chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: MMR
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: This spontaneous report was received from a nurse referring to a patient of unknown age and unknown gender. Information about concurrent condition, concomitant medication and medical history was not provided. On 06-SEP-2018, the patient was vaccinated with VARIVAX (lot # R012531, expiration date 01-MAY-2020; strength, dose and route were not reported) for prophylaxis. On 21-SEP-2018 the patient was vaccinated with M-M-R II (lot # R000556, expiration date 08-JAN-2020; strength, dose and route were not reported) for prophylaxis. No adverse effects were reported in the patient.
Sex: U
Vaccine: FLUN4
Symptoms: Myalgia, Nasal discomfort
Clinical narrative: A spontaneous report has been received from a physician. The report concerns a patient of unknown gender (age not provided) of Unknown ethnic origin. No medical history was reported. The following demography was reported for the patient's parent: Sex: Unknown No concomitant products were reported. The patient started treatment with FLUMIST QUADRIVALENT (batch number(s) Not reported), nasal, on an unknown date for flu vaccine. On 15-FEB-2019, the patient experienced nasal irritation  and physician reporting that when giving flumist in the past patients have experienced myalgia.   Treatment with FLUMIST QUADRIVALENT was not changed. The outcome of the event(s) of nasal irritation and physician reporting that when giving flumist in the past patients have experienced myalgia was unknown.  The events were considered non-serious.
Sex: U
Vaccine: VARZOS
Symptoms: Chills, Malaise
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of malaise in a adult patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, unknown after receiving SHINGRIX, the patient experienced malaise and chills. On an unknown date, the outcome of the malaise and chills were unknown. It was unknown if the reporter considered the malaise and chills to be related to SHINGRIX. Additional details were provided as follows: The age at the vaccination was not reported. The age group was not reported but was selected as an adult as per vaccine indication. The reporter stated that, the patient experienced malaise and chills after receiving 1st dose of SHINGRIX. The events were not extreme allergic reaction but mild as described as malaise and chills. This case has been linked to case US2019GSK053162, reported by same reporter.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Loss of consciousness, Syncope, Unresponsive to stimuli
Clinical narrative: This case was reported by a pharmacist via sales rep and described the occurrence of syncope in a 71-year-old female patient who received SHINGRIX for prophylaxis. The patient's past medical history included syncopal attack (experienced for routine childhood vaccines). Previously administered products included Flu vaccine (routinely receives yearly and received both pneumonia shots with no adverse reaction) and Pneumococcal vaccine (both pneumonia shots, no adverse reaction). On 14th March 2019, the patient received the 1st dose of SHINGRIX. On 14th March 2019, less than a day after receiving SHINGRIX, the patient experienced syncope (serious criteria GSK medically significant), passed out (serious criteria GSK medically significant) and unresponsive to stimuli (serious criteria GSK medically significant). The patient was treated with ammonia. On 14th March 2019, the outcome of the syncope, passed out and unresponsive to stimuli were recovered/resolved. It was unknown if the reporter considered the syncope, passed out and unresponsive to stimuli to be related to SHINGRIX. Additional details were provided as follows: The patient experienced syncope and passed out for about 30 seconds to 1 minute. The patient was unresponsive to ammonia inhalants throughout 30 seconds to 1 minute. The patient was admitted to local hospital. The patient was discharged on the same day. The patient did not received any other vaccine during the course of time. The reporter provided consent to follow up.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Decreased appetite, Diarrhoea, Erythema, Fatigue, Pain in extremity
Clinical narrative: Pain, redness, swelling, itchiness in left arm, substantial fatigue, lack of appetite, diarrhea. This is day 4 after vaccine. Symptoms not yet abating.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Peripheral swelling, Pruritus
Clinical narrative: Pain, redness, swelling, itchiness in left arm, substantial fatigue, lack of appetite, diarrhea. This is day 4 after vaccine. Symptoms not yet abating.
Age: 67.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Limb discomfort, Peripheral swelling, Skin warm
Clinical narrative: PT HAS SWELLING IN THE SHAPE OF HALF MOON UNDER HER DELTOID WITH REDNESS. NO PAIN. WARMTH IS NOTED. SHE DOES C/O HEAVINESS IN HER RIGHT ARM SINCE THE VACCINE INJECTION.
Age: 32.0
Sex: M
Vaccine: PPV
Symptoms: Blood culture, Blood gases, Blood lactic acid, Chills, Full blood count
Clinical narrative: Pt felt fine after leaving the clinic after 4-5 hours patient went to the ED felt, fever, tachycardia, chills, myalgia's, developed a painful rash on LUE.
Age: 32.0
Sex: M
Vaccine: PPV
Symptoms: Influenza virus test, Liver function test, Metabolic function test, Myalgia, Pyrexia
Clinical narrative: Pt felt fine after leaving the clinic after 4-5 hours patient went to the ED felt, fever, tachycardia, chills, myalgia's, developed a painful rash on LUE.
Age: 32.0
Sex: M
Vaccine: PPV
Symptoms: Rash, Tachycardia
Clinical narrative: Pt felt fine after leaving the clinic after 4-5 hours patient went to the ED felt, fever, tachycardia, chills, myalgia's, developed a painful rash on LUE.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Burning sensation, Dizziness, Dyspnoea, Injection site pain, Musculoskeletal disorder
Clinical narrative: Patient experienced pain and burning that radiated from left arm to neck. She stated she became short of breath, dizzy, rash, and loss of function in the left arm. Patient's husband contacted 911 and administered EPIPEN at direction of EMS.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Neck pain, Pain, Pain in extremity, Rash
Clinical narrative: Patient experienced pain and burning that radiated from left arm to neck. She stated she became short of breath, dizzy, rash, and loss of function in the left arm. Patient's husband contacted 911 and administered EPIPEN at direction of EMS.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Headache, Injection site erythema, Injection site swelling, Pain
Clinical narrative: Fever, severe headache, body aches, upset stomach, swelling and redness at injection site.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Fever, severe headache, body aches, upset stomach, swelling and redness at injection site.
Age: 69.0
Sex: M
Vaccine: PPV
Symptoms: Asthenia, Chest X-ray abnormal, Chills, Cough, Pneumonia
Clinical narrative: 03/04/2019 diagnosed with pneumonia. Confirmed by x-ray. Treatment with antibiotics, LEVAQUIN. Cough syrup, Promethazine. Lots of rest. Symptoms were hacking and retching cough. Running nose and congestion. Fever and chills. Weakness.
Age: 69.0
Sex: M
Vaccine: PPV
Symptoms: Pyrexia, Respiratory tract congestion, Retching, Rhinorrhoea
Clinical narrative: 03/04/2019 diagnosed with pneumonia. Confirmed by x-ray. Treatment with antibiotics, LEVAQUIN. Cough syrup, Promethazine. Lots of rest. Symptoms were hacking and retching cough. Running nose and congestion. Fever and chills. Weakness.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Fatigue, Headache, Immediate post-injection reaction, Injection site discomfort
Clinical narrative: Shoulder discomfort at location site. Pain, tenderness to the touch immediately following injection. In the afternoon the following day, I started with a headache, body aches, joint pain (shoulders, hips and neck), fatigue and fever (max. 101.0 F).
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pyrexia
Clinical narrative: Shoulder discomfort at location site. Pain, tenderness to the touch immediately following injection. In the afternoon the following day, I started with a headache, body aches, joint pain (shoulders, hips and neck), fatigue and fever (max. 101.0 F).
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Mobility decreased, Pain in extremity, Peripheral swelling
Clinical narrative: Pain, Swelling and reduced arm mobility lasting longer than 3 days.
Age: 0.75
Sex: F
Vaccine: DTAP, IPV, PNC13
Symptoms: Crying, Hypotonia, Inability to crawl, Lethargy, Pyrexia
Clinical narrative: Mom called office on 3/5/2019 at 5 pm to state that the child has been having fevers all day and was lethargic, she hasn't given any TYLENOL/MOTRIN at all due to not wanting to interfere with immune response, mom was advised to give 3.75 mls of TYLENOL and if child has no improved within 1 hour child needed to be evaluated in the ER or urgent care setting. Mom called back on 3/25/2019 in the AM to advised that child had a reaction to vaccines and described the symptoms of fevers x 1 week, not wanting to crawl, crying when not being held and limp in nature, child wasn't evaluated at time of noted symptoms. Mom states that symptoms lasted approx 1 week then resolved and child is currently acting normal.
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to a patient of unknown age and gender. Concomitant medication included sterile diluent. Information about concurrent condition, drug reactions/allergies and medical history was not provided. On 07-MAR-2019, the patient was administered PROQUAD (subcutaneous, lot: R011215, expiration date was 15-OCT-2019; strength and dose were not reported) for prophylaxis and VARIVAX (subcutaneous, lot: R012531, expiration date was 01-MAY-2020; strength and dose were not reported) for prophylaxis concomitantly (Overdose). No adverse effects was reported.
Sex: U
Vaccine: VARZOS
Symptoms: Chills, Malaise
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of malaise in a adult patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, unknown after receiving SHINGRIX, the patient experienced malaise and chills. On an unknown date, the outcome of the malaise and chills were unknown. It was unknown if the reporter considered the malaise and chills to be related to SHINGRIX. Additional details were provided as follows: The age group was not reported but was selected as adult as per vaccine indication. The reporter stated that, the patient experienced malaise and chills after receiving 1st dose of SHINGRIX. The events were not extreme allergic reaction but mild. This case is linked to case US2019AMR048820, reported by same reporter.
Age: 66.0
Sex: F
Vaccine: PNC13
Symptoms: Decreased appetite, Ear discomfort, Fatigue, Hypoacusis, Injection site erythema
Clinical narrative: This is a spontaneous report from a contactable consumer. A 66-year-old female patient received PREVNAR 13 at single dose on 11Mar2019 in left arm. Relevant medical history and concomitant medications were unknown. On 11Mar2019 redness and swelling appeared at injection site, with fatigue, muscle pain, and loss of appetite. Redness and swelling increased until approximately 4 inches in diameter, radiating from the injection site on 14Mar2019. Sensation of fluid in ear and decreased hearing started on 13Mar2019, with fluid draining continuously from right ear on 14Mar2019. The outcome of the events was reported as unknown except for ear discomfort with outcome of not recovered. Information on the batch/lot number has been requested.
Age: 66.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site swelling, Middle ear effusion, Myalgia, Otorrhoea
Clinical narrative: This is a spontaneous report from a contactable consumer. A 66-year-old female patient received PREVNAR 13 at single dose on 11Mar2019 in left arm. Relevant medical history and concomitant medications were unknown. On 11Mar2019 redness and swelling appeared at injection site, with fatigue, muscle pain, and loss of appetite. Redness and swelling increased until approximately 4 inches in diameter, radiating from the injection site on 14Mar2019. Sensation of fluid in ear and decreased hearing started on 13Mar2019, with fluid draining continuously from right ear on 14Mar2019. The outcome of the events was reported as unknown except for ear discomfort with outcome of not recovered. Information on the batch/lot number has been requested.
Sex: U
Vaccine: DTAP
Symptoms: Myalgia
Clinical narrative: Initial information received on 19-Mar-2019 regarding an unsolicited valid non-serious case received from a consumer/non-HCP. This case involves a patient of unknown demographics who experienced moderate to serious side effects with myalgia, while he/she received vaccine DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. In November 2018, the patient received a dose of suspect DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE produced by unknown manufacturer lot number not reported via unknown route in unknown administration site. On an unknown date, the patient developed a non-serious moderate to serious side effects with myalgia following the administration of DIPHTHERIA and TETANUS AND ACELLULAR PERTUSSIS VACCINE. Patient had to visit emergency room at the Hospital. Lab test not reported. Final diagnosis was moderate to serious side effects with myalgia. It was not reported if the patient received a corrective treatment. The patient outcome was reported.
Age: 0.17
Sex: M
Vaccine: VARCEL
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: None stated.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Guillain-Barre syndrome
Clinical narrative: Guillain Barre Syndrome.
Age: 70.0
Sex: M
Vaccine: FLU3, PNC13
Symptoms: Pain in extremity, Paraesthesia
Clinical narrative: EFFECT STARTED COUPLE DAYS AFTER VACCINATION. SORENESS OF BOTH ARMS, TINGLING RADIATING TO NECK AND BACK AND BACK TO HEAD. CAN'T LIFT.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Injection site inflammation, Injection site reaction, Loss of personal independence in daily activities, Myalgia
Clinical narrative: Red area and inflammation at the shot site, arm muscle ache developing the next day and lasting 4 additional days that interfered with daily activity, general fatigue lasting 4 days, red rash at shot site developed on the 3rd day and remained for 7 days.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash erythematous
Clinical narrative: Red area and inflammation at the shot site, arm muscle ache developing the next day and lasting 4 additional days that interfered with daily activity, general fatigue lasting 4 days, red rash at shot site developed on the 3rd day and remained for 7 days.
Age: 81.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Pain in extremity
Clinical narrative: ARM EXTREMELY SORE, REDNESS AT INJECTION SITE THAN HAS SPREAD DOWN THE ARM OVER THE WEEKEND. PT TOOK 400MG IBUPROFEN IMMEDIEATELY AND 2 650MG APAP.
Age: 3.0
Sex: M
Vaccine: DTAPIPVHIB, FLU4, HEPA, MMR
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Developed redness, swelling and itching in right thigh in the evening following vaccination. Still has swelling of thigh and itchiness.
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Gait inability, Mental status changes, Pyrexia
Clinical narrative: Change in mental status and capacity, unable to walk and weakness, fever, chills.
Age: 37.0
Sex: F
Vaccine: MMR
Symptoms: Expired product administered
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a 37-year-old female patient. Her concurrent condition, pertinent medical history, concomitant medication and drug reactions/allergies were not provided. On 06-MAR-2019, the patient was vaccinated with an expired dose of (rHA) M-M-R II injection, lot # N004433, expiry date 07-FEB-2019 (strength, dose and route of administration were not reported) for prophylaxis. The pharmacist was inquiring about revaccination of the patient. The outcome of the patient receiving an expired vaccine was unknown.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant, referring to a patient of unknown age and gender. Information about the patient's medical history, drug reactions or allergies and concomitant medications were not provided. On 15-MAR-2019, the patient was vaccinated with an expired dose (two days post expiration date) of M-M-R I) for prophylaxis, lot number N008365 and expiration date 13-MAR-2019 (dosage schedule, anatomical location and route of administration were not provided). The sterile diluent that was used to reconstitute the M-M-R II was not expired. No adverse effect reported.
Age: 16.0
Sex: F
Vaccine: HPV9
Symptoms: Dyskinesia
Clinical narrative: GARDASIL shot given 3/18/19. Involuntary movement per mom 3/19/19 -> not seen mom refuse to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Herpes virus infection, Herpes zoster, Herpes zoster infection neurological, Influenza like illness
Clinical narrative: Information has been received on 18-MAR-2019 regarding a case in litigation from a lawyer concerning a male patient of unknown age. There was no information provided regarding the patient's concurrent conditions, medical history or concomitant medications. In or around 03-JAN-2017, the patient was inoculated with the ZOSTAVAX (lot number, expiration, dose and route unknown) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster.) Shortly after receiving ZOSTAVAX, the patient suffered intense body pain, fatigue and flu like symptoms and developed a rash on his back. Consequently, the patient was diagnosed with herpes zoster, and later diagnosed with post varicella zoster neuropathy, thoracic neuralgia, translumbar polyradiculopathy, peripheral neuropathy and recurrent herpetic infections. As a direct and proximate result of ZOSTAVAX, the patient's symptoms have resulted in physical limitation not present prior to using ZOSTAVAX. The patient also experiences mental and emotional distress due to resulting physical limitations and seriousness of the patient's condition. As a result of ZOSTAVAX, the patient sustained severe and permanent personal injuries. Further, as a tragic consequence of ZOSTAVAX, the patient suffered serious, progressive, permanent and incurable injuries, as well as conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of ZOSTAVAX, the patient has suffered and incurred damages, including medical expenses, loss of accumulations and other economic and non-economic damages.  Herpes zoster, post varicella zoster neuropathy, thoracic neuralgia/translumbar polyradiculopathy, peripheral neuropathy and recurrent herpetic infections were considered to be disabling. Upon internal review, peripheral neuropathy was considered to be medically significant. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Neuralgia, Neuropathy peripheral, Pain, Radiculopathy, Rash
Clinical narrative: Information has been received on 18-MAR-2019 regarding a case in litigation from a lawyer concerning a male patient of unknown age. There was no information provided regarding the patient's concurrent conditions, medical history or concomitant medications. In or around 03-JAN-2017, the patient was inoculated with the ZOSTAVAX (lot number, expiration, dose and route unknown) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster.) Shortly after receiving ZOSTAVAX, the patient suffered intense body pain, fatigue and flu like symptoms and developed a rash on his back. Consequently, the patient was diagnosed with herpes zoster, and later diagnosed with post varicella zoster neuropathy, thoracic neuralgia, translumbar polyradiculopathy, peripheral neuropathy and recurrent herpetic infections. As a direct and proximate result of ZOSTAVAX, the patient's symptoms have resulted in physical limitation not present prior to using ZOSTAVAX. The patient also experiences mental and emotional distress due to resulting physical limitations and seriousness of the patient's condition. As a result of ZOSTAVAX, the patient sustained severe and permanent personal injuries. Further, as a tragic consequence of ZOSTAVAX, the patient suffered serious, progressive, permanent and incurable injuries, as well as conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of ZOSTAVAX, the patient has suffered and incurred damages, including medical expenses, loss of accumulations and other economic and non-economic damages.  Herpes zoster, post varicella zoster neuropathy, thoracic neuralgia/translumbar polyradiculopathy, peripheral neuropathy and recurrent herpetic infections were considered to be disabling. Upon internal review, peripheral neuropathy was considered to be medically significant. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Eye injury, Optic nerve injury, Visual field defect, Visual impairment
Clinical narrative: This initial spontaneous case was received from a lawyer regarding a case in litigation concerning a female patient of unspecified age. No information was provided regarding medical history, concurrent conditions, or concomitant medications. In 2017, the patient was inoculated with ZOSTAVAX for routine health maintenance and for the prevention of shingles (dose, route, and lot # not provided). Shortly after receiving ZOSTAVAX (onset date not further specified), the patient began experiencing issues with her vision. Over the next few months (date not further specified), these issues worsened, resulting in her suffering diminished peripheral vision in both eyes, damage to the optic nerve in her left eye, and severe damage to her right eye. As a result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. As a direct and proximate result of ZOSTAVAX, the patient's symptoms and diagnoses have resulted in physical limitations not present prior to using the Company's product. As a result of the manufacture, marketing, advertising, promotion, distribution, and/or sale of ZOSTAVAX, the patient sustained severe and permanent personal injuries. Further, as a tragic consequence of the Company's wrongful conduct, the patient 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. The outcome of the events was not recovered/not resolved. Causality assessment was related. Issues with her vision, diminished peripheral vision in both eyes, damage to the optic nerve in her left eye, and severe damage to her right eye were considered disabling. Upon internal review, damage to the optic nerve in her left eye was considered to be medically significant. Additional information has been requested.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Blister, Influenza, Injection site pain, Myalgia
Clinical narrative: I got the shot, the second one required six months apart, on Feb 13 at approx. 9:30 am. By 7 pm that same night (approx) I began to feel feverish and had some rather severe muscle aches. I had no reactions to the first round of the vaccine six months earlier except for injection site soreness. I treated the flu symptoms with Advil which worked well. The next morning I noticed four blister-type sores on the inner left thigh! Two of the blisters looked to be about the size of dimes or slightly smaller. The other two were quite small and disappeared in a week. The larger two, however, slowly crusted over exactly like chicken pox and have slowly diminished in size. As of this writing two very small scabs are still there. I have taken a series of pictures over the time period in question if you would want me to share them. Two doctors have looked at them and said they were related the vaccine. I also had a few days of physical weakness and malaise after the vaccination which seems to persist to a lesser extent even now. The injection site soreness was worse than the first shot in the series given in Oct 2018. This  site soreness has gone away but is replaced with a deep ache in the shoulder joint (rotator?) near that injection site.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Pyrexia, Scab
Clinical narrative: I got the shot, the second one required six months apart, on Feb 13 at approx. 9:30 am. By 7 pm that same night (approx) I began to feel feverish and had some rather severe muscle aches. I had no reactions to the first round of the vaccine six months earlier except for injection site soreness. I treated the flu symptoms with Advil which worked well. The next morning I noticed four blister-type sores on the inner left thigh! Two of the blisters looked to be about the size of dimes or slightly smaller. The other two were quite small and disappeared in a week. The larger two, however, slowly crusted over exactly like chicken pox and have slowly diminished in size. As of this writing two very small scabs are still there. I have taken a series of pictures over the time period in question if you would want me to share them. Two doctors have looked at them and said they were related the vaccine. I also had a few days of physical weakness and malaise after the vaccination which seems to persist to a lesser extent even now. The injection site soreness was worse than the first shot in the series given in Oct 2018. This  site soreness has gone away but is replaced with a deep ache in the shoulder joint (rotator?) near that injection site.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Palpitations
Clinical narrative: Patient said we she went home from shot that her heart was racing for a few seconds. She does not normally experience this. She told me after administration of second shot.
Age: 21.0
Sex: M
Vaccine: TYP
Symptoms: Rash
Clinical narrative: Pt got the typhoid vaccine at 0800 waited in the clinic 20 mins. Pt then went back to work then around 1330 came into to the clinic with a rash on his left heel and a rash on the top side of his left foot.
Age: 48.0
Sex: F
Vaccine: VARCEL
Symptoms: Erythema, Pain, Pruritus, Swelling
Clinical narrative: PATIENT REPORTS APPROXIMATELY 2 DAYS AFTER VARICELLA INJECTION SHE NOTICED SWELLING APPROXIMATELY 10 CM IN LENGTH AND AN APPROXIMATELY AN INCH IN THICKNESS WITH REDNESS, PAIN AND ITCHING. REPORTS THE SWELLING, REDNESS AND ITCHING LASTED APPROXIMATELY 2 WEEKS.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Blood test, Cardiac monitoring, Chest X-ray, Chills, Computerised tomogram head
Clinical narrative: Chills, Nausea, then fainted.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Electrocardiogram, Nausea, Syncope
Clinical narrative: Chills, Nausea, then fainted.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia, Urticaria
Clinical narrative: Fever 101.7 for 24 hours. Welps three inched raised for 4 days.
Age: 1.67
Sex: F
Vaccine: HIBV, IPV
Symptoms: Pyrexia, Rash, Seizure, Tremor
Clinical narrative: Landed in the emergency room that night with a 104 fever, rash and shaking/convulsions.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site irritation, Injection site warmth
Clinical narrative: AT THE TIME OF PATIENT GETTING HER SECOND VACCINATION; SHE REPORTED HAVING A RED AREA ABOUT 2 INCHES IN DIAMETER AROUND THE INJECTION SITE FOR ABOUT 2-3 WEEKS, AFTERWARDS UNTIL RESOLUTION, SHE DESCRIBED IT AS WARM TO TOUCH, AND FELT IRRITATION WHEN MOVING THE ARM. SHE DENIED ANY BOTHERSOME PAIN ABOUT THE AREA. THE PATIENT REPORTED NOT SEEKING ANY MEDICAL ATTENTION AS THINKING HER IMMUNE SYSTEM WAS DOING ITS JOB.
Age: 59.0
Sex: F
Vaccine: TDAP
Symptoms: Rash erythematous, Rash generalised
Clinical narrative: Red pinpoint rash all over body. Used oral BENADRYL and BENADRYL cream. Rash did not itch. Hydrocortisone cream will be tried. States rash is better today than on Saturday.
Age: 47.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Influenza like illness, Pain, Pyrexia
Clinical narrative: Flu like symptoms - body aches, headache, fatigue, fever.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Arthralgia, Fatigue, Headache, Influenza like illness
Clinical narrative: Redness and swelling at the shot site, significant pain at the shot site that lasted more than 2 weeks, significant lingering arm muscle pain when doing routine activities after the first two weeks passed,  overall feeling of having the flu for more than 5 days, significant all over muscle and joint pain, headache, upset stomach, fatigue all lasting more than 15 days, lingering arm soreness 3 weeks after the shot was administered. Red rash appeared in a band at the shot site on the second day after the shot and was visible for about 12 days. Overall significant impact on daily routine and mobility.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site reaction, Injection site swelling, Loss of personal independence in daily activities
Clinical narrative: Redness and swelling at the shot site, significant pain at the shot site that lasted more than 2 weeks, significant lingering arm muscle pain when doing routine activities after the first two weeks passed,  overall feeling of having the flu for more than 5 days, significant all over muscle and joint pain, headache, upset stomach, fatigue all lasting more than 15 days, lingering arm soreness 3 weeks after the shot was administered. Red rash appeared in a band at the shot site on the second day after the shot and was visible for about 12 days. Overall significant impact on daily routine and mobility.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Mobility decreased, Myalgia, Pain in extremity, Rash erythematous
Clinical narrative: Redness and swelling at the shot site, significant pain at the shot site that lasted more than 2 weeks, significant lingering arm muscle pain when doing routine activities after the first two weeks passed,  overall feeling of having the flu for more than 5 days, significant all over muscle and joint pain, headache, upset stomach, fatigue all lasting more than 15 days, lingering arm soreness 3 weeks after the shot was administered. Red rash appeared in a band at the shot site on the second day after the shot and was visible for about 12 days. Overall significant impact on daily routine and mobility.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Aphonia, Chills, Dry mouth, Dysphonia, Ear pain
Clinical narrative: Couldn't sleep, shivering, fever, hands & feet were freezing cold, headache from temple to temple...couldn't even put on my glasses, couldn't stand sunlight & big toe and first toe on right foot felt like fireworks were going off in them....(still feel funny) for 24-36 hrs after the 2nd shot. Then sinus stuffed up but couldn't blow anything out and ears hurt when I swallowed but no sore throat, voice got raspy and eventually lost my voice for just over a week. I felt like my head and mouth dried up regardless of how much water I drank.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Insomnia, Pain in extremity, Peripheral coldness, Photophobia
Clinical narrative: Couldn't sleep, shivering, fever, hands & feet were freezing cold, headache from temple to temple...couldn't even put on my glasses, couldn't stand sunlight & big toe and first toe on right foot felt like fireworks were going off in them....(still feel funny) for 24-36 hrs after the 2nd shot. Then sinus stuffed up but couldn't blow anything out and ears hurt when I swallowed but no sore throat, voice got raspy and eventually lost my voice for just over a week. I felt like my head and mouth dried up regardless of how much water I drank.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia, Sinus congestion
Clinical narrative: Couldn't sleep, shivering, fever, hands & feet were freezing cold, headache from temple to temple...couldn't even put on my glasses, couldn't stand sunlight & big toe and first toe on right foot felt like fireworks were going off in them....(still feel funny) for 24-36 hrs after the 2nd shot. Then sinus stuffed up but couldn't blow anything out and ears hurt when I swallowed but no sore throat, voice got raspy and eventually lost my voice for just over a week. I felt like my head and mouth dried up regardless of how much water I drank.
Age: 1.0
Sex: M
Vaccine: MMR
Symptoms: Asthenia, Decreased appetite, Malaise, Otorrhoea, Pyrexia
Clinical narrative: Patient reacted with hives after his 1st MMR on three occasions. 1st, reacted without cause post-shot. 2nd and 3rd, hive reactions from foods previously deemed safe and ingested on a regular basis. Noted auto-immune complications. In the week following the MMR shot, patient acquired a perforated ear drum (with no ear aches or infections prior), with excessive discharge. Antibiotics prescribed. Perforation still present after 1 month. With thick discharge. 2nd round of antibiotics started mid-March (CIPRO). Patient had two different incidents with high fever (above 102 F) after his MMR immunization, the first within 6 days following the shot, and the 2nd within 10 days of the immunization. Both fevers included malaise/lack of energy, poor appetite, neediness.
Age: 1.0
Sex: M
Vaccine: MMR
Symptoms: Tympanic membrane perforation, Urticaria
Clinical narrative: Patient reacted with hives after his 1st MMR on three occasions. 1st, reacted without cause post-shot. 2nd and 3rd, hive reactions from foods previously deemed safe and ingested on a regular basis. Noted auto-immune complications. In the week following the MMR shot, patient acquired a perforated ear drum (with no ear aches or infections prior), with excessive discharge. Antibiotics prescribed. Perforation still present after 1 month. With thick discharge. 2nd round of antibiotics started mid-March (CIPRO). Patient had two different incidents with high fever (above 102 F) after his MMR immunization, the first within 6 days following the shot, and the 2nd within 10 days of the immunization. Both fevers included malaise/lack of energy, poor appetite, neediness.
Sex: F
Vaccine: VARZOS
Symptoms: Blindness, Herpes zoster
Clinical narrative: This initial spontaneous case was received from a lawyer regarding a case in litigation concerning a female patient of unspecified age. No information was provided regarding medical history, concurrent conditions, or concomitant medications. In 2015, the patient was inoculated with ZOSTAVAX at a pharmacy for routine adult health maintenance for the prevention of shingles (dose, route, and lot # were not provided). The vaccine did not prevent shingles as intended and subsequently, the patient experienced vision loss. She was treated by an optometrist for the vision loss. As a direct and proximate result of ZOSTAVAX and/or despite receiving ZOSTAVAX for the long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was not recovered/not resolved. Causality assessment was related. Upon internal review, vision loss was considered to be medically significant. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Pneumonia, Vision blurred
Clinical narrative: This initial spontaneous case was received from a lawyer regarding a case in litigation concerning a male patient of unspecified age. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On or around 24-JUN-2016, the patient was inoculated with ZOSTAVAX for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster) (dose, route, and lot # not provided). Shortly after receiving ZOSTAVAX (onset date not further specified), the patient suffered sudden intermittent blurred vision, with episodes of blurry vision occurring several times a day. On an unspecified date, the patient also suffered bilateral pneumonia requiring hospitalization and continued care and treatment. As a direct and proximate result of the Company's defective ZOSTAVAX vaccine, the patient's symptoms have resulted in physical limitations not present prior to using the Company's product. The patient also experiences mental and emotional distress due to resulting physician limitations and seriousness of his condition. As a result of the manufacture, marketing, advertising, promotion, distribution, and/or sale of ZOSTAVAX, the patient sustained severe and permanent personal injuries. Further, as a tragic consequence of the Company's wrongful conduct, the patient 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 patient 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 resolved. Causality assessment was related. Sudden intermittent blurred vision, with episodes of blurry vision occurring several times a day and bilateral pneumonia were considered to be disabling. Upon internal review, bilateral pneumonia was considered to be a medically significant event. Additional information has been requested.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Chemotherapy, Oesophageal carcinoma, Radiotherapy, Surgery
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of esophageal cancer in a 75-year-old female patient who received SHINGRIX for prophylaxis. In July 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced esophageal cancer (serious criteria GSK medically significant). The patient was treated with chemotherapy, nos (Chemotherapy) and non-drug therapy (Radiation Therapy). On an unknown date, the outcome of the esophageal cancer was unknown.  It was unknown if the reporter considered the esophageal cancer to be related to SHINGRIX. Additional details were provided as follows: This case was reported by the patient for herself. Shortly after receiving SHINGRIX, the patient was diagnosed with esophageal cancer. The patient went through chemotherapy, radiation therapy and surgery. The patient was due for 2nd dose of SHINGRIX, however the pharmacist was enquiring about any blood transfusion or radiation therapy. The reporter gave consent for follow up.
Age: 81.0
Sex: M
Vaccine: TDAP
Symptoms: Intraocular pressure increased
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of increased intraocular pressure in a 81-year-old male patient who received BOOSTRIX for prophylaxis. The patient's past medical history included intraocular pressure high (8 years before the reporting date), glaucoma, eye operation and cataract extraction (after surgeries eye pressure had been 11 and 13 for the past 2-3 years). On 7th March 2019, the patient received BOOSTRIX (intramuscular). On 13th March 2019, 6 days after receiving BOOSTRIX, the patient experienced increased intraocular pressure. On an unknown date, the outcome of the increased intraocular pressure was unknown. The reporter considered the increased intraocular pressure to be related to BOOSTRIX. Additional details were provided as follows: This case was reported by the patient's wife. The patient received BOOSTRIX on the left arm. The patient pressure in his eyes had jumped up from 13 to 23 in one aye and 26 in the other eye. The eye doctor and pharmacist thought that the increased pressure was due to the vaccine and he was supposed to return in 3 months for another check. The emergency room visit was required. Lab Comments: The patient's eye pressure jumped from 13 in each eye up 23 in one eye and 26 in the other eye.
Age: 0.75
Sex: F
Vaccine: PNC13
Symptoms: Eczema, Feeling abnormal, Lethargy, Pyrexia
Clinical narrative: About a week after she received this vaccination she had a fever that ran from 100-101 for the next couple of days. She was lethargic and didn't seem like herself but had no other signs of anything being wrong in terms of illness. No runny nose, no cough, no congestion, nothing. Immediately after this vaccine, she developed pretty severe eczema around her legs, thighs, stomach, back, pretty much all over. After a few weeks it did become a little milder but, as I said, it has never gone away. She never had any skin issues before this vaccination and I find it is too closely correlated to not be related.
Age: 4.0
Sex: F
Vaccine: MMRV
Symptoms: Wrong product administered
Clinical narrative: Wrong Immunization given.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Cold sweat, Loss of consciousness
Clinical narrative: Patient received her second dose of the SHINGRIX on 3/20/19 in the afternoon. She reports she woke up the next morning in a cold sweat and her husband states she "blacked out." When she came to again she had chills for almost one hour and remained in bed for the remainder of the day. She reported the reaction on 3/23/19 and said she's been feeling herself and good since the morning of 3/22/19.
Age: 18.0
Sex: M
Vaccine: HPV9
Symptoms: Anxiety
Clinical narrative: Crippling Anxiety.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Loss of personal independence in daily activities, Pain, Pyrexia
Clinical narrative: It was like having shingles again for about 36 hours--chills, fever, achiness, fatigue, tenderness of head (where shingles manifested themselves last fall, despite having had the earlier shingles vaccine). Unable to do normal activities for a day. Did not have this reaction to the first dose of the new shingles vaccine.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Tenderness
Clinical narrative: It was like having shingles again for about 36 hours--chills, fever, achiness, fatigue, tenderness of head (where shingles manifested themselves last fall, despite having had the earlier shingles vaccine). Unable to do normal activities for a day. Did not have this reaction to the first dose of the new shingles vaccine.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Antinuclear antibody, C-reactive protein, Cough, Fatigue, Full blood count
Clinical narrative: Fever 100.4-103, myalgia, fatigue (extreme), cough intermittently for 30 days after vaccination.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: HIV test, Metabolic function test, Myalgia, Pyrexia, Rheumatoid factor
Clinical narrative: Fever 100.4-103, myalgia, fatigue (extreme), cough intermittently for 30 days after vaccination.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Tuberculin test
Clinical narrative: Fever 100.4-103, myalgia, fatigue (extreme), cough intermittently for 30 days after vaccination.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Injection site pain, Pain in extremity, Pyrexia
Clinical narrative: Sore arm approximately 4 hours post. Severe chills began 10 hours post, progressed to fever ranging 100.7 to 101. Nausea started at 11 hours post, and persistent vomiting began 15 hours post. Vomiting stopped 20 hours post and others symptoms began to abate at 24 hours post. Ibuprofen was tolerated at that point and fever, headache and chills dissipated by 30 hours post. Resumed normal activity (with rest breaks needed) 48 hours post. Injection site remains sore but anticipated to resolve within next 24-48 hours. Doctor notified this am (three days from injection).
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Vomiting
Clinical narrative: Sore arm approximately 4 hours post. Severe chills began 10 hours post, progressed to fever ranging 100.7 to 101. Nausea started at 11 hours post, and persistent vomiting began 15 hours post. Vomiting stopped 20 hours post and others symptoms began to abate at 24 hours post. Ibuprofen was tolerated at that point and fever, headache and chills dissipated by 30 hours post. Resumed normal activity (with rest breaks needed) 48 hours post. Injection site remains sore but anticipated to resolve within next 24-48 hours. Doctor notified this am (three days from injection).
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Back pain, Pain, Pyrexia
Clinical narrative: Patient reported fever, aches and pains - specifically in back, and overall weakness for several days.
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Pyrexia
Clinical narrative: Strong chills, feverish beginning @ 6:30 p.m. and lasting until about 1:00 p.m. the following day.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, PNC13
Symptoms: Body temperature increased, Dyskinesia, Eye movement disorder, Fatigue, Febrile convulsion
Clinical narrative: Febrile seizure occurred approximately 9 days after immunization with MMR. Was well following immunizations, no runny nose, cough or other URI symptoms until 03/25/19 when began feeling tired after dinner. Put to bed early but when mom went up to check on him he was moving oddly, then when she rolled him over to his side his eyes rolled back in his head and he tensed. EMS was called. Episode lasted around 5 minutes. No resuscitation needed. Temp on EMS arrival was 102.8. Post ictal state observed in ER x2 hours before discharge home. Followed up in our office next day. Flu negative. Afebrile since prior evening. Full examination completed and no other source for fever identified on exam. Suspect febrile seizure related to febrile immune response from MMR vaccination.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, PNC13
Symptoms: Influenza virus test negative, Postictal state, Tension
Clinical narrative: Febrile seizure occurred approximately 9 days after immunization with MMR. Was well following immunizations, no runny nose, cough or other URI symptoms until 03/25/19 when began feeling tired after dinner. Put to bed early but when mom went up to check on him he was moving oddly, then when she rolled him over to his side his eyes rolled back in his head and he tensed. EMS was called. Episode lasted around 5 minutes. No resuscitation needed. Temp on EMS arrival was 102.8. Post ictal state observed in ER x2 hours before discharge home. Followed up in our office next day. Flu negative. Afebrile since prior evening. Full examination completed and no other source for fever identified on exam. Suspect febrile seizure related to febrile immune response from MMR vaccination.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Head injury, Loss of consciousness, Nausea, Pain in extremity
Clinical narrative: Patient experienced extreme arm pain, dizziness, nausea, and sedation from the vaccine. Roughly 4-6 hours after the shot, she passed out at home, hitting her head and went to the ER that  evening for a full checkup.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Sedation
Clinical narrative: Patient experienced extreme arm pain, dizziness, nausea, and sedation from the vaccine. Roughly 4-6 hours after the shot, she passed out at home, hitting her head and went to the ER that  evening for a full checkup.