chrisvoncsefalvay/vaers-outcomes huggingface dataset:
4/17/2021 Patient was observed post Covid-19 immunization for 30 minutes based on pre-vaccination screening .  During the observation period, she experienced an adverse reaction with the following symptoms:  tightness to chest and sweety.   Assessment : Time of assessment 350pm. Alert and oriented, Anxious, Stridor, Diaphoretic, Nausea and tightness in chest, redness to face.   Actions taken:  Vitals sign taken  VAERS form obtained and completed by RN.  VS at 350pm BP- 11/61, P- 81, O2- 97%, r Water given recheck of VS at 418pm BP- 122/71, P- 84, O2- 84%       Medications administered: No medication administered.   Disposition: Reports no further symptoms of adverse reaction after observation for 45 minutes. Discharged home. The Patient was provided with Vaccine Information Sheet and instruction to access the V-Safe system.      Immunizations Administered    Name Date Dose VIS Date Route   Pfizer COVID-19 Vaccine 4/17/2021  3:28 PM 0.3 mL 12/11/2020 Intramuscular
4 hr and 24 min after immunizations, had episodes of stretching of arms, turning head to side, glazed appearance, unable to gain eye contact.  Lasted less than 1 min, no color change.  Looking back, mom thinks she had same reaction after 2 and 4mm immunizations.  No other history of seizure activity.
09:00 PM - every  joint in my body hurt that evening. I had to leave work; I couldn't finish my eight hours. All my joints hurt - even my toe joints. I called my doctor. I had a fever.  That went away in 2-3 days. Two weeks later or so- on February 5, I started feeling pretty bad. I started having chest pains. It progressed. No coughing. By the 10th, I ended up in ER. I thought I was having a heart attack - chest pain I was hospitalized. I am still dealing with that issue. I received morphine I'm diagnosed with Pleurisy -like virus - the lining of chest wall can become inflamed and when I breathe in and out it causes severe pain. Tachycardia - fast heart rate. I'm on anti-inflammatory - Naproxen - 500 mg twice a day and I'm already improving. I saw a cardiac dr today - he says my heart seems fine. I still have a fast heart rate. Pleural Rubbing - he could hear it on my chest wall. I had a positive antibody test - COVID -on January 20th. I'm recovering but I am not recovered.
Immediately post vax, the pt experienced severe swelling in the right arm at the site of injection. It felt very hard under the skin. A high fever was experienced. This lasted for a couple of days. He also slept for a very long period about 16 hours. Treated with Tylenol and Benadryl.
erythemia, swelling, numbness from fingers to armpit, tenderness, h/a, nausea, cellulitis; given Decadron & Cephalexin & ATB x 5 days;
NOT FELT RIGHT/FEEL OFF IN TERMS OF MENTAL ACUITY, CLARITY AND SHARPNESS WAS DECLINED; 5-6 CENTIMETERS OF BLOOD CLOTTING IN THE SAPHENOUS VEIN IN THE RIGHT LEG; This spontaneous report received from a patient concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular) dose was not reported, administered on 14-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 14-APR-2021, the subject experienced 5-6 centimeters of blood clotting in the saphenous vein in the right leg. On 20-APR-2021, the subject experienced not felt right/feel off in terms of mental acuity, clarity and sharpness was declined. On 21-MAY-2021, Laboratory data included: Ultrasound scan (NR: not provided) 5-6 centimeter clot. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from not felt right/feel off in terms of mental acuity, clarity and sharpness was declined, and had not recovered from 5-6 centimeters of blood clotting in the saphenous vein in the right leg. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard operating procedure as the case assessed as non-serious.
This spontaneous report as received from a healthcare worker (immunization official) refers to an unspecified number of patients of unknown age and gender. Medical history, concurrent conditions and concomitant medications were not provided. The healthcare worker reported that doses of VARIVAX (Merck) injection (lot # L029472, expiration date 06-AUG-2017, dose and route of administration were not provided), which were exposed to the temperatures outside of the recommended range (temperature 9.5 Fahrenheit degrees (F), time frame 1 hour 18 minutes) had been administered to unspecified patients approximately in 2016 (reported as on unspecified dates since 13-JAN-2016). No adverse effects were reported. There was no previous temperature excursion. Additional information has been requested.
A 51 year old nurse reported that she received an injection of flu shield and subsequently developed a fever and felt sick. No further info was available at the date of this report.
Patient received 2 vaccinations separated by 1 inch in the same deltoid muscle. Next day he feels pain around the arm, and the next day it was red and swelling. Patient received intravenous BENADRYL and recover promptly.
lost sense of taste; 102 fever; chills; body ache; This spontaneous case was reported by an other health care professional and describes the occurrence of AGEUSIA (lost sense of taste), PYREXIA (102 fever), CHILLS (chills) and MYALGIA (body ache) in a 54-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028A and 012A) for COVID-19 vaccination.     The medical history was not provided by the reporter.  Concomitant products included METOPROLOL SUCCINATE (TOPROL XL), NIFEDIPINE (PROCARDIA [NIFEDIPINE]), HYDROCHLOROTHIAZIDE, OLMESARTAN MEDOXOMIL (BENICAR HCT), ROSUVASTATIN CALCIUM (CRESTOR) and TESTOSTERONE CIPIONATE (DEPO-TESTOSTERONE) for an unknown indication.   On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Dec-2021, the patient experienced PYREXIA (102 fever), CHILLS (chills) and MYALGIA (body ache). On 03-Dec-2021, the patient experienced AGEUSIA (lost sense of taste). At the time of the report, AGEUSIA (lost sense of taste) had not resolved and PYREXIA (102 fever), CHILLS (chills) and MYALGIA (body ache) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-Dec-2021, Body temperature: 102 (abnormal) 102 fever. On 11-Dec-2021, SARS-CoV-2 test: negative (Negative) Negative.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment medications were provided.  Company comment: This is a spontaneous case concerning a 54-year-old, male patient with no medical history reported who experienced the unexpected non-serious AESI of Ageusia with concurrent expected non-serious events of Pyrexia, Chills and Myalgia. The events Pyrexia, Chills and Myalgia occurred one day and the event Ageusia two days after the boost dose of mRNA-1273 Vaccine. COVID-19 was excluded as the test was negative. The rechallenge was not applicable, as the patient received third dose. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.; Sender's Comments: This is a spontaneous case concerning a 54-year-old, male patient with no medical history reported who experienced the unexpected non-serious AESI of Ageusia with concurrent expected non-serious events of Pyrexia, Chills and Myalgia. The events Pyrexia, Chills and Myalgia occurred one day and the event Ageusia two days after the boost dose of mRNA-1273 Vaccine. COVID-19 was excluded as the test was negative. The rechallenge was not applicable, as the patient received third dose. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.
Hep A given on 2/1/2022 expired on 1/28/2022
Patient states she experienced - and is experiencing - extreme pain and discomfort at the injection site (left deltoid) of the Fluad Quadrivalent vaccine more than 10 days after vaccination.
Around 6:30pm I became very hot and dizzy, I sat down and splashed cold water on my face which seemed to help a little. I took tylenol (acetaminophen 500mg) and two glasses of water. As the night progressed, my lower back started to hurt and my headache continued to progress. I went to bed early to sleep it off but was woken up by overheating and headache. I took more tylenol around 3am and grabbed an icepack, this seemed to help alleviate the symptoms.
She is past the 6 month window; experienced flu-like symptoms; made her very tired; This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a 57-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On 1st July 2019, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, less than 9 months after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced influenza-like symptoms, tiredness and incomplete course of vaccination. On an unknown date, the outcome of the influenza-like symptoms and tiredness were recovered/resolved and the outcome of the incomplete course of vaccination was unknown.   It was unknown if the reporter considered the influenza-like symptoms and tiredness to be related to Shingrix.  Additional details were provided as follows: The patient received 1st dose of Shingrix experienced flu-like symptoms, mainly it made her very tired.   She was past the 6-month window and till the time of reporting, did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. She did not want to provide her MD contact information. This case is 1 of 2 cases reported by the same reporter.
Patient mother called the pharmacy and said her daughter (the patient) experienced face swelling a few hours after the vaccine. She called her doctor and they advised her to take benadryl.  She called on 5/19/2021 to ask if her daughter can get a letter from the pharmacy stating that she s exempt from getting the COVID vaccine for school.  Also, she stated her daughter is feeling better and swelling is going down, and her daughter did not have any other symptoms.  I informed her that I can provide her with a letter saying that she cannot get the 2nd dose of Moderna vaccine due to allergic reaction but that might not exempt her from other covid vaccine.
Persistent swelling in L upper arm and pain. He was diagnosed with a lipoma via ultrasound imaging on 9/13/21 via ultrasound of his arm. The lipoma was surgically removed on 10/5/2021 and surgery was more complicated than a simple lipoma excision. The lipoma was tunneled underneath his deltoid muscle.
My last flu shot was in 1968 and got sick from it; Initial information received on 14-Dec-2020 regarding an unsolicited valid non-serious case received from a consumer via media.  This case involved an unknown age patient who reported patients last flu shot was in 1968 and got sick from it (Illness), while he/she received vaccine INFLUENZA VACCINE.  The patient's medical history, concomitant medication, medical treatment(s), vaccination(s) 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 and expiry date not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient reported patients last flu shot was in 1968 and got sick from it (Illness), unknown latency following the administration of INFLUENZA VACCINE. Also reported did get a pneumonia shot but never have gotten the flu.  Relevant laboratory test was not reported.  Final diagnosis was my last flu shot was in 1968 and got sick from it.  It was not reported if the patient received a corrective treatment.  The outcome was reported as Unknown for my last flu shot was in 1968 and got sick from it.  There would be no information available on batch number for this case
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 50-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 12Aug2021 as dose 1, single (Lot number: EW0171), in left arm, on 01Sep2021 as dose 2, single (Lot number: EW0172), in left arm and on 02Mar2022 as dose 3 (booster), single (Lot number: FL3198) at the age of 50 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "thyroid disease" (unspecified if ongoing); "sulpha drugs" (unspecified if ongoing), notes: Known allergies: sulpha drugs. Concomitant medication(s) included: LEVOTHYROXIN; SINGULAIR. Past drug history included: Wellbutrin, reaction(s): "Known allergies: wellbutrin". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Unknown results, notes: Treatment of COVID-19; (05Jul2022) Negative; (06Jul2022) Negative; (07Jul2022) Negative; (08Jul2022) Negative; (10Jul2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19. The patient started taking Paxlovid 29Jun and took it twice daily for 5 days as prescribed.
Wheezing. Eye redness. Hypoesthesia oral. Lip swelling. Cough. Fever. Chills. Generalized muscle aches. This case was extracted from the VAERS database via a QSCAN search on 24 February 2009 (reference number 333768). A 53 year old male patient received an intramuscular injection of FLUZONE SV 2008-2009 (lot number U2748AA) on 15 October 2008. Within four hours post-vaccination, he began experiencing a cough with some mild wheezing. Within six hours post-vaccination, his upper lip became swollen and numb. By eight hours post-vaccination, he complained of extreme eye redness, fever, chills, and generalized aches. All symptoms resolved without treatment within 24 hours. Of note, the patient reported that he experienced fever and chills eight hours post-vaccination following flu vaccine "years ago". The patient had no food allergies, and had not eaten anything the evening after vaccination.
Developed hives 10-15 minutes after immunization. Examine by Dr BENADRYL given.
face swelling; cheeks were red and hot; cheeks were red and hot; hives on my neck; Allergic reaction; This is a spontaneous report from a contactable consumer (patient). A 53-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EW0169, expiration date not provided), 1st dose via an unspecified route of administration, administered in arm right on 20Apr2021 at age of 53 years old as a single dose for COVID-19 immunisation.  Medical history included anxiety, known allergies: fruits with a seed in the center i.e. peaches, cherries, apricots etc (fruit allergy). Concomitant medication included sertraline. The patient experienced allergic reaction including face swelling, cheeks were red and hot and hives on my neck., all on 20Apr2021 12:30.  No treatment received for the events. The outcome of the events was recovered in 2021. The report was reported as non-serious by reporter. The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, patient had not been tested for COVID-19.
Burning sensation at injection site at approximately 1:30pm.  Raised, red, 2inch by 2inch itchy and painful bump at injection site noticed about 3:30pm. Fine red rash covering injected arm noticed at 5:15pm.  Swollen glands noted on neck and throat at 5:15pm.
Tiredness; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Tiredness) in a 54-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Crohn's disease.    No Medical History information was reported.   On 12-Jul-2022, the patient received third 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 an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. and ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate Free. In July 2022, the patient experienced FATIGUE (Tiredness). At the time of the report, FATIGUE (Tiredness) was resolving. Patient received moderna third dose as a booster dose. No concomitant medications were reported.  The reporter's causality for the event of felt tired with HUMIRA(ADALIMUMAB) was reported as no reasonable possibility.  No treatment medications were reported.
c/o R arm hurt on 5/2/08 & then on 5/3/08 arm redness & warmth developed.  7 1/2" L x 6" W redness & warmth R upper arm.  Able to lift arm overhead & strong hand squeezage.  Dx: Local reaction to shot, allergic vrs. cellulitis.  TC to mom 5/5/08 & she did begin Keflex 500mg TID x5 days due to increased redness below elbow.  Taking as prescribed.
people die from our vaccine; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (people die from our vaccine) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (people die from our vaccine). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (people die from our vaccine) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication were provided. No treatment details were provided.
resulting inflammation & pain; resulting inflammation & pain; inappropriate site of vaccine administration/shot was given too high in arm; SIRVA - shot was given too high in arm; have had continuous shoulder pain; SIRVA - shot was given too high in arm; have had continuous shoulder pain; This non-serious case was reported by a consumer and described the occurrence of shoulder injury related to vaccine administration in a 67-year-old female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 06-SEP-2022, the patient received Shingles vaccine (unknown arm). On 06-SEP-2022, less than a day after receiving Shingles vaccine, the patient experienced shoulder injury related to vaccine administration (Verbatim: SIRVA - shot was given too high in arm; have had continuous shoulder pain), shoulder pain (Verbatim: SIRVA - shot was given too high in arm; have had continuous shoulder pain) and vaccine administered at inappropriate site (Verbatim: inappropriate site of vaccine administration/shot was given too high in arm). On an unknown date, the patient experienced pain (Verbatim: resulting inflammation & pain) and inflammation (Verbatim: resulting inflammation & pain). On 27-JUN-2023, the outcome of the shoulder injury related to vaccine administration and shoulder pain were resolved (duration 9 months 21 days). The outcome of the pain and inflammation were not reported and the outcome of the vaccine administered at inappropriate site was unknown.   It was unknown if the reporter considered the shoulder injury related to vaccine administration, shoulder pain, pain and inflammation to be related to Shingles vaccine.     It was unknown if the company considered the shoulder injury related to vaccine administration, shoulder pain, pain and inflammation to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 27-JUN-2023 This report was submitted via the online direct entry reporting system. The patient reported SIRVA (Shoulder injury related to vaccine administration) also stated that shot was given too high in arm and had continuous shoulder pain. Patient stated it resulted into inflammation and pain.  She meant that some of the medicine obviously went the wrong place instead of into the bloodstream. The symptoms were treated. The reporter consented to follow up via email. The patient received shot too high in arm which led to vaccine administered at inappropriate site.
Developed blood clot in right leg (behind knee); This is a spontaneous report from a contactable consumer (patient). A 34-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date not provided), via an unspecified route of administration, administered in Arm Left first dose on 26Feb2021 11:15 at single dose for covid-19 immunisation. The patient's medical history included Developed blood clots after twin c section. The patient has been off blood thinners for 2.5 years. The patient was not pregnant at time of vaccination. The patient's concomitant medications included venlafaxine hydrochloride (EFFEXOR) and vitamin d [vitamin d nos]. On 17Mar2021, the patient Developed blood clot in right leg (behind knee). The patient was put on blood thinners as treatment. The events cause the patient emergency room visit and physician office visit. The outcome of the event was recovering.  Information on the lot/batch number has been requested.
Moderna COVID-19 Vaccine EUA 3 am - Was awakened with severe headache, which passed after several minutes of being up out of bed.  No medication required. For 2 days had tolerable discomfort in left upper arm, especially when raised arm outward and upward.
BURNING EYES APROXIMATELY 15 MINUTES AFTER VACCINATION - RESOLVED @07:55 ACCORDING TO PATIENT -NO BREATHING PROBLEM, NO RASH
pt recvd vax;to hosp w/ raised rash;MD felt probably exanthem from a viral infect; had bilateral ear infect;
This spontaneous report was received from an office manager refers to a patient of unknown age and gender. On 06-AUG-2013, the patient was vaccinated with a dose of GARDASIL (lot# H021346, expiration date 01-OCT-2015) that underwent unsupported temperature excursions. No adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.