felt better and safe to go home with husband. I counseled both husband and patient to look out for signs/symptoms of anaphylactic reactions and to go to hospital if trouble breathing or severe swelling occurred. I called patient at home at 4:11 PM and verified that she is doing better and feels like her normal self with no further adverse reactions to report.
Age: 4.0
Sex: M
Vaccine: FLU4
Symptoms: Febrile convulsion
Clinical narrative: FEBRILE SEIZURE.
Age: 54.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Chills, Induration, Mass, Pain, Pain in extremity
Clinical narrative: Nurse hit a vein, arm now sore, hard and hot lump, very painful. Fever and chills, achiness.
Age: 54.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Pyrexia, Skin warm
Clinical narrative: Nurse hit a vein, arm now sore, hard and hot lump, very painful. Fever and chills, achiness.
Age: 54.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Erythema, Injection site cellulitis, Injection site irritation, Injection site joint pain, Injection site pain
Clinical narrative: Nurse hit a vein, arm now sore, hard and hot lump, very painful. Fever and chills, achiness.
Age: 54.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site swelling, Injection site warmth, Pain in extremity, Vaccine positive rechallenge
Clinical narrative: Nurse hit a vein, arm now sore, hard and hot lump, very painful. Fever and chills, achiness.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Fever of 104 degrees F.
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling, Pain in extremity
Clinical narrative: Patient noticed pain in the right arm the next day and also redness and swelling around the injection site. The redness and swelling spread down the arm to the elbow joint and wrapped around the arm. The pain and the redness and swelling resolved within a few days and she was fine. She did not see a medical doctor.
Age: 66.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site cellulitis, Rash, Rash morbilliform
Clinical narrative: Cellulitis at injection site and diffuse morbilliform rash on arms.
Age: 41.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site warmth, Pain, Rash
Clinical narrative: Patient has pain, rash, and injection site is warm. Took BENADRYL and got a little better.
Age: 15.0
Sex: F
Vaccine: HIBV, TDAP
Symptoms: Dizziness, Nausea
Clinical narrative: Patient felt dizzy and nauseated after immunization administration. BP 100/72. Had patient lie down in clinic, ice pack given to back of neck, gave juice and crackers to eat. Patient recovered fully before discharge from clinic by Dr.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Injected limb mobility decreased, Pain in extremity, Product administered at inappropriate site
Clinical narrative: PT believes that they received a vaccine too high on he arm, which resulted in what the patient described as such great pain that he couldn't use his arm and it required him to see a doctor.
Age: 20.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Blood iron, Blood thyroid stimulating hormone, Human chorionic gonadotropin, Ill-defined disorder, Laboratory test
Clinical narrative: Pt had 2 prior episodes of illness/hospitalizations. 11/9/18 - pharyngitis and fever - 11/13/18 viral syndrome. She was admitted 11/30/18 for fever and leukocytosis.
Age: 20.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Leukocytosis, Pharyngitis, Pyrexia, Reticulocyte count, Urine analysis
Clinical narrative: Pt had 2 prior episodes of illness/hospitalizations. 11/9/18 - pharyngitis and fever - 11/13/18 viral syndrome. She was admitted 11/30/18 for fever and leukocytosis.
Age: 20.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Viral infection, White blood cell count increased
Clinical narrative: Pt had 2 prior episodes of illness/hospitalizations. 11/9/18 - pharyngitis and fever - 11/13/18 viral syndrome. She was admitted 11/30/18 for fever and leukocytosis.
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Full blood count normal, Myalgia, Pyrexia, Rash erythematous, Rash vesicular
Clinical narrative: Myalgias, fever x 3 days. Bilateral vesicular erythematous chest rash x 7 days.
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Red blood cell sedimentation rate normal
Clinical narrative: Myalgias, fever x 3 days. Bilateral vesicular erythematous chest rash x 7 days.
Age: 56.0
Sex: F
Vaccine: FLUR4
Symptoms: Pruritus, Rash
Clinical narrative: Itching, rash developed on both arms, legs and thighs.
Age: 1.42
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Injection site reaction, Rash, Rash erythematous
Clinical narrative: 12/04/18 Patient is a 17 month old male who presents for evaluation of rash and other nonspecific skin eru. Shot reaction. Patient here with mom for PENTACEL. Vaccination given. Patient developed red rash around injection site almost immediately. Childrens Diphenhydramine liquid 12.5mg/5ml - 2ml given orally now per Dr. He had no other symptoms. Acting fine. No breathing or swallowing issues. Breast feeding ok. Rash disappeared quickly-in about 15 minutes. VAERS report will be completed. Phone call to mom 12/05/18. Mom calls back. Patient is fine today. She gave him one more dose of BENADRYL, then no more after 8pm. They checked on him through the night and he was doing ok. She has no concerns at this time. I explained to mom that we would be completing the VAERS report and sending it in just so she is aware. I told her what was in it and that a copy of the note that was written on the incident will be attached. I did tell her that she may hear from either the manufacturer Sanofi or Dept of Health, but I was not sure. She had no further questions today.
Age: 65.0
Sex: F
Vaccine: FLU4
Symptoms: Myalgia, Pain in extremity
Clinical narrative: Muscle type soreness, pain down arm, soreness alternates between shoulder and elbow.
Age: 10.0
Sex: F
Vaccine: FLUC4
Symptoms: Nausea, Vomiting
Clinical narrative: Patient vomited and felt nauseous 10 minutes after vaccination.
Age: 12.0
Sex: M
Vaccine: FLU4, HPV9, MNQ, TDAP
Symptoms: Erythema, Local reaction, Pain in extremity, Peripheral swelling
Clinical narrative: Localized redness, swelling and pain in arm. BENADRYL and  TYLENOL.
Age: 2.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site cellulitis, Injection site pain, Injection site rash, Injection site swelling, Injection site warmth
Clinical narrative: Parent brought patient back to the clinic due to (L) leg swelling, injection site being hot and painful. Rash, no fever. Dxd with (L) leg cellulitis and was prescribed CEFDINIR powder for reconstitution 75mg/ml 9.75 ml PO q8hrs x 10days.
Age: 1.0
Sex: M
Vaccine: FLU4, HEPA, HIBV, MMR, PNC13, VARCEL
Symptoms: Injection site cellulitis, Injection site erythema, Injection site rash, Injection site swelling
Clinical narrative: Mother brought patient to the clinic on 12/4/18. Rash seen on 12/3/18. (L) upper thigh with redness, swelling. Spreading. Dxd with cellulitis of (L) leg. Rx - clindamycin 75mg/5mL 8mL po q 8 hrs x 10 days.
Age: 56.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Body temperature increased, Chills, Pain, Vertigo, Vomiting
Clinical narrative: Started 9 hours later with 101 temp, vomiting, chills, aches. Next morning, vertigo. Doctor called in medicine. Missed whole week of work.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient of unknown age and gender. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about 27-AUG-2014, the patient was inoculated with ZOSTAVAX by a physician as recommended for permanent prevention and protection against shingles and zoster-related conditions (dose, route, and lot # not provided). On an unknown date in 2014, patient was diagnosed with shingles and/or other zoster-related injuries (herpes zoster) after and despite being inoculated with the ZOSTAVAX vaccine. The patient suffered serious physical, emotional and economic damages because of injuries. On or about 21-SEP-2014, the patient was treated for shingles (herpes zoster). The lawyer reported that as a direct and proximate result of the ZOSTAVAX vaccine, patient has and will continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering, extensive medical care and treatment for these injuries, significant medical and related expenses because of these injuries; including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events was unknown. Causality assessment was reported as related for the events.
Age: 13.0
Sex: F
Vaccine: FLU4, HPV9, MNQ, TDAP
Symptoms: Abdominal pain upper, Dizziness
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Act (VAERS # 685401) on 06-JUN-2017. This spontaneous report refers to a 13-year-old female patient. The patient had no concurrent illnesses and medical history. Information on the patient's prior vaccinations and the other medications were not reported. On 10-MAR-2017, the patient was vaccinated with GARDASIL 9 lot # L040054 (expiration date: 26-DEC-2017) (dose and frequency were not reported), dose 1, intramuscularly in the right arm for prophylaxis. Other suspect therapies included BOOSTRIX batch/lot # LZ972, dose 6, intramuscularly in the left arm, FLUZONE batch/lot # U5595CA, intramuscularly in the right arm and MENACTRA batch/lot # U5415AA, dose 1, intramuscularly in the left arm for prophylaxis. On 10-MAR-2017, after 5 minutes of receiving her shot, the patient stated that her stomach was hurting. The patient was asked if she needed to go to the bathroom and she said yes. The patient was accompanied to the restroom and she said she got really dizzy and lightheaded. She was made to lower her head onto her knees, and was given a wet towel from the sink. After the episode the patient was accompanied to the exam room along with her mother where she was laid down. The patient's feet were elevated and another cloth was placed on her head and neck. Her blood pressure (BP) was 87/56 at that time. Approximately, 5 minutes later her BP remained the same. At 9:10 she felt well enough to sit up on the table. The patient's BP was taken again and it was 101/80. She had some fresh water and was ready to leave. She was accompanied to the waiting room with her mom and sister where they were getting a release for school. At 10:00 the patient's mom stated that the patient was fine and was watching TV on the couch when asked on call. The outcome of abdominal pain upper and dizziness was reported as recovered. The causality assessment was not reported. Follow up information has been received from the Regulatory Authority on 31-OCT-2018. The primary reporter was specified as a healthcare worker who administered the vaccines. The patient was vaccinated on 10-MAR-2017 at 09:45. Additional information is not expected from the agency as follow up information cannot be obtained. Follow- up call was placed to Registered Nurse on 03-DEC-2018. The R.N reports that the contact person was no longer with office and the office has no idea who the patient was being referred to in this report. The R.N has no information further.
Age: 59.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Periorbital swelling, Skin burning sensation, Swelling of eyelid
Clinical narrative: Patient stated one day after receiving vaccine her eyes became "puffy" and red with c/o burning.  Lasted 4 days. No injection site problem except "some soreness".
Age: 59.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Eye irritation, Injection site pain, Ocular hyperaemia, Swelling of eyelid
Clinical narrative: Patient stated one day after receiving vaccine her eyes became "puffy" and red with c/o burning.  Lasted 4 days. No injection site problem except "some soreness".
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a patient of unknown age and gender. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient's healthcare provider recommended and/or prescribed ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. On or about 2014, a healthcare provider at a health department administered the ZOSTAVAX to the patient (lot number, dosage and route of administration not provided). On or about 2014, the patient was treated by a healthcare provider for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs including care for hospitalization (dates unknown), physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions (unspecified); lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events was considered to be not recovered. Additional information has been requested.
Age: 37.0
Sex: M
Vaccine: FLU4, FLU4, HEPA
Symptoms: Injection site erythema, Injection site nodule
Clinical narrative: Inflammatory Nodule that is red and tender to touch.
Age: 37.0
Sex: M
Vaccine: FLU4, FLU4, HEPA
Symptoms: Erythema, Inflammation, Needle issue, Nodule, Syringe issue
Clinical narrative: Inflammatory Nodule that is red and tender to touch.
Age: 37.0
Sex: M
Vaccine: FLU4, FLU4, HEPA
Symptoms: Tenderness
Clinical narrative: Inflammatory Nodule that is red and tender to touch.
Age: 40.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Abortion spontaneous, Exposure during pregnancy
Clinical narrative: This is a retrospective pregnancy case. This 40-year-old female subject was enrolled in an open label study: a prospective, exploratory, cohort study to detect and describe any abnormal pregnancy outcomes in women intentionally or unintentionally vaccinated with either FLUARIX® or FLUARIX® QUADRIVALENT or FLULAVAL® or FLULAVAL® QUADRIVALENT during pregnancy or within 28 days preceding conception. The subject received Flu Seasonal QIV Quebec on 12th October 2018, for prophylaxis. On 13th October 2018, 1 days after receiving Flu Seasonal QIV Quebec, the subject developed miscarriage. Serious criteria included GSK medically significant. Additional event(s) included vaccine exposure during pregnancy. The outcome of miscarriage was unknown. The outcome(s) of the additional event(s) included vaccine exposure during pregnancy (unknown). The pregnancy ended in a spontaneous abortion at less than 22 weeks gestation with no apparent congenital anomaly present. It was unknown if the investigator considered the miscarriage to be related to Flu Seasonal QIV Quebec. Additional information received as follows: The patient was 3 months pregnant with twins. The healthcare professional reported that the patient received a dose of FLULAVAL and the next day had a miscarriage. On 13th October 2018, the patient was on an flight and miscarried on the flight. The reporter gave consent to follow up. The contact details for follow up were provided.
Sex: M
Vaccine: FLUX, FLU3
Symptoms: Alanine aminotransferase increased, Aspartate aminotransferase increased, Asthenia, Lethargy, Liver function test abnormal
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of white blood cell decreased in a male patient who received Influenza vaccine unspecified 2009-10 season for prophylaxis. On an unknown date, the patient received Influenza vaccine unspecified 2009-10 season at an unknown dose. On an unknown date, unknown after receiving Influenza vaccine unspecified 2009-10 season, the patient experienced white blood cell decreased and elevated liver enzymes. On an unknown date, the outcome of the white blood cell decreased and elevated liver enzymes were unknown. It was unknown if the reporter considered the white blood cell decreased and elevated liver enzymes to be related to Influenza vaccine unspecified 2009-10 season. Additional details were provided as follows: This case was reported by the patient who himself was a healthcare professional (HCP). In 2010, the patient received an unknown brand of influenza vaccine from a Pharmacy. The patent said after he was vaccinated with the unknown brand of flu vaccine, his white blood cells decreased and he also had increase in liver enzymes. The patient was questioning what contained in the flu vaccine that would cause this type of reaction. Till the time of reporting, the patient had not received a GSK flu vaccine in the present year. The patient did not consent to follow-up.
Sex: M
Vaccine: FLUX, FLU3
Symptoms: White blood cell count decreased
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of white blood cell decreased in a male patient who received Influenza vaccine unspecified 2009-10 season for prophylaxis. On an unknown date, the patient received Influenza vaccine unspecified 2009-10 season at an unknown dose. On an unknown date, unknown after receiving Influenza vaccine unspecified 2009-10 season, the patient experienced white blood cell decreased and elevated liver enzymes. On an unknown date, the outcome of the white blood cell decreased and elevated liver enzymes were unknown. It was unknown if the reporter considered the white blood cell decreased and elevated liver enzymes to be related to Influenza vaccine unspecified 2009-10 season. Additional details were provided as follows: This case was reported by the patient who himself was a healthcare professional (HCP). In 2010, the patient received an unknown brand of influenza vaccine from a Pharmacy. The patent said after he was vaccinated with the unknown brand of flu vaccine, his white blood cells decreased and he also had increase in liver enzymes. The patient was questioning what contained in the flu vaccine that would cause this type of reaction. Till the time of reporting, the patient had not received a GSK flu vaccine in the present year. The patient did not consent to follow-up.
Sex: M
Vaccine: FLUX, FLU3
Symptoms: Hepatic enzyme increased, White blood cell count decreased
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of white blood cell decreased in a male patient who received Influenza vaccine unspecified 2009-10 season for prophylaxis. On an unknown date, the patient received Influenza vaccine unspecified 2009-10 season at an unknown dose. On an unknown date, unknown after receiving Influenza vaccine unspecified 2009-10 season, the patient experienced white blood cell decreased and elevated liver enzymes. On an unknown date, the outcome of the white blood cell decreased and elevated liver enzymes were unknown. It was unknown if the reporter considered the white blood cell decreased and elevated liver enzymes to be related to Influenza vaccine unspecified 2009-10 season. Additional details were provided as follows: This case was reported by the patient who himself was a healthcare professional (HCP). In 2010, the patient received an unknown brand of influenza vaccine from a Pharmacy. The patent said after he was vaccinated with the unknown brand of flu vaccine, his white blood cells decreased and he also had increase in liver enzymes. The patient was questioning what contained in the flu vaccine that would cause this type of reaction. Till the time of reporting, the patient had not received a GSK flu vaccine in the present year. The patient did not consent to follow-up.
Age: 49.0
Sex: F
Vaccine: HEPA, FLU4, HEPA
Symptoms: Culture negative, Incisional drainage, Injection site erythema, Injection site infection, Injection site nodule
Clinical narrative: Inflammatory Nodule that is red and tender to touch.
Age: 49.0
Sex: F
Vaccine: HEPA, FLU4, HEPA
Symptoms: Injection site warmth
Clinical narrative: Inflammatory Nodule that is red and tender to touch.
Age: 49.0
Sex: F
Vaccine: HEPA, FLU4, HEPA
Symptoms: Erythema, Inflammation, Needle issue, Nodule, Syringe issue
Clinical narrative: Inflammatory Nodule that is red and tender to touch.
Age: 49.0
Sex: F
Vaccine: HEPA, FLU4, HEPA
Symptoms: Tenderness
Clinical narrative: Inflammatory Nodule that is red and tender to touch.
Age: 64.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Blood test, Injection site haemorrhage
Clinical narrative: Patient started to bleed to from injection site. Bleeding continued for an abnormally long time. Patient reported going to hospital to receive treatment and reported she returned to hospital for second visit, reason unknown why.
Age: 64.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Injection site haemorrhage
Clinical narrative: Patient started to bleed to from injection site. Bleeding continued for an abnormally long time. Patient reported going to hospital to receive treatment and reported she returned to hospital for second visit, reason unknown why.
Age: 71.0
Sex: F
Vaccine: FLUA3, FLUA3
Symptoms: Oral pruritus, Throat irritation
Clinical narrative: The patient received FLUAD IM vaccine on 12/5/18 at approximately 11:40AM. At 12:00PM, the patient stated that she had an itchy throat/tongue but no trouble breathing (no throat swelling) or injection site reaction. I gave patient a 12.5mg dose of diphenhydramine oral solution at 12:05PM as patient stated she is extremely sensitive to BENADRYL and I would monitor her in case we needed to administer more. At 12:10PM, the patient stated that she was not feeling any worse and was having no issues breathing or talking. She still had some itchiness/tickling in the back of her throat but airway was ok. At 12:15PM, patient continued to improve and still had no issues breathing or swelling of throat or tongue. Throat was slightly itchy, but no worsening of symptoms reported. I sat with patient and husband from approximately 12:20PM to 12:35PM to continue to monitor situation and patient continued to improve with no worsening, but improvement in symptoms. At 12:35PM, patient felt better and safe to go home with husband. I counseled both husband and patient to look out for signs/symptoms of anaphylactic reactions and to go to hospital if trouble breathing or severe swelling occurred. I called patient at home at 4:11PM and verified that she is doing better and feels like her normal self with no further adverse reactions to report.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Erythema, Fatigue, Feeling cold, Headache
Clinical narrative: Soreness and redness in arm, 8 hours later while asleep awoke to shivering, shaking and extreme cold. Added blankets, and was worried about seizures. Took tylenol and the shaking stopped.  Woke up next morning to temp of 101.4. Had muscle aches, headache and fatigue and continue fever. Took tylenol to control fever. This continue for at least 30 hours. Contacted by doctor and was advised to come to office if symptoms continued or worsened or seek urgent care if symptoms worsened. Unable to get out of bed for 2 days.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Mobility decreased, Myalgia, Pain in extremity, Pyrexia, Tremor
Clinical narrative: Soreness and redness in arm, 8 hours later while asleep awoke to shivering, shaking and extreme cold. Added blankets, and was worried about seizures. Took tylenol and the shaking stopped.  Woke up next morning to temp of 101.4. Had muscle aches, headache and fatigue and continue fever. Took tylenol to control fever. This continue for at least 30 hours. Contacted by doctor and was advised to come to office if symptoms continued or worsened or seek urgent care if symptoms worsened. Unable to get out of bed for 2 days.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Decreased appetite, Fatigue, Headache, Injection site pain, Nausea
Clinical narrative: Pain at injection site began as mild pain, progressed to moderate and severe pain that lasted from about 2 hours after injection on 03Dec2018 until 11am on 05Dec2016. Also experienced, fever that rose on 03Dec2018 to 99.8 by 7pm. Then 102.4 at 2:30am and 104.2 at 4:45am, and 101.8 at 8:24am on (04Dec2018), gradually reducing to a temperature of 97.6 by 6:00pm on 04Dec2018.  As of 05Dec2018 temperature remains normal. Adverse symptoms that also occurred were headache, fatigue, nausea, and loss of appetite. Took extra strength Excedrin for fever and pain throughout the day on 03Dec and 04Dec2018, and maintained clear fluid intake. All AE's resolved as of 05Dec18. No intervention other than self care needed.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: Pain at injection site began as mild pain, progressed to moderate and severe pain that lasted from about 2 hours after injection on 03Dec2018 until 11am on 05Dec2016. Also experienced, fever that rose on 03Dec2018 to 99.8 by 7pm. Then 102.4 at 2:30am and 104.2 at 4:45am, and 101.8 at 8:24am on (04Dec2018), gradually reducing to a temperature of 97.6 by 6:00pm on 04Dec2018.  As of 05Dec2018 temperature remains normal. Adverse symptoms that also occurred were headache, fatigue, nausea, and loss of appetite. Took extra strength Excedrin for fever and pain throughout the day on 03Dec and 04Dec2018, and maintained clear fluid intake. All AE's resolved as of 05Dec18. No intervention other than self care needed.
Age: 27.0
Sex: M
Vaccine: ANTH
Symptoms: Blood pressure decreased, Cardiac stress test, Cold sweat, Dizziness, Echocardiogram
Clinical narrative: Within one week of anthrax vaccine began passing out. After testing (cardio echo, stress test, tilt table) medical staff concluded diagnosis was syncope. Initial symptoms were dizziness, nausea, tachycardia feeling, cold sweats, shaking, tunnel vision, blood pressure drop, pass out.
Age: 27.0
Sex: M
Vaccine: ANTH
Symptoms: Loss of consciousness, Nausea, Syncope, Tachycardia, Tilt table test positive
Clinical narrative: Within one week of anthrax vaccine began passing out. After testing (cardio echo, stress test, tilt table) medical staff concluded diagnosis was syncope. Initial symptoms were dizziness, nausea, tachycardia feeling, cold sweats, shaking, tunnel vision, blood pressure drop, pass out.
Age: 27.0
Sex: M
Vaccine: ANTH
Symptoms: Tremor, Tunnel vision
Clinical narrative: Within one week of anthrax vaccine began passing out. After testing (cardio echo, stress test, tilt table) medical staff concluded diagnosis was syncope. Initial symptoms were dizziness, nausea, tachycardia feeling, cold sweats, shaking, tunnel vision, blood pressure drop, pass out.
Age: 61.0
Sex: F
Vaccine: FLUX
Symptoms: Headache, Injection site pain, Pain, Pyrexia
Clinical narrative: Pain for 5 days at injection site; Headache; Body aches and pain; Febrile 101 temp.
Age: 35.0
Sex: M
Vaccine: FLUC4
Symptoms: Differential white blood cell count, Full blood count, Headache, Hypersensitivity, Idiopathic urticaria
Clinical narrative: Patient was seen at pharmacy for flu vaccine. Hours later the patient reported swelling and tingling in face, lips and throat. Experienced headache. Was seen at Urgent Care for allergy possibly due to flu vaccine. He was diagnosed with idiopathic urticaria.
Age: 35.0
Sex: M
Vaccine: FLUC4
Symptoms: Lipids, Metabolic function test, Paraesthesia, Paraesthesia oral, Pharyngeal paraesthesia
Clinical narrative: Patient was seen at pharmacy for flu vaccine. Hours later the patient reported swelling and tingling in face, lips and throat. Experienced headache. Was seen at Urgent Care for allergy possibly due to flu vaccine. He was diagnosed with idiopathic urticaria.
Age: 35.0
Sex: M
Vaccine: FLUC4
Symptoms: Swelling face
Clinical narrative: Patient was seen at pharmacy for flu vaccine. Hours later the patient reported swelling and tingling in face, lips and throat. Experienced headache. Was seen at Urgent Care for allergy possibly due to flu vaccine. He was diagnosed with idiopathic urticaria.
Age: 66.0
Sex: M
Vaccine: PPV
Symptoms: Injection site pain
Clinical narrative: Severe pain in arm/shoulder where shot was administered. Began around 3:30 pm on same date and pain was minimal at start but continued to become more severe up until around midnight where pain was VERY servere.
Sex: F
Vaccine: VARCEL
Symptoms: Antibody test negative, Exposure during pregnancy
Clinical narrative: This spontaneous prospective pregnancy report was received from a 25 year old female consumer, concerning to herself. The patient's medical history included varicella (reported as when she was a child she had chickenpox). Her drug reactions or allergies were not provided. No information was provided regarding the patient's concomitant medications. On an unknown date, the patient was vaccinated with VARIVAX (strength, dose, route of administration, anatomical location, lot number and expiration date were not provided) as prophylaxis. The patient became pregnant on 22-OCT-2018 (estimated date of conception). At the reporting time, the gestational age was 7 weeks; consequently the last menstrual period (LMP) was on 08-OCT-2018 and the estimated date of delivery (EDD) would be on 15-JUL-2019. On 04-NOV-2018, she was performed an unspecified titer test for work that did not show immunity to varicella (antibody test negative). The outcome of antibody test negative and its relationship with VARIVAX were not reported. The pregnancy outcome was pending.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient's healthcare provider recommended and/or prescribed ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. On or about 29-SEP-2009, a healthcare provider administered the ZOSTAVAX to the patient (lot number, dosage and route of administration not provided) at a medical clinic. On or about 03-MAR-2013, the patient was treated by a physician for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs including care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death; aggravation of preexisting conditions and activation of latent conditions (unspecified); lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events was considered to be not recovered. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient's healthcare provider recommended and/or prescribed ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. On or about 2011, a healthcare provider administered the ZOSTAVAX to the patient (lot number, dosage and route of administration not provided). On or about 27-OCT-2016, the patient was treated by a healthcare provider at a hospital for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs including care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death; aggravation of preexisting conditions and activation of latent conditions (unspecified); lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events was considered to be not recovered. Additional information has been requested.