chrisvoncsefalvay/vaers-outcomes huggingface dataset:
she got tunnel vision; almost passed out; Blood pressure dropped to 70/50; heart rate went up to 140; whole body got cold and tingly; whole body got cold and tingly; This is a spontaneous report from a contactable pharmacist (patient) reported for herself. A 25-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; brand: Pfizer Biotech; lot number: EL0142) via an unspecified route of administration at left arm on 30Dec2020 at 12:45 PM at a single dose (dose number: 1) for COVID-19 immunization. Facility where the most recent COVID-19 vaccine was administered was workplace clinic. Medical history included premature ventricular contractions (PVCs). No known allergies (no allergies to medications, food, or other products). The patient was not pregnant. No other vaccine in four weeks and no other medications in two weeks. The patient experienced adverse events included blood pressure dropped to 70/50, heart rate went up to 140, whole body got cold and tingly and she got tunnel vision and almost passed out. The events all started on 30Dec2020 at 12:45 PM. The events were reported as non-serious. No treatment received for events. The outcome of events was resolving. Prior to vaccination, the patient was not diagnosed with COVID-19, and since the vaccination, the patient had not been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the close temporal relationship, the association between the event tunnel vision with BNT162b2 can not 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.
No reaction. Clinical after giving the injection saw the expiration date. Expiration date 2/15/22 and gave vaccine 2/21/22.
About 4 hours after the vaccine, I had a rapid heart rate for over 24 hours.  I stayed in bed and didn't do any physical activity.  I am worried about taking the 2nd dose of vaccine.
Headache, shortness of breath, burning sensation in chest, joint pain, fatigue, brain fog, trouble sleeping. Began one day after first dose and still present 12 days later.
Information has been received from a nurse concerning a 25 year old female non-smoker who on 28-APR-2011 was vaccinated with the first dose of GARDASIL (Lot # 666597/0768Z exp 17-OCT-2012). Concomitant therapy included LOESTRIN 24 FE. The nurse reported that the patient developed hot flashes and chills simultaneously along with dizzy spells, a "few days" after the first dose of GARDASIL and the patient had "about 2 episodes a week." The patient called office to seek medical attention. No treatment was given for the events. No lab diagnostics studies were performed. At the time of the report, the patient had not recovered. Additional information has been requested.
Day 1: 8 p.m. itching, redness under arm; followed by edema to elbow (left arm). Day 2: edema to fingers. Day 3: MRI, Levaquin, Medrol dose pack. Day 6: Severe, sharp, stabbing pain, right thigh, followed by severe circular bruising.
I am not certain it was related to the vaccine, but I experienced several episodes of mild transient migratory urticarial skin hives in the days following my vaccination.  The first episode occurred 17 hours after the vaccine, located over the right knee and lower leg, lasting 2 hours.  The second episode occurred 36 hours after the vaccine, located on the left forearm, lasting 1 hour.  The third episode occurred 48 hours after the vaccine, located over the right knee, lasting 2 hours.  There were no other symptoms.  All three episodes resolved spontaneously.
Patient given a Pfizer booster shot. Provider verified her birthday and purpose of the visit. Patient stated she needed to get a Pfizer booster shot at the day of the visit. Upon charting after administration, provider realized she was 8 days from turning 18.
GIven half dose when it should have been .3 cc this was corrected the following day (11/13/21) with full dose given.
A non-serious spontaneous report of hives has been received from a consumer concerning a six-year-old male, subsequent to FLUMIST. Neither relevant medical history nor concomitant medications have been reported for this patient. On 10-Nov-2011, the patient received FLUMIST. The patient developed huge hives all over his body within five hours of receiving FLUMIST. The outcome of the event hives was unknown.
Vaccine administered at 1500. At 1650 pt c/o extreme itching and SOB. AT 1705 pt reports increase in itching, and swelling around eyes. Eyes red and puffy. Eppy 1:100 0.5ml SQ. Albuterol sun, Benadryl 50 mg IV, Solumedrol 125 mg x 4 doses given.  03/06/2007 MR received from o/n hospital stay for c/o chest pain and dyspnea following her flu shot.  Pt. also experienced circumoral paresthesias, and numbness down her left arm 2' to hyperventilation, as she became increasingly panicked.  Pt. was given 4 baby ASA, and SL nitroglycerine en route to hospital as well as O2 vai NC. PE: Urticaria noted on face and abdomen. (+) periorbital swelling. Pt anxious, otherwise WNL. Assessment: Chest pain appears to be chest wall tenderness, dyspnea and hyperventilation, and acute allergic reation probably to flu vaccine. Fianl DX:  Acute allergic reaction likely to flu serum.
pain at injection site; This is a spontaneous report from a non-contactable consumer, the patient. A   5-decade-old female patient (late 40's) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: unknown), via an unspecified route of administration on 'approx' 30Dec2020 as a single dose,  for COVID-19 vaccination.  The patient medical history includes ongoing rheumatoid arthritis, ongoing blot clots (previously hospitalized for treatment of blood clots ). Concomitant medication included adalimumab (HUMIRA) and on 'blood thinners for prevention of blood clots'.  On Dec2020, the patient experienced pain at injection site (kind of dull pain, very similar to a tetanus shot). 'Just the first day, took some Tylenol so I could sleep and woke up next day feeling fine.' Therapeutic measures were taken as a result of pain at injection site included Tylenol. The clinical outcome of pain at injection site was recovering.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
(L) arm - swollen, bruise, knot at location of flu shot on Nov 7th. Per pt had lots of bleeding following admin. arm hurting/sore, held off on PNA shot 2/2 above. Tried to go MD 11/9 office closed.
Hive like rash on chest, back, and face that would come and go for a couple of days. Diarrhea for 3 days so far.
Info has been received from a 68 year old male consumer with no medical history and no known allergies who was vaccinated with a 1st and 2nd dose of pneumococcal vaccine 23 polyvalent in approx 2000 and in May 2002, respectively. Concomitant therapy included "TOPOROL" metoprolol succinate (TOPROL XL TABLETS) and aspirin. Within 2 weeks of the 2nd dose of pneumoccal vaccine 23 polyvalent, the pt experienced unusual joint pain and swelling. On 08/28/2002 it was reported that the symptoms had not decreased. Unspecified medical attention was sought. Additional info has been requested.
Patient stated that evening she felt fatigued and went to bed early. She said she slept much longer than she usually does ("slept for an entire day"). The next day she still felt malaise, nausea, and complained of a headache. Later that day, she tried to go out to eat, hoping that would make her feel better. The nausea continued with dry heaves. She even passed out at the restaurant and they had to call her a squad to transport her to the local ER. When there, the told her she was dehydrated and most likely experiencing adverse effects from the SHINGRIX vaccine.
Started violently shaking uncontrollably for 30 minutes. Nothing I did helped or stopped it, I kept biting my tongue and could not walk, my entire body was shaking very very aggressively, I stayed laid down and focused on relaxing my body, eventually it calmed down on its own and I quickly tried to fall asleep before it came back, I feel fine today, just really shaken up and frightened. I did not call anyone and have not seen any doctor about it. I thought I was having a seizure, except was conscious.
BIVALENT COVID VACCINE, PFIZER, GIVEN 9/28/22, #GJ524; pt had a positive COVID test 9/7/21 at SNF, Health and Rehab; 9/8/22 admitted to hospital with CP, poor oral intake, dark black stools, nausea; cough, low BP; O2 supplementation; AKI; acute on chronic hypoxic respiratory failure; CXR showed pneumonia; Decadron given; DNR/DNI; dc'd back to SNF on 9/26/22; pt passed away in the SNF
swelling of left deltoid, redness, warm to touch. swelling from shoulder to 3 inches above elbow. slight fever on 5-15-08. swelling started on 5-15-08 mid morning. Mother applied warm compress, gave tylenol x one.
A  lot of pain/horrible body aches; can barely move; This is a spontaneous report from a contactable consumer and patient (non-contactable). This patient of an unspecified age and gender reported that the patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose 2, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. Previously, patient received first dose of PFIZER-BIONTECH COVID-19 VACCINE via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose 1, single for covid-19 immunization and no adverse event reported for it. Reportedly, the patient wondered that has anyone experienced horrible body aches with their second covid vaccine (Pfizer), and if so, how long did it last. The patient got his on Tuesday and the patient was still dealing with a lot of pain (unspecified date) and can barely move today (unspecified date). But the patient was glad that the patient had vaccine. Event took place after use of product. The outcome of events was not recovered. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
PATIENT RECEIVED THE JOHNSON AND JOHNSON JANSSEN COVID-19 VACCINE (FIRST DOSE) AND PASSED OUT TWICE WITHIN 5 MINUTES OF GIVING THE SHOT.  AMBULANCE WAS CALLED OUT AND PATIENT WAS FINE.
This case was obtained from a non-scientific publication (lay press article) on 05 December 2011 (via a company representative). A high school student (patient demographics not provided) had received a dose of Pertussis vaccine (trade name, manufacturer name, lot number, route and site not reported) on an unspecified date and was subsequently confirmed as contracting Pertussis. The patient was reportedly contagious from 07-25 November 2011. Recovery status was not reported. Documents held by sender: None.
Breakthrough case admission after 4 vaccines  Pfizer 2/24/21 Lot# EN6200;  Pfizer 3/27/21 Lot# En6208; Pfizer 9/21/21 lot# FF8825;  Pfizer 4/21/22 lot# FJ9943
Left deltoid warm to touch, erythema, induration. Was started on Cephalexin for possible cellulitis.
This spontaneous report received from a consumer concerned a female of unspecified age, race and ethnic origin. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) 1 in total, dose, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, it was reported that, the patient had been in and out of hospital since and experienced blood clots, unimaginable nerve pain in her legs, she had to have a catheter for the rest of her life and she experienced kidney problems and was hospitalized (date unspecified). The number of days of hospitalization was not reported and it was unsure if the patient was discharged from the hospital. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from kidney problems, and catheter for the rest of life, and the outcome of blood clots and unimaginable nerve pain in legs was not reported. This report was serious (Hospitalization Caused / Prolonged). This case is a duplicate of 20221134018. Following receipt of additional information from reporter on 11-NOV-2022. It was determined that nullification and deletion was required for Manufacturer Report Number (20221134018) as it was duplicate of Manufacturer Case Number (20221133176). All relevant information regarding Manufacturer Report Number (20221134018) will be submitted under Manufacturer Case Number (20221133176). Sender's Comments: V0: 20221133176-blood clot. The event has an unknown/unclear temporal relationship, is unlabeled, and is scientifically plausible. There is no information on any other factors potentially associated with the event. Therefore, the WHO Causality is considered indeterminate. The company causality is considered unassessable. 20221133176-kidney problems, unimaginable nerve pain in her legs, catheter for the rest of her life. The event has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event. Therefore, the WHO Causality is considered indeterminate. The company causality is considered unassessable.
Patient is a 90 y.o. female with known history of HTN, GERD, Parkinson's who presented from assisted living on 3/24/2023 with shortness of breath that began earlier that morning. Found to have Covid with mild respiratory failure. Treated with steroids and paxlovid. Weaned to RA before discharge. Hospital course complicated by delirium - steroid induced with baseline opioid and benzo on board .        Assessment and Plan   COVID-19 pneumonia Acute respiratory failure with hypoxia - Presented with: Shortness of breath the morning of admission - Positive COVID-19: Tested positive on 3/24 at ER - Vaccination status: Vaccinated with Pfizer most recently 10/27/2022 - CXR on admission with mild atelectasis - Oxygen status: Currently on room air with normal wob - stop Decadron, s/p 5-day course of Paxlovid   Toxic metabolic encephalopathy - related to hospital stay, steroids, infection  - noted 3/28 upon waking, mild and waxing and waning, improved 3/29 and 3/30 but still not sleeping well - noted worsening on multiple occasions after benzo administration  - stop steroids, stop IVF , safe for d/c today, d/c home ativan I discussed with daughter via telephone and recommended we explore other  medications with pcp. From my perspective she should not be on tramadol + ativan at 90 years old with fall risk , memory risk , and confusion. They will discuss with dr.    Hyponatremia - suspect related to poor intake / illness - remains slightly low but stable, stop fluids,  follow up pcp   Anxiety and depression - on Prozac, Remeron - continued, Ativan prn at home discontinued , likely needs additional agent (atarax and benzo not good options)   Parkinson's disease - known chronic issue - continue home Sinemet  Essential hypertension - high in the hospital, she is convinced I added coreg / she doesn't take at home, she states its making her feel "crummy" - pharmacist confirms she fills at home but we decided to reduce to 3.125 to see if her sx improve , follow up with pcp   History of multinodular goiter - known issue  - continue home methimazole   Chronic constipation -Continue home miralax once daily   Chronic back pain, scoliosis - Continue home
02:00 PM "feeling goggy" HR: 113, BP: 120/80 sitting, 120/60 standing, 02:02 PM Drinking fluids orally  02:34 PM BP:172/120  02:36PM  BP: 140/110  02:39 PM HR: 80,  02:47 PM SO2 RA 98%, HR: 82, BP: weak (nurse can not hear well) 02:54 PM 140/104 sitting right arm SO2 RA 99% Hr: 82 3:00 PM pt. feeling better, however she  left with EMS team
Past Vaccine window; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Past Vaccine window) in a 21-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20a) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Past Vaccine window). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Past Vaccine window) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication were provided by the reporter  No treatment medication were provided by the reporter.  She has not received her second dose, and it has been five months now. Patient's mother wanted to know whether she can get her second dose now, or if she needs to start the series all over again. (There was no expiration date on the vaccination card).   Most recent FOLLOW-UP information incorporated above includes: On 10-Aug-2021: Patient indentifiers, and event information updated
The patient was administered vaccine that was past the expiration timeframe. The vial was opened on Friday, 8/6/2021 and should have expired at 1600 that day.  The expired vaccine was used on Monday 8/11/2021.  There were no adverse events noted from giving the expired vaccine.  The clinic contacted Pfizer for directions on what should be done. Pfizer stated they could not advise or give us guidance. Pfizer stated that there was no research or studies on the efficacy of the vaccine outside of the time window they recommend and they could not advise us if re-vaccination was appropriate treatment.   The CDC was contacted for advice.  They stated that they would have to get back with us. We are now waiting to hear back if she should re do the first dose.
Mental confusion and short term memory loss, weakness and numbness in left hand. Numbness and weakness improved after 2 days. Mental fog continued until Jan. 25th. First day I actually felt normal was 1/26,2021.
Case received from a healthcare professional on 08-Nov-2013.: A male patient had received his intramuscular dose of ADACEL (batch number unknown, anatomical site of administration not reported) on an unspecified date in Oct-2013. There was no other vaccinations reported within 4 weeks of vaccination. Two weeks before reporting, the patient experienced anaphylaxis. He was still experiencing dizziness and nausea at the time of the report. His condition led to ER/doctor visit. He was not recovered at the time of the report. No further information was available as the reporter refused to provide details on patient, details on responsible physician, details on pre-existing illnesses at the time of the vaccination and relevant diagnostic/lab data. The patient outcome is not recovered. Documents held by sender: None.
Sore neck and neck area to upper shoulders.  Could barely move neck and it was terribly painful on 10/22, 10/23 and still is painful today.  Muscles in neck are still sore.
This spontaneous report as received from a physician refers to a 1 year old patient of unknown gender. No information regarding the patient's medical history and concurrent conditions was provided. On 25-APR-2017, the patient was vaccinated with an improperly stored dose of M-M-R II (rHA, recombinant human albumin), lot number M039904, (dose, dose number, injection site, route of administration and expiration date were not provided) for prophylaxis. The vaccine underwent a temperature excursion of 48 degrees Fahrenheit for 30 minutes. It was also stated that the dose of vaccine was reconstituted with properly stored sterile diluent injection. There was no Digital Data Logger involved. No adverse effects were reported. There were no previous temperature excursions reported. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1704USA001661: US-009507513-1704USA001660: US-009507513-1704USA000587:
lump in neck around clavicle, soft around it but inside, something does feel hard, the lymph node; lump in neck around clavicle, soft around it but inside, something does feel hard, the lymph node; lump in her neck, around the clavicle. It is tender to the touch and the inside feels soft around the whole big thing; She thinks it is probably a lymph node she is feeling inside. It is probably inflamed around it.; elevated uric acid; This is a spontaneous report from a contactable nurse (patient). A 65-years-old female patient received booster dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: 341458A, Expiration date not reported), via an unspecified route of administration, in left arm on 27Sep2021 14:45 (at the age of 65) as dose 3 (booster), single for COVID-19 immunization. Medical history included arthritis, was on supplement and had eye disorder, all from an unknown date and unknown if ongoing. Patient had no family history. Patient previously took flu shot and shingles shot, experienced body aches and low grade fever. Patient previously received first dose of bnt162b2 (Lot number: EJ1685) via an unspecified route of administration, administered in left arm on 22Dec2020 as dose 1, single, and second dose bnt162b2 (Lot number: EL1283) via an unspecified route of administration on 12Jan2021 as dose 2, single, both for COVID-19 immunization and experienced did not have a problem with the other 2 doses (dose 1 and dose 2). No prior vaccinations within 4 weeks and no additional vaccines administered on same date of the Pfizer suspect. Concomitant medication included ascorbic acid, tocopheryl acetate, xantofyl, zeaxanthin, zinc (AREDS, once daily) taken for supplementation therapy, eye disorder, start and stop date were not reported; colecalciferol (D3, once daily) taken for supplementation therapy from an unspecified start date and ongoing; curcuma longa (TURMERIC [CURCUMA LONGA], once daily) taken for supplementation therapy, start and stop date were not reported (all taken for a couple of years). On 29Sep2021, in the afternoon, the patient experienced lump in neck around clavicle, soft around it but inside, something does feel hard, the lymph node. She thought it was probably a lymph node she is feeling inside. It was probably inflamed around it. It was reported that, the lump was tender to the touch and the inside feels soft around the whole big thing. She did not think it is anything to worry about. She had no fever, and no shortness of breath. She did put a little ice on it for about 2 minutes. On an unknown date in 2021, patient experienced elevated uric acid. Events did not require a visit to Emergency Room and Physician Office. The patient underwent lab tests and procedures which included blood uric acid: elevated on an unknown date in 2021. The outcome of elevated uric acid was unknown, and the other events were not recovered.   Follow-up attempts completed. No further information expected.