chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 48.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Rash, Urticaria
Clinical narrative: Hives, redness, rash
Age: 72.0
Sex: F
Vaccine: FLU4
Symptoms: Flushing, Pain in extremity, Yawning
Clinical narrative: Patient had a sharp pain  down her entire arm several hours after the initial injection that lasted for about 8 hours.  She also had facial flushing, but no fever.  Patient also said she was yawning every 30 seconds or so.
Age: 3.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Redness, swelling and warmth to injection site
Age: 60.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site streaking, Rash, Rash erythematous
Clinical narrative: Injection site redness, tenderness, some red lines surrounding injection site. Red raised rash on trunk of body. Patient reported rash starting 10/24/2020 in the evening. advised patient to utilize ice at injection site and oral antihistamine to control rash.  Also advised patient to follow up with pcp. Sent notification to patient pcp.
Age: 60.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Rash papular
Clinical narrative: Injection site redness, tenderness, some red lines surrounding injection site. Red raised rash on trunk of body. Patient reported rash starting 10/24/2020 in the evening. advised patient to utilize ice at injection site and oral antihistamine to control rash.  Also advised patient to follow up with pcp. Sent notification to patient pcp.
Age: 65.0
Sex: F
Vaccine: FLUA4
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Reaction at the site of injection; swelling, redness, hot to touch
Age: 75.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site inflammation, Injection site pruritus, Injection site rash
Clinical narrative: The patient advocate (daughter) was concerned about her mothers red inflamed mark on the patients left arm.  The mark was approximately 3 inches bellow where the actual injection was (I performed the injection on the deltoid muscle, and the mark the patient was concerned about was on the patients bicep).  I advised icing it for 15 minutes, to use hydrocortisone cream 2 to 3 times per day on the red area which is away from where the vaccine injection was, to use 1 tab of claritin per day for 3 days, and fluticasone nasal spray incase this is related to an allergy or bug bite, will diminish the rash quickly. She stated it was itching pretty badly.
Age: 67.0
Sex: F
Vaccine: FLUA4
Symptoms: Neck pain, Pruritus
Clinical narrative: SUBSEQUENT "PAIN IN NECK AND ITCHING ON LEFT SIDE" WERE RELATED TO VACCINE AND WAS REFERRED TO PHYSICIAN FOR EVALUATION.  PATIENT REPORTED A VISIT TO PROVIDER AND SAID THE PAIN AND ITCHING WERE GETTING BETTER. PROVIDER TOLD PATIENT TO LET THEM KNOW IF SYMPTOMS WORSEN OR DON'T GET BETTER.
Age: 62.0
Sex: F
Vaccine: FLU4
Symptoms: Immediate post-injection reaction, Injected limb mobility decreased, Injection site pain, Limb discomfort, Magnetic resonance imaging abnormal
Clinical narrative: I received the shot at approximately 1pm and immediately felt pain in my arm down to my fingers. I verbally communicated this at the time. I came home and took a 500mg Tylenol. By 8pm my arm felt very heavy. By 11pm my arm felt is if it was paralyzed/dead weight and I could not lift it. I took two 500mg Tylenols and went to bed. The next morning it was some better in regard to feeling paralyzed as I could move it some but it still felt very heavy. Over the next 7 to 14 days my arm became seemingly weaker, the movement became more restricted and extremely painful.  I called the nurse line approximately 9/30/2020 and was advised to call my orthopedic surgeon (DR.) because I had rotator cuff surgery on that shoulder 4 years earlier (September 2016).  I saw Dr. 10/1/2020. He indicated that the shot was a lil too high and was concerned about frozen shoulder due to my limited movement and pain. He gave me a cortisone shot in the back left bursa. It helped for about 36 hours. I went back to Dr. and was referred for an MRI. I got the MRI on 10/7/2020. On 10/12 I returned to the Dr. for the MRI results. The MRI indicated frozen shoulder and a couple small tears in the tendon. I was referred for physical therapy (PT) for a couple weeks to see if that helps before any further steps. My first PT appointment was that same afternoon.  My next Dr. appointment is 10/26/2020.
Age: 62.0
Sex: F
Vaccine: FLU4
Symptoms: Muscular weakness, Pain in extremity, Periarthritis, Product administered at inappropriate site, Tendon injury
Clinical narrative: I received the shot at approximately 1pm and immediately felt pain in my arm down to my fingers. I verbally communicated this at the time. I came home and took a 500mg Tylenol. By 8pm my arm felt very heavy. By 11pm my arm felt is if it was paralyzed/dead weight and I could not lift it. I took two 500mg Tylenols and went to bed. The next morning it was some better in regard to feeling paralyzed as I could move it some but it still felt very heavy. Over the next 7 to 14 days my arm became seemingly weaker, the movement became more restricted and extremely painful.  I called the nurse line approximately 9/30/2020 and was advised to call my orthopedic surgeon (DR.) because I had rotator cuff surgery on that shoulder 4 years earlier (September 2016).  I saw Dr. 10/1/2020. He indicated that the shot was a lil too high and was concerned about frozen shoulder due to my limited movement and pain. He gave me a cortisone shot in the back left bursa. It helped for about 36 hours. I went back to Dr. and was referred for an MRI. I got the MRI on 10/7/2020. On 10/12 I returned to the Dr. for the MRI results. The MRI indicated frozen shoulder and a couple small tears in the tendon. I was referred for physical therapy (PT) for a couple weeks to see if that helps before any further steps. My first PT appointment was that same afternoon.  My next Dr. appointment is 10/26/2020.
Age: 43.0
Sex: F
Vaccine: FLU4
Symptoms: Lymph node pain, Lymphadenitis
Clinical narrative: Patient described her armpit (of the arm that got the vaccine)  being very swollen and tender. She got the vaccine on Friday and she called with this complaint this morning (Sunday).
Age: 82.0
Sex: M
Vaccine: FLU4
Symptoms: Blood test, Death, Decreased appetite, Intensive care, Lethargy
Clinical narrative: Pt felt ill later in the day on 10/21/2020 and vomited. Pt was described as lethargic on 10/22 and 10/23 and lack of appetite also observed those days. Pt was brought to local ER where he was admitted to the ICU. He had bloodwork done when admitted to ICU but was not specified to me. Pt died 10/24 around 3AM
Age: 82.0
Sex: M
Vaccine: FLU4
Symptoms: Malaise, Vomiting
Clinical narrative: Pt felt ill later in the day on 10/21/2020 and vomited. Pt was described as lethargic on 10/22 and 10/23 and lack of appetite also observed those days. Pt was brought to local ER where he was admitted to the ICU. He had bloodwork done when admitted to ICU but was not specified to me. Pt died 10/24 around 3AM
Age: 73.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Mass, Musculoskeletal stiffness, Pain, Swelling
Clinical narrative: Shot given 10/23 at 01:45 pm. Pt experienced a lump, pain, stiffness, and swelling on 05:00 pm on 10/23.  On sat 10/24 pt noticed redness as well.
Age: 40.0
Sex: F
Vaccine: FLUC4
Symptoms: Computerised tomogram, Hypoaesthesia, Injection site hypoaesthesia, Injection site warmth
Clinical narrative: I received the injection in right deltoid and after 10 minutes of waiting my entire right deltoid/shoulder right side of neck and face  went numb and hot feeling.  Immediately notified the nurse.  Was transferred via Ambulance to local ER
Age: 76.0
Sex: F
Vaccine: FLU4
Symptoms: Pain in extremity, Peripheral swelling, Skin reaction
Clinical narrative: Patient was given the shot. Said she went home and had a sore arm. Took a shower that night then went to bed. In the morning around 8AM the arm she recieved the injection in was red and swollen. Patient came in to pharmacy to show the pharmacist and stated the swelling had went down from earlier. Not sure if she took any medications or did anything to alletivate the issue. Counseled her to talk to her PCP about what happened and to recieve gudiance for future flu shot injections. Also told her if she wanted to go the next step she could also recieve an allergy test.
Age: 69.0
Sex: F
Vaccine: FLU4
Symptoms: Dysphagia, Heart rate increased, Pharyngeal swelling, Vomiting
Clinical narrative: Four hours after the vaccine I experienced an uncomfortable swelling in back of my throat; difficulty swallowing; rapid heart rate (twice normal); vomiting x 1. The throat swelling and difficulty swallowing lasted 8 hours. (I haven't vomited in decades; this was clearly abnormal).
Age: 65.0
Sex: F
Vaccine: FLUC4
Symptoms: Urticaria
Clinical narrative: patient reported getting hives a couple of days after vaccination.  They were mostly on her legs and she had started taking zyrtec to help them clear (at the time of reporting).  Patient did get hives a couple of years ago with a flu shot...but did not have a problem last year.
Age: 21.0
Sex: M
Vaccine: FLU4
Symptoms: Hyperhidrosis, Loss of consciousness, Muscle spasms, Syncope
Clinical narrative: patient experienced syncope roughly 10-15 minutes after receiving afluria.  Patients father reported spasms while conscious. Upon awaking patient was sweating.  Time unconscious was under 5 minutes.
Age: 41.0
Sex: M
Vaccine: UNK
Symptoms: Rash, Rash papular
Clinical narrative: Broke out in red bumpy rash on face.  Took 1 Benadryl immediately upon noticing the symptoms.  Was gone by the next morning.
Age: 39.0
Sex: F
Vaccine: PPV
Symptoms: Blood test, Chest discomfort, Electrocardiogram, Musculoskeletal discomfort, Peripheral swelling
Clinical narrative: Day of and following day swelling over large area of upper arm and discoloration area very hot to touch, 2nd day after intense chest and back pressure
Age: 39.0
Sex: F
Vaccine: PPV
Symptoms: Skin discolouration, Skin warm
Clinical narrative: Day of and following day swelling over large area of upper arm and discoloration area very hot to touch, 2nd day after intense chest and back pressure
Age: 84.0
Sex: M
Vaccine: FLU4
Symptoms: Cerebrovascular accident, Computerised tomogram, Dizziness, Dysstasia, Fall
Clinical narrative: HAD DINNER AROUND 6:30 PM, SUBSEQUENTLY ABOUT 7:30 P.M. WENT TO THE BATHROOM AND THREW UP EVERYTHING I HAD EATEN, I TRIED TO CLEAN UP THE MESS I HAD CREATED AND FOUND I WAS DIZZY AND COULDN'T STAND UP EASILY. I KEPT FALLING TO MY RIGHT SIDE. I DECIDED TO GO TO BED AND WOKE UP THE NEXT MORNING CONSTANTLY FALLING TOWARD MY RIGHT. I HAD SOMEONE TAKE ME TO THE EMERGENCY AT THE HOSITAL WHERE I WAS ADMITTED AND WAS TESTED.
Age: 84.0
Sex: M
Vaccine: FLU4
Symptoms: Magnetic resonance imaging, Scan with contrast, Vomiting
Clinical narrative: HAD DINNER AROUND 6:30 PM, SUBSEQUENTLY ABOUT 7:30 P.M. WENT TO THE BATHROOM AND THREW UP EVERYTHING I HAD EATEN, I TRIED TO CLEAN UP THE MESS I HAD CREATED AND FOUND I WAS DIZZY AND COULDN'T STAND UP EASILY. I KEPT FALLING TO MY RIGHT SIDE. I DECIDED TO GO TO BED AND WOKE UP THE NEXT MORNING CONSTANTLY FALLING TOWARD MY RIGHT. I HAD SOMEONE TAKE ME TO THE EMERGENCY AT THE HOSITAL WHERE I WAS ADMITTED AND WAS TESTED.
Age: 73.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Anaesthesia, CSF protein, CSF white blood cell count, Central nervous system lesion, Hypoaesthesia
Clinical narrative: Patient began experiencing numbness and weakness in extremities on 09/11/2020 and by 09/13/2020 sought care at local emergency room where he was diagnosed with Transverse Myelitis
Age: 73.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Immunoglobulin therapy, Laboratory test, Lhermitte's sign, Magnetic resonance imaging brain normal, Magnetic resonance imaging spinal abnormal
Clinical narrative: Patient began experiencing numbness and weakness in extremities on 09/11/2020 and by 09/13/2020 sought care at local emergency room where he was diagnosed with Transverse Myelitis
Age: 73.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Muscular weakness, Myelitis transverse, Plasmapheresis
Clinical narrative: Patient began experiencing numbness and weakness in extremities on 09/11/2020 and by 09/13/2020 sought care at local emergency room where he was diagnosed with Transverse Myelitis
Age: 73.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Hypoaesthesia, Magnetic resonance imaging spinal, Muscular weakness, Myelitis transverse, Plasmapheresis
Clinical narrative: Patient began experiencing numbness and weakness in extremities on 09/11/2020 and by 09/13/2020 sought care at local emergency room where he was diagnosed with Transverse Myelitis
Age: 60.0
Sex: M
Vaccine: UNK, FLUA4
Symptoms: Unevaluable event
Clinical narrative: Left shoulder stiffness and pain about three days after receiving flu vaccine in same arm.
Age: 60.0
Sex: M
Vaccine: UNK, FLUA4
Symptoms: Injection site pain, Injection site reaction, Musculoskeletal stiffness, Ultrasound scan
Clinical narrative: Left shoulder stiffness and pain about three days after receiving flu vaccine in same arm.
Age: 69.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Arthralgia, Asthenia, Discomfort, Joint range of motion decreased, Musculoskeletal stiffness
Clinical narrative: PATIENT STATES EXTREME PAIN AND LIMITED RANGE OF MOTION IN ARM PERSISTING MORE THAN 7 DAYS POST-INJECTION.  PATIENT STATES SHE FELT THE INJECTION WAS GIVEN TOO HIGH IN THE ARM.
Age: 69.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Pain, Pain in extremity, Sleep disorder
Clinical narrative: PATIENT STATES EXTREME PAIN AND LIMITED RANGE OF MOTION IN ARM PERSISTING MORE THAN 7 DAYS POST-INJECTION.  PATIENT STATES SHE FELT THE INJECTION WAS GIVEN TOO HIGH IN THE ARM.
Age: 69.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: PATIENT STATES EXTREME PAIN AND LIMITED RANGE OF MOTION IN ARM PERSISTING MORE THAN 7 DAYS POST-INJECTION.  PATIENT STATES SHE FELT THE INJECTION WAS GIVEN TOO HIGH IN THE ARM.
Age: 50.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Bed rest, Bedridden, Chills, Dehydration, Fatigue
Clinical narrative: 10/23 8 pm: chills, mild fatigue, mild nausea 10/24 6 am: splitting/strong headache, fever, muscle aches, sore arm, dehydration, fatigue - bed ridden 10/24 rest of day: same symptoms, fever maxed out at 102.1 at 4 pm - bed ridden 10/25: 8 am: fever, chills, headache gone, sore arm and slight muscle ache remains, but currently functional
Age: 50.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Headache, Myalgia, Nausea, Pain in extremity, Pyrexia
Clinical narrative: 10/23 8 pm: chills, mild fatigue, mild nausea 10/24 6 am: splitting/strong headache, fever, muscle aches, sore arm, dehydration, fatigue - bed ridden 10/24 rest of day: same symptoms, fever maxed out at 102.1 at 4 pm - bed ridden 10/25: 8 am: fever, chills, headache gone, sore arm and slight muscle ache remains, but currently functional
Age: 50.0
Sex: F
Vaccine: FLU4
Symptoms: Eyelid ptosis, Neck pain, Pain in extremity
Clinical narrative: Flu vaccine was given on 10/15/20, that night she complained of left arm pain into neck, took naproxen with improvement. 10/17/20 she had a droopy left eye, saw her opthalmologist on 10/19/20 and given steroid drops. She has f/u in 2 weeks. She has not seen much improvement with eye drops.
Sex: F
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE details were available; expired dose of PNEUMOV AX 23 was given to a patient; This non-valid spontaneous report as received from a pharmacist refers to an unspecified patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On 01-OCT-2020, the patient was vaccinated with an expired dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) 0,5 ml, lot # R033080, expiration date 06-JUN-2020 (route of administration and anatomical location ere not reported) for prophylaxis. There was no adverse event reported.  The case is non-valid due to lack of the patient's identifiers.  Follow up information was received from the nurse practitioner on 20-OCT-2020, regarding a 72 year old female patient who was vaccinated on 05-OCT-2020 with an expired dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23). The case is now considered as valid due to patient's details provided. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: R033080; expirationdate: 06-JUN-2020; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Age: 22.0
Sex: U
Vaccine: HEP
Symptoms: Hepatitis B surface antibody negative, Incorrect dose administered
Clinical narrative: needed revaccination dues to titers being low and had to return back to college; 22 year old patient received 0.5 ml of RECOMBIVAX, in result of a misuse, the adult dose was 1 .0 ml; The patient has already completed the series for hepatis B in the past, unknown by reporter exact date, needed revaccination dues to titers being low and has to return back to college; This spontaneous report was received from a physician, concerning a 22-year-old patient of unknown gender. No information was provided regarding the patient's pertinent medical history, concomitant medications and drug reactions or allergies.  On an unspecified date (reported as in the past), the patient completed the vaccination scheme for hepatitis B. However, the patient needed revaccination due to titers being low (hepatitis b surface antibody negative) and had to return back to college. So, on 12-OCT-2020, the patient received hepatitis b vaccine (recombinant)(RECOMBIVAX HB), at a dose of 0.5 ml for prophylaxis (strength, route of administration, lot number and expiration date were not reported) in result of a misuse, the adult dose was 1.0ml (incorrect dose administered and inappropriate schedule of product administration).
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: Improperly stored VARIVAX administered after storage outside of PI.; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reaction or allergy and concomitant therapy was provided.   On 01-OCT-2020, the patient was administered improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) (lot # S012037, expiration date 17-APR-2021, strength, dose and route were not reported) for prophylaxis.    Administered dose of varicella virus vaccine live (oka/merck) (VARIVAX) were stored -14 degree Celsius (C) to -10 C (-10.5 C) for 1 hour and 11 minutes. Previous temperature excursion included -10 C to 8 C (-3.9 C) for 2 hours and 23 minutes. The digital data logger was involved.
Age: 68.0
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation concerning to an approximately 78 years old patient of unknown gender. Information regarding medical history, concurrent conditions and concomitant medications was not provided. On or about 27-MAY-2011, the patient was inoculated with zoster vaccine live (ZOSTAVAX) at a pharmacy (dosage regimen, route of administration, lot number and expiration date were not reported) for the long-term prevention of shingles and zoster-related conditions. On an unknown date, subsequently the patient was treated by a physician for the following injuries resulting from Plaintiffs ZOSTAVAX use: herpes zoster. The outcome of the event was considered as not recovered. The reporter considered the events to be related to zoster Vaccine Live (ZOSTAVAX).
Age: 1.0
Sex: F
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE/PQCs reported; Caller reported administration of PROQUAD after product experienced temperature excursion.; This spontaneous report was received from a consumer, referring to a 1-year-old female patient. The patient did not have any known pertinent medical history, drug reactions, allergies or concomitant medications.  On 07-OCT-2020, the patient was vaccinated with an improperly stored measles, mumps, rubella and varicella (Oka-Merck) virus vaccine live (rHA) (PROQUAD) injection, administered in the left vastus lateralis (lot number T015598 which has been verified to be valid, expiration date reported and validated as 02-NOV-2021) (dose and frequency were unknown by the reporter; vaccination scheme and route of administration were not reported) as prophylaxis. The administered dose of the vaccine was stored at a temperature of 15 degrees Fahrenheit (F) to 46 F (23.7 F), during a time frame of 2 hours and 19 minutes, as recorded by a digital data logger. There was no previous temperature excursion. The patient did not seek medical attention. There were no laboratory diagnostic studies performed, and no treatment was given for the adverse event. No additional adverse events were reported in the patient.
Sex: F
Vaccine: PPV
Symptoms: Dizziness, Mouth swelling, Paraesthesia, Swelling of eyelid
Clinical narrative: swelling of the mouth; Swelling of eyelids; light headiness; tingling; This spontaneous report as received from a pharmacist refers to a 56 year old female patient. Information regarding the patient's medical history, concurrent conditions and concomitant medications was not provided. The patient had no known allergies.  On 10-OCT-2020, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23), by intramuscular route (strength, dose, frequency, anatomical location, lot # and expiration date were not provided) for prophylaxis. On the same date, the patient went to urgent care due to swelling of the mouth and eyelids; the patient also experienced light headiness and tingling (mouth swelling, paraesthesia, dizziness and swelling of eyelid). At the reporting time, the patient had not recovered from the adverse events. The causality assessment was not provided.
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: expired VAQTA was administered to a patient; This spontaneous report was received from a nurse referring to a patient of unknown age.  No information was provided regarding the patient's medical history, concurrent conditions, drug reactions/allergies or concomitant medications.  On 16-OCT-2020, the patient was vaccinated with hepatitis a vaccine, inactivated (VAQTA) for prophylaxis (dose, route and site of administration and lot number were not reported).  The vaccine had expired on 24-AUG-2020 (expired product administered) and had not undergone a prior temperature excursion.    The outcome of expired product administered was unknown.
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster
Clinical narrative: Large blisters across her stomach and hip and was diagnosed with shingles.; Information has been received from a lawyer regarding a case in litigation, concerning a female patient (pt) of unknown age. Information regarding the pt's concurrent conditions, medical history and concomitant medications was not provided.  On or around 16-OCT-2016, the pt was vaccinated with zoster vaccine live(ZOSTAVAX) (dose, route of administration, anatomical location, lot number and expiration date were not reported) for prevention of shingles (herpes zoster).   On an unspecified, reported as "shortly after receiving Defendants' Zostavax vaccine", the pt suffered large blisters across her stomach and hip and was diagnosed with shingles. As a direct and proximate result of pt's use of the zoster vaccine live (ZOSTAVAX) vaccine, she had sustained severe and permanent personal injuries, including but not limited to: 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. She also had suffered and incurred damages, including medical related expenses, the loss of accumulations; and other economic and non-economic damages as a result of these injuries.  By the time of this report, the patient had not recovered from shingles. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: herpes zoster; This initial spontaneous report was received on from a lawyer regarding a case in litigation and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medication were not provided.   On an unspecified date, the patient was vaccinated with a dose zoster vaccine live (ZOSTAVAX) (dosage regimen was not reported) for the long-term prevention of shingles.  On an unspecified date, the patient presented shingles. As a direct and proximate result, the patient symptoms had resulted in physical limitations not presented prior vaccination. The patient also experienced mental and emotional distress due to resulting physical limitations and seriousness of patient's conditions.  As a direct and proximate result, the patient suffered severe and permanent physical injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury.   The reporter considered the event of shingles to be related to zoster vaccine live (ZOSTAVAX).
Sex: F
Vaccine: HPV4, HPV9
Symptoms: Seizure
Clinical narrative: seizures; Product origin unknown; This spontaneous report as received from a consumer concerning a female patient of unknown age.    There was no information about the patient's medical history, concurrent conditions or concomitant medication On 16-OCT-2020, the patient was vaccinated with an unspecified dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(manufacturer unknown) or quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (manufacturer unknown) for prophylaxis (dose, route of administration, lot number and expiration date were not reported). The reporter did not specify (and likely did not know) which HPV vaccine, the patient received It was reported that the patient started having seizures soon after she received hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(manufacturer unknown) or quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine  (manufacturer unknown) reported as " HPV vaccine", on the same date. The causal relationship between the event of seizures and therapy with: hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(manufacturer unknown) or quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (manufacturer unknown) were not reported. Upon internal review the event of  seizures was considered to be medically significant.
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Coccidioidomycosis
Clinical narrative: Valley fever; This spontaneous report was received from a currently 79-year-old female patient, concerning to herself. The patient's medical history, previous drug reactions or allergies and concomitant medications were not reported.     On and unspecified date in 2009, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) (reported as pneumonia) for prophylaxis (strength, dose, route of administration, anatomical location, lot # and expiration date were not provided).  On an unknown date, the patient developed valley fever (coccidioidomycosis).   The outcome of coccidioidomycosis was not reported. The reporter considered coccidioidomycosis to be related to Pneumococcal Vaccine, Polyvalent (23-valent)(manufacturer unknown).     Upon internal review, coccidioidomycosis was determined to be a medically significant event.  This is one of two reports received from the same patient.; Sender's Comments:  US-009507513-2001USA002937:
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Hyperaesthesia, Hypoaesthesia, Mobility decreased, Pain in extremity, Paraesthesia
Clinical narrative: Right arm was hyper sensitive to touch / increased sensitivity in arm; Numbness in her arm; Tingling in her arm; Cannot move arm or straighten it; Winced in pain when she touched it; This case was reported by a nurse via sales rep and described the occurrence of touch sensitivity increased in a 17-year-old female patient who received Men B NVS (Bexsero) (batch number ABXB02BA, expiry date 26th February 2022) for prophylaxis.   Co-suspect products included Hepatitis A vaccine for prophylaxis and Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2020-2021 season) for prophylaxis.   On 13th October 2020, the patient received the 1st dose of Bexsero .5 ml, Hepatitis A vaccine and Influenza vaccine Quadrivalent 2020-2021 season. On 15th October 2020, 2 days after receiving Bexsero, Hepatitis A vaccine and Influenza vaccine Quadrivalent 2020-2021 season, the patient experienced touch sensitivity increased, numbness of upper extremities, tingling of extremity, mobility decreased and pain in arm. On an unknown date, the outcome of the touch sensitivity increased, numbness of upper extremities, tingling of extremity, mobility decreased and pain in arm were unknown.   It was unknown if the reporter considered the touch sensitivity increased, numbness of upper extremities, tingling of extremity, mobility decreased and pain in arm to be related to Bexsero, Hepatitis A vaccine and Influenza vaccine Quadrivalent 2020-2021 season.  Additional details were as follows: The age at vaccination was not reported. Nurse reported that patient got first dose of Bexsero on 13 th October,on right arm. and on same day patient received the Hepatitis A vaccine and flu vaccine in left arm. On 15th October patient complaint about events like right arm was hyper sensitive to touch and experienced numbness and tingling in her arm.  It was reported that nothing visible to eyes and looked normal, no redness or swelling also she stated that patient had been keeping her elbow in flex position and not able to move arm or straighten it. The physician also reported hyperaesthesia (increased sensitivity in arm and patient winced in pain when she touched it). The doctor told her to lay low for a couple of days. The reporter consented to follow up.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Tenderness
Clinical narrative: Right arm was hyper sensitive to touch / increased sensitivity in arm; Numbness in her arm; Tingling in her arm; Cannot move arm or straighten it; Winced in pain when she touched it; This case was reported by a nurse via sales rep and described the occurrence of touch sensitivity increased in a 17-year-old female patient who received Men B NVS (Bexsero) (batch number ABXB02BA, expiry date 26th February 2022) for prophylaxis.   Co-suspect products included Hepatitis A vaccine for prophylaxis and Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2020-2021 season) for prophylaxis.   On 13th October 2020, the patient received the 1st dose of Bexsero .5 ml, Hepatitis A vaccine and Influenza vaccine Quadrivalent 2020-2021 season. On 15th October 2020, 2 days after receiving Bexsero, Hepatitis A vaccine and Influenza vaccine Quadrivalent 2020-2021 season, the patient experienced touch sensitivity increased, numbness of upper extremities, tingling of extremity, mobility decreased and pain in arm. On an unknown date, the outcome of the touch sensitivity increased, numbness of upper extremities, tingling of extremity, mobility decreased and pain in arm were unknown.   It was unknown if the reporter considered the touch sensitivity increased, numbness of upper extremities, tingling of extremity, mobility decreased and pain in arm to be related to Bexsero, Hepatitis A vaccine and Influenza vaccine Quadrivalent 2020-2021 season.  Additional details were as follows: The age at vaccination was not reported. Nurse reported that patient got first dose of Bexsero on 13 th October,on right arm. and on same day patient received the Hepatitis A vaccine and flu vaccine in left arm. On 15th October patient complaint about events like right arm was hyper sensitive to touch and experienced numbness and tingling in her arm.  It was reported that nothing visible to eyes and looked normal, no redness or swelling also she stated that patient had been keeping her elbow in flex position and not able to move arm or straighten it. The physician also reported hyperaesthesia (increased sensitivity in arm and patient winced in pain when she touched it). The doctor told her to lay low for a couple of days. The reporter consented to follow up.
Age: 54.0
Sex: F
Vaccine: UNK, UNK, VARZOS
Symptoms: Chills, Dysgeusia, Erythema, Feeling abnormal, Feeling hot
Clinical narrative: Red area on the arm where she received her Shingrix; Hot area on the arm where she received her Shingrix; Shivering; Temperature of 99 degrees; felt achey; Funny taste in her mouth; Weird sensation; This case was reported by a pharmacist via sales rep and described the occurrence of erythema in a 54-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included paracetamol (Acetaminophen) unknown for an unknown indication and ibuprofen for an unknown indication.   On 14th October 2020, the patient received the 1st dose of Shingrix. On an unknown date, the patient started Acetaminophen at an unknown dose and frequency and ibuprofen at an unknown dose and frequency. On an unknown date, less than a week after receiving Shingrix and not applicable after starting Acetaminophen, the patient experienced erythema, extremities hot feeling of, shivering, fever, pain, taste peculiar and weird feeling. On an unknown date, the outcome of the erythema and extremities hot feeling of were recovering/resolving and the outcome of the shivering, fever, pain, taste peculiar and weird feeling were unknown.   The reporter considered the erythema, extremities hot feeling of, shivering, fever, pain, taste peculiar and weird feeling to be related to Shingrix.  Additional details were as follows: The age at vaccination was not reported. Patient who is pharamcist reported that she received the 1st dose fo shingrix on wednesday 14th october,2020 and experienced events. Patient took acetaminophen and ibuprofen at different times post vaccination and She reported that she had a red, hot, area on the arm where she received her Shingrix that was not painful or raised. On 17th october when patient called that time these events was still there but resolving. She also reported that during the night after she received her dose, she woke up at 2am with shivering and then She got a blanket and put on socks and went back to sleep, and it did not occur again. She also reported that She had a temperature of 99 degrees one time, the day after vaccination also She felt achey, on and off after receiving Shingrix, which resolved within 2 days. Patient also noted a funny taste in her mouth and a weird sensation (that was not described further) the two days post Shingrix but was not sure if that was related to the vaccine. She believed that all of these events were due to Shingrix. The reporter consented to follow up.
Age: 54.0
Sex: F
Vaccine: UNK, UNK, VARZOS
Symptoms: Pain, Pyrexia
Clinical narrative: Red area on the arm where she received her Shingrix; Hot area on the arm where she received her Shingrix; Shivering; Temperature of 99 degrees; felt achey; Funny taste in her mouth; Weird sensation; This case was reported by a pharmacist via sales rep and described the occurrence of erythema in a 54-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included paracetamol (Acetaminophen) unknown for an unknown indication and ibuprofen for an unknown indication.   On 14th October 2020, the patient received the 1st dose of Shingrix. On an unknown date, the patient started Acetaminophen at an unknown dose and frequency and ibuprofen at an unknown dose and frequency. On an unknown date, less than a week after receiving Shingrix and not applicable after starting Acetaminophen, the patient experienced erythema, extremities hot feeling of, shivering, fever, pain, taste peculiar and weird feeling. On an unknown date, the outcome of the erythema and extremities hot feeling of were recovering/resolving and the outcome of the shivering, fever, pain, taste peculiar and weird feeling were unknown.   The reporter considered the erythema, extremities hot feeling of, shivering, fever, pain, taste peculiar and weird feeling to be related to Shingrix.  Additional details were as follows: The age at vaccination was not reported. Patient who is pharamcist reported that she received the 1st dose fo shingrix on wednesday 14th october,2020 and experienced events. Patient took acetaminophen and ibuprofen at different times post vaccination and She reported that she had a red, hot, area on the arm where she received her Shingrix that was not painful or raised. On 17th october when patient called that time these events was still there but resolving. She also reported that during the night after she received her dose, she woke up at 2am with shivering and then She got a blanket and put on socks and went back to sleep, and it did not occur again. She also reported that She had a temperature of 99 degrees one time, the day after vaccination also She felt achey, on and off after receiving Shingrix, which resolved within 2 days. Patient also noted a funny taste in her mouth and a weird sensation (that was not described further) the two days post Shingrix but was not sure if that was related to the vaccine. She believed that all of these events were due to Shingrix. The reporter consented to follow up.
Sex: U
Vaccine: MENB
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Pain
Clinical narrative: injection site pain; SWELLING; redness; general aches and pains; This case was reported by a nurse via sales rep and described the occurrence of injection site pain in an unspecified number of an adolescent patients who received Men B NVS (Bexsero) for prophylaxis.   On an unknown date, the patient received the 1st dose of Bexsero. On an unknown date, unknown after receiving Bexsero, the patient experienced injection site pain, swelling, erythema and general body pain. On an unknown date, the outcome of the injection site pain, swelling, erythema and general body pain were unknown.   It was unknown if the reporter considered the injection site pain, swelling, erythema and general body pain to be related to Bexsero.  Additional details were reported as follows: The age at vaccination was not reported. The reporter felt they were getting more patients reporting adverse events with Bexsero. Some were from call backs after receiving Bexsero. But also, they were calling patients back for a 2nd dose and patients were asking if they would get the same adverse event with 2nd dose. Complaints were pain at the injection site, swelling, redness, general aches and pains. The reporter wondered if they got a bad batch of vaccine. The reporter did not consent to follow up. This case is 1 of the 13 cases, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR210157:same reporter US-GLAXOSMITHKLINE-US2020AMR210158:same reporter US-GLAXOSMITHKLINE-US2020AMR210162:same reporter US-GLAXOSMITHKLINE-US2020AMR210160:same reporter US-GLAXOSMITHKLINE-US2020AMR210163:same reporter US-GLAXOSMITHKLINE-US2020AMR210164: US-GLAXOSMITHKLINE-US2020AMR210159:same reporter US-GLAXOSMITHKLINE-US2020AMR210161:same reporter US-GLAXOSMITHKLINE-US2020AMR210165:same reporter US-GLAXOSMITHKLINE-US2020AMR210166:same reporter US-GLAXOSMITHKLINE-US2020AMR210156:same reporter US-GLAXOSMITHKLINE-US2020208660:same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: temp of 104.4; This case was reported by a consumer via call center representative and described the occurrence of fever in a 74-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, 1 day after receiving Shingrix, the patient experienced fever. On an unknown date, the outcome of the fever was unknown.   It was unknown if the reporter considered the fever to be related to Shingrix.  Additional details were reported as follows: This case was reported by the patient. The age at vaccination was not reported. Next day after receiving Shingrix, the patient had a temperature of 104.4 degrees F. The patient asked if the patient would get the 2nd dose.
Sex: U
Vaccine: FLU4
Symptoms: Injection site pain
Clinical narrative: pain at the injection site; This case was reported by a pharmacist and described the occurrence of injection site pain in an unspecified number of patients who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2020-2021 season) (batch number Z7275, expiry date 30th June 2021) for prophylaxis.   On an unknown date, the patient received Fluarix Quadrivalent 2020-2021 season. On an unknown date, less than a month after receiving Fluarix Quadrivalent 2020-2021 season, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was unknown.   It was unknown if the reporter considered the injection site pain to be related to Fluarix Quadrivalent 2020-2021 season.  Additional details were reported as follows: The age at vaccination was not reported. At the reporter's facility they had complaints of pain at the injection site two to three weeks following the administration of Fluarix Quadrivalent. The reporter asked has this been a common complaint this season.
Age: 32.0
Sex: U
Vaccine: FLU4
Symptoms: Cellulitis, Injection site erythema, Injection site vesicles
Clinical narrative: cellulitis; area of redness / around injection site/ egg sized area of redess; small blisters around injection site; This case was reported by a pharmacist via sales rep and described the occurrence of cellulitis in a 32-year-old patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2020-2021 season) for prophylaxis.   On 16th October 2020, the patient received Fluarix Quadrivalent 2020-2021 season. In October 2020, less than a week after receiving Fluarix Quadrivalent 2020-2021 season, the patient experienced cellulitis (serious criteria GSK medically significant), injection site erythema and injection site blisters. On an unknown date, the outcome of the cellulitis, injection site erythema and injection site blisters were unknown.   It was unknown if the reporter considered the cellulitis, injection site erythema and injection site blisters to be related to Fluarix Quadrivalent 2020-2021 season.  Additional details were reported as follows: The patient received vaccie in clinic and next day called to report egg sized area of redness with small blisters around injection site. The patient drew a ring around the site and presented to clinic after the redness went beyond the ring. On 19th October 2020, patient was treated with cellulitis.
Sex: U
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Nausea
Clinical narrative: Very upset stomach; Lots of nausea; This case was reported by a consumer via interactive digital media and described the occurrence of upset stomach in a adult patient who received SHINGRIX for prophylaxis.   On 16th October 2020, the patient received the 2nd dose of SHINGRIX. In October 2020, less than a week after receiving SHINGRIX, the patient experienced upset stomach and nausea. On an unknown date, the outcome of the upset stomach and nausea were not recovered/not resolved.   It was unknown if the reporter considered the upset stomach and nausea to be related to SHINGRIX.  Additional details were provided as follows: The age at vaccination was not reported. The age group was captured as adult as per vaccine indication. The patient still experienced very upset stomach with lots of nausea. The patient asked if this was normal?
Sex: U
Vaccine: VARZOS
Symptoms: Pain, Pyrexia
Clinical narrative: fever of 104.4; had body aches; This case was reported by a consumer via interactive digital media and described the occurrence of fever in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   In August 2020, the patient received Shingrix. In August 2020, 1 day after receiving Shingrix, the patient experienced fever and general body pain. On an unknown date, the outcome of the fever and general body pain were unknown.   It was unknown if the reporter considered the fever and general body pain to be related to Shingrix.  Additional information was provided as follows: The age at vaccination was not reported. The age group was captured as an adult as per vaccine indication. The patient next day after receiving vaccine, had body aches and a fever of 104.4 degrees C. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Neuralgia, Rash
Clinical narrative: Rash developed on forehead; Nerve pain down leg; This case was reported by a other health professional via sales rep and described the occurrence of rash in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On an unknown date, 1 day after receiving Shingrix, the patient experienced rash and nerve pain. On an unknown date, the outcome of the rash and nerve pain were unknown.   It was unknown if the reporter considered the rash and nerve pain to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix and had rash developed on forehead and nerve pain down leg. The Rash and nerve pain persist. The patient had followed up with primary care physician and speculates event was related to vaccine administration.
Sex: U
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: fever; This case was reported by a consumer via interactive digital media and described the occurrence of fever in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 19th October 2020, the patient received Shingrix. In October 2020, 24 hrs after receiving Shingrix, the patient experienced fever. On an unknown date, the outcome of the fever was unknown.   It was unknown if the reporter considered the fever to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The age group was not reported but was captured as adult as per vaccine indication.  The patient received vaccine and 24 hours later experienced fever. The patient asked whether this event was expected after vaccination.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site discolouration
Clinical narrative: arm to turn black and blue at the injection site; This case was reported by a other health professional via interactive digital media and described the occurrence of injection site coloration in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced injection site coloration. On an unknown date, the outcome of the injection site coloration was unknown.   It was unknown if the reporter considered the injection site coloration to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The reporter stated that the arm turn to black and blue at the injection site.