chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Started with soreness in the arm; Turned into horrible muscle and joint aches; Turned into horrible muscle and joint aches; pounding headache; an immense amount of pressure behind the eyes; uncontrollable body aches; This is a spontaneous report from a contactable other hcp (patient). A 22-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number=En5318), via an unspecified route of administration on 29Jan2021 11:30 (at 22-year-old) at single dose (Right arm) for COVID-19 immunization. The patient medical history was not reported. Patient had known allergies. Facility type vaccine was Public Health Clinic/Veterans Administration facility. No other vaccine was administered in four weeks. No other medications in two weeks. Patient had no covid prior to vaccination. The patient was covid tested post vaccination. There were no concomitant medications. The patient took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number=El3248), on 08Jan2021 12:00 (at 22-year-old) on Right arm for COVID-19 immunization. It was reported that it started with soreness in the arm. Turned into horrible muscle and joint aches, pounding headache, an immense amount of pressure behind the eyes, and uncontrollable body aches. This lasted from about 12 hours and then got progressively better. By hour 48 he was totally fine. Events started on 29Jan2021 22:00.  No treatment was received for events. The patient underwent lab tests and procedures which included covid test: Nasal Swab: negative on 31Jan2021. The outcome of the events was recovered.
Received DPH and IPV. Reporting medication error. To date , no reported adverse reaction from IPV over vaccination. Born 3wk's premature.
(I copied the notes from my doctor's visit and edited them) Patient developed dizziness at work during a virtual meeting while she was doing a presentation, while standing at her desk. She felt flushed, like her face was very hot and her computer screen looked like it was shaking side to side. She had to close the computer and lay down. Her symptoms resolved  since then. Patient has ongoing stress, does not get a good sleep as she raises a toddler . Remedies they have tried for relief of symptoms include: rest . Patient has  a history of  lightheadedness  in past. Patient asymptomatic at visit time, ate her lunch.
Patient developed a Herpes Zoster on left side of neck 24 hours after vaccine administration
Patient received COVID-19 vaccination on 12/31/20. She got lymph node swelling on the left side of her neck about 10 days later and then a couple of days after that she broke out in a rash c/w shingles for which she was treated with valtrex.
Fever,  chills, muscle aches,  headache,  nausea, site pain.  Taking tylenol and resting.
After about 5 minutes I began to have a metalic taste in my mouth that lasted for a couple of days.
COVID-19; COVID-19; This is a spontaneous report from a contactable consumer . A patient of unspecified age and gender received bnt162b2 (COVID-19 VACCINE - MANUFACTURER UNKNOWN), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE 1, SINGLE, dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE 2, SINGLE for COVID-19 immunisation. The reporter stated not to know which vaccine the patient received, just knew that the patient was fully immunized with an unspecified COVID-19 vaccine. The patient's medical history and concomitant medications were not reported.  The patient experienced COVID-19 (medically significant) on 21Jul2021 with outcome of unknown. The patient started to feel symptomatic on 21Jul2021. The patient underwent lab tests and procedures which included COVID-19 virus test: positive on 22Jul2021.  The lot number for the vaccine, bnt162b2, was not provided and will be requested during follow-up.
red, hot, and itchy area around injection site- size of a grapefruit; red, hot, and itchy area around injection site- size of a grapefruit; red, hot, and itchy area around injection site- size of a grapefruit; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (red, hot, and itchy area around injection site- size of a grapefruit), VACCINATION SITE PRURITUS (red, hot, and itchy area around injection site- size of a grapefruit) and VACCINATION SITE ERYTHEMA (red, hot, and itchy area around injection site- size of a grapefruit) in an 88-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination.     No medical history was reported.  Concomitant products included DILTIAZEM for an unknown indication.   On 12-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 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 13-Mar-2021, the patient experienced VACCINATION SITE WARMTH (red, hot, and itchy area around injection site- size of a grapefruit), VACCINATION SITE PRURITUS (red, hot, and itchy area around injection site- size of a grapefruit) and VACCINATION SITE ERYTHEMA (red, hot, and itchy area around injection site- size of a grapefruit). On 20-Mar-2021, VACCINATION SITE WARMTH (red, hot, and itchy area around injection site- size of a grapefruit), VACCINATION SITE PRURITUS (red, hot, and itchy area around injection site- size of a grapefruit) and VACCINATION SITE ERYTHEMA (red, hot, and itchy area around injection site- size of a grapefruit) had resolved.            Treatment for events included ice. Action taken with mRNA-1273 in response to the event was not applicable.
I experienced high blood pressure reading and made an appointment with  my doctor one week later because it continued to be extremely high. He stated that my blood pressure swings erratically often and that he was not concerned because of my age and the foods, caffeine, and alcohol could have attributed to the elevation in blood pressure. He also asked me to continue tracking it and to contact him if I experienced any headaches, light headedness or if my blood pressure became too erratically high again.
Patch at the injection site that looks like sunburn; Soreness in the arm; A spontaneous report was received from a (Consumer) concerning a  76 Years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events (PT term) list.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On  22/Jan/2021 date or an unknown date, The patient experienced the events list (verbatims) Per voicemail received: 76-year-old female Caller received the Moderna vaccine on 13Jan2021, all I had was a "little soreness in the arm. As of this morning, 22Jan2021, "I have a patch at the site of the injection." "About 2X4 inches," that "looks like a sunburn." Caller stated, It's not bothering me, I just wanted to report that "I'm having apparently a reaction to the vaccine." ****************************** Patient left another voicemail responding to the callback attempted. Upon callback, patient confirmed information provided in voicemail that was originally made. The reaction lasted about two days and it's back to looking normal. She took no medications in regards to her reaction and has no other questions at this time. Consent given to Safety for follow-up. 25JAN2021  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.
Approx  6 hours post vaccine patient states she felt dizzy and  short of breath with chest tightness/heaviness.  EMS found her to be hypertensive with SBP greater than 200. Pt brought to ER, cardiac work up completed, Pt admitted for further observation
myocarditis; This is a spontaneous report from a Pfizer-sponsored program. No patient identifiers were provided but the reporter has firsthand knowledge of the patient and was reporting on a specific patient. A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiration date were not reported) via an unspecified route of administration on an unspecified date as dose number unknown, single for COVID-19 immunization. Medical history and concomitant medications were not reported. On an unspecified date, the patient experienced myocarditis. Reporter called in regards to CEO withheld and spreading misinformation on the covid-19 vaccine, and they are criminals. Also paid 2.3 billion in fraudulent marketing in 2009. Complaints of kids being killed from having the covid-19 vaccine and will not inject his children with chemicals. Also stated that we should be killed for doing that. States that he knows people that have died from the Pfizer covid-19 vaccine and has a friend that was treated for myocarditis after the vaccine. The outcome of the event was unknown.  This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
some chills; Feeling achy; different vaccine, gave second dose of Shingrix; second Shingrix 27 days after first dose; This case was reported by a physician via sales rep and described the occurrence of chills in a 74-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included RECOMBINANT VARICELLA ZOSTER VIRUS SURFACE GLYCOPROTEIN E (SHINGRIX).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix and an unknown time after receiving SHINGRIX, the patient experienced chills, pain, wrong vaccine administered and drug dose administration interval too short. On an unknown date, the outcome of the chills and pain were recovered/resolved and the outcome of the wrong vaccine administered and drug dose administration interval too short were unknown.   It was unknown if the reporter considered the chills and pain to be related to Shingrix.  Additional details provided were as follows: Age at vaccination was not reported. Patient received her second Shingrix vaccine 27 days after the first dose which led to shortening of vaccination schedule. A new nurse in the clinic and when the patient presented to the clinic for a different vaccine one week ago, the nurse gave her second dose of Shingrix early, which led to wrong vaccine administered. The patient had one night of some chills and feeling achy, but otherwise had no other problems with the vaccine given early. Follow-up would not be possible as no contact details available.
Fever; This case was reported by a consumer via call center representative and described the occurrence of fever in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 11th March 2020, the patient received the 2nd dose of Shingrix. In March 2020, less than a week after receiving Shingrix, the patient experienced fever. On an unknown date, the outcome of the fever was unknown.   It was unknown if the reporter considered the fever to be related to Shingrix.  Additional case details were reported ad follows: The age at vaccination was not reported. The caller disconnected the call, therefore limited information was provided.
pt states that her arm bled as she was getting the vax which caused it to bruise.  Next day she had a head ache and was light headed which this lasted a couple of days.  Now a couple of weeks later she has developed 2 x 3' red itchy rash just below the injection site and a slight spot just above it.  Pt will contact her PCP.
15FEB96 fever of 102 that evening along w/several episodes of sz-like activity;these lasted approx 20-30sec;MD stated there was nothing they could do, but to give APAP;mom video taped sz the next day & showed to MD;MD order CAT scan & EEG;
1 week after my injection I developed a approximate baseball size circle at my injection sight with mild warmth and tenderness and swelling. I had axillary lymph node swelling, neck muscle soreness, fatigue, and frontal and temporal headache. I still have a red circular area at my injection sight but it is gradually improving (4 days out from redness occurring). The symptoms seemed worse than the initial reaction the first few days after my injection. I am a health care provider and have taken photos daily but have not gone for an office visit at this time.
Pain; swelling in both hips; stiffness in both hips; lower back pain and stiffness; lower back pain and stiffness; This is a spontaneous report received from a contactable consumer, the patient. A 49-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6207) via unspecified route of administration, in the left arm on 17Mar2021 at 08:45 (at the age 49-year-old) as a single dose for COVID-19 immunisation. Medical history included coronary artery disease. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medication includes LIPITOR from an unknown start date and for an unknown indication. The facility where the most recent COVID-19 vaccine was administered was at pharmacy. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccination. On 18Mar2021 at 16:00, the patient experienced pain, swelling and stiffness in both hips with lower back pain and stiffness. The patient did not receive treatment for adverse events. The clinical outcome of the events pain, swelling in hips, stiffness in hips, lower back pain and back stiffness was not recovered.   No follow-up attempts are needed. No further information is expected.
9/24: SOB developed; 9/26: O2 saturation in 80s with wheezing noted on exam, prescribed PO steroids and albuterol; 9/27: Presented to ED with initial work-up significant for elevated D-dimer and troponin leak, suspicious for PE, admitted, started on Lovenox and HFNC while awaiting CTA; 9/29: Sudden left upper extremity pain/weakness with no pulses on doppler, left axillary artery thrombus identified, underwent emergent thrombectomy, underwent CTA and head CT confirming bilateral PE and identifying cerebellar stroke; remained intubated due to respiratory failure; started on heparin drip; 10/5: extubated; 10/14: discharged to short-term rehabiliation facility on Eliquis; 11/4: discharged home
On the second morning after the vaccine, I could feel a cold sore coming on. I get them maybe once a year or so, so I took a valcyclovir tablet (two 500mg tablets) as I always do, and it usually nips it in the bud. (I then usually take a single tablet for four more days to finish the course). This time, the infection continued to blossom and I had quite a bad cold sore on my upper lip for over a week, despite taking the normal course of valcyclovir. (The really odd thing is that my best friend had the Pfizer vaccine a couple of months before I had my shot, and the EXACT SAME THING happened to her! She is also prone to herpes cold sore infections like me, and hers broke out at exactly the same time post-vaccination, despite taking the valcyclovir once it started.) Very strange.
Pt received vaccine in am on 5/13. Pt called back that afternoon to report N/V. Pt was also taking MACROBID. PCP spoke to pt & was advised to d/c MACROBID & switch to CIPRO.
Pt c/o nausea BP 133/91, HR 71, RR 18.  Pt stable and released from vaccination site.
Expired Boostrix administered; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 11-year-old female patient who received DTPa (Reduced antigen) (Boostrix) (batch number BR352, expiry date 27th August 2022) for prophylaxis.   On 29th August 2022, the patient received Boostrix. On 29th August 2022, unknown after receiving Boostrix, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 29-AUG-2022 Reporter's comment: Nurse reported a patient received a dose of Boostrix that had expired on 27th August 2022. The reporter consented to follow-up. Additional Supportive Information:  The patient received a dose of Boostrix which was already expired, which led to expired vaccine used.
"Chills and aches" the day and evening of the shot.  After a couple of weeks, Pt began to experience various pains at different points of his body.  He developed severe indigestion resulting in him visiting his physician on April 19th where he was put on a 7-day steroid regimen.  One week later, early on Monday morning, April 26, 2021, Pt collapsed in his bathroom at home, was unresponsive, and pronounced dead by the paramedics who responded.
Patient presented to the pharmacy to receive the shingles vaccination.  Pharmacist verified patient demographics, completed paperwork/pre-work for the shingles vaccination.  Patient completed their portion of the Vaccine Administration Record.  Pharmacist completed the pharmacy's portion of the VAR for the Covid-19 vaccination.  Patient was taken into vaccination area by the pharmacist and dispensed the Covid-19 vaccination.  Patient was not dispensed the shingles vaccination.  Patient experienced no immediate symptoms/reactions.  This was the patient's 3rd Covid-19 vaccination.  Patient was not authorized for it under the current guidelines.
Client called and c/o of pain on left side of body. She is being f/u with her doctor.
Balance issues; nauseau; alterations to sense of smell; inability to focus; constant feeling needing to urinate/ inability to feel when I need to urinate; headache; joint pain; exhaustion; muscle aches; This is a spontaneous report from a contactable consumer or other non hcp.     A 39-years-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) , dose 1 via an unspecified route of administration, administered in Arm Left on 24Feb2021 at 13:00 (Batch/Lot Number: EN6198) as single dose for covid-19 immunisation.  Relevant medical history was not reported. Concomitant medications included probiotics and ascorbic acid, betacarotene, calcium sulfate, colecalciferol, cyanocobalamin, ferrous fumarate, folic acid, nicotinamide, pyridoxine hydrochloride, retinol acetate, riboflavin, thiamine mononitrate, tocopheryl acetate, zinc oxide (PRENATAL VITAMINS [ASCORBIC ACID;BETACAROTENE;CALCIUM SULFATE;COLECALCIFEROL;CYANOCOBALAMIN;FERROUS FUMARATE;FOLIC ACID;NICOTINAMIDE;PYRIDOXINE HYDROCHLORIDE;RETINOL ACETATE;RIBOFLAVIN;THIAMINE MONONITRATE;TOCOPHERYL ACETATE;ZINC OXIDE]).  The patient previously took gluten and experienced drug hypersensitivity.  On 24Feb2021 the patient experienced balance issues  nausea, alterations to sense of smell, inability to focus, constant feeling needing to urinate/ inability to feel when I need to urinate, headache, joint pain, exhaustion, muscle aches, all with outcome of not recovered.  Therapeutic measures were taken as a result of events.   No follow-up attempts are possible; no further information is expected.
fluzone qiv pfs due to age 13 months. doses were given 3 weeks apart instead of 4 weeks apart with no reported adverse event; Initial information received on 06-Nov-2023 regarding an unsolicited valid non-serious case received from other health professional.  This case involves a 13-month-old male patient who was given influenza quadrival A-B vaccine [Fluzone QIV]; 3 weeks apart instead of 4 weeks apart with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 03-Oct-2023, the patient received unknown Dose 1 of suspect influenza quadrival A-B vaccine, Suspension for injection (Batch number: UT8040NA; Expiry date: 30-Jun-2024) and then on 24-Oct-2023 he again received unknown Dose 2 of the same vaccine (Batch number: UT8134MA; expiry date: 30-Jun-2024) via unknown route in unknown administration site for Immunization; doses were given 3 weeks apart instead of 4 weeks apart with no reported adverse event (inappropriate schedule of product administration) (same day latency).  Reportedly, Pt needed a 2 dose series of FLUZONE QIV PFS due to age 13 months. Doses were given 3 weeks apart instead of 4 weeks apart.  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 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.
rigors, body aches, nausea, vomiting once and headache/ migraine
This spontaneous case reported by a patient's family member/friend, describes the occurrence of pyrexia (fever), chills, arthralgia (joint pain), myalgia (muscle pain) and headache in a 26-year-old male patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch/lot# 037C21A) for COVID-19 immunization. No medical history reported. On Jul 15, 2021, patient received the second dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On an unknown date, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On Jul 16, 2021, patient experienced pyrexia (fever), chills, arthralgia (joint pain), myalgia (muscle pain) and headache. At the time of the report, pyrexia (fever), chills, arthralgia (joint pain), myalgia (muscle pain) and headache) outcome: unknown. No concomitant medication or treatment information provided.
A bruise developed after injection and lasted a few days. A rash developed at sight and half way down to elbow the day after injection and lasted 7 day. Now she has painful light bruise with a slight red ring around (not circular in form). The area is very warm and tender to the touch. I advised to monitor for worsening symptoms as it may be infection.
This spontaneous report as received from a licensed practical nurse refers to a 17 weeks old female infant. On 29-NOV-2012, the patient (reported as preterm infant) was vaccinated with dose 1 ROTATEQ (lot number was reported as 0208AE, expiry date, dose and route were not reported) at the age of 17 weeks. No concomitant medications were reported. No adverse effects reported. It was unspecified if the patient had sought medical attention. Additional information has been requested.
loss of appetite; extreme fatigue; This is a spontaneous report received from a contactable consumer from medical information team for a Pfizer sponsored program. The reporter is the patient.  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as 1st dose, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DECREASED APPETITE (non-serious), outcome "unknown", described as "loss of appetite"; FATIGUE (non-serious), outcome "unknown", described as "extreme fatigue".  Additional information: The patient stated that he experienced loss of appetite and extreme fatigue after the first dose of the Pfizer covid vaccine. The patient wanted to know if it was ok to take the second dose due on 01Apr. He did not have any respiratory problems. The patient considered the report as non-serious.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Administered vaccines in box # 13, after administered pt experienced syncopal episode. Pt was in sitting position at the time & laid down, supine position, with legs elevated. Pt symptoms fully resolved after 10 min. After 15 min pt assisted to standing position. Pt left fine. After pt was assisted to standing position, left office in good condition.