chrisvoncsefalvay/vaers-outcomes huggingface dataset:
sore upper right arm with limited mobility with pain about 4 hours after the vaccination and lasting 48 hours - body/joint aches starting around 24 hours after vaccination - low grade fever 99.3 starting at 24 hours after vaccination - lethargic  the afternoon the day after vaccination- took to ibuprofen 9:30 pm and symptoms were gone the next morning.
Feeling inner ear pressure/ feeling clogged, which is now ringing in both my ears.
Face red around nose and mouth; I'm cold; Feel like lots of pins pricking me; This is a spontaneous report received from contactable consumer (patient). This 57-year-old non-pregnant female patient received a dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number unknown) via an unspecified route of administration in the right arm on 26Mar2021 at 11:15 (at the age of 57-years-old) as a single dose for COVID-19 immunisation. Medical history included allergy from an unknown date and unknown if ongoing. Prior to vaccination the patient was not diagnosed with COVID-19 and had not received any other vaccines in the 4 weeks prior to the COVID vaccine. Concomitant medications included melatonin, cetirizine hydrochloride (ZYRTEC), and naproxen sodium (ALEVE), all from unknown dates for unknown indications. The patient reported that 48 hours after the shot, she experienced face red around nose and mouth. She took diphenhydramine hydrochloride (BENADRYL) and was feeling better, although she reported she was cold and felt like lots of pins were pricking her. It was reported that no treatment was received for the events. The clinical outcome of face red around nose and mouth was recovering; the outcomes of I'm cold and feel like lots of pins pricking me were unknown. It was also reported that since vaccination the patient had not been tested for COVID-19.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
pt recvd vax 1SEP95;pt's mom described fussiness over the next 5-7 days;no change in cry but persistent fussiness & fever (temp not taken)
Pt began screaming about 4 hrs p/inject & continued from late afternoon throughout the night, also ran t013;
administered expired vaccine to patients, after the manufacture date of expiration; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered expired vaccine to patients, after the manufacture date of expiration) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered expired vaccine to patients, after the manufacture date of expiration). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administered expired vaccine to patients, after the manufacture date of expiration) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant products were not provided. It was reported that the vial did not undergo temperature excursion and it was unknown when the vial was initially stored in the refrigerator Treatment medications were not reported.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2022: Follow up received contains Non significant information.
left upper arm 16cm x 10cm erythematous, edematous area. Warmth, mild induration to injection site.
Red patch; red circle appeared around the injection site; It is itchy; barely hurts.; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of INJECTION SITE ERYTHEMA (Red patch), INJECTION SITE ERYTHEMA (red circle appeared around the injection site), VACCINATION SITE PRURITUS (It is itchy) and VACCINATION SITE PAIN (barely hurts.) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     Concurrent medical conditions included Cholesterol on 07-Feb-2021 and Asthma on 07-Feb-2021. Concomitant products included SALBUTAMOL SULFATE (INHALERIN) for Asthma, PHYTOSTEROLS NOS (CHOLESTROL MANAGER) for Cholesterol.    On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Feb-2021, the patient experienced INJECTION SITE ERYTHEMA (Red patch), INJECTION SITE ERYTHEMA (red circle appeared around the injection site), VACCINATION SITE PRURITUS (It is itchy) and VACCINATION SITE PAIN (barely hurts.). At the time of the report, INJECTION SITE ERYTHEMA (Red patch), INJECTION SITE ERYTHEMA (red circle appeared around the injection site), VACCINATION SITE PRURITUS (It is itchy) and VACCINATION SITE PAIN (barely hurts.) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment medications were not provided by reporter.
This is a spontaneous report received from a contactable consumer or other non-HCP, program ID: (005570). The reporter is the patient. A patient (no qualifiers provided) received the 2nd dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# EE0169), on May 4, 2021, single dose, for COVID-19 immunization. Medical history and concomitant medications not reported. Vaccination history included the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# EW0162), on Apr 13, 2021, for COVID-19 immunization, reaction: "I completely lost my sense of taste and smell." The patient experienced ageusia and anosmia; onset 2021, with outcome of not recovered. Patient described: "My sense of smell and taste has never returned in any normal or consistent capacity." Sender's comments: Linked report: US-PFIZER INC-202200926529 (same reporter/patient, different drug, similar event); US-PFIZER INC-PV202200016058 (same reporter/patient, different drug, similar event).
First vaccine was administered on 3/27/2021 in my left arm lot # EP6955. I experienced a sore arm and fatigue. On 4/4/2021 I began feeling ill with full body aches, fever (between 101-103), chills, sweating, sore throat, mild headache. On 4/5/2021 I wested tested for COVID 19, Flu A&B, and Strep throat. I tested positive for both Strep throat an COVID 19. I was given azithromycin for the strep and took Tylenol to lower the fever. My symptoms lasted till 4/8/2021. After that I was just very fatigued and nausea came and went. under the strong recommendation of my PCP, I then received my second dose of the Pfizer vaccine on 4/17/2021. Approximately 8 hours after the vaccine I suddenly felt ill. I was dizzy, nauseous and felt like I was going to faint. I experienced chills and was shaking uncontrollably for approximately 30 minutes. I vomited once, took Tylenol and went to bed. Throughout the night I felt mild chills, body aches and moderate nausea. I got up at 7am on 4/18/2021 with had a migraine headache (a sharp pain behind my life eye that went straight through to the base of my skull. I spent the day taking Tylenol and relaxing on the couch. At approximately 6pm I began itching. a few little dots showed up on my neck and leg. An hour later my legs, arms and neck had many very itchy red spots. I took a Benedryl and went to bed at 8pm. I woke up at 2am 4/19/2021 completely covered with itchy red spots (arms, legs, torso, neck, genitals, scalp, butt, face). I took more Benadryl and went back to sleep. The rash was extremely itchy and seemed to keep spreading. I went to my PCP at 8:45am and she prescribed Prednisone. Throughout the day the rash continued itch and my left eye, both ears,  bottom  lip, and knees began to swell. I spoke with a nurse over the phone who said to continue with the prednisone and Benadryl. On 4/20/2021, I woke up and the rash is not as pronounced or as itchy but still visible and still pretty itchy. Both my lips, left eye and both ears are still very swollen.
Few days after the vaccine I started feeling skin tremors in my lower leg on the left side. The tremors felt like I was sitting on my cell phone on vibrate. They seemed to be in sync with my heart beat. They lasted over a week, then went away. Later I noticed in the same location of the tremors there were some blood blisters. None of this was painful.
Subsequent to receiving Tetanus and Diphtheria Toxoids Adsorbed Purogenated pt developed an injection site reaction on week post vax.
Received Influenza vaccine 11/15/05. Reports that next day 11/16/06, redness, swelling and burning pain at site of injection and "itchy rash" on abdomen, scalp times 3 days. Saw PCP on 11/17/06 who RX antihistamine and Ibuprofen. No redness or swelling observed on 11/20/06. Subjection reports of decreased pain by 11/27/06.
(R) axillary nerve pain, sharp pain (R) arm, pain & tingling (R) thumb.
first dose years ago, second dose not received; This case was reported by a physician and described the occurrence of incomplete course of vaccination in a 69-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st Shingrix dose at pharmacy 4 years ago).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. At the time of the reporting, it was unknown if the patient received the second dose, which led to incomplete course of vaccination. The reporter was inquiring about administering 2nd dose of Shingrix to patient or restarting series. The reporter consented to follow up. No additional details were available from reporter.
Patient complained of high temperature, greater than 102 degrees with knot at injection site.  Mom voices high fussiness.  This is second time child has had high temperature with increased fussiness upon receiving Prevnar.
I felt weak and anxious, pulse was high. Home blood pressure monitor showed high blood pressure and pulse of 98. I called for an ambulance. EMT person measured blood pressure to be Systolic-195 Diastolic-95. EMT person advised me that the hospital is filled and I will wait there many hours to be examined by an MD. I decided to stay home and take an extra Amlodipine tablet, and sleep aid pill "Relaxium". EMT stayed and observed me while my blood pressure decreased to a safe level. EMT advised me to buy a new blood pressure device for accuracy. MD advised me to not take many BP readings one after another and to relax, and increased my Amlodipine daily dosage.
Frontal headache "head pounding" chest tightness and some shortness of breath (although speaking normally) and "feeling cold" - visibly shivering. vs normal P-76-R-16 PERRLA, Lungs CTA bilat, no wheezing or & breath sounds, heart RRR, No rash to fore, neck, arm, chest.
PENTACEL was given 3 days post expiration, with no reported adverse event; Initial information was received on 28-Apr-2021 regarding an unsolicited valid non-serious case from a nurse.  This case involves an unknown age and gender patient who was given DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (lot number- UJ160AAA, expiry date-24-Apr-2021) via an unknown route in unknown administration site for prophylactic vaccination, 3 days post expiration on 27-Apr-2021, with no reported adverse event while receiving vaccine.  Medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided.  It was case of an actual medication error due to expired vaccine used (latency: same day).  At the time of report, 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 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.
Had a few cold like symptoms directly after but something more serious has recently happened that may or may not be related. Husband was just diagnosed with Myleodysplastic syndrome with no known cause or why it came on suddenly.
On 5/16/2021, I developed canker sores at the back of my mouth.  I'd never had them before.  I tried treating them on my own but ended up calling the doctor's office 5/20/21 for advice.  I was told to apply Campho Phenique to the sores and they resolved after about a week and a half. During the first week in July, I noticed I'd lost  all of the old growth on the sides of my head, near the front.  I've had alopecia for a little over 2 years due to stress but the hair was growing back.  The new growth on the top of the head was unaffected.  I will be seeing my dermatologist this week for this.
Headache; Ear aches; Muscle pain; Skin sensitive to the touch; Sore throat; Malaise; This is a spontaneous report from a contactable consumer, the patient. A 33-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3302) via an unspecified route of administration in the left arm on 08May2021 at 14:30 at the age of 33-years-old as a single dose for COVID-19 immunisation. Medical history included asthma, COVID-19 and penicillin allergy. Prior to the vaccination, the patient was diagnosed with COVID-19. Concomitant medications included XYZAL, SINGULAIR, WELLBUTRIN, VENTOLIN, and WIXELA, all for unknown indication from an unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient previously took AMOXICIILIN, LEVOQUIN, DOXYCYCLINE, PERCOCET, and experienced drug allergy. The patient previously received the first dose of dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8731) via an unspecified route of administration in the left arm on 17Apr2021 at 14:30 at the age of 33-years-old as a single dose for COVID-19 immunisation. On 09May2021 at 06:00, the patient experienced headache, ear aches, muscle pain, skin sensitive to the touch, sore throat, and malaise. Therapeutic measures were not taken as a result of the events. The events did not result in doctor or other healthcare professional office or clinic visit and emergency room or department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events headache, ear aches, muscle pain, skin sensitive to the touch, sore throat, and malaise was resolving at the time of this report.   No follow-up attempts are needed. No further information is expected.
3 days later I noticed a red circle. Over the next couple of days it grew and I went to urgent. My whole body began to itch
DRUG INDUCED POLYNEUROPATHY 3/27/2022 WEAKNESS  DRUG INDUCED POLYNEUROPATHY 3/27/2022 BILAT PNEUMONIA  DRUG INDUCED POLYNEUROPATHY 3/27/2022 CANCER METASTATIC TO BONE  DRUG INDUCED POLYNEUROPATHY 3/27/2022 METABOLIC ENCEPHALOPATHY
fever; Body aches; tired; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever), MYALGIA (Body aches) and FATIGUE (tired) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Weight loss. Concurrent medical conditions included Relapsing-remitting multiple sclerosis, Energy decreased, Juvenile myoclonic epilepsy, Urinary tract infection NOS, Incontinence and Postmenopausal depression. Concomitant products included RITUXIMAB (RITUXAN), OCRELIZUMAB (OCREVUS), MODAFINIL, LEVETIRACETAM DIHYDROCHLORIDE (KEPPRA [LEVETIRACETAM DIHYDROCHLORIDE]), LAMOTRIGINE, METHENAMINE, TAMSULOSIN, MIRABEGRON (MYRBETRIQ), ESTROGENS CONJUGATED, MEDROXYPROGESTERONE ACETATE (PREMPRO) and ESCITALOPRAM OXALATE for an unknown indication.    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PYREXIA (fever), MYALGIA (Body aches) and FATIGUE (tired). At the time of the report, PYREXIA (fever), MYALGIA (Body aches) and FATIGUE (tired) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Neutralising antibodies: negative (Negative) Negative.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 21-Jul-2021: Significant follow-up (vaccination date and event outcome)
Myalgia, Arthralgia, Fever, injection site pain and swelling  Narrative:
Patient was vomiting. Patient was given (2) ondansetron orally disintegrating tablets, USP 4mg.
Tingling in hands 1 wk after; Day 10 after vaccine body aches, weakness, Day 14 she had inability to walk and total loss of motor control in hands.
She states her Left arm has started swelling and is red; She states her Left arm has started swelling and is red; This is a spontaneous report received from a contactable consumer (patient herself). A female patient of an unspecified age received both doses of the BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection (Batch/Lot number was not reported)  via an unspecified route of administration, administered in the left arm on the 05Apr2021 and 26Apr2021 as single dose for COVID-19 immunization. Medical history included history of surgeries in her left arm on unknown dates. The patient's concomitant medications were not reported. Clinical course reported as: She stated that her Left arm started swelling and was red.  She has a history of surgeries in her left arm and has had 4 total bouts of melanoma on her left side: 1 in the left leg, 2 in her arm, and 1 on her left back. Lymph nodes for both arms are gone due to being removed. She doesn't know if she should be placing an ice pack on the arm to help with inflammation and redness or if it will interfere with the vaccine. The Health Department where she got the vaccine advised her to call Pfizer. The outcome of events was unknown.    No follow-up attempts are needed. No further information is expected.
pt recv vax 11AUG97 & 12AUG97 mom reported pt very tired w/sore red arm;eval same day;lt arm w/2" erythematous;
Immediate swelling of injection area upon administration. Swelling was very hard, felt like a lump. Didn't come down for 45 minutes. Small bump.
Initial information received on 12-Mar-2019 regarding an unsolicited valid non-serious case received from a physician. This case involves a greater than 50 years old patient (gender unknown) who received a dose of IPOL batch number: N1J451M via intradermal route in the arm on an unknown date instead of TUBERSOL. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was an actual medication error due to wrong vaccine administered and inappropriate route of vaccination. A greater than 50 years old patient received IPOL instead of receiving a TUBERSOL in arm intradermally. No side effects were known at this time. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders 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. List of documents held by sender: none.
The covid vaccine made a penis grow out of my forehead. My doctor says this happens all the time with these vaccinations.
administered an expired dose of ACT-HIB to a patient, with no reported adverse event; Initial information received on 15-Aug-2023 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 4 years old male patient who was administered an expired dose of HIB (PRP/T) VACCINE [ACT-HIB] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 14-Aug-2023, the patient received a dose 4 dose 0.5 ml of suspect HIB (PRP/T) vaccine Powder and solvent for solution for injection (strength unknown) lot UJ796AA expiry date: 12-Aug-2023 via intramuscular route in the left thigh for Immunization.  On 14-AUG-2023 patient was administered an expired dose of act-hib to a patient, with no reported adverse event (expired product administered) on the same day following the administration of HIB (PRP/T) VACCINE.  Action taken was not applicable.  At time of reporting, the outcome was Unknown for the event administered an expired dose of act-hib to a patient, with no reported 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 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.
LEFT HIP PAIN TRAVELING DOWN LEG.  RIGHT SHOULDER PAIN-NUMBNESS.  GENERAL OVERALL BODY/JOINT PAIN .
This patient was inadvertently administered an adult dose of havrix instead of the pediatric dose, so essentially got a double dose of vaccine.  The vaccine he received had expired on 12/15/22 so a week prior to administration.  The patient was examined by me.  Advised Mom of the erroneous administration of the vaccine and things to look out for.  The morning after vaccine received, parent reported a purple blister on the toe and a red line going from injection site to the toe.  Also reported fever and abdominal pain.  On call provider recommended ED eval.  Obviously current symptoms may be unrelated.
itchiness/redness/heat at site of injection  Benadryl 25mg po given     Heatredness remains, itchiness resolved post one hour