chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Swelling
Clinical narrative: Very bad headache lasting about 36 hours, muscle pain all over my  body, arm pain so severe I could not sleep without taking pain killer (advil), took shoot on Friday and the next day on Saturday my left collar bone was painful to touch, swollen, itchy. Very, very tired for a couple of days as well as cold (shivering), upset stomach at times. It is now Sunday and the headache is almost gone but the pain in the arm and collarbone pain/itchiness is still there. The arm feels better but the collarbone pain/itchiness is a little worse than the day before when I first noticed it.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Paraesthesia
Clinical narrative: Patient reported she felt "electric zaps" all throughout her body periodically over 24 hours. These zaps started within 24 hours of her receiving the vaccine per patient.
Age: 52.0
Sex: F
Vaccine: UNK
Symptoms: Chills, Eye swelling, Headache, Influenza like illness, Pain in extremity
Clinical narrative: I received the shingles vaccine on Thursday night and by started having chills fever intense pain in the arm I had the injection. I was in bed all Friday Saturday I was still feeling like I had the flu but u set my eyes was swollen and my face felt right. By Sunday most of the flu like symptoms were gone and my eyes looked like I hadn't in weeks because the swelling went down and now there were bags. My arm still has radiating pain down it and I have a severe headache.
Age: 52.0
Sex: F
Vaccine: UNK
Symptoms: Pyrexia
Clinical narrative: I received the shingles vaccine on Thursday night and by started having chills fever intense pain in the arm I had the injection. I was in bed all Friday Saturday I was still feeling like I had the flu but u set my eyes was swollen and my face felt right. By Sunday most of the flu like symptoms were gone and my eyes looked like I hadn't in weeks because the swelling went down and now there were bags. My arm still has radiating pain down it and I have a severe headache.
Age: 2.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Inflammation, Pyrexia, Tenderness
Clinical narrative: Immunology 3/3/2020 for PCV23 injection to right arm, after injection fever and mild erythema to right arm.  3/4/2020 small local redness to right arm, tmax 103.8F   3/5/2020 increased area of redness- continued fevers, tmax 101F, increased tenderness to right arm, favoring arm. Large erythematous inflammatory reaction to right shoulder extending down upper arm to just above elbow.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Abdominal pain, Anaphylactic reaction, Cough, Swelling, Urticaria
Clinical narrative: 10:05 Anaphylaxis  ( coughing, swelling, hives, belly pain),  10:15 AM sent her to ER and gave her EPIPEN JR. 11:08 AM gave her dexamethasone and 11:32 AM gave her famotidine
Age: 27.0
Sex: M
Vaccine: TDAP
Symptoms: Haemorrhage, Immediate post-injection reaction, Inflammation
Clinical narrative: Once I had given the injection, he started bleeding and it immediately inflamed.
Age: 59.0
Sex: F
Vaccine: UNK
Symptoms: Asthenia, Fatigue, Feeling cold, Headache, Nasal dryness
Clinical narrative: Extreme exhaustion, extreme cold, headache, dry nostrils, weakness
Age: 64.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Burning sensation, Chills, Feeling abnormal, Loss of personal independence in daily activities, Pyrexia
Clinical narrative: FEVER, CHILLS SINCE INJECTION , FEEL AWFUL SWELLING, CANCELLED ACTIVITIES, RASH,BURNING SENSATION, WARM
Age: 64.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Rash, Skin warm, Swelling
Clinical narrative: FEVER, CHILLS SINCE INJECTION , FEEL AWFUL SWELLING, CANCELLED ACTIVITIES, RASH,BURNING SENSATION, WARM
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: pt stated she got rash
Age: 0.83
Sex: M
Vaccine: DTAP, HIBV, PNC13
Symptoms: Aphasia, Autism spectrum disorder, Brain injury, Dyskinesia, Toe walking
Clinical narrative: Autism due to the heavy metals in the vaccinations-Noticed brain injury. Toe walking, arm flapping, nonverbal after vaccines
Age: 0.83
Sex: M
Vaccine: DTAP, HIBV, PNC13
Symptoms: Vaccination complication
Clinical narrative: Autism due to the heavy metals in the vaccinations-Noticed brain injury. Toe walking, arm flapping, nonverbal after vaccines
Age: 77.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: large area of soreness, redness, and warmth located under and anterior to the injection site (deltoid)
Age: 66.0
Sex: F
Vaccine: TDAP
Symptoms: Pain in extremity
Clinical narrative: patient claims arm is still sore after 4 days
Age: 68.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pruritus, Injection site rash, Paraesthesia
Clinical narrative: Patient stopped by on 3/8 to show pharmacist the area under the site was red, circular- looked like a rash-  no pain, tingling sensation, was able to move arms without pain- the site was just red and a little itchy as per patient- ongoing after got the vaccine. Advised the patient to use hydrocortisone and if no improvement in 2 days to see the doctor to verify if a true allergic reaction.
Age: 0.17
Sex: F
Vaccine: RV5
Symptoms: Haematochezia
Clinical narrative: Blood in stool 3 days after vaccine. No intusscuption. Was told it was dairy allergy but it isn't
Age: 66.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Nightmare
Clinical narrative: Terrifying nightmares
Age: 66.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Chills, Fibromyalgia, Influenza like illness, Nasopharyngitis
Clinical narrative: Terrifying nightmares
Age: 74.0
Sex: F
Vaccine: TDAP, VARZOS
Symptoms: Laboratory test, Loss of consciousness, Pyrexia
Clinical narrative: On approximately 3/2 or 3/3 (patient was unsure due to losing consciousness) patient was found by friend unconscious in her apartment with a fever reported to be 105 degrees F.  Patient was taken to hospital and released to nursing home care.
Age: 76.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Headache, Myalgia, Nodule, Pain in extremity
Clinical narrative: The day after the shot arm pain , redness, soreness and heat set into arm. It was followed by headache, muscle aches/pain in mid section.  Patient reports a knot developed on spine during the same time period. Patient has recovered from the fever,aches, and pains but still has a knot on her spine and has not seen a doctor for this at this time. It was recommended that she seek care to determine the cause of the knot on her spine.
Age: 76.0
Sex: F
Vaccine: PPV
Symptoms: Pyrexia
Clinical narrative: The day after the shot arm pain , redness, soreness and heat set into arm. It was followed by headache, muscle aches/pain in mid section.  Patient reports a knot developed on spine during the same time period. Patient has recovered from the fever,aches, and pains but still has a knot on her spine and has not seen a doctor for this at this time. It was recommended that she seek care to determine the cause of the knot on her spine.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Headache, Injection site pain, Nausea
Clinical narrative: I had the following same reactions two months ago also with the 1st shot.  Both times it started 12 hours after the shot was given; fever, chills, severe headache, extreme soreness at shot area on arm, under arm and left side, nausea, palpitations, weakness.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Palpitations, Pyrexia
Clinical narrative: I had the following same reactions two months ago also with the 1st shot.  Both times it started 12 hours after the shot was given; fever, chills, severe headache, extreme soreness at shot area on arm, under arm and left side, nausea, palpitations, weakness.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Back pain, Body temperature increased, Headache, Influenza, Neck pain
Clinical narrative: Flu, temperature on and off 101, 99.8, 100, Body soreness so painful  Headache and muscles in neck and back  Extreme pain in left arm
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pain in extremity
Clinical narrative: Flu, temperature on and off 101, 99.8, 100, Body soreness so painful  Headache and muscles in neck and back  Extreme pain in left arm
Age: 0.75
Sex: F
Vaccine: FLUA3
Symptoms: Autoimmune haemolytic anaemia, Jaundice, Pallor
Clinical narrative: Patient become pale and jaundiced and was diagnosed with warm AIHA.
Age: 54.0
Sex: F
Vaccine: FLUC4
Symptoms: Burning sensation, Pruritus
Clinical narrative: Patient states that even months (4 months) after the vaccine it has a burning sensation without touching it and it itches occasionally
Age: 51.0
Sex: M
Vaccine: TD
Symptoms: Arthralgia, Asthenia, Cold sweat, Decreased appetite, Dizziness
Clinical narrative: Adverse Event: High fever, joint pain, dizziness, weakness, cold sweats, change of taste of food, loss of appetite, left arm pain where injected. Treatment:  Stay hydrated, stay home in bed. Outcomes: Joint pain went away in one day, fever broke after 3 days, cold sweats continue, weakness continues.
Age: 51.0
Sex: M
Vaccine: TD
Symptoms: Injection site pain, Pyrexia, Taste disorder
Clinical narrative: Adverse Event: High fever, joint pain, dizziness, weakness, cold sweats, change of taste of food, loss of appetite, left arm pain where injected. Treatment:  Stay hydrated, stay home in bed. Outcomes: Joint pain went away in one day, fever broke after 3 days, cold sweats continue, weakness continues.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Blood test, Cough, Electrocardiogram, Eye pruritus, Eye swelling
Clinical narrative: About 1 hour after shot, I had a coughing fir that felt like I could not recover breath. Then, eyes began to itch and swell. I thought I had something in them, and rinsed them well. Got worse with redness and itching. Progressed to irritated throat, inside mouth, and down to throat. My cough caused pain that felt like a radiating pain on each side of throat-this was not esophagus pain-just pain on coughing. I began to have a very flushed face, heat and pinking. I called the pharmacy and was advised to go to an emergency room, which I did. I was evaluated, EKG, throat Xray, and they pushed Benedryl, Prednisone, and Pepcid. I was observed for over 4 hours, as my blood pressure needed to come down-Sent home w/prednisone - still not symptom free after 7 weeks, totally.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Feeling hot, Flushing, Ocular hyperaemia, Oropharyngeal pain, Pain
Clinical narrative: About 1 hour after shot, I had a coughing fir that felt like I could not recover breath. Then, eyes began to itch and swell. I thought I had something in them, and rinsed them well. Got worse with redness and itching. Progressed to irritated throat, inside mouth, and down to throat. My cough caused pain that felt like a radiating pain on each side of throat-this was not esophagus pain-just pain on coughing. I began to have a very flushed face, heat and pinking. I called the pharmacy and was advised to go to an emergency room, which I did. I was evaluated, EKG, throat Xray, and they pushed Benedryl, Prednisone, and Pepcid. I was observed for over 4 hours, as my blood pressure needed to come down-Sent home w/prednisone - still not symptom free after 7 weeks, totally.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Stomatitis, Throat irritation, X-ray
Clinical narrative: About 1 hour after shot, I had a coughing fir that felt like I could not recover breath. Then, eyes began to itch and swell. I thought I had something in them, and rinsed them well. Got worse with redness and itching. Progressed to irritated throat, inside mouth, and down to throat. My cough caused pain that felt like a radiating pain on each side of throat-this was not esophagus pain-just pain on coughing. I began to have a very flushed face, heat and pinking. I called the pharmacy and was advised to go to an emergency room, which I did. I was evaluated, EKG, throat Xray, and they pushed Benedryl, Prednisone, and Pepcid. I was observed for over 4 hours, as my blood pressure needed to come down-Sent home w/prednisone - still not symptom free after 7 weeks, totally.
Sex: F
Vaccine: VARZOS
Symptoms: Encephalitis viral, Eye infection, Meningitis aseptic, Meningitis bacterial, Ophthalmic herpes simplex
Clinical narrative: bacterial meningitis; aseptic meningitis; viral encephalitis; herpes simplex keratitis; This spontaneous report has been received from a lawyer regarding a case in litigation, concerning a female patient of unknown age. Her concurrent conditions, medical history and concomitant medications were not provided. In or around 29-SEP-2012, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (strength, lot #, expiration date, dose, frequency, injection anatomical location or route of administration were not provided) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). On 30-SEP-2012 (reported as "one day after vaccination"), the patient suffered and was diagnosed with bacterial meningitis, aseptic meningitis and viral encephalitis. She also suffered severe eye infections and was ultimately diagnosed with herpes simplex keratitis. As a direct and proximate result of the defective zoster vaccine live (ZOSTAVAX), her symptoms had resulted in physical limitations not present prior to using the vaccine. She also experienced mental and emotional distress due to resulting physical limitations and seriousness of her condition. As a result, the patient sustained severe and permanent personal injuries. Further, as a tragic consequence, she suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result, the patient had suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome for all the events was not recovered. The reporter considered all the events to be related to zoster vaccine live (ZOSTAVAX).  All the events were classified as disabling events according to the reporter.  Upon internal review, the meningitis bacterial, meningitis aseptic, encephalitis viral and ophthalmic herpes simplex were considered medically significant events.
Sex: U
Vaccine: MENB, MENB
Symptoms: Back pain, Diarrhoea, Nausea, Pyrexia
Clinical narrative: fever; back pain; nausea; diarrhea; This is spontaneous report from a contactable nurse via a Pfizer sales representative. This nurse reported similar events for 5 patients. This is the 1st of 5 reports. A patient of unspecified age and gender received the 1st dose of meningococcal group b rlp2086 (TRUMENBA), via an unspecified route of administration, on an unspecified date, at single dose, for immunisation. Medical history and concomitant medications were not reported. The patient experienced fever, back pain, nausea and diarrhea all on an unspecified date with outcome of unknown. The events were considered serious as caused patient's hospitalization, because the reaction was so severe.  The information on the lot/batch number has been requested.; Sender's Comments: The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, as appropriate. The case will be reassessed if additional information becomes available.,Linked Report(s) : US-PFIZER INC-2020096760 Same reporter/ drug/ event, different patient;US-PFIZER INC-2020096759 Same reporter/ drug/ event, different patient;US-PFIZER INC-2020096758 Same reporter/ drug/ event, different patient;US-PFIZER INC-2020096761 Same reporter/ drug/ event, different patient
Age: 89.0
Sex: F
Vaccine: VARZOS, PPV, VARZOS
Symptoms: Aphasia, Fear, Mobility decreased
Clinical narrative: Shingrix we have no data she had at pharmacy  HPI 89-year-old female who returns for multiple medical problems. Diabetes, diet controlled. Due for labs. Feels well. Does not check her blood sugar regularly. Hypertension, chronic, takes medication is and is compliant. is due for refill of Lisinopril today. Denies any chest pain, shortness of breath, edema or headache. CAD status post stenting. Following with cardiology in taking her medications faithfully. Squamous cell carcinoma diagnosed at last visit. Since then she has seen her dermatologist who
Age: 89.0
Sex: F
Vaccine: VARZOS, PPV, VARZOS
Symptoms: Bereavement, Culture urine positive, Cystitis, Dysuria, Movement disorder
Clinical narrative: Shingrix we have no data she had at pharmacy  HPI 89-year-old female who returns for multiple medical problems. Diabetes, diet controlled. Due for labs. Feels well. Does not check her blood sugar regularly. Hypertension, chronic, takes medication is and is compliant. is due for refill of Lisinopril today. Denies any chest pain, shortness of breath, edema or headache. CAD status post stenting. Following with cardiology in taking her medications faithfully. Squamous cell carcinoma diagnosed at last visit. Since then she has seen her dermatologist who
Age: 89.0
Sex: F
Vaccine: VARZOS, PPV, VARZOS
Symptoms: Speech disorder, Urine analysis abnormal, Vaccination complication, White coat hypertension
Clinical narrative: Shingrix we have no data she had at pharmacy  HPI 89-year-old female who returns for multiple medical problems. Diabetes, diet controlled. Due for labs. Feels well. Does not check her blood sugar regularly. Hypertension, chronic, takes medication is and is compliant. is due for refill of Lisinopril today. Denies any chest pain, shortness of breath, edema or headache. CAD status post stenting. Following with cardiology in taking her medications faithfully. Squamous cell carcinoma diagnosed at last visit. Since then she has seen her dermatologist who
Age: 29.0
Sex: F
Vaccine: HPV9
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: I received a GARDASIL 9 shot and I am about 3 weeks pregnant; No adverse effect reported; This spontaneous prospective pregnancy report as received from a 29 years old female patient referring to herself. The patient's concomitant medication included levothyroxine. The patient had no pertinent medical history and no drug reactions or allergies.      On 12-FEB-2020, the patient received 1 shot of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (strength, dose detail, route, lot # and expiration date were unknown) for prophylaxis. The patient was about 3 weeks pregnant at the time of receiving hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (exposure during pregnancy). The patient's last menstrual period (LMP) was on approximately 31-JAN-2020 and estimated due date (EDD) was on approximately 06-NOV-2020. No adverse effect was reported. The pregnancy outcome was outcome pending.
Sex: U
Vaccine: PPV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No adverse event; Pharmacist may have administered 2 doses of PNEUMOVAX 23 on the same day to a patient; This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. Information regarding the patient's pertinent medical history, concurrent conditions, concomitant and historical drugs, drug reactions and allergies was not provided.  On 28-FEB-2020, the patient was vaccinated with 2 doses of pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) lot # S033516, expiration date on 29-JUN-2021 (route and anatomical location were not provided), for prophylaxis, ot the same visit. No adverse events were reported.
Sex: M
Vaccine: HPV4, HPV9
Symptoms: Loss of personal independence in daily activities, Mental impairment, Neurological symptom
Clinical narrative: Incapacitated or in some way was slowed down to where he wasn't responding in day to day functioning educationally as he would prior to getting the vaccine / he was no longer attending college; He had a neurological reaction; This initial informartion was received from a physician, via a company representative, regarding a case in litigation, referring to a currently 20 to 21 years old male patient. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not reported. The physician reported that he was unable to determine if the patient was administered Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL) or hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) which were administered as routine preventative (route of administration, frequency, lot # and expiration date were not provided). On an unspecified date in 2015 (reported as about 5 years ago), the patient was administered the first dose of the vaccine. On an unspecified date, the patient was administered the second dose of the vaccine, at which time the patient was a student at the University. The physician stated that, on an unspecified date after the second dose of vaccination, the patient's parents suspected he had a neurological reaction (neurological symptom) to the vaccine. The pt was "incapacitated or in some way was slowed down to where he wasn't responding in day to day functioning educationally as he would prior to getting the vaccine" (mental impairment). The physician reported the patient was no longer attending college potentially as a result of vaccine injury. At the time of reporting, the outcome of the patient was unknown. The reporter considered the events to be related to HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast)(GARDASIL 9) or to Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine(GARDASIL).  Upon internal review, the mental impairment was considered medically significant and disabling.
Sex: F
Vaccine: VARZOS
Symptoms: Chest discomfort, Cough, Dyspnoea, Obstructive airways disorder, Pneumonia
Clinical narrative: bilateral pneumonia; obstructive chronic bronchitis with acute exacerbation; This spontaneous report has been received from a lawyer regarding a case in litigation, concerning a female patient of unknown age. Her concurrent conditions, medical history and concomitant medications were not provided. In or around 24-DEC-2016, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (strength, lot #, expiration date, dose, frequency, injection anatomical location or route of administration were not provided) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). Shortly after receiving zoster vaccine live (ZOSTAVAX), she suffered shortness of breath, cough, fever, tightness and wheezing which resulted in diagnoses of bilateral pneumonia and obstructive chronic bronchitis with acute exacerbation (obstructive airways disorder). As a direct and proximate result of the defective zoster vaccine live (ZOSTAVAX), her symptoms had resulted in physical limitations not present prior to using the vaccine. She also experienced mental and emotional distress due to resulting physical limitations and seriousness of her condition. As a result, the patient sustained severe and permanent personal injuries. Further, as a tragic consequence, she suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result, the patient had suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome for both events was not recovered. The reporter considered both events to be related to zoster vaccine live (ZOSTAVAX).  The pneumonia and obstructive airways disorder were considered disabling events by the reporter.  Upon internal review, the pneumonia was considered a medically significant event.
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia, Wheezing
Clinical narrative: bilateral pneumonia; obstructive chronic bronchitis with acute exacerbation; This spontaneous report has been received from a lawyer regarding a case in litigation, concerning a female patient of unknown age. Her concurrent conditions, medical history and concomitant medications were not provided. In or around 24-DEC-2016, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (strength, lot #, expiration date, dose, frequency, injection anatomical location or route of administration were not provided) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). Shortly after receiving zoster vaccine live (ZOSTAVAX), she suffered shortness of breath, cough, fever, tightness and wheezing which resulted in diagnoses of bilateral pneumonia and obstructive chronic bronchitis with acute exacerbation (obstructive airways disorder). As a direct and proximate result of the defective zoster vaccine live (ZOSTAVAX), her symptoms had resulted in physical limitations not present prior to using the vaccine. She also experienced mental and emotional distress due to resulting physical limitations and seriousness of her condition. As a result, the patient sustained severe and permanent personal injuries. Further, as a tragic consequence, she suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result, the patient had suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome for both events was not recovered. The reporter considered both events to be related to zoster vaccine live (ZOSTAVAX).  The pneumonia and obstructive airways disorder were considered disabling events by the reporter.  Upon internal review, the pneumonia was considered a medically significant event.
Sex: F
Vaccine: VARZOS
Symptoms: Eye pain, Herpes ophthalmic, Keratitis, Vision blurred
Clinical narrative: herpes keratitis; This spontaneous report has been received from a lawyer regarding a case in litigation, concerning a female patient of unknown age. Her concurrent conditions, medical history and concomitant medications were not provided. In or around 21-SEP-2012, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (strength, lot #, expiration date, dose, frequency, injection anatomical location or route of administration were not provided) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). Shortly after receiving zoster vaccine live (ZOSTAVAX), she suffered sudden blurry vision, pain in left eye and inflammation of the cornea in her left eye and was diagnosed with herpes keratitis (herpes ophthalmic). As a direct and proximate result of the defective zoster vaccine live (ZOSTAVAX), her symptoms had resulted in physical limitations not present prior to using the vaccine. She also experienced mental and emotional distress due to resulting physical limitations and seriousness of her condition. As a result, the patient sustained severe and permanent personal injuries. Further, as a tragic consequence, she suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result, the patient had suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome for herpes ophthalmic was not recovered. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).  The herpes ophthalmic was considered a disabling event by the reporter.  Upon internal review, the herpes ophthalmic was considered a medically significant event.
Sex: F
Vaccine: VARZOS
Symptoms: Deafness neurosensory
Clinical narrative: sensorineural hearing loss; This spontaneous report has been received from a lawyer regarding a case in litigation, concerning a female patient of unknown age. Her concurrent conditions, medical history and concomitant medications were not provided. In or around 22-AUG-2017, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (strength, lot #, expiration date, dose, frequency, injection anatomical location or route of administration were not provided) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). Shortly after receiving zoster vaccine live (ZOSTAVAX), she suffered sensorineural hearing loss (deafness neurosensory). As a direct and proximate result of the defective zoster vaccine live (ZOSTAVAX), her symptoms had resulted in physical limitations not present prior to using the vaccine. She also experienced mental and emotional distress due to resulting physical limitations and seriousness of her condition. As a result, the patient sustained severe and permanent personal injuries. Further, as a tragic consequence, she suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result, the patient had suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome for deafness neurosensory was not recovered. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).  The deafness neurosensory was a disabling event according to the reporter.  Upon internal review, the deafness neurosensory was considered a medically significant event.
Sex: F
Vaccine: HPV9
Symptoms: Accidental exposure to product, Exposure via eye contact, Exposure via skin contact, Headache
Clinical narrative: The pharmacy Intern had a minor headache; the pharmacy intern stated she was preparing a syringe to administer GARDASIL 9 and while drawing up the vaccine there was a mist in her face, and she felt some particles go into her eyes; the pharmacy intern stated she was preparing a syringe to administer GARDASIL 9 and while drawing up the vaccine there was a mist in her face, and she felt some particles go into her eyes; the pharmacy intern stated she was preparing a syringe to administer GARDASIL 9 and while drawing up the vaccine there was a mist in her face, and she felt some particles go into her eyes; the pharmacy intern stated she was preparing a syringe to administer GARDASIL 9 and while drawing up the vaccine there was a mist in her face, and she felt some particles go into her eyes; This spontaneous report was received from a pharmacy intern referring to herself, a 26-year-old female patient. The patient had no pertinent medical history, nor concomitant medications. The patient's concurrent conditions were not reported. The patient's previous drug allergies or reactions included peanut allergy.  On 04-MAR-2020, the pharmacist intern was preparing a syringe to administer hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (strength, dosage regimen, and route of administration were not reported; and lot number R026716 has been verified to be valid, expiration date reported and validated as 30-MAY-2021) as prophylaxis, and while drawing up the vaccine there was a mist in her face, and she felt some particles went into her eyes (occupational exposure to product, exposure via eye contact, exposure via skin contact, accidental exposure to product). The pharmacy intern cleaned out both eyes with an advance eye rinse kit containing purified water, and experienced a minor headache the same date. The pharmacy Intern was encouraged to follow up with her physician. Laboratories diagnostics or studies were not performed.  There had been no vision problems and she was feeling fine at the time of the report.  The causal relationship between therapy with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) and the headache was not reported.
Age: 17.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Immediate post-injection reaction, Syncope
Clinical narrative: immediately had a "syncopal episode"; This initial spontaneous report was received from a nurse referring to a 17 years old female patient. The patient had no concomitant medications, pertinent medical history or drug reactions/allergies.  On 28-FEB-2020, 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) (lot # 1621931, expiration date 26-JAN-2022; strength and dose details were not reported) intramuscularly for prophylaxis (reported as routine vaccination).    On the same day, the patient immediately had a "syncopal episode". The nurse placed the patient in a supine position, elevated her feet and observed her for 20 minutes. After the 20 minutes, the patient's syncope was resolved. There was no treatment given for the event. The patient did not seek medical attention, as the event occurred at the office and was handled immediately. There were no lab diagnostics/studies performed. The causality assessment was not reported.  Upon internal review, syncopal episode was determined to be medically significant. 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: 1621931; expirationdate: 26-JAN-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: No; reasonfornoneval: 81 Other; reasonfornonevalother: No information about availability; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not suggest a causal association with the device or device constituent
Age: 47.0
Sex: F
Vaccine: PPV
Symptoms: Type 2 diabetes mellitus
Clinical narrative: type 2 diabetes; This spontaneous report has been received from a medical assistant referring to a currently 65 years old female patient. The patient's pertinent medical history, drug reactions/allergies, concurrent condition and concomitant medication were unknown by the reporter.      On 29-APR-2002, the patient was vaccinated with a dose of pneumococcal polysaccharide vaccine (manufacturer unknown) (strength, dose, frequency, route, lot number and expiration date were not reported) for prophylaxis.         On an unknown date, the patient was diagnosed with type 2 diabetes.  It is unclear if the event occurred prior to or after the patient was vaccinated with the pneumococcal polysaccharide vaccine (manufacturer unknown). It was unknown if the patient received treatments. The outcome of type 2 diabetes was unknown.    The causality between the event and pneumococcal polysaccharide vaccine (manufacturer unknown) was not provided.  Upon internal review, the event type 2 diabetes was determined to be medically significant.
Age: 61.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Inappropriate schedule of product administration
Clinical narrative: received pneumococcal vaccine on 11-FEB-2008, 02-JUN-2012 and 20-FEB-2015; This spontaneous report has been received from a health care professional and a lawyer, referring to a 65 year old female patient. Historical vaccines included influenza virus vaccine (unspecified), typhoid vaccine (unspecified), typhoid Vi polysaccharide vaccine, hepatitis B virus vaccine (unspecified) and hepatitis A virus vaccine (unspecified). The patient's medical history included shingles and chicken pox. The patient's concurrent conditions included disability. The patient did not use alcohol. The patient was a tobacco user.      On 11-FEB-2008 and 02-JUN-2012 the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (dose, route, strength, batch/lot# and expiration date were unknown) for prophylaxis. On 20-FEB-2015 the patient was vaccinated with pneumococcal 13v conj vaccine (crm197) (dose, route, strength, batch/lot# and expiration date were unknown) (inappropriate schedule of vaccine administered).  The case is linked to case# US-009507513-1811USA012120 due to the same patient.; Sender's Comments:  US-009507513-1811USA012120:
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: case of shingles approximately 6 weeks post first dose of Shingrix; This case was reported by a other health professional via sales rep and described the occurrence of shingles in a 82-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, 6 weeks after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient had a shingles approximately 6 weeks post first dose of Shingrix. The reporter agree to follow up from GSK.
Sex: F
Vaccine: VARZOS
Symptoms: Eye pain, Headache, Injection site irritation, Pyrexia, Vomiting
Clinical narrative: injection site irritation; Headache; eye pain; fever; vomiting; This case was reported by a pharmacist via sales rep and described the occurrence of injection site irritation in a female patient who received Herpes zoster (Shingrix) (batch number 2B3P2, expiry date 10th May 2022) for prophylaxis.   On 23rd January 2020, the patient received Shingrix. In January 2020, less than a week after receiving Shingrix, the patient experienced injection site irritation, headache, eye pain, fever and vomiting. On an unknown date, the outcome of the injection site irritation, headache, eye pain, fever and vomiting were not recovered/not resolved.   It was unknown if the reporter considered the injection site irritation, headache, eye pain, fever and vomiting to be related to Shingrix.  Additional information was provided as follows: The age at vaccination was not reported. On 30th January 2020, the patient was notified of the issue. The patient had side effects till the time of reporting. The reporter consented to follow up. This case is linked with US2020AMR031263, reported by same reporter.
Sex: U
Vaccine: VARZOS
Symptoms: Discomfort, Hypoaesthesia, Musculoskeletal pain, Musculoskeletal stiffness, Product administered at inappropriate site
Clinical narrative: shoulder that received the vaccine; shoulder that received the vaccine still felt sore; shoulder that received the vaccine still felt sore / heavy; shoulder that received the vaccine still felt sore / heavy / numb; shoulder that received the vaccine still felt sore / heavy / numb/ tight; This case was reported by a pharmacist via sales rep and described the occurrence of shoulder pain in a adult patient who received Herpes zoster (Shingrix) (batch number 2B3P2, expiry date 10th May 2022) for prophylaxis.   On 15th January 2020, the patient received Shingrix. In January 2020, less than 3 weeks after receiving Shingrix, the patient experienced shoulder pain, sensation of heaviness, numbness in shoulder and shoulder muscle stiffness. On an unknown date, the patient experienced vaccine administered at inappropriate site. On an unknown date, the outcome of the shoulder pain, sensation of heaviness, numbness in shoulder, shoulder muscle stiffness and vaccine administered at inappropriate site were unknown.   It was unknown if the reporter considered the shoulder pain, sensation of heaviness, numbness in shoulder and shoulder muscle stiffness to be related to Shingrix.  Additional information was provided as follows: The age at vaccination was not reported. The age group was captured as adult as per vaccine indication. The patient received vaccine in shoulder, which led to vaccine administered at inappropriate site. The patient stated that their shoulder that received the vaccine still felt sore, heavy, numb and tight. The reporter consented to follow up. This case is linked with US2020AMR031239, reported by same reporter.
Sex: F
Vaccine: VARZOS
Symptoms: Dyspnoea, Rash
Clinical narrative: rash appeared on her face; difficulty breathing; This case was reported by a pharmacist via call center representative and described the occurrence of rash in a 66-year-old female patient who received Herpes zoster (Shingrix) (batch number G72Z4, expiry date 13th March 2022) for prophylaxis.   On 14th February 2020, the patient received the 1st dose of Shingrix. On 17th February 2020, 3 days after receiving Shingrix, the patient experienced rash and difficulty breathing. The patient was treated with benadryl (nos) (Benadryl). On an unknown date, the outcome of the rash and difficulty breathing were unknown.   It was unknown if the reporter considered the rash and difficulty breathing to be related to Shingrix.  Additional details were provided as follows: The patient received 1st dose of Shingrix and experienced rash appeared on her face and she had difficulty breathing. The patient went to the emergency room and was given oral benadryl and oral steroids for treatment. The reporter consented to follow up. This case seems to be possible duplicate of case US2020031400. However, no further details or confirmation of both cases are for the same patient or not.
Age: 67.0
Sex: F
Vaccine: PNC13
Symptoms: Chest X-ray abnormal, Drug ineffective, Impaired work ability, Lower limb fracture, Malaise
Clinical narrative: Fractured her knee; Developed pneumonia; Developed pneumonia; In 07Jul2017 she had the pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) and in 03Aug2018 she got the PCV13.; This is a spontaneous report from a contactable consumer who reported for herself, a 68-year-old female patient who received pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) (PREVNAR 13), also reported as PCV 13, first dose on 07Jul2017 at 66 years of age, and a second dose on 03Aug2018 at 67 years of age, both via an unspecified route of administration at a single dose for prevention. The patient's medical history was not reported. There were no concomitant medications. The patient previously took pneumococcal polysaccharide vaccine, 23-valent for immunization, which was read from her shot record. In 07Jul2017 she had the pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) and in 03Aug2018 she got the PCV13. Patient stated that in 01Jan2020, she developed pneumonia. Patient was told the pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) would protect her up to 2017. She stated that she didn't have a need to have the shot but she got it anyway because she was somewhere and she had to go to rehab. Before she could go to rehab, either her surgeon or her regular doctor told her she had to get the pneumonia shot. Patient stated got her second one at a pharmacy. When she was at the hospital, they told her she would need to get a second pneumonia shot. She decided to just go to pharmacy for the second one a year later. Patient stated she had to call in sick to work on holiday, which was unthinkable, but she wasn't able to go. She did not make it to the doctor until 07Jan2020 because of the holidays and the clinic was too full to see her. She finally contacted her doctor around 07Jan2020 and he did X-rays and that's when they discovered the pneumonia. Patient stated that her having to go to a care home happened before having to get shots. She also stated that she had fractured her knee and she lives by herself and they wouldn't let her go home. The outcome of the events "developed pneumonia" coded to drug ineffective and pneumonia was recovered on Jan2020; while outcome of the remaining events was unknown.  information on the lot/Batch number has been requested.
Age: 67.0
Sex: F
Vaccine: PNC13
Symptoms: Pneumonia
Clinical narrative: Fractured her knee; Developed pneumonia; Developed pneumonia; In 07Jul2017 she had the pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) and in 03Aug2018 she got the PCV13.; This is a spontaneous report from a contactable consumer who reported for herself, a 68-year-old female patient who received pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) (PREVNAR 13), also reported as PCV 13, first dose on 07Jul2017 at 66 years of age, and a second dose on 03Aug2018 at 67 years of age, both via an unspecified route of administration at a single dose for prevention. The patient's medical history was not reported. There were no concomitant medications. The patient previously took pneumococcal polysaccharide vaccine, 23-valent for immunization, which was read from her shot record. In 07Jul2017 she had the pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) and in 03Aug2018 she got the PCV13. Patient stated that in 01Jan2020, she developed pneumonia. Patient was told the pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) would protect her up to 2017. She stated that she didn't have a need to have the shot but she got it anyway because she was somewhere and she had to go to rehab. Before she could go to rehab, either her surgeon or her regular doctor told her she had to get the pneumonia shot. Patient stated got her second one at a pharmacy. When she was at the hospital, they told her she would need to get a second pneumonia shot. She decided to just go to pharmacy for the second one a year later. Patient stated she had to call in sick to work on holiday, which was unthinkable, but she wasn't able to go. She did not make it to the doctor until 07Jan2020 because of the holidays and the clinic was too full to see her. She finally contacted her doctor around 07Jan2020 and he did X-rays and that's when they discovered the pneumonia. Patient stated that her having to go to a care home happened before having to get shots. She also stated that she had fractured her knee and she lives by herself and they wouldn't let her go home. The outcome of the events "developed pneumonia" coded to drug ineffective and pneumonia was recovered on Jan2020; while outcome of the remaining events was unknown.  information on the lot/Batch number has been requested.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Contusion, Discomfort, Injection site discolouration, Injection site discomfort, Injection site irritation
Clinical narrative: I began having severe left arm pain, down to my hand, four hours after the vaccination.  This pain subsided after a number of hours.  I began to experience moderate discomfort in my left shoulder, upper arm, armpit and pectoral muscle area, which made sleeping uncomfortable.  The next day, March 6, I experienced moderate malaise, continued pain as described above, and increasing pain and a feeling of swelling or fullness in my armpit and pectoral area.  It felt like the armpit lymph node and the sentinel lymph nodes on the front of my left shoulder were swollen and irritated.  On Saturday March 7 and Sunday, March 8, I experienced no malaise, but the feeling of fullness and painful lymph nodes increased.  On Sunday afternoon, at about 4 PM, I removed my blouse and saw that was looked like a large bruise had formed on my left breast and a paler bruise appearing discoloration was under my arm.  the feeling of fullness in my lymph nodes and armpit had subsided, but still remained to a certain extent.  When I got up at 6:30 AM on March 9, I observed that what had appeared bruise like had become quite red.  The discolored area was smaller, but the underside of my breast had a red somewhat lumpy appearing rash like skin effect. This rash does not itch.  I still have a feeling of fullness in my armpit and my shoulder and pectoral muscles are stiff and moderately sore, with normal range of motion.  Otherwise, I feel well, with no fever or pain or rash anywhere else.  I feel fairly normal, except for some concern over this side effect