chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 2.0
Sex: F
Vaccine: DTAP, MMR, PNC13
Symptoms: Abdominal pain, Abnormal behaviour, Aphasia, Condition aggravated, Crying
Clinical narrative: large lump on injection site after each vaccine she had a fever for 2 weeks off and on at around 6 months of age used to say momma or DaDa lost all speech each time vaccinated complete regression happened both girls shared similar symptoms. There were meeting all developmental milestones until 6 months of age when we first saw a difference in their behavior. Days of fever, uncontrollable crying, and swelling at the injection site occured with each vaccination they recieved. Following their 3/20/2019 (MMR/DTAP/PCV 13) vaccines, symptoms dramatically worsened. They stopped responding to their names, stopped letting people hold/console them, loss of eye contact, baby babble stopped even basic "ma ma" and dada". Immune problems occured, sick more often, loose bowel movements, crying holding their abdomens, severe diaper rashes, banging their heads on the floor and walls, overwhelmed by noises / sensory issues), flicking of items with fingers These symptoms prompted us to pursue speech and occupational therapy for the girls, at which time they were diagnosed with a developmental delay.
Age: 2.0
Sex: F
Vaccine: DTAP, MMR, PNC13
Symptoms: Decreased eye contact, Dermatitis diaper, Developmental delay, Developmental regression, Diarrhoea
Clinical narrative: large lump on injection site after each vaccine she had a fever for 2 weeks off and on at around 6 months of age used to say momma or DaDa lost all speech each time vaccinated complete regression happened both girls shared similar symptoms. There were meeting all developmental milestones until 6 months of age when we first saw a difference in their behavior. Days of fever, uncontrollable crying, and swelling at the injection site occured with each vaccination they recieved. Following their 3/20/2019 (MMR/DTAP/PCV 13) vaccines, symptoms dramatically worsened. They stopped responding to their names, stopped letting people hold/console them, loss of eye contact, baby babble stopped even basic "ma ma" and dada". Immune problems occured, sick more often, loose bowel movements, crying holding their abdomens, severe diaper rashes, banging their heads on the floor and walls, overwhelmed by noises / sensory issues), flicking of items with fingers These symptoms prompted us to pursue speech and occupational therapy for the girls, at which time they were diagnosed with a developmental delay.
Age: 2.0
Sex: F
Vaccine: DTAP, MMR, PNC13
Symptoms: Dyskinesia, Head banging, Hyperacusis, Immune system disorder, Injection site mass
Clinical narrative: large lump on injection site after each vaccine she had a fever for 2 weeks off and on at around 6 months of age used to say momma or DaDa lost all speech each time vaccinated complete regression happened both girls shared similar symptoms. There were meeting all developmental milestones until 6 months of age when we first saw a difference in their behavior. Days of fever, uncontrollable crying, and swelling at the injection site occured with each vaccination they recieved. Following their 3/20/2019 (MMR/DTAP/PCV 13) vaccines, symptoms dramatically worsened. They stopped responding to their names, stopped letting people hold/console them, loss of eye contact, baby babble stopped even basic "ma ma" and dada". Immune problems occured, sick more often, loose bowel movements, crying holding their abdomens, severe diaper rashes, banging their heads on the floor and walls, overwhelmed by noises / sensory issues), flicking of items with fingers These symptoms prompted us to pursue speech and occupational therapy for the girls, at which time they were diagnosed with a developmental delay.
Age: 2.0
Sex: F
Vaccine: DTAP, MMR, PNC13
Symptoms: Injection site swelling, Malaise, Pyrexia, Sensory disturbance, Unresponsive to stimuli
Clinical narrative: large lump on injection site after each vaccine she had a fever for 2 weeks off and on at around 6 months of age used to say momma or DaDa lost all speech each time vaccinated complete regression happened both girls shared similar symptoms. There were meeting all developmental milestones until 6 months of age when we first saw a difference in their behavior. Days of fever, uncontrollable crying, and swelling at the injection site occured with each vaccination they recieved. Following their 3/20/2019 (MMR/DTAP/PCV 13) vaccines, symptoms dramatically worsened. They stopped responding to their names, stopped letting people hold/console them, loss of eye contact, baby babble stopped even basic "ma ma" and dada". Immune problems occured, sick more often, loose bowel movements, crying holding their abdomens, severe diaper rashes, banging their heads on the floor and walls, overwhelmed by noises / sensory issues), flicking of items with fingers These symptoms prompted us to pursue speech and occupational therapy for the girls, at which time they were diagnosed with a developmental delay.
Age: 72.0
Sex: F
Vaccine: FLU4
Symptoms: Hypothermia
Clinical narrative: Hypothermia 94.3 body temp on 10/27/2020 5:00 pm took two Ibuprofen (400 mg) thinking she had fever
Age: 23.0
Sex: M
Vaccine: FLU4, TDAP
Symptoms: Dizziness, Head injury, Syncope, Urinary incontinence
Clinical narrative: Patient experienced syncope shortly after receiving second shot (Fluarix). He hit is head, urinated, and felt slightly light headed after becoming aware within 15 seconds.
Age: 48.0
Sex: F
Vaccine: TDAP
Symptoms: Injected limb mobility decreased, Injection site pain
Clinical narrative: left shoulder pain & loss of range of motion  Treatment: ice, Aleve, physical therapy
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Bacterial infection, Cellulitis, Feeling hot, Malaise, Pain
Clinical narrative: Patient received shot on 10/9/2020. Patient started to feel unwell the following day. By 10/13/2020 her arm felt really hot. Patient stated that even clothes touching her arm caused burning pain. Patient went to Doctor 10/14/2020 and was diagnosed with bacterial cellulitis. Doctor prescribed Cephalexin 500 qid for 10 days which patient took. Prescribed Prednisone 20 mg qd which patient did not take.
Age: 9.0
Sex: F
Vaccine: FLU4
Symptoms: Dizziness, Lip discolouration
Clinical narrative: Shortley afer vaccination patient started experiencing dizziness and was seated with parent on her lap. Her lips were discolored But no difficulty in breathing or swelling of Lips, etc. Called 911 for precautions, Learned patient had not eaten a full meal since lunch. Paramedics Arrived - Monitored & left with parents.
Sex: F
Vaccine: VARZOS
Symptoms: Rash pruritic, Urticaria
Clinical narrative: 10/23/2020 pt reported iching rash/ Hive of the Left arm, resolved in 1/2 days on 10/26/2020 10/27/2020 report to VAER
Age: 74.0
Sex: F
Vaccine: FLU4
Symptoms: Feeling abnormal, Headache, Nausea, Pain, Pyrexia
Clinical narrative: Pt received high dose vaccination on 10/26/20. Woke up early this am (10/27) feeling poorly. Headache, nausea, body aches, low grade fever 99.7. tx Tylenol 500mg - 1000mg q 6H prn, push fluids call if not resolved. Check BP Discussed stroke/CVA + going to ER
Age: 74.0
Sex: F
Vaccine: FLU4
Symptoms: SARS-CoV-2 test, SARS-CoV-2 test negative
Clinical narrative: Pt received high dose vaccination on 10/26/20. Woke up early this am (10/27) feeling poorly. Headache, nausea, body aches, low grade fever 99.7. tx Tylenol 500mg - 1000mg q 6H prn, push fluids call if not resolved. Check BP Discussed stroke/CVA + going to ER
Sex: M
Vaccine: VARZOS
Symptoms: Eye pain, Headache, Ocular discomfort, VIth nerve paralysis
Clinical narrative: right 6th nerve palsy; Information has been received from a lawyer and a male patient (pt) of unknown age regarding a case in litigation. Information about concurrent condition, medical history and concomitant medication was not reported. On or around 05-FEB-2015, the pt was vaccinated with zoster vaccine live (ZOSTAVAX) (strength, dose, lot #, expiration date and route unknown) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). Shortly after receiving the zoster vaccine live (ZOSTAVAX) vaccine, the pt suffered a sudden onset of right-sided headaches, pressure behind his right eye with pain extending below his right occipital region and was diagnosed with right 6th nerve palsy. As a direct and proximate result of the zoster vaccine live (ZOSTAVAX) vaccine, the pt's symptoms had resulted in physical limitations not present prior to using the product. The pt also experienced mental and emotional distress due to resulting physical limitations and seriousness of his condition. As a result of the zoster vaccine live (ZOSTAVAX), the pt sustained severe and permanent personal injuries. Further, the pt suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of the product, the pt had suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. Outcome of the event was not reported. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).  Upon internal review, right 6th nerve palsy was determined to be medically significant. The event of right 6th nerve palsy was considered disabling by the reporter.
Age: 77.0
Sex: F
Vaccine: FLU4, FLUA3
Symptoms: Injection site pain, Sleep disorder
Clinical narrative: Unable to lay on left shoulder. Experienced severe shoulder pain. Still experiencing symptoms today. Unable to sleep due to pain.
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Blood test abnormal, Burning sensation, C-reactive protein increased, Dizziness, Neuropathy peripheral
Clinical narrative: he developed neuropathy; He believed this an Autoimmune response; Small fiber neuropathy/Diagnosed him with small fiber neuralgia; genetic predisposition to the antigen in the vaccine; Burning sensation to his feet, thighs, legs, groin, and face / burning feet radiating up to thighs and face intermittently; Dizziness / general dizziness; Orthostatic Hypotension; This case was reported by a dentist via call center representative and described the occurrence of neuropathy in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of peripheral coldness (1st dose received on 4th March 2020, reference case US2020AMR211621).   On 21st July 2020, the patient received the 2nd dose of Shingrix. In August 2020, 1 month after receiving Shingrix, the patient experienced burning sensation, dizziness and orthostatic hypotension. On an unknown date, the patient experienced neuropathy (serious criteria GSK medically significant), autoimmune disorder (serious criteria GSK medically significant), small fiber neuropathy and predisposition to disease. The patient was treated with gabapentin. On an unknown date, the outcome of the neuropathy, autoimmune disorder, burning sensation and predisposition to disease were unknown and the outcome of the small fiber neuropathy, dizziness and orthostatic hypotension were not recovered/not resolved.   It was unknown if the reporter considered the neuropathy, autoimmune disorder, small fiber neuropathy, burning sensation, dizziness, orthostatic hypotension and predisposition to disease to be related to Shingrix.  Additional details were provided as follows: The reporter was a dentist and also a patient. The age at vaccination was not reported. The patient experienced dizziness, and a burning sensation to his feet, thighs, legs, groin and face. The patient developed neuropathy from the Shingrix vaccinations and his doctor diagnosed him with small fiber neuralgia/neuropathy. One month after vaccination, the patient developed orthostatic hypotension and general dizziness from mid August 2020 and it had been progressive. The patient experienced burning feet radiating up to thighs and face intermittently and he was under the care of a neurologist and on 3 gabapentin a day. The reporter believed that, this was an autoimmune response, genetic predisposition to the antigen in the vaccine. The reporter wanted to report these adverse events to someone higher up in the company. The reporter did not consent to follow-up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR211621:same patient, same reporter, 1st dose
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Autoimmune disorder, Burning sensation, Disease susceptibility, Dizziness, Neuropathy peripheral
Clinical narrative: he developed neuropathy; He believed this an Autoimmune response; Small fiber neuropathy/Diagnosed him with small fiber neuralgia; genetic predisposition to the antigen in the vaccine; Burning sensation to his feet, thighs, legs, groin, and face / burning feet radiating up to thighs and face intermittently; Dizziness / general dizziness; Orthostatic Hypotension; This case was reported by a dentist via call center representative and described the occurrence of neuropathy in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of peripheral coldness (1st dose received on 4th March 2020, reference case US2020AMR211621).   On 21st July 2020, the patient received the 2nd dose of Shingrix. In August 2020, 1 month after receiving Shingrix, the patient experienced burning sensation, dizziness and orthostatic hypotension. On an unknown date, the patient experienced neuropathy (serious criteria GSK medically significant), autoimmune disorder (serious criteria GSK medically significant), small fiber neuropathy and predisposition to disease. The patient was treated with gabapentin. On an unknown date, the outcome of the neuropathy, autoimmune disorder, burning sensation and predisposition to disease were unknown and the outcome of the small fiber neuropathy, dizziness and orthostatic hypotension were not recovered/not resolved.   It was unknown if the reporter considered the neuropathy, autoimmune disorder, small fiber neuropathy, burning sensation, dizziness, orthostatic hypotension and predisposition to disease to be related to Shingrix.  Additional details were provided as follows: The reporter was a dentist and also a patient. The age at vaccination was not reported. The patient experienced dizziness, and a burning sensation to his feet, thighs, legs, groin and face. The patient developed neuropathy from the Shingrix vaccinations and his doctor diagnosed him with small fiber neuralgia/neuropathy. One month after vaccination, the patient developed orthostatic hypotension and general dizziness from mid August 2020 and it had been progressive. The patient experienced burning feet radiating up to thighs and face intermittently and he was under the care of a neurologist and on 3 gabapentin a day. The reporter believed that, this was an autoimmune response, genetic predisposition to the antigen in the vaccine. The reporter wanted to report these adverse events to someone higher up in the company. The reporter did not consent to follow-up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR211621:same patient, same reporter, 1st dose
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Orthostatic hypotension, Small fibre neuropathy
Clinical narrative: he developed neuropathy; He believed this an Autoimmune response; Small fiber neuropathy/Diagnosed him with small fiber neuralgia; genetic predisposition to the antigen in the vaccine; Burning sensation to his feet, thighs, legs, groin, and face / burning feet radiating up to thighs and face intermittently; Dizziness / general dizziness; Orthostatic Hypotension; This case was reported by a dentist via call center representative and described the occurrence of neuropathy in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of peripheral coldness (1st dose received on 4th March 2020, reference case US2020AMR211621).   On 21st July 2020, the patient received the 2nd dose of Shingrix. In August 2020, 1 month after receiving Shingrix, the patient experienced burning sensation, dizziness and orthostatic hypotension. On an unknown date, the patient experienced neuropathy (serious criteria GSK medically significant), autoimmune disorder (serious criteria GSK medically significant), small fiber neuropathy and predisposition to disease. The patient was treated with gabapentin. On an unknown date, the outcome of the neuropathy, autoimmune disorder, burning sensation and predisposition to disease were unknown and the outcome of the small fiber neuropathy, dizziness and orthostatic hypotension were not recovered/not resolved.   It was unknown if the reporter considered the neuropathy, autoimmune disorder, small fiber neuropathy, burning sensation, dizziness, orthostatic hypotension and predisposition to disease to be related to Shingrix.  Additional details were provided as follows: The reporter was a dentist and also a patient. The age at vaccination was not reported. The patient experienced dizziness, and a burning sensation to his feet, thighs, legs, groin and face. The patient developed neuropathy from the Shingrix vaccinations and his doctor diagnosed him with small fiber neuralgia/neuropathy. One month after vaccination, the patient developed orthostatic hypotension and general dizziness from mid August 2020 and it had been progressive. The patient experienced burning feet radiating up to thighs and face intermittently and he was under the care of a neurologist and on 3 gabapentin a day. The reporter believed that, this was an autoimmune response, genetic predisposition to the antigen in the vaccine. The reporter wanted to report these adverse events to someone higher up in the company. The reporter did not consent to follow-up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR211621:same patient, same reporter, 1st dose
Age: 41.0
Sex: F
Vaccine: FLU4, UNK
Symptoms: Myalgia, Pain in extremity, Skin warm, Swelling, X-ray
Clinical narrative: Flu vaccine given at a Flu clinic by pharmacist.  I am unsure of the manufacturer or which flu vaccine it was.  Injection hurt much more than usual and left shoulder very sore.  Shoulder hurts constantly, especially when raising up or across the body.  Hurt worse after the first couple of days, and is still incredibly painful 3 weeks later (today).  Referred to an orthopedic specialist for further evaluation.
Age: 41.0
Sex: F
Vaccine: FLU4, UNK
Symptoms: Injection site pain, Pain, X-ray
Clinical narrative: Flu vaccine given at a Flu clinic by pharmacist.  I am unsure of the manufacturer or which flu vaccine it was.  Injection hurt much more than usual and left shoulder very sore.  Shoulder hurts constantly, especially when raising up or across the body.  Hurt worse after the first couple of days, and is still incredibly painful 3 weeks later (today).  Referred to an orthopedic specialist for further evaluation.
Age: 9.0
Sex: M
Vaccine: FLU4
Symptoms: Dizziness, Fall, Head injury, Loss of consciousness, Syncope
Clinical narrative: Pt fell on his head backwards.  upon regaining consciousness he said he felt dizzy and then collapsed.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP
Symptoms: Poor feeding infant, Vomiting
Clinical narrative: Upon returning home from doctor?s office after vaccine was administered, at 13:30 child was unable to latch for breastfeeding. By 16:00 child could latch but started to vomit after nursing. Vomiting continued through the day and night after each feeding, vomiting 3+ times after each feeding. Child developed tremors in his legs around 19:00 that would start and stop spontaneously. Parents called the doctor?s office around 21:30 and the nurse on the answering service told parents to take child to ER. Parents called the doctor on her personal line and she said to continue to monitor child but that due to the fact that he is nursing and having wet diapers there was no need to go to the ER. Symptoms are still ongoing and no treatment has been administered.
Age: 38.0
Sex: M
Vaccine: ANTH, TYP
Symptoms: Injection site pain, Pain
Clinical narrative: Patient received vaccinations on the morning of 27OCT.  Reported generalized body aches and local vaccination site (L arm) soreness with difficulty fully raising arm later in the evening and continued through the following day.  Patient presented to clinic the following day where he was determined to be clinically stable and no other apparent cause of symptoms based on history and examination other than likely vaccine-related adverse event.  He declined as needed symptom meds and discharged with instructions to follow-up for any emergent symptoms or any other concerns.
Age: 29.0
Sex: F
Vaccine: UNK
Symptoms: Dizziness, Dysgeusia, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Within 5 minutes of injection I began to feel lightheaded and dizzy. I had to sit in my vehicle for around 10 minutes before I felt safe driving home from work. I also experienced a metallic taste in my mouth. After sleeping from 9AM until 4:30 PM, I woke up with a reddened and swollen knot the size of a ping pong ball on my left bicep (where the injection was administered). The area is swollen and painful. I did not seek any treatment.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Extra dose administered, No adverse event, Wrong product administered
Clinical narrative: There was not an adverse event.  The patient came in asking for pneumovax 23, but Shingrix was mistakenly given in its place.  The patient has already had both recommended doses of Shingrix previously on 11/12/19 and 2/26/20.  So, this dose was her third dose of the vaccine.
Age: 15.0
Sex: F
Vaccine: HPV9
Symptoms: Pallor, Posture abnormal, Unresponsive to stimuli
Clinical narrative: Pt color turned pallor; pt became non-verbal; began to slide from her chair; Information has been received from a health authority regarding a 15-years-old female patient. The patient's medical history, drug allergies, previously drug reactions, concurrent conditions and concomitant medications were reported as none known.  On 09-SEP-2019, the patient was vaccinated with the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) intramuscularly in the left arm, as prophylaxis (lot number 1621934 with expiration date not reported but upon internal validation established as ) (dose and strength were not reported).  On the same date, after receiving the hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, the patient color turned pallor, and she became non-verbal and started to slide from her chair. The patient's mother cuddled her and she did not slide from the chair. Within 30 seconds, the patient was alert, oriented and verbal again. The patient never lost consciousness. The patient was allowed to lie down in the clinic room where she was observed. On the same date, the patient recovered from the events.  The causal relationship between hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) and the aforementioned adverse events was not provided.  Per information received on 23-OCT-2020, all telephone attempts to obtain follow-up information have been unsuccessful.  This is a downgrade case.  System mistakenly auto-checked serious criteria medically significant for the adverse event became non-verbal (Unresponsive to stimuli ) but the reporting health authority considered the events non-serious. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. ; devicelotnumber: 1621934; expirationdate: 29-JAN-2022; 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 suggest a causal association with the device or device constituent
Age: 3.0
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: the patient was administered improperly stored VARIVAX; This spontaneous report was received from a medical assistant and refers to a 3-year-old patient of unknown gender. The patient's concurrent conditions, medical history and concomitant medications were not reported.  On 10-AUG-2020, the patient was vaccinated with improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) injection, lot # S025608, expiry date 18-AUG-2021 (dose, route of administration and anatomical location were not provided), which was reconstituted with properly stored sterile diluent (lot # S037030, expiry date 05-JUL-2022), for prophylaxis. The vaccine experienced temperature excursion of -12.5 Celsius degrees (range of temperature -14 to -10 Celsius degrees) for 1 minute and temperature excursion of -14 Celsius degrees (range of temperature -14 to -10 Celsius degrees) for 1 minute (there were multiple excursions). There was no previous temperature excursion. Digital data logger was involved.
Sex: M
Vaccine: FLUX, PPV, UNK
Symptoms: Erythema, Fatigue, Infusion site pain, Rash, Rash macular
Clinical narrative: the arm got red and splotchy and had a minor rash and also some infusion site pain; the arm got red and splotchy and had a minor rash and also some infusion site pain; the arm got red and splotchy and had a minor rash and also some infusion site pain; he was incredibly fatigued; This spontaneous report was received from a consumer via a company representative referring to a male patient of unknown age. Information about medical history, concurrent conditions and concomitant therapies was not provided.       On 15-OCT-2020, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23), influenza virus vaccine (unspecified) and diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid (strength, dose, route, lot # and expiration date were not reported) for prophylaxis.      On the same day, the patient got red and splotchy, a minor rash, and some infusion site pain in the arm that he received pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) and influenza virus vaccine (unspecified), and he was also incredibly fatigued the rest of that day. The outcome of the events was unknown. The causality assessment was not reported.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient of an unknown age and gender. No information was provided regarding medical history, concurrent conditions, or concomitant medications.  On or about 13-AUG-2012 , the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot #, expiration date, dose, dose # and route not specified) for the long-term prevention of shingles and zoster-related conditions. Subsequently on an unknown date, the patient was treated for shingles. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient has sustained and would continue to sustain severe physical injuries, emotional distress, mental anguish, economic, losses and other damages. The outcome of the event shingles was not recovered. The causality assessment was considered as related by the lawyer.
Age: 62.0
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Herpes zoster; This initial spontaneous report was received from a lawyer regarding a case in litigation concerning to a currently 68 years old patient of unknown gender. Information regarding medical history, concurrent conditions and concomitant medications was not provided. On or about 23-MAR-2015, the patient was inoculated with zoster vaccine live (ZOSTAVAX) at a clinic (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: 31.0
Sex: F
Vaccine: MMRV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: no adverse event; patient out of the PI age range; This spontaneous report was received from a nurse referring to a 31 year old female patient. The patient's historical drugs, medical history, concomitant therapies and concurrent conditions were not reported.  On 16-OCT-2020, the patient was vaccinated with Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) for prophylaxis (strength, dose, route, frequency, lot# and expiration date were not reported). The patient was out of the product information age range. No side effects reported.
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: no other AE reported; Varivax administered to a patient after excursion occurred; This spontaneous report was received from a nurse and  refers to a patient of unknown gender and age. The patient's concurrent conditions, medical history and concomitant therapies were not provided.  On 19-OCT-2020, the patient was vaccinated with a dose of improperly stored varicella virus vaccine live (oka/merck)(VARIVAX) 0.5 ml , lot # T000344, expiration date 05-JAN-2020 for prophylaxis. The vaccine was incorrectly stored for 1 hour and 23 minutes (-5.0 degrees Celsius) and for 1 hour and 6 minutes( -6.5 degrees Celsius). There was no previous excursion. Data logger was involved. No other adverse events were reported.
Age: 23.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus
Clinical narrative: redness, itchy and tender to the touch at the site of the injection; redness, itchy and tender to the touch at the site of the injection; redness, itchy and tender to the touch at the site of the injection / vaccination was notably more painful at the moment of injection compared to past experience with vaccinations; This spontaneous report was received from a consumer (patient's mother) referring  to a 23 year old female patient.      The patient's concurrent conditions and medical history were not reported. Concomitant therapies included an unspecified influenza vaccine "flu shot several weeks ago without sequelae".   On 21-OCT-2020, the patient was vaccinated with varicella virus vaccine live (oka/merck)(VARIVAX) in the right arm for prophylaxis (dose, dose number, route, lot, and exp date were not reported). The vaccine was administerfed by a medical technician in the office. The reporter mentioned that the patient was notably more painful at the moment of injection compared to past experiences with vaccinations. Then, on 23-OCT-2020, the patient experienced redness, itchy, and tender to the touch at the site of the injection on the upper triceps region of her right arm. The patient denied fever or other symptoms.  The patient did not receive additional vaccines on 21-OCT-2020 and denied having prior episodes like these, following previous vaccinations.   The patient was able to go to work on the reporting day, did not seek medical attention and she did not received treatment.
Sex: M
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration
Clinical narrative: A patient came in last night who had received his first shot over 1 year ago; This spontaneous report was received from a pharmacist referring to a male patient of unknown age.  The patient's pertinent concurrent conditions, medical history, concomitant medications and previous drug reactions or allergies were not provided.  On an unspecified date in October 2019 (reported as one year ago), the patient was vaccinated with first dose hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) as prophylaxis (concentration, dose, anatomical location and route of administration were not reported), the patient is about a year late for his second dose) (inappropriate schedule of product administration).
Sex: F
Vaccine: HPV9
Symptoms: Rash, Rash pruritic
Clinical narrative: she experienced a rash off and on for three days; This spontaneous report was received from a 42 year-old female patient concerning     herself. The patient's medical history, concurrent conditions and concomitant therapies were not provided. The patient's historical drugs included flu shot 1 month prior.     On 12-OCT-2020, the patient was vaccinated with the first dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) (strength, dose, route, lot# and expiration date were not provided) for prevention of HPV.      On the evening of 19-OCT-2020, the patient experienced a minor rash on feet and legs, that resolved. However, the next evening on 20-OCT-2020 she "began to have a more severe rash that was all over my entire body, except head," this was noted on her back, chest, arms, legs, almost everywhere. According to her, this was very itchy and she went to the drugstore and purchased diphenhydramine hydrochloride (BENADRYL) and cortisone. The patient stated that the rash went away but returned again on 21-OCT-2020 on her legs and feet again, she took the diphenhydramine hydrochloride (BENADRYL) again and it finally resolved on 22-OCT-2020 with no more instances of rash.                    The causal relationship between the event and HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) was not provided.
Age: 1.0
Sex: F
Vaccine: MMR, MMRV
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: There were no reactions/adverse effects; a child in their clinic who inadvertently received PROQUAD and MMR-II at the same time; a child in their clinic who inadvertently received PROQUAD and MMR-II at the same time; This spontaneous report was received from a pharmacist referring to a 1-year-old female patient. Information regarding the patient's concurrent conditions, medical history, historical drugs and concomitant therapies was not provided.   On 23-OCT-2020, the patient inadvertently received at the same time measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) intramuscularly for immunisation (strength, dose, frequency, lot number and expiration date were not reported for neither). There were no reactions/adverse effects at the time of the event.
Sex: U
Vaccine: HEP
Symptoms: Product administered at inappropriate site
Clinical narrative: Adminitered in Gluteal Region Instead of Deltoid; Initial Report Received on 17-Sep-2020 and 18-Sep-2020  Non-Significant Follow-up Received on 19-Oct-2020:  Duplicate information that was previously received.   A Nurse Practitioner reported that a 46-year-old female received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization intramuscularly in the left gluteus.  No medical history was reported.   No concomitant medications were reported.  On 18-Aug-2020, the patient received a dose of HEPLISAV-B (Lot # 933625, expiration date 12-Sep-2021, NDC # not reported) from Occupational Health at a hospital. The injection was administered intramuscularly in the left gluteus medius instead of the deltoid. The patient did not report any adverse reactions to the injection and no other vaccines were administered at the same time.  No additional information was reported.    Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Sex: U
Vaccine: HEP
Symptoms: Syringe issue, Underdose
Clinical narrative: Full Dose Not Administered; Leakage from Syringe; Initial Report Received on 29-Sep-2020  A Medical Clinic Practice Manager reported to an Account Manager that a 23-year-old female received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization and there was leakage between the chamber and top of the syringe while it was being administered.  No medical history was reported.   No concomitant medications were reported.  On 28-Sep-2020, the patient received a dose of HEPLISAV-B (Lot #933625, expiration date 12-Sep-2021 and NDC # not reported) to the right deltoid, and there was leakage between the chamber and top of the syringe while it was being administered. The patient did not report any reactions to the injection.   At the time of the report, no additional information was available.   At the time of report, the quality investigation was in progress and there was no indication of a malfunction.    Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Sex: U
Vaccine: HEP
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: Received Second Dose of HEPLISAV-B 23 Days Later; Initial Report Received on 08-Oct-2020  A workplace supervisor reported that a 23-year-old female employee (race and ethnicity not provided) received the second dose of HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization 23 days after the first dose.  No medical history was reported.   No concomitant medications were reported.  On 08-Sep-2020, the patient received the first dose of HEPLISAV-B (Lot # 933621, expiration date 26-Jul-2021 and NDC # not reported) at an unspecified facility.  23 days later, on 02-Oct-2020, the patient received the second dose of HEPLISAV-B (Lot # 933621, expiration date 26-Jul-2021 and NDC # not reported) at an unspecified facility.  At the time of report, the patient had not reported any reactions to the vaccination.   Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Sex: U
Vaccine: VARZOS
Symptoms: Peripheral swelling
Clinical narrative: swelling of the feet and hands; This case was reported by a consumer via interactive digital media and described the occurrence of peripheral swelling 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 peripheral swelling. On an unknown date, the outcome of the peripheral swelling was unknown.   It was unknown if the reporter considered the peripheral swelling to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but it was selected as adult as per the vaccine indication. The patient received Shingrix and had swelling of the feet and hands and wanted to know does it cause the symptoms.
Sex: U
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Rash; This case was reported by a consumer via interactive digital media and described the occurrence of rash 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 rash. On an unknown date, the outcome of the rash was not recovered/not resolved.   It was unknown if the reporter considered the rash to be related to Shingrix.  Additional details were provided as follows: The age at the vacination was not reported. The age group was not reported but it was selected as adult as per the vaccine indication. The patient received Shingix and had rash. The reporter asked how long did rash last.
Sex: U
Vaccine: VARZOS
Symptoms: Eye pain
Clinical narrative: severe eye pain; This case was reported by a consumer via interactive digital media and described the occurrence of eye pain in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 23rd October 2020, the patient received Shingrix. On 24th October 2020, 1 days after receiving Shingrix, the patient experienced eye pain. On an unknown date, the outcome of the eye pain was not recovered/not resolved.   It was unknown if the reporter considered the eye pain 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. The age group was not reported but was selected as an adult as per vaccine indication. A day before reporting, the patient received Shingrix vaccine. On the day of reporting, the patient was having severe eye pain and asked what could be done.
Sex: F
Vaccine: HEP
Symptoms: Gastrointestinal disorder, Loss of personal independence in daily activities, Pain
Clinical narrative: missed a week of work; pain; GI problems; This case was reported by a consumer via call center representative and described the occurrence of activities of daily living impaired in a female patient who received Hepatitis B vaccine for prophylaxis.   The patient's past medical history included chickenpox and mumps. Previously administered products included Hepatitis B vaccine with an associated reaction of pain (1st dose received in october 1995 for further tolerance refer case US2020AMR209271), Nordette (Discontinued in 2011), MMR with an associated reaction of pain (for further tolerance refer case US2020AMR209271) and Dtap with an associated reaction of erythema (for further tolerance refer case US2020AMR209271).   In May 1996, the patient received Hepatitis B vaccine. On an unknown date, more than 2 years after receiving Hepatitis B vaccine, the patient experienced activities of daily living impaired, pain and gastrointestinal disorder. Rechallenge with Hepatitis B vaccine was positive. On an unknown date, the outcome of the activities of daily living impaired, pain and gastrointestinal disorder were recovered/resolved.   It was unknown if the reporter considered the activities of daily living impaired, pain and gastrointestinal disorder to be related to Hepatitis B vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Hepatitis B vaccine experienced missed a week of work, she was in pain and had GI problems. The reporter informed that she  had a hard time with vaccine her physician  advised against Boostrix in 2005 (she did not get it) instead she wears gloves in public and keeps her hands clean. The reporter did not consented to follow up. No further information was available.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR209271:For 1st dose
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Fatigue, Headache, Hypersomnia, Injection site pain
Clinical narrative: "very tender" (AE: Tender injection site).; her arm was hot (AE: Warm Injection site); fever; aches / Body ache; upset stomach; headache; fatigue / felt very tired; slept for 12 hours; This case was reported by a consumer via call center representative and described the occurrence of injection site tenderness in a 75-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included paracetamol (Tylenol).   On 16th October 2020, the patient received the 1st dose of Shingrix. On 17th October 2020, 1 days after receiving Shingrix, the patient experienced injection site tenderness, injection site warmth, fever, general body pain, upset stomach, headache, fatigue and sleep excessive. On an unknown date, the outcome of the injection site tenderness, injection site warmth, fever, general body pain, upset stomach, headache, fatigue and sleep excessive were recovered/resolved.   It was unknown if the reporter considered the injection site tenderness, injection site warmth, fever, general body pain, upset stomach, headache, fatigue and sleep excessive to be related to Shingrix.  Additional details were provided as follows: The patient was vaccinated with 1st dose of Shingrix. Next day after vaccination at evening patient had fever, aches ( Body ache) her arm was hot (Warm Injection site) and "very tender" (Tender injection site).  The patient also had upset stomach, headache, fatigue,felt very tired and patient slept for 12 hours. The patient reported that symptoms were resolved in less than 24 hours. Lot and expiration date were unknown. Agent failed to ask in which arm vaccine was administered.  The reporter consent to follow up.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site warmth, Pain, Pyrexia
Clinical narrative: "very tender" (AE: Tender injection site).; her arm was hot (AE: Warm Injection site); fever; aches / Body ache; upset stomach; headache; fatigue / felt very tired; slept for 12 hours; This case was reported by a consumer via call center representative and described the occurrence of injection site tenderness in a 75-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included paracetamol (Tylenol).   On 16th October 2020, the patient received the 1st dose of Shingrix. On 17th October 2020, 1 days after receiving Shingrix, the patient experienced injection site tenderness, injection site warmth, fever, general body pain, upset stomach, headache, fatigue and sleep excessive. On an unknown date, the outcome of the injection site tenderness, injection site warmth, fever, general body pain, upset stomach, headache, fatigue and sleep excessive were recovered/resolved.   It was unknown if the reporter considered the injection site tenderness, injection site warmth, fever, general body pain, upset stomach, headache, fatigue and sleep excessive to be related to Shingrix.  Additional details were provided as follows: The patient was vaccinated with 1st dose of Shingrix. Next day after vaccination at evening patient had fever, aches ( Body ache) her arm was hot (Warm Injection site) and "very tender" (Tender injection site).  The patient also had upset stomach, headache, fatigue,felt very tired and patient slept for 12 hours. The patient reported that symptoms were resolved in less than 24 hours. Lot and expiration date were unknown. Agent failed to ask in which arm vaccine was administered.  The reporter consent to follow up.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Immediate post-injection reaction, Injection site erythema, Injection site induration, Injection site pain, Injection site warmth
Clinical narrative: having a fever; Pain at injection site; developed redness at the injection site; heat at the injection site; hardness at the injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 66-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 1st August 2020, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 1st August 2020, immediately after receiving Shingrix, the patient experienced injection site pain, injection site erythema, injection site warmth and injection site induration. On 2nd August 2020, the patient experienced fever. The patient was treated with benadryl (nos) (Benadryl). On 4th August 2020, the outcome of the injection site pain, injection site erythema, injection site warmth, injection site induration and fever were recovered/resolved.   It was unknown if the reporter considered the injection site pain, injection site erythema, injection site warmth, injection site induration and fever to be related to Shingrix.  Additional details were reported as follows: The patient received 1st dose of Shingrix and immediately after vaccination had a pain at the injection site. Later that evening, the patient developed redness, heat and hardness at the injection site. The next day after vaccination, patient reportes fever. The patient took a Benedryl for symptoms and they cleared up within 2 and half days. The patient asked about receiving the 2nd vaccine. The reporter did not consent to follow up.