chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Likely pericarditis.  2 days s/p Pfizer COVID dose 2, presented to local ED with 2 hours of severe substernal chest pain beginning at 0200; self-resolved at 0400. Initial Troponin of 7000+, Diffuse ST changes on EKG. Admitted to hospital for further workup, serial troponins. No further chest pain during admission. Troponins downtrending during admission, cardiology consulted, EKG showed improvement. Dc'd 2/15/22 in stable and symptomatic condition with cardiology followup.
Patient is a 70 yo F with PMHx COPD chronically on 3L O2, CHF, DM Type II, Hypothyroidism, HTN, CAD, GERD and OSA not on bipap anymore at home presenting to the ER with difficulty breathing on 6/3/21. Due to acuity of condition limited history able to be obtained from patient and limited history obtained from patient's sign other on admit, who reported patient was having difficulty breathing earlier the day of admit and patient's boyfriend called EMS. Patient's boyfriend did report she was at baseline and denied any changes in management except she received her second dose of the COVID vaccine the day prior 6/2/21. EMS found the patient in respiratory distress and placed on non-rebreather and given 10mg Decadron. Once in the ER patient continued to appear in respiratory distress despite 3 treatments with Duo-nebs and patient was placed on NIPPV. Due to aggressive behavior of hitting staff and agitation in which patient appeared confused and attempted to continuously pull out IV lines and oxymask patient was given two separate doses of IV 0.5mg Ativan. pt arrived with a fever of 101.1, tachycardia 148, hypertension 190/144, respiratory rate of 38 she was admitted with severe SIRS response/possible sepsis with acute hypoxic respiratory failure without septic shock:       - CXR negative for acute pathology/CT neg for acute pathology       - ESR 64, CRP 5.5, D-dimer 540       - no leukocytosis present on lab work, renal and hepatic function WNL       - EKG showed sinus tachycardia at rate 133 with RBBB       - UA negative for acute infection        - Blood cultures negative       - Patient was started on IV Vancomycin and Zosyn  which was discontinued the following day as infection ruled out        - HS troponin 18, 1hr 15, delta -3       - ABG showed normal pH with hypercapnia at 58   she was also admitted for Acute metabolic encephalopathy:        - Patient became agitated and was hitting staff in the ER        - Unable to focus or respond more than a couple short words in ER without closing eyes         - Given Ativan 0.5mg IV twice in ER as attempting to pull off lines and oxygen            she was admitted to the ICU. the following day she was doing better but had body wide tremulousness and muscle fasciculations. she was eventually transferred to the medical floor. IV fluids were discontinued. Her fever defervesced. Eventually oxygen was weaned down to her baseline and she was discharged on 6/8/21 back home with home health services. She was felt to have severe SIRS response following covid 19 vaccination and it is now listed as an allergy. To her knowledge she has never been infected with covid-19
8 days post vaccine, pt presented with 1 day h/o wheezing and local induration at site of injection.
Upon receiving the second dose of the COVID-19 vaccine, I immediately felt tingling or chills in the arm where the shot was administered.  This developed into muscle soreness as I sat through the waiting period before leaving the facility.  (For this reason, I had taken acetaminophen at about 8:30 that morning.)  I experienced both of these symptoms after my first shot of this COVID-19 vaccine, so these did not concern me.  After taking a nap back at my house, I woke up about 3:30 p.m. experiencing some partial numbness in my left arm, which received the injection.  It was not inhibitive, but I can somewhat relate it to the neuropathy my mother experienced before being diagnosed with diabetes in 2005.  It was a bit like the tingling I first experienced after the injection, but throughout the injected arm.  As I continued through that afternoon and evening, my arm kept getting stiffer and stiffer.  This prompted me to take my temperature at about 8 p.m. and then again at 10 p.m. Both of these tests resulted in a normal temperature of 98.3 or 98.4 degrees.  By the time I was about to climb into bed at midnight, the stiffness had spread to my shoulder joint -- such that almost any movement of that arm elicited some mild discomfort, especially if I leaned against the wall with that shoulder or raised my arm above my head.  I took a third dose of acetaminophen.  My normal prone sleeping position was not comfortable with this stiffness, so I did my best to sleep on my back.  Next, I woke up too hot about 3:30 a.m. (Wednesday, May 26) and could not get back to sleep.  Full-body chills set in soon after, prompting me to turn off my ceiling fan.  I faced some mild nausea as I attempted to get comfortable in bed again.  I suspected I was feverish by at least 4 a.m., but I did not get up to check my temperature until 5 a.m. The thermometer gave a reading of 100.3 degrees, so I took another dose of acetaminophen (my fourth in 24 hours) and tried to go back to sleep.
One day post vax the pt developed "severe" cellulitis. She went to the ER and was prescribed a Medrol dose-pack and Benadryl. As of 3/5/01 the reporter stated that the pt had not yet responded to the prescribed meds. This is 1 of 2 pt from this facility who developed cellulitis following receipt of Pnu-Imune lot # 471-040. Addtl info recvd from the reporter on 6/8/01 stated that the pt recovered.
pt recv vax & devel a rash;the reporter noted 2 hlth care workers had failed to seroconvert (WAES97041731);
pt recv vax 15NOV96 & devel redness @ inj site appeared the next day;area got inc red & hard;pt was not exceptionally fussy;ran low grade fever over weekend;today area approx 1 1/2" medial to inj site is very hard & purplish red;
Patient said her arm was warm at the site of the injection and turned very red almost to her elbow. She said it lasted about 2 days and then it went away.
Burning in eyes; redness in eyes; headaches; fever; upset stomach; This case was reported by a consumer via interactive digital media and described the occurrence of burning in eyes in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced burning in eyes, eye red, headache, fever and upset stomach. On an unknown date, the outcome of the burning in eyes, eye red, headache, fever and upset stomach were unknown.   It was unknown if the reporter considered the burning in eyes, eye red, headache, fever and upset stomach to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 17-JAN-2023 Reporter's Comment: This case was reported by a patient via (Shingrix GSK) interactive digital media. The patient had experienced burning redness in eyes, headaches, fever, upset stomach. The follow-up could not be possible as no contact details were available.
Gray dot on thigh; This case was reported by a nurse and described the occurrence of skin discoloration in a 2-month-old patient who received DTPa-HBV-IPV (Pediarix) (batch number N7HL3, expiry date unknown) for prophylaxis.   Co-suspect products included dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis and Hib (Hiberix) (batch number Y772R, expiry date unknown) for prophylaxis.   On 19th August 2022, the patient received the 1st dose of Pediarix, Pediarix Pre-Filled Syringe Device and the 1st dose of Hiberix. On 21st October 2022, 63 days after receiving Pediarix, Pediarix Pre-Filled Syringe Device and Hiberix, the patient experienced skin discoloration. On an unknown date, the outcome of the skin discoloration was unknown.   It was unknown if the reporter considered the skin discoloration to be related to Pediarix, Pediarix Pre-Filled Syringe Device and Hiberix.   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: 16-NOV-2022 Reporter's Comments:  The patient experienced gray dots noted on legs (right thigh) after receiving Pediarix, Hiberix The reporter was consented to follow up. Additional supportive information: The patient received 2nd dose of Pediarix (batch number T5425) and Hiberix ( 5Y9N9) on 21st October 2022 This was 1 of several linked cases, reported by same reporter.; Sender's Comments:  US-GSK-US2022AMR171025:Same reporter US-GSK-US2022AMR171007:Same reporter US-GSK-US2022AMR171034:Same reporter US-GSK-US2022AMR171044:Same reporter US-GSK-US2022AMR171042:Same reporter US-GSK-US2022AMR171039:Same reporter US-GSK-US2022AMR171028:Same reporter US-GSK-US2022AMR149561:Same reporter US-GSK-US2022AMR149560:Same reporter US-GSK-US2022AMR149551:Same reporter US-GSK-US2022AMR148962:Same reporter US-GSK-US2022AMR148961:Same reporter US-GSK-US2022AMR148919:Same reporter US-GSK-US2022AMR171056:Same reporter US-GSK-US2022AMR171052:Same reporter US-GSK-US2022AMR171062:Same reporter US-GSK-US2022AMR171050:Same reporter US-GSK-US2022AMR171048:Same reporter US-GSK-US2022AMR171083:Same reporter US-GSK-US2022AMR171088:Same reporter US-GSK-US2022AMR171095:Same reporter US-GSK-US2022AMR171047:Same reporter US-GSK-US2022AMR171095:Same reporter US-GSK-US2022AMR171083:Same reporter US-GSK-US2022AMR171088:Same reporter US-GSK-US2022AMR171169:Same reporter US-GSK-US2022AMR171174:Same reporter US-GSK-US2022AMR171264:Same reporter US-GSK-US2022AMR171230:Same reporter US-GSK-US2022AMR171197:Same reporter US-GSK-US2022AMR148961: US-GSK-US2022AMR149560: US-GSK-US2022AMR149561:
My left upper arm became itchy yesterday (14 days  after getting the vaccine).  The itch seemed to come from within or under the top layer of skin.  It was distinctly noticeable but not severe. The area was mildly itchy the entire evening. It was less itchy today (almost 24 hours later) - almost gone.  Around the injection site, there is a about a 2.5 inch circle where the skin is light pink (I am a white person). It seemed a little bumpy last night, but the skin is smooth to the touch now.
Administered only the diluent component; Administered only the diluent component; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a 57-year-old female patient who received Herpes zoster (Shingrix) (batch number 7BC47, expiry date 9th June 2023) for prophylaxis.   On 18th August 2022, the patient received Shingrix. On 18th August 2022, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 19-AUG-2022 Reporter's Comment: The medical assistant reported that administering only the Shingrix diluent component to a patient one day before the reporting, without the lyophilized component. No additional details were provided. The reporter did not gave consent to follow up. Additional Supportive Information: The patient received only the Shingrix diluent component to without the lyophilized component in left arm, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
No adverse reaction to vaccine.  Pt positive for covid in april 2021.  recieved 2 doses of pfizer vaccine (1/2021&2/2021)
Elderly   ES to inpatient Dx: Severe sepsis with hypoxic respiratory failure 2/2 COVID pneumonia with possible superimposed bacterial pneumonia. Bivalent boost in 10/2022
pt recv vax;noticed lt arm nodule at inject site, pain and numbness of shoulder and fingertips;continual pain subsided and replaced w/ gen soreness of entire lt arm;numbness;lt area functional but weak;dx of pinched nerve in cervical
Fever, Chills, Body Aches, Nausea, Bad Headache, Dizziness, Stomach Pains, Sore Arm for 2 days. I took Tylenol, rested, ate light & drank water.
Hives, fever, chills, body aches, migraines, vertigo, photosensitivity, phonophobia, nausea, fatigue, dizzy light-headed, loss of voice, sob,  diarrhea, and sore arm.  No outcome still ongoing testing and seeing specialists.
felt dizzy; her blood pressure readings are higher than normal; breastfeeding her 9-month-old baby; breastfeeding her 9-month-old baby; This is a spontaneous report from a contactable consumer (patient). A 40-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 16Apr2021 (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Caller stated she didn't take prescribed medications and was also breastfeeding her 9-month-old baby. She explained she received the first dose of the Pfizer-BioNTech COVID-19 vaccine last Friday, 16Apr2021 and developed potential side effects this morning, 20Apr2021. She explained she felt dizzy and her blood pressure readings are higher than normal, around 140/90-95. She specified her blood pressure was fine yesterday (19Apr2021) and was on average around 110/70. Outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021502578 child case
Red itchy rash on arms, legs, buttocks and one breast that was present for 4 days and is now clearing.
This spontaneous report as received from a physician via field representative refers to a 50 year old female patient. On 07-DEC-2014 the patient was vaccinated with ZOSTAVAX (Lot#, strength, dose, route were not reported) at a unspecified pharmacy. On 09-DEC-2014, 3 days after onset of therapy the patient experienced local reaction (type of reaction unspecified) at the injection site and had come to the office to sought medical attention on the same day. No further symptoms were reported. Lab diagnostics studies were not performed. No interventions to prevent serious criteria and not hospitalized. No product quality complaint was involved. The outcome of event was unknown. The reporter causality was unknown. Additional information has been requested.
throat fullness and upper chest tightness that started 7 minutes after administration and lasted for ~2 hours
Bitemporal headaches, nausea, blurred vision, malaise intermittent, beginning 3-4 days p/vax; no hx of migraine in past;
Pfizer BioNTech Covid-19 Vaccine Adverse Effect. Upon submitting the completion of his Pfizer vaccine series to the state registry, the Pharmacist on Duty checked system to ensure the administration was properly reported.  At this time, he realized the patient had received the Janssen Covid-19 Vaccine on 3/5/21 Lot #1805025. When asked prior to administration if he had received a previous COVID-19 vaccine, the patient denied previously receiving any doses of Covid-19 vaccines.  When the pharmacy manager called to follow up with the patient and inquire about the J&J vaccine, the patient stated he would have to look for the paperwork and get back to the pharmacy about whether or not he received the J&J vaccine. He stated he was not experiencing any additional side effects beyond a sore arm at this time.
Pt c/o fatigue, decreased appetite on the evening of 6/17/08.  Woke up at 5:15am on 6/18/08 c/o headache, nausea, weakness in arms, "shocking" sensation on arms & trunk (from neck down to abdomen) - this sensation would come in "waves".  T 98.3 axillary.  All s/s resolved except fatigue.
received on 07/13/2022, expired on 06/30/2022; This case was reported by a nurse via patient support programs and described the occurrence of expired vaccine used in a 12-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA571A, expiry date 30th June 2022) for prophylaxis.   On 13th July 2022, the patient received Menveo. On 13th July 2022, unknown after receiving Menveo, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   Linked case(s) involving the same patient:  US2022107247   Additional Information: GSK Receipt Date: 14-JUL-2022 Reporter's Comment: Nurse reported that the patient had received an expired dose of Menveo. The reporter consented to follow-up. Additional Supportive Information:  The patient received a dose of Menveo vaccine which was already expired in 30th June 2022, which led to expired vaccine used.; Sender's Comments:  US-GSK-US2022107247:FU1 - Deleted
4yo patient inadvertently received Adacel instead of Daptacel, no AE; 4yo patient inadvertently received Adacel instead of Daptacel, no AE; Initial information received on 03-Oct-2019 regarding an unsolicited valid non-serious case received from a consumer/non-hcp (other).  This case involves a 4 years old female patient who inadvertently received a 0.5 ml fifth dose of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] (batch number and site of administration were not reported) instead of DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE [DAPTACEL] via intramuscular route on 25-Sep-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included POLIO VACCINE INACT 3V (VERO) (IPOL [POLIO VACCINE INACT 3V (VERO)]); MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR); VARICELLA ZOSTER VACCINE (VARICELLA VACCINE); and INFLUENZA VACCINE (INFLUENZA VACCINE).  It was an actual medication error due to wrong vaccine administered and Inappropriate age at vaccine administration.  At the time of reporting the patient had no adverse 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 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.  List of documents held by sender: none.
patient reports that 3 days after and as of today the arm that she had the shot in has been itching. No rash.
4 days after first dose started getting frequent and severe heart palpitations at night lasting 4 - 8 hours.; This is a spontaneous report from a contactable consumer or other non-health care professional (Patient). A 38-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EW0191 and expiration date was no reported), first dose via an unspecified route of administration, administered in Arm Left on 27May2021 11:15 (at the age of 38 years) as single for covid-19 immunisation. Medical history included gastroesophageal reflux disease from an unknown date and unknown if ongoing. Concomitant medication(s) included ibuprofen (MANUFACTURER UNKNOWN) and acetaminophen (MANUFACTURER UNKNOWN) taken for an unspecified indication, start and stop date were not reported. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient was not diagnosed with COVID-19, prior vaccination and since the vaccination. On 31May2021 the patient experienced 4 days after first dose started getting frequent and severe heart palpitations at night lasting 4 - 8 hours. The adverse event resulted in Doctor or other healthcare professional office/clinic visit. The outcome of the event was unknown.    Follow-up attempts are completed. No further information is expected.
PT HAD COLD SWEATS & SHAKING FROM HYPOGLYCEMIA, HUSBAND GAVE HER 3 GLUCOSE PILLS PLUS ORANGE JUICE AND AT THAT POINT PT'S BLOOD SUGAR WAS AT 77. BLOOD SUGARS CONTINUED TO FLUCUATE GOING UP TO 300 THEN SHOOING BACK DOWN TO 62-72. BLOOD SUGARS BECAME NORMAL AGAIN ON OCTOBER 26TH.
Patient was given the 6 months to 5 years Bivalent Booster for his first vaccine instead of the 6 months to 5 years old Monovalent primary series.
About a week an a half after receiving my first COVID Moderna vaccine, hives began appearing all over my body. They were mainly at night and appeared on my stomach, arms, legs, and back. The hives went away with Zyrtec, but would reappear 24 hours later when the Zyrtec was out of my system. I had to take Zyrtec every day for about 5 months or else the hives would come back (worsened at night). The hives were itchy and in very large clusters. I had no other illnesses and was tested for mono but it was negative. One day the hives simply stopped appearing.
Pain at inject site: From 2 hours to 24 hours Swollen lymph nodes: From 12 hours to 3 days; primarily near injection site, especially left armpit Headache: From 12 hours to 6 days; treated with acetaminophen and ibuprofen Fever: From 24 hours to 3 days; treated with acetaminophen and ibuprofen Nausea: From 24 hours to 3 days Tiredness: From 24 hours to 5 days Vertigo: From 2.5 days to 7 days; slightly alleviated by Zyrtec (Pseudoephedrine and Cetirizine)
pt recv vax 20MAR98 & devel brachial plexitis causally r/t the vax;apparently did not appear for medical follow up until 18MAY98;
Pityriasis rosea; This is a spontaneous report received from contactable reporter(s) (Physician) from a sales representative.  A 12-year-old patient received BNT162b2 (BNT162B2), on 12May2021 as dose 1, single (Lot number: ER8737) intramuscular for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: PITYRIASIS ROSEA (non-serious) with onset 15May2021, outcome "recovered" (May2021). The event "pityriasis rosea" required physician office visit. Therapeutic measures were not taken as a result of pityriasis rosea.  Additional information: Event took place after use of product. Pfizer product had a causal effect to the adverse event was reported as Yes (Possibly). Prior vaccination and relevant tests was reported as None. Family medical history relevant to AE was reported as Not applicable. AE required visit to Dermatology.  Follow-up attempts are completed. No further information is expected.  Amendment: This follow-up report is being submitted to amend previous information: Re-assessed the case as valid.
I woke up one morning with fever, headache, coughing, and dizziness. I tried to get tested and went to the ER. They tested me and told me I had Covid-19. I followed up with my PCP and she gave me a Z-Pak, steroid and cough medicine. On the 24th I woke up with a horrible sore throat and my head was spinning. I went back to the ER and they admitted me and told me that I had a stroke that the Covid-19 I had caused my heart to go into AFib which caused me to have a stroke. Which now has caused me to have vertigo with my ear. I'm now going to be seeing specialist for this.
Swollen at the site within 7 days and continues to the present. No rash but hot to the touch, itches, & hurts.