chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 45.0
Sex: F
Vaccine: COVID19, PNC20
Symptoms: Dysphagia, Erythema, Hypoaesthesia oral, Paraesthesia oral, Throat irritation
Clinical narrative: Patient experienced scratchy throat 5 to 10 min after receiving the two vaccinations.  She came over to the pharmacy counter and I told her to sit down in front of me for a little bit.  After another 10 min she complained that her tongue and lips felt numb and tingled, and was having slight difficulty swallowing.  Her chest looked red.  At this point I called for EMS and continued to monitor.  She never had full blown anaphylactic symptoms, and an Epipen was never used.  After being evaluated by EMS in the ambulance she declined futher treatment and drove herself home.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, No adverse event, Product administration error
Clinical narrative: Immunocompromised patient was here for his 1st booster with Pfizer and LVN vaccinator accidentally administered 1st booster shot early. Patients third dose of his primary series was administered on March 30 2022. First booster dose should have been administered three months after 3rd dose. Patient had no adverse reaction or side effects at time of administration and was assessed by RN on duty and informed of error. On call MD was also notified and no further treatment was recommended by MD.
Age: 11.0
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Product administered to patient of inappropriate age, Tenderness, Wrong product administered
Clinical narrative: Pentacel dose was inadvertently given to an 11 year old patient instead of Tdap.  She developed right arm tenderness and was seen again 2 days later and was prescribed Tylenol and advised to use ice packs
Age: 1.0
Sex: F
Vaccine: HEPA, VARCEL
Symptoms: Blister, Erythema
Clinical narrative: Redness and blister all over body after vaccines administered after getting home from clinic. Physician determined reaction was from varicella vaccine.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Cardiac disorder, Pain in extremity, Peripheral swelling
Clinical narrative: arm hurt and swollen, heart issues
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature increased, Injection site erythema, Injection site pain, Injection site pruritus, Injection site warmth
Clinical narrative: At about 3PM on 10/27/2021, I received my first Moderna booster for COVID-19. About an hour and a half later, the injection site turned red and became itchy. I ran a temperature of 101 degrees. By the morning of 10/28/2021, there was a 4-to 5-inch radius around the site that was red, hot, and itchy. It itched for 6 days. By 10/29/2021, there was pain that extended from the right side of my neck to my right elbow. I had had tendonitis before, and it reminded me of this. The pain continues to the time of this writing. On 6/7/2022, I went to an orthopedist to be treated for a condition not related to the vaccine. While I was there, I asked them if anything could be done to also treat the pain in my neck and arm. The doctor advised that it sounded like I had tendonitis, and she gave me a cortisone injection in the right shoulder. The cortisone shot has helped, though it has not completely eliminated the pain, and the doctor has recommended exercises for me to do. I am to return on 7/19/2022 for a follow-up. I will also add that I received my second Moderna booster on 5/18/2022, and this exacerbated the pain.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Neck pain, Pain, Tendonitis
Clinical narrative: At about 3PM on 10/27/2021, I received my first Moderna booster for COVID-19. About an hour and a half later, the injection site turned red and became itchy. I ran a temperature of 101 degrees. By the morning of 10/28/2021, there was a 4-to 5-inch radius around the site that was red, hot, and itchy. It itched for 6 days. By 10/29/2021, there was pain that extended from the right side of my neck to my right elbow. I had had tendonitis before, and it reminded me of this. The pain continues to the time of this writing. On 6/7/2022, I went to an orthopedist to be treated for a condition not related to the vaccine. While I was there, I asked them if anything could be done to also treat the pain in my neck and arm. The doctor advised that it sounded like I had tendonitis, and she gave me a cortisone injection in the right shoulder. The cortisone shot has helped, though it has not completely eliminated the pain, and the doctor has recommended exercises for me to do. I am to return on 7/19/2022 for a follow-up. I will also add that I received my second Moderna booster on 5/18/2022, and this exacerbated the pain.
Age: 65.0
Sex: M
Vaccine: PPV
Symptoms: Axillary pain, Fatigue, Injection site discolouration, Injection site pain, Injection site rash
Clinical narrative: General feeling of unwell, fatigue, injection site pain radiating to armpit, edema at armpit, discoloration/rash at site, on shoulder and under armpit.  Shooting pain in left shin, temperature at 99.7.
Age: 65.0
Sex: M
Vaccine: PPV
Symptoms: Malaise, Oedema peripheral, Pain, Pain in extremity, Rash
Clinical narrative: General feeling of unwell, fatigue, injection site pain radiating to armpit, edema at armpit, discoloration/rash at site, on shoulder and under armpit.  Shooting pain in left shin, temperature at 99.7.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Limb discomfort, Mobility decreased, Musculoskeletal discomfort
Clinical narrative: Patient called today stating her arm and shoulder are still "bothering her" and she feels that she is unable to "properly use her arm". She is concerned about the placement of the shot, she feels it might have been done too high in her arm and potentially caused damage. She says the shot itself didn't hurt but that the symptoms developed the next day and have worsened and now she is unable to lift her arm or properly use it and it is not getting any better. I told her that it may take a couple of days to feel better, each shot is different, and that I would report the event. She could also speak to the pharmacist who administered it if she called in on Saturday when he was working.
Age: 47.0
Sex: F
Vaccine: YF
Symptoms: Dyspepsia, Dyspnoea, Ear discomfort, Eustachian tube dysfunction, Hypersensitivity
Clinical narrative: within 10 minutes nasal stuffiness began, and was unable to take full breaths through nose but was able to breathe normally through mouth; used Asmanex inhaler and felt some relief, figured it was an anxiety response, given history; woke next morning with ear pressure and inability to hear clearly; call to allergist indicated need to visit urgent care; urgent care physician confirmed allergic response to something and diagnosed "1. Allergic reaction, initial encounter T78.40XA and 2. Dysfunction of both eustachian tubes  H69.83  tube dysfunction and mentioned in notes "TM clear.  White.  Air-fluid level noted.  Somewhat bulging.  Immobile to Valsalva", prescribed a return to oral prednisone already on hand for allergic reactions, an increase to double of normal dose of xyzal, add zantac, and add Astelin spray; next morning (~36 hours after vax) ear pressure had not decreased, and gastric distress (reminiscent of the worst case experienced when my entire body was inflamed before getting under the care of an allergist) had begun.  At this time, ~50 hours post vax, inflammation in sinuses, nasal cavity, ear canals remain and are same or worse than when began meds to control, digestive is decreasing with use of H2 blocker, anti-inflammatory diet, and quality probiotic
Age: 47.0
Sex: F
Vaccine: YF
Symptoms: Hypoacusis, Nasal congestion, Paranasal sinus inflammation, Tympanic membrane disorder
Clinical narrative: within 10 minutes nasal stuffiness began, and was unable to take full breaths through nose but was able to breathe normally through mouth; used Asmanex inhaler and felt some relief, figured it was an anxiety response, given history; woke next morning with ear pressure and inability to hear clearly; call to allergist indicated need to visit urgent care; urgent care physician confirmed allergic response to something and diagnosed "1. Allergic reaction, initial encounter T78.40XA and 2. Dysfunction of both eustachian tubes  H69.83  tube dysfunction and mentioned in notes "TM clear.  White.  Air-fluid level noted.  Somewhat bulging.  Immobile to Valsalva", prescribed a return to oral prednisone already on hand for allergic reactions, an increase to double of normal dose of xyzal, add zantac, and add Astelin spray; next morning (~36 hours after vax) ear pressure had not decreased, and gastric distress (reminiscent of the worst case experienced when my entire body was inflamed before getting under the care of an allergist) had begun.  At this time, ~50 hours post vax, inflammation in sinuses, nasal cavity, ear canals remain and are same or worse than when began meds to control, digestive is decreasing with use of H2 blocker, anti-inflammatory diet, and quality probiotic
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Rash pruritic, Rash pustular, Skin warm
Clinical narrative: I have never had Atopic dermatits/eczema before.  Started around 48h post injection.    Pustule type rash both antecubital areas- Worse next day and spreading-  More prominent, bright, hot and now also on R jaw line.  Took Benadryl & valacyclovir incase it was a weird flare of some HSV type thing ( Have had HSV flares post flu vaccines in the past) Rash was not itching in the beginning but became very itchy on about day 4.  More areas of breaking out-  Large band around R waist and skinny band below R waist where my under ware rubbed.  Most of breaking out was on the R side (Vaccine on the R arm) but was some on L antecub area. Tried more Benadryl  PO and topicals like Aveeno anti-itch to rash area.  Went on 6/2 to Urgent care.  Rx for Kenalog topical to rash.  Felt this made it worse.  so stopped that.   Taking Cetirizine daily and Benadryl at bedtime finally helped the itching along with Aveeno topical, cool compresses & ice to extra itchy spots. Started to finally get better on 6/7.  Most areas calming down but did get a new area on R clavicle area on 6/6
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Cough, Discomfort, Exposure to SARS-CoV-2, Fatigue
Clinical narrative: I knew I had been exposed to COVID-19 on Friday April 01, 2022. On Sunday I started having congestion but tested negative. By that Monday I tested positive, I was very congested, had extreme back, I could not lie down or get comfortable.  I kept testing positive for fourteen days. I had a telehealth visit with the doctor who advised me take over the counter Dayquil and Nyquil for my symptoms. By week three I stopped testing positive but had a cough, lingering fatigue and some congestion.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Respiratory tract congestion, SARS-CoV-2 test positive
Clinical narrative: I knew I had been exposed to COVID-19 on Friday April 01, 2022. On Sunday I started having congestion but tested negative. By that Monday I tested positive, I was very congested, had extreme back, I could not lie down or get comfortable.  I kept testing positive for fourteen days. I had a telehealth visit with the doctor who advised me take over the counter Dayquil and Nyquil for my symptoms. By week three I stopped testing positive but had a cough, lingering fatigue and some congestion.
Age: 17.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Hyperhidrosis
Clinical narrative: Patient felt dizziness once standing up to leave after waiting 10 min post vaccine. This resolved after lying on the ground and elevating his feet.  He also experienced some sweating during the dizzy spell. After about 40 minutes, all his symptoms resolved.
Age: 94.0
Sex: F
Vaccine: COVID19
Symptoms: Extra dose administered, Inappropriate schedule of product administration
Clinical narrative: Patient's third dose was given on 2/16/2022.  The 4th dose (2nd booster) was given less than 4 months after on 6/8/2022.
Age: 37.0
Sex: F
Vaccine: UNK
Symptoms: Dizziness, Nausea, Pain in extremity, Palpitations, Pyrexia
Clinical narrative: lightheadedness, nausea,  racing heart rate, fever, left arm soreness.
Age: 91.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Chronic obstructive pulmonary disease, Death, Influenza A virus test, Influenza B virus test
Clinical narrative: Case completed primary Covid vaccine in April 2021, then died of Covid in May 2022. Hospitalized at Medical Center. Was admitted to hospital with Change in mental status, fevers and exacerbation of COPD. She progressively grew more ill, and died in hospital after 3 days of care.
Age: 91.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Mental status changes, Pyrexia, Respiratory syncytial virus test, SARS-CoV-2 test positive
Clinical narrative: Case completed primary Covid vaccine in April 2021, then died of Covid in May 2022. Hospitalized at Medical Center. Was admitted to hospital with Change in mental status, fevers and exacerbation of COPD. She progressively grew more ill, and died in hospital after 3 days of care.
Age: 53.0
Sex: M
Vaccine: VARZOS
Symptoms: Back pain, Cold sweat, Fatigue, Feeling abnormal, Pyrexia
Clinical narrative: Pt. had pain in back, didn't feel good at work.  Had shaking, cold sweat, fatigue and fever of 101.0 degrees F.
Age: 53.0
Sex: M
Vaccine: VARZOS
Symptoms: Tremor
Clinical narrative: Pt. had pain in back, didn't feel good at work.  Had shaking, cold sweat, fatigue and fever of 101.0 degrees F.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, HEPA, MMR, VARCEL
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: Left Upper Arm pain and swelling around site of injection.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Alcohol use, Anxiety, Blepharospasm, Chest pain, Cold sweat
Clinical narrative: 2ND MODERNA VACCINE WAS ADMINSTERED. WITHIN SECONDS OF ADMINISTRATION PT BEGAN MOVING BACK AND FORTH, LOOKED FLUSHED AND I ASKED IF SHE WAS OK. PT RESPONSE WAS, ?YES, I DOWNED A BEER RIGHT BEFORE COMING IN TODAY!? (NO SMELL OF ETOH) I BEGAN TO EXPLAIN THAT ETOH BEFORE VACCINATIONS IS NOT A GOOD IDEA, WHEN THE PT BEGAN TO HAVE SUDDEN EYE TWITCHING AND SLUMPED OVER FOR SEVERAL SECONDS.  PT WAS RESPONSIVE TO QUESTIONS, COLOR WAS PALE AND CLAMMY. SHE SAID SHE LAST ATE AROUND 11AM. SHE ANSWERED QUESTIONS APPROPRIATELY. HER AND COMPANION STATED SHE HAD BEEN HAVING PAIN IN HER FEET FOR SOME TIME, ALONG WITH ANXIETY RELATED PAIN, (CHEST PAIN) THAT HER PCP HAD ORDERED STRESS TEST BUT SHE HAD NOT COMPLETED YET. PT BEGAN TO FEEL LIGHTHEADED AGAIN AND MENTIONED SEEING SOMETHING, THEN EYE TWITCHING OCCURRED FOR SEVERAL SECONDS. 911 WAS CALLED. VITAL SIGNS WERE TAKEN: 1ST SET SHOWED INCREASED HEART RATE OF 116 COUNTED, 147 (AUTOMATED DEVICE). 2ND SET OF VITALS ? BP: 101/60 HR79, EMTS WERE ON LOCATION THERE VITALS ? BP:102/71, HR 76, WITH REGULAR RHYTHM. THERE WAS NO APARENT PHYSICAL REACTION AT INJECTION SITE, NO REDNESS ON CHEST OR ABDOMEN, NO CHANGES IN VOCAL RESPONSE, PT WAS ABLE TO VERBALIZE NORMALLY, THE PT AT WAS RESPONSIVE, REFUSED TRANSFER TO HOSPITAL WITH EMT AND AGREED THAT IF SHE HAD ANY PROBLEMS OR CONCERNS SHE WOULD FOLLOW UP WITH PCP OR ED.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Dizziness, Dyskinesia, Flushing, Heart rate increased
Clinical narrative: 2ND MODERNA VACCINE WAS ADMINSTERED. WITHIN SECONDS OF ADMINISTRATION PT BEGAN MOVING BACK AND FORTH, LOOKED FLUSHED AND I ASKED IF SHE WAS OK. PT RESPONSE WAS, ?YES, I DOWNED A BEER RIGHT BEFORE COMING IN TODAY!? (NO SMELL OF ETOH) I BEGAN TO EXPLAIN THAT ETOH BEFORE VACCINATIONS IS NOT A GOOD IDEA, WHEN THE PT BEGAN TO HAVE SUDDEN EYE TWITCHING AND SLUMPED OVER FOR SEVERAL SECONDS.  PT WAS RESPONSIVE TO QUESTIONS, COLOR WAS PALE AND CLAMMY. SHE SAID SHE LAST ATE AROUND 11AM. SHE ANSWERED QUESTIONS APPROPRIATELY. HER AND COMPANION STATED SHE HAD BEEN HAVING PAIN IN HER FEET FOR SOME TIME, ALONG WITH ANXIETY RELATED PAIN, (CHEST PAIN) THAT HER PCP HAD ORDERED STRESS TEST BUT SHE HAD NOT COMPLETED YET. PT BEGAN TO FEEL LIGHTHEADED AGAIN AND MENTIONED SEEING SOMETHING, THEN EYE TWITCHING OCCURRED FOR SEVERAL SECONDS. 911 WAS CALLED. VITAL SIGNS WERE TAKEN: 1ST SET SHOWED INCREASED HEART RATE OF 116 COUNTED, 147 (AUTOMATED DEVICE). 2ND SET OF VITALS ? BP: 101/60 HR79, EMTS WERE ON LOCATION THERE VITALS ? BP:102/71, HR 76, WITH REGULAR RHYTHM. THERE WAS NO APARENT PHYSICAL REACTION AT INJECTION SITE, NO REDNESS ON CHEST OR ABDOMEN, NO CHANGES IN VOCAL RESPONSE, PT WAS ABLE TO VERBALIZE NORMALLY, THE PT AT WAS RESPONSIVE, REFUSED TRANSFER TO HOSPITAL WITH EMT AND AGREED THAT IF SHE HAD ANY PROBLEMS OR CONCERNS SHE WOULD FOLLOW UP WITH PCP OR ED.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pallor, Posture abnormal
Clinical narrative: 2ND MODERNA VACCINE WAS ADMINSTERED. WITHIN SECONDS OF ADMINISTRATION PT BEGAN MOVING BACK AND FORTH, LOOKED FLUSHED AND I ASKED IF SHE WAS OK. PT RESPONSE WAS, ?YES, I DOWNED A BEER RIGHT BEFORE COMING IN TODAY!? (NO SMELL OF ETOH) I BEGAN TO EXPLAIN THAT ETOH BEFORE VACCINATIONS IS NOT A GOOD IDEA, WHEN THE PT BEGAN TO HAVE SUDDEN EYE TWITCHING AND SLUMPED OVER FOR SEVERAL SECONDS.  PT WAS RESPONSIVE TO QUESTIONS, COLOR WAS PALE AND CLAMMY. SHE SAID SHE LAST ATE AROUND 11AM. SHE ANSWERED QUESTIONS APPROPRIATELY. HER AND COMPANION STATED SHE HAD BEEN HAVING PAIN IN HER FEET FOR SOME TIME, ALONG WITH ANXIETY RELATED PAIN, (CHEST PAIN) THAT HER PCP HAD ORDERED STRESS TEST BUT SHE HAD NOT COMPLETED YET. PT BEGAN TO FEEL LIGHTHEADED AGAIN AND MENTIONED SEEING SOMETHING, THEN EYE TWITCHING OCCURRED FOR SEVERAL SECONDS. 911 WAS CALLED. VITAL SIGNS WERE TAKEN: 1ST SET SHOWED INCREASED HEART RATE OF 116 COUNTED, 147 (AUTOMATED DEVICE). 2ND SET OF VITALS ? BP: 101/60 HR79, EMTS WERE ON LOCATION THERE VITALS ? BP:102/71, HR 76, WITH REGULAR RHYTHM. THERE WAS NO APARENT PHYSICAL REACTION AT INJECTION SITE, NO REDNESS ON CHEST OR ABDOMEN, NO CHANGES IN VOCAL RESPONSE, PT WAS ABLE TO VERBALIZE NORMALLY, THE PT AT WAS RESPONSIVE, REFUSED TRANSFER TO HOSPITAL WITH EMT AND AGREED THAT IF SHE HAD ANY PROBLEMS OR CONCERNS SHE WOULD FOLLOW UP WITH PCP OR ED.
Age: 20.0
Sex: M
Vaccine: COVID19
Symptoms: Fall, Loss of consciousness, Tremor
Clinical narrative: THE PATIENT PASSED OUT AND FELL OUT OF HIS CHAIR ABOUT 5 MINUTES AFTER RECEIVING THE VACCINE. IT WAS REPORTED THAT HIS HANDS WERE SHAKING AS HE WAS FALLING
Age: 45.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Incorrect dose administered, Laboratory test
Clinical narrative: received full dose instead of half dise, dizziness
Age: 45.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: received full dose instead of half dise, dizziness
Age: 66.0
Sex: F
Vaccine: PNC20
Symptoms: Fatigue, Headache, Injection site erythema, Injection site inflammation, Injection site pruritus
Clinical narrative: Day 1: Fatigue and mild headache Day 5: Upper right arm began itching Day 6: On upper right arm, red spots and small patches appeared that were raised and itchy. Day 7: On upper right arm, the red spots merged into larger patches, which were still raised, very itchy, and warm.Over the course of the day, the patches continued to merge, and formed one large area of inflammation, measuring 4"H x 3"W. Day 8: The inflamed area was one solid red area (4"H x 3"W), itchy, warm, and clearly outlined.  Day 9: The rash and inflammation began to lessen. Day 10: The rash  and inflammation had mostly disappeared.
Age: 66.0
Sex: F
Vaccine: PNC20
Symptoms: Injection site rash, Injection site swelling, Injection site warmth
Clinical narrative: Day 1: Fatigue and mild headache Day 5: Upper right arm began itching Day 6: On upper right arm, red spots and small patches appeared that were raised and itchy. Day 7: On upper right arm, the red spots merged into larger patches, which were still raised, very itchy, and warm.Over the course of the day, the patches continued to merge, and formed one large area of inflammation, measuring 4"H x 3"W. Day 8: The inflamed area was one solid red area (4"H x 3"W), itchy, warm, and clearly outlined.  Day 9: The rash and inflammation began to lessen. Day 10: The rash  and inflammation had mostly disappeared.
Age: 5.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered, Product administered to patient of inappropriate age
Clinical narrative: Wrong dose. Patient was given pfizer 0.3ml for 12+. Patient observed for 15 min and physician discussed situation with the parent.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Condition aggravated, Decreased appetite, Impaired work ability, Nausea
Clinical narrative: Nausea weakness multiple seizures that began at midnight the following morning and continued throughout 6/8 into 6/9. I missed 2 days worth of work. I had loss of energy no appetite
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Seizure
Clinical narrative: Nausea weakness multiple seizures that began at midnight the following morning and continued throughout 6/8 into 6/9. I missed 2 days worth of work. I had loss of energy no appetite
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Extra dose administered, Product administered to patient of inappropriate age
Clinical narrative: Patient received her second dose of the Janssen vaccine today. Pharmacist did not check her date of birth because this was her second dose. Patient is 17 years old.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Magnetic resonance imaging head normal, Magnetic resonance imaging normal, Myoclonus, Tinnitus
Clinical narrative: Tinnitus worsened dramatically within 24 hours after getting boosted. I have had middle ear myoclonus (objective tinnitus - clicking left ear) intermittently since Fall 2019. Mostly at night during hours of sleep, only a minor annoyance.  The morning after I got boosted, the tinnitus remained during the day, and MUCH MORE FORCEFULLY AND ALMOST CONTINUALLY.  I scheduled an appointment with an otologist April 25. He recommended I have an MRI - brain & external ear canal, done May 3, normal. I have followed up with the otologist who prescribed medication (Nortriptyline) which has not reduced the tinnitus. In fact it has continued to worsen.
Age: 3.0
Sex: M
Vaccine: DTAP
Symptoms: Gait disturbance, Inflammation, Pain, Peripheral swelling
Clinical narrative: swollen and inflamed thigh, limping, pain.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test normal, Chest discomfort, Dyspnoea, Feeling of body temperature change, Hormone level abnormal
Clinical narrative: After 3rd booster, I started experiencing chronic hives that shift from place to place all over my body. In conjunction with the hives, I am also experiencing nerve irritation/sensations (like icy-hot) that rotates all over my body in the same places that the hives happen to be. When I am having a bad flare-up, then I also start experiencing tightness in my chest and difficulty breathing. These symptoms get worse when my hormones are fluctuating.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Inflammatory marker increased, Nervous system disorder, Urticaria
Clinical narrative: After 3rd booster, I started experiencing chronic hives that shift from place to place all over my body. In conjunction with the hives, I am also experiencing nerve irritation/sensations (like icy-hot) that rotates all over my body in the same places that the hives happen to be. When I am having a bad flare-up, then I also start experiencing tightness in my chest and difficulty breathing. These symptoms get worse when my hormones are fluctuating.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Phlebitis, Skin discolouration
Clinical narrative: Patient's husband called about 30 minutes after she had received her Pfizer vaccination.  He said she had developed a pill sized blue/purple lump on the vein of her wrist that was on the same arm that the vaccine was administered on.  It was advised he take her to seek medical attention, preferable the ER. Patient's husband agreed to take her to seek medical attention and to update us on her status.
Age: 64.0
Sex: F
Vaccine: PNC20, VARZOS
Symptoms: Pain in extremity, Peripheral swelling
Clinical narrative: Patient's left arm swelled up and was sore to touch.  Has not improved since date of immunization.  Ironically, right arm is fine.  Patient has taken Benadryl to treat reaction and is going to see her PCP for additional treatment.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Contusion, Fatigue, Haemorrhage, Immune thrombocytopenia, Laboratory test
Clinical narrative: Patient became fatigued and noticed excessive bleeding and bruising in September 2021, but didn't understand there was a problem until January 2022. After a few appointments with PCP, he was referred to a Hematologist for Immune Thrombocytopenia. Hematologist did a battery of tests and continues to do so to rule out ITP as a secondary condition.  First treatment: Dexamethasone, 40 mg/day orally for 4 days on 5/9/2022 Outcome: Temporary increase of platelet count from a low of 30 (10^3/uL) to a high of 190 two weeks after treatment. Four weeks after treatment, platelet count returned to ~40.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Platelet count decreased
Clinical narrative: Patient became fatigued and noticed excessive bleeding and bruising in September 2021, but didn't understand there was a problem until January 2022. After a few appointments with PCP, he was referred to a Hematologist for Immune Thrombocytopenia. Hematologist did a battery of tests and continues to do so to rule out ITP as a secondary condition.  First treatment: Dexamethasone, 40 mg/day orally for 4 days on 5/9/2022 Outcome: Temporary increase of platelet count from a low of 30 (10^3/uL) to a high of 190 two weeks after treatment. Four weeks after treatment, platelet count returned to ~40.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Interchange of vaccine products, Pain
Clinical narrative: Pt was to receive 2nd booster of Pfizer, but Tech did not follow safety protocol, pulled a Janssen & Placed at Pfizer station, drew up 0.3 ml and labelled sheet as Pfizer, documented Pfizer lot number and expiration.  Gave sheet and drawn up syringe to pharmacist, who knew a Moderna and Pfizer were at the stations already.  Pharmacist pulled the Moderna and saw a Pfizer at the station.  Pharmacist gave IM shot to patient, Patient stated it stung .  Pharmacist noted that.  30 minutes later when the tech went to draw the Pfizer doses for the next group.  She realized she had pulled out a Janssen and had set it at the Pfizer station and drew it as a Pfizer.  (at end of the day pharmacist drew out of Pfizer what was left. Based on our shots that day it was one shot over.  Drew out contents of Janssen and sure enough , some vaccine was missing in spite of no Janssen shots scheduled.  Confirmed pt got a substandard dose of Janssen instead of mRNA Pfizer shot).
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature increased, Extra dose administered, Fatigue, Feeling cold, Injection site erythema
Clinical narrative: Nearly 24 hours later felt fatigued and nauseous. Then within the next hour had low grade temp with internal chilling and eventually by 9pm temp was 102. Continued with low grade temp the next 24 hours. Nausea was almost constant for the next 4 days.  Arm at injection site was red hot and very sore for 5 days. The area was about 2 x 4.  Had all of these symptoms ( minus the nausea)with  the first booster. Had significant lymph node swelling with first booster. Was in bed with headache, fever, and fatigue with that one. That booster was Pfizer #FF8839.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Injection site warmth, Nausea
Clinical narrative: Nearly 24 hours later felt fatigued and nauseous. Then within the next hour had low grade temp with internal chilling and eventually by 9pm temp was 102. Continued with low grade temp the next 24 hours. Nausea was almost constant for the next 4 days.  Arm at injection site was red hot and very sore for 5 days. The area was about 2 x 4.  Had all of these symptoms ( minus the nausea)with  the first booster. Had significant lymph node swelling with first booster. Was in bed with headache, fever, and fatigue with that one. That booster was Pfizer #FF8839.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Cardiac failure congestive, Cardiac imaging procedure abnormal, Cardiac ventricular thrombosis, Cardiomegaly, Cardiomyopathy
Clinical narrative: Shortness of breath, enlarged heart, thrombus in my left ventricle, low ejection fracture, congestion heart failure, cardiomyopathy.  Wore life vest for four month and finally had to get a internal cardiac defibrillator on June 3, 2022.  I have been on a heart failure protocol of medication since the end of January 2022.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea, Echocardiogram abnormal, Ejection fraction decreased, Implantable defibrillator insertion, Multiple gated acquisition scan abnormal
Clinical narrative: Shortness of breath, enlarged heart, thrombus in my left ventricle, low ejection fracture, congestion heart failure, cardiomyopathy.  Wore life vest for four month and finally had to get a internal cardiac defibrillator on June 3, 2022.  I have been on a heart failure protocol of medication since the end of January 2022.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling, Injection site urticaria
Clinical narrative: Pain at injection site, redness and swelling at injection site,  hives, itchiness on left bicep. Treatment: drink water, take Claritin Allergy  24-hour, take Ibuprofen, rest
Age: 50.0
Sex: M
Vaccine: COVID19, TDAP, VARZOS
Symptoms: Insomnia, Urticaria
Clinical narrative: pt reported getting hives in various parts of the body from 10:30pm on 6/6/22 to 2:30am on 6/7/22.  He did not take anything for it and it resolved on its own.  He had difficulty sleeping during that timeframe, but was able to go back to sleep later.  He is unclear which vaccine could have caused the reaction.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Angina pectoris, Chest pain, Dizziness, Fear, Helplessness
Clinical narrative: Palpations and burning sensation of the heart for about 1 hour. After that dizziness and low blood pressure (96/56) for about 24 hours. The second COVID-19 shot (Moderna 059H21A) on 12/28/21 gave me palpations only for about 10 minutes but I still had dizziness and low blood pressure for around 24 hours
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Hypotension, Palpitations
Clinical narrative: Palpations and burning sensation of the heart for about 1 hour. After that dizziness and low blood pressure (96/56) for about 24 hours. The second COVID-19 shot (Moderna 059H21A) on 12/28/21 gave me palpations only for about 10 minutes but I still had dizziness and low blood pressure for around 24 hours
Age: 42.0
Sex: U
Vaccine: HEPAB
Symptoms: Headache, Somnolence
Clinical narrative: Extreme drowsiness. Mild headache
Age: 11.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Fall, Feeling abnormal
Clinical narrative: Patient had his Booster Covid vaccine the day before. The next day in the afternoon, he felt light headed, went to the bathroom to run water and he fell. He was "out of it" for a few seconds and then came to. He was seen and back to baseline
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Diarrhoea, Fatigue, Headache
Clinical narrative: Headache, Myalgia, Arthralgia, Diarrhea,  NauseaVomiting,  Chills, Fatigue Narrative:
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Nausea, Vomiting
Clinical narrative: Headache, Myalgia, Arthralgia, Diarrhea,  NauseaVomiting,  Chills, Fatigue Narrative:
Age: 52.0
Sex: M
Vaccine: VARZOS
Symptoms: Palpitations
Clinical narrative: Dr. said when I asked him if he was ready for his #2 dose - he said no because for 5 days he had heart palpitations. First time that had ever happened to him. Kept an eye on it
Age: 65.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Fatigue, Injection site erythema, Injection site swelling
Clinical narrative: Strong immune response day following injection. Injection site swelled and redness/erythema spread to axilla and elbow. Caused significant fatigue. Responded well to Ibuprofen and Benadryl.
Age: 33.0
Sex: U
Vaccine: TYP, YF
Symptoms: Computerised tomogram, Electrocardiogram, Hypoaesthesia, Magnetic resonance imaging head, Magnetic resonance imaging spinal
Clinical narrative: Left Arm/Leg Numbness with Face Tingling Right Leg Numbness Numbness and Tingling continue
Age: 33.0
Sex: U
Vaccine: TYP, YF
Symptoms: Paraesthesia, Ultrasound scan
Clinical narrative: Left Arm/Leg Numbness with Face Tingling Right Leg Numbness Numbness and Tingling continue
Sex: U
Vaccine: COVID19, COVID19, COVID19
Symptoms: Blood pressure increased, Burning sensation, Cardiovascular insufficiency, Neuropathy peripheral, Paraesthesia
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An adult patient received BNT162b2 (BNT162B2), on 14Mar2021 at 10:00 as dose 1, single (Batch/Lot number: unknown), in left arm, on 06Apr2021 at 10:00 as dose 2, single (Batch/Lot number: unknown), in right arm and on 11Jan2022 at 12:00 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: penicillin" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), outcome "unknown", COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19.  Patient received the treatment of Antiviral paxlovid for COVID19 from 25May2022 till  29May2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19, COVID19, COVID19
Symptoms: Antibody test, Antinuclear antibody, Antinuclear antibody increased, Blood pressure increased, Blood pressure measurement
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An adult patient received BNT162b2 (BNT162B2), on 14Mar2021 at 10:00 as dose 1, single (Batch/Lot number: unknown), in left arm, on 06Apr2021 at 10:00 as dose 2, single (Batch/Lot number: unknown), in right arm and on 11Jan2022 at 12:00 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: penicillin" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), outcome "unknown", COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19.  Patient received the treatment of Antiviral paxlovid for COVID19 from 25May2022 till  29May2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19, COVID19, COVID19
Symptoms: Burning sensation, Haematoma, Heart rate, Heart rate increased, Hypoaesthesia
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An adult patient received BNT162b2 (BNT162B2), on 14Mar2021 at 10:00 as dose 1, single (Batch/Lot number: unknown), in left arm, on 06Apr2021 at 10:00 as dose 2, single (Batch/Lot number: unknown), in right arm and on 11Jan2022 at 12:00 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: penicillin" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), outcome "unknown", COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19.  Patient received the treatment of Antiviral paxlovid for COVID19 from 25May2022 till  29May2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19, COVID19, COVID19
Symptoms: Insomnia, Laboratory test, Middle insomnia, Neuropathy peripheral, Peripheral coldness
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An adult patient received BNT162b2 (BNT162B2), on 14Mar2021 at 10:00 as dose 1, single (Batch/Lot number: unknown), in left arm, on 06Apr2021 at 10:00 as dose 2, single (Batch/Lot number: unknown), in right arm and on 11Jan2022 at 12:00 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: penicillin" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), outcome "unknown", COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19.  Patient received the treatment of Antiviral paxlovid for COVID19 from 25May2022 till  29May2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19, COVID19, COVID19
Symptoms: Poor peripheral circulation, Thrombosis
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An adult patient received BNT162b2 (BNT162B2), on 14Mar2021 at 10:00 as dose 1, single (Batch/Lot number: unknown), in left arm, on 06Apr2021 at 10:00 as dose 2, single (Batch/Lot number: unknown), in right arm and on 11Jan2022 at 12:00 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: penicillin" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), outcome "unknown", COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19.  Patient received the treatment of Antiviral paxlovid for COVID19 from 25May2022 till  29May2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An adult patient received BNT162b2 (BNT162B2), on 14Mar2021 at 10:00 as dose 1, single (Batch/Lot number: unknown), in left arm, on 06Apr2021 at 10:00 as dose 2, single (Batch/Lot number: unknown), in right arm and on 11Jan2022 at 12:00 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: penicillin" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), outcome "unknown", COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19.  Patient received the treatment of Antiviral paxlovid for COVID19 from 25May2022 till  29May2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 40.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Anaphylactic reaction, Dizziness, Dysphagia, Dyspnoea, Flushing
Clinical narrative: Immediate onset of anaphylaxis to include breaking out in hives, restricted airway with difficulty breathing and being able to speak, horse voice, hypertensive emergency blood pressure, hoarse voice, severe onset of Anaphylaxis. Pharmacy pharmacist administered three doses of EpiPen?s as well as 50 ML IM  Benadryl Intramuscularly. Patient also administered albuterol treatment while waiting for EMS. Patient received a total of seven EpiPen?s, three I am Benadryl injections, steroids, anti-histamine, Pepcid, oxygen.
Age: 40.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hyperhidrosis, Pruritus, Throat tightness
Clinical narrative: Immediate onset of anaphylaxis to include breaking out in hives, restricted airway with difficulty breathing and being able to speak, horse voice, hypertensive emergency blood pressure, hoarse voice, severe onset of Anaphylaxis. Pharmacy pharmacist administered three doses of EpiPen?s as well as 50 ML IM  Benadryl Intramuscularly. Patient also administered albuterol treatment while waiting for EMS. Patient received a total of seven EpiPen?s, three I am Benadryl injections, steroids, anti-histamine, Pepcid, oxygen.
Age: 40.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Anaphylactic reaction, Dysphonia, Dyspnoea, Hypertensive emergency, Immediate post-injection reaction
Clinical narrative: Immediate onset of anaphylaxis to include breaking out in hives, restricted airway with difficulty breathing and being able to speak, horse voice, hypertensive emergency blood pressure, hoarse voice, severe onset of Anaphylaxis. Pharmacy pharmacist administered three doses of EpiPen?s as well as 50 ML IM  Benadryl Intramuscularly. Patient also administered albuterol treatment while waiting for EMS. Patient received a total of seven EpiPen?s, three I am Benadryl injections, steroids, anti-histamine, Pepcid, oxygen.
Age: 40.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Obstructive airways disorder, Speech disorder, Urticaria
Clinical narrative: Immediate onset of anaphylaxis to include breaking out in hives, restricted airway with difficulty breathing and being able to speak, horse voice, hypertensive emergency blood pressure, hoarse voice, severe onset of Anaphylaxis. Pharmacy pharmacist administered three doses of EpiPen?s as well as 50 ML IM  Benadryl Intramuscularly. Patient also administered albuterol treatment while waiting for EMS. Patient received a total of seven EpiPen?s, three I am Benadryl injections, steroids, anti-histamine, Pepcid, oxygen.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Cardiac imaging procedure abnormal, Pericarditis, X-ray
Clinical narrative: Diagnosis of pericarditis
Age: 0.75
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported; improperly stored vaccine was administered; This spontaneous report was received from an office manager referring to a 9-month-old patient of unknown gender. The patient's concomitant medications, concurrent conditions, medical history and drug reactions/allergies were not reported.  On 06-MAY-2022, the patient received improperly stored Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (LIQUID PEDVAXHIB) (lot # T042013, expiration date: 22-JUL-2023, strength, dose and route were unknown) for prophylaxis (product storage error). The vaccine was exposed to 11.43 degrees Celsius for 4 hours and 45 minutes. There was no previous temperature excursion. No additional adverse event was reported.  This is one of several reports from the same reporter.; Sender's Comments:  US-009507513-2205USA003131: US-009507513-2205USA002848: US-009507513-2205USA002913: US-009507513-2205USA002951: US-009507513-2205USA002965: US-009507513-2205USA002988: US-009507513-2205USA003043: US-009507513-2205USA003118: US-009507513-2205USA003266:
Age: 0.33
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Poor quality product administered, Product packaging issue
Clinical narrative: she has a box of ROTATEQ in which the foil pouches containing ROTATEQ are unsealed; No other AE; three doses have been given out of that box; This spontaneous report was received from a registered nurse referring to a 4-months-old patient of unknown gender. Information about medical history, concurrent conditions and concomitant therapies was not provided.  On 15-FEB-2022, the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) at a dose of 2 milliliter (ml) orally, lot # 1742077 verified to be valid with an expiration date reported and established as 12-SEP-2022 (strength and vaccination scheme frequency were not provided) for prophylaxis. It was reported that the box of used rotavirus vaccine, live, oral, pentavalent (ROTATEQ) contained unsealed foil pouches and that three doses had been administered out of that box (Poor quality product administered, Product packaging issue). It was noticed on 11-MAY-2022 and the reporter could not be sure whether the foil pouches containing the administered dose were also unsealed. The patient did not have any adverse effects or symptoms following administration of the vaccine (No adverse event).  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2205USA003440: US-009507513-2205USA003333:
Age: 0.25
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported; During temperature excursion case/ improperly stored vaccine was administered; This spontaneous report was received from an office manager, referring to a 3 months old patient of unknown gender. The patient's pertinent medical history, drug reactions/allergies and concomitant therapies were unknown.     On 21-MAR-2022, the patient was vaccinated with improperly stored haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) (lot# T042013, expiration date 22-JUL-2023; formulation, strength, dose, frequency and route were not provided) for prophylaxis (product storage error). The storage temperature of the vaccine was 11.43 degrees Celsius for a time frame of 4 hours and 45 minutes. There was no previous temperature excursion. No additional adverse event (AE) or product quality complaint (PQC) reported.; Sender's Comments:  US-009507513-2205USA003131:
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: An expired dose (expired on 4/11/22/) of Vaqta Hep A adult vaccine was given to a patient on 5/3/22; This spontaneous report was received from an unspecified reporter via Sanofi and refers to an adult patient of unknown gender and age.  The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On 03-MAY-2022, the patient was administered an expired dose of hepatitis a vaccine, inactivated (VAQTA) intramuscular injection, expiration date: 11-APR-2022, administered for prophylaxis (strength, lot #, and route of administration were not provided).