chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Child has a trach and is ventilator dependent. Tolerated injections well but began to sneeze a few minutes after vaccination and became sweaty. The home health nurse and mother suctioned her and gave an atrovent breathing treatment then undressed her and used cool washclothes to wipe her face and back. Mother stated child looked dusky in the face and noted her left arm was red along with her left ear being red. Pulse ox was ~85% and heart rate around 160s.  Mother and home health nurse took child to the emergency room to be evaluated for possible allergic reaction to the vaccines.
fever 36hr p/vax;h/a, chills 7-8hr p/vax;motrin 200, APAP 500 pre ER;in ER APAP 650/Motrin 600;IV fluids & Solumedrol;
Rash started at injection site and went down to a scar which was due to a tuberculosis vaccine administered to me as an infant; little redness only at scar one week later; This is a spontaneous report from a contactable consumer, the patient. A 68-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7534) via an unspecified route of administration in the right arm on 16Mar2021 at 15:45 (at the age of 68-years-old), as a single dose for COVID-19 immunisation. Medical history included breast cancer on 2006, lumpectomy, radiation treatments, allergies to crafting and allergies to sulfa products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medications included atorvastatin 10 mg (MANUFACTURER UNKNOWN), metagenics bone builder forte (MANUFACTURER UNKNOWN) both for an unknown indication from an unknown date. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On an unknown date, the patient previously received tuberculosis vaccine which was administered as an infant in Italy. On 17Mar2021 at 12:00, the patient experienced rash which developed within 24 hours which started at injection site and went down to a scar which was due to a tuberculosis vaccine administered to her as an infant in Italy where she was born. The rash got better each day but at the time of report the patient had little redness only at scar one week later. The events did not result in doctor or other healthcare professional office or clinic visit, and emergency room or department or urgent care. No therapeutic measures were taken for the reported events. The clinical outcome of the event rash started at injection site and redness was recovering at the time of this report.   No follow-up attempts are needed. No further information is expected.
The very next day after receiving the injection, I was extremely fatigued. On the following Tuesday 4/12 I woke up with a headache that persisit for 16 hours.
I awoke at 2:00 AM the morning after the shot and was freezing. I could not stop shivering . Temperature was 101.4. Nauseous As the day progressed, I became achy and super tired. Developed red itchy rash on left inside arm from wrist to elbow.  Injection site was very sore and I developed a large red circle surrounding the injection site. I treated with Tylenol every 6 hours. Symptoms subsided over a 3 day period.
Parents report that for 24 hours after vaccine, both patient's eyes severely deviated to the side.
This spontaneous report was received from a certified medical assistant and refers to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not provided. On 25-MAY-2016, the patient as vaccinated with VARIVAX (Merck) (lot number, expiry date, dose and route); and also, on the same date, the patient was vaccinated with PROQUAD (Merck) (lot number, expiry date, dose and route). Concomitant therapies were not provided. No adverse event was reported. No product quality complain (PQC) was involved. Additional information has been requested.
19 year old male reports feeling dizzy, excessive sweating, nauseous and looks pale. Patient is placed on stretcher with legs elevated. Vital signs BP 85/60, SAT 97% P59, R24. Dxt 120 mg. Patient was evaluated by health personnel and Doctor. He was observed for 30 minutes. After 15 minutes patient was feeling better. He was observed for any changes. Patient was evaluated by medical emergency personnel. BP 120/80, 2:15 pm. Patient reports feeling better.
7 days post injection, itching started at the injection area.  After several hours, I experienced increased itching and by the following morning, there was an area of softball/baseball sized hardness and swelling covered by a bright red itchy rash that was warm to the touch.  I called my physician and he prescribed an antibiotic fearing I had developed an infection.  I was on Clindamycin 3x daily for 5 days.  Within 3-1/2 to 4 days the rash had disappeared, the itch and swelling had also gone away.  My arm appeared and felt normal, with the exception of occasional itching for a couple more days with no rash appearing at all.  To date, everything seems normal.
suspected vaccination failure; shingles; This case was reported by a consumer via (Shingrix GSK Chatbot) interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingles vaccine (received dose in 2004).   On an unknown date, the patient received Shingrix. On an unknown date, more than 2 years after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix.  Additional details were provided as follows: The case was reported by the consumer for himself/herself. The age at vaccination was not reported. The reporter stated that, had the Shingles shot in 2018, now have shingles at the time or reporting. This case was considered as suspected vaccination failure, since the details regarding the completion of primary vaccination schedule and laboratory confirmation for shingles were not provided.
Hospitalized 12/28/21-12/30/21  SOB,  cough, body aches, dyspnea,  hypoxia, bilateral pleural effusion,
p/vax pt exp an inj site rxn described as itching, red & swelling, 2 days p/vax;tx w/DPH;pt did not c/o any sickness;allergy to pollen;arm was reported to have got hot to touch & an unbearable itch & swollen 1/2 way down top part of arm;
PPV23 GIVEN 5/26/2009 IN LEFT DELT.  5/28/2009 LEFT ARM RED, SWOLLEN, WARM TO TOCH FROM ONE INCH BELOW INJECTION SITE TO ELBOW.  PATIENT STATES 5/27/09-ARM RED AND SWOLLEN NEAR INJECTION SITE.  PATIENT STATES 5/28/09 SWELLING IS MOVING DOWN THE ARM
within 24 hours: 1. bodywide hives 2. extreme pruritis 3. polyarticular arthralgia and arthritis  treated with Benadryl, loratadine and prednisone taper
JITTERY; MULTIPLE KINDS OF PAIN IN INJECTION ARM; FEVERISH FEELING; MUSCLE ACHE; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced jittery, multiple kinds of pain in injection arm, feverish feeling, and muscle ache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the muscle ache, feverish feeling, multiple kinds of pain in injection arm and jittery was not reported. This report was non-serious.
On JulyI 15, my arm starting swelling and very sore at the injection site. On July 16, I woke up with a fever of 102.4 degrees. It took six hours for my temperature to come down to 100 degrees. For six days my temperature fluctuated in the 100 degree range.  I also had sores in mouth,  severe headache and high fever. I felt terrible and unable to do anything  with my whole body hurt. I test for COVID-19 but it was negative. My doctor called in a prescription for my mouth which helped.  For my fever and body aches I would take Tylenol which helped. After six days I finally started feeling better.
Redness developed 2/7, on 2/10. Redness measured 9x7 cm.
Information has been received from a health professional concerning an approximately 15 month old male who in October 2001 was vaccinated with hepatitis B virus vaccine (+) HIB conjugate vaccine. In January 2002, the patient experienced autism. Upon internal review autism was considered to be an other medical event (OMIC). Additional information has been requested.
This spontaneous report as received from a medical assistant refers to 17 months child patient of unknown gender. The medical assistant stated there was a power outage on 12-APR-2014 and the VARIVAX doses from the freezer needed to be transported to unspecified hospital for proper storage. She stated VARIVAX was exposed to 46F for 1 hour, at worst. The patient received VARIVAX dose 0.5 ml, intramuscularly, lot J006358 expiry 23-MAY-2015, between 12-APR-2014 and 24-APR-2014. There was a site visit from local health department on an unspecified date. No adverse effects was reported. This is one of several reports from the same source. Additional information has been requested.
Progressively stiff and swollen MCP joint. Progressively worsened over 2 weeks, 24 hours of relief with second vaccine on 2/23/21 and then increasing swelling until could barely move affected joint. Joint continues to be swollen and stiff to this day.   Full body stiffness progressively worsening since 2/8 date that hand joint began to be specifically stiff and swollen.
Day 2 December 20 woke up with dizziness and nausea, and soreness to left arm  Day 3 December 21 having continued constant dizziness and waves of nausea thus far Spoke with Dr per phone she suggested to take Dramamine, which eased dizziness but feeling odd.  Unable to register for  v-safe not going thru from your end?
received the liquid portion only; received the liquid portion only; This case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a 11-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMXA6378, expiry date 1st May 2023) for prophylaxis.   On 27th July 2022, the patient received Menveo. On 27th July 2022, unknown after receiving Menveo, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 01-Aug-2022 Reporter's Comments: The nurse reported on 1st August 2022, that the patient received the liquid portion of Menveo only on 27th July 2022. The reporter consented for follow up.  Additional Supportive Information: the patient received received the liquid portion of Menveo only on 27th July 2022, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
PATIENT STATED THAT VACCINES CAUSE HER A LOT OF PAIN IN THE BACK AND WENT TO THE DOCTOR AND DOCTOR IS TREATING HER LIKE IF SHE HAS SHINGLES AND PRESCRIBED HER VALTREX, TYLENOL #3 AND GABAPENTIN.
In the morning I noticed my left leg was discolored so I went to the Emergency room where they diagnosed with a blood clot in one of the deep veins in my left leg. I was put on blood thinners and kept over night for observation and then sent home on blood thinners the next day. and I'm also on compression socks
Patient received vaccine 03/18/21 at approximately 1200. At 1205 the patient reported a tightness in her throat and a tingling in her arm. At 1209 Epinephrine 0.5 mg (0.5 mL) was administered IM. EMS called. At 1213 O2 saturation was 98 At 1215 BP was 169/87 HR was 73 At 1218 O2 saturation was 97 BP 167/83 HR 68 At 1220 O2 saturation was 98 BP 169/83 HR 76 At 1221 EMS arrived and took patient to the ED via ambulance. Update (03/19/21) Called patient to follow up and she stated she was evaluated at Medical Center ED and monitored for approximately an hour before being discharged home on 03/18/21. She stated she has had no further s/sx.
No additional adverse effects reported; a patient was administered improperly stored PEDVAXHIB; This spontaneous report was received from a nurse and refers to a 14-month-old patient of unknown gender. No information regarding the patient's concurrent conditions, medical history and concomitant medications was provided.  On 20-DEC-2019, the patient was vaccinated with improperly stored haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) lot # R027329, expiration date 12-JUL-2021 (dose, route and site of administration were not provided) for prophylaxis. The administered vaccine experienced multiple temperature excursion 0.3 Celsius degrees below 2 Celsius degrees for 45 minutes. There was no previous temperature excursion. Data logger was involved. No additional adverse effects were reported.
4/30/21 - fatigue, headache, fever, sore arm 5/1/21 - very sore arm, raised red painful rash (not itchy) on arm  that is warm to the touch.
pt cried & c/o pain in lt arm 5PM; t102-APAP given; site swollen (golf ball size) & rash around it went 3/4 way around arm 1-2"; By 645PM rash on stomach; By 10PM t103, crying c/o aching, rash;
Developed erythema and induration and warmth and tenderness and edema R lateral arm - started about 24h after imz but worsened significantly between 24-48h.  diagnosis: cellulitis.  treated with clindamycin.
Vaccine 10:15am. Temp 100.5 by 6:00 p.m. Chills by 8:00 pm. Tremors, nausea, and some balance issues fall x4 10pm - 4a.m
Skin rash with blisters under skin approximate size 2 inch x 3 inch (deck of cards). Physician advised using Hydrocortisone topically - rash area was reduced to "silver dollar" size when I viewed 12/8/12.
EMPLOYEE- who states that she just had the COVID vaccine yesterday and cannot lift arm all the way up/only can lift half way. She also states that there is a radiating pain that goes from the injection site down her arm to the fingers. She additionally mentions a lump on back of shoulder (not red, mildly painful). States the injection site is mildly red but no swelling or pain. She denies fever but has mild body aches.
Episodes of angioedema of tongue increased; three or four in 2020 to about 16 or 17 in 2022.  Had an episode the week before the first shot; then another a week or two after the second shot (got second shot on 2/12/21, booster on 10/08/21) and about every three weeks after that.  Previously they were much more spaced out and less regular.  Controlled with prednisone, usually (sometimes goes away on its own.)  Also developed atrial flutter in April, 2021; Hospitalized for a few days. Cardiac ablation performed in May.
received expired dose of Bexsero; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a patient who received Men B NVS (Bexsero) (batch number ABXB29BA, expiry date 30th June 2022) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Bexsero and Bexsero Pre-Filled Syringe Device. On an unknown date, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 08-Aug-2022 Reporter's comment: The pharmacy intern reported that a patient inadvertently received an expired dose of Bexsero on an unknown date. The healthcare professional (HCP) opted out of follow-up. The reporter did not consent to follow-up. Additional supportive information: The patient received an expired dose of Bexsero, which led to expired vaccine used.
Troubled sleep (tossing & turning, frequent waking); slight fever; injection site pain; This is a spontaneous report from a contactable consumer. An adult male patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration on 11Apr2021 (Lot number was not reported) as single dose for covid-19 immunization. Patient received dose 1 for covid-19 immunization on unknown date. The patient's concomitant medications were not reported. The patient experienced troubled sleep (tossing & turning, frequent waking), slight fever, injection site pain on 11Apr2021. The outcome was recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained
Rash all over body. Fever for 3 days approx. 10 days after vaccine.
Muscles have been getting more tight; Muscle spasms and cramps; Pain is worse with movement of his right arm/difficulty picking things up/dropping things; His right arm started hurting; Pain/radiating up my shoulder and into my neck/down my biceps into my forearm and fingertips/pain in his arm, armpit, chest, and down his while right side; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (His right arm started hurting), PAIN (Pain/radiating up my shoulder and into my neck/down my biceps into my forearm and fingertips/pain in his arm, armpit, chest, and down his while right side), MUSCLE TIGHTNESS (Muscles have been getting more tight), MUSCLE SPASMS (Muscle spasms and cramps) and MOBILITY DECREASED (Pain is worse with movement of his right arm/difficulty picking things up/dropping things) in a 43-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 008C21A and 039A21A) for COVID-19 vaccination.     No medical history was provided by the reporter.    On 02-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 08-Jun-2021, the patient experienced PAIN IN EXTREMITY (His right arm started hurting) and PAIN (Pain/radiating up my shoulder and into my neck/down my biceps into my forearm and fingertips/pain in his arm, armpit, chest, and down his while right side). On an unknown date, the patient experienced MUSCLE TIGHTNESS (Muscles have been getting more tight), MUSCLE SPASMS (Muscle spasms and cramps) and MOBILITY DECREASED (Pain is worse with movement of his right arm/difficulty picking things up/dropping things). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Adverse reaction, at an unspecified dose and frequency; IBUPROFEN for Adverse reaction, at an unspecified dose and frequency; ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) for Tooth pain, at an unspecified dose and frequency and LIDOCAINE for Adverse reaction, at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (His right arm started hurting), PAIN (Pain/radiating up my shoulder and into my neck/down my biceps into my forearm and fingertips/pain in his arm, armpit, chest, and down his while right side), MUSCLE TIGHTNESS (Muscles have been getting more tight), MUSCLE SPASMS (Muscle spasms and cramps) and MOBILITY DECREASED (Pain is worse with movement of his right arm/difficulty picking things up/dropping things) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, X-ray: normal (normal) normal.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications include HIV antiviral medications. Diagnostic test included MRI scan, result yet to receive.   This case was linked to MOD-2021-368910, MOD-2021-368955 (Patient Link).
Rt thigh - area red, warm - area increased in size and developed a lg. red lump.
p/vax pt had severe/prolonged crying, pull legs up, very fussy lasted 1sk;
70 doses of Pfizer-BioNTech COVID-19 vaccine for pediatric patients (orange cap) batch/lot# FK5618  assigned a beyond-use-date (BUD, do not use after date) by the manufacturer due to previous storage and handling issues at another facility. The doses mistakenly administered to 70 patients on 11/26/2021.
PT HAD A RASH ON RIGHT ARM WHERE INJECTION SITE WAS, IT WAS WARM TO THE TOUCH.
difficulty moving the shoulder; This non-serious case was reported by a physician via sales rep and described the occurrence of mobility decreased in a female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   Co-suspect products included INFLUENZA VACCINE for prophylaxis.   On an unknown date, the patient received Arexvy (intramuscular) and INFLUENZA VACCINE. On an unknown date, an unknown time after receiving Arexvy, the patient experienced mobility decreased (Verbatim: difficulty moving the shoulder). The outcome of the mobility decreased was resolved (duration 8 weeks).   It was unknown if the reporter considered the mobility decreased to be related to Arexvy.     It was unknown if the company considered the mobility decreased to be related to Arexvy.   Additional Information: GSK Receipt Date: 25-OCT-2023 A GSK MSL Field Representative reported that a physician stated in his office that 3 female patients (no distinguishing factors provided), all received the Arexvy vaccine, and had difficulty moving the shoulder the vaccine was administered in for 6 to 8 weeks after administration. One of the female patients also received a flu shot (unknown product information) in her other arm at the same time as receiving the Arexvy vaccine, and had no difficulty with mobility in the flu shot arm. The GSK MSL Field Representative did not have any further information about this event, nor any information about lot/expiry or date of administration. The reporter consented to follow up. This case is linked with US2023147931, same reporter.; Sender's Comments:  US-GSK-US2023AMR149219:3rd female patient US-GSK-US2023147931:
Dizziness and Hot flash surges within the 15 minute time immediately after and occasionally thereafter for about an hour. Heavy fatigue all afternoon into the evening Extreme muscle fatigue 2 and 3 days afterwards in my legs making it feel like a statin reaction hard to walk with a normal stride.
Pt was administered the adjuvant portion of the vaccine only 0.5 ml IM. Pt arm sore x 5 days after administration, no other side effects.
Pt recv vax & devel inj site rxn of redness,warmth,itching & a lump. This is 1 of 3 pt from this site to exp adverse rxn p/vax w/lot #4968263.
Irregular heartbeat reported by my home BP Monitoring device in 4 successive sessions 03082021 03:20 PM through 03102021 10:12 AM. I have been monitoring my BP x2 or x3/week since 06142020 without a single report of irregular heartbeat' until the day of my 2nd COVID shot 03082021. My PCP recommended I come in for EKG on 03092021 and then for Echocardiogram and Zio Patch at Hospital 03112021. Completed Zio Patch and sent it 03152021 to lab for analysis.