chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Condition aggravated, Dizziness, Dizziness postural, Fall, Feeling abnormal
Clinical narrative: presented at the clinic for a booster shot of Moderna after his initial Jannsen vaccine. He received the Moderna Booster vaccine (lot 037F21A) to the LD at 1333 and experienced what appeared to be a vasovagal event while seated in the vaccination chair immediately after his vaccine. MAOlga Torreblanca alerted this writer, RN. Mr. presented with diaphoresis and pallor, was slumped in the chair, and was unresponsive to touch or verbal stimuli for approximately 30-40 seconds.  He recovered spontaneously and reported that he felt a touch dizzy. He also reported that he was very anxious before the vaccine and that he has an extensive history of vasovagal events after vaccination or blood draws. His vital signs at 1340 were: BP sitting 110/60, HR was 72, and SPO2 was 98% on RA. At 1341, he transferred to the cot, rising from the chair without difficulty and walking with a steady gait. He accepted juice and ate a snack that he had brought with him. His pallor had improved and he was no longer diaphoretic at this point.  At 1348, he reported that he felt less dizzy and almost normal. At 1352, he attempted to sit at the edge of the cot, but reported that increased his dizziness and elicited a tingling sensation to his hands. Vital signs at this time were: BP 96/62 sitting, HR 81 and SPO2 99% on RA. He laid back down and continued to work on PO fluid intake. Both he and his wife reported that they were unsure what his baseline BP ,was.  At 1401, he denied dizziness or tingling sensations, but reported that he felt off. His VS at 1401 were: BP 100/60 laying with an HR of 68. By 1416, he was able to sit up and reported that he felt slightly better. Not quite as dizzy. Maybe 85-90% normal.? At 1418, his BP sitting was 102/66, HR was 60, and SPO2 was 99% on RA.  At 1420, he rose and stood without difficulty. His BP was 98/62 standing, HR 67, SPO2 was 99% RA. He walked a few steps without trouble and with a steady gait. At 1429, he was standing and reporting that he felt normal. His BP standing was 102/64, HR was 59, and SPO2 was 98% on RA.  Both Mr. and his wife were educated on vasovagal responses and when to seek medical care. His wife reports that she will drive them home and stay with Mr. to monitor him throughout the day. They exited the facility at 1429.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Hyperhidrosis, Immediate post-injection reaction, Interchange of vaccine products, Pallor, Paraesthesia
Clinical narrative: presented at the clinic for a booster shot of Moderna after his initial Jannsen vaccine. He received the Moderna Booster vaccine (lot 037F21A) to the LD at 1333 and experienced what appeared to be a vasovagal event while seated in the vaccination chair immediately after his vaccine. MAOlga Torreblanca alerted this writer, RN. Mr. presented with diaphoresis and pallor, was slumped in the chair, and was unresponsive to touch or verbal stimuli for approximately 30-40 seconds.  He recovered spontaneously and reported that he felt a touch dizzy. He also reported that he was very anxious before the vaccine and that he has an extensive history of vasovagal events after vaccination or blood draws. His vital signs at 1340 were: BP sitting 110/60, HR was 72, and SPO2 was 98% on RA. At 1341, he transferred to the cot, rising from the chair without difficulty and walking with a steady gait. He accepted juice and ate a snack that he had brought with him. His pallor had improved and he was no longer diaphoretic at this point.  At 1348, he reported that he felt less dizzy and almost normal. At 1352, he attempted to sit at the edge of the cot, but reported that increased his dizziness and elicited a tingling sensation to his hands. Vital signs at this time were: BP 96/62 sitting, HR 81 and SPO2 99% on RA. He laid back down and continued to work on PO fluid intake. Both he and his wife reported that they were unsure what his baseline BP ,was.  At 1401, he denied dizziness or tingling sensations, but reported that he felt off. His VS at 1401 were: BP 100/60 laying with an HR of 68. By 1416, he was able to sit up and reported that he felt slightly better. Not quite as dizzy. Maybe 85-90% normal.? At 1418, his BP sitting was 102/66, HR was 60, and SPO2 was 99% on RA.  At 1420, he rose and stood without difficulty. His BP was 98/62 standing, HR 67, SPO2 was 99% RA. He walked a few steps without trouble and with a steady gait. At 1429, he was standing and reporting that he felt normal. His BP standing was 102/64, HR was 59, and SPO2 was 98% on RA.  Both Mr. and his wife were educated on vasovagal responses and when to seek medical care. His wife reports that she will drive them home and stay with Mr. to monitor him throughout the day. They exited the facility at 1429.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Presyncope, Unresponsive to stimuli
Clinical narrative: presented at the clinic for a booster shot of Moderna after his initial Jannsen vaccine. He received the Moderna Booster vaccine (lot 037F21A) to the LD at 1333 and experienced what appeared to be a vasovagal event while seated in the vaccination chair immediately after his vaccine. MAOlga Torreblanca alerted this writer, RN. Mr. presented with diaphoresis and pallor, was slumped in the chair, and was unresponsive to touch or verbal stimuli for approximately 30-40 seconds.  He recovered spontaneously and reported that he felt a touch dizzy. He also reported that he was very anxious before the vaccine and that he has an extensive history of vasovagal events after vaccination or blood draws. His vital signs at 1340 were: BP sitting 110/60, HR was 72, and SPO2 was 98% on RA. At 1341, he transferred to the cot, rising from the chair without difficulty and walking with a steady gait. He accepted juice and ate a snack that he had brought with him. His pallor had improved and he was no longer diaphoretic at this point.  At 1348, he reported that he felt less dizzy and almost normal. At 1352, he attempted to sit at the edge of the cot, but reported that increased his dizziness and elicited a tingling sensation to his hands. Vital signs at this time were: BP 96/62 sitting, HR 81 and SPO2 99% on RA. He laid back down and continued to work on PO fluid intake. Both he and his wife reported that they were unsure what his baseline BP ,was.  At 1401, he denied dizziness or tingling sensations, but reported that he felt off. His VS at 1401 were: BP 100/60 laying with an HR of 68. By 1416, he was able to sit up and reported that he felt slightly better. Not quite as dizzy. Maybe 85-90% normal.? At 1418, his BP sitting was 102/66, HR was 60, and SPO2 was 99% on RA.  At 1420, he rose and stood without difficulty. His BP was 98/62 standing, HR 67, SPO2 was 99% RA. He walked a few steps without trouble and with a steady gait. At 1429, he was standing and reporting that he felt normal. His BP standing was 102/64, HR was 59, and SPO2 was 98% on RA.  Both Mr. and his wife were educated on vasovagal responses and when to seek medical care. His wife reports that she will drive them home and stay with Mr. to monitor him throughout the day. They exited the facility at 1429.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Back pain, Impaired work ability, Injection site pain, Neuralgia, Pain
Clinical narrative: typical pain at injection site subsided in 2 days, followed 10 days after booster new pain at injection site spreading to upper back and arm approximately 6 inches diameter from injection site, especially upon waking in the morning, called in sick one day and took ibuprophen on 12th day, pain does not get worse but keeps spreading out slowly, by 14th day feeling nerve pain down left arm (like a tingling) that comes and goes, now on 18th day, pronounced sensation like pain upon waking every morning in a specific diameter from injection site, diameter increasing each day, approximately 9 inch diameter now, this only happens once upon waking, continued nerve pain down left arm that comes and goes, it is very disconcerting,
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Paraesthesia
Clinical narrative: typical pain at injection site subsided in 2 days, followed 10 days after booster new pain at injection site spreading to upper back and arm approximately 6 inches diameter from injection site, especially upon waking in the morning, called in sick one day and took ibuprophen on 12th day, pain does not get worse but keeps spreading out slowly, by 14th day feeling nerve pain down left arm (like a tingling) that comes and goes, now on 18th day, pronounced sensation like pain upon waking every morning in a specific diameter from injection site, diameter increasing each day, approximately 9 inch diameter now, this only happens once upon waking, continued nerve pain down left arm that comes and goes, it is very disconcerting,
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Chills, Malaise
Clinical narrative: Severe chest pain woke me up around 3 am on 11/11/21.  Chills.  My husband got me an aspirin.  I went back to sleep until about 8 am.  I didn't feel well all day but the chest pain was mostly gone.  11/12/21, today, I still had some mild chest pain.  I didn't contact my PCP.  This report wouldn't let me change the date from 11/13/21.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Computerised tomogram, Hypercalcaemia, Lymphadenectomy, Lymphadenopathy
Clinical narrative: elevated tropinin critical 30, hypercalcemia, critical, lymphadenopathy requiring resection
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Troponin increased
Clinical narrative: elevated tropinin critical 30, hypercalcemia, critical, lymphadenopathy requiring resection
Age: 55.0
Sex: F
Vaccine: COVID19, FLU4
Symptoms: Chills, Cough, Headache, Pain, Pyrexia
Clinical narrative: Within 5 hrs. started with body aches, then chills. Within 8hrs earlier symptoms continued with additional symptoms of headache, dry cough, worsening of aching/pain, fever 103°.  Symptoms lasted 4 days and stated to slowly resolve.  Took motrin 800 MG and alternated with Tylenol 1000 MG, cool compresses, Benadryl 50 MG throughout course of symptoms.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site rash, Myalgia
Clinical narrative: Day after my second dose I had terrible muscle aches that seems pretty common. (The next morning and all day)But what I looked up and said wasn?t common was the rash I developed on my arm around the injection site. That was a day and a half after the injection. Started this morning and still just as bad tonight. Not the end of the world of course, but I looked it up and said it was rare and maybe it?s just because People aren?t reporting it? So I wanted to report it. I didn?t have it the first dose either. Just second dose. Still glad I got the vaccine finally just want people to know that a rash is possible. It?s from top of should you almost my elbow.  Bigger bumps than my normal skin rashes I have had in the past. Injection site looks good itself.  A rash can be possible too.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Depression
Clinical narrative: Severe depression started on the second day of my symptoms. It has lessened with time but more than a month later, I?m still suffering from it daily.
Age: 12.0
Sex: M
Vaccine: COVID19
Symptoms: Anxiety, Heart rate increased, Pallor
Clinical narrative: On Friday, 11/12/21, client received his first dose of Pfizer Covid-19 vaccine (LOT #: FF8839) at 1:53 PM in his left deltoid. During assessment questions, client's father stated client's medical history included anemia, denied any allergic reactions and was to be a 15 minute observation. At 1:56 pm, while waiting in Observation Area, client stated to EMT, his heartbeat felt "stronger" after the 15 minutes of sitting down and receiving the vaccine. Vitals were started and taken every 5 minutes. At 1:00 PM: BP 128/72, HR 92, O2 sat 99%, RR 16. Client stated he ate breakfast at 6am and did not drink any water today. At 2:01 PM: BP 128/70, HR 86, O2 sat 99%, RR 16. Client stated he feels "normal" and client's mother stated to EMT that pallor is normal for him and that he normally has anxiety with vaccines. At 2:07 PM: BP 132/70, HR 96, O2 sat 100%, RR 14. Client feels "normal," denies headache, pain, feeling lightheaded. Client was offered a water bottle to which he drank the entire bottle. At 2:12: BP 128/70, HR 96, O2 sat 100%, RR 16. Client states he "feels good now," and stated he no longer is experiencing any symptoms. At 2:21 PM: BP 126/72, HR 85, O2 sat 100% and RR 16. Client states he feels "completely normal," with no symptoms. No further interventions needed. Client and his family was educated on when to call 911 and encouraged to consult with his pediatrician about this incident to make sure it is safe for him to receive his second dose. Client left vaccination site with a steady gait at 2:24 PM with his family.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Condition aggravated, Induration, Peripheral swelling, Pruritus
Clinical narrative: Arm swollen, hard, hot ... All joints had burning sensation, any with previous injury worse ... Skin felt raw and itchy
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Skin erosion, Skin warm
Clinical narrative: Arm swollen, hard, hot ... All joints had burning sensation, any with previous injury worse ... Skin felt raw and itchy
Age: 10.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Eye contusion, Eyelid oedema
Clinical narrative: An Eyelid Edema appeared (on the top lid and inner corner of his left eye) giving him the appearance of a black eye, though no injury occurred to cause it.
Age: 10.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Contusion
Clinical narrative: An Eyelid Edema appeared (on the top lid and inner corner of his left eye) giving him the appearance of a black eye, though no injury occurred to cause it.
Age: 12.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: Patient was administered the pediatric dose (0.2 mL) of Pfizer COVID vaccine but he is 12 years old and should have received the adult 12+ (0.3) dose.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Contusion, Fibrin D dimer, Impaired healing, Pain, Peripheral swelling
Clinical narrative: A vein in my arm ruptured. I went to urgent care the next day because I could raise my right arm without pain. The inside of my arm was black and blue and it was hot to touch. Given antibiotics in case of blood infection. Told was thrombophlebitis.  Arm took weeks to heal. Swelling and bruising spread from my elbow to my arm pit.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Skin discolouration, Skin warm, Thrombophlebitis, Ultrasound scan abnormal, Vein rupture
Clinical narrative: A vein in my arm ruptured. I went to urgent care the next day because I could raise my right arm without pain. The inside of my arm was black and blue and it was hot to touch. Given antibiotics in case of blood infection. Told was thrombophlebitis.  Arm took weeks to heal. Swelling and bruising spread from my elbow to my arm pit.
Age: 8.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Rash
Clinical narrative: Facial rash including ears.  Tiredness.
Age: 25.0
Sex: M
Vaccine: COVID19
Symptoms: Arthropod bite, Inflammation, Pruritus, Rash macular
Clinical narrative: Increased inflammatory reaction to mosquito bites  Random blotches of itchy skin recurring over months (started in October 2021
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Lip swelling, Urticaria
Clinical narrative: 1st Pfizer vaccine (had previously had Johnson & Johnson 4/10/2021).  Next day hives on neck and left antecubital with swelling of left upper lip and chest tightness.  No findings in arm directly at vaccination site.  Received antihistamines and epinephrine and steroids.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Injection site pain, Interchange of vaccine products, Joint range of motion decreased
Clinical narrative: I just wrote all this and the website timed out and deleted it all. ARGH!!! Starting over... I noted that the injection was very high up on my arm, and that it hurt more than the flu vaccine I had a month or two ago, and more than the J&J vaccine did. Not terrible, but I felt it more. But the soreness quickly got pretty bad. Around 9:30 I noted I could hardly move my left arm around much without significant, wincing pain. That night I didn't sleep well. Thursday I woke up early and tired, and my arm had very limited range of motion and it has stayed that way. Thur night I again didn't sleep that well and woke up early and tired. I lay in bed and googled shoulder pain after vaccine, and learned about SIRVA. It sounded exactly like my symptoms. I have a very slender, runner's build and for whatever reason I think they injected it into the bursa or some other area of my arm, and not the deltoid muscle. My arm can be down at my side with no pain. I can type this with both hands, with maybe a 1 on the pain scale, close to nothing. That's because the angle of my shoulder is pretty close to the angle of rest. But if I try to reach up for something, I can't go past my hair with my hand. And going across my body, I can't go more than 2" past my right bicep with my left hand. It hurts to get dressed and undressed. It's hard to put on or take off my hat or face covering when I go outside or back inside. I'd say I have about 30-35% of normal range of motion in my left arm/shoulder.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Loss of personal independence in daily activities, Pain, Poor quality sleep
Clinical narrative: I just wrote all this and the website timed out and deleted it all. ARGH!!! Starting over... I noted that the injection was very high up on my arm, and that it hurt more than the flu vaccine I had a month or two ago, and more than the J&J vaccine did. Not terrible, but I felt it more. But the soreness quickly got pretty bad. Around 9:30 I noted I could hardly move my left arm around much without significant, wincing pain. That night I didn't sleep well. Thursday I woke up early and tired, and my arm had very limited range of motion and it has stayed that way. Thur night I again didn't sleep that well and woke up early and tired. I lay in bed and googled shoulder pain after vaccine, and learned about SIRVA. It sounded exactly like my symptoms. I have a very slender, runner's build and for whatever reason I think they injected it into the bursa or some other area of my arm, and not the deltoid muscle. My arm can be down at my side with no pain. I can type this with both hands, with maybe a 1 on the pain scale, close to nothing. That's because the angle of my shoulder is pretty close to the angle of rest. But if I try to reach up for something, I can't go past my hair with my hand. And going across my body, I can't go more than 2" past my right bicep with my left hand. It hurts to get dressed and undressed. It's hard to put on or take off my hat or face covering when I go outside or back inside. I'd say I have about 30-35% of normal range of motion in my left arm/shoulder.
Age: 33.0
Sex: F
Vaccine: UNK
Symptoms: Arthralgia, Headache, Lymphadenopathy, Myalgia
Clinical narrative: Swollen glands. Sore muscles, headache. Joint pain
Age: 23.0
Sex: M
Vaccine: COVID19
Symptoms: Extra dose administered, Inappropriate schedule of product administration
Clinical narrative: Medication error- Booster dose of Moderna COVID vaccine was due 12/05/2021.  Booster dose was given 11/12/2021
Sex: U
Vaccine: PPV
Symptoms: Inappropriate schedule of product administration, Wrong product administered
Clinical narrative: No additional AE reported; The nurse reports that the consumer also received a dose of PNEUMOVAX 23 about 2 years ago; a dose of PNEUMOVAX 23 was inadvertently administered instead of PREVNAR 13; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, allergies, drug reactions, concomitant therapies or medical history provided. On 13-OCT-2021, the patient was inadvertently administered pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) (lot#T040202 verified as valid, expiration date: 11-SEP-2022) in dose 0.5 ml for prophylaxis (route of administration and anatomical location were not reported). The vaccine was administered inadvertently, instead of pneumococcal vaccine conj 13v (crm197) (PREVENAR 13) (wrong product administered). The nurse reported that the patient also received a dose of pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) about 2 years ago, on an unspecified date in approximately 2019 (inappropriate schedule of product administration). No additional adverse events were reported. The outcome of the events was unknown.
Sex: F
Vaccine: FLUX, HEPA, IPV
Symptoms: No adverse event, Product storage error
Clinical narrative: no additional adverse experience; VAQTA vaccine which underwent a supported temperature excursion; This spontaneous report was received from a healthcare worker and refers to a 10-year-old female patient. The patient's concomitant medications included unspecified influenza and polio vaccine. No information regarding the patient's concurrent conditions, medical history, drug reactions or allergies was provided.  On 07-OCT-2021, the patient was vaccinated with a dose of improperly stored hepatitis a vaccine, inactivated (VAQTA), intramuscularly to the right deltoid, lot # T037329 , expiration date 30-APR-2022 for prophylaxis (exact dose, route of administration were not reported) by a nurse practitioner in the clinic.  Administered dose of vaccine has been stored in the temperature of 16.5 degrees Celsius for 2 hours. There were no previous temperature excursions reported. It was unknown if Digital Data Logger was involved. No adverse events were reported.   Additional information was not expected.
Age: 0.25
Sex: M
Vaccine: PPV
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: No additional AE; 3 Month Old Patient was administered PNEUMOVAX 23 instead of the intended 13-valent pneumococcal conjugate vaccine (PCV);; 3 Month Old Patient was administered PNEUMOVAX 23; This spontaneous report was received from a nurse prescriber and refers to a 3 month old male patient. Concomitant therapies included rotavirus vaccine, hepatitis b vaccine, diphtheria vaccine toxoid (+) pertussis vaccine acellular (+) tetanus vaccine toxoid (DTAP), hib vaccine (HIB) and polio vaccine inact (IPV). No information regarding the patient's pertinent medical history, illness at vaccination and drug reactions or allergies was provided.   On 13-OCT-2021, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) lot # T039322, expiration date 09-SEP-2022 intramuscularly for prophylaxis (exact dose and anatomical location were not reported) instead of pneumococcal vaccine 13v (manufacturer unknown) (inappropriate age at vaccine administration; wrong product administered). It was unknown if the vaccine/device is available for return/evaluation and if the vaccine/device was used according to the instruction leaflet. The vaccine operator was trained. The temperature excursion did not occur. The nurse reported that she was unable to contact the guardian after 4 attempts.  No additional adverse event.
Sex: U
Vaccine: HPV9
Symptoms: Diarrhoea, Dizziness, Headache, Nausea, Pain
Clinical narrative: dizzines and fever; fever; headache; body ache; nausea; diarrea; only able to eat crackers with medication; This spontaneous report as received from a other refers to a patient of unknown age. The patient's pertinent medical history, previous drug reactions or allergies and concomitant medication were unknown by reporter.  On 12-OCT-2021, the patient was vaccinated with a dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) lot # T028929 with expiration date on 08-MAR-2023, at 0.5 milliliter dosage, intramuscular ly in the right deltoid for prophylaxis.    Subsequently, the patient experienced dizziness, and low grade fever. The fever was consistent with medication, but without Tylenol, the fever reached 103 (units not provided). Other symptoms included: headache, body aches, nausea, and diarrhea and the patient was Only able to eat crackers with medication (dysphagia).   The outcome of dizziness, dysphagia, diarrhoea, nausea, pain, headache and pyrexia was unknown.    The causality assessment between vaccination with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) and the aforementioned events was not reported.
Sex: U
Vaccine: HPV9
Symptoms: Pyrexia
Clinical narrative: dizzines and fever; fever; headache; body ache; nausea; diarrea; only able to eat crackers with medication; This spontaneous report as received from a other refers to a patient of unknown age. The patient's pertinent medical history, previous drug reactions or allergies and concomitant medication were unknown by reporter.  On 12-OCT-2021, the patient was vaccinated with a dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) lot # T028929 with expiration date on 08-MAR-2023, at 0.5 milliliter dosage, intramuscular ly in the right deltoid for prophylaxis.    Subsequently, the patient experienced dizziness, and low grade fever. The fever was consistent with medication, but without Tylenol, the fever reached 103 (units not provided). Other symptoms included: headache, body aches, nausea, and diarrhea and the patient was Only able to eat crackers with medication (dysphagia).   The outcome of dizziness, dysphagia, diarrhoea, nausea, pain, headache and pyrexia was unknown.    The causality assessment between vaccination with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) and the aforementioned events was not reported.
Age: 75.0
Sex: U
Vaccine: PPV
Symptoms: Expired product administered
Clinical narrative: No other issues or concerns noted a time of call; Patient administered expired PNEUMOVAX 23; This spontaneous report was received from a registered nurse and refers to a 75 year old patient. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On 19-OCT-2021, the patient was vaccinated with expired dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) lot # S028602, expiration date 28-JUN-2021 for prophylaxis (exact dose, anatomical location and route of administration were not reported). No other issues or concerns noted a time of call.
Sex: U
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: no adverse events; PROQUAD was administered after improperly stored; This spontaneous report as received from a medical assistant refers to a currently 4 year old patient of unknown gender. On 14-OCT-2021, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (lot # T027115 exp date 07-FEB-2022) (0.5 mL route not reported). The temperature of excursion was 6°F to 14°F (8.5 °F) for 18 minutes and 6°F to 14°F (11.9 F) for 1 hour. Cumulative timeframe was 1 hour and 18 minutes. There was no previous temperature excursion.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; This spontaneous report was received from a lawyer and a male patient (pt) of unknown age regarding a case in litigation. The pt's concurrent conditions, medical history, drug reactions or allergies were not reported. In or around December 2013, the pt was inoculated with Zoster Vaccine Live (ZOSTAVAX) (dose, lot #, expiration date, route of administration and anatomical location not provided) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). Shortly after receiving Zoster Vaccine Live (ZOSTAVAX), the pt suffered shingles. As a direct and proximate result of Zoster Vaccine Live (ZOSTAVAX) vaccine, the pt symptoms had resulted in physical limitations not presented prior to using Zoster Vaccine Live (ZOSTAVAX). The pt also experienced mental and emotional distress due to resulting physical limitations and seriousness of his condition. As a result of the manufacture, marketing, advertising, promotion, distribution and or sale of Zoster Vaccine Live (ZOSTAVAX), the pt sustained severe and permanent personal injuries. Further, as a tragic consequence the pt suffered serious, progressive, permanent and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result, the pt suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. At the reporting time, the outcome of the event was considered as not recovered and the reporter considered the event to be related to Zoster Vaccine Live (ZOSTAVAX).  The reporter considered herpes zoster to be disabling event.
Sex: F
Vaccine: VARZOS
Symptoms: Condition aggravated, Dizziness, Exophthalmos, Eye pain, Herpes zoster
Clinical narrative: reoccurrence of the symptoms (second shingles outbreak) 2 months ago; lingering pain in her left side; since October 2020 she has had 2 massive shingles attacks; my eyeball looked like it was popping out; pain in her left eye; dizziness; vomiting; Zostavax given intramuscularly; This spontaneous report was received from a female consumer of unknown age reporting on herself. The patient's concurrent conditions included spinal operation, bone disorder and drug hypersensitivity. The patient's medical history, historical drugs and concomitant medications were not provided.  On an unknown date in 2009, the patient was vaccinated with zoster vaccine live(ZOSTAVAX) along with sterile diluent, intramuscular (incorrect route of product administration) (dose, lot number and expiration date were not reported) for herpes zoster.        Since October 2020, the patient had experienced 2 episodes fo shingles (herpes zoster). The first outbreak occurred in October 2020, when the patient developed eye pain and that her eye was popping out (exophthalmos), vomiting and dizziness. The patient managed the outbreak with valacyclovir. Two months ago, in September 2021, the patient experienced a second outbreak of herpes zoster that was followed by a lingering pain, and once again, the patient treated the herpes zoster with valacyclovir.      The outcome of exophthalmos, vomiting, dizziness and eye pain was unknown. The outcome of the first outbreak of herpes zoster was reported as resolved on an unknown date. The outcome the second event of herpes zoster was reported as resolving. The outcome of pain was reported as not resolved. The causal relationship between the events and the vaccines were not reported.  Upon internal review, the event of exophthalmos was considered medically significant.
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect route of product administration, Pain, Vomiting
Clinical narrative: reoccurrence of the symptoms (second shingles outbreak) 2 months ago; lingering pain in her left side; since October 2020 she has had 2 massive shingles attacks; my eyeball looked like it was popping out; pain in her left eye; dizziness; vomiting; Zostavax given intramuscularly; This spontaneous report was received from a female consumer of unknown age reporting on herself. The patient's concurrent conditions included spinal operation, bone disorder and drug hypersensitivity. The patient's medical history, historical drugs and concomitant medications were not provided.  On an unknown date in 2009, the patient was vaccinated with zoster vaccine live(ZOSTAVAX) along with sterile diluent, intramuscular (incorrect route of product administration) (dose, lot number and expiration date were not reported) for herpes zoster.        Since October 2020, the patient had experienced 2 episodes fo shingles (herpes zoster). The first outbreak occurred in October 2020, when the patient developed eye pain and that her eye was popping out (exophthalmos), vomiting and dizziness. The patient managed the outbreak with valacyclovir. Two months ago, in September 2021, the patient experienced a second outbreak of herpes zoster that was followed by a lingering pain, and once again, the patient treated the herpes zoster with valacyclovir.      The outcome of exophthalmos, vomiting, dizziness and eye pain was unknown. The outcome of the first outbreak of herpes zoster was reported as resolved on an unknown date. The outcome the second event of herpes zoster was reported as resolving. The outcome of pain was reported as not resolved. The causal relationship between the events and the vaccines were not reported.  Upon internal review, the event of exophthalmos was considered medically significant.
Sex: U
Vaccine: VARZOS
Symptoms: Blindness, Herpes zoster
Clinical narrative: loss of vision; herpes zoster; Information has been received from a lawyer regarding a case in litigation which referred to a currently elderly (approximately 77 years old) patient (pt) of unknown gender. Information regarding concomitant medications, concurrent conditions or medical history was not provided. On or about 02-JUN-2008, the pt was vaccinated with zoster vaccine live (ZOSTAVAX) for the long-term prevention of shingles and zoster-related conditions (exact dose, dose number, route of administration, anatomical site of vaccination, lot number and expiration date were not provided) at a physician's office. Subsequently (on an unknown date), the pt was treated for herpes zoster and loss of vision (blindness). The outcome of the events was unknown. The causal relationship between the events and zoster vaccine live (ZOSTAVAX) was assessed as related.  Upon internal review, the event blindness was determined to be medically significant.
Sex: F
Vaccine: COVID19
Symptoms: Mobility decreased, Musculoskeletal stiffness
Clinical narrative: Bad i could hardly walk to the bathroom; Stiffness in her legs; This is a spontaneous report from a contactable consumer based on information received by Pfizer (manufacturer control number: US-AMGEN-USASP2021177227), license party for ENBREL.  This non-serious spontaneous report (USASP2021177227) was reported on 13/OCT/2021 by a consumer and involves a female patient who experienced could hardly walk to the bathroom [mobility decreased], stiffness in her legs while receiving Enbrel with Single Dose Prefilled Autoinjector. No historical medical condition was reported. The patient's current medical condition included rheumatoid arthritis. No concomitant medications were provided. The patient's co-suspect medication included Pfizer Biontech Covid-19 Vaccine (tozinameran). The patient began Enbrel with Single Dose Prefilled Autoinjector on an unknown date in 1995. On an unknown date, the patient reported after receipt of the second Pfizer COVID 19 vaccine, she experienced such stiffness in her legs so bad she could hardly walk to the bathroom. The patient noted treating herself with turmeric and the stiffness was resolved. The outcome of the event musculoskeletal stiffness was reported as recovered/resolved. The outcome of the event mobility decreased was reported as unknown. The event musculoskeletal stiffness was resolved on an unknown date. Action taken with Enbrel and Single Dose Prefilled Autoinjector was continued for the events mobility decreased and musculoskeletal stiffness. The causal relationship between the events mobility decreased, musculoskeletal stiffness, Enbrel, and Single Dose Prefilled Autoinjector was not provided by the consumer. No further information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: sore a little bit; This case was reported by a consumer via interactive digital media and described the occurrence of pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced pain. On an unknown date, the outcome of the pain was not recovered/not resolved.   It was unknown if the reporter considered the pain to be related to Shingles vaccine.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient got the first Shingle shot and had still sore a little bit. The follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Social problem
Clinical narrative: During the pandemic, second dose ten months after first; This case was reported by a consumer via (Shingrix GSK Chatbot) interactive digital media and described the occurrence of social problem in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose of Shingrix on an unknown date ten months ago from 2nd dose).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced social problem. On an unknown date, the outcome of the social problem was unknown.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient reported that during the pandemic he/she was unable to get the 2nd dose of Shingrix until ten months after the 1st dose. The patient enquired if the coverage would be the same as gotten the 2nd dose within two to six months.
Sex: M
Vaccine: COVID19, VARZOS
Symptoms: Hypersensitivity, Pyrexia, Rash, Swelling, Urticaria
Clinical narrative: auto immune or severe allergic reaction; low grade fever; Urticaria and large "well"; swelling; rash; This case was reported by a consumer via other manufacturer and described the occurrence of allergic reaction in a 62-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included COVID 19 VACCINE PFIZER (batch number FD0809, expiry date unknown) for prophylaxis.   The patient's past medical history included chronic obstructive pulmonary disease and pain (Long term pain management). Concomitant products included FLONASE and OXYCODONE.   On an unknown date, the patient received Shingrix and COVID 19 VACCINE PFIZER. On an unknown date, unknown after receiving Shingrix, the patient experienced allergic reaction, fever, urticaria, swelling, and rash. On an unknown date, the outcome of the allergic reaction, fever, urticaria, swelling, and rash were unknown.   It was unknown if the reporter considered the allergic reaction, fever, urticaria, swelling, and rash to be related to Shingrix.  Additional details were provided are as the case was reported by patient himself. The age at vaccination was not reported. The patient received a dose of Shingrix 2 years ago and had started noticing low grade fever and basically an allergic reaction, he guessed that it would be referred to Urticaria and primarily large, well in one location and then he had started having swelling, and well in another location and all of these was extremely similar to an auto immune or allergic reaction. The patient had received Flonase and Oxycodone as concomitant. The patient was informed about role of Pfizer Drug Safety and stated, he got the shot on Friday and  started noticing the rash on Sunday and he guessed that he was concerned that it might be getting worse, what was the date on Sunday that's, when he started really noticing something. The patient stated tonight (04 November 2021), he just took over the counter allergy medication, half an hour ago, he mentioned that he was not sure to fix it up approximately 2 years ago. The patient had a severe allergic reaction to Shingrix vaccine and following that he ended up having 6 months serious shot of Zovair for that allergic reaction as treatment. The patient stated  that you asking him about the vaccine specifics and he had some documentation but he did not thought that it had that detail of information gave him just a minute and saw what he could found.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect route of product administration
Clinical narrative: Shingrix sub q; This case was reported by a nurse via sales rep and described the occurrence of intramuscular formulation administered by other route in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix (subcutaneous). On an unknown date, unknown after receiving Shingrix, the patient experienced intramuscular formulation administered by other route. On an unknown date, the outcome of the intramuscular formulation administered by other route was unknown.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix subcutaneously which led to intramuscular formulation administered by other route. The reporter agreed to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: missed a 2nd Shingrix dose by a couple of years; This case was reported by a other health professional via (Shingrix GSK Chatbot) interactive digital media and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose couple of years ago from reporting date).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. It was reported that the patient had missed a 2nd Shingrix dose by a couple of years, which led to incomplete course of vaccination. The reporter asked if the patient had to start over. The follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: first shot in December 2019 but I never took second; This case was reported by a consumer and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in December 2019).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The reporter was patient. The age at vaccination was not applicable for this report. The patient had the first Shingrix shot but he/she never took the second shot, which led to incomplete course of vaccination.  The patient asked should get the second one now almost two years later or do he/she need to start over with the first shot?
Sex: F
Vaccine: VARZOS
Symptoms: Biopsy brain abnormal, Central nervous system lymphoma, Coma, Neurological symptom
Clinical narrative: Primary CNS Lymphoma, diagnosis after a high-risk brain biopsy; Was in a coma-like state; Neurological symptoms; This case was reported by a consumer via sales rep and described the occurrence of central nervous system lymphoma in a female 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 central nervous system lymphoma (serious criteria hospitalization and GSK medically significant), coma (serious criteria hospitalization and GSK medically significant) and neurological symptom. The patient was treated with rituximab and methotrexate. On an unknown date, the outcome of the central nervous system lymphoma, coma and neurological symptom were unknown.   It was unknown if the reporter considered the central nervous system lymphoma, coma and neurological symptom to be related to Shingrix.  Additional details were provided as follows: The case was reported by patient's son. The age at vaccination was not reported. The patient experienced neurological symptoms after 1st dose of shingrix. The patient was currently at the hospital and had been diagnosed with a rare case of Primary CNS Lymphoma. She was in a coma-like state two weeks ago but now after a Rituximab and methotrexate cocktail she was awake and eating/breathing on her own. The diagnosis was made after a high-risk brain biopsy deep near the brain stem. The reporter agree to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Condition aggravated, Herpes zoster
Clinical narrative: had it, after my first vaccine.; This case was reported by a consumer via interactive digital media and described the occurrence of shingles in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (have had it 3 times in the last 16 months).   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, 3 weeks after receiving Shingles vaccine, 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 Shingles vaccine.  Additional details were provided as follows: The reporter was patient. The age at vaccination was not reported. The patient had shingles 3 weeks after first vaccine.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Illness, Paraesthesia, Vaccination failure
Clinical narrative: Suspected vaccination failure; Outbreak; Tingling that always comes before an outbreak; Extremely sick; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, tingling and sickness. The patient was treated with acyclovir. On an unknown date, the outcome of the vaccination failure, shingles, tingling and sickness were unknown.   It was unknown if the reporter considered the vaccination failure, shingles, tingling and sickness to be related to Shingles vaccine.  Additional details were provided as follows: The case was reported by patient's wife. The age at vaccination was not reported. The patient received Shingles vaccine and was extremely sick for at least 2 weeks after the vaccination. The patient took acyclovir when tingling occurs before shingles outbreak. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming herpes zoster were unknown at the time of reporting. This case is linked with the case US2021AMR230893, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR230893:Same reporter.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: I had shot and still got shingles/ Suspected vaccination failure; Got shingles; This case was reported by a consumer via  interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The case was self-reported by the patient. The age at vaccination was not reported. The reporter stated that, he/she had the shot and still got shingles. The follow-up would not possible as no contact details were available. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.