chrisvoncsefalvay/vaers-outcomes huggingface dataset:
full dose was not given due to leaking; full dose was not given due to leaking/the syringe and barrel were not put on tightly so the full dose was not given due to leaking; This spontaneous case was reported by a pharmacist and describes the occurrence of INCORRECT DOSE ADMINISTERED (full dose was not given due to leaking) and DEVICE CONNECTION ISSUE (full dose was not given due to leaking/the syringe and barrel were not put on tightly so the full dose was not given due to leaking) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. UNK and 062E21A) for COVID-19 vaccination.     No Medical History information was reported.   On 11-Sep-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Sep-2021, the patient experienced INCORRECT DOSE ADMINISTERED (full dose was not given due to leaking) and DEVICE CONNECTION ISSUE (full dose was not given due to leaking/the syringe and barrel were not put on tightly so the full dose was not given due to leaking). At the time of the report, INCORRECT DOSE ADMINISTERED (full dose was not given due to leaking) and DEVICE CONNECTION ISSUE (full dose was not given due to leaking/the syringe and barrel were not put on tightly so the full dose was not given due to leaking) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient on Saturday, 11Sept2021 and the syringe and barrel were not put on tightly so the full dose was not given due to leaking. The note said that the provider had a gut feeling that more than half of the dose was injected Concomitant medications was not provided by the reporter. Treatment information was not provided
Information has been received from a registered nurse concerning a 6 year old male with no medical history or allergies who on 10-MAY-2007 was vaccinated SC on right thigh with the first 0.5 ml dose of Zostavax (Lot# 656859/0357U) instead of a dose of Varivax. There was no illness at the time of vaccination. It was reported as human error and not a product confusion. The nurse reported that child did not experience any difficulties. Unspecified medical attention was sought. A product quality complaint was not involved. Additional information has been requested.  Additional information has been recived from the registered nurse who stated that child had no adverse reaction. It was reported that there was nothing seen on the site of vacccination. No diagnostic laboratory teta were undertaken.  No further information is expectcted.
Multiple flares from psoriatic arthritis; Bad reaction after each shot; This spontaneous case was reported by a consumer and describes the occurrence of PSORIATIC ARTHROPATHY (Multiple flares from psoriatic arthritis) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PSORIATIC ARTHROPATHY (Multiple flares from psoriatic arthritis) (seriousness criterion medically significant) and VACCINATION COMPLICATION (Bad reaction after each shot). At the time of the report, PSORIATIC ARTHROPATHY (Multiple flares from psoriatic arthritis) and VACCINATION COMPLICATION (Bad reaction after each shot) outcome was unknown.            Concomitant product was not provided by the reporter.  Patient reported that after receiving 2nd dose she experienced multiple flares from psoriatic arthritis.  Treatment information was not provided 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.   This case was linked to MOD-2021-052726 (Patient Link).   Reporter did not allow further contact; Sender'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.
pt had a previous hospitalization at Hospital and was diagnosed positive for COVID in their ED; she was intubated in the ED and suffered cardiac arrest; CPR was performed; she was transferred to Medical Center where she was treated with COVID specific therapies; she was extubated but BiPAP dependent; family pursued tracheostomy; pt was reintubated and experienced a perioperative PEA arrest; pt became febrile; ABX were given; pt's condition deteriorated and she suffered A Fib requiring vasopressors; pt's condition worsened and she had PEA arrest, ACLS was performed but was unsuccessful; pt died in the hospital
10/12 Influenza Vaccination 1/2 hour later, developed sudden onset of abdominal cramps and diarrhea-explosive with incontinence also nausea and vomiting fever. Rehydration with IV fluids. Acetaminophen for fevers. Dx: Gastroenteritis and Colitis. 10/22/09 Medical records received from date 10/12/09. DX: acute gastroenteritis, treated, resolved. Presenting SX: received vax, within 1 hour pt c/o abdominal cramps and diarrhea 8-9x, incontinent x1, nausea, vomit x2. Assessment: WNL except hyperactive bowel sounds. ICD9 codes: 787.01, 558.9, 285.0, 792.1.
I had body chills, body aches and pain. I had a headache. About 3 weeks later I got a bad sore throat. I went to the doctor, they did a strep test, negative. They also did a COVID-19 test, negative. I then lost my voice for 3 months. I have been having breathing issues.
Patient came to the pharmacy today, 7/1/2022 stating that she has been experiencing muscle pain and can not move her left hand since receiving second dose dose of pfizer vaccine on 11/19/2021.
Others have got Shjngles after being vaccinated / Suspected Vaccination Failure; Others have got Shjngles after being vaccinated; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in an unspecified number of patients who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) 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 Shingles vaccine.  Additional details were provided as follows: The age at vaccination was not applicable for this report. The reporter stated that the patients got shingles after being vaccinated with Shingles vaccine. The patients did not get it as bad.  This case was considered as suspected vaccination failure, since the details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were not provided. This case had been linked with case US2021AMR095110, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR095110:Same reporter.
Rash was very itchy; Started to develop a rash in a circle about the size of the bandage on arm,pretty big rash,started out smaller (size of a quarter) but expanded on arm 3 to 3.5 inches or about tennis ball size; This spontaneous case was reported by a consumer and describes the occurrence of RASH PRURITIC (Rash was very itchy) and RASH (Started to develop a rash in a circle about the size of the bandage on arm,pretty big rash,started out smaller (size of a quarter) but expanded on arm 3 to 3.5 inches or about tennis ball size) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination.     Concomitant products included AZILSARTAN MEDOXOMIL, CHLORTALIDONE (EDARBYCLOR) for Blood pressure management, ROSUVASTATIN for an unknown indication.    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, the patient experienced RASH PRURITIC (Rash was very itchy) and RASH (Started to develop a rash in a circle about the size of the bandage on arm,pretty big rash,started out smaller (size of a quarter) but expanded on arm 3 to 3.5 inches or about tennis ball size). The patient was treated with CORTISONE at an unspecified dose and frequency. In February 2021, RASH (Started to develop a rash in a circle about the size of the bandage on arm,pretty big rash,started out smaller (size of a quarter) but expanded on arm 3 to 3.5 inches or about tennis ball size) had resolved. At the time of the report, RASH PRURITIC (Rash was very itchy) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient reported that her doctor thought the cause of the rash was the bandage. Dosage for Edarbyclor tab  was 40-25mg. The patient medical condition include blood pressure.   This case was linked to MOD-2022-458783, MOD-2022-458784 (Patient Link).
The same night of my 2nd shot, I experienced chills, body aches all over and a headache.  When I woke up in the morning the chills had stopped and the aches where only from the waist down.  I also kept having sharp shooting pain in my uterus on the left side off and on.  And my left nipple itched off and on.  I took an ibuprofen 800mg and the lower body aches went away, but I still had a slight headache.
Patient came in to vaccination site stating this would be her 3rd COVID-19 shot. Her CDC card also stated she had recevied her 1st and 2nd primary shots in February 2021 and March 2021. After she had received 0.3 ml Pfizer vaccination, her record was requested and it showed she received a 3rd primary vaccination in November 2021. This would make her inelliglbe for a booster shot at this time due to it not being 5 months since her 3rd primary shot. Patient did state she was immunocompromised, but did not state with what condition. Troubleshooting: reviewed when to call record with vaccinators and scribes, why patient shouldn't have received a 4th shot.
On the morning following vaccine (2/21), patient woke up feeling unwell and had small rash on L arm. Over the course of several days, the rash progressed to involve most of body, along with feeling short of breath, burning/itching  skin, joint pains and fever to 103..4 by self report on 2/23.  She came to our hospital2/24  due to sever discomfort in skin.   VS on adm in ED P 120 T 100.2 O2 satn 94%.  When we saw her at the bedside the following day 2/25 she had non blanching tense  erythema of  lower legs, described by dermatology as  pink urticarial appearing papules coalescing into plaques on the extremities and trunk (abdomen and chest>back)".  On my exam, she had "Confluent red, non blanching on lower legs (ie, more purpuric), blanching and confluent on inner thighs and anterior thighs.  More papular-confluent on R arm.  Min on abd, spares back and posterior thighs, palms and face.  Oropharynx and conj are ok" (Derm felt lesions were more urticarial than macular papular). She had some cough, chest tightness.  On the following day, when we walked her, her RA O2 satn dropped to mid 80s% then up to RA satn 93%.  She also had joint pains, particularly in hands. She was started on 70 mg of prednisone on 2/25--and improved thereafter.   By 2/28, her RA satn at rest was 98%, but dropped to 94% with walking.   The rash, skin discomfort and chest tightness improved.  Even her clients now say, she no longer sounds "like a dead horsse"  (she told me this on phone when I asked her vaccine details and told her I was reporting). Pt had taken bactrim for 7 days after 2/2 covid visit.  She had taken bactrim multiple times in the past without a problem for UTIs
Severe yellow mucus from nose and lungs.  Coughing all night.  Dizzy, headache, eyes watering. Later in weeks to come mucky bowel movements, then constipation.  Vision problems, eye floaters flashes and walking problems.  Taste of eggs for 2 weeks when coughing or blowing nose.  Still having issues.
nausea; muscle pain; shaking; chills; fever of 100, symptoms came back fever of 100.6; This non-serious case was reported by a consumer via call center representative and described the occurrence of nausea in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Flu vaccine with an associated reaction of nonspecific reaction (patient always gets a reaction when she receives a flu vaccine).   On 24-APR-2023, the patient received the 1st dose of Shingrix. On 25-APR-2023, 1 days after receiving Shingrix, the patient experienced nausea (Verbatim: nausea), muscle pain (Verbatim: muscle pain), tremor (Verbatim: shaking), chills (Verbatim: chills) and fever (Verbatim: fever of 100, symptoms came back fever of 100.6). The outcome of the nausea, muscle pain, tremor, chills and fever were not resolved.   It was unknown if the reporter considered the nausea, muscle pain, tremor, chills and fever to be related to Shingrix.  It was unknown if the company considered the nausea, muscle pain, tremor, chills and fever to be related to Shingrix.   Linked case(s) involving the same patient: US2023AMR063861   Additional Information: GSK Receipt Date: 1-MAY-2023. Reporter was the patient. The patient stated that the next day she experienced fever of 100, chills, shaking, muscle pain, and nausea.  Patient symptoms started to get better towards the end of the week but yesterday on Sunday 30 April 2023, patient stated that all the same symptoms came back fever of 100.6, chills, shaking, muscle pain and nausea.  The patient also stated that she always got a reaction when she received a flu vaccine.  The patient did not said what type of reaction she got or specified which flu vaccine she received. The reporter did not consent to follow-up.; Sender's Comments:  US-GSK-US2023AMR063861:Same reporter
My left eyelid will not open in the mornings. I try to open it on its own, but I have to open it with my fingers, then hold it open and I have to force my eye to blink several times in order for it to be normal. It does this every morning. Its like it is paralyzed.
SORE ARM FOR FEW HOURS; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. 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, and batch number were not reported) dose, start therapy date were not reported for covid-19 prophylaxis. 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 patient experienced sore arm for few hours. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sore arm for few hours. This report was non-serious.
Fever, chills, skin painful to touch, body pain, nausea, headache, lethargy. Hot flashes, nausea, fatigue and headache continuing 72 hours after shot.
The customer stated that the injection hurt at the time. I rubbed the arm and she had no other complaints - she came in after 3 days and stated she had spoken to her Dr. and he thought I had nicked a nerve.
pressure in chest; a reaction; solid 55 hours it was awful; 103.8 fever that wouldn't break/fever was still high; This spontaneous case was reported by a consumer and describes the occurrence of CHEST DISCOMFORT (pressure in chest), VACCINATION COMPLICATION (a reaction), FEELING ABNORMAL (solid 55 hours it was awful) and PYREXIA (103.8 fever that wouldn't break/fever was still high) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036C21A and 023C21A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure. Concomitant products included THYROID (ARMOUR THYROID) for an unknown indication.   On 05-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced CHEST DISCOMFORT (pressure in chest), VACCINATION COMPLICATION (a reaction), FEELING ABNORMAL (solid 55 hours it was awful) and PYREXIA (103.8 fever that wouldn't break/fever was still high). At the time of the report, CHEST DISCOMFORT (pressure in chest), VACCINATION COMPLICATION (a reaction) and FEELING ABNORMAL (solid 55 hours it was awful) outcome was unknown and PYREXIA (103.8 fever that wouldn't break/fever was still high) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 103.8 (High) High. On an unknown date, X-ray: result not reported (Inconclusive) Result not reported (2 X-rays).         Concomitant medication include blood pressure medication.  Patient reported after IV, and 2 X-rays her fever was still high, they gave her meds and in 10 hours she was fine. Treatment included extra strength Tylenol.   This case was linked to MOD-2021-410125, MOD-2021-410145 (Patient Link).
Arm swelling and rash. Rash comes with hard swelling and itchiness. I initially experienced it the day after my injection for up to 4 days after, and the rash came back on day 7.
Severe arm pain, myalgia, chills, temperature orally 99.9; severe nausea, headache, lethargy, fatigue. Nausea, myalgia and headache lasted approximately 12 hours; fatigue-24 hours.
Patient developed pain within in 12 hours. Within 36 hours patient broke out in blisters across the back of her arm.
pt starting w/an elevated temp & an upset stomach this occurred approx 3 1/2 hrs post vax; pts leg & arms ached during noc; temp was never actually taken by mom but states pt was hot to touch; 28AUG92 rash of fine red bumps was noted;
I have Covid Toes.  Red, splotchy, rough dark colored patches, red spots and itchy pain
Experienced a warm feeling all over her arm; This spontaneous case was reported by a consumer and describes the occurrence of SKIN WARM (Experienced a warm feeling all over her arm) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced SKIN WARM (Experienced a warm feeling all over her arm). At the time of the report, SKIN WARM (Experienced a warm feeling all over her arm) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not reported.  No treatment details were provided   Most recent FOLLOW-UP information incorporated above includes: On 13-Jul-2021: follow up received on 13-07-2021 contain no new information
On the evening of getting the vaccine, I experienced chills, fatigue, and body aches. These symptoms were mostly resolved within 24 hours. 5 days later, I noticed a tender lump in my arm on the opposite side of the vaccine injection site.
The patient developed erosive lesions that oozed 48 hours after the receipt of 4yo immunizations (including VARIVAX). Initially began on the nose and spread at nares and to right arm. Fever developed for 1 day 72 hours after vaccine given.
Within 10 hours post vax, the pt experienced swollen arm. The next day, she experienced flu. She indicated that since the vaccination, she has been experiencing chronic rhinitis, headaches, and white phlegm. She has been treated with Entex-LA and migraine pills.
This spontaneous report as received from a certified medical assistant/healthcare worker refers to multiple patients of unknown demographics. On unknown dates the patients were vaccinated with doses of improperly stored PROQUAD (Merck) (Lot # reported as 1008354, expiry date: 11-SEP-2016). No adverse effects reported. The outcome was unknown. No product quality complaint was involved. This report is one of several reports from the same reporter. Additional information has been requested.
Neuropathy in the right arm (not the arm I got the shots), irradiating to head and left foot.
Had Gardasil vaccine at school physical on 6/18/14. Woke at 0330 itching with rash around neck and back, then turned into large welts.  The rash extended down his trunk. He received Benadryl and Zantac at home. No respiratory involvement, given prescripton for prednisone.
Left upper arm, red and swollen (almost covering whole upper arm). Temperature last night was 100F to 101F, due to Prevnar vaccine. (Also had HIB given in LA).
Patient had Osats down to 80 around 20mins after vaccination with pulse upwards of 130. Gave patient 3-4L of O2. Patient did not respond and so epinephrine administered. EMS called. Patient's Osat was around 90 with pulse ranging from 80-120 after EMS arrived and consent received from family.
Site: Pain at Injection Site-Mild, Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Mild, Systemic: Hypotension-Mild, Systemic: Nausea-Mild, Systemic: Weakness-Mild, Additional Details: Patient described feeling nauseas about 10- 15 minutes after vaccination then patient fainted.  Patient regained alertness a couple minutes after fainting but was still weak and unable to get up.  Paramedics came and patient was found to be hypotensive after 15-20 minutes patients blood pressure restored and she was at full alertness and paramedics signed her release.
1 minute after injection: light headed, dizziness 3 minutes: headache 15 minutes: chills, headache, dizziness , arm pain at injection site 40 minutes: malaise, headache, chills, dizziness, arm soreness at injection site All symptoms continued  for over 24 hours before subsiding.
facility denied to give her second dose because she is under age; Soreness; Daughter is under age; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Soreness), PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Daughter is under age) and PRODUCT DOSE OMISSION ISSUE (facility denied to give her second dose because she is under age) in a 20-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination.     Concurrent medical conditions included Immune system disorder NOS.    On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Feb-2021, the patient experienced PAIN (Soreness) and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Daughter is under age). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (facility denied to give her second dose because she is under age). At the time of the report, PAIN (Soreness), PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Daughter is under age) and PRODUCT DOSE OMISSION ISSUE (facility denied to give her second dose because she is under age) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   concomitant medications included immunosuppressants No treatment information was reported.