chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Substantial swelling in elbow (same arm as injection).  Day 1, swelling confined to bursa, approx. size of golf ball.  Day 2, swelling spread to upper forearm and skin was red, and I had a slight fever.  Day 3, swelling began to recede, redness faded to pink, I no longer had a fever.  Day 4, continued improvement.  By Day 5, 95% normal.  Fairly substantial pain on Days 1 & 2 when I touched my elbow/forearm, but no pain otherwise.  Never any pain (except typical mild soreness) from injection site.  Days 1-6, I took 1 OTC naproxen twice per day and applied ice to elbow and forearm every hour or two during the day.
- Patient report redness around both eyes 2 days after vaccine which last for more than 10 days. Patient denied vision change - Patient is counseled to see physician for further evaluation - Patient describe burning sensation - Patient is using Neosporin to reduce burning sensation.
First dose on 21Jan2021; second dose not yet received; hHs lost 30 pounds since having the first dose; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (First dose on 21Jan2021; second dose not yet received) and WEIGHT DECREASED (hHs lost 30 pounds since having the first dose) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (First dose on 21Jan2021; second dose not yet received) and WEIGHT DECREASED (hHs lost 30 pounds since having the first dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (First dose on 21Jan2021; second dose not yet received) had resolved and WEIGHT DECREASED (hHs lost 30 pounds since having the first dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2021-138800 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-138800:Same reporter (wife case)
It started as a tickle in my throat and I started coughing and the pharmacist checked my pulse. I got a really bad metallic taste in my mouth and the ambulance came and I refused treatment. I had massive headaches.
24 hours after vaccine hives on right and left firearms and on right and left feet. Took 2 25mg Benadryl. Hives subsided. Next day, 11/7/22 hives noted under left eye.  Went to Urgent Care Clinic. Doctor gave. Steroid shot and prescribed prednisone for 5 days
About one week after I received the Covid vaccine, I got a rash on my left arm. It was about 3 inches across. It did not itch, was not warm, no raised portions. It was red, mostly solid in color.
received the vaccine and is currently 14 weeks pregnant; A spontaneous report was received from a 34 year old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and is currently 14 weeks pregnant.  As provided by the reporter, the patient had no history of allergies to medications or food, and no history of alcohol, nicotine or marijuana intake. The patient had no family history of congenital anomalies/genetic disease. The patient had no previous pregnancy history.  Concomitant medications taken during pregnancy included prenatal vitamins minerals nos, vitamins nos and acetylsalicylic acid.   The expected due date was estimated as 27 Jun 2021.   On 28 Dec 2020, at 10:12 am, the patient received their first of two planned doses of mRNA-1273 intramuscularly (lot :026L20A) in her right arm for prophylaxis of COVID-19 infection while currently 14 weeks pregnant. The patient reported no side effects to vaccine.  Action taken with mRNA-1273 vaccine was unknown.  The outcome of the event of vaccine exposure during pregnancy was considered unknown; Reporter's Comments: This is a case of vaccine exposure during pregnancy with no associated AEs for this 34 year old female who is 14 weeks pregnant. Patient will continue to be contacted for further monitoring of AEs during the pregnancy
Chest pain and swollen neck breathing on shot 1. Shot 2 no trouble breathing or sickness but within day or 2 right eye going blurry. 10 days later, still double vision and blurry in right eye, with no issues prior to vaccine.
3 month old male patient was administrated a dose; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 3-month-old male patient who received Flu Seasonal QIV Quebec (FluLaval Quadrivalent 2021-2022 season) (batch number e9r44, expiry date 30th June 2022) for prophylaxis.   Co-suspect products included flu seasonal qiv quebec pre-filled syringe device (Flulaval Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 1st October 2021, the patient received FluLaval Quadrivalent 2021-2022 season and Flulaval Tetra Pre-Filled Syringe Device. On 1st October 2021, unknown after receiving FluLaval Quadrivalent 2021-2022 season and Flulaval Tetra Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration 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 details were provided as follows: It was reported that 3 months old patient was administrated a dose of the FluLaval Quadrivalent by mistake, which led to inappropriate age at vaccine administration.  The HCP did not clarify from what season the vaccine administrated belonged to.  No further events were reported. The reporter agreed to be contacted for follow-up.
Nurse accidentally administered 2nd dose of Moderna one week too early. When patient came in for booster dose on 1/20/2023, the error was realized and client was administered a repeat dose of primary moderna to complete series per CDC guidelines. Client/ MOC was made aware of error and ensured that there is no safety concerns or harm according to CDC data for repeating dose. Advised to return in 2 months for booster dose. MOC verbalized understanding.
local react & fever to 103.8 20 hrs p/shot & mild h/a; little nausea; no vomiting; signs & sz subsided w/in next 48 hrs;
Patient was given second dose of Moderna COVID-19 vaccine at 615pm.  Patient waited in area near pharmacy then left to go shopping.  She was shopping in store and returned to the pharmacy at 700pm with a her items in a shopping cart and said that she was having a nose bleed as pharmacy staff was leaving pharmacy for closing.  Patient had already contacted EMS on her personal cell phone and was sitting the in pharmacy waiting area.  Staff went to get her paper towels for her nose and contacted a member of store management to assist.  Store management came over with blood born spill kit and was watching patient as she waited for EMS to arrive. Patient was not given any medication or items for nosebleed other than paper towels to aid with the bleeding. Patient had stated that she had a nosebleed last month that was similar to the one she was having at the moment. EMS arrived and guided her to a stretcher and removed her from the building.
This case was reported by a consumer via call center representative and described the occurrence of dementia in a female patient who received SHINGRIX for prophylaxis. On 25th July 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced dementia (serious criteria GSK medically significant) and Parkinson's disease (serious criteria GSK medically significant). On an unknown date, the outcome of the dementia and Parkinson's disease were unknown. It was unknown if the reporter considered the dementia and Parkinson's disease to be related to SHINGRIX. Additional details were reported as follows: This case was reported by the patient's husband. The age at vaccination was not reported. When the patient received 1st dose of SHINGRIX, at the that time the patient was not diagnosed with the dementia-Parkinson's disease. The patient required by her healthcare provider to have their 2nd dose not later than end of 25th January 2019 (which was the prescribed 6 month window). The reporter wanted to know, was this 2nd dose vaccine really necessary or would it not gave bad side effects.
Patient received her vaccine, 20 minutes later reported a rash forming on her chest, and mild chest tightness. She has a history of Mast Cell Activation Syndrome, and had pre-medicated with Zyrtec. At 1420 the nurse administered 25mg PO Benadryl. at 1450, she felt her symptoms and decreased, and went home with her spouse.
Pt had inflammation, redness and warm to touch. Rash started at injection site and was moving down the arm. Pt was asked to see MD STAT and follow up with RPh as well.
Numbness in left arm, left side of neck and left side of face, on 8/4/2021. Resolved without treatment.
flu; Initial information received on 14-Nov-2020 regarding an unsolicited valid non-serious case received from a consumer or non-healthcare professional.  This case involves patient who experienced flu, when received vaccine INFLUENZA VACCINE.  The patient's medical history, past medical treatment, vaccination, concomitant medication and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by (unknown manufacturer lot number not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious flu (influenza) (unknown latency) following the administration of INFLUENZA VACCINE.  Laboratory details were not reported.   It was not reported if the patient received a corrective treatment.  The event outcome was unknown for influenza.  There will be no information available on the batch number for this case.
Pt started series with 6m-4yr formulation of COVID vaccine.  His third dose of primary series should've been monovalent vaccine 5-11yr, however Bivalent 5-11yr COVID Vaccine was ordered and administered.
an expired pentacel was given to a patient with no reported adverse event; Initial information received on 21-Mar-2023 regarding an unsolicited valid  non-serious case received from an other health professional.  This case involves a 1 years old male patient to whom an expired diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine [Pentacel (VERO)] was given with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included hepatitis A vaccine INACT (HAVRIX) for Prophylactic vaccination.  On 21-Mar-2023, the patient received 0.25 ml (milliliter) of suspect diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine, suspension for injection(lot number: UJ613AAA, expiry date: 25-Feb-2023) (1x) (once) (With unknown strength) via intramuscular route in the right thigh for immunization.  On 21-Mar-2023 the reporter reported that an expired pentacel was given to a patient with no reported adverse event (expired product administered) (latency: same day).  No lab data were reported.  Action taken: not applicable.  At time of reporting, the outcome was Unknown for an event.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Pain in arm - really swollen - flu-like symptoms. Next day - day 2 - red lines 4 x 7 around vaccination spot - went to Dr. was put on a prescription for bacteria infection. Memory loss, tired and no energy.
increasing soreness over coarse of first two days (so far); injection site sore, red, hard, and hot
Hard to breathe; Heart Palpitations; Dose number: 1 Administration date: 26Jun2021/ Dose number: 2 Administration date: 11Jul2021; Dose number: 1 Administration date: 26Jun2021/ Dose number: 2 Administration date: 11Jul2021; This is a spontaneous report from a contactable consumer (patient). A 16-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection, Batch/Lot number was not reported) via an unspecified route of administration, administered in Arm Left on 11Jul2021 13:00 (age at vaccination 16-years-old) as dose 2, single for covid-19 immunisation. Medical history included Leg-calve perches' disease, food allergy and milk allergy. The patient's concomitant medications were not reported. The patient previously took BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection, Batch/Lot number was not reported) via an unspecified route of administration, administered in Arm Left on 26Jun2021 13:00 (age at vaccination 16-years-old) as dose 1, single for covid-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient did not receive other medications in two weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient was not tested COVID-19 post vaccination. On 14Jul2021 22:30 the patient experienced heart palpitations and hard to breathe. The adverse events were resulted in a visit to Emergency room/department or urgent care. The patient was received treatment for the events. The patient underwent lab tests and procedures which included blood test: unknown results, electrocardiogram: unknown results, x-ray: unknown results on unknown date. The outcome of the events was unknown.  The lot number for the vaccine, was not provided and will be requested during follow up.
Flu type feeling a few hours after injecting but went away within two hours. Exhaustion following morning. Swelling of armpit area of injection arm feeling like there was a tennis ball in armpit, along with moderate to severe tenderness, still continuing.
1st dose 2018, 2nd not yet; This case was reported by a other health professional via call center representative and described the occurrence of incomplete course of vaccination in a 73-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in 2018).   On an unknown date, the patient did not  receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date: 23-September-2022 Reporter's comment: Reporter stated that patient had not received a second dose yet. Additional supportive information: Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.. Reporter consent to follow up via email above in HCP details.
Left deltoid site red, swollen itchy. (Approx. 6 inch size redness whole upper deltoid- almost to elbow). Less redness over time.
Dose administered and needle withdrawn nearly immediately. Nearly all of dose leaked from injection site. Based on CDC interim guidance, less than 1/2 of dose administered. Therefore, repeat dose given in contralateral arm (right arm).
pt recv vax 6JUL95 & 14JUL98 broke out w/chickenpox-red spots-clear blisters;
This is a spontaneous report from a contactable physician via Pfizer sales representative. A 69-year-old female patient started to receive PREVNAR 13; (lot number X30160 and expiration date Sep2020), via an unspecified route of administration on an unspecified date at 0.5 ml, single on the deltoid muscle of left arm for immunization. The patient's medical history and concomitant medications were not reported. It was reported that the patient's arm had red circle and pain for 3 weeks. The patient never had problems with other vaccines in the past. Outcome of the events was recovered on an unspecified date.
This spontaneous case, initially received from a pharmacist on 15-Oct-2018, (initial and follow-up 1 combinedly processed) concerns a 57-year-old, adult female patient. On an unspecified date, FLUCELVAX QIVc was stored at a maximum temperature of 56 F for 8 hours following a power outage. On 13-Oct-2018, the patient was administered FLUCELVAX QIVc (dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number: 252668 and expiry date: 30-Jun-2019) which was stored inappropriately. At the time of this report, no adverse event was reported. The reporter assessed the case as non-serious. This case 201804534 was cross-linked to source case: 201804533 due to same reporter.
Chest pain. Dx: Pericarditis 2 hrs smallpox vax. Tx: Advil
Covid-19 positive on 25-Dec-2021; This spontaneous case was reported by a physician and describes the occurrence of COVID-19 (Covid-19 positive on 25-Dec-2021) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient had no known drug allergies and the patient did not have history of cancer, Leukemia, HIV or AIDS or any other condition that weakens the Immune system. The patient did not have history of myocarditis or pericarditis.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Dec-2021, the patient experienced COVID-19 (Covid-19 positive on 25-Dec-2021). At the time of the report, COVID-19 (Covid-19 positive on 25-Dec-2021) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 25-Dec-2021, SARS-CoV-2 test: positive (Positive) Positive (PCR).     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant product use was reported.  The patient had no acute illnesses at the time of vaccination and up to one month before vaccination.  No treatment information was provided.  Company Comment: This is a Spontaneous case concerning a 57-year-old male patient, with no medical history reported, who experienced the non-serious unexpected AESI of COVID-19. The event occurred in the context of the administration of a dose of the mRNA-1273 vaccine of an unknown dose and schedule of vaccination. Relevant test was performed: PCR positive for COVID-19. Very limited information is available regarding clinical course and diagnostic work-up. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report. The case was assessed as non-serious.   This case was linked to MOD-2022-531910 (Patient Link).; Sender's Comments: This is a Spontaneous case concerning a 57-year-old male patient, with no medical history reported, who experienced the non-serious unexpected AESI of COVID-19. The event occurred in the context of the administration of a dose of the mRNA-1273 vaccine of an unknown dose and schedule of vaccination. Relevant test was performed: PCR positive for COVID-19. Very limited information is available regarding clinical course and diagnostic work-up. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report. The case was assessed as non-serious.
Soreness on the arm; Maternal exposure during pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) and PAIN IN EXTREMITY (Soreness on the arm) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. The patient's last menstrual period was on an unknown date and the estimated date of delivery was 07-Mar-2021. On 09-Jan-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy). On an unknown date, the patient experienced PAIN IN EXTREMITY (Soreness on the arm). On 09-Jan-2021, MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) had resolved. At the time of the report, PAIN IN EXTREMITY (Soreness on the arm) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.; Sender's Comments: This is a case of product exposure during pregnancy with the associated AE , Pain in extremity, for this 40-year-old female. Patient will continue to be contacted for further monitoring of AEs during the pregnancy. Based on the current available information and temporal association between the use of the product and the start date of the event, Pain in extremity,  a causal relationship cannot be excluded.
Vaccinated with vaccines that were in the fridge for 33 days; Expiration date on the box for the 30 days until 18JUN2021; The staff did not dispose of the vaccine vials and continued to use it today on 22JUN2021; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccinated with vaccines that were in the fridge for 33 days) and PRODUCT STORAGE ERROR (Expiration date on the box for the 30 days until 18JUN2021; The staff did not dispose of the vaccine vials and continued to use it today on 22JUN2021) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 22-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccinated with vaccines that were in the fridge for 33 days) and PRODUCT STORAGE ERROR (Expiration date on the box for the 30 days until 18JUN2021; The staff did not dispose of the vaccine vials and continued to use it today on 22JUN2021). On 22-Jun-2021, EXPIRED PRODUCT ADMINISTERED (Vaccinated with vaccines that were in the fridge for 33 days) and PRODUCT STORAGE ERROR (Expiration date on the box for the 30 days until 18JUN2021; The staff did not dispose of the vaccine vials and continued to use it today on 22JUN2021) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were provided by the reporter.  The pharmacy received a box of Moderna COVID 19 vaccine on 19-May-2021 and put the expiration date on the box for the 30 days until 18-Jun-2021. It was stored in the refrigerator which was 37-44 degrees Fahrenheit. The staff did not dispose of the vaccine vials and continued to use it on 22-Jun-2021 to vaccinate five patients with vaccines that were in the fridge for 33 days. The patients were vaccinated with their second dose from 10:00 to 11:00 AM on 22-Jun-2021. No treatment medications were provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 22-Jun-2021: No new medical information was received.