chrisvoncsefalvay/vaers-outcomes huggingface dataset:
My Ooxgyen was dipping into high 70s  tolow 80s with oxygen  @4 lpm, Also very dehydrated  and went to hospital dur to feet and ankles swelling up alot.. In the hospital for 9 days to lower clots from legs and constant high oxygen therapy also hemoglobin and hematicrit went upper range. Im home now doing better, but I dont think I should take the 2nd dose.
mild Covid; mild Covid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; BNT162b2 (BNT162B2), 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 and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "mild Covid".  Clinical course: The patient reported that "I have had 5 Pfizer shots. I just got mild Covid this week . My question is when can I get next booster"  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5, BNT162b2 has been requested and will be submitted if and when received.
Patient tested positive for Covid-19 on 11/22/22, was hospitalized on 12/4/22, and subsequently died on 12/20/22.
got arm rash from both doses of the vaccine; Chills; Fever 101.9; Very tired and exhausted; Swollen  covid arm; Night sweat; Red; COVID arm; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Swollen  covid arm), NIGHT SWEATS (Night sweat), ERYTHEMA (Red), VACCINATION SITE REACTION (COVID arm) and RASH (got arm rash from both doses of the vaccine) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013L20A and 039K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Colitis and Osteoporosis. Concomitant products included DENOSUMAB (PROLIA) for Osteoporosis, BUDESONIDE, LOPERAMIDE HYDROCHLORIDE (LOMOTIL [LOPERAMIDE HYDROCHLORIDE]), LOPERAMIDE HYDROCHLORIDE (IMODIUM), ESTRADIOL, COLECALCIFEROL (VITAMIN D3), VITAMIN B12 NOS (VITAMIN B 12 [VITAMIN B12 NOS]), BIOTIN and LIFITEGRAST (XIIDRA) for an unknown indication.   On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 17-Feb-2021, the patient experienced PERIPHERAL SWELLING (Swollen  covid arm), NIGHT SWEATS (Night sweat), ERYTHEMA (Red), VACCINATION SITE REACTION (COVID arm), CHILLS (Chills), PYREXIA (Fever 101.9) and FATIGUE (Very tired and exhausted). On an unknown date, the patient experienced RASH (got arm rash from both doses of the vaccine). At the time of the report, PERIPHERAL SWELLING (Swollen  covid arm), NIGHT SWEATS (Night sweat), VACCINATION SITE REACTION (COVID arm), RASH (got arm rash from both doses of the vaccine), CHILLS (Chills), PYREXIA (Fever 101.9) and FATIGUE (Very tired and exhausted) had resolved and ERYTHEMA (Red) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 17-Feb-2021, Pyrexia: 101.9 (High) 101.9.         No treatment information for the event was provided.   This case was linked to MOD-2021-021462 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 08-Jul-2021: Updated concomitant drugs and patient medical history.
Information has been received from a nurse practitioner concerning a female who was vaccinated with the second dose of GARDASIL 0.5 mL.  About an hour after receiving the vaccine, the patient experienced an episode of where her heart was racing and a shortness of breath.  The patient's outcome was unknown.  The patient sought unspecified medical attention.  Additional information has been requested. Follow up information has been received from the nurse practitioner concerning the female patient who on 01-OCT-2008 was vaccinated with the second dose of GADASIL (lot number 659184/0843X) 0.5 ml. Later in the day of vaccination, not necessarily an hour, the patient experienced the episode of her heart was racing and a shortness of breath. The adverse event was not reported to the nurse practitioner until the patient went to the office for the third dose of GARDASIL, which was not given. Additional information has been requested.
At 10:00am PST on 03/19/2021, the upper part of my left arm broke out into a rash and hives developed as did extreme soreness. I think it is called "Covid Arm." I took a Claritin to help the itchiness go away and went back to working normally.
I had significant arm pain around the injection site after receiving the Janssen/J&J booster.  This was described as a normal reaction. However, the pain lasted for over a week and was quite significant. It has subsided now and does not constitute a significant deterrent to receiving the same vaccination. However, the pain was significant.
It is reported that a pt rec'd a TD adult vaccine on 4/10/01. Reportedly sometime after the vaccine the pt developed redness, warmth, tenderness and itching at the injection site.
1410 Vaccine administered IM/ RD. Tolerated without difficulty. Waited for 15 minutes after administration without any problems. Ambulatory discharge to private car.  1430 Patient returned to clinic with complaint of all 5 fingers on left hand tingling and numb. Also c/o right sided tingling of lip and right sided neck numbness. B/P 118/82, Pulse 94, temp 97.8 SAO2 98% on Room Air. Benadryl liquid 50 mg PO given. 1445 Improvement with lip tingling and in 1 finger. C/O numbness continues in 4 fingers.1500 Symptoms improving. States neck numbness gone. Lip tingling gone. 1515 B/P 112/78, pulse 72, temp 98.0, SAO2 99% on room air. All symptoms subsided. Denies any problems or complaints at this time. Informed patient t
Sudden onset of vomiting.  22 reported episodes.  Resulted in hospitalization.
8/22/2022 I felt like a truck hit me. Just felt awful, low grade fever. Tested with at Home COVID-19 test, positive. Reached out to doctor in the evening, who returned the call on 8/23. Doctor proscribed Paxlovid. Symptoms improved 8/24, though I experienced awful taste in my mouth while on the Paxlovid. Took about 5 days for symptoms to improve. I experienced mostly fatigue during that time. After 10 days, everything was back to normal.
Patient wanted COVID booster at clinic appointment. Vaccine was pulled from fridge and diluted, however RN was unsure how much dilutant was used. 0.2mL was pulled from vial for the injection. 0.2mL was injected into patient's L arm. Patient was observed for 15 min post injection with no adverse reactions reported or noted.
About 11:00 PM patient was shivering uncontrollably, had a fever at the back of her neck, and had cold hands and feet.  The shivering lasted several hours but stopped by the time patient woke up around 5 AM.  No additional treatment was provided.  No symptoms occurred afterward.
severe swelling of arm where shot was given;unable to use arm 1st 24hrs; severe fever 9104) 8th day & 9th day (103.3)
C/o mild dizziness/headache that resolved after about 15  minutes. Child returned to class.  410 PM phone call to mother to inform of mild reaction. Child fine as far as she knows. Vaccine event report done per recommendation of Dr.
Fever and chills, beginning 14 hours post injection.  Lasted for 20 hours.  Alternated acetaminophen and ibuprofen.  Sore arm.  Began 14 hours post injection and continues, but improving 72 hours later. Redness, swelling and hot left shoulder, upper arm.  Continues but improving 72 hours post onset. Left shoulder/upper arm itches.  Onset 08/01/2020 at 09:30 a.m.
First dose on 4/1 039A21A. I had 5 short-term Afib incidents between 1/1 through vac date. Afib incidents on April 2 12 17 19 24 27, incidents between 10 mins and 2 hours. Second dose 4/29 Afib started at 7:45, intermittent. Heart rate was 100. Fever of 101, chills, vomiting, by 19:45. Heart rate 102. Next day HR in 90s, muscle & joint aches. Went to doctor on May 1. High temp was 100.8, HR high was 164, until ER visit.
Information has been received on 30-MAR-2017 from a medical assistant regarding a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapy were not reported. On 15-MAR-2017 the patient was vaccinated with a dose of ZOSTAVAX lot # M037013, expiration 22-NOV-2017 subcutaneous for prophylaxis which underwent a temperature excursion. Other suspect therapies included sterile diluent (STERILE DILUENT). The vaccine was stored between 6 degrees F and 14 degrees F for 1 hour and 4 minutes and between 15 degrees F and 46 degrees F (also reported as 40.2 degrees F) for 105 hours and 5 minutes. No previous temperature excursion was reported. The call was made due to a data logger. The patient has not reported an adverse experience. No additional information was provided. Additional information has been requested.
I am experienced life-altering injuries after receiving the 1st shot on April29.   My hands and feet feel numb. Dr prescribed nerve pain medication Gabapentin and slightly dull my pains but hasn?t been resolved.  Every morning my feet feels swollen and like stepping on pins and needles. I can?t walk or bike for long periods like I used to and have to endure and suffer from nerve pains.
bad chills high fever follow by pain in the body following day vomiting too weak to walk now today i feel like I am going to get the chills a gain feeling weak.
Patient notice hard area on deltoid of left arm (site of injection) the day after administration.  By the second day after administration the upper left extremity was warm to the touch, red, and edematous.  Pt was given Percocet for pain and cold compress.
Patient immediately felt faint after needle was withdrawn from arm.  Patient was able to verbalize this.  Assisted to the floor and legs elevated.  Patient monitored for 30min.  Juice and chips given.  Mom with patient. 2nd dose scheduled.  Will have patient lying down for 2nd vaccine on April 14th
Severe Allergic Reaction- swollen tongue, swollen throat, hoarseness. Symptoms started approximately 45 mins after vaccine and worsened over 3 hours post vaccine. In ER received IV Decadron, IV Benadryl, and IVF NS. Observed for 2.5 hours symptoms improved discharged home with Medrol , pepcid, and to take oral Benadryl every 6 hours for 48 hours.
medical assistant administered Quadracel to a 9 year old child instead of Tdap and IPV, no AE; 9 year old patient administered Quadracel, no AE; Initial information received on 10-Oct-2019 regarding an unsolicited valid non-serious case received from other health professional.   This case involves a 9 years old patient who received vaccine DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [QUADRACEL] lot C5656AA (Expiry date unknown) via unknown route in the right deltoid on 03-Oct-2019, instead of POLIOMYELITIS VACCINE (INACTIVATED) and DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE. This would have been a fifth dose of IPV. This was also a fifth dose of DTaP.  The patient's past vaccination(s) included fourth dose of IPV (POLIOMYELITIS VACCINE (INACTIVATED)) on 22-MAR-2011. The patient's past medical history, medical treatment(s) and family history were not provided.  Concomitant medications included MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR) and VARICELLA ZOSTER VACCINE (VARICELLA VACCINE).   It was an actual medication error case due to inappropriate age at vaccine administration and wrong vaccine administered.  It was reported that it was intended to vaccinate a 9 year old child for Tdap and IPV Quadracel was given in the right deltoid. Later it was realized that Quadracel is not indicated for use in a 9 year old.  At the time of reporting no adverse reaction was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  Information on the batch number was requested.
Systemic: Dizziness / Lightheadness-Medium, Systemic: Nausea-Medium, Additional Details: pt felt very dizzy and nauseaous immediately after the vaccine, had her sit with head down for about 30 minutes, blood pressure and pulse low (95/50, pulse 63 ) but pt was concious and said she was feeling better. told her to go to ER if feeling worse and will reach out to check in with pcp and patient
Pt. states received Phizer vaccine and 06/23/2021 woke nauseous, headaches, chills, trouble catching breath. Plans physician visit 07/08/2021 to receive Ultrasound due to stomach problems. Low appetite, fatigued.
Patient vaccinated 9/7. Patient presented 9/9 to pharmacy displaying redness and swelling in the right arm. Swelling mainly just above the elbow on the posterior surface of the arm. Redness starting just below the vaccination site to the elbow. On 9/9 I recommended the patient take BENADRYL and follow up if the symptoms do not improve.
5/11/11 Client became anxious & had difficulty breathing after receiving Tdap. At the ER visit - no treatment at ER - left & went to Drs office - received medicine for sinus infection, pelvic infection and IV fluids. Still on antibiotics. Still has anxiety & palpitations that come & go. Pt reacted adversely to Tdap. Immediately after administration pt stated she felt bad and started to get anxious. Throughout pt was talking coherently and stated she felt bad. I was unable to get the pt to lay down as she said her symptoms would be worse if she laid down. At this point I called for help. With 2 other people we were finally able to get the pt to calm down & to get her VS. BP at 11:24AM was 120/70, P=120. Pt's extremities were cool to the touch. We still had difficulty getting pt to lay down. Pt was fearful that if she laid down she would not be able to breathe. Flushing then noted along pt's right cheek & neck. Pt coherent and oriented well. Once pt's anxiety relieved repeat P=96 at 11:35AM, repeat BP at 11:37AM was 124/75 P=83 at this point the EMT came at 11:40AM and pt was c/o tongue tingling and feeling sleepy. The EMTs took over and pt was transported to hospital. 5/27/11 LM to call. 5/31/11 TC to pt - she states that she finished her medications - antibiotics. States she has had no problems - no anxiety, palpitations. No other problems.
expired daptacel was administered / no AE; Initial information was received on 31-Aug-2021 regarding an unsolicited valid non-serious case from nurse and physician via call center via Medical Information (Reference number- 00748845)  This case is linked to 00748869 (same reporter).  This case involves a three-year-old female patient who was vaccinated with an expired dose of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] (expired product administered).  The patient's medical history, past medical treatments, vaccinations and family history were not provided.  Concomitant medications included HEPATITIS A VACCINE (HEPATITIS A VACCINE) for prophylactic vaccination.  On 06-Aug-2021, the patient received a fourth dose of 0.5 mL of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE (lot number: C5643AA and expiry date: 17-Jul-2021) via an intramuscular route in the right thigh for prophylactic vaccination.  It was an actual medication error case due to expired vaccine used (latency: same day).  It was reported "Nurse reports that expired DAPTACEL was administered to 2 patients. Nurse asks if there are any recommendations for when expired DAPTACEL is administered."  At the time of reporting, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. 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.; Sender's Comments:  US-SA-2021SA290302:
consumer, reports that 3 days p/vax exp a fever & rash; f/u w/MD visit scheduled for 8JUN92;
Pt states fever of 101.7 pain at injection site with a white pimple looking area. Swelling to the size of half dollar according to patient.
Received 2 vaccine doses, 2.5 months apart. Both times: notable local injection site redness and swelling (expected). Within 24 hours: nausea, subjective fever, feeling unwell. Within 48 hours: intense sneezing and rhinorrhea with a non-productive cough. Within 36 hours: Subjective  fever with clear productive coughing, unrelenting, with 3-4 pillow  orthopnea persisting to reporting date accompanied by severe bronchspasm (almost refractory to albuterol nebulizer treatment q6h). All symptoms slowly improving slowly after day 6 but persisting to date of report.
Narrative: Patient received her first dose of the Pfizer COVID-19 Vaccine on 8/16/21 at Facility. There was no obvious adverse/allergic reaction noted during the 15-minute monitoring period after she received the vaccine. However, later that afternoon, within 4 hours of receiving the vaccine she started noticing an itch rash with hives/welts on her side with some small bumps on her face as well. She did not experience any difficulty breathing or wheezing. This reaction qualified a non-severe but immediate allergic reaction to the first dose of vaccine because it occurred within 4 hours. Therefore, it is not recommended that she get a second dose of an mRNA vaccine.
Bells Palsy 1st injection on 12/20/21 symptoms started 1/7/21,  2nd dose on 1/10/21 immediate numbness in mouth and tightness in throat which triggered bells palsy symptoms immediately
After first dose: large localized raised rish with hives, swelling, bruising reproted to PCP, fever and fatigue. After second shot same reaction. After third shot less localized reaction but fever and fatigue. Starting around 4/2021 (2 months post fully vaccinated) reproted nocturnal leg cramps severe and debilitating.  Continued reprots and problems with this including increaisng involuntary movements and fasciculations.  Referred to neurology first opinion bengin fasciculations.  referred to second neurologist for increasing cramps and fasciculations after thrird dose. Second neuriologist did EMG showing fasciculations in all muscles groups of lower limbs plus cramping.Dx: Cramp fasciculation syndrome, further wor pending.  Trials of flexeril, gabapentin, tizanidine, cardizem, benadryl, baclafen.  No relief for continued --progressing symptoms. All labs have ruled out other causes. MRI spine ruled out oterh causes. EMG ruled pout neuomuscular deggeneration. Nerve conduction showed continued fasciculations and cramping.
1) Persistent dizziness. 2) Ongoing transient rash - foot burning blisters. 3) Chills/sweat/aches. 4) Anxiety.
Symptoms began 6 hours following the vaccination.  They began with a sore, scratchy throat followed by a 7 - 12+ day course of fever, sore throat, myalgia, nasal coongestion, cough, weakness, fatigue, runny nose, dry cough followed by a productive cough.  Symptoms of nasal/sinus congestion, runny nose, chest congestion, productive cough continue.
Severe elevation of blood pressure as high as 180/100; This is a spontaneous report from a contactable physician reporting for himself. A 35-year-old male received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1686 and expiry date unknown), intramuscular on 30Dec2020 16:00 at a single dose on the left arm for COVID-19 immunization. Patient has no medical history. The patient's concomitant medications were not reported. The patient was not diagnosed with COVID-19 prior to vaccination. Patient has not been tested for COVID-19 since the vaccination. Patient has no known allergies. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The most recent COVID-19 vaccine was administered at the hospital. Patient received the second dose on 21Jan2021 16:00 (lot number: EL1283) intramuscular on the left arm. After the second dose in left arm, after about 24 to 48 hours, vesicular pruritic erythematous patches in multiple locations of my left arm, left arm pit, left upper back, left chest occured, peaking on day three and still remain after ond week. The blisters have opened leaving behind painful ulcers. This is not a rash that disappears in a few days. It will take much longer than that to heal. There was no rash with the first dose. Also, with both doses, patient had severe elevation of blood pressure as high as 180/100 within 2 to 5 hours on 30Dec2020, requiring about 3 doses of clonidine over 7 days where blood pressure would cycle up and down. Patient has no history of allergic reactions to any medications in the past or other vaccines in childhood. Otherwise, young healthy male with no history of hypertension. The adverse event resulted in doctor or other healthcare professional office/clinic visit. Patient was recovering from the event. Event reported as non-serious.; Sender's Comments: Based on the compatible temporal association, there was a reasonable possibility that the vaccination with BNT162B2 played a contributory role in triggering the onset of blood pressure increased. 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.