chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient received vaccination on 10/11/2021 at approximately 6:35pm at our pharmacy. Noting reported at that time. On 11/03/2021 the patient came to the pharmacy to let us know her vaccine was given too high on her arm and it did cause pain/injury. She was reluctant to give her name/DOB because she did not want to get anyone in trouble or fired. I assured her that we would not do that, we just want to prevent any further issues. She then gave me her information. She said she was not upset or mad, just wanted to let us know. She said she was feeling better but did undergo physical therapy and some pain medications.
Moderna COVID-19 EUA. Severe headache, chills, nausea, dizziness, shortness of breath, and rash where I was injected
Cellulitis at site of immunization and beyond the next day after immunization given.  Pt treated with Augmentin.
Diarrhea; This is a spontaneous report from a contactable consumer, the patient. A 60-year-old male patient received first single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot number: EP6955), via an unspecified route of administration on the left arm on 15Mar2021 at 14:00 (at the age of 60-year-old) for COVID-19 immunization. Medical history and concomitant medications were not reported. He has no allergies to medications, food or other products. Furthermore, he has not received any other vaccine four weeks prior to COVID-19 vaccine neither was not diagnosed with COVID-19 prior to vaccination. On 15Mar2021 at 18:45, he experienced diarrhea. Since the vaccination, the patient had not been tested for COVID-19. No therapeutic measures were taken to treat this event. The clinical outcome of the diarrhea was not recovered at the time of this report. No follow-up attempts are needed. No further information is expected.
Vascular insufficiency, significant flushing with prolonged blanching with pressure test (thumb pressure.) Started 3 hours after 2nd dose.
Dizziness every 5 -15 minutes, brain fog, nausea, headache all since injection
received a 3rd dose of Shingrix; This case was reported by a pharmacist via call center representative and described the occurrence of extra dose administered in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on an unknown date) and Shingrix (received 2nd dose on an unknown date).   On an unknown date, the patient received the 3rd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown.  Additional details were provided as follows: The age at vccination was not reported. The patient received 3rd dose of Shingrix at the pharmacy, which led to extra dose administered. The reporter wanted to know what to tell her patient. The pharmacist was unable to provide any of the patient demographic information or the answers to the content questions for the Shingrix vaccine adverse event at the time of the call due to the fact that the vaccine was given to the patient at a different chain pharmacy. The consent to follow up was unknown as the reporter did not asked for consent to follow up with patient's health care professional.
Pt had allergic reaction to vaccine the next day of receiving vaccine but didn't report us (or) doctor until after 11 days. Doc gave him Rx for MEDROL DOSE PAK.
squamous cell carcinoma 8 days after 3 inches below site. Required surgery to remove but did not require MOHS
Dose administered after 30 day beyond use date/administered an expired vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after 30 day beyond use date/administered an expired vaccine) in an adult female patient who received mRNA-1273 (Spikevax) (batch no. 045L21A) for COVID-19 prophylaxis.     Concurrent medical conditions included Hypertension, Nervous system disorder NOS (Nerve condition) and Drug allergy (Aspirin). Concomitant products included HYDROCHLOROTHIAZIDE, LOSARTAN POTASSIUM (HYZAAR) for Hypertension, GABAPENTIN for Nervous system disorder NOS.    On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after 30 day beyond use date/administered an expired vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered after 30 day beyond use date/administered an expired vaccine) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   Height and weight was unknown. It was reported that they put on the ready to use sticker and had to go back from 01-Jul-2022 through 05-Jul-2022 and found one more patient to add to their case apart from the initial 2 patients. Treatment information was not provided.
COVID-19 infection positive; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19 infection positive) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced COVID-19 (COVID-19 infection positive). At the time of the report, COVID-19 (COVID-19 infection positive) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, COVID-19: (Positive) positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication details were not provided. Treatment details were not provided. Husband got dose first dose on 15Mar2021. Tested positive for COVID recently.
Injection site was painful to the touch, hot, hard, and red. The redness swelled into a 3? area. After two weeks, the redness subsided, but there is still a hard ?knot? at the injection site, and it continues to be hard and painful if pushed.
This is in follow-up to report(s) previously submitted on 7/16/2007. Information has been received from a physician, concerning a 13 year old, female student, with no known drug or food allergies, who on 14-JUN-2007 was vaccinated IM, with the first dose of GARDASIL (Lot #657617/0384U). There was no concomitant medication. On 21-JUN-2007 (previously reported as 15-JUN-2007), the patient developed a generalized, red, raised, pruritic rash. Treatment included BENADRYL. Subsequently, the patient recovered from the rash (date of recovery unspecified). No further information is expected.
vaccine was administered 13 days expired with no reported adverse event; Initial information was received on 18-May-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves an unknown age and gender patient to whom diphtheria/tetanus/5 hybrid ac pertussis/ipv(vero)/hib(prp/t) vaccine [Pentacel (VERO)] was administered 13 days expired with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 17-May-2023, the patient received an unknown dose of suspect diphtheria/tetanus/5 hybrid ac pertussis/ipv(vero)/hib(prp/t) vaccine Suspension for injection (lot UJ662AA, expiry date: 04-May-2023), strength, was unknown) via unknown route in unknown administration site for Immunization.  On 17-May-2023 the patient was administered 13 days expired with no reported adverse event (expired product administered) (latency: same day) following the administration of diphtheria/tetanus/5 hybrid ac pertussis/ipv(vero)/hib(prp/t) vaccine.  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the 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.
MMR given 10-15-12: fever up increased 102 degrees onset 10/15/12 rash extensive from ears across body, fussy, crying, rash appeared 10/15/12 on (R) side of body, face, torso, then improved 45 minutes after vaccine. 10/25/12 mom states fever 102 last noc no fever this AM rash gone.
Severe 9/10 scale symptoms Migraine like headache,  photophobia . Muscle aches, Most severe for first 18 hrs. 36 hrs duration. Skin was hypersensitive to touch,painful. 24 hrs duration  Fever 101.5   -  103.2 .   Didnt take any meds to reduce fever or above symptoms.  Fatigue.  No energy for anything other than getting up to the bathroom.  Slept off and on for 36 hrs.. Brain fog!! Still have it after 4 days,and moderate fatigue.
extremely nauseated; my eyes kind of crossed; Well after the shot I could barely even walk from the first tent to the second tent; UTI; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (patient) reported that a 69-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date not provided), via an unspecified route of administration on 20Jan2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The reported stated she receive the first dose of the COVID-19 vaccine on Wednesday 20Jan2021 and she had a "strange" reaction on 20Jan2021. Specifically, she states, "as soon as she pushed it in, I became extremely nauseated, my eyes kind of crossed and I had to sit in my car for 4 hours afterwards because I couldn't drive. They had 2 tents set up. Tent 2 was for people who had previous reactions or allergies and tent 1 was for people who had no reactions. Well after the shot I could barely even walk from the first tent to the second tent I stayed there for 45 minutes and then I could barely even walk to my car." Caller wants to know if she should get the second dose of the vaccine. She was started on the antibiotic sulfamethoxazole;trimethoprim (BACTRIM) on 22Jan2021 for a UTI which started after receiving first dose of COVID-19 vaccine in Jan2021. She would like to know if it is okay to use this medication since she just received the vaccine. She reported that she submitted her urinalysis the same day that she received the vaccine on 20Jan2021. The patient underwent lab tests and procedures which included urinalysis: with unknown results on 20Jan2021. Therapeutic measures were taken as a result of UTI. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Patient received Moderna vaccination on 2/8/21 and 3/12/21 to become fully vaccinated. Patient tested positive for COVID19 on 9/7/21 and was admitted 9/15/21. Patient is still currently admitted for treatment.
A few hours after receiving the vaccine, I developed fevers lasting until 3 days as high as 104.7, self-care of Tylenol and Iced towels. I started seeing spots/ floaters in my left eye. I made an appt the following day and was advised I had 3 hemorrhages in my left eye, the spots/floaters are still there. Fatigue, full body pain, vomiting lasted one day, the day after the vaccine, dizziness and Tenderness in left arm where the vaccine was given, still slight pain 3 weeks later.
Mild fever; Slight headache; This is a spontaneous report from a contactable consumer (patient). A female  patient of an unspecified age received a first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Unknown, Batch/Lot number: Unknown), via unknown route of administration on 20Mar2021 as a SINGLE DOSE for covid-19 immunization at other. It is unknown whether the patient was pregnant at the time of vaccination. The patient's medical history and concomitant medications were not reported. It is unknown whether, patient receive any other vaccines within 4 weeks prior to the COVID vaccine or if the patient diagnosed with COVID-19 prior to the vaccination. On an unspecified date, patient experienced Mild fever and slight headache. It is unknown whether any treatment received for the adverse event. Also, it is unspecified since the vaccination, if the patient been tested for COVID-19. Outcome of both the events were unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Swelling,hives & pain around njection site (COVID Arm)/ nausea/dull headache/upset stomach
About 24 hrs after receiving vaccine (R) upper arm became swollen, warm, red, and itchy. It continued to progress and pt returned to MD to evaluated on 8-1-09.  Area of redness measured 5x3 inches. Pt was started on BACTRIM for potential secondary cellulitis.
delerium; Severe myalgia; full body rash; swollen legs; facial swelling; slurred speech; stomach pain and cramping; nausea; headache; injection for vaccine received same date; injection for vaccine received same date; injection for vaccine received same date; This is a spontaneous report from a contactable consumer (patient). A 16-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose via an unspecified route of administration, administered in left arm on 15Apr2021 (Lot Number: EP7533, at the age of 16-year-old) as single dose, and second dose via an unspecified route of administration, administered in right arm on 15Apr2021 (Lot Number: EW0171, at the age of 16-year-old) as single dose for covid-19 immunization. Medical history included post streptococcal reactive arthritis and bee sting allergy. The patient's concomitant medications were not reported. On 16Apr2021, the patient experienced severe myalgia, full body rash, swollen legs, facial swelling, slurred speech, delerium, stomach pain and cramping, nausea, headache. Headache and stomach pain have lasted 7 days. Rash and myalgia lasted 5 days. Delerium, facial swelling, leg swelling and slurred speech lasted 12-24 hours and were relieved by Benedryl. The treatment for the event included Ibuprofen, Acetaminophen, diphenhydramine. The injection for vaccine received same date on 15Apr2021. Prior to vaccination, the patient was not diagnosed with COVID-19. 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 vaccine. The patient did not receive any other medications within 2 weeks of vaccination. The patient was not pregnant. The outcome of the events severe myalgia and full body rash was recovered on 21Apr2021, for events stomach pain and cramping and headache was recovered on 23Apr2021, for other events delirium, swollen legs, facial swelling, slurred speech, nausea was recovering.
pt recv vax 1996 & approx 5min p/vax pt devel a wheal size of a nickel;a cool compress was applied to the wheal;w/in 5min the wheal had disappeared;pt recovered from exp;
Patient temp was elevated to 100.1. Injection area was reddened and swollen to the size of an orange. This lasted all of Saturday and Sunday. She started to take Benadryl, but did not help. She presented to the clinic today. Examining doctor advised her to use ice on affected area, and to take Tylenol for the discomfort.
Dog bite happened on May 16, 2010. Tetanus shot given May 19. Skin allergies appeared. I had self medication (BENADRYL syrup for children and tablet. Allergies were on and off. I asked help from clinic and advised me to get medical attention from medical center.
I developed a C. difficil infection in April 2021. I've had C. diff recurrences for five years of our so and do not think it was related to the Covid-19 vaccine.
This is a spontaneous report from a contactable physician via a Pfizer sales representative. A 70-year-old female patient received PREVNAR 13, intramuscular on 01Oct2018 at 0.5 ml, single dose for pneumococcal pneumonia prevention. Medical history and concomitant medications were reported as none. On 01Oct2018 the patient experienced swollen arm and arm red in color. The reporter was not sure if the patient received any treatment for the adverse events. The outcome of events was unknown. Information on the batch number has been requested.
The patient received his first dose of Covid vaccination on Saturday 3/27/2021 (at 1:48pm)  and called the pharmacy back around 4:30 to report swelling and numbness  on the right side of face.  The pharmacist on duty instructed him to go to the nearest emergency room.
Pt. called on 03/11/2016 and complained of pain and redness around the injection site, but it was not itchy. The pt. was advised to seek medical attention if the redness doesn't go away.
Developed hives on body one day after receiving Hib and Prevnar.  Whole family ill with viral illness.  Denied respiratory distress/fever.  Given Benadryl 1/2 tsp by mouth every 6 hours as needed.  Spoke with mom next day - did better - rash free all day.  Developed hives again that night.  Offered office visit - did not take.  Suspect hives due to viral illness, but timed just after immuniztions.  Also had new foods on day of hives developing.
This spontaneous report as received from a medical assistant refers to multiple patients of unknown age and gender. The patients' medical history, current conditions and concomitant medications were unknown. On unknown dates, the patients were vaccinated with improperly stored GARDASIL 9 (dose, route, lot number and expiry date were not reported) for prophylaxis. The reporter did not have any information about the excursion details. No adverse events were reported. There was no product quality complaint involved. This is one of the several reports from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1612USA009619: US-009507513-1612USA009620: US-009507513-1612USA009621.
First symptoms: nausea and tingles/prickling feeling across entire body. Second symptoms: intense/severe upper back pain that spread to chest/diaphragm area.
On 01/16/2023 I received my Covid-19 vaccine. On 02/05/2023 in the afternoon I noticed an aching discomfort under my left arm which continued to get worse through out the night. the next day the pain continued and started to spread toward my back and the pain continued throughout the day continuing to my spine then to my left breast. The pain was aching as well as burning. I would feel sharp pain shooting out toward my back and front. After reaching out to the doctor I was told to put warm compress and take my VALTREX. Symptoms are ongoing.
I did not feel well almost right away, but decided to go home and rest. I been having severe headaches, achy arm for two days, body aches/joints aches for three days, sore throat, fatigue, achy skin, ears hurt/ached, warm temp (low grade 99.5ish, some chills, eyes were watery, became very sensitive to light - any exposure to sun/light brings on more of a headache or worsens headache, my eyes feel like they are "bugging out." The symptoms have been consistent across the last week.  Early in the week I became restless at night/not sleeping well, ansty/racy, out of my skin, dizzy, and loopy feeling. Then sore throat increased Tuesday and it became uncomfortable to swallow. I could feel sensations down my throat, sternum and across my chest. I had an overall tightness with subtle itch. My tongue started to ache with a bad taste in mouth, burning mouth syndrome like, along with red dots all over my tongue and clustered more heavily on the front/sides. I also had other mouth sores come and go all week. My left ear had some ringing a handful of times and occasional hot ears the last couple days.
This spontaneous report as received from a medical assistant refers to 11 year old patient of unknown gender. On an unknown date in April 2014, between 12-APR-2014 and 24-APR-2014, the patient was vaccinated with a dose of (Oka/Merck) VARIVAX lot # J012210, expiry 28-SEP-2015 ("VFC" stock), 0.5 ml, once, intramuscular. The medical assistant stated there was a power outage on 12-APR-2014 and the (Oka/Merck) VARIVAX doses from the freezer needed to be transported to unspecified hospital for proper storage. She stated (Oka/Merck) VARIVAX was exposed to 46F for 1 hour, at worst. There were no prior excursions. There was a site visit from local health department on an unspecified date. No adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
Heart palpitations & chest heaviness in breathing for about 15 to 30 minutes right after the shot but subsided & went away after drinking a small bottled water  drank after the shot.
Narrative: Pt presented to ED at 23:20 on 7/23/2022 with c/o shortness of breath x2 days, hiccups all day, and "just feels bad." Pt notes increased cough and SOB; increased dry cough for almost a week. Pt tested COVID positive 7/24/22 and admitted to hospital from 7/24 to 7/29 with primary diagnosis of "acute COVID-19 infection." is a 74 yo gentleman with stage IIIb/IV CKD, Chronic CHF due to systolic dysfunction EF 20-25%, COPD, who presented on 7/24/22 with shortness of breath and dry cough, patient found to be positive for covid 19 (s/p vaccination x2, booster x1 1/2022). The patient was admitted to the medical floor on airborne precautions. He was started on decadron, but was not a candidate for remdesivir given GFR 28-30. The perfusion portion of V/Q scan was negative for perfusion defects. The patient improved clinically, he has been advised to get a COVID booster in 3-4 weeks.
About 7 hours after injection -- arm & shoulder area began to ache.  By evening arm, shoulder and neck were very sore.  All muscles and joints felt achy all over my body -- waking me up Friday night and keeping me feeling very achy and tired and ill all day Saturday.  Relief came with single aspirins taken 3 times periodically to address symptoms as they re-emerged.  Sunday morning I woke up with achiness gone and only slight itching & soreness at injection site .
Dizziness Fever Full body shakes  Chills Exhaustion Migraine  Sweats
Since getting the first vaccine injection I have had significant hair loss over the past year and half. At one point it seemed to be growing back but after getting the third vaccine it started to fall out rapidly again.
After giving the shot the patient developed hives on face and arms and began to cough. Mother returned to the pharmacy where the pharmacist inject IM diphenahydramine 50mg/ml IM into right arm. Dose given was 0.5ml or 25mg (westward brand Lot #117340 exp 11/19) Pharmacist monitored vital signs every 10 minutes while the medication took effect. EPIPEN was available in case of worsening condition but was not needed. After 20 minutes the hives were gone and the patient was not experiencing any other adverse effects other than being tired. Patient on mother left pharmacy and was told to take diphenahydramine as needed and if any worsening condition to go to emergency room. Called mother on 10/28/18 at 10:00am to see how patient was doing and she stated that other than being tired from the diphenahydramine there were no additional adverse reactions.