chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Chronic spontaneous urticaria after COVID-19 vaccine. Hives/urticaria all over body (head, ears, neck, chest, torso, arms, hands legs, feet) started on 12/20/21 (11 days after 3rd dose of Moderna vaccine). - Welt areas will last for 30-60 minutes with intense itching. They will then spontaneously resolve but another spot on body would begin. Also with skin writing. Any pressure to skin will cause flare up of hives. Started having wheezing/difficulty breathing on 12/31/21. - Changed diet/soaps/etc without help. - Tried a course of prednisone + topical steroids- no help. - Hydroxyzine - no help. - Levocetirizine - no help. - Now on Zyrtec BID (most helpful but mild help). - Albuterol BID for wheezing (helpful).
This spontaneous report as received from a nurse prescriber via a company representative refers to a 19 year old female patient. The patient's pertinent medical history included sprained ankle. No historical medications nor drug reactions/allergies were reported. On 21-FEB-2017, the patient was vaccinated with GARDASIL 9 injection, 0,5 ml, first of 3 doses (schedule: 0,2,6 months), intramuscularly (lot # M034195, expiration date unknown) for prophylaxis. Concomitant therapies included IBUPROFEN. On 21-FEB-2017, after receiving her first dose of vaccine, the patient experienced rash and hives on her face and neck and her rash/hives were itchy. The nurse prescriber gave the patient an injection of an unspecified dose of BENADRYL for these effects. The outcome of the events was reported as not recovered. The relatedness between the events and GARDASIL 9 was not reported. Upon internal review the events of itchy rash and hives on face and neck treated with injection of BENADRYL were considered as medically significant. Additional information has been requested.
Pt presented to Emergency Room at local Medical Center on August 29, 2011 with complaints of not feeling right and fell at home.  The patient was diagnosed with COVID-19 infection, he was previously fully vaccinated on 2/19/2021 & 3/12/2021.  Patient completed Remdesivir and Decadron, patients oxygen requirements increased during hospitalization, requiring additional course of steroids.  Patient required CPAP during the Hospital Course.  After using the CPAP, the patient developed a facial abscess.  ENT did an incision and drainage.  The patient completed antibiotics. Patient was admitted to a Specialty Hospital.  to continue care.   On 10/27/2021 the patient met with the physician and family members and due to his significant decline, poor prognosis and increased oxygen needs, the patient chose to go comfort cares and expired on 10/27/2021 1835.
When I woke up I thought I had a cold. I was sneezing a lot and had a runny nose. Three days I later I tested positive for COVID at Drive Up test site.  After seven days, I had a tele visit with my doctor and she ordered the monoclonal antibodies. I had some nausea which last about 3 days.
patient woke up the next day with fever( face and neck very hot, temp unknown), shot arm(Rt Delt) pain & swelling, swollen gland on Rt side of neck, fatigue.  Patient couldl not move her neck upon waking up, but neck became mobile later in the morning. I informed her that these are possible reactions with Shingrix, she can take tylenol for the fever and pain if tolerable, and contact her doctor if symptoms worsen.
Muscle aches in arms, legs, hands, feet and gluteus. Chills. Mild nausea.
Site: Pain at Injection Site-Medium, Additional Details: pt came in for second dose. states she is still having pain from first dose and was treated by md for it
Facial erythema, periorbital edema and flare of atopic dermatitis within one hour of vaccine admin.  Treated by Pediatrician with oral antihistamines and oral steroids.
This case was reported by a pharmacist and described the occurrence of jaundice in a patient who received hepatitis B vaccine recombinant (Engerix-B) for prophylaxis. On an unspecified date, the patient received an injection of Engerix B. Approximately two to three days post-immunization, the patient experienced jaundice and increased liver function tests. The event resolved a few days later, without treatment. The reporting pharmacist considered the events were possibly related to vaccination with Engerix-B. The jaundice in this report is considered to be medically serious (OMIC).
One day after injection red circle marking over deltoid. Went away in 48 hrs. Intense muscle aches and chills and fatigue. Approx one week after injection the red marking/hive appeared again, larger, raised very very hot and itchy. This lasted for 24 hrs. Took benedryl.
in bed most of the time; started to get dizzy and can't get up; started to loose appetite; This spontaneous case was reported by a consumer and describes the occurrence of DECREASED APPETITE (started to loose appetite), ASTHENIA (in bed most of the time) and DIZZINESS (started to get dizzy and can't get up) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006M20A and 032L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 19-Feb-2021, the patient experienced DECREASED APPETITE (started to loose appetite). On an unknown date, the patient experienced ASTHENIA (in bed most of the time) and DIZZINESS (started to get dizzy and can't get up). At the time of the report, DECREASED APPETITE (started to loose appetite) had not resolved and ASTHENIA (in bed most of the time) and DIZZINESS (started to get dizzy and can't get up) outcome was unknown. Not Provided          No concomitant medications were provided by the reporter. No treatments medications were reported. I t was reported that she shouldn't be having side effects since it's been this long.   Most recent FOLLOW-UP information incorporated above includes: On 05-May-2021: Significant follow up: outcome of event updated and reporter contact details added.
This is a non-serious spontaneous case, initially received from other non-health professional via pharmaceutical manufacturer (Merck) on 07-May-2018, concerning a female patient of unspecified age. On an unspecified date, the patient was administered with Influenza vaccine (dose, route of administration, anatomical location, batch number, expiry date, trade name, manufacturer: not reported) and PNEUMOVAX 23 (dose, route of administration, anatomical location, batch number, expiry date: not reported). On an unspecified date, next day of vaccination, the patient experienced redness and swelling at injection site. At the time of this report, the outcome of the events was not reported.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 02Nov2022 as dose 5 (booster), single (Lot number: GJ3277) at the age of 67 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 04Mar2021 as dose 1, single (Lot number: EL9263), in left arm, on 25Mar2021 as dose 2, single (Lot number: EL9263), in right arm, on 16Oct2021 as dose 3 (booster), single (Lot number: FF8841), in left arm and on 14Jul2022 as dose 4 (booster), single (Lot number: FM0173), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Pernicious Anemia" (unspecified if ongoing); "High cholesterol" (unspecified if ongoing); "known allergies: Macadamia nuts" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jun2023, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient received treatment for COVID-19 with Paxlovid (Batch/lot no: GJ6048) from 18Jun2023 to 22Jun2023.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300232210 Same patient, different drug/ AE;
Within 20 minutes post vax the pt developed a golf ball sized swelling of his elbow. The swelling was reported to be an allergic reaction. As of 3 day post vax the swelling persisted. Pt is being seen by a specialist.
Positive Covid test, 10/19/2022 Cogestion, coughing, fever of 101.7 Teleconferencce 10/23/2022: prescription for Lagevrio Three days of Lagevrio: rash on ribs and back, so Lagevrio discontinued Continuing to test positive at this writing, No fever for four days
pt recv vax 6NOV96 & 14NOV96 pt exp a febrile sz & devel a mild varicella-like rash;pt was hosp;
Severe nerve pain in left leg; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 25 year-old female patient received bnt162b2 (BNT162B2), administration date 02Apr2021 (Lot number: ER8733, Expiration Date: Jul2021) at the age of 25 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: BUSPAR. The following information was reported: NEURALGIA (non-serious) with onset 02Apr2021, outcome "not recovered", described as "Severe nerve pain in left leg". Therapeutic measures were taken as a result of neuralgia.  Additional information: It was reported that severe nerve pain in left leg happening since the vaccine and have seen multiple doctors, she have to go scans, she need to be in contact about this with someone, she just need to talk to some body that was to report and talk to some body. The patient was treated with Gabapentin 100 mg three times a day for the event.  No follow-up attempts are possible. No further information is expected.
Approximately, 5 minutes, post vax, pt had wheals and sweating. P40 and descreased response.
Nine days after injection I have rash at injection site and lump above my collarbone. I feel ok.
Muscle twitching, legs cramps and vibration (from my face down)  July 2004 - started Neurontin Jan 2006 started IVIG. 3/13/07 Received medical records from PCP which only extend from 5/04 to 8/05 & therefore do not include record of IVIG.  T/C to PCP office & message left for return call.  Records indicate patient experienced low vibration sensation of legs, arms & chest beginning in 5/04 & heart palpitations.  Tx w/neurontin.  Eval by rheum in 7/04 for possible Lyme dx & that eval indicates + Lyme test x 2.  Exam was neg.  Dx at that time was neuropathy s/s & + Lyme dx serology, possibly from Lyme vax or to infection.  Tx w/month course of doxycycline for diagnostic purposes.  Eval by neuro 8/04 & felt s/s were somatic anxiety induced.  D/C neurontin as felt patient did not have neuropathy of any sort.  Returned to rheum 8/04 w/o change in s/s & continued to feel pulsating & numbness of face, legs & arms.  Felt did not have Lyme dx at that point since no good response to antibiotic tx.  Received multiple evals by various neuro specialists w/o resolution of s/s.  Final neuro eval in 5/05 for continued s/s of vibration, fatigue & some vague cognitive difficulties. Repeat multiple labs in 5/05 revealed possible active Lyme infection as well as post Lyme/post vax autoimmune process & started on Plaquenil & Biaxin.  Regimen provided some improvement.   5/18/07 Received medical records from neuro which reveal initial eval was 5/10/05 which revealed patient experienced vibrating sensation all over which had begun abruptly approx 1 year prior which increa sed w/fatigue or activity & was helped by Neurontin.  Also c/o cognitive difficulties.  Patient had been seen by 5 previous neurologists.  Exam of 5/05 revealed decreased ankle jerks, diminished sensation of ankles. Treated w/plaquenil & Biaxin w/questionable improvement. Records indicate treatment w/IVIG began in 1/07 w/very gradual improvement & decline when IVIG reduced.  Continued on IVIG as of 4/2/07 FINAL DX:  active & chronic Lyme disease, post Lyme autoimmune syndrome. 04/01/2010 The patient has small fiber neuropathy (confirmed by a skin biopsy again, collected 3/5/07). The patient has a vibration in her body from her face down. The patient has random muscle twitching.
p/vax pt had sz;extensive tests have shown no cause;pt had a second sz 9/9/99-more tests-no cause;
Shingles. I'm not sure if the shot contributed to the breakout or expedited it but it was a very large breakout on Thursday on my left side causing me to go to my gynecologist. I thought I may have been getting a rash from my bra. I was advised by a family to report to vaers to see if the shot was related. I do not want to report any false information just wanted make you aware.
Patient started experiencing pain on 4-5-21 She went to her doctor on 4-8-21 where she was diagnosed with shingles.
Urinating blood. Took  to the doctor on Wednesday 5/19/21, they confirmed that he has blood in his urine, and so far, they don't know what is causing it. All tests for infection, etc., with his urinalysis came back negative.  has never urinated blood in his entire life. We took him in on Friday May 14th to get his 1st COVID shot (Pfizer), less than 3 days later he started peeing blood, and he still is, every single day since.
Possible administration of invalid dose to patients; Freezer temperature never reached an acceptable range and was always warm by at least 2 degree C.; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Freezer temperature never reached an acceptable range and was always warm by at least 2 degree C.) and POOR QUALITY PRODUCT ADMINISTERED (Possible administration of invalid dose to patients) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) (batch no. 025C21A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. In April 2022, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Freezer temperature never reached an acceptable range and was always warm by at least 2 degree C.). On an unknown date, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Possible administration of invalid dose to patients). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Freezer temperature never reached an acceptable range and was always warm by at least 2 degree C.) and POOR QUALITY PRODUCT ADMINISTERED (Possible administration of invalid dose to patients) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not provided.  It was reported that there are 4 days temperature data (between 1-Apr-2022 and  4-Apr-2022) for the freezer storage unit, however it never reached an acceptable range and was always warm by at least 2 degree C. Between 22-Feb-2021 to 26-Apr-2022 there was no other temperature data available. Total 6640 doses of COVID-19 Moderna Vaccine were received by this facility during this time period and LOT numbers were provided (057M21A, 025L21B, 066H21A, 069H21A, 027H21B, 032F21A, 011F21A, 004F21A, 025C21A, 017C21A, 002C21A, 042B21A, 031B21A, 027B21A, 026B21A, 016B21A, 008B21A, 045A21A, 001B21A, 029A21A, 025A21A, 001A21A). Some vials may have been moved to a refrigerator at some point. There was no temperature data for that storage unit.  Treatment information was not reported.
ordered to receive Pediarix and ActHIB but the consumer received Pentacel and Pediarix, no AE; ordered to receive Pediarix and ActHIB but the consumer received Pentacel and Pediarix, no AE; that the consumer is behind on their vaccine schedule, no AE; Initial information received on 24-Oct-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 9 months old female patient who was vaccinated with a 0.5 mL dose of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (frequency once) (lot number: UJ129AAA, expiry date: 03-Nov-2020 via intramuscular route in the right thigh on 22-Oct-2019 and DIPHTHERIA VACCINE TOXOID, HEPATITIS B VACCINE RHBSAG (YEAST), PERTUSSIS VACCINE ACELLULAR 3-COMPONENT, POLIO VACCINE INACT 3V (VERO), TETANUS VACCINE TOXOID [PEDIARIX] lot number not reported via unknown route in unknown administration site on 22-Oct-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   It was an actual medication error case due to extra dose administered, and wrong vaccine administered and Inappropriate schedule of vaccine administered. It was reported that the patient ordered to receive Pediarix and ActHIB but the consumer received Pentacel and Pediarix. The nurse reported that the consumer received a double dose of the Dtap-IPV component on the day of the injections due to the Pentacel and Pediarix contain those components; that the medication error occurred on 22Oct2019. The consumer is behind on their vaccine schedule.  It was reported that the patient had no adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. 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.
patient came in on 8/30/2020 to complain of uncontrollable itching and stated nothing has changed but getting her flu shot. She stated that it started after the flu shot and believes it to be its cause. She stated no change in medications or other medications. She also stated that she hasnt change anything in her life aka shampoo or had any new allergies.
Moderna Booster given 8/28/21. Around 9/1/21 she developed headache. Admitted to hospital 9/5/21 with spontaneous subdural hematoma and subarachnoid hematoma. Bleeds were attributed to warfarin and aspirin 81mg and not the vaccine. (but just to be careful, I'm submitting this report).
Allergic reaction to PNEUMOVAX23, reaction inclueded rash; This spontaneous report was received from a physician regarding a 77 year-old female patient. The patient's concurrent conditions, pertinent medical history, drug reactions, allergies, concomitant therapies were not provided.   On 18-NOV-2008, the patient was vaccinated with Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX23) 0.5 ml intramuscular, as routine immunization (prophylaxis), lot number 0980x has been verified to be a valid lot number, with expiration date 24-MAY-2010.    On an unspecified date, the physician was calling to inquire if patient had allergic reaction to Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX23), was a chance she would have an allergic reaction to either of the current COVID vaccine available. This because on 18-NOV-2009, the patient had an allergic reaction to Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX23) (drug hypersensitivity), reaction included rash, and the extent of the allergic reaction was unknown by the reporter.   The outcome of the event drug hypersensitivity was not provided.   The causal relationship between the event drug hypersensitivity and therapy with Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX23) was reported as related.
Patient began having chest pain initiating inferior to left breast and radiating upward through chest approximately 5 minutes after receiving Pfizer Covid-19 Vaccine.  Blood pressure taken ~7 minutes from administration was 125/67 mmHg and Pulse: 65 BPM.  Pain waxed and waned and was not relieved from sitting down or standing up.  EMT were called for possible heart attack, BP and pulse ~17 minutes after administration was 136/76mmHg and 76 BPM.  EMTs arrived and brought her to ambulance for EKG which was normal.  Patient stated she felt better and refused going to the hospital for further work-up.  Prior to vaccine administration patient was at the gym on the treadmill for 30 minutes.  unknown how long before vaccine administration
morning of 14MAY exp fever & chills;T101-102.8 w/local rxn to lt arm w/erythema approx 4cm in diameter over entire lateral portion of deltoid;warm to touch;mildly tender;pt seen by MD 15MAY;
Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Mild, Systemic: Chest Tightness / Heaviness / Pain-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Flushed / Sweating-Medium, Systemic: Hyperventilation-Mild, Systemic: Nausea-Medium, Additional Details: Approximately 5 minutes after administration patient appeared "clammy" upon asking patient how she felt she reported feeling very hot and nauseous. Patient initially reported reservations about getting the shot prior to administration and was "very nervous about having to get it."  Roughly 10 minutes after administration patient was getting short of breath, breathing rapidly, and appeared very distraught. Told patient epipen was available and patient requested it, breathing became easier after.
sleepy p/vax next day vomit x1, diarrhea x 3 for 2 days;day 2fussy cont to be fussy a wk later, although not as bad;parents describe pt as a different child since shots;
Patient experienced extensive arm redness in the vaccinated arm; This case was reported by a other health professional via sales rep and described the occurrence of erythema of extremities in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced erythema of extremities. On an unknown date, the outcome of the erythema of extremities was recovered/resolved.   It was unknown if the reporter considered the erythema of extremities to be related to Shingrix.     Additional Information: GSK Receipt Date: 23-JUN-2022 Reporter's Comments: The physician described that a patient at their clinic had experienced extensive arm redness in his vaccinated arm following his dose of Shingrix. His condition led to a visit with his physician. The condition did resolve over some time, and the patient was given the second dose of Shingrix without incident. No further information regarding the patient event was available at time of this report. The local GlaxoSmithKline vaccines representative would be collecting further information from the reporter on 24th June 2022, if possible. The reporter was consented to follow up.
A patient received her 3rd BEXSERO vaccination today (Extra Dose); This non-serious case was reported by a other health professional via call center representative and described the occurrence of extra dose administered in a 19-year-old female patient who received Men B NVS (Bexsero) (batch number 5yp3L, expiry date 31-JAN-2026) for prophylaxis.   On 08-NOV-2023, the patient received the 3rd dose of Bexsero (left deltoid). On 08-NOV-2023, an unknown time after receiving Bexsero, the patient experienced extra dose administered (Verbatim: A patient received her 3rd BEXSERO vaccination today (Extra Dose)). The outcome of the extra dose administered 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 Information: GSK receipt date: 08-NOV-2023 The reporter stated that the patient received the 3rd Bexsero vaccination, which led to extra dose administered. The reporter consented to follow up.