chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Hemolytic flares; peripancreatic fat stranding indicating possible small bowel microvascular thrombosis; Five days after the second dose of the Pfizer-BioNTech vaccine, he developed abdominal pain; This is a literature report.  A male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "PNH" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1), for COVID-19 immunisation. The following information was reported: HAEMOLYSIS (medically significant), outcome "recovered", described as "Hemolytic flares"; THROMBOSIS (medically significant), outcome "recovered", described as "peripancreatic fat stranding indicating possible small bowel microvascular thrombosis"; ABDOMINAL PAIN (non-serious), outcome "recovered", described as "Five days after the second dose of the Pfizer-BioNTech vaccine, he developed abdominal pain". The patient underwent the following laboratory tests and procedures: computerised tomogram abdomen: peripancreatic fat, notes: stranding indicating possible small bowel microvascular thrombosis; fibrin d dimer: elevated. Therapeutic measures were taken as a result of haemolysis, thrombosis, abdominal pain.  The lot number for the vaccine BNT162B2 was not provided and will be requested during follow up.; Sender's Comments: Based on the reported information ,a causal relationship between the events haemolysis and Thrombosis and suspected drug 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,Linked Report(s) : US-PFIZER INC-202101854431 same article, different patients/events;US-PFIZER INC-202101854432 same article, different patients/events;US-PFIZER INC-202101854433 same article, different patients/events
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 64-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 01Nov2022 at 17:00 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 63 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "lichen plano pilarus" (unspecified if ongoing). Concomitant medication(s) included: PIOGLITAZONE, start date: 01Jan2015. Past drug history included: Amoxycillin, reaction(s): "known allergies: Amoxycillin". 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". Therapeutic measures were taken as a result of drug ineffective, covid-19 which included treatment with Paxlovid from 01Jun2023 to 06Jun2023.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300222720 same reporter/patient, different drug/event;
CONFIRMED IMMUNOLOGICAL VACCINE FAILURE; MEDICATION ERROR; This spontaneous report was received from literature. This report concerned an 80 year old female of unspecified ethnicity. The objective of this study was to describe the impact of rituximab on humoral response to COVID-19 booster vaccine and antibody kinetics in patients with ANCA vasculitis. The patient's height, and weight were not reported. The patient's concurrent conditions included: Microscopic polyangiitis phenotype and and ANCA (anti-neutrophil cytoplasmic antibody) vasculitis. The patient was previously (5 month before vaccine first dose) treated with rituximab and steroids for microscopic polyangiitis. The patient had no previous COVID-19 infection or did not required dialysis during periods of vaccination. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration and batch number were not reported) one total dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. Concomitant medications included Moderna covid-19 vaccine (mRNA) for prophylactic vaccination. On an unspecified date, the patient experienced confirmed immunological vaccine failure and medication error. Laboratory data (dates unspecified) included: Estimated GFR (Glomerular filtration rate) at the time of booster dose of vaccine was 34 mL/min/(1.73 x m2), Proteinuria was 304 mg, ANCA (titer myeloperoxidase) was less than 9 u/ml, SARS-CoV-2 IgG antibody test was less than 12 AU (arbitrary units) and CD19 count less than 20 cell/ml. Immunoglobulin G antibodies to spike protein S1 subunit of on SARS-CoV-2 were measured using ELISA (Enzyme-linked immunosorbent assay) at least one month post completion of vaccination. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the confirmed immunological vaccine failure and medication error was not reported. The author has provided data for the first demonstration of antibody development post booster dose of the COVID-19 vaccine in associated vasculitis (AAV) patients on rituximab maintenance therapy. This report was serious (Other Medically Important Condition). This case associated with product quality complaint.; Sender's Comments: V0 20210927182- COVID-19 VACCINE AD26.COV2.S-confirmed immunological vaccine failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS.
Intradermal injection given to left forearm but did not wheal. Repeat injection given to successfully to back of left arm.
two doses of Bexsero were given to a patient the same day; This non-serious case was reported by a physician via call center representative and described the occurrence of overdose in a 16-year-old female patient who received Men B NVS (Bexsero) (batch number 5AR2D, expiry date 31-DEC-2025) for prophylaxis.   Concomitant products included MENINGOCOCCAL B VACCINE (BEXSERO).   On 05-JUN-2023, the patient received Bexsero. On 05-JUN-2023, an unknown time after receiving Bexsero, the patient experienced overdose (Verbatim: two doses of Bexsero were given to a patient the same day). The outcome of the overdose 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: 05-JUN-2023 The physician called to report that two doses of Bexsero were given to a patient the same day which led to overdose. The reporter consented to follow up via email. The Vaccine Administration Facility is the same as Primary Reporter.
the arm he had the shot in, he has loose skin under the arm; he feels numb under the bottom of his feet; numbness under his feet but today it is more pronounced; This is a spontaneous report from a contactable consumer or other non hcp. An 82-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EN5318), via an unspecified route of administration on 05Feb2021 (82-years-old at the time of vaccination) as a SINGLE DOSE for COVID-19 immunization. The reported indication was reported as that is what was offered. The patient's medical history included stents in his heart and back condition. The patient's concomitant medications were not reported. The patient reported that skin from his elbow to his armpit is more "flabby" than normal and he has "numbness under" his feet. He also reports having a prior injury, degenerative disc, in his back that sometimes causes numbness under his feet but today it is more pronounced. On 05Feb2021, the patient experienced having a problem with his arm he had the shot in, he has loose skin under the arm, he feels numb under the bottom of his feet. The outcome of the event the arm he had the shot in, he has loose skin under the arm was recovering and other events was not recovered.  Follow-up (05Feb2021): Upon follow up, new information included: Age at time of onset of reaction/event details, patient details, adverse event details, medical history details, Event onset details, Lot details.  Follow-up attempts are completed. No further information is expected.
Hospitalization: 9/2/22  - 9/19/22.  Presentation to the ED: dyspnea x 1 day.  COVID-19 + date: 9/2/22. Treatment: Continue with daily vitamin-C, nebulizer and inhaler treatment p.r.n. Remdesivir and dexamethasone.  Discharge to: SNF.
Noticed that she staring getting fatigued 5/24/21 took time off work noticed fatigue in legs that she attributed to recent  foot surgery stopped being able to do gardening,  Was not able to use stairs. Had nausea vomiting, Went to ER 6/25/21  Troponin levels 2000 diagnosed with renal failure and Myocardial infarction on EKG. Angiogram was normal  Heart was functioning at 40-45% . Dx with Takotsubo Cardiopathy. Also noted rash on top of both feet . Was given blood thinner shots in ErR and noted brown vaginal spotting . Also reports two weeks post second vaccine. uncomfortble weird pain in neck bone located at base of skull can not feels anything protruding. Feels clicking when she moves her head pain started after vaccine and has not gone away.
Newborn boy (2 hours of life) received by error a shot; This case was reported by a pharmacist via sales rep and described the occurrence of inappropriate age at vaccine administration in a male patient who received DTPa (Reduced antigen) (Boostrix) (batch number 3A745, expiry date 12th March 2024) for prophylaxis.   On 11th April 2022, the patient received Boostrix. On 11th April 2022, unknown after receiving Boostrix, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown.   Additional Information: GSK receipt date: 11-Apr-2022 Reporter's comment:  The reporter reported that a newborn patient (2 hours of life) received a dose of Boostrix by error. No reactions were noted. The reporter consented to follow up via email. Additional Supportive Information: A newborn patient received a dose of Boostrix by error, which led to inappropriate age at vaccine administration.
Hives on legs, arms, abdomen per parent phone call on 9/6/17.
(Redness & swelling) local reaction developed within 72 hours controlled with diphenhydramine 50mg every 4-6 hours & ice (developed at site of Zostavax inj.).
12/26-27:tingling in legs evening only; 12/27-1/2:tingling all over evening only; 1/3-1/8:tingling all over all day; 1/9:tingling all over + burning sensation in hands & feet all day; 12/26-1/9:off/on sensation of urgent bowel movement (w or w/o actual BM); 1/6-9: frequent, scanty urination & off/on mild chest tightness & shortness of breath; 12/26-1/9:increased neck & face pain & headache intensity.  Neurologist eliminated Sinemet (started 10/2016) & cut dose of Azilect in half (now .5 mg) on 1/6/2017.
High fever starting the morning after the vaccine. Coughing/coughing fits w/gasps for air. Fever went above 104 degrees F. aching joints/stiffness.
The patient experienced a mild injection site reaction on her left arm. She noticed the reaction on 10/21/16. She will use an ice pack and acetaminophen and monitor the site. If it worsens, she will go to the Student Health Center.
Patient received first dose Moderna back in April 2021. Was administered Pfizer 10/11/2021 as a second dose. No issues/side effects at this time.
Approximately 10 days after the Moderna booster I broke out in hives all over my body. It started on hamstring area and spread within a couple hours to entire body. Along with the rash I had a shortness of breath and chest tightness.   I initially took Sudafed until I went to urgent care and they provided me with a steroid pack Prednisone 50 mg taper pack. My initial reaction was controlled but did not improve. The steroid pack gave me other side effects that actually made it worse, including insomnia and worsening chest tightness/shortness of breath.   After the steroid pack, I went to primary care physician, dermatologist, and allergist. I was diagnosed with Dermatographia urticaria, Chronic urticaria, recurrent periodic urticaria, and allergic rhinitis.   I was instructed to take 360 mg of Allegra Fexofenadine and 40 mg of Pepcid AC Famotidine for three weeks, then taper down over the following two weeks, for a total of five weeks. When taken, it controls my reaction. However, when I wean off the medication, it goes back to its normal state of dermographia and urticaria.  It is March 3, 2022, more than two months from initial symptoms.  I was told by Allergist on 3/1/2022 that she has seen 3 - 5 patients for the last couple weeks who got their Moderna booster and have the same symptoms.
**ALL ISSUES BEGAN JUL-NOV 2021 AND ARE ONGOING AT PRESENT (DEC 22, 2021)** FREQUENT, SEVERE HEADACHES; INTENSE HIP PAIN; INTENSE KNEE PAIN; MODERATE-TO-SEVERE HAND, WRIST PAIN; INTENSE SHOULDER PAIN; SORES IN GUMS; RASHES IN VARIOUS AREAS AROUND BODY; DERM ISSUE - CUTS FORMING AROUND INNER AREA OF THUMBS, ROUGHLY EVERY 2 WEEKS; FREQUENT BOUTS OF EXTREME EXHAUSTION; EXHAUSTION/TIREDNESS CAUSES ME TO FALL ASLEEP DAILY WHILE DRIVING; HEART PAIN ON REGULAR BASIS; INTENSE PAIN IN UPPER LEFT NOSTRIL; MULTIPLE, VARIOUS GASTROINTESTINAL COMPLICATIONS/PAINS; NECK, BACK PAIN; FREQUENT MENTAL FOG, CONFUSION; NUMBNESS IN ARMS, LEGS AT LEAST ONCE DAILY; ARMS AND LEGS GO COMPLETELY NUMB / WITHOUT FEELING AT TIMES; NEW, SUDDEN ONSET HEAD HAIR LOSS; FREQUENT SWOLLEN LYMPH NODES UNDER CHIN; FREQUENT LOW-GRADE FEVERS; FREQUENT IRRITATED, SORE THROAT; BODY OFTEN FEELS EXTREMELY HEAVY AND CUMBERSOME DURING NORMAL DAILY ACTIVITIES (WALKING, GOING UPSTAIRS/DOWNSTAIRS, LIFTING MY LIMBS); MULTIPLE DERMATALOGICAL ISSUES (SCALES, YELLOW CRUST AROUND NIPPLES; SORES/SCABS ON HEAD; SMALL PUSTULES ON HANDS, KNEES, FEET); NEW BREAST LUMP IN LEFT BREAST; ABNORMALLY HEAVY, FREQUENT MENSTRUAL BLEEDING
Patient stated: "On Sunday I started having some really weird chest pain. The next morning it was a lot worse and my resting heart rate was consistently in the 120s. I was walking around and went up the stairs at work and I couldn't catch my breath so I contacted my doctor's office and they recommended that I go to the ER. So I did, and they ran a whole bunch of tests and couldn't find anything wrong so the doctor said it could be pleurisy, but it didn't get worse when I took a deep breath so I have my doubts that that's what it was. He also said I could be having a stronger reaction to the vaccine which I guess made more sense because that was the only thing that had recently changed. He gave me three days of Prednisone and the chest pain did improve over the next week. I asked my doctor's office what they thought and they still recommended that I get it, but I'm just nervous about it now. "
Around 8pm tightness of chest and difficulty taking deep breathes was noticed - took Benadryl and symptoms eased. Upon waking was lightheaded and took blood pressure irregular heartbeat detected. Low blood pressure, dizziness  and irregular heartbeat detected for around a month then self corrected.  Was able to see pcp who suggested I see neurologist. Neurologist appointment in September 2021.
I was fine for the first week, during which time I reported that through the program. Yesterday (Day 9 after injection) I noticed a red, itchy patch at the injection site. It is still there today.
Patient was given a vaccine dose that had expired at 2:40 pm that morning.  Patient  has had no symptoms or adverse reaction since.
Administrated a 0.25 mL booster shot,instead of 0.50 mL 3rd shot; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL UNDERDOSE (Administrated a 0.25 mL booster shot,instead of 0.50 mL 3rd shot) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised.   On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 ml. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ACCIDENTAL UNDERDOSE (Administrated a 0.25 mL booster shot,instead of 0.50 mL 3rd shot). At the time of the report, ACCIDENTAL UNDERDOSE (Administrated a 0.25 mL booster shot,instead of 0.50 mL 3rd shot) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication information was not provided. Treatment information was not provided.
No additional adverse events reported; The patient received an imporperly stored dose of ROTATEQ; This spontaneous report was received from a medical assistant, regarding a patient of unknown age and gender. The patient's pertinent medical history, concomitant medications and drug reactions or allergies were not provided.   On 22-APR-2020, the patient was vaccinated with an improperly stored dose of rotavirus vaccine, live, oral, pentavalent(ROTATEQ), 1 dose for prophylaxis (strength, dose volume, frequency, route, lot # and expiration date were not provided). The vaccine underwent a temperature excursion at a temperature of 35°F during 8 hours as recorded by a data logger. There was no previous temperature excursions.
Sore arm; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (Sore arm) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore arm). At the time of the report, PAIN IN EXTREMITY (Sore arm) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.   Reporter did not allow further contact
Seizure type of activity. Slight jerking movements, foam at mouth, rolled eyes and contracted arms.
very sore left arm with in hrs . Went on to devlop 7/10 neck left shoulder joint and lower back pain with in hrs . Extreme exhustion and nausea, headache  -couldnt eat dinner on thursday night had a brief left ear ache through the night and periods of extreme chills /shaking , no food friday , called out sickNow RIGHT arm hurting ! -symptoms continued went to bed at 1800 hrs and woke up at midnight with soaking wet bedlinens and pjs . Family helped me change linen . Took M otrin 800mgs po and slept throguh the rest of the night woke up sat AM and was perfectly fine , hungry and back to usual self ( Of interest : was hospitalized with COVID 19 pneumonia march 2020 for one week ,received the anti malaria drug ( at that time was the recommended tx .) Still tested  positive  4 months out in July 2020 at location(that sample is frozen at facility  - and have not rested ( maybe had an acute response to the vaccine  due to antibodies from primary infection ???
Severe headache, took tylenol, lasted approx 24 hrs. Chills, bundled up and slept eventually, lasted approx. 10 hrs. 3 days later red rash started on left arm from inj. site almost to elbow and width of arm. Have taken 2 benadryl. Still have rash. It's Sunday 02/28/2021
Information has been received from a pharmacy intern concerning a 67 year old female with no allergies who on 25-JUL-2008 was vaccinated with ZOSTAVAX,  0.5 mL SC. Concomitant therapy included vitamin D (unspecified), fluticasone furoate and DYAZIDE. On 09-AUG-2008, 15 days after administration the patient experienced redness, itching and blisters at the injection site (4-5 inches in diameter). She was seen several times for injection site reaction and was monitored but not treated. Physician did not diagnosis the symptoms as related to ZOSTAVAX. The blisters were scabbing over and the patient was recovering. Additional information has been requested. This is in follow-up to reports previously submitted on 9/24/2008. Initial and follow-up information has been received from a physician pharmacy intern and a consumer concerning a 67 year old female writer with no allergies who on 25-JUL-2008 was vaccinated with ZOSTAVAX (Merck) 0.5ml SC. Concomitant therapy included vitamin D (unsecified), DYAZIDE. After injection, the site was warm, red and itchy. There symptoms subsided over the next week. On 09-AUG-2008, "two weeks later" (also reported as 15 days after administration) the patient noticed a small bump in the area. She thought it might be a bit- it itched. Over the next few days, more bumps appeared- all itchy- plus a general red area (same site as origanial injection over redness). The bumps began to blister and grow. She was out of town and away from her physician, but by 14-AUG-2008 the patch on her arm looked like bubble wrap with over 1/2 dozen blisters - a couple 1/2 - 3/8 inch in diameter (also reorted as 4-5 inches in diameter. She went to a walk in medical clinic. The doctor was stymied- landed the biggest blisters - gave her an antibiotic (Ampicillin IP she remeber correctly). Other bumps continued to appear and grow. She saw the physician on 19-AUG-2008 after returning home. Eventually - within a week or so - all blisters had self-drained, skin dried, fell off. No scars. The patient reported a rash that developed on her left deltoid area after she got the ZOSTAVAX (Merck). At the time the physician looked at it, it appeared to be large, bullous areas right around injection site. These areas were flat at the time, having drained their fluid. but appeared to be 2cm in diameter. The patient reported she had a small round bandaid on at the time of the injection but it was not on for extended period of time. The blistering then came after that. The physician did not sure whether this is an adverse reaction to the vaccine or whether it is an allergy to the adhesive in the bandaid. Additional information is not expected.
This spontaneous report as received from a pharmacist refers to a newborn male patient of unknown age. On 17-10-2012 13:35, the patient was vaccinated with RECOMBIVAX HB that had been exposed to temperatures below 32F for 6 hours. During that 6 hour time period, the vaccine was exposed to 28.8F for 1.5 hours. Administration route not reported. Two lot# were involved and the lot# were reported as: 0294AE, expiry date on 06-SEP-2014; and 0385AE, expiry date 08-NOV-2014. It was unspecified which lot# the patient was administered. The outcome was unknown. It was unspecified if the patient sought medical attention. This is one of several reports received from the same source. Additional information has been requested.