chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Systemic: Autoimmune Disease (diagnosed by MD)-Severe, Systemic: Neurological Disorder (diagnosed by MD)-Severe, Additional Details: GUILLAIN-BARRE SYNDROME
Rash on face, in ear ,arms,,soreness on left shoulder ,headache,,itch in eyes,,pain on left hand ,,fatigue,,
After getting the 2nd dose of the vaccine she "blacked out"; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (After getting the 2nd dose of the vaccine she "blacked out") in a female patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced LOSS OF CONSCIOUSNESS (After getting the 2nd dose of the vaccine she "blacked out") (seriousness criterion medically significant). At the time of the report, LOSS OF CONSCIOUSNESS (After getting the 2nd dose of the vaccine she "blacked out") outcome was unknown.            Concomitant product use was not provided by the reporter.  Treatment information was not provided.  Company comment-:This is a spontaneous case concerning a female patient of unknown age with no medical history reported who experienced the serious (medically significant) and unexpected event of loss of consciousness after a second dose of mRNA-1273 vaccine was administered. No further details were provided for medical review. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.   This case was linked to MOD-2022-551327 (Patient Link).; Sender's Comments: This is a spontaneous case concerning a female patient of unknown age with no medical history reported who experienced the serious (medically significant) and unexpected event of loss of consciousness after a second dose of mRNA-1273 vaccine was administered. No further details were provided for medical review. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.
Fast heart rate/ atial Fib went to the emergency on 3/8/2021 at 8pm
Started off with a low fever, runny nose, and irritability about one to two hours after receiving flu vaccine. I gave him Children's Motrin. He had diarrhea around 8:30 PM so I bathed him.  After his bath, I notice he had very large welts on his thighs and rear end, that later got so raw that they started to bleed. Both the welts/hives and the diarrhea continued for at least two weeks.
a patient was administered an expired dose of Pentacel, No AE; a patient was administered an expired dose of Pentacel because the expiration date on the box was confusing, No AE; Initial information was received on 07-Jul-2021 regarding an unsolicited valid non-serious case received from an other health care professional via physician (under Global Medical Information (GMI) Inquiry Number 00672403).  This case is linked to case 2021SA226436 (same reporter sister's case).  This case involves a four months old female patient who was administered an expired dose of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE [PENTACEL (VERO)] because the expiration date on the box was confusing (Expired product administered and Product label confusion).  The patient's medical history, medical treatments, vaccinations and family history were not provided.  Concomitant medications included ROTAVIRUS VACCINE and PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PNEUMOCOCCAL VACCINE CONJ 13V (CRM197)) for prophylactic vaccination.  On 29-Jun-2021, the patient received a 0.5 mL dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE lot number: UJ350AAA and Expiry date: 22-Jun-2021, Frequency: once, Strength : standard via intramuscular route in the left thigh for prophylactic vaccination.  It was case of an actual medication error due to expired vaccine used and expiration date format confusion (latency: same day).  It was reported "The caller declined to provide an email address, stated the office does not have one. The caller reported that two patients were administered expired Pentacel because the expiration date on the box was confusing. The caller wanted to know what they need to do now, for those patients. Caller reported that the expiration date on the box was written as 22/06/21 so the staff thought this meant it expired 21Jun2022, not 22Jun2021."  At time of reporting, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out by the regulatory authority. 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.
Information has been received from a physician concerning a 65 year old female who was vaccinated with ZOSTAVAX. It was reported that 2 weeks after vaccination, the patient developed shingles. The shingles covered 3 dermatones and 1 lasted for about 1 month. The patient had recovered at the time of report. Unspecified medical attention was sought. A product quality complaint was not involved. Additional information has been requested. This is in follow-up submitted on 12/21/2007.  Information has been received from a physician concerning a 79 year old female who on 21-JUL-2007 was vaccinated in the right arm with a first dose ZOSTAVAX (Merck) (given by her daughter).  On 27-JUL-2007 in the AM, (previously reported as 2 weeks after vaccination), the patient developed shingles.  The shingles covered 3 dermatones and 1 lasted for about 1 month.  Relevant diagnostic test and laboratory data included:  varicella-zoster Ab, IgG, S-positive;  varicella-zoster Ab, IgM, S-negative;  varicella positive;  skin culture- no growth after 3 days;  white blood  count-6.8 10E3/MM3;  red blood count-5.58 10M3/MM3;  platelet count-179 10E3/MM3;  herpes simplex virus/rapid PCR (HERP)-negative;   hemoglobin-14.2 g/dL;  hematocrit-41.38;  mean corpuscular volume 90.1FL;  mean corpuscular hemoglobin 31.0 pg;  mean corpuscular hgb conc 34.5%; red cell distribution width-12.7%;  mean platelet volume 12.0 FL;  granulocytes-86.7%;  lymphocytes-9.6%;  monocytes-3.5% eosinophils-0.0%;  basophils-0.2%; granulocytes absolute number-5.9;  lymphocytes absolute number -0.7;  monocytes absolute number 0.2;  eosionophils absolute number-0.00 10FL/mml;  basophils absolute number-0;  erythrocyte sedimentation rate-8 mm/hr.  The patient had recovered at the time of report.  Unspecified medical attention was sought.  A product quality complaint was not involved.  Additional information has been requested.
Patient felt dizzy after maybe about 5-10minutes of receiving Fluzone HD, as pt was walking out of the store. He had to lay down on the floor as he was feeling weak.He was attended by an EMT, and was taken to hospital.
Fever on Saturday October1st followed by hives.  Tmax 101, now afebrile
has the chickenpox, along w/several other children in daycare;pt recv vax 11JUL97;
Large Swollen golf ball size diameter swelling and discomfort that was hot to the touch. Treated with warm compress at first and then Iced for 20 minutes every hour with 600 mg of Ibuprophin and some antihistamine.
Pt was vaxed approx 5 minutes later, pts sister was informed nurse that pt had fainted outside; pt was found lying down; alert & oriented to person, place & time; VS P50, Resp22 & BP 98/60; no injuries noted;
This case was reported by a consumer (the subject) and described the occurrence of raised red bump at injection site in a 60-year-old female subject who was vaccinated with FLULAVAL (GlaxoSmithKline). The subject's medical history included allergy to antibiotic and cellulitis leg. On 7 September 2010 at 14:00 the subject received 1st dose of FLULAVAL (.5 ml, unknown route, right arm). On 7 September 2010, 1 hour after vaccination with FLULAVAL, the subject experienced raised red bump at injection site, injection site blisters, injection site hot to touch and itching near injection site. The subject was treated with warm compress, cool compress and clarithromycin. At the time of reporting the events of raised red bump at injection site and injection site blisters were worse, the itching near injection site was unresolved and the outcome of the injection site blisters was unknown. The subject experienced a raised red area at the injection site that covered an area on her arm approximately 10 inches long by 4 inches wide. It was hot to the touch and blistered and the outer edges were itchy. Her physician recommended alternating lukewarm and cold compresses and pt her on clarithromycin. She had taken 3 doses at the time of the reporting and the redness was getting worse and spreading.
body aches; Fatigue; laying around; vaccine expired two hours before he got it; This is a spontaneous report from a contactable physician. A 18-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: unknown), via an unspecified route of administration, administered in arm on 01May2021 (at the age of 18 years) as 2nd dose, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: unknown), via an unspecified route of administration on an unspecified date as 1st dose, single for COVID-19 immunization and meningococcal vaccine b (MENB) taken on Feb2021. The patient had no other vaccinations the dates he got his Pfizer COVID-19 vaccine or in the four weeks prior. On 01May2021, saturday patient received second dose of vaccine which was expired two hours before he got, which the patient should not had got and was called back in. On 02May2021 patient experienced side effects such as body aches, laying around, and fatigue. The reporter informed about seriousness that she felt it is significant, in that there was already hesitancy, so for them to mess up on this is significant. The outcome of event was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the event Expired vaccine used, fatigue and the suspect drug BNT162B2. Also, there is limited information in the case provided, the causal association between the event pain, bedridden and the suspect drug BNT162B2 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Within 12 hours of vaccinations fever to 101.8, malaise, headache, chills.  Inflammation ie swelling erythema tenderness at injection site.  10/7/08 Reviewed hospital medical records of 7/13-7/15/2008. FINAL DX: cellulitis of LUE s/p tetanus & pneumovax; possible post vaccination reaction Records reveal patient experienced LUE injection site pain & redness, fever, chills, cough, HA, fatigue, neck discomfort.  Initially seen in ER 7/13 for same, LP done, dx w/inflammatory reaction & d/c to home on oral antibiotics.  Experienced recurrent fever, increased LUR pain, erythema & swelling w/streaking under the arm, poor appetite.  Tx w/IV antibiotics, d/c to home on continued oral antibioticsw/PCP f/u.
PATIENT RECIEVIED VACCINE ON 1/4/2021, THE FOLLOWING DAY PATIENT BEGAN EXPERENCING PAIN DOWN BACK AND BOTH LOWER EXTREMITIES.
Almost Nauseated Stiffness and swelling in knees some diarrhea tightness of lungs
Onset of symptoms: piercing sensation in legs, feet, ankles, knees and leg . Pain and pins and needles. Worsened at night. Tingling in fingers.  1:) Urgent care 2.) ER Dept 3.) Primary Care Dr. suspected Guillian Barre
Congestion, loss of taste/smell, diarrhea, ear pain, eye irritation
I got a very bad taste in my mouth and everything kind of smelled bad; really bad sense of smell and taste; Also, food smells and tastes differently; I got a very bad taste in my mouth and everything kind of smelled bad; really bad sense of smell and taste; Also, food smells and tastes differently; when I got my 2nd dose it became more intense/it has only gotten worse; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 29 year-old female patient received bnt162b2 (BNT162B2), administration date 22Feb2022 (Batch/Lot number: unknown) at the age of 29 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose1), administration date: 02Feb2022, when the patient was 29 years old, for COVID-19 immunization, reaction(s): "I got a very bad taste in my mouth and everything kind of smelled bad", "I got a very bad taste in my mouth and everything kind of smelled bad". The following information was reported: TASTE DISORDER (non-serious), PAROSMIA (non-serious) all with onset Feb2022, outcome "not recovered" and all described as "I got a very bad taste in my mouth and everything kind of smelled bad; really bad sense of smell and taste; Also, food smells and tastes differently"; CONDITION AGGRAVATED (non-serious) with onset Feb2022, outcome "not recovered", described as "when I got my 2nd dose it became more intense/it has only gotten worse". Therapeutic measures were not taken as a result of taste disorder, parosmia, condition aggravated.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Lose of ability to stand to feet, tingling in both feet then to hands, weakness in legs, arms, and hands. Could not lift legs.Swelling in feet and lower leg ,bothsides!
Tingling in mouth and on tongue, Went to alergiest, went to walk-in clinic, took benedryl. Soreness in right arm (lasted for 6 days), headaches, nausea, diarrhea (nausea and diarrhea lasted for 1-2 days).
Patient developed low grade fever 18 hours after vaccine associated with bilateral hand and foot parthesias associated with reported loss of grip strength as well.  Resolved by approx 72 hours after vaccine except for some residual heel pain.
Swollen  lymph node's to the size of a grapefruit, under left are
Patient had severe swelling around face and rash on body approximatley 2 days after vaccine given. Pt. treated with prednisone. Swelling has improved with steroid tx.
Symptoms started approximately 4 hors after injections. Didn't want to eat supper. Screamed when she stood up. Cried "alot" between 5:30 pm and bed time at 8:30 pm. Mom says redness size of nickel, no "knot".  On Thursday, 08/30/01, symptoms continued per mom so appt was made at the doctors for 3 pm and taken to the appt. The doctor ordered amoxicillin. The parent gave the child Tylenol thru Thursday and it was not needed on Friday.
Patient presented at pharmacy for primary Pfizer covid vaccination and influenza vaccination.  Both products were retrieved.  Pfizer primary monovalent vaccine had been removed from pharmacist vaccination refrigerator to refrigerator in back of pharmacy.  On shelf where it had been located Pfizer Ped Bivalent 5-<12yo was placed.  Patient was given vaccinations. Error was noticed at pharmacy close when reporting to immunization registry was performed.  Pfizer was called on open of business on 10/26/2022 and report # eeirfb1kt was created with them, I was referred to call CDC for advice on how to proceed with immunization to protect our patient.  Per CDC we are to administer Pfizer monovalent covid-19 adult dose in three weeks and then again in two months following that.  Patient was called to be informed and to relay immunization plan.  Patient was not home so voice message to call pharmacy was left for her.
HSV-2 and had a frequent outbreak from the time patient got vaccinated with the covid 19 vaccine from Moderna; This spontaneous case was reported by a patient and describes the occurrence of HERPES SIMPLEX (HSV-2 and had a frequent outbreak from the time patient got vaccinated with the covid 19 vaccine from Moderna) in a male patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     Concurrent medical conditions included Herpes simplex type II (since patient was a teenager).    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced HERPES SIMPLEX (HSV-2 and had a frequent outbreak from the time patient got vaccinated with the covid 19 vaccine from Moderna). At the time of the report, HERPES SIMPLEX (HSV-2 and had a frequent outbreak from the time patient got vaccinated with the covid 19 vaccine from Moderna) had not resolved.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       No concomitant medications were reported.  The patient had HSV2 since he was a teenager, and was getting more frequent outbreaks.  Patient was looking online for answers and found a trial working on a similar vaccine for herpes simplex and interested in being a trial or in whatever mechanism for patient to try the vaccine and see if would work. Patient had 2 young children and was frightened that would pass the infection. Patient used patches and creams, but both were troublesome, and patient would like to have better option. Patient was prescribed a preventive medicine before, but couldn't afford it and never got to try it.
left armpit began to significantly hurt; entire arm was sore; This is a spontaneous report received from a non-contactable consumer, the patient. A 45-year-old non pregnant female patient received her second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EN6203) via an unspecified route of administration in the left arm on 24Mar2021 at 10:00 (at the age of 45-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported.  The patient had a history of allergy to mangos. The patient received loratadine (ALAVERT) for unknown indication and birth control pill within two weeks of vaccination. The patient previously received her first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6203) via an unspecified route of administration in the left arm on 03Mar2021 at 11:00 (at the age of 45-years-old) as a single dose for COVID-19 immunisation. The patient did not receive other vaccines within 4 weeks. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient had not tested for COVID-19, since the vaccination. On 25Mar2021 at 18:00, the patient had experienced approximately 30 hours after vaccination her left armpit began significantly hurt and the entire arm was sore. In the following day morning, her pain had diminished to almost nothing. The patient did not receive any treatment for the reported events. Adverse event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events left armpit began to significantly hurt and entire arm was sore was resolving at the time of report.  No follow-up attempts are needed. No further information is expected.
05/13/2021:  Very slight sore arm, time 15:30.  Very sore arm and moderately high fatigue with some faint body aches, time  appx 20:00.  05/14/2021: Arm pain lessened but moderately high aches and muscle fatigue and slight nausea, appx 08:00. OTC cold and flu medicine alleviated symptoms. Light symptoms continued until appx 16:00
This spontaneous information was received from a medical assistant and unspecified reporter on 04-SEP-2018 and 19-FEB-2019 respectively, and it was recognized as a non-valid because report did not obtain any patient identify. Upon receipt of follow up information it was determined that this case is now valid because the patient identifier was received. Follow up information has been received from a medical assistant during a telephone call on 20-FEB-2019, concerning a 4 weeks patient of unknown gender. Information on the patient's concomitant medications, pertinent medical history and drug reactions or allergies was not provided. On 04-SEP-2018, the patient was vaccinated with improperly stored dose of ROTATEQ (lot # was reported as R012001, which was invalid, expiration date: 06-NOV-2020; dosing details not reported) orally for prophylaxis (inappropriate age at vaccine administration). No adverse effect was reported. The temperature excursion was from 47 degree Fahrenheit to 77 degree Fahrenheit with a time frame of 30 minutes. There was no previous temperature excursion. Data logger was involved. No product quality complaint was involved. This is one of two reports received from same reporter. Sender's Comments: US-009507513-1809USA001773.
Child was in office for a 6 month physical on 9/09/08. Prior to adminsitering vaccinations black dots were noticed on the child's left thigh. It was noted that the child's previous visit was on 7/08/08 at which time the child received the following vaccinations: Prevnar, DTaP, IPV, Rotateq, and HIB. It is documented that DTaP and IPV administered in the left thigh. All the other vaccinations were given in the right thigh or by mouth. Needles were changed prior to administration. 04/16/2009 DTAP was administered using VanishPoint syringe. IPV was administered using Safety Glide.
she tested positive with Covid Virus; she tested positive with Covid Virus; This is a spontaneous report from a Pfizer sponsored program. A contactable female consumer (patient) of an unspecified age received second dose of BNT162B2 (Covid shot, PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/lot number: Unknown, Expiry Date: Unknown), via an unspecified route of administration on 16Jan2021 at single dose for COVID-19 immunization. Patient had historical vaccine BNT162B2, first dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On 31Mar2021, she tested positive with Covid virus. She got Covid-19 virus after receiving both doses. The patient underwent lab test and procedures included covid-19 test positive on 31Mar2021. The outcome of event was unknown.   Information about lot/batch number has been requested.
I developed weakness in my right leg and a fall. At the end of that week, I saw a physician's assistant. He said to drink more water as the result of a CT Scan during a follow up to surgery. I had major surgery on July 11, 2022. The CT Scan showed dehydration. He didn't really address the issue in my leg, but I continue to have weakness. About four days ago, I fell again and the weakness has continued since then.