chrisvoncsefalvay/vaers-outcomes huggingface dataset:
By nighttime on 10/25, I had a golf ball size welt on my left bicep and I could not raise my arm, almost at all.  For 4 days, I experienced a headache, pain at injection site with swelling, fatigue and a slight fever.  Symptoms have progressed to the point they are at now with swollen joints, joint pain, fatigue, occasional brain fog and the feeling like ants are crawling on the back of my skull, like a gurgling sensation in the same location.  Pain is worse on my right side .... hip, knee and ankle and L5 S1 back surgery location with my knee pain being the worst to the point on some days, I do not feel like getting out of bed and my leg will buckle when trying to put put weight on it.
I've been tired, achy, no appetite, weird prickly sensation on skin. I have felt sick for over a week. I'm slightly better each day.
A physician reported that a 24 month old male received an injection of Prevnar on 1/26/01. Approx. 4 to 6 hours later, the child developed hypotension, stridor, retraction in all lung fields, delayed capillary refill and "severe" depression in breathing. The physician described this as an anaphylactic reaction. The child was seen in an ER. He was treated with fluids, Decadron and Benadryl. The child was hospitalized and discharged the next day. Anaphylactic reaction is considered "Medically Important".
pancreatic cancer diagnosis; This spontaneous case was reported by a consumer and describes the occurrence of PANCREATIC CARCINOMA (pancreatic cancer diagnosis) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 041L20A and 013M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PANCREATIC CARCINOMA (pancreatic cancer diagnosis) (seriousness criterion medically significant). At the time of the report, PANCREATIC CARCINOMA (pancreatic cancer diagnosis) outcome was unknown.            Concomitant product use was not provided by the reporter.  Patient started taking the chemotherapy on 16Mar2021 for the event pancreatic cancer diagnosis.; Sender's Comments: Very limited information regarding this event has been provided at this time.  Further information is not suspected. Based on reporter's causality the event "Pancreatic cancer" is assessed as unlikely related to mRNA-1273.
each time, only had sore spot to touch; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An elderly female patient received bnt162b2 (BNT162B2), on 19Mar2021 as dose 2, single (Lot number: EN6206) at the age of 70 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: bnt162b2 (First dose, Lot. EN6200), administration date: 26Feb2021, when the patient was 70-year-old, for COVID-19 immunization, reaction(s): "each time, only had sore spot to touch". The following information was reported: PAIN (non-serious), outcome "unknown", described as "each time, only had sore spot to touch". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Each time, only had sore spot to touch and negative COVID-19 test (PCR) after the vaccinations.
pt recv vax 9SEP98 & 11SEP98 lt deltoid area from shoulder & elbow swollen 7 warm;blisters (small patch) seen about 2" under inj site;pt referred to MD:
approx 1yr p/vax pt devel fever 103. MD found pt had a classic case of chickenpox
mild temperature; felt lethargic; her arm is swollen and painful; her arm is swollen and painful/ pain in legs; heart was beating too fast/can feel her heart beating; her hands were shaking; pins and needles in her legs; numbness in hands/fingers; heaviness in arms hands and fingers; small rash; muscle aches; No strength; could not get out of bed; This is a spontaneous report from a contactable consumer (patient) via Pfizer sponsored program.   A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and expiration date were not reported), via an unspecified route of administration on 01Apr2021 as dose 1, single for covid-19 immunization. The patient's medical history included tested positive in Jun/Jul, mild diarrhea and pain in abdomen and legs. Concomitant medications were not reported. On an unknown date, the patient experienced mild temperature, felt lethargic, could not get out of bed, her arm was swollen and painful, heart was beating too fast/could feel her heart beating, hands were shaking, pins and needles in her legs, numbness in hands/fingers, heaviness in arms hands and fingers, small rash, muscle aches, and no strength. She stated she had been a bad experience/reaction to the vaccine. She spoke to her doctor today, who told her not to take second shot. The patient underwent lab tests and procedures which included body temperature: abnormal on an unknown date. The outcome of all the events was unknown.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained. No further information is expected.
Patient thought she was receiving the booster dose of the Pfizer covid-19 vaccine. The flu vaccine (Fluarix) was administered by mistake. No adverse side effects were reported. Patient stated she already received the flu vaccine this year.
This spontaneous report as received from a pharmacist refers to an unspecified number of patients of unknown age and gender. No information on patients' medical history or concurrent conditions was provided. On an unknown dates, the patients were vaccinated with the doses of improperly stored MMR II injection, lot # K00614, expiration date 29-APR-2016 (dose and route of administration were not reported). No information on patients' concomitant medication was provided. No adverse effects were reported. This is one of the several reports from the same reporter. Additional information has been requested.
Redness, soreness at injection site 3 cm deep erythematous area w/ a 6 cm lighter erythematous area left upper arm, warmth & tenderness, no weeping or palsations. Rx with: Azithromax Loratadine Hydroxyzine.
rash on her ribcage; shivers / chills; headache; feeling tired; redness/ (at the injection site); little rash on the right arm (at the injection site); This case was reported by a consumer and described the occurrence of shivers in a 69-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (prior outbreak of shingles near her eye (last September)). Previously administered products included zostavax and shingrix with an associated reaction of injection site pain (refer the case US2020229492).   On 17th November 2020, the patient received the 2nd dose of Shingrix. On 17th November 2020, less than a day after receiving Shingrix, the patient experienced shivers, headache, tiredness, injection site erythema and injection site rash. On 18th November 2020, the patient experienced rash. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the shivers, headache and tiredness were recovered/resolved and the outcome of the injection site erythema, injection site rash and rash were not recovered/not resolved.   The reporter considered the shivers, headache, tiredness, injection site erythema and injection site rash to be related to Shingrix. It was unknown if the reporter considered the rash to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported After receiving the 2nd dose of Shingrix the patient experienced shivers, chills, headache, feeling tired. These events were "horrible" but they have since resolved. The patient experienced redness or little rash on the right arm (at the injection site) which has not yet resolved. On 18th November 2020 she noticed that she had a rash on her ribcage. The ribcage rash is better at the time of report (it is not painful nor does it itch) but it has not resolved. This case has been linked with case US2020229492, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020229492:same patient (1st dose
Raised, red rash on bilateral flank areas and buttocks with itching. Also patch on R upper arm. Also have noticed behavioral changes including sudden onset of various fears ever since dose 1 of nasal mist given on 10/31/09.
The rash at site of injection was about 5 inches top to bottom; This case was reported by a nurse via sales rep and described the occurrence of injection site rash in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced injection site rash. On an unknown date, the outcome of the injection site rash was unknown.   It was unknown if the reporter considered the injection site rash to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported but was between 50 to 60 years. The patient experienced a very large rash in 2 areas on the arm where injection was given. The patient experienced injection site rash about 5 inches top to bottom and 2nd lower rash was about half dollar size. This case is 1 of the 2 linked cases, reported by the same reporter.
It was reported that a pt rec'd Tetanus Toxoid absorbed vaccination on 11/16/00. Approx 10 days after the vaccination the pt developed urticaria over her entire body and was hospitalized twice. No details were provided. Further information is requested.
This case was reported by a consumer via call center representative and described the occurrence of influenza in a 84-year-old patient who received FLUARIX. The patient's past medical history included influenza. Concurrent medical conditions included pain. Concomitant products included LOVAZA, Losartan, Vitamin B12, biotin, NASONEX, Calcium Carbonate + Vitamin D, clonidine, furosemide, levothyroxine, simvastatin and spironolactone. On an unknown date, the patient received FLUARIX at an unknown dose. On an unknown date, an unknown time after receiving FLUARIX, LOVAZA and Losartan, the patient experienced influenza (serious criteria hospitalization), blood pressure high (serious criteria hospitalization), aphasia (serious criteria hospitalization) and extra dose administered. On an unknown date, the outcome of the influenza, blood pressure high and aphasia were recovered/resolved and the outcome of the extra dose administered was unknown. It was unknown if the reporter considered the influenza, blood pressure high and aphasia to be related to FLUARIX. Additional information: The patient only got one very mild case of the flu (since she started medication with LOVAZA). She used to get flu twice a year and would be in the hospital for weeks. One year she got a double dose of FLUARIX and ended up in the hospital with very high blood pressure and she couldn't talk. Please refer to case US2015028273 for tolerance to co-suspect drugs LOVAZA and Losartan.
4 hours post-vaccine, started to shiver 6 hours post-vaccine spiked fever of 102.2 7 hours post-vaccine developed headache and began to vomit 8 hours post-vaccine, I went to the ER They found I had tachycardia for the duration of my visit (11pm - 3 am). Administered Toradol and IV fluids, discharged me with good vitals, but still tachycardia, headache, and vomiting. The next day (3/20), I still had a bad headache and could  not keep liquids down. I vomited perhaps 12 times, then called the doctor. She sent me to Urgent Care to receive injections of Toradol and Phenergan. Within the hour, I  could drink. Then shortly after, I  could eat. I  felt better for one day. The next day (3/22), my heart started pounding, and I was unable to sleep horizontally. I  needed to sleep on 3 pillows due to chest discomfort. My chest still feels very uncomfortable. Abdominal breathing is helping to an extent. I have had to stay in bed and greatly reduce my activities since receiving the vaccine.  Today is one week, and I am still in bed.
9 days after injection developed injection site reaction of redness, swelling, itching, warm to touch along with mild rash on bilateral lower extremities.
Tinnitus Both ears, but more in the left.  The condition has improved a lot sense it began.  It is now milder and less frequent.  I have days with it and days without it.  It is very random.
increased heart rate; breathing difficulty; This is a spontaneous report from a contactable consumer. An 82-year-old male patient received first dose of BNT162B2(lot number=EK5730), via an unspecified route of administration on 15Jan2021 13:45 at single dose, left arm for covid-19 immunization. Medical history included partial obstruction in coronary artery, arthritis, allergies to pregabalin (LYRICA), levofloxacin (LEVAQUIN). Concomitant medication included cortisone. The patient experienced increased heart rate and breathing difficulty on 15Jan2021 13:45 with outcome of recovered in Jan2021. The events were non-serious. No treatment received for the adverse event. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.
He had COVID disease 1 week ago; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (He had COVID disease 1 week ago) in an adult male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In November 2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In January 2023, the patient experienced COVID-19 (He had COVID disease 1 week ago). At the time of the report, COVID-19 (He had COVID disease 1 week ago) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant information was reported. Patient had COVID disease 1 week ago (14 months after the last shot).  Patient had an appointment last week to receive the Bivalent shot, but patient was canceled it. No treatment information was reported.   Reporter did not allow further contact
Developed eye pain that turned into a sty in lower left eyelid. Sty burst 7 days later. Cycle started the day after eye symptom; heavier and spotted for three day after cycle normal 5 days. Canker sore in mouth 11/7/2021.  Started cycle again two weeks early 11/8/2021, second dose same day but after the cycle started.
PATIENT CAME TO  PHARMACY  LOOKIN G FOR A SHINGLES (SHINGRIX) VACCINE BUT RECEIVED A DOSE OF PFIZER/BIONTECH COVID VACCINE INSTEAD.  THE ADDITIONAL DOSE MEANS PATIENT HAS RECEIVED 4 DOSES OF COVID VACCINE.  PATIENT HAS NOT REPORTED ANY ADVERSE EFFECTS AS OF THE DATE OF THIS REPORT.
Fever, headache, mild hallucination and agitation triggering general anxiety and discomfort. Lingering headaches, myalgia, and exhaustion for the following week.
Patient felt dizzy after receiving flu shot; patient was guided to the floor and was put in supine position. Patient did not lose consciousness and was not hurt in the process. Patient returned to baseline after 30 minutes of observation.
11:05am Aunt escorted her in to HS clinic after receiving 5 vaccs (HepB, IPV, influenza, MMR, & Tdap).  Hives on face, itching. No other symptoms. T 97.5 P92 reg, BP 118/80. Called Clinic to inform.  Recommend to Aunt to call her HCP (on catch-up schedule: ck if she should go for next round of shots in July). Aunt plans to give her Benadryl & Tylenol & will monitor. Instructed to take her to urgent care if develops any probs with breathing, swelling, etc.  Aunt verbalizes understanding.  Student left ambulatory with aunt. Next day 5/18/11 student returned to school, no other probs.
Received vaccine at 1:08 PM. At approximately 1:30 PM participant came back to training room wanting to know if it was normal to feel like her throat was tight and tongue swollen. The nurse told her no that it was not normal and that the nurse would need to administer an epinephrine injection. Participant was conscious, alert and oriented. Appeared anxious, face red splotchy. Nurse sat participant down and administered epinephrine 1:1000 0.3mL SQ Right Upper Arm. EMS called. Pulse 84. Respirations 28. Skin warm and dry.  Transported by EMS to ER. Per EMS O2 98% Room Air, BP 150/90. Patient states feeling better on EMS departure.
Patient was given his Afluria vaccine on our office at Primary Care. He asked for a prescription for a Pneumovax to take to the pharmacy. He took that prescription to Pharmacy. While there the pharmacist working gave him - Pneumovax, Zoster, Tdap and Hep A per staff at the pharmacy. Patient called Primary care Complaining of body aches and pains and shortness of breath. We sent him to the ED Department at Hospital and contacted Pharmacy regarding the reaction. They stated they would follow up on it.
a dose of Ipol was given to a patient that had expired/no AE; Initial information received on 28-May-2020 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 14 years old male patient who on 27-May-2020, received an expired 0.5 mL second single dose of vaccine IPV (VERO) [IPOL] (lot P1A371m and expiry date 27-Apr-2020) via intramuscular route in the right deltoid for prophylactic vaccination (expired vaccine administered).  The patient's medical history, past medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HEPATITIS B VACCINE (HEPATITIS B VACCINE) and HPV VACCINE (HPV VACCINE).  It was an actual medication error case due to expired vaccine used.  At the time of report, no adverse effects had been observed.   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.
Shoulder pain at injection site that resolved over 48 hrs; mild chills and fatigue that resolved within 24 hrs.
This spontaneous report as received from a Licensed Practical Nurse refers to 6 unspecified patients of unknown age. Nurse reported that on 13-AUG-2014, the 6 unspecified patients inadvertently received expired dose of MMR II (lot# H014648, expiration date 03-AUG-2014). No adverse effect reported. Additional information has been requested.
Vaccine Admin. 5/22 at 10:00 AM. 11:00 AM, reports weakness, lightheadedness, headache. 13:00 PM-headache-went home from work-Excedrin at 10:30 AM. 18:00 PM-fever 100.4, Motrin. 23:00 PM, fever 99.6-Bodyaches-Skelaxin 800mg. 5/23/06, fever 100.4 down to 98.2 with Motrin. 5/24/06=Persistent body aches, lightheadedness.
Approx 5-6 hours after vaccination she felt an itchy throat and broke out in hives on chest and legs. She took benadryl and this resolved. Approx 24 hours later she started with sore throat and cough and mild SOB.
Following vaccine inventory, it was discovered patient was given (1) dose of varicella antigen in addition to (1) dose of PROQUAD (instead of (1) dose of varicella and (1) dose of MMR). Thus, patient was likely given double dose of Varicella. We contacted CDC and the incident was reported to patient's father. Follow up appointment scheduled with patient.
Information has been received from a physician concerning a 9 weeks old female, with no medical history, who on 08-MAY-2007, at 12:30 p.m., was vaccinated with a first oral dose of Rotateq (Lot# 656385/0030U). The same day the patient received other vaccines as well as getting her ears pierced. Concomitant vaccines administered at the same time included a first dose in the left thigh of TRIPEDIA (Lot# C2628AA), a first dose in the right thigh of COMVAX (Lot# 655548/1243F) and a first dose in the left thigh of IPOL. There was no illness at the time of vaccination. It was noted that after getting her ears pierced the physician put lidocaine/prilocaine (EMLA) cream which had warnings of having the side effect of redness and rash. At 3:00 p.m., on 08-MAY-2007 the patient developed a rash that started on her face and front. It was reported that by midnight the patient's parents called the physician because the rash had gotten really bad. Then by 12:01 a.m. the patient went to the emergency room. At the emergency room the patient was given prednisolone sodium phosphate (ORAPRED). The physician saw the patient again on 10-MAY-2007 and 11-MAY-2007, but the rash was still very bad. It was noted that there was no fever and no wheezing. Subsequently, the patient recovered. No product quality complaint was involved. No other information was provided. Additional information has been requested.
Temperature of 104.5 / Severe pain in lower back. Severe sweating.  Swelling of joints. Loss of appetite. No energy. Lower coccyx pain and in hip joints, ear canals and diaphram.
About 8hrs post injection: joint pain, chills, body aches, fatigue, temp 99.4 About 12 hours post injection: severe headache, worsening of above symptoms, temp 102.0 About 30 hours post injection: above symptoms continued and temp 103.5 About 48 hours post injection: reduction in symptom severity but all symptoms still present, temp 100.7
Sore arms after the first dose; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "Sore arms after the first dose".  Additional information: Patient was due to get her second dose of Pfizer Covid-19 vaccine tomorrow (23Apr2021) but she wanted to know if the first and second dose of the Pfizer Covid-19 vaccine has the same efficacy and what are the side effects of the vaccine.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.