chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Angiogram, Blood gases, Depressed level of consciousness, Dysarthria, Facial paralysis
Clinical narrative: 73 yo F with renal mass was given her second Covid-19 vaccine IM in her right deltoid (lot# EN6206) on 3/4 at 1312.  In the final minutes of this patient's 15 minute observation period, patient was noticed to have pulled her mask down and was looking at the observer as if she wanted to say something.  Observer asked pt if she was ok.  Patient nodded yes. A minute later, the patient dropped her purse and mumbled something.  Patient's arm went up and patient became stiff and started seizing. Observer immediately called for help.  Vitals, glucose and oxygen was placed on patient.  EMS was called.  Provider notified and went to patient who was sitting upright in chair actively having bilateral generalized
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Generalised tonic-clonic seizure, Hemiparesis, Intracranial mass, Joint dislocation, Muscular weakness
Clinical narrative: 73 yo F with renal mass was given her second Covid-19 vaccine IM in her right deltoid (lot# EN6206) on 3/4 at 1312.  In the final minutes of this patient's 15 minute observation period, patient was noticed to have pulled her mask down and was looking at the observer as if she wanted to say something.  Observer asked pt if she was ok.  Patient nodded yes. A minute later, the patient dropped her purse and mumbled something.  Patient's arm went up and patient became stiff and started seizing. Observer immediately called for help.  Vitals, glucose and oxygen was placed on patient.  EMS was called.  Provider notified and went to patient who was sitting upright in chair actively having bilateral generalized
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Musculoskeletal stiffness, Mydriasis, Postictal state, Renal cell carcinoma, Seizure
Clinical narrative: 73 yo F with renal mass was given her second Covid-19 vaccine IM in her right deltoid (lot# EN6206) on 3/4 at 1312.  In the final minutes of this patient's 15 minute observation period, patient was noticed to have pulled her mask down and was looking at the observer as if she wanted to say something.  Observer asked pt if she was ok.  Patient nodded yes. A minute later, the patient dropped her purse and mumbled something.  Patient's arm went up and patient became stiff and started seizing. Observer immediately called for help.  Vitals, glucose and oxygen was placed on patient.  EMS was called.  Provider notified and went to patient who was sitting upright in chair actively having bilateral generalized
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Slow response to stimuli, Speech disorder, Tachycardia, Temporomandibular joint surgery
Clinical narrative: 73 yo F with renal mass was given her second Covid-19 vaccine IM in her right deltoid (lot# EN6206) on 3/4 at 1312.  In the final minutes of this patient's 15 minute observation period, patient was noticed to have pulled her mask down and was looking at the observer as if she wanted to say something.  Observer asked pt if she was ok.  Patient nodded yes. A minute later, the patient dropped her purse and mumbled something.  Patient's arm went up and patient became stiff and started seizing. Observer immediately called for help.  Vitals, glucose and oxygen was placed on patient.  EMS was called.  Provider notified and went to patient who was sitting upright in chair actively having bilateral generalized
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Nausea, Pain
Clinical narrative: Nausea  body aches
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Computerised tomogram head, Computerised tomogram thorax, Full blood count, Full blood count normal, Metabolic function test
Clinical narrative: Swelling around the base of the neck (left, right and front) and up the sides of the neck; initially treated with heat/cold therapy and ibuprofen; no impact on the swelling; visits to the primary physician, ER and referral to ENT all unable to explain or alleviate issue
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Swelling
Clinical narrative: Swelling around the base of the neck (left, right and front) and up the sides of the neck; initially treated with heat/cold therapy and ibuprofen; no impact on the swelling; visits to the primary physician, ER and referral to ENT all unable to explain or alleviate issue
Sex: U
Vaccine: VARZOS
Symptoms: Dyspnoea, Swelling face
Clinical narrative: swelling in the face; short of breath for a week; This case was reported by a consumer and described the occurrence of shortness of breath in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   In January 2021, the patient received the 1st dose of Shingrix. On an unknown date, less than a month after receiving Shingrix, the patient experienced shortness of breath and facial swelling. On an unknown date, the outcome of the shortness of breath and facial swelling were recovered/resolved.   It was unknown if the reporter considered the shortness of breath and facial swelling to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but captured as adult as per vaccine indication. When the patient received 1st shingles shot a month ago from the day of reporting, the patient had a shot of breath for a week or so and some swelling in the face. For tolerance in 2nd dose refer case US2021AMR035414.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR035414:Same reporter
Age: 0.33
Sex: M
Vaccine: DTAPIPV
Symptoms: No adverse event
Clinical narrative: Patient has no known adverse effects from the vaccine.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature fluctuation, Fatigue, Lymph node pain, Lymphadenopathy, Myalgia
Clinical narrative: Received dose on 01/12/2021 - left arm - muscle soreness.  however on 01/14/2021 developed left axillary lymph node became very swollen and very painful -discomfort.  Also became very fatigued and temperature not stable bouncing down to 97.4 - 99.9.  these all lasted for about 3 days and then completely went away
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Dysgeusia, Headache, Pain, Taste disorder
Clinical narrative: I had the most peculiar taste in my mouth. It wasn't entirely a metal taste, but it was strong enough it overwhelmed the taste of everything else for about 6 hours. I could still taste other things, but the primary taste and the one that remained in my mouth was this odd, almost metal taste.  The next day (after the taste was gone)-  it would have been almost 24 hours from the time of the injection - I was hit with a bad headache and body aches like I haven't had in many years. The body ache was gone the next morning, and the headache lingered another day past that. Today, Tuesday March 9, is the first day I feel like myself again.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Myalgia, Pyrexia
Clinical narrative: Headache, muscle aches, fever over 100. Lasted one day. No treatment, only rest. Day two symptoms were gone.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Bradyphrenia, Decreased appetite, Ear discomfort, Feeling abnormal, Head discomfort
Clinical narrative: My head felt heavy; it felt like my head was surrounded by water.  Lots of pressure around my ears. My mind was very foggy; I could not think clearly.  It was hard to concentrate and focus.  It felt like I was extremely groggy but not sleepy.   My think pattern was very slow.   My appetite decreased;  I felt nauseous a couple of times. No fever.  I took 2 Tylenol tablets (regular dose), and laid down to rest for several hours.   The longer the day went, the more severe the symptoms become.  I took another 2 Tylenol tablets at bedtime, and went to bed earlier.  During the day I drank lots of fluids, and ate light food.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Somnolence
Clinical narrative: My head felt heavy; it felt like my head was surrounded by water.  Lots of pressure around my ears. My mind was very foggy; I could not think clearly.  It was hard to concentrate and focus.  It felt like I was extremely groggy but not sleepy.   My think pattern was very slow.   My appetite decreased;  I felt nauseous a couple of times. No fever.  I took 2 Tylenol tablets (regular dose), and laid down to rest for several hours.   The longer the day went, the more severe the symptoms become.  I took another 2 Tylenol tablets at bedtime, and went to bed earlier.  During the day I drank lots of fluids, and ate light food.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue
Clinical narrative: extreme fatigue; This case was reported by a consumer and described the occurrence of fatigue in a 64-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of fatigue (1st dose received in October 2020 for further tolerance refer case US2021038319).   In January 2021, the patient received the 2nd dose of Shingrix. On an unknown date, 8 hrs after receiving Shingrix, the patient experienced fatigue. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the fatigue was recovered/resolved.   It was unknown if the reporter considered the fatigue to be related to Shingrix.  Additional details were reported as follows: The case was reported by the patient's spouse. The patient experienced extreme fatigue which reporter described as negative symptoms. The reporter stated that the fatigue started 8 hours after the vaccination in the patient's right arm and resolved after 12 hours. The reporter did not consent to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021038319:same reporter, same vaccine, different dose (1st dose)
Age: 86.0
Sex: M
Vaccine: COVID19
Symptoms: Pruritus, Rash
Clinical narrative: Rash arm, neck shoulder on vaccine side and pruritus
Sex: U
Vaccine: COVID19
Symptoms: Unevaluable event
Clinical narrative: Your form will not let me pass
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pain, Pyrexia
Clinical narrative: 36 hours of body aches, fever, headache.  48 hours of fatigue.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Anorectal discomfort, Proctalgia
Clinical narrative: Client stated that she felt "pain, discomfort in rectum 1 minute after vaccination."  Client observed for 20 minutes, reported a decrease in discomfort.  Declined further observation.  Driven home by spouse.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site reaction, Injection site swelling, Skin reaction
Clinical narrative: Severe skin reaction at site-almost like cellulitis-reddened and extremely swollen
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Musculoskeletal stiffness, Pain in extremity
Clinical narrative: stiff rotator cuff, arm soreness-8-12 hours duration, feeling better today after seeing dr.
Sex: F
Vaccine: VARZOS
Symptoms: Goitre, Lymphadenopathy, Pain in extremity, Peripheral swelling, Rash
Clinical narrative: Subacute Thyroiditis / enlarged her thyroid; rash from wrist to arm and shoulder; arm was swollen and sore.; arm was swollen and sore.; neck glands / were swollen; thyroid around left side were swollen / Thyroid and it was enlarged; This case was reported by a consumer via other manufacturer and described the occurrence of subacute thyroiditis in a 72-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included penicillin allergy (no name,manufacturer, lot or expiration.), allergic reaction to analgesics (no name,manufacturer, lot or expiration.), bee sting hypersensitivity, grass allergy and ragweed allergy.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced subacute thyroiditis, rash, pain in extremity, swelling arm, lymphadenopathy cervical and thyroid gland swelling. On an unknown date, the outcome of the subacute thyroiditis, rash, pain in extremity, swelling arm, lymphadenopathy cervical and thyroid gland swelling were unknown.   It was unknown if the reporter considered the subacute thyroiditis, rash, pain in extremity, swelling arm, lymphadenopathy cervical and thyroid gland swelling to be related to Shingrix.  Additional information were provided as follows: The age at vaccination was not reported. The patient received shingrix and experienced enlarged her thyroid and glands and threw everything out of whack. The patient had a rash from wrist to arm and shoulder, her arm was swollen and sore, her neck glands and thyroid around left side were swollen. The patient had it on her left arm and contacted her doctor and she had her see an endocrinologist. An Ultrasound of her thyroid was performed and it was enlarged. The physician advised not to get the second dose. Till the time of reporting, consent to follow was unknown. Note- there was descripancy in reported information. In narrative the statement is reported that Shingles vaccine reaction 18 Oct 2019, Shingrex two part one. The first one is the one that she had the reaction to. But this date is not specified was of 1st dose, 2nd dose or reaction onset date
Sex: F
Vaccine: VARZOS
Symptoms: Thyroiditis subacute, Ultrasound scan
Clinical narrative: Subacute Thyroiditis / enlarged her thyroid; rash from wrist to arm and shoulder; arm was swollen and sore.; arm was swollen and sore.; neck glands / were swollen; thyroid around left side were swollen / Thyroid and it was enlarged; This case was reported by a consumer via other manufacturer and described the occurrence of subacute thyroiditis in a 72-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included penicillin allergy (no name,manufacturer, lot or expiration.), allergic reaction to analgesics (no name,manufacturer, lot or expiration.), bee sting hypersensitivity, grass allergy and ragweed allergy.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced subacute thyroiditis, rash, pain in extremity, swelling arm, lymphadenopathy cervical and thyroid gland swelling. On an unknown date, the outcome of the subacute thyroiditis, rash, pain in extremity, swelling arm, lymphadenopathy cervical and thyroid gland swelling were unknown.   It was unknown if the reporter considered the subacute thyroiditis, rash, pain in extremity, swelling arm, lymphadenopathy cervical and thyroid gland swelling to be related to Shingrix.  Additional information were provided as follows: The age at vaccination was not reported. The patient received shingrix and experienced enlarged her thyroid and glands and threw everything out of whack. The patient had a rash from wrist to arm and shoulder, her arm was swollen and sore, her neck glands and thyroid around left side were swollen. The patient had it on her left arm and contacted her doctor and she had her see an endocrinologist. An Ultrasound of her thyroid was performed and it was enlarged. The physician advised not to get the second dose. Till the time of reporting, consent to follow was unknown. Note- there was descripancy in reported information. In narrative the statement is reported that Shingles vaccine reaction 18 Oct 2019, Shingrex two part one. The first one is the one that she had the reaction to. But this date is not specified was of 1st dose, 2nd dose or reaction onset date
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Myalgia, Pyrexia
Clinical narrative: Fatigue, headache, muscle aches, fever of 100.7
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Eye pain, Eye pruritus, Headache, Vitreous detachment, Vitreous floaters
Clinical narrative: I developed severe headache for two to three days after getting the 2nd dose of the Covid-19  vaccine starting approx. 3 hours after the vaccine. I took Celebrex as the head aches were quite severe(7-8/10) with difficulties in focusing due to the pain.  I received my first Covid-19 vaccination shot on 12/16/2020 and did not have any significant side effects besides mild pain in my left arm at the injection site the next day and it resolved with no intervention.   Then on 01/14/2021 I developed floaters in my right eye that was very sudden around early afternoon that progressed to large black spots obscuring my vision. It was associated with headache and deep eye itching and pain. I was unable to look at the computer and that is when I called my eye doctor and was told to come to see her right away. She then diagnosed me with Posterior Vitreous Detachment and referred me right away to see Dr. retinal specialist.
Age: 78.0
Sex: M
Vaccine: UNK
Symptoms: Pyrexia, Rash erythematous, Rash pruritic
Clinical narrative: roundshot area. Today fever is gone but rash is visible and very redwith itch.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: Occasional dizziness not previously experienced except on rare occasions.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Pain of skin, Pruritus, Swelling, Urticaria
Clinical narrative: 8 days after vaccine shot, welt appeared on vaccination arm. 2 X 4 inches. Raised area more than a rash. Itched and stinging sensation.  Lasted 10 days.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site warmth
Clinical narrative: Injection site red; Injection site hot to touch; Injection site itchy; Injection site soreness; This case was reported by a consumer and described the occurrence of injection site erythema in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, 72 hrs after receiving Shingrix, the patient experienced injection site erythema, injection site warmth, injection site itching and injection site pain. On an unknown date, the outcome of the injection site erythema, injection site warmth, injection site itching and injection site pain were unknown.   It was unknown if the reporter considered the injection site erythema, injection site warmth, injection site itching and injection site pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but was selected as adult as per vaccine indication. After the 2nd dose, injection site was red, hot to touch, itchy and sore.
Age: 91.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: In between the 2nd dose being scheduled and administered, the guidance changed. The injection was given within the 4 day grace period, but was before the 28 day mark.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Cold sweat, Eye irritation, Fatigue, Tremor
Clinical narrative: Yesterday at 4:45pm i started feeling extremely tired and shaking of cold sweats. Every single joint of my body hurt like if i lifted heavy weights..  I then took an 800 ml of ibuprofen (DUEXIS ) and went to sleep.. This morning felt better but my eyes feel irritated like when you have fever. Temperature is normal  Working from home so I stop every other hour to relax my eyes...  No headache or body pain.  Just a little tired.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Fatigue, Headache
Clinical narrative: Fatigue, head ache, dizziness, feeling weak
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Pain, Pyrexia
Clinical narrative: Startinf 12 hours after vaccine, I experienced a very sore injection site, fever, and body aches. I took Tylenol which lessened symptoms but did not completely make them go away. Symptoms subsided after after 48 hours after vaccine.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Cold sweat, Dizziness, Mydriasis, Pulse abnormal, Unresponsive to stimuli
Clinical narrative: Approximately 10 mins post vaccination, staff was alerted by bystander that patient was not responding despite seated position in chair with eyes open. Patient noted to be cool, clammy, weak pulse (radially), dilated pupils. States felt lightheaded. BP stable in 120's systolic. EMS called. By EMS arrival (approximately 5 mins post staff notification of patient condition), color was returning to face. Patient stating felt much better. Transported to local ER and discharged after approximately 2.5 hours. Patient did report had traveled (about 5-6 hours in car) day before, had minimal liquid intake during and after travel, and did not sleep well in local hotel. Reports did eat breakfast prior to vaccination.  Spoke with patient around 1140am. Stated was returning from ER. Feeling much better. Discharged without follow up and instructed to ensure he was hydrated, ate, and slept well before 2nd dose. Also instructed  to wait 30 mins post vaccination for monitoring after covid #2.
Sex: U
Vaccine: VARZOS
Symptoms: Influenza like illness, Loss of personal independence in daily activities, Pyrexia
Clinical narrative: Fever; Flu like symptoms; In bed 4 days; This case was reported by a consumer via interactive digital media and described the occurrence of fever in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced fever, influenza-like symptoms and activities of daily living impaired. On an unknown date, the outcome of the fever, influenza-like symptoms and activities of daily living impaired were recovered/resolved.   It was unknown if the reporter considered the fever, influenza-like symptoms and activities of daily living impaired to be related to Shingrix.  Additional details were provided as follows: The patient self reported the case. The age group was not reported but was selected as adult as per vaccine indication. The patient wanted to find out the ingredients of the vaccine.  The patient had a bad reaction to the first shot, was in bed 4 days with fever and flu like symptoms.  For tolerance of 2nd dose, refer case US2021AMR043058.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR043058:Same reporter.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Abnormal faeces, Diarrhoea, Faeces discoloured, Full blood count, Metabolic function test
Clinical narrative: Diarrhea began day after vaccination, 6 + stools per day, initially yellow and fishy smelling, now brown water, no blood. appetite good.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Stool analysis
Clinical narrative: Diarrhea began day after vaccination, 6 + stools per day, initially yellow and fishy smelling, now brown water, no blood. appetite good.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain, Pyrexia
Clinical narrative: body aches starting 15 hours post-injection, fatigue starting 17 hours post-injection, fever starting 18 hours post-injection. Fever lasted 6 hours, fatigue and body aches continued into next day lasting 24 hours
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chest discomfort, Dizziness, Heart rate increased, Throat clearing
Clinical narrative: 11:39Chest tightness, clients albuterol inhaler- 11:58 feeling the need to "clear throat", dizziness, leg weakness increased heart rate 25mg benadryl. symptoms resolved at 12:42
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: In between the 2nd dose being scheduled and administered, the guidance changed. The injection was given within the 4 day grace period, but was before the 28 day mark.
Age: 74.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Seizure
Clinical narrative: Seizure
Age: 74.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Pyrexia, Seizure
Clinical narrative: Seizure
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pain, Pruritus, Rash macular, Skin warm
Clinical narrative: Large  red area at injection site also smaller red blotches below the large area, Seems to be getting worse and covering more of my left arm. Feels warm to the touch, itchy, my arm is sore to the touch at injection site.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Death
Clinical narrative: Had vaccine on 3/3/2021 at approximately 1 PM.  She was found on her couch deceased on 3/8/2021.  Possible death on 3/5/2021.  She called her sister and told sister that back hurt worse than usual and she would lay on the couch and rest.  This is where she was found.  Unknown if from vaccine, but due to vaccination on Wednesday proceeding her death, report is being filed.
Age: 56.0
Sex: M
Vaccine: UNK
Symptoms: Haematochezia, Rectal haemorrhage
Clinical narrative: i had rectal bleeding afterwards not as bad now but still spotting blood in my stool
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pain, Pyrexia
Clinical narrative: Fever 100.1, Chills, Ache
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Fatigue, Headache, Nausea
Clinical narrative: Started with chills about 12 hours after the shot, headaches, nausea, light-headedness (nearly passed out), dry-heaving, fatigue (slept on and off for 24 hours) Symptoms lasted about 36 hours and then I felt fine again.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: In between the 2nd dose being scheduled and administered, the guidance changed. The injection was given within the 4 day grace period, but was before the 28 day mark.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Muscle spasms, Nausea, Oral herpes
Clinical narrative: Muscle cramps, nausea , headache, chills, fever 100.4
Sex: M
Vaccine: VARZOS
Symptoms: Dyspnoea, Fatigue, Influenza like illness, Laboratory test abnormal, Lyme disease
Clinical narrative: Tested for Lyme disease during this and it was positive; Flu-like symptoms; Shortness of breath; Fatigue; This case was reported by a physician via sales rep and described the occurrence of lyme disease in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced lyme disease (serious criteria GSK medically significant), influenza-like symptoms, shortness of breath and fatigue. On an unknown date, the outcome of the lyme disease was unknown and the outcome of the influenza-like symptoms, shortness of breath and fatigue were recovered/resolved.   It was unknown if the reporter considered the lyme disease, influenza-like symptoms, shortness of breath and fatigue to be related to Shingrix.  Additional details were provided as follows: Age at vaccination was not reported. It was reported that after 1st dose, the patient experienced flu-like illness, shortness of breath, fatigue. It took weeks to resolve. The patient was tested for Lyme disease during this and it was positive. This was his first diagnosis of Lyme disease. This occurred about 1 year ago.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Oropharyngeal pain
Clinical narrative: Started developing a sore throat two days after the vaccination.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Immediate post-injection reaction, Injection site haemorrhage, Syncope, Unresponsive to stimuli
Clinical narrative: Patient and husband arrived to received covid-19 vaccine together, 12:30 pm and 12:45 pm appointments. I informed patients that if they wanted to, they can both enter room together. Both patients were counseled on side effects/ what to expect. Patient was administered the Moderna COVID-19 Vaccine first in left arm. Upon vaccination, patient's arm began to bleed from injection site. I informed patient I would clean her arm, and attempted to hold gauze in place myself. Patient stated she would hold the gauze instead. After applying bandaid and cleaning area, I began process to vaccinate her husband. While vaccinating husband, patient stated she felt dizzy/faint. Patient sat in chair. Husband stated she is prone to fainting spells. I offered EMS services.Husband refused. I elevated patient's legs with other chair. Patient started to become non-responsive.  I stated I would use an epi-pen. Patient's husband refused epipen. Informed technician, to contact 911. Informed technician to contact front end manager. Patient continued to be non-responsive. Asked husband if I should get patient juice. Ran to get patient orange juice and straw. Husband wet patient with water. Patient started drinking orange juice through straw. Felt better. Started becoming responsive. PAtient and husband waited for EMS. Refused EMS services.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Cough, Decreased appetite, Dyspnoea, Myalgia
Clinical narrative: Approximately 10 days after the vaccination I began to develop muscle and joint pain on my left side. two days later I started to have problems breathing and the muscle pain, all on my left side, worsened. A day or two later I developed a fever of 102 and the muscle and joint pain became worse, again all on the left side of my body. To treat the fever I took Motrin, this also helped with the headache. I also had a lose of appetite as these symptoms progressed and lost about 7 pounds. I developed a cough that persisted for about 7 days. These symptoms were intense for about three days and persisted at varying intensity for about 10 days.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Approximately 10 days after the vaccination I began to develop muscle and joint pain on my left side. two days later I started to have problems breathing and the muscle pain, all on my left side, worsened. A day or two later I developed a fever of 102 and the muscle and joint pain became worse, again all on the left side of my body. To treat the fever I took Motrin, this also helped with the headache. I also had a lose of appetite as these symptoms progressed and lost about 7 pounds. I developed a cough that persisted for about 7 days. These symptoms were intense for about three days and persisted at varying intensity for about 10 days.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Rash vesicular
Clinical narrative: vesicular rash right mid-back
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Fever
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Death, Impaired work ability, Malaise
Clinical narrative: Patient received dose #2 of her Moderna COVID vaccine on 2/25/21. Patient called in to work the next day 2/26/21 because she was not feeling well. Patient did not show up to work on Monday 3/1/21 and her supervisor, called the PD to check in on her and she was found deceased in her home.
Sex: U
Vaccine: VARZOS
Symptoms: Fatigue
Clinical narrative: extremely tired; This case was reported by a consumer and described the occurrence of tiredness in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On 27th February 2021, less than a week after receiving Shingrix, the patient experienced tiredness. On an unknown date, the outcome of the tiredness was not recovered/not resolved.   It was unknown if the reporter considered the tiredness to be related to Shingrix.  Additional details provided as follow: Age at vaccination  and gender of the patient is not reported. The patiient asked how long does the side effects last. It has been 2 and half days since 2nd shot and was still extremely tired. No other adverse event was reported. No further information available.
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Anxiety, Dysgeusia, Muscle twitching, Taste disorder
Clinical narrative: Patient is a 33 y.o. male who received the Moderna lot # 001B21A on 3/9/2021. The patient experienced the following reaction(s) during the immediate of observation: Patient c/o "weird taste in mouth, metallic taste." Patient was treated/managed as follows:    PMH of DM and asthma. Patient reports taking metformin and lisinopril at home. Vital signs, monitor 0937 BP 146/92, HR 75, RR 18, O2 sat 97% on room air. Patient reports taste in mouth resolving.  0947 BP 126/90, HR 72, RR 17, O2 sat 97% on room air. Patient reports anxiety and twitching in lips. No swelling noted. Denies numbness and tingling. Water provided. 0954 Patient reports twitching in lips and taste resolved. 1008 Patient reports "feeling better." Patient escorted to car by significant other and documenting nurse. Patient given educational material regarding vaccine and advised to continue to self-monitor per the CDC guidance.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Fatigue, Headache, Myalgia
Clinical narrative: Chills, Headache, Myalgia, Arthralgia, Fatigue, Rash on forearms
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Chills, Headache, Myalgia, Arthralgia, Fatigue, Rash on forearms
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Headache, Nausea, Pyrexia
Clinical narrative: nausea, diarrhea, 102 degree fever with chills, slight headache
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Sinusitis, Vision blurred
Clinical narrative: 1  month after second dose of the COVID 19 moderna vaccine i developed hazzy /foggy vision associated with headache right > left side and i was evaluated by ophthalmology and all were normal , also was evaluated by ENT and was suspected sinusitis and has been on antibiotics for 10 days now now the right headache has moved to the left side , the hazy vision has gotten better but the headache is persistent and does not respond to OTC medications . Similar symptoms in colleagues 1 month after the 2nd dose of the vaccine .
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Pain
Clinical narrative: Chills, shivers, headache, body aches and soreness
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Pharyngeal swelling, Pruritus
Clinical narrative: Itching and the sensation of throat swelling. Did not get severe. I took 2 Benadryl with no change. NO RACING PULSE . NO SWELLING OF LIPS OR FACE. Symptoms disappeared after roughly 8 hours.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site induration, Nodule
Clinical narrative: post vaccine nodule, no redness, no pain or tenderness, hard bump size of quarter at injection site immediately after receiving injection
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Reaction at the injection site - red, raised, swollen, and inflamed. Went away on its own after approximately 24 hours.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Tongue pruritus, Vital signs measurement
Clinical narrative: Pt reports itchy tongue and lightheadedness. no h/o DM, no meds taken today. juice given
Sex: U
Vaccine: VARZOS
Symptoms: Autoimmune haemolytic anaemia, Idiosyncratic drug reaction, Night sweats, Pain, Pyrexia
Clinical narrative: Idiosyncratic reaction to my first Shingrix shot; Hives; Rash; Fever aches; Night sweats; Fever; Autoimmune hemolytic anemia; This case was reported by a consumer via media and described the occurrence of autoimmune hemolytic anemia in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced autoimmune hemolytic anemia (serious criteria GSK medically significant), idiosyncratic drug reaction, hives, rash, pain, night sweat and fever. On an unknown date, the outcome of the autoimmune hemolytic anemia, hives, rash, pain, night sweat and fever were recovered/resolved and the outcome of the idiosyncratic drug reaction was unknown.   The reporter considered the autoimmune hemolytic anemia, idiosyncratic drug reaction, hives, rash, pain, night sweat and fever to be related to Shingrix.  Additional details were reported as follows: This case was reported by patient himself/herself. The age at vaccination was not reported. The age group was not reported but was selected as an adult as per vaccine indication. The patient stated that he/she had an idiosyncratic reaction to his/her 1st Shingrix shot which he/she believe was reported to the FDA. The patient had experienced rash/hives, fever aches, night sweats and fever and developed autoimmune hemolytic anemia which persisted for 6 months. The follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Rash, Urticaria
Clinical narrative: Idiosyncratic reaction to my first Shingrix shot; Hives; Rash; Fever aches; Night sweats; Fever; Autoimmune hemolytic anemia; This case was reported by a consumer via media and described the occurrence of autoimmune hemolytic anemia in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced autoimmune hemolytic anemia (serious criteria GSK medically significant), idiosyncratic drug reaction, hives, rash, pain, night sweat and fever. On an unknown date, the outcome of the autoimmune hemolytic anemia, hives, rash, pain, night sweat and fever were recovered/resolved and the outcome of the idiosyncratic drug reaction was unknown.   The reporter considered the autoimmune hemolytic anemia, idiosyncratic drug reaction, hives, rash, pain, night sweat and fever to be related to Shingrix.  Additional details were reported as follows: This case was reported by patient himself/herself. The age at vaccination was not reported. The age group was not reported but was selected as an adult as per vaccine indication. The patient stated that he/she had an idiosyncratic reaction to his/her 1st Shingrix shot which he/she believe was reported to the FDA. The patient had experienced rash/hives, fever aches, night sweats and fever and developed autoimmune hemolytic anemia which persisted for 6 months. The follow-up would not possible as no contact details were available.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Myalgia
Clinical narrative: woke up feeling all my muscles acked, felt like i had a fever, tired for 2 days,aching lasted 3 hours
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Hyperhidrosis, Pyrexia, Respiratory tract congestion
Clinical narrative: Fever, fatigue, congestion, sore arm, sore muscles.  The fever started the morning after the shot, and lasted all day. On the second day I woke up with the fever continuing, though the symptoms weren't as strong, and by 3pm they were gone.  But that evening when getting ready for bed I experienced extreme shaking and chills, and sweated all throughout the night.  On day three I continue to be fatigued, but no fever.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Tremor
Clinical narrative: Fever, fatigue, congestion, sore arm, sore muscles.  The fever started the morning after the shot, and lasted all day. On the second day I woke up with the fever continuing, though the symptoms weren't as strong, and by 3pm they were gone.  But that evening when getting ready for bed I experienced extreme shaking and chills, and sweated all throughout the night.  On day three I continue to be fatigued, but no fever.
Age: 1.0
Sex: F
Vaccine: DTAP
Symptoms: Epistaxis
Clinical narrative: My daughter who has never had any nosebleeds woke up with a nosebleed 2 hours after the vaccine.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Decreased appetite, Headache, Injection site induration, Injection site pain
Clinical narrative: Fever, pain, hardness and fever at injection site. Pretty severe body and muscle aches.  Upset stomach and lack of appetite.  Pretty bad headache mainly in my forehead.   All but the pain and soreness at the inject.ion site subsided by the next day  Arm is still tender today.  Only had mild tenderness with the first shot similar to a regular flu shot.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site warmth, Myalgia, Pain, Pyrexia
Clinical narrative: Fever, pain, hardness and fever at injection site. Pretty severe body and muscle aches.  Upset stomach and lack of appetite.  Pretty bad headache mainly in my forehead.   All but the pain and soreness at the inject.ion site subsided by the next day  Arm is still tender today.  Only had mild tenderness with the first shot similar to a regular flu shot.
Sex: M
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: RASH ON SHOULDER; This case was reported by a pharmacist via sales rep and described the occurrence of rash in a adult male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced rash. Shingrix was interrupted. On an unknown date, the outcome of the rash was unknown.   It was unknown if the reporter considered the rash to be related to Shingrix.  Additional details were provided as follows:  The age at vaccination was not reported.  The patient was around 55 years old. After receiving dose of Shingrix, the patient experienced rash on shoulder. The patient did not want to take 2nd dose of Shingrix. The reporter consent to follow up.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Feeling of body temperature change
Clinical narrative: Client reported abdominal discomfort 10 minutes after vaccination.  Stated, "I think that my sugar is low."  Blood sugar 114.  Complained of feeling hot and cold.  Exited car and spat out clear secretions.  Client observed for 30 minutes.  Reported that abdominal discomfort felt "A little better." Declined further observation.  Driven off site by her son.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Computerised tomogram, Facial operation, Full blood count, Loss of consciousness, Multiple fractures
Clinical narrative: Passed out approximately an hour after vaccine administration after waiting in the facility for over 30 mins, while driving. Stopped breathing, broke bones in 8 different places in my face requiring surgery. Still recovering.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Respiratory arrest, X-ray
Clinical narrative: Passed out approximately an hour after vaccine administration after waiting in the facility for over 30 mins, while driving. Stopped breathing, broke bones in 8 different places in my face requiring surgery. Still recovering.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Decreased appetite, Headache, Lethargy, Pyrexia
Clinical narrative: Severe chills at 11:30 pm night of vaccine.  Lasted 1  1/2 hours.  Woke up next day with mild fever and slight headache. Both went away shortly thereafter. Felt lethargic all day, little appetite.  Felt 100% better next day.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pyrexia
Clinical narrative: Fever, unknown temp. Lasted 4 hours, the next day  was very tired headache
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Injection site rash, Myosclerosis, SARS-CoV-2 test negative, Skin warm
Clinical narrative: Pain at injection site, large-scale rash that lasted 2 weeks, skin very warm to the touch, muscle felt 'hard'
Age: 72.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Burning sensation, Erythema, Hypoaesthesia, Pain in extremity, Peripheral swelling
Clinical narrative: I got swollen, red,  burning, painful toes, but only the big  toes.  Numbness in my toes and ankles.  Is this known as Corona  Toe?
Age: 72.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Guillain-Barre syndrome, Malaise
Clinical narrative: I got swollen, red,  burning, painful toes, but only the big  toes.  Numbness in my toes and ankles.  Is this known as Corona  Toe?
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Pyrexia
Clinical narrative: Fatigue began first lasting for 24 hrs.  Fever noticed after first 12 hours along with chills.  Took one Tylenol  15 hrs after first symptom which did not provide any relief.  At hour 20 the fever returned to normal and fatigue and chills subsided.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Oral herpes, SARS-CoV-2 test negative
Clinical narrative: Initial 48 hour period showed little to no reaction. Then chills and  fever of 101 followed by more chills and low grade fluctuating fever going on over 48 hours.  The unusual event is  that this reaction occurred 8 days after vaccination beginning on 3/7/21. Has not resolved completely yet as of 3/9/21. Because of the delay, I took a covid19 pcr test which was negative.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Muscle spasms, Muscle tightness, Pain in jaw
Clinical narrative: Pins and needles feeling throughout body. Especially arms and legs. Muscle tightening and cramping, most concentrated to hands, feet and jaw. Jaw pain. Headache. Fatigue.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia
Clinical narrative: Pins and needles feeling throughout body. Especially arms and legs. Muscle tightening and cramping, most concentrated to hands, feet and jaw. Jaw pain. Headache. Fatigue.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Abdominal pain, Decreased appetite, Feeling abnormal, Headache
Clinical narrative: Headaches, sore arm, rash, shot site itches, fever, upset stomach, abdominal pain on lower left side off and on, feel off, lethargic and loss of appetite.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pruritus, Lethargy, Pain in extremity, Pyrexia, Rash
Clinical narrative: Headaches, sore arm, rash, shot site itches, fever, upset stomach, abdominal pain on lower left side off and on, feel off, lethargic and loss of appetite.
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: COVID-19, Herpes zoster, Post herpetic neuralgia, Vaccination failure
Clinical narrative: shingrix approximately 2 years ago both doses / shingles outbreak; non rash shingles outbreak; seems to have developed into PHN; covid; This case was reported by a physician via sales rep and described the occurrence of vaccination failure in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix and the 2nd dose of Shingrix. On an unknown date, more than 2 years after receiving Shingrix and 2 years after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, post herpetic neuralgia and covid-19. On an unknown date, the outcome of the vaccination failure, shingles, post herpetic neuralgia and covid-19 were unknown.   It was unknown if the reporter considered the vaccination failure, shingles, post herpetic neuralgia and covid-19 to be related to Shingrix and Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The reporter stated that, the patient received 2 doses of Shingrix approximately 2 years ago. Recently after developing covid had a non rash shingles outbreak that seems to have developed into post herpetic neuralgia. The reporter did not consent to follow up. This case was considered as suspected vaccination failure, since the details regarding laboratory confirmation for shingles was not provided.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Fatigue, Headache, Nausea
Clinical narrative: nausea fever headache body ache  vomiting chills fatigue joint pain    all lasted until the 9th
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia, Vomiting
Clinical narrative: nausea fever headache body ache  vomiting chills fatigue joint pain    all lasted until the 9th
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: Fever, aches
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Eye pain, Eye swelling, Fatigue, Feeling abnormal
Clinical narrative: I experienced body aches, headache, anxiety in my chest (once), tiredness.  One other thing that happened that may not be related is that my secondary implant eye socket became very sore and swelled up.  It could of been for another reason but the timing was uncanny.  I am feeling fine now and none of my reactions were that troubling.  I have experienced about 3 times a sudden feeling in my  body that made me think I wonder if that was the vaccine but I am feeling great now and all is good.  Thank you so very much for all the research and production of these life saving vaccines.