chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 27.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Headache, Pain, Pyrexia, Taste disorder
Clinical narrative: I had complete loss of smell and taste November 26th and tested positive for Covid-19 on the 28th. At the time, it started as my smell and taste fading out. Day one of noticeable symptoms also included a slight fever at approximately 99.7 degrees, full body aches as if I'd been in a car accident, chills, a headache, shortness of breath and fatigue. The fever and chills and body aches had gone away after only two days but the shortness of breath and fatigue persisted at least 3 weeks or late December.  By January, I was slowly having my smell and taste back to normal. Early in February, around Feb. 4th, after my first vaccine and approximately 5 days before my second one, my smell and taste became horribly distorted. It started with mint and toothpaste. It started tasting/smelling like mold with pottery clay. After about 2 or three days, almost all foods began tasting and smelling like it was musty, moldy and rotten. Like dead fish or expired meat.  I first noticed with food but now it's other things as well. Cleaning agents like disinfectant wipes smell the exact same as a jar of peanut butter which is a strong, musty, moldy smell.  A pot roast bought the day of at Kroger was cooked by my fiance and it smelled so rancid to me I almost vomitted. Almost everything smells and tastes horrible and it's been about two weeks. The only things that seem normal are bubblegum, fruity pebbles and most beverages although not all. Coffee has the same pungent smell.  I have has to switch my diet almost completely to yogurt, fruity pebbles and meal replacement shakes. Along with a multivitamin so I don't miss anything.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Appendicectomy, Appendicitis, Blood potassium decreased, Peritonitis, White blood cell count increased
Clinical narrative: Hospitalization- admitted on 2/14 for appendicitis and peritonitis; had appendectomy. Discharged on 2/18
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site swelling, Pruritus
Clinical narrative: Arm itches and is swelling around injection site. Delayed reaction (started 8 days after)
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Atrial fibrillation
Clinical narrative: 6 hours after I had vaccine I developed A fib which lasted for 3 hours before I converted. I haven?t had an episode of a fib in over a year.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Vision blurred
Clinical narrative: Patient received vaccine at 16:05 and at approximately 16:15, the patient reported blurred vision in her right eye.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Injection site discolouration, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Sore, swollen, red upper arm, extending outward from injection site, developed 2/17/21, following a couple days of feeling extremely fatigued.  Arm still sore, but swelling seems to be decreasing; the area is still noticeably discolored in an oval shape covering the deltoid region.  No treatment, monitoring only.  PCP is out of the country and office closed.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test normal, Chills, Electrocardiogram normal, Fatigue, Headache
Clinical narrative: Experienced feeling of heart racing and sustained tachycardia 85-110 even while sleeping.  Had pulsometer and Fitbit to track pulse.  Called Scripps covid Nurseline next day and was advised to go to urgent care since increased heart rate was a possible allergic reaction.  Other symptoms included chills, fever, fatigue, extreme headache, which began ~8 hr after shot.  Identical twin sister also has tachycardia from her second Moderna shot and still has one week after second shot.  For me, pulse lowers in response to Benedryl for about 5 hrs.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Palpitations, Pyrexia, Tachycardia
Clinical narrative: Experienced feeling of heart racing and sustained tachycardia 85-110 even while sleeping.  Had pulsometer and Fitbit to track pulse.  Called Scripps covid Nurseline next day and was advised to go to urgent care since increased heart rate was a possible allergic reaction.  Other symptoms included chills, fever, fatigue, extreme headache, which began ~8 hr after shot.  Identical twin sister also has tachycardia from her second Moderna shot and still has one week after second shot.  For me, pulse lowers in response to Benedryl for about 5 hrs.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Nausea, Vertigo
Clinical narrative: Sometime in the middle of the night/early am Jan 6 I rolled over in bed and had vertigo, it felt like I was doing flips. The whole day I had to be careful I would get vertigo so bad it I moved to quick. I went to my Chiropractor, he thought it was the benign and had me do a specific maneuver. It made me nausea for an hour then went away.  As long as I didn't bend over funny I though I was ok. On the 9th and 10th I felt general dizzy, I would turn and just kind of felt like I was spinning.  I took Sudafed because my ears felt full. Then the vertigo was just gone.
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Depressed level of consciousness, Pyrexia
Clinical narrative: Patient developed a fever to 102.3 and had a decreased level of responsiveness with rigors. An infectious evaluation including COVID 19 testing, respiratory viral panel, basic lab evaluation (including CBC and CMP), and physical exam were all unremarkable. She was provided PR acetaminophen which reduced her fever and she returned to normal. After clinical improvement, she mentioned that she has developed similar reactions to previous medications (PCN) and vaccines (unknown which type) that always improve with acetaminophen. She did not annotate this on her vaccine screening form. She was provided acetaminophen and had no further symptoms. Will plan to provide her with scheduled acetaminophen after dose 2.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event
Clinical narrative: None stated.
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Headache, Nausea
Clinical narrative: Patient states she feels nauseous after receiving vaccine and developed a headache.  b/p 144/76,p-83, R 18, 02 sat 99% Temp 96.1.  After observing patient for 20 minutes patient c/o sever left sided abd pain and was taken to ED for further evaluation
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain
Clinical narrative: Pain at injection site for Moderna vaccine #2 left upper arm. continues >16 days
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: MEDICAL ASSISTANT GAVE 1ML INSTEAD OF 0.5 ML. SHE DID NOT NOTIFY US UNTIL AFTER THE LAST PATIENT WAS GIVEN THE SHOT. SHE OPENED A NEW VIAL TO COMPLETE THE PATIENTS. EMPLOYEE WAS TERMINATED AND WE CONTACTED PATIENTS TO SEE IF THEY WERE FIND AND TO ADVISE THEM ABOUT GOING TO E.R. IF CONDITION WORSENED.  CALLED DAILY TO VERIFY WELL-BEING.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Chest discomfort, Chills, Diarrhoea, Dizziness, Dry mouth
Clinical narrative: Started with tightness of chest, (under the lower part of ribcage); sporadic hot flashes and dizziness; pulse going up to 95,( when normal is in the 60's).  Then sat down an hour later and almost immediately a deep tiredness.  got off work early, went home and had no other problems until I attempted to go to sleep.  Somewhere around nine o'clock, I started getting muscle cramps so I went to the couch.  Shortly after, my right arm, (vaccinated arm) became extremely sore; shortly after, my total body ached; no relief from lying on my left, right, stomach or back; hurt to even sit upright.  Then, I started getting cold chills; which alternated with hot flashes and periods of nausea.  My mouth went extremely dry, so when I struggled to go use the bathroom, I would wobble my way to the kitchen and want to take a big drink of water, attempted to swallow two tylenol, gagged and started throwing up.  Went back to bed and started getting continuous headaches that would move to different places.  This happened the rest of the night and most of Thursday when most of the worst symptoms happened.  Was able to sleep Thursday  night and thought I was feeling better, until I stood up.  Today, I was not able to stand longer than one half an hour at any one point; had to lie down and rest while doing any kind of activity.  I haven't been able to keep anything down; either vomiting or diarrhea. Have been slowly feeling better with occasional headache.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Feeling cold, Headache, Hot flush, Muscle spasms
Clinical narrative: Started with tightness of chest, (under the lower part of ribcage); sporadic hot flashes and dizziness; pulse going up to 95,( when normal is in the 60's).  Then sat down an hour later and almost immediately a deep tiredness.  got off work early, went home and had no other problems until I attempted to go to sleep.  Somewhere around nine o'clock, I started getting muscle cramps so I went to the couch.  Shortly after, my right arm, (vaccinated arm) became extremely sore; shortly after, my total body ached; no relief from lying on my left, right, stomach or back; hurt to even sit upright.  Then, I started getting cold chills; which alternated with hot flashes and periods of nausea.  My mouth went extremely dry, so when I struggled to go use the bathroom, I would wobble my way to the kitchen and want to take a big drink of water, attempted to swallow two tylenol, gagged and started throwing up.  Went back to bed and started getting continuous headaches that would move to different places.  This happened the rest of the night and most of Thursday when most of the worst symptoms happened.  Was able to sleep Thursday  night and thought I was feeling better, until I stood up.  Today, I was not able to stand longer than one half an hour at any one point; had to lie down and rest while doing any kind of activity.  I haven't been able to keep anything down; either vomiting or diarrhea. Have been slowly feeling better with occasional headache.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Nausea, Pain, Pain in extremity, Vomiting
Clinical narrative: Started with tightness of chest, (under the lower part of ribcage); sporadic hot flashes and dizziness; pulse going up to 95,( when normal is in the 60's).  Then sat down an hour later and almost immediately a deep tiredness.  got off work early, went home and had no other problems until I attempted to go to sleep.  Somewhere around nine o'clock, I started getting muscle cramps so I went to the couch.  Shortly after, my right arm, (vaccinated arm) became extremely sore; shortly after, my total body ached; no relief from lying on my left, right, stomach or back; hurt to even sit upright.  Then, I started getting cold chills; which alternated with hot flashes and periods of nausea.  My mouth went extremely dry, so when I struggled to go use the bathroom, I would wobble my way to the kitchen and want to take a big drink of water, attempted to swallow two tylenol, gagged and started throwing up.  Went back to bed and started getting continuous headaches that would move to different places.  This happened the rest of the night and most of Thursday when most of the worst symptoms happened.  Was able to sleep Thursday  night and thought I was feeling better, until I stood up.  Today, I was not able to stand longer than one half an hour at any one point; had to lie down and rest while doing any kind of activity.  I haven't been able to keep anything down; either vomiting or diarrhea. Have been slowly feeling better with occasional headache.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Injection site mass, Injection site pain
Clinical narrative: Left arm was very sore at injection site for four days.  I had a large lump on the arm at the injection site for four days.  Mild fatigue for   two days.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Pharyngeal swelling, Respiratory distress, Wheezing
Clinical narrative: respiratory distress (new), audible wheezing, shortness of breath, sensation of throat swelling or closure
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Erythema, Fatigue, Feeling abnormal, Headache
Clinical narrative: Severe arm pain in the middle of the night - woke me up (the arm pain lasted at least a week); Saturday morning- nausea and headache and I took Motrin. As the day progressed, 4-6pm fever started - went to 102.8 and Motrin lowered to about 101. Very fatigued, body aches, nauseated and headache got worse. I didn't want to keep my eyes open. Fever lasted until Monday and I felt very unwell. I called Clinic Monday morning - Advice nurse -and she suggested I get a COVID test. I felt so miserable - I laid in bed for whole week. It took all my energy to get to the bathroom. I went to work on that Wednesday to deliver my rounds of meds and went back home to bed. Friday, Jan 22nd - Doctor   - redness wrapped all around my arm (from the inch down from shoulder and two inches above elbow)  and it was warm to the touch (it wasn't painful at that point) but it itched like mad and he ordered an anti-nausea medication for me. Arm recovered before second dose. Nausea lasted to the second dose. I was anti-nausea medication  - Andanzitron - 8 mg tablets (Clinic) - to get through my days. Nausea has gotten a little better but still have to take medication from time to time. Second dose received 5th of February.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Nausea, Pain, Pain in extremity, Pruritus
Clinical narrative: Severe arm pain in the middle of the night - woke me up (the arm pain lasted at least a week); Saturday morning- nausea and headache and I took Motrin. As the day progressed, 4-6pm fever started - went to 102.8 and Motrin lowered to about 101. Very fatigued, body aches, nauseated and headache got worse. I didn't want to keep my eyes open. Fever lasted until Monday and I felt very unwell. I called Clinic Monday morning - Advice nurse -and she suggested I get a COVID test. I felt so miserable - I laid in bed for whole week. It took all my energy to get to the bathroom. I went to work on that Wednesday to deliver my rounds of meds and went back home to bed. Friday, Jan 22nd - Doctor   - redness wrapped all around my arm (from the inch down from shoulder and two inches above elbow)  and it was warm to the touch (it wasn't painful at that point) but it itched like mad and he ordered an anti-nausea medication for me. Arm recovered before second dose. Nausea lasted to the second dose. I was anti-nausea medication  - Andanzitron - 8 mg tablets (Clinic) - to get through my days. Nausea has gotten a little better but still have to take medication from time to time. Second dose received 5th of February.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, SARS-CoV-2 test negative, Skin warm, Sleep disorder, Somnolence
Clinical narrative: Severe arm pain in the middle of the night - woke me up (the arm pain lasted at least a week); Saturday morning- nausea and headache and I took Motrin. As the day progressed, 4-6pm fever started - went to 102.8 and Motrin lowered to about 101. Very fatigued, body aches, nauseated and headache got worse. I didn't want to keep my eyes open. Fever lasted until Monday and I felt very unwell. I called Clinic Monday morning - Advice nurse -and she suggested I get a COVID test. I felt so miserable - I laid in bed for whole week. It took all my energy to get to the bathroom. I went to work on that Wednesday to deliver my rounds of meds and went back home to bed. Friday, Jan 22nd - Doctor   - redness wrapped all around my arm (from the inch down from shoulder and two inches above elbow)  and it was warm to the touch (it wasn't painful at that point) but it itched like mad and he ordered an anti-nausea medication for me. Arm recovered before second dose. Nausea lasted to the second dose. I was anti-nausea medication  - Andanzitron - 8 mg tablets (Clinic) - to get through my days. Nausea has gotten a little better but still have to take medication from time to time. Second dose received 5th of February.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema
Clinical narrative: Erythematous circular rash with surrounding white clearing close to injection site
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Discomfort, Incorrect route of product administration, Pain in extremity
Clinical narrative: Received complaint call 2/19/21 from patient regarding administration site being anterior arm for 1st dose of Covid-19 vaccine on 2/16/21. Submitted photos with band-aid placement towards anterior mid-upper arm.  Complaints of pain/discomfort to arm (whole arm) also in shoulder area.  Discussed that arm discomfort can come with vaccination as an expected outcome.  Describes that she did not have pain in arm during injection when administered.  Clients concern is regarding administration and if administered in tissues versus muscle if vaccine will still be absorbed by body and be effective.  Consulted with "medical professionals" regarding technique and was encouraged to call vaccine administration site.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain, Cold sweat, Diarrhoea, Fatigue
Clinical narrative: Abdominal Cramps, mild diarrhea, slight fatigue  20210216, 6:30 PM Cold Sweats, fatique  20210217, 2:00 AM Abdominal Cramps, mild diarrhea, fatigue  20210216, 8:00 AM - 8:00 PM No treatment
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Cellulitis, Chills, Fatigue, Headache, Lethargy
Clinical narrative: Cellulitis left arm,  fever, body aches, chills, ?feels like I have covid again?, headache. Fatigue, lethargy, All sympotoms x 3-4 days,
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: Cellulitis left arm,  fever, body aches, chills, ?feels like I have covid again?, headache. Fatigue, lethargy, All sympotoms x 3-4 days,
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Enlarged painful lymph nodes near collarbone in the crevice of neck, treated with warm compress, acetametaphine, and 14 days of doxycycline
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Arthralgia, Fatigue, Headache, Myalgia
Clinical narrative: Tiredness, muscle aches, joint pain, headache, and stomach cramps.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Headache
Clinical narrative: Severe headache, persistent intermittent cough everyday. Some days only in the AM. Other days only in the PM. Currently headache is more PM and nagging intensity with cough mostly evening.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: When Lead Vaccinator drew the 1.8 ml diluent from the vial, she inadvertently injected it back into the diluent vial. She then withdrew the COVID vaccine dose from the Pfizer vial. Patient received 0.3 ml of undiluted vaccine in left deltoid. Error was not realized until after patient left and the vaccinator realized there were no other doses available to draw from the COVID vaccine vial. Looked at diluent vial and saw diluent was in bottle. Clinic contacted Physician contact and was informed that patient should be informed of error and may experience more soreness in arm but no serious adverse reactions from overdose. Patient informed and informed as directed. Reeducation given to Lead Vaccinator. Diluent vial removed from draw area once diluent was removed from vial after incident to prevent further incidents from occurring.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash macular
Clinical narrative: Diffuse erythematous macular rash. itchy, non tender.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia oral
Clinical narrative: Tingling lips and tongue. Oral Benadryl 25 mg at 2:45 p.m.  Second 25 mg Benadryl at 3:40 p.m.  Tingling has subsided somewhat
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect product formulation administered
Clinical narrative: Vaccine supposed to be mixed with adjuvenated solution prior to administration. Instead of mixing with solution, APRN gave just the adjuvenated solution without the live vaccine.
Age: 89.0
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Abdominal distension, Abdominal pain, Constipation, Faecaloma, Intestinal malrotation
Clinical narrative: RECEIVED BOTH COVID VACCINES 01/27/21 & 02/17/21. ON 02/19/21 WENT TO ICC RASH ON ARMS X1 MONTH, AND ABDOMINLA PAIN AND WAS SENT TO THE ER.  ON 02/19/21 REPORTED TO ER AND ADMITTED INPATIENT AFTER BEING  DIAGNOSED WITH  ABDOMINAL PAOIN, UNSPECIFIED LOCATION, ABDOMINLA DISTENTION, CONSTIPATION, FECAL IMPACTION, AND MALROTATION OF CECUM.
Age: 89.0
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Rash
Clinical narrative: RECEIVED BOTH COVID VACCINES 01/27/21 & 02/17/21. ON 02/19/21 WENT TO ICC RASH ON ARMS X1 MONTH, AND ABDOMINLA PAIN AND WAS SENT TO THE ER.  ON 02/19/21 REPORTED TO ER AND ADMITTED INPATIENT AFTER BEING  DIAGNOSED WITH  ABDOMINAL PAOIN, UNSPECIFIED LOCATION, ABDOMINLA DISTENTION, CONSTIPATION, FECAL IMPACTION, AND MALROTATION OF CECUM.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Pain in extremity, Paraesthesia
Clinical narrative: Patient reports that at the time of injection she felt numbness in her left thumb and tingling in her arm.   It quickly resolved but over the past few hours has been on and off numb for the past few hours.  She says at one point her pinky felt numb, then the side of her arm but strength is normal.  Her arm is also sore.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Nodule, Pruritus
Clinical narrative: patient says he developed a lump in arm that was growing and had itching. he called md and doctor told him to take Benadryl. Benadryl resolved symptoms
Sex: U
Vaccine: VARZOS
Symptoms: Balance disorder, Herpes zoster, Post herpetic neuralgia, Visual impairment
Clinical narrative: multiple outbreaks of herpes zoster; post herpetic neuralgia; vision problems; balance problems; This initial spontaneous report was received on from a lawyer regarding a case in litigation and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medication were not provided.   On an unspecified date, the patient was vaccinated with a dose zoster vaccine live (ZOSTAVAX) (strength, dose, route of administration, lot # and expiration date were not reported) for the prevention of shingles (herpes zoster).  On an unspecified date, shortly after receiving the vaccine, the patient suffered multiple outbreaks of herpes zoster, post herpetic neuralgia, vision problems and balance problems. As a direct and proximate result of the plaintiff's symptoms had resulted in physical limitations not present prior to using the vaccine. Plaintiff also experienced mental and emotional distress due to resulting physical limitations and seriousness of her condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), plaintiff sustained severe and permanent personal injuries. Further, as a tragic consequence of Merck's wrongful conduct, Plaintiff suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury.   The reporter considered the events to be related to zoster vaccine live (ZOSTAVAX).
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Diarrhoea, Mobility decreased, Pain in extremity, Pyrexia, Vomiting
Clinical narrative: severe vomiting; diarrhea; fever / more severe; arm soreness; trouble lifting the arm that lasted 4-5 days.; This case was reported by a consumer via call center representative and described the occurrence of vomiting in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   In October 2020, the patient received the 1st dose of Shingrix. On an unknown date, less than 3 months after receiving Shingrix, the patient experienced vomiting, diarrhea, fever, pain in arm and mobility decreased. On an unknown date, the outcome of the vomiting, diarrhea, fever, pain in arm and mobility decreased were recovered/resolved.   It was unknown if the reporter considered the vomiting, diarrhea, fever, pain in arm and mobility decreased to be related to Shingrix.  Additional details were provided as follows: Age at event onset was not reported but it could be 62 or 63 years old. The reporter was a GSK employee reporting an event told to him by the patient who was his sister in law.  The patient had her 1st dose in October 2020 and the symptoms were more severe and included, severe vomiting, diarrhea, fever and the same arm soreness and trouble lifting the arm that lasted 4 to 5 days. The reporter did not consent to follow-up. For tolerance in 2nd dose refer case US2021003151.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021003151:same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Condition aggravated, Rash
Clinical narrative: Rash developed on upper torso / persisted and gotten worse / entire torso, from and back; This case was reported by a consumer via interactive digital media and described the occurrence of rash in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 23rd November 2020, the patient received Shingrix. On 23rd December 2020, 30 days after receiving Shingrix, the patient experienced rash. 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. Age group was not reported but captured as adult as per vaccine indication. A rash developed on upper torso. The rash had persisted and gotten worse.  It now covered entire torso, from and back of the patient.  The reporter asked was this normal, and asked about recommendation.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Body temperature, Headache, Pain, Pain in extremity, Peripheral swelling
Clinical narrative: Hurt to lift her arm; Swelling at the top of her left arm; Headache; Fever; This case was reported by a consumer and described the occurrence of pain in arm in a 51-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included Herpes zoster (Shingrix).   In December 2020, the patient received the 2nd dose of Shingrix (intramuscular). In December 2020, less than a week after receiving Shingrix and an unknown time after receiving Shingrix, the patient experienced pain in arm, headache, fever and swelling arm. The patient was treated with prednisone. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the pain in arm, headache and fever were recovered/resolved and the outcome of the swelling arm was recovering/resolving.   It was unknown if the reporter considered the pain in arm, headache, fever and swelling arm to be related to Shingrix.  Additional details were provided as follows: The case was reported by consumer's spouse. The patient had the 2nd dose of Shingrix in December, 2020.  Either that night or the next night, the patient experienced a higher Fever of 101.5 degree Fahrenheit for four to eight hours, a severe Headache for six to twelve hours, the patient continues to had Swelling at the top of her left arm.  The patient had a swollen band around the top of her arm which make it hurt to lift her arm. The patient started prednisone last night and was feeling better today on the day of reporting. The reporter consented to follow up. The case had been linked with US2021AMR008109 1st dose of the patient reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR008140:Husband's 2nd dose US-GLAXOSMITHKLINE-US2021007475:Husband's 1st dose US-GLAXOSMITHKLINE-US2021AMR008109:same patient, 2nd dose
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Hurt to lift her arm; Swelling at the top of her left arm; Headache; Fever; This case was reported by a consumer and described the occurrence of pain in arm in a 51-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included Herpes zoster (Shingrix).   In December 2020, the patient received the 2nd dose of Shingrix (intramuscular). In December 2020, less than a week after receiving Shingrix and an unknown time after receiving Shingrix, the patient experienced pain in arm, headache, fever and swelling arm. The patient was treated with prednisone. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the pain in arm, headache and fever were recovered/resolved and the outcome of the swelling arm was recovering/resolving.   It was unknown if the reporter considered the pain in arm, headache, fever and swelling arm to be related to Shingrix.  Additional details were provided as follows: The case was reported by consumer's spouse. The patient had the 2nd dose of Shingrix in December, 2020.  Either that night or the next night, the patient experienced a higher Fever of 101.5 degree Fahrenheit for four to eight hours, a severe Headache for six to twelve hours, the patient continues to had Swelling at the top of her left arm.  The patient had a swollen band around the top of her arm which make it hurt to lift her arm. The patient started prednisone last night and was feeling better today on the day of reporting. The reporter consented to follow up. The case had been linked with US2021AMR008109 1st dose of the patient reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR008140:Husband's 2nd dose US-GLAXOSMITHKLINE-US2021007475:Husband's 1st dose US-GLAXOSMITHKLINE-US2021AMR008109:same patient, 2nd dose
Age: 51.0
Sex: M
Vaccine: VARZOS
Symptoms: Headache, Pain in extremity, Pyrexia
Clinical narrative: Arm Pain; Headache; Fever; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 51-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   In October 2020, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, 1 day after receiving Shingrix, the patient experienced pain in arm, headache and fever. On an unknown date, the outcome of the pain in arm, headache and fever were recovered/resolved.   It was unknown if the reporter considered the pain in arm, headache and fever to be related to Shingrix.  Additional details were provided as follows: The consumer was the caller.  The patient reported that he had the 1st Shingrix vaccine in October, 2020.  That night or the next night, the patient experienced Fever, Headache, and arm pain for four to five hours. For tolerance in 2nd dose refer case US2021AMR008140. The reporter consent to follow up. This is 1 of 4 case reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021007474:Wife's 2nd dose US-GLAXOSMITHKLINE-US2021AMR008109:Wife's 1st dose US-GLAXOSMITHKLINE-US2021AMR008140:same patient, 1st dose
Age: 95.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect route of product administration, Vaccination site erythema, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Warm to touch to left arm including around the elbow; Redness to left arm including around the elbow; Swelling to left arm including around the elbow; Unsure if the injection site was muscle or subcutaneous; A spontaneous report was received from a healthcare professional concerning a 95-year-old, male consumer who developed redness, swelling, warm to touch after receiving a second dose of Moderna's COVID-19 vaccine administered at inappropriate site.  The patient's medical history was not provided. No relevant concomitant medications were reported.  The patient received their first of two planned doses of mRNA-1273 (Lot number:039k20a) intramuscularly in the right arm on 30 Dec 2020. On 26 Jan 2021, approximately 3 days prior to the onset of the symptoms, patient received their second of two planned doses of mRNA-1273 (Lot number: 012M20A) unknown route of administration in the left arm for prophylaxis of COVID-19 infection.  The patient was administered mRNA-1273 vaccine incorrectly, on 26 JAN 2021. On 29 Jan 2021 redness, swelling, and warm to touch noted to all the left arm including around the elbow. Treatment for the event include Benadryl(diphenhydramine) onetime only dose and cold compress. Area circled with marker.    The patient received both scheduled dose of mRNA-1273 prior to the event; therefore, action taken with the drug in response to the event is not applicable.  The event, vaccine administered at inappropriate site, was considered resolved. The outcome for the events redness, swelling and warm to touch, was not provided.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, COVID-19 pneumonia
Clinical narrative: COVID-19 pneumonia; A spontaneous report was received from a nurse concerning a male patient, who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced Covid-19 pneumonia.  The patient's medical history was not provided. Concomitant medications were not reported.  On 20 Jan 2021, six days prior to the onset of events, the patient received their first two planned doses of mRNA-1273 (Batch number: unknown) intramuscularly for the prophylaxis of COVID-19 infection.  On 26 Jan 2021, the patient experienced symptoms of Covid-19 pneumonia. The reporter stated, the was patient tested positive for Covid-19 on 04 Feb 2021 and currently recovering from pneumonia.  No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not reported.  The outcome of event, Covid-19 pneumonia, was considered resolving.; Reporter's Comments: This case concerns a male subject of unknown age who experienced a serious unexpected event of COVID-19 pneumonia. Event onset on 26Jan21, 6 days after first dose of mRNA-1273 on 20Jan21. SARS-CoV-2 test positive on 04Feb21. Treatment not reported. Event resolving. Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Sex: U
Vaccine: COVID19
Symptoms: Incorrect dose administered, Needle issue, Syringe issue
Clinical narrative: Received part of the dose but not full; Needle issue; Syringe issue; A spontaneous report was received from a nurse concerning a patient of an unknown age and sex who received Moderna's COVID-19 vaccine (mRNA-1273) and needle and syringe came apart, fell on the ground and received part of the dose but not full,  Medical history was not reported. No concomitant medication was reported.  On an unknown date, prior to the onset of the events needle and syringe came apart, fell on the ground and received part of the dose but not full, the patient received their first of two planned doses of mRNA-1273 (lot/batch: unknown) via an unknown route in an unknown anatomical location for prophylaxis of COVID-19 infection.  Treatment medication was not reported.  Action taken with mRNA-1273 in response to the events needle and syringe came apart, fell on the ground and received part of the dose but not full was not provided.  The outcome of the events needle and syringe came apart, fell on the ground and received part of the dose but not full  was resolved.; Reporter's Comments: This report refers to a case of patient of an unknown age  who experienced non-serious unexpected events of needle and syringe came apart, fell on the ground and received part of the dose but not full (needle issue, syringe issue and incomplete dose administered) for mRNA-1273, lot # unknown. There were no reported AEs associated with this case of needle and syringe came apart, fell on the ground and received part of the dose but not full.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Stevens-Johnson syndrome
Clinical narrative: Stevens-Johnson Syndrome; A spontaneous report was received from a health care provider regarding a 71-year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced Stevens Johnson Syndrome, which results in blisters and rashes all over the body.  The patient's medical history not included. No Concomitant medication was provided.  On 02 Feb 2021, prior to the onset of the events, the patient received one of two planned doses of mRNA-1273 (Lot number: 025L20A) for prophylaxis of COVID-19 infection.    On 03 Feb 2021, the day after the mRNA-1273 vaccine was given, the patient experienced Stevens Johnson Syndrome, causing rashes and blisters all over her body.  Treatment information was not reported.   Action taken with mRNA-1273 was not reported.  The outcome of the events, Stevens Johnson Syndrome, causing rashes and blisters all over the patient's body, was not reported.; Reporter's Comments: Very limited information regarding this event has been provided at this time.  Further information has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea, Neuropathy peripheral, Vaccination complication, Vaccination site swelling
Clinical narrative: sharp pain in feet (neuropathy); swelling at site of injection; felt yucky and not feeling good at all; bad diarrhea; A spontaneous report was received from a consumer concerning a male patient, who received Moderna's COVID-19 Vaccine(mRNA-1273) and experienced sharp pain in feet, vaccination site swelling, bad diarrhea and not just feeling good.  The patient's medical history was not provided. No relevant concomitant medications were reported.    On 03 Feb 2020, the patient received their first of two planned doses of mRNA-1273 (batch number-010M20A) for prophylaxis of COVID-19.  On 04 Feb 2020, at 4:00 AM, the patient experienced sharp pain in feet, vaccination site swelling, bad diarrhea and not just feeling good.  No treatment medication was reported.  The outcome of events sharp pain in feet, vaccination site swelling, bad diarrhea and not just feeling good were reported Recovering/Resolving.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Platelet count, Platelet count decreased
Clinical narrative: Patient had low platelets and had to have a platelet transfusion; This is a spontaneous report received from a contactable nurse. A 54-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EL3248, Pfizer product), via an unspecified route of administration on right arm on 07Jan2021 at single dose for COVID-19 immunization in hospital. The patient's medical history included ongoing possibly has rheumatoid arthritis. No known allergies to medications, food, or other products. Concomitant medication included meloxicam (MOBIC) and multivitamin. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Pfizer product), intramuscularly on left arm on 17Dec2020 (54-year-old, Lot number: EH9899) at single dose for COVID-19 immunization. The patient did not diagnose with COVID-19 prior to vaccination. The patient did not test for COVID-19 since the vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 04Feb2021 11:00, the patient experienced low platelets and had to have a platelet transfusion. The patient visited doctor or other healthcare professional office/clinic and visited emergency room/department or urgent care due to the event. The event was considered as non-serious by the nurse. The outcome of the event was not recovered.; Sender's Comments: Based on the temporal relationship, the association between the event low platelets requiring platelet transfusion with BNT162b2 can not be fully excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Cyanosis, Headache, Lip disorder, Oropharyngeal pain
Clinical narrative: still her sore throat was going bad, didn't get better/sore throat had been going on for two weeks; her headaches were the same/She had a headache that didn't go away; her eyes sight, her vision sometimes was not clear/Her vision had also been affected. Sometimes she cannot see clearly; her lips looked like when had a high fever, which she hadn't and it's blue, the skin was going off/Her lips looked like she had a fever. Her lips were blue. Her lips were losing skin; her lips looked like when had a high fever, which she hadn't and it's blue, the skin was going off/Her lips looked like she had a fever. Her lips were blue. Her lips were losing skin; This is a spontaneous report from a contactable consumer (patient). A 68-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via unspecified route of administration on 22Jan2021 at single dose for COVID-19 immunization. The relevant medical history and concomitant medications were not reported. The patient stated that still her sore throat was going bad, didn't get better and her headaches were the same, her eyes sight, her vision sometimes was not clear and her lips looked like when had a high fever, which she hadn't and it's blue, the skin was going off and she didn't know. Her biggest concern was her headache and her sore throat. She called her Doctor and he said there was nothing that he can do to call for advice. She had been taking every 4 hours Tylenol and taking antiseptic for her sore throat which had helped her in numb that site and help her for like 1 hour-1 hour and a half but then it came back. She had side effects that were still active. The worst side effect was a sore throat. Her sore throat had been going on for two weeks at the time of the report. Sometimes it seemed like it was going to get better, and then it came back. Her vision had also been affected. Sometimes she cannot see clearly. She had a headache that didn't go away. Her lips looked like she had a fever. Her lips were blue. Her lips were losing skin. She had taken her temperature, and she didn't have a fever. The outcome of the events was not recovered.  Information about lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Visual impairment
Clinical narrative: still her sore throat was going bad, didn't get better/sore throat had been going on for two weeks; her headaches were the same/She had a headache that didn't go away; her eyes sight, her vision sometimes was not clear/Her vision had also been affected. Sometimes she cannot see clearly; her lips looked like when had a high fever, which she hadn't and it's blue, the skin was going off/Her lips looked like she had a fever. Her lips were blue. Her lips were losing skin; her lips looked like when had a high fever, which she hadn't and it's blue, the skin was going off/Her lips looked like she had a fever. Her lips were blue. Her lips were losing skin; This is a spontaneous report from a contactable consumer (patient). A 68-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via unspecified route of administration on 22Jan2021 at single dose for COVID-19 immunization. The relevant medical history and concomitant medications were not reported. The patient stated that still her sore throat was going bad, didn't get better and her headaches were the same, her eyes sight, her vision sometimes was not clear and her lips looked like when had a high fever, which she hadn't and it's blue, the skin was going off and she didn't know. Her biggest concern was her headache and her sore throat. She called her Doctor and he said there was nothing that he can do to call for advice. She had been taking every 4 hours Tylenol and taking antiseptic for her sore throat which had helped her in numb that site and help her for like 1 hour-1 hour and a half but then it came back. She had side effects that were still active. The worst side effect was a sore throat. Her sore throat had been going on for two weeks at the time of the report. Sometimes it seemed like it was going to get better, and then it came back. Her vision had also been affected. Sometimes she cannot see clearly. She had a headache that didn't go away. Her lips looked like she had a fever. Her lips were blue. Her lips were losing skin. She had taken her temperature, and she didn't have a fever. The outcome of the events was not recovered.  Information about lot/batch number has been requested.
Age: 85.0
Sex: M
Vaccine: COVID19
Symptoms: Amnesia, Blood test, Cognitive disorder, Magnetic resonance imaging, Sleep study
Clinical narrative: brain has slowed down; starting to lose his memory/memory loss; This is a spontaneous report from a contactable consumer. An 85-year-old male patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot nubmer: EL1283), via an unspecified route of administration on 29Jan2021 at a single dose on the right arm for COVID-19 immunization.  Medical history included heart valve replacement on an unknown date. The patient stated that he was taking concomitant medications (unspecified) but nothing out of the ordinary. It was reported that on 31Jan2021, Sunday afternoon, he noticed that he was starting to lose his memory. He said he suddenly forgot his age and had to ask his wife about it. He said he has consulted his doctor about this already, but still wants to give Pfizer a call to ask for advice on what to do. He also said he wants to go on record that he's having this kind of experience after receiving the vaccine. He said he has serious memory loss. It was bad Sunday afternoon and Monday morning but Monday afternoon it got better. The day before the report it was better but on the day of the report it is bad again. He went to see doctor regarding this; he hopes he doesn't lose his memory. He stated that on 01Feb2021 his brain has slowed down; his memory is gone. He went to see his primary care doctor, on 02Feb2021 he went to see another doctor, a brain doctor. He did a sleep test on 04Feb2021 with unknown results.  The patient stated that he is still struggling with it. He has seen his doctor and is working on it but wanted to let Pfizer know about this and would like us to know the conditions and if Pfizer would have any information on this happening. The patient had blood tests and an MRI done on an unspecified date in 2021 with unknown results. The patient did not receive treatment for the events. The outcome of the events is not recovered.