chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Cough, Decreased appetite, Dizziness
Clinical narrative: Sudden onset of red and swollen arm, tiredness, weakness, trembling, chills, fever (100.1),  dizziness, headache, runny nose, loss of appetite,cough After 24 hours began to dissipate.  It is now the 3rd day and except for tiredness I'm feeling more normal
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Fatigue, Headache, Peripheral swelling, Pyrexia
Clinical narrative: Sudden onset of red and swollen arm, tiredness, weakness, trembling, chills, fever (100.1),  dizziness, headache, runny nose, loss of appetite,cough After 24 hours began to dissipate.  It is now the 3rd day and except for tiredness I'm feeling more normal
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Rhinorrhoea, Tremor
Clinical narrative: Sudden onset of red and swollen arm, tiredness, weakness, trembling, chills, fever (100.1),  dizziness, headache, runny nose, loss of appetite,cough After 24 hours began to dissipate.  It is now the 3rd day and except for tiredness I'm feeling more normal
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site rash
Clinical narrative: Rash at injection site.   I still have it after a week and a half.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Disturbance in attention, Dizziness, Fatigue, Injection site pain, Nausea
Clinical narrative: Nausea, Light Headness, Extreme Tiredness, Unable to Concentrate, Tenderness at the Injection Site
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Lethargy, Muscle fatigue, Pyrexia
Clinical narrative: Severe headache, muscle fatigue, chills.  Fever of 102.  Side effects lasted 24 hours.  Next 24 hours were fatigue, low grade fever 99+ and  general lethargy
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Decreased appetite, Fatigue, Headache
Clinical narrative: Knee and Lower back pain.   Fatigue.   Loss of appetite.   Headache.   Symptoms began 6 hours after vaccine on Monday 2-1-2021  and lasted all day the next day.   Symptoms started to subside Tuesday night,  2-2-2021.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Injection site pain, Sleep disorder
Clinical narrative: At 0300 (15 hrs after 2nd shot) woke with chills. Slept under 3 blankets -usually use only one.    Chills mostly over by 0700. Still feel fatigued. Slight tenderness on arm of injection site.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling, Pyrexia, Skin discolouration
Clinical narrative: I started running a fever 101.8  and after 48 hours fever was gone. Swelling to my arm and my arm was pink.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Blood pressure decreased, Dizziness, Electrocardiogram normal, Hypertension
Clinical narrative: Within 10-minutes of vaccination, the patient reported feeling lightheaded. EMS assess the patient on-site and they were found to be hypertensive (152/88). No PMHx of HTN. Patient was anxious during evaluation. Their 12-leade EKG and other vitals were WNL. Patient's BP decreased (140/66) during the evaluation and refused transport to a hospital. Patient appeared improved and was in proper decision making capacity.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Lip discolouration, Lip swelling, Paraesthesia oral, Throat tightness
Clinical narrative: Pt described tight throat, tingling mouth, and swelling lower lip.  Upper and lower lips bright pink on observation.  25mg PO benadryl administered to good effect, pt reported symptoms resolved within 5 minutes of administration.  pt completed observation time and safely exited the facility.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Nausea, Pain in extremity, Vomiting
Clinical narrative: Nausea, vomiting, headache, arm soreness
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Pain, Pyrexia
Clinical narrative: fever, chills, body aches
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Bone pain, Insomnia
Clinical narrative: Severe bone and joint pain started about 21 hours after the injection and lasted for approximately 36 hours. I took oxycodone (7.5mg), but  it only took the edge off of the pain. It felt like a nasty RA flare up. Since then, I have more bone and joint pain than usual. I am afraid to take the second dose.   Insomnia since receiving the injection. (ongoing) I can't be sure that this is related to the vaccine, but I work with others who are also experiencing ongoing insomnia since receiving the Moderna vaccine.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Error: Diluent Administered Instead of Vaccine
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Breast pain, Fatigue, Hypoaesthesia oral
Clinical narrative: about an hour after shot: Numbness on back of tongue, extreme tiredness. Took about an hour nap. Woke up feeling better.  Appx 3 days later ( 1/15/2021) from shot, soreness in both breasts. This symptom lasted for about a total of 1 week from date of noticing. 1/22/2021.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Hyperhidrosis, Myalgia, Pyrexia
Clinical narrative: 12 hours after receiving the vaccine, I experienced fever with sweats, chills, rigors, myalgias, headache and sinus congestion that lasted almost 36 hours.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Sinus congestion
Clinical narrative: 12 hours after receiving the vaccine, I experienced fever with sweats, chills, rigors, myalgias, headache and sinus congestion that lasted almost 36 hours.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Dyspnoea, Hypertension
Clinical narrative: Within 15-minutes of vaccination, the patient reported feeling short of breath and lightheaded. Patient stated this was a regular occurrence and that it happens multiple times a week. Patient also attributed it to her anxiety. Patient was hypertensive (180/88), A&Ox4 with GCS15. Patient sat down to catch her breath and stated improvement. Patient refused transport.
Age: 70.0
Sex: M
Vaccine: UNK
Symptoms: Arthralgia, Fatigue, Pain
Clinical narrative: Joint ache, fatigue body ache
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: sore arm x 2 days
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Malaise, Peripheral swelling
Clinical narrative: 9 days after shot my arm is still red and swollen   I was very sickly for a few days afterwards
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Inflammation
Clinical narrative: inflammation in right hand
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Blood thyroid stimulating hormone, Chest X-ray normal, Electrocardiogram normal, Electrolyte imbalance, Full blood count normal
Clinical narrative: Palpitations, fever, near syncope, nausea, tremors
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Palpitations, Presyncope, Pyrexia, Tremor
Clinical narrative: Palpitations, fever, near syncope, nausea, tremors
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Troponin normal, Urine analysis normal
Clinical narrative: Palpitations, fever, near syncope, nausea, tremors
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Pyrexia
Clinical narrative: Chills fever headache
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Pain, Pyrexia
Clinical narrative: Chills off and on Body aches constant Fatigue  Fever off and on
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Cough, Diarrhoea, Fatigue, Feeling cold
Clinical narrative: First day of the shot immediately I had a headache and my stomach started to hurt really bad. My arm hurt and swelled up for a few days with a large red bump. After a few days the bump went away. Im still having headaches, ive had diarrhea from day 1. I already struggle with my bowels and go to the bathroom way to much already and after given the vaccine those next days and still days continuing after I cant stay out of the bathroom. In 6 hours i had over 7 to 10 bowel movements and I hadnt ate a thing. As i thought I was getting better I woke uo the next day with my throat swelled up and i was all congested like a cold my body is very tired very sore a very light cough formed as well too my breathing is ok so far, my body on the inside feels like its on fire but im cold on the outside, one minute i was cold them im burning up. Its making me very overwhelmed and my nerves are all over the place.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Frequent bowel movements, Headache, Immediate post-injection reaction, Nasopharyngitis
Clinical narrative: First day of the shot immediately I had a headache and my stomach started to hurt really bad. My arm hurt and swelled up for a few days with a large red bump. After a few days the bump went away. Im still having headaches, ive had diarrhea from day 1. I already struggle with my bowels and go to the bathroom way to much already and after given the vaccine those next days and still days continuing after I cant stay out of the bathroom. In 6 hours i had over 7 to 10 bowel movements and I hadnt ate a thing. As i thought I was getting better I woke uo the next day with my throat swelled up and i was all congested like a cold my body is very tired very sore a very light cough formed as well too my breathing is ok so far, my body on the inside feels like its on fire but im cold on the outside, one minute i was cold them im burning up. Its making me very overwhelmed and my nerves are all over the place.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pain in extremity, Peripheral swelling, Pharyngeal swelling, Respiratory tract congestion
Clinical narrative: First day of the shot immediately I had a headache and my stomach started to hurt really bad. My arm hurt and swelled up for a few days with a large red bump. After a few days the bump went away. Im still having headaches, ive had diarrhea from day 1. I already struggle with my bowels and go to the bathroom way to much already and after given the vaccine those next days and still days continuing after I cant stay out of the bathroom. In 6 hours i had over 7 to 10 bowel movements and I hadnt ate a thing. As i thought I was getting better I woke uo the next day with my throat swelled up and i was all congested like a cold my body is very tired very sore a very light cough formed as well too my breathing is ok so far, my body on the inside feels like its on fire but im cold on the outside, one minute i was cold them im burning up. Its making me very overwhelmed and my nerves are all over the place.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Eyelid pain, Sensitive skin, Swelling of eyelid
Clinical narrative: My right eye bottom eyelid swollen and very sensitive and painful. Took two rounds of Benadryl yesterday and will be taking more today.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Induration, Pruritus, Skin warm, Swelling
Clinical narrative: Hard, swollen, hot, itchy, red.   Size evening of injection was approximately 1" diameter.  Next morning was 3" diameter and now 48 hours later, spreading has grown to 5" diameter.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Cardiovascular evaluation, Gastritis
Clinical narrative: Acute gastritis
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Cardiac arrest, Death, Diabetes mellitus, Endotracheal intubation, Fall
Clinical narrative: Patient expired. Per Emergency MD note: "This is a 72-year-old male with what sounds like diabetes, atrial fibrillation, and hypertension who presents via EMS in cardiac arrest.  It sounds like he received his Covid vaccine last week.  Initially he had some mild effects from it.  However over the last day or so he has felt very unwell.  He apparently called his wife today and told her that he was not feeling well and so she returned home.  Shortly thereafter he attempted to get up from his chair.  He then collapsed and fell forward onto his face.  Sounds like his wife had some difficulty rolling him over to perform CPR.  When EMS arrived they found him in PEA.  He received a total of 5 rounds of epinephrine.  At some point they did have return of spontaneous circulation.  However just prior to arriving in the emergency department they lost pulses again.  The patient was intubated with an 8 oh endotracheal tube prior to arrival."
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Hypertension, Malaise, Pulse absent, Pulseless electrical activity, Resuscitation
Clinical narrative: Patient expired. Per Emergency MD note: "This is a 72-year-old male with what sounds like diabetes, atrial fibrillation, and hypertension who presents via EMS in cardiac arrest.  It sounds like he received his Covid vaccine last week.  Initially he had some mild effects from it.  However over the last day or so he has felt very unwell.  He apparently called his wife today and told her that he was not feeling well and so she returned home.  Shortly thereafter he attempted to get up from his chair.  He then collapsed and fell forward onto his face.  Sounds like his wife had some difficulty rolling him over to perform CPR.  When EMS arrived they found him in PEA.  He received a total of 5 rounds of epinephrine.  At some point they did have return of spontaneous circulation.  However just prior to arriving in the emergency department they lost pulses again.  The patient was intubated with an 8 oh endotracheal tube prior to arrival."
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Syncope
Clinical narrative: Patient expired. Per Emergency MD note: "This is a 72-year-old male with what sounds like diabetes, atrial fibrillation, and hypertension who presents via EMS in cardiac arrest.  It sounds like he received his Covid vaccine last week.  Initially he had some mild effects from it.  However over the last day or so he has felt very unwell.  He apparently called his wife today and told her that he was not feeling well and so she returned home.  Shortly thereafter he attempted to get up from his chair.  He then collapsed and fell forward onto his face.  Sounds like his wife had some difficulty rolling him over to perform CPR.  When EMS arrived they found him in PEA.  He received a total of 5 rounds of epinephrine.  At some point they did have return of spontaneous circulation.  However just prior to arriving in the emergency department they lost pulses again.  The patient was intubated with an 8 oh endotracheal tube prior to arrival."
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site paraesthesia, Paraesthesia
Clinical narrative: Moderna COVID-19 Vaccine EUA Pain and tingling in arm that received the vaccination. Started about 4-5 hours after receiving the injection. Centered at injection site, but goes all the way down my arm and into my fingers.
Age: 53.0
Sex: M
Vaccine: UNK
Symptoms: Injection site bruising, Injection site erythema, Pain in extremity
Clinical narrative: My arm where the shot was administered started to turn red and then black and blue then traveled down my arm towards my elbow. Arm was very sore. Symptoms lasted three weeks .
Age: 16.0
Sex: F
Vaccine: MENB
Symptoms: Arthralgia, Injection site warmth
Clinical narrative: Shoulder pain, warm on area of injection
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Blood gases, Body temperature increased, Chest X-ray, Computerised tomogram
Clinical narrative: patient could not eat ,drink or swallow medication, temp was 102F. Pt was weak, uncoordinated and could not walk. He was leaning over and had a change in mental status. 911 was called and patient went to the hospital by ambulance. He had chest xray, IV fluids and urine sample was collected.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Decreased appetite, Dysphagia, Fluid replacement, Full blood count, Gait inability
Clinical narrative: patient could not eat ,drink or swallow medication, temp was 102F. Pt was weak, uncoordinated and could not walk. He was leaning over and had a change in mental status. 911 was called and patient went to the hospital by ambulance. He had chest xray, IV fluids and urine sample was collected.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Influenza virus test, Mental status changes, Metabolic function test, SARS-CoV-2 test, Thirst decreased
Clinical narrative: patient could not eat ,drink or swallow medication, temp was 102F. Pt was weak, uncoordinated and could not walk. He was leaning over and had a change in mental status. 911 was called and patient went to the hospital by ambulance. He had chest xray, IV fluids and urine sample was collected.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Troponin I, Urine analysis
Clinical narrative: patient could not eat ,drink or swallow medication, temp was 102F. Pt was weak, uncoordinated and could not walk. He was leaning over and had a change in mental status. 911 was called and patient went to the hospital by ambulance. He had chest xray, IV fluids and urine sample was collected.
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Hyperhidrosis, Influenza like illness, Myalgia
Clinical narrative: Achy muscles/joints when going to bed. Very sore arm upon waking up(barely slept all night). Flu like symptoms of chills/sweats began around 6 am and have progressed over the last 3 hours.
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Sleep disorder
Clinical narrative: Achy muscles/joints when going to bed. Very sore arm upon waking up(barely slept all night). Flu like symptoms of chills/sweats began around 6 am and have progressed over the last 3 hours.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Feeling cold, Heart rate increased, Mobility decreased
Clinical narrative: I received the shot approximately 7:20 am.  When I first got the shot I had an itchy throat approx. ten minutes after the shot with a small hot spot at the back of my tongue.  Then at approx 4:00 pm I started feeling fatigue.  I went home from work after 5:00 pm and I ate dinner and felt very fatigue and achy.  So I went to bed and had cold chills, was achy had a rapid hard heart beat and had a head ache.  When I woke the next morning I felt like I could not get out of bed, at approximately 5:10 in the morning.  My muscles felt like they could not get me up so my husband pulled me up to my feet.  I continued to walk around the house and get ready for work.  I am at work now at 9:00 am and still feeling fatigue.   I emailed my doctor to give him information of how I am reacting and questioned him whether I should receive the second shot.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Muscular weakness, Pain, Throat irritation, Tongue eruption
Clinical narrative: I received the shot approximately 7:20 am.  When I first got the shot I had an itchy throat approx. ten minutes after the shot with a small hot spot at the back of my tongue.  Then at approx 4:00 pm I started feeling fatigue.  I went home from work after 5:00 pm and I ate dinner and felt very fatigue and achy.  So I went to bed and had cold chills, was achy had a rapid hard heart beat and had a head ache.  When I woke the next morning I felt like I could not get out of bed, at approximately 5:10 in the morning.  My muscles felt like they could not get me up so my husband pulled me up to my feet.  I continued to walk around the house and get ready for work.  I am at work now at 9:00 am and still feeling fatigue.   I emailed my doctor to give him information of how I am reacting and questioned him whether I should receive the second shot.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pain, Rash, Swelling
Clinical narrative: About 8 days after vaccine, 02/02/2021, I noticed a 1-2 inch circular redness with light rash, and slight swelling with mild soreness. It is lighter red today, 02/05/2021, and has not increased in diameter.
Age: 0.83
Sex: F
Vaccine: DTAPIPV, FLUX(H1N1), HEP, HIBV, PPV
Symptoms: Body temperature increased, Crying, Irritability, Pain in extremity, Rash
Clinical narrative: the child's legs hurt; the child's legs hurt and could not be touched; restless; runny nose; fever temperature of 101F; rash all over the body; crying; fussy; This spontaneous report was received from a patient's mother via a field base employee and refers to a 10-month-old female patient. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 19-JAN-2021 the patient was vaccinated with haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB), diphtheria toxoid, pertussis acellular 5-component vaccine, poliovirus vaccine inactivated (mrc-5), tetanus toxoid (QUADRACEL), pneumococcal conj vaccine (unspecified), hepatitis b vaccine (recombinant) (RECOMBIVAX HB) and influenza virus a vaccine (unspecified) (exact doses, anatomical locations, lot # and expiration dates were not reported; route of administration reported as oral and intramuscular injection) all for prophylaxis.    On 20-JAN-2021, the patient experienced fever (101 Fahrenheit), runny nose, rash all over the body, she was crying, restless, fussy, and her legs hurt and could not be touched. On 21-JAN-2021, the child was taken to the hospital for evaluation (sought medical attention). It was unknown by reporter if any treatment was given; the child was not admitted to the hospital, and sent home the same day. The patient had never had any reaction to vaccines before and they tested the child for COVID-19, results were negative. The outcome of the events was unknown.        Causality assessment was not provided.
Age: 0.83
Sex: F
Vaccine: DTAPIPV, FLUX(H1N1), HEP, HIBV, PPV
Symptoms: Restlessness, Rhinorrhoea, SARS-CoV-2 test negative, Tenderness
Clinical narrative: the child's legs hurt; the child's legs hurt and could not be touched; restless; runny nose; fever temperature of 101F; rash all over the body; crying; fussy; This spontaneous report was received from a patient's mother via a field base employee and refers to a 10-month-old female patient. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 19-JAN-2021 the patient was vaccinated with haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB), diphtheria toxoid, pertussis acellular 5-component vaccine, poliovirus vaccine inactivated (mrc-5), tetanus toxoid (QUADRACEL), pneumococcal conj vaccine (unspecified), hepatitis b vaccine (recombinant) (RECOMBIVAX HB) and influenza virus a vaccine (unspecified) (exact doses, anatomical locations, lot # and expiration dates were not reported; route of administration reported as oral and intramuscular injection) all for prophylaxis.    On 20-JAN-2021, the patient experienced fever (101 Fahrenheit), runny nose, rash all over the body, she was crying, restless, fussy, and her legs hurt and could not be touched. On 21-JAN-2021, the child was taken to the hospital for evaluation (sought medical attention). It was unknown by reporter if any treatment was given; the child was not admitted to the hospital, and sent home the same day. The patient had never had any reaction to vaccines before and they tested the child for COVID-19, results were negative. The outcome of the events was unknown.        Causality assessment was not provided.
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Headache, Herpes zoster, Post herpetic neuralgia, Rash
Clinical narrative: Rosacea; Postherpetic Neuralgia; Shingles; Information has been received from a lawyer regarding a case in litigation and referred to a female patient of unknown age. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On or around 28-JAN-2015, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster) (strength, dose, route, lot# and expiration date were not reported). Shortly after receiving zoster vaccine live (ZOSTAVAX), the patient suffered a rash in her face and redness and pain in her forehead area. The patient was diagnosed with shingles, rosacea and postherpetic neuralgia. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient's symptoms had resulted in physical limitations not present prior to using the product. The patient also experienced mental and emotional distress due to resulting physical limitations and seriousness of her condition. As a result of the manufacturer, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), the patient sustained severe and permanent personal injuries. Further, as a tragic consequence of zoster vaccine live (ZOSTAVAX), the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient had suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the events shingles, rosacea and postherpetic neuralgia was considered as not recovered. The events were considered related to zoster vaccine live (ZOSTAVAX).   The lawyer considered the events shingles, rosacea and postherpetic neuralgia to be disability.
Sex: F
Vaccine: VARZOS
Symptoms: Rosacea
Clinical narrative: Rosacea; Postherpetic Neuralgia; Shingles; Information has been received from a lawyer regarding a case in litigation and referred to a female patient of unknown age. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On or around 28-JAN-2015, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster) (strength, dose, route, lot# and expiration date were not reported). Shortly after receiving zoster vaccine live (ZOSTAVAX), the patient suffered a rash in her face and redness and pain in her forehead area. The patient was diagnosed with shingles, rosacea and postherpetic neuralgia. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient's symptoms had resulted in physical limitations not present prior to using the product. The patient also experienced mental and emotional distress due to resulting physical limitations and seriousness of her condition. As a result of the manufacturer, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), the patient sustained severe and permanent personal injuries. Further, as a tragic consequence of zoster vaccine live (ZOSTAVAX), the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient had suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the events shingles, rosacea and postherpetic neuralgia was considered as not recovered. The events were considered related to zoster vaccine live (ZOSTAVAX).   The lawyer considered the events shingles, rosacea and postherpetic neuralgia to be disability.
Age: 13.0
Sex: M
Vaccine: HPV9
Symptoms: Lymphadenopathy
Clinical narrative: Lymph nodes enlarged; This spontaneous report was received from a physician via company representative, referring to a 13 year old male patient. The patient's historical drugs, medical history, concomitant therapies and concurrent conditions were not reported.  On 13-JUN-2020, the patient was vaccinated with HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) lot# R030453 has been verified to be a valid lot number (expiration date not reported, but upon internal validation established as 23-JUL-2021), for prophylaxis (strength, dose, route and frequency date were not reported).  On 19-JUN-2020, the patient came back into the office with a complaint of enlarged lymph nodes (lymphadenopathy). The patient sought medical attention; however, it was unknown if received any treatment or if diagnostic laboratories were performed.  On 19-SEP-2020, the patient was seen again, and the report indicates that 2 nodes resolved and 1 node still palpable, but any medical issue had resolved.  At the time of reporting, the outcome of lymphadenopathy was reported as resolving. Additionally, the causality assessment between lymphadenopathy with HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) was reported as not related. 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: R030453; expirationdate: 23-JUL-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not suggest a causal association with the device or device constituent
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: "I have a 32-year-old patient who received 2 doses of GARDASIL, 10 plus years ago."; No other AE reported; This spontaneous report as received from a pharmacist refers to a currently 32-year-old female patient. The patient's concurrent condition, concomitant medication and medical history were not provided.  On an unknown dates, (reported as "10 plus years ago"), the patient was vaccinated with two doses of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) (exact dose, route of administration, anatomical location, lot # and expiration date were not reported) for prophylaxis. Therefore the patient experienced inappropriate schedule of product administration. No adverse events were reported. The reporting pharmacist wanted to know if she could give her the third dose "even if it has been 10 plus years ago".
Age: 73.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: sore arm; This case was reported by a consumer and described the occurrence of pain in arm in a 73-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included heart attack and diabetes.   On 10th August 2020, the patient received the 1st dose of Shingrix. On 11th August 2020, 1 days after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional details were provided as follows: The case was reported by patient's wife. The patient received first dose of Shingrix and had a sore arm the next day that lasted 1 to 2 days. For tolerance of 2nd dose refer case US2020243287.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020243287:same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: localized redness / small redness at the site injection; which is sore when I press on the site; This case was reported by a consumer and described the occurrence of injection site erythema in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 7th October 2020, the patient received the 1st dose of Shingrix. On an unknown date, less than 3 months after receiving Shingrix, the patient experienced injection site erythema and injection site tenderness. On an unknown date, the outcome of the injection site erythema and injection site tenderness were unknown.   It was unknown if the reporter considered the injection site erythema and injection site tenderness to be related to Shingrix.  Additional information was provided as follows: The age at vaccination was not reported. The age group was selected as adult as per the vaccine indication. The patient received 1st dose of Shingrix and experienced a localized redness about the size of a baseball, which was sore when pressed on the site and also had a small redness at the site injection. The patient was concerned about getting a 2nd dose.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; This case was reported by a other health professional  and described the occurrence of shingles in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced 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 information was provided as follows: The age at vaccination was not reported. The age group was selected as adult as per the vaccine indication. The patient received 1st dose of Shingrix and experienced shingles. The reporter was asking when should be the 2nd dose given in such situations.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Musculoskeletal discomfort, Musculoskeletal pain, Myalgia
Clinical narrative: More muscle pain / aggravated; Hip and joint pain / joint pain described as severe; Muscle skeleton pain; This case was reported by a nurse and described the occurrence of musculoskeletal pain in a 54-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included psoriatic arthritis. Previously administered products included Flu vaccine with an associated reaction of arthralgia (received flu vaccine in 2015, refer case US2020AMR261139 ).   On 26th October 2020, the patient received the 1st dose of Shingrix. On 26th October 2020, less than a day after receiving Shingrix, the patient experienced musculoskeletal pain. On an unknown date, the patient experienced muscle pain and arthralgia. On an unknown date, the outcome of the musculoskeletal pain was recovered/resolved and the outcome of the muscle pain and arthralgia were unknown.   It was unknown if the reporter considered the musculoskeletal pain, muscle pain and arthralgia to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The nurse reported the patient administrated Shingrix on 26th October 2020 with the 1st dose of Shingrix and felt a muscle skeleton pain after the injection.  The muscular skeletal pain she experienced after dose of Shingrix began a couple of weeks no exact date provided. The  reporter described the muscular skeletal pain as more muscle pain that also aggravated previous hip and joint pain. The reporter consented to follow up. There is discrepancy in the time to onset of m muscle skeleton pain, the onset date was provided same as vaccination date, however in the narrative it was mentioned couple of weeks and few days after vaccination.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR261139:Same reporter
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Mobility decreased, Pain in extremity
Clinical narrative: Still having arm pain / Arm is painful/Still having / pain at the injection site / Sore at the injection site; Decreased mobility in arm / Difficulty reaching arm behind back; This case was reported by a consumer and described the occurrence of pain in arm in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, less than 2 months after receiving Shingrix, the patient experienced pain in arm and mobility decreased. On an unknown date, the outcome of the pain in arm and mobility decreased were not recovered/not resolved.   It was unknown if the reporter considered the pain in arm and mobility decreased to be related to Shingrix.  Additional details were provided as follows: Age at vaccination was not reported. The patient received first dose Shingrix two months ago and went to pharmacy to receive second dose, but pharmacist would not administer second dose due to the patient still had arm pain at the injection site from the first dose.  Arm was painful and sore at the injection site, and the pain was not much lessened or went away from two months ago. The patient stated that arm hurt just as bad as it did after injection. The patient described decreased mobility in arm such as reaching behind back to arm in jacket or sleeve. Difficulty reaching arm behind back. The patient described pain as being punched in arm. The reporter consented to follow up.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Injection site pain, Pyrexia
Clinical narrative: Injection site arm pain; Headache; Fever; This case was reported by a consumer and described the occurrence of injection site pain in a 64-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 7th December 2020, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. On 7th December 2020, immediately after receiving Shingrix, the patient experienced injection site pain, headache and fever. On an unknown date, the outcome of the injection site pain, headache and fever were not recovered/not resolved.   It was unknown if the reporter considered the injection site pain, headache and fever to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix and had injection site arm pain almost immediately. The patient developed headache and fever as well and that these symptoms persist. The reporter did not consent to follow up. The reporter did not had vaccine information for this AE and declines follow up. This case linked with US2020243291, reporter by same reporter for patient husband.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020243291:Same Reporter
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Rash papular
Clinical narrative: bumpy rash on left side neck and chest; This case was reported by a physician and described the occurrence of papular rash in a 76-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 19th November 2020, the patient received the 1st dose of Shingrix (intramuscular). On 23rd November 2020, 4 days after receiving Shingrix, the patient experienced papular rash. The patient was treated with dermatologicals nos (Calamine Lotion). On an unknown date, the outcome of the papular rash was recovered/resolved.   It was unknown if the reporter considered the papular rash to be related to Shingrix.  Additional details were reported as follows: The patient received Shingrix in the left deltoid and 4 days later the patient developed bumpy rash on left side of neck and chest, the patient self medicated using calamine lotion.  The adverse event reported as resolved lasting for 2 weeks. The reporter did not consent to follow up.
Age: 89.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Nausea, Rash, Vaccine positive rechallenge
Clinical narrative: Rash; Nausea; Shivering; This case was reported by a consumer and described the occurrence of rash in a 89-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of rash (1st dose received on an unknown date, reference case US2020AMR244350).   On 8th December 2020, the patient received the 2nd dose of Shingrix (intramuscular). On 8th December 2020, less than a day after receiving Shingrix, the patient experienced rash, nausea and shivering. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the rash, nausea and shivering were unknown.   It was unknown if the reporter considered the rash, nausea and shivering to be related to Shingrix.  Additional details were provided as follows: The patient had reported the case for himself. The patient experienced shivering, nausea, and rash that occurred after receiving the vaccine. The patient had rash after the first dose of Shingrix, but did not believe it was related to the vaccine at the time. All information was not available. The patient did want his physician contacted, but did not know the phone number. The reporter did not consent to follow-up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR244350:Same reporter
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Pain
Clinical narrative: BODY ACHES, CHEST PAIN
Age: 26.0
Sex: F
Vaccine: UNK, UNK
Symptoms: Extra dose administered, Injection site bruising, Injection site erythema, Injection site pain, Urticaria
Clinical narrative: On the morning after I received my second dose of the Moderna injection, I took the Band-Aid off and there was a giant welt-like thing on my left arm.  It doesn't itch, very mid redness and just feels sore like you normally are after getting a shot.  No other signs or symptoms, just sore arm (feels like a bruise) and red welt-like circle on my arm.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Somnolence, Tachycardia
Clinical narrative: Tachycardia, beginning ~24.75 hours after injection, lasting 7 hours including periods of sleep. No treatment, symptoms  abated after 7 approximately 7 hours.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Immediate post-injection reaction, Paraesthesia, Paraesthesia oral
Clinical narrative: pt allergic to shellfish, pt immediately reported tingling of tongue, lips, tingling of hands and feet 50 mg of Benadryl given EMS on site EpiPen given by EMS and transported to Hospital
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Headache, Pain
Clinical narrative: Sever Headache ,joint pain ,body aches
Age: 26.0
Sex: M
Vaccine: COVID19
Symptoms: C-reactive protein, Computerised tomogram, Full blood count, Impaired work ability, Loss of personal independence in daily activities
Clinical narrative: Moderate to severe axillary lymphadenopathy requiring missing work and inability to perform his functions as a first responder/wear protective gear
Age: 26.0
Sex: M
Vaccine: COVID19
Symptoms: Lymphadenopathy, Red blood cell sedimentation rate, Ultrasound scan
Clinical narrative: Moderate to severe axillary lymphadenopathy requiring missing work and inability to perform his functions as a first responder/wear protective gear
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Malaise, Muscle spasms, Myalgia, Pyrexia
Clinical narrative: About ten hours after the inoculation I developed a fever of 100.4 along with muscle aches/cramps. My fever broke the next morning, but I still felt very weak and sick. This morning I feel much better.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Burning sensation, Erythema, Pain in extremity, Pruritus, Rash
Clinical narrative: About 8 days after my first vaccine shot, my left arm got a large rash.  Sometimes it would itch or burn or hurt, but not all the time.  It would get bigger and smaller.  It would be very red and then less red.  It just came and went.  After about a week or so, it went away.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Injection site induration, Injection site pruritus, Injection site swelling, Skin warm
Clinical narrative: 1 week after receiving injection, injection site is extremely itchy, swollen, hard, red, warm to touch....approximately 3" x 4".  After 2 days, all symptoms began to resolve.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Pain, Pyrexia
Clinical narrative: Fatigue, headache, body aches, fever, chills
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Erythema, Flushing, Oropharyngeal discomfort, Urticaria
Clinical narrative: 1110: arrived for vaccination 1115: vaccinated 1117: honked horn to alert traffic 1118:  (providers) assessed patient and discovered pt in NAD but described mild throat sensation, and she was experiencing flushing and redness through chest with 1 hive on face. 50mg of Bendryl was given to the patient to swallow which she did without issue.   1125:She reported feeling better within a few minutes.  Patient was asked to wait in vehicle with her parents for an additional 20 minutes which at that point we reassessed and pt reported that she felt slightly anxious but fine otherwise.urticaria fading  1138:  left site after infrmed decision where she was given the option for transport/referral
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Muscular weakness, Pain
Clinical narrative: LESS THAN 12 HOURS AFTER INJECTION I BEGAN HAVING CHILLS AND COMPLETE BODY ACHES.  THESE LASTED 24HRS WITH TYLENOL 1000MG Q6HRS HELPING BUT COMPLETELY RESOLVING SYMPTOMS. 24-48HRS I STILL FELT MY MUSCLES WERE WEAK, BUT NO ACHES OR CHILLS. BY 72 HOURS AFTER INJECTION I FELT NORMAL/BASELINE.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Myalgia, Oropharyngeal pain
Clinical narrative: Severe muscle aches, fatigue, headache, sore throat and chills, all lasting 24 hours beginning about 9 hours post vaccine.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety
Clinical narrative: patient experienced anxiety attack was given water and recovered on site and left on own will
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Seizure, Tachycardia, Tremor
Clinical narrative: After receiving vaccine, Employee complained of tachycardia (P=100),  some dizziness.  Employee drank water and juice.  Employee appeared like she might vomit and started shaking, employee was lifted from her chair to the floor.   Employee was turned to her right side and was having a seizure.  CODE Team was called and Employee was taken to Emergency room via stretcher.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Nausea, Retching
Clinical narrative: Severe headache with nausea and dry heaving
Age: 45.0
Sex: M
Vaccine: UNK
Symptoms: Arthralgia, Headache, Lethargy, Pain, Pyrexia
Clinical narrative: Fever,  headache, body ache, joint pain, lethargy
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Decreased appetite, Fatigue, Headache, Insomnia, Myalgia
Clinical narrative: Exhaustion starting around 7 pm and lasting until 4:00 pm the following day. Insomnia starting around 9:30 pm and lasting as long. Headache from 9:30 pm to 5 pm the next day. Tenderness around vaccination site from 2.5 hours after shot until present. Stabbing pain in muscle on other arm from 5 pm to 8 pm the following day. Nausea and lack of appetite for the whole day after the shot.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain in extremity, Vaccination site pain
Clinical narrative: Exhaustion starting around 7 pm and lasting until 4:00 pm the following day. Insomnia starting around 9:30 pm and lasting as long. Headache from 9:30 pm to 5 pm the next day. Tenderness around vaccination site from 2.5 hours after shot until present. Stabbing pain in muscle on other arm from 5 pm to 8 pm the following day. Nausea and lack of appetite for the whole day after the shot.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain, Pyrexia
Clinical narrative: 100.3 fever for two days.  Severe body aches and headache
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Aphasia, Balance disorder, Chest pain, Lethargy, Mobility decreased
Clinical narrative: Post Covid vaccination patient appeared to be starting to fall from chair. He appeared lethargic and unable to speak or hold himself upright.  Vitals where taken and 2 liters Via mask administered. Increased to 4 liters after no improvement in pulse o2. wife who stated he was released from the ED yesterday and stated he needed a stent. Patient nodded that he was having substernal chest pain without radiation. four 81mg Asa given and nitro administered after  verbally ordered. EMS arrived and transported patient.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature increased
Clinical narrative: 14 hours after injection, temperature  went up to 102.2  degrees for   about 5-6 hours.  Then down to 100 degrees
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Fatigue, Injection site pain, Injection site swelling
Clinical narrative: Mild fever, chills, body aches, joint pain, nausea, fatigue, pain/swelling at injection site
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Nausea, Pain, Pyrexia
Clinical narrative: Mild fever, chills, body aches, joint pain, nausea, fatigue, pain/swelling at injection site
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Chills, Dizziness, Fatigue, Headache
Clinical narrative: 2/3/21 Started with headache. Then overnight fever and chills. Dizzy, body ache, frequent urination. Next morning 2/4/21, fever, headache, upset stomach, body aches, fatigue. I had to quit work and go to bed.  2/5/21 fever has passed. Still have headache and some body aches.