chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: VARZOS
Symptoms: Bacteraemia, Cough, Leukocytosis, Pneumonia
Clinical narrative: persistent cough for weeks and was diagnosed with pneumonia complicated by GPC bacteremia with leukocytosis; persistent cough for weeks and was diagnosed with pneumonia complicated by GPC bacteremia with leukocytosis; Information has been received from a lawyer concerning a case in litigation and refers to a female patient of unknown age. No information regarding the pt's medical history, concurrent conditions and concomitant medications was reported. On or about 18-JUL-2017, the pt was inoculated with zoster vaccine live(ZOSTAVAX) injection (dose, route of administration, vaccination site, lot # and expiry date were not specified) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). Shortly after receiving zoster vaccine live (ZOSTAVAX), the pt suffered a persistent cough for weeks and was diagnosed with pneumonia complicated by gram-positive (GPC) bacteremia with leukocytosis. As a direct and proximate result of the Company's defective zoster vaccine live (ZOSTAVAX) vaccine, the pt's symptoms have resulted in physical limitations not present prior to using the Company's product. The pt also experienced mental and emotional distress due to resulting physical limitations and seriousness of her condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), the pt sustained severe and permanent personal injuries. Further, as a tragic consequence of the Company's wrongful conduct, the pt suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of the Company's conduct, the pt has suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the events was not recovered. The causality was related.   The events of pneumonia complicated by gram-positive (GPC) bacteremia with leukocytosis were considered to be disabling.  Upon internal review, the events of pneumonia complicated by gram-positive (GPC) bacteremia with leukocytosis were determined to be medically significant.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; Information has been received from a lawyer concerning a case in litigation and refers to a female patient of an unknown age. No information regarding the pt's medical history, concurrent conditions and concomitant medications was reported. In 2008, the pt was inoculated with zoster vaccine live (ZOSTAVAX) injection (dose, route of administration, vaccination site, lot # and expiry date were not specified) as prescribed and/or administered by a healthcare provider for the long-term prevention of shingles and/or zoster-related conditions. Subsequent to the pt's zoster vaccine live (ZOSTAVAX) inoculation, the pt was treated by a healthcare provider at a hospital for shingles. As a direct and proximate result of the pt's use of the zoster vaccine live (ZOSTAVAX) vaccine, the pt had and would continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; 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 include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future. The outcome of the event was not recovered. The causality was related.
Age: 1.0
Sex: U
Vaccine: VARCEL
Symptoms: Herpes zoster
Clinical narrative: Herpes zoster; This spontaneous report was received from a physician via field representative refers to a currently 3 years old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were unknown. On an unknown date (at the age of 12 months), the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) (strength, dose, route, anatomical location, lot # and expiration date not reported) for prophylaxis. On an unknown date, the patient experienced herpes zoster. The patient sought medical attention. No lab diagnostic or study was performed. It was unknown if any treatment was given for the event. No product quality complaint (PQC) was present. The outcome of herpes zoster was reported as resolved.  The causality assessment was not provided by the reporter.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration, Parosmia
Clinical narrative: Altered sense of smell / various food items smell differently than before dose 2; Inappropriate Schedule of Vaccine; This case was reported by a consumer via call center representative and described the occurrence of altered smell sensation in a 66-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of herpes zoster (received 1st dose on 16th January 2019, refer case US2019177086).   On 22nd August 2019, the patient received the 2nd dose of Shingrix. On 22nd August 2019, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On 26th August 2019, the patient experienced altered smell sensation. On an unknown date, the outcome of the altered smell sensation was recovered/resolved and the outcome of the drug dose administration interval too long was unknown.   It was unknown if the reporter considered the altered smell sensation to be related to Shingrix.  Additional details were provided as follows: Four days after vaccination, the experienced an altered sense of smell. She reports that various food items smell differently than before administration of dose 2. This did not occur after 1st dose. The reporter did not consent to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Blood bilirubin increased, Purpura, Rash, Rash erythematous, Rash pruritic
Clinical narrative: Bilirubin is 2.3; Red purpura type rash on his trunk and arms; Red purpura type rash on his trunk and arms; Flat red lessions; Itchy; This case was reported by a consumer and described the occurrence of red rash in a 86-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included glaucoma (does not take any meds except eye drops). Concomitant products included antiglaucoma preparations and miotics (Eye Drops For Glaucoma-Name Unknown).   On 13th September 2019, the patient received the 1st dose of Shingrix. On 14th September 2019, 1 days after receiving Shingrix, the patient experienced red rash, purpuric rash, skin lesion and itchy rash. On 24th September 2019, the patient experienced bilirubin increased. On an unknown date, the outcome of the red rash, purpuric rash, skin lesion, itchy rash and bilirubin increased were unknown.   It was unknown if the reporter considered the red rash, purpuric rash, skin lesion, itchy rash and bilirubin increased to be related to Shingrix.  Additional case details were provided as follows: The reporter reported adverse event experienced by their father. The age at vaccination was not reported but it could be 85 years or 86 years.  The patient did not take any medications except eye drops for glaucoma for many years. The patient developed a red purpura type rash on his trunk and arms, had flat red lesions and was itchy. The patient's lab work for a physical exam was performed on 24th September 2019 and his bilirubin was found to be 2.3. The reporter stated, after some research they found that, the hepatitis B vaccine has an adjuvant AS01B. According to an FDA (Food and Drug Administration report), this agent can temporarily cause elevated CRP (C reactive protein), bilirubin, monocytes, leukocytes, and neutrophils among other issues. When searched for Shingrix, it also had same adjuvant. So, the reporter asked, could the AS01B in Shingrix also cause the same elevations. The patient would have an abdominal ultrasound in coming week, but the reporter wanted to ask if this was a possibility.
Sex: M
Vaccine: VARZOS
Symptoms: Skin lesion
Clinical narrative: Bilirubin is 2.3; Red purpura type rash on his trunk and arms; Red purpura type rash on his trunk and arms; Flat red lessions; Itchy; This case was reported by a consumer and described the occurrence of red rash in a 86-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included glaucoma (does not take any meds except eye drops). Concomitant products included antiglaucoma preparations and miotics (Eye Drops For Glaucoma-Name Unknown).   On 13th September 2019, the patient received the 1st dose of Shingrix. On 14th September 2019, 1 days after receiving Shingrix, the patient experienced red rash, purpuric rash, skin lesion and itchy rash. On 24th September 2019, the patient experienced bilirubin increased. On an unknown date, the outcome of the red rash, purpuric rash, skin lesion, itchy rash and bilirubin increased were unknown.   It was unknown if the reporter considered the red rash, purpuric rash, skin lesion, itchy rash and bilirubin increased to be related to Shingrix.  Additional case details were provided as follows: The reporter reported adverse event experienced by their father. The age at vaccination was not reported but it could be 85 years or 86 years.  The patient did not take any medications except eye drops for glaucoma for many years. The patient developed a red purpura type rash on his trunk and arms, had flat red lesions and was itchy. The patient's lab work for a physical exam was performed on 24th September 2019 and his bilirubin was found to be 2.3. The reporter stated, after some research they found that, the hepatitis B vaccine has an adjuvant AS01B. According to an FDA (Food and Drug Administration report), this agent can temporarily cause elevated CRP (C reactive protein), bilirubin, monocytes, leukocytes, and neutrophils among other issues. When searched for Shingrix, it also had same adjuvant. So, the reporter asked, could the AS01B in Shingrix also cause the same elevations. The patient would have an abdominal ultrasound in coming week, but the reporter wanted to ask if this was a possibility.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site rash, Rash
Clinical narrative: Rash at the injection site; Rash on abdomen and back; This case was reported by a consumer and described the occurrence of injection site rash in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 27th September 2019, the patient received the 1st dose of Shingrix. In September 2019, less than a week after receiving Shingrix, the patient experienced injection site rash and rash. On an unknown date, the outcome of the injection site rash and rash were unknown.   It was unknown if the reporter considered the injection site rash and rash to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix and had rash at the injection site and on her abdomen and back. The patient inquired whether she should receive the 2nd injection in 2 to 5 months. The patient asked would my rash be worse for the 2nd dose.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Injection site pain, Myalgia, Vaccine positive rechallenge
Clinical narrative: Pain at injection site; Headache; Muscle aches; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 66-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of injection site pain (received 1st dose on 11th April 2019, refer case US2019177136).   On 5th September 2019, the patient received the 2nd dose of Shingrix. On 5th September 2019, less than a day after receiving Shingrix, the patient experienced injection site pain, headache and muscle pain. Rechallenge with Shingrix was positive. In September 2019, the outcome of the injection site pain, headache and muscle pain were recovered/resolved.   It was unknown if the reporter considered the injection site pain, headache and muscle pain to be related to Shingrix.  Additional case details were reported as follows: The reporter was patient's husband The patient received vaccine in left arm. The patient experienced the symptoms on the same day when she received the 2nd dose of vaccine. The injection site pain was lasted 3 to 4 days. The muscle aches and headache resolved within 2 days. The phone number or address was not available. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Adverse event, Inappropriate schedule of product administration
Clinical narrative: Adverse event; Inappropriate schedule of vaccine; This case was reported by a pharmacist via call center representative and described the occurrence of adverse event in a 67-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   In April 2018, the patient received the 1st dose of Shingrix. On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced adverse event and incomplete course of vaccination. On an unknown date, the outcome of the adverse event and incomplete course of vaccination were unknown.   The reporter considered the adverse event to be unrelated to Shingrix.  Additional details were received as follows: The age at vaccination was not reported. After 1st dose, the patient underwent treatment that was unrelated to Shingrix, and did not get the 2nd dose until July, 2019, which led to incomplete course of vaccination.  The reporter consented to follow up.
Age: 65.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Chest discomfort, Dizziness, Dyspnoea, Headache, Malaise
Clinical narrative: Lightheaded/ Dizziness; Chest Heaviness/ lungs pressure/ lung heaviness; Headache; began to have a washing feeling; This case was reported by a pharmacist via call center representative and described the occurrence of light headedness in a 65-year-old female patient who received Herpes zoster (Shingrix) (batch number 27J4P, expiry date 12th April 2021) for prophylaxis.   Co-suspect products included AFLURIA for prophylaxis.   Previously administered products included Flu vaccine (never had reaction with previous flu vaccines).   On 18th September 2019, the patient received the 1st dose of Shingrix and the 1st dose of AFLURIA .5 ml. On 18th September 2019, 20 min after receiving Shingrix, the patient experienced light headedness, chest heaviness, headache and feeling abnormal. On 18th September 2019, the outcome of the light headedness, chest heaviness, headache and feeling abnormal were recovered/resolved.   It was unknown if the reporter considered the light headedness, chest heaviness, headache and feeling abnormal to be related to Shingrix.  Additional case details were provided as follows: The patient reported the adverse events experienced by herself. The patient received Shingrix and on the same day received a yearly flu vaccine in right gluteus medius. Following vaccination she got into driving and approximately 20 min later, she began to have a washing feeling which she described as a feeling that was rising upwards and enveloping her head, washing over her.  The patient then began to feel lightheaded and dizzy and thought to pull over and find somewhere to park. She arrived to where she needed to be.  She also described her chest and lungs felt heavy and described it as a feeling of knowing exactly where her lungs were similar to if they were outlined on paper due to heaviness feeling.  She did not have shortness of breath or difficulty breathing but described heavy and prominent feeling of her lungs.  The patient stated, lightheaded and dizziness lasted approximately 30 minutes to an hour, chest and lung heaviness approximately 15 to 30 minutes, but the headache lingered around a little longer after an hour but was not bad. The patient consented to follow up.  She stated, she would call back to provide batch number and expiry date of Shingrix vaccine and confirm name and possibly manufacturer of co-suspect flu vaccine and she provided details.
Age: 62.0
Sex: F
Vaccine: FLU4
Symptoms: Cough, Decreased appetite, Dehydration, Dyspnoea, Headache
Clinical narrative: cough; difficulty breathing; lethargy; decreased appetite; high Fever; muscle weakness; headache; dehydration; This case was reported by a consumer via call center representative and described the occurrence of fever in a 62-year-old female patient who received Flu Seasonal QIV Dresden (Fluarix Tetra 2019-2020 season) for prophylaxis.   On 18th September 2019, the patient received Fluarix Tetra 2019-2020 season (intramuscular). On 23rd September 2019, 5 days after receiving Fluarix Tetra 2019-2020 season, the patient experienced fever, muscle weakness, headache, dehydration, difficulty breathing, lethargy and decreased appetite. On 25th September 2019, the patient experienced cough. The patient was treated with salbutamol sulphate (Albuterol). On 30th September 2019, the outcome of the fever, muscle weakness, headache, dehydration, cough, difficulty breathing, lethargy and decreased appetite were recovered/resolved.   It was unknown if the reporter considered the fever, muscle weakness, headache, dehydration, cough, difficulty breathing, lethargy and decreased appetite to be related to Fluarix Tetra 2019-2020 season.  Additional details were provided as follows: The patient received Fluarix tetra 2019-2020 in the laft arm. The developed high fever of 103.7 degree F and this was associated with headache, muscle weakness. lethargy, dehydration due to decreased appetite and difficulty to breath. Seven days after vaccination, the patient experienced cough.  On 25th September 2019, the patient was seen at the doctor's office and flu test was done which was negative.  Again, the patient was seen at the doctor's office on 28th September 2019 and she was given nebulizer treatment with Albuterol. She had completely recovered at the time of reporting. The reporter consented to follow up.
Age: 62.0
Sex: F
Vaccine: FLU4
Symptoms: Influenza virus test negative, Lethargy, Muscular weakness, Pyrexia
Clinical narrative: cough; difficulty breathing; lethargy; decreased appetite; high Fever; muscle weakness; headache; dehydration; This case was reported by a consumer via call center representative and described the occurrence of fever in a 62-year-old female patient who received Flu Seasonal QIV Dresden (Fluarix Tetra 2019-2020 season) for prophylaxis.   On 18th September 2019, the patient received Fluarix Tetra 2019-2020 season (intramuscular). On 23rd September 2019, 5 days after receiving Fluarix Tetra 2019-2020 season, the patient experienced fever, muscle weakness, headache, dehydration, difficulty breathing, lethargy and decreased appetite. On 25th September 2019, the patient experienced cough. The patient was treated with salbutamol sulphate (Albuterol). On 30th September 2019, the outcome of the fever, muscle weakness, headache, dehydration, cough, difficulty breathing, lethargy and decreased appetite were recovered/resolved.   It was unknown if the reporter considered the fever, muscle weakness, headache, dehydration, cough, difficulty breathing, lethargy and decreased appetite to be related to Fluarix Tetra 2019-2020 season.  Additional details were provided as follows: The patient received Fluarix tetra 2019-2020 in the laft arm. The developed high fever of 103.7 degree F and this was associated with headache, muscle weakness. lethargy, dehydration due to decreased appetite and difficulty to breath. Seven days after vaccination, the patient experienced cough.  On 25th September 2019, the patient was seen at the doctor's office and flu test was done which was negative.  Again, the patient was seen at the doctor's office on 28th September 2019 and she was given nebulizer treatment with Albuterol. She had completely recovered at the time of reporting. The reporter consented to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: inappropriate vaccine schedule; This case was reported by a other health professional via call center representative and described the occurrence of incomplete course of vaccination in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were received as follows: This case was reported via chat.  The age at vaccination was not applicable for this report. The age group adult selected as per vaccine specification.  A pharmacy tech reported that a patient was outside the six month window for the second dose of Shingrix, which led to incomplete course of vaccination. The reporter did not consented to follow up.  The reporter declined to provide information.
Sex: M
Vaccine: RAB
Symptoms: Headache, Nausea, Product administered at inappropriate site, Vomiting
Clinical narrative: Vaccine Administered at Inappropriate Site; Headache; Nausea; Vomiting; This case was reported by a consumer via call center representative and described the occurrence of headache in a male patient who received Rabies NVS (RabAvert) for prophylaxis.   On 30th September 2019, the patient received the 2nd dose of RabAvert. On 30th September 2019, less than a day after receiving RabAvert, the patient experienced headache, nausea and vomiting. On an unknown date, the patient experienced vaccine administered at inappropriate site. On an unknown date, the outcome of the headache, nausea and vomiting were recovering/resolving and the outcome of the vaccine administered at inappropriate site was unknown.   It was unknown if the reporter considered the headache, nausea and vomiting to be related to RabAvert.  Additional details were received as follows: The age at vaccination was not reported.  In that night, the patient started experiencing a bad headache and nausea and vomiting. She stated that his symptoms were reported to the doctor and that he was doing better now and is willing to eat. Caller originally called inquiring if the gluteal muscles should be used for administration as the healthcare provider injected the Rabavert into her son's buttocks. The reporter did not consented to follow up.  The reporter have to leave any demographic information.
Age: 50.0
Sex: M
Vaccine: HEP, TDAP
Symptoms: Fatigue, Feeling hot, Nausea, Pain in extremity, Swelling
Clinical narrative: Pt called triage RN on 11/3/19 to report SE. States (L) arm pain [7/10], swelling, feeling warm, fatigue, & nausea. States swelling is 3 inches larger than normal. Symptoms onset early on 10/3/19 AM.
Age: 44.0
Sex: F
Vaccine: FLU4, HEPAB, VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Patient received second dose of Varivax vaccine on 10/07/2019. Patient reports taking ibuprofen 3 tabs every 6 hours on 10/07/2019, did not take ibuprofen on 10/08/2019, then on 10/09/2019 three tabs were taken every 10 hours. Patient reports that the redness, swollen, warm to touch, felt like sunburn, pale pink color outside and dark pink color in the middle of area, from mid arm to elbow started on Wednesday 10/09/2019 at around 7am. Remains today on 10/10/2019.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Insomnia, Musculoskeletal pain, Neck pain, Pain in extremity
Clinical narrative: Right & left arms to shoulder pain. Neck pain. This is still painfull more then a month later. Must have a pillow under my arm. Taking advil. Haven't slept more then 2 hours at a time.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site discomfort, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Pt arrived as a walk-in to clinic on 10/9/19 c/o (L) distal upper arm swelling/discomfort. SX started yesterday (10/8/19). Pt reports redness/warm to touch but is improving.
Age: 82.0
Sex: F
Vaccine: FLUA3
Symptoms: Injection site pruritus, Injection site rash, Injection site warmth
Clinical narrative: 2" diameter rash at injection site. Little itching, warm to touch. No temp. No flu symptoms. Improvement by 10/9.
Sex: U
Vaccine: FLU3
Symptoms: Dyspnoea, Pain, Pyrexia
Clinical narrative: Pt complained of breathing problem, generalized body ache, fever. Advised patient to go to ER.
Age: 10.0
Sex: M
Vaccine: MMR
Symptoms: Cough, Eye inflammation, Pyrexia, Rash, Rhinorrhoea
Clinical narrative: RASH OVER ENTIRE BODY, DRY COUGH, FEVER, RUNNY NOSE, INFLAMED EYES
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Blood glucose, Fall, Hypoacusis, Injection site pain, Loss of consciousness
Clinical narrative: RUE pain at injection site all night.   Woke up the morning after the injection and started to feel nauseated while brushing her teeth.  While in the bathroom first thing that morning she then suffered a syncopal event; felt like she could not see or hear anything and lost consciousness (not witnessed) and awoke on the floor.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Nausea, Syncope, Visual impairment
Clinical narrative: RUE pain at injection site all night.   Woke up the morning after the injection and started to feel nauseated while brushing her teeth.  While in the bathroom first thing that morning she then suffered a syncopal event; felt like she could not see or hear anything and lost consciousness (not witnessed) and awoke on the floor.
Age: 1.5
Sex: M
Vaccine: DTAP, MMR
Symptoms: Brain stem auditory evoked response abnormal, Cochlea implant, Cytogenetic analysis normal, Cytomegalovirus test negative, Deafness
Clinical narrative: One day after MMR vaccine administered, went to ER with high fever to 105 and lethargic behavior. Diagnosed with viral syndrome and discharged home. Went on for 3 days. He seemed fine. a few weeks later, stopped listening "like going through terrible twos" and felt that his behavior was related to age. Took a few months to recognize that he wasn't hearing. Stopped developing in speech. Went to audiologist, thought maybe fluid. Then did ABR and found profound hearing loss. A year of hearing aids, then cochlear implant.  ABRs were exactly the same (no progression)
Age: 1.5
Sex: M
Vaccine: DTAP, MMR
Symptoms: Hearing aid user, Lethargy, Pyrexia, Speech disorder developmental, Viral infection
Clinical narrative: One day after MMR vaccine administered, went to ER with high fever to 105 and lethargic behavior. Diagnosed with viral syndrome and discharged home. Went on for 3 days. He seemed fine. a few weeks later, stopped listening "like going through terrible twos" and felt that his behavior was related to age. Took a few months to recognize that he wasn't hearing. Stopped developing in speech. Went to audiologist, thought maybe fluid. Then did ABR and found profound hearing loss. A year of hearing aids, then cochlear implant.  ABRs were exactly the same (no progression)
Age: 33.0
Sex: F
Vaccine: FLU4
Symptoms: Syncope
Clinical narrative: Patient woke from sleep at 1:30 am and had a syncopal episode when walking to the bathroom.
Age: 36.0
Sex: F
Vaccine: FLU4
Symptoms: Lip pruritus, Pruritus, Throat tightness
Clinical narrative: The patient had itching on arm, nose, ears, lips , chest wall, throat felt tight
Age: 60.0
Sex: F
Vaccine: FLU4
Symptoms: Headache
Clinical narrative: Pt reported Headaches since monday every morning then goes away later in the day.  Pt took Asparin for couple days. As of today Thursday 10/10/19 12:54. Pt does not have headache.
Age: 72.0
Sex: M
Vaccine: FLU3
Symptoms: Atrial enlargement, Blood glucose increased, Chest discomfort, Chills, Dyspepsia
Clinical narrative: chills, sweats, headache, eyes hurt, muscle aches, muscle pain, sore throat, rhinorrhea, SOB, band like pressure around ribs, indigestion
Age: 72.0
Sex: M
Vaccine: FLU3
Symptoms: Dyspnoea, Electrocardiogram abnormal, Eye pain, Headache, Hyperhidrosis
Clinical narrative: chills, sweats, headache, eyes hurt, muscle aches, muscle pain, sore throat, rhinorrhea, SOB, band like pressure around ribs, indigestion
Age: 72.0
Sex: M
Vaccine: FLU3
Symptoms: Influenza virus test negative, Myalgia, Oropharyngeal pain, QRS axis abnormal, Rhinorrhoea
Clinical narrative: chills, sweats, headache, eyes hurt, muscle aches, muscle pain, sore throat, rhinorrhea, SOB, band like pressure around ribs, indigestion
Age: 63.0
Sex: M
Vaccine: TYP
Symptoms: Full blood count, Influenza like illness, Metabolic function test, Red blood cell sedimentation rate
Clinical narrative: Patient having flu like symptoms
Age: 45.0
Sex: F
Vaccine: FLU4
Symptoms: Feeling hot, Injection site paraesthesia, Paraesthesia
Clinical narrative: Heat sensation, and tingling in left arm that extended from site of injection to middle finger of left hand.
Age: 7.0
Sex: M
Vaccine: FLUC4
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Redness, swelling, warmth to injection site - 4cm X 7cm surrounding injection site.  Provider instructed to place cold pack on the site and take ibuprofen as directed, if worsens to return to clinic.
Age: 20.0
Sex: F
Vaccine: TYP
Symptoms: Burning sensation, Fatigue, Full blood count, Metabolic function test, Thyroid function test
Clinical narrative: palinopsia, fatigue and reported feeling like her "brain was on fire"
Age: 20.0
Sex: F
Vaccine: TYP
Symptoms: Visual perseveration, Vitamin D
Clinical narrative: palinopsia, fatigue and reported feeling like her "brain was on fire"
Age: 18.0
Sex: M
Vaccine: FLU4
Symptoms: Hypoaesthesia, Nausea, Syncope, Visual impairment, Vomiting
Clinical narrative: Patient experienced a brief period of syncope with nausea,  darkened vision, a feeling of numbness, but no loss of consciousness.  Patient then vomited a very small amount of fluid and after a few minutes of waiting reported feeling much better.  After a few more minutes of waiting, they walked around the store and then left without further incident.  Entire incident from vaccine administration to patient leaving was approximately 20 minutes.
Age: 24.0
Sex: F
Vaccine: FLU4
Symptoms: Headache, Rash macular
Clinical narrative: Patient woke up with macular rash on torso and a headache.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Chest pain, Chills, Decreased appetite, Dyspnoea, Fatigue
Clinical narrative: Low grade fever, chills, shortness of breath, body ache, headache, loss of appetite, extreme fatigue, red, swollen injection site, significant painful swelling in neck, upper chest and shoulder area on same side of body as injection.  Had to stay in bed for 2 days, drank lots of fluids,  increased my oxygen from 2 lpm to 3 lpm.  Did not contact my Primary Care Physician because I thought i was just having a 24 hour reaction to the vaccine.  The fever and chills persisted for 2 days, on the 3rd day I was able to get out of bed but was still experiencing fatigue and shortness of breath.  Pain and swelling in my neck and chest lasted for 5 days after the initial injection.  The injection site, 3 days after I received the injection, was red and swollen, very painful.  Area measured approx. 4" high and 7" across on my upper arm.  One month later I can still feel a lump under my skin at the injection site, about 3/4" in diameter.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Headache, Injection site erythema, Injection site mass, Injection site pain, Injection site swelling
Clinical narrative: Low grade fever, chills, shortness of breath, body ache, headache, loss of appetite, extreme fatigue, red, swollen injection site, significant painful swelling in neck, upper chest and shoulder area on same side of body as injection.  Had to stay in bed for 2 days, drank lots of fluids,  increased my oxygen from 2 lpm to 3 lpm.  Did not contact my Primary Care Physician because I thought i was just having a 24 hour reaction to the vaccine.  The fever and chills persisted for 2 days, on the 3rd day I was able to get out of bed but was still experiencing fatigue and shortness of breath.  Pain and swelling in my neck and chest lasted for 5 days after the initial injection.  The injection site, 3 days after I received the injection, was red and swollen, very painful.  Area measured approx. 4" high and 7" across on my upper arm.  One month later I can still feel a lump under my skin at the injection site, about 3/4" in diameter.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Neck pain, Pain, Pyrexia, Swelling
Clinical narrative: Low grade fever, chills, shortness of breath, body ache, headache, loss of appetite, extreme fatigue, red, swollen injection site, significant painful swelling in neck, upper chest and shoulder area on same side of body as injection.  Had to stay in bed for 2 days, drank lots of fluids,  increased my oxygen from 2 lpm to 3 lpm.  Did not contact my Primary Care Physician because I thought i was just having a 24 hour reaction to the vaccine.  The fever and chills persisted for 2 days, on the 3rd day I was able to get out of bed but was still experiencing fatigue and shortness of breath.  Pain and swelling in my neck and chest lasted for 5 days after the initial injection.  The injection site, 3 days after I received the injection, was red and swollen, very painful.  Area measured approx. 4" high and 7" across on my upper arm.  One month later I can still feel a lump under my skin at the injection site, about 3/4" in diameter.
Age: 30.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: AT SITE OF INJECTION DEVELOPED A ROUND CIRCLE INCREASED TO A SIZE OF SILVER DOLLAR AND HOT TO TOUCH.  CURRENTLY  DOUBLE SIZE OF SILVER ,SORE, AND HOT
Age: 1.0
Sex: F
Vaccine: MMRV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: There was no adverse reaction. The child was given MMRV and Varicella. Per the provider they wanted documentation about the incident. The mother was contacted on 10/9/2019 when the error was found. She is bring the child in 10/10/2019 for a follow up with the provider.
Sex: F
Vaccine: HPV9
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: 27 weeks and 6 days pregnant received dose of Gradasil 9 on 01/10/2019; no adverse effect; This spontaneous prospective pregnancy report was received from a nurse regarding a female patient of unknown age. The patient's medical history, concurrent condition and concomitant medications were not reported. The nurse described that a 27 weeks and 6 days pregnant vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (exposure during pregnancy) on 01-OCT-2019, lot # 1621934 and expiry date 29-JAN-2022 (strength, dose, route were not reported) for prophylaxis. The nurse stated that it was not product confusion and no adverse effects reported. The patient became pregnant with last menstrual period (LMP) of 20-MAR-2019 and estimate date of delivery 25-DEC-2019. The pregnancy outcome was pending.
Sex: U
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse effects; received expired dose of VARIVAX; This spontaneous report was received from a medical assistant regarding a patient of unknown age and gender. The patient's medical history and concurrent condition were not reported. Concomitant therapies included sterile diluent. The medical assistant was reported that on 01-OCT-2019, patient was vaccinated expired dose of varicella virus vaccine live (oka/merck)(VARIVAX) 0.5ml,once(expired product administered), lot # N017700 and expiry date 09-JUN-2019, (strength, route were not reported) for prophylaxis. varicella virus vaccine live (oka/merck)(VARIVAX) was reconstituted with properly stored sterile diluent (lot # and expiry date was unknown). No adverse effects were reported. There was no product quality complaint.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: a bad case of the shingles; This spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. The patient's concurrent conditions, medical history and concomitant medications were not reported.  On or around 10-OCT-2014, the patient was administered zoster vaccine live (ZOSTAVAX) (dose, route of administration, anatomical location, lot # and expiry date were not provided) for routine health maintenance and for the prevention of shingles (herpes zoster). On an unknown date (reported as shortly after the vaccination), the patient suffered a bad case of the shingles. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient's symptoms resulted in physical limitations not present prior to using zoster vaccine live (ZOSTAVAX). She also experienced mental and emotional distress due to resulting physical limitations and seriousness of her condition. The patient sustained severe and permanent personal injuries. Further, as a tragic consequence of zoster vaccine live (ZOSTAVAX) vaccination, she suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result, the patient had suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of shingles was reported as not recovered. The event of shingles was considered to be related to zoster vaccine live (ZOSTAVAX).  The event of shingles was considered to be disabling.
Age: 45.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Pruritus, Urticaria
Clinical narrative: raised red hives on right arm with itching approximately 10 minutes after vaccine administration
Age: 23.0
Sex: F
Vaccine: HEPA
Symptoms: Asthenia, Dizziness, Lethargy, Loss of consciousness, Nausea
Clinical narrative: On 10/07/2019 at 2:50 pm RN, administered IM to Right deltoid, Hep A vaccine , Havrix. Within a minute of vaccine administration patient stated that she was feeling light headed. Offered cold water which she drank. After a couple of minutes she became lethargic and passed out. Ammonia capsule was used under her nose. After a few seconds she became responsive again. Patient continues to c/o feeling nauseated. B/P 90/60 with manual cuff.  Patient lowered to the floor and feet were elevated. Stated that helped some. Patient remained in this position for several minutes. Once patient able to sit upright she drank some cola. She stated she still felt weak. Her b/p 128/76.  Was advised she would need someone to drive her home for her safety. Patient called her grandmother who arrived and patient released to her. Patient was able to ambulate to lobby unassisted without difficulty.
Age: 2.0
Sex: F
Vaccine: DTAP, HEPA
Symptoms: Expired product administered
Clinical narrative: Expired DTaP (10-05-19)  administered
Age: 44.0
Sex: M
Vaccine: FLU4
Symptoms: Blood glucose increased, Body temperature increased, Chills, Diabetes mellitus, Full blood count normal
Clinical narrative: Resident started having chills, temp of 101.3, nausea, vomitting at approx 7:00pm. Stat labs and UA were done and orders for IV anti biotics.  While the nurse was waiting for the IV team, the resident temp increased to 103.0 at which time the MD gave orders to send to the ER.
Age: 44.0
Sex: M
Vaccine: FLU4
Symptoms: Metabolic function test, Nausea, Urine analysis normal, Vomiting
Clinical narrative: Resident started having chills, temp of 101.3, nausea, vomitting at approx 7:00pm. Stat labs and UA were done and orders for IV anti biotics.  While the nurse was waiting for the IV team, the resident temp increased to 103.0 at which time the MD gave orders to send to the ER.
Age: 45.0
Sex: F
Vaccine: FLU4
Symptoms: Nausea, Tinnitus, Vertigo
Clinical narrative: Constant tinnitus right ear only, similar to white noise x2 weeks. Mild vertigo and occasional nausea noted with position changes.  Urgent care visit 10/7/19 revealed no ear infection or wax build up.   Negative medical history, no changes in daily activities, negative allergy symptoms, or any possible exposure to loud noises prior to flu shot.
Age: 93.0
Sex: F
Vaccine: VARZOS
Symptoms: Feeling abnormal, Mobility decreased, Pain, Pain in extremity
Clinical narrative: Patient called to report that she "felt bad" and her arm hurts when she moves it, and that she could hardly move it.  Patient was encouraged to call her physician.  Unknown if  she did. Doctor's office notified 10/10/19 1:12pm.
Age: 62.0
Sex: M
Vaccine: FLUR4
Symptoms: Injection site bruising, Injection site swelling
Clinical narrative: The patient told us that on the day of the vaccine the skin at the injection site was raised and swollen. He told us that he did lay on that side while sleeping and woke up to a large bruise on the upper arm around the area of injection.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Nausea
Clinical narrative: Linger nausea after bending down ( to pick up something or tie a shoe).  Feeling Chills.
Age: 12.0
Sex: F
Vaccine: UNK, UNK
Symptoms: Dizziness, Injection site erythema, Injection site pain, Injection site reaction, Injection site swelling
Clinical narrative: Lesion   Location:  left arm, deltoid area Color:   skin colored to faint redness Diameter:  10 width ( entire deltoid) of  tenderness and swelling with pain extending distally to 16 cm down arm  Border and Symmetry:  Ovoid, follows deltoid, no distinct border of enduration Inflammation:  present Given Injections for HPV and Influenza in left deltoid 10/7/2019 by Dr's nurse about 2 day(s) ago but is now concerned because:    Mother reports patient felt faint afterwards and laid down for about 15 min,  then 30 min later c/o "arm felt heavy" and pain, that progressed with swelling noted yesterday and pain spreading to neck and shoulder today   Other symptoms: tingling in fingers ( 3 lateral )  Noticed today
Age: 12.0
Sex: F
Vaccine: UNK, UNK
Symptoms: Limb discomfort, Neck pain, Pain in extremity, Paraesthesia, Skin lesion
Clinical narrative: Lesion   Location:  left arm, deltoid area Color:   skin colored to faint redness Diameter:  10 width ( entire deltoid) of  tenderness and swelling with pain extending distally to 16 cm down arm  Border and Symmetry:  Ovoid, follows deltoid, no distinct border of enduration Inflammation:  present Given Injections for HPV and Influenza in left deltoid 10/7/2019 by Dr's nurse about 2 day(s) ago but is now concerned because:    Mother reports patient felt faint afterwards and laid down for about 15 min,  then 30 min later c/o "arm felt heavy" and pain, that progressed with swelling noted yesterday and pain spreading to neck and shoulder today   Other symptoms: tingling in fingers ( 3 lateral )  Noticed today
Age: 59.0
Sex: F
Vaccine: FLUC4
Symptoms: Flushing, Pruritus, Pyrexia, Rash, Rash erythematous
Clinical narrative: Patient states 3 hours after receiving her flu shot she had a deep red blotchy rash all over her body with fever up to 100.5.  She was extremely itchy, it was flush with skin, not raised, looked like a sunburn.  Fever was gone about 18 hours later and rash was gone about 24 hours later.
Age: 59.0
Sex: F
Vaccine: FLUC4
Symptoms: Rash macular
Clinical narrative: Patient states 3 hours after receiving her flu shot she had a deep red blotchy rash all over her body with fever up to 100.5.  She was extremely itchy, it was flush with skin, not raised, looked like a sunburn.  Fever was gone about 18 hours later and rash was gone about 24 hours later.
Age: 75.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity, Product administered at inappropriate site
Clinical narrative: Patient reported severe arm pain and that husband had to help her get dressed. Nurse at place of work told her shot was too high on arm. At time of reporting, patient said pain was improving.
Age: 70.0
Sex: F
Vaccine: FLUA3
Symptoms: Arthralgia, Chills, Cold sweat, Diarrhoea, Dysphonia
Clinical narrative: Approx. 12 hrs after injection the following symptoms began: severe headache,  hoarse throat,  acute  joint pains, chills resulting in cold sweats, low grade fever, nausea, diarrhea. Symptoms continued at same intensity for approx 10 hrs.   Symptoms  are improving 17 hrs after injection.   Contacted primary care physician who is monitoring via phone.  Knows my clinical history and says these are all results of vaccine.. to call if no improvement.  Since I am improving, have not contacted doctor a second time..
Age: 70.0
Sex: F
Vaccine: FLUA3
Symptoms: Headache, Nausea, Pyrexia
Clinical narrative: Approx. 12 hrs after injection the following symptoms began: severe headache,  hoarse throat,  acute  joint pains, chills resulting in cold sweats, low grade fever, nausea, diarrhea. Symptoms continued at same intensity for approx 10 hrs.   Symptoms  are improving 17 hrs after injection.   Contacted primary care physician who is monitoring via phone.  Knows my clinical history and says these are all results of vaccine.. to call if no improvement.  Since I am improving, have not contacted doctor a second time..
Age: 65.0
Sex: F
Vaccine: UNK
Symptoms: Asthenia, Cough, Diarrhoea, Dizziness, Hyperhidrosis
Clinical narrative: Sore left arm/shoulder and neck, Fever,  head sweating, post nasal drip, Cough, diarrhea, dizziness, weakness
Age: 65.0
Sex: F
Vaccine: UNK
Symptoms: Musculoskeletal pain, Neck pain, Pain in extremity, Pyrexia, Upper-airway cough syndrome
Clinical narrative: Sore left arm/shoulder and neck, Fever,  head sweating, post nasal drip, Cough, diarrhea, dizziness, weakness
Age: 18.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Chest discomfort, Chills, Dizziness, Headache, Injection site pain
Clinical narrative: 18 yo male had Menveo and Tdap yesterday; last night began experiencing localized pain at injection site, subjective fever, chills, tightness in chest, N/V and dizziness. Continues to have symptoms today, including tachycardia and headache
Age: 18.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Local reaction, Nausea, Pyrexia, Tachycardia, Vomiting
Clinical narrative: 18 yo male had Menveo and Tdap yesterday; last night began experiencing localized pain at injection site, subjective fever, chills, tightness in chest, N/V and dizziness. Continues to have symptoms today, including tachycardia and headache
Age: 76.0
Sex: F
Vaccine: FLUA3
Symptoms: Contusion, Pain in extremity
Clinical narrative: SORE ARM WITH BRUISING LAST OVER 2 WEEKS
Age: 70.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Musculoskeletal disorder, Rash
Clinical narrative: patient stated arm did not work on 10/8/19, in the pharmacy the right arm had what looked like a rash to the underside of arm
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Diarrhoea, Dizziness, Feeling abnormal, Full blood count, Metabolic function test
Clinical narrative: Patient reports feeling poorly starting the night of vaccine. She reports nausea, dizziness, diarrhea, vertigo and had an episode of syncope leading patient to seek treatment at the emergency department
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Nausea, Syncope, Urine analysis, Vertigo
Clinical narrative: Patient reports feeling poorly starting the night of vaccine. She reports nausea, dizziness, diarrhea, vertigo and had an episode of syncope leading patient to seek treatment at the emergency department