chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Nausea, Pain, Pyrexia
Clinical narrative: Woke up with severe chills and body aches, especially in the lower back region.  Progressed into nausea within 30 minutes.  Fever fluctuating between 0.5-2 degrees above normal body temp.  Nausea and chills subsided after about 2 hours, body aches dulled.  Headache and severe fatigue persisted the entire rest of the day.
Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain, Nausea, Vomiting
Clinical narrative: Nausea vomiting, abdominal pain
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Urticaria
Clinical narrative: Welts on various places beginning on the 8th, breathing difficulty beginning on the 9th.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Migraine, Nausea
Clinical narrative: First 24 hours: Severe chills, migraine, total body aches, fatigue, nausea 1-5 days: Fatigue, slight chills off-on, waves of nausea, headaches
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: First 24 hours: Severe chills, migraine, total body aches, fatigue, nausea 1-5 days: Fatigue, slight chills off-on, waves of nausea, headaches
Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: Decreased appetite, Dizziness, Fatigue, Feeling abnormal
Clinical narrative: Fatigue, lightheadedness, dizziness, brain fog, decrease in appetite - all symptoms started at Item 5 and are currently continuing.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Fatigue, Headache, Myalgia
Clinical narrative: Starting around 8:00pm started to experience muscle and joint pain in lower back and hips and headache. Left arm became warm to touch and felt slightly swollen. Chills and fever started to set in. Chills lasted for about 3 hours. Fever with a high of 101.7 degrees F noted around 2am. Took tylenol, which brought fever down, and reduced headache and muscle aaches. Fever remained between 99 and 100 degrees F for most of the following day. Took another tylenol in the late afternoon. Fever finally broke by the evening on 4/10/2021. Still fatigued for all of 4/10/2021. Woke up on 4/11/2021 with out any other adverse effects. Fever, headache, and muscle aches passed. Still a little tired, but felt more energized.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling, Pyrexia, Skin warm
Clinical narrative: Starting around 8:00pm started to experience muscle and joint pain in lower back and hips and headache. Left arm became warm to touch and felt slightly swollen. Chills and fever started to set in. Chills lasted for about 3 hours. Fever with a high of 101.7 degrees F noted around 2am. Took tylenol, which brought fever down, and reduced headache and muscle aaches. Fever remained between 99 and 100 degrees F for most of the following day. Took another tylenol in the late afternoon. Fever finally broke by the evening on 4/10/2021. Still fatigued for all of 4/10/2021. Woke up on 4/11/2021 with out any other adverse effects. Fever, headache, and muscle aches passed. Still a little tired, but felt more energized.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Dry skin, Injection site discomfort, Injection site pain, Injection site reaction, Injection site swelling
Clinical narrative: I began feeling soreness at the injection site started within 12 hours of receiving the vax.  The soreness progressively became worse over the next 7-9 days and was accompanied by swelling of the muscle around the injection site (peaking at about 7 days post-injection). The discomfort at times extended down my arm, but never past my elbow.  When extending my arm outwards (e.g., when reaching for something), I would feel an unusual stiffness and moderate discomfort in my arm.  As of April 12 (13 days post-vax), the swelling is largely gone, but there is still some discomfort when extending my arm outwards.  In addition, there appear to be dry patches of skin between the injection site and my armpit.  I have not sought medical treatment for these adverse reactions to date, nor do I anticipate needing to unless the discomfort becomes more intense.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Musculoskeletal stiffness
Clinical narrative: I began feeling soreness at the injection site started within 12 hours of receiving the vax.  The soreness progressively became worse over the next 7-9 days and was accompanied by swelling of the muscle around the injection site (peaking at about 7 days post-injection). The discomfort at times extended down my arm, but never past my elbow.  When extending my arm outwards (e.g., when reaching for something), I would feel an unusual stiffness and moderate discomfort in my arm.  As of April 12 (13 days post-vax), the swelling is largely gone, but there is still some discomfort when extending my arm outwards.  In addition, there appear to be dry patches of skin between the injection site and my armpit.  I have not sought medical treatment for these adverse reactions to date, nor do I anticipate needing to unless the discomfort becomes more intense.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Injection site pain, Injection site swelling, Musculoskeletal stiffness, Neck pain
Clinical narrative: 2 hours after  vaccine  I developed a headache which lasted until the evening  and at injection site  started to become swollen and painful  and lasted 2 days . Then on  04/05 1921 I woke up with a swollen and pain at injection site  on left arm and the right side and back side of my neck hurting and stiff. It has slowly subsided  however still  continues.  I am  feeling more tired than normal.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Disturbance in attention, Inner ear disorder, Sleep disorder, Tinnitus
Clinical narrative: I got tinnitus in both ears about 24 hours after second injection. High pitched ringing constant. I after a week I went to an ENT and then an audiologist. I have been put on a high dose of prednisone steroids (90 mg with a body weight of 200 lbs) now for three days. No improvement. The ringing is terrible, it is hard to sleep and concentrate. I now have to turn the volume up on tv and music to hear things that I could hear before.
Age: 26.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Lymphadenopathy, Pyrexia, Tonsillar hypertrophy
Clinical narrative: All symptoms are for the second dose. Fever and chill 16-18 hours after the vaccine, which subsided quickly.  Swollen lymph nodes at the armpit of the arm injected with the vaccine 24 hours after the vaccine, still ongoing. Severely swollen tonsils, still ongoing.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Sensitive skin
Clinical narrative: The day after my vaccine my skin became very sensitive. Every morning I inject my Lantus insulin on my stomach but the day after my vaccine I noticed that I felt pain when inserting the needle. This had not happened before.  The pain I felt when injecting disappeared on the  seventh day.  I am back to normal now and have no pain when injecting my insulin.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Cytomegalovirus test, Dizziness, Full blood count abnormal, Metabolic function test, Urine analysis
Clinical narrative: While at rest pt developed vomiting, and had 3 episodes of vomiting. Pt also had dizziness associated with the vomiting.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: While at rest pt developed vomiting, and had 3 episodes of vomiting. Pt also had dizziness associated with the vomiting.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site induration, Injection site pruritus, Injection site warmth
Clinical narrative: Large red patch on left arm near injection site, very firm and itchy and warm to the touch
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Slight allergic reaction.  Broke out in Hives approximately half hour after receiving shot
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Chills, Headache, Incoherent, Injection site pain
Clinical narrative: Symptoms for Moderna's COVID-19 vaccine: Day 1: pain on site of vaccine/feverish/headache/felt delirious; Day 2: arm, neck & chest pain on side of vaccine/headache/feverish with chills & body aches/headache persists; Day 3: Much improved; arm still stiff and sore; all other symptoms absence.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site reaction, Musculoskeletal stiffness, Neck pain, Pain, Pyrexia
Clinical narrative: Symptoms for Moderna's COVID-19 vaccine: Day 1: pain on site of vaccine/feverish/headache/felt delirious; Day 2: arm, neck & chest pain on side of vaccine/headache/feverish with chills & body aches/headache persists; Day 3: Much improved; arm still stiff and sore; all other symptoms absence.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Breast pain, Dizziness, Feeling hot, Injection site erythema, Injection site pain
Clinical narrative: Very painful during injection and after, felt lightheaded, hot, nauseous (nausea lasted only 15 min) woozy feeling lasted 24 hrs. Breast pain first two nights after vaccine. Apr 6 arm pain worsened along with increased swelling and redness. Noticed left clavicle lymph node was enlarged. Today arm has slight red rash and itching.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pruritus, Injection site swelling, Lymphadenopathy, Nausea
Clinical narrative: Very painful during injection and after, felt lightheaded, hot, nauseous (nausea lasted only 15 min) woozy feeling lasted 24 hrs. Breast pain first two nights after vaccine. Apr 6 arm pain worsened along with increased swelling and redness. Noticed left clavicle lymph node was enlarged. Today arm has slight red rash and itching.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Myalgia, Pyrexia
Clinical narrative: fever, chills, muscle pain
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Immediate post-injection reaction, Injection site pain, Injection site paraesthesia, Injection site reaction, Joint range of motion decreased
Clinical narrative: Immediately after the vaccine was injected I felt a sensation down my arm and into my hand.  It felt strange and tingly all the way down.  This feeling lasted for several days.  The feeling has subsided a little but I still have a weird sensation in my hand, mostly on the outer side, and in my ring and pinky fingers.  I looked online and it seems consistent with the injection hitting a nerve in my arm.  My upper arm around the injection site is still sore 2 1/2 weeks after the vaccination and I don't have full range of motion in my left arm without some pain.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Sensory disturbance
Clinical narrative: Immediately after the vaccine was injected I felt a sensation down my arm and into my hand.  It felt strange and tingly all the way down.  This feeling lasted for several days.  The feeling has subsided a little but I still have a weird sensation in my hand, mostly on the outer side, and in my ring and pinky fingers.  I looked online and it seems consistent with the injection hitting a nerve in my arm.  My upper arm around the injection site is still sore 2 1/2 weeks after the vaccination and I don't have full range of motion in my left arm without some pain.
Age: 18.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, Vomiting
Clinical narrative: fever and throwing up
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Hyperhidrosis, Pain, Vaccination complication
Clinical narrative: Chills, body aches, sweats, exhaustion, COVID arm
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Menstruation irregular
Clinical narrative: Menstrual cycle started 8 days early and began a few hours after receiving my first dose of the vaccine.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Hypopnoea, Syncope, Unresponsive to stimuli
Clinical narrative: Vaso vagal syncopy symptoms developed while sleeping. Brief shallow breathing, not responsive to verbal questions for 2-3 minutes. History of Vaso vagal responses to shots as child, but not for past 20 years. Symptoms this evening were consistent with experience as a child .
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain
Clinical narrative: Pain directly below injection site. Extremely tender to even gentle touch, feels like a very deep bruise, but no visible bruising. This has occurred after a week and a half of no side effects.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Ear discomfort, Ear pain, Hyperacusis, Tinnitus
Clinical narrative: Ear ringing, ear pain and feeling fullness in ear. Dizziness. Sensitive to loud noise for the past four weeks since the start of the vaccination
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Nausea, Pyrexia
Clinical narrative: I have had a fever, chills, and nausea off and on since 4/10/21. The fever can get high at times and it does take a long time to bring it down. Sometimes medication doesn?t work.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation
Clinical narrative: Later in the evening following injection, began noticing a burning/wearing along my spine itself. Had not ever felt that before. Took Aleve and and reg Neurontin dose and applied ice packs. Eased up after a couple of hours, but to be honest, I'm not looking forward to the second dose next week if I have a repeat performance. It won't stop me from getting the shot, just a bit concerned it might be worse. Has anyone else with nerve damage to spine or other areas noticed this effect? Just curious.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pruritus, Injection site rash, Injection site swelling
Clinical narrative: Swelling, itchy rash, mild redness on the arm where the vaccine is injected
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Swelling face
Clinical narrative: Left-side facial swelling 1 day post  vaccination.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal discomfort, Abdominal distension, Abdominal pain upper, Asthenia, Body temperature increased
Clinical narrative: 2nd shot Petechiae sever around both eyes within a few hours of injection, no trauma, coughing,  vomiting, vision became slightly cloudy after 48 hours.  Vomiting after 24hours briefly.  Body aches, dizzy, time perception off, 102 fever 2 days. Weakness and stomach discomfort bloating pain. Severe testicular pain.  1st injection  lot 026A21A 106 fever for 3 days, fever 4 days, symtoms 1 week, weakness, cold flashes, hot flashes, tingling, testicular pain, sleep issues, severe time skips and slow downs. Chest ache. Muscle aches.  Had covid-19 in July 2020 contracted via facility
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Cough, Dizziness, Pain, Periorbital haemorrhage, Testicular pain
Clinical narrative: 2nd shot Petechiae sever around both eyes within a few hours of injection, no trauma, coughing,  vomiting, vision became slightly cloudy after 48 hours.  Vomiting after 24hours briefly.  Body aches, dizzy, time perception off, 102 fever 2 days. Weakness and stomach discomfort bloating pain. Severe testicular pain.  1st injection  lot 026A21A 106 fever for 3 days, fever 4 days, symtoms 1 week, weakness, cold flashes, hot flashes, tingling, testicular pain, sleep issues, severe time skips and slow downs. Chest ache. Muscle aches.  Had covid-19 in July 2020 contracted via facility
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Time perception altered, Vision blurred, Vomiting
Clinical narrative: 2nd shot Petechiae sever around both eyes within a few hours of injection, no trauma, coughing,  vomiting, vision became slightly cloudy after 48 hours.  Vomiting after 24hours briefly.  Body aches, dizzy, time perception off, 102 fever 2 days. Weakness and stomach discomfort bloating pain. Severe testicular pain.  1st injection  lot 026A21A 106 fever for 3 days, fever 4 days, symtoms 1 week, weakness, cold flashes, hot flashes, tingling, testicular pain, sleep issues, severe time skips and slow downs. Chest ache. Muscle aches.  Had covid-19 in July 2020 contracted via facility
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Left armpit swollen and tender
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Bell's palsy
Clinical narrative: Bell's Palsy
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Angiogram pulmonary abnormal, Chest pain, Pleuritic pain, Pulmonary embolism
Clinical narrative: right sided pleuritic chest pain started 04/11/2021.
Age: 88.0
Sex: M
Vaccine: COVID19
Symptoms: Aphasia, Dehydration, Feeling abnormal, Full blood count, Hypoaesthesia
Clinical narrative: "brain fog"- unable to speak clearly, or speak at all, complete numbness of hands, then return of feeling- spontaneously comes and goes. This is in a 88 year old who previously was walking 1/4 mile unassisted, making dinner himself, doing all ADLs- has completely declined since 2nd dose.
Age: 88.0
Sex: M
Vaccine: COVID19
Symptoms: Loss of personal independence in daily activities, Metabolic function test, Urine analysis
Clinical narrative: "brain fog"- unable to speak clearly, or speak at all, complete numbness of hands, then return of feeling- spontaneously comes and goes. This is in a 88 year old who previously was walking 1/4 mile unassisted, making dinner himself, doing all ADLs- has completely declined since 2nd dose.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Joint swelling, Paraesthesia, Peripheral swelling, Pruritus
Clinical narrative: Approx 1 hour after receiving first dose of Moderna patient reported itching and tingling at neck, scalp, eyebrows, and bilateral forearms. Reports right wrist swelling and and bilateral hand swelling.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Blister, Injection site pruritus, Injection site swelling
Clinical narrative: on April 11, 2021 my arm begin to itch and swell at the site where I received the vaccine. It looks like a shingle.  I put cortizone on it and doubled up on valtrex. It seems to be going away.
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Chills, Headache, Tremor
Clinical narrative: Extreme back pain, shaking, chills, headache
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Nausea, Pain, Pyrexia, Tremor
Clinical narrative: Approximately 5 hours post vaccine severe chills occurred for the next four hours. Intense shaking to try to warm up body, I used three comforters in room set to 70F in order to achieve any warmth. Just prior to the immediate onset of chills I felt tired as if at the end of a busy day. After severe chills I had extreme body aches mostly in lower half ( butt and legs and lower back). About midnight through the next 24 hours I had severe fever (~ 102 when measured), 2 x 200 mg ibuprofen did not reduce however 2 x 500 mg of tylenol did help but effects wore off before next recommended dose. Spent 24 hours in bed with fever the day after the vaccination. In addition to the severe chills and severe fever and sever body aches, there were times of nausea. Appetite was ok, actually hungry during the fever. 36 hours post injection still no arm pain, lower back starting to feel better, but still have small fever. I typically walk 3-4 times a week 4-5 miles each time, no medications, no high blood pressure, no allergies. Had flu shot in Sept 2020, no effects.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Nausea, Pain in extremity
Clinical narrative: Sore/aching/painfully arm. Slept for two days. Felt nauseous right after shot. Headache for two days
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Chills, Dizziness, Migraine, Nausea
Clinical narrative: Within 5 minutes of receiving  the shot, I had stomach cramps and felt extremely nauseous. I had periods of nausea and dizzy spells for the following week. I had an extreme migrane the night of the shot and chills throughout the next week. I did not report the symptoms to  anyone because I had not heard that these were reactions to this vaccine. After I heard that others were experiencing similar symptoms, I felt I should report my experience.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Chills, Dizziness, Nausea, Pain
Clinical narrative: Body aches and chills (8 hours after) fever, nausea, chills, body aches, dizziness, and chest pain (12 hours after)
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Body aches and chills (8 hours after) fever, nausea, chills, body aches, dizziness, and chest pain (12 hours after)
Age: 27.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Headache, Nausea, Pain, Syncope
Clinical narrative: I was fine with dose number one I only had some pain in my arm. With dose number two I had fainted the next morning. Had cold chills. Body aches. A severe headache and nausea.
Age: 42.0
Sex: F
Vaccine: UNK
Symptoms: Lymphadenopathy, Ultrasound scan abnormal
Clinical narrative: Swollen  nodes in neck 48 hours after the vaccine. It lasted for 7 days.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Swollen Lymph nodes under injection arm.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Chills, Diarrhoea, Dyspepsia
Clinical narrative: Severe headache, chills, fever, muscle aches, low back/hip pain, heartburn--all began the night of 04/08/2021 (same day as vaccination) Diarrhea--began night of 04/11/2021 Headache persists, though less severe--04/12/2021
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Myalgia, Pyrexia
Clinical narrative: Severe headache, chills, fever, muscle aches, low back/hip pain, heartburn--all began the night of 04/08/2021 (same day as vaccination) Diarrhea--began night of 04/11/2021 Headache persists, though less severe--04/12/2021
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Chills, Mobility decreased, Pain
Clinical narrative: COMPLETE WEAKNESS, FULL BODY ACHES, CHILLS. PATIENT UNABLE TO GET OUT OF BED.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Contusion, Erythema, Headache, Mobility decreased, Nausea
Clinical narrative: Syncope, vertigo, nausea, fever- started approx 24 hrs post vaccine. Syncope, vertigo, and nausea lasted approx 6 hours. Low grade fever was gone by morning. Headache off and on for 3 days, last time Saturday morning. Severe arm pain- swollen, red, hot to the touch, knot in arm and bruising. Sharp pains from area, hurts to raise arm, currently ongoing. Have been treating with ice and ib profen, little relief.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Nodule, Peripheral swelling, Pyrexia, Syncope, Vertigo
Clinical narrative: Syncope, vertigo, nausea, fever- started approx 24 hrs post vaccine. Syncope, vertigo, and nausea lasted approx 6 hours. Low grade fever was gone by morning. Headache off and on for 3 days, last time Saturday morning. Severe arm pain- swollen, red, hot to the touch, knot in arm and bruising. Sharp pains from area, hurts to raise arm, currently ongoing. Have been treating with ice and ib profen, little relief.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash, Sleep disorder
Clinical narrative: Overall Rash- very itchy at night early morning day after receiving shot- can not sleep
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site rash
Clinical narrative: rash on upper arm near injection site
Sex: F
Vaccine: VARZOS
Symptoms: Biopsy, Erythema, Influenza, Laboratory test, Viral test
Clinical narrative: she began having slight issues with her scalp/get these things off of her head (red, look like shingles); she began having slight issues with her scalp/get these things off of her head (red, look like shingles); flu symptoms; This spontaneous report was received from an 80-year-old female patient referring to herself. Information about medical history, concurrent conditions and concomitant therapies was not provided.    In October 2015, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (1 time injection; strength, dose, route, lot # and expiration date were not reported) for preventative.         In 2015 (by the end of the year), the patient began having slight issues with her scalp, she had to begin cutting her own hair after she would get these things off of her head (red, look like shingles). The patient had been going to numerous physicians (primary care, infectious disease, ear nose throat (ENT), dermatologist and none of them had been able to solve her problem. This had been ongoing for 5 and a half years and it just dawned on the patient recently that it might be from the vaccine since it started right after getting the vaccine, none of the physicians knew it might be a reaction of the vaccine and now she would try to give that information to one of the physicians to hopefully resolve the issue with her scalp. In 2015, the patient also got flu symptoms, she would get over it and then got the flu symptoms again. The patient sought medical attention, biopsy, swab, labs/tests were performed. The outcome of the events was reported as not recovered. The consumer considered red, look like shingles to be related to zoster vaccine live (ZOSTAVAX). Causality assessment between event flu symptoms and zoster vaccine live(ZOSTAVAX) was unknown.
Sex: U
Vaccine: HPV9
Symptoms: Product storage error
Clinical narrative: Improper storage of product in use; This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. The patient's pertinent medical history, concomitant medication, previous drug reactions, and allergies were not reported.      On 22-MAR-2021, the patient was vaccinated with one hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (lot number S033308, which has been verified to be valid, the expiration date was reported and validated as 08-APR-2022), as prophylaxis (dose, dose number, route of administration, and anatomical site of vaccination were not provided).  The suspect vaccine was exposed to a temperature of 0 hours 30 minutes and 0 seconds (product storage error), as recorded by digital data logger. Additionally, a previous temperature excursion was reported of 46.4 degrees F for a time frame of 0 hours 30 minutes and 0 seconds. The reporter stated all the patients were asymptomatic.  This is one of several reports received from the same reporter. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. ; manufactureraddress: ; manufacturercity:  manufacturerstate: ; manufacturercountry:; devicelotnumber: S033308; expirationdate: 08-APR-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not suggest a causal association with the device or device constituent; Sender's Comments:  US-009507513-2104USA001370: US-009507513-2104USA001371: US-009507513-2104USA001372: US-009507513-2104USA001376: US-009507513-2104USA001373: US-009507513-2104USA001392: US-009507513-2104USA001378: US-009507513-2104USA001390: US-009507513-2104USA001379: US-009507513-2104USA001387: US-009507513-2104USA001389: US-009507513-2104USA001393: US-009507513-2104USA001381: US-009507513-2104USA001394: US-009507513-2104USA001377:
Sex: U
Vaccine: HPV9
Symptoms: Product storage error
Clinical narrative: Improper storage of product in use; This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. The patient's pertinent medical history, concomitant medication, previous drug reactions, and allergies were not reported.      On 12-MAR-2021, the patient was vaccinated with one hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (lot number T007035, which has been verified to be valid, the expiration date was reported and validated as 01-MAY-2022), as prophylaxis (dose, dose number, route of administration, and anatomical site of vaccination were not provided).  The suspect vaccine was exposed to a temperature of 0 hours 30 minutes and 0 seconds (product storage error), as recorded by digital data logger. Additionally, a previous temperature excursion was reported of 46.4 degrees F for a time frame of 0 hours 30 minutes and 0 seconds. The reporter stated all the patients were asymptomatic.  This is one of several reports received from the same reporter. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T007035; expirationdate: 01-MAY-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not suggest a causal association with the device or device constituent; Sender's Comments:  US-009507513-2104USA001297:
Sex: U
Vaccine: HPV9, UNK
Symptoms: Product storage error
Clinical narrative: Improper storage of product in use; This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. The patient's pertinent medical history, concomitant medication, previous drug reactions, and allergies were not reported.      On 18-MAR-2021, the patient was vaccinated with one hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (lot number T007035, which has been verified to be valid, the expiration date was reported and validated as 01-MAY-2022), as prophylaxis (dose, dose number, route of administration, and anatomical site of vaccination were not provided).  The suspect vaccine was exposed to a temperature of 0 hours 30 minutes and 0 seconds (product storage error), as recorded by digital data logger. Additionally, a previous temperature excursion was reported of 46.4 degrees F for a time frame of 0 hours 30 minutes and 0 seconds. The reporter stated all the patients were asymptomatic.  This is one of several reports received from the same reporter. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); devicelotnumber: T007035; expirationdate: 01-MAY-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not suggest a causal association with the device or device constituent; Sender's Comments:  US-009507513-2104USA001297:
Sex: U
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: No additional AEs were reported; Medical assistant reported a temperature excursion for PROQUAD which was improperly stored and administered to a patient.; This spontaneous report was received from a medical assistant, referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, previous drug reactions or allergies and concomitant medications were not provided.   On 15-MAR-2021, the patient was vaccinated with a improperly stored of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD), as prophylaxis (formulation, concentration, dose, vaccination scheme frequency, route of administration and anatomical site of vaccination were not reported; lot number T027294, which has been verified to be valid, expiration date reported and validated as 08-FEB-2022). The vaccine administered experienced a temperature excursion of 20.04 degrees Fahrenheit (F), for a time frame of 40 minutes as recorded by a data logger (product storage error). There was no previous temperature excursion reported. No additional adverse events were reported.
Age: 10.0
Sex: F
Vaccine: MMR
Symptoms: Abdominal pain upper, Anaphylactic shock, Anxiety, Chest pain, Confusional state
Clinical narrative: nervous; vomiting; anaphylactic shock; she felt like she was having a heart attack; chest pains; confused; kind of like not knowing what was going on; heart racing; stomach pains; anxious; This spontaneous report was received from a currently 50 years old female patient referring to herself. The patient's concomitant medication, pertinent medical history and drug reactions/allergies were not provided.  Between 1980 and 1982, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (manufacturer unknown) (dose, strength, lot# and expiration date were not provided) via injection route to prevent measles, mumps, and rubella.   Between 1980 and 1982, the patient was administered the vaccine in school and had terrible reactions to the vaccine when she was between 10 and 12 years old. The patient went into anaphylactic shock and felt she was having a heart attack, vomiting, chest pains, confused, kind of like not knowing what was going on, heart racing, stomach pains and anxious. The patient's parents took her to the emergency room and she only remembered that a needle was given in her arm in hospital but not remembered anything else. The patient's mother walked the patient to car to house. The patient was now scheduled to have the coronavirus 2019 (COVID-19) vaccine on Sunday (unspecified) and she was nervous. The patient sought medical attention.   The outcome of the events was recovered. The causality between the events and the suspect therapy was not provided.   Upon internal review, anaphylactic shock and heart attach were determined to be medically significant.
Age: 10.0
Sex: F
Vaccine: MMR
Symptoms: Memory impairment, Palpitations, Vomiting
Clinical narrative: nervous; vomiting; anaphylactic shock; she felt like she was having a heart attack; chest pains; confused; kind of like not knowing what was going on; heart racing; stomach pains; anxious; This spontaneous report was received from a currently 50 years old female patient referring to herself. The patient's concomitant medication, pertinent medical history and drug reactions/allergies were not provided.  Between 1980 and 1982, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (manufacturer unknown) (dose, strength, lot# and expiration date were not provided) via injection route to prevent measles, mumps, and rubella.   Between 1980 and 1982, the patient was administered the vaccine in school and had terrible reactions to the vaccine when she was between 10 and 12 years old. The patient went into anaphylactic shock and felt she was having a heart attack, vomiting, chest pains, confused, kind of like not knowing what was going on, heart racing, stomach pains and anxious. The patient's parents took her to the emergency room and she only remembered that a needle was given in her arm in hospital but not remembered anything else. The patient's mother walked the patient to car to house. The patient was now scheduled to have the coronavirus 2019 (COVID-19) vaccine on Sunday (unspecified) and she was nervous. The patient sought medical attention.   The outcome of the events was recovered. The causality between the events and the suspect therapy was not provided.   Upon internal review, anaphylactic shock and heart attach were determined to be medically significant.
Age: 59.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Peripheral swelling
Clinical narrative: arm swelling and redness; arm swelling and redness; This spontaneous report was received from a registered nurse referring to a 59-year-old female patient. Information about medical history, concurrent conditions and concomitant therapies was not provided.        On 08-MAY-2019, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (0.5 milliliter, intramuscular; lot # and expiration date were not reported) for active immunization for the prevention of pneumococcal disease caused by the 23 serotypes contained in the vaccine (prophylaxis).         On the same day, the patient experienced arm swelling and redness. The patient did not receive treatment for the adverse events and has fully recovered. The causality assessment was not reported.
Age: 0.75
Sex: F
Vaccine: DTAPHEPBIP, DTAPIPVHIB
Symptoms: Extra dose administered
Clinical narrative: received Pentacel and Pediarix / consumer received a double dose of the Dtap-IPV component on the day of the injections / Pentacel and Pediarix contain those components; the consumer is behind on their vaccine schedule; This case was reported by a nurse via other manufacturer and described the occurrence of overdose in a 9-month-old female patient who received DTPa-HBV-IPV (Pediarix) for prophylaxis.   Co-suspect products included dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis and PENTACEL (batch number UJ129AAA, expiry date 11th March 2020) for prophylaxis.   On 22nd October 2019, the patient received Pediarix, Pediarix Pre-Filled Syringe Device and PENTACEL. On 22nd October 2019, unknown after receiving Pediarix and Pediarix Pre-Filled Syringe Device, the patient experienced overdose and inappropriate schedule of vaccine administered. On an unknown date, the outcome of the overdose and inappropriate schedule of vaccine administered were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional information was provided as follows: It was reported that the patient ordered to receive Pediarix and ActHIB but the patient received Pentacel and Pediarix. The nurse reported that, the patient received a double dose of the Dtap-IPV component on the day of the injections due to the Pentacel and Pediarix contain those components, which led to overdose of Dtap-IPV.  The patient was behind on their vaccine schedule, which led to inappropriate schedule of vaccine administered. This suspected adverse reaction report was submitted and classified as a medication error solely.
Sex: U
Vaccine: VARZOS
Symptoms: Feeling abnormal, Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; Shingles / have all had shingles; When your allergic to the shingles vaccine / had shingles; So miserable/worst; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a adult 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, allergy and feeling miserable. On an unknown date, the outcome of the vaccination failure, shingles, allergy and feeling miserable were unknown.   It was unknown if the reporter considered the vaccination failure, shingles, allergy and feeling miserable to be related to Shingles vaccine.  Additional details were provided as follows: The reporter was the patient. The age at vaccination was not reported. The age group was not reported but was captured as an adult as per vaccine indication.  The patient felt worst on allergic to the shingles vaccine & had to endure the daily activities. The patient had shingles after vaccination. The patient had never heard that there was an age limit on vaccine. The patient stated that they were going through 3rd year and it was very miserable. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, time to onset and lab test confirmation was unknown at the time of reporting.
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Got the one shot several years ago / just the second of this new series; we're only itchy; This case was reported by a consumer via interactive digital media and described the occurrence of drug dose administration interval too long in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine (received old shingles shot on an unknown date) and Shingles vaccine (1st dose of new series received several years ago of reporting date).   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced drug dose administration interval too long and pruritus. On an unknown date, the outcome of the drug dose administration interval too long and pruritus were unknown.   It was unknown if the reporter considered the pruritus to be related to Shingles vaccine.  Additional details provided were as follows: The patient recently received second shot of this new series,which led to lengthening of vaccination schedule. The patient stated that, the patient was only itchy after 2nd dose. This case has been linked to US2021AMR078315, reported by patient for her husband. Note- since the reported information is not clear, the events are coded conservatively.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR078315:same reporter
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue
Clinical narrative: tiredness after first dose of Shingrix; This case was reported by a other health professional via call center representative and described the occurrence of tiredness in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 6th December 2020, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 6th December 2020, 8 hrs after receiving Shingrix, the patient experienced tiredness. On an unknown date, the outcome of the tiredness was recovered/resolved.   It was unknown if the reporter considered the tiredness to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received 1st dose of Shingrix and experienced tiredness. The reporter did not consent to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Electric shock sensation, Injected limb mobility decreased
Clinical narrative: Had an issue with mobility of injected arm for quite a while/issue with injected arm; She had a "zing" down to her fingertips; This case was reported by a consumer via call center representative and described the occurrence of injected limb mobility decreased in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced injected limb mobility decreased and electric shock sensation. On an unknown date, the outcome of the injected limb mobility decreased was resolved with sequelae and the outcome of the electric shock sensation was unknown.   The reporter considered the injected limb mobility decreased to be related to Shingrix. It was unknown if the reporter considered the electric shock sensation to be related to Shingrix.  Additional details were provided as follows: The reporter was the neighbor of the patient. The age at vaccination was not reported. The patient received Shingrix and had an issue with mobility of the injected arm for quite a while and also had a zing down to her fingertips. The reporter did not consent to follow-up.
Age: 70.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: cardiac stents; unspecified surgeries; received the first dose 12/2019 / has not yet received her second dose; This case was reported by a consumer via call center representative and described the occurrence of coronary stent placement in a 70-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   In December 2019, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced coronary stent placement, surgery and incomplete course of vaccination. On an unknown date, the outcome of the coronary stent placement, surgery and incomplete course of vaccination were unknown.   It was unknown if the reporter considered the coronary stent placement and surgery to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The patient voluntarily stated about her history but dates were unknown in relation to the 1st Shingrix dose as having cardiac stents and history of unspecified surgeries. The patient had no lot and expiration date. Till the time of reporting patient did not receive the 2nd dose, which led to incomplete course of vaccination. The reporter consented to follow up.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: had injection site pain for 3 days; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 57-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 1st April 2021, the patient received the 1st dose of Shingrix (intramuscular). In April 2021, less than a week after receiving Shingrix, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was recovered/resolved.   It was unknown if the reporter considered the injection site pain to be related to Shingrix.  Additional details were provided as follows: This case was reported by patient herself. The patient was vaccinated with Shingrix in her right deltoid muscle and had injection site pain for 3 days and then it was resolved. The reporter consented to follow up.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Hyperhidrosis, Pain
Clinical narrative: Fever , chills , excessive sweating , body aches , headache , fatigue
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Fever , chills , excessive sweating , body aches , headache , fatigue
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Feeling hot
Clinical narrative: Patient reports feeling "hot and fatigued" roughly 30 minutes post-vaccination. He states he is feeling mild dizziness but denies and other symptoms. Patient was given juice and observed sitting in wheelchair. Patient reports symptom improvement and walked out on his own
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Influenza like illness, Myalgia, Pyrexia
Clinical narrative: Severe Flu like symptoms. Fever, chills, weakness, muscle aches,
Age: 21.0
Sex: M
Vaccine: COVID19
Symptoms: Rash, SARS-CoV-2 antibody test, Tryptase
Clinical narrative: Rash
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Chills, Diarrhoea, Injection site pain, Nausea
Clinical narrative: Intense pain at injection site Nausea  Vomiting Diarrhea  Fever Body aches Chills Stomach ache
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia, Vomiting
Clinical narrative: Intense pain at injection site Nausea  Vomiting Diarrhea  Fever Body aches Chills Stomach ache
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Pain, Tremor
Clinical narrative: Extreme chills and severe shaking lasted 4hrs tapering off after 230AM without medicine.  Body aches and severe headache (not migraine) lasted almost 24hrs; took 500mg Tylenol at 5am with little relief, took 240mg baby Aspirin approx 8am, took 10mg Maxalt at 9am with some more relief, but headache persisted.  Took 325mg Aspirin about 3pm and felt near total relief by 5pm.  Body aches also relieved by afternoon.  No issues the next day (Sunday).
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Herpes zoster, Pulmonary pain, Rash
Clinical narrative: Back pain lung pain then rash so i went to doctors, and she explain I got shingles.
Age: 0.08
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Abdominal pain upper, Asthenia, Feeding disorder, Headache
Clinical narrative: Within 40 minutes I began to feel weak, followed by nausea and severe headaches.  A few hours later acute abdominal pain that left me doubled over and lasted for 8 hours and 40 hours of stomach pain that left me unable to eat.
Age: 0.08
Sex: F
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: Within 40 minutes I began to feel weak, followed by nausea and severe headaches.  A few hours later acute abdominal pain that left me doubled over and lasted for 8 hours and 40 hours of stomach pain that left me unable to eat.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Hyperhidrosis, Nausea, Vomiting
Clinical narrative: 4/4/2021 nausea,vomiting,fatigue,sweating,headache. 24 hours.