chrisvoncsefalvay/vaers-outcomes huggingface dataset:
a little pain on the lower nipple; I have like a pinch in my heart in a little pain on the lower nipple; This is a spontaneous report from a contactable consumer, the patient. A 49-year-old male patient received unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Ew0161) via an unspecified route of administration on 17Apr2021 at 13:00 as a single dose for COVID-19 immunisation. The patient had not reported any other health issue. The patient did not have any known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 21Apr2021, the patient experienced pinch in heart in a little pain on the lower nipple. It was unknown whether any therapeutic measures were taken as a result of the event. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event pinch in heart in a little pain on the lower nipple was unknown at the time of this report.   No follow-up attempts are needed. No further information is expected.
Experienced numbness and tingling after the injection into left deltoid; Experienced numbness and tingling after the injection into left deltoid; This is a spontaneous report from a contactable Pharmacist. A 12-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EW0217), via an unspecified route of administration in left deltoid, on an unspecified date as single dose for COVID-19 immunization. Medical history and concomitant medication were not reported. Patient had previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: not reported), via an unspecified route of administration, on an unspecified date as single dose for COVID-19 immunization and had no reaction. On an unspecified date, patient experienced numbness and tingling after the injection into left deltoid and it's still on going. Reporter seriousness for experienced numbness and tingling after the injection into left deltoid was unspecified. Outcome of event was not resolved.
Erythema,, warmth and pain at injection sites.  Low grade fever.  Rash on trunk and legs
This spontaneous report as received from a nurse, refers to a currently 15 year old patient of unknown gender. No pertinent medical history, drug reactions/ allergies or concurrent conditions were reported. On an unknown date, the patient was vaccinated with a dose of improperly stored GARDASIL 9 (which had a lot # of R001262 and an expiration date of 10-NOV-2001; however, dosage number and route of administration were not reported), for prophylaxis. Nonetheless, no adverse effects were reported. The vaccine experienced the following potential temperature excursion: Unknown temperature for 1 day. Reportedly, there had been no previous temperature excursions and the aforementioned one were not identified due to a data logger. Furthermore, no product quality complaint was involved. This is one of the several reports received from the same reporter. Sender's Comments: US-009507513-1807USA011814.
Symptoms: extreme muscle pain, tenderness, visible swelling of muscles, headache, fatigue, lower back pain, joint pain, scrotal swelling
Started around January 11, 2021. I began having lengthy atrial fibrillation often. I had cardiac ablation in 2016 and have been fine since until this Covid vaccination. I also have genital herpes and would have an outbreak every few months. After the Moderna Covid injection, I had the nerve-associated pain last for about 6 weeks and then began having outbreaks on top of the outbreak. I have a couple of outbreaks a month and continue to have A-fib episodes sometimes daily and many weekly.
Moderna Bivalent Booster 0.25mcg was given to patient but was to be given 0.5mcg, wrong dosage given.
I have had jaw pain and a migraine every day since getting my vaccine. The morning after I got my vaccine I started throwing up around 4AM. I had a fever and muscle aches for about 24 hours. The jaw pain and migraine have come back every day since. It now has been over 6 weeks!
I took the vaccination on Monday 11/28/06. I experience a week of nausea, unusual fatigue, and headaches.  By the end of week I was so nauseated that couldn't really eat.  I didn't take any medicine. By the weekend, I started feeling better.
ERRONEOUS VACCINE MMR, VARICELL AND PREVNAR ORDERD MMRV, VARICELLA AND PREVNAR ADMINISTERED IN ERROR REC'D TWO VARICELLA VACCINE AND MMRV AT 12MO OF AGE
This spontaneous case, initially received on 15-Mar-2018 was reported by other health professional and concerns a 54-year-old male patient. The patient's medical history was not reported. The patient's historical vaccine included pneumococcal vaccine. On an unspecified date first temperature excursion of the vaccine occurred. On 01-Feb-2018, after the first temperature excursion, the patient was administered with AFLURIA (TIV) (dose: 0.5 ml, anatomical location: right arm, route of administration and batch number: XT59906, expiry date: 06-Jun-2018). On an unspecified the vaccine was stored out of range of 65 hours and 35 minutes, reaching a highest temperature of 60 F which was the fifth (5th) excursion with those vaccines.
Pain in the left arm; unable to lift/move her left arm above 15 degrees; arm is very sore; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Pain in the left arm), HYPOKINESIA (unable to lift/move her left arm above 15 degrees) and PAIN IN EXTREMITY (arm is very sore) in a 23-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L209) for an unknown indication.     No Medical History information was reported.    On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 ml. On 14-Jan-2021, the patient experienced PAIN IN EXTREMITY (Pain in the left arm), HYPOKINESIA (unable to lift/move her left arm above 15 degrees) and PAIN IN EXTREMITY (arm is very sore). At the time of the report, PAIN IN EXTREMITY (Pain in the left arm), HYPOKINESIA (unable to lift/move her left arm above 15 degrees) and PAIN IN EXTREMITY (arm is very sore) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
29OCT92 250PM mom states pt neck is swollen both sides, swollen around eyes & face is red & has rash;
Rapid heart beat 45 mins after injection - feeling hot but no fever - headache. Took a Benadryl and Tylenol.
maximum temp reached 46.4 degrees F/ 8 degrees C minimum temp reached: 31.3 degrees F / Below 0 degrees C maximum time period exposed: 1 hour and 30 minutes and FLUZONE HIGH DOSE were administered with no adverse event; Initial information received on 08-Sep-2022 regarding an unsolicited valid non-serious case received from a pharmacist.  This case is linked to cases 2022SA374787, 2022SA375305, 2022SA376599, 2022SA377972, 2022SA378232 and 2022SA379755.  This case involves an unknown age and unknown gender patient who was given INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] after maximum temp reached 46.4 degrees F/ 8 degrees C minimum temp reached 31.3 degrees f / below 0 degrees c maximum time period exposed 1 hour and 30 minutes with no adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 07-Sep-2022, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (lot UJ882AE Exp date: 30-Jun-2023) via unknown route in unknown administration site for Immunization.  On 07-Sep-2022 (same day), the patient developed a non-serious maximum temp reached 46.4 degrees f/ 8 degrees c minimum temp reached: 31.3 degrees f / below 0 degrees c maximum time period exposed: 1 hour and 30 minutes and fluzone high dose were administered with no adverse event (poor quality product administered).  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event.   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 in the guidelines. 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.
24 hrs p/vax pt exp hives & rash; treated w/DPH & events resolved p/3 days;
At 2:45 PM, noted left hand felt heavy and tingly. Felt short of breath, heart rate faster/pounding. Lasted 3 minutes and arm swelling at site; brown in color. Shortness of breath for about 16 hours. Took over the counter Benadryl - total 6 pills.
Patient received two doses of Pfizer Bivalent COVID19 vaccine.  10/13/22 Pfizer Bivalent GJ2524 in Right arm 12/15/22 Pfizer Bivalent GH9693 in Left Arm Per patient, she forgot that she received a dose 2 months prior and did not have her previous CDC cards with her. Per patient, she felt tired 24 hours post injection with 2nd bivalent booster. No other side effects reported.
Itching on the upper & lower extremities and back; hives noted on lower back with RN assessment 1105- Benadryl 12.5mg x2 chewable tablets given 1120- Benadryl 12.5mg x2 chewable tablets given & hydrocortisone cream supplied by staff applied to arms & lower back 1140- cleared by site lead
About a week after administration of vaccine pt started to develop an itchy rash on arms & legs -Pt seeing Dr on 8/11/19
Upon injection, immediately swelled up to size of golf ball, no erythema or other signs/symptoms of anaphylaxis, reports no other symptoms. 30 minutes later swelling has gone down some and seems to be healing.
Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Systemic: Body Aches Generalized-Severe, Systemic: Chills-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Exhaustion / Lethargy-Medium, Systemic: Headache-Medium
Client did not have immediate adverse event following vaccine administration. Client died on 6/11/2021, approximately 8 weeks after receiving COVID19 Janssen vaccine. Cause of death is unknown by this reporter.
Had 2 Moderna vaccines and each time spent 3 days with flu Like symptoms; Lethargy; This spontaneous case was reported by a patient and describes the occurrence of INFLUENZA LIKE ILLNESS (Had 2 Moderna vaccines and each time spent 3 days with flu Like symptoms) and LETHARGY (Lethargy) in a 65-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     The patient's past medical history included Flu (Last had flu) in 1975.   On an unknown date, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (Had 2 Moderna vaccines and each time spent 3 days with flu Like symptoms) and LETHARGY (Lethargy). At the time of the report, INFLUENZA LIKE ILLNESS (Had 2 Moderna vaccines and each time spent 3 days with flu Like symptoms) and LETHARGY (Lethargy) had resolved.            Concomitant product use was not provided by the reporter.  The patient had 2 Moderna vaccines and each time spent 3 days with flu like symptoms and lethargy. Kept trying to work it into calendar. Happened to be with her hypochondriac husband who goaded patient into getting the Omicron booster there on the spot! Pfizer Astounding - no reaction experienced.  The patient had not gotten yearly flu shots.  Treatment information was not provided.
COVID 19 Treatment; COVID 19 Treatment; Dose #1: Moderna/ Dose #2: Moderna / Dose #3: Moderna / Dose #4 Pfizer; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 45-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 15Sep2022 as dose 4 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 13Feb2021 as dose 1, single (Batch/Lot number: unknown), on 13Mar2021 as dose 2, single (Batch/Lot number: unknown) and on 09Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Gout" (unspecified if ongoing). Concomitant medication(s) included: ALLOPURINOL; PRILOSEC [OMEPRAZOLE MAGNESIUM]. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 15Sep2022, outcome "unknown", described as "Dose #1: Moderna/ Dose #2: Moderna / Dose #3: Moderna / Dose #4 Pfizer"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: Treatment of COVID-19; (Dec2022) Negative, notes: Then tested negative for three days; (Dec2022) Positive, notes: Then got very sick again and tested positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical information: Anti-viral details includes COVID 19 Treatment PAXLOVID, the treatment started on 12Dec2022 and treatment stopped on 17Dec2022. Other medication in 2weeks product were Allopurinol and Prilosec. Rebound COVID. Took Paxlovid for 5 days. Then tested negative for three days. Then got very sick again and tested positive. There was no known allergies.   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.
Numbness radiating  down left arm, numbness moving up neck and left side of ear and scalp.  Multiple Hives on arms , chest, and back.
Starting at 9pm I got uncontrollable chills to the point where my whole body was shaking. I pulled multiple blankets on me but could not get warm. I then felt very sick to my stomach and threw up. After that the chills went away but I felt extremely hot. In the morning my body was VERY sore especially around my kidneys. I also have a headache and feel weak.
Red rash at injection site, swelling, warm to touch.  Mother took patient to facility to have it checked out.  Returned home.
Patient is a 84 y.o. male with a history hard of hearing, Afib on AC, NICM with reduced EF, pacemaker, IDDM2, CKD, OSA on CPAP who presented to medical center with SOB and recent COVID positive 2/12/23. Found to have acute hypoxic hypercarbic RF, elevated d-dimer, Echo with positive McConnel sign and transferred to hospital 2/23/2023 for further management. Course complicated by continuous BiPAP requiring transfer to MICU and further complicated by bacteremia, AKI, hyperkalemia.    1. Acute on Chronic Hypoxic Respiratory Failure: Baseline 2-4L O2 by NC (per family member) with known COPD and CHF. Acute component due to pulmonary edema, COPD, and COVID infection. Required continuous BiPAP on admit with OLH CXR: left base opacity felt to be atelectasis. Weaned to baseline oxygen at discharge  2. COVID Infection: Positive home test 2/12/23 with positive PCR 2/23/23. Vaccinated with Pfizer x5, last 9/2022. Out of window for supplemental therapies, on Decadron (last dose 3/5/23). Improved. Isolation ended 3/1/23. 3. Elevated D-dimer: D-dimer 3018 but on renal reduced AC.  VQ scan at OLH low prob PE. OLH TTE mild to moderate right ventricular size, positive McConnel sign, RVSP 35. RMH TTE 2/24/23 EF 60%, mildly dilated right ventricle with mild hypokinesis, biatrial enlargement. Bilateral lower extremity dopplers 2/24/23 without DVT. S/p heparin gtt, transitioned to home renally dosed Eliquis. Low suspicion for PE but remains on AC regardless for other indication (atrial fibrillation).  4. Bacteremia: Blood cultures 2/2 positive for staph epidermis and 1/2 positive for lactococcus garvieae on 2/23/23. TEE 3/1/23 did not reveal signs of endocarditis or pacemaker infection. IV Vanco transitioned to Cefazolin -> linezolid. Infectious disease followed 5. AKI on CKD IIIb: Follows with Dr. (Neph). Atrophic left kidney. Cr 2.05 2/3/23, uptrended to 3.6 at OLH. Renal US 2/24/23 c/w medical renal disease. Cr improved with diuresis. Nephrology followed and recommended continued supportive care. Cr improved to presumed new baseline, creatinine 1.5 at time of discharge  6. Recurrent Hyperkalemia: Present on admission, >5 and then peaked to 6.2 on 2/24/23. EKG v-paced without peaked T waves. Asymptomatic. Potassium 5.0, 4.9, 5.1 on days leading up to discharge  7. Acute on Chronic diastolic CHF with pulmonary HTN.  TTE as discussed, no pericardial effusion. Admission BNP 10k. CXR 2/23/23 with small left pleural effusion. S/p IV diuresis. Continued GDMT and lasix at discharge  8. Acute metabolic encephalopathy: Noted inpatient at times with reported waxing/waning confusion. Likely multifactorial due to above medical issues. Resolved at time of discharge  9. Elevated Troponin: initial 54, EKG V-paced without ischemic changes. Denied CP. Suspect demand ischemia. TTE as above. No further workup  10. Atrial fibrillation, hypertension, coronary artery disease, Type 2 Diabetes: management unchanged at discharge
interchange of vaccine products; vaccine administered outside the recommended dosing schedule; This spontaneous report was received from a pharmacist and refers to a 23 year old female patient. The patients concurrent conditions, pertinent medical history or drug reactions were not reported.   On 06-AUG-2012, at 15 years old, the patient began series with the initial dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL)  (strength, lot #, expiration date, dose, route and frequency were not reported), the next doses of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) were administered to the patient on 08-JAN-2020 and 15-JUN-2020, both for prophylaxis at 0.5 milliliter dosage (strength, lot #, expiration date, route and frequency were not reported) (interchange of vaccine products and inappropriate schedule of product administration).
Blood clot in the right lower leg; This is a spontaneous report from a contactable consumer (patient). This 58-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) second dose at the age of 58-year-old (lot number=EN 6201) on 12Feb2021 at 12:30 PM as single dose on Left arm for COVID-19 immunization. Prior to vaccination, the patient was not diagnosed with COVID-19. Medical history included Diabetes, CAD, arthritis and known allergies Yes. The patient was not Pregnant at Time of Vaccination. Concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received other medications within 2 weeks of vaccination. The patient previously took bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) first dose at the age of 58-year-old (lot number=EL1283) on 22Jan2021 at 12:30 PM as single dose on Right arm for COVID-19 immunization. The patient experienced adverse event of Blood clot in the right lower leg on 10Mar2021 at 04:00 PM. The adverse event result in Doctor or other healthcare professional office/clinic visit. The treatment of Blood thinner received for the adverse event. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the event was Unknown.  No follow-up attempts are needed. No further information is expected.
wake up every few hours; did not sleep well; really cold; lactic acid feeling; felt pretty sick; felt off in his body; terrible aches in his arms; fever; terrible aches in his shoulders; pain; This spontaneous case was reported by a consumer and describes the occurrence of SLEEP DISORDER (wake up every few hours), POOR QUALITY SLEEP (did not sleep well), NASOPHARYNGITIS (really cold), BLOOD LACTIC ACID (lactic acid feeling) and MALAISE (felt pretty sick) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Infection. Concomitant products included CIPROFLOXACIN (CIPRO [CIPROFLOXACIN]) and METRONIDAZOLE for Infection.   On 11-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Feb-2021, the patient experienced SLEEP DISORDER (wake up every few hours), POOR QUALITY SLEEP (did not sleep well), NASOPHARYNGITIS (really cold), BLOOD LACTIC ACID (lactic acid feeling), MALAISE (felt pretty sick), MALAISE (felt off in his body), PAIN IN EXTREMITY (terrible aches in his arms), PYREXIA (fever), ARTHRALGIA (terrible aches in his shoulders) and PAIN (pain). On 12-Feb-2021, SLEEP DISORDER (wake up every few hours), POOR QUALITY SLEEP (did not sleep well), NASOPHARYNGITIS (really cold), BLOOD LACTIC ACID (lactic acid feeling), MALAISE (felt pretty sick), MALAISE (felt off in his body), PAIN IN EXTREMITY (terrible aches in his arms), PYREXIA (fever), ARTHRALGIA (terrible aches in his shoulders) and PAIN (pain) had resolved.
an 8 year old was administered Kinrix; This case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 8-year-old patient who received DTPa-IPV (Kinrix) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration 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: 22-SEP-2022 Reporter's comment: The nurse reported that the 8 years old patient was administered Kinrix vaccines.  At the time of call, the nurse did not have the patient details, date of administration, or the information of what vaccines were given.  The reporter did not have the lot number/expiration date information of the doses.  The vaccine administration facility was the same as primary reporter. The reporter consented to follow-up. Additional Supportive Information: 8 years old patient was administered Kinrix vaccine, which led to inappropriate age at vaccine administration. This case was 1 of the 3 cases reported by the same reporter.; Sender's Comments:  US-GSK-US2022136456:Same reporter US-GSK-US2022136446:Same reporter US-GSK-US2022136459:same reporter US-GSK-US2022136463:Same reporter US-GSK-US2022136453:Same reporter US-GSK-US2022136454:Same reporter US-GSK-US2022136455:Same reporter US-GSK-US2022136461:Same reporter US-GSK-US2022136466:Same reporter US-GSK-US2022136465:Same reporter US-GSK-US2022136465:Same reporter
Lump with swelling and erythema appeared on left deltoid after DTAP immunization