chrisvoncsefalvay/vaers-outcomes huggingface dataset:
After the second dose I wasn?t feeling great, I slept an entire day and woke up Thursday feeling great, Thursday evening I developed burning and itchy hives all over my neck chest and face, my face appeared swollen, I also had a smaller outbreak on my legs I took benedryl which seemed to calm the reaction some when I woke up the following morning, and another dose seemed to calm it some more
My skin started to become itch with red spots; My skin started to become itch with red spots; This is a spontaneous report from a contactable other healthcare professional (patient). A 38-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot/batch number and expiry date unknown), via an unspecified route of administration at the left arm on 13Jan2021 09:15 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient was not pregnant at the time of vaccination. The patient reported that her skin started to become itch with red spots on 30Jan2021 14:00. No treatment was received for the events. The patient was not diagnosed with COVID-19 prior to vaccination. The patient has been tested for COVID-19 since the vaccination. The patient underwent lab tests and procedures which included nasal swab: negative on 27Jan2021. The outcome of the events were recovering. Events were reported as non-serious.  Information on the lot/batch number has been requested.
30 minutes later, flushing, dizziness, lightheadedness, panic and lump in throat. Lasted 20 minutes. No treatment
Noted 5 hrs after administration, hives developed in body. Decadron and Benadryl given.
On 8/15/21 patient began to feel sick with malaise/nausea/vomiting gasping for air.  He was driving and had to stop frequently to rest.  He began to vomit blood as well as seeing blood in his stool. At one of his stops he was having trouble breathing and emergency called for him.  Arrive to ER Spo2 in the 70's.  Patient required Optiflow and is still currrently on 80% 8LPM.  Covid test negative.  Antibotics started then stopped with CT Chest resulted Multi pulmonary emboli bilaterally as well as possible Renal infarct as well as bilateral DVT's.  Heparin drip started.  Pt. continues to need Bipap and medications for BP.
This spontaneous report as received from a nurse refers to unspecified number of patients of unknown age and gender. The patients' medical history, current conditions and concomitant medications were not reported. On 16-NOV-2016 the patients were vaccinated with improperly stored dose of VAQTA (lot # M017982, expiry date: 13-SEP-2017; lot # M030598, expiry date: 13-OCT-2017; lot # M003011, expiry date: 15-NOV-2017; lot # M036459, expiry date: 18-JAN-2018; lot # M012261, expiry date 01-FEB-2018). The vaccine was exposed to a temperature of 53 Fahrenheit for 1 hour and 45 minutes. There were no previous temperature excursions. The call was because of a data logger. No adverse events were reported. There was no product quality complaint involved. This is one of the several reports from the same reporter. Additional information has been requested.
arm was more red; This spontaneous case was reported by a pharmacist and describes the occurrence of ERYTHEMA (arm was more red) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 023l20a and 037k20a) for COVID-19 vaccination.     Patient did not have any medical history related to mentioned adverse event and did not have any acute and chronic illnesses at the time of vaccination. No other vaccines were given to the patient within 1 month prior to Moderna COVID-19 vaccination.  Concurrent medical conditions included Penicillin allergy, Allergy to topical drugs (rash to oilment) and Allergy to antibiotic (doxycycline). Concomitant products included LISINOPRIL and VITAMINS NOS for an unknown indication.   In December 2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In January 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced ERYTHEMA (arm was more red). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. In 2021, ERYTHEMA (arm was more red) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The adverse event did not cause the patient to seek medical care.  The patient recalled that the patient experienced a similar event when she had received the polio vaccine or small pox vaccine.  The patient received the first dose on 05-Dec-2020 or 06-Dec-2020.   This case was linked to MOD-2022-669117, MOD-2022-669121 (Patient Link).
left arm hurts; peed with a strange smell and left some pink in the toilet; patient peed with a strange smell; This spontaneous case was reported by a patient family member or friend and describes the occurrence of PAIN IN EXTREMITY (left arm hurts), CHROMATURIA (peed with a strange smell and left some pink in the toilet) and URINE ODOUR ABNORMAL (patient peed with a strange smell) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension, Cholesterol and Hemorrhoids.    On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Feb-2021, the patient experienced CHROMATURIA (peed with a strange smell and left some pink in the toilet) and URINE ODOUR ABNORMAL (patient peed with a strange smell). On an unknown date, the patient experienced PAIN IN EXTREMITY (left arm hurts). At the time of the report, PAIN IN EXTREMITY (left arm hurts), CHROMATURIA (peed with a strange smell and left some pink in the toilet) and URINE ODOUR ABNORMAL (patient peed with a strange smell) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       concomitant medications included: Blood pressure, cholesterol medication and unspecified medications.  No treatment information was provided.
Vaccine Administration Error.   Bivalent Booster should of been given.   No reaction reported.
Received #3 Moderna boost on Saturday 4/23/22 to left deltoid with no immediate abnormal s/e to arm. Next day patient reported slight flu-like symptoms. On 4/26/22 patient arrived at Walk In Clinic reporting radiating 4/10 pain level in left top shoulder, associated deltoid, and left underarm pit with swelling and tenderness.
Bronchiolitis. A mother reported that her child received 2nd Prevnar, Haemophilus B conjugate, DTaP and poliomyelitis virus vaccine administration the infant developed wheezing, irritability, weepy eyes and a runny nose. The mother reported that the infant was diagnosed with bronchiolitis and an ear infection. He was treated with Albuterol and Amoxicillin. The wheezing resolved by 1/21/01. The infant recovered fully from bronchiolitis. Follow-up info received from the physician on 06/08/2001, indicated tha the infant was seen by the physician on 01/20/2001 with bronchiolitis, wheezing, and otitis media. The physician stated that at the time the child was immunized, "bronchiolitis was epidemic in the community," and that she "did not believe his illness was an adverse reaction to Prevnar."
24 hours after the vaccine, itchy blisters on the sole of my right foot showed up. Before the vaccine, my foot was fine.  Also, I had a nose bleed in the same night the blisters showed up.  These were minor nuisance but I would like this to be documented somewhere.
Anaphylaxis presenting with eye swelling, lip swelling, rash, and shortness of breath
Systemic: Fainting / Unresponsive-Medium, Additional Details: Patient had 3rd dose of Pfizer Covid-19 vaccine. Sat with mom and apparrently fainted. Nurse from clinic alerted us to call the ambulance per mom's request. I called emergency number and requested ambulance. I then went over to see the patient at the time she was sitting in the chair and was responsive, but the mom said she had fainted and they alerted the nurse. The patient was then moved into a room in the clinic where she could lay back. The patient was able to ambulate on her own.
I collapsed in my home and was unable to catch my breath. I had to take breathing treatment. I received blood thinner. I'm still having trouble breathing. They found a blood clot in my lungs.
Received vax lt thigh 07JUN95; redness & hardened area lt thigh developed 2 days later; now slowly improving in redness; no fluctuance;
BRUISE ON RIGHT FOREARM; TIREDNESS; SENSATION OF TONGUE COATED IN SALT; This spontaneous report received from a patient concerned a 64 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: pollen allergy, allergies nos, food allergy, alcoholic, and non smoker, and other pre-existing medical conditions included: No medical disorder. Patient reported no drug abuse or illicit usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 206A21A, expiry: UNKNOWN) dose was not reported, administered on 30-JUL-2021 for prophylactic vaccination. Concomitant medications included ascorbic acid, and calcium/colecalciferol. On 30-JUL-2021, the patient experienced sensation of tongue coated in salt. On 31-JUL-2021, the patient experienced tiredness. On AUG-2021, the patient experienced bruise on right forearm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from tiredness on 31-JUL-2021, and had not recovered from bruise on right forearm, and sensation of tongue coated in salt. This report was non-serious.
Loud pulsing in ear like a heartbeat. Racing heart; Headaches; Fatigue.
Elevated blotchy rash on back and chest, treated with benadryl by local ER. Improving in these sites when examined today, but pruritic rash is migrating to LEs today.  Additionally scattered pustules "folliculitis-like" around the primary innoculation site and in a patch on the left FA.
1) After 3 days of Moderna Dose 1, on 1/23/21, I developed visual disturbances for about 15 minutes, where i have a constant bright round spot in my field of vision (LEFT eye only)  that stays even after blinking. (Like the residual bright spot that stays after a camera flashlight flashes you). It eventually resolved without any treatment after approx 15 to 20 min.  2) Also with looking from my left eye, I also see some ripples on my top left corner of my visual field. (like water ripples), and that also lasted about 15 min. I have not encountered any eye issues of this nature before, and i had my last optometrist check in 9/2020 and all was normal.  3) Dizziness was experienced when moving and turning my head ONLY while lying in supine position after both doses. With 1st dose, dizziness lasted about 1 week while lying down, and with 2nd dose, dizziness was experienced for about 1 day only. No dizziness with standing and turning head.  4) Axillary lymph node on left arm (arm that shot was administered) was swollen after both doses that lasted for few days, then resolved. Swelling of lymph node was palpable, about the size of a pea.
SUSPECTED CLINICAL VACCINE FAILURE; SUSPECTED COVID-19 INFECTION; RECURRING MIGRAINE HEADACHE; This spontaneous report received from a patient concerned a male of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included recurrent migraine headache. 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 and has been requested. No concomitant medications were reported.  On an unspecified date, the patient caught covid-19 and symptoms were moderate at the point of reporting. The patient had a recurring migraine headache, chills, congestion and heavy pain to chest especially when the patient coughs or sneezes. The patient experienced suspected clinical vaccine failure. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suspected clinical vaccine failure, suspected covid-19 infection and recurring migraine headache was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0. 20210804055-COVID-19 VACCINE AD26.COV2.S.- Suspected clinical vaccine failure. This event is considered not related. The event has a unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: SPECIAL SITUATIONS
redness, tender 3 1/2"/3 1/2" @ anterior/thigh;
4"x3.75" erythema on left lateral arm, cellulitis area receiving warm compress, and antibiotic Omnicef.
This case was reported by a pharmacist and described the occurrence of injection site pain in a 82-year-old female subject who was vaccinated with influenza virus vaccine (Fluarix, GlaxoSmithKline) for prophylaxis. On 19 February 2008 the subject received unspecified dose of Fluarix (.5 mL, left arm). On 19 February 2008, less than one day after vaccination with Fluarix, the subject experienced injection site pain and bruising at the injection site. At the time of reporting the events were unresolved. The pharmacist considered the events were probably related to vaccination with fluarix.
Whole body shaking chills Whole body muscle pain Joint pain Headache Fever 102 degrees F
pt recv vax 9AM 3JAN97 & approx noon felt heaviness in chest & felt puny lasted till approx noon 5JAN97;
Joint pain started in her hands, they were painful and swollen/ moved to her right side of her arm/ in her upper arm and was in her feet and toes; Joint pain started in her hands, they were painful and swollen/ moved to her right side of her arm/ in her upper arm and was in her feet and toes; Caller states this is debilitating, she can't even walk up the steps without her toes killing her; This is a spontaneous report from a contactable consumer (patient). A female patient about 49-year-old received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in arm left on 18May2021 10:00 (Batch/Lot Number: EW0167) as dose 2, single for covid-19 immunisation. Patient age at vaccination was 48 years old. Medical history included ongoing neck and back pain. Historical vaccine included 1st dose of BNT162B2 (LOT: EW0176) on 27Apr2021 at 10:00 on left arm for covid-19 immunisation. Patient age at 1st dose of vaccination was 48 years old. The patient's concomitant medications were not reported. She experienced joint pain after her second dose and went to her physician and she had several tests. She did blood work to see if she was Lyme's, arthritis and it wasn't. Joint pain began in the end of May2021, beginning of Jun2021. Caller confirmed joint pain had worsened. It was debilitating, she can't even walk up the steps with her toes killing her. It started in her hands, they were painful and swollen. It moved to her right side of her arm and she couldn't use it. It was in her upper arm and was in her feet and toes. Her doctor put her on prednisone. Outcome of the events was not resolved.
Patient up to date on COVID vaccinations who admitted with cellultis and found incidentally positive for COVID.  Provider note:  "44 year old female with triple-negative metaplastic carcinoma of the left breast with a biopsy-proven metastasis to her axillary lymph nodes and with local ulcerations/invasion of her skin.  She completed neoadjuvant chemotherapy 5 weeks ago.  She was scheduled for modified radical mastectomy on 8/24/22, but now presents with cellulitis of her left breast due to a seroma vs abscess in the left pectoralis musculature.  Also incidentally found to be COVID +."
pt recv vax & devel swollen hands & feet & a urticarial rash on arms & trunk; parents indicated that the rash fades & returns; No further details were provided;
Patient complains of redness and hotness in the injection site for two days. No fever or any other symptoms. Advised patient to ice the area and take BENADRYL and TYLENOL if needed for the pain.
Moderate dizziness immediately following injection.  Resolved within 20 minutes. Mild dizziness off and on for 24 hours. Just rested and hydrated. Day 11: Swelling, heat, itching at injection site. Injection site had visible red ring with splotchy center. Over the course of the next 2 hours, development of moderate full body rash, itching, mild swelling for 5+ days. Treating with over the counter antihistamine and hydrocortisone as needed.
Soreness in arm; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Soreness in arm) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027c21a and 027c21a) for COVID-19 vaccination.     No Medical History information was reported.   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) (Intramuscular) dosage was changed to 1 dosage form. On 05-May-2021, the patient experienced MYALGIA (Soreness in arm). At the time of the report, MYALGIA (Soreness in arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment medication reported by the reporter
received the vaccine on 12/18, 12/19 woke up with a headache and fatigue: lasted until the end of the day.
2nd Shingrix vaccine administered 4 weeks after 1st Shingrix vaccine.; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too short in a 68-year-old male patient who received Herpes zoster (Shingrix) (batch number BA5GK, expiry date 4th November 2022) for prophylaxis.   Concomitant products included Herpes zoster (Shingrix).   On 5th May 2021, the patient received the 2nd dose of Shingrix. On 5th May 2021, unknown after receiving Shingrix, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the drug dose administration interval too short was unknown.  Additional details were provided as follows: Pharmacist reported 2nd Shingrix vaccine administered 4 weeks after 1st Shingrix vaccine which led to shortening of vaccination schedule. The reporter consented to follow up.
Severe chills (heater turned to 80 F); no fever headache malaise widespread body aches nausea lightheadedness/dizziness  ongoing not alleviated by APAP or ibuprofen
3/20/06- fatique, weakness, knot of back. 3/22/06- could not void. 3/25/06 ER for stomach distention- was told to increase fluids, drink cranberry juice, hydrocodone prescribed for back. 3/29/06 feeling better, voiding but not as much as normally would as stated by patient.
Triggered nightmares leading to severe state of the feeling of complete and total hopelessness.  I called my psychologist for this felt exactly like it did when I had a reaction to Venaflaxine in 2009 which lead to me being suicidal within 24 hours of use of that medication.  The complete despair I felt on the 20th was that same type of despair and hopelessness to the point that I started thinking about ending my life..but again, knew I was in trouble and got help.
Patient received expired Moderna Covid-19 vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received expired Moderna Covid-19 vaccine) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 059H21A) for COVID-19 vaccination.     No Medical History information was reported.    In April 2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In April 2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received expired Moderna Covid-19 vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received expired Moderna Covid-19 vaccine) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.   The patient received second booster dose. It was not reported when the vial was initially stored in refrigerator. The vial did not undergo temperature excursion.  No treatment details were reported.
Weak, disoriented, vomiting for 12.5 hours Migraine for 2 days   Terrible. This is poison!
On 11/05/2022, at approximately noon, I noticed I had a few red spots on my arms and legs. As the day progressed, I was getting more and more spots. I took BENADRYL and went to bed. I woke up in the night and my body was on fire. I was covered in red spots everywhere except my face. They were burning and itchy and lasted about 3 weeks. I tried BENADRYL, hydrocortisone, lotion, and nothing helped. The pain was excruciating. No doctors would see me because of how I looked physically. Just before Christmas, the spots stopped burning but were still present and some still are today. Now they look like bruises. I also had a very hard time breathing. It was labored and more so laying down. Walking a short distance, I was winded. My children had the same labored breathing. It felt like a panic attack.
p/vax pt remained swollen for 14 days, w/soreness, swelling & inflammation;
pt recvd vax;w/in 8 hrs,devel swelling of lips & body,hives & pruritus,T 103.5 & excessive crying,unable to sleep;seen at er at 8 hr intervals x 5;given epinephrine,dph,prednisone,meds cont x 4 days;well p/ that;NKA;
Itchy red welt like rash at site of injection about 3x1 in, three small bumps on left leg behind knee and on inner thigh, small pimple like and raised and red, one has scabbed over already. Pt awoke itching all over at 4am and noticed the reactions, itching has localized and is much less now.
Pt reports fatigue and soreness in whole body, fever, and productive cough starting one day after immunization.  Pt also says that there may be a tiny bit of discoloration around the area the vaccine was given.
Patient is 13 weeks and 5 days pregnant. Patient was administered the Measles, Mumps and Rubella vaccine.
This spontaneous report has been received from a clinic unit clerk and refers to a 4-month-old male patient. The patient's medical history, concurrent conditions, drug allergies/reactions, and concomitant therapies were not reported. On 11-MAY-2017, the patient was vaccinated with improperly stored dose of PEDVAXHIB (lot # M034187, expiration date 17-MAY-2019; dose, route of administration, and frequency were not reported) and ROTATEQ orally (lot # M018958, expiration date 03-MAR-2018; dose and frequency were not reported) both for prophylaxis. The vaccine data logger measured a temperature range from 32°F to 35°F for a total time frame of 25 minutes. There was no previous temperature excursion. No adverse effects were reported, and no product quality complaint (PQC) was not involved. Additional information has been requested.