chrisvoncsefalvay/vaers-outcomes huggingface dataset:
patient received the Arexvy adjuvant; patient received the Arexvy adjuvant; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On an unknown date, the patient received Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced inappropriate preparation of medication (Verbatim: patient received the Arexvy adjuvant) and inappropriate dose of vaccine administered (Verbatim: patient received the Arexvy adjuvant).The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 11-OCT-2023 The reporter reported that the patient received the Arexvy adjuvant without it being reconstituted with the lyophilized antigen, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter did not have any patient demographics, lot number, or expiration date to provide. The reporter consented to follow up.
Right deltoid area very red, warm to touch. Edema. Patient apply ice to area.
Tongue tingling /numbness/twitching after few minutes after Moderna vaccine  Lip numbness  8 weeks later vertigo/dizziness started
A nurse reported that a 12 month old male received his first dose of Prevnar, MMR (Merck) and Varivax (Merck) vaccines on 6/19/00. On 6/20/00, he developed a fever of 102F. As of 6/23/00, the fever continued. Additional information received from the physician on 6/24/00, indicated that the pt received his 3rd dose of IPV (Aventis Pasteur SA) on 6/19/00. On 6/20/00, he developed an injection site reaction characterized by redness and warmth at the site of Prevnar and IPV vaccine administration. The injection site reaction resolved on 6/22/00. On 6/23/00, the fever persisted. He was seen by the physician; a dx of viral pharyngitis was made. The pt subsequently, recovered.
Kidney failure; Lupus Nephritis; This is a spontaneous report received from a contactable consumer. This consumer (patient) reported for herself that the 61-year-old female patient received second dose of bnt162b2 (BNT162B2, COVID 19, brand: Pfizer Covid19) at the age of 61-year-old, dose 2 via an unspecified route of administration, administered in Arm Left on 10Apr2021 14:00 (Batch/Lot Number: ER8737) as dose 2, single for covid-19 immunisation. Medical history included Diabetis from an unknown date and unknown if ongoing, High blood pressure from an unknown date and unknown if ongoing. She is not pregnant or not pregnant at the time of vaccination. No known allergies. The patient's concomitant medications were not reported. The patient previously took first dose of bnt162b2 (BNT162B2, COVID 19, brand: Pfizer Covid19) at the age of 61-year-old in Arm Left on 20Mar2021 14:00 (Batch/Lot Number: EP7534) for covid-19 immunization. The patient experienced kidney failure on 06Jun2021 15:00 with outcome of not recovered , lupus nephritis on 06Jun2021 15:00 with outcome of not recovered.  Seriousness criteria of the events was hospitalization, disability, medically significant, life threatening. The patient was hospitalized for kidney failure and lupus nephritis for 5 days. The patient underwent lab tests and procedures which included sars-cov-2 test (Nasal swab): unknown results on 2021. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The adverse event result in [Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization, Life threatening illness (immediate risk of death from the event), Disability or permanent damage]. It is unknown if the treatment received. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19.
patient called the pharmacy and said that she experienced redness, itching, swelling, and nausea the day after she received her vaccination.  Patient said she went to urgent care to receive treatment and was prescribed prednisone to help with her symptoms
Patient had complaints of joint and body aches and pains, generalized complaints of not feeling well and fatigue.
On 3/28/19 I woke up and had pain on my left arm, it felt heavy and when I tried to lift my head my neck felt stiff and I could hardly lift my head off the pillow.  I applied heat, took tylenol arthritis and applied icy hot but the pain continued.  I called my doctor's office and spoke to the girl in the office I expected her to tell the doctor but she did not.  Later when I called again she said I should have gone to the office.  I mentioned I could not lift my head off the pillow.  Today 5/6/19 I feel better but I still have headache and ear ache (right side).
On 9th day after injection( Feb 3) felt itching to injection site on upper left arm.  Observed approx 1.5 inch diameter red circle, warm to touch and muscle area felt slightly swollen, but not painful to touch.  Day 9 and 10 applied a cold wet compress for 5 minutes about 2 times a day.  Circle remains, however, redness receding in center with red margins.  Because I felt no side effects or discomfort to site in first days, I did not look at injection site not visible when facing a mirror.  Thus, I do  not know if red circle has been present the entire time since receiving injection or if it suddenly appeared on Day 9. I did photograph the site today, Day 11.  I have had no other adverse symptoms.
Same adverse effects as first short: fever of 101.6 which has slowly been going down, fluctuating, but  today, 6th day after shot fever still 99.6.  I have felt chills and sweats, lethargic, achy, today sore throat.  Below site of shot had large bright pink 3inch circle very hot for first few days.  I'm hoping the temperature stabilizes soon.  It took 8 days to stabilize after first shot.  My second shot's effects are the same as the first short.  By the way, I suffered through Covid for 3-4 weeks from last midMarch through early April and I do still have antibodies and presume that is why I had the reaction to the first shot but I wasn't expecting the same for the second.  I had also read in a magazine that people with antibodies didn't need the 2nd shot, however, my Dr. recommended that I get it. Treatment: I took Tylenol for the fever and aches.  I was finally better after first shot in 8 days.  I am not completely recovered yet from the second but I am confident I will have recovered completely in  a few days.
Pt experienced Weakness, dizziness, vomiting, headache soreness @ inj. site.
Vaccine (TWINRIX #3) Administered 6-2-09 (other doses= (1)5-28-08, (2) 11-17-08) Pt complained of sore muscle in left deltoid since administration.
BRUE; This spontaneous report was received via a company representative from the patient's mother and refers to an infant of an unspecified age and gender.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 01-MAR-2023, the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, administered for prophylaxis (strength, lot #, expiry date, and route of administration were not provided); and with haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) intramuscular injection, unk, administered for prophylaxis (strength, lot #, expiry date, and route of administration were not provided).  On the same date (reported as hours after receiving vaccine), the patient was taken to the emergency room and experienced Brief resolved unexplained event (BRUE). At the time of reporting, the outcome of the event BRUE was not known.   The patient's mother stated that she was told by attending doctor that the event was most likely related to rotavirus vaccine, live, oral, pentavalent (ROTATEQ) and haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB).
Tightness in chest; Nauseous; Headaches; Achiness; This is a spontaneous report from a non-contactable consumer or other non hcp. A 52-years-old female patient received bnt162b2 (BNT162B2, Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration, administered in Arm Right on 05Mar2021 11:45 as DOSE 1, SINGLE for covid-19 immunisation. Medical history included gluten sensitivity from an unknown date and unknown if ongoing, Amoxicillin, Sulfa drugs (drug hypersensitivity) from an unknown date and unknown if ongoing. There were no concomitant medications. The patient previously took amoxicillin and experienced drug hypersensitivity. On 05Mar2021 at 12:00 the patient experienced tightness in chest, nauseous, headaches and achiness. Patient was not pregnant at the time of vaccination. Patient did not receive other vaccine in four weeks of vaccination. Patient did not receive other medications in two weeks of vaccination. Patient was not diagnosed with COVID, prior vaccination. Patient has not been tested for COVID, post vaccination. No other medical history was given. The outcome for the events was recovering. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
24 hour post injection patient developed redness, swelling and pain extending from base of rt. deltoid to end of tricep (rt. Arm).. no evidence for skin infection. Vital signs was normal and with out fever.
This spontaneous report was received from a registered nurse referring an unknown number of patients of unknown age and gender. The patients' pertinent medical history, concurrent conditions and concomitant medications were not reported. On unknown dates, the unspecified patients were vaccinated with VARIVAX (lot number L025205 and expiration date 07-JUL-2017, lot number L042266 and expiration date 27-OCT-2017, lot number L048462 and expiration date 02-DEC-2017, lot number L048465 and expiration date 02-DEC-2017, lot number M009765 and expiration date 23-FEB-2018, dose and route of administration were not reported). The temperature of excursion was 24.1F and the time frame was 5 hours and 41 minutes. There was no previous temperature excursion. No adverse effects were reported. No product quality complaint (PQC) was involved. Follow-up information has been received from the registered nurse on 14-NOV-2016. The administration of improperly stored vaccine occurred on 17-JUN-2016. A new lot L044524 was reported (expiration date was not reported) for VARIVAX. It was stated that based on stability data, the vaccine was good to use. This is one of the two reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1607USA009049: MERCK 1607USA010526:Mfr number.
"Welts" 2 at injection site, edemetous, red, hot to touch x 24 hours.
difficulty breathing, throat closing, a productive cough, & red, watery eyes are reported in a pt who recvd flu vax 18OCT93; pt is allergic to ASA & Ibuprofen; pt had a cold last wk & took Keflex & seldane D;
Pt had inconsolable, unusual cry for 2 1/2 hrs several hrs p/vax; seen in MD office but no treatment given;
No menstruation in the months of Apr or May so far; This is a spontaneous report from a contactable consumer. This 47-year-old non-pregnant female consumer (patient) reported for herself that she received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: DCHD/cu EW 0170) via an unspecified route of administration on an unspecified date on left arm (at 47-year-old), as dose 2, single for COVID-19 immunization. Medical history of included asthma, wheezing, pulmonary function test decreased, dyspnoea, drug hypersensitivity (start date and ongoing status unknown). Concomitant medications included fluticasone propionate, salmeterol xinafoate (Advair) taken for an unspecified indication, start and stop date were not reported; cetirizine hydrochloride (Zyrtec [Cetirizine Hydrochloride]) taken for an unspecified indication, start and stop date were not reported; levothyroxine taken for an unspecified indication, start and stop date were not reported; spironolactone taken for an unspecified indication, start and stop date were not reported. It was mentioned that patient was diagnosed with COVID-19 prior to vaccination. She has not been tested for COVID-19 since the vaccination. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: Eng 204 DCHD/cu,) via an unspecified route of administration on 02Apr2021 at 01:00 PM on left arm (at 47-year-old), as dose 1, single for COVID-19 immunization. It was mentioned that the patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 12Apr2021 the patient had no menstruation in the months of Apr or May so far, and problem might continue. No treatment was received. The patient had not recovered. The device date was 29May2021.  Follow-up (01Jul2021): Follow-up attempts completed. No further information was expected.  Follow-Up (23Jul2021): Follow-up attempts are completed. No further information was expected.
reaction; This spontaneous case was reported by an other health care professional and describes the occurrence of VACCINATION COMPLICATION (reaction) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (reaction). At the time of the report, VACCINATION COMPLICATION (reaction) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment medications were reported.
after approx three hours became highly irritable only sleeping/screaming/nursing for three days. Persisting change in affect. Onset of diarreah within 24 hours. Onset of sleep disturbance persisting increase in reflux and dietary intolerance.
Thyroiditis after coronavirus disease 2019 (COVID-19) mRNA vaccine; Thyroiditis after coronavirus disease 2019 (COVID-19) mRNA vaccine; This is a literature report.  A 35-year-old male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: AUTOIMMUNE THYROIDITIS (medically significant), THYROIDITIS (medically significant), all with latency 10 days after the suspect product(s) administration, outcome "recovering" and all described as "Thyroiditis after coronavirus disease 2019 (COVID-19) mRNA vaccine". The patient underwent the following laboratory tests and procedures: Anti-thyroid antibody: Negative; Negative, notes: Negative; Blood thyroid stimulating hormone: <0.01 MiU/mL, notes: <0.01; Low; Thyroid stimulating immunoglobulin: Negative, notes: Negative; Thyroxine free: 2.52 ng/dL; Tri-iodothyronine: 328 ng/dL, notes: elevated; Ultrasound thyroid: A heterogeneous and swollen thyroid, lacking, notes: nodules. Therapeutic measures were taken as a result of autoimmune thyroiditis, thyroiditis.; Sender's Comments: Based on the current available limited information in the case provided, the causal association between the events and the use of suspect product BNT162B2 cannot be fully 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-202200889142 Same article/drug/event and Different patient.;
this was patient's third dose of the same medication. she admitted the shot felt painful this time following the injection (Thursday morning 5/19). She reported that starting Friday night (5/20) that she started having a puffy face and itching at the injection site. She came to the pharmacy today (5/21) to follow-up, and pharmacist counseled her on major signs of anaphylaxis (difficulty breathing or throat closing). Also pharmacist encouraged patient to visit urgent care quickly to be further evaluated and prescribed medication since her dr office is closed. Her dr office's nurse recommended patient to try benadryl to bring face and arm swelling down.
This spontaneous report has been received from a nurse practitioner regarding a patient of unknown age and gender. The patient's concurrent condition, medical history and concomitant medications were not reported. On 20-MAR-2013, the patient was vaccinated VARIVAX dose 1, lot # 0610AE (dose, vaccination site, route, expiry date unknown). No adverse effects were reported. The reporter stated that inconsistencies in storage temperature were identified on extensive review and records. The reporter stated that vaccine was not thawed. The nurse practitioner reported that there was insufficient data to provide 100 percent assurance on vaccine stability. This is one of several reports received from the same reporter. Additional information has been requested.
Pt. was given influenza vaccine and had allergic reaction 45-60 min later Rash noted around neck, all over back. Rash was red and warm to touch.
Not able to swallow full dose; Tasted very bad, appeared oily; SWALLOW FULL DOSE DUE TO SPITTING OUT; This non-serious case was reported by a nurse via sales rep and described the occurrence of regurgitation of medication in a 3-month-old male patient who received Rota (Rotarix lyophilized formulation) (batch number SKBYL9YN) for prophylaxis. This case was associated with a product complaint.   On 07-APR-2023, the patient received Rotarix lyophilized formulation. On 07-APR-2023, an unknown time after receiving Rotarix lyophilized formulation, the patient experienced accidental underdose (Verbatim: Not able to swallow full dose) and pharmaceutical product complaint (Verbatim: Tasted very bad, appeared oily). In APR-2023, the patient experienced regurgitation of medication (Verbatim: SWALLOW FULL DOSE DUE TO SPITTING OUT). The outcome of the regurgitation of medication was not reported and the outcome of the accidental underdose and pharmaceutical product complaint were unknown.   It was unknown if the reporter considered the regurgitation of medication to be related to Rotarix lyophilized formulation and Rotarix Oral Applicator Device.     It was unknown if the company considered the regurgitation of medication to be related to Rotarix lyophilized formulation and Rotarix Oral Applicator Device.   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: 21-APR-2023 The patient was not able to swallow full dose of Rotarix liquid due to spitting out. It was observed that the vaccine tasted very bad and appeared oily as it dribbled out of the corners of the mouth. The patient did not receive a second dose.  The patient made face as if it tasted too bad to swallow. The patient previously had used Rotarix vial presentation and had no problems. The reporter agreed to follow up from GlaxoSmithKline.  The patient was not able to swallow full dose of Rotarix liquid due to spitting out and observed that the vaccine tasted very bad and appeared oily as it dribbled out of the corners of the mouth, which led to accidental underdose and pharmaceutical product complaint. This was 1 of 12 linked cases, reported by the same reporter.; Sender's Comments:  US-GSK-US2023AMR058971:Same reporter US-GSK-US2023AMR059644:Same reporter US-GSK-US2023AMR059645:Same reporter US-GSK-US2023AMR059807:Same reporter US-GSK-US2023AMR059808:Same reporter US-GSK-US2023AMR060400:Same reporter US-GSK-US2023AMR060460:Same reporter US-GSK-US2023AMR060463:Same reporter US-GSK-US2023AMR060476:Same reporter US-GSK-US2023AMR060491:Same reporter US-GSK-US2023AMR060516:Same reporter US-GSK-US2023AMR060516:Same reporter US-GSK-US2023060947:Same reporter. FU1 - deleted US-GSK-US2023AMR058971:Same reporter
Obtained H1N1 in hospital 11/4 within a few hours myalgias, fever, felt "ill". fever resolved in 24 hours. Myalgia improving
No adverse event; Administered Moderna Covid-19 Bivalent doses to treat long-haul COVID symptoms; 42 Patients received bivalent booster with 38 having improvement of symptoms; This spontaneous case was reported by a physician and describes the occurrence of OFF LABEL USE (Administered Moderna Covid-19 Bivalent doses to treat long-haul COVID symptoms), THERAPEUTIC RESPONSE UNEXPECTED (42 Patients received bivalent booster with 38 having improvement of symptoms) and NO ADVERSE EVENT (No adverse event) in a patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for Long COVID.     No Medical History information was reported.    In 2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. In 2023, the patient experienced OFF LABEL USE (Administered Moderna Covid-19 Bivalent doses to treat long-haul COVID symptoms) and THERAPEUTIC RESPONSE UNEXPECTED (42 Patients received bivalent booster with 38 having improvement of symptoms). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, OFF LABEL USE (Administered Moderna Covid-19 Bivalent doses to treat long-haul COVID symptoms), THERAPEUTIC RESPONSE UNEXPECTED (42 Patients received bivalent booster with 38 having improvement of symptoms) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for OFF LABEL USE (Administered Moderna Covid-19 Bivalent doses to treat long-haul COVID symptoms) and THERAPEUTIC RESPONSE UNEXPECTED (42 Patients received bivalent booster with 38 having improvement of symptoms).    No concomitant medications were reported.  Reporter stated she had been administering the 65 plus bivalent dose to her patients who have symptoms of long-haul COVID and has seen 88-90% success rate in resolving the symptoms of long-haul COVID. Vaccine was given within current guidelines except seven were under 65.  It was reported that, vaccine was given to patients for long COVID between Mar-2023 and 01-Aug-2023. 42 patients received bivalent boosters with 38 having improvement of symptoms and 50% or more.  Patients treated for skin lesions, brain related problem, systolic blood pressure was 220, tachycardia greater than 150, and body aches which was improved. No adverse reactions occurred.  No treatment medications were reported.  This case contains information about patient 18 out of 42 patients.   This case was linked to US-MODERNATX, INC.-MOD-2023-735199 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-735199:Master case Patient 1