chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 29.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Tachycardia
Clinical narrative: Patient notes that she received the COVID vaccine around 1800 today. After receiving the vaccine she notes she had developed a headache. She was otherwise doing fine until around 2000-2100 when she noticed her left arm become numb with paresthesias from her left bicep to her hand with whole arm localization. She felt her hands and wrists were puffy at this time and somewhat swollen. She reports feeling "floaty"/Dizzy at this time, and at least once had to sit down due to this. She started feeling her heart race and some associated SOB, this has since resolved. She notes that she had two loose stools around this time as well.   This progressed to develop into right numbness/paresthesias from her mid right forearm down to her hands. As the evening progressed she developed itchiness of her bilateral arms and torso. She notes that she has had a waxing/waning reddish rash on her arms that has been pruritic. She has since developed intermittent nausea, and still endorses feeling some "skipped beats."   While in the ED from Triage to repeat evaluations her lips began having progressive swelling. She had been given Benadryl 50mg, Zofran 4mg, 1L IVF. Given ongoing tachycardia and lip swelling she was given Prednisone 40mg and Epinephrine for allergic reaction and concern for anaphylaxis.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea, Nausea, Pain, Pyrexia, Vomiting
Clinical narrative: Fever, Nausea, Vomiting, body aches, Diarhea  taking po fluids trying to stay hydrated with po fluids.  rest
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Gait inability, Groin pain, Pain in extremity
Clinical narrative: Serious pain in right leg from the groin to the thigh for 2 days can?t walk at all
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Gait inability, Neuralgia, Pain in extremity
Clinical narrative: Nerve pain from my groin on both legs down to my ankles for 2 days couldn?t walk
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Erythema, Feeling hot, Headache, Malaise, Pain
Clinical narrative: 7 hours post vaccine, I had very runny nose, thick clear  mucus kept coming out of my nose. I felt feverish although my temperature is within normal limits. I had a mild headache and very sore arm on the vaccine site, body aches and malaise which I know are part of the list of side effects I would experience post vaccine, but then about midnight, I developed a huge rash or hive near my left armpit. Then, on Sunday, 12/20/2020, more big hives appeared on my body and my left hand is very itchy and the palm looked red and more swollen than my right hand. I took some antihistamine and notified my doctor via an e-mail. He told me to take diphenhydramine 50 mg every 6 hours. The hives are still present and much bigger and appear in more areas of my body.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Peripheral swelling, Pruritus, Rash, Rhinorrhoea, Urticaria
Clinical narrative: 7 hours post vaccine, I had very runny nose, thick clear  mucus kept coming out of my nose. I felt feverish although my temperature is within normal limits. I had a mild headache and very sore arm on the vaccine site, body aches and malaise which I know are part of the list of side effects I would experience post vaccine, but then about midnight, I developed a huge rash or hive near my left armpit. Then, on Sunday, 12/20/2020, more big hives appeared on my body and my left hand is very itchy and the palm looked red and more swollen than my right hand. I took some antihistamine and notified my doctor via an e-mail. He told me to take diphenhydramine 50 mg every 6 hours. The hives are still present and much bigger and appear in more areas of my body.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: 7 hours post vaccine, I had very runny nose, thick clear  mucus kept coming out of my nose. I felt feverish although my temperature is within normal limits. I had a mild headache and very sore arm on the vaccine site, body aches and malaise which I know are part of the list of side effects I would experience post vaccine, but then about midnight, I developed a huge rash or hive near my left armpit. Then, on Sunday, 12/20/2020, more big hives appeared on my body and my left hand is very itchy and the palm looked red and more swollen than my right hand. I took some antihistamine and notified my doctor via an e-mail. He told me to take diphenhydramine 50 mg every 6 hours. The hives are still present and much bigger and appear in more areas of my body.
Age: 31.0
Sex: F
Vaccine: ANTH
Symptoms: Injection site reaction
Clinical narrative: Local site reaction developed within 24 hrs after receiving the vaccine.   Seen about 2 days after the vaccine, it began to fade.  No medications or other treatments given.  Advised patient to follow up if desired.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Palpitations, Pruritus, Supraventricular tachycardia
Clinical narrative: Around 1230pm I started to itch, then got nausea, then felt palpitations, checked my own heart rate using and I watch and heart rate was on svt with a rate of 160. I held my breath and heart rate came down after 5 min to a rate of 80 Sinus rhythm.
Age: 31.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Cold sweat, Dyspnoea, Heart rate increased, Nausea, Pruritus
Clinical narrative: Rapid heart beat, difficulty breathing, itching, rash, clamminess, cold sweats, nausea
Age: 31.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Rash
Clinical narrative: Rapid heart beat, difficulty breathing, itching, rash, clamminess, cold sweats, nausea
Age: 31.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Dry mouth, Dyspnoea, Heart rate increased, Hyperhidrosis
Clinical narrative: Rapid heart beat, difficulty breathing, itching, rash, clamminess, cold sweats, nausea
Age: 31.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Nausea, Pallor, Palpitations, Peripheral coldness
Clinical narrative: Rapid heart beat, difficulty breathing, itching, rash, clamminess, cold sweats, nausea
Age: 31.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Cold sweat, Dyspnoea, Heart rate increased, Nausea, Pruritus
Clinical narrative: pt c/o heart racing and very sweaty as per patient description. Heat rate was 134. She was c/o nausea. put patient in relining position especially when she c/o of difficulty breathing. Pulse was rapid and faint. Hands cold and pale. She also c/o dry mouth. Called Ambulance at approx at 2:20. Stayed with employee until ambulance arrived and transported. HR down to approx 122 by the time ambulance arrive.
Age: 31.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Rash
Clinical narrative: pt c/o heart racing and very sweaty as per patient description. Heat rate was 134. She was c/o nausea. put patient in relining position especially when she c/o of difficulty breathing. Pulse was rapid and faint. Hands cold and pale. She also c/o dry mouth. Called Ambulance at approx at 2:20. Stayed with employee until ambulance arrived and transported. HR down to approx 122 by the time ambulance arrive.
Age: 31.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Dry mouth, Dyspnoea, Heart rate increased, Hyperhidrosis
Clinical narrative: pt c/o heart racing and very sweaty as per patient description. Heat rate was 134. She was c/o nausea. put patient in relining position especially when she c/o of difficulty breathing. Pulse was rapid and faint. Hands cold and pale. She also c/o dry mouth. Called Ambulance at approx at 2:20. Stayed with employee until ambulance arrived and transported. HR down to approx 122 by the time ambulance arrive.
Age: 31.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Nausea, Pallor, Palpitations, Peripheral coldness
Clinical narrative: pt c/o heart racing and very sweaty as per patient description. Heat rate was 134. She was c/o nausea. put patient in relining position especially when she c/o of difficulty breathing. Pulse was rapid and faint. Hands cold and pale. She also c/o dry mouth. Called Ambulance at approx at 2:20. Stayed with employee until ambulance arrived and transported. HR down to approx 122 by the time ambulance arrive.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Urticaria
Clinical narrative: About 1 1/2 hour after injection, one hive appeared on face.  Face and arm, head itchy.  No rash.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Hyperhidrosis, Myalgia, Pyrexia
Clinical narrative: Fever of 101.2F. Cold chills. sweats. Muscle aches. Headache. Lasted for 14 hours and treated with OTC tylenol and advil.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: Patient reported felling light headed and dizzy after vaccination. Immunizer questioned patient as to last known meal. Patient had not eaten breakfast. Given orange juice and a light snack. Side effects subsided within 20 minutes and patient was able to return to work. Immunization given under emergency protocol. Patient is a healthcare worker in a long term care facility. Was able to resume normal duties after being monitored by immunizing staff.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: redness, swelling and pain at injection site
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Pain, Pyrexia
Clinical narrative: Fever 102' Chills Body Aches Fatigue
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: redness, swelling and itching at injection site
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Tremor
Clinical narrative: Pfizer-BioNTech COVID-19 Vaccine EUA: Shortly after receiving Pfizer-BioNTech COVID-19 vaccine patient experienced dizziness and "shakiness" in extremities. No hives, no swelling, no shortness of breath, no chest pain, no loss of consciousness, no numbness, and no tingling noted at any time. Initial vital signs: blood pressure 140/78 mmHg, temperature 98.7 degrees Fahrenheit, pulse 106 beats per minute, respiratory rate 20 breaths per minute, oxygen saturation 98% on room air. Repeat vitals 14 minutes later: blood pressure 125/88 mmHg, temperature 98.6 degrees Fahrenheit, pulse 110 beats per minute, repiratory rate 18 breaths per minute, oxygen saturation 98% on room air. Thirty minutes after repeat vitals assessed patient stated they felt much better and able to leave clinic ambulatory with a steady gait. Patient was awake alert and oriented the entire time.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature increased, Chills, Feeling cold, Feeling hot, Flushing
Clinical narrative: Woke up this morning around 5:30 with chills, could not get warm, took temperature around 6:30-100.4, right side of the throat is slightly scratchy, took temperature again at 7:15am- 99.7, feel very flushed and warm, starting drinking water and took Tylenol
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Throat irritation
Clinical narrative: Woke up this morning around 5:30 with chills, could not get warm, took temperature around 6:30-100.4, right side of the throat is slightly scratchy, took temperature again at 7:15am- 99.7, feel very flushed and warm, starting drinking water and took Tylenol
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Chest X-ray, Chills, Diarrhoea, Full blood count, Hypersensitivity
Clinical narrative: About 1-2 hours after receiving the vaccine, I began to have tongue Hb and throat swelling?mild to moderate. About 3-4 hours later, I had one episode of diarrhea, followed by chills and palpitations. I took Benadryl and Zantac around 8P.  When I woke up in the morning, I still had tongue and throat swelling (no trouble breathing), so went to the ER and was treated for an allergic reaction with IV Benadryl, Solumedrol, and Pepcid.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Metabolic function test, Palpitations, Pharyngeal swelling, Swollen tongue
Clinical narrative: About 1-2 hours after receiving the vaccine, I began to have tongue Hb and throat swelling?mild to moderate. About 3-4 hours later, I had one episode of diarrhea, followed by chills and palpitations. I took Benadryl and Zantac around 8P.  When I woke up in the morning, I still had tongue and throat swelling (no trouble breathing), so went to the ER and was treated for an allergic reaction with IV Benadryl, Solumedrol, and Pepcid.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Hypoaesthesia, Impaired work ability, Injection site pain
Clinical narrative: Employee had tingling and numbness in arm a few minutes after injection.  This improved within 30 she left the clinic at 40 minutes post vaccine injection.  While driving home employee reports having a sudden onset of headache, palpitations and thick speech.  Her sister with whom she was taking on the phones told her that her  speech sounded strange.  Employee had pulled over and called 911.  EMS spent time with her and her symptoms subsided so they released her to her own care.  She went home and noted nausea, chills then had the onset of a migraine.  She took po Benadryl thinking this would help if she was having an allergic reaction.  Employee reports feeling achy and chilled so missed work on Saturday.  Sunday she was well enough to report to work.  Monday upon checking in with this employee she reports mild soreness at injection site, otherwise no residual symptoms
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Migraine, Nausea, Pain, Palpitations, Paraesthesia
Clinical narrative: Employee had tingling and numbness in arm a few minutes after injection.  This improved within 30 she left the clinic at 40 minutes post vaccine injection.  While driving home employee reports having a sudden onset of headache, palpitations and thick speech.  Her sister with whom she was taking on the phones told her that her  speech sounded strange.  Employee had pulled over and called 911.  EMS spent time with her and her symptoms subsided so they released her to her own care.  She went home and noted nausea, chills then had the onset of a migraine.  She took po Benadryl thinking this would help if she was having an allergic reaction.  Employee reports feeling achy and chilled so missed work on Saturday.  Sunday she was well enough to report to work.  Monday upon checking in with this employee she reports mild soreness at injection site, otherwise no residual symptoms
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Speech disorder
Clinical narrative: Employee had tingling and numbness in arm a few minutes after injection.  This improved within 30 she left the clinic at 40 minutes post vaccine injection.  While driving home employee reports having a sudden onset of headache, palpitations and thick speech.  Her sister with whom she was taking on the phones told her that her  speech sounded strange.  Employee had pulled over and called 911.  EMS spent time with her and her symptoms subsided so they released her to her own care.  She went home and noted nausea, chills then had the onset of a migraine.  She took po Benadryl thinking this would help if she was having an allergic reaction.  Employee reports feeling achy and chilled so missed work on Saturday.  Sunday she was well enough to report to work.  Monday upon checking in with this employee she reports mild soreness at injection site, otherwise no residual symptoms
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Feeling hot, Headache, Hypertension, Tachycardia
Clinical narrative: Patient developed sudden onset of headache with hypertension (BP 205/112), tachycardia (HR 137), redness and hives around 10 minutes after receiving the Pfizer covid vaccine (time 1600). She described "feeling a wave of heat climbing from her feet up to her face". 911 called and patient was transported to ER at around 1630. Upon arrival her BP trended down to 129/89 with HR of 78. She did not report difficulty breathing, and she did not receive additional medications while in ER. She was monitored for around 2 hours and discharged at 1847.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Patient developed sudden onset of headache with hypertension (BP 205/112), tachycardia (HR 137), redness and hives around 10 minutes after receiving the Pfizer covid vaccine (time 1600). She described "feeling a wave of heat climbing from her feet up to her face". 911 called and patient was transported to ER at around 1630. Upon arrival her BP trended down to 129/89 with HR of 78. She did not report difficulty breathing, and she did not receive additional medications while in ER. She was monitored for around 2 hours and discharged at 1847.
Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Injection site pain, Myalgia, Pyrexia, SARS-CoV-2 antibody test negative
Clinical narrative: Pfizer-BioNTech COVID-19 Vaccine EUA Woke up 12/21 feeling feverish, fatigued, and myalgia, as well as injection site soreness, got worse in the afternoon, peaked around 6pm but started to improve in the evening. Completely gone the following morning 12/22. No treatment taken
Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test negative
Clinical narrative: Pfizer-BioNTech COVID-19 Vaccine EUA Woke up 12/21 feeling feverish, fatigued, and myalgia, as well as injection site soreness, got worse in the afternoon, peaked around 6pm but started to improve in the evening. Completely gone the following morning 12/22. No treatment taken
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Flushing, Hyperhidrosis
Clinical narrative: Within 1-2 minutes of vaccination, pt felt flushing. He sat down in waiting room. He started to sweat and felt dizzy. Pt requested help. He was brought back to medical room. Pt laid down for 5 minutes and felt better. He ate a snack and drank some water. BP was 162/102 initially. BP was 144/96 after 13 minutes.  Pt states he has had similar reactions after giving blood.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature increased, Chills, Feeling abnormal, Headache
Clinical narrative: Started to have more and more soreness at injection site after administration. Then soreness turned into muscle and joint pain. After about 6-7 hrs from injection time started to feel really bad. I took an Advil before trying to lay down. Was unable to sleep, started getting chills and headache. I took my temperature and it was 102.4. I then took some Tylenol and put some wet clothes on. Temp stayed at 102.4 for a few hours and then finally broke. My temperature went down to 101.4 and stayed there for awhile and now is 99.2.  Feeling better than I was, still have severe  headache and  soreness in body.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Myalgia, Pain, Sleep disorder
Clinical narrative: Started to have more and more soreness at injection site after administration. Then soreness turned into muscle and joint pain. After about 6-7 hrs from injection time started to feel really bad. I took an Advil before trying to lay down. Was unable to sleep, started getting chills and headache. I took my temperature and it was 102.4. I then took some Tylenol and put some wet clothes on. Temp stayed at 102.4 for a few hours and then finally broke. My temperature went down to 101.4 and stayed there for awhile and now is 99.2.  Feeling better than I was, still have severe  headache and  soreness in body.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Decreased appetite, Fatigue, Headache
Clinical narrative: Woke up with fever, chills, muscle aches, joint pain, headache, fatigue. Nausea, loss of appetite. treated with Tylenol which controlled fever. Slept a lot.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Hypersomnia, Myalgia, Nausea, Pyrexia
Clinical narrative: Woke up with fever, chills, muscle aches, joint pain, headache, fatigue. Nausea, loss of appetite. treated with Tylenol which controlled fever. Slept a lot.
Sex: F
Vaccine: HPV4
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: place of injection went a little red and a little turgid; place of injection went a little red and a little turgid; the injector injected it in my subcutaneous behind my arm wrongly; This spontaneous report was received from a 22-year-old female patient, who referred to herself. No information regarding the patient's concurrent conditions, medical history, drug reactions or allergies and concomitant medications was provided.  On 26-NOV-2020, the patient was vaccinated with last dose (the third one) of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) subcutaneous in an unspecified arm (exact dose, lot number, expiration date were not reported) for prophylaxis.  On 27-NOV-2020, after about 24 hours, the place of injection went a little red (injection site erythema) and little turgid (injection site swelling). The patient wanted to know if the vaccine injected subcutaneously (she was not sure, if the needle touched the muscle or not, because the injector injected it angular) would it effect and if it would be ok for her to inject one more vaccine extra for being sure. The outcome of the events was unknown.  The relatedness between the events and quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) was not reported.
Age: 8.0
Sex: U
Vaccine: HEP
Symptoms: Incorrect dose administered, Product administered to patient of inappropriate age
Clinical narrative: two children age 8 and 9 were given RECOMBIVAX HB 1.0ml dose inadvertently; two children age 8 and 9 were given RECOMBIVAX HB 1.0ml dose inadvertently; This spontaneous report was received from a consumer referring to a 8 year old patient of unknown gender. There was no information about the patient's concurrent conditions, drug reactions, allergies, medical history, and concomitant therapies provided.     On 09-OCT-2020, the patient was vaccinated with hepatitis b vaccine (recombinant) (RECOMBIVAX HB) 1.0ml dose inadvertently (lot # T016182 with expiration date  25-JAN-2023; route was not reported) for prophylaxis (incorrect dosage administered and product administered to patient of inappropriate age).  This is one of the two reports received from the same reporter.; Sender's Comments:  US-009507513-2012USA009082:
Sex: U
Vaccine: VARZOS
Symptoms: Cardiovascular disorder, Pleurisy, Respiratory tract infection viral
Clinical narrative: acute cardiovascular event; pleurisy; viral respiratory infection; This spontaneous report was received from a lawyer referring to a patient of unknown age and gender.   The patient's relevant medical history, drug reactions/allergies and concomitant medication were not reported. In or around 12-DEC-2017, the patient was vaccinated with zoster vaccine live(ZOSTAVAX) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster) (lot number and expiration date were not reported). Shortly after receiving zoster vaccine live(ZOSTAVAX) vaccine, Plaintiff suffered an acute cardiovascular event, which was associated with a viral respiratory infection and pleurisy.  As a direct and proximate result, Plaintiff's symptoms have resulted in physical limitations, mental and emotional distress due to resulting physical limitations and seriousness of his condition, severe and permanent personal injuries. Further, as a tragic consequence the Plaintiff 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.  Upon internal review acute cardiovascular event was considered a medically significant event.
Sex: U
Vaccine: VARZOS
Symptoms: Deafness, Facial paralysis, Facial paresis, Hypoaesthesia, Tooth disorder
Clinical narrative: hearing loss; Bell's Palsy; dental issues; This spontaneous report was received from a lawyer referring to a patient of unknown age and gender.   The patient's relevant medical history, drug reactions/allergies and concomitant medication were not reported. In or around 09-AUG-2012, the patient was vaccinated with zoster vaccine live(ZOSTAVAX) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster) (lot number and expiration date were not reported). Shortly after receiving zoster vaccine live(ZOSTAVAX) vaccine, Plaintiff suffered left facial weakness and numbness and was diagnosed with acute Bell's Palsy. Plaintiff also suffered hearing loss and dental issues as a result of his suffering Bell's Palsy.  As a direct and proximate result, Plaintiff's symptoms have resulted in physical limitations, mental and emotional distress due to resulting physical limitations and seriousness of his condition, severe and permanent personal injuries. Further, as a tragic consequence the Plaintiff 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.  Upon internal review, Bell's Palsy and hearing loss were considered a medically significant event.
Sex: U
Vaccine: VARZOS
Symptoms: Rash, Rash vesicular
Clinical narrative: varicella type rash; This spontaneous report was received from a lawyer referring to a patient of unknown age and gender. The patient's relevant medical history, drug reactions/allergies and concomitant medication were not reported. In or around 15-DEC-2017, the patient was vaccinated with zoster vaccine live(ZOSTAVAX) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster) (lot number and expiration date were not reported). Shortly after receiving zoster vaccine live(ZOSTAVAX) vaccine, Plaintiff suffered a painful varicella type rash on his arm. As a direct and proximate result, Plaintiff's symptoms have resulted in physical limitations, mental and emotional distress due to resulting physical limitations and seriousness of his condition, severe and permanent personal injuries. Further, as a tragic consequence the Plaintiff 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.  Upon internal review, the event was considered as disabling.
Age: 65.0
Sex: U
Vaccine: VARZOS
Symptoms: Cardiovascular disorder, Pneumonia
Clinical narrative: pneumonia; cardiovascular issues; Information has been received from a lawyer regarding a case in litigation referring to a patient (pt) of unknown age or gender. The pt's concurrent conditions, medical history and concomitant medications were not reported. On or about 22-SEP-2016 (at approximately 65 years old), the pt was inoculated with zoster vaccine live (ZOSTAVAX) (dosage regimen, route of administration, anatomical location, lot number and expiration date were not provided) at a pharmacy for the long-term prevention of shingles and zoster-related conditions. Subsequently, the pt was treated by a health care provider for the following injuries resulting from the zoster vaccine live (ZOSTAVAX) use: pneumonia and cardiovascular issues. The outcome of the claimed events was not provided, and causal relationship was reported as related to zoster vaccine live (ZOSTAVAX).  Upon internal review, pneumonia was determined to be medically significant event.
Age: 1.67
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No additional AEs reported.; Caller is a pharmacist reporting that he was informed a 20 month old received a dose of PROQUAD and VARIVAX.; This spontaneous report was received from a pharmacist, referring to 20-months-old patient, of unknown gender. The patient's pertinent medical history, current conditions, previous drug reactions or allergies and concomitant medications were not reported.   On 15-DEC-2020, the patient received a dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) and varicella virus vaccine live (oka/merck) (VARIVAX) (formulations, strengths, vaccination schemes, routes of administration, anatomical sites of vaccination, lot numbers and expiration dates were not provided) (inappropriate schedule of product administration), both vaccines were administered as prophylaxis. No additional adverse events were reported.
Sex: U
Vaccine: MMRV
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE reported.; The vaccine expired on December 1, 2020 and was administered on December 14, 2020.; This spontaneous report was received from a registered nurse, referring to a patient of unknown age and gender. The patient's pertinent medical history, current conditions, previous drug reactions or allergies and concomitant medications were not provided.    On 14-DEC-2020, the patient was vaccinated with an expired dose (expired product administered) of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD), at a dose of 0.5 milliliter (ml), as prophylaxis (formulation, strength, vaccination scheme, route of administration and anatomical site of vaccination were not provided; lot number S017250 which has been verified to be valid, expiration date reported and validated as 01-DEC-2020). No additional adverse events were reported.
Sex: M
Vaccine: PPV
Symptoms: Influenza like illness, Pain, Reaction to preservatives, Vomiting
Clinical narrative: vomiting; Flu-vaccine produces the same results, and attributes that to the preservatives; flu-like symptoms (body aches, being in bed for 3 days); This spontaneous report was received from a 71 year old male patient with hypertension and drug allergy (tramadol hydrochloride), reporting on himself.    No information was provided regarding patient's medical history.  Concomitant therapies included verapamil and unspecified beta blockers.     On approximately 2014 (reported as "in either 2014 or 2015"), the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) for pneumonia (dose, route and site of administration, lot number and expiration date were not reported).       The patient reported having flu-like symptoms to include vomiting and body aches as well as being in bed for 3 days.  The patient did not seek medical attention, none lab diagnostic test were performed and did not received any treatment for the events.  The outcome of influenza like illness, vomiting and reaction to preservatives was unknown.   The reporter stated that the flu vaccine produced the same results and considered the events attributable to the preservatives.  The reporter considered the events to be disabling.
Sex: M
Vaccine: HEP
Symptoms: Hepatitis B antibody negative
Clinical narrative: blood titer were drawn and showed "non-reactive" for RECOMBIVAX; This spontaneous report was received from a physician referring to a 21-year-old male patient. The patient had no concomitant medications, pertinent medical history or drug reactions/allergies.     In 1999, the patient was vaccinated with hepatitis b vaccine (recombinant) (RECOMBIVAX HB) (1 dosage form; strength, route, lot # and expiration date were not reported) on the recommended schedule when he was a child for prophylaxis.         On 10-DEC-2020, his blood titer was drawn and showed "non-reactive" for hepatitis b vaccine (recombinant) (RECOMBIVAX HB) (hepatitis b surface antibody negative). The patient saw the physician. The outcome of the event was unknown. The causality assessment was not reported.
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration, Product dose omission issue
Clinical narrative: missed the second dose of GARDASIL 9 today; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, drug reactions, allergies, medical history, and concomitant therapies provided.      On an unknown date, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) 1 dose (strength, route, lot # and expiration date were not reported) for prophylaxis. On 16-DEC-2020, the patient that missed the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) due to the schedule of a COVID 19 vaccine next week (inappropriate schedule of vaccine administered). The patient was told that they could not receive any other vaccines 2 weeks prior or 2 weeks after the injection of the COVID 19 vaccine.
Age: 18.0
Sex: F
Vaccine: HPV9
Symptoms: Vasculitis
Clinical narrative: vasculitis in toes; This spontaneous report was received from a consumer referring to her 18 years old daughter. The patient's concomitant therapy included vitamin d (unspecified). The patient had no pertinent medical history and no drug reactions/allergies.     On an unknown date in August 2020, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection (strength, dose, route, lot number and expiration date were not reported) for prophylaxis. On an unknown date in December 2020 (reported as approximately 2 weeks ago), 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) injection (strength, dose, route, lot number and expiration date were not reported) for prophylaxis.     On an unknown date in December 2020 (reported as approximately 2 weeks ago and a few days later), the patient developed vasculitis in toes. Treatment of unspecified antibiotics was given for the event. There was no lab diagnostics. The outcome of the event was not recovered (reported as worsening). The causality between the event and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was not provided.
Age: 66.0
Sex: U
Vaccine: VARZOS
Symptoms: Pneumonia
Clinical narrative: pneumonia; Information has been received from a lawyer regarding a case in litigation referring to a patient (pt) of unknown age or gender. The pt's concurrent conditions, medical history and concomitant medications were not reported. On or about 02-FEB-2016 (at approximately 66 years old), the pt was inoculated with zoster vaccine live (ZOSTAVAX) (dosage regimen, route of administration, anatomical location, lot number and expiration date were not provided) at a pharmacy for the long-term prevention of shingles and zoster-related conditions. Subsequently, the pt was treated by health care providers for the following injury resulting from the zoster vaccine live (ZOSTAVAX) use: pneumonia. The outcome of the claimed event was not provided, and causal relationship was reported as related to zoster vaccine live (ZOSTAVAX).  Upon internal review, pneumonia was determined to be medically significant event.
Age: 4.0
Sex: U
Vaccine: MMRV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Per caller, patient did not have any adverse reactions.; Nurse calling from HCP office to report that a duplicate dose of PROQUAD was accidentally administered to a 4 year old patient on 8/20/2020 that had already received their dose on 12/16/2019.; This spontaneous report was received from a nurse, referring to a 4-year-old patient of unknown gender. The patient's pertinent medical history, current conditions, previous drug reactions or allergies and concomitant medications were not reported.   On 16-DEC-2019, the patient received the first dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (formulation, strength, vaccination scheme, route of administration, anatomical site of vaccination, lot number and expiration date were not provided); on 20-AUG-2020, the patient accidentally received a duplicate dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD), at a dose of 0.5 milliliter (ml) (formulation, strength, vaccination scheme, route of administration and anatomical site of vaccination were not reported, lot number S005880, which has been verified to be valid, expiration date reported and validated as 25-AUG-2020), due to the first dose did not show up in the recording system for vaccines which was the reason for duplicate administration (duplicate therapy error), both vaccines were administered as prophylaxis. The caller reported that, the patient did not experience any adverse reaction (no adverse event).
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: The patient did not report any additional AEs; MMR II and VARIVAX were both given IM instead of SubQ; This spontaneous report was received from a pharmacist, referring to a male patient of unknown age. The patient's pertinent medical history, concurrent conditions, concomitant medications, previous drug reactions, or allergies were not reported.  On 16-DEC-2020, the patient was vaccinated with one dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) injection and with one dose of varicella virus vaccine live (oka/merck) (VARIVAX) injection (strengths, vaccination schemes and anatomical sites of injection were not reported; lot numbers and expiration dates were unknown by the reporter), both therapies intramuscularly as prophylaxis (incorrect route of product administration). The patient did not report any additional adverse effects (AE).
Age: 18.0
Sex: F
Vaccine: PPV
Symptoms: Anaphylactic reaction, Chest discomfort, Throat irritation, Wheezing
Clinical narrative: patient had an anaphylactic reaction to the PNEUMOVAX23 vaccine/ Caller states that within 1 hour, her throat, was itchy, she experienced chest heaviness/ tightness, wheezing upon examination; This spontaneous report was received from a physician referring to a 18-year-old female patient. The patient's pertinent concurrent conditions, medical history, concomitant medications and previous drug reactions were unknown by the reporter.  On 06-JAN-2016, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) 1 time dose as vaccination (prophylaxis); lot number L035687 and expiration date was not reported, but upon internal validation established as 16-FEB-2017 (strength, number of administered dose, route of administration and anatomical location were not reported).    On the same date, whit in an hour of vaccination, the patient's throat was itchy, also, she experienced chest heaviness/ tightness and wheezing upon examination which was also reported as anaphylactic reaction to pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23), the patient sought medical attention and a dose of epinephrine hydrochloride (EPIPEN) was given as treatment, it was unknown by the reporter if any laboratory diagnostic or studies were performed.  On an unspecified date in January 2016, the patient recovered from anaphylactic reaction (reported as she did better).   The causality between the event anaphylactic reaction and Pneumococcal Vaccine, Polyvalent (23-valent)(PNEUMOVAX23) was considered related.  Upon internal review, the event anaphylactic reaction was considered medically significant. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: L035687; expirationdate: 16-FEB-2017; deviceage and unit: 0; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not suggest a causal association with the device or device constituent
Age: 9.0
Sex: U
Vaccine: HEP
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: two children age 8 and 9 were given RECOMBIVAX HB 1.0ml dose inadvertently; two children age 8 and 9 were given RECOMBIVAX HB 1.0ml dose inadvertently; This spontaneous report was received from a consumer referring to a 9 year old patient of unknown gender. There was no information about the patient's concurrent conditions, drug reactions, allergies, medical history, and concomitant therapies provided.     On 09-OCT-2020, the patient was vaccinated with hepatitis b vaccine (recombinant) (RECOMBIVAX HB) 1.0ml dose inadvertently (lot # T016182 with expiration date 25-JAN-2023; route was not reported) for prophylaxis (incorrect dosage administered and product administered to patient of inappropriate age).  This is one of the two reports received from the same reporter.; Sender's Comments:  US-009507513-2012USA005693:
Age: 21.0
Sex: M
Vaccine: RAB
Symptoms: COVID-19, Dyspnoea, Myalgia, SARS-CoV-2 test positive
Clinical narrative: tested positive for Covid-19; muscle ache; shortness of BREATH; This case was reported by a nurse via licensee and described the occurrence of coronavirus test positive in a 21-year-old male patient who received Rabies NVS (RabAvert) for prophylaxis.   Co-suspect products included rabies vaccine needle device (Rabavert Needle Device) injection needle for prophylaxis and rabies vaccine pre-filled syringe device (Rabavert Pre-Filled Syringe Device) injection syringe for prophylaxis.   Concomitant products included Rabies NVS (RabAvert).   On 9th November 2020, the patient received the 2nd dose of RabAvert, Rabavert Needle Device and Rabavert Pre-Filled Syringe Device. On 21st November 2020, 12 days after receiving RabAvert, Rabavert Needle Device and Rabavert Pre-Filled Syringe Device and an unknown time after receiving RabAvert, the patient experienced muscle pain and shortness of breath. On 22nd November 2020, the patient experienced coronavirus test positive. On an unknown date, the outcome of the coronavirus test positive, muscle pain and shortness of breath were unknown.   It was unknown if the reporter considered the coronavirus test positive, muscle pain and shortness of breath to be related to RabAvert, Rabavert Needle Device and Rabavert Pre-Filled Syringe Device.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The patient getting pre-exposure immunization with Rabavert tested positive for COVID-19.  The patient had the 1st dose of Rabavert on 2nd November 2020. The patient started presenting symptoms muscle ache and shortness of breath last Saturday (21st November 2020) and tested positive for COVID-19 on 22nd November 2020. Next dose was scheduled for Saturday. The patient must now need to remain isolated, quarantined. The reporter asked if they postpone the dose meant for day 28 or if there was a problem or what happens if they vaccine a few days later
Sex: U
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Myalgia, Pain
Clinical narrative: muscle aches; headache; tiredness; aches; This case was reported by a consumer via interactive digital media and described the occurrence of myalgia in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 25th November 2020, the patient received Shingrix. On 26th November 2020, 1 days after receiving Shingrix, the patient experienced myalgia, headache, tiredness and pain. On an unknown date, the outcome of the myalgia, headache, tiredness and pain were not recovered/not resolved.   It was unknown if the reporter considered the myalgia, headache, tiredness and pain to be related to Shingrix.  Additional details were provided as follows: The age group was not reported but was selected as per the vaccine indication. The patient received the Shingrix shingle vaccine and felt muscle aches, headache and tiredness.  The reporter wanted to know was it safe to take Ibuprofen for the aches and headache.
Sex: U
Vaccine: FLUX
Symptoms: Unevaluable event
Clinical narrative: last flu vaccine sent me to the hospital; This case was reported by a consumer via interactive digital media and described the occurrence of hospitalization in a patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis.   On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season. On an unknown date, unknown after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced hospitalization (serious criteria hospitalization). On an unknown date, the outcome of the hospitalization was unknown.   It was unknown if the reporter considered the hospitalization to be related to Influenza vaccine Quadrivalent unspecified season.  Additional information was provided as follows: The age at vaccination was not reported. The patient stated that if anyone dies from the vaccine its the fault of people like you. The last flu vaccine sent patient to the hospital.
Sex: F
Vaccine: VARZOS
Symptoms: Breast cancer female, Chemotherapy, Incomplete course of vaccination
Clinical narrative: Breast cancer; This case was reported by a consumer via interactive digital media and described the occurrence of breast cancer in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   In February 2020, the patient received the 1st dose of Shingrix. In March 2020, between 1 and 3 months after receiving Shingrix, the patient experienced breast cancer (serious criteria GSK medically significant). Shingrix was discontinued. On an unknown date, the outcome of the breast cancer was unknown.   It was unknown if the reporter considered the breast cancer to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. It was reported that patient received 1st dose of shingrix in February 2020 and in March 2020 patient was dignosed with breast cancer. The patient stated that not received the 2nd dose due to chemotherapy.
Age: 90.0
Sex: F
Vaccine: VARZOS
Symptoms: Back pain, Gait inability, Headache, Mobility decreased, Muscular weakness
Clinical narrative: Uses a walker / Can't walk today; Legs / extremely painful.; Back / extremely painful.; Bad headache; Could hardly get up; Her legs wouldn't hold her / Legs and back are weak; This case was reported by a consumer via call center representative and described the occurrence of headache in a 90-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of no adverse event (1st dose received in September 2020).   On 30th November 2020, the patient received the 2nd dose of Shingrix. On 30th November 2020, less than a day after receiving Shingrix, the patient experienced headache, mobility decreased and muscle weakness. On 1st December 2020, the patient experienced unable to walk, leg pain and back pain. The patient was treated with paracetamol (Tylenol). On an unknown date, the outcome of the headache was not recovered/not resolved and the outcome of the mobility decreased, muscle weakness, unable to walk, leg pain and back pain were unknown.   It was unknown if the reporter considered the headache, mobility decreased, muscle weakness, unable to walk, leg pain and back pain to be related to Shingrix.  Additional details were provided as follows: The patient had no problems after her first Shingrix shot. The patient had her second Shingrix shot in right arm a day before reporting and that night she got up to get Tylenol for a bad headache and she could hardly get up, her legs would not hold her. The patient used a walker and she can not walk on the day of reporting, her legs and back were weak and extremely painful. The reporter consented to follow up.