chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Started breaking out in hives, first on the arm that injection was received in, and the progressed to full body hives.  Parents paged Pediatrician on call and gave Zyrtec, which was all they had at home.  Benadryl was given around 11:30PM and hives resolved shortly after dosing with Benadryl.
SEVERE pain and pressure in Left axilla with swollen lymph nodes, in addition to local reaction with redness, induration (2"X3"), pain and itching at injection site.
No adverse reaction Menveo was not mixed properly. MA used sterile H2O not the diluent from the box.
fainted; swelling in the area /skin around pacemaker; real bad lymph node swelling; had an itch on the skin; vomiting; This is a spontaneous report from a contactable consumer (patient). A female patient of age 32 (units: unknown) received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: unknown), dose 2 via an unspecified route of administration on unspecified date as 2nd dose, single dose for COVID-19 immunization. Patient medical history and concomitant medications were not reported. Patient previously received bnt162b2, dose 1 on an unspecified date for COVID-19 immunization. The patient had Pfizer vaccine and had a question about the side effects because she couldnt find any information on it and her doctor hadnt heard of it. On an unspecified date, the patient experienced swelling in the area/skin around pacemaker, real bad lymph node swelling and had an itch on the skin. She went to emergency room with vomiting and fainted about 20 minutes after receiving the vaccine. Patient underwent lab test and procedures include work up: there was all negative. The patient questioned about the side effects because she couldn't find any information on it and her doctor hadn't heard of it. The outcome of all the events was unknown.  Information about lot/ batch number has been requested.
This case was reported by a healthcare professional and described the occurrence of red bump at injection site in an adult female subject who was vaccinated with BOOSTRIX (GlaxoSmithKline). On an unspecified date the subject received a dose of BOOSTRIX (unknown). At an unspecified time after vaccination with BOOSTRIX, the subject experienced local reaction of red itchy bumps at injection site (red bump at injection site and injection site pruritus). The reporter had very limited information, no other details were provided. At the time of reporting the outcome of the red itchy bumps at injection site was unspecified. This is the second of two reports made by the reporter, for the other case please see A1056647A. Follow up to the initial report received by GSK on 9 January 2013 and by the Safety Department on 14 February 2014. This complaint was associated with a product quality complaint. Follow up was received from the Quality Assurance Department on 14 February 2014. Based on results of the investigation by GSK Quality Assurance, the product complaint was assessed to be unsubstantiated.
3-23-21 3:47PM PT STATES SHE 'FEELS PANICKY'. A/O, PINK, W/D, RESP REG WITH EASE. NO ACUTE DISTRESS NOTED. NO SOB/DYSPNEA, NO PAIN, NO DIFFICULTY SWALLOWING. COMFORT AND REASSURANCE GIVEN. 3:52PM STATES 'FEELS BETTER NOW'. AMBULATORY TO EXIT WITH HUSBAND; GAIT BRISK AND STEADY. NO ACUTE DISTRESS NOTED. 3-24-21 9AM TC: HUSBAND STATES PT 'FEELS BETTER.'
mom states fever 102 that PM p/shots; 21JUL92 in AM fever 105; pt getting APAP; 21JUL92 PM seen in ER w/t103; mom states nothing was done by MD; to return home & cont APAP;
Body aches, chills, swollen throat, severe head ache, dizzy. Got sick around 10 pm on Friday 5/14/2021.  Felt better Sunday morning 5/16/2021.  The injection sick had a large red circle, swollen inflamed and hot to touch. That went away on Tuesday 5/18/2021.
That night chills, fever 102, diarhrea, Shortness of breath. Shortness of breath continued to get worse, 3rd day went to ER. Stated I was in heart failure. Took multiple doses of lasix, BNP was over 2200, followed up  with family Dr. contacted Cardiologist, he had echo and lab work done,  BNP down to 1200. I did not have the shortness of breath until after vaccine. Still am having. See primary Dr Monday and follow-up with Cardiologist the 28th.
Fell into deep asleep 5 hrs earlier than usual for 6 continuous hours.  Then woke up with 105 degree fever.  Gave Tylenol. No effect.  Then Motrin + Tylenol together helped.  3 continuous days fevers, vomiting six times, emergency hospital twice.  Doctor once.
37 Weeks pregnant at time of 1st vaccination.  EDD 01/31/2021 Scheduled c-section d/t breech presentation at 37 weeks and failed version at 38 weeks. Delivered 01/28/2021- healthy baby, no complications for mother or child.  Symptoms first began March 2021 Right eye pain, light sensitivity, redness and inflammation. Responded very well to ibuprofen. However, pain persister 1+ weeks before I scheduled appt with opthamology. After multiple exams/appts, he diagnosed as epischleritis, prescribed round-the-clock ibuprofen and steroid drops.  This helped, but after steroid taper completed- symptoms returned. MD recommended I see another doctor for second oppinion.  I then saw , DO (opthamology) who had same diagnosis along with dry eye. DO prescribed steroid drops(different name than previous drops) and round-the-clock ibuprofen as well as increased water intake and tear duct plugs. After this round of treatment, symptoms subsided.   As of today (8-2-93) redness and light sensitivity are gone, but occasional mild eye pain persists.
Death after Moderna mRNA vaccines; This literature-non-study case was reported in a literature article and describes the occurrence of COVID-19 (Death after Moderna mRNA vaccines) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.       Concurrent medical conditions included Lung disease and Rheumatoid arthritis. Concomitant products included LEFLUNOMIDE for Rheumatoid arthritis.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced COVID-19 (Death after Moderna mRNA vaccines) (seriousness criteria death and hospitalization). The reported cause of death was SARS-CoV-2 infection. It is unknown if an autopsy was performed.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered COVID-19 (Death after Moderna mRNA vaccines) to be related.    Concomitant therapy also included B cell depleting therapy. Treatment medications were not reported. The patient was on invasive ventilation.  Company Comment: This literature non-study case concerns a 66-year-old, female patient with pre-existing lung disease, rhematoid arthrits and with concomitant treatment of B cell depletion therapy and Leflunomide, who experienced the unexpected, fatal AESI of COVID-19. The event occurred after receiving mRNA-1273 as second dose of COVID-19 vaccine. The patient was hospitalized due to the event and required invasive mechanical ventilation. She subsequently died on an unknown date. Clinical course leading demise were not reported in the case. It is unknown if autopsy was performed. The patient's pre-existing conditions and concomitant medications remain as confounders for contracting the COVID-19 and for the fatal outcome. The benefit-risk relationship of mRNA-1273 is not affected by this report.   This case was linked to MOD-2022-496508, MOD-2022-496509, MOD-2022-496510 (Patient Link).; Sender's Comments: This literature non-study case concerns a 66-year-old, female patient with pre-existing lung disease, rhematoid arthrits and with concomitant treatment of B cell depletion therapy and Leflunomide, who experienced the unexpected, fatal AESI of COVID-19. The event occurred after receiving mRNA-1273 as second dose of COVID-19 vaccine. The patient was hospitalized due to the event and required invasive mechanical ventilation. She subsequently died on an unknown date. Clinical course leading demise were not reported in the case. It is unknown if autopsy was performed. The patient's pre-existing conditions and concomitant medications remain as confounders for contracting the COVID-19 and for the fatal outcome. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Reported Cause(s) of Death: SARS-CoV-2 infection
Delayed hypersensitivity reaction one week after receiving vaccine with redness, warmth, pain, rash and swelling of right arm injection site. Additional symptoms included nausea, headache, temperature 99.8F.
Came home cranky after getting shot - next AM 12/1/09 given Zyrtec woke up with bright red cheeks on face -  no fever, appetite good very cranky gave Zyrtec Mon. evening due to stuffy nose. Woke up Tues with bright cheeks and was crankier. SX resolved by Wednesday 12/2/09.
Patient passed out shortly after administering the flu vaccination. He was unresponsive for over one minute. Once responsive again patient reported being very warm and patient vomited multiple times.
pt states she developed severe leg cramps from knees to toes.  She could not sleep or walk due to the pain.  This pain lasted about 10 days.  After lunch every day she gets a headache that last about 4 hours.  When this happens she has no energy and does not feel like doing anything but laying down.  She states that about after 2 months she feels like her symptoms are getting some better but still deals with this everyday.
left Facial paralysis, left eye tearing - dispatch to ED to R/O stroke. Pt was diagnosed with Bells Palsy and discharged home with prednisone and valacyclovir.
ADMINISTERED EXPIRED VACCINE; This spontaneous report received from a health care professional concerned a 52 year old male. 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, route of admin not reported, batch number: 205A21A expiry: 21-SEP-2021) dose was not reported, administered on 08-OCT-2021 to Right Deltoid for prophylactic vaccination. No concomitant medications were reported. On 08-OCT-2021, the patient experienced administered expired vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of administered expired vaccine was not reported. This report was non-serious. This case, from the same reporter is linked.
Pt received a Kinrix (which is a combination vaccine that includes IPV) as well as a separate IPV vaccination on the same day. Pt sustained no known adverse effects. Pt's parent was notified as soon as the issue was discovered and asked to notify her PCP if any adverse effects became apparent.
Extremely sore in deltoids, temp 102, red with splotchs about 4x4 inches with and round with a lump the size of a golfball. Had to see her Dr. twice
Patient with no reported past medical history or past surgical history presented to ED and found to have massive bilateral pulmonary embolism. Upon presentation, patient was confused and lethargic. The morning of the event, niece reports that patient was in her usual state of health this am and had gone downstairs to the kitchen this afternoon, when she was downstairs she began complaining of nausea and generalized back pain. Her niece went to grab her things to take patient to the hospital but when she returned she found the patient laying on the floor due to weakness and pain, no reported fall or trauma. Chest/Abd/Pelvis CT Angio was significant for large PE in R and L main pulmonary arteries. No family history of DVT/PE.
severe chills; She was so sick; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 21Apr2021 15:00 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CHILLS (non-serious), outcome "unknown", described as "severe chills"; ILLNESS (non-serious), outcome "unknown", described as "She was so sick". Therapeutic measures were taken as a result of chills, illness. Additional information: The patient was advised by the pharmacists to take Tylenol. The patient stated that this was from the vaccine and wanted to confirm if this is really because of it.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
amenorrhea, was on period at time of vaccine, that period was heavier than usual with more cramping,  has not had a period since the one she was having at the time of the first dose of vaccine.  She did get second dose of vaccine on time as well.
Per school nurse: patient had seizure (15 min in duration) last evening (10/28).  Found today in class with blueness and loss of consiousness for about 3.5 minutes.  EMS at scene to transport to ER.  Patient awake, alert.  Slightly confused after 3.5 minutes.  No history of seizure like tonic/clonic movements with today's episode.
Have headaches; Fever; Shivering; Muscle pain; This case was reported by a consumer via interactive digital media and described the occurrence of headache in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 26th April 2022, the patient received the 2nd dose of Shingrix. In April 2022, less than a week after receiving Shingrix, the patient experienced headache, fever, shivering and muscle pain. On an unknown date, the outcome of the headache, fever, shivering and muscle pain were not recovered/not resolved.   It was unknown if the reporter considered the headache, fever, shivering and muscle pain to be related to Shingrix.     Additional Information: GSK Receipt Date: 27-APR-2022 Reporter's comment: This case was reported by a patient via interactive digital media. The patient had 2nd dose of Shingrix the day prior to the reporting. The patient experienced headache, fever, shivering and muscle pain. The patient asked how long do these effects last.
administered patient 1st dose of janssen vaccine. patient stated they have a phobia of needles and immunizations. administered vaccine and had patient wait outside pharmacy for 15 min. went to check on patient a few minutes later and they stated they were feeling light headed but this was normal for them because they get so nervous. had patient move to bench in front of pharmacy to be able to monitor them and went out again a few minutes later to check on patient. they stated they still felt light headed and dizzy so had technician sit with them on bench for remainder of time to be monitored
Fever started 1 day after receiving vaccine. Pt vomited x 1, was lethargic for about 48'. Slight sore throat 2 days later.
Pfizer 5/28 and 6/25. Positive on 12/30
Woke up with pain in left leg lower calf on  February 26 one week after my second vaccine. Had pain and throbbing in leg couldn?t sleep with pain so on  the evening of March 3rd I went to urgent care . Doctor didn?t think it was blood clot because I had no swelling or redness in my leg but gave me a script for ultrasound. I couldn?t get an appointment until  the morning of March 5th . Was diagnosed with a very large blood clot in lower leg  going up past my knee. I am now in Eliquis blood thinner for 3 months while they run tests
Extreme itching sensation at injection site. Site is swollen, hard to the touch, and there is a .5 inch diameter circle around the site.
Pt given undiluted vial of Pfizer Covid-19 vaccine.  No adverse effects as of the time of filing this report 5 hours later.
In approximately 12 hours I began having a ringing in my left ear, the same side I received my injection on.  It is now 48 hours after the injection and I am still having the ringing in my left ear and not my right ear has started as well.
Patient came to our pharmacy and want a Flu vaccine for his work. I administer the vaccine after he answer all questionnaire. He left and 30 minutes later called and swoll he experience Flu-like symptom; fatigue, tingling lip, metallic.
Severe chest pain , low grade fever and extreme fatigue  Chest pain/ fever got better with 800 mg of ibuprofen every 6 hours  and seemed to resolve itself in 2 days
Approximately 4 hours after receiving the shot on April 10, 2021, I started to burp and taste stomach acid. This continued through the night. Prior to going to bed at midnight, I started to experience slight stomach pain. At 2am in the morning (4/11) after receiving the shot I started vomiting and had diarrhea which lasted for about one hour. After returning to bed I had severe chills.   I ate the same foods throughout the day as 3 other adults and 1 child and none experienced similar symptoms.
This spontaneous report was received from a physician, via company representatives and from a support services director, concerning to a patient of unknown age and gender. Information regarding medical history, concurrent conditions and concomitant medications was not provided. On 23-JUL-2014 the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 0.5 ml (lot number and expiration date: K004016 and 08-MAR-2015 respectively; strength, and route administration were not provided). Nonetheless, no adverse effects were reported. On an unspecified dates, PNEUMOVAX 23 vaccine had two temperature excursions; one of 192 hours with a lowest recorded temperature of 34 F (1.111111111 Celsius) and other one of 1128 hours with a lowest recorded temperature of 33 F (0.555555556). The vaccine status was reported as "in excursion". The vaccine storage criteria and the vaccine excursion were reported as "Refrigerator(R)". This is one of the several reports received from the same reporter. Additional information has been requested.
red rash; rash; This case was reported by a consumer via interactive digital media and described the occurrence of red rash in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 22nd July 2022, the patient received the 1st dose of Shingrix. In July 2022, less than a week after receiving Shingrix, the patient experienced red rash and rash. On an unknown date, the outcome of the red rash and rash were unknown.   It was unknown if the reporter considered the red rash and rash to be related to Shingrix.     Additional Information: GSK Receipt Date: 24-JUL-2022 Reporter's Comments: The case was reported via interactive digital media. The patient received his/her 1st shingles vaccine on Friday and now had a red rash all over torso.  The reporter asked what should do. Additional Supportive Information: The follow-up would not possible as no contact details were available.
Sore arm, 2nd day tongue swelled huge went to ER got shot of Benadryl and steroid  tired and some dizzy
Got vaccine 1/9  1/12 - Second day at 3amI had extreme nasuea, almost threw up.  medium stomach pain during the day, I was constipated that whole day.  Finally constipation ended at 7pm.   1/13 - 1/15 arm was sore, felt like pulled muscle, very slight, vaccine injection spot was slightly raised  1/16 - injection spot was very itchy, very inflammed, very red and hard, hot to the touch  1/17 had stomach issues and fatigue, arm less inflammed but still red and hard and warm.
Patient received Pfizer COVID vaccine on 3/12/21 and 4/9/21. On 1/23/22, patient tested positive for COVID. On 2/2/22, patient admitted to our med/surg unit with symptomatic bradycardia, dyspnea, AKI, and hypertension. Patient was discharged home the next day on 2/3/22.
my arm started turning red, swollen; very painful; itchy; feverish; allergic reaction; my arm started turning red, swollen; This is a spontaneous report from a contactable consumer. A 78-years-old non-pregnant Female patient received second dose of BNT162B2, (formulation: Solution for injection, Lot Number: Phizer, EN5378), via an unspecified route of administration, administered in Arm Left on 20Feb2021 at 11:00 as dose 2, single for covid-19 immunization. Medical history included drug hypersensitivity (sulfa drugs). The patient previously took zofran [ondansetron] and experienced drug hypersensitivity, monosodium glutamate and experienced drug hypersensitivity. The patient previously had tetanus vaccine and experienced hypersensitivity. Concomitant medications received in two weeks included naproxen sodium (ALEVE). There were no other vaccine in four weeks. The patient did not had Covid prior vaccination and did not tested for Covid post vaccination. The patient previously received first dose of BNT162B2, (formulation: Solution for injection, Lot Number: EL3245), via an unspecified route of administration, administered in Arm Right on 28Jan2021at 14:00 as dose 1, single for covid-19 immunization. On 21Feb2021 at 13:00, the patient experienced her arm started turning red, swollen, very painful, itchy, feverish and allergic reaction. It was reported that the day after the shot on Feb20, her arm started turning red, swollen, very painful, itchy, and feverish in a circle around the injection site in a 4 and 3/ 4inch diameter circle. The only relief night or day was when she had an ice pack on it. She could just sleep in short naps for the next 3 nights. The patient feared it to be infected, but as the edges of the area are lightening, it could be an allergic reaction. Cortisone cream did not help. She made numerous calls but was not able to get an appointment to be seen right away even virtually; and since it was improving, she will probably quit trying, Just wanted Pfizer to be aware this can happen and to alert those health professionals involved as to the possibility of this and how to advise patients. The events very painful, feverish and allergic reaction were not treated. The patient was recovering from all events.  Follow-up attempts completed. No further information expected.
Client requested to receive his first  Jynneos vaccine. Client reported history of anaphylaxis to bee stings and penicillin. Client reported he gets hives from septra, keflex, doxycycline and clindamycin. Client confirmed he has no allergic reactions to gentamicin and ciprofloxacin and has "never heard of those." PHN text medical consult to Dr. at 9:57 am. Per Dr., "yes you can vaccinate as he has no reaction to cipro or gentaimcin." Client received Jynneos vaccine lot #FDP00014 in left forearm ID at 10:19 am. At 10:29 am PHN, checked on the client who had redness and swelling 1.5 inches around the site of vaccination. Client denied itchiness of the red area and denied itchiness anywhere else. Client denied dizziness and nausea. PHN, observed clients skin on his torso, back, arms, and legs, no hives or rashes noted. Client denied no new cough or swelling of the throat. Client was relaxed, breathing at a regular rate, alert and oriented to person, place, time, and situration. PHN, observed no swelling of the face or left arm. At 10:35 am client stated he had a headache, 2/10 pain. PHN gave juice and a snack to client to eat. PHN, called Dr. at 10:40 am. Per Dr. client doesn't need treatment for allergic reaction. Dr. confirmed local redness and irritation has been reported. Vitals taken by EMT, at 10:43 am. 96% SPo2, HR 96 bpm, RR 20, BP 134/74. Client reports a history of COPD and headaches. Client reported headache continued at 2/10, stated not getting worse. Client reported he "may have had a headache before the vaccine" and gets them frequently. PHN, checked skin for rashes again, none were observed. PHN, educated sign and symptoms of allergic reaction and when to call 9-1-1. At 10:50 am, client completed 30 minute observation period and rode away steadily on his bike, no concerns.
Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: Allergic: Rash (specify: facial area, extremeties)-Medium, Systemic: Allergic: Rash Generalized-Medium